Drug Development and Pipeline - The company is developing novel medicines targeting the cystic fibrosis transmembrane conductance regulator (CFTR) protein, aiming to restore normal CFTR function for approximately 90% of cystic fibrosis patients who carry the F508del mutation[29]. - SION-719, a potent NBD1 stabilizer, is currently in a Phase 2a trial, with topline data expected in mid-2026, following positive Phase 1 results announced in June 2025[37][38]. - The company’s pipeline includes SION-451, also a potent NBD1 stabilizer, which is being evaluated in dual combinations with other modulators, with topline data anticipated in mid-2026[37][38]. - The ongoing Phase 2a PreciSION CF trial is evaluating SION-719 in combination with Trikafta, with topline data expected in mid-2026[83]. - The company has advanced both SION-451 and SION-719 to the next phase of development, targeting NBD1 stabilization for CF treatment[80]. - The company expects topline data from the Phase 1 dual combination trial of SION-451 in mid-2026[94]. - SION-109 is currently being evaluated in combination with SION-451 in a Phase 1 dual combination trial, following successful Phase 1 trials for safety and tolerability[137]. Treatment Efficacy and Patient Outcomes - The current standard of care, Trikafta, does not stabilize NBD1, and at least two-thirds of patients on Trikafta do not achieve normal CFTR function, defined as sweat chloride levels below 30 mmol/L[55]. - Approximately 69% of patients treated with Alyftrek did not achieve normal CFTR function, indicating a significant unmet need for more effective treatment options[56]. - Two-thirds of CF patients on Trikafta still have sweat chloride levels above normal, indicating ongoing CFTR dysfunction[58]. - A two-year interim study showed that while pulmonary exacerbations improved, they were not normalized, and mental health issues increased among patients on Trikafta[59]. - Alyftrek demonstrated non-inferiority to Trikafta, with sweat chloride improvements of approximately 3 to 8 mmol/L, but 69% of patients did not achieve normal CFTR function[60]. - The median predicted survival age for individuals with cystic fibrosis born in the U.S. between 2020 and 2024 is just 65 years, highlighting the ongoing need for improved therapies[45]. Safety and Tolerability - SION-719 was generally well tolerated, with no serious adverse events reported, and 60% of participants experienced any treatment-emergent adverse events (TEAEs) across all doses[86]. - The most common TEAEs included headache (23%), diarrhea (10%), and nausea (8%), with no TEAEs leading to treatment discontinuation[87]. - SION-451 was also well tolerated, with 50% of participants experiencing any TEAEs, and no serious adverse events reported[98]. - The most frequent TEAEs for SION-451 included headache (18%) and influenza (5%), with no TEAEs leading to treatment discontinuation[99]. - SION-109 was generally well tolerated across all dose levels in the Phase 1 trial, with 38% of participants experiencing any treatment-emergent adverse events (TEAEs) and no serious adverse events reported[140][141]. - The most frequent TEAEs included headache (13%), abdominal pain (5%), and increased alanine aminotransferase (5%)[142]. - The majority of adverse events reported in clinical trials for SION-2222 were mild to moderate, indicating a favorable safety profile[129]. Mechanism of Action and Preclinical Findings - Preclinical studies indicated that SION-719 and SION-451 increased NBD1 thermal stability by approximately 16°C compared to ETI[106]. - Binding affinity for SION-719 to F508del-NBD1 was approximately 4.3 nM, while SION-451 had a binding affinity of approximately 2.4 nM[108]. - Both SION-719 and SION-451 showed potential to restore F508del-CFTR folding and maturation to levels similar to wild-type CFTR[109]. - SION-719 and SION-451 improved the half-life of F508del-CFTR to 12.6 hours and 14.2 hours respectively, compared to 1.7 hours for F508del-CFTR alone[116]. - Treatment with SION-719 as a single agent demonstrated a greater effect on F508del maturation than ETI, achieving wild-type levels of corrected F508del-CFTR protein[112]. - In the CFHBE model, SION-719 and SION-451 improved F508del-CFTR activity to levels near those observed with the triple combination ETI[120]. - SION-451 in combination with SION-2222 or SION-109 showed significant improvements in CFTR function, with half-lives reaching 16.4 hours[116]. Intellectual Property and Licensing - The company aims to expand and protect its intellectual property estate to maximize the value of its pipeline[48]. - The company co-owns a patent family with Sanofi covering SION-719 and SION-451, with a statutory expiration date of September 2043[159]. - The patent family covering SION-109 has a statutory expiration date of November 2040, indicating a strong intellectual property position[160]. - The company entered into a license agreement with Sanofi, paying an upfront fee of $1.5 million and a reimbursement of $0.3 million for R&D expenses, with potential milestone payments of up to $40.0 million[167]. - The company is required to pay royalties to Sanofi in the low single-digit percentage range based on net sales of licensed products, with the royalty term terminating upon the expiration of the last-to-expire patent claim or regulatory exclusivity[167]. - The company entered into a license agreement with AbbVie, paying an upfront fee of $5.0 million and issuing 1,414,445 shares of common stock, with potential milestone payments of up to $360.0 million[180]. - The company is required to pay royalties to AbbVie in the low to mid single-digit percentage range based on net sales of licensed products, with the royalty term terminating similarly to the Sanofi agreement[180]. - The AbbVie License Agreement includes a right of first negotiation for AbbVie regarding any commercial license transaction prior to Phase 3 clinical trials[181]. - The company has assumed all global development and commercialization responsibilities for three clinical-stage CFTR modulator therapies under the AbbVie License Agreement[178]. Regulatory Compliance and Market Considerations - Regulatory compliance is critical, with extensive requirements imposed by the FDA and other authorities, necessitating significant time and financial resources for drug development and approval[186]. - The company must submit an IND to the FDA before beginning the first clinical trial in the U.S., which includes preclinical test results and manufacturing information[190]. - Clinical trials are conducted in three phases: Phase 1 focuses on safety and dosage, Phase 2 evaluates efficacy and safety in a limited patient population, and Phase 3 generates data for FDA approval[199]. - The FDA has a goal of reviewing standard NDAs within ten months and priority NDAs within six months from the filing date[208]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval to ensure the drug's benefits outweigh its risks[207]. - A Complete Response Letter from the FDA indicates that the application will not be approved in its current form and outlines deficiencies that must be addressed[211]. - The company must submit progress reports detailing clinical trial results at least annually to the FDA[200]. - The FDA conducts inspections of manufacturing facilities to ensure compliance with cGMP requirements before approving an NDA[205]. - The company must disclose results of clinical trials after completion, with penalties for failure to register or report results timely[197]. - Pediatric data requirements must be met for certain NDAs, and the FDA may grant deferrals or waivers under specific circumstances[209]. - The FDA may impose conditions on approved products that can significantly affect market potential and profitability, including post-approval studies and risk management mechanisms[212]. - Orphan Drug Designation allows for exclusivity for seven years if the product is the first FDA-approved treatment for a rare disease, with specific conditions for maintaining exclusivity[215]. - The FDA's Fast Track designation facilitates expedited review for drugs addressing serious conditions, allowing rolling submissions of NDA sections[218]. - Breakthrough Therapy designation provides intensive guidance from the FDA and similar benefits to Fast Track, aimed at drugs showing substantial improvement over existing therapies[220]. - Priority Review designation shortens the FDA's review timeline from ten months to six months for drugs that significantly improve safety and effectiveness[221]. - Accelerated Approval allows drugs to be approved based on surrogate endpoints, contingent on post-approval confirmatory studies to verify clinical benefits[222]. - The Hatch-Waxman Amendments establish a five-year non-patent exclusivity period for new chemical entities, delaying ANDA submissions until this period expires[226]. - Three years of market exclusivity is granted for non-NCE NDAs if new clinical investigations are essential for approval, protecting new indications or dosages[227]. Competitive Landscape - The company faces substantial competition from established players like Vertex, which has multiple approved CFTR modulators, including Trikafta[152]. - The CF patient populations are well-characterized, with treatment typically occurring at centralized CF care centers, suggesting a focused approach for commercialization[150].

Revenue Recognition - The company recognized revenues of $65 million in 2025 from amending the license agreement with AstraZeneca, following previous milestone revenues of $2 million, $6 million, $7.5 million, and $10 million in 2020, 2021, 2022, and 2023, respectively [435]. - In December 2023, the company recognized $23.5 million in revenue from a license agreement with Gilead, reflecting the initial transaction price allocated to the license performance obligation [439]. - For the year ended December 31, 2025, the company recognized $7,764 in Phase 1 services revenues, while $22,864 and $23,459 were recognized in 2024 and 2023, respectively [441]. Financial Performance - Share-based compensation expense recognized under ASC 718 was approximately $1.9 million, $3.0 million, and $3.6 million for the years ended December 31, 2025, 2024, and 2023, respectively [446]. - The company included deferred revenues of $10,970 in current liabilities and $24,943 in non-current liabilities as of December 31, 2025 [441]. Market Trends - Biologics accounted for 31% of FDA approved drugs in 2023, increasing to 32% in 2024, but projected to decrease to 25% in 2025, indicating a competitive landscape for new therapeutic candidates [429]. Risk Factors - The company’s financial income is subject to interest rate risk, which can significantly impact net loss and capital markets [428]. - The company’s cash and cash equivalents are invested in bank deposits or marketable securities, making them sensitive to fluctuations in interest rates [428]. - The company evaluates estimates related to revenue recognition and share-based payments on an ongoing basis, which may differ from actual results under different assumptions [430][431]. Currency Impact - The depreciation of the dollar against the NIS was 12.5% in 2025, while it appreciated by 0.6% and 3.1% in 2024 and 2023, respectively [427].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 0-23702 STEVEN MADDEN, LTD. (Exact name of registrant as specified in its charter) Delaware 13-3588231 (State or other ...

Financial Performance - Net sales for Q4 2025 were $1.40 billion, a 2.1% increase compared to Q4 2024, while full year 2025 net sales were $5.36 billion, a decrease of 0.6% year-over-year[3][12] - Net earnings for Q4 2025 were $44 million, or $0.30 per diluted share, compared to a net loss of less than $1 million in Q4 2024; full year net earnings were $441 million, or $2.99 per diluted share, up 63.7% from $270 million in 2024[9][14] - Adjusted EBITDA for Q4 2025 was $278 million, representing 19.8% of net sales, an increase from $271 million or 19.7% in Q4 2024; full year adjusted EBITDA was $1,134 million, or 21.2% of net sales, up from $1,111 million in 2024[10][16] - Gross profit for Q4 2025 was $398.4 million, compared to $406.8 million in Q4 2024, resulting in a gross margin of approximately 28.4%[34] - Operating profit for the year ended December 31, 2025, was $725.7 million, a decrease from $735.9 million in 2024[34] - Net earnings from continuing operations for Q4 2025 were $44.4 million, compared to a loss of $0.4 million in Q4 2024, with net earnings for the year at $505.5 million, up from $264.7 million in 2024[34] - The company reported a basic net earnings per share of $0.30 for Q4 2025, compared to a loss of $0.05 in Q4 2024, and $3.44 for the full year 2025, up from $1.82 in 2024[34] - Non-GAAP adjusted net earnings for Q4 2025 were $113.5 million, resulting in adjusted diluted EPS of $0.77, reflecting a 3.5% increase compared to the previous year[47] - The adjusted net earnings for the year ended December 31, 2025, were $493.2 million, with adjusted diluted EPS of $3.34[47] Cash Flow and Debt - Free cash flow for full year 2025 was $459 million, a slight increase from $454 million in 2024, despite a decrease in cash flow from operations to $628 million from $728 million[20] - The company generated $628.0 million in net cash from operating activities for the year ended December 31, 2025, compared to $728.0 million in 2024[39] - The company experienced a significant reduction in interest expense, net, to $218.9 million for the year 2025, compared to $247.6 million in 2024[34] - Net debt decreased to $3.7 billion as of December 31, 2025, down from $4.0 billion in 2024, with a net leverage ratio of 3.2x compared to 3.6x in the previous year[22] - The company’s total debt decreased to $4,009.7 million as of December 31, 2025, down from $4,403.9 million in 2024[49] - Non-GAAP net debt stood at $3,665.7 million, with a net leverage ratio of 3.2x, improved from 3.6x in the previous year[49] Segment Performance - The Protective segment saw a 3% increase in net sales to $464 million in Q4 2025, while the Food segment increased by 2% to $937 million; however, both segments experienced volume decreases[7][18][19] - The adjusted EBITDA margin for food in Q4 2025 was 21.6%, while for protective it was 17.3%[44] - The company experienced a volume decline of 1.4% in food products for Q4 2024, while protective products saw a volume increase of 1.3%[41] - For the year ended December 31, 2025, total net sales are projected to be $5,359.8 million, with food at 67.1% and protective at 32.9%[41] Tax and Special Items - The effective tax rate for Q4 2025 was 56.6%, significantly lower than 100.5% in the prior year, influenced by updates related to tax audits and accruals[8] - The effective income tax rate for GAAP was 56.6% for Q4 2025, while the non-GAAP adjusted income tax rate was 30.0%[45] - Special items impacted net earnings by $69.1 million in Q4 2025, with a loss per share impact of $0.47[47] Corporate Actions - The company announced an acquisition agreement with CD&R for an enterprise value of $10.3 billion, with stockholders set to receive $42.15 per share in cash[5][6] - The company will not host a conference call to discuss the results due to the pending acquisition, indicating a shift in corporate structure post-acquisition[23] Asset and Liability Management - Total current assets increased to $1,919.5 million as of December 31, 2025, from $1,891.8 million in 2024, driven by higher trade receivables and inventories[37] - Total liabilities decreased to $5,775.3 million as of December 31, 2025, from $6,397.6 million in 2024, primarily due to a reduction in long-term debt[37] - Capital expenditures for full year 2025 were $170 million, down from $220 million in 2024, reflecting a focus on cost management[20] Currency Impact - The total change in net sales for 2024 was impacted by a foreign currency translation gain of $32.7 million, representing a 0.6% increase[41] - The company reported a total constant currency change (non-GAAP) of $(65.5) million for the year ended December 31, 2024, indicating a 1.2% decline[41] - The company experienced a foreign currency exchange loss of $4.5 million in Q4 2025 due to highly inflationary economies[47]

Exhibit 99.1 Astrana Health, Inc. Reports Fourth Quarter and Year End 2025 Results Company to Host Conference Call on Monday, March 2, 2026, at 5:30 a.m. PT/8:30 a.m. ET · Reports total revenue for the year ended of $3,181.8 million, up 56% year-over-year, and at the higher end of guidance · Reports adjusted EBITDA for the year ended of $205.4 million and free cash flow of $104.5 million ALHAMBRA, Calif., March 2, 2026 /PRNewswire/ -- Astrana Health, Inc. ("Astrana," and together with its subsidiaries and a ...

Exhibit 99.1 Astrana Health, Inc. Reports Fourth Quarter and Year End 2025 Results Company to Host Conference Call on Monday, March 2, 2026, at 5:30 a.m. PT/8:30 a.m. ET · Reports total revenue for the year ended of $3,181.8 million, up 56% year-over-year, and at the higher end of guidance · Reports adjusted EBITDA for the year ended of $205.4 million and free cash flow of $104.5 million ALHAMBRA, Calif., March 2, 2026 /PRNewswire/ -- Astrana Health, Inc. ("Astrana," and together with its subsidiaries and a ...

As of February 20, 2026, there were 640,544,661 shares of common stock outstanding. Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______. Commission File Number: 000-20859 GERON COR ...

Ongoing PreciSION CF Phase 2a proof-of-concept trial evaluating NBD1 stabilizer SION-719 as an add-on to standard of care in participants with cystic fibrosis is on track with topline data anticipated in mid-2026 Ongoing Phase 1 trial evaluating NBD1 stabilizer SION-451 in proprietary dual combinations with SION-2222 and with SION-109 in healthy volunteers is on track with topline data anticipated in mid-2026 Maintained strong cash position with approximately $310.3 million in cash and cash equivalents, exp ...

Exhibit 99.1 XERIS BIOPHARMA REPORTS RECORD PERFORMANCE FOR FOURTH QUARTER AND FULL YEAR 2025 AND PROVIDES FULL YEAR 2026 GUIDANCE Achieved record quarterly and full-year total revenue of $86 million and $292 million, respectively Provides full year 2026 total revenue guidance range of $375 million to $390 million Hosts conference call and webcast today at 8:30 a.m. ET CHICAGO, IL; March 2, 2026 – Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving ...

Exhibit 99.1 uniQure Announces 2025 Financial Results and Provides Recent Company Updates ~ Held Type A meeting with FDA to discuss AMT-130 for Huntington's disease; Company evaluating Phase III development considerations and plans to request follow-up Type B meeting in the second quarter of 2026 ~ ~ Completed enrollment of the first cohort in the Phase I/IIa study of AMT-260 in refractory mesial temporal lobe epilepsy, with additional clinical data expected in the first half of 2026~ ~ Presented updated Ph ...