Oncobiologics (NASDAQ:OTLK) said it is preparing for the U.S. commercial launch of LYTENAVA after the Food and Drug Administration approved the product as the only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration, or wet AMD, in the United States.
President and Chief Executive Officer Bob Jahr called the approval a “transformational achievement” for the company and said the focus has shifted from regulatory work to establishing commercial, reimbursement, supply and medical-affairs capabilities needed to support a launch later this year.
U.S. market opportunity and launch plans
The company estimates the U.S. anti-VEGF retina market totals about $8.5 billion annually. It cited an estimated 3.6 million injections of off-label repackaged bevacizumab across retinal indications in 2025, including roughly 2.2 million injections for wet AMD.
Jahr said the company’s base-case objective is for LYTENAVA to generate more than $500 million in peak annual U.S. sales by 2030. That forecast assumes repackaged bevacizumab remains available in the market and does not assume universal adoption, he said.
During the question-and-answer session, Jahr said a disruption in the compounded or repackaged bevacizumab market could create “just under a $300 million” sales upside, although he noted that any displaced use could also shift to competing biosimilars.
The company is pursuing a focused commercial model because it views the retina market as concentrated among a relatively defined group of specialists and high-volume practices. It plans to hire approximately 30 customer-facing commercial employees and about 20 field reimbursement personnel. The reimbursement team will help practices navigate coverage, acquisition, coding, inventory and patient-access considerations in the physician-administered buy-and-bill market.
Jahr said the company expects to submit an application for a permanent HCPCS code by the end of the third quarter and anticipates receiving a permanent J-code in April 2027. The company said it has sufficient supply for its planned launch and is scaling its commercial supply processes.
Pricing, clinical data and adoption assumptions
Outlook Therapeutics expects LYTENAVA’s wholesale acquisition cost to be below $500 per vial. Jahr said pricing is intended to be competitive with biosimilars and other anti-VEGF treatments while reflecting the product’s differentiated profile. He said the company has considered patient affordability, payer access and the operational needs of retina practices in developing its approach.
The approved label is based on the NORSE TWO registrational study. According to Jahr, 41.7% of patients treated with LYTENAVA gained at least 15 letters in visual acuity at month 11, compared with 23.1% of patients treated with ranibizumab.
Management said its market segmentation work identified just under 800 retina physicians—about one-third of the physician target base—that represent slightly less than half of the company’s $500 million U.S. sales target. These practices tend to use compounded or repackaged bevacizumab because of payer step-edit requirements, Jahr said.
The company’s forecast assumes the entry of ranibizumab and aflibercept biosimilars, continued price pressure for biosimilars, and potential approvals of other therapies, including TKIs, IL-6 therapies and gene therapy. It also incorporates continued pressure related to reduced funding availability from the Good Days Foundation, Jahr said.
Financial results and revenue outlook
Executive Vice President and Chief Financial Officer Lawrence Kenyon reported an adjusted net loss attributable to common stockholders of $10.9 million, or $0.09 per basic and diluted share, for the third quarter of fiscal 2026. That compared with an adjusted net loss of $15.8 million, or $0.44 per share, in the prior-year quarter.
As of June 30, the company had $11.2 million in cash and cash equivalents. After the quarter ended, the company announced a $55 million public offering of common stock and accompanying warrants, expected to generate approximately $51.1 million in net proceeds after underwriting discounts and offering expenses. The proceeds are intended to support the U.S. launch of LYTENAVA, working capital and general corporate purposes.
Kenyon said the company expects total net revenue during the first 12 months after the U.S. launch to range from $50 million to $75 million, with Europe accounting for approximately 10% to 15% of the total. About 10% of first-year revenue is expected in the first three months after launch, increasing to roughly 50% in the fourth quarter following launch.
The company expects quarterly selling, general and administrative expenses to approximately double from current levels by the end of calendar 2026, followed by an additional increase of approximately 10% during 2027. Research and development expense is expected to remain relatively steady over the next 12 months as the company advances its prefilled syringe program.
European expansion
LYTENAVA is currently available in Germany, Austria and the United Kingdom. Kenyon said European unit sales rose 46% in the fiscal third quarter compared with the second quarter, while fourth-quarter unit sales were on track to match current levels despite the expected summer slowdown.
The company expects to launch in the Netherlands in early 2027 following its national reimbursement submission. Commercial partner Mediconsult is preparing for a Swiss launch in 2027. Jahr said the company is also assessing potential expansion opportunities in Latin America, Asia, the Middle East and North Africa, while taking a selective approach to additional European markets because of pricing and reimbursement pressures.
About Oncobiologics (NASDAQ:OTLK)
Oncobiologics, Inc is a clinical-stage biopharmaceutical company specializing in the development of biosimilar therapeutics for cancer and autoimmune diseases. Leveraging recombinant DNA technology and advanced formulation platforms, the company aims to create high-quality, cost-effective alternatives to originator biologic drugs. Oncobiologics’ research focus includes monoclonal antibodies and growth factors that support oncology treatment and immunomodulation.
Founded in 2005 and headquartered in Marlborough, Massachusetts, Oncobiologics maintains research facilities in the Greater Boston area and an integrated manufacturing site in Hyderabad, India, through its wholly owned subsidiary.
