On March 13, 2024 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), reported financial results for its fiscal fourth quarter and full year ended December 31, 2023 and recent business highlights (Press release, Coherus Biosciences, MAR 13, 2024, View Source [SID1234641106]):

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RECENT BUSINESS HIGHLIGHTS

CORPORATE RESTRUCTURING SOLIDIFIES FOCUS ON ONCOLOGY

On March 1, 2024, Coherus closed the divestiture of the ophthalmology franchise to Sandoz for upfront, all-cash consideration of $170 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets.
On or before April 1, 2024, Coherus plans to prepay $175 million of the $250 million principal balance of its term loan with Pharmakon Advisors LP ("Pharmakon"), leaving a residual balance of $75 million and reducing projected annualized Pharmakon related interest payments by about 70%.
The sharpened focus in oncology and a subsequent restructuring is expected to result in a reduction in workforce of 30% by the end of 2024, including 35 employees associated with the ophthalmology divestiture, for an estimated annualized cost savings of more than $25 million.
Expected SG&A and R&D expenses for 2024 reduced from $301.5 million in 2023 to $250-265 million representing at least a 12% decrease year over year.
The $25 million toripalimab NPC approval milestone due to be paid to Junshi Biosciences in Q1 2024 has been restructured such that $12.5 million will be paid in Q2 2024 and the remainder in Q1 2025, potentially adjusted downward for proceeds from Canadian rights.
UDENYCA RESULTS and ONBODY LAUNCH UPDATE

UDENYCA net product sales increased 10% in the fourth quarter 2023 to $36.2 million compared to $33.0 million in the third quarter. Total unit demand grew 7% quarter over quarter. UDENYCA Autoinjector presentation unit demand grew 129% quarter over quarter. Since commercial launch in May 2023, more than 727 accounts have ordered the Autoinjector presentation.
UDENYCA ONBODY, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv, was launched in February 2024. High customer demand coupled with confirmed payer coverage, drove robust uptake with 138 accounts ordering ONBODY within the first four weeks of launch.
Based on data from IQVIA, rolling 4-week UDENYCA market share as of March 1 was 26%.
LOQTORZI LAUNCH UPDATE

LOQTORZI is the first and only FDA-approved treatment for recurrent or metastatic NPC in all lines of therapy with commercial launch commencing on January 2, 2024.
NCCN Guidelines recommend LOQTORZI as the only immunotherapeutic agent with Preferred Category 1 status in first-line treatment for adults with metastatic or recurrent locally advanced NPC in combination with chemotherapy; LOQTORZI monotherapy is also recommended in NCCN guidelines as the only preferred regimen in subsequent lines of therapy.
Category 1 represents the highest level of evidence and uniformity among panel members in terms of agreement that translates into ease of reimbursement and the ability to establish a new standard of care for these patients.
Payer coverage for LOQTORZI has been confirmed across Medicare Fee for Service, as well as national and regional commercial health plans.
Early demand uptake tracking to expectations, with over 59 NPC targeted accounts ordering the product since launch.
NOVEL IMMUNO-ONCOLOGY PIPELINE ADVANCES

In January 2024, Coherus entered into a clinical collaboration with INOVIO to evaluate LOQTORZI (toripalimab-tpzi) in combination with INO-3112 in a Phase 3 clinical trial as a potential treatment for patients with locoregionally advanced, high-risk, HPV16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer.
Coherus presented new Phase 1b/2 clinical data for casdozokitug, a first-in-class IL-27 antagonist at the 2023 ESMO (Free ESMO Whitepaper) IO Congress in December and 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January. Results show encouraging signs of antitumor activity and an acceptable safety profile for casdozokitug alone and in combination with PD-(L)1 inhibitors with or without bevacizumab in HCC and NSCLC respectively. Importantly, responses were associated with IL-27 related biomarkers and data support planned clinical trials with casdozokitug/ toripalimab-tpzi in NSCLC and HCC.
New preclinical data for CHS-1000 has been selected for a poster presentation at the upcoming 2024 AACR (Free AACR Whitepaper) Annual Meeting being held April 5-10, 2024, in San Diego.
Coherus plans to file an Investigational New Drug (IND) application in second quarter of 2024 for CHS-1000, a novel ILT4-targeted antibody.
"Throughout 2023, Coherus demonstrated significant progress in transforming the Company’s business model and product portfolio for long-term sustainable growth," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "We are clearly focused on driving our revenues, reducing our costs, and advancing our pipeline, with constant attention to long-term shareholder value. The divestiture of CIMERLI and debt paydown improves our capital structure and sharpens our focus on oncology. With a robust portfolio of FDA-approved products and a promising immuno-oncology pipeline, we are now better positioned than ever to execute on our mission of extending the lives of cancer patients."

FOURTH QUARTER and FULL YEAR 2023 FINANCIAL RESULTS

Net revenue was $91.5 million during the three months ended December 31, 2023 and included $36.2 million of net sales of UDENYCA, $52.4 million of net sales of CIMERLI, $2.2 million of net sales of YUSIMRY which was launched in July 2023 and $0.6 million of net sales of LOQTORZI which began shipping to distributors in December 2023 in preparation for launch. Net revenue was $45.4 million during the three months ended December 31, 2022. For the twelve months ended December 31, 2023 and 2022, net revenue was $257.2 million and $211.0 million, respectively. The increases in total net revenues were driven by the launches of CIMERLI and YUSIMRY and by the return to growth of UDENYCA throughout 2023.

Cost of goods sold (COGS) was $84.6 million and $14.2 million during the three months ended December 31, 2023 and 2022, respectively, and $159.0 million and $70.1 million during the full year ended December 31, 2023 and 2022, respectively. The increases in COGS for the three month and the annual periods each included a $47.0 million charge for the write-down of slow moving YUSIMRY inventory and the related partial recognition of certain firm purchase commitments. Increases in COGS also included $19.4 million and $47.5 million in royalty costs compared to the quarterly and annual periods in the prior year, respectively and increases in product costs of $11.5 million and $25.0 million, respectively, primarily driven by CIMERLI sales. The increase in the year over year COGS was partially offset by a $26.0 million write-down in the third quarter 2022 of inventory at risk of expiration and due to the sale in the second half 2023 of certain of those UDENYCA units having a total original cost of $9.9 million but no carrying value following the write-down. UDENYCA COGS includes a mid-single digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid 50% royalty on gross profits.

Research and development (R&D) expense for the three months ended December 31, 2023 and 2022 was $26.4 million and $29.0 million, respectively. For the full year ended December 31, 2023 and 2022, R&D expense was $109.4 million and $199.4 million, respectively. The decline compared to the prior year periods primarily resulted from the reduction in scope of the toripalimab collaboration and from the recognition in the first quarter of 2022 of the $35.0 million option exercise fee paid to Junshi Biosciences to license CHS-006. R&D expense for the full year of 2022 also included development costs for additional presentations of UDENYCA and certain manufacturing expenses for YUSIMRY which began to be capitalized in mid-2022.

Selling, general and administrative (SG&A) expense was $49.5 million and $53.6 million during the three months ended December 31, 2023 and 2022, respectively, and $192.0 million and $198.5 million during the full year ended December 31, 2023 and 2022, respectively. The decline in SG&A expense in both periods compared to the prior year periods primarily reflects lower headcount, partially offset by transaction costs associated with the Surface acquisition.

Net loss for the fourth quarter of 2023 was $79.7 million, or $(0.71) per share on a basic and diluted basis, compared to a net loss of $58.9 million, or $(0.76) per share on a basic and diluted basis for the same period in 2022. Net loss for the full year of 2023 was $237.9 million, or $(2.53) per share on a basic and diluted basis, compared to a net loss of $291.8 million, or $(3.76) per share on a basic and diluted basis for the full year of 2022.

Non-GAAP net loss for the fourth quarter of 2023 was $68.9 million, or $(0.62) per share on a basic and diluted basis, compared to non-GAAP net loss of $47.1 million, or $(0.60) per share on a basic and diluted basis for the same period in 2022. Non-GAAP net loss for the full year of 2023 was $186.2 million, or $(1.98) per share on a basic and diluted basis, compared to non-GAAP net loss of $234.8 million, or $(3.02) per share on a basic and diluted basis for the full year of 2022. 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 $117.7 million as of December 31, 2023, compared to $191.7 million at December 31, 2022.

2024 R&D and SG&A Expense Guidance
Coherus is introducing a guidance range of combined 2024 R&D and SG&A expenses from $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of strategic acquisitions, collaborations or investments, 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, March 13, 2024, starting at 5:00 p.m. Eastern Time

To access the conference call, please register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI41e6b8f8ab024eefafe43493f6fd0cdf

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Webcast: View Source

An archived webcast will be available on the "Investors" section of the Coherus website at View Source