Precigen NASDAQ: PGEN reported a sharp increase in first-quarter 2026 revenue as the company’s first commercial product, PAPZIMEOS, continued its U.S. launch following FDA approval in August 2025.
On the company’s earnings call, President and CEO Dr. Helen Sabzevari said PAPZIMEOS generated net product revenue of $21.6 million in the first quarter, its first full quarter of availability, compared with $3.4 million in the fourth quarter of 2025. Total company revenue for the quarter was $23.3 million.
PAPZIMEOS is approved as a first-line treatment for adults with recurrent respiratory papillomatosis, or RRP. Sabzevari said the launch has shown “accelerating momentum” across both major medical centers and community practices.
“The early success and trajectory continues to build on this landmark achievement for the patients, families, healthcare providers, the Recurrent Respiratory Papillomatosis Foundation, and all of those impacted by this devastating disease,” Sabzevari said.
PAPZIMEOS Launch Gains Traction
Sabzevari attributed the uptake to several factors, including the FDA’s full approval and broad label, which does not restrict treatment based on the number of surgeries a patient has previously undergone. She also cited clinical data showing efficacy and durability, ease of administration and distribution, and a recent expert position paper published in The Laryngoscope.
The paper, sponsored by the RRP Foundation and authored by 16 U.S. physicians specializing in RRP, recommended PAPZIMEOS as the new standard of care and preferred first-line therapy, according to Sabzevari.
Chief Commercial Officer Phil Tennant said registrations in the company’s PAPZIMEOS patient hub had reached approximately 400 patients as of the call, with 25% coming from community settings. He said that figure does not include patients enrolled directly by institutions outside the company’s hub.
Tennant also said payer coverage has been “exceptional,” with more than 90% of insured lives in the U.S. covered across commercial, Medicare and Medicaid plans. He added that the permanent J-code assigned April 1 is expected to simplify claims processing and support broader access.
“The significant quarter-over-quarter revenue growth is a clear sign that the healthcare community is embracing PAPZIMEOS,” Tennant said.
Financial Results Show Narrower Operating Loss
Chief Financial Officer Harry Thomasian said Precigen posted an operating loss of $6 million in the first quarter. Net loss was $7.9 million, or $0.02 per basic and diluted share.
Research and development expenses were $5.6 million, down $4.8 million from the prior-year quarter. Thomasian said most of the decline was due to PAPZIMEOS manufacturing costs being expensed before FDA approval. He said R&D expense is expected to increase as the year progresses.
Selling, general and administrative expenses were $21 million, up $8.7 million from the prior-year quarter, driven mainly by increased commercial activity tied to PAPZIMEOS.
Precigen ended the quarter with $56.7 million in cash equivalents and investments. Cash used in operations was $43.8 million, including $13 million in cash outflows the company does not expect to recur in future quarters this year. Thomasian also noted that first-quarter operating cash use did not include cash receipts from PAPZIMEOS sales because of customer payment terms.
Thomasian said the company expects cash used in operations in the second quarter to be “significantly lower” than in the first quarter. He reiterated that Precigen expects its cash, investments and collection of PAPZIMEOS receivables to fund operations through cash flow break-even by the end of 2026 and said the company does not currently see a need to access capital markets for additional funding.
Company Declines to Provide Revenue Guidance
During the question-and-answer session, analysts asked for more detail on the number of patients treated, hub conversion rates and expectations for second-quarter revenue. Tennant said the company is not commenting on the specific number of patients who have initiated treatment, though he said patients have begun completing the 12-week regimen since dosing started in November.
Tennant said it was still early to provide detailed hub conversion metrics, adding that the company would like to review another few quarters of data before communicating trends such as time to conversion.
Sabzevari said Precigen is not providing formal guidance but pointed to the increase from the fourth quarter to the first quarter and said the company continues to see expansion across medical centers and community practices.
Tennant said revenue carried over from the fourth quarter into the first quarter was “pretty minimal” given the fourth-quarter revenue level, but that some revenue spillover should be expected in future quarters because PAPZIMEOS is administered over a 12-week regimen.
Clinical and Pipeline Updates
Sabzevari said Precigen plans to initiate a pediatric trial of PAPZIMEOS in the fourth quarter of 2026. The company’s marketing authorization application for PAPZIMEOS also remains under review by the European Medicines Agency.
Precigen is evaluating redosing of PAPZIMEOS in an ongoing clinical trial. Sabzevari said the company has begun redosing patients, particularly those who had partial responses in earlier trials, and will report information from that effort.
The company also plans to present updated durability data for PAPZIMEOS at the American Society of Clinical Oncology meeting next month. Sabzevari said the data will add to the company’s evidence on safety, durability and efficacy, and may support further expansion efforts.
Sabzevari also highlighted PRGN-2009, an immunotherapy using the same AdenoVerse platform as PAPZIMEOS. The therapy is designed to train the immune system to recognize and eliminate tumor cells infected with HPV-16 and HPV-18, which are associated with major HPV-driven cancers such as head and neck and cervical cancers.
PRGN-2009 is being studied in multiple Phase 2 trials in combination with pembrolizumab in head and neck and cervical cancers. Sabzevari said the company expects to provide data updates in the second half of the year.
“I believe we are building the foundation of a meaningful portfolio for Precigen and for the community of our patients,” Sabzevari said in closing remarks.
About Precigen NASDAQ: PGEN
Precigen, Inc NASDAQ: PGEN is a biotechnology company focused on the discovery, development and commercialization of genetic medicines. The company leverages proprietary gene and cell therapy platforms to design targeted therapies for oncology, infectious diseases and rare conditions. Precigen's approach combines synthetic biology, immuno-oncology and microbiome engineering to create precision treatments intended to enhance efficacy while minimizing off-target effects.
The centerpiece of Precigen's technology is its OmniCAR platform, which enables the rapid generation of adaptable chimeric antigen receptor (CAR) T-cell products.
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