To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Precigen (NasdaqGS:PGEN) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsHarry Thomasian Jr. - CFOHelen Sabzevari - President and CEOJason Butler - Managing Director of Biotechnology Equity ResearhMichael DiFiore - Managing DirectorPhil Tennant - Chief Commercial OfficerRútul R. Shah - COOSteven Harasym - VP of Investor RelationsConference Call ParticipantsBrian Chung - Investment Risk AnalystSwayampakula Ramakanth - Managing Director and Senior Equity AnalystOperatorThis call is being ...

Precigen Reports Full Year 2025 Financial Results and Business Updates Accessibility StatementSkip Navigation GERMANTOWN, Md., March 25, 2026 /PRNewswire/ -- Precigen, Inc.(Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced full year 2025 financial results and business updates. "With the FDA approval and launch of PAPZIMEOS, 2025 marked a transformational year for Precigen as we trans ...

Company Overview - Precigen Therapeutics is a biotech company focused on cell and gene therapy for various indications, including rare diseases and oncology [3] - The company is based in Maryland and aims to utilize differentiated technology and platforms tailored to specific indications with a clear regulatory strategy [3] Product Development - Precigen has successfully developed its first drug, PAPZIMEOS, which received approval in a rapid timeframe of four years from discovery to development [3]

Company Overview - Precigen operates in the biotechnology sector, focusing on developing next-generation gene and cell therapies through proprietary platforms and innovative genetic engineering [5][7] - The company has a market capitalization of $1.2 billion and reported a revenue of $6.3 million for the trailing twelve months (TTM) [4] - Precigen's net income for the TTM is a loss of $425.9 million, with a significant third-quarter net loss attributable to common shareholders of $325 million, primarily due to non-cash items [4][10] Recent Developments - On November 14, Tang Capital Management disclosed a new position in Precigen, acquiring 12.4 million shares valued at approximately $40.8 million, representing 1.6% of the fund's $2.6 billion in U.S. equity assets [2][9] - Precigen's stock price has increased by 282% over the past year, closing at $3.48, significantly outperforming the S&P 500, which rose by 13% in the same period [3] Product and Market Position - The company has launched PAPZIMEOS, the first FDA-approved therapy for recurrent respiratory papillomatosis, which has shown strong early demand with over 100 patients enrolled in its Patient Hub [8][10] - Precigen's strategy includes targeting unmet medical needs with disease-modifying therapeutics and engineered solutions, aiming to establish a competitive edge in the evolving healthcare landscape [5][10]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $123.6 million in cash, cash equivalents, and investments, following a drawdown of the first tranche of its credit facility [16] - The company ended the quarter with approximately $3 million in inventory, representing manufacturing costs incurred post-approval of PAPZIMEOS [17] - The net loss attributable to common shareholders for the quarter was $1.06 per share, which included two large non-cash accounting items totaling $0.95 per share [18] Business Line Data and Key Metrics Changes - PAPZIMEOS was granted full FDA approval in August 2025, marking a significant milestone for the company and the treatment of recurrent respiratory papillomatosis (RRP) [5][6] - The drug has shown a 51% complete response rate, with 86% of patients experiencing a reduction in surgical burden after treatment [3][4] Market Data and Key Metrics Changes - The company has engaged with 90% of target institutions covering a significant portion of the estimated 27,000 adult patients with RRP in the U.S. [9] - Over 80 million lives are covered under payer policies for PAPZIMEOS, including Medicare and Medicaid [10] Company Strategy and Development Direction - The company aims to establish PAPZIMEOS as the new standard of care for adults with RRP, with ongoing efforts for geographic expansion and pediatric clinical trials [7][12] - The company has made significant investments in in-house CGMP manufacturing operations to ensure control over production and meet anticipated demand [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching cash flow breakeven by the end of 2026, supported by projected revenues from PAPZIMEOS [17][31] - The management highlighted the strong pent-up demand for PAPZIMEOS, with expectations for continued patient enrollment and treatment initiation [35][46] Other Important Information - The company has implemented a new ERP system to support its commercial operations and manage processes effectively [19] - The pivotal study for PAPZIMEOS is noted as the first and only clinical trial in RRP with a robust statistical primary endpoint [4] Q&A Session Summary Question: Any updates on patient reimbursement approvals or dosing? - The company has started shipping PAPZIMEOS to institutions, and payer coverage is progressing well, with expectations for patient dosing to increase in Q4 [22][24] Question: What assumptions are made regarding cash flow breakeven? - The company is not providing specific revenue guidance but expects to reach cash flow breakeven by the end of 2026 [30][31] Question: How long is the expected bolus of patients for therapy? - The company anticipates a prolonged bolus of patients due to the existing demand and the broad label for PAPZIMEOS, which includes all adult RRP patients [34][36] Question: How is revenue recognized for PAPZIMEOS? - Revenue is recognized upon transfer of title when the drug is shipped to healthcare entities, not upon patient injection [43][44] Question: Will all registered patients receive PAPZIMEOS? - The company expects a high percentage of registered patients to ultimately receive treatment, with a sense of urgency from the physician community [45][46]

Core Insights - Precigen, Inc. announced third quarter 2025 financial results and business updates, highlighting the successful launch of PAPZIMEOS, the first FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP) [1][5][7]. Business Highlights - PAPZIMEOS received full FDA approval in August 2025, marking a significant advancement in treatment options for adults with RRP [6][7]. - The company has engaged over 90% of target institutions and registered over 100 patients in the PAPZIMEOS Patient Hub since the launch [2][6][7]. - Strong early interest and demand for PAPZIMEOS have been reported, with significant progress in private health insurance coverage, now covering over 100 million lives [5][6][7]. Financial Performance - Total revenues for Q3 2025 increased by $2.0 million compared to Q3 2024, primarily driven by collaboration and licensing revenue [8]. - Research and development expenses rose by $1.0 million, or 9%, due to increased manufacturing and regulatory costs related to PAPZIMEOS [9]. - Selling, General and Administrative (SG&A) expenses surged by $14.2 million, or 144%, largely due to costs associated with the commercialization of PAPZIMEOS [10]. - The company recorded a net loss attributable to common shareholders of $325.3 million for Q3 2025, significantly higher than the $24 million loss in Q3 2024, influenced by non-cash items [13][26]. Clinical and Market Developments - Long-term follow-up results from the pivotal clinical trial of PAPZIMEOS showed durable complete responses in 83% of patients after a median follow-up of 36 months [7]. - The company submitted a Marketing Authorization Application to the European Medicines Agency for PAPZIMEOS in November 2025, indicating plans for geographic expansion [6][7].

Group 1 - Precigen, Inc. has signed a credit facility agreement worth up to $125 million to support its commercialization efforts for PAPZIMEOS and expand into international markets [2][3][4] - The credit facility consists of two tranches: the first tranche of $100 million was funded at closing, while the second tranche of $25 million can be drawn at the company's discretion until March 21, 2027 [2][4] - The funding aims to bolster the company's position in the U.S. market and pursue pediatric and other HPV-related indications, indicating potential for near-term revenue growth [3][4] Group 2 - Precigen is a biopharmaceutical company focused on the discovery and clinical-stage development of gene and cell therapies targeting diseases in immuno-oncology, autoimmune disorders, and infectious diseases [5]

Core Insights - Precigen is a biopharmaceutical company focused on innovative precision medicines for difficult-to-treat diseases with high unmet needs [1] - The company has received FDA approval for PAPZIMEOS, the first drug approved for treating recurrent respiratory papillomatosis in adults [2] - PAPZIMEOS is a nonreplicating adenoviral vector-based immunotherapy targeting HPV 6 and 11, which are believed to cause the disease [2] - The FDA granted full approval on August 15, ahead of the PDUFA date of August 27, and the drug is set to launch in early Q4 of this year [2]

Product & Indication - PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with Recurrent Respiratory Papillomatosis (RRP)[11, 44, 55] - PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis[27] - The recommended dose of PAPZIMEOS is 5×10^11 particle units (PU) per injection, administered subcutaneously four times over a 12-week interval[27] Clinical Data - The pivotal study demonstrated a 51% Complete Response Rate (95% CI [34-69%])[37] - 15 out of 18 Complete Responders evaluated at 2 years demonstrated continued Complete Response[37] - PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2[37] Commercial Strategy & Launch - The company is employing a targeted launch strategy with a field team covering >90% of ENT patient potential[47] - 93 IDNs and community hospitals account for 80% of initial target potential, with a total target universe of ~500 accounts[48] - 18 dedicated sales territories will cover >90% of ENT patient potential[47] RRP Market - Approximately 27,000 adult patients in the US have RRP[16] - IDNs and Community hospitals account for >90% of identified patient potential[46]