Expenses aligned with expectations as the company fully transitioned into commercialization mode.
Liquidia closed Q2 2025 with $173 million in cash and cash equivalents, supporting ongoing commercialization and pipeline investments.
Q2 revenue totaled $8.8 million, including $6.5 million from YUTREPIA product sales and $2.3 million from treprostinil injection promotion services with Sandoz.
R&D expenses are expected to increase in the second half of 2025 due to ongoing label studies and initiation of the pivotal L-606 study.
SG&A expenses, excluding noncash and variable treprostinil costs, are expected to remain flat in upcoming quarters.
Cash, cash equivalents, and marketable securities totaled $614 million at the end of Q2 2025, down from $714 million at the end of 2024, primarily due to completion of a $200 million share repurchase program.
Dynavax reported record Q2 2025 net product revenue for HEPLISAV-B at $92 million, a 31% increase year-over-year.
GAAP net income was $19 million in Q2 2025 compared to $11 million in Q2 2024.
HEPLISAV-B gross margin improved to 85% in Q2 2025 from 83% in Q2 2024, with full-year 2025 gross margin expected around 80%.
Non-GAAP adjusted EBITDA improved to $37 million in Q2 2025 from $20 million in Q2 2024.
R&D expenses increased slightly to $17 million in Q2 2025 from $15 million in Q2 2024, reflecting pipeline progress.
SG&A expenses rose to $50 million in Q2 2025 from $42 million in Q2 2024, mainly due to $13 million in proxy contest-related costs.
Total revenues for Q2 2025 were approximately $95 million, up 29% year-over-year.
Cash, cash equivalents, and marketable securities totaled approximately $319.5 million as of June 30, 2025.
FILSPARI net product sales reached approximately $72 million in the U.S., representing significant year-over-year growth of about 82%.
License and collaboration revenue included a one-time $17.5 million milestone payment from CSL Vifor due to full approval of FILSPARI in Europe.
Net loss narrowed significantly to $12.8 million or $0.14 per share from $70.4 million or $0.91 per share in the prior year period.
On a non-GAAP basis, net income was $11.9 million or $0.13 per share compared to a net loss of $50.1 million previously.
Research and development expenses decreased to $49.4 million from $54.3 million year-over-year, reflecting reduced clinical activity in the Phase III HARMONY study.
Selling, general, and administrative expenses increased to $76.2 million from $64.8 million, driven by amortization of FILSPARI royalties and investments in launch and preparation for FSGS.
THIOLA and THIOLA EC contributed $23 million in net product sales, though generic competition is anticipated in coming quarters.
Travere Therapeutics reported strong Q2 2025 financial results with total revenue of $114.4 million, including $94.8 million in U.S. net product sales.
Discontinuation of M6 Artificial Disc Product Lines and Its Impact
Orthofix announced the discontinuation of the M6 artificial cervical and lumbar disc product lines in February 2025.
Pro forma results exclude M6 impact, with a focus on margin improvements driven by this discontinuation.
The discontinuation has contributed to approximately 50% of the margin expansion in Q2 2025, indicating a significant shift in product portfolio and profitability strategy.
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.
Breyanzi revenues were $344 million, growing 122% globally, with U.S. sales more than doubling to $255 million.
Camzyos global sales were $260 million, growing 86%, driven by new patient starts and inventory build.
Cash, cash equivalents, and marketable securities totaled roughly $13.9 billion as of June 30.
Cash flow from operations was about $3.9 billion in the second quarter.
Cobenfy sales were $35 million in the quarter and $62 million year-to-date, tracking as expected with steady weekly prescription growth.
Diluted earnings per share was $1.46, including a $1.5 billion or $0.57 per share charge related to the BioNTech partnership.
Eliquis global sales were $3.7 billion, growing 6%, with U.S. sales up 4% and ex-U.S. sales up 12%.
Gross margin was approximately 73%, primarily due to product mix.
Growth portfolio sales increased approximately 17% year-over-year, driven primarily by demand for the IO portfolio, Breyanzi, Reblozyl, and Camzyos.
Opdivo global sales were approximately $2.6 billion, up 7%, with strong U.S. launch in MSI-high colorectal cancer and growth in first-line non-small cell lung cancer.
Operating expenses were approximately $260 million lower than the prior year, reflecting strategic productivity initiatives.
Qvantig sales were approximately $30 million, with a successful U.S. launch and permanent J-Code received on July 1.
Reblozyl global sales were $568 million in the quarter, with 30% growth in the U.S. and 46% growth outside the U.S.
Sotyktu sales grew 29% globally, with 5% growth in the U.S. despite higher rebates.
The company is on track to pay down $10 billion of debt by the first half of 2026.
Total company revenues were approximately $12.3 billion in Q2 2025, reflecting strong demand across the business.
Dafinchi