Cash and cash equivalents ended at $370 million, with an additional $275 million received upfront from the Aspaveli capped royalty purchase agreement with Sobi.
EMPAVELI revenue was $21 million in Q2, up 5% quarter-over-quarter, with patient compliance at 97%.
Free goods usage impacted SYFOVRE revenue by approximately $13 million in Q2, with similar impacts expected for the rest of 2025.
Operating expenses were $212 million in Q2, down from $229 million in Q2 2024; 2025 OpEx expected to be in line with 2024.
SYFOVRE injections grew 6% quarter-over-quarter, with over 95,000 doses delivered (82,000 commercial and 13,000 free goods).
The royalty purchase agreement provides $275 million upfront plus $25 million in milestones, with defined caps allowing Apellis to participate in long-term upside.
Total revenue for Q2 2025 was $178 million, including SYFOVRE net product revenue of $151 million.
ANI achieved all-time highs in net revenue, adjusted non-GAAP EBITDA, and EPS in Q2 2025, driven by strong growth across Rare Disease and Generics units.
The company highlighted broad momentum, with Rare Disease demand accelerating, especially for Cortrophin Gel, and positive results in their retina franchise.
Management emphasized that the quarter's performance was driven by underlying demand rather than seasonality or one-time benefits, with new patient starts more than doubling year-over-year.
Adjusted EPS was $0.45, at the top of guidance but down 29% year-over-year, reflecting strong revenue execution and OpEx management offset by higher remediation costs.
Codman Specialty Surgical segment revenue was $304 million, up 0.7% reported but down 0.3% organic, with neurosurgery up 0.3% organically and ENT growth below expectations due to reimbursement pressures.
GAAP goodwill impairment charge of approximately $511 million was recorded due to macroeconomic uncertainties and supply recovery risks; this is a noncash charge with no impact on liquidity or operations.
Gross margin declined 450 basis points to 60.7%, primarily due to higher operational costs from shipholds remediation; adjusted EBITDA margin was 17.1%, down 290 basis points.
Integra LifeSciences delivered global revenue of $415.6 million in Q2 2025, slightly down 0.6% reported and 1.4% organic versus prior year, impacted by shipholds but offset by mid-single digit portfolio growth.
Operating cash flow was $9 million; free cash flow was negative $11.2 million due to capital investments.
Tissue Technology segment revenue was $111.6 million, down about 4% reported and organic, with strong growth in Integra Skin and DuraSorb offset by shipholds impacting MediHoney and private label declines.
Breast Health revenue declined 5.8% or 10.8% organically excluding Endomagnetics and SSI, but grew sequentially compared to Q2 and slightly exceeded internal goals.
Diagnostics revenue grew 0.9% or 2.9% organically excluding COVID-related sales, with molecular diagnostics leading growth at 2.4% globally and 7.3% in the U.S. excluding COVID.
Net margin was 23.8%, down 100 basis points year-over-year but up 60 basis points sequentially.
Non-GAAP EPS was $1.08, a 1.9% increase year-over-year and $0.01 above the high end of guidance.
Non-GAAP operating margin was just above 30%, with gross margin at 60.3%, down 80 basis points due to product mix and a reserve related to Fluoroscan discontinuation.
Operating cash flow was $343 million, with $1.88 billion in cash and short-term investments and a net leverage ratio of 0.6x.
Operating expenses increased 2.2% driven by acquisitions and deferred compensation, but excluding acquisitions, expenses declined 4.3%.
Skeletal revenue grew 62.1% as shipping resumed for the final DEXA model, meeting pent-up demand.
Surgical revenue increased 6.3% or 1.2% organically excluding Gynesonics, driven by strong international growth of 24.8%.
Total revenue for the third quarter was $1.024 billion, representing a slight growth of 0.4% and exceeding the high end of guidance by about $14 million.
Cash, cash equivalents, and restricted cash totaled $15 million as of June 30, 2025, down from $24.9 million as of September 30, 2024.
Current cash is sufficient to fund operations into the next calendar year, beyond the expected FDA end of Phase 2 meeting for Inovasaram.
For Q3 2025, research and development costs decreased to $3 million from $4.8 million in the prior quarter due to the wind down of the Phase 2b quality clinical study for Inovasaram.
For the nine months ended June 30, 2025, R&D costs increased to $12.7 million from $9.5 million due to Phase 2b clinical study expenses, partially offset by decreased spending on terminated programs.
Net loss from continuing operations for the nine months was $17 million or $1.16 per diluted share, improved from $26.7 million or $2.04 per diluted share in the prior period.
Net loss from continuing operations was $7.3 million or $0.50 per diluted share, improved from a net loss of $10.3 million or $0.71 per diluted share in the prior year quarter.
Net loss from discontinued operations related to the FC2 business was $7.2 million or $0.49 per diluted share, including a $4.3 million loss on sale.
Net working capital was $9.5 million as of June 30, 2025, compared to $23.4 million as of September 30, 2024.
Selling, general and administrative expenses decreased to $5 million from $5.8 million primarily due to lower share-based compensation.
Selling, general and administrative expenses for the nine months decreased to $15.4 million from $18.4 million due to lower share-based compensation.
The company is not profitable and has negative cash flow from operations, requiring additional capital to support drug development.
The company recognized a gain on sale of fee assets of $485,000 compared to $110,000 in the prior quarter.
The company recorded gains on sale of NTAPI assets of $2.2 million and a gain on extinguishment of debt of $8.6 million related to the sale of the FC2 Female Condom business.
Dafinchi