Reported Q2 revenues of $720 million and adjusted EBITDA of $184 million, with confidence in raising 2025 guidance.
Emphasized diversified portfolio and multiple growth drivers including new product launches, complex medicines, biosimilars, and strategic partnerships.
Projected continued growth with a focus on innovative and affordable medicines, aiming to be America's #1 affordable medicines company.
Cash, cash equivalents, and marketable securities totaled $539 million as of June 30, 2025, including $80 million raised through an ATM facility.
Crysvita contributed $120 million in Q2 2025, with $79 million from North America, $35 million from Latin America and Turkey, and $7 million from Europe.
Dojolvi generated $23 million, Evkeeza $15 million, and Mepsevii $8 million in Q2 2025, all showing steady growth.
Net cash used in operations was $108 million for Q2 and $275 million for the first half of 2025.
Net loss for the quarter was $115 million or $1.17 per share.
Total operating expenses were $274 million, including $165 million in R&D, $87 million in SG&A, and $23 million in cost of sales, with $39 million in noncash stock-based compensation.
Ultragenyx reported total revenue of $166 million in Q2 2025, a 13% increase over Q2 2024, and 20% growth for the first half of 2025 compared to the same period in 2024.
Cash and equivalents stood at $462 million as of June 30, 2025.
Drug discovery revenue increased 19% year-over-year to $14.2 million, reflecting recognition of a $150 million upfront payment from the Novartis collaboration.
Net loss narrowed to $43 million ($0.59 per share) from $54 million ($0.74 per share) in Q2 2024.
R&D expenses decreased over 15% to $43.1 million, driven by expense shifts and cost reduction initiatives.
Sales and marketing expenses increased 11% to $10.7 million, while G&A expenses rose 7% to $25.2 million.
Software gross margin declined to 68% from 80% in Q2 2024 due to revenue mix changes and investments in the predictive toxicology initiative.
Software revenue grew 15% year-over-year to $40.5 million, driven by hosted contracts and Gates Foundation grant contributions.
Total operating expenses decreased 6% to $79 million compared to Q2 2024.
Total revenue for Q2 2025 was $54.8 million, a 16% increase year-over-year.
Adjusted non-GAAP EBITDA was $54.1 million, a 63% increase from the prior year period, and adjusted non-GAAP EPS was $1.80, up from $1.02.
ANI Pharmaceuticals reported record Q2 2025 results with net revenues of $211.4 million, up 53% year-over-year on an as-reported basis and 37% organically.
Cash flow from operations was $110.8 million in the first half of 2025, with unrestricted cash increasing to $217.8 million at quarter-end.
Generics revenues increased 22% to $90.3 million, supported by new product launches including prucalopride tablets with 180-day exclusivity.
Non-GAAP gross margin improved to 64.9%, up over 6 points from the prior year, due to favorable product mix and strong generics performance.
Operating expenses increased, with R&D up 130% to $16 million and SG&A up 66% to $67.1 million, reflecting investments in sales teams and clinical studies.
Rare Disease revenues doubled year-over-year to $104 million, driven by Cortrophin Gel revenues of $81.6 million, up 66% year-over-year.
Sanofi Partnership Milestone and Future Collaboration Opportunities
Novavax received a $175 million milestone payment from Sanofi following FDA approval of Nuvaxovid in the U.S. in Q2 2025.
The partnership with Sanofi now positions Sanofi to lead commercialization of Nuvaxovid in select global markets for the 2025-2026 season.
Novavax expects to receive additional milestones related to marketing authorization transfers in the U.S. and EU later in 2025 and in late 2026.
The collaboration includes potential royalties from new combination vaccines that include Novavax's COVID vaccine, expanding long-term revenue streams.
Management highlighted the strategic value of the multifaceted Sanofi agreement, including milestones and royalties, as a key growth driver.
Sanofi's comments on the potential of COVID-flu combo vaccines are seen as encouraging for future collaboration prospects.
Da Vinci procedures increased 17% globally, with U.S. growth led by benign general surgery and international growth led by non-urology procedures.
GAAP net income was $658 million or $1.81 per share, up from $527 million or $1.46 per share last year.
Gross margin declined to 67.9% from 70% last year due to higher facilities costs, product mix, and tariffs.
Instrument and accessory revenue per procedure remained stable at approximately $1,800.
Pro forma operating margin was 39%, and pro forma earnings per share increased 23% to $2.19.
Second quarter revenue grew 21% to $2.44 billion, driven by strong procedure growth and capital placements.
SP procedures grew 88% year-over-year, and Ion procedures grew 52% to approximately 35,000.
System placements totaled 395, including 180 da Vinci 5 systems and 23 SP systems, with strong U.S. capital placements but macro challenges in Japan, China, and Europe.
Cash, cash equivalents, and restricted cash totaled $253.4 million as of June 30, 2025, with a cash runway extended into 2028.
General and administrative expenses decreased to $10.3 million in Q2 2025 from $12.3 million in Q2 2024, due to reduced share-based compensation and headcount.
Net loss for Q2 2025 was approximately $9.2 million or $0.34 per diluted share, improved from a net loss of $17.2 million or $0.64 per diluted share in Q2 2024.
Research and development expenses decreased to $29.6 million in Q2 2025 from $58.7 million in Q2 2024, reflecting lower manufacturing and clinical costs for COVID, flu, and OTC programs, partially offset by higher clinical costs for cystic fibrosis.
Revenue for Q2 2025 was $28 million, down $22 million year-over-year, primarily due to lower revenues from the CSL collaboration and amortization of upfront payments as CoStave progresses toward commercialization.
Total operating expenses for Q2 2025 were $40 million, down from $71 million in Q2 2024, driven by reduced manufacturing costs, clinical trial expenses, payroll, and employee benefits.
Dafinchi
