On March 10, 2025 Coherus BioSciences, Inc. (Coherus or the Company, Nasdaq: CHRS), reported financial results for the fourth quarter and full year 2024 and provided an overview of recent business updates (Press release, Coherus Biosciences, MAR 10, 2025, View Source [SID1234651037]).

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"2024 represents our transformation into an innovative oncology company, culminating in the agreement to divest UDENYCA," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "In 2025, we will be sharply focused on maximizing the revenue potential for LOQTORZI while advancing the development of our pipeline, including our first-in-class IL-27 antagonist, casdozokitug, and our CCR8-targeting antibody, CHS-114, in combination with LOQTORZI."

"Upon the completion of the UDENYCA divestiture and pay-off of our significant debt and royalty obligations, we are projecting a cash position of approximately $250 million," continued Mr. Lanfear. "These efforts, combined with organizational streamlining, are expected to provide Coherus with a cash runway exceeding two years, funding the development pipeline through key data catalysts in 2025 and 2026."

RECENT BUSINESS UPDATES

UDENYCA RESULTS AND DIVESTITURE

UDENYCA net product sales for Q4 2024 were $46.3 million, an increase of 28% compared to $36.2 million for Q4 2023, despite the temporary supply interruption. UDENYCA net product sales for FY 2024 were $206.0 million, an increase of 62% compared to $127.1 million for FY 2023.
Production of UDENYCA by the Company’s third-party labeling and packaging contract manufacturing organization (CMO) resumed in November 2024. An additional final packaging and labeling CMO is expected to deliver saleable product in late Q1 or in early Q2 2025, subject to U.S. Food and Drug Administration (FDA) authorization.
In December 2024, Coherus announced the divestiture of the UDENYCA franchise for up to $558.4 million. The transaction is subject to shareholder approval and other closing conditions and is expected to close late in the first quarter or early in the second quarter of 2025.
LOQTORZI RESULTS

LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), commercially launched across all lines of therapy in January 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.
LOQTORZI net product sales for Q4 2024 were $7.5 million, an increase of 29% compared to $5.8 million in Q3 2024. LOQTORZI net product sales in FY 2024 were $19.1 million.
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. 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 in combination activity in hepatocellular carcinoma (HCC).

Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC opened for enrollment.
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 of 38% compared to initially announced 27%1, and complete responses (CR) per RECIST v1.1 increased to 17.2% compared to previously announced 10.3%2 and initial assessment of 0%1, demonstrating both an increase in overall response rate (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.
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 expects 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.
Report first data for Phase 1b CHS-114/toripalimab combination dose optimization study in 2L HNSCC in Q2 2026.
Initiate 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.
FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS

Three Months Ended
December 31, Year Ended
December 31,
(in thousands) 2024 2023 Change 2024 2023 Change
Products
UDENYCA (a) $ 46,278 $ 36,189 $ 10,089 $ 205,951 $ 127,064 $ 78,887
CIMERLI – divested March 1, 2024 100 52,449 (52,349 ) 27,079 125,388 (98,309 )
YUSIMRY – divested June 26, 2024 33 2,214 (2,181 ) 7,541 3,574 3,967
LOQTORZI 7,522 554 6,968 19,131 554 18,577
Total net product revenue 53,933 91,406 (37,473 ) 259,702 256,580 3,122
Other revenue 211 118 93 7,258 664 6,594
Total net revenue $ 54,144 $ 91,524 $ (37,380 ) $ 266,960 $ 257,244 $ 9,716

(a) If the contemplated UDENYCA Sale is approved, Coherus anticipates the transaction would close late in the first quarter or early in the second quarter of 2025.

Net revenue for the fourth quarter of 2024, as compared to 2023, decreased $37.4 million primarily due to the Company’s divestiture of CIMERLI and YUSIMRY, partially offset by an increase in UDENYCA and LOQTORZI net sales.

For the full year 2024, UDENYCA net revenue increased $78.9 million primarily due to increased market share, offset by a change in UDENYCA segment mix and the impact of the fourth quarter temporary UDENYCA supply interruption. The $98.3 million decrease in net revenues of CIMERLI was primarily the result of the CIMERLI Sale. LOQTORZI net revenue reflects initial sales beginning in December 2023 following FDA approval. Other revenue in 2024 included $6.3 million for the sale to Apotex of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) was $33.9 million and $84.6 million during the three months ended December 31, 2024 and 2023, respectively, and $117.6 million and $159.0 million during the years ended December 31, 2024 and 2023, respectively. The decrease in COGS for the fourth quarter of 2024 compared to the same period in the prior year was primarily due to the $47.0 million charge in 2023 related to slow moving YUSIMRY inventory and products that were divested during the first half of 2024.

The decrease in cost of goods sold in the full year 2024 compared to 2023 was primarily due to a decrease of $56.9 million in costs from CIMERLI, which was divested during the first quarter of 2024 and a $47.0 million charge in the fourth quarter of 2023 related to slow moving YUSIMRY inventory. These decreases were partially offset by a $59.6 million increase in costs related to UDENYCA and LOQTORZI in 2024, which includes $14.1 million in charges for the write-down of UDENYCA inventory that did not meet acceptance criteria.

Research and development (R&D) expenses were $21.2 million and $26.4 million for the three months ended December 31, 2024 and 2023, respectively, and $93.3 million and $109.4 million for the years ended December 31, 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 increased costs for development of casdozokitug and CHS-114.

Selling, general and administrative (SG&A) expenses were $41.3 million and $49.5 million during the three months ended December 31, 2024 and 2023, respectively, and $167.7 million and $192.0 million during the years ended December 31, 2024 and 2023, respectively. The declines compared to the prior year periods were driven primarily by lower headcount and decreased operating costs following divestitures. The decrease for the year 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, that was acquired in the Surface Oncology, Inc. acquisition and $6.7 million in divestiture-related costs incurred in the fourth quarter 2024.

Interest expense was $5.3 million and $10.6 million during the three months ended December 31, 2024 and 2023, respectively, and $27.2 million and $40.5 million during the years ended December 31, 2024 and 2023, respectively. The declines in both periods were primarily due to fully paying off the $250.0 million principal amount of the 2027 Term Loans in the second quarter 2024, partially offset by interest on the revenue participation right purchase and sale agreement and the $38.7 million principal amount of the senior secured term loan facility, both commencing May 8, 2024.

Gain on sale transactions, net was $176.6 million for the year ended December 31, 2024 and included a $153.8 million gain on the first quarter 2024 divestiture of our CIMERLI ophthalmology franchise and a $22.8 million gain on the second quarter 2024 divestiture of our YUSIMRY immunology franchise.

Net income (loss) for the fourth quarter of 2024 was a net loss of $50.7 million, or $(0.44) per share on a diluted basis, compared to a net loss of $79.7 million, or $(0.71) per share on a diluted basis for the same period in 2023. Net income for the year ended December 31, 2024 was $28.5 million, or $0.25 per share on a diluted basis, compared to a net loss of $237.9 million, or $(2.53) per share on a diluted basis for year ended December 31, 2023.

Non-GAAP net loss for the fourth quarter of 2024 was $32.5 million, or $(0.28) per share on a diluted basis, compared to $68.9 million, or $(0.62) per share for the same period in 2023. Non-GAAP net loss for the year ended December 31, 2024 was $86.3 million, or $(0.75) per share on a diluted basis, compared to $186.2 million, or $(1.98) 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 $126.0 million as of December 31, 2024, compared to $117.7 million as of December 31, 2023.

2025 Outlook

Coherus projects post-UDENYCA-close cash of approximately $250 million and cash runway projections exceeding two years, past key data readouts expected in 2026. Approximately 50 employees associated with UDENYCA are expected to transfer to Accord BioPharma, Inc. as part of the asset purchase agreement and Coherus’ headcount will be reduced by approximately 30% following the transaction to approximately 155.

Conference Call Information

When: Monday, March 10, 2025, starting at 5:00 p.m. Eastern Time

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