Graphite Bio Inc Aktienkurs
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📘 Marktkapitalisierung
📈 Was ist das?
Die Marktkapitalisierung zeigt, wie viel ein Unternehmen laut Börse aktuell wert ist.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Sie hilft Unternehmen in Größenklassen (Large, Mid, Small Cap) einzuordnen und gibt Hinweise auf Marktmacht und Stabilität.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Große Unternehmen gelten als stabiler, zahlen oft Dividenden, wachsen aber langsamer.
- Kleine Firmen können stärker wachsen, sind aber schwankungsanfälliger.
- Die Marktkapitalisierung ist ein guter Indikator für Unternehmensgröße, aber kein Maß für Unter- oder Überbewertung.
📘 Enterprise Value (Unternehmenswert)
📈 Was ist das?
Der Enterprise Value (EV) zeigt, was ein Unternehmen tatsächlich kostet, wenn man es komplett übernehmen würde – inklusive Schulden und abzüglich Cash.
🧮 Wie wird es berechnet?
(= Marktkapitalisierung + Nettoverschuldung)
🏛️ Wofür ist es wichtig?
Der EV ist eine realistischere Bewertungsbasis als die Marktkapitalisierung, da er die Kapitalstruktur berücksichtigt. Er ist Grundlage für Kennzahlen wie EV/FCF oder EV/Sales.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Der Enterprise Value zeigt, was ein Unternehmen tatsächlich wert ist – unabhängig davon, wie es finanziert ist.
- Er ist besonders wichtig für professionelle Investoren, da er eine objektivere Grundlage für Bewertungsvergleiche bietet als die Marktkapitalisierung allein.
- Ein Unternehmen mit hoher Verschuldung erscheint im EV teurer, eines mit viel Cash günstiger – auch wenn sie an der Börse gleich viel wert sind.
📘 Nettoverschuldung
📈 Was ist das?
Die Nettoverschuldung zeigt, wie viele Schulden nach Abzug des verfügbaren Cashs tatsächlich verbleiben.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Sie zeigt, wie stark ein Unternehmen von Fremdkapital abhängig ist – und wie gut es in der Lage ist, seine Schulden kurzfristig zu bedienen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine niedrige oder negative Nettoverschuldung bedeutet hohe finanzielle Stabilität.
- Unternehmen mit viel Cash und geringer Verschuldung sind besser gerüstet für Krisen.
- Eine hohe Nettoverschuldung erhöht das Risiko – besonders bei steigenden Zinsen oder konjunkturellen Schwächen.
📘 Cash
📈 Was ist das?
Der Cashbestand zeigt, wie viele liquide Mittel einem Unternehmen sofort zur Verfügung stehen.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Er gibt Auskunft über die finanzielle Flexibilität: Ein hoher Cashbestand ermöglicht Investitionen, Rückkäufe oder Krisenresistenz.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hoher Cashbestand zeigt finanzielle Stärke und Handlungsspielraum.
- Cash kann für Investitionen, Schuldentilgung oder Aktienrückkäufe genutzt werden.
- Allerdings: Zu viel ungenutztes Kapital kann auch auf mangelnde Investitionsideen hinweisen.
📘 Anzahl ausstehender Aktien
📈 Was ist das?
Die Anzahl ausstehender Aktien gibt an, wie viele Aktien eines Unternehmens aktuell im Umlauf sind und von Investoren gehalten werden.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Sie ist die Grundlage für viele Kennzahlen wie Gewinn je Aktie (EPS), Marktkapitalisierung oder KGV.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Je weniger Aktien im Umlauf sind, desto höher fällt z. B. der Gewinn je Aktie aus – wichtig für Bewertung und Dividendenrendite.
- Aktienrückkäufe verringern die Anzahl ausstehender Aktien – und steigern den Wert je Aktie.
- Kapitalerhöhungen haben den gegenteiligen Effekt: mehr Aktien → Verwässerung der bestehenden Anteile.
📘 Kurs-Gewinn-Verhältnis (KGV)
📈 Was ist das?
Das KGV zeigt, wie oft der Gewinn pro Aktie im aktuellen Aktienkurs enthalten ist – also wie „teuer“ eine Aktie im Verhältnis zum Gewinn ist.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Das KGV gehört zu den bekanntesten Bewertungskennzahlen. Es hilft Anlegern einzuschätzen, ob eine Aktie im Vergleich zu ihrem Gewinn eher günstig oder teuer erscheint.
🧮 Berechnung
📊 KGV (TTM) = bezogen auf den Gewinn der letzten 12 Monate (Trailing Twelve Months):🎯 Was bedeutet das für Anleger?
- Ein niedriges KGV kann auf eine günstige Bewertung hindeuten – oder auf Probleme im Geschäftsmodell.
- Ein hohes KGV kann Wachstumserwartungen widerspiegeln – oder eine überbewertete Aktie.
📘 Kurs-Umsatz-Verhältnis (KUV)
📈 Was ist das?
Das KUV zeigt, wie viel Anleger für 1 € Umsatz eines Unternehmens zahlen – unabhängig vom Gewinn.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Das KUV ist besonders bei wachstumsstarken oder noch nicht profitablen Unternehmen hilfreich. Es zeigt, wie hoch der Umsatz an der Börse bewertet wird.
🧮 Berechnung
Marktkapitalisierung = 184,68 Mio. $ | Umsatz (TTM) = 20,99 Mio. $
Marktkapitalisierung = 184,68 Mio. $ | Umsatz erwartet = 19,42 Mio. $
🎯 Was bedeutet das für Anleger?
- Ein niedriges KUV kann auf Unterbewertung hindeuten – oder auf schwache Margen.
- Ein hohes KUV kann hohe Erwartungen widerspiegeln – oder übermäßigen Optimismus.
- Besonders sinnvoll bei Wachstumsunternehmen, bei denen der Gewinn oder Free Cashflow (noch) keine Aussagekraft hat.
📘 Unternehmenswert zu Umsatz (EV/Sales)
📈 Was ist das?
EV/Sales zeigt, wie viel Anleger für 1 € Umsatz eines Unternehmens zahlen, wenn man auch Schulden und Cash berücksichtigt – es ist eine kapitalstrukturbereinigte Version des KUV.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Diese Kennzahl eignet sich besonders für den Vergleich von Unternehmen mit unterschiedlicher Verschuldung – sie zeigt, wie teuer ein Unternehmen tatsächlich im Verhältnis zum Umsatz ist.
🧮 Berechnung
Enterprise Value = -73,71 Mio. $ | Umsatz (TTM) = 20,99 Mio. $
Enterprise Value = -73,71 Mio. $ | Umsatz erwartet = 19,42 Mio. $
🎯 Was bedeutet das für Anleger?
- EV/Sales ist neutral gegenüber der Kapitalstruktur und eignet sich gut für Unternehmensvergleiche.
- Ein niedriges Verhältnis kann auf eine günstig bewertete Aktie hindeuten – ein hohes Verhältnis auf hohe Erwartungen oder Überbewertung.
- Besonders nützlich bei wachstumsstarken, noch nicht profitablen Firmen.
📘 Unternehmenswert zu Free Cashflow (EV/FCF)
📈 Was ist das?
EV/FCF zeigt, wie viele Jahre es dauern würde, bis ein Unternehmen seinen Unternehmenswert durch freien Cashflow „zurückverdient”.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Diese Kennzahl hilft, Unternehmen auf Basis ihrer tatsächlichen Cash-Erträge zu bewerten – unabhängig von Bilanzierungsregeln oder buchhalterischem Gewinn.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein niedriges EV/FCF deutet auf eine günstige Bewertung bei starker Cashgenerierung hin.
- Ein hohes EV/FCF kann entweder auf Optimismus oder auf temporär schwachen Cashflow hindeuten.
- Besonders hilfreich bei reifen, profitablen Unternehmen mit stabilen Cashflows.
📘 Kurs-Buchwert-Verhältnis (KBV)
📈 Was ist das?
Das KBV zeigt, wie hoch der Marktwert eines Unternehmens im Verhältnis zu seinem bilanziellen Eigenkapital ist.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Das KBV ist besonders bei Substanzwerten (z. B. Banken, Industrie) relevant. Es hilft Anlegern zu erkennen, ob ein Unternehmen unter oder über seinem buchhalterischen Vermögen bewertet ist.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein KBV unter 1 kann auf Unterbewertung oder schwache Rentabilität hindeuten.
- Ein KBV über 1 zeigt, dass der Markt dem Unternehmen Mehrwert über den Buchwert hinaus zuschreibt (z. B. Marken, Patente, Wachstum).
- Das KBV eignet sich besonders gut für Unternehmen mit stabilen, materiellen Vermögenswerten.
📘 Dividende je Aktie
📈 Was ist das?
Die Dividende je Aktie zeigt, wie viel Geld ein Unternehmen pro Aktie an seine Aktionäre ausschüttet – typischerweise jährlich oder quartalsweise.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Sie ist die absolute Größe der Auszahlung je Aktie – wichtig für alle, die regelmäßige Erträge suchen oder Dividendenstrategien verfolgen.
🎯 Was bedeutet das für Anleger?
- Eine stabile oder wachsende Dividende je Aktie ist oft ein Zeichen für ein solides Geschäftsmodell.
- Die Dividende je Aktie allein sagt aber nichts über die Rendite – dafür ist auch der Aktienkurs relevant (→ Dividendenrendite).
- Langfristig steigende Dividenden sind oft ein sehr gutes Merkmal (z. B. Dividenden-Aristokraten).
📘 Dividendenrendite
📈 Was ist das?
Die Dividendenrendite zeigt, wie hoch die Dividende eines Unternehmens im Verhältnis zum Aktienkurs ist.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Sie hilft dabei, Dividendenaktien vergleichbar zu machen – unabhängig vom absoluten Auszahlungsbetrag.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine stabile Dividendenrendite kann auf verlässliche Ausschüttungen hinweisen.
- Ein Vergleich der 1J- und 5J-Rendite hilft zu erkennen, ob das Dividendenwachstum mit dem Kurswachstum Schritt hält.
- Eine niedrige Rendite ist nicht zwingend negativ – sie kann auf starkes Kurswachstum hindeuten.
📘 Dividendenwachstum
📈 Was ist das?
Das Dividendenwachstum zeigt, wie stark ein Unternehmen seine Dividende je Aktie über die Zeit gesteigert hat.
🧮 Wie wird es berechnet?
5J: durchschnittliche jährliche Wachstumsrate (CAGR)
🏛️ Wofür ist es wichtig?
Stetig steigende Dividenden gelten als Zeichen für finanzielle Stärke und Aktionärsorientierung – besonders interessant für langfristige Investoren.
🎯 Was bedeutet das für Anleger?
- Ein stabiles Dividendenwachstum ist ein Zeichen nachhaltiger Ertragskraft.
- Ein hohes Dividendenwachstum kann ein erheblicher Hebel deiner Rendite sein:
- Wenn ein Unternehmen z. B. 1 € Dividende zahlt und diese über 5 Jahre jährlich um 15 % erhöht, bekommst du im 5. Jahr bereits 2 € je Aktie – doppelt so viel wie zu Beginn!
📘 Ausschüttungsquote (Payout)
📈 Was ist das?
Die Ausschüttungsquote zeigt, wie viel Prozent des Unternehmensgewinns (pro Aktie) als Dividende an die Aktionäre ausgeschüttet wird.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Die Quote hilft einzuschätzen, ob eine Dividende auf Dauer tragfähig ist – besonders im Verhältnis zum erzielten Gewinn.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine niedrige Ausschüttungsquote bedeutet: Das Unternehmen behält einen größeren Teil des Gewinns für Investitionen – typisch für Wachstumsunternehmen.
- Eine moderate Quote (z. B. 25–50 %) steht oft für ein gesundes Gleichgewicht zwischen Ausschüttung und Zukunftsinvestitionen.
- Hohe Ausschüttungsquoten können attraktiv wirken, sind aber riskanter, wenn die Gewinne schwanken oder sinken.
📘 Dividendensteigerungen in Folge (Erhöhungen)
📈 Was ist das?
Diese Kennzahl zeigt, wie viele Jahre in Folge ein Unternehmen seine Dividende pro Aktie erhöht hat – ohne Kürzung oder Aussetzung.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Ein langer Track Record kontinuierlicher Erhöhungen spricht für Verlässlichkeit, solide Finanzen und aktionärsfreundliche Unternehmenspolitik.
🎯 Was bedeutet das für Anleger?
- Ein langer Zeitraum mit Dividendensteigerungen stärkt das Vertrauen – besonders in Krisenzeiten.
- Solche Unternehmen gelten als verlässlich und planbar für Einkommensinvestoren.
- Je länger die Serie, desto stärker das Commitment gegenüber den Aktionären.
📘 Umsatz
📈 Was ist das?
Der Umsatz zeigt, wie viel ein Unternehmen insgesamt mit seinen Produkten und Dienstleistungen verdient – also den Bruttoerlös vor Abzug von Kosten.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Der Umsatz ist eine der zentralen Kennzahlen zur Einschätzung der Unternehmensgröße, Marktstellung und Wachstumskraft.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein wachsender Umsatz zeigt eine steigende Nachfrage und kann ein guter Frühindikator für Gewinnsteigerungen sein.
- Vergleiche von aktuellem und erwartetem Umsatz geben Hinweise auf das Marktumfeld und Analystenerwartungen.
- Wichtig: Starker Umsatz allein genügt nicht – auch Margen und Profitabilität zählen.
📘 EBITDA
📈 Was ist das?
EBITDA steht für „Earnings Before Interest, Taxes, Depreciation and Amortization“ – also Gewinn vor Zinsen, Steuern und Abschreibungen. Es zeigt das operative Ergebnis eines Unternehmens, bereinigt um bilanztechnische und finanzierungsbedingte Effekte.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
EBITDA ist eine verbreitete Kennzahl zur Beurteilung der operativen Leistungsfähigkeit – insbesondere bei kapitalintensiven Unternehmen oder im internationalen Vergleich.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hohes oder wachsendes EBITDA spricht für starke operative Erträge – unabhängig von Bilanzierung oder Steuerlast.
- EBITDA ist besonders nützlich, um Unternehmen branchenübergreifend zu vergleichen.
- Wichtig: EBITDA ist keine offizielle Gewinnkennzahl – Abschreibungen und Finanzierungskosten werden ausgeklammert.
📘 EBIT
📈 Was ist das?
EBIT steht für „Earnings Before Interest and Taxes“ – also Gewinn vor Zinsen und Steuern. Es zeigt das operative Ergebnis eines Unternehmens nach Abschreibungen, aber vor Finanzierungs- und Steueraufwand.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
EBIT ist eine zentrale Kennzahl zur Beurteilung der Profitabilität aus dem Kerngeschäft – unabhängig von Kapitalstruktur oder Steuersystem.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hohes EBIT deutet auf ein profitables Kerngeschäft hin – vor Zinslasten oder steuerlichen Effekten.
- Es erlaubt objektivere Vergleiche zwischen Unternehmen mit unterschiedlicher Finanzierung.
- Im Vergleich mit EBITDA zeigt EBIT bereits den Einfluss von Abschreibungen auf das operative Ergebnis.
📘 Nettogewinn
📈 Was ist das?
Der Nettogewinn ist der verbleibende Jahresüberschuss (oder -fehlbetrag) eines Unternehmens – nach Abzug aller Kosten, Steuern, Zinsen und Abschreibungen
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Der Nettogewinn ist die zentrale Erfolgskennzahl – er zeigt, wie profitabel ein Unternehmen nach allen Kosten tatsächlich arbeitet.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein steigender Nettogewinn zeigt, dass das Unternehmen effizient wirtschaftet – trotz aller Kosten.
- Die Entwicklung des Gewinns beeinflusst z. B. direkt das KGV und weitere Kennzahlen.
- Im Zeitverlauf lässt sich ablesen, wie stabil und profitabel ein Geschäftsmodell wirklich ist.
📘 Free Cashflow (FCF)
📈 Was ist das?
Der Free Cashflow gibt Aufschluss über die echte finanzielle Stärke eines Unternehmens – unabhängig von Bilanzierungsregeln. Er zeigt, wie viel Spielraum für Dividenden, Aktienrückkäufe oder Schuldenabbau besteht.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
FCF reflects a company’s real financial strength – regardless of accounting profits. It shows how much flexibility a company has for dividends, share buybacks, or debt reduction.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hoher Free Cashflow bedeutet, dass ein Unternehmen echte Finanzkraft besitzt – unabhängig vom bilanzierten Gewinn.
- Er ist oft die solideste Grundlage für nachhaltige Dividenden und Aktienrückkäufe.
- Sinkender FCF kann ein Warnsignal sein – auch wenn der Gewinn stabil aussieht.
📘 Umsatzwachstum
📈 Was ist das?
Das Umsatzwachstum zeigt, wie stark sich die Erlöse eines Unternehmens im Vergleich zum Vorjahr verändert haben – tatsächlich (TTM) und auf Prognosebasis (erwartet).
🧮 Wie wird es berechnet?
Erwartet = (Umsatz erwartet ÷ Umsatz Vorjahr − 1) × 100
Erwartetes Wachstum basiert auf Analystenschätzungen für das laufende Geschäftsjahr.
🏛️ Wofür ist es wichtig?
Ein wachsender Umsatz ist ein zentrales Signal für steigende Nachfrage, Geschäftsausweitung und Marktanteilsgewinne – besonders bei Wachstumsunternehmen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Wachstum ist der Motor langfristiger Wertsteigerung – besonders bei Technologie- und Wachstumsaktien.
- Wichtig ist nicht nur das aktuelle Wachstum, sondern auch dessen Nachhaltigkeit.
- Prognosen zeigen, ob Analysten weiteres Potenzial erwarten – oder eine Verlangsamung.
📘 EBITDA-Wachstum
📈 Was ist das?
Das EBITDA-Wachstum zeigt, wie stark das operative Ergebnis eines Unternehmens vor Zinsen, Steuern und Abschreibungen im Vergleich zum Vorjahr gestiegen oder gesunken ist.
🧮 Wie wird es berechnet?
Erwartet = (erwartetes EBITDA ÷ EBITDA Vorjahr − 1) × 100
Erwartetes Wachstum basiert auf Analystenschätzungen für das laufende Geschäftsjahr.
🏛️ Wofür ist es wichtig?
Ein steigendes EBITDA ist ein Zeichen für verbesserte operative Ertragskraft – unabhängig von Finanzierungsstruktur oder Abschreibungen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Starkes EBITDA-Wachstum signalisiert operative Effizienz und Skalierung – besonders relevant in Wachstumsphasen.
- EBITDA-Wachstum ist ein Frühindikator für Margen- und Gewinnentwicklung – sollte aber stets im Zusammenhang mit Umsatz und EBIT betrachtet werden.
📘 EBIT Wachstum
📈 Was ist das?
Das EBIT-Wachstum zeigt, wie stark das operative Ergebnis eines Unternehmens (nach Abschreibungen, aber vor Zinsen und Steuern) im Vergleich zum Vorjahr gewachsen ist.
🧮 Wie wird es berechnet?
Erwartet = (erwartetes EBIT ÷ EBIT Vorjahr − 1) × 100
Erwartetes Wachstum basiert auf Analystenschätzungen für das laufende Geschäftsjahr.
🏛️ Wofür ist es wichtig?
Das EBIT-Wachstum ist ein direkter Indikator für die wirtschaftliche Entwicklung des operativen Geschäfts – unter Berücksichtigung der Kapitalintensität (Abschreibungen).
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Steigendes EBIT signalisiert wachsende operative Rentabilität – auch unter Berücksichtigung von Abschreibungen.
- Das EBIT-Wachstum ist ein wichtiges Maß zur Beurteilung von Geschäftsmodellen mit hohen Investitionskosten.
- Im Zusammenspiel mit Umsatz- und EBITDA-Wachstum ergibt sich ein umfassendes Bild zur operativen Entwicklung.
📘 Nettogewinn-Wachstum
📈 Was ist das?
Das Nettogewinn-Wachstum zeigt, wie stark der Jahresüberschuss eines Unternehmens gegenüber dem Vorjahr gestiegen oder gesunken ist – sowohl tatsächlich (TTM) als auch auf Basis von Prognosen (erwartet).
🧮 Wie wird es berechnet?
Erwartet = (erwarteter Nettogewinn ÷ Nettogewinn Vorjahr − 1) × 100
Der erwartete Wert basiert auf Analystenschätzungen für das laufende Geschäftsjahr.
🏛️ Wofür ist es wichtig?
Der Gewinn ist die entscheidende Ergebnisgröße für ein Unternehmen. Ein wachsender Nettogewinn deutet auf steigende Effizienz, stabile Kostenkontrolle und nachhaltige Ertragskraft hin.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Wachsender Nettogewinn stärkt die Bewertung, Dividendenfähigkeit und Kursfantasie.
- Stagnierender oder rückläufiger Gewinn trotz Umsatzwachstum kann auf Margendruck hinweisen.
📘 Free Cashflow-Wachstum
📈 Was ist das?
Das Free-Cashflow-Wachstum zeigt, wie sich der freie Mittelzufluss eines Unternehmens im Vergleich zum Vorjahr verändert hat – also der Betrag, der nach allen operativen Ausgaben und Investitionen übrig bleibt.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Free Cashflow ist der echte, verfügbare Geldzufluss. Wachstum in diesem Bereich ist ein Zeichen für finanzielle Stärke und steigende Flexibilität bei Dividenden, Rückkäufen oder Investitionen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Sinkender Free Cashflow kann auf steigende Investitionen, höhere Kosten oder stagnierende operative Erträge hindeuten.
- Besonders bei Dividendenwerten ist das FCF-Wachstum wichtig – denn Dividenden werden letztlich aus dem verfügbaren Cash gezahlt.
- Ein negativer Trend sollte genauer analysiert werden – er ist nicht zwangsläufig schlecht, aber potenziell ein Warnsignal.
📘 Bruttomarge
📈 Was ist das?
Die Bruttomarge zeigt, wie viel vom Umsatz nach Abzug der direkten Herstellungskosten (Material, Produktion) als Bruttogewinn übrig bleibt – also der „Rohgewinn“ eines Unternehmens.
🧮 Wie wird es berechnet?
Auch: Bruttomarge = Bruttogewinn ÷ Umsatz × 100
🏛️ Wofür ist es wichtig?
Die Bruttomarge gibt Aufschluss über die Profitabilität eines Produkts oder Geschäftsmodells vor Fixkosten, Steuern und Zinsen. Sie zeigt, wie effizient ein Unternehmen produzieren oder einkaufen kann.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe Bruttomarge deutet auf starke Preissetzungsmacht und effiziente Herstellung hin.
- Sinkende Bruttomargen können auf Kostensteigerungen oder Preisdruck hindeuten.
- Besonders im Vergleich zu Wettbewerbern liefert die Bruttomarge wertvolle Einblicke in die Geschäftsqualität.
📘 EBITDA-Marge
📈 Was ist das?
Die EBITDA-Marge zeigt, wie viel vom Umsatz als operativer Gewinn vor Zinsen, Steuern und Abschreibungen (EBITDA) übrig bleibt. Sie misst die operative Effizienz – ohne Verzerrungen durch Finanzierung oder Buchwerte.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Die EBITDA-Marge hilft zu verstehen, wie viel operativer Gewinn ein Unternehmen aus jedem Euro Umsatz erzielt – unabhängig von Kapitalstruktur oder steuerlichem Umfeld.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe EBITDA-Marge zeigt starke operative Ertragskraft – unabhängig von Bilanzierungseffekten.
- Die Marge ermöglicht gute Vergleiche zwischen Unternehmen und Branchen.
- Ein stabiler oder wachsender Wert kann auf effiziente Kostenkontrolle und Skalierbarkeit hindeuten.
📘 EBIT-Marge
📈 Was ist das?
Die EBIT-Marge zeigt, wie viel Prozent des Umsatzes als operativer Gewinn nach Abschreibungen, aber vor Zinsen und Steuern übrig bleiben.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Die EBIT-Marge misst die operative Ertragskraft eines Unternehmens unter Berücksichtigung der Kapitalintensität (z. B. Maschinen, Anlagen). Sie eignet sich gut zum Vergleich von Geschäftsmodellen mit unterschiedlich hohen Abschreibungen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe EBIT-Marge zeigt, dass ein Unternehmen auch nach Abschreibungen effizient arbeitet.
- Sie ist besonders relevant in kapitalintensiven Branchen.
- Langfristig stabile oder steigende Margen sind ein Zeichen wirtschaftlicher Stärke und Preissetzungsmacht.
📘 Nettomarge
📈 Was ist das?
Die Nettomarge zeigt, wie viel vom Umsatz am Ende als „Reingewinn“ übrig bleibt – also nach Abzug aller Kosten, Zinsen, Steuern und Abschreibungen.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Die Nettomarge gibt an, wie effizient ein Unternehmen über alle Stufen hinweg wirtschaftet. Sie zeigt, wie viel Gewinn tatsächlich je Euro Umsatz übrig bleibt.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe Nettomarge zeigt, dass ein Unternehmen nicht nur operativ stark ist, sondern auch seine Finanzierung und Steuerbelastung im Griff hat.
- Vergleiche mit Wettbewerbern geben Einblicke in die wirtschaftliche Qualität.
- Sinkende Nettomargen trotz Umsatzwachstum können ein Warnsignal sein – etwa für steigende Kosten oder sinkende Effizienz.
📘 Free Cashflow Marge
📈 Was ist das?
Die Free-Cashflow-Marge zeigt, wie viel vom Umsatz nach Abzug aller operativen Ausgaben und Investitionen tatsächlich als freier Mittelzufluss übrig bleibt.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Diese Marge misst die echte Liquidität, die ein Unternehmen erwirtschaftet – unabhängig von Bilanzierungsregeln oder Abschreibungen. Sie ist besonders relevant für Dividenden, Rückkäufe und Investitionen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe Free-Cashflow-Marge zeigt, dass ein Unternehmen nachhaltig liquide Mittel erwirtschaftet.
- Sie ist ein starkes Signal für finanzielle Stabilität und Ausschüttungspotenzial.
- Wichtig ist der langfristige Trend – sinkende Werte können auf steigende Investitionen oder rückläufige operative Effizienz hindeuten.
📘 Eigenkapitalquote
📈 Was ist das?
Die Eigenkapitalquote zeigt, wie hoch der Anteil des Eigenkapitals an der Bilanzsumme eines Unternehmens ist – also wie stark es sich aus eigenen Mitteln finanziert.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Eine hohe Eigenkapitalquote steht für finanzielle Stabilität, Krisenfestigkeit und gute Bonität. Sie ist besonders relevant bei der Beurteilung der Verschuldung.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe Eigenkapitalquote signalisiert finanzielle Stabilität – besonders in Krisenzeiten.
- Ein niedriger Wert kann auf ein höheres Risiko oder eine aggressive Verschuldung hinweisen.
- Wichtig: Die Eigenkapitalquote sollte immer gemeinsam mit der Eigenkapitalrendite betrachtet werden. Nur so lässt sich beurteilen, ob ein Unternehmen nicht nur solide, sondern auch effizient wirtschaftet.
📘 Eigenkapitalrendite (ROE)
📈 Was ist das?
Die Eigenkapitalrendite zeigt, wie effizient ein Unternehmen mit dem Kapital seiner Aktionäre arbeitet – also wie viel Gewinn es pro Euro Eigenkapital erwirtschaftet.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Die Eigenkapitalrendite ist eine zentrale Rentabilitätskennzahl. Sie hilft Anlegern zu erkennen, ob das Unternehmen eine attraktive Verzinsung auf das eingesetzte Eigenkapital erwirtschaftet.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Eine hohe Eigenkapitalrendite spricht für ein starkes, effizientes Geschäftsmodell.
- Besonders interessant ist sie bei kapitalintensiven Firmen oder solchen mit hoher Eigenkapitalquote.
- Wichtig: Ein sehr hoher ROE kann auch auf hohe Schulden hinweisen – daher sollte sie immer im Kontext mit der Eigenkapitalquote betrachtet werden.
📘 Return on Capital Employed (ROCE)
📈 Was ist das?
ROCE misst die Gesamtrentabilität eines Unternehmens – also wie effizient es das eingesetzte Kapital (Eigen- und Fremdkapital) zur Gewinnerzielung nutzt.
🧮 Wie wird es berechnet?
Das eingesetzte Kapital ist das gesamte betriebsnotwendige Kapital, unabhängig von der Finanzierungsquelle.
🏛️ Wofür ist es wichtig?
ROCE eignet sich besonders gut für den Vergleich unterschiedlich finanzierter Unternehmen. Es zeigt, wie effektiv ein Unternehmen Kapital investiert – unabhängig von der Kapitalstruktur.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hoher ROCE zeigt, dass ein Unternehmen sein Kapital effizient einsetzt – unabhängig davon, ob es durch Eigen- oder Fremdkapital finanziert ist.
- Je höher der ROCE im Vergleich zu ähnlichen Unternehmen, desto mehr Wert schafft das Unternehmen mit seinem investierten Kapital.
- Besonders wichtig ist der ROCE bei Firmen mit hohen Investitionen – z. B. in Industrie, Energie oder Infrastruktur.
📘 Return on Invested Capital (ROIC)
📈 Was ist das?
ROIC zeigt, wie effizient ein Unternehmen das Kapital investiert, das langfristig im operativen Geschäft gebunden ist – unabhängig davon, ob es aus Eigen- oder Fremdkapital stammt.
🧮 Wie wird es berechnet?
- NOPAT = „Net Operating Profit After Taxes“
- Investiertes Kapital = operatives Vermögen abzüglich nicht-verzinster Schulden
🏛️ Wofür ist es wichtig?
ROIC ist eine der präzisesten Kennzahlen zur Bewertung der Kapitalrendite – besonders im Vergleich zur Eigenkapitalrendite, weil es Verzerrungen durch Schulden vermeidet. Er zeigt, ob ein Unternehmen Mehrwert für alle Kapitalgeber schafft.
🎯 Was bedeutet das für Anleger?
- Ein hoher ROIC zeigt, wie gut ein Unternehmen mit dem tatsächlich investierten (betriebsnotwendigen) Kapital wirtschaftet.
- Im Unterschied zu ROCE wird nur Kapital betrachtet, das wirklich zur Finanzierung operativer Aktivitäten dient – und verzinst werden muss.
- Besonders hilfreich, um die Kapitalrendite von Unternehmen mit viel „überschüssigem“ Kapital oder zinsfreien Verbindlichkeiten realistisch zu vergleichen.
📘 Verschuldungsgrad (Leverage Ratio)
📈 Was ist das?
Der Verschuldungsgrad zeigt, wie stark ein Unternehmen durch verzinsliche Schulden (z. B. Kredite und Anleihen) im Verhältnis zum Eigenkapital finanziert ist.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Die Kennzahl hilft, das finanzielle Risiko und die Abhängigkeit von Fremdkapital zu beurteilen. Ein hoher Verschuldungsgrad kann die Eigenkapitalrendite steigern – birgt aber auch erhöhte Risiken bei Zinsanstiegen oder Liquiditätsengpässen.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein niedriger Verschuldungsgrad steht für finanzielle Stabilität und Unabhängigkeit.
- Ein hoher Wert kann auf erhöhte Risiken hinweisen – insbesondere bei schwankenden Zinsen oder konjunkturellen Schwächen.
- Wichtig: Immer im Kontext zur Branche und Kapitalintensität bewerten.
📘 Ergebnis je Aktie (EPS)
📈 Was ist das?
Das Ergebnis je Aktie (EPS) zeigt, wie viel Gewinn auf eine einzelne Aktie entfällt – und ist eine der wichtigsten Kennzahlen zur Bewertung von Unternehmen.
🧮 Wie wird es berechnet?
Die verwässerte Aktienanzahl berücksichtigt auch potenzielle neue Aktien, etwa durch Optionen, Wandelanleihen oder andere Umtauschrechte.
🏛️ Wofür ist es wichtig?
EPS bildet die Basis für viele Bewertungskennzahlen wie KGV, PEG oder Payout Ratio. Es macht den Gewinn für Aktionäre vergleichbar – unabhängig von der Unternehmensgröße.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- EPS hilft, die Profitabilität pro Aktie zu erfassen – und ist besonders wichtig im Zeitvergleich oder im Vergleich mit Analystenschätzungen.
- Steigendes EPS kann ein Zeichen für stabiles Wachstum oder Aktienrückkäufe sein.
- Wichtig: Verwende verwässertes EPS für realistische Bewertungen – besonders bei stark aktienbasierten Vergütungssystemen.
📘 Free Cashflow je Aktie (FCF je Aktie)
📈 Was ist das?
Der Free Cashflow je Aktie zeigt, wie viel freier Mittelzufluss einem Unternehmen pro Aktie zur Verfügung steht – nach Investitionen, aber vor Dividenden oder Schuldentilgung.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Der FCF je Aktie zeigt, wie viel liquide Mittel pro Aktie tatsächlich im Unternehmen verbleiben – wichtig für Dividenden, Aktienrückkäufe oder Schuldentilgung. Im Gegensatz zum Gewinn ist er schwerer manipulierbar und daher besonders aussagekräftig.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hoher Free Cashflow je Aktie ist ein Zeichen für hohe finanzielle Flexibilität.
- Er zeigt, wie viel Kapital ein Unternehmen effektiv einsetzen oder ausschütten kann.
- Besonders relevant für dividendenstarke Unternehmen oder solche mit starker Kapitalrendite.
📘 Short Interest
📈 Was ist das?
Short Interest zeigt, wie viele Aktien eines Unternehmens aktuell leerverkauft wurden – also von Investoren geliehen und verkauft, in der Erwartung fallender Kurse.
🧮 Wie wird es berechnet?
Der Wert zeigt den Anteil der Aktien, der aktuell auf fallende Kurse spekuliert wird.
🏛️ Wofür ist es wichtig?
Short Interest dient als Stimmungsindikator: Ein hoher Wert deutet auf Skepsis oder negative Erwartungen gegenüber dem Unternehmen hin – kann aber auch zu einem „Short Squeeze“ führen, wenn der Kurs plötzlich steigt.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein niedriger Short Interest deutet auf Vertrauen in das Unternehmen hin.
- Ein hoher Wert kann ein Warnsignal sein – oder eine Chance, wenn sich die Stimmung dreht.
- Besonders spannend in volatilen Märkten oder vor wichtigen Quartalszahlen.
📘 Employees
📈 Was ist das?
Die Mitarbeiteranzahl zeigt, wie viele Personen ein Unternehmen weltweit beschäftigt – ein Indikator für Größe, Struktur und Geschäftsmodell.
🧮 Wie wird es berechnet?
🏛️ Wofür ist es wichtig?
Sie hilft bei der Einschätzung von Skaleneffekten, Effizienz und Personalkosten. Zusammen mit Umsatz und Gewinn lassen sich Kennzahlen wie Produktivität je Mitarbeiter ableiten.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Viele Mitarbeiter bedeuten große operative Komplexität – aber auch hohes Umsatzpotenzial.
- Produktivität je Mitarbeiter ist ein wichtiger Indikator für Effizienz.
- Besonders spannend bei stark wachsenden Tech- oder Industrieunternehmen.
📘 Umsatz je Mitarbeiter
📈 Was ist das?
Der Umsatz je Mitarbeiter zeigt, wie viel Erlös ein Unternehmen durchschnittlich pro Beschäftigtem erwirtschaftet – eine Kennzahl für Effizienz und Produktivität.
🧮 Wie wird es berechnet?
Die Mitarbeiterzahl stammt in der Regel aus dem letzten verfügbaren Jahresbericht.
🏛️ Wofür ist es wichtig?
Diese Kennzahl hilft, Geschäftsmodelle zu vergleichen – insbesondere zwischen arbeitsintensiven und technologiegetriebenen Unternehmen. Ein hoher Wert deutet auf Automatisierung, Effizienz oder hohen Wertschöpfungsanteil hin.
🧮 Berechnung
🎯 Was bedeutet das für Anleger?
- Ein hoher Umsatz je Mitarbeiter spricht für ein skalierbares und margenstarkes Geschäftsmodell.
- Ein niedriger Wert kann auf arbeitsintensive Prozesse oder geringere Wertschöpfung hinweisen.
- Besonders hilfreich beim Vergleich von Tech- vs. Industrieunternehmen.
Graphite Bio Inc Aktie Analyse
Analystenmeinungen
13 Analysten haben eine Graphite Bio Inc Prognose abgegeben:
Analystenmeinungen
13 Analysten haben eine Graphite Bio Inc Prognose abgegeben:
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Graphite Bio Inc — Q1 2026 Earnings Call
1. Management Discussion
Good afternoon, ladies and gentlemen, and welcome to the LENZ Therapeutics' First Quarter 2026 Financial Results Conference Call. [Operator Instructions] Following prepared remarks from management, we will conduct a question-and-answer session. And instructions will follow at that time. As a reminder, this call is being recorded.
At this time I would like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead.
Thank you. Good afternoon, and thank you for joining us today. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. We are joined today by Eef Schimmelpennink, our President and Chief Executive Officer; Shawn Olsson, our Chief Commercial Officer; and Dr. Marc Odrich, our Chief Medical Officer.
Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LENZ's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the SEC, which can also be found on our website.
In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our first quarter 2026 Form 10-Q which is being filed today.
With that, I will now turn the call over to Eef.
Thank you Dan. Good afternoon everyone. In Q1, our performance was consistent with the expectations we outlined on our last call. We delivered approximately 25,000 paid and filled prescriptions, bringing total monthly units sold since launch to roughly 46,000 and generated $1.9 million in net revenue, including $1.7 million in product sales.
New patient adoption has continued to grow, but not yet at the pace we are aiming for. And I want to address that directly. We've done the work to understand the dynamics. We've identified what needs to change, and we're executing on those changes now.
What continuously gives us confidence are the strong fundamentals underlying that top-line number, and the strength in the category we are building around VIZZ. Our product clearly works in the real world, which is reinforced by consistent feedback from both doctors and patients, underscoring that real-world efficacy is living up to expectations. We have built a growing base of prescribing physicians, with over 10,000 unique prescribers through the first quarter, and new prescribers writing for the first time every day. And we are seeing a very clear productivity signal emerge within our prescriber base.
At this same approximate stage of launch, for our 46,000 filled scripts, VIZZ is generating roughly 30% more scripts per prescriber than VUITY, a pattern that holds true across all our prescribing deciles. In other words, we're reaching the same level of total volume with fewer prescribers because physicians who adopt VIZZ are prescribing it more consistently. This is an example of the encouraging dynamics that we're experiencing as we build a truly new category. Early adoption builds more gradually, but as prescribing habits are developed, they drive consistent uptake.
In addition, we continue to see promising patient adoption and persistence. Once patients move from a sample to purchasing the product, many stay on therapy, which we have seen reflected in early refill behavior and, importantly, in purchasing patterns. Over 2/3 of our e-pharmacy volume is now coming from 3-month prescriptions, a meaningful increase in our e-pharmacy consumer purchasing behavior from Q4 to Q1. This highlights the point we want to make from a sampling launch: our patients try the product first, convert after experiencing the benefit, and then continue use. Taken together, this gives us confidence that we're building the category on a durable foundation, and we view these metrics as important early indicators which will scale over time.
At the same time, and as we've noted during our last call, building a new category will take time, particularly as prescribing habits and patient behavior continue to evolve. Through Q1, the pace of new patient starts and routine ECP prescribing was more gradual than we expected it to be. We have a laser focus on improving that over the coming months and will hold ourselves accountable to demonstrating these upcoming quarters.
As we are now several months into our launch, we believe we have identified the key barriers to adoption. Over recent months, we focused on these areas in depth, including through extensive work with advisory boards and direct engagement with both physicians and patients, to better understand how to improve both the prescribing process and the patient experience.
There are 2 primary areas where we see clear opportunities to drive adoption. First, on the physician side, VIZZ is well understood. Brand awareness is extremely high among ECPs and VIZZ is recognized as best in class. However, it is not yet being brought up proactively enough in the patient conversation. This requires an important behavioral shift, as physicians learn to incorporate a new type of treatment into a routine exam flow. It does not historically include the integration of a novel pharmaceutical option for treatment of presbyopia.
Second, on the consumer side, the path from awareness to prescription and ultimately to purchase is naturally a multi-step one. Surveys and direct feedback have highlighted where the patient journey can be further improved to support conversion.
Based on these insights, we are sharpening execution and have already taken targeted actions to accelerate adoption. Again, on the physician side, we're refining how VIZZ is introduced in the exam room to make it simpler and more natural to bring into the conversation. One example is a renewed focus on contact lens patients, where VIZZ provides a clear and immediate value to that practice by helping patients stay in their lenses longer. This serves as a practical entry point that corresponds to a significant part of their patient and revenue base.
We're highlighting ECP success stories from peers to illustrate how VIZZ has been integrated into practice, specifically for these patients as examples of real world wins. This helps physicians better understand and use VIZZ more consistently to drive real value, and from there expand usage more broadly across the presbyopia population.
Importantly, as I've mentioned, these refinements are informed by direct work with advisory boards and testing panels of physicians, where we have incorporated real-world feedback on what works and how to improve both the ECP conversation and patient experience.
On the patient side, we're evolving how patients get started on therapy. We've introduced tools, including a simple QR-based getting started with VIZZ experience video, that clearly explains how to use the product and what to expect, helping patients complete the initial trial and transition more confidently to ongoing use. Additional materials to support this effort are finalized and will be rolled out shortly.
In addition, and we've omitted, we're enabling physicians to sell VIZZ directly to patients in their practices. This can simplify access and reduce friction in the conversion progress. Early feedback on this approach has been encouraging, while we remain mindful that this is not available in all markets.
Taken together, these actions are designed to increase both how often VIZZ is introduced in the exam room and the conversion from trial to ongoing use. Shortly, Shawn will go into more detail on how we're executing against these priorities. In parallel, as we scale the product, we're also continuing to improve the overall user experience. We are transitioning to an FDA-approved, large scale manufacturing process that will further improve our direct product cost of goods. This also allows for a tighter formulation specification and enhanced vial format, which we expect will further improve both ease of use and comfort upon instillation. These are natural advancements as we move from initial launch to broader scale, and are part of our ongoing focus on optimizing the patient experience.
Our attention now is on execution against the key drivers that I highlighted today. We expect that these actions will drive meaningful and measurable progress in ECP and consumer adoption as we advance through the year. We have a product that clearly works in a large and under-benefited market, and we continue to see strong validation from both patients and physicians on the value it brings. At the same time, we're building a new category, where both prescribing habits and patient behavior will need to evolve.
Importantly, we have solid and actionable understanding on how we can influence that evolution to accelerate adoption. We've already begun to act on these insights and initiatives. And these actions continue to roll out across the field and the patient journey. We're focused on demonstrating meaningful and sustained script growth over the coming months and quarters.
Lastly, in parallel we're seeing strong momentum outside the U.S. There are recent European and U.K. submissions, as well as meaningful inbound partnering interest from key markets including Europe and Latin America. Combined with our existing partnerships across China, Southeast Asia, Canada, and the Middle East, we believe we're building a strong foundation for global expansion.
With that, I'll hand it over to Shawn, who will go into more detail on how we're executing against these priorities. Shawn?
Thank you Eef. Good afternoon everyone. As Eef outlined, we are in the early stages of building a new category. And our focus is on translating strong product performance and early adoption signals into consistent and scalable growth. From a commercial perspective, we're encouraged by what we are seeing in the field. Eye care professionals prescribing VIZZ are seeing it work in their practices. And that confidence is translating into repeat prescribing behavior. We are seeing a growing number of physicians not only prescribe VIZZ, but write it multiple times. In fact, approximately 60% of prescribing ECPs have now written VIZZ multiple times. Which we view as a strong signal of confidence and early habit formation.
ECP awareness and interest is high. Understanding of the product is strong. And consumer interest and awareness is growing. What we're focused on now is how we translate that interest into consistent prescribing behavior and consumer adoption. And importantly, doing so in a way that shows tangible progress in new script growth in this early phase of launch.
Focusing on our eye care professional strategy. We continue to see strong engagement and adoption among physicians. Just a few months into launch, aided awareness is in the high 90s and unaided awareness is over 80%. Which tells us VIZZ is already well known in the eye care community for the treatment of presbyopia.
We are also seeing that physicians clearly understand the product. They consistently describe VIZZ as differentiated, pupil selective, and ciliary sparing. While delivering a 10 hour duration. That level of clarity is important because it helps address the major barrier of being compared to previous products in this category. Where our focus is now is translating that understanding into consistent behavior. This is about helping physicians bring VIZZ into the patient conversation more naturally and more frequently. And integrating it into their standard eye exam flow.
We are also seeing this translate into prescribing behavior. As Eef mentioned, at a comparable stage of launch, VIZZ is generating significantly higher scripts per prescriber than what was observed with VUITY. And importantly, we see that pattern consistently across the prescriber base. What that looks like in practice is that once physicians begin to prescribe VIZZ and integrate it into their workflows -- into their workflow, they tend to prescribe it more frequently compared to what we saw with VUITY at a similar stage. This is not limited to a small group of high volume writers, but something we are seeing more broadly across the prescriber base.
This ties directly to how we have designed the launch. With sampling, patients experience the product first, and physicians utilize these experiences to build an understanding and confidence in VIZZ. That creates a more natural fit in the practice, where prescriptions are written with greater confidence and consistency. And we see this as an early indicator of how adoption can continue to build over time.
As we've been working through this in the field, this also helped clarify where we should focus to further accelerate adoption. One of the areas we're seeing the strongest early traction is in contact lens patients. This is a well-known challenge for eye care professionals. The contact lens population peaks in the 30 to 39 year old age range. And as this group ages, up to 71% of patients drop out of contact lenses after the age of 50. Often reluctantly, with presbyopia being a key driver. This is not just a clinical issue but a core contributor to practice revenue, where contact lenses and related services play a significant role.
What we're hearing from physicians is that VIZZ provides a very practical solution to that problem. As one physician put it, this is a way to keep my patients in contact lenses and improve their experience at the same time. This is a clear example of where ECPs can benefit for their patients and in their practice, through the regular adoption and prescription of VIZZ, as a patient satisfaction and retention strategy. That ability to both improve patient outcomes and support the practice makes this a highly relevant and actionable use case.
Importantly, this is not just anecdotal. Our most recent consumer survey showed that approximately 50% of VIZZ users reported they used contact lenses as their primary form of distance vision correction, reinforcing that this is both a meaningful and scalable opportunity to drive adoption.
Turning toward consumer strategy, we are encouraged by the early momentum we are seeing. But most importantly, this is where we see a key opportunity to improve conversion and scale adoption. Patients are interested in the product, and we are seeing strong engagement across our channels. What we are focused on now is improving how patients move from awareness to prescription and ultimately to purchase. The journey in a new category for a prescription drug is naturally more complex. A patient sees an ad, learns about the product, schedules an appointment, receives the sample and then decides whether to move forward with the prescription. Each step creates an opportunity to either progress or drop off. And our focus is on making that process simpler, clearer, and more intuitive.
We are already seeing encouraging signals. Our direct consumer campaign is driving strong engagement with significant increases in website traffic and early indications that patients are entering the funnel. We are also seeing that when patients convert, they're engaging in a more committed way. In our e-pharmacy channel, which represents more than half of our prescriptions, over 2/3 of the volume is now coming through 3-month prescriptions, which is a strong signal of intense and early persistence.
At the same time, we're actively refining our approach to improve conversion. On the messaging side, we have shifted to a direct problem solution consumer value proposition centered around tired of reading glasses, which directly connects with the everyday experience of presbyopia and positions VIZZ as a simple alternative.
We are also improving how patients get started on therapy. This includes stronger expectation setting around how the product works, clear dosing instructions and what to expect in the first few days. We have also prepared simple onboarding tools such as QR-based resources that guide patients through the initial experience and help them transition from trial to ongoing usage.
In addition, we are continuing to expand and refine our media approach. This includes testing additional channels such as linear television in select markets while actively optimizing our creative and media mix based on real-time performance data to ensure we're driving the most effective engagement.
We're also seeing increased interest from physicians in directly selling VIZZ to patients from their practices where permitted. This approach is currently being implemented in select markets and structured in a way that maintains our expected economics while giving patients the additional flexibility -- sorry, while giving practices the additional flexibility to serve their patients. We believe this could also offer a significant benefit of convenience for the patient where they can leave the ECP visit with product in hand, reducing the hurdle of pharmacy abandonment.
Finally, these efforts are supported by the expansion of our field organization, which will be fully deployed by the end of this quarter. This increases the reach of our field sales team to approximately 15,000 targeted eye care professionals, allowing us to respond to inbound demand from physicians outside our initial target group and to build higher frequency territories. The combination of increased reach and frequency is critical to reinforcing both physician behavior and patient conversion. Taken together, these actions are focused on increasing the number of patients who move from initial interest to trial and from trial to ongoing usage.
Overall, we're encouraged by what we are seeing in the early stages of the launch. We have strong physician engagement, bigger patient interest and a growing set of levers to drive adoption. At the same time, our focus now is on translating these actions into meaningful and sustained NRx script growth over the coming months and quarters. We believe we have the right elements in place and our priority is executing against them with discipline to build momentum from here.
With that, I'll turn the call over to Dan to walk you through our financial results.
Thank you, Shawn. As both Eef and Shawn have stated, we are encouraged by the performance of VIZZ in the hands of patients and ECPs as we build the presbyopia market. The early signs of broad ECP uptake are there, as evidenced by the over 10,000 prescribers in the first 2 quarters of launch. A figure higher than any recent launch in ophthalmology at this stage. Additionally, consumers are emerging with positive real-world experiences every day as product awareness deepens and our early launch efforts begin to take hold.
Our first quarter results were highlighted by the approximately 25,000 paid and filled prescriptions of VIZZ, which was a 19% increase compared to Q4. Resulting in approximately $1.7 million in net product revenues. Our units continue to be driven by both a combination of new patient prescriptions and increasingly by monthly refill units, including both single monthly packs and 3-month orders, which are available through our e-pharmacy. While it is early at this stage of launch to be declarative about projecting annual refill rates, we are encouraged by what we are seeing in the initial trends.
In Q1, and consistent with last quarter, we noted blended gross to net discounts across our distribution channels of less than 10%, resulting in approximately $67 in net revenue per monthly pack of VIZZ. Additional blended costs of the respective distribution channels of approximately $7 per unit were incurred that flow into operating expenses within SG&A, resulting in a net cash per unit of $60 per pack. That is unchanged from last quarter, and in line with our long-standing expectations.
Additionally, we recognized license revenue in Q1 of $250,000 from the distribution agreement signed in January with Lunatus, our ex-U.S. distribution partner in the Middle East region. As I discussed on our Q4 call, there is significant effort underway with our existing ex-U.S. commercial partnerships as we advance towards multiple additional regulatory approvals for VIZZ, and we remain focused on the continued expansion of our global network of commercial alliances. We look forward to reporting additional progress in the months and quarters ahead.
Turning now to operating expenses. Our cost of sales in the first quarter totaled $1.1 million and was comprised primarily of 2 nonrecurring events, resulting in charges to cost of sales in the period that were unrelated to product sales. The first was a period cost stemming from an out of specification temperature excursion of inventory while in transit from our manufacturer. We expect recovery from this product loss from our insurance provider in the second quarter.
In addition, we incurred a onetime charge for packaging supplies associated with the previously mentioned FDA-approved manufacturing process improvement and transition. Direct product cost of sales related to our Q1 product sales were immaterial, and we anticipate VIZZ to trend to an approximately 90% direct product gross margin over time.
Total SG&A expenses increased to $45 million in Q1 2026, or approximately $40.7 million net of noncash stock-based compensation. This was a 13% quarter-over-quarter increase from Q4 and was driven by our planned DTC launch investment. As is consistent with last quarter, approximately 80% of our SG&A was driven by sales and marketing, with the remaining representing general and administrative expenses. Of note, we anticipate that our Q1 2026 OPEX SG&A and the resulting cash burn is higher than our go forward quarterly run rate over the balance of 2026. Total research and development expenses were 0 in Q1, which is consistent with last quarter.
Finally, our net loss per share, both basic and diluted, was $1.32 per share in the first quarter of 2026 on a net loss of $41.5 million.
We ended Q1 2026 with approximately $258.4 million in cash, cash equivalents and marketable securities, and our Q1 2026 net cash burn of approximately $34 million was consistent with Q4 and in line with our budget. As we discussed on our recent year-end call, our current sales force expansion is in our 2026 operating plan and we will continue to target an allocation of approximately 80% of our SG&A to sales and marketing.
In summary, we entered the second quarter of 2026 at an important point in the launch, with a clear operational plan, a strong cash position, and conviction that the actions underway will translate into meaningful growth.
With that, I'll turn the call back over to Eef.
Thanks Dan. To conclude, I'm incredibly proud of the LENZ team and the progress we have made over the first 2 quarters of our launch. We're seeing what we hope to see, a product that clearly works, encouraging early signs of patient persistence, and a growing base of prescribing physicians.
At the same time, we're under no illusions about where we need to go. While building a completely new category takes time, and enacting changes in both prescribing habits and patient behavior is crucial. And we have progressed from diagnosing the early adoption dynamics to actively addressing them. We're committed to demonstrating clear and measurable progress over the coming quarters, and we look forward to reporting back on that.
Our focus now is on accelerating new patient adoption through disciplined execution in the field and continued investment behind the category. We believe we are in the early stages of building what can become a significant and durable market. And as we continue to execute our priorities, translating VIZZ into meaningful and sustained script growth. We look forward to updating you on that progress as we move through the year.
And with that, I'd like to open up the call for questions.
[Operator Instructions] And our first question comes from the line of Stacy Ku with TD Cowen.
2. Question Answer
And we appreciate the details of VIZZ launch discussion. So we have a few follow ups. First, it's still early days with linear TV and of course the first steps of the sales force expansion. Just help us understand, are you able to go into additional detail on encouraging signs beyond the current prescription trajectory. Are you able to identify a specific type of practice that is prescribing VIZZ multiple times. So that's the first question.
And then on the second question, we do appreciate that 3-month metric from the e-pharmacy, it's very interesting. We wanted to confirm, for the next earnings call, will we be getting specifics on refill dynamics. So that's the second question.
Now the third, we're just trying to understand how we should be thinking about sampling and competitive dynamics. Tenpoint, Yuvezzi, they've now launched. Just help us understand what type of counter detailing we might be seeing in real time. Should we also expect samplings from both Yuvezzi and Qlosi.
And then last, on VIZZ safety. This may be contextualized, what we're seeing in the FAERS database for the launch. Now that VIZZ has been on the market for over 6 months, what are your views on VIZZ's safety profile? And maybe Shawn, maybe you could share perspectives from the patients and prescribers.
Thanks Stacy. Great set of questions there. Shawn will actually start giving you out and give some insights in the signs that we are seeing on our DTC and linear TV impacts. I'll actually now see if -- let me address the refill one first before we then go to the samples and that DTC impact.
Clearly, that's a key that we've been very clear on from the beginning, we will start to share in the second half of this year. And just to repeat what we said earlier, the reason that we've always focused on the second half of the year is that we really want to see those cohorts of patients that we can look at that refill step refill step mature a little bit over time. And if you think about our Q4, so first order of launch patients, obviously order that first script in Q4 and refill in Q4. We're also seeing is that, as we've mentioned, it's time to move over to the 3 pack and logically for our 3 pack you're going be back for a reorder in at least 3 months. So we feel important to see that patient behavior a little bit more, which is why we've always indicated that we'll start sharing those refill data in the second half of this year.
So I'll hand over to Shawn to talk about the DTC impact and samples and what we're seeing competition do. And then Marc will address your safety question.
So safety things for -- or for your question about the DTC. So what I can say so far, the early indicators are strong. So the engagement with the ads are high. We look at the click-through rates. We look at the cost per thousand impressions, and we're seeing the numbers that we want to see there. And our website traffic is up significantly. We see peak of up to 10x what we used to see on our website traffic.
The consumer awareness itself is building. We are hearing that Sarah Jessica Parker is resonating very well, and we have a broad digital reach ongoing. That being said, awareness is still early overall. So we still have more to do on driving greater consumer awareness, but we've seen an encouraging response from that low base and more patients entering that funnel. So what we're seeing is we're having great success on platforms like YouTube, where we're seeing ad recall and ad awareness lifts better than benchmark, and we're seeing a similar ad recall lift on Pinterest as well.
So this category is naturally slower to convert because of all the steps required to get to the prescription. But we continue to monitor this and actively optimize our campaign to ensure we have the best media that's out there and refine the creative testing is needed. As I said in the earlier opening remarks, we leaned in more to the problem solution marketing of tired of readers, here's a solution, which is VIZZ. So our focus right now is that strong conversion improvement, and we expect to see a stronger impact over time because DTC typically takes a few quarters to mature.
So the next question there is around the competitive so -- environment. So we continue to see VIZZ as a category of one product differentiated by its unique MOA. That being said, the market can definitely support multiple entrants. There's a large unmet need and other people out there speaking on the benefits of eye drops and presbyopia is an overall benefit to the category. This is a product where trial is very easy.
So our sampling strategy wants the patient to try the product. We know in head-to-head, if you were to try the different products, our product stands alone in terms of 10 hours of efficacy and that broad patient population. So efficacy ultimately determines winner, and we feel very strong about our efficacy. We know that the prior products didn't really satisfy the market, and this is clearly differentiated with our long duration, broader efficacy, different MOA and only people selective myotic. So that real-world experience is reinforcing that iteration and competition helps build that awareness, but our focus remains execution-driven on driving this.
Before we go to Marc, just 2 quick additions to that. So your question on if the competition is Qlosi and Yuvezzi are they sampling? Yes, maybe not as broadly as we are, with the VIZZ samples but they are putting in the market. And then maybe the underlying part of your question is, for sure, if we were to stop sampling, which we're not intending to do, you would see NRx go up. I think you'd also start to see the behavior that you saw with VUITY. So from the beginning, sampling has been a core part of our strategy. We will continue to do that. And as I mentioned earlier, we're actually seeing the behavior that we want to see being driven by sampling. You sample, they like it, they convert to buying the product, and getting more sticky than if your order is just basically a sample.
So with that, let me hand it over to Marc to talk a little bit more about the safety profile and what we've learned to date.
Thank you, Stacy, for your question. And it's one we're happy to get into because our data is genuinely one of the strongest parts of the VIZZ story so far. 6 months in, we've shipped approximately 46,000 boxes, which is roughly 1.2 million doses, in addition to widespread sampling on top of that. We've created some very broad use of VIZZ.
What we're seeing in the real world is fully consistent with the label. The non-serious AEs being reported are mostly transient and in line with what we saw in the clinical program. On the retinal side, it is important to start with the natural background rate. In the total population, this is about 27 per 100,000, with risk increasing with age and level of myopia.
So considering the background incident rate and the significant use of VIZZ thus far, 0 retinal detachments and only 2 retinal tears is much lower than what you would expect. Importantly, both retinal tears occurred in patients with pre-existing retinal risk factors, meaning they carried elevated risk independent of any treatment. Our retina experts have reviewed both cases and assessed them as likely non-causal.
Honestly, again, given the number of patients now on VIZZ and the background rate of around 27 per 100,000, you would expect to see more events than this. We believe that 2 cases at this level of exposure isn't a signal, but really just non-causal background incidence.
I know everyone is looking at what VUITY saw, so let's talk about VUITY for a moment. At what we believe is a comparable exposure to where we are today, VUITY had about 34 retinal events on the books, 22 of them were detachments. We believe that this shows what we have said all along: aceclidine is a different molecule than the other 2 other miotics on the market, with a different mechanism of action, and we're seeing a really different safety story play out in the real world. VIZZ is the only pupil-selective miotic. It doesn't significantly engage the ciliary body, and ciliary body engagement is the pathway most associated with retinal traction risk in this class. Across thousands of medical discussions we've had with eye care professionals, the ECP community clearly understands that mechanistic difference, and they consistently associate VIZZ with a lower perceived retinal risk profile than other miotics for presbyopia.
As exposure continues to grow, what matters is that the retina-related AE rate stays below background and that we don't see a mechanistic signal. To date, that's exactly what we're seeing. The product is safe, the data supports it, and we'll continue to be transparent as the real-world experience builds.
And to just -- to add on to a little bit to the last part of that question that you had, Stacy, on what the perspective is from the ECPs and the patients. Well, I can tell you from out in the field what I see, the doctors clearly understand that aceclidine is pupil-selective. They completely understand that because of one, the MOA that's in the PI that directly states it. And two, when people use this product, we continue to hear about that benefit of distance vision, which is avoiding that ciliary muscle, and that's why they're getting that benefit in distance vision as well. So the doctor and ECP community completely understands and aligns with the unique nature that is only available through aceclidine.
And from the consumer standpoint, their focus really isn't on that, but when I think of consumers, it's making sure we set that right expectation regarding to the stinging upon instillation or redness that's on instillation is transient over time. And that's where we've been putting a lot of work into the getting started videos and QR codes, as well as training the doctors to set that right expectation for the patients.
Your next question comes from the line of Yigal Nochomovitz with Citi.
Thanks for all the detail. Appreciate all the color as you move through the first few quarters of the launch. You mentioned that the prescribers are not proactively talking enough about VIZZ in their initial patient convos. I'm wondering if you could just sort of expand a little bit more on that. I know you mentioned Eef and Shawn that contact lens wearers was an area of focus. I'm just wondering if there are other categories or other aspects of a patient's profile that would be good natural hooks in order to introduce the VIZZ concept in the course of an initial patient conversation.
And then I know earlier before the launch, you talked about average utilization somewhere in the 5 months of the year range which varies depending upon heavy users versus light users. I'm just wondering if you believe that that's still a valid assumption or if you think that needs to be adjusted.
Thanks, Yigal. So starting with the prescribers focused on how often they bring up VIZZ. So we need them bringing up VIZZ more often in their standard exam. Their standard exam is pretty quick, right? They'll go through an eye exam in 20 minutes, and they have a regimen that they follow. And once you get it into almost like a muscle memory, you consistently do the same thing unless the patient proactively brings up VIZZ. So we need to help them change how they run through that standard process.
And so what we did and what we're doing to do that is we actually worked a lot on our message sharpening, so we're making it easier for the doctor to bring it up quickly. And part of that is this video and QR code. Now they don't have to spend the time, as much time walking the patient through expectation setting as well as how to use the drop, how to put in an eye drop, we've moved that over to a digital video format. That way, the doctor can bring it up easier and quickly in their natural eye exam. So this product still has broad adoption, but in our research, what we've seen so far of consumers is 50% almost of our patients that are on VIZZ use contact lenses as their primary vision correction. And that's a natural benefit for both the patient and the practice.
So that's why we're focusing and leaning heavier into the contact lens strategy right now to create that muscle memory for the doctor. It's clear physician value, and it's a clearly identifiable patient. And by doing that, we can help create that cycle of I can always bring up VIZZ, and I can do it quickly. So that's really where we're focused in terms of making sure the prescribers bring it up more often.
Two other parts of that question beyond contact lenses, like Shawn mentioned, it's an important group. It's 10 plus million people, a very valuable one. We're seeing the groups that we've mentioned before. So without too much detail, it's the people that have had LASIK before, the people that are striving for an active lifestyle. We're also seeing great success in emmetropes, so people that have never been to a optometrist, they come in because they're now becoming presbyopic. So all those categories play. The contact lens one is one that we can very easily help the doctor understand what the value is for a patient and for them.
And then on the refill rate, yes, we've always spoken about the 5 refills a year, and you can see our commentary on conference in light of what we said before.
Your next question comes from the line of Iren Amin with Piper Sandler.
Maybe to start, you talked about going to physician offices directly to sell VIZZ in select markets. Can you maybe just talk about how this might impact your margin? Because there would be an economic incentive to physicians. So I was just wondering how the math will work for both the company and for physicians. And I guess, what target markets are you expecting to reach out to, and how many of these are in your top 1,000 ECP prescribers?
Thank you. This is Shawn, and I'll cover a key aspect to the selling direct model and explain how that functions and operates. So for optometrists, generally, in about half of the markets in the U.S., half of the states, optometrists are able to sell prescription drugs out of their practice. So where it's allowed we offer the opportunity for doctors to buy the product directly from LENZ. That product ships to the doctor's office. From that point on, they're able to prescribe it and sell it to the patient.
From an economic standpoint, you should think of this as the same economics to LENZ as a product that flows through our e-pharmacy or a product that flows through a retail channel. And our target markets are those ones, and specifically, where this is an optional avenue, which goes back to about 25 of the 50 states.
I think, Biren the only thing I would add to that is the revenue transaction is when we talk about gross to nets and net kind of the net price per to the company of $60 net cash per monthly unit, you can roughly estimate that from a modeling standpoint. So I wouldn't differentiate it from a channel perspective. It's just different kind of methods of selling direct and avoiding some of those costs of the wholesaler or the other distribution costs. Otherwise, very high-quality revenue transaction because it's a direct transaction between us and the doc. So in short, no meaningful difference in net economics to the company.
And then maybe if I could have one more question. I think at the end of March, the company stated that emerging presbyopes were identified kind of as early adopters, and you wanted to expand beyond this group. Can you maybe talk about those efforts in terms of expanding beyond the emerging presbyopes to a broader group over the last 6 weeks or so?
Thanks, Iren. As said, maybe you referred to it that in the last call, indeed, we said that not so much from a consumer point of view, but from a ECP point of view, their initial focus on who had this product, patient type, for whom this product would work well was we saw somewhat limited to early presbyopes. That was a carryover, frankly, what we believe and what we hear from VUITYs launch, because they have that limited efficacy. They really focused on this group early, emerging emmetropic patients of presbyope.
We clearly work in a much broader population. That's part of what that sharpening and messaging is to continue for our sales force to remind the doctors that while that is a appropriate category, it's just a fraction of the patient population that you can use this product in. So again, that's part of where the messaging has changed.
And so tactically, what that has means actually move that knowledge to the doctors. We actually developed an additional piece for the field that they're out there using, specifically focused on that broad inclusion of our study trial, where it showed that we worked just as well in both moderate and advanced presbyopia as well. Tactically, also, what it means is we've updated some e-mail campaigns and posts that are targeted at ECPs that bring in peer-to-peer statements of other doctors sharing those successes that they've had with VIZZ in nonearly presbyopes to help bring that across from a peer-to-peer view as well as an advertising view.
Your next question comes from the line of Marc Goodman with Leerink Partners.
This is Alyssa on for Marc. Thank you for all the detail on the update. Just a few questions from us. Could you give a little bit more color on the ECP direct sales initiative? I know you said they could order directly from LENZ, but would that be timed shipments, or would it be at-will ordering as they deplete their inventory? And also could you discuss the network TV direct to consumer advertising and what markets exactly you're launching that in the pilot period? Thank you very much.
Great. Thanks for the question, Alyssa. This is Shawn again. Just a little bit more color on the ECP direct sales initiative. So these are an engagement that we enter into with the doctor. We have a contract between us and them that outlines the rules and the model itself. It is at-will ordering, so they have to order a case of product at a time, and then we ship it to them directly. At that time, they're charged and we collect payment ahead of us shipping the products out to them.
So it really is a very simple model. We enter a contract with the doctor, we send the doctor an invoice for at least one case at a time, they pay the invoice for the case, we ship it directly to that doctor, and from there, they can then prescribe and sell the product to the patient in their market. So it's at-will under a contract.
And then in terms of our network TV, so we've just started to do network TV in select key markets. There are a few different markets across the U.S. that we're doing this in, and we're doing it to make sure we can see what the signal is in those markets. We're running linear TV. We're still only a few weeks into it's too early to provide any details on that list.
Your next question comes from the line of Lachlan Hanbury-Brown with William Blair.
Maybe on the direct to ECP sales approach, should we read from that you are maybe seeing some abandonment obviously between writing the script and patients actually filling it and that this is obviously going to sort of hopefully reduce that issue? Or is this maybe also obviously to get the physicians incentivized and make it top of mind for them, if they're seeing it in their office every day?
And then maybe a second one, Shawn. I know you mentioned the change in the, certainly the name of the DTC campaign. Wondering how much more of the sort of actual content of that has changed with this new sort of problem/solution approach that you're taking?
Thanks a lot. I appreciate the questions. So the Direct to ECP Program, that initiative was came out of just pure ECP demand as well as consumer convenience, as we want to make sure that process is easy as possible. It didn't come out of an abandonment issue. It truly was something that the doctors have been requesting for a while, and we now have the infrastructure in place to support.
In terms of the content of the DTC. The tired of reading glasses and then the solution of VIZZ was a change to bring a direct alignment between those that are in readers and frustrated as a solution to that. It doesn't result in an overall change of any core creative. The creative itself still stands strong. SJV continues to test well. It's more about creating that direct connection right off the bat when people see the ad. So that's the only reason for that change.
When you think of that lean into these contact lens patients, those are the people in reading glasses. When you think of those LASIK patients, those are the ones in reading glasses, so it's just bringing a tighter connection on the value proposition of VIZZ.
So maybe one other just on the direct to ECP. Do you have clauses in those contracts to ensure that they charge a certain price? Or is there a sort of ceiling or floor to what they can charge in there?
Yes. So the way that it's structured to make sure that we're setting up the right way, so we have the price that we sell it to the doctor and then the doctor can set their own final price to the patient. However, with the guardrails we have in place, so it is very clear in our materials that for $79, you can buy it from the e-pharmacy. We've got our Rx card at $79. We have a retail structure in the background. So those now are on the actual pricing pressures. We'll hone in that price for the ECP.
Our final question comes from the line of Matthew Caufield with H.C. Wainwright.
Regarding the refills, any further observations on switching from the 1-month to the 3-month dynamics? And is that something that could have greater clarity during second half 2026? And then just additionally, with the R&D dropping to 0 for the quarter, is that drop anticipated to remain for the foreseeable future, keeping the R&D at 0 and the OpEx essentially just concentrating on the SG&A for the launch moving forward?
So on the refills, yes, we definitely see patients move. Classic example is somebody ordered a 1-pack first, and then because they like it, they move to 3-pack and they continue to do that. So that dynamic is an important one and one that we highlighted. If you look at the e-pharmacy site, which is obviously the only place where you can get a 3-pack, but that channel represents, more or less, well, the majority of our volume. You see that 3-pack now drives about 2/3 of the volume that we sell through e-pharmacy. So definitely an important factor of what we're selling.
And going back to what we said earlier, we do anticipate as we move into the second half of the year, we'll be able to little bit -- to give a little bit more color on some actual statistics around that refill behavior. And then on the R&D, Dan?
Yes. I will take that question on the R&D spend. So I think the short answer is yes, you should expect R&D to be substantially 0. We kind of signaled over the course of 2025 a shift in the capital allocation of the company with the completion of the CLARITY studies in early last year and movement towards commercial. So you would've seen R&D be effectively 0 in Q4 and again in Q1, and that should be the expectation for the foreseeable future.
Got it. Congrats on the progress.
And that concludes our Q&A session as I'm showing no further questions in queue. Thank you for your participation, and we will now conclude today's conference call. You may now disconnect.
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Graphite Bio Inc — Q4 2025 Earnings Call
1. Management Discussion
Ladies and gentlemen, and welcome to the Lenz Therapeutics Year-End 2020 Financial Results Conference Call. [OperatorInstructions]. At this time I would like to turn the call over to Dan Chevallard. Thank you.
Good morning, and thank you for joining us today. My name is Dan Chevallard, Chief Financial Officer of Lenz Therapeutics. We are joined today by Schimmelpennink, our President and Chief Executive Officer; and Shawn Olsson, our Chief Commercial Officer; as well as Dr. Marc Odrich, Chief Medical Officer, who will join us for the question-and-answer session.
Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LENZ's future expectations, plans, prospects, book strategy, regulatory and commercial plans and expectations, cash runway projections and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the SEC and which can also be found on our website.
In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our 2025 Form 10-K, which will be filed later today.
With that, I'll now turn the call over to Evert.
Thank you, Dan. Good morning, everyone, and thank you for joining us. We are now about 5 months into the launch of this that will summarize what we are today in 3 simple observations. First, the product clearly works. Hoping many of you are all are hearing as you read your own parties.
Second, what we're seeing so far suggests the promising share of patients for byproducts and the refill. And third, we are clearly knowing a new treatment category. And while new categories take time to develop, the signals we are seeing reinforce our confidence that this can become the muster market opportunity, we've always envisioned -- at this early stage of the launch, our priority is putting the right foundations in place, list every and scale and adoption can accelerate over time.
Importantly, we are executing this launch from a position of significant financial strength. We closed the fourth quarter with over $292 million in cash which gives us the resources and flexibility to continue investing in building this category. Let me take you through each of these observations, starting with the product itself.
Across the field, we continue to hear consistent feedback from both doctors and patients. The clinical performance result in our trials is translating directly into the real world. This work strictly but 9 patients noticing the effect within about 30 minutes and with the benefits of the near vision typically lasting throughout the workday.
Importantly, we're also seeing the same broad patient profile we observed in our clinical program. Net brand manager considers the scale of the opportunity, but the cafe approximately 28 million people in the United States, and this is the first important only once daily eyedrop capable of addressing such a broad segment of that population. -- ultimately creates the opportunity for a large and durable category.
From launch through the end of this quarter, we believe that we are on track to have sold over 45,000 boxes of this described by more than 10,000 eye care professionals, creating a strong and rapidly expanding base of physicians adopting the products. In fact, the number of subscriber factors we have seen at this stage of the launch already significantly exceeds what we observed with several recent eye care launches.
Importantly, we are seeing strong mortality within that base as we will beat up into prescribing behavior, we're seeing a very encouraging pattern among the highest volume prescribers. From a normalized same script volume for our employee 5,000 scripts and compare prescriber frequency across top deciles of our CPs. The data suggests that our top 1,000 prescribers are filling over 40% more scripts per doctor than what was reserved at comparable point in the view we launch.
And based on the same data, we estimate that the total amount of prescribing practice that the beauty to get to this volume is approximately 2x terms. But this tells us is that once physicians understand how to integrate this into their practice, they are successful with it. We view it as an important signal because it suggests that the opportunity is not only do things to bring more physicians into the category, but also to increase productivity across the broader ECP base as we learned from these sub-prescribers and use those insights as a blueprint to scale across the fuel.
Equally important, we are seeing encouraging early signals around patient persistence. What we are seeing so far suggests that patients, who try to product and use the purchasing after continue using it. This is exactly behavior we hope to see at this stage of the launch. Our sale strategy is a key part of this by allowing patients to try the product first, we see a natural self-selection dynamic -- of patients who experience the benefit and choose the purchase are more likely to continue using it.
This does mean that the early new patient numbers develop differently compared to the launch of Beauty, but patients often had to purchase the product before trying it. That approach us to a faster initial ramp, but also a rapid drop off as many patients did not continue therapy. Our approach is designed to build a more durable patient mix from the stat. Even if that results in a more gradual pay ramp in new patients.
On the retail signals we are seeing are encouraging, the pace at which new patients are coming on true therapy is, therefore, developing more steadily, which is consistent with what we often see that an essentially a new treatment category is being established. These other typical dynamics you see when new categories are introduced and new prescribing helps are being developed.
And importantly, they are very investable through focused execution in the field, combined with effective issuer marketing. So let me discuss that some more. From our composition in the field, there are 2 themes that emerge ECPs as they've built prescribing habits that will get this recommended to more patients more often. First, is must learn how to best work this into their patient discussion and start from a place of unfamiliarity with respect to how to consultations or presbyopia hydro.
Second, many physicians primarily think of this or early [indiscernible], basis are just beginning to experience near basin challenges. The reality is much simpler. This can be introduced during a routine exam with a short 102nd discussion, and it works for a much smaller patient population than only emerging areas.
Taking that mindset and helping physicians integrate the product naturally into their exam level is a key focus for us. Based on what we've learned over these first months of launch, -- we are leading in operationally to accelerate production with sharpened physician messaging to address the 2 themes I just discussed.
Specifically, our sales force is working closely with eye care professionals on how to naturally integrate this into the patient proposition and introduced to products during a routine exam by a simple, quick discussion. At the same time, we are reinforcing the breadth of the patient population. This works across a wide range of results, including contenders, patients with biolytic to the patients and not only early emerging as was.
In addition, we are expanding our field presence to a total field organization of 117 reps. This expansion will allow us to increase scope frequency with existing prescribers, while also expanding the number of physicians we actively cover, enabling us to react to strong inbound interest from Dr. [indiscernible] that's currently in a target panel, but already was prescribing this because patients are asking about it or because they learn about the products through other channels.
We are making this investment because we see a clear opportunity to accelerate adoption in the field, further integrating this into everyday clinical practice. Besides Brazilian Atlas, creating a new category also requires consumer awareness we are continuing to build the subside of the category.
Many of you have complemented us direct to consumer campaign, which features series partner and asked when we expect to see that translate into prescription trends. As a reminder, we launched a DTC campaign in mid-January, is February group representing the first full month of activity.
We are encouraged by the early cycles we're seeing. The campaign is resonating with consumers and clearly driving engagement. But syntactic is now running roughly 5x higher than our baseline levels and during national activations -- we've seen spikes of up 10x normal track. At the same time, we see regulation in a new category takes time. Across good human-driven categories, people typically need to see it at 5 to 7x foot economy.
In our case, the journey from awareness to prescription naturally takes longer. The consumers see the advertisements learns about the product, potential employment with IT professional received a sample only then transitions to purchasing a prescription. Pharmaceutical direct campaigns like ours that will typically take at least 2 quarters to translate into prescription trends.
What we are seeing today are encouraging early indicators of that process, and we would expect a more meaningful impact on script volume as we move into the second half of the year. In other words, the consumer awareness engine is now beginning to build momentum, while in parallel, we continue to focus on helping physicians integrate this more consistently into that patient discussions.
With that, let me briefly summarize, where I believe we are today. We have a product that clearly works and is delivering the real world results we expected to see. We are seeing encouraging further signals of our patient assistance and we have already built a strong and rapidly growing foundation of prescribing physicians.
At the same time, we're building a new treatment category, which naturally takes time to that. But as I've noted the early signals we're seeing give us confluence that we are underwrite path. With the operational actions we're taking the deals expansion of the sales force and the growing consumer awareness to provide direct-to-consumer campaign, both the physician and consumer reduction engines and now be able to build momentum.
As prescriber has built, and consumer lens grows, we expect to see an acceleration in new patient starts from that foundation. The opportunity in front of us remains exactly what we've always believed to be a large and underpenetrated market with 128 million smiles in the United States as a product that can meaningfully improve operations managed and near vision.
Our focus now is straightforward, continue executing, continue expanding adoption and continue building what we believe can evolve blockbuster category.
With that, I'll now turn the call over to Shawn to give more insights into our commercial strategy.
Thank you, Evert, and good morning, everyone. As a quick reminder, Presbyopia is the largest unmet vision condition in the United States. It impacts approximately 128 million people, a population nearly 4x larger than those of dry on -- in fact, we FX, more Americans than dry eye, Dymedex, tonomyopia, macadegeneration, diabetic correct and glaucoma combined.
This is uniquely positioned to address this opportunity. and performing exactly where it matters. The product works and early persistent signals are encouraging. Because this is a new category creation, as they've noted, ramp of new patients is developing gradually as physicians are starting to build the habit of introducing eyedrop option for routine business.
We're focused on accelerating update by sharpening our physician messaging expanding our sales force to increase reach and frequency and building consumer pull through DTC so that more patients are offered is in the exam room and more come in asking about this. I will unpack these details and insights across our key strategic pillars. Doctors recommend us and consumers request us pine. Focusing first on our eye care professional strategy. We are encouraged by the progress of doctors to recommend this.
First 5 months of the launch, aided awareness is already at 98% and unaided awareness is already at 79%. As a reminder, unaided awareness means that by doctor brought a bid in the survey as an edoxagypribeopia unsolicited. So both metrics are above our targets and demonstrating that ECPs are very aware of this.
In the same survey, we're also seeing accuracy of TVS messages resonating ECPs as they're prompted to write in what they know about this. We see consistent answers, such as fecal selected, fuel selective, different MOA, not iloparbine last numbers. The results demonstrate that ECPs understand this well.
Confidence and this is also clear as reflected by more than 14,000 ECT locations enrolled in our fund. And most importantly, we expect to have over 10,000 prescribing ECDs by the end of Q1, which exceeds what we observed of several recent eye care product launches, including Milo and XMD at this stage of their launch.
In addition to the broad PCP prescriber base, we're also seeing ECB confidence as over 55% of these doctors have written me multiple times. As we look at the first 5 months of launch, we're also gaining important insights that continue to reinforce our confidence in the opportunity for this. First, we're seeing that access optometrists and ophthalmologists is not a meaningful barrier for LENZ.
As evidenced by our consistent execution of our field team, which continues to deliver approximately 7 calls per day. Secondly, our sampling strategy is working. We see that most patients are able to obtain a sample. And when they do to help identify those who like the product, which in turn has supported encouraging recirates.
In terms of prescriber mix, it remains 80% optometry and 20% ophthalmology with our expected top prescribers performing as anticipated. As stated earlier, once these ECPs have integrated vision of the practice, they are successful with it as data suggests, our top 1,000 ECPs are building over 40% more scripts per doctor than what was observed at a comparable point with view.
Interestingly, we're also seeing adoption broadened across lower decile liters, which is an encouraging sign for the depth of the opportunity. Particularly notable is the growing number of eye care professionals writing this multiple times, who never of duty. We view that as an important proof point. It suggests that this is not simply capturing prior prescribers in this category, but it's expanding physician engagement with the prescription presbyopia opportunity more broadly.
And finally, while others under this market airline success means this remains a true category build effort. We're working to build new prescribing attracts and overcome legacy perceptions from prior costs. And our market research confirms there is still an opportunity to further educate PCs that made us not just for early price deals and have more routinely integrate business discussions into the standardizing fan.
Based on what we've learned in these initial months, we've already begun to implement clear step coleoption. We're expanding -- we're excited to expand our field organization from 8 representatives to 117 representatives as I noted earlier. We follow an in-field organization to cover a broader set of EVPs who are already prescribing this and increased call frequency with high care professionals.
This expands the outside fields team reached to approximately 15,000 ECPs. We believe that added recent frequency on part supporting behavior change needed to build a category and integrate this as a routine part of the press VOP discussion. We've already been nonrecurring expanded field and expected to be fully on board in Q2.
At the same time, the field is focusing on the messages that matter most to bring up bids more often, including the broader legion criteria from our clinical studies, which included moderate and Vance presbyopia and strong success that we're seeing in the moderate and advanced redials as well as practical tools to make operating visits to patients a simple and seamless addition to the office business.
Moving to our consumer strategy of driving patients to robust bid by name. We are encouraged by the early momentum we're seeing. This launch and through the end of March, we expect to have sold more than 45,000 monthly tax events -- and importantly, this is proving to be a product that works for patients and is generating encouraging repo behavior. We are already seeing patients on aquarefills, transition from 1-month to 3-month prescriptions and, in many cases, start directly with a 3-month order, which reinforces our view on the benefit of the product that is the most important near-term driver of growth is focusing on increasing NRxs.
To support that, in addition to our work we just discussed with ECPs to bring visitation more often, we've recently launched our direct-to-consumer campaign and has seen strong early update the on shortly.
Our spoke first in Seresto Parker is resonating well with this consumers and our advertising is now running across a broad mix of high-impact media, including YouTube, Instagram, TikTok, ESPN, Paramount+, Uber, Pinterest and other platforms, helping us reach consumers where they spend their time and driving not only sustained increase in our visits but up to a 10x increase in visits to this com.
We've also been activation influencers across a diverse set of audiences from well-known realty personalities, directly is voices and sports media and iconic actors who are now the presbyope age. In addition, we're seeing strong pickup across broad media platforms, including Good Morning America, New York Live, New York Times and Late night TV.
As we look at what we are learning from our early consumer launch efforts, our consumer mix today is approximately 60% female and 40% male, with the majority of the users between the ages of 45 and 65 which is consistent with the audience we target and expected to reach. As we highlighted earlier, it typically takes a couple of quarters to see DTC take hold and are encouraged by the early performance indicators of our advertising.
For click-through rates and cost per impressions are exceeding relevant benchmarks. For example, our early and brand awareness from YouTube is performing 2x above benchmark. We're seeing similar lifts across both men and women and demographics. Just as importantly, these campaigns are giving us useful insights into how our various creative assets perform on cross-format and audiences. Including which visuals, messages and executions are resonating the most strongly with consumers.
Even with our early encouraging DTC metrics, we're actively optimizing our creative ads and media placement to maximize impact. for increasing investment allocation behind the higher-performing placements while reducing the allegation of lower-performing media, allowing us to concentrate resources where we are seeing strongest respondents. We're also introducing new permutations of trades into the next, which bring up the everyday frustration with reading glasses, which we believe is an important point of recognition as consumers consider this.
Starting in April, we will pilot linear TV commercials in select markets across our top states to test patient response. Linear advertising is our traditional TV commercials on your common network stations like ABC, NBC and cable through typical providers like Comcast. Together, these actions will continue to optimize our media mix add messaging and build additional consumer demand for biz.
We're encouraged by the progress we've made, we are seeing broad physician adoption, growing commercial demand an encouraging early repeat behavior. And the first time that our consumer campaign is beginning to activate that market. We continue to believe this is a category 1 -- as the only approved Presbyopia eye drop with up to 10 hours of duration, this offers the differentiated profile that we believe is well aligned with in need of both consumers and eye care professionals that is demonstrated by the DCP adoption encouraging patient persistence.
I'd now like to hand the call over to Dan Chevallard, our CFO, to step through our financial results.
Thank you, Shawn. As both Evert and Shawn Shane outlined, the fourth quarter in Houston trade launch has been a tremendous time for lens as we have proudly introduced this into the U.S. marketplace, representing a novel solution for the treatment of presbyopia with 128 million Americans frustrated with their near vision.
As has been highlighted, this is a true market build and 1 that we're doing for a position for financial strength. This morning, I'd like to focus my remarks into 3 sections. First, summarizing our 2025 financial results, then discuss our outlook on 2026 capital allocation and I will conclude by highlighting the significant progress made on the global expansion of this through our international partnership strategy.
First, and as has been mentioned, we continue in the launch of this from a position of financial strength. Ending 2025 with approximately $292.3 million in cash, cash equivalents and marketable securities. We remain at 3 and ended 2025 with approximately 31.3 million shares of common stock outstanding. Our Q4 results were highlighted by net product revenues of approximately $1.6 million in our first quarter of product launch with over 20,000 monthly paid and filled prescriptions.
As you will recall, we launched this with availability through 2 consumer channels. The first, our e-pharmacy perceives prescriptions from the ECP processes individual orders and ship product directly to the consumer's home. We recognize revenue when our product is delivered to the consumer. Our second channel, the more traditional retail pharmacy is a channel supplied by our network of wholesalers.
As is typical through this channel, we recognize revenue and shipments of bids are received by the wholesaler, not upon delivery to the patient. Turning now to our operating expenses. We've discussed in previous quarters our planned ramp in spend as we move into launch, specifically driven by our commercial strategy. Our total Q4 operating expenses was approximately $40 million, including $4 million of noncash stock-based compensation expense compared to $31.4 million in Q3 of 2025.
Importantly, net cash earned in the fourth quarter was approximately $32 million. Passive goods sold in the fourth quarter totaled $400,000 and was primarily driven by indirect product costs associated with nonrecurring manufacturing processes. Going forward, we anticipate this to trend to an approximately 9% direct product gross margin.
Total SG&A expenses increased to $39.6 million in Q4 2025 were approximately $35.9 million net of noncash stock-based compensation compared to $9.4 million for the same period in 2024. I driven almost entirely by the establishment of sales force and launch of this, including a significant nonrecurring investment in Q4 to enable the launch of our DTC campaign in early Q1 of 2026.
Sequentially, quarter-over-quarter, SG&A increased by approximately 43% from $27.6 million in the third quarter. In recent quarters, we have discussed the importance of capital allocation at lens and a significant weighting of our SG&A spend towards sales and marketing to support this. In Q4, approximately 80% of our SG&A was driven by sales and marketing with the remaining representing general and administrative expenses. This is a trend that we expect to continue.
Total research and development expenses decreased to 0 in Q4 2025 compared to $5.9 million in the same period last year. Sequentially, R&D expenses decreased quarter-over-quarter by 100% and from $38 million in the third quarter. This reduction was anticipated and was primarily a result of the conclusion of our positive Phase III CLARITY study and subsequent approval of this in July.
Finally, our net loss per share, both basic and diluted, was $1.16 per share in the fourth quarter of 2025 on a net loss of $35.9 million compared to a net loss per share of $0.46 in the fourth quarter of 2024 and a net loss of $12.7 million. As we look ahead to 2026, I wanted to highlight a few points to help further characterize our P&L. First, on the revenue front, and after our first quarter of sales, we noted a better-than-anticipated blended gross to net ratio of approximately 90% or $67 per monthly package of this.
Additional non-gross to net cost of the respective distribution channels have consistently resulted in a net cash per unit of $60 per monthly package with the difference going into our SG&A line. This net cash created of $60 is consistent with our long-standing expectations. Our Q4 2025 cash burn was substantially in line with our go-forward quarterly expectations over 2026.
The recently initiated sales force expansion was in our 2026 operating plan -- we will continue to target an allocation of approximately 75% to 80% of our OpEx to sales and marketing with an aim to maintain recently flat G&A spend period-over-period. R&D spend now becomes a de minimis line item on the P&L.
The last point I'd like to highlight is an update on our recent progress, advancing the global expansion of this for our international partnership strategy. We've seen significant progress across the globe in recent months and now anticipate potential approvals in multiple geographies in early 2027.
Breaking that down, as we initially announced in Q3 of last year, the NDA review in China is now well underway. In May 2025, we executed a commercialization agreement with Lotus Pharmaceutical and are happy to report that of the eighth country license in Southeast Asia, we have NDAs submitted and under review in 3 countries, including South Korea, Thailand and Singapore.
As announced in early March, we recently submitted our central marketing authorization application to the European Medicines Agency for approval in Europe. With our submission of the Medicines and Healthcare Products Regulatory Agency or MHRA in the U.K. to follow. Tea, our commercial partner in Canada continues to make progress towards their submission to Health Canada and significant regular regulatory activities are already underway with Lunatus, our commercial partner for the recently signed 9 country distribution agreement in the Middle East region.
In total, Five ex-U.S. NDA or equivalent submissions have been completed, and we anticipate over 10 to be completed by the end of this year with multiple potential approvals possible in 2027. In summary, we feel confident about where we are both financially and strategically, and the team is well positioned to execute and advance this on the back of a strong balance sheet with a broad strategic network of partners making regulatory advancements globally.
With that, I'll turn the call back over to Eve.
Thanks, Dan. To conclude, I'm incredibly proud of the land team and the progress we are making in these early months of launch. We're seeing what we hope to see. The product clearly works, encouraging early signals of patient resistance and a growing base of prescribing physicians. We are now focused on accelerating new patient adoption through disciplined execution in the field and continued investment behind the category.
We believe we are in the early stages of Bilia can become a significant and durable market. As we continue to execute on describing how it's built and consumer lands grows -- we expect to see a declaration in new patient starts from this foundation. We look forward to updating you on our continued progress in the quarters ahead. With that, I'd like to open up the call for questions.
[Operator Instructions] Your first question comes from Stacy Ku with TD Cowen.
2. Question Answer
We really appreciate all the detailed commentary on the Viz launch so far. We have a couple of questions. So first, maybe further discuss that sampling dynamic to NRx and the retention that you're seeing how is refill, let's say, high level tracking to your internal expectations so far? So that's the first question. And then second, as you're trying to broaden patient demand, -- maybe talk a little bit more about the investments and where you think they can help with the friction points that you listed? Do you believe that select television advertising plans will also take about 2 quarters to lift prescriptions.
We're asking because -- from what we remember, our consultants told us that duty ads were everywhere. Of course, the prescribers were not necessarily prepared to set expectations on beauty's efficacy profile, which has been your focus, but just help us understand that dynamic. And maybe a reminder on the size of the Beauty sales force as you're expanding your sales as well?
And then the third question is on the prescriber additions. If you're willing to comment, what percentage are from your initial target group versus the inbounds from patient demand? And are you seeing a certain practice profile, where the prescriber becomes a repeat?
I appreciate your questions. Let me start off with the NRx and refill dynamic and give a little bit more color and then Shawn will talk about the BCC and EDP question. So we feel very good about where we are or actively, as I've mentioned, accelerating option. If you look at the strong foundation that we built with the over 10,000 prescribing ECPs and more than $45,000 is sold.
We believe that that's a great start. And what most early is to see that it works, as I've mentioned, that we see that patients who choose the purchase continue to use it, and we're seeing both. So new patient sites are developing as expected for a new category that takes it is time, I mentioned, -- we're actively working to continue to accelerate that as per plan.
So significantly or specifically, we're expanding our sales force, like I mentioned, 59 batch to drive both breadth and frequency and sure, I'll probably talk about that a little bit more as to answer your ECP question, because it allows us to increase coverage of physicians that are already showing interest and also increases how after we engage with those existing prescribers -- how long that, as I mentioned, we'll continue to build the consumer end through DTC and that ties into your second part or the third question.
I think -- so as we go to pivot into the refills -- we know that this is a refill driven category and early sales are encouraging. We're seeing patients come back and reorder. If we now look at that goal or of patients that got that first quarter in Q4 over the first quarter of our launch. We're seeing them come back and we are -- we see patients move from initially a 1-month back now to a 3-month impact suggesting that they are committed and they're liking the product.
We're also seeing patients on new product not starting initially on multi-month supplies. So in online, that tells us that they had a chance to settle back to say we say works elite in the life product in up to start at with treatment. So all of that, we feel very consistent with a product that's delivering for patients. It's still early. So we want to make sure that we see this dynamic develops over multiple quarters again the fans that we're seeing so far aligned with what we would expect.
So with that, let me switch over to Shawn to talk about the CCP.
Thanks, Stacy, thanks for the questions. When we look at broadening the patient demand and where we're focusing our investments to help -- our primary focus has always been digital advertising to hit the patients where they are. So we know what these patients look like and we do that prior to launch, right? We knew that to make over $100,000 a year. They're mostly between 45 and 65. They're in major city centers.
And that digital marketing is working. What we look at every single day is what's our click-through rates of different ads what's our cost per impressions of not only for ads for different media placements. So inside that digital aspect is really a lot of optimizing, right? Do we actually see more benefit when we're putting the assets on YouTube versus when we put them on Instagram and how that translates to business to our website.
So that's a lot of optimization. The influencer standpoint, same thing, we look at the influencers post and we say, okay, and we saw the post by Heather Dubrow and she got 650,000 views. What does that look like and what it translates -- so a lot of them is optimizing. With the addition of Linear, what we're also seeing is there are select markets where the patients are early adopters -- and therefore, as we continue to evolve and optimize that media mix, it's a good opportunity to bring linear TV in those select markets and past that response that we continue to optimize to get that broader adoption.
You are correct when Vuyo launched, they put -- we're putting a big substantial media plan out there. So we're being much more focused with targeting each individual that we want to drive in versus driving a shock an approach of selling a 125 million people about it to make sure we have an efficient campaign. You also brought the sales force size -- so looking into more and more about the V launch. It appears they had a sales force of roughly 300 people specifically focused on duty.
So therefore, expansion from to 116 it also makes sense, but also a more rationally sized sales force. So jumping into that, which was the second part of your question on the target groups of ECT and where are they sitting? So our field, the outside portion of the field was focused on performing about 12,000 eye care professionals that covered decile 4 through 10 of beauty tending the highest prescribers -- and we continue to see that today, our decile 10 doctors are our highest prescribers as well, and we have the inside sales team covering the lower decile.
The growth from targeting 12,000 to 15,000 ECPs on the outside field is because we were seeing those lower decile ones prescribing repeatedly as well as a good portion that we actually called in our analysis MA. These are doctors that have never written viewing. So we have doctors at never real beauty that are now wanting to write bids.
And so a good way to think about it is our target initial group of outside sales was 12,000 ECPs, and we've now grown that to 15,000 ECPs because of those deciles that were not on targets. Now when we do that, we're growing not only the number of targets, but when we expand this field from 88 to 117, which are also seen in the ECPs per rep. -- is being smaller.
So we can get in that doctor office more often and really work with them to make sure that you get to that 10 set conversation to bring it up to every patient and understand that they can offer this to more patients, not the early presides.
So hopefully that answer your question, Stacy.
Your next question comes from the line of Yigal Nochomovitz with Citi Group.
Yes. Just a few questions here. I'm wondering if you could spend a little more time talking about the these top 1,000 writers in terms of their behavior and how they approach the conversation with the patient knowledge of the product. I know you mentioned that many of the ECPs that aren't familiar with this believed apparently romaneously that it was only for the early presbyopes and not for the other categories you mentioned, Shawn, like the contact lens wearers, the ones with prior Lasan the pseudophakic -- so I'm just curious how that crept into the message that some people apparently didn't understand that it was for a much, much broader set? And how are you planning to help correct that perception and then discuss the behavior of these top riders that seem to get it and have gotten it from the very beginning. So that was my first question.
Thanks, great question. Shawn, and I will tag team on that a little bit. So just to double click on that a has very encouraging for us to see those 2 things that I've said. One is that it's only taking us about half of the amount of prescribing doctors to get to the same script volume that Beauty got to 45,000. So I think what that tells us is that doctors are enthusiastic.
They like working with a trial. And especially like [indiscernible]. as you in that group, it look at the top 100 you see that they're actually riding 40% more. So those are the factors that grow the most of beauty providing even more for us. And your question on what makes and different again, I'll hand over to Shawn shortly.
It's really around taking out how to, one, bring this up consistently and easily and quickly and operate as an alternative option to their patients, setting their expectations around what to expect from a drug and then realizing that, as you've mentioned as well, this is truly something that they can offer to pretty much every eligible presbia in that practice.
So I think that's what makes them different. And we're obviously trying to bundle it up and share that with all the other doctors out there already describing on all the new ones that we're tapping into to that vendor over for Shawn to give you some even more color on that.
Yes. Absolutely. And thank you all for the question. So as it on a lot of the key points, but jumping in a little bit deeper. So our top 1,000 prescribers. Again, they're tied to those higher destocounts. So these are doctors that are more comfortable implementing new technologies, historically are also higher prescribers. So this is something that they are more used to doing in general on a day-to-day basis.
What we're seeing is they follow that standard process, which we always can do message, make sure to give the patient an example and attracts right, allow all the patients to try and then give them the script as well. And as they expanded, they offer up as an option to more patients. They figured out how to do the 10-second pitch, how to offer it inside our expectations.
In terms of your questions on the understanding of the broader use, why are some still thinking only about the early read deal, but this is really an effect of the previous product on the market, which really was tested in the under population and the Apex really only worked in that very early emerging resi, therefore, people naturally go there. It is sticky more to make sure people understand that we really did show just as much success in moderate and advanced presbyopia.
And then we show them the graphs actually show those that have worse presbyopia, gain more lines -- and that's a process to understand that this product truly does work for that full scope of press.
Okay. Awesome. And then this is really quick, just maybe for -- maybe Shawn also -- this is just more of an operational question. You mentioned doing the TV ads. I think that wasn't in the original blueprint I'm sure it was one of your scenarios. But I assume this doesn't mean that your emphasis and investment in terms of targeting the regional influencers, 1 layer below the SAPs that that's still in place as it was with the initial plan?
And then also, are you able to track -- I know I mentioned the conversion to the uptick in the web traffic when you have various campaigns that are delivered to the market. Are you able to track the conversion rates there? And are you seeing higher conversion to Rxs as a result of these waves coming to the website?
Great questions, Yigel. So first, about the CBS. So our strategy remains the same on primarily focused on digital ads and the influencers. So we never plan to do a broad national linear TV campaigns. However, what we're seeing is there are key markets that are prescribing a lot more often than others. And so this is a perfect opportunity to drop linear advertising on network TV and cable in those targeted markets in a responsible, financially responsible way to see what response we see.
So that's the opportunity that's now provided itself of linear TV. So because as key markets, we test the response and in testing those responses, you need exactly what you just brought up. How does that translate to then visits to the lab -- and then does that then translate to actual scripts later on. And that's exactly what we're continuing to look at every day.
So we can see when we actually run different ads in different markets, other than responds to long traffic. I think we're early on in DTC. So we don't have a durcorrelation from the webcast to then a strip later on. There's a connection there, but it's something that we'll continue to look at for correlation to make sure we continue to further optimize those CTCs.
Your next question comes from the line of Marc Goodman with Lee Partners.
This is Alyssa on for Mark. So you previously highlighted 3 different patient categories as the foundation of the advertising strategy. Could you update us on which of the segments are driving the early adoption today? And then secondly, I might have missed this, but on the distribution, can you clarify whether prescriptions are being fulfilled entirely through the e-pharmacy channel? Or if retail is now kind of contributing to that? And how is the mix between those 2 and it sell.
Great. Thanks for the question. So if you think back to our strategy in terms of early adopters, we want to focus on those that are in contact -- we want to focus those that have had post refractive surgery and what we call the active lifestyle. So we commissioned a survey of patients that have recently received the product.
And what we're seeing is those targets are right. when we actually look at the data, we're saying about half of the patients on this have on contracts, about 1/3 of them have had leased in the past and that about 1/4 of them have been BOTOX in the past 12 months. Now that quarter number is a little bit bias because we have an equal split of men and women, about 60% female, 40% male in terms of our prescriptions.
And BOTOX does tend to be about 90% women, 10% men, so that will lift up that percentage overall. But we feel good about our targets that we're focused on there. And then in terms of the mix of the retail as well as the pharmacy both meaningful channels we've not broken out or shared that mix yet.
Your next question comes from the line of Biren Amin with Piper Sandler.
For Q1, can you maybe tell us what the split is between the 1-month pack and the 3-month pack -- my second question is I think previously you had estimated 5 refills per year. In your early adopters, do you feel that, that still would align with your annual refill projections?
And then third question -- or third question is, can you talk about how many of the samples in Q4 converted to scripts in Q1, I think that would be a good barometer of patient experience.
Thanks, Biren. Great questions. And obviously, we all know that ultimately, these distis are going to be very important to detect the progress of the launch. We're also remaining with what we said before that we fill actual refill percentages is something that we really start to look at in the second half of the year, we'll start to communicate that.
But what we do see at the moment on your various questions is that as I mentioned earlier, that fact is important in the market, and we're seeing that move. And this is early days -- so like for many of these statistics and the parameters that we've spoken about, we really want to see a couple of quarters to see how to square bugs before we feel that it's a reasonable number that we can start to share.
Same goes for refills. Like I mentioned earlier, we're encouraged by what we're seeing. We also need to remind ourselves that the coat that we already can follow hit the 1 from Q4 of last year. So first 3 months of being in the market with this. But first, consumers have genes to buy the part and that's probably a mix between initially when we just started to bring samples out resumes at both the having sampled and later in the quarter that we now most of the people want had a chance to sample.
So on top of that, you see that somebody bought a treat, for example, in December is clearly happening you would expect that person to come back until maybe late Q1 or even into Q2. So that means that the numbers that we're seeing now, we're really looking at them more as a barometer than the actual number.
But clearly, as we said, what we're seeing is encouraging us, and we feel that we have a product that has led up to what we want to see that people like that once they order it been sticky and they continue to buy.
Your next question comes from the line of Jason Gerberry with Bank of America.
This is Melanie on for Jason. First, can you share any more details about indicators that are most encouraging regarding the DC program that can spur growth? And secondly, anything you can share about key thresholds you're looking to see in NRx and refills in the second quarter.
Thanks, Melanie. I appreciate it. So in terms of the DTC program, when we think of our DTC, what we're really looking to see is are we driving consumer activation, right? And so in terms of this stage of a DTC program, wherever so fairly early on, the easiest items to look at that we're looking for or indicators are, are we driving awareness? And are we driving increases in web traffic -- and are we doing at a responsible financial spend.
So the indicators we continue to look at are we increasing people that are going to website. ERPs a sustained increase in most that visitors we're staying up to a 10x increase in web visitors depending on what we're running. That's very good. When I look across the metrics of our DTC, I'm looking at what are we paying for 1,000 impressions, what are we paying per click.
Again, what we're seeing right now with our ads, we're testing well. We're actually doing better than benchmarks or click-through rates as well as spend per impression. So that's looking positive -- and then what we continue to look at is as we talk to the patients, serving them so ad, did that time come in. And so those are all the metrics that we're continuing to look at.
The second question was around key thresholds that we're looking for as we enter into the second quarter. I think just moving back to what I said earlier. There's 2 elements that we're focusing on and that Chorus highlighted as well, activating the doctors to redo more patients more often. Obviously, that's something that's ongoing. And then you really start to see that BDC play out. build things all take a little bit of time. This is why we said that.
The -- this is not only for us but in general and Nielsen report that you pick up, we'll show you that it takes at least 2 quarters to really see that translate into B2C and early indicators that Stronach we're seeing very positive Similarly, with the expansion of the sales force happening in Q2, we would expect that to take the time for that to take effect. But we really are expecting more of a step change and acceleration of new patients as both of these mechanisms will take hold closer to the second half of the year.
Your next question comes from the line of Lachlan Hanbury-Brown with William Blair.
I guess the first, I'd be curious what you're finding in terms of how often or how many samples doctors are giving out. Finding the reps when they go back for fridges empty or they still have some. Do they have to go back earlier, just spoken to a few docs that tend not to give the samples. They refer to rightescript. So kind of curious to see what you're seeing on the sampling in the volume front there.
And then maybe a second 1 on the prescribers curious what you're seeing in terms of the time it takes for them to go from a single prescription to become a repeat prescriber? Is it -- is there -- there's a cohort of doctors that basically immediately prescribe it to multiple people and then others that prescribe 1 and takes much longer? Or is there a trend you're seeing there?
Thanks, Lachlan. Good questions. Let me start off with dissembly and then build a little bit more on the sampling strategy and the conversion and how we think about that. So sampling in case is really designed to bring the right patients so it's a central part of our strategy, as we highlighted early on -- because of the products has such an immediate observable effect. So we want to get samples out there that's how what we focused on.
If we get as many samples as needed to as many offices as possible to make sure that those patients can reexperience the products first and then self-select in titan we're seeing that, that's working. We believe that currently probably more than 90% of people that start with this or new patients have had a sample first. So again, that strategy is working. What's also important is to understand how this samples works.
So the samples are dispensed as you've mentioned, directly by physicians -- so once our reps leave the samples with the doctor, there's no way for us to track individual samples and how they're being handed out to patients and how many are being head on, but what we do see is that most of the doctors now handing on because like there's a group of doctors that you just prefer to write a script directly.
And we'll continue to work with them to actually start to change that have as well. So we actually and don't really look at conversion as a key metric at this point. The samples for us are very cost effective and it's really a way to get as many people as we can to try to put make some they like it and then they're self-led in, like I said earlier, that this do lead to indeed a much more sticky patient population.
I think your second question was around prescribing dynamics. And what we see is that, as you would expect at this stage as a mix. What Shawn highlighted, there's a great amount of doctors that are already doing what we would like them to do, provide a sample together with the script -- there's also reactors that wants to sample first and have the patient pull back, like the rig script, the doctor is said to your point, right scripts meaningly to sample.
So all the different flavors that you can pick up are going out there and that focus of us now to take that and Blue brings up factors that we know are very successful with the product, the high percentage of the patients converting start to apply that or cat to the rest of the Dr. Cohorts.
Our next question comes from the line of Matthew Caufield with HC Winright.
Can you speak more to the nuances you're seeing in terms of that initial refill patients? Like for instance, have the refills been predominantly those early presbyopes so far?
Yes, great question. So when we look at the consumers get in a little bit more detail. So we dig into it and look at those people are adopting the fastest, and we're seeing the repos come through. Again, what we're seeing when we break it down, it's 50% win and 40% men, predominantly that 55 to 64-year old, there are certain states that we see perform better than others, -- and when we dig into them, they are our target patients that are doing it is, as I stated earlier, after those patients have 1 context in the past, about 1/3 of them have had leased it 1/4 had BOTOX, but again, it's a bit biased by the next Melmar.
So we are right on that core target. We're hitting the right patients that want to use it. I think the most important thing is they get a sample and try it because that self-selection is so important. And that's what really drives that repeat behavior is getting us to self-select and try the product, know is for them and they continue to use it. I think that's the important we want to focus on.
That concludes our question-and-answer session. As I'm showing no further questions. Thank you for your participation, and we will now conclude today's conference call. You may now disconnect.
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Graphite Bio Inc — Citi Annual Global Healthcare Conference 2025
1. Question Answer
Okay. Welcome, everyone to the third day of Citi's Global Healthcare Conference. I'm Yigal Nochomovitz, biotech analyst here at Citi. So we have a really, really super interesting company next, its LENZ Therapeutics. I have with me the CEO, Evert Schimmelpennink. Thank you, so much for joining.
Obviously, a tremendous amount of progress since you did the reverse merge, did the Phase III data successfully built the commercial infrastructure, got the approval and now, of course, have launched the product biz. So tell us where you are? Tell us a little bit about the early launch? How it's going? What you're preparing for 1Q just -- set the stage?
Absolutely. Thanks, Yigal. Obviously, thanks for the invite. Great to be here at the Citi Conference. Yes, we're very excited about everything that we're seeing. And to your point, and just facing our focusing on the last couple of months from the approval that we got the early -- late July, to the launch, which we executed early October and then now 8 or 9 weeks into the launch. It's been an extremely exciting time for the company.
Everything that we're seeing either from the numbers side and we're obviously seeing a lot more than what's in the public domain to the feedback that we're getting from doctors on how to product works in real life, to, frankly, what we're hearing from investors at all these conferences that are all doing their own doctor checks as they shoot.
The feedback is very, very aligned on how the products works in the real world. It works really well for pretty much every patient, which is very aligned with our clinical trial. It works very rapidly. People notice a near vision, improve and get back to real good near vision in 10, 15 minutes.
It's got a very long duration. So it absolutely works for the full workday just as we saw in the clinical trial. Anecdotally, we're hearing 11, 12 hours. The distance vision impact that we noticed in our clinical trial as well is real. People talk about that, "Hey, my distance vision is getting crisper, clearer, more vivid. So that's great to hear. That's not a label claim, but it's a very nice obviously added benefit that patients or consumers experience.
And it's a very comfortable product in its use. In the clinical trials, we were very much focused on the headache rate. Miotic have a tendency to create mild headaches. We saw very little of it in the clinical trial to begin with. And hardly anything we're hearing about it in the real world. So that's great. The two things that come up is the product might give a little bit of a sting on first installation, a 10, 15 second, thing if it happens, doesn't happen anymore on day 2, day 3.
Similarly, people may notice a little bit of hyperemia, also that's very transient. If it happens, it lasts maybe up to 30 minutes on day 1, maybe half of that in duration day 2 and then day 3, 4, 5, no longer really happens. So highly tachyphylactic and something that doctors feel it's very easy to manage for patients. And we're seeing that again in our numbers. The numbers continue to give us a lot of confidence in the launch. if I see in this stage where it's really around getting docs to recommenders, and I'm sure we're going to talk about that and not yet have we turned on the DTC, which we'll do in the Q1.
So you started with e-pharmacy at the very beginning. Before that, I guess you just started with the samples and then you sort of dialed in the e-pharmacy. Now you're starting to dial in the retail component -- the retail pharmacy component. Can you speak to that as far as how it's going to start to boost the trajectory? That's before, of course, turn on the direct to consumer.
Absolutely. So both channels are now fully available. So if you think about how we launched the product, so early October, October 4 is when we first had samples in the market. And at that moment, we also have product available at the e-pharmacy. So e-pharmacy, in our case, is more of a fulfillment station where we have products sitting there as orders come in, they get fulfilled and that ship to the consumers.
Pretty much at that moment, we also had product at the wholesalers, but that just takes a little bit of time to propagate it into the channel. So we've always been very clear around the fact that we expected that by mid-November, both channels would be fully up and running, and that's exactly the case. So you can order your product through e-pharmacy and get a deliver to you home, guaranteed fixed price, or you can just get it sent it to your local CVS, Walgreens and pick it up there. And again, both are fully available now.
Is it a bit too early to tell as far as utilization for patients that have gotten scripts, they're probably still in their first 25 days, right? So it's maybe a little early to know about the refill rate. That's more something to learn later next year.
Absolutely. No. So it's good to see that without going into numbers, but we are seeing people refilling. We are seeing people ordering 3 packs. But indeed, it's much too early to go into, and it's not really telling a whole lot at this moment. So -- as I think about what we'll start to share with the Street going forward is we'll continue to focus initially on the numbers or the stats that we gave at our November earnings call, which were all around what's our awareness. It was already up over 90%, which is phenomenal for a new product to have a 90-plus percent awareness, but talking about how many practices, how many doctors have access to samples. And just to double click on that a little bit. For us, it's really important that ultimately we get to a stage where most, if not all of our target factors have samples available.
So we want to make sure that as a consumer, actually once we turn on DTC, if you think, hey, this is something I want to try that you don't have to go and look for which practice has samples. You can go into your local Main Street and the 3 optometrists there, should all have samples available. So that's one thing that we continue to strive for. So we'll give an update around where we are there.
And then we'll give updates around what are the unique amount -- what are the unique doctors that have prescribed. So 4 weeks in. We had 2,500 doctors that already wrote, which I believe is a phenomenal number. But we extend 40% had already written more than once. So we'll update that number for the end of the quarter.
And similarly, we'll update the amount of scripts that have been filled. So that was 5,000 in the first 4 weeks in. And again, we'll give an update on that number. We'll then turn DTC on, and I think what we're focused on in, let's call it, the first half of the year is how that driving new patient starts. So that's the main metric for the first half of the year. Turning DTC on usually takes a couple of months to see that effect. Again, that's not unlogical. Somebody sees the ad, they usually need to see it a couple of times, that make an appointment, get the eyes checked, get their sample, turn in or turn towards buying a script.
And then if there's a 1 month, which is the minimum, it obviously takes at least a month before they refill. If they buy a 3 pack, it's going to take at least 3 months. So first half of the year, I think of it really as you want to see that nice steady growth in new patient stats and more towards the first -- in the middle of the year, we'll start talking about, okay, what is the refill rate that we're seeing that because that's the key second metric for this to all work.
So long-winded to your answer on when is it that we'll start to get insight in the refill rate and think of it more as a Q2, Q3 type metric.
Tell us more. There's a lot of components to DTC. It sounds simple, but it's not simple. It's a lot of strategy. You've hired really, really strong head of marketing. We'd love to hear more about the choice of the celebrities, folks person. What are the facets of the DTC campaign? How do you target? The technology is obviously really good where if you're near a place where you potentially are a customer, you could be tagged on your phone. Just kind of go through all that and where the ads are going to appear? Who are you going to target? What that's going to look like?
Yes. Indeed, there's a lot of different aspects in it. So let's maybe start with spokesperson, Sarah Jessica Parker, who we've had her as a topic from day 1. But it's great that -- I thought it was great, and Sean thought she was great. Obviously, while we're decision makers, we're not the experts in this. So how that works as you think about who's your target customer. We know that a product like this skews slightly female. And we're seeing that even in our current script data coming in.
It's like 60-40 female, male. Its slight -- it skews a little bit more to the 45 to 55 year olds. We're seeing orders all over the age spectrum up to 75-year-old, but a little more in that age group. And then it's a little bit more city center urban buying there. So if you think about how do you get that group activated, you look for somebody that really speaks to that group.
We also look at our product, which we really look at as a category of 1. So this is the only product that gets below 2 millimeters. This is the only product that really improves your near vision. So we also want a category of 1 spokesperson. So this needs to be somebody that's an A list, the lead character in her movies needs to be a female. So that's how you build that list. We ultimately will win it down to about 5 with Sarah on the top.
And then you start to do what's called scores. So here's where companies do a lot of surveying where they show somebody the name or show somebody a photo and go across all age groups and dynamics to see is this somebody that really resonates. And she does like she's the ideal person for this. So her role in the DTC to get to your question is she needs to stop people when that's calling on their Instagram or their TikTok or their Facebooks where they go, oh, what she's talking about.
So you click on, you look at the ad and then she brings you into our campaign into our website, gets the brand awareness. So that's really her role. So you'll see her show up in all our commercials, and those commercials are showing up mostly digitally. So on the same platforms that I was just talking about on the Hulu's, the Disney's, all the nonlinear TV because that's where we can really target people. Like we don't need to target 128 million people or 300 million people and find the ones that have presbyopia because we know if you're over 45, you have it. We know if you're over 45 in contact lenses, you even over index in interest, LASIK, if you're active aging, you use BOTOX.
So those groups, we can target very easily digitally. So that's what we'll do. Now underneath that brand figure, there's a lot of influencers that you'll start to see coming up. Those are the people that you actually follow. So you have more confidence and interest in what they're saying. So that is how that all wraps together. And the nice thing is that you can fine-tune that like almost minute by you can run something different in Houston versus Phoenix and see how that difference works and what plays better. And think of it as a huge dashboard that have a lot of dials that you continue to fine-tune.
You've hired the right people in the advertising world to measure the effectiveness of these digital ad campaigns. And as you say, they can be rapidly fine-tuned shift if necessary as you collect more data on the uptake.
Absolutely. So frankly, from the beginning, let's call it, 5 years ago, when we started into what's now LENZ. Our approach has always been to work with the best. That means we work with the best team. We bring the best people in-house, but we also work with the best companies to support us. And we've done that with manufacturing. We've done that for development. We've now done it logically also with everybody, everything commercially. So the companies that are and the firms are supporting us aren't the number one firms in that field, whether it's on commercial side, on the marketing side, whether it's on the ad buys, which is what this is all about, whether it's how do you find your talent, how do you do the commercials. These are all the tough for us.
I mean I know you can't speak to specific numbers post the earnings call, but just sort of generally speaking, you see the data. How are you feeling about the trends post the earnings call and as you move. And the update, just to that question, you mentioned the update. So is that going to be like an early January update where you're going to give a snapshot of what 4Q looks like? Are you going to get that one on the 4Q call in like late Feb. Can you tell us about that?
Yes, let me answer both. So first off, like, again, we strongly believe that we had great data and great stats coming out of the first 4 weeks. I don't think there's a lot of products that in the first 4 weeks, drive 500 scripts, 2,500 doctors that have written a script right off the bat. So that shows that there is a lot of interest in the products and a lot of confidence in the product, and that's what this faces all around.
I mentioned before, creating awareness in the doctor community, giving them confident, giving them samples, the first thing they do is they open up a pack and use it in their own eyes, give it to couple of staff members. Maybe 1 or 2 patients in that early phase already get to that amount of scripts.
5,000. Just to clarify, 5,000.
5,000 scripts, 2,500 doctors that have written. So that's great data right there, and we're seeing that trend continue. And again, this is all before we turn on DTC. So all these patients are patients that are getting it because the doctor talks to them about it. That's going to change once we turn on DTC like we just talked and spoke about.
We know how focused everyone is rightfully so script data and all the other stats, we also know that neither Symphony, nor IQVIA is accurate at all and give you insight and how the launch is going. So you can imagine that early January will give an update around those steps that I just said, doctors that are prescribing, how often and how many scripts in first 4 weeks.
Then there'll be another update around our earnings call in March. And the next update is like going to be in May around Q1 update. So you'll see that there's like roughly a 2-month cadence that will give inside in how the launch is going. Just to make sure that everyone has to keep on guessing.
Right. So it's an important point you made that IQVIA and Symphony are not doing a good job of tracking or people attempt to use those channels to project or model that -- there was a point where you were saying it was good, but that was like in the first week or something.
Correct.
Now it's not, it's diverged.
So we'd always said that don't look at IQVIA or Symphony because it's not be accurate and the reason that it's not accurate as we use both e-pharmacy channel like we just said, and then the retail channel, both those firms buy retail data and then extrapolate it into what ultimately will be call a pretty accurate number. Nobody on the e-pharmacy side sells that there.
So we were always saying that they're not going to catch anything on the e-pharmacy, you'll need to rely on us. We were a little bit surprised in the first 4 weeks to see that Symphony, not IQVIA, but Symphony somehow had piped into some data, which was directionally correct. Like it wasn't perfect, but it was correct enough for us to wanted to explain or at least highlight that to the Street that in the first 4 weeks, they were picking up scripts and directionally it was correct. Now that accuracy has gone down. And it's not like it's up week by week. So the percentages is different week by week that they catch, but it's definitely wrong. And the same is on the retail side. So as much as I'm going to continue to say, don't look at it, I know everybody will, but it's not correct.
Okay. So then tell us a little bit more about plans. Of course, you're launching in the United States, but you do have some agreements and partnerships in place ex U.S. Let's hear a little bit about that.
Yes. So you all may have seen that on Monday, we announced that the submission of the NDA went in, in South Korea. That's through our partnership with Lotus. That's something that we signed earlier in the year for Southeast Asia. So obviously South Korea, used market and very interesting markets around that. So that's with Lotus Pharmaceuticals. Then we have a partnership in place for Greater China, actually signed that a couple of years ago, like 3 years ago, because they had to do our own clinical trial.
That clinical trial read out identical to our trial, which itself was great validation that in different company, different cohorts of patients, different PIs, obviously, exactly the same data, highly validating for the product. And again, a great predictive of what we see in the market now. So they submitted their NDA in June, and then we signed an agreement with for Canada earlier this year as well. So these are partnerships that are in place. Other key markets, obviously, Europe is one.
We're actually pushing our own registration there. We want to make sure that we get that market the time to realize what the value of the product is, there's a lot of interest already. But you can imagine that, the better we launch and the more value we show in the U.S., the more valuable that license become.
And you'll continue to see us do deals in auto territories as well. So there's a huge market opportunity ex U.S. 1.8 billion presbyopes outside of -- globally, 128 million in the U.S., so a very large market that we'll start to tap into.
Speaking about globality and everything related to manufacturing and supply chain. I mean you had some important wins in terms of how the United States orders and customers rated or characterized your product. Can you talk about that?
Absolutely. Yes. And it was certainly a question that we got a lot about 6 months ago on how the tariffs are going to impact us. If I think about our supply chain, the API cycle in is made in the U.S. The IP around the products also sits with the company and there for in the U.S. So it's a completely wholly owns product for us.
Those 2 make that this is a U.S.-based product is a U.S. manufactured product, even though we ship the API to Europe to have the fill/finish done. So that's where the actual little low field seals, little containers get made and then it comes back into the U.S., but it comes back into the U.S. duty-free, tariff-free. So it's a U.S.-based product for all those reasons. Excellent supply chain, like I said earlier, we wanted to work with only the best firms out there. The supplier of these b-field seals is actually the company that way back when, invented how to do that technology. Having said that, and even though the supply chain is fully capable of doing massive volumes, just for redundancy, we're making sure that we have second source API and second source fill/finish in place as well, and that's near to those missions.
So that's a very good summary. As far as other products, is that something that you would consider, are you fully focused on biz at the moment.
Yes. We're fully focused on this. I mean there's not that many, let's call it, $3 billion-plus opportunities out there. So it's in our interest and frankly, our shareholders' interest to make sure that we fully focus on getting this one, right? So the majority of all the brain cells, all the human power that we have is focused on that. Having said that, this can and will be a phenomenal cornerstone product, a much larger portfolio. That's all going to be BD and M&A driven.
So a few of us keep our eyes out, no pun intended, on what's out there. I see that more as a post-2026 opportunity. So we'll definitely be active, but we want to make sure that in the next 12 months, we really show the opportunity and the success around this, and then we'll start to pivot into the broader company strategy.
And I think it's also important to spend a few minutes just talking about what's happened in the past in the presbyopia field and some of the products that have been successful that they not been so successful. So if you can just speak to that. And then are there other competitors that are noteworthy that you need to pay attention to currently?
Yes, great question. So there's 3 -- just to sketch it at a high level. So there's 3 miotics, so 3 active ingredients. You got pilocarpine, which is what VUITY launched with. VUITY was the AbbVie drug that launched 3 years ago, you have the aceclidine, which is obviously our active ingredient. We're the only ones with aceclidine and then you got [indiscernible] call carbachol. The aceclidine is the only pupil selective miotic. So there's 2 muscles in the eye that are important for presbyopia.
There's the iris sphincter, that's the muscle that you want to stimulate that gives you that small penal pupil. And then the ciliary body that you want to avoid because that impacts your distance vision and can drive other side effects. That's also the reason why both VUITY, what you saw there was mostly focused in the study on ametropes and then carbachol, which is a 10-point product is 100% focused on ametropes because they impact that distance vision. So if you work with people that are amotropic, which have good distance vision, you hope to minimize the effect there. So VUITY had a good launch because they solve the promise of an eye drop that solves for presbyopia or clears up your blurring near vision.
But in order to do that, you need -- your people needs to be below 2 millimeters. That's undisputed. All the data shows that. It's not only our data, it's actually AbbVie's data, the VUITY data that shows that all the academic data. If you're not below 2 millimeters, you're not going to see a good near vision impact.
The smallest people size that VUITY got to was 2.3 millimeters, then they quickly bounce back up. Their statistical significance that lost that at hour 3. So in the market, once people use the product, they actually realize that, one, it doesn't work a whole lot of people, only works in 1 in 4 people.
If it works, it works maybe for 2, 2.5 hours. That's why VUITY failed. So to solve the promise, a lot of people bought into the promise, bought 1 bottle and never refilled. We obviously have a completely different profile. If you compare our profile to VUITY, we're at least 3x more efficacious. So up to 75% of efficacy on clinical trials, 93% if you look at 2040.
So this works for almost everyone. Our 10-hour data is better than VUITY's peak efficacy. So it works at least 2x longer for 6x larger population because we're effectively an all-comer study. So if you now compare some of the other profiles, and there's not that many left, either the other pilocarpine product or the carbachol product, it is like VUITY. So if you just overlay the couple size and efficacy, it's like VUITY. So we'll pay attention to any competitor, but we continue to really see this as a category of one, our market to frankly build because there's no market at the moment and our market to dominate.
The commercial strategy also is quite different than what VUITY did, right? Because VUITY was focused more on the ophthalmologist unless on the non-ophthalmologist, the optician market.
Yes. No, good point. So Vuity obviously was part of the back that Allergan AbbVie already carried, which was heavily focused on ophthalmology. So the call points were mostly ophthalmology. But you see that this product gets sold mostly or written, I should say, mostly through optometry. And we've always looked at it like an 80-20, 80% optometry, 20% ophthalmology.
That's why our sales force is set up in that way. That's why our call points are like that. And we see that split exactly like that coming through in these first 8, 9 weeks of data. It is truly 80% optometry, 20% ophthalmology. So that's one difference. I think the other big difference is that -- and I touched on it earlier, but very heavily sample focused. VUITY did the opposite.
They started with samples, but then realize if you give somebody a sample, VUITY, they're not going to buy it because the product doesn't work. So they actually pull the samples away from the doctors. Like I said a couple of times now, Q4 is focused on getting as many samples in doctors' hands, predominantly to make sure that they get that confidence that then patients can use it.
So I would expect us to have the uptick that we're currently seeing a nice steady, good growth at a good clip, but then continued growth where VUITY tapered off real quickly because they obviously showed that they didn't work.
I mean that was an important point that I think some investors may have gotten confused by around the earnings call related to the samples and how to think about the samples relative to the paid scripts. And maybe you could just spend a minute or 2 just clarifying or helping people understand that you will continue with the samples as you continue to build the paid market.
Absolutely. No, thanks for bringing it up and giving me the opportunity to clarify that. So during our earnings call, we indicated or we shared that we had, at that point, distributed 70,000 samples into the market, which roughly equates to about 7,000 offices or doctors. That didn't mean that there's 70,000 consumers that have tried a sample, obviously.
And in our mind, that was not something that we have to clarify because we're continuously putting samples out there as we are still doing today. I think some investors willingly or not move to -- well, if you have 70,000 samples in the market, there's 70,000 consumers that use the product and you get 5,000 scripts, what's that conversion rate?
That's obviously not how it works. So we have those samples in doctors' offices, like I said earlier, the first pack, the second pack, the third pack is used by the doctor themselves, then some go to the office staff. By the time that a patient gets a pack, that's maybe pack 9 or 10.
And then a lot of offices just have those samples. So we're going to move to describing the amount of offices that have samples because that's the more important thing like I referred to earlier. We want to make sure that all those offices have samples. So what we're currently seeing is that our reps are going back in.
So we have a 3- to 4-week call cycle. First thing they do is check how many samples are left. If there's 0 samples and the doctor has written 20 scripts, great, they're going to get 20 samples the next time or maybe even 30. If there's 0 samples left, but no scripts, clearly, the samples are used in the wrong way. So that's the dynamic that's happening now. There's doctors' offices that are on there, the second that third refilled already. So we're going to focus on the next updates, like I said earlier, say these are the amount of doctors that have samples.
That's a relevant metric. And then to your second point, yes, we'll continue to do this. Like there's 4 million new press release every year. There's 28 million out there. So the samples are a very cost-effective way for us to get people to try the product. It's not a huge line item in our P&L, so you can continue to see us sample lightly.
And then the other one, which would be good to clarify is you mentioned hyperemia earlier. Help people understand -- for those that haven't read my explanation, you've had the explanation, what happened there in terms of how in clinical trials, there was somewhat of a disconnect in how that was recorded or not reported versus what people are seeing in the market?
Yes. So if you think about hyperemia happening here, it's like I said, it's very short-lived. It's maybe a maximum of 30 minutes or so for most people, and it's very tachyphylactic. So after a couple of days, it doesn't even occur anymore.
So how the clinical trial is set up, like in most instances, patient gets the drop in their eye, gets set into the waiting room. Hyperemia is not something that you notice as a person. Like you don't notice your eyes are, unless you look in a mirror like it doesn't itch, it doesn't burn, it doesn't hurt.
So there's people sitting in the waiting room and actually being very excited because within 10, 15 minutes, they can see their phone again. So they're focused on that. They go, wow, this thing works. This is pretty amazing that an eye drop can do that. And 30 minutes later, they're actually called back in. That's the first time that the doctor sees them.
And actually, they obviously do all the vision tests and they get their eyes looked at. 30 minutes in, like I said earlier, for most people, the hyperemia is dissolved. And for those that it's not, it's very mild. So that's how we, if you combine the 2, had about a 15% hyperemia rate in the clinical trial.
That's why that was out there in real world, have all these doctors that are using it, using it on themselves, and they are looking in the mirror. So they are looking at other people's eyes, and they are realizing that maybe it happens a little bit more. For them, that's not really an issue.
Like when we were talking to them, they're going like, well, why is this a big issue? If I fit somebody with contact lenses, they're going to get red eye for the first day or 2. If somebody if I give somebody a dry eye drop, it's way worse than what we're seeing here. It's so transient. If it's really an issue for somebody even dosing your first 2 days, then put a double [indiscernible], it clears up in 2 days. So I think that clarification, how we've changed the messaging around that has landed very well as we can see in all our data now.
And interestingly, it's the opposite with the headaches, you're seeing -- why are you seeing less headaches, which is good. You're seeing less headaches now versus in the studies. What's is there an explanation for that or...
No, we were -- like we saw it, frankly, like 11% in the study, which is, if you take out the normal rate, it's not that high to begin with. Think about this, people would come in 7, 8, 9 times over the course of the study. And every time they're asked, how you're doing, if you score a little bit of a headache once, then you score obviously is 100%. That's how it works.
So I think it's something that if you focus on it enough, you'll see it. In the real world, it's something that doesn't really happen. But also there, and we saw it in a clinical trial, that's also highly tachyphylactic. What we saw in the trial is that if you want of the 11% that has a headache, chances that you have it on day 2 are only 44%, 7 days in, it's like 25% roughly. So it's tachyphylactic to begin with. It's great to see that we're not seeing it in the real world.
I think we talked earlier about refill rates. And since you have the 1 month and the 3 month, talk a little bit how are you going to talk about the refill rate? If I go and get a 3 months, it's as though I could have gotten 2 refills, right?
And that's how it comes.
So how are you going to just mathematically like talk about that to the market?
Yes. So a 3-pack gets registered as 1 NRx, so 1 new script and 2 refills. So that's how we'll report it. That's also IQVIA and Symphony will pick it up. So you'll see it there as, again, 2 refills on your first script. We're seeing people ordering 3 packs, which is encouraging.
But frankly, we're not reading too much into it at the moment. Like at the moment, I don't even know if that person had a sample yes or no or whether they were just intrigued by the idea and want this. We won't know if they're reordering the 3-pack logically until at the earliest month 4. So again, it's great to see that people are ordering them, but this is something that we'll be much more focused on, let's call it, Q2, Q3. This period is really around how many patients are starting.
I know over the years since you've been talking about the launch, you identified certain market segments that you would expect to be have high uptake. Are there areas where you're seeing uptake? I know it's very early and you're still analyzing the data. But are there areas where you're seeing surprisingly higher uptake than you would have expected based on some other demographics and you said, oh, that's interesting? We wouldn't have expected to see that piece of the market demonstrate interest.
Yes. So what we're seeing at the moment from a data perspective or a segmentation perspective is relatively limited. So we have obviously up-to-date and daily information coming through the e-pharmacy. And that's why we see age of the patient group, male, female, and the location. That's the basic information that we're getting.
But the good thing there is that it's playing out exactly like we predicted and how we planned and how we put a strategy around it. So like I said earlier, it's SKUs, slightly female, so 60% female, 40% female in the orders that we're currently seeing. 45- to 55-year-old, order more than the 55- to 65-year-olds, who order more than the 65 and over, but we see scripts in all categories.
And we are seeing it more being ordered in those urban areas that I spoke about. So it's playing out exactly like we thought. Those other groups that we've spoken about before, the people that are in contact lenses, the people have had LASIK, people are active aging, that's info that we'll start to get once we turn the DTC because that's when you specifically start to target them and you can do metrics on that. So a little bit too early to see that. But given that everything that we're seeing now is spot on, we have confidence that we are right there as well.
And you picked up -- I mean you did a lot of work, as I understand, to pick the price. So just kind of walk us through how you did that? Why was that the right number?
Yes. So how you set pricing on a product is most of us will work with a company called Kantar, who are the, again, the best company to do this with. So you do large pricing studies where you have whole panels of consumers or future consumers that basically price point by price point, you ask, would you still buy this? So that's how you build your price elasticity curves, and we've done that multiple times over.
It very clearly shows that the $79 that we sell at a monthly pack maximize price. Interestingly or maybe not so interestingly, that was exactly the price that we sold that as well if you use the same company. So $79, that's where you revenue optimize. Now you do see a smaller but still interesting other price point that people buy at, that's around $65, $66.
So that's why we're having that 3 pack that at $198, which works out to be $66 a month. If you buy the 3 pack, that's what -- that's the price that you pay there. So that's how those 2 price points came to be. We're not hearing any pushback on price, like we're not hearing back from the market that I want to use this, but like $79 is too much for me.
Just to emphasize, it's cash pay, but you need a prescription. So -- and what else has to happen for the physician to give the prescription, what other tests or checks do they have to do for...
Yes. So nothing mandatory, but recommended and it's good practice to begin with, is an eye exam. So we encourage that, and we train our sales force and our physicians on it that the ideal patient comes in, either you tell them about this or they come asking about this once we've turned DTC on, you -- do your normal eye exam, then you do a retina exam.
And then following the retina exam, you tell them about the product, how to use it, what to expect, glad to have them leave with a sample and a script. So that retina exam, again, it's good practice to begin with to do that annually is good practice for a product like this.
And last question. So Sarah Jessica Parker, obviously, a big name. Like is there a date or is there a reference point like when in 1Q, is this -- are we going to start to see her face on your side and on the phone. Can you characterize like when is it actually going to happen? Is there a launch date for her being the spokesperson?
Yes. No. So we're -- like what we're saying is it's going to happen. We'll turn DTC on in Q1. We're ready for it. Like what we -- and the reason that we did Q1 and not Q4, and frankly, most companies would wait 12 or 18 months is that we're a self-pay product. So we don't have to wait until the product is on formulary and covered by insurance.
So we're not helped on the back end by that. At the same time, you don't want to do it too early because you want to make sure that your doctor base is ready to serve all those patients that are coming in, that they know about the product, you going back to that, that there is awareness that have confidence because they've used it, and therefore, they're ready to prescribe. We're at that point now, we feel. We'll continue in the next couple of months, and it will continue to grow, but we're getting very close to, in our mind, being ready to start the DTC.
There is a practical component to it. We shut the commercial a couple of weeks ago in New York. That needs to go through production that needs to be signed up. That needs to go through an RN, what's called MLR, then it needs to be shown to the FDA. So there's just steps involved, logistics involved that need to take that course. But you'll see it and you won't be able to miss it.
Okay. All right. Thank you very much, Evert.
Thank you, Yigal. Really appreciate it.
Thanks, everyone.
Okay. Thanks.
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Graphite Bio Inc — Q3 2025 Earnings Call
1. Management Discussion
Good afternoon, ladies and gentlemen, and welcome to the LENZ Therapeutic Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded.
At this time, I'd like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead.
Thank you. Good morning, and thank you for joining us today. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. I'm joined today by Evert Schimmelpennink, President and Chief Executive Officer; and Shawn Olsson, Chief Commercial Officer; as well as Dr. Mark Odrich, Chief Medical Officer, who will join us for the question-and-answer session.
Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LENZ's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the SEC, which can also be found on our website.
In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statement. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our third quarter 2025 Form 10-Q, which is being filed today.
With that, I will now turn the call over to Ev.
Thank you, Dan. Good morning, everyone, and thank you for joining us. This is an incredibly exciting time at LENZ as today marks our very first earnings call as a commercial company. The third quarter and recent period have been truly transformational for us, defined by the FDA approval of VIZZ in July, which came ahead of our August PDUFA date and by the successful commercial launch of VIZZ in the U.S. in early October.
VIZZ is the first and only aceclidine-based eye drop for the treatment of presbyopia in adult. We are proud to have brought this important innovation to the market. We're now just 1 month into the launch, and our main focus is on giving doctors the opportunity to experience VIZZ in the real world, trying it themselves, with the staff and with some other patients. And already, we're seeing tremendous enthusiasm from the eye care professional community as VIZZ makes its way into their practices.
As of the end of October, more than 2,500 doctors have already prescribed VIZZ. What's particularly impressive is that 40% of those prescribers have already written multiple prescriptions. All of this has led to over 5,000 paid scripts for VIZZ being filled by [indiscernible] in October, a number that represents a very impressive start of our launch, clearly showing both consumer interest and satisfaction with VIZZ. And these are just some of the early milestones, only about 4 weeks into our launch that we're very encouraged by.
This early adoption is aligned with the consistent and very positive feedback we are hearing. Doctors tell us, VIZZ delivers rapid meaningful improvement in vision and a long duration of effect for a broad group of presbyopes. They also point out that it's clearly differentiated from anything that used before. Anecdotally, we hear about noticeable improvements in distance vision and the early feedback that we're getting from the fields also suggest that instances of headache, the side effect that we were most focused on in our clinical trials appear to be minimal.
All of this aligns with the fact that aceclidine is the only pupil-selective and [indiscernible], which again really bodes well for the uptake of VIZZ. In line with our label, the most noted AEs appear to be brief initial staying on installation and transient hyperemia. And based upon early results, we're hearing more of it than we initially expected. AEs in our trials, like an all well-run clinical studies are a combination of doctor observations and direct patient feedback doctor asks for.
Our initial thoughts on the potential variance is driven by 2 main factors. First, in our trials, doctors would dose the patient and then return to them for the first set of measurements 30 minutes later. By then the redness, if it happens, lessens or resolved. And second, the following 5 days, subjects would dose at home. And by day 7, the next in-office visit, the patient had already progressed past the Tachyphylaxis phase.
This appears to be very much in line with what doctors and patients are reporting now. But stinging and redness tend to be short-lived and fade quickly for most people and the rapid and very noticeable improvement in near vision outweighs these highly transient early effects. Importantly, many doctors describe it as Tachyphylactic, meaning it becomes less noticeable after just a few days, in line with what we're hearing from patients as well.
We've already tailored our field messaging based on this feedback, helping doctors to set expectations and share their experiences with confidence, so patients know exactly what to expect and why it's worth it. And we're seeing this work in their practices. As I mentioned, this fourth quarter is really focused on providing doctors with confidence and the right processes to prescribe VIZZ. That is essential groundwork as we prepare for our direct-to-consumer campaign early next year. Ensuring that ECPs and their staff are ready to serve what we believe will be a significant inbound wave of patients.
We think of our DTC campaign as the second phase of our launch, and we're thrilled to announce that Sarah Jessica Parker will serve as a spokesperson. She needs no introduction. SJP as we prefer to be called, is an iconic figure and like this truly represents a category of 1. We believe this partnership perfectly reflects our brands and the confidence, style and authenticity we wanted this campaign to embody. And we are excited to share more as we roll out the campaign in early 2026.
We also strengthened our balance sheet during the quarter. In October, we completed a direct placement to a single large institutional investor through our ATM, raising more than $123 million and bringing our current total cash position as we launch VIZZ to roughly $324 million. All these significant milestones position LENZ as a disruptive new entrant into the ophthalmology space as we look to establish this as a standard of care for adults frustrated with presbyopia.
We've talked before about the 3 phases each doctor moves through as they get ready to recommend us, awareness of VIZZ, confidence in the product and willingness to prescribe. Let me touch on where we are in each of these areas at the end of October, roughly 4 weeks after the first samples reached the field.
First, we've made tremendous progress on awareness for VIZZ among the eye care professional community. The mid-October survey showed awareness among doctors at 90%. This is an outstanding number for such an early stage of launch and speaks to the strong engagement we're seeing. And we believe it bodes well for product uptake and long-term adoption.
Moving to confidence. As we spoke about, VIZZ is built through real-world experience. It's about doctors using VIZZ themselves, observing its effect and hearing positive feedback from start and early patients. Driving that experience for October alone, we've already distributed more than 70,000 samples to roughly 7,000 offices, initial average of about 10 five pack samples per office. The interest level has been very high, not only from our target doctors, but also from many outside vet group. That tells us the word is spreading and the enthusiasm is broad.
And finally, willingness to prescribe. This is where awareness and confidence translate into action. As I mentioned earlier, more than 2,500 doctors have already prescribed VIZZ in the first few weeks and over 1,000 of them have prescribed multiple times. VIZZ has resulted in over 5,000 filled scripts in October. That's an incredibly strong start VIZZ early in the launch, something we're pleased with and want to recognize our sales force for. We've been lucky to have been able to pick the best of the best at our specialty reps, and they are out in the field delivering each and every day.
Having them building this willingness to prescribe with the ECP community is fundamental to our success and sets us up for the next phase, our direct-to-consumer campaign in the first quarter of 2026.
Before I hand it to Shawn, I want to reiterate our confidence in VIZZ and the strength of this launch. We know the efficacy of VIZZ is excellent and what we're hearing from doctors in the field continues to align closely with them, if not better in some cases. VIZZ is the first and only truly practical pharmacologic solution for presbyopia, one that restores near vision without compromising distance vision and that integrates seamlessly into everyday practice.
As I said before, this is more than just a product launch. This is the start of a new category, one built on real-world efficacy, genuine doctor and patient confidence and seamless access to both samples and product.
With that, I'll hand it over to Shawn Olsson, our Chief Commercial Officer, to share more color on how the launch is progressing. Shawn?
Thank you, Ev and good morning, everyone. As a quick reminder, presbyopia is the largest unmet vision condition in the United States. It affects approximately 128 million people, population nearly 4x larger than those of dry eye. In fact, presbyopia affects more Americans than dry eye, demodex, child myopia, macular degeneration, diabetic retinopathy and glaucoma combined.
Our commercial organization remains fully focused on one clear objective in Q4 and the first pillar of our commercial strategy, driving doctors to recommend VIZZ. We know that eye care professionals adoption is the critical foundation for our launch, and we're executing a clear 3-step strategy.
First, driving eye care professional awareness of VIZZ, then building confidence and ultimately establishing willingness to prescribe. Let's start with driving awareness of VIZZ. Our awareness phase has been highly successful and is largely complete. As Ev mentioned, we successfully achieved 90% eye care professional awareness of VIZZ since approval.
This is a phenomenal awareness driven by a robust multichannel campaign. This included a broad media plan with over 5 million digital impressions, a strong presence at major industry events such as Vision [ XO ] West, Academy Optometry and the Academy of Ophthalmology and the exceptional effort of our 88-person field sales team. We're conducting over 13,000 calls every 4 weeks. Our memorable singles global brand name has also contributed to this remarkable awareness.
Moving into building confidence in VIZZ. In October, we progressed from the awareness of VIZZ to the confidence in VIZZ. This stage is powered by real-world experience through our sampling strategy and peer-to-peer engagement at speaker drove app. To date, we've distributed over 70,000 samples to 7,000 ECP office, driving exceptional engagement. We're seeing positive organic stories emerge across LinkedIn, TikTok, Facebook and other social media platforms as both ECPs and patients share their experiences.
One notable story involved a skeptic doctor converting to a VIZZ believer after a LENZ sales rep challenged them to put VIZZ to the test. This ultimately ended up with the eye doctor and patients sharing their positive experience with VIZZ on FOX News, which ultimately was syndicated across multiple markets.
We also launched our KOL-led speakers bureau in October. We have already held over 50 of the 140 events planned for Q4. These sessions highlight VIZZ's unique MOA, robust clinical performance and ease of integration into the practice. To ensure credibility, our speakers were among the first to receive product samples and share their real-world results. Ultimately, we're seeing great progress and the confidence in this phase. The feedback is positive, and it's clear this product is highly effective at restoring near vision with a rapid onset and long duration.
As a reminder, the primary issue with the long-term adoption of UE was for most patients, it did not work. And when it did work, it did not work long enough. We continue to see this as a category of 1, and this stands alone in this category as the only drug achieving the necessary sub-2 millimeter people to restore near vision for up to 10 hours in both clinical trials and real-world use. We continue to hear great feedback from eye care professionals and their enthusiasm and person experiences are building strong confidence in both the product and its result.
Finally, we move to willingness to prescribe, the culmination of awareness and confidence. Our goal is to bring ECP to this stage by the end of Q4. Already more than 2,500 ECPs have prescribed VIZZ with 40% writing multiple prescriptions, resulting in over 5,000 prescriptions filled through October. We believe this clearly demonstrates a strong belief in the product's performance and alignment with the patient's need is already being established for an effective presbyopia solution in the first few weeks of launch.
Looking ahead to the consumer phase, as we prepare for 2026, we are well positioned to transition to the consumer phase of our launch. This category has proven to be highly responsive to promotion, both from prior launches and the organic virality surrounding VIZZ. In Q1 of 2026, we will initiate our direct-to-consumer campaign, driving the second pillar of our commercial strategy, which is consumers to request us finding.
Our team has been preparing extensively for this consumer campaign. As a Category 1 product, we must break through the advertising clutter as we compete for the consumers' views, inspire authentic belief in VIZZ and ensure consumers see VIZZ as a worthy investment. To achieve that, we knew we needed a direct-to-consumer campaign spokesperson with stopping power. who resonates with our target consumers, who is an authentic user of VIZZ and aligns to a category of one lifestyle product.
We are excited to share that we achieved all of these objectives and partnered with Sarah Jessica Parker to lead the VIZZ DTC campaign. In fact, our marketing team just completed the commercial shoot in New York City with SJP yesterday, and we are thrilled. The marketing team's efforts are now focused on finalizing the creative assets and ad spots to support our Q1 2026 consumer campaign launch. We look forward to providing further details on our exciting DT strategy in the months ahead.
With that, I'll hand the call over to Dan Chevallard, our Chief Financial Officer, to highlight our financial results. Dan?
Thank you, Shawn, and good morning. As has been mentioned, the third quarter of 2025 and recent period has been an extremely productive and exciting time at LENZ, headlined by our FDA approval and the commercial launch of VIZZ, but also included great progress with our ex-U.S. strategic partners and more recently, from the standpoint of substantially strengthening our balance sheet, which I will go to in a moment, not to mention the exciting news that Shawn just shared on our DTC campaign.
Importantly, and before I proceed, please note our first product sales of VIZZ occurred in October. So, there were no product revenues in the third quarter. The script data that we highlighted today was from the month of October only. As Ev mentioned, in early October, we received a meaningful inbound inquiry from a single large institutional investor on our ATM, which ultimately resulted in an initial block trade of $80 million, but was then followed by a second block trade of approximately $44 million, exhausting the remaining available balance on our ATM program.
Pro forma for these placements, we ended Q3 2025 with approximately $324 million in cash, cash equivalents and marketable securities. We view the timing, magnitude and conviction of this single inbound as a tremendous validation of our launch strategy and the promise of this and again, reiterate our cash on hand is anticipated to fund the company's cash runway to post-launch positive operating cash flow.
I'd like to now turn to our ex-U.S. strategic partnerships where we had progress and advancements on multiple fronts. In the third quarter, we recorded total license revenue and received cash payments of $12.5 million, which can be broken into 3 parts. First, we recognized revenue -- license revenue and received payments for 2 separate $5 million milestones under our development and commercialization agreement with Corxel Pharmaceuticals in China, totaling $10 million, including a China-based regulatory milestone upon submission of the NDA for LNZ100 to the Center for Drug Evaluation of the NMPA in China and a U.S. FDA-based regulatory milestone upon the approval of VIZZ in the United States.
In addition, and as we announced in July, we executed an exclusive license and commercialization agreement granting Laboratoires Thea to register and commercialize VIZZ for the treatment of presbyopia in Canada. Under the terms of the licensing and commercialization agreement, LENZ received and recognized as license revenue a $2.5 million upfront payment and will be eligible to receive over $67.5 million in additional regulatory and commercial milestone payments, as well as tiered double-digit royalties on net sales.
Moving on now to our third quarter operating expenses. I previously discussed a planned ramp in our total operating expenses, specifically driven by commercial spend as we move into the second half of 2025. As anticipated, our total Q3 2025 OpEx increased to $31.4 million, a 44% increase over Q2 and well aligned with our operating plan.
Total SG&A expenses increased to $27.6 million in Q3 compared to $6.5 million for the same period in 2024, driven primarily by the increase in commercial headcount, including the full financial cost of our sales force for the entirety of the quarter and substantial pre-commercial marketing, advertising and other commercial planning activities to support the commercial launch of VIZZ. Sequentially, SG&A increased quarter-over-quarter by approximately 116% from $12.8 million in the second quarter.
I would like to highlight a key point that we have made on previous calls and in what will be a consistent objective and that we will continue to be measured in our spend on the general and administrative side of the organization as we aim to remain lean and efficient G&A team and have the predominant growth in SG&A be driven by spend to support our commercial strategy.
Total research and development expenses decreased to $3.8 million in Q3 2025 compared to $6.5 million for the same period in 2024. Sequentially, R&D expenses decreased quarter-over-quarter by 58% from $9.1 million in the second quarter. As a reminder, the majority of our research and development expenses prior to FDA approval of VIZZ enjoy -- prior to the FDA approval of VIZZ in July of 2025 were dedicated to our manufacturing operation efforts to establish pre-approval commercial product and sample inventory to support our launch.
Finally, our net loss per share, both basic and diluted, was $0.59 per share in the third quarter of 2025 on a net loss of $16.7 million compared to a net loss per share of $0.38 per share in the third quarter of 2024 on a net loss of $10.2 million. We ended Q3 2025 with approximately 28.6 million shares of common stock outstanding. Pro forma for the October ATM activity I noted previously, we have approximately 31.3 million shares outstanding today.
In summary, we feel this quarter and recent period has been on schedule from a spend perspective and are pleased to have recently bolstered our balance sheet from both dilutive and nondilutive sources. It has never been in a stronger financial position than we are today to support the VIZZ launch.
With that, I'll turn the call back over to Ev.
Thanks, Dan. To conclude, I'm exceptionally proud of the LENZ team for all that we have accomplished, an early FDA approval for VIZZ, preparing the team for launch, maintaining an extremely strong financial foundation and now seamlessly executing in these first weeks of our launch. Driving ECP awareness, confidence and willingness to prescribe ahead of activating our DTC campaign in Q1 2026. We look forward to our early momentum to continue and updating you on our progress as we launch this as a true category 1 product.
And with that, I'd like to open up the call for questions.
[Operator Instructions] Your first question comes from the line of Stacy Ku from TD Cowen.
2. Question Answer
Thanks so much for providing such a fulsome update. So, first question is on the speaker-led bureaus and maybe some of the other approaches you are all taking to appropriately set expectations. Could you maybe talk further about how the commercial team is working with these KOLs to maximize discussion and expectation setting on the VIZZ profile, just provide a little bit more detail here. I just want to make sure we understand how motivated patient is able to appreciate the efficacy versus the transient redness and stinging. That's the first question. And then second, wondering if you're able to disclose some of the week-over-week cadence of prescriptions for October as we think about those over 5,000 prescriptions that are coming from the clinicians. And then last question, I wanted to just understand -- still early days, but if you're hearing any anecdotal feedback, be curious if any folks are immediately opting for the 3 months versus 1 month. Just trying to understand how the patients are trialing these days.
Thanks, Stacy. Good questions in there. We'll pick them up one by one and tag team on it. So, on your first one, I think importantly, just to highlight that what we're not hearing is this product doesn't work. So, the discussion actually usually focuses on that, that people realize and doctors realize that as soon as you put a drop in somebody eyes, but in and totally 10, 15 minutes, your vision improves. That's very important to realize, and that's what we continue to hear back. And like we said, what we're also hearing is that people notice that also the distance vision in many instances approves. That's always the center of the discussion.
Now no different than when we launched this product and how we prepare for it. Like with every product, it's important to set expectations and tell patients that these are the positive things that you are going to likely experience and you may be one of the patients that experiences one of the side effects that is on the label. That's setting up expectations was always and continue to be a focus of our sales force and are doing that extremely well. What we've seen is, as I highlighted in the call is that I think like most miotics, we were in our trial and in preparation for launch, most focused on potential headaches in a small subset of the population, and that doesn't appear to be happening a lot.
So, one of the few almost minor changes that we've made there is that as the sales force talks about some of those potential side effects, the focus has now shifted away from this potential headache more to the potential redness. Our trend here is I think that's important to highlight as well and that with a few days of use, that's something that for most patients no longer happens. And again, there, it's important to realize that this is nothing new for an eye doctor. If they fit somebody with bifocal lenses, they tell them to use it for a couple of weeks to get used to it. Same for many other products. So, this truly is not a big thing. What we're hearing from doctors and for many of them is if this really is something that allows patients, they immediately offer up some eye whitening agent to use in those first couple of days.
So, that's what we're doing on the sales force end in those 13,000 calls that they're doing on a 4-week basis. Maybe Shawn can talk about what we're doing on the KOL side on the speaker bureau.
Yes. Absolutely. So, thanks for the question, Stacy. So, when you think of all these speaker bureau events, we're running over 140 this quarter alone, and that will continue on in 2026. So, obviously, in our speaker bureau, we lay out the expectation setting for patients in there as well as how to introduce it to the patient. In that section specifically, we've now updated our speaker bureau deck, and we actually lead with highlighting the discussion around eye redness and how its transient goes away. I think that's very important.
We've also incorporated actual real-life photos of the before and after every -- at 5 minutes, 15 minutes and 30 minutes, so people can see the transient nature on it, as well as the pictures of the eyes from day 1 and day 4. And so it can contextualize for the doctors. Again, this is something they're used to. This is a item that really focuses on near vision and it does a great job restoring your vision quickly and long versus the transient nature of the redness.
Thanks, Shawn. And real quick, and I'll combine your next 2 questions on trends in script data and [indiscernible]. Important again is that we really look at this fourth quarter as getting that experience of VIZZ out there. We're truly very encouraged by the initial script data that we see. Just to remind everyone, initially and up to, frankly, not even fully now, the product was only available in the pharmacy, which is why we continue to highlight that full availability of the product is not going to be until the middle of November.
What that means is that not all retail pharmacies are fully available or patients that go there might not immediately be able to get that product. So, against that backdrop, we are very encouraged to share that we've already had 5,000 filled scripts. I think it's too early to start sharing what the trends are. One thing that we do notice that actually, if you look at Symphony data, it's more accurate than we initially thought. So, I'll leave you with that comment there.
And then we are seeing some patients opt in for the treatment. Again, that's only available through e-pharmacy. So, it doesn't make sense at this moment to comment on what that percentage is. That's something that we feel once we have that full quarter behind us, this full quarter behind us, and we truly have both channels fully available, that's a more meaningful step to look at.
Your next question comes from the line of Yigal Nochomovitz from Citigroup.
Congrats on the early launch process. I had a few. I guess with regard to the 5,000 or over 5,000 paid scripts, I wonder if you could contextualize that in the context of what we saw with VUITY and how you compare in the early days there. And then obviously, you're essentially flooding the market with samples. And so could you just comment on the conversion from samples to paid scripts and how you expect that to evolve over time? And then lastly, if you could briefly just comment on the choice of the spokesperson in SJP, how did you arrive at her? Has she used the product yet?
Thanks, Yigal. Great questions. Like I said, we're very encouraged by what we're seeing in our launch. I think different than VUITY this is very much focused on driving that experience. So, getting to the amount of scripts that we've just shared, again, like I said earlier, not the full channels firing just yet is something that we think bodes really well and compares really well to what we saw there.
I see the second part of your question there, the sample conversion?
Yes.
Yes, sorry. The sample conversion is something that I know is something that people look at for maybe more traditional launch. Remember that this sample is just a 5 pack, and it's all about making sure that whoever wants to try the product has access. So, definitely just early in the launch. We're not as focused on what that conversion is, but much more focused on making sure that really every meaningful doctor's office in the country has availability of samples. Also, what we're seeing is that the very first thing that happens as our reps deliver the samples is the doctor reps open a pack, product in their own nice and the staff. So again, I think early on, it's not really a metric that we're focused on also from a cost of goods perspective. This is not a very meaningful part of our P&L.
So, in short, we'll continue to float the market with samples. We think it's a great tool that will drive patient uptake.
And then the last question on the choice of spokesperson. So, when we're evaluating the spokesperson for VIZZ, we had a lot of criteria that we analyzed against. One, the person had to be authentic, right? Really had to be someone that was a presbyope. It had to align to our consumers. Again, when we look at the early sales of VUITY, we knew that it was predominantly in major metropolitan areas. It also biased a little bit more towards female than male. We want to make sure we got consumer aligned this.
We want to make sure we also had alignment with our brand. When we think of VIZZ, we wanted someone that's elevated, someone that's a category of one or someone that stands out amongst everyone else. And our first choice was Sarah Jessica Parker for this, and we couldn't be more happy.
Now this is a person who is authentic. One of our requirements is they must have used the product, tried the product and they liked it. And one of the reasons we waited until now to share who that slurry was is we need to get them samples so they can try the product and get them on to VIZZ. And so this person -- Sarah Jessica Parker has used the product and does like the product. We're really excited to partner with her and to launch in Q1 of 2026 with that campaign.
Your next question comes from the line of Biren Amin from Piper Sandler.
And thanks for sharing a lot of the metrics around the launch. I had a question around that. So, you highlighted how you detailed the 17,000 unique eye care professionals. And of those, I think about 7,000 ECP offices have been sampled and then 2,500 ECPs are now unique prescribing. So maybe just talking through that funnel, is the expectation in the next few months that the remainder of the 10,000 ECP detailed that haven't been sampled will be sampled. And then the conversion rate from sample to prescribing ECP, what characteristics are you seeing on that? And is the expectation that, that number will grow given the samples across the 7,000 ECPs?
Thanks, Biren. Shawn, I will again tag team him on this one. So, as we think about providing samples to these offices, again, the call rate at the moment, and we've got no reason to believe that this is going to change is about 13,000 visits every 4 weeks by our sales force, which again is a tremendous achievement and want to highlight the great work that they're doing out there.
If we say 7,000 sample or 70,000 samples delivered, that's 7,000 offices. What we know and what you see is that many of these offices have more than one doctor in it. So, the actual amount of doctors that have samples will be slightly higher than the 7,000. But ultimately, as I mentioned earlier, the aim is indeed to have samples available at every office that wants it. So, we'll continue to push for that. The current focus is really to get our sales force to those targeted doctors, doctors that are prescribing doctors that have maybe previously prescribed VUITY.
But what we are seeing, and I mentioned that in my prepared remarks as well, is that there's a lot of interest from offices outside of those initial 12,000 to 15,000 that we're focused on. So, we're definitely putting mechanisms in place to ensure that we can provide them with our background and samples for the product as well. And definitely, that number continues to grow. And we see that, frankly, on a daily basis on the numbers that we see coming in.
So, maybe Shawn can talk a little bit more on what we see in doctors that are -- those first ones that are converting into being less.
Yes. So, we'll continue to roll out these samples over the next few months. Our samples, as a reminder, will be always ongoing. We want the patients to try the product before they actually move into a script. When we look at these writers, what we're seeing is, again, general trends as expected, right? When we look at the VUITY launch, we saw that the early adopters are those in metropolitan areas, those that are predominantly optometrists, and we continue to see that, and we continue to focus on those people in terms of our call cycles and continued rollout of samples.
Your next question comes from the line of Marc Goodman from Leerink Partners.
Two questions. First, for the patients who've gotten prescriptions, can you give us any sense of like what are they like? Are they men? Are they women? Do they tend to be your typical early presbyopes? Are they a little bit later? Just anything you can tell us about them and what would be unique about them? And then second, on the DTC, just how extensive will this be? Is this going to be like analog where you're watching 6:30 news on television like the old days? Or is it digital only?
Yes. Great question, Marc. Thanks for that. So, if we look at the filled prescriptions to date, because this is coming through our e-pharmacy, we do have a lot of information on the demographics of patient. And again, it's in line with what we expected, right? So, we see the prescriptions. It's mostly people in that 45 to 65-year-old age group, right, still gainfully employed. We are seeing a bias towards female over male, again, as expected, and we're seeing it in those metropolitan areas. So right, really those more developed areas along with what we saw with VUITY and being the biggest space in markets.
This is great confirmation before I move on to what your second question is your DTC. These are the areas the adopters expected and that we're seeing and our DTC has targeted them as well. And what we find in these early adopters is they're not necessarily on analog TV or linear TV is the other common name for it. What we see is they're spending time on a more digital environment, which is your Instagram, your Facebook, your YouTube and your Pinterest. And so that's where the majority of our DTC will be focused. So, it is predominantly digital and hitting on where they spend the time.
The great news is with our already market research that told us the early patients are as well as the confirmation of what we're seeing in early patients, we can further target them through where they live, what they research online, what their annual income is to have a successful DTC campaign.
Your next question comes from the line of Jason Gerberry from Bank of America.
This is Pavan Patel on for Jason. First is, can you maybe help us break down the use of e-pharmacy versus traditional retail pharmacies within those initial 5,000 scripts? Just trying to get a sense of how closely we're going to be able to track those patients and get a sense of expected refills. And I think Ev may have mentioned that there's some supply that's being available on e-pharmacies that is different versus retail pharmacies. Just if you could clarify those comments. And then my second question is with regards to the SG&A run rate for 4Q. I guess, how should we be thinking about that? And then as we look towards 1Q of 2026, can you just help us quantify the expected step-up in spend associated with the new DTC campaign with the spokesperson? Thank you.
I'll take the first one and Dan will talk about the SG&A. So, like I explained earlier, currently in these first weeks of launch, initially, the product was only available through e-pharmacy. And only in the last couple of weeks, slowly, the retail pharmacy has come online. So, whatever that split at the moment is, it will not be representative of how this will go forward. So, I think it's too early to give any call on what that split is. What we are seeing, and I think that's expected is that Symphony and IQVIA as it comes online will have a good sense, we expect of the product that's flowing through retail, less so on the e-pharmacy side, although as I mentioned earlier, we're surprised to see that Symphony is tracking the e-pharmacy side to a degree.
And then I think your question was around the difference in availability of product through e-pharmacy. I think as we mentioned a lot, there's a 3 pack that's available for consumers to buy at a discounted rate of $198 per pack. That $66 that could translate into $66 a pack, which obviously compares to the $79 if you do a one pack. Importantly, from a bottom line perspective, it's the same to us, but obviously gives that advantage to the patient. That pack is only available through e-pharmacy. So that's the difference there.
And then on the SG&A side, I'll hand it over to Dan.
Thanks, Ev. And Pavan, thanks for the question. So just to break down the OpEx overall, what we talked about this year were 2 trends. One was you should expect SG&A to ramp into the second half, which I'll characterize for you. And then you also should expect R&D to do the opposite, which also has done. So, R&D of $9.1 million in the second quarter down to $3.8 million in the third quarter, you should expect that to continue to taper.
And on the SG&A side, having spent $12.8 million in Q2 for SG&A and that bumping to $27.6 million in Q3, that trend is what you could reasonably expect. Now Q3 did include some one-timers you would expect around the moment of launch. There were some onetime costs. But what we've always said for 2026 was assume a commercial spend of $80 million to $100 million per year, inclusive of the DTC. And then layer on top of that, the G&A spend on the order of $20 million to $25 million. That kind of 4:1 ratio we've consistently talked about of sales and marketing versus G&A.
I would just reiterate that at this point in time. So, if you take those assumptions and model them into 2026, we would be comfortable with that and are continuing to guide in that way.
Your next question comes from the line of Lachlan Hanbury-Brown from William Blair.
Congrats on the progress. I guess, you mentioned that there's been a decent amount of nontarget doctors that have expressed interest and you're putting mechanisms in place to support them. Can you just elaborate on what that is? I mean are you going to need more sales reps to support what looks like thousands more doctors than the current target list? And then maybe a quick second one. Any comments on the sort of average time to fill at the moment that you're seeing in the e-pharmacy so far?
Great question as well, thanks. So, on the non-targets, one of the mechanisms that is in place is that we also have an inside sales force of 10 people that are available to connect with those offices. And we do have a mechanism where we can actually ship samples to them. What you also see is that for sales force, and we definitely again want them to continue to focus on our target accounts even in the same literally street as an untargeted one that is prescribing and that's obviously data that's all available. That's an easy stuff for them to make as well.
But some of the things we've always spoken about, and you guys know that, that over time, we may increase the sales force. We have no plans to do that any earlier, but it is obviously something that we'll continue to look at. And as soon as that makes sense, we will pull that, that trigger. So that's on those 2 mechanisms.
And then time to fill can be very quickly. We see and that's what's in place on the e-pharmacy side that you leave the office with a script in hand, you fill it out on your phone and just normal shipping is in most instances, 2 to 5 days. If you really want the product earlier, that's a priority shipping in place as well. And we see that work well on the retail side, similar timelines at the moment. So, we don't think that there's like a hurdle or a delay in filling the script.
Okay. And then maybe another one. You mentioned in the press release, I think there are about 9,000 ECPs have opted into the find a doctor tool on.vizz.com, which seems like a great number so far, but that's obviously not the whole target universe. So, I was just wondering what is sort of the barrier to getting the rest of the targets to opt in? Is it that they want experience or you just haven't got to them yet to talk about it?
No. Thanks for actually bringing that question up. I think it's an important distinction that unlike different companies or what we often see is where you just buy a data set, but in our case, eye care professionals, we want this to go very differently. It's an opt-in process. So, doctors have actively one BD their own, 2 have samples and then 3 opt in to find a doc, it's a bottoms-up fill. And again, I think the number that you're seeing there highlights the enthusiasm that doctors have for the products.
Anything you want to add, Shawn?
I say again, it's early in the launch. We're already continuing to see that grow very rapidly. And the great thing is by making sure it's this bottom-up build, it's people that we know that we've spoken to multiple times, they're understanding the MOA differences, they believe in the product, and then we're bringing them on to this process of our money back.
Your next question comes from the line of Gary Nachman from Raymond James.
So, back to the initial people using VIZZ, so the 5,000 first Rxs, can you also profile them a bit in terms of the buckets you've talked about? Are they contact lens wearers, LASIK patients, those getting aesthetic treatments? And are you seeing any pushback at all with consumer sentiment generally pretty low with the price of VIZZ? Is that holding back any Rx uptake?
Great question, Gary. Thanks for that. So, when we look at the initial users, we can't see a lot of data. What I can tell you on these initial users is there are people that are already in the practice because we haven't turned on DTC yet, it's really doctors speaking to patients that are already coming through their practice. So, it's mostly those. We can't break it out into which bucket yet of are they post LASIK or not. We'll be able to get better insight in that after we turn on our DTC and we've targeted those groups. But it does appear to be those already in the practice would then lend itself more towards like the contact lens users or people that are just going in for random checks more than the other groups.
In terms of pricing, we're not hearing much pushback at all on pricing, which is great. I think the biggest feedback we're hearing is, hey, this product works, it works fast and it works long. And so, we really see that as promising and haven't seen pushback on pricing.
Okay. And then just one more for Ev. The distance benefit that you're hearing pretty consistently, it sounds like in addition to the near vision benefit. How important is that for VIZZ's overall profile and how patients are viewing that? And will you consider a study looking at distance vision maybe to add to the label in addition to whatever data you have already?
Thanks, Gary. So, we are indeed hearing it, and that's great and something, obviously, in our Phase III data, we saw that some 41% of people in the study show if we measure the distance vision improvement there. That's clearly something that in practice translates. So that's great. It's all anecdotal at the moment. It's not key in our mind to make this successful as a near vision improvement drug. But obviously, it's a nice added benefit. We're hearing doctors experiment with it in that way and maybe experiment is not the right word, but they see again highly anecdotally that people that are minus half, minus 1, minus 1.5 are able to go without their distance correction.
Highly anecdotal, something that we are obviously following, something that we are thinking of maybe ultimately do a different study on because that could be a group of patients that you can actually serve with our product as well. So again, great to see encouraging, not a make or break for the success of this as a presbyopia drop, but obviously very nice benefit.
Your final question comes from the line of Matthew Caufield from H.C. Wainwright.
And obviously very excited for the launch. You had mentioned the focus on optometrists compared to ophthalmologists. And I was just curious how you anticipate that specific split playing out in the near term regarding the sales force targeting for driving the launch and how that might evolve in the coming quarters?
Yes. Thanks, Matt. So when you look at our sales force targeting, it's aligned to where we saw the early prescribers of VUITY. So their targets are roughly 80% optometry and then 20% ophthalmology. And so, we'll continue to look at the prescriber base, but don't see any changes to that mix in the near term right now. We're seeing consistently that, again, this does continue to be an optometry play product. And so, we're confident in that 80-20 split.
That concludes our question-and-answer session. As I'm showing there are no further questions, thank you for your participation, and we now conclude today's conference call. You may now disconnect.
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Graphite Bio Inc — Morgan Stanley 23rd Annual Global Healthcare Conference
1. Question Answer
All right. Good morning, everyone. Thank you very much for coming to the fireside chat today with LENZ. My name is [ Rob Deane ]. I'm a Managing Director in the Investment Banking division.
I just had a brief disclaimer that I need to read before we get started here. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative.
And now with that, we have the pleasure of hosting Eef Schimmelpennink, President and CEO of LENZ Therapeutics. We're very delighted to have Eef join us today for our Q&A session to share some insights into LENZ Therapeutics and their recently approved therapy for presbyopia.
Maybe with that, Eef, before we get started, can you just tell us a little bit around how LENZ Therapeutics got started for those that may not be familiar with your story?
Absolutely. And first of all, thanks for having us, it would be always great to be here and see so many of you here.
The LENZ Therapeutics has been around for a little bit. And like you said, we just got our drug for presbyopia approved a little bit over a month ago, early actually to effect, and I'm sure we're going to talk about that before. But real brief, the history of the company, it's a very smart ophthalmologists about maybe a decade or so ago now. We're looking at the presbyopia landscape, and we're seeing those doughnut-hole shape IOL lenses being brought to development. And they realize that, yes, it's going to work because we know it's basic optics. So if you have a pinhole pupil, you can create that with a lens or like we do with a pharmaceutical, you're going to improve your near vision, but they also realize that, that's pretty invasive to do that with an IOL that you permanently implant and otherwise help the eye.
So they set out to achieve the same thing, but then with an eye drop. That thought was, well, if you could do this with an eye drop, that would be phenomenal. It's reversible, noninvasive. Obviously, the better way to do that.
The three, let's call it miotics that are known, they were the first to go out with this idea, looked at logically pilocarpine first because that's a product that was first generation glaucoma used in the eye in the U.S. and immediately discarded that because of its side effects. In fact looking at thumbs that the aceclidine, which is our active ingredient was actually brought to market by Merck, the German Merck back in the '70s, '80s, feels pretty much as a glaucoma product for reasons that actually makes it a perfect presbyopia product. So fast forward, that's the asset that I picked up about 4.5 years ago, 5 years ago and that we built LENZ Therapeutics around. And as I said, we're very pleased to have that product approved now.
Great. Thank you for providing some of the context. Can you tell us a little bit about what this is and how it can be -- it can benefit patients with presbyopia. And also maybe starting to dig in a little bit around its differentiation versus other presbyopia therapeutics. I think you mentioned intraocular lenses, but just thinking about the differentiation in the treatment paradigm and the landscape.
Absolutely. So maybe let's start actually by -- and we've used the term presbyopia a few times now. I know that when I was first pitched this idea by the investors that we were putting the Series A together, I literally had to Google what presbyopia was and, oh, that's what I have.
So presbyopia is the inevitable loss of near vision that happens when you age. So most of us, as we hit like roughly 45 start to notice that our near vision becomes more and more blurry and we pull a phone away from our faces to still keep it in focus. We're in a darker restaurant. We can't read the menu. You see all the people that put their lights on, on the menu. That's presbyopia. We're never going to market it like that to consumers. I'm sure we're going to talk about the marketing, but just as background, that's it. Because it happens to everyone, that market is obviously huge. It's 128 million presbyopia patients in the U.S. alone, again, effectively everyone over 45.
So what you want to do with this eye drop is create a small pinhole pupil, like I've mentioned earlier, and it's very important to get to below 2 millimeters. And that's also where the differentiation comes in because only at a pupil size below 2 millimeters is where you really start to drive that impact on near vision. That's where you really have that increased depth of focus and your near vision comes back. So very important to get to below 2 millimeters.
And if you then pull that a little bit further on, what's the ideal target product profile needs to be an eye drop that is once a day. So think of this as you wake up in the morning, brush your teeth, put your eye drop in and you're good to go for the full workday actually the previous speaker used the set it and forget it as well. That's how we talk about it as well. It's a set it and forget it. So it needs to work quickly, but also it needs to work on. So for the full workday, you need to have that benefit of increased near vision. So really bringing that seamless vision back to what it was when you were 30, 35. You wouldn't -- we never thought about the fact that if you want to look at something up close, your lens needs to do something.
Very clearly, that's what we achieved with our product. It's been tested logically in very large Phase III trials, and we've seen a near universal effect. 93% of patients get back to at least 20/40 and 20/40 is what ophthalmologists call 20/happy. That's when you can read without reading glasses. So 93% of patients within an hour at that level, 20/40 or better at 10 hours, which is the last time point that we measured, still 7 out of 10 patients at that level. So truly a product that works for almost everyone. We have a very broad inclusion criteria. It's basically an all-comer study. So it works for almost everyone, works rapidly and works long.
Great. Thank you. Now digging into some of the clinical data, obviously, you got to improve, but your data showed really impressive efficacy with over 70% of patients achieving three lines or greater near vision improvement at both 30 minutes and three hours post dose and also 40% still showing this improvement out to 10 hours to your earlier point.
Now your Phase III CLARITY trials also showed 95% of participants achieving at least two lines of near vision improvement. So with so many positive aspects of this particular therapeutic, how do you think about what to emphasize in your messaging as you're doing today? Also, can you try to elaborate on the new 20/40 data you recently revealed at launch?
Yes. No, absolutely. Great question. And you heard me go there a little bit just before. So for context, if we talk about three lines, and that's the FDA endpoint. So the FDA endpoint is improvement of at least three lines or more without losing a line in distance vision. And spoiler alert, we don't impact distance vision negatively. We actually had a little bit of improvement in distance vision, so we don't have that issue, but that's the FDA endpoint. Those are the same three lines for those of you in the audience that go to an optometrist that they make you read on those reading charts. So if you can improve three lines, that means that in most instances, you better get back to 20/20, 20/30.
So that's the endpoint. Those are the percentages that [ Rob ] you just mentioned. Again, at 30 minutes, we have 71% of patients hitting at least a three-line improvement. And remember, we have patients coming in that were 20/80, 20/100. Basically, that's from side 60 or so that you're reading up close. So very effective. Out of 10 hours, we still have about 40% doing that.
Now what we realized that as we started to prepare and talking to and we had our label to our KOLs and our doctors, they all go, that's great, but does this thing work for my patients? And that's why you're no longer talking about three lines or two lines or five, six, seven lines, which we also saw an improvement. They want to know, am I getting my patient to at least 20/40 more than 20/happy that I was talking about.
That's new data that we've been sharing since the last couple of weeks, the data that I just referenced that 93% of patients are again, near universal efficacy across a very broad patient group, 93%, 20/40 or better, 70% still at 10 hour. So that's the emphasis that we're changing now, and it's much more of a real-life example or a real-life statistic because it really means that you can read without your reading glasses.
Great. Thank you. Now that this is commercially approved, can you tell us about your commercial strategy? You've mentioned having an 88-person sales force now. How is the sales force being deployed? What are some of the key metrics you're going to be tracking to measure their effectiveness in the initial launch phase?
Yes. Thanks for that question. So if you think about commercial strategy, it's a three-pillar strategy. First one is doctors to recommend us. That's where the sales force comes in, and we'll double-click on that. The second pillar is consumers to request us by name. That's really the DTC consumer campaign that we're starting in Q1, and I'm sure we're going to talk about that as well. And then the third one is making sure that there's a seamless access to our product. So that's very easy access to first a sample that's acting as a bridge to final products and using e-pharmacy or retail pharmacy to have that product show up on the doorstep of our consumers, and again, a very easy way.
On the first one and to your question, doctors to recommend us, that's truly indeed the sales force being out there. But before that, we already have the MSL team. So we had 10 people and still have a 10 optometry lab. MSL team that started to have doctor-to-doctor discussions late last year. They already had 4,000, 5,000 discussions with unique doctors. So these are, on average, because we're measuring everything, 23-minute discussions that they have talking about aceclidine because they can do that in a doctor-to-doctor discussion, the importance of being below 2 millimeters and what makes our drug different.
Now that we have the product approved, we had about a month or so before our sales force fully in place, trained them up with the label, with the final training and they're out there now. So 88 reps talking to about 13,000 doctors and then as an inside sales force of about 10 people that are expanding that to about 15,000 doctors.
So the stages that they're going through are the ones that I'm sure most of you will be familiar with. It's all about awareness now and that awareness has shot up tremendously. So most doctors are aware of this now, even though we've only been out for near three or four weeks, they've already done over 10,000 sales calls.
And then moving that doctor in that journey to confidence, and that's where the sample is coming. So we've been guiding or very confident that we'll have samples in the market next month, October. The reps are going to hand deliver those samples to the doctors. They can obviously start using that on themselves on their office staff and on patients. So that's going to give them the confidence in the product, which will then move them to ready to prescribe.
What we even see at this moment is that there's a good group of doctors already in that ready to prescribe bucket. There's definitely a group of doctors that look at the data and say, this is phenomenal. I can see how this is different. I want to use it. I'm waiting for samples. There's very few doctors that say, I'm not interested. I think 3%, 4% of doctors that go, you know what, let's take presbyopia eye drop is not something for my practice. So very good foundational interest there already.
Great. Thank you. And your research shows over 60% of the roughly 130 million presbyopes in the U.S. would strongly consider an eye drop solution. And I think -- that seems fairly intuitive. Now how do you think about segmenting this population? And do you have different strategies in place to get in front of these various segments that you might have in mind?
Yes. No, so that really starts to tie into that second pillar, consumers to request us by name. But like you said, there's 128 million presbyopes out here in the U.S. That's a huge target audience. The good thing is that we don't have to teach disease awareness. Again, nobody knows what presbyopia is, but we all know that our vision is getting more and more blurring. But you don't want to put your marketing effort out across or diluted across 128 million presbyopes. Now it works for all of them. So I expect that we'll see in those different groups, people using the product.
Across that 128 million, as I think you've mentioned, there's a 60% high interest in the presbyopia eye drug. So if you just blanket, do a survey, that's the number that you get back, which is incredibly high. I've never seen a product that gets that kind of feedback.
When we start to segment and say, okay, let's find in those 128 million, the groups that over-index to now think about 90% or more have a high interest to try and use a product like this. There's very clear groups that you see there. The first group and each of those groups is definitely over 10 million in itself.
The first group are people that are wearing contact lenses. So they've made a decision usually in their 20s that they want to be glasses free. So they need a distance correction in most cases and have been using contact lenses for that for the better part of their lives, 20, 25 years. So clearly invested paying money to be glasses free. Now they hit 45, 50 and they realized that my near vision is going, there's not a good bifocal contact lens. So that's being pushed out of contact lenses and into wearing either bifocal glasses or reading glasses over the contact lens is clearly something that they don't want.
So they're very eager to find a product that allows them to stay in contact lenses, and that's what this eye drop does. It's literally, and we have plenty of contact lens whereas in our study. You put the drop in, in the morning, that wait 10 minutes to put your contact lenses in and now you have that seamless vision again that you were used to. So important group to target, also a very important group for optometrists because this is a group that comes back every year because they use a subscription for the contact lenses. It is a very valuable patient to them. That's the first group.
Second group, somewhat similar are people that had LASIK in the past. They put down back in the day, $5,000 or so for eyes. It's a little bit less now. But again, invested in glasses-free life. And they're coming back to the optometrist, 45, ophthalmologists going, my LASIK is wearing off. What they don't realize is it's not the LASIK wearing off, but they're becoming presbyopic. So same issue, same solution. With this eye drop, you can say -- you can just obviously keep the distance vision through your LASIK and then improve your near vision with the eye drop over 10 million people there.
And then there's a third group, what we call active aging. These are people that care about their looks. They want to go on with their active lives. Those are people that are maybe using Botox or other ways that care about their aesthetics and don't want to put reading glasses. It's difficult to target or get the number of what the Botox users is in itself. In my experience, I was in San Diego, there's at least 10 million Botox users in California alone. But it's definitely a very large group. So those are the initial groups that we're going after that we can target very, very easily with our DTC campaigns.
Great. Thank you. Now thinking about your commercial strategy now given that the cash pay therapeutic, how do you think about pricing? And are there any dynamics that are unique to cash pay treatments that we should be aware of as you're ramping up commercialization efforts?
Yes. No. So this is indeed a 100% cash pay product, which we like a lot. It makes -- it means that we're insulated from PBMs. There's no negotiations with insurance companies. It's a very fast cycle from sale to your revenue. It also means that you truly have a very healthy revenue stream there, you can control that yourself. There's no erosion on it, if you will.
So then it comes down to pricing. And as you would expect, we've done a lot of pricing studies with Kantar and looked at what's the ideal price point for a product like this. And we came out at $79 a month which, by the way, and I know that you asked about VUITY earlier, it's the same price that VUITY priced at. So not only do we have the Kantar studies, we can actually look at VUITY, which is a pilocarpine-based product that AbbVie launched three years ago that, frankly, had a great launch. They very rapidly got up to about 6,000 new scripts per week. They sold to about 150,000 patients at that $79 price point. So very clearly, it's a price point that works. It's a price that people are willing to pay for.
We did see a second price opt for them at a slightly lower number, and that's why we also are selling a three-month pack at $198, so $66 per month, that's self-funding. Basically, it's the reduction in shipping fee and distribution fee because we're still obviously just the one shipment that we're passing on to the consumer.
So same for us from a bottom line perspective, better for the consumer if they buy at that price. But again, we feel and we've seen it as a price that works. We like the cash pay. The very first scripts are going to be hitting our bottom line. There's nothing that we need to buy down in that.
Thank you. You mentioned VUITY, as you mentioned, strong launch initially and failed to really capture the market. What are some of your key learnings from the VUITY experience? And what can you do or what will you plan on doing differently?
So we learn a lot from VUITY, and it's unique or somewhat unique, I think that you have a product in the market before that but had a great launch, but that didn't fill. So let's talk a little bit about why VUITY really didn't deliver on the promise that was clearly there. We had an internal target of about $150 million for year one.
Not surprisingly, the product needs to work, but different than maybe many of the other products that we're used to, where it takes months to whatever C or cholesterol level go down. This is an instant gratification product. This is a product where I promise you that if you put this drop in, you're going to be able to read your text messages again on your phone without your reading glasses within 30 minutes on day one. So I can't mark it through that. I can't tell you or use it for -- if you don't see that, just keep using it for three months and it might improve, that's not how this works.
So if you go out with that message, you better deliver that. So VUITY went out with that message, but didn't deliver it. So many people, and I was one of them, went out, bought a bottle of VUITY, they came in a bottle, used it for a couple of days, and we're like disappointed. And that's where the comparison on data comes in.
If you look at VUITY, the challenge that they had was because it's a different mechanism, and pilocarpine also stimulates what's called the ciliary body and that drives distance vision impact and other side effects. They couldn't go up to a concentration and actually get the pupil down to below 2 millimeters. So the smallest pupil that VUITY gets to at our 1 is about a 2.3 millimeter pupil. And then very rapidly, it achieves back up to 2 to 3 millimeters. So that effective window they never really get into. And therefore, only one in four patients even noticed an effect. So that was issue one, didn't work for a lot of people. That's why they initially have samples out, but then after a couple of weeks, they literally pull the samples out of the offices because they realize that people sample, they're not going to buy it. So took the samples away. So issue one didn't work for a lot of people.
Issue two, if it didn't work, so if you want of those four, then it didn't work long enough. So people felt that, again, it worked for me, but it worked for about 2, 2.5 hours. And that was the average that you were hearing back, and that was what doctors were hearing back.
If you now look at the curve on how VUITY launched, again, very strong launch. The first three months when they only were promoting to doctors for the same thing that we're doing in Q4, they got up to about 3,000 new scripts a week, then doctors started to catch on that, well, this doesn't really work. It started to go down, but then they turn on DTC, this is a population that you can activate very easily with DTC. So they turn on DTC at least that version of it, and then it shut back up to about 6,000. But again, nobody refilled. So six months in, they stopped promoting it nine months and they took it out of the back.
Thank you. You mentioned kind of going through kind of the initial launch experience for VUITY. What are some of the key markers of success that you'll be focused on in the first couple of quarters following launch, like, say, early next year?
So actually, let me continue a little bit on the VUITY because the second part of your question was what did we learn from VUITY? And we did learn a lot. VUITY obviously, had a great start despite the fact that they focused on ophthalmology. So their sales force was mostly ophthalmology because it fitted with the rest of that. But what we have is all the data where all the scripts came from 150,000 scripts, almost exclusively 80% came through optometry.
So what we're doing differently is that 88-person sales force is calling on optometry 80% of the targets, ophthalmology, 20% of the target. So we obviously have a very -- and we've learned that from VUITY. We've learned that doctors need about a quarter to actually get familiar with the product. So that's a quarter four that we're in or getting into now that we're using to educate the doctor skip and sample skip and their confidence before we turn on DTC in Q4. So those are some of the things that we've learned from VUITY and how that translates into metrics.
So a couple of things, and I use every opportunity that I get to emphasize that, and I know that you guys are not going to listen, but don't look at IQVIA for script data. This is going to be a two-channel distribution. e-pharmacy is not being picked up by IQVIA. That's where A part, potentially a significant part of the scripts will flow through. So we've got that channel. We're promoting that. That's the channel where consumers will have the best price. It's also the channel where we'll have most script on our consumers. However, if you prefer to be in line at the CVS for two hours, you can still get it through the retail pharmacy, if that's what you want to do. So IQVIA is only picking up the retail pharmacy and then putting some sort of factor on it to guesstimate what's in the retail channel.
So what we'll help you with is appropriately give you insight on what script data really is. I don't expect that we'll do that at our earnings call in November because we're only a couple of weeks into our launch, but other metrics that will be relevant that we'll start to share is what are the amount of doctors that have prescribed, what are the amount of doctors that prescribed multiple times? What's our reach with samples? What are the amount of consumers that have signed up for the vizz.com website.
And then we'll start to talk about what's our NRx rate. And then very importantly, and I think that's how most of us, for sure, will judge the success of the launch. What's our refill rate because that's ultimately what we need to start showing is that not only are we pulling patients in, but we're actually keeping them on product.
Yes. So seeing a bunch of investors here. I'm guessing that they'll try to think about benchmarking you against VUITY, but you raised some great points, including how you folks won't be able to really rely on IQVIA data. So how do you think you'll be benchmarked against VUITY? Or is that even a fair comparison given kind of your product profile?
I think it's a great comparison for the launch. So we know that VUITY did well in the launch. So what we see, and we've obviously spoken a lot with our covering analysts. We have eight covering analysts. And if you look at consensus, it's in a very tight band. What most people are doing is saying, great, VUITY got up to 3,000 new scripts early on when they were only promoting two doctors, and that doubled to 6,000 when they started -- when they turn on the DTC.
Even though you've got a product that's at least 3x more efficacious, works at least 3x longer, but also for a 6x larger population because VUITY was mostly focused on young emmetropic for people without distance vision correction. Despite all of that, you have an AbbVie. So let's say you get up to 2,000 new scripts a week with your sales force and then 4,000 if you also double that with DTC. So that's, I think, the baseline or I know that's the baseline that most investors and analysts look at for the launch. Then it comes down to refill rates. And that's where, obviously, the two curves need to be very different.
So what we know when we ask patients in a study where hundreds of patients obviously in or where you do a general survey with a target profile, people say 80% of the consumers say, I'm going to use this four to seven days a week. So basically, people are saying, I've tried it, it works, why would I not use it every day. So that would be 10 refills a year.
What we also know is that, yes, contact lenses, and it compares a little bit like contact lenses because you got that -- you know where it works. You also know at a 95% refill rate, the dry eye products, like 55% refill rate. General medicines at about a 50% refill rate. So it's easy to say I'm going to use it every day. It doesn't know what's happened. So we're literally cutting that those 10 refills. So five refills a year or five fills a year is a 42% refill rate. So that's the second part of the equation that you need to actually start modeling it out.
So use VUITY for launch in our mind, we're saying 42% refill rate. If you put all that together, it's a $3 billion market. We're currently getting credit. We're a $1.1 billion, $1.2 billion company. We're currently getting credit for about a $350 million peak revenue. So that's where the upside is.
Thank you. Through your CLARITY trials, what's the most surprising feedback you received from either patients or doctors and their perspectives on this?
So my most favorite one, it's actually on one of our -- on the consumer website on the vizz.com website. Now we have patients in that actually were on the product. So real testimony is unscripted. There's a woman on the called Deanna, who goes, I couldn't believe it actually works. And that's what we've got back quite a few times because it's kind of a miracle that you put a drop in and you can see up close again, especially for those like me that can't do it anymore and you put that product in and you can apparently see again. So that's feedback that is very raw, but that keep coming back from people.
We had many doctors tell about their patient experiences where one of the doctors dosed in groups, they have like 10, 12 patients coming in on a Saturday for the first dosing and they would very -- in a very fun way, talk about there's the five patients in the waiting room that are very happy because they're reading the magazines without the reading glasses and then there's the five clumpy people that were on the vehicle. So those are just anecdotal insights.
If you look at data, again, it was off the charts on efficacy on near vision. What we also saw is that, and I touched on it very briefly early on, is that we actually improved distance vision as well. So on average, people have about a line or so of distance vision improvement. That's especially impressive if you realize that these people are either 20/20 because of just distance correction that they're wearing or they're on eyes. So it's not that we're putting them in without the contact lenses. They've got the contact lenses in or their normal glasses and they're still improvement distance vision.
That's something that we noticed, especially LASIK people actually noticed because then they realized what 20/20 is. They used to have that and now they no longer have it, and maybe 2025, they aged out a little bit. We're giving them that line back to this is what it was like when I just had LASIK.
Thank you. I know we're coming up on time. So maybe talking about your -- digging into your commercial strategy because I'm sure a lot of investors are going to be thinking about how to set expectations around this initial launch and also what some of your readiness that you've already discussed.
Now what factors will influence your DTC marketing launch timing? Also, can you tell us what this campaign will entail. And you hit on some of this, but I think it would be good to dig into it a little bit further.
Yes. So from a timing perspective, like I said earlier, we'll turn it on in Q1, just to make sure that doctors have a moment to really get used to the product. So there's 40 million presbyopes that are coming through the doors of optometrists organically every year. So that's a group that they can already treat once we have the product. We know that you can activate the 80 million or so of presbyopes that are not seeing optometrists because they're emmetropic like me and they buy their reading glasses of Amazon. You can activate that group really easily. So there's going to be a big bolus of patients that are coming in, and online once we turn on DTC.
What's going to look like is what you expect from a current day commercial campaign. So we'll have a celebrity, very big name, on top of that, that everyone will know. She because this is skewing a little bit on the female side will be the face of the campaign we'll use to really put that messaging out.
Then there's a group of influencers below that. And then we know that these patients or consumers, we know exactly where they take or consume their media. This is not surprisingly, still Facebook, Instagram, YouTube, nonlinear TV. So that's where that DTC campaign will go out. And you can start to see a little bit of that, not on the -- we're not pushing it out yet, but if you look at our website, look at our material, we're really going for that lifestyle high-end products. And that's where the name VIZZ, obviously, was chosen with a lot of thought that went into it. We picked that three years ago because we wanted to have a very rememberable consumer-facing name. So very happy that we got that name approved.
Great. Last question. Looking forward, I think we're all very excited to see the initial sales traction and also I'm looking around this room, many people are probably willing to try it. I'm seeing a few wearing glasses in the room. Other than actual dollar figures, revenue numbers, what other KPIs or events should folks be paying attention to and looking for?
Yes. I think it goes back a little bit to what I said earlier. I think the big benchmarks or events that are going to happen over the next months and quarters are really going to be around how many doctors are picking this up, are writing this multiple times. How is this being picked up by the media, we've seen it already. We've not done anything ourselves yet. But when we got approval, this goes around like wildfire. This is something that so many people can identify with. So I think those are the pieces that will really start to show what this launch is all about.
Great. Well, thank you very much for your time today. Perhaps next year's conference, we're going to have some samples here.
It usually the first question I get from investors, did you bring samples?
Yes. All right. Well, thank you very much for your time. Thank you.
Thanks, everyone.
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Graphite Bio Inc — Citi's Biopharma Back to School Conference
1. Question Answer
So again, welcome, everyone, to Citi's Back to School Biopharma Conference in Boston. It's day 2. I'm Yigal Nochomovitz, biotech analyst here at Citi. The next session is with a great company called LENZ Therapeutics. We've been covering them for, I guess, over a year now, 1.25 years. We have the CEO, Eef Schimmelpennink. Eef, welcome. Thank you so much.
Thanks, Yigal. Thanks for having us.
Obviously, you've had a lot going on, to say the least, including an FDA approval a week ahead of schedule. So maybe we could just start out, talk about the product a little bit, it's called VIZZ. What the launch plans are? What the opportunity looks like? And how things -- you see things evolving over the next few quarters?
Absolutely. And again, thanks for having us. Back to school, I wish. But everything that we got going on, it feels like back to school. Now we do have a lot going on, as you say. So maybe just super brief. I think most of the people in the room and listening in are well aware of what we're doing. But the CliffsNotes version is that we've developed an eye drop that treats presbyopia.
Presbyopia is the loss of your near vision that happens to all of us as we age. So you become 45, you'll start to see many of us hold our phones further away from our face, so having a difficulty reading a menu at night. That's because your lens hardens.
And what we've developed in this eye drop is actually a way to restore your near vision without impacting your distance vision through an eye drop. So think of this as you wake up in the morning, brush your teeth, put your eye drops in and for the full workday, your near vision is back.
So that's the product that we developed. And as you said that we got approved by the FDA late July, earlier than our PDUFA date. So very pleased with that. And we're pleased to have, at that moment, been able to reveal the brand name VIZZ. So we're currently in, I would say, beyond prepping for the launch, we are launching now, and I'm sure we're going to double-click on what that means in a second.
Okay. Well, tell us a little bit more detail about exactly the plans because a lot's going to happen over the next weeks and months. There's going to be samples, and then you're going to do various phases of the marketing rollout.
So kind of can we double-click into what some of those steps are, and when they're going to happen and sort of how you're going to move from the initial outreach to eventually the social media, the influencers and things of that nature?
Yes. Yes. So important to understand with this product that it's a script, obviously, FDA approved, you need a doctor to write a script with the self-pay products, and it's a huge market. It's 128 million presbyopes out there. So it takes a lot of dedication and very strong execution to obviously roll a product like this out.
So we unpacked that a little bit and actually going to take us back to late last year when a 10-person MSL force was out, already starting to have those doctors-to-doctor conversations, educating the 15,000 or so doctors that we're targeting on a Aceclidine because that's our active ingredient. And as MSLs, they could actually obviously have that discussion with them.
So that's where we started to lay the groundwork. They're explaining how important it is to get to a small pinhole pupil, what our data was like and how -- and that's key to our product, how it's ciliary sparing, which means it doesn't impact the distance vision. So those three messages were key to get out there.
Then we were confident in the approval. We're very pleased with how we work with the FDA. So we actually hired our sales force, if you will, at risk. So by July 1, ahead of the PDUFA date, we had a full sales force onboard. So think about 100 reps, 88 in field and about 12 or so inside sales. They are targeting those same 15,000 doctors.
So we started to train them up. And then once we have the approval, we actually were able to train them on the label. So that happens immediately after the approval, and that sales force is out there now as well, obviously, detailing the product to doctors. That's when it's a good moment to maybe pivot into the commercial strategy that you've asked about.
So a three-pronged commercial strategy. First tier there is to make sure or get doctors to recommend us, that is that sales force. So that's a sales force out there, like I said, the 88, that are really detailing the product now to doctors, making sure they understand what this is, how it's different, what they can expect, when its used, telling them about the clinical data and then indeed, giving them the samples. And we'll talk about the samples in a little bit.
So that's going to give them that confidence in how the product works, what they need to tell their patients and how to write the product. It will take the remainder of the year to rebuild that confidence with the doctors.
And then in Q1 of next year, we will turn on to DTC. We know that this is a market that's very easily -- easy to motivate. We all -- once you're at that age, you know what this means. You're not going to be talking about presbyopia, but you'll talk about blurring in vision and wanting to take your life back.
So that's what that campaign is going to be all about, and that will start to activate people that maybe normally don't go to an optometrist or people that are frustrated with their reading glasses. So that's the second part of the strategy.
And yes, we'll have influencers, and I know that you've got your own list of favorites that we should put in. We're not ready to obviously share any names yet, so I just want to preempt that question. At the right moment, we'll talk about them, and we're sure that's going to be a name that's going to resonate very well with a lot of people.
And then the third part of that strategy is what we call seamless journey to use. So that means that we want to make it very simple for a consumer to go from your visit to your optometrists to your 5-day sample to then getting the product delivered to your home, and you can actually start using it.
Okay. All right. So a lot to dig into there. So on the 15,000, it would be helpful if you could just describe who these 15,000 are because when I've done channel checks and asked people about the competitor, which we talked about at some point, VUITY, I mean, apparently, there, they kind of had the -- they inverted it, and they are really spending too much time with ophthalmologists and not enough time with optometrists and opticians, and you're obviously taking a very different approach. So can you kind of walk us through that?
Yes. Absolutely. So there's a lot of things that we could learn from VUITY, which was the product that was launched by AbbVie about 3 years or so ago now. And one of the things is, we can actually look at the data and see who actually prescribed VUITY. VUITY failed because the product didn't work and nobody refilled.
But if you look at that early launch in the first 6 months or so, they had a phenomenal launch. But what we saw was that about 80% of the scripts actually gets written by optometry, which is not unlogical if you think about it, like that's the entry point for something like this.
However, AbbVie VUITY, they had VUITY in the back with their glaucoma medicines, which is obviously ophthalmology. So that call point was mostly ophthalmology, but still despite, they were not being in the optometry office. They were still able to drive those scripts.
So if you think about what that means for us, with that knowledge, we obviously inverted, to your point, our strategy. So 80% of the call point of the sales calls will be optometry, calling on what's the first 4 deciles in a 10 deciles, obviously, setup.
So that's where the sales force will go, like 12,500. And then the 2,500 that are more in the white space will be inside sales. Those are the people that were the highest prescribers of VUITY, but also of other products. So yes, very different setup there, really focused on where you'll find these consumers, which is mostly optometry.
And then maybe walk us through also just the mechanics because obviously, when I speak to clients about you guys, everyone is actually quite interested and they have very specific questions about how could I get it and what are the samples. So how does it actually work? I mean, you go in, you get a -- tell us how it works and what's the process.
Absolutely. So let's talk about the patient journey. So important to know is that there's already 40 million presbyopes just annually being seen in optometry. So that's those -- that's just a patient group or a consumer group that's sitting there. So 250 on average per month per doctor in those 15,000 that we're targeting.
That are already on some...
They are not just therapy, that are just coming in because they have a distance vision correction that needed to wear contact lenses or -- and they are then aging in to being presbyopic. So those are the people that we don't have to find there.
So let's start with a person like that. He or she comes in complaints about their near vision, so they get their test and goes "Yes, your near vision is not good." So you already know that, and they're frustrated with their reading glasses or they're aging into it. And they go, "Something is wrong with my eyes." And the doctor, in a much more polite way, and I'm going to say "It is, yes, you're getting old. This is just part of what's happening."
And then at that moment, a doctor will offer up, "Hey, this is alternative solution that you have to reading glasses or bifocals, which is an eye drop. Do you want to try it?" It's a free sample 5 days that somebody will then walk away with.
Very important is that, that will go hand-in-hand with a script. So we want that doctor to, at that moment, also write a script, we -- even though we are in both channels, so both e-pharmacy and retail channel, we'll try to get them to e-pharmacy.
And you literally walk out the door with your 5-day sample and a text message on your phone that's saying, "There you go, thank you for your interest in this. Hope enjoy your sample. Here's your script." you're filling your credit card details, your address, you click yes, and it shows up on your doorstep 5 days later.
So that's how simple and seamless that's going to be. E-pharmacy, we can do a 1 month or a 1 pack for $79. You can also buy 3 months for effectively $66 a pack or $198 for that 3 pack.
Okay. So now you talked about some of the DTC turning on in 1Q. I do get that question, the choice of doing that in 1Q versus sooner was carefully taken obviously. So just can you walk us through the pacing there in terms of why that's strategic to do it then?
Absolutely. So you want to make sure that the doctors are actually prepared and know what this product does, that they're comfortable with it, and you need to give them a couple of months to get there. So that's what Q4 is all going to be about they'll have their samples. We want them to use it on 10, 20, 30 patients. They're probably going to use it on themselves before you send that bolus of new patients.
There's nothing more frustrating for a doctor than have patients asking for a product that they're not aware of. It's very embarrassing if you were to come in and go, "Hey, doctor, can you write me this?" And they go, "Write you what?"
Now so we're putting a lot of effort in making sure that, that is a good process and that we give them that time, and that's why we feel that if you take about a quarter or so for that, we have a 3-week call cycle. So in a quarter, each of those doctors will have been seen by our reps, let's call it, about 3, 4 times.
So you mentioned sort of the headline number, the 128 million, but your focus -- and that's a big number, but you're focused on certain segments there, which are you expect to be good high adopters would have affinity for this type of product, based on certain demographics that you've discussed. Can you go through that?
Absolutely. So important to understand is that this product works effectively for everyone. So that's what we've seen in our trial. We have a very broad inclusion criteria from 45 to 74 years of age, very different reflection, so different distance vision corrections. So it's almost an all-comer study. So that's 128 million people out there.
From a commercial point of view, from a marketing point of view, you want to segment that because like that's just a very broad group to go after. Now if you look across that group, what the interest in a presbyopia eye drop is, it's about 60%. That's incredibly high to begin with. So across that group, there's very high interest.
So I think across that group, you'll start to see usage. But from a how do you target groups within the -- within that we've looked at different groups that over-index. Now you're thinking about 80%, 90-plus percent of people of interest in use. And the 3 groups would be people that wear contact lenses, so they've chosen to be glasses-free. They're from age 20, 25 on, have contact lenses because they don't want to wear glasses. And now they turn 45, and they realized that my near vision is going.
There's not a good contact lens alternative. There's both bifocal contact lenses, but they work for very few people. So they're now forced to actually go into glasses. With this eye drop, they can continue to wear their contact lenses for distance correction and the eye drop for near vision. So that's one group that is very -- is over-indexing significantly.
Second group would be people that have had LASIK. Similar story. They've paid back in the day, $5,000 or so per eye to be glasses free, and they now claim it that LASIK is wearing off, which is not the case, like the distance vision is still okay because of the LASIK. But then near vision, again, through presbyopia, is being impacted. Same thing with this eye drop, they can continue to be glasses-free.
And then the third group is what we call like the active aging group, the people that care about their looks, care about their active lives. That's the group that just doesn't want to be seen with glasses because it doesn't fit their lifestyle, doesn't fit their look. Again, each of those groups, you can target very easily. Those will be the early adopters. It doesn't mean that those will be the only users.
And when you think about sort of the categories or the types of usage patterns, I could imagine there would be people that would be using it basically all the time because they love it. And then there may be people that see it as something to do in certain situations, social events or whatever it happens to be. So how does that all work out in terms of your assumptions for what would be like the run rate of use on a per patient basis?
No, great question and in my mind, the key question towards our success. And this is where frankly, if we look at the data that we have from people that have used the product, whether it's in our clinical trials, we've had hundreds of people obviously on the products. When you ask them do you want to continue to use the product, 75% say absolutely. So that's -- again, it's a very high number. So it's something that you would normally see.
And then when you ask them how often do you see yourself use it, they are saying 4 to 7 days a week. So they're basically in that camp, where you're saying, what you mentioned is like if this works, why would I not use it every day.
So that number would equate to about 10 refills a year. We want to be obviously very conservative in that approach. That's basically us slashing that number. So rather than saying 10 refills, let's assume it's 5 refills.
Now we've not heard a lot of patients that say, "Oh, this is a great drop for -- if I go out at night." That doesn't seem to be what people are looking for. They're looking for an all-day solution. But again, we're being very conservative. So that's a 42% refill rate or 5 fills a year.
Okay. Well, you mentioned the all-day aspect a few times, so I want to make sure we cover the -- how that's potentially differentiated versus -- and we talked about VUITY. So -- but there are a few others. There's this Qlosi, and there's another drug from Tenpoint that's moving forward.
So can we just go through the competitive dynamics and where you see the differentiation? Obviously, with VUITY, as you point out, the efficacy just wasn't there. And by lunchtime, it was kind of not working super well. Yes. So what -- how do you fit into the competitive landscape? And what's the value proposition versus the specifically these other ones?
So how we talk about it, and that's -- we try to do it without any arrogance is that we really see this as a category of one. So it's very clear what consumers want. So once-a-day eye drop, that works for your full workday, works for almost everyone, and it's very comfortable. So against those 4 parameters, if you just clearly look at the data, it's just a very clear difference.
Let me very briefly go over how we stack up against VUITY. So from a very simple way of saying it, we're at least 3x more efficacious. If you look at our 30-minute efficacy, we're in the 70% range for 3-line gains, which is the FDA endpoint. We're in the high 90s for 2-line gains, which is sort the [ 20/40 ], which means you can go without reading glasses, compared that to like a 22%, 23% for VUITY. So at least 3x more efficacious, at least 3x more longer in duration.
VUITY lost efficacy in one of the clinical trials at 3 hours. And that's why most people say, yes, it works like 2.5 hours, maybe 3. At 10 hours, we still have [ 0001 ] p values. So that was the last time point that we've measured.
And then the other thing is that we tested in, like I said earlier, a very broad patient population. So not only focused on [ inotropes ], which is what you see most other products do, but truly -- so [ inotropes ] are people that do not have distance vision correction, but this is across a broad population. So that's how we're different than VUITY.
And VUITY failed not because people didn't want an eye drop, but VUITY failed because it didn't deliver. There was a lot of enthusiasm on 150,000 people out there that tried it. But we're, frankly, disappointed, and I was one of them, it doesn't really work.
So if you compare -- and I'm not here to talk about other products, but if you compare us against VUITY and then the other two that you've mentioned, you see that Qlosi is twice-a-day drop in exactly the same profile as VUITY, and you see the same thing for [ Pyricol ].
So we welcome competition, but it's hard to see because it's proven by VUITY that that's a profile that consumers don't want. So we're focused on our success and driving it clearly as we are launching now.
So -- and then let's talk about the name because you spent obviously a lot of time thinking about the branding and the simplicity of the message, and not just the name but the whole sort of aspect of the branding, the website, everything that envelops that whole message. So just talk about the process of how you arrived at this name.
No, we're very pleased with that. It's one of only a handful of single-syllable names that's been approved by the FDA over the last 15 years. So that's not by accident. So we started the branding process probably 2.5 years ago, now maybe 3 years ago, always with this vision of we don't want your standard pharmaceutical product and product marketing and a name that sounds like it's coming straight out of the chemistry book.
So from the beginning, we've worked with the right companies to say we want something that's really that category 1, that's really that lifestyle brand that we want to build and a name that fits that. So when we -- when this was on that list early on, it tested incredibly well. The name recollection is off the charts. If you basically tell people 20 names. And then at the end of the day, you ask them, which one do you still recall, VIZZ comes out, immensely high.
And we went in with only one name to the FDA, and we got that approved or conditionally approved probably 18 months or so ago now. So we've been obviously keeping it on the rep since while we were developing the whole thing. I'm just extremely pleased with it. The feedback has been great. Like we're not doing any marketing yet. But if you look at what's on Instagram, the TikTok and the other channels, it's already -- people are picking it up. It's resonating.
Well, you're doing a lot of good things because I actually get your marketing because I signed up, and I'm already getting the e-mails. Like every 2 weeks, I get an e-mail from you about this. So something is working well. All right. And then talk about the -- so you're launching the -- when is -- the samples are coming -- how specific did you say? Like when...
We're very confident that we'll have samples in October. Let me just explain a little bit what's driving that gap between approval and October because we get that question sometimes on, "Hey, is something wrong?" Nothing Is wrong. This is really just logistically driven, very different than oncology launches that I've done and many of us in the room here have done, where you need a couple of thousands, usually vials, which are easily to hand pack.
These are in the tens of thousands, hundreds of thousands. So we couldn't prepack this, like this is too much to pack at risk because you know that the FDA, last minute, will also always ask a change in your labeling and the one that we always -- and again, it was good to work with the FDA.
So let's say, the one that we use often as an example of what they change is literally the day before approval or so they came with. If you look at our packaging, it says 1.44% concentration. They felt that there wasn't enough room between the decimal point and the 1 and the 4. So they wanted that to change by like 1/10 of a millimeter, which means you change that, and all your packaging changes again.
So we waited until that was all done with final labeling. So that's all done now. That's all printed, and we are packaging now. We've already -- we started producing bulk as early as April of last year. So we're sitting on a lot of bulk products that's now just being packaged, that will go through the logistics and then show up at the pharmacy.
You get that question. And I get the question just in terms of what to expect for the fourth quarter because that will be, I assume, a sample-heavy period and not necessarily one that's going to reflect the revenue potential or even the beginning of the revenue potential. Is that accurate or fair?
No, that's how we think of it. Think of this truly as this is the quarter that we want to use to establish that confidence with doctors that this is a product that works, that the patients like.
And I think how that will go with most doctors is that they will try themselves, they will try it on a handful of patients, then a handful will go to 10 or 15. And then once that confidence is there, that's when they will start to widely prescribe. So that's how we think about Q4. And we're frankly looking forward to that, obviously.
And then a couple of other things, importantly with regard to manufacturing. You talked about -- I think you first mentioned it at the R&D Day back in New York regarding obviously, the question on manufacturing and where it's manufactured and what customs has said about your product. So remind everyone about that because we're very front-footed about that, either by design or by some luck. I'm not going to...
We like to think by design, and maybe the government helped us a little bit. But yes, I've never had so many questions about tariffs in my career. But if you think about the product, the APIs or [indiscernible] U.S. manufactured all the IP that's in the U.S. companies, obviously, U.S. We then ship the API to Germany to actual -- the company that invented this blow-fill-seal container technology, they'll do the fill, finish, and then it gets shipped back.
So that's just, I would say, normal course of business about a year ago, a little bit over a year ago as we were thinking about our commercial supply chain. We're already engaged with the U.S. authorities and the custom authorities and border groups.
We feel this is an American-based product. And they agreed. So we have all that in place. So that's the -- by design. And then maybe the by-luck thing is that obviously, what was it, late last year, early this year when the whole tariff discussion starts to [Audio Gap].
Yes. Okay. And then as far as some other little sort of odds and ends, as far as storage, I mean, this is something where you can take it with you for your day or you -- and it doesn't -- it can -- you can keep -- you should keep it in the fridge when you're not -- for the doses you don't need for that day, but it can be portable and can stay at room temperature.
Yes. And even the one -- so it's very simple to -- already similar to most eye drops. So we'll get it to your home. Actually, the last piece, not -- but we'll get it to the wholesale call chain. And then what you see as a consumer, if you order a monthly pack, that's all room temperature. So you don't have to keep that in a fridge, you can keep it outside of the fridge for a month.
And important to know there is how that works with the FDA. You actually need to show that the product is stable for twice the amount as what they were giving in a label. So we've shown that this is stable for at least 2 months to give you 1 month at room temperature. So you can keep that in your bathroom, you can keep somewhere at work, wherever you want. So customer facing is room temperature.
And then the other thing you mentioned earlier, so obviously, this is cash pay, given what you talked about. But it is a script, and so it will require -- or there's a recommendation for a retina exam. So how does that work? Like what do the opticians have these machines? I understand a lot of them have them already in the practices.
No, absolutely. So this is common practice. So if you -- let's forget about this for the moment. If you go to your optometrist for your annual exam, they will, 99 out of 100 times, give you a retina exam.
In most instances, they'll use an Optos or a type of Optos machine, which is basically just taking a photo at the back of your eye. If they don't have that, 89 -- 85% to 90% of optometrists have that machine because it's a cash maker for them. If it don't have to do a dilated exam, which is the old-fashioned way of doing it.
So this is something that every optometrist can do. So it's not a hurdle or anything, and it's actually good practice, and it's a moneymaker. It's a recommendation for our product just because it's, in general, a good thing to do. So this is not something out of the norm. Anybody can or any optometrist will be able to do that.
Okay. And then as you progress and you start reporting numbers over the next several quarters, what are some of the metrics that would be helpful that you're going to convey to investors to understand both in terms of the scripts and making sure that people understand the numbers correctly, and there's some -- there's not necessarily concordance between what's actually being ordered and what the data shows? So just kind of walk us through that because there's different channels, and it's not necessarily that simple.
No. It's very important, and we keep stressing that whatever one is don't look at IQVIA in the first couple of quarters to gauge how the launch is going. We expect -- like I said, we have 2 channels, retail pharmacy and e-pharmacy. IQVIA only picks up retail pharmacy. It's hard for us to predict how much will go there, but we're obviously -- we like the e-pharmacy channel for a couple of reasons.
IQVIA doesn't pick up any script data from the e-pharmacy. So we'll make sure that appropriately, we'll inform investors what the revenue, what the script data is over the course of time. So what you'll -- the parameters that we'll start to talk about first, what are the amount of doctors that have prescribed once, amount of doctors that have prescribed multiple times.
And then we'll start to roll in on what's our NRx or total Rx rate, so how many scripts, and then ultimately, what's the refill rate. And again, like I said earlier, I think, firstly, what's our NRx rate is going to be scrutinized by us, I mean everybody else, as we should, and then more in the Q1, Q2 time frame, it's okay, are we seeing that refill rate that was missing, frankly, with VUITY because that's going to underpin the success of us.
Well, correct me if I'm wrong on my thinking, but I would think even as -- if I were to get it, I would think that I would do the 5 days of the samples, but then most of the channels should go -- I would think, would go through e-pharmacy because they're going to go, they're going to do the visit, they're going to have of 5 days, and then it will be ordered electronically. And they won't have to make a separate trip to the CVS, right?
That's what you would expect. And in general, and more and more about pharmaceuticals are going through that channel. So not only for us, but you'll see that in many different products. I guess the GLP-1 is a great example. Now we're actually that's one step further where deliveries of this world, we're actually taking that part of the channel on themselves, obviously, something that we're not doing.
So I think it's a fair assumption. But until we have that data, we can't really know for sure. So we'll, over the course of the quarters, see how this shapes up. And then IQVIA will ultimately catch up. But in the first couple of quarters, it's just not going to be accurate.
Yes. Okay. Let's spend a little bit of time in the remaining minutes, just so -- I mean we just started talking about the United States, but there are other markets. So you have a partner in Asia. Tell us a little about that and also Canada, but then there's some other geographies where it's open. So how are you thinking about those?
Yes. So we've been, from the beginning, very clear. We will clearly launch this product in the U.S. and take it on ourselves. Ex U.S. is an enormous opportunity because, not surprisingly, everybody gets or becomes presbyopic ex U.S. as well. So something of a benchmark out there. If you look at BOTOX, about 1/3 of BOTOX revenue, which is somewhat comparable to what we're doing here, is ex U.S. So huge opportunity there.
We licensed Greater China early, now probably about 3 years ago because they had to do their own clinical trial. And we wanted to make sure that we obviously didn't lose time there. So that trial went out about a year ago, actually now with identical outcomes to us, again, a great testimony to the product in different company, different population, exactly the same data. So they've submitted their NDA. So think of them launching probably like 12 or 18 months or so behind us.
Then more recently, we signed a deal for Southeast Asia with a very successful company in that region, so I think South Korea and markets there. And then shortly after that, we signed with [indiscernible] the Canada.
So those are territories that we wanted to do early for different regions. Others, we're not that -- we don't feel is that urgent to get.
For example, Europe licensed out. We're taking care of the registration there. That market opportunity is obviously huge, and we feel that for us to extract the most value for it might be -- we might be better off showing success in the U.S. first. But ultimately, whether it's Europe or Middle East, Africa, Latin America; all those markets will be covered.
And what's the structure there? Is it -- are they going to follow your blueprint where it's the samples and it's cash pay and it's -- you go to the optician? Or do they have sort of more freedom to do it however they want to do it, would it be different?
I think most markets definitely initially will follow that model. And I think many companies are very grateful for the branding that we've put up and all the work that we've put into it. So I would expect them to follow that. There might be some smaller differences per geography, but I think overall, it will follow the same model.
I guess I should have checked, but in Greater China, are they using a different -- or would they use VIZZ? Or are they going to do something else or...
No, we want them to use VIZZ.
They would use VIZZ. Okay. So it will be globally -- the branding will be globally consistent?
Yes.
Okay. Very good. And then, of course, they will use their manufacturing?
Yes. So in most cases, absolutely.
Yes. Right. Okay. Now of the -- just going back to the -- you mentioned the 88 reps. And so of the -- how many of -- is the goal that everyone is going to get a visit and had an intro, teach-in for VIZZ before the product is actually available? Or is that feasible to get all those...
Yes. No, and it feels and it is a lot of doctors. But if you break it down, very rough math, so 12,500 doctors that were being -- that we're visiting with, let's call it, roughly close to 1,000 reps. That gets you to 135 or so doctors per rep. If they do 5, 6, 7 a day, that's a 3-week call cycle. So every 3 weeks, ideally, they see all the doctors in that territory, means 3 weeks, there's 12,000 being called on. So that's the call cycle.
So absolutely, the aim is, and we're right on track there, that before they actually have samples, still have done maybe 2, sometimes in some cases, 3 visits. So first visit is introduction, just a quick [indiscernible] and this is what the cycle is. Second visit is a deeper dive into the data, this is how we would like to prescribe it, this is what you can expect and the doctor in a couple of weeks, I'll be back with samples.
I mean now that you've had essentially a month and a few days of sort of experience in the field with the label, carrying the label in hand, I assume you're collecting feedback.
And I'm curious, what kind of questions you're getting from the prescribing base that's maybe different than what you might have expected or just anything that's clarifying or how you might want to refine the message? Or just what are you learning about their understanding of the product that helps you do a better job?
Yes. No, we're -- as you would expect, so we're keeping a very close eye on that. We actually had another meeting on it yesterday. And it's great to see that the feedback is right in line with what we expected. So I think a great data point is that the number of doctors that are saying, "no, not interested" is low single digit. So sometimes it's...
They may not be interested.
They've seen VUITY. They go like, "I just don't believe an eye drop or it's going to cannibalize on my readers business." That group is super small. So that's great to see.
Then there's, and rightfully so, a large group that says "This sounds really interesting, tell me more, get me samples. I want to get a feel for what this is really like." And then there's a group that believes in it, that goes, "Yes, absolutely," and is ready to start prescribing. So it's playing out the way that we expected it, which is very encouraging. So again, very happy with that.
Okay. Now of course, you've spent a lot of energy, rightfully so, on this, getting to this point. Is there a plan to have a portfolio approach and potentially in-license other products? Or is it full steam ahead on VIZZ, get that launched on a good trajectory, start to bring in the revenues, cash flows and then think about product expansion? How do you think that?
No. So yes to both, but in a sequence. So by design, we've built this company around one product. And that's not because there's not other interesting things out there, but we really felt that to drive success, we wanted every brain cell, every dollar focused on this. There's not that many -- I think there's hardly any $3 billion opportunities, in general, in pharma out there that are as close to being launched. So that's the design.
Now once we've shown success, we can definitely see that as being a cornerstone product in a larger portfolio. That would all be M&A, BD driven. Like it doesn't make sense for us to add a product that's in early-stage clinical development that we could maybe launch 4, 5, 6 years from now. We would want products that can either fit the back if we continue to be in optometry very quickly or we can leverage our consumer knowledge that will have our self-pay products and the knowledge that we have.
Great. Well, this has been terrific. Congrats on the approval. And best of luck with the early samples. And I think I'm going to try it.
Absolutely. Okay. Thanks, Yigal. Thank you, everyone.
Thank you.
Bye-bye.
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Graphite Bio Inc — Special Call - LENZ Therapeutics, Inc.
1. Management Discussion
Good morning, ladies and gentlemen, and welcome to the LENZ Therapeutics Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded. At this time, I would like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead.
Thank you. Good morning, and thank you to everybody for joining us at this exciting moment for LENZ Therapeutics. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. We are joined today by Evert Schimmelpennink, our President and Chief Executive Officer; Dr. Marc Odrich, Chief Medical Officer; and Shawn Olsson, our Chief Commercial Officer. Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LENZ's future expectations, plans, prospects, corporate strategy, commercial plans and expectations, cash runway projections and performance.
Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the SEC and which can also be found on our website. With that, it's my pleasure to now turn the call over to Ev.
Thank you, Dan. Good morning, everyone, and thank you for joining us. Today marks a proud and defining moment for LENZ. Yesterday afternoon, we announced the FDA approval of LNZ100, now known commercially as this, the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. With this approval, this becomes the only once-daily eye drop with clinically proven near vision improvement lasting up to 10 hours. This milestone reflects years of scientific development and disciplined execution in our mission to transform the treatment landscape for 128 million adults in the U.S. living with near vision loss. This is the result of tremendous commitment and collaboration from the LENZ team and our development partners, the dedication of our clinical investigators and the contributions of the hundreds of participants in our clinical trials.
I want to thank them all for their hard work. I also want to acknowledge the review team within the ophthalmology division of the FDA for their consistently high engagement throughout our NDA review process. As you know, presbyopia is a gradual and inevitable loss of near vision that occurs with age. It happens to virtually all of us and often first present itselves has difficulty reading a menu, using a phone or focusing on objects of close. For many, it's one of the earliest signs of aging and a daily source of frustration. Reading glasses or progressive lenses have been the default workaround. They are inconvenient and for most people, not a real solution.
There is a true unmet need for a product that restores seamless vision near and far. And with this, people do not have that alternative, a once-daily eye drop designed to improve near vision while preserving distance vision for a full workday, offering a hassle-free and effective way to manage presbyopia. We believe yesterday's approval will establish a new standard of care in presbyopia. As we have shown that this is not only best-in-class, but frankly, the only in a class of pupil-selective ciliary-sparing miotics, something that is clearly recognized by the FDA and reflected in our approved label, which reads this is a predominantly pupil-selective miotic that interacts with the iris with minimal ciliary muscle stimulation.
This is uniquely engineered, highly differentiated and designed to deliver quick onset and lasting benefit for the vast majority of presbyopes. That's why we see this not just as a launch, but as the foundation of a new category, one defined by real-world efficacy, doctor and patient-centric messaging, coupled with seamless and broad access to samples and products. With the approval in hand, we are activating our branded commercial launch plan immediately. Our 88-member sales force fully hired and trained as of July 1, has begun field deployment earlier this month. This team was hand selected from over 8,500 applicants and represents the top pharmaceutical sales talent in the country.
It will be supported by our optometrist-led medical sales liaison team and our inside sales team. In parallel, we've also kicked off our direct-to- eye care professional marketing campaign, which focuses on the unique mechanism of action of aceclidine, its impressive clinical results and how it fits in eye care practices. Together, they will engage an initial universe of 15,000 eye care professionals across the U.S., ensuring broad education and rapid awareness from day 1. This approach allows us to first equip providers with the tools, confidence and training they need and allows them to start serving the roughly 40 million presbyopes, they are already seeing annually in their practices.
This phase is key to do before our expected rollout of our direct-to-consumer campaign in the first quarter of 2026, which will drive branded demand directly to consumers and tapping into the roughly 80 million presbyopes hopes that currently are not seeing an eye doctor. The brand itself, this was built with a vision of a category of lifestyle brand in mind. It is clean, modern and highly memorable. It emerged from extensive consumer testing and market research and it stands as of only 9 single [indiscernible] brand names approved by the FDA in the past 15 years. We believe that's a testament to its clarity, its strength and the premium positioning it conveys. Switching over to product availability. We expect samples to start to be available at targeted optometrist offices no later than October, with commercial product to be broadly available mid-Q4. Pricing of this will be $79 for a box of 25 vials with a 3-month supply available for $198.
What makes me proud of today is not just the approval, but the people behind it. We have purpose-built lens for this moment with the right team, the right strategy and the financial strength to execute. We've built something bold, differentiated and disruptive, and I'm incredibly proud of the team that brought us to this point. Before I turn the call to Shawn to walk through our commercial rollout strategy, I'd like to first hand the call to Marc Odrich, our Chief Medical Officer. Marc will share additional perspectives on what today's approval means for the eye care professional community and why this represents a true advancement in presbyopia care. Marc?
Thank you, Ev, and good morning, everyone. As Ev mentioned, the FDA approval of LNZ100, or VIZZ, is not only a milestone for LENZ, but also a pivotal event for the eye care professional community. Presbyopia has long been a frustrating and difficult-to-treat condition. The ability to now offer patients a once-daily on-label treatment that is both well tolerated and effective is something we believe will have a lasting clinical impact. The approval of VIZZ was based on 3 rigorous Phase III trials: CLARITY 1 and CLARITY 2, which evaluated efficacy and safety in 466 participants dosed daily over 42 days and CLARITY 3, which assessed long-term safety in 217 participants over a 6-month period. VIZZ achieved all primary and secondary endpoints, demonstrating meaningful near vision improvement within 30 minutes of dosing, with durability extending to at least 10 hours.
This benefit was consistent and reproducible across the program. All of this was reflected well by the FDA in our label, which says that VIZZ is indicated for the treatment of presbyopia in adults. This reflects the broad inclusion of patients in our trials and the large market we can serve. The label describes the onset of the VIZZ effect on presbyopia from 30 minutes post dose and lasting 10 hours. Notably, VIZZ is the only product that has shown efficacy for 10 hours, the last time point we measured in our trials. The label also describes the mechanism of action of aceclidine as a predominantly pupil-selective miotic that interacts with the iris with minimal ciliary muscle stimulation.
VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision, clearly highlighting the unique mechanism of action of VIZZ. Equally important, VIZZ was well tolerated. Across more than 30,000 treatment days, there were no serious treatment-related adverse events. The most common reactions were mild, transient and self-resolving. For patients, the clinical impact is compelling. In the CLARITY trials, 93% of participants achieved near vision of 20/40 or better just 30 minutes after installation. At 1 hour, that figure remained at 93% and nearly 7 in 10 participants maintain 20/40 or better vision at 10 hours, all following a single daily dose.
This level of rapid onset, durability and consistency represents a meaningful advancement in the treatment of presbyopia. What gives me even greater confidence is what we've heard directly from the eye care professional community. Our 10-member all-optometrist medical science liaison team has conducted thousands of peer-to-peer conversations already this year. Their insights have consistently reinforced what we see in the data that there is a strong clinical appetite for a pupil-selective ciliary-sparing miotic that fits into the daily workflow of eye care professionals and meets the needs of a large and diverse patient population.
For many providers, VIZZ represents the first truly practical pharmacologic solution for presbyopia, one that doesn't compromise distance vision and that can be integrated into real-world practice. Before I hand the call over to Shawn Olsson, our Chief Commercial Officer, to walk through our launch strategy, I want to again recognize the broader LENZ team, our partners, our clinical investigators and especially the patients who participated in the CLARITY trials. We are grateful for their role in making this approval possible. Shawn?
Thank you, Marc, and good morning, everyone. As both Ev, and Marc have shared, this is a proud and transformational moment for LENZ and one we've been building toward with a focus and urgency for the past several years. I'd like to start by thanking the entire LENZ team from sales and marketing to medical affairs and operations for the incredible work leading up to today. We have built a best-in-class commercial engine, and we are fully prepared for launch. With FDA approval in hand, we are immediately launching our sales activities, supported by our branded go-to-market efforts to bring VIZZ to eye care professionals across the country.
Let me start with the commercial opportunity. Presbyopia is the largest unmet vision condition in the United States. It affects approximately 128 million people, a population nearly 4x larger than those of dry eye. In fact, presbyopia affects more Americans than dry eye, Demodex blepharitis, childhood myopia, macular degeneration, diabetic retinopathy, and glaucoma combined. And yet treatment today remains largely unchanged, reading glasses, progressive lenses or simply struggling through. That's what makes this moment so unique. With VIZZ, we are bringing a once-daily preservative-free eye drop to the market with rapid onset that is well tolerated and with clinically proven efficacy lasting up to 10 hours.
What makes VIZZ different and why we believe it can reshape the treatment landscape is its mechanism of action. Powered by aceclidine, VIZZ is a predominantly pupil-selective miotic that interacts with the iris, and avoids overstimulating the ciliary muscle. This results in a pinhole effect that improves depth of focus, allowing patients to see up close without compromising distance vision. And as [indiscernible] noted earlier, this differentiation is now clearly reflected in our approved FDA label, something we're very excited about. So how are we bringing this to market? We've designed our commercial strategy not just to support a product launch, but to establish a new category.
VIZZ stands alone as the first and only once-daily FDA-approved aceclidine-based treatment for presbyopia that lasts up to 10 hours and is effective across a broad population of presbyopes. We are positioned as a true category of one, and this is supported in our ECP surveys that highlighted 82% of ECPs were already likely to prescribe VIZZ based on the clinical data. This is now about introducing a disruptive lifestyle forward solution into a space where innovation has been long overdue. Our commercial strategy remains built on 3 pillars. First, we want doctors to recommend us. We've now launched our Make it Visible campaign to support this pillar, aimed at driving awareness of VIZZ and educating eye care professionals on the unique mechanism of action, clinical profile and practical fit of VIZZ.
Our 88-member sales force fully trained and deployed as of July 1st is laser-focused on targeted education, sampling and early trial adoption across our initial target of 15,000 optometrists and ophthalmologists. In just a short time in the field, they have already completed more than 8,000 meetings with doctors focused on our unbranded message, a number that will increase rapidly as we now pivot to our branded VIZZ discussions. This effort is supported by our optometrist-led MSL team and inside sales group, both of which are fully aligned and already engaging clinicians. Importantly, the feedback from the eye care professionals has been strongly positive, reinforcing our belief that VIZZ will resonate as a much-needed innovation in this space. We are confident that our focused and coordinated launch efforts are laying the groundwork for VIZZ to take its place as an effective treatment option for a broad population of presbyopes.
Secondly, we want consumers to request us by name. We've developed a modern lifestyle brand grounded in consumer research, one that we believe will resonate strongly with consumers. It's worth noting how rare it is to receive FDA approval for a single [indiscernible] brand name. In fact, as mentioned, VIZZ is only the ninth single [indiscernible] brand name approved in the past 15 years and has tested exceptionally well with consumers on the memorability scale. We believe that distinction underscores both the simplicity and strength of our brand, which we've intentionally designed to have the power to stand alone as a category of one.
We expect our direct-to-consumer campaign to begin in Q1 of 2026, using high-impact creative and trusted personalities to introduce VIZZ as a modern, empowering alternative to readers. Third, we want to ensure a seamless journey to use. This includes broad sampling availability at doctor's office -- eye care professionals' offices and commercial access through both retail pharmacies and e-pharmacy. Product samples are expected in market in October with full commercial availability of product by mid-Q4. As stated earlier, VIZZ will be priced at $79 for a box of 25 single-use vials with a 3-month supply available from $198 through our e-pharmacy partner.
We believe this approach, physician-led adoption followed by consumer activation gives VIZZ the best opportunity to establish early momentum and long-term leadership in this category. Our website, vizz.com is now live and will serve as an informational and experience destination for both consumers and eye care professionals. It reflects the brand vision we've been building toward a modern premium consumer brand. In short, we've built the team, the tools and strategy to deliver, and we look forward to updating you as we execute the launch. With that, I'll hand the call over to Dan Chevallard, our Chief Financial Officer, to speak to our financial position and launch support strategy. Dan?
Thank you, Shawn. Before I begin, I would just like to once again acknowledge all of the hard work that has gone into the approval of LNZ100, or as it will now be known VIZZ by the LENZ team and our partners. The team at LENZ is extremely strong, and today's announcement is a special moment for all of us. With the approval of VIZZ, I wanted to take a moment and highlight a few key financial points, priorities and go-forward launch metrics. First, and as we have guided for the past 5 quarters, we are in a position of financial strength, and we anticipate our cash on hand will be sufficient to support our commercial and corporate operations through positive operating cash flow.
To that end, we are launching VIZZ with over $205 million in cash, which is a significant beat compared to the $190 million that we most recently guided on our first quarter earnings call. The primary driver of the incremental cash at launch from our most recent guidance includes upfront payments from our recent regional licensing transactions in Southeast Asia with Lotus and Canada with Théa, respectively. Next, I'd like to highlight our initial commercial spend priorities. As Shawn mentioned, our 88-member sales force was fully hired as of July 1, is now fully trained and will be in the market with our branded material immediately. Shawn has highlighted our initial emphasis on direct-to-ECP marketing grounded in the first pillar of our commercial strategy of doctors to recommend us.
And our commercial launch spend over the remainder of 2025 will be almost entirely dedicated to support the sales force over these first months, emphasizing our sampling strategy, ECP education through the launch of our speaker program initiative and preparing for our Q1 2026 direct-to-consumer campaign launch. This, in turn, will result in a ramp of our commercial spend into 2026, where we have guided a go-forward all-in commercial spend estimated to be $80 million to $100 million per year in 2026 and beyond. Lastly, and to get in front of a question that we often receive, I would like to highlight a few key early launch metrics that we will be focused on.
In the first quarters of launch, we believe an early measure of our success will be driven by the focused efforts of our sales representatives as they engage with their target call plans and initial prescriber conversion. We anticipate this being something we can quantitatively measure as a predictive indicator of ECP engagement in several ways. Initially, we will focus on: one, how many unique ECPs have written a script of VIZZ; and two, how many ECPs have written multiple scripts within our target ECP universe. Once scripts begin to become meaningful likely into the new year, our focus will then shift towards total new patient starts or NRxs. This will further evolve as we get into 2026, where the emphasis on NRxs will continue, but then also shift to include total scripts or TRxs with an emphasis importantly on RRxs or refill prescriptions in the second quarter of next year. As you will recall, the third pillar of our commercial strategy is focused on the ease of access for the consumer.
As we have discussed previously, our sampling campaign is core to our commercial strategy, and we anticipate samples will be available in the market as early as October of this year. This will then be followed by commercial product being broadly available by mid-Q4 through both the traditional retail pharmacy and e-pharmacy channels. We like this commercial product distribution strategy as it will provide both LENZ and the consumer with multiple available channels for VIZZ with an aim to reduce any barriers to product access. However, we would like to take this opportunity to caution immediately not to rely on weekly IQVIA data early in the launch phase.
Script data will likely not flow accurately early on and have a substantial lag, principally between e-pharmacy and IQVIA. We will be sure to help clarify channel mix and script levels in the first quarters of launch. We're looking forward to the tremendous months ahead as we launch VIZZ, supported by our fantastic sales force as they work to prepare the ECP community for samples and commercial product availability in the months ahead. With that, I will conclude my remarks, and I'll turn the call back over to Ev for final remarks.
Thanks, Dan. As you can see, our team is ready for this moment. The commercial team is locked and loaded. The sales force is world-class, and we've built the company for this moment, a foundation of financial strength. We're very confident in our ability to execute the successful launch of this and are thrilled to bring forward the first and only daily up to 10-hour lasting presbyopia solution to the market. With that, I'd like to open up the call for questions.
[Operator Instructions] And our first question comes from the line of Stacy Ku with TD Cowen.
2. Question Answer
Congrats on the VIZZ approval. And by the way, the website is very nice. So we have a few questions. First, in the time before now and the October sampling, maybe, Shawn, can you talk about that full 88 fully trained sales force and what type of outreach is possible? Maybe talk about prescribers that are -- are you going back to the prescribers that are already familiar with LENZ, 100 in addition to VUITY? And just how long will it take to educate your target 1,500 ECPs? Are you going to be able to target them multiple times before October comes around? So just help us set expectations there as you talk about hitting the ground running. So that's question number one.
Question number two is really about expectation setting. So as we think about maybe that phase from then sampling to commercial launch, Daniel and Marc, maybe talk about the right expectation setting as you all collaborate, maybe what considerations may be important as you think about consumer launch versus maybe a health care launch and what considerations you all are taking there, especially as it relates to what you're setting in terms of maybe this website. I see it saying up to 10 hours and the commentary today all suggests that that's what you all are using. But once daily durability is probably already sufficient at 8 hours with pretty high patient satisfaction. So just help us understand how you all are thinking about things here.
And then, of course, related to expectations on efficacy, when it comes to the safety profile, our KOL checks suggest that patients will defer to the prescriber opinion. But is that the case for you all as you're doing much deeper diligence? So that's the second question. And then I really appreciate, Dan, all the different metrics that you've talked about. But maybe in the beginning, Dan or Shawn, what kind of users do you expect to see in the beginning? Obviously, we have patients that have some experience from the CLARITY trials. Are there going to be patient -- are the early patients going to be ones that want to use this more frequently with less dabblers? Or are you kind of expecting to see kind of the full mix? So just help us set expectations in terms of the early launch. So just as we think about kind of samples to launch to commercial launch.
Thanks, Stacy, and thanks for the congrats. A lot of questions in there. Let's try to group them a little bit. We'll talk a little bit and Shawn will kick that off with initial sales tactics, how they're rolling out the sales force. And Shawn, if you can -- in that question, maybe also address the question of who do we initially see in the patient group as the early adopters. I can talk about expectation settings a little bit there as well. And then on the safety profile, I'll take that one. Your assumption there or how you stated it, Stacy, that patients will defer mostly to the ECP is correct. I think that's how most patients will get their information.
Good thing is, as you know, and as we've shown in our clinical trials that this is a very well-tolerated product. And we've seen that throughout our trials. We see it in our AE profile. So the treatment-related AEs, as we've spoken about before, are all mild, short living and resolved, therefore, quickly. Importantly, especially as we've been talking through with the MSL force with the doctors, that notion of aceclidine is not being ciliary stimulating reads very well or translates very well into discussions. The doctors immediately translate that and understand that, that is likely to solve for many of the more serious AEs that are obviously coming up as a question.
So we feel that, that discussion is one that we'll continue to obviously have and our sales force will in an appropriate way. [indiscernible] label will kind of talk about that now, and that will form a great basis for that confidence that doctors have in our product. So with that, Shawn, maybe you can talk a little bit about sales force.
Absolutely. And Stacy, thank you for the question. Happy to give a lot more color around that sales force in the early months. So as we stated, we have the 88 outside field reps. In terms of their call points, continues to remain those 15,000 eye care professionals that we've seen in the past that have prescribed VUITY multiple times. So they're calling on those people that we know in the past have had the experience with VUITY and we're willing to prescribe it, and that's where they start. In terms of how things move forward, so in July alone, that team already did over 8,000 doctor call visits. As we think between now and sample availability in mid-October, that field will be out there calling on their targets, and I would expect multiple visits per doctor prior to that mid-October date. And that's because it's roughly about a 3-week call cycle for our field.
And when we think about those visits, what that looks like is, obviously, the first visit, they're going to be introducing VIZZ itself, that follow-on visit, they'll be reinforcing the messages and also carrying along consumer pieces that will live within that eye care practice, right, and preparing the doctor for their expectations of the sample's arrival and making sure that when they get the samples, they have enough to try it on multiple patients to get a good analysis of that product. And we absolutely want to fight the right expectations, which goes into your next question. We were very deliberate in the up to 10 hours. We saw in our product at 10 hours, nearly 7 out of 10 patients were still 20, 40 or better. But this is definitely a category and a consumer product.
You want to set that expectation of up to 10 hours and then let them delighted when it meets or even may exceed. And so that's how we want to make sure we set the right expectations. And as we're setting -- when we're providing the samples to the doctor, setting the expectations and even though our product is very well tolerated, making sure they pass that information on to the consumer as well of what potential side effects could be so they have a delightful experience as well. Lastly, on the users that we expect, the first users we would expect since our initial promotion is direct to eye care professional, we expect our early adopters to be the ones that are already going into the practice.
So if talked about the 40 million people that already get an eye exam. We know from our market research, those that are most interested are those that are in contacts and want to stay in contacts. And those patients are already going to the doctor and they're already getting their eye exam every year. So in terms of as people start to adopt it, I'd expect the early users to be the ones that are already in that practice and already coming in. Thank you for the question, Stacy.
Comes from the line of Yigal Nochomovitz with Citigroup.
Congratulations on the early approval. I guess the first question is, did you expect it a week early? And how much does this extra week help you in terms of getting a bit of a leg up on the prelaunch work?
Thanks, Yigal. Yes, we're definitely pleased to see obviously that approval coming through. And I have to say, and I tried to weave into the prepared remarks as well that our interactions with the FDA have been excellent. They've been highly engaged, as we've shared in some of the previous calls. We've not seen any changes on the team and they stayed very committed to the task and what we all know was and still is a turbulent time within the agency. So very pleased and thankful for that. From the beginning, they've indicated that since it is a new chemical entity, it would likely go the full time until PDUFA approval. And as you would expect, over the last couple of weeks, things go a little bit more silent. So we were frankly ready and expecting the approval to come in late next week. But like I said, I was pleasantly surprised when that e-mail hit my inbox yesterday.
Great moment for the company that we briefly celebrated appropriately after the close of the market. How that helps us is we've spoken before that we've manufactured a lot of both products in advance. We expect this launch to be on a very high volume initially focused on samples. But we obviously could not start packaging the final product until we've had final label and had the discussions and knew that, that was all completed from us. That's currently the case logically. So that's really the team at the manufacturing facilities now ramping up that -- those final stages of production, packaging and then ensuring shipments, which is actually what's driving that gap between the approval today and then our guidance that samples will be in the market as early as October. So very pleased again with the approval, the additional work -- additional week definitely helps, and we're working hard to get the products into the market.
Got it. And then on the label, I was just curious if you could comment on if this was, as we expected, specifically with respect to some of the statements on the label regarding the retina exam, the way the drug is stored, as well as the dosing instructions, if that was consistent with your expectations.
It definitely was. I think we've been very clear about that from the beginning that even though -- and again, the FDA clearly recognizes that our MOA is different than pilocarpine, we'd always expected that the FDA looks at the retina exam as a class effect. And we actually think that, that's a good thing. I think it's a great way to include the ECP community in this, allow them to expand the patient population. Shawn mentioned and we mentioned in our prepared remarks, only about 1 in 3 [indiscernible] actually sees an eye doctor. Most others and frankly, like me, turn to Amazon or wherever for their $2 readers, there's 80 million additional patients that can be brought into their practices. So nothing unexpected there. We like our label. We think it's nicely and clearly differentiated on important points and importantly highlights the fact that we have data up to 10 hours, which nobody else has, that it's severe sparing and a very easy product to use.
And then with regard to the -- just the storage specifically on the refrigeration, is anything specific to say there? I know you mentioned that it can be stored at room temperature for 30 days, which seems fine.
Yes. No, that's something that was important to us and that we obviously designed the product for. So think of this product as cold chain up to the wholesaler, which is obviously very common for many, many eye drugs and many other products. But as soon as it hits the consumer door, it can actually be room temp, which is important. You don't want to burden the consumer with having to keep this product in that fridge. So we can ship from wholesaler to consumer room temperature as well. And it's very important. And then this is just the normal eye drop that's still in your counter or [indiscernible]
And then for Shawn, any further details or expectations with respect to how you're going to build the social media campaign and when we might learn more about high-profile influencers that may participate in your marketing?
Yigal, yes, when we think about the social media campaign, what you will expect is you'll start to see all of our pages turn on. So that will include our pages on YouTube, our pages on Instagram, right, all of our pages on Facebook. So you'll start to see all those come alive with the evergreen content. And then in terms of when we think about the influencers and celebrity, that's really going to take place in 2026, when we turn on that direct-to-consumer campaign. We're really going to focus in Q4, Q4 we're really going to focus on getting the practitioners, the eye doctors comfortable with the product, using the samples, early prescribing. And then once 2026 hits, that will be when we start to turn on the DTC and bring it through the celebrities.
Next question comes from the line of Marc Goodman with Leerink Partners.
Yes. I was just curious, what is your competitor Qlosi kind of staying out there their marketing pitch? And then how are you going to kind of counter detail with your marketing pitch? It just seems kind of obvious how much your better product is, but I'm just curious like what are they saying out there?
Thanks, Marc. I think that's a question that's asked, but haven't to [indiscernible]. I think that the focus of that product is obviously very different than ours. And although we take all competition seriously, we don't see that there's a lot of traction in the market, and it's not something that comes up importantly in any of the discussions that either our team or the sales team has in the market. Frankly, one of the first questions that mostly come up and again, not to drive a wedge, but this is not another [indiscernible] . Is it the moment that we explain that it's not. That's why the discussion turns to great. Obviously, the MSL team is the only team to date that could actually talk about the data.
The data is very impressive and people see that and it's very clear to compare products and see how different the data is. So our messaging is not focused on how we're different. It's how our product works, how well it works, what it does to patients. And as Shawn said, set the right expectations for that. So we're very focused on cycling on our product as we should be.
Dan, that $80 to $100 per year, is that including the cost of the field force?
Yes, that's inclusive for 2026.
Our next question comes from the line of Jason Gerberry with Bank of America.
Congrats on the approval and label. A couple for me. Just when we think about 4Q, how many samples do you expect to deliver into the market space -- and if you could estimate a conversion rate on that to actual paid script, that would be an interesting data point just in terms of how you're thinking about the sampling effort and maybe what that could yield? And then my second question is just on the pupil selectivity language in Section 12 of the label. How obvious do you think that's going to be to HCPs that may confer a differentiated safety profile versus sort of the class safety warning that's in the label. So I'm just kind of curious how much of an educational lift is going to be needed there with the HCPs. And then my last question around the cash and the commentary about getting to breakeven. I think in the past, I recall maybe some comments about doing that within 3 quarters of the launch. So wondering if you could confirm if that's still an appropriate way to think about the time course to getting to breakeven on the launch.
Thanks, Jason. We'll break those questions out and Marc and Dan, will take 2 and 3. So on the samples, our aim is to make sure that all those 15,000 doctors that we're targeting will ultimately have access to samples. We know that if you look at our data, 93% of patients in at least 20/40, within 30 minutes. So we can frankly pretty much guarantee you that you're presbyope and put a spark into your eyes, you'll be able to see a text message going [indiscernible] .
And then that's that experience that we want to be able -- is likely available. I want to make sure it's widely available in the market because that's going to allow doctors and patients to decide, hey, is this something for me? So while we're not going to give numbers on how many samples that means, you can expect that, that's something that our sales force is going to be focused on to make sure that those samples are well stocked and well used in doctors' offices.
And in the call cycle, the 3 call cycle that Shawn was talking about, that gives them an opportunity to see how quickly doctors are going through samples and how that is converting into scripts. So again, that conversion rate is something that we'll start to see at some point, probably not something that we can and will share likely. But the more important point is here that we will sample very...
If I could just follow up quickly on that point. The 15,000 targeted HCPs, I'd imagine that the 40 million that are in the treatment system, that HCP footprint is broader to cover the full 40 million, right? I mean the 15,000 HCPs, I recall that's a mix of ODs and ophthalmologists that have more of a medical practice. So just maybe if you can clarify that point.
Yes. I'm happy to do so. So yes, there's many more HCPs at 15,000 is 80-20 on optometrists, ophthalmologists really built around practice sites, as well as focus on doctors that back in the day described [indiscernible] prescribing other products. And it's fair to assume that these are the doctors that are ultimately seeing the majority of general patients across the market. So they are covering most of the eye exams in those 15,000.
And then on the differentiation and how easy that is to understand, and I'll pass it on to Marc. And again, we're very pleased that the label differentiates there. Obviously, it's something that now our sales force can talk about. And we have a lot of experience between the, frankly, up to 3,000 or 4,000 discussions that the MSLs have already had, 8,000 or so that the sales force has, the sales force has not been able to talk about that just yet. But Marc, maybe give your experience as the leader of the MSL team on how easy it is for an ECP to translate the difference in LOA into a different safety profile.
So thank you, Jason. Thank you for the question. As you do point out in the PI, our prescriber information, Section 12-1, the mechanism of action clearly differentiates us from the other miotics. And what it really speaks to is the selectivity of this particular agent. The experience has been through our MSL, our medical safety liaisons -- medical science liaisons, sorry, that this has great resonance with the eye care practitioners. They all understand immediately that a drug that does affect the ciliary muscle predominantly and does -- I'm sorry, affects the iris sphincter predominantly and is ciliary muscle sparing is a unique opportunity. And the traction that we see is all of them understanding immediately that the capability of this drug is to constrict the pupil and not induce both the side effects and the effects of ciliary muscle, which would mean that you would cause myopic shifts with those that do touch the ciliary muscle in addition to other issues.
So it has great traction, and I think it's unique in its ability to speak to the eye care professionals in a way that really appeals to the science and the strategic difference of this drug.
Maybe I'll take that last question. Jason, you asked about the cash guidance there. So a couple of just quick highlights. So we're very pleased with our cash position and have been extremely consistent with how we guided around cash runway and our ability to get all the way to positive cash flow. In fact, this is the fifth consecutive quarter we've guided in that way. And if you actually reflect back as a newly public company, our ending cash or our cash at PDUFA is remarkably similar to the cash that we had at the end of the first quarter of 2024. When we then stated we had cash to positive cash flow.
As far as the revenue guidance and the time to breakeven, that's not something that has ever come from us. We've not guided on revenues and don't plan to for the foreseeable future. But thanks for the question.
Our next question comes from the line of Biren Amin with Piper Sandler.
Congrats on the approval. Maybe to start on your DTC strategy. What's the driver starting in the first quarter of next year compared to initiating sooner during mid-4 when the product would be fully available? I think that campaign is pretty much ready to go. So just your thoughts there in terms of timing. And then I guess, based on -- second question, on the -- your MSL conversations this year with optometrists and ECPs, you mentioned that you had received strong feedback from those conversations. Were there any points of hesitancy that were brought up during those conversations? If so, what were they? And then third question on the e-pharmacy IQVIA lag. What's the typical lag that one should expect between e-pharmacy and reporting in IQVIA?
Thanks, Biren. Great questions. So Shawn will obviously talk about the DTC and the lag in data from IQVIA and the -- how well you can lean on that or maybe Dan, will lay into that. I'll start off with the feedback that we get from Amazon and then Marc, please add to it. What we see and what I alluded to earlier is that the first question that comes up mostly is, is this pilot happen? And I always say, no, it's not. It's very easy to start to have that discussion. How is the LOA difference, but the importance of getting below 2 millions and then showing our data. And what we see is that in the course of that discussion, people are maybe a little bit more skeptical early on in one meeting, turn to -- the data is just very, very strong.
So any hesitancy, I wouldn't call it really hesitancy, but I think there's a question out there, which is the right one on great, this all looks great. When can I get a product, I'm going to get a sample and I'm going to start using this on my patients to see what this does in the real world. And again, that's where our confidence comes in, just looking at the product, looking at the profile and frankly, looking at the feedback that we had from hundreds of patients in our study and how they reacted to the product.
We've shared some of those -- some of that feedback in the Commercial Day. It's on the website now. I know many of you have spoken to investigators that were in our trials. Universally, people are saying that this thing works. People put it in their, put it up in their eye and they can see it once again, and they like that, obviously. So that's, I think, how most of those discussions are going. We've studied many of them. And again, very high confidence in what this will do in the community. Anything to add to that, Marc?
No. I think the key is the initial conversation that you pointed out with the eye care professionals once they hear it's not pilocarpine and once they hear our clear messaging on what is the optimal pupil size and what we have done to pursue it and the data supporting that, they are very involved and interested. They are engaged. And the engagement is really the unique feature here. The eye care professionals are looking for this. They're hungry for this. And I think the patients will be hungry also once this becomes ubiquitous in the market.
Thanks, Marc, and Shawn, if you can talk about why we've timed the DTC to Q1?
Yes. Focusing in on why we focused on Q1 for the [Star] DTC, what we've learned in our discussions with eye care professionals is they want some time to get experience with the product before consumers are then driven into that practice. And so our expectation is by Q1, we'll have enough visits and sample is used by the doctor that it's the accurate and right time to turn on the direct-to-consumer campaigns. This is feedback we also learned in talking to doctors from the launch with VUITY where that DTC came on a little bit too soon. But it is great to hear you say that you see, it looks like everything is ready for DTC.
And you're right, everything looks great and is ready to go. It's more about the timing of when it's the right time to turn it on to make sure that the doctors are ready before we send more consumers into their office. And then a quick comment on the e-pharmacy. When you think of IQVIA data in general, they aggregate data that they buy from predominantly retail pharmacies. So that would not include potentially data from our e-pharmacy. And so because of that, they will be blind to that data. That reconciliation does happen, but I would think of that as months, not weeks to get that all set up and talking to each other. And that's why it's very important not to focus on the data coming through IQVIA early on, and we can give more guidance on clarity of what's going on as that gets closer.
Next question comes from the line of Lachlan Hanbury-Brown with William Blair.
Congrats on the approval. I guess the first question I have is on the dosing instructions calling for 2 drops and still 2 minutes apart. Just was that your expectation and how it was done in the trial? And then do you think that there could be a risk that patients might only instill drop sometimes? And if they do, do you have a sense of what that would do for the efficacy that they experience? And then a second question is just on a publication plan to get additional data out there, so that MSLs and so on can speak to that like the 2-line gain in the 20/40 and so on. I mean is that having already been presented at the conference, are they already able to speak about that? Or are you looking to sort of publish stuff in peer-reviewed journals so that they have that in hand?
Thanks, Lachlan. So on the dosing, yes, we expected that, and that's obviously exactly how we tested the product in our trials. It's a very easy dosing regimen. It's obviously very easy to follow. So we're pleased to see that. It's a great way to get the product to work the way we wanted to work. We've not tested it as a one drug. So I'm not going to elaborate or I can't elaborate on what that would do and how different that would be. But obviously, we've seen great data product as we've used it. We don't think that there's a risk around it. We quite know what that would be. And these are single-use trials that have enough product in there for exactly a dosing regimen that you need, you can't close them out. So I don't think there's any risk there.
And as to the publication strategy, yes, we are planning to formally publish. Frankly, most, if not all of our data is already out there. So Amazon can talk about all the data that's there. And similarly, Salesforce can obviously with the data that's in the label can talk about that. There will also be a very broad speaker program where we'll have upwards of 50 KOLs that are being trained on our messaging that will expand that message to some of the different endpoints that we've made. Anything on that on your end, Marc, that you can add and want to add, we can talk about, for example, 2 line gains, 20/40, you and/or Shawn?
No, Shawn, I think you covered the question. I have nothing to add.
From my side, again, a lot of this data, you'll actually start to see roll out be available. Publication strategies are obviously underway, but the ability to use them is still okay from our legal guidance.
Next question comes from the line of Gary Noshman with Raymond James.
And my congrats as well on the early approval. So with the initial physician marketing effort that's starting immediately, is there a reason you can't make samples available prior to October? Why are you waiting a couple of months for that? Assuming the ECPs will want to see those as soon as possible once you start making noise with them? And then how will you be encouraging the conversion of samples to paid Rxs? So what tools will you have in place to do that? And then lastly, what sort of patient assistance will you offer in terms of rebates and discounts to help with access? So what should we anticipate average net pricing will be relative to the $79 and $198 pricing you mentioned?
Great question. Thanks, Gary. Last 2, Shawn will address. I'll just very briefly reiterate what I said earlier. The gap between our approval and samples available in the market is purely a practical one. We have to wait for final label. This is not an oncology product where you've got a couple of thousand vials that you can hand back. These are many, many, many samples packs and retail packs that have to be and are being fined. So that's just driving the timing to get that logistically done, start shipped and into the channel. So we'll keep everybody abreast on when those samples are available. And Shawn talk about how we're driving the conversion of samples to script and how we secure pricing to the patients...
Absolutely. So starting with the patient assistance first. What we really like about this market and this product is it's a cash pay market, right? So where other companies often have to worry about what exactly is the out-of-pocket and the volatility and timing of when it's covered by insurance, we can offer immediate access right away. Through our e-pharmacy partner, it will have a $79 price for that 1-month 25- vial supply. For those that are super users, they have the option to go for a 3-month supply, which is $198. So it drops that per month price substantially. And then for those that want to be available to pick it up in the retail, we will also have partnerships with GoodRx to make sure that we have a consistent pricing at the retail channel.
So when you think of the consumer out-of-pocket, really should be focused around that $79 per 1-month supply, potentially depending on mix, the $198 for the 3-month supply. So those are the patient programs we have available, and we're very happy how it creates a very clear pricing system. In terms of encouraging the conversion from samples to scripts, that falls right into our third pillar on ease of access. We want to have scripts out there because we know they work, right? When people try it, they feel it, and they know that they can see better. To help on that transition to script, our strategy will be working with the doctors to make sure they set the right expectations, so there's a positive experience. Also, we want them to move forward with both the sample and the script, and therefore, they move very quickly from trial to usage, and they can do that by sending the script to the e-pharmacy. The patient gets that text on their phone and they fill the script when they're ready. And that's how we'll help manage that trial to conversion step. Hopefully, that answers your question.
Yes. And if I could just squeeze in one follow-up. When you guys start the DTC campaign in early '26, just how robust will it be? So I'm curious what portion of the $80 million to $100 million in annual spend will be going towards that and your confidence you'll get a good ROI on that investment. So maybe how long before you get good pull-through from the DTC campaign, maybe what your experience and marketing folks are telling you?
I'll give a brief answer. Sorry Shawn. We've seen from VUITY and other launches that this is obviously a population that's highly motivated and you can activate well. So you can think about that number of $80 million to $100 million, that will be a significant part of that will go to DTC.
Next question comes from the line of Matthew Caufield with H.C. Wainwright.
Major congrats, guys. In speaking with optometrists and ophthalmologists KOLs, there's obviously been a strong desire for samples that you've discussed. But there's also been mention of trying the product in office while the patient basically waits in the waiting room and then reviewing the VIZZ benefit and profile together. Is that something that you think could be realistic in office and/or encouraged from the sales team strategically?
Great question. And what we see is that, yes, there's a portion of doctors that want to do this in office, and that's completely fine. We've obviously seen how the product works. And think of that 30 minutes as, frankly, just our first realistic time point that we could measure in the clinical trial. We could see and we've seen that the effect might start earlier than that. So I think it's very well feasible for some doctors that want to put the drops in the patient and together with the patients, see what it does. And what they'll see is and what they should see is the same result that we've seen in our clinical trial, a very rapid onset for almost every single patient. So that's definitely something that can be done.
Major congrats again guys, to the team.
That concludes our question-and-answer session as I'm showing no further questions. Thank you for your participation, and we will now conclude today's conference call. You may now disconnect.
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Graphite Bio Inc — Goldman Sachs 46th Annual Global Healthcare Conference 2025
1. Question Answer
All right. Hi, everyone. Thanks for joining us at the Goldman Sachs Annual Healthcare Research Conference. I'm joined by Eef Schimmelpennink, who we're thrilled to have with us today to talk a bit about LENZ as a company as well as their key programs, which is rapidly approaching a key regulatory update in August.
So with that, we will go ahead and begin. Eef, maybe we can just start on that regulatory note. You're expecting a PDUFA on August 8. Any updates there or anything you can share about the regulatory path?
Absolutely. First, obviously, thank you all for having us here at Goldman. Always pleased to be here, great meetings. So on the PDUFA side, just as a reminder, our PDUFA is August 8 of this year. So I think, about 60 days left to go, 59 days, rapidly approaching. And our dialogue with the FDA is great, very productive. We're clearly on top of the pile. We had our late cycle review with the FDA about 1.5 weeks, 2 weeks now ago, maybe. It was a [indiscernible] meeting, literally a 7-minute meeting in which the FDA takes you through their agenda.
Agenda point 1 is to date, no major observations, any questions. Agenda point 2, no minor observations, any questions, no additional data required. They confirmed no AdCom and reiterated on track for a PDUFA date -- PDUFA date of August 8. So we continue to feel confident in that process and continue to look forward to have that be a moment where our product is approved, we know final label, and we're ready to start commercializing.
Great. Wonderful. With that question behind us, maybe we zoom back out and talk a little bit about LNZ100. There are a number of therapeutics in development and approved for presbyopia and LNZ100 is the only formula that uses aceclidine. Can you talk to us a little bit about what that means from an MOA perspective, safety, differentiation of the profile overall and duration?
Absolutely. So to maybe start that and orient you, important to realize what the MOA of these products is, it's very straightforward. You want to make sure that you give somebody a small pinhole pupil. And it's known that, that pinhole pupil needs to be below 2 millimeters because that's when you really see that depth of focus increasing. And with that near vision improve. So I think small pupil below 2 millimeters translates in 2, 3, 4, 5 lines of near vision improvement.
Now there's 3 molecules, [indiscernible], that's the class of drugs that can actually give you a small pinhole pupil, aceclidine, pilocarpine, carbachol. The founders of what's now LENZ Therapeutics were the first ones to come up with this idea, and we're able to pick the best, in fact, the only molecule that can effectively get you into a small pinhole pupil without driving side effects. And the reason for that is that aceclidine is the only pupil selective miotic.
So what that means is that there's 2 muscles in your eye that are relevant to look at. One is the iris sphincter. That's the muscle that controls the size of your pupil. So you want to stimulate that to get to a small pinhole pupil. And there's a second muscle called the ciliary body that ties the lens to your retina. That's the one that you want to avoid because if you overstimulate that, your lens moves forward in your eye and you get what's called a myopic shift, your distance vision blurs. So yes, maybe you got better near vision, but now you're left with blurry distance vision.
It can also drive more serious side effects that clearly you want to avoid. So with the aceclidine being the only pupil selective miotic, it's effectively the only product that now in clinical data, and it's available now for all 4 products. It's the only product that can get people's pupils to below 2 millimeters. We had 233 out of our 234 patients in our Phase III studies to below 2 millimeters and keep them there for the full 10 hours. It's a very different profile for VUITY and all the other products are like VUITY. And that translates into a very different efficacy profile.
If you look at our efficacy profile at -- we had 71% of our participants had at least 3 lines of near vision improvement, 95% of them improving at least by 2 lines, which is clinically meaningful. So if we compare and contrast that against VUITY, those same numbers for VUITY at [ hour 1 ] with 25% versus our 71. At our 10, they had about 10% left, which is 40% for us. So our 10-hour data at 40% is actually better than VUITY'S peak efficacy. So 2 other products out there besides VUITY. One is called Qlosi, which is a low-dose pilocarpine product that's dosed twice.
You look at that efficacy profile, again, very similar to VUITY. And then very recently, the Phase III data from Brimochol as a carbachol plus brimonidine product became available, again, almost the same as VUITY. So all those products, the minimum pupil size that they get to is about 2.3 and then very quickly, they leave that and are clearly outside of the window where you can drive near vision improvement.
Very helpful, very clear. Maybe we can move. We've hit regulatory differentiation from a mechanistic perspective and product phenotype. Let's talk commercial. So you've been pretty clear in quoting a $3 billion-plus market size. We appreciate there are about 130 million presbyopes and 4 million new incidents every year. Can you talk to us a little bit beyond the epidemiology, what goes into your assumptions for that $3 billion-plus figure, how you get there? And then beyond that $3 billion, are there any avenues to exceed that?
No, good question. And frankly, one where we got a little bit of pushback and I thought we'd being overoptimistic, but actually that we're being too conservative. So let me walk you through that. 128 million presbyopes in the U.S. alone. And this is a self-pay product. So the first cut that we make is saying that, okay, people need to earn at least $100,000 individually to be able to buy a product like this. So that takes the 128 million down to 23 million.
Then we've done a lot of research in how eager are people to try out a product, a presbyopia eye drop. On average, that's 60%. There's groups in there that are over-indexed into the 80s and 90s, and we'll talk about that later. But on average, 60% willing to try. So that takes that 23 million to, let's call it, 13 million. Then we know from our studies and elsewhere that people have used the product, and we ask them, do you want to continue to use the product after the study, 75% says yes. So 75% out of that 13 million gets you to about 9 million. Just for the fun of it, we take another 1 million out. So that's 8 million ultimate users long term. So 6% penetration out of the 128 million.
So the second factor to get to the $3 billion is obviously how often are they going to use it? This is where we take the biggest haircut, frankly. Again, if we ask people that have been in our study, how often do you think you would use that product? They say 5 to 7 days a week. If we do the same with large surveys, where we give people the product profile that we have and tell them that this is an eye drop for presbyopia, how often would you use it? Same numbers, 5 to 7 days a week. So that would translate into about 10 refills a year.
But again, this is where we go very conservative and say, it's one thing to put that into a survey, something else to actually buy it. So let's cut that in half. So rather than 10 refills, 5 refills a year, which would be 3 days a week of use, 42% refill rate.
And then the third and last element is obviously price. We've not guided on price, but what we know is that VUITY actually had a phenomenal launch, and that price point was about $79. So at that price point, they had 150,000 consumers going out buying actual scripts sold. So it's fair to assume that the $79 price will be around where we will price. So if you take 8 million users times 5 refills a year times a $79 price, that gets you to the $3 billion. So that's obviously U.S. only. That's at a low refill rate. That's ignoring the 4 million presbyopes that are coming or joining our forces every year. It's also ignoring anything ex U.S. So a lot of additional upside beyond that $3 billion in our mind.
So that's going to require, especially if you're wrong on the more conservative assumptions that requires a pretty big commercial sales force or at least, I should say, a thoughtful and strategic one. So can you talk a little bit about investments made to date? What's left between now and August 8, PDUFA, estimated PDUFA? And what do you have yet to kind of build out and get going before launch?
Yes, fair question. So let me begin at the end, very little left to do. Almost of our complete sales force has been hired. We're hiring last final physicians this week actually. But how do we get there? It's a sales force of 88 salespeople in the field. We have 10 inside salespeople that we already have hired. So what we did probably about 2 years ago now is actually look at that VUITY launch and find which doctors represented 85% of the VUITY scripts. So that's obviously -- those doctors are the ones that you want to go after. It's about 15,000 of them. And then we start to map that out and how do you get territories that are evenly based and give reps the same amount of opportunity to do well.
So that got us to those 88 territories that we will serve with our reps and then the white space, the Montanas of this world is what we're focusing on with our inside sales. 88 reps is a very benchmarked, very well benchmarked number. If you look at Tarsus that I know many of you will be familiar with. They launched with 86 reps. VUITY back in the day had about a little over 90 reps. So very similar number. What's different with VUITY is that our call point will actually be optometry. So VUITY or AbbVie focused the sales force on ophthalmology. That's what the rest of the back was focused on.
The sales actually or the scripts came through optometry, 80% optometry. So despite the fact that they were on the wrong call point, they were driving 3,000 new scripts a week through optometry mostly. So we go to optometry mostly, 80% of our reps will go there. VP of Sales came over from AbbVie. He launched VUITY, joined us about 2 years ago because he knows the market, sees the opportunity, but wants to do it with a great product. We hired our DMs late last year -- sorry, our IDs late last year, then DMs very early this year. And like I said, we had over 8,000 applicants for the 88 field positions, 80% are filled. We're filling the last ones this week.
So what that means is that by July 1, our sales force will be ready and trained up for a potentially earlier approval. And I don't think that that's going to come, but we want to be there anyway, but being ready for August 8 and being able to do the sales cycle.
Big effort.
Big effort, yes.
Interesting change in energy, I'm sure, at the company as well. You -- in your recent Commercial Day, you were pretty clear about 3 very specific customer segments that you were targeting as part of your initial marketing plan. Can you talk to us a little bit about those 3 segments?
Sure. Yes. So I mentioned a little bit earlier, 128 million presbyopes, on average, they index 60% in willingness to try. That's the top box out of a box of 5. That's a lot to target. So what you want to do early on with especially your DTC, but also pointing your doctors to the groups that you know are over-indexing in willingness to try, which means that they're in the 90 percentages. There's 3 very distinct groups, easy to identify people that wear in contact lenses. There's 47 million people that wear contact lenses in the U.S. That number drops off a cliff at 45, 47 because people become presbyopic and now they need to wear an extra pair of glasses, which defeats the use of wearing contact lenses.
With this drop, you can stay in contact lenses. We've had many contact lens wearers in our study, and this works perfectly together. So that's group #1. It's a very valuable group for optometry as well. So they want to keep them in contact lenses.
Group # 2, people have had LASIK. Over 10 million people have had LASIK. And many of them are now slowly becoming presbyopic and they start to say, my LASIK wears off and optometrists [indiscernible] no, it's nothing to do with LASIK, you becoming presbyopic. But same thing. They've paid money to be without glasses and now they need to wear glasses. So highly motivated to do something different and stay out of glasses. Again, these drops work with LASIK very well.
And then the third group, we used to call them the MediSpa people. I think it's now calling the beautiful people or the lifestyle people, but people that focus on appearance, whether it's people that indeed go to a MediSpa or just want to remain beautiful and wearing reading glasses doesn't fit with that. They over-index into like the 95%.
So 3 groups, very easy to identify for a doctor. Those are the groups that will go after first. It doesn't mean that use outside of those 3 groups is not happening. It works for everyone. So it's definitely going to be patients or consumers outside of those 3 groups as well.
You touched on this a little bit in an earlier question. But anything else you'd highlight vis-a-vis other competitor product launches that you would do differently? You talked about call point differentiation in terms of the way that we are approaching it versus the way that AbbVie approached it with VUITY. Anything else you'd flag or feel like that covered.
Maybe the last thing, and I have a lot of respect for companies like AbbVie and having grown up at least watchful even in Pfizer. These companies know what they're doing. Like they become so big by doing good stuff consistently. So we've learned a lot from VUITY and a lot of things that will -- that we've assimilated. There's also a couple of things that we'll do differently. Like VUITY when they turn on DTC and was effective because they doubled their amount of scripts from 3,000 to 6,000. But their version of DTC was for $36 million. Commercial is on the hallmark channel.
We feel that that's probably not where our target patients live. That's not where they get their information and the people that watch data and TV is maybe -- or maybe not the group that you want to go after. So we'll do that differently. We'll spend the same. We're actually spending more on DTC. I think about it, $80 million, $75 million to $80 million in year 1 on DTC, but much more in line with how you see brands being built today. So digital, our consumers live on Reddit, YouTube, Facebook, which they're a little bit older, Instagram, TikTok comes up. That's where you're going to capture them. We'll have a big A-lister celebrity, micro influencers below it, lots of different very targeted commercials that you'll see popping up on your phone that you can actually now read without dropping.
As someone squarely in the target demographic, I'll look forward to that. Maybe we could talk -- it's actually a good segue to the cash pay model. So maybe you could talk a little bit more about the cash pay model for LNZ100 as you see it. And very specifically, if we could go into some of the advantages and considerations, this concept of quality of revenue, maybe it's something that you can touch on lack of formulary reimbursement, anything about gross to net incentive or lack thereof for generic pharmacy switch. If you could package all of that, I'd be interested to hear across all of those elements.
Yes. So this is indeed a self-pay product, and we like that a lot. It has a lot of advantages, especially in today's world. So think of it, like we said, let's hypothetically say it's an $80, what we call retail price. So it's not a WACC price, but retail to net makes for a very healthy, quick revenue stream. So self-pay products, from a P&L point of view, what that will mean is you can think about a 25% or so retail to net spread. So $60 in this example, net to lens from the very first script because we don't have to get to lives covered, insurances, all of that, which normally takes at least a year or so for a company to work through. And during that time, you can, one, not fully focus on commercialization because every patient that you drive in, you need to buy down.
So it's costing a lot of money. In our case, the very first script that gets bought hits our bottom line in a very meaningful way. So again, we like that aspect of it. It also indeed insulates us from many of the dynamics that we're currently seeing. No PBM negotiations, no MFN questions, no PBM parts in the insurance companies. It's a very nice insulated stream, something that we're hearing spec pharma companies now also talk to us. It's not the same, obviously, as a GLP-1 value stream, but it definitely has elements of it. It's got the same element of you're selling this more to a consumer than to a doctor, if you will, you can capture the supply chain yourself or capture the revenue stream yourself, you can be flexible with your pricing. So all things, again, that we like about the fact that it will be a self-pay product.
Great. And maybe on that topic of consumer appreciation or customers' perception of the product, stickiness is a concept that matters a lot. Can you talk to us a little bit about that? Why is stickiness important in a market like presbyopia specifically? And what do you intend to do to ensure that stickiness?
Yes. No, 100%. Like if I think about the proof points for LENZ over the next quarters year, I think they're twofold and they're going to come really quickly. So the first one, and let's call it just arbitrarily Q1 of next year, we'll all be watching what's our [ NRxs ]. Are we getting patients on script? Are we getting that first script done? And then it's going to be great without people refilling because that's where VUITY fills. Yes. VUITY had a great launch, 150,000 scripts in year 1, which would be over 100 million if they had a half decent refill rate, which they didn't. So it dropped off a cliff and got stuck at like 20 million or 25 million. So those 2 are the 2 that we're going to follow -- all of us are going to follow widely.
I think that's going to be different with us for a couple of reasons. One, the biggest one, the product works. So again, I don't want to go through the numbers, but the product is about 3x more efficacious, works at least 3x longer, but also for a 6x larger population. So that efficacy is there. We can pretty much guarantee if you're a presbyope able to drop a product in your eyes, you'll be able to see a text message because 95% improves at least 2 lines. Then it all comes down to do you like it? Are you going to buy it? So we're going to sample very, very heavily. We'll have a 5-day sample pack.
So it's not going to cannibalize on our ultimate revenue because we want people to experience it. When we look at our clinical trials, the Phase II and the large Phase IIIs, there's a lot of people that literally went, wow, like how does this work? And for those that have seen our Commercial Day, we had a couple of patients in there that went like I was skeptical going in, like how can an eye drop improve my near vision, but it did. It was surprising. It was crazy. That's what people -- that's how people describe it. So we want them to sample. And what I believe is that if somebody from a sample goes to a script, different than with VIUTY, that's somebody that liked the product because VIUTY sampled a very -- initially to sample a little bit, but they realized that product wasn't very effective.
So they literally sent that reps back in and pulled the samples out of the doctor's office. So now they're only selling the promise of an eye drop to treat near vision. People bought in on the promise, paid $80 and didn't work. So I think the fact that we have heavy sampling means that the moment that we see NRxs, our chance that those are sticky and people refill is a lot higher. So that's what we'll be watching for. I think a year from now, we'll know a lot more.
I was going to put you on the spot a little bit unplanned and ask you to try to give a time framework for when you know whether the stickiness has stopped.
I think Q2 2026. That's where I feel is we'll start to see it. It will not have been fully played out. But if you don't see it in the second quarter, then yes, we'll need to start figuring out what's driving that because what I didn't touch on is how the launch from a timing perspective will go. So let's assume August 8 approval. Sales force will start doing their calls. We're guiding to product in the market in Q4. That delta sits because this is such a large volume product, and we're obviously having a lot of product made. We actually started producing in February of this year. So we'll be sitting on a lot of bulk.
We need final label to do the final packaging on it and then get that product into the market. So that's what's driving that gap. So Q1 will be the first full quarter. Again, we should see NRxs then. And Q2, we should start to see how that translates into our NRxs.
Application. And you also just touched on this briefly as it pertains to your Feb production start. But supply chain and manufacturing, can you give us a little primer on how have you invested in inventory? What does your supply chain look like? How do you think about that, again, moving forward, depending on the demand curve that we had.
So I'll start by saying before I lay out the supply chain that we're duty-free and free from tariffs. And we look very smart because we figured that out back in November of last year, just as part of our normal commercial prep and how the supply chain works is our API is produced in the U.S. and our IP sits in the U.S. So it's deemed a U.S. product because the fill/finish, even though that's happening in Germany, is not seen as a major value driving step.
So API gets sent to Germany. We produce these little low-field seals, many of them. And once we have them finally -- once we have the final packaging done, we ship them back into the U.S. Again, as a duty-free product.
We're producing ample products to make sure that whatever our forecast is, and that's a number I'm not going to share, that we can do much more of that. This plant can do large, large volumes out of redundancy, not for a capacity reason, but just for a security reason. We're actually also putting a second and third site, state site online in 2026, 2027. That's a supply chain well tested. We actually produced our commercial products -- sorry, our clinical product at commercial scale already and obviously commercial now.
And in terms of geography of the state sites, how does that play into the equation? Does it matter? Do you have strategic places within the U.S. or...
No, it's a one site API production, but also there, we're putting second and third sites, online. Now the moment that the product comes back into the U.S., it obviously goes to 3 different wholesalers. There's a separate group that does all the samples. So that's where it gets spread up.
Great. You touched on tariffs, again, very clear. Maybe another area that we could touch on is just product protection, specifically IP, your 3 concentric rings. Let's dive deep on that.
Very good. The product is very well protected. And indeed, you can think of it as like 3 elements there. So the first one, recycled in is a new chemical entity for the U.S., which means that upon approval, we expect 5 years of data exclusivity. So right off the bat, 5 years that nobody can do anything. Then the core IP portfolio, we have 8 granted patents in the U.S. now, take that protection to 2044. So from today, 20 years of IP that sits both on medical treatment, so aceclidine for the use in presbyopia and formulation patents. That whole portfolio is very strong.
You can imagine that when we took the company public last year and before that, Series B, we had all the [indiscernible] and the coolies and you name them kicking the ties on it, all advising their clients that, yes, this is a very strong IP portfolio that's worth investing in. That block is IP block. There's like 10 or 12 patents that are under review that will continue to strengthen the IP portfolio.
And then on the back end, because -- but this is not a molecule that will be genericized in a traditional way because it's a self-pay product. So there's no insurance company that when a generic is available, would drive that switch. Whoever wants to come in 2044 or beyond, would need to do the same and need to build the same brand, which we know is not an easy feat and something that just drives a very nice long tail, something that we realize is also seen as very interesting by Big Pharma.
Great. Brand equity, if you will, as you think about it. Okay. So maybe now shifting since Dan isn't up here on stage with us to more of the financial set of questions. You're well funded, and you've publicly messaged that. You've messaged, in fact, good funding through positive operating cash flow. Can you tell us a little bit about expectations for commercial uptake versus spend in your early quarters of launch?
And then as you think about cushion, discretionary spend, use of capital, what is the framework you use internally to plan for strategic...
Let me start with the first one. We took the company public about 5 quarters ago now. And from the moment that we went public on that first call, we guided to the fact that we could indeed get to cash flow positivity with the cash that we then had. Since over the last year, we strengthened the balance sheet with about $50 million. We did one-off deals with investors that really wanted to put money into the stock and build positions. And then we had some nondilutive cash coming in through licensing deals. That's why we're guiding now, and we've actually taken our guidance up to $190, 1-9-0, million cash at PDUFA date, and we expect that to potentially even grow.
So like I said, we were guiding to be able to get to cash flow positive with a margin back then. We've added $50 million to the balance sheet. So we continue to feel more and more confident that a very real feasibility, if you will.
So what does the P&L look like? We're very targeted tightly run company by design. So if you think about our P&L post launch, like I think I mentioned earlier, we'll be spending about $100 million on the commercial side of the house. So that's about $25 million on the sales force. So the 88 reps with that team. These are not oncology reps. These reps, you can look it up because they obviously are subscription are out there. They make between $110,000 and $150,000 plus bonus. So that gets you to about a $25 million cost sales force, which leaves logically call it $75 million to $80 million for marketing, which is mostly DTC. That DTC is going to start in Q1 of 2026.
Then on top of that, on the G&A side, think of it as roughly $25 million. Like I said, it's a very tightly run company. We have no R&D by design and not a lot of additional overhead on IP or other areas. So we look in some elements, very similar to a company like Tarsus on the commercial spend, very different on the G&A side of it.
And maybe last point, just as you think about capital allocation, very clear on no R&D spend and that being intentional. How do you think about over the evolution of the next couple of years as you're in the unique position of being a not yet commercial biopharma company staring right at profitability, not too far from now. How do you think about the offensive, BD in licensing versus plowing some money back into R&D in the future?
Great question and something that we're definitely focused on. So if I think about that from a timing perspective, so we feel that LNZ100 can be and will be a great cornerstone molecule for a larger portfolio. What kind of portfolio looks like? You can do more front of the eye, you can go back of the eye even or say, no, we're a lifestyle company that knows how to sell a consumer product in a self-pay market, but it's still a script.
So that's sort of that lens, no pun intended, that we look at how do we expand the portfolio. That's something that, in my mind, will be M&A BD driven. Those would need to be products that we can add to the portfolio, let's call it 2027 time frame. So let's show success in 2026, but then have products available to add to the portfolio in the 2027-ish time frame. And again, that would all be M&A BD driven.
Great. Good. Well, thank you. We've got about a minute left. Anything keeping you up at night that we have not covered that you should touch on or any final comments?
Very little keeping me up at night. We have a phenomenal team, which is great. I mean this is a big thing. It's a lot of execution. So yes, we're spending as we should a lot of time on it. But this team has done it before. And the nice thing about it, and again, by design, I built the company this way, it's a one-product company. So there's no A or B teams. There's no -- we don't have to prioritize. This is what we do.
One piece that we didn't touch on is that we are obviously highly focused on licensing -- sorry, commercializing the product in the U.S., but we'll license ex U.S. We have a partnership in place with China that we did early because they had to do their own clinical trial. That clinical trial read out 9 months or so ago. It's carbon copy from our data, which is obviously, again, very validating, different country, different company, different population, same results.
About a month or so ago, we announced a deal for Korea and Southeast Asia, highly competitive process. They can leverage our U.S. dossier and U.S. approval. So it's the right time to do that then. And that's how we continue to look at Europe, Middle East, Africa, Canada, Latin America. Those will all be territories that over time will come online, but all through partners.
Great. Thank you for joining us. Appreciate it.
Great. Thank you. Yes, thank you.
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Finanzdaten von Graphite Bio Inc
Umsatz
Der Umsatz stellt die Summe aller Einnahmen eines Unternehmens z. B. für dessen Produkte oder Dienstleistungen dar.
Umsatz (TTM) einfach erklärtDirekte Kosten
Direkte Kosten sind die Kosten, die direkt im Zusammenhang mit der Herstellung des Produkts oder der Dienstleistung entstehen.
Bruttoertrag
Der Bruttoertrag gibt an, wie viel vom Umsatz nach Abzug der direkten Herstellkosten im Unternehmen verbleibt. Berechnet man den prozentualen Anteil vom Umsatz, spricht man von der Bruttomarge (engl. Gross Margin).
Brutto Marge einfach erklärtVertriebs- und Verwaltungskosten
Die Vertriebs- & Verwaltungskosten (engl. Selling, General & Administrative expenses, kurz SG&A) beinhalten alle Aufwände für Marketing und den Verkauf sowie die allgemeine Verwaltung des Unternehmens.
Forschungs- und Entwicklungskosten
Die Forschungs- und Entwicklungskosten (engl. research & development costs, kurz R&D) geben Auskunft darüber, wie viel das Unternehmen in die Forschung und die Entwicklung seiner Produkte investiert. Vor allem prozentual vom Umsatz und im Vergleich zu direkten Wettbewerbern sind die Kosten interessant.
EBITDA
Das EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) ist der Gewinn des Unternehmens vor Zinsen, Steuern und Abschreibungen. Berechnet man den prozentualen Anteil vom Umsatz, spricht man von der EBITDA-Marge.
Abschreibungen
Abschreibungen stellen Wertminderungen von Vermögensgegenständen des Unternehmens dar (z.B. durch Abnutzung von Maschinen).
EBIT (Operatives Ergebnis)
Das EBIT (engl. Earnings Before Interest and Taxes) ist der Gewinn des Unternehmens vor Zinsen und Steuern, das auch als operatives Ergebnis bezeichnet wird. Berechnet man den prozentualen Anteil vom Umsatz, spricht man von
der EBIT-Marge.
Nettogewinn
Der Nettogewinn stellt den Gewinn oder Verlust nach Abzug aller Kosten dar.
Nettogewinn einfach erklärtaktien.guide Premium
| Mär '26 |
+/-
%
|
||
| Umsatz | 21 21 |
-
100 %
|
|
| - Direkte Kosten | 1,49 1,49 |
-
7 %
|
|
| Bruttoertrag | 2 2 |
-
10 %
|
|
| - Vertriebs- und Verwaltungskosten | 125 125 |
264 %
264 %
595 %
|
|
| - Forschungs- und Entwicklungskosten | 13 13 |
49 %
49 %
61 %
|
|
| EBITDA | -118 -118 |
99 %
99 %
-562 %
|
|
| - Abschreibungen | 0,36 0,36 |
300 %
300 %
2 %
|
|
| EBIT (Operatives Ergebnis) EBIT | -118 -118 |
99 %
99 %
-564 %
|
|
| Nettogewinn | -109 -109 |
128 %
128 %
-519 %
|
|
Angaben in Millionen USD.
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| Hauptsitz | USA |
| CEO | Mr. Schimmelpennink |
| Mitarbeiter | 152 |
| Gegründet | 2017 |
| Webseite | lenz-tx.com |


