ARCALYST collaboration profit grew 75% year-over-year to $104.8 million in Q2 2025, driven by sales volume and disciplined commercial investments.
ARCALYST net revenue was $156.8 million in Q2 2025, a 52% year-over-year increase driven by new patient enrollments, prescribers, and active commercial patients.
Cash balance increased by approximately $40 million to $307.8 million in Q2 2025, with expectations to remain cash flow positive on an annual basis.
Net income was $17.8 million in Q2 2025 compared to a net loss of $3.9 million a year ago, reflecting strong revenue growth and moderate expense growth.
Operating expenses grew 26% year-over-year due to cost of goods sold, collaboration expenses, and SG&A supporting ARCALYST commercialization.
Adjusted EPS grew 56% driven by higher adjusted EBITDA, favorable foreign exchange, and lower interest expense.
Adjusted gross margin improved 470 basis points to 45.6%, with Affordable Medicines segment margin up 270 basis points to 44.3%.
Affordable Medicines revenue was $433 million, growing 1% despite last year's 14% growth, driven by new product launches adding $33 million.
AvKARE revenues declined 4% to $163 million but improved gross margin by 540 basis points and operating income by 44%.
First half 2025 revenues grew 4%, adjusted EBITDA grew 12% to $354 million, and adjusted EPS increased 50% to $0.45.
Net leverage reduced to 3.7x adjusted EBITDA from 3.9x in December 2024 following a successful debt refinancing that extended maturities to 2032 and reduced interest costs by over $33 million annually.
Q2 revenues reached $720 million with adjusted EBITDA of $184 million, reflecting 3% revenue growth and 13% adjusted EBITDA growth year-over-year.
Specialty segment revenue grew 23% to $128 million, led by CREXONT ($11 million), RYTARY ($9 million, up 19%), and UNITHROID ($4 million, up 12%).
Cash and equivalents totaled $580 million, with an additional $170 million in committed government funding, providing total available liquidity of around $750 million.
General and administrative expenses were approximately $19 million, down from $20 million, including ongoing intellectual property defense costs.
Net loss for the quarter was roughly $35 million, an improvement from a $37 million loss in Q2 2024.
Research and development expenses were about $39 million, slightly lower than the previous year by $2 million due to timing of program-specific expenses.
Revenue for Q2 2025 was approximately $17 million, up from $7 million in Q2 2024, driven by a $10 million lump sum licensing fee from the Trianni platform.
Sales and marketing expenses decreased slightly to $3 million compared to the prior year.
Adjusted EBITDA was negative $83 million in Q2 2025 versus negative $3 million in Q2 2024, reflecting risk adjustment and Part D cost impacts partially offset by cost initiatives.
Medical cost trends were around 6% in the first half of 2025, consistent with prior expectations.
Medical margin was negative $53 million in Q2 2025 compared to positive $106 million in Q2 2024, driven by underperformance in burden of illness programs and prior period adjustments.
Medicare Advantage membership declined to 498,000 from 513,000 year-over-year, reflecting a measured growth approach and market exits.
Q2 2025 revenue was $1.4 billion, down from $1.48 billion in Q2 2024, primarily due to lower risk adjustment and unfavorable Part D development.
Cash and equivalents totaled $187.4 million at quarter-end, with cash use down approximately 60% year-over-year.
Net loss was $18.5 million, 46% lower than Q2 2024.
Non-GAAP gross margin expanded by 110 basis points to 38.4%, with product gross margin increasing nearly 400 basis points to 48.9%.
Non-GAAP operating expenses declined 19% to $25.4 million, resulting in a non-GAAP operating loss of $13.4 million, a 36% improvement from the prior year.
Recurring revenue reached $22.5 million, up 11% from Q2 2024, including a 17% increase in consumable revenue.
Revenue for Q2 2025 was $31.4 million, a 15% increase year-over-year, driven by strong Tablo console sales and consistent utilization.
Commercial Transformation and Sales Process Overhaul
The commercial transformation aims to capitalize on large enterprise and IDN opportunities, with a focus on moving from early-stage to later-stage deals.
The company has retooled its sales team to target hospital CNOs and other key decision-makers, emphasizing change management and clinical benefits.
Progress includes a more disciplined approach to sales forecasting, pipeline management, and deal closure, setting the stage for sustained growth.
Regulatory Progress and BLA Submission Strategy for INO-3107
Inovio remains on track to submit its BLA for INO-3107 in the second half of 2025, with a goal of file acceptance by year-end.
The company has completed the design verification testing of the CELLECTRA 5PSP device, a key regulatory milestone.
Inovio has requested a rolling submission of its BLA under breakthrough therapy designation, aiming for a 6-month review period and a potential PDUFA date around mid-2026.
The company successfully completed an FDA inspection of its clinical trial operations, an important step in regulatory compliance.
Differences in trial design and technology, such as DNA medicine versus viral vectors, distinguish INO-3107 from competitors' programs.
Positive Phase III Data for Obesity Drug Orforglipron
Lilly announced positive topline results from the ATTAIN-1 Phase III trial of orforglipron, an oral GLP-1 receptor agonist, in people with obesity without diabetes.
Patients on the highest dose of orforglipron lost over 27 pounds (12.4% of body weight), with notable improvements in metabolic markers such as blood pressure, cholesterol, and inflammation.
The safety profile was consistent with the injectable GLP-1 class, with gastrointestinal side effects being most common and low discontinuation rates (5-10%).
Lilly plans to submit orforglipron for regulatory approval globally within the year, with additional Phase III trials ongoing in diabetes, weight maintenance, and other indications.