Coherus BioSciences Files 2023 Annual Report on Form 10-K

TL;DR

<b>Coherus BioSciences, Inc. has submitted its 2023 annual report (10-K) detailing financial performance and corporate activities.</b>

AI Summary

Coherus BioSciences, Inc. (CHRS) filed a Annual Report (10-K) with the SEC on March 15, 2024. Coherus BioSciences, Inc. filed its 2023 Form 10-K on March 15, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business is Biological Products (No Diagnostic Substances). The filing includes details on stock offerings and capital changes throughout 2022 and 2023. Key financial statement components like Retained Earnings, Additional Paid-In Capital, and Accumulated Other Comprehensive Income are reported for multiple fiscal years.

Why It Matters

For investors and stakeholders tracking Coherus BioSciences, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Coherus BioSciences' financial health and operational status for the fiscal year 2023, crucial for investors to assess the company's performance and future prospects. The detailed financial data, including changes in equity and accumulated income/loss, offers insights into the company's capital structure and profitability trends over several years.

Risk Assessment

Risk Level: medium — Coherus BioSciences, Inc. shows moderate risk based on this filing. The company operates in the highly competitive and regulated biotechnology sector, which presents inherent risks related to drug development, regulatory approvals, and market adoption, as indicated by its SIC code (2836) and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Coherus BioSciences' financial position and the challenges within the biopharmaceutical industry.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the 10-K filing)
• 2024-03-15 — Filing Date (Date the 10-K was filed)
• 78851516 — Other Assets Noncurrent (Value as of 2023-12-31)
• 112215260 — Property Plant and Equipment Net (Value as of 2023-12-31)

Key Players & Entities

• Coherus BioSciences, Inc. (company) — Filer name
• Dennis M. Lanfear (person) — Business and Mail Address contact
• BioGenerics, Inc. (company) — Former company name
• 2836 (dollar_amount) — Standard Industrial Classification code

FAQ

Risk Factors

• Regulatory Environment [high — regulatory]: The biopharmaceutical industry is subject to extensive regulation by government authorities, impacting product development, manufacturing, marketing, and pricing.
• Market Competition [high — market]: The company faces intense competition from other biotechnology and pharmaceutical companies, including those with established products and significant market share.
• Financial Performance and Funding Needs [medium — financial]: The company's ability to achieve profitability and manage its cash burn rate is critical, as it may require significant future funding for operations and product development.
• Product Development and Commercialization Risks [high — operational]: The success of Coherus BioSciences depends on the successful development, regulatory approval, and commercialization of its product candidates, which are subject to numerous risks.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-15: 10-K Filing Date — Date Coherus BioSciences submitted its annual report.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This is the primary document filed by Coherus BioSciences, containing detailed financial and operational information for the fiscal year.)

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share CHRS The Nasdaq
• $170.0 million — for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CI
• $17.8 million — on of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepa
• $1.5 b — ain, United Kingdom, and Japan) totaled $1.5 billion, and sales were expected to incre
• $3.5 billion — les were expected to increase to almost $3.5 billion in 2032. Fueling this growth are the co
• $1.7 b — 2, garnering major-market sales of over $1.7 billion, and we expect these agents to be

Filing Documents

• chrs-20231231x10k.htm (10-K) — 3997KB
• chrs-20231231xex1.htm (EX-1) — 329KB
• chrs-20231231xex2.htm (EX-2) — 1061KB
• chrs-20231231xex3.htm (EX-3) — 17KB
• chrs-20231231xex4.htm (EX-4) — 551KB
• chrs-20231231xex5.htm (EX-5) — 21KB
• chrs-20231231xex7.htm (EX-7) — 96KB
• chrs-20231231xex8.htm (EX-8) — 19KB
• chrs-20231231xex9.htm (EX-9) — 152KB
• chrs-20231231xex10.htm (EX-10) — 48KB
• chrs-20231231xex10d40.htm (EX-10.40) — 201KB
• chrs-20231231xex21d1.htm (EX-21.1) — 4KB
• chrs-20231231xex23.htm (EX-23) — 6KB
• chrs-20231231xex31.htm (EX-31) — 15KB
• chrs-20231231xex32.htm (EX-32) — 14KB
• chrs-20231231xex33.htm (EX-33) — 12KB
• chrs-20231231xex97.htm (EX-97) — 26KB
• chrs-20231231x10k007.jpg (GRAPHIC) — 70KB
• chrs-20231231xex1002.jpg (GRAPHIC) — 4KB
• chrs-20231231xex9001.jpg (GRAPHIC) — 1KB
• chrs-20231231xex9002.jpg (GRAPHIC) — 1KB
• 0001558370-24-003436.txt (&nbsp;) — 20013KB
• chrs-20231231.xsd (EX-101.SCH) — 116KB
• chrs-20231231_cal.xml (EX-101.CAL) — 116KB
• chrs-20231231_def.xml (EX-101.DEF) — 513KB
• chrs-20231231_lab.xml (EX-101.LAB) — 933KB
• chrs-20231231_pre.xml (EX-101.PRE) — 799KB
• chrs-20231231x10k_htm.xml (XML) — 3190KB

Business

Business 3 ITEM 1A.

Risk Factors

Risk Factors 25 ITEM 1B. Unresolved Staff Comments 71 ITEM 1C. Cybersecurity 71 ITEM 2.

Properties

Properties 72 ITEM 3.

Legal Proceedings

Legal Proceedings 72 ITEM 4. Mine Safety Disclosures 72 PART II ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 73 ITEM 6. [Reserved] 74 ITEM 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 74 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 90 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 91 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 135 ITEM 9A.

Controls and Procedures

Controls and Procedures 135 ITEM 9B. Other Information 137 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 137 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 138 ITEM 11.

Executive Compensation

Executive Compensation 138 ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 138 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 138 ITEM 14. Principal Accounting Fees and Services 138 PART IV ITEM 15. Exhibits and Financial Statement Schedules 139 ITEM 16. Form 10-K Summary 139

Signatures

Signatures 144 UDENYCA, 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 Annual Report on Form 10-K are, to the knowledge of Coherus, the property of their respective owners. ii Table of Contents As used in this Annual Report on Form 10-K, unless the context requires otherwise, references to "Coherus," the "Company," "we," "us," and "our," and similar references refer to Coherus BioSciences, Inc. and its wholly owned subsidiaries.

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended (the "Securities Act"), and the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statements that are not statements of historical facts contained in this Annual Report on Form 10-K may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by words such as "aim," "anticipate," "assume," "attempt," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "potential," "seek," "should," "strive," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: whether we will be able to continue to maintain or increase sales for our products; our expectations regarding our ability to develop and commercialize our product candidates in the United States and Canada; our ability to maintain regulatory approval for our products and our ability to obtain and maintain regulatory approval of our product candidates, if and when approved; our expectations regarding government and third-party payer coverage and reimbursement; our ability to manufacture our product candidates in conformity with regulatory requirements and to scale up manufacturing capacity of these products for commercial supply; our reliance on third-party contract manufacturers to supply our product candidates and products for us; our expectations regarding the potential market size and the size of the patient populations for our products and product candidates, if approved for commercial use; our expectations about making req

Business

Item 1. Business Overview We are a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative cancer treatments and the commercialization of our portfolio of United States Food and Drug Administration ("FDA")-approved oncology products, including LOQTORZI (toripalimab-tpzi). Our strategy is to build a leading immuno-oncology business funded with cash generated from our diversified portfolio of FDA-approved therapeutics. As of March 15, 2024, our commercial portfolio includes two FDA-approved biosimilar products. Our first product, UDENYCA, a biosimilar to Neulasta, a long-acting G-CSF, was launched commercially in the United States in January 2019. The FDA approved the prior approval supplement ("PAS") for an autoinjector ("AI") presentation of UDENYCA on March 3, 2023, and on May 22, 2023 we announced the availability of UDENYCA AI for commercial sale. On December 26, 2023 we announced that the FDA approved the PAS for our third pegfilgrastim presentation, the UDENYCA on-body injector ("UDENYCA ONBODY"). UDENYCA ONBODY became commercially available in the first quarter of 2024. Our second product, YUSIMRY (adalimumab-aqvh), a biosimilar to Humira (adalimumab), was launched in the United States in July 2023. Another product, CIMERLI (ranibizumab-eqrn), was approved by the FDA in August 2022 as a biosimilar product interchangeable with Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. We launched CIMERLI commercially in the United States in October 2022. On January 19, 2024, we entered into a Purchase and Sale Agreement (the "Purchase Agreement") by and between us and Sandoz Inc., a Delaware corporation ("Sandoz"). Pursuant to the terms and subject to the conditions set forth in the Purchase Agreement, on March 1, 2024,

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View this 10-K filing on SEC EDGAR