Aug 14, 2026 earnings call — LYTENAVA FDA approval and U.S. commercial launch
FDA approved LYTENAVA; company expects more than $500 million in peak annual sales by 2030.
Revenue $0.0B (est $0.0B) · EPS $-0.09 (est $-0.08) · Next-quarter revenue outlook $0.1B–$0.1B
Key quotes
"Only 3 weeks ago, the FDA approved LYTENAVA as the only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States."
"In NORSE TWO, 41.7% of patients treated with LYTENAVA gained at least 15 letters at month 11 compared to 23.1% of patients treated with ranibizumab."
"Subsequent to quarter end, we just announced a $55 million public offering of common stock and accompanying warrants, representing approximately $51.1 million in expected net proceeds after underwriting discounts and offering expenses that is expected to close today."
Analyst Q&A 5
U.S. sales if repackaged bev changes
Q (Julian Harrison · BTIG): He asked how much upside there is to the $500 million U.S. sales guide if FDA intervenes on compounding, how prescribers and payers view LYTENAVA vs repackaged bev, and how many early adopters they have identified and their share.
A: Management said there is a significant upside if compounded repackaged bev availability is disrupted — just under a $300 million upside. They said their segmentation shows about 1/3 of retina physicians (just under 800) represent just below 50% of the $500 million, and they expect to capture between 30% and 35% of the 2.2 million wet AMD injections. They also described payer mix: a little under half is commercial/fee-for-service with Medigap, Medicare Advantage is a little over 35%, almost 40%, and in over 2/3 of the market compounding is required to be tried.
"Roughly, if there's any disruption in the compound repackaged bev or any significant change in its availability, there's roughly just under a $300 million upside into that in terms of what could potentially happen." — Robert Jahr (CEO)
How biosimilars affect forecast
Q (Brian Kemp Dolliver · Brookline): He asked how biosimilars and other new drug entries changed their forecast and why their estimates look higher than consensus.
A: Management said their forecast assumes compounded product stays available, ranibizumab and aflibercept biosimilars enter on time, and there is ongoing decreased pricing pressure for biosimilars. They also assumed TKIs, IL-6s and gene therapy approvals on time, continued pressure from the Good Days Foundation, and called their estimate conservative with potential upsides such as a prefilled syringe and the permanent J-code.
"Everything that I'm giving to you assumes the following: that compounded stays in the market, all biosimilars, ranibizumab and aflibercept biosimilars enter on time and that there's ongoing decreased pricing pressures for all the biosimilars." — Robert Jahr (CEO)
Patient costs after Good Days funding fell
Q (Douglas Tsao · H.C. Wainwright): He asked how reduced Good Days Foundation funding affects patient out-of-pocket costs and practices' use of repackaged bev versus branded or biosimilars.
A: Management said Good Days now has less funding and much of its support went to the more expensive, longer-acting competitors, which raises out-of-pocket questions. They noted the patient mix includes fee-for-service plus supplemental Medigap, commercial, and Medicare Advantage, so the 20% Medicare out-of-pocket is not universal; practices are sophisticated and the company will support patients where possible but has Medicare limitations; they also said biosimilar out-of-pocket varies, noting Pavblu can be quite expensive and ranibizumab biosimilars can be near Lucentis ("around 230, 250") with out-of-pocket around 50.
"However, as we look at our target market and we look and consider the fee-for-service plus supplemental Medigap, we look at commercial and we look at Medicare Advantage, that out-of-pocket is not universal across all patients and all segments." — Robert Jahr (CEO)
Plans for Europe and Asia rollout
Q (Edward Woo · Ascendiant): He asked if U.S. approval speeds up their European rollout and whether Asia is a target market.
A: Management said yes — with FDA approval they are assessing LatAm, parts of Asia, MENA and broader Europe, though some regions may require additional bridging studies and they have inbound partner interest. They said they will be strategic in Europe to avoid price/tender downward spirals, may prefer partners with ophthalmology experience, and see broader expansion as more sensible when the prefilled syringe is available while they focus on execution in current markets like the Netherlands, Austria and Switzerland.
"So the first one, yes, we are doing an assessment now that we have the FDA approval for the package of that in the compendia, what other regions." — Robert Jahr (CEO)
Europe progress and revenue potential
Q (Brian Kemp Dolliver · Brookline): He asked what will drive improvement in Europe given weak results, and how big Europe could be versus the $500 million U.S. opportunity by 2030.
A: Management said they have rightsized Europe costs and are seeing unit demand growth, but face country-specific barriers such as Germany's compounding rules, U.K. capacity issues, and pricing pressure from biosimilar tenders; they will be strategic and focus on markets where they can get the right economics. For scale, they said Europe would be much smaller than the U.S. peak — "probably 1/4 of that" or less — and that the U.S. will be 90% or more of total commercial net revenue.
"I would say it's probably 1/4 of that." — Robert Jahr (CEO)