Coherus BioSciences Inc
For the period ended Mar 31, 2025. Filed May 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 12, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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Item 2. Results of Operations
Comparison of Three Months Ended March 31, 2025 and 2024
Revenue
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|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | |||||||||
| (in thousands) · 2025 · 2024 · Change | |||||||||
| LOQTORZI | | $7,348 | | $1,988 | | $5,360 | |||
| Other revenue | | | 251 | | | 320 | | | (69) |
| Total net revenue | | $7,599 | | $2,308 | | $5,291 | |||
The increase in net revenue for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to higher volume of LOQTORZI, which launched in December 2023.
We expect net revenue from continuing operations in 2025 to be higher than in 2024 because of continued growth of LOQTORZI.
Cost of Goods Sold
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|---|---|---|---|---|---|---|
| · · · · | ||||||
| · · Three Months Ended March 31, | ||||||
| (in thousands) · · 2025 · 2024 · Change | ||||||
| Cost of goods sold | | $2,653 | | $1,439 | | $1,214 |
| Gross margin | | 65% | 38% | | ||
The increase in cost of goods sold from continuing operations for the three months ended March 31, 2025 compared to the same period in the prior year was primarily due to higher demand of LOQTORZI, which launched in December 2023.
We expect cost of goods sold from continuing operations for 2025 to be higher than 2024 because of continued growth of LOQTORZI.
Research and Development Expense
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|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| (in thousands) · · 2025 · 2024 · Change | ||||||
| Research and development | | $24,356 | | $28,424 | | $(4,068) |
The decrease in research and development expense from continuing operations in the three months ended March 31, 2025 compared to the prior period was primarily due to the following:
| ● | a decrease of $8.2 million in co-development costs for toripalimab and CHS-006 resulting from reducing the scope of the development plan for toripalimab in the United States and the termination of the TIGIT Program announced in January 2024; |
| ● | a decrease of $1.6 million in personnel and stock-based compensation expense primarily due to fewer employees; and |
| ● | a decrease of $0.9 million for fewer expenditures during the quarter for the development of CHS-1000. |
The decrease was partially offset by the following:
| ● | an increase of $5.0 million for the development of CHS-114; and |
| ● | an increase of $2.0 million for the development of casdozokitug. |
We expect our research and development expense in 2025 to be higher than 2024 due to continued investments in our immuno-oncology pipeline.
Selling, General and Administrative Expense
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| · · Three Months Ended March 31, | ||||||
| (in thousands) · 2025 · 2024 · Change | ||||||
| Selling, general and administrative | | $26,025 | | $40,232 | | $(14,207) |
The decrease in selling, general and administrative expense from continuing operations in the three months ended March 31, 2025 was primarily due to the $6.8 million net impairment charge in the first quarter of 2024 relating to the write-off of the net carrying value of the out-license intangible asset of $10.6 million and the final remeasurement of the CVR liability of $3.8 million related to NZV930 to its fair value of zero, lower professional fees of $3.1 million, a lower average headcount which resulted in reductions of $2.2 million in employee-related costs and $1.2 million in stock-based compensation.
We expect our selling, general and administrative expense from continuing operations for the full year 2025 to be lower than the full year 2024 primarily as a result of decreased operating costs and headcount due to divestitures.
Interest Expense
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|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| (in thousands) · · 2025 · 2024 · Change | ||||||
| Interest expense | | $2,150 | | $3,118 | | $(968) |
The decrease in interest expense from continuing operations in the three months ended March 31, 2025 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 new interest on the $38.7 million 2029 Term Loan and the LOQTORZI portion of the Revenue Purchase and Sale Agreement, each commencing May 8, 2024.
Interest expense from discontinued operations was $3.0 million and $8.0 million in the three months ended March 31, 2025 and 2024, respectively, and related to the 2026 Convertible Notes, the UDENYCA portion of the Revenue Purchase and Sale Agreement, and $175.0 million of the $250.0 million principal amount due under the 2027 Term Loans.
We expect interest expense from continuing operations to be lower in 2025 than 2024, primarily as a result of repaying the remaining $75.0 million principal amount of the 2027 Term Loans during the second quarter of 2024.
Other Income (Expense), Net
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| · · Three Months Ended March 31, | ||||||
| (in thousands) · 2025 · 2024 · Change | ||||||
| Other income (expense), net | | $187 | | $2,869 | | $(2,682) |
Other income (expense), net from continuing operations in the three months ended March 31, 2025 changed unfavorably compared to the same period in the prior year primarily due to the decrease in foreign exchange gains of $1.0 million, the change in fair value of the LOQTORZI Royalty Fee Derivative Liability of $0.8 million, and the reduction in investment and interest income of $0.5 million.
Net Income (Loss) from Discontinued Operations, net of tax
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| · · Three Months Ended March 31, | ||||||
| (in thousands) · 2025 · 2024 · Change | ||||||
| Net income (loss) from discontinued operations, net of tax | | $(9,171) | | $170,911 | | $(180,082) |
Net income (loss) from discontinued operations, net of tax in the three months ended March 31, 2025 changed unfavorably compared to the same period in the prior year primarily due to the $153.6 million gain on sale of the CIMERLI ophthalmology franchise in March 2024, as well as $42.6 million lower net revenue driven by 2024 divestitures and wholesaler allocations related to the supply interruption in fourth quarter of 2024, which were not lifted until the end of February 2025.
Liquidity and Capital Resources
Certain relevant measures of our liquidity and capital resources are summarized as follows:
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|---|---|---|---|---|---|---|
| · · March 31, · · December 31, | ||||||
| (in thousands) | 2025 | 2024 | ||||
| Financial assets | | | | | | |
| Total Cash and cash equivalents | | $82,411 | | $125,987 | ||
| | | | | | | |
| Financial liabilities(1): | | | | | ||
| 2029 Term Loan | | $36,781 | | $36,698 | ||
| Revenue Purchase and Sale Agreement | | | 29,575 | (2) | | 28,743 |
| 2026 Convertible Notes | | 228,569 | (2) | 228,229 | ||
| Total Financial liabilities | | $294,925 | | $293,670 | ||
| (1) | See “Note 8. Financial Liabilities” in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q. |
| (2) | We are using a portion of the proceeds of the UDENYCA Sale, which closed on April 11, 2025, to pay off the $230.0 million in aggregate principal amount of the 2026 Convertible Notes. In addition, in April 2025 we bought out the royalty obligations related to UDENYCA which comprised the majority of the balance of the Revenue Purchase and Sale Agreement. See “Note 13. Subsequent Events” in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q. |
As of March 31, 2025, we had cash and cash equivalents of $82.4 million and an accumulated deficit of $1.6 billion. We have generated significant operating losses in all years since our inception with the exceptions of net income of $28.5 million in 2024, primarily due to the CIMERLI Sale in March 2024 and YUSIMRY Sale in June 2024, $132.2 million net income in 2020, and $89.8 million net income in 2019.
We have funded our operations primarily through sales of our common stock, issuance and incurrence of convertible and term debt, the Revenue Purchase and Sale Agreement, the Sale Transactions and sales of our products. The following is a summary of recent liquidity events and financing transactions:
| ● | On March 1, 2024, we sold our CIMERLI ophthalmology franchise to Sandoz for $187.8 million in cash, inclusive of $17.8 million for CIMERLI product inventory and prepaid manufacturing assets. |
| ● | On April 1, 2024, cash from the CIMERLI Sale was used to repay $175.0 million of the total principal balance of $250.0 million of the 2027 Term Loans. |
| ● | On May 8, 2024, we entered into the 2029 Term Loan for the principal amount of $38.7 million, with proceeds of $37.5 million, net of original issuance discount, which was used as part of the full repayment of the 2027 Term Loans. For a summary of the material terms of our 2029 Term Loan, please refer to “Note 8. Financial Liabilities” in the Notes to Condensed Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q. |
| ● | On May 8, 2024, we entered into the Revenue Purchase and Sale Agreement, receiving $37.5 million by selling rights to receive future payments based on a percentage of U.S. net sales of UDENYCA and LOQTORZI. The proceeds were used as part of the full repayment of the 2027 Term Loans. On April 15, 2025, we paid $47.7 million to buy out the Purchaser Group’s right to receive the Revenue Payments with respect to UDENYCA in accordance with the Revenue Purchase and Sale Agreement. |
| ● | On June 26, 2024, we sold our YUSIMRY immunology franchise to HKF for $40.0 million in cash and the assumption of $17.0 million of inventory purchase commitments by HKF. |
| ● | On June 27, 2024, we sold to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada for $6.3 million. |
| ● | On April 11, 2025, we completed the divestiture of the UDENYCA Business to Intas for upfront, all-cash consideration of $483.4 million, inclusive of $118.4 million for UDENYCA product inventory. Such consideration is subject to certain adjustments that will be finalized following the closing pursuant to the UDENYCA Purchase Agreement. In addition, we are also eligible to receive two additional Earnout Payments of $37.5 million each, provided that certain minimum UDENYCA Net Sales thresholds are met during specified periods after the closing of the UDENYCA Sale. |
| ● | On April 1, 2025, we announced that we had entered into the Repurchases with certain holders of its 2026 Convertible Notes, pursuant to which we agreed to repurchase certain 2026 Convertible Notes from such holders at a cash repurchase price equal to 100% of their principal amount, together with the accrued and unpaid interest to, but excluding, the date of repurchase. The Repurchases were conditioned upon, among other things, the closing of the UDENYCA Sale. At the closing of the Repurchases on April 15, 2025, approximately $170 million aggregate principal amount of the 2026 Convertible Notes were repurchased and approximately $60 million aggregate principal amount of 2026 Convertible Notes remained outstanding. On April 16, 2025, we filed a Schedule TO with the SEC and sent a fundamental change notice to the holders of the remaining approximately $60 million aggregate principal amount of 2026 Convertible Notes offering to repurchase such remaining 2026 Convertible Notes on May 15, 2025 pursuant to the Fundamental Change Repurchase Right (as defined in the Indenture) at a cash repurchase price equal to 100% of their principal amount, together with the accrued and unpaid interest to, but excluding, the date of repurchase. |
We may utilize our ATM Offering from time to time in order to sell our common stock. As of March 31, 2025, we had approximately $64.9 million of our common stock remaining available for sales under the ATM Offering.
We believe that our available cash and cash equivalents, cash collected from divestitures, product sales, and ATM Offering proceeds received to date will be sufficient to fund our planned expenditures and meet our obligations for at least the twelve months following our financial statement issuance date.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates and the extent to which we may enter into additional agreements with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated research and development activities, and on-going and future licensing and collaboration obligations. We may need to raise additional funds in the future; however, there can be no assurance that such efforts will be successful or that, if they are successful, the terms and conditions of such financing will be favorable. Our future funding requirements will depend on many factors, including the following:
| ● | cash proceeds from product sales; |
| ● | the payment of interest, principal and royalties related to our financial liabilities; |
| ● | the costs of manufacturing, distributing and marketing our product; |
| ● | the cost of manufacturing clinical drug supplies and establishing commercial supplies of our product candidates and product; |
| ● | the percentage of customers that continue to purchase our product and that do not switch to products made by our competitors; |
| ● | the terms and timing of any other collaborative, licensing and other arrangements that we have established or may establish; |
| ● | the timing, receipt and amount of sales, profit sharing or royalties, if any, from any product candidates that are approved in the future; |
| ● | the number and characteristics of product candidates that we pursue; |
| ● | the scope, rate of progress, results and cost of our clinical trials, preclinical testing and other related activities; |
| ● | the costs of acquiring originator comparator materials and manufacturing preclinical study and clinical trial supplies and other materials from CMOs and related costs associated with release and stability testing; |
| ● | whether we receive either of the Earnout Payments from the sale of the UDENYCA Business; |
| ● | the cost, timing and outcomes of regulatory approvals; and |
| ● | the extent to which we divest, acquire or invest in businesses, products or technologies. |
For further discussion of risks related to our financial condition and capital requirements, please see “Risk Factors— Risks Related to Our Financial Condition and Capital Requirements.”
Contingent Milestones
We have obligations to make future payments to third parties that become due and payable upon the achievement of certain development, regulatory and commercial milestones (such as clinical trial achievements, the filing of a Biologics License Application (“BLA”), approval by the FDA or product launch). These milestone payments and other similar fees are contingent upon future events and therefore are only recorded when it becomes probable that a milestone will be achieved or other applicable criteria will be met. Because the achievement of these milestones had not reached the threshold for recognition as of March 31, 2025, such contingencies were not recorded in our financial statements.
The following presents a summary of our active partnerships and collaborations that have contingent regulatory and sales milestones as of March 31, 2025:
| | | | | |
|---|---|---|---|---|
| Counterparty | | Description | | Remaining Potential Aggregate Milestone Amount |
| Junshi Biosciences | | LOQTORZI | | $355.0 million (1) |
| Adimab LLC | | Casdozokitug | | $13.0 million |
| Vaccinex, Inc. | | CHS-114 | | $15.0 million |
| (1) | $65.0 million relates to regulatory milestones for indications that are not currently the subject of our clinical trials and $290.0 million relates to sales milestones. |
Contingent Value Rights
We have recorded a contingent consideration liability for the fair value of the potential payments under the CVR Agreement in connection with the Surface Acquisition. These potential payments during the 10-year period following September 8, 2023 are only due if wefirst receive milestone- or royalty-based payments under certain license agreements or upfront payments pursuant to ex-U.S. licensing agreements. Payments can be in the form of cash, stock or a combination of cash and stock. The CVR liability associated with GSK and contingent consideration are recorded in other liabilities, non-current on the condensed consolidated balance sheets at March 31, 2025.
Other Commitments
We enter into contracts in the normal course of business with CROs for preclinical research studies and clinical trials, research supplies and other services and products for operating purposes. We have also entered into agreements with several CMOs for the manufacture and clinical drug supply of our commercial and product candidates. Our non-cancelable purchase commitments as of March 31, 2025 were $59.0 million, as outlined in Note 9. Commitments and Contingencies in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q, and subsequent to March 31, 2025, $49.1 million of these purchase commitments was transferred to Intas in conjunction with the UDENYCA Sale.
There have been no significant changes to our leases during the three months ended March 31, 2025, as compared to the discussion in our 2024 Form 10-K.
Summary Statement of Cash Flows
The following table summarizes our cash flows for discontinued and continuing operations on a combined basis as follows:** **
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|---|---|---|---|---|---|---|
| · · Three Months Ended | ||||||
| · · March 31, | ||||||
| (in thousands) · · 2025 · 2024 | ||||||
| Net cash used in operating activities | | $(25,826) | | $(46,766) | ||
| Net cash provided by (used in) investing activities | | | (17,486) | | 202,763 | |
| Net cash provided by (used in) financing activities | | | (264) | | | 887 |
| Net increase (decrease) in cash, cash equivalents and restricted cash | | $(43,576) | | $156,884 | ||
Net cash used in operating activities
Cash used in operating activities of $25.8 million for the three months ended March 31, 2025 was primarily due to net loss of $56.6 million adjusted for non-cash items including change in fair value of derivatives of $12.6 million, stock-based compensation expense of $5.4 million, other non-cash adjustments of $1.9 million, and changes in our operating assets and liabilities of $10.9 million.
Cash used in operating activities of $46.8 million for the three months ended March 31, 2024 was primarily due to the net income of $102.9 million adjusted for non-cash items including stock-based compensation expense of $7.3 million, impairment of out-license asset net of CVR liability remeasurement of $6.8 million, and other non-cash adjustments of $1.3 million, partially offset by the net gain on Sale Transactions of $153.6 million and the changes in our operating assets and liabilities of $11.4 million.
Net provided by (used in) investing activities
Cash used in investing activities of $17.5 million for the three months ended March 31, 2025 was primarily due to a $12.5 million milestone payment in connection with the 2 nd Amendment with Junshi Biosciences and $4.7 million in retention bonus payments in connection with the CIMERLI Sale.
Cash provided by investing activities of $202.8 million for the three months ended March 31, 2024 was primarily due tocash proceeds of $187.8 million from the CIMERLI Sale, proceeds from sale of investments in marketable securities of $8.7 million, and proceeds from maturities of investments in marketable securities of $6.2 million.
Net cash provided by (used in) financing activities
Cash used in financing activities of $0.3 million for the three months ended March 31, 2025 was due to tax payments related to net share settlement of RSUs.
Cash provided by financing activities of $0.9 million for the three months ended March 31, 2024 was primarily due to proceeds of $1.5 million proceeds from the ATM Offering, net of issuance costs, partially offset by $0.7 million in tax payments related to net share settlement of RSUs.
Discontinued operations
Cash flows from continuing operations and discontinued operations are presented together in the condensed consolidated statement of cash flows. During the three months ended March 31, 2025, changes in operating assets and liabilities of discontinued operations were primarily due to an increase in inventory of $22.9 million. During the three months ended March 31, 2024, changes in operating assets and liabilities of discontinued operations resulted in a net cash inflow primarily due to a decrease in prepaid manufacturing of $10.0 million and a decrease in inventory of $2.4 million.
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of our condensed consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue generated and expense incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
There have been no significant changes to our critical accounting estimates during the three months ended March 31, 2025, as compared to the critical accounting estimates described in our 2024 Form 10-K. We believe that the critical accounting estimates discussed in the 2024 Form 10-K are meaningful to understanding our historical and future performance, as these estimates relate to the more significant areas involving management’s judgments and assumptions.
Recent Accounting Pronouncements
For a description of the impact of recent accounting pronouncements, see Note 1. Organization and Summary of Significant Accounting Policies in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
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