Casdozokitug

- Coherus to focus exclusively on innovative immuno-oncology programs that include LOQTORZI®, an FDA approved, next-generation programmed cell death protein 1 (PD-1) inhibitor - - Proceeds to fund development of key combination programs with LOQTORZI, including casdozokitug, a first-in-class, clinical-stage interleukin-27 (IL-27) antagonist, and CHS-114, a highly selective chemokine receptor 8 (CCR8) antibody - - Post-closing proceeds to repay the entirety of the company’s $230 million convertible notes due April 2026 - - Coherus management to host investor conference call today, Tuesday, December 3, 2024, at 8:00 a.m. Eastern Time - REDWOOD CITY, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company NASDAQ: CHRS,) today announced that it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for the divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise for up to $558.4 million. This includes an upfront payment of $483.4 million, to be adjusted for inventory at close, and $75.0 million in potential net sales milestone payments. Coherus plans to use a portion of the transaction proceeds to fully repay the entirety of the Company’s $230.0 million in existing convertible notes due April 2026 and $49.1 million to buy-out certain royalty obligations related to UDENYCA. “The proposed divestiture of UDENYCA represents the successful execution of our strategy to focus R&D and commercial resources on Coherus’ innovative immuno-oncology portfolio and to strengthen our financial position,” said Denny Lanfear, Coherus Chairman and Chief Executive Officer. “We have created significant value with our UDENYCA franchise, and this proposed transaction allows us to monetize that value in order to maximize the opportunity ahead for LOQTORZI (toripalimab-tpzi), a novel PD-1 inhibitor with growing sales and the only FDA-approved treatment for nasopharyngeal carcinoma (NPC), allowing us to accelerate and advance the development of our I-O pipeline in combination with LOQTORZI.” “In addition, by paying off our convertible notes in their entirety, we will significantly improve our capital structure and align our operational footprint with our strategic focus. As we enter this new phase of growth, we are well positioned to drive significant value for both patients and shareholders as we advance our mission to extend cancer patient survival.” Terms of the AgreementUnder the terms of the Agreement filed as an exhibit to Coherus’ Current Report on Form 8-K today, Coherus will receive an upfront cash payment of $483.4 million, subject to closing adjustments for final inventory valuation, plus two net sales milestone payments totaling $75.0 million. In exchange, Intas will receive identified assets related to the UDENYCA franchise, including the UDENYCA pre-filled syringe, the UDENYCA autoinjector, and UDENYCA ONBODY™ and will assume identified liabilities. Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, plans to assume full responsibility for the UDENYCA franchise in the U.S. following the Agreement closing. The Coherus Board of Directors unanimously recommends that Coherus shareholders vote in favor of the proposed UDENYCA divestiture described by the Agreement. A Coherus proxy statement relating to the proposed transaction will be filed with the Securities and Exchange Commission (the SEC) and mailed to Coherus shareholders when available. The closing of the proposed transactions contemplated by the Agreement is subject to customary closing conditions, including approval by Coherus shareholders, expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, any required approval by the Committee on Foreign Investment in the United States (CFIUS) as well as certain other conditions. The proposed transaction is expected to close by the end of Q1 2025. Financial Considerations of the DivestitureImportantly, upon close of the proposed transaction, the Company expects to use tax attributes, which were previously not deemed realizable, to offset substantially all of the U.S. federal income taxes related to the divestiture. Following close of the proposed transaction, Coherus plans to initiate a process to fully repay the Company’s outstanding $230.0 million in aggregate principal amount of 1.5% Convertible Senior Subordinated Notes due 2026.At closing Coherus will pay $49.1 million to buy out the right to receive royalties on net sales of UDENYCA in accordance with the Revenue Participation Right and Sale Agreement with Coduet Royalty Holdings, LLC that commenced May 8, 2024. The Company expects to realize substantial cost savings on a going forward basis by: Paying off certain financial liabilities resulting in expected annual financing cash savings exceeding $10.0 million, with the remaining $38.7 million in secured debt (maturing May 2029) costing approximately $5 million to service annually;Transferring certain full-time employees to Intas to support UDENYCA; andEliminating UDENYCA-related overhead and commercial expenses. The Company plans to provide an updated Q4 2024 sales projection and Q1 2025 cash projection in early January 2025. However, current post-close cash runway projections exceed two years, past key data readouts expected in 2026. Focus on Immuno-Oncology Portfolio and Key Upcoming MilestonesCoherus intends to strengthen and sharpen its focus on the advancement of its innovative, next-generation, immuno-oncology portfolio in combination with LOQTORZI. LOQTORZI is a next-generation, differentiated PD-1 marketed in the U.S. in two indications. Coherus plans to maximize the value of this product by: Continuing to build launch momentum as the first and only FDA-approved treatment for recurrent, locally advanced or metastatic NPC;Developing new indications by combining LOQTORZI with internal pipeline assets to advance two drug candidates; andEntering into capital-efficient external partnerships for additional label expansions. Additional partnerships evaluating LOQTORZI with novel promising cancer agents are planned for 2025. Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC). The Company plans to: Initiate a Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in first-line (1L) HCC in Q4 2024;Announce final data from its Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC in Q1 2025; andReport data from its Phase 1 study of casdozokitug/toripalimab in second to fourth line (2-4L) NSCLC in 1H 2025. CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Phase 1 dose escalation is complete, establishing safety and proof of mechanism. Coherus plans to: Report Phase 1 monotherapy biopsy data as well as CHS-114/toripalimab combination safety data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025;Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L head and neck squamous cell carcinoma (HNSCC) in Q1 2025 with a first data readout expected in Q2 2026; andInitiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026. AdvisorsJ.P. Morgan Securities LLC is acting as Coherus’ financial advisor and Latham & Watkins LLP as legal counsel to Coherus. Conference Call Information When: Tuesday, December 3, 2024, starting at 8:00 a.m. Eastern Time To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BId14c70118ce44561902dd39c791136fa Please dial in 15 minutes early to ensure a timely connection to the call. Webcast Link: https://edge.media-server.com/mmc/p/ypqpachc A replay of the webcast will be archived on the “Investors” section of the Coherus website at http://investors.coherus.com About Coherus BioSciencesCoherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors, including HNSCC. CHS-1000 is a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2). An IND for CHS-1000 was allowed to proceed by the FDA in the second quarter of 2024 and proceeding to the first-in-human clinical study is subject to further evaluation in our portfolio prioritization process. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta. Neulasta® is a registered trademark of Amgen, Inc. Forward-Looking Statements The statements in this press release include express or implied forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act about the proposed transaction between the Company and Intas that involve risks and uncertainties relating to future events and the future performance the Company and the UDENYCA business. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the Agreement and related matters, including, but not limited to, the ability to satisfy the closing conditions to consummate the proposed transaction at all or in the estimated time; prospective performance and opportunities with respect to the Company or the UDENYCA business; post-closing operations and the outlook for the Company or the UDENYCA business; the Company’s targets, plans, objectives or goals for future operations, including those related to the UDENYCA business, product candidates, research and development, and product candidate approvals; future receipt of sales milestone payments from the proposed transaction; projections of or targets for cost savings related to transfers of employees and reductions in indebtedness; projections of the amount of time that the Company’s will be able to operate using its cash balance and proceeds from the proposed transaction; statements about the potential uses of proceeds from the transaction and the assumptions underlying or relating to such statements. These forward-looking statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, assumptions and changes in circumstances, many of which are beyond the control of the Company. A number of important factors, including those described in this press release, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing for completion of the proposed transaction; uncertainties as to the Company’s ability to obtain the approval of its shareholders required to consummate the proposed transaction; the possibility that competing offers will be made by third parties; uncertainties of receipt of sales milestone payments in the future; the occurrence of any event, change or other circumstance that may give rise to a right of one or both of Intas and the Company to terminate the Agreement; the possibility that the proposed transaction may not be completed in the time frame expected by the Company or at all, including due to the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations); the risk that the proposed transaction disrupts the Company’s current plans and operations or diverts the attention of the Company’s management or employees from ongoing business operations; the risk that the Company may not realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; the effects of the proposed transaction on relationships with the Company’s employees, suppliers, business or collaboration partners or governmental entities, or other third parties as a result of the proposed transaction; the ability to retain and hire key personnel; significant or unexpected costs, charges or expenses resulting from the proposed transaction; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the Company after the consummation of the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed transaction on the market price of the Company’s common stock and/or the Company’s operating or financial results; uncertainties as to the long-term value of the Company’s common stock; and the nature, cost and outcome of any litigation and other legal proceedings involving the transaction, the Company or its directors, including any legal proceedings related to the proposed transaction. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the transaction described above will in fact be consummated in the manner described or at all. For a further discussion of these and other factors that could cause the Company’s future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, filed with the SEC on November 6, 2024, as updated by the Company’s subsequent periodic reports filed with the SEC and, when available, the proxy statement of the Company relating to the proposed transaction. Any forward-looking statements speak only as of the date of this press release and are made based on the current good faith beliefs and judgments of the Company’s management, and the reader is cautioned not to rely on any forward-looking statements made by the Company. Unless required by law, the Company is not under any duty and undertakes no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes. Additional Information and Where to Find It In connection with the proposed transaction, the Company expects to file with the SEC a proxy statement on Schedule 14A, and it may also file other documents regarding the proposed transaction with the SEC. Promptly after filing its definitive proxy statement with the SEC, the Company will mail the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY THE PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION, RELATED MATTERS AND THE PARTIES TO THE PROPOSED TRANSACTION. You may obtain a free copy of the proxy statement and other relevant documents (if and when they become available) that are or will be filed with the SEC for free at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on the Company’s website at https://investors.coherus.com/sec-filings or by contacting the Company’s Investor Relations Department at IR@coherus.com. Participants in the Solicitation The Company and certain of its directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about the directors and executive officers of the Company, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement for its 2024 Annual General Meeting, which was filed with the SEC on April 15, 2024 and other documents that may be filed from time to time with the SEC. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests in the proposed transaction, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC regarding the proposed transaction when such materials become available. Coherus BioSciences Contact Information:For investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com For media:Argot Partners(212) 600-1902coherus@argotpartners.com

– Net revenue of $70.8 million in Q3 2024 driven by 30% increase in UDENYCA® net revenue, quarter-over-quarter – – UDENYCA labeling and packaging production resuming at third-party contract manufacturing organization – – LOQTORZI® launch progressing to plan, revenues increase 50% quarter-over-quarter – – Innovative immuno-oncology pipeline advancing to proof-of-concept studies in combination with toripalimab – – Conference call today at 5:00 p.m. Eastern Time – REDWOOD CITY, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2024 and recent business highlights: “Revenue growth was strong in the third quarter, with the UDENYCA franchise increasing 30% compared to the second quarter, and 100% over Q3 2023. LOQTORZI sales grew more than 50% compared to the second quarter of 2024,” said Denny Lanfear, Coherus Chairman and Chief Executive Officer. “Our sharpened focus on oncology is delivering results. Third quarter 2024 revenues are now comparable to Q3 2023, despite our divestitures, with higher gross profit, lower operating expenses and lower interest expense.” “We continue to make progress towards our long-term vision of bringing innovative, next-generation therapies to extend cancer patient survival. Our competitively positioned pipeline, in combination with LOQTORZI, is advancing to plan in tumor types with high unmet medical need and with robust supportive biology,” continued Mr. Lanfear. RECENT BUSINESS HIGHLIGHTS UDENYCA® RESULTS UDENYCA net product sales were $66.1 million in Q3 2024, an increase of 30% compared to $50.9 million in Q2 2024 and a 100% increase compared to $33.0 million in Q3 2023.Q3 revenue was driven by a 54% increase in demand for ONBODY™ and a higher overall net selling price.In Q3, UDENYCA maintained its #2 position in the pegfilgrastim class with 28% market share. UDENYCA SUPPLY UPDATE Coherus’ third-party labeling and packaging contract manufacturing organization (CMO) for UDENYCA has informed the Company that production will resume this week, a few weeks later than previously targeted and disclosed. Based on the production schedule, the backlog of UDENYCA lots of approximately 120,000 units will be completed without further interruption or delay by the end of the year.The Company has also made significant progress in its previously announced efforts to diversify its labeling and packaging resources. An additional final packaging and labeling CMO has already started production testing and is expected to start manufacturing saleable product by the end of 2024. Commercial supply from that CMO is expected to commence in the first quarter of 2025, subject to U.S. Food and Drug Administration (FDA) authorization. Once the second facility is commercially operational, the Company projects that its labeling and packaging capacity will have doubled to over one million UDENYCA units annually, consistent with the rest of its supply chain. LOQTORZI® LAUNCH UPDATE LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), commercially launched across all lines of therapy on January 2, 2024.LOQTORZI net product sales were $5.8 million in Q3 2024, an increase of 54% compared to $3.8 million in Q2 2024.The number of LOQTORZI treated patients grew by more than 60% in Q3, with new patient uptake primarily in relapsed locally advanced and 1L metastatic disease, the key driver of long-term revenue growth.Since launch, nearly 80% of all National Comprehensive Cancer Network (NCCN) institutions have written prescriptions for at least one new patient. ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE This quarter, the Company expects to open a Phase 2 randomized study evaluating casdozokitug, an immune regulatory IL-27 antagonist in combination with toripalimab and bevacizumab for the treatment of unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) in treatment-naive patients.The Company also anticipates final data from its Phase 2 trial of casdozokitug combined with atezolizumab and bevacizumab in first-line HCC in the first quarter of 2025. Coherus has received FDA orphan drug status and fast track designation for casdozokitug in HCC.A Phase 1 study evaluating CHS-114, a highly selective cytolytic anti-CCR8 antibody, is ongoing. In the first half of 2025, Coherus expects to report Phase 1 data from expansion cohorts evaluating CHS-114 as monotherapy and in combination with toripalimab in patients with advanced/metastatic head and neck squamous cell carcinoma (HNSCC).Coherus plans to initiate Phase 1b dose optimization studies of CHS-114 in combination with toripalimab in patients with HNSCC and gastric cancer in the first quarter of 2025, with initial data for both studies expected in the first half of 2026. THIRD QUARTER 2024 FINANCIAL RESULTS Net revenue was $70.8 million during the three months ended September 30, 2024, and included $66.1 million of net sales of UDENYCA and $5.8 million of net sales of LOQTORZI. Net revenue was $74.6 million during the three months ended September 30, 2023 and included $33.0 million in net sales of UDENYCA and $41.4 million attributable to the Company’s divested products, CIMERLI and YUSIMRY. Net revenue was $212.8 million and $165.7 million for the nine months ended September 30, 2024 and 2023, respectively. Total net revenue attributable to the Company’s divested products, CIMERLI and YUSIMRY, during the first nine months of 2024 and 2023 was $34.5 million and $74.3 million, respectively. In addition, the first nine months of 2024 included other revenue of $7.0 million mainly comprising the $6.3 million up-front cash payment received for the outlicense to Apotex, Inc. of the Canadian rights to LOQTORZI on June 27, 2024. Cost of goods sold (COGS) was $20.7 million and $32.7 million during the three months ended September 30, 2024 and 2023, respectively, and $83.7 million and $74.4 million during the nine months ended September 30, 2024 and 2023, respectively. The decrease in COGS for the third quarter of 2024 compared to the same period in the prior year was primarily due to $24.1 million of COGS in the third quarter of 2023 related to CIMERLI and YUSIMRY, which were divested during the first half of 2024, partially offset by a $9.7 million increase in product costs driven by increased UDENYCA volume. The increase in COGS for the nine months ended September 30, 2024 compared to the same period in the prior year was primarily due to a $27.8 million increase related to volumes driven by UDENYCA and LOQTORZI, $4.5 million in connection with a CMO contract change, and $2.5 million in LOQTORZI royalties. These increases were partially offset by non-recurring COGS related to products divested during the first half of 2024 mentioned above. Research and development (R&D) expenses were $21.7 million and $25.6 million for the three months ended September 30, 2024 and 2023, respectively, and $72.1 million and $83.1 million for the nine months ended September 30, 2024 and 2023, respectively. The decreases were primarily due to savings from reduced headcount and lower costs related to biosimilar product divestitures, partially offset by costs for development of casdozokitug and CHS-114. Selling, general and administrative (SG&A) expenses were $34.7 million and $48.2 million during the three months ended September 30, 2024 and 2023, respectively, and $126.4 million and $142.5 million during the nine months ended September 30, 2024 and 2023, respectively. The declines in SG&A compared to the prior year periods were driven primarily by lower headcount. The decrease for the nine-month period was partially offset by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, obtained in the Surface Oncology, Inc. acquisition. Interest expense was $5.4 million and $10.3 million during the three months ended September 30, 2024 and 2023, respectively, and $21.8 million and $29.9 million during the nine months ended September 30, 2024 and 2023, respectively. The declines in both periods were primarily due to prepaying $175.0 million of the principal amount due under the 2027 Term Loans on April 1, 2024 and the remaining $75.0 million principal amount on May 8, 2024, partially offset by interest on the senior secured term loan facility of up to $38.7 million and the revenue participation right purchase and sale agreement, both commencing May 8, 2024. Gain on sale transactions, net was $176.6 million for the nine months ended September 30, 2024 and included a $153.8 million gain on the divestiture of our CIMERLI ophthalmology franchise, which closed during the first quarter of 2024, and a $22.9 million gain on the divestiture of our YUSIMRY immunology franchise, which closed during the second quarter of 2024. There was no gain on sale transactions in the nine months ended September 30, 2023. Net loss for the third quarter of 2024 was $10.8 million, or $(0.09) per share on a diluted basis, compared to a net loss of $39.6 million, or $(0.41) per share on a diluted basis for the same period in 2023. Net income for the nine months ended September 30, 2024 was $79.2 million, or $0.65 per share on a diluted basis, compared to a net loss of $158.2 million, or $(1.79) per share on a diluted basis for nine months ended September 30, 2023. Non-GAAP net loss for the third quarter of 2024 was $1.7 million, or $(0.01) per share on a diluted basis, compared to $26.9 million, or $(0.27) per share for the same period in 2023. Non-GAAP net loss for the nine months ended September 30, 2024 was $53.8 million, or $(0.47) per share on a diluted basis, compared to $117.3 million, or $(1.33) per share for the same period in 2023. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures. Cash, cash equivalents and investments in marketable securities were $97.7 million as of September 30, 2024, compared to $117.7 million as of December 31, 2023. 2024 R&D and SG&A Expense Guidance Coherus projects combined R&D and SG&A expenses for 2024 to be in the range of $250 to $260 million. This guidance includes approximately $30 million of stock-based compensation expense and excludes the effects of acquisitions, collaborations, investments, divestitures including expenses incurred on behalf of and reimbursed by Sandoz Inc. and Hong Kong King-Friend Industrial Company Ltd. to satisfy Coherus’ obligations under the transition services agreements with those entities, restructuring, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below. Conference Call Information When: Wednesday, November 6, 2024, starting at 5:00 p.m. Eastern Time To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI6dfb4eba6e9a4322a716df863233a53fPlease dial in 15 minutes early to ensure a timely connection to the call. Webcast: https://edge.media-server.com/mmc/p/fgk872yp An archived webcast will be available on the “Investors” section of the Coherus website at https://investors.coherus.com/events-presentations. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1 study as a monotherapy in patients with advanced solid tumors and in combination with toripalimab in patients with head and neck cancer. CHS-1000 is a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2). Our IND for CHS-1000 was allowed to proceed by the FDA in the second quarter of 2024 and proceeding to the first-in-human clinical study is subject to further evaluation in our portfolio prioritization process. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®. Neulasta® is a registered trademark of Amgen Inc. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ expectations about identifying synergies between its I-O pipeline and its commercial operations; Coherus’ expected timing for initiating studies and reporting clinical data for its pipeline product candidates; Coherus’ future projections for R&D and SG&A expenses; Coherus’ expectations about long term revenue growth; Coherus’ expected future packaging and labeling capacity for UDENYCA and Coherus’ expectations about the timing for the end of its UDENYCA supply interruption, including timing for resumption of UDENYCA production from its labeling and packaging CMO, timing for the backlog of UDENYCA lots to be completed by its labeling and packaging CMO and projections for the number of units to be completed, the expected timing for its additional packaging and labeling CMO to manufacture final saleable product, receive FDA authorization for UDENYCA production and commence commercial supply. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ reliance on third-parties; the risks and uncertainties related to manufacturing and supply of Coherus’ products, the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 filed with the Securities and Exchange Commission on or about the date of this press release, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission. Coherus’ results for the fiscal quarter ended September 30, 2024 are not necessarily indicative of its operating results for any future periods. UDENYCA®, UDENYCA® ONBODY™, and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information:For Investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com For Media:Argot Partners(212) 600-1902coherus@argotpartners.com Coherus BioSciences, Inc.Condensed Consolidated Statements of Operations(in thousands, except share and per share data)(unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023Net revenue$70,774 $74,568 $212,816 $165,720 Costs and expenses: Cost of goods sold 20,741 32,703 83,695 74,425 Research and development 21,676 25,647 72,101 83,068 Selling, general and administrative 34,744 48,224 126,441 142,521 Total costs and expenses 77,161 106,574 282,237 300,014 Loss from operations (6,387) (32,006) (69,421) (134,294)Interest expense (5,362) (10,268) (21,812) (29,923)Gain (loss) on Sale Transactions, net (1,086) — 176,646 — Loss on debt extinguishment — — (12,630) — Other income (expense), net 2,084 2,253 6,420 5,598 Income (loss) before income taxes (10,751) (40,021) 79,203 (158,619)Income tax provision — (380) — (380)Net income (loss)$(10,751) $(39,641) $79,203 $(158,239) Net income (loss) per share: Basic$(0.09) $(0.41) $0.69 $(1.79)Diluted$(0.09) $(0.41) $0.65 $(1.79) Weighted-average number of shares used in computing net income (loss) per share: Basic 115,210,091 97,738,509 114,263,256 88,277,936 Diluted 115,210,091 97,738,509 126,563,551 88,277,936 Coherus BioSciences, Inc.Condensed Consolidated Balance Sheets(in thousands)(unaudited) September 30, December 31, 2024 2023Assets Cash and cash equivalents$97,690 $102,891 Investments in marketable securities — 14,857 Trade receivables, net 167,559 260,522 TSA receivables, net 31,241 — Inventory 119,015 130,100 Intangible assets, net 54,313 71,673 Other assets 35,182 49,561 Total assets$505,000 $629,604 Liabilities and Stockholders’ Deficit Accrued rebates, fees and reserve$163,315 $169,645 TSA payables and other accrued liabilities 33,637 — Term loans 36,618 246,481 Convertible notes 227,891 226,888 Other liabilities 131,512 180,015 Total stockholders' deficit (87,973) (193,425)Total liabilities and stockholders’ deficit$505,000 $629,604 Coherus BioSciences, Inc.Condensed Consolidated Statements of Cash Flows(in thousands)(unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023Cash, cash equivalents and restricted cash at beginning of the period$159,692 $73,360 $103,343 $63,987 Net cash used in operating activities (62,016) (54,300) (49,048) (161,947) Proceeds from maturities of investments in marketable securities — 43,398 6,200 108,148 Proceeds from sale of investments in marketable securities — — 8,688 13,282 Cash and cash equivalents acquired from Surface Acquisition — 6,997 — 6,997 Cash received from CIMERLI sale — — 187,823 — Cash received from YUSIMRY sale — — 40,000 — Milestone based license fee payment to Junshi Biosciences — — (12,500) — Purchases of investments in marketable securities — — — (19,507)Other investing activities, net 444 151 652 517 Net cash provided by investing activities 444 50,546 230,863 109,437 Proceeds from 2029 Term Loan, net of debt discount & issuance costs (141) — 36,979 — Proceeds from Revenue Purchase and Sale Agreement, net of issuance costs (9) — 36,486 — Proceeds from issuance of common stock under ATM Offering, net of issuance costs — 11,437 1,455 18,198 Proceeds from issuance of common stock under Public Offering, net of issuance costs — — — 53,625 Proceeds from issuance of common stock upon exercise of stock options — 53 291 170 Proceeds from purchase under the employee stock purchase plan — — 685 1,337 Repayment of 2027 Term Loans, premiums and fees — — (260,387) — Taxes paid related to net share settlement (10) (175) (2,466) (3,261)Other financing activities (7) (210) (248) (835)Net cash (used in) provided by financing activities (167) 11,105 (187,205) 69,234 Net (decrease) increase in cash, cash equivalents and restricted cash (61,739) 7,351 (5,390) 16,724 Cash, cash equivalents and restricted cash at end of the period$97,953 $80,711 $97,953 $80,711 Reconciliation of cash, cash equivalents, and restricted cash Cash and cash equivalents$97,690 $80,259 $97,690 $80,259 Restricted cash balance 263 452 263 452 Cash, cash equivalents and restricted cash$97,953 $80,711 $97,953 $80,711 Non-GAAP Financial Measures To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net loss, and the related per share measures, which exclude from net income (loss), and the related per share measures, stock-based compensation expense, certain acquisition-related expenses, amortization of intangible assets, gain (loss) on divestiture, impairments of intangible assets, contingent consideration, loss on debt extinguishment and restructuring charges related to our reduction in workforce. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business. Coherus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. Coherus BioSciences, Inc.Reconciliation of GAAP Net Income (Loss) to Non-GAAP Net Loss(in thousands, except share and per share data)(unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023GAAP net income (loss)$(10,751) $(39,641) $79,203 $(158,239)Adjustments: Stock-based compensation expense(1) 6,868 9,954 21,418 31,364 Loss (gain) on Sale Transactions, net 1,086 — (176,646) — Loss on debt extinguishment — — 12,630 — Impairment of out-license asset and remeasurement of CVR liability, net — — 6,772 — Restructuring charges related to reduction in workforce(1) — — — 4,876 Acquisition-related costs, including amortization of intangibles(2) 1,142 2,830 2,776 4,691 Non-GAAP net loss$(1,655) $(26,857) $(53,847) $(117,308) GAAP Net income (loss) per share, basic$(0.09) $(0.41) $0.69 $(1.79)Net income (loss) per share, diluted$(0.09) $(0.41) $0.65 $(1.79)Shares used in computing basic net income (loss) per share 115,210,091 97,738,509 114,263,256 88,277,936 Shares used in computing diluted net income (loss) per share 115,210,091 97,738,509 126,563,551 88,277,936 Non-GAAP Net loss per share, basic and diluted$(0.01) $(0.27) $(0.47) $(1.33)Shares used in computing basic and diluted net loss per share 115,210,091 97,738,509 114,263,256 88,277,936 (1) In the nine months ended September 30, 2023, stock-based compensation of $1.0 million was classified within Restructuring charges related to reduction in workforce. (2) Beginning in the third quarter of 2023, the Company began excluding acquisition-related costs in its non-GAAP financial information. To conform to this change, $1.9 million of acquisition-related costs, including amortization of intangibles incurred during the quarter ended June 30, 2023 has been excluded from SG&A expense for the nine months ended September 30, 2023.