Outlook Therapeutics(OTLK) - 2025 Q3 - Quarterly Results

Corporate and Financial Highlights The company reported its first commercial revenue in Q3 FY2025, alongside a net loss, while achieving European market entry and progressing its U.S. FDA BLA review Financial Highlights Outlook Therapeutics reported its first-ever revenue in Q3 FY2025, alongside a GAAP net loss and an improved adjusted net loss, concluding the quarter with a reduced cash position Q3 FY2025 vs Q3 FY2024 Financial Results | Metric | Q3 FY2025 | Q3 FY2024 | | :--- | :--- | :--- | | Revenue | $1.5 million | $0 | | Net Loss Attributable to Common Stockholders | $20.2 million | N/A (Net Income of $44.4M due to non-cash gains) | | Net Loss per Share (basic & diluted) | $0.55 | $0.89 | | Adjusted Net Loss Attributable to Common Stockholders | $15.8 million | $19.2 million | | Adjusted Net Loss per Share (basic & diluted) | $0.44 | $0.83 | - The company's cash and cash equivalents stood at $8.9 million as of June 30, 2025[5] - Adjustments to net loss for Q3 FY2025 primarily excluded a $2.3 million loss from change in fair value of promissory notes and a $2.0 million loss from change in fair value of warrant liability[4] Corporate and Operational Highlights Outlook Therapeutics has successfully transitioned into a commercial-stage company with the first commercial sales of LYTENAVA™ in Europe, with a significant near-term U.S. FDA PDUFA goal date for ONS-5010 - The company achieved its first commercial sales of LYTENAVA™ (bevacizumab gamma) in Europe, with the first patients dosed in Germany and the UK[7][8] - The U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of August 27, 2025, for the review of the Biologics License Application (BLA) for ONS-5010[6][7] Business and Product Update The company provides updates on the commercial launch of LYTENAVA™ in Europe, the U.S. regulatory progress for ONS-5010, and key product characteristics European Commercial Update LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for treating wet age-related macular degeneration (wet AMD), being the first and only authorized ophthalmic formulation of bevacizumab for this indication in the European Union and the UK, supported by a strategic collaboration with Cencora - LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for treating wet AMD in adults in the European Union and UK[9] - The company aims to mitigate risks associated with the current off-label use of repackaged bevacizumab, which is frequently used in Europe (approx. 2.8 million injections annually) and the U.S. (approx. 2.7 million injections annually)[10] - A strategic collaboration with Cencora is in place to support market access and efficient distribution of LYTENAVA™ globally[11] U.S. Regulatory Update The FDA has accepted the resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for the treatment of wet AMD, undergoing a Class 2, six-month review with a PDUFA goal date of August 27, 2025, and expected to receive 12 years of regulatory exclusivity if approved - The FDA acknowledged the BLA resubmission for ONS-5010 in April 2025 and set a PDUFA goal date of August 27, 2025[12] - The resubmission was based on efficacy and safety data from the NORSE EIGHT clinical trial, conducted to address the FDA's requirement for a second adequate and well-controlled study[13] - Upon potential approval, ONS-5010, to be branded as LYTENAVA™ in the U.S., is expected to receive 12 years of regulatory exclusivity[12] About ONS-5010 / LYTENAVA™ ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab, a monoclonal antibody that neutralizes vascular endothelial growth factor (VEGF) to reduce blood vessel formation and leakage in the retina, approved for wet AMD in the EU and UK, and currently an investigational product in the United States - The product is a recombinant humanized monoclonal antibody (mAb) that selectively binds to and neutralizes all isoforms of human VEGF[16] - It has received Marketing Authorization from the European Commission and the UK's MHRA for the treatment of wet AMD[14][17] - In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) remains an investigational product pending FDA approval[15][18] Financial Statements and Non-GAAP Reconciliation This section presents the company's consolidated statements of operations and balance sheet, along with a reconciliation of GAAP to non-GAAP financial measures Consolidated Statements of Operations For Q3 FY2025, Outlook Therapeutics reported its first revenues, leading to a gross profit, and incurred significant operating expenses, resulting in a net loss Q3 FY2025 Statement of Operations Highlights (in thousands) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues, net | $1,505 | $0 | | Gross profit | $1,065 | $0 | | Research and development | $7,135 | $11,202 | | Selling, general and administrative | $9,679 | $8,361 | | Loss from operations | $(15,749) | $(19,563) | | Net (loss) income | $(20,152) | $44,409 | | Net loss per share, diluted | $(0.55) | $(0.89) | Condensed Consolidated Balance Sheet As of June 30, 2025, the company's balance sheet reflects a decrease in cash and cash equivalents, with total assets significantly lower than current liabilities, resulting in a substantial stockholders' deficit Balance Sheet Highlights (in thousands) | Line Item | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,901 | $14,928 | | Total assets | $22,392 | $28,823 | | Current liabilities | $31,489 | $42,554 | | Total stockholders' deficit | $(37,190) | $(73,077) | Non-GAAP Financial Measures and Reconciliation Outlook Therapeutics utilizes non-GAAP measures, such as adjusted net loss, to present a clearer view of core operating performance by excluding specific non-cash items, demonstrating an improved adjusted net loss compared to the prior year - The company uses non-GAAP financial measures, such as "adjusted net loss attributable to common stockholders," to exclude non-cash items like changes in fair value of warrants and promissory notes, which management believes are not related to its core business[19] GAAP to Non-GAAP Reconciliation for Q3 (in thousands) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net (loss) income attributable to common stockholders (GAAP) | $(20,152) | $44,409 | | Adjustments (e.g., fair value changes, warrant expenses) | $4,324 | $(63,625) | | Adjusted net loss attributable to common stockholders (non-GAAP) | $(15,828) | $(19,216) |