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Puma Biotechnology Reports Fourth Quarter and Full Year 2025 Financial Results

On February 26, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2025. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2025 compared to the fourth quarter and full year 2024.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the fourth quarter of 2025 was $59.9 million, compared to $54.4 million in the fourth quarter of 2024. Product revenue, net for the full year 2025 was $204.1 million, compared to $195.2 million in 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $13.4 million, or $0.27 per basic share and $0.26 per diluted share, for the fourth quarter of 2025, compared to net income of $19.3 million, or $0.39 per basic and diluted share, for the fourth quarter of 2024. The fourth quarter of 2025 included a net change in a valuation allowance that unfavorably impacted net income by $3.2 million, or $0.06 per basic and diluted share, compared to the fourth quarter of 2024, which included a partial release of a valuation allowance that favorably impacted net income by $7.1 million, or $0.15 per basic and diluted share. Net income for full year 2025 was $31.1 million, or $0.62 per basic share and $0.61 per diluted share, compared to net income of $30.3 million, or $0.62 per basic and diluted share, for full year 2024.

Non-GAAP adjusted net income was $15.1 million, or $0.30 per basic share and $0.29 per diluted share, for the fourth quarter of 2025, compared to non-GAAP adjusted net income of $21.1 million, or $0.43 per basic and diluted share, for the fourth quarter of 2024. Non-GAAP adjusted net income for full year 2025 was $38.1 million, or $0.76 per basic share and $0.75 per diluted share, compared to non-GAAP adjusted net income of $38.5 million, or $0.79 per basic share and $0.78 per diluted share, for full year 2024. Non-GAAP adjusted net income excludes stock-based compensation expenses. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2025 was $14.4 million, compared to $15.6 million in the fourth quarter of 2024. Net cash provided by operating activities for full year 2025 was $41.8 million, compared to net cash provided by operating activities of $38.9 million for full year 2024. At December 31, 2025, Puma had cash, cash equivalents, and marketable securities of $97.5 million, compared to cash, cash equivalents, and marketable securities of $101.0 million at December 31, 2024. Total debt at December 31, 2025 was $22.5 million, compared to total debt at December 21, 2024 of $67.0 million.

"Our financial performance in the fourth quarter and full year 2025 demonstrates continued momentum, with net income marking our third consecutive year of profitability, a testament to our disciplined execution and careful fiscal stewardship," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our current guidance forecasts that we will continue to be profitable in 2026, which we believe is a result of this continued financial discipline. In parallel, we continue to advance alisertib clinically through ALISCA-Breast1 and ALISCA-Lung1, targeting patient populations in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and extensive-stage small cell lung cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q2 2026); (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q2 2026); and (iii) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the fourth quarter of 2025, total revenue was $75.5 million, of which $59.9 million was product revenue, net and $15.6 million was royalty revenue. This compares to total revenue of $59.1 million for the fourth quarter of 2024, of which $54.4 million was product revenue, net and $4.7 million was royalty revenue. For the year ended December 31, 2025, total revenue was $228.4 million, of which $204.1 million was product revenue, net and $24.3 million was royalty revenue. This compares to total revenue in 2024 of $230.5 million, of which $195.2 million was product revenue, net and $35.3 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $58.4 million for the fourth quarter of 2025, compared to $45.7 million for the fourth quarter of 2024. Total operating costs and expenses were $191.1 million for full year 2025, compared to $199.5 million for full year 2024.

Cost of Sales

Cost of sales was $23.2 million for the fourth quarter of 2025, compared to $13.9 million for the fourth quarter of 2024. Cost of sales was $58.2 million for full year 2025, compared to cost of sales of $64.4 million for full year 2024. The $6.2 million decrease was primarily due to a decrease of product unit sales to our sub-licensees and the related cost of sales (primarily sales in China), partially offset by higher domestic sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $18.4 million for the fourth quarter of 2025, compared to $16.6 million for the fourth quarter of 2024. SG&A expenses for full year 2025 were $70.8 million, compared to $80.2 million for full year 2024. The $9.4 million year-over-year decrease in SG&A expenses resulted primarily from legal fees associated with the AstraZeneca litigation in 2024.

Research and Development Expenses

Research and development (R&D) expenses were $16.8 million for the fourth quarter of 2025, compared to $15.2 million for the fourth quarter of 2024. R&D expenses for full year 2025 were $62.1 million, compared to $54.9 million for full year 2024. The $7.2 million year-over-year increase in R&D expenses resulted primarily from increased alisertib study activity.

Total Other Income (Expenses)

Total other income was insignificant for the fourth quarter of 2025, compared to total other expenses of $1.2 million for the fourth quarter of 2024. Total other expenses were $1.5 million for full year 2025, compared to $6.9 million for full year 2024.

Deferred Income Taxes

In the fourth quarter of 2025, Puma recorded a $7.1 million income tax expense, offset by a $3.8 million partial release of a valuation allowance resulting in a non-cash, deferred tax expense of approximately $3.2 million. The valuation allowance was established to offset Puma’s deferred tax assets, which are primarily related to its historical losses. In the fourth quarter of 2024, Puma released a portion of its valuation allowance that resulted in a non-cash, deferred tax benefit of $7.1 million.

First Quarter 2026 and Full Year 2026 Financial Outlook

First Quarter 2026

Full Year 2026

Net Product Revenue

$36–$39 million

$194–$198 million

Royalty Revenue

$2–$3 million

$20–$23 million

License Revenue

Total Revenue

$38–$42 million

$214–$221 million

Net Income/(Loss)*

$(8)–$(10) million

$10–$13 million

Gross to Net Adjustment

29.5%–30.5%

27.5%–28.5%

*The outlook above does not include any potential adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2025 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 26, 2026. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

(Press release, Puma Biotechnology, FEB 26, 2026, View Source [SID1234663088])

Prokarium to present at the Annual European Association of Urology (EAU) Congress

On February 26, 2026 Prokarium’s CEO, Ibs Mahmood, reported that it will be presenting at the 41st Annual EAU Congress, London, UK, 13-16th March 2026.

Presentation information:

Presentation Title: PARADIGM 1 – A multi-center Phase 1 study evaluating the safety and clinical effect of a novel microbial immunotherapeutic (ZH9) in patients with relapsed NMIBC – A first interim review (Abstract ID: A0089)
Session Title: High-risk NMIBC: Evolving BCG–immunotherapy strategies and technical advances in TURB (Abstract Session 05)
Session Date and Time: Friday 13th March, 16:20 – 16:56

(Press release, Prokarium, FEB 26, 2026, View Source [SID1234663087])

Personalis Reports Fourth Quarter and Full Year 2025 Results and Recent Highlights

On February 26, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial and operational results for the fourth quarter and full year ended December 31, 2025 and recent business highlights and provided financial guidance for the full year 2026.

Fourth Quarter and Recent Strategic and Operational Highlights

●
Secured Milestone Medicare Coverages for Breast & Lung Cancer: Received Medicare coverage approval in the fourth quarter for the surveillance of cancer recurrence in breast cancer patients, and also, received Medicare coverage for Stage I to III non-small cell lung cancer (NSCLC) in the first quarter of 2026; both are expected to be key catalysts for clinical revenue generation and market share growth in the MRD space.
●
Published Landmark TRACERx Data: Highlighted data from one of the largest and most comprehensive NSCLC patient cohorts to date in the journal Cell, demonstrating the clinical importance of Personalis’ ultrasensitive MRD approach.
●
Validated ctDNA Dynamics: Published VHIO data in Clinical Cancer Research titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," further reinforcing the clinical validity of the NeXT Personal platform in a broad array of cancer types.
Full Year 2025 Financial Results Compared with 2024

●
Total Revenue: $69.6 million compared with $84.6 million.
●
Clinical Momentum: Clinical test revenue of $2.0 million, more than double the $0.8 million.
●
Volume Performance: Clinical test volume reached 16,233 tests, a nearly 400% increase over the 3,285 test volume in 2024.
●
Core Revenue Streams: Pharma testing services and all other customers contributed $49.0 million. Revenue from enterprise sales (Natera) and population sequencing (the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP)) totaled $17.6 million. Other revenue included a $1.0 million royalty payment for the patents licensed by the Company.
Fourth Quarter 2025 Financial Results Compared with 2024

●
Quarterly Revenue: $17.3 million compared with $16.8 million.
●
Accelerating Volume: Delivered 6,183 clinical tests in the fourth quarter, representing a 41% sequential increase over the third quarter of 2025.

●
Clinical Revenue: Clinical test revenue of $0.9 million, compared with $0.2 million.
●
Core Revenue Streams: Pharma testing services and all other customers contributed $10.9 million. Revenue from enterprise sales (Natera) and population sequencing (the VA MVP) totaled approximately $4.5 million. Other revenue included a $1.0 million royalty payment for the patents licensed by the Company.
●
Strong Cash Position: Ended the year with approximately $240.0 million in cash, cash equivalents, and short-term investments. This includes approximately $109.0 million in net proceeds from the Company’s At-The-Market (ATM) sales program, executed at a weighted-average price of $8.43 per share.
CEO Commentary

"Our performance in 2025 was transformative, demonstrated by 400% year-over-year clinical volume growth and pivotal Medicare coverage for breast and lung cancer," said Chris Hall, Chief Executive Officer and President. "We enter 2026 with a fortified balance sheet of approximately $240 million in cash, which allows us to expand our investments in our ‘Win-in-MRD’ strategy. While we are in the early stages of reimbursement, we are driving volume now to secure long-term market leadership. We expect 2026 to be a year of rapid commercial expansion, with clinical revenue projected to grow approximately five-fold as we operationalize our recent coverage wins."

Full Year 2026 Outlook

Personalis expects the following for the full year of 2026:

●
Total company revenue in the range of $78.0 to $80.0 million.
●
Clinical revenue of $10.0 to $11.0 million, including Medicare reimbursement from breast and lung cancer surveillance; clinical volume expected to be in the range of 43,000 to 45,000 tests.
●
Revenue from pharma testing services and all other customers in the range of $55.0 to $56.0 million.
●
Revenue from population sequencing and enterprise sales of approximately $13.0 million.
●
Gross margin in the range of 15% to 20%, reflecting the strategic decision to accelerate clinical volume adoption ahead of full reimbursement coverage to establish market share.
●
Net loss of approximately $105.0 million.
●
Cash usage of approximately $100.0 million, driven by commercial investments to support the projected 5x clinical revenue growth.

(Press release, Personalis, FEB 26, 2026, View Source [SID1234663086])

Pacira BioSciences Reports Fourth Quarter and Full-Year 2025 Financial Results

On February 26, 2026 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, reported financial results for the fourth quarter and full-year of 2025.

"2025 was a year of disciplined execution for Pacira. With the launch of our 5×30 strategy, we reignited momentum across the business and delivered strong, measurable progress. Our products benefitted more than 2.5 million patients, generated $726 million in revenue, and achieved the highest gross margins in our company’s history. Together, these results clearly validate the impact and promise of our 5×30 strategy," said Frank D. Lee, chief executive officer of Pacira BioSciences.
"Our performance continues to be led by EXPAREL, which is benefitting from expanding reimbursement, growing commercial adoption, and strengthened intellectual property providing protection into the 2040s. We further extended our commercial reach through strategic collaborations, while advancing clinical programs positioned to deliver a data-rich year. Pacira enters 2026 stronger than ever as we continue to redefine what is possible in innovative non-opioid pain management," continued Mr. Lee.

2025 Fourth Quarter and Full-Year Financial Highlights

•Fourth quarter revenues of $196.9 million and full-year revenues of $726.4 million.
•Fourth quarter GAAP net income of $1.6 million or $0.04 per basic and diluted share and full-year GAAP net income of $7.0 million or $0.16 per basic and diluted share.
•Fourth quarter adjusted EBITDA of $38.7 million and full-year adjusted EBITDA of $186.5 million.
•Repurchased 2.0 million shares of common stock at an average price of $24.94, for a cost of $50.0 million in the fourth quarter, bringing the full year 2025 to 5.9 million shares of common stock repurchased for a cost of $150.0 million.
See "Non-GAAP Financial Information" below.
Recent Business Highlights
•Enhanced Board of Directors with Appointment of Samit Hirawat, M.D. In January 2026, the company announced the appointment of Samit Hirawat, M.D., to its Board of Directors, bringing more than 25 years of clinical development and industry expertise. This appointment increases the size of the company’s Board of Directors to 10 members. Most recently, Dr. Hirawat served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol

Myers Squibb, where he oversaw the worldwide clinical development portfolio and advanced multiple transformative therapies across therapeutic areas.
•Strategic Partnership with LG Chem to Bring EXPAREL to Select Asian-Pacific Markets. In January 2026, the company announced an agreement with LG Chem designed to expand access to opioid-sparing postsurgical pain control for patients in select Asian-Pacific markets. Through this partnership, LG Chem has the exclusive rights to commercialize EXPAREL in the region. Under the terms of the agreement, Pacira received an upfront payment, will supply EXPAREL product and receive a transfer price as well as tiered royalties on future commercial sales. LG Chem plans to file for marketing authorizations in South Korea and Thailand in 2026.
Fourth Quarter 2025 Financial Results
•Total revenues were $196.9 million in the fourth quarter of 2025, a 5 percent increase over the $187.3 million reported for the fourth quarter of 2024.
•EXPAREL net product sales were $155.8 million in the fourth quarter of 2025, a 5 percent increase over the $147.7 million reported for the fourth quarter of 2024.
•ZILRETTA net product sales were $33.0 million in the fourth quarter of 2025, essentially flat versus the $33.1 million reported for the fourth quarter of 2024.
•Fourth quarter 2025 iovera° net product sales were $7.0 million, an 8 percent increase over the $6.5 million reported in the fourth quarter of 2024.
•Total operating expenses were $194.5 million in the fourth quarter of 2025, versus the $162.5 million reported for the fourth quarter of 2024.
•Research and development (R&D) expenses were $37.5 million in the fourth quarter of 2025, compared to $23.9 million in the fourth quarter of 2024. The company’s fourth quarter 2025 R&D expenses included a $5.0 million upfront payment for the in-licensing of PCRX-2002 (previously known as AMT-143) from AmacaThera, Inc.
•Selling, general and administrative (SG&A) expenses were $101.6 million in the fourth quarter of 2025, compared to $79.6 million in the fourth quarter of 2024. The company’s fourth quarter 2025 SG&A expenses were impacted by a number of unanticipated costs associated with business development due diligence and litigation.
•GAAP net income was $1.6 million, or $0.04 per basic and diluted share in the fourth quarter of 2025, compared to $16.0 million, or $0.35 per basic share and $0.34 per diluted share in the fourth quarter of 2024.
•Non-GAAP net income was $24.4 million, or $0.58 per basic share and $0.57 per diluted share in the fourth quarter of 2025, compared to $44.3 million, or $0.96 per basic share and $0.91 per diluted share in the fourth quarter of 2024.
•Adjusted EBITDA was $38.7 million in the fourth quarter of 2025, compared to $62.5 million in the fourth quarter of 2024.
•Pacira ended the fourth quarter of 2025 with cash, cash equivalents and available-for-sale investments ("cash") of $238.4 million.
•Pacira had 42.5 million basic and 43.0 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2025.
See "Non-GAAP Financial Information" below.

Full-Year 2025 Financial Results
•Total revenues were $726.4 million in 2025, a 4 percent increase over the $701.0 million reported in 2024.
•EXPAREL net product sales were $575.1 million in 2025, a 5 percent increase over the $549.0 million reported in 2024.
•ZILRETTA net product sales were $116.6 million in 2025, a 1 percent decrease versus the $118.1 million reported in 2024.
•Full-year iovera° net product sales were $24.2 million, a 6 percent increase over the $22.8 million reported in 2024.
•Total operating expenses were $707.2 million in 2025, compared to $774.3 million in 2024. Included within 2024 is a goodwill impairment of $163.2 million.
•R&D expenses were $117.3 million in 2025, compared to $81.6 million in 2024. The company’s 2025 R&D expenses included a $5.0 million upfront payment for the in-licensing of PCRX-2002 from AmacaThera, Inc.
•SG&A expenses were $368.8 million in 2025, compared to $294.1 million in 2024. The company’s 2025 SG&A expenses were impacted by a number of unanticipated costs associated with business development due diligence and litigation.
•GAAP net income was $7.0 million, or $0.16 per basic and diluted share in 2025, compared to a GAAP net loss of $99.6 million, or $2.15 per basic and diluted share in 2024. Included in the GAAP net loss in 2024 was a $163.2 million impairment of goodwill based upon an assessment that the then-fair value of goodwill was less than its carrying value.
•Non-GAAP net income was $122.3 million, or $2.74 per basic share and $2.65 per diluted share in 2025, compared to $157.7 million, or $3.41 per basic share and $3.20 per diluted share in 2024.
•Adjusted EBITDA was $186.5 million in 2025, compared to $223.9 million in 2024.
•Pacira had 44.6 million basic and 45.0 million diluted weighted average shares of common stock outstanding in 2025.
•For non-GAAP measures, Pacira had 46.7 million and 50.2 million diluted weighted average shares of common stock outstanding in 2025 and 2024, respectively.
See "Non-GAAP Financial Information" below.
Share Repurchase Program
During the fourth quarter of 2025, the company repurchased 2.0 million shares of its common stock at an average price of $24.94, through open market transactions for $50.0 million, bringing the company’s total shares repurchased in 2025 to 5.9 million for $150.0 million. At December 31, 2025, the company had 41.1 million shares of common stock outstanding and $150.0 million remaining on its current share repurchase authorization, which expires December 31, 2026.

2026 Financial Guidance
Today the company is providing full-year 2026 financial guidance as follows:
•EXPAREL net product sales of $600 to $620 million;
•Total revenue of $745 million to $770 million;
•Non-GAAP gross margin of 77 to 79 percent;
•Non-GAAP R&D expense of $105 million to $115 million;
•Non-GAAP SG&A expense of $320 million to $340 million; and
•Stock-based compensation of $54 million to $62 million.
See "Non-GAAP Financial Information" below.
Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, February 26, 2026, at 4:30 p.m. ET. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register at investor.pacira.com/upcoming-events. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

(Press release, Pacira Pharmaceuticals, FEB 26, 2026, View Source;991.htm [SID1234663085])

OPKO Health Reports Fourth Quarter 2025 Business Highlights and Financial Results

On February 26, 2026 OPKO Health, Inc. (NASDAQ: OPK) (OPKO) reported business highlights and financial results for the three and 12 months ended December 31, 2025, and introduces financial guidance for the first quarter and full year 2026.

Highlights from the fourth quarter of 2025 and recent weeks include the following:

Entered into a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies. This new partnership leverages ModeX’s MSTAR technology platform with Regeneron’s proprietary binders to develop single molecule candidates that target multiple distinct biological pathways in several clinical indications. ModeX received an upfront payment and is entitled to potential milestone payments exceeding $200 million for each program. The overall potential value of the collaboration exceeds $1 billion if multiple products from the collaboration are successful. In addition, ModeX is eligible to receive tiered royalties on global net sales, reaching low double digits at the highest tier. Regeneron is responsible for funding all preclinical and clinical development, as well as all commercialization activities.

Merck completed the Phase 1 Epstein-Barr virus vaccine trial (NCT06655324). This investigational vaccine candidate is being developed in collaboration with Merck. The Phase 1 trial evaluating safety and tolerability in over 200 healthy adults was completed in the fourth quarter of 2025. Additional studies are in progress to inform dose and adjuvant selection for potential Phase 2 studies.

MDX2003, a first-in-class trispecific T-cell engager-expander for the treatment of leukemia and lymphoma, was approved for Phase 1 studies in Australia, which are expected to begin in the first half of 2026. Also, an abstract was presented at 2025 ASH (Free ASH Whitepaper) Annual Meeting. In November, an abstract titled "MDX2003, a novel tetraspecific T cell engager-expander targeting CD19xCD20xCD3xCD28, demonstrates potent preclinical activity against B cell malignancies" was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. In an animal model, MDX2003 prevented further tumor growth at low doses and was well-tolerated with low levels of cytokines in the blood and no observable toxicity.

Abstract for MDX2004, a first-in-class trispecific antibody-fusion protein immune rejuvenator, was presented at SITC (Free SITC Whitepaper) 2025. In November, an abstract titled "MDX2004, a novel immune rejuvenator targeting CD3, CD28, and 4–1BB, augments tumor immunity in preclinical animal models" was presented at SITC (Free SITC Whitepaper) 2025, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The ongoing Phase 1/2a study (NCT07110584) is designed to evaluate the safety, tolerability and biologic activity of MDX2004 as an immunotherapy for advanced cancers.

Abstract for MDX2001 cMet-Trop2/CD3-CD28, a first-in-class tetraspecific T-cell engager, was presented at ESMO (Free ESMO Whitepaper) 2025. In October, an abstract titled "A phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001, a tetraspecific T cell engager-expander in patients with advanced solid tumors" was presented at ESMO (Free ESMO Whitepaper) Congress 2025, the annual meeting of the European Society for Medical Oncology. The MDX2001 cMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in select solid tumors expected to begin in the first half of 2026.

FDA permission to proceed to Phase 1 granted to MDX2301, a tetravalent bispecific antibody that neutralizes all known strains of SARS-CoV2, for the prevention and treatment of COVID-19 infection. Supported by non-dilutive funding from BARDA, the clinical trial in healthy volunteers is scheduled to begin in the second quarter of 2026, with pharmacokinetic and immunogenicity data expected later this year.

Expanded partnership with Entera Bio to advance first-in-class oral long-acting PTH tablet for patients with hypoparathyroidism. This third program under the collaboration combines OPKO’s proprietary long-acting PTH variants with Entera’s proprietary N-Tab technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. OPKO and Entera Bio each hold a 50% pro-rata ownership interest in the long-acting PTH hypoparathyroidism program and each is responsible for 50% of the program’s development costs.

Fourth Quarter Financial Results

Consolidated: Consolidated total revenues for the fourth quarter of 2025 were $148.5 million compared with $183.6 million for the 2024 period, with the decrease principally resulting from the sale of certain BioReference assets in 2025. Operating loss for the fourth quarter of 2025 was $38.3 million compared with operating loss of $33.1 million for the 2024 quarter. Net loss for the fourth quarter of 2025 was $31.3 million, or $0.04 per share, compared with net income of $14.0 million, or $0.01 per diluted share, for the 2024 quarter. Net income for the fourth quarter of 2024 included a realized gain of $54.1 million from the sale of shares of GeneDx, as well as non-cash other income of $21.4 million.
Pharmaceuticals: Revenue from products in the fourth quarter of 2025 was $43.7 million compared with $37.4 million in the fourth quarter of 2024, driven by a positive net foreign exchange impact of $4.0 million and by higher sales volumes in our international operations. Revenue from Rayaldee was $8.8 million compared with $9.1 million in the comparable prior-year quarter. Revenue from the transfer of intellectual property and other was $33.7 million in the fourth quarter of 2025 compared with $43.1 million in the 2024 period. Gross profit share payments for NGENLA, which totaled $12.5 million in the 2025 period compared with $9.6 million in the 2024 period, reflect the global commercial progress by Pfizer. In addition, the fourth quarter of 2025 included $4.3 million in royalty revenue from Eli Lilly following the commercial launch of mazdutide in China by their partner Innovent Biologics and a $7.0 million upfront payment from Regeneron. The comparable period of 2024 included a $12.5 million milestone payment from Merck, as well as a $7.0 million decrease in commercial milestones at our Eirgen business and a $4.1 million decrease in revenue from our contract with BARDA. Total costs and expenses increased to $88.0 million in the fourth quarter of 2025 from $82.6 million in the prior-year period, primarily due to higher cost of revenue related to higher sales volume, higher research and development expenses driven by advancements in early-stage programs and employee-related expenses reflecting an increase in headcount to support ongoing clinical activities. Operating loss was $10.7 million in the fourth quarter of 2025, which included $18.3 million in depreciation and amortization expense, compared with operating loss of $2.1 million in the fourth quarter of 2024, which included $18.1 million of depreciation and amortization expense.

Diagnostics: Revenue from services in the fourth quarter of 2025 was $71.1 million compared with $103.1 million in the prior-year period. The decrease was principally a result of the sale of certain BioReference assets in 2025 and the resulting decline in clinical test volume, and lower clinical test reimbursement rates, partially offset by increased demand and higher average reimbursement for the 4Kscore test, resulting in a 16% increase in revenue to $7.0 million in the 2025 quarter compared with $6.0 million in revenue in the 2024 quarter. Total costs and expenses were $89.4 million in the fourth quarter of 2025 compared with $124.8 million in the fourth quarter of 2024. The decrease was primarily attributable to the assets sold and to continued cost-reduction initiatives at BioReference. Operating loss was $18.3 million in the fourth quarter of 2025, which included $4.1 million of depreciation and amortization expense, compared with operating loss of $21.7 million in the 2024 period, which included $6.0 million of depreciation and amortization expense. The fourth quarter of 2025 was impacted by non-recurring transition-related adjustments of $5.8 million, primarily from severance, asset write-offs, third-party revenue adjustments, and capital tax expense. The fourth quarter of 2024 included revenue of $26.3 million and costs and expenses of $32.9 million from the oncology assets that were sold to Labcorp on September 15, 2025.

Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents and restricted cash were $369.1 million as of December 31, 2025. As of December 31, 2025, approximately $87.3 million of OPKO’s common stock had been repurchased, including $13.5 million in the fourth quarter of 2025, under the program since its authorization in July 2024. Approximately $112.7 million remained authorized and available for future repurchases.

2026 Financial Guidance: The table below reflects financial guidance for the first quarter and full year 2026 (in millions):

For the three months ended March 31, 2026 For the year ended December 31, 2026
Low High Low High
Revenue
Services revenue $ 71 $ 75 $ 300 $ 312
Product revenue 38 45 160 170
IP and other revenue 15 20 70 80
Total revenues 125 140 530 560

Included in revenue
Pfizer profit share 5 6 34 37
BARDA contract 7 9 18 22

Total costs and expenses 170 180 725 750

R&D included in costs and expenses 30 32 125 135

Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss fourth quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until March 5, 2026, by dialing 855-669-9658 (U.S.) or 412-317-0088 (International) and providing the passcode 2367034. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

(Press release, Opko Health, FEB 26, 2026, View Source [SID1234663084])