On May 12, 2025 Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2025 and provided an overview of recent business highlights (Press release, Coherus Biosciences, MAY 12, 2025, View Source [SID1234652873]).
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"The completion of the UDENYCA divestiture in April positions us to focus on our innovative oncology portfolio," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "This includes maximizing LOQTORZI revenues, advancing our novel immuno-oncology candidates in combination with LOQTORZI to key data milestones in 2026, and progressing label expanding indications for LOQTORZI in novel combinations. The commercial launch of LOQTORZI continues to progress with patient demand growing more than 15% in the first quarter of 2025 versus the fourth quarter of last year."
"At AACR (Free AACR Whitepaper) last month, we reported promising early clinical data from our ongoing Phase 1 clinical trial evaluating CHS-114, which supports continued evaluation of CHS-114 in combination with other therapies, including toripalimab in HNSCC," stated Theresa LaValle, Ph.D., Coherus Chief Scientific and Development Officer. "We believe CHS-114 has the potential to treat many solid tumors outside of head and neck cancer, including other large, underserved immuno-oncology indications, such as colorectal cancer. As an innovative, revenue-generating oncology company, Coherus is well positioned to fully realize the value of our pipeline focused on extending the survival of cancer patients."
RECENT BUSINESS HIGHLIGHTS
LOQTORZI RESULTS
LOQTORZI is the only FDA-approved and available treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy.
LOQTORZI net product sales for Q1 2025 were $7.3 million, with patient demand growing in excess of 15% compared to Q4 2024.
In November 2024, the National Comprehensive Cancer Network (NCCN) revised its treatment guidelines for NPC to designate LOQTORZI as the only treatment with Preferred status in NPC, both in first line (1L) with a Category 1 designation and in second line (2L) and later NPC.
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION IMMUNO-ONCOLOGY PIPELINE
LOQTORZI (toripalimab-tpzi) 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:
Combining LOQTORZI with internal pipeline assets, casdozokitug and CHS-114, in additional indications; and
Entering into capital-efficient external partnerships for additional label expansions. We are pursuing additional partnerships, evaluating LOQTORZI with novel, promising cancer agents in 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.
The Company reported early clinical data at AACR (Free AACR Whitepaper) 2025 from an ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic HNSCC. The data showed a confirmed partial response in a heavily pre-treated PD-1 refractory patient, a 50% depletion in CCR8+ Treg, and an increase in CD8+ T cells, consistent with anti-tumor activity, demonstrating proof of mechanism. The safety profile was consistent with advanced disease and the known safety profile of toripalimab.
The Company initiated a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L HNSCC in Q1 2025 with a first data readout expected in Q2 2026.
The Company initiated 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.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory NSCLC and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).
Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in 1H 2026.
The Company reported final data at ASCO (Free ASCO Whitepaper)-GI 2025 from a Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC. The data showed an overall response rate (ORR) increased to 38% compared to 27%1 initially announced, and complete responses per RECIST v1.1 increased to 17.2% compared to 10.3%2 previously announced and the initial assessment of 0%1. These data demonstrate both an increase in ORR and a deepening of responses compared to previous datasets. Importantly, responses were seen in viral and nonviral disease, and toxicity was consistent with the known safety profiles of atezolizumab and bevacizumab, with no new safety signals identified.
UDENYCA RESULTS (DISCONTINUED OPERATIONS)
UDENYCA net product sales for Q1 2025 were $31.5 million.
In April 2025, Coherus announced the completion of the previously announced divestiture of its UDENYCA franchise for up to $558.4 million. At the closing of the transaction, Coherus received an upfront payment of $483.4 million, including $118.4 million for UDENYCA inventory, and is eligible to receive potential milestone payments of up to $75 million.
DISCONTINUED OPERATIONS FINANCIAL STATEMENT PRESENTATION
In accordance with the relevant accounting rules, the biosimilar business, inclusive of the UDENYCA, YUSIMRY and CIMERLI franchises, has been classified as discontinued operations for all periods presented. The results of the discontinued operations have been reported as a separate component of income on the condensed consolidated statements of operations, and the assets and liabilities of the discontinued operations have been presented separately in the condensed consolidated balance sheets.
FIRST QUARTER 2025 FINANCIAL RESULTS
Net revenue from continuing operations was $7.6 million and $2.3 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $5.3 million was primarily due to higher volume of LOQTORZI, which launched in December 2023.
Cost of goods sold (COGS) from continuing operations was $2.7 million and $1.4 million during the three months ended March 31, 2025 and 2024, respectively. The increase was primarily due to higher volume of LOQTORZI, which launched in December 2023.
Research and development (R&D) expenses from continuing operations were $24.4 million and $28.4 million for the three months ended March 31, 2025 and 2024, respectively. The decrease was primarily due to the reduction in co-development costs for toripalimab, termination of the TIGIT Program announced in January 2024 and savings in personnel and stock-based compensation from reduced headcount, partially offset by increased costs for development of casdozokitug and CHS-114.
Selling, general and administrative (SG&A) expenses from continuing operations were $26.0 million and $40.2 million during the three months ended March 31, 2025 and 2024, respectively. The decrease was driven primarily by the net $6.8 million charge in the first quarter of 2024 associated with the full write-off of the out-license intangible asset and associated release of the contingent value right liability related to NZV930, which was acquired in the Surface Oncology, Inc. acquisition, as well as lower average headcount and decreased operating costs following Coherus’ recent divestitures.
Interest expense from continuing operations was $2.2 million and $3.1 million during the three months ended March 31, 2025 and 2024, respectively. The decrease was primarily due to prepaying the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest on the $38.7 million senior secured term loan facility and the LOQTORZI portion of the Revenue Participation Right Purchase and Sale Agreement among Coherus and Coduet Royalty Holdings, LLC (Revenue Purchase and Sale Agreement), which each commenced May 8, 2024.
Net loss from continuing operations for the first quarter of 2025 was $47.4 million, or $(0.41) per share on a diluted basis, compared to $68.0 million, or $(0.60) per share on a diluted basis, for the same period in 2024.
Non-GAAP net loss from continuing operations for the first quarter of 2025 was $40.9 million, or $(0.35) per share on a diluted basis, compared to $53.6 million, or $(0.48) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.
Net income (loss) from discontinued operations, net of tax was a net loss of $9.2 million, or $(0.08) per share on a diluted basis, for first quarter of 2025 compared to net income of $170.9 million, or $1.52 per share on a diluted basis, for the same period in 2024. The change was primarily due to the $153.6 million gain on sale of the CIMERLI ophthalmology franchise in March 2024 and the negative impacts on UDENYCA revenues in Q1 2025 following the temporary supply interruption experienced that occurred in Q4 2024, including supply allocations to wholesalers which were not removed until the end February 2025.
Cash and cash equivalents totaled $82.4 million as of March 31, 2025, compared to $126.0 million as of December 31, 2024. The upfront, all-cash consideration of $483.4 million for the divestiture of the UDENYCA franchise was received in April 2025 and thus will be reflected as part of Coherus’ Q2 2025 financial information, when reported. Also to be reflected as part of the Q2 2025 financial information, will be the use of a portion of the divestiture proceeds in April 2025 to pay $47.7 million to buy out the portion of the Revenue Payments rights with respect to UDENYCA in accordance with the Revenue Purchase and Sale Agreement, and the April 2025 payments to repurchase approximately $170 million aggregate principal amount of Coherus’ 1.5% Convertible Senior Subordinated notes due 2026 (2026 Convertible Notes). Coherus further expects to repurchase the remaining approximately $60 million aggregate principal amount of 2026 Convertible Notes on May 15, 2025 pursuant to the Fundamental Change Repurchase Right (as defined in the indenture, dated as of April 17, 2020, between Coherus and U.S. Bank Trust Company, National Association).
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When: Monday, May 12, 2025, starting at 5:00 p.m. Eastern Daylight Time
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