Durvalumab

REYKJAVIK, Iceland, Nov. 11, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB) (“Alvotech” or the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced financial results for the nine months to September 30, 2026, and provided a business update. Supplemental information, including the management presentation providing additional details and a business update, is available on our website: . 1 Financial Highlights for the Nine Months to September 30, 2026 2 Adjusted total revenue 2 was $323.4 million compared to $420.0 million in the same period last year. Gross Margin was 54% compared to 59% in the same period last year. Adjusted EBITDA 2 was $78.3 million compared to $68.0 million in the same period last year. Reported cash balance at the end of the period was $61.5 million compared to $172.4 million on December 31, 2025. 9M 2026 9M 2025 Change 3Q 2026 3Q 2025 Change Product and Service Revenue 164.2 237.4 -30.8% 58.2 32.6 78.3% License and Other Revenue 158.9 182.4 -12.9% 53.2 81.1 -34.4% Other Income 0.4 0.3 45.2% 0.2 0.1 39.8% Total revenue 323.4 420.0 -23.0% 111.6 113.9 -2.0% Gross margin 54% 59% 54% 69% Adjusted EBITDA 78.3 68.0 15.1% 31.5 14.4 118.8% Recent Business Highlights The FDA accepted Alvotech’s Biologics License Application (BLA) for AVT80, a proposed biosimilar to Entyvio ® (vedolizumab) in prefilled syringe and autoinjector presentations for subcutaneous administration. Alvotech is responsible for development and manufacturing, while Teva has licensed the U.S. commercial rights. Alvotech and its commercial partner Advanz Pharma submitted the first known regulatory submission worldwide for a proposed biosimilar to Eylea HD (aflibercept 8 mg). The marketing application was submitted to the European Medicines Agency. Alvotech signed an agreement with Lotus Pharmaceuticals covering the commercialization rights in the U.S. and selected Asian markets for AVT34, a proposed biosimilar to Imfinzi ® (durvalumab) and AVT87, a proposed biosimilar to Hemlibra ® (emicizumab). Alvotech retains the right to also commercialize both products directly in the U.S. alongside Lotus. Alvotech and LOTTE Biologics entered a long-term partnership under which LOTTE biologics will manufacture drug substance for multiple biosimilars at its facility in Syracuse, New York. The arrangement expands Alvotech’s U.S. manufacturing footprint, adding additional capacity and flexibility to its global supply network. The U.S. Food and Drug Administration (FDA) approved a new process for manufacturing Simlandi ® , Alvotech’s biosimilar to Humira ® , in the Reykjavik manufacturing facility. The new process more than doubles output per batch, allowing the same quantity of Simlandi to be produced in fewer batches and thus freeing up manufacturing capacity for other products. The FDA also approved the production of drug substance for Simlandi ® in a second production suite at Alvotech’s Reykjavik site, resulting in added flexibility and increased manufacturing capacity. Lisa Graver, Chief Executive Officer, comments: “Our commercial performance strengthened in the third quarter, with product and service revenue reaching $58 million, up 6% sequentially and 78% year over year. Following the completion of the manufacturing improvement program in the first half of the year, we are continuing to increase supply to meet strong underlying demand across our markets. “The two recent FDA approvals for Simlandi at our Reykjavík facility represent significant milestones. The addition of a second approved manufacturing suite and an enhanced process that more than doubles output per batch give us greater capacity and operational flexibility to support our expanding commercial portfolio. “We have also made important advances in our pipeline, including regulatory milestones for our proposed biosimilars to Entyvio and high-dose Eylea. Our agreement with Lotus creates an opportunity for Alvotech to participate directly in U.S. commercialization, while our partnerships with LOTTE Biologics and Fujifilm strengthen our future manufacturing network. Our priority now is to translate this progress into planned product deliveries in the fourth quarter, while continuing to build the platform for long-term growth.” Outlook for the Full Year 2026 Alvotech maintains its full-year 2026 guidance for total revenue of $650-$700 million and EBITDA of $180-$220 million, with performance now expected toward the lower end of the range. The Company remains focused on executing planned product deliveries in the fourth quarter, as production and commercial supply continue to ramp up following the manufacturing improvement program completed in the first half of the year. Invitation to management presentation Join us to listen to the live audio webcast at 8:00 AM EST (13:00 GMT, 14:00 CET) on Thursday, November 12, 2026. Materials for the webcast are available at . The audio webcast will be accessible via the following link: To participate via telephone in the Q&A session, register using this link: Contacts Media contacts – alvotech.media@alvotech.com Benedikt Stefansson Sarah MacLeod Investor Relations contacts – alvotech.ir@alvotech.com Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez Financial calendar Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change. Quarter Date of release Date of earnings call Q4 2026 March 10, 2027 March 11, 2027 Upcoming events Alvotech’s management team will appear at several investor conferences in November 2026. Please visit our events page to find more information about the timing of these events and how to register for live webcasts. Please note that all details are subject to change. Date Event Location Tuesday, November 17, 2026 UBS Global Biopharma Conference London Wednesday, November 18, 2026 Jefferies Global Healthcare Conference London Tuesday, November 24, 2026 DNB Carnegie Healthcare Conference Oslo Wednesday, November 25, 2026 SEB Healthcare Seminar Stockholm About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira ® (adalimumab), Stelara ® (ustekinumab), Simponi ® (golimumab), Eylea ® (aflibercept) and Prolia ® /Xgeva ® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. Non IFRS Financial Measures This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results. Reported to Adjusted Reconciliation for the nine months ended September 30, 2026 and 2025 2026 9M 2025 9M USD millions Reported Adjustment Adjusted Reported Adjustment Adjusted Product and Service Revenue 164.2 - 164.2 237.4 - 237.4 License and Other Revenue 158.9 - 158.9 182.4 0.3 182.6 Other Income 0.4 - 0.4 0.3 (0.3) - Total revenue 323.4 - 323.4 420.0 - 420.0 Cost of Product Revenue (150.1) 1.1 (149.0) (174.3) 1.4 (172.9) R&D (63.6) (0.5) (64.1) (144.5) (7.6) (152.1) G&A (98.9) 35.0 (63.9) (71.3) 16.8 (54.5) Operating Profit (Loss) 10.8 35.6 46.3 30.0 10.7 40.6 D&A (32.0) - (32.0) (27.4) 0.0 (27.4) EBITDA 42.8 35.6 78.3 57.4 10.7 68.0 Reported to Adjusted Reconciliation for the quarters ended September 30, 2026 and 2025 2026 3Q 2025 3Q USD millions Reported Adjustment Adjusted Reported Adjustment Adjusted Product and Service Revenue 58.2 - 58.2 32.6 - 32.6 License and Other Revenue 53.2 - 53.2 81.1 - 81.1 Other Income 0.2 - 0.2 0.1 - 0.1 Total revenue 111.6 - 111.6 113.9 - 113.9 Cost of Product Revenue (51.8) 0.2 (51.6) (35.0) 0.1 (34.9) R&D (17.2) 0.2 (17.0) (51.6) (3.5) (55.1) G&A (29.7) 6.9 (22.8) (25.9) 6.2 (19.8) Operating Profit (Loss) 12.8 7.3 20.1 1.3 2.8 4.1 D&A (11.4) - (11.4) (10.3) 0.0 (10.3) EBITDA 24.2 7.3 31.5 11.6 2.8 14.4 Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income or Loss for the nine months ended September 30, 2026 and 2025 USD in thousands, except for per share amounts Nine months ended September 30, 2026 Nine months ended September 30, 2025 Product and service revenue 164,152 237,382 License and other revenue 158,883 182,366 Other income 379 261 Cost of product and service revenue (150,103) (174,278) Research and development expenses (63,613) (144,508) General and administrative expenses (98,919) (71,271) Operating profit 10,779 29,952 Effects resulting from business combination — 7,977 Finance income 8,980 170,687 Finance costs (168,684) (108,449) Exchange rate differences (5,280) (21,226) Net gain on modification and extinguishment of financial liabilities — 17,703 Non-operating (loss) / profit (164,984) 66,692 (Loss) / profit before taxes (154,205) 96,644 Income tax benefit 13,546 39,822 (Loss) / profit for the period (140,659) 136,466 Other comprehensive (loss) / profit Item that will be reclassified to profit or loss in subsequent periods: Exchange rate differences on translation of foreign operations (2,794) 3,310 Total comprehensive (loss) /profit (143,453) 139,776 (Loss) / profit per share Basic (loss) / profit for the period per share (0.45) 0.47 Diluted (loss) / profit for the period per share (0.45) 0.47 Unaudited Condensed Consolidated Interim Statements of Financial Position as of September 30, 2026 and December 31, 2025 USD in thousands Non-current assets September 30 December 31 2026 2025 Property, plant and equipment 367,141 356,398 Right-of-use assets 145,349 138,294 Goodwill 12,377 12,835 Other intangible assets 174,340 81,834 Contract assets 177,885 122,934 Other long-term assets 18,200 8,578 Deferred tax assets 208,038 192,211 Total non-current assets 1,103,330 913,084 Current assets Inventories 242,252 220,054 Trade receivables 65,179 69,740 Contract assets 54,978 64,440 Other current assets 83,584 46,984 Receivables from related parties 5,252 438 Cash and cash equivalents 61,468 172,359 Total current assets 512,713 574,015 Total assets 1,616,043 1,487,099 Unaudited Condensed Consolidated Interim Statements of Financial Position as of September 30, 2026 and December 31, 2025 USD in thousands Equity September 30 December 31 2026 2025 Share capital 3,380 2,929 Share premium 2,269,996 2,105,691 Other reserves 11,248 15,331 Translation reserve (1,442) 1,352 Accumulated deficit (2,550,449) (2,409,790) Total equity (267,267) (284,487) Non-current liabilities Borrowings 1,341,286 1,262,147 Derivative financial liabilities 90,540 53,994 Lease liabilities 151,559 137,999 Contract liabilities 4,184 5,500 Deferred tax liability 7,943 7,868 Total non-current liabilities 1,595,512 1,467,508 Current liabilities Trade and other payables 90,214 126,124 Lease liabilities 12,969 12,078 Current maturities of borrowings 54,967 36,921 Liabilities to related parties 3,368 3,325 Contract liabilities 3,742 30,364 Taxes payable 2,014 1,041 Other current liabilities 120,524 94,225 Total current liabilities 287,798 304,078 Total liabilities 1,883,310 1,771,586 Total equity and liabilities 1,616,043 1,487,099 Unaudited Condensed Consolidated Interim Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 USD in thousands Cash flows from operating activities Nine months ended September 30, 2026 Nine months ended September 30, 2025 (Loss) / profit for the period (140,659) 136,466 Adjustments for non-cash items: Depreciation, amortization and impairment 31,976 27,438 Effects resulting from business combination — (7,977) Change in allowance for receivables 569 703 Change in inventory reserves 5,707 8,713 Share-based payments 7,094 6,166 Change in commercial provision 20,200 — Net gain on modification and extinguishment of financial liabilities — (17,703) Finance income (8,980) (170,687) Finance costs 168,684 108,449 Exchange rate difference 5,280 21,226 Income tax benefit (13,546) (39,822) Operating cash flow before movement in working capital 76,325 72,972 Increase in inventories (27,905) (85,871) Decrease in trade receivables 3,992 100,235 Increase in receivables with related parties (4,814) (882) Increase in contract assets (46,649) (29,333) Increase in other assets (37,673) (8,169) (Decrease) / increase in trade and other payables (35,446) 25,092 Decrease in contract liabilities (27,324) (49,694) Increase / (decrease) in liabilities with related parties 43 (1,205) Increase in other liabilities 2,840 12,070 Cash (used in) / from operations (96,611) 35,215 Interest received 806 294 Interest paid (109,061) (22,338) Income tax paid (746) (455) Net cash (used in) / from operating activities (205,612) 12,716 Unaudited Condensed Consolidated Interim Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 USD in thousands Nine months ended September 30, 2026 Nine months ended September 30, 2025 Cash flows from investing activities Acquisition of property, plant and equipment (40,357) (55,731) Acquisition of intangible assets (88,164) (24,632) Net cash outflow on acquisition of subsidiary — (14,036) Proceeds from the sale in joint venture — 5,950 Net cash used in investing activities (128,521) (88,449) Cash flows from financing activities Repayments of borrowings (33,585) (18,402) Repayments of principal portion of lease liabilities (9,274) (8,285) Proceeds from new borrowings 113,676 12,028 Transaction cost from new borrowings (2,811) — Gross proceeds from equity offering 164,600 82,481 Fees from equity offering (8,521) (3,759) Net cash from financing activities 224,085 64,063 Decrease in cash and cash equivalents (110,048) (11,670) Cash and cash equivalents at the beginning of the period 172,359 51,428 Effect of movements in exchange rates on cash held (843) 3,090 Cash and cash equivalents at the end of the period 61,468 42,848 ______________________________ 1 Supplemental information, including the management presentation, is provided solely for reference and is not part of this SEC form 6‑K and the form 6‑K should not be read together with, or construed as referring to, the supplemental information. 2 Unless otherwise specified, all figures presented in the Financial Highlights are on an adjusted basis and exclude items that are not indicative of our ongoing operating performance. See the tables on ‘Reported to Adjusted Reconciliation’ and disclaimer on ‘Non IFRS Financial Measures’, at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update.

SYDNEY, AUSTRALIA, Nov. 11, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel immunotherapies, today announced the grant of a new patent (number 12,788,796) entitled “ Combined Preparations for the Treatment of Cancer or Infection ” by the United States Patent and Trademark Office (USPTO). With this latest grant, Immutep now holds five United States patents within this patent family. The portfolio has expanded progressively through a series of patents granted in December 2020, March 2021, June 2023, July 2026 and, most recently, this latest patent. The claims of the new patent build on the protection provided by the four previously granted patents and are directed to combined preparations and pharmaceutical compositions comprising eftilagimod alfa (“efti”) and a PD-1 pathway inhibitor. Specifically, the claims encompass combinations with BMS-936559, durvalumab, atezolizumab and avelumab. The expiry date of the patent is 23 March 2038 (including 806 days of patent term adjustment). The patent grant provides additional protection for the use of efti in combination with PD-1 pathway inhibitors, a key class of immunotherapies used in modern cancer treatment, further expanding Immutep’s patent portfolio covering efti-based combination therapies. Immutep has also filed a continuation application to pursue additional embodiments of the invention. Marc Voigt, CEO of Immutep, said: “We are pleased to receive this latest US patent grant, which further strengthens the intellectual property protection surrounding efti. As we pursue our focused development strategy for efti, a good patent portfolio remains an important strategic asset, supporting future development and partnering opportunities. We believe in the potential of this unique biomolecule and that carefully selected clinical settings could provide meaningful opportunities for continued evaluation and value creation.” About Eftilagimod Alfa (Efti) Eftilagimod alfa (efti) is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that activates antigen-presenting cells through the MHC Class II pathway, engaging both innate and adaptive immunity, including the priming of cytotoxic CD8+ T cells and the production of co-stimulatory signals and cytokines. Its favourable safety pro combination with anti-PD-(L)1 therapy, radiotherapy and/or chemotherapy. Efti has received Fast Track designation from the U.S. Food and Drug Administration in first-line head and neck squamous cell carcinoma and first-line non-small cell lung cancer, and Orphan Drug Designation in soft tissue sarcoma. About Immutep Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding anticipated clinical development, regulatory progress and potential benefits of eftilagimod alfa. These forward-looking statements are based on current expectations, estimates and projections, and involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied in such statements. Factors that could cause actual results to differ materially include risks associated with clinical trial outcomes, regulatory developments, and the Company’s ability to advance its product candidates. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this release. Immutep undertakes no obligation to update or revise such statements, except as required by applicable law. Disclaimer This announcement has been prepared for informational purposes only and does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction. Australian Investors/Media: Eleanor Pearson, Sodali & Co. +61 2 9066 4071; eleanor.pearson@sodali.com U.S. Investors/Media: Matthew Beck, astr partners +1 (917) 415 1750; matthew.beck@astrpartners.com