RECENT BUSINESS HIGHLIGHTS
UDENYCA RESULTS and ONBODY LAUNCH UPDATE
UDENYCA net product sales were
UDENYCA Autoinjector presentation unit demand grew 158% in Q1 2024 compared to Q4 2023.
UDENYCA ONBODY, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv, was launched in
Based on data from
LOQTORZI LAUNCH UPDATE
LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic NPC, commercially launched on
Academic research hospital formulary position achieved on 55% of the 33 NCCN institutions, with the remaining institutional reviews scheduled or in process. Formulary position is expected to be achieved with all NCCN institutions by the end of Q2 2024.
Payer coverage has been confirmed on >85% of medical benefit lives in health plans including Medicare Fee for Service, Medicare Advantage, and national and regional commercial plans respectively.
LOQTORZI net sales in Q1 of
Product-specific, permanent J Code has been granted by the
NOVEL IMMUNO-ONCOLOGY PIPELINE ADVANCES
Coherus entered into an agreement with the
Clinical data from the dose escalation stage of the Phase 1 study of CHS-114, a highly selective antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-CCR8 antibody, will be presented at the 2024 ASCO Annual Meeting in June.
'The strength of our company's first-quarter performance reflects our ongoing commitment to driving top-line revenues, controlling operating expenses, advancing our pipeline, and improving our capital structure,' said
FIRST QUARTER 2024 FINANCIAL RESULTS
Net revenue was
Cost of goods sold (COGS) was
Research and development (R&D) expense was
Selling, general and administrative (SG&A) expense for the three months ended
Gain on Sale, net for the divestiture of the ophthalmology franchise, which closed during the three months ended
Net income for the first quarter of 2024 was
Non-GAAP net loss for the first quarter of 2024 was
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
About
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. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the novel pathway ILT4 with a response from the FDA on our IND filing expected in the second quarter of 2024.
Coherus markets LOQTORZI (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, UDENYCA (pegfilgrastim-cbqv), a biosimilar of Neulasta, and YUSIMRY (adalimumab-aqvh), a biosimilar of Humira.
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' ability to identify synergies between its I-O pipeline and its commercial operations; Coherus' expected timing for an FDA response to its IND for CHS-1000; Coherus' future projections for R&D expense and SG&A expense and Coherus' expectations about revenues and long term growth.
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' competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus' regulatory filings; the risk of FDA review issues; the risks of competition; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' products and product candidates 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 filing on Form 10-Q for the fiscal quarter ended
UDENYCA, UDENYCA ONBODY, YUSIMRY 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.
Contact:
Email: IR@coherus.com
Email: media@coherus.com
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