REDWOOD CITY, Calif., March 13, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for its fiscal fourth quarter and full year ended December 31, 2023 and recent business highlights:
RECENT BUSINESS HIGHLIGHTS
CORPORATE RESTRUCTURING SOLIDIFIES FOCUS ON ONCOLOGY
UDENYCA® RESULTS and ONBODY LAUNCH UPDATE
LOQTORZI™ LAUNCH UPDATE
NOVEL IMMUNO-ONCOLOGY PIPELINE ADVANCES
“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 here to receive dial-in information and a personal PIN to access the live call:
Please dial-in 15 minutes early to ensure a timely connection to the call.
Webcast: https://edge.media-server.com/mmc/p/7c7bss7i
An archived webcast will be available on the “Investors” section of the Coherus website at https://investors.coherus.com/events-presentations.
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the novel pathway ILT4 with an IND filing planned in the first half of 2024.
Coherus markets LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1 inhibitor, UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.
Neulasta® is a registered trademark of Amgen, Inc.
Humira® is a registered trademark of AbbVie Inc.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to identify synergies between its I-O pipeline and its commercial operations; Coherus’ expected timing for filing an IND for CHS-1000; Coherus’ future projections for R&D expense and SG&A expense; Coherus’ expectations for timing, principal paid and interest payment reductions for its term loan with Pharmakon Advisors, LP; the size of the reduction of workforce in 2024; and Coherus’ expectations that it will be able to realize value in the future from its pipeline.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risks of competition; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ products and product candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission on or about the date of this press release, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission. Coherus’ results for the fiscal year ended December 31, 2023 are not necessarily indicative of its operating results for any future periods.
UDENYCA®, UDENYCA® ONBODY™, 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 press release are, to the knowledge of Coherus, the property of their respective owners.
Coherus Contact Information:
For Investors:
Jami Taylor
Head of Investor Relations
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For Media:
Jodi Sievers
VP, Corporate Communications
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| Coherus BioSciences, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net revenue | $ | 91,524 | $ | 45,352 | $ | 257,244 | $ | 211,042 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods sold | 84,567 | 14,202 | 158,992 | 70,083 | ||||||||||||
| Research and development | 26,368 | 29,022 | 109,436 | 199,358 | ||||||||||||
| Selling, general and administrative | 49,494 | 53,621 | 192,015 | 198,481 | ||||||||||||
| Total costs and expenses | 160,429 | 96,845 | 460,443 | 467,922 | ||||||||||||
| Loss from operations | (68,905 | ) | (51,493 | ) | (203,199 | ) | (256,880 | ) | ||||||||
| Interest expense | (10,619 | ) | (9,385 | ) | (40,542 | ) | (32,474 | ) | ||||||||
| Loss on debt extinguishment | — | — | — | (6,222 | ) | |||||||||||
| Other income (expense), net | (129 | ) | 2,008 | 5,469 | 3,822 | |||||||||||
| Loss before income taxes | (79,653 | ) | (58,870 | ) | (238,272 | ) | (291,754 | ) | ||||||||
| Income tax provision (benefit) | — | — | (380 | ) | — | |||||||||||
| Net loss | $ | (79,653 | ) | $ | (58,870 | ) | $ | (237,892 | ) | $ | (291,754 | ) | ||||
| Basic and diluted net loss per share | $ | (0.71 | ) | $ | (0.76 | ) | $ | (2.53 | ) | $ | (3.76 | ) | ||||
| Weighted-average number of shares used in computing basic and diluted net loss per share | 111,492,596 | 77,955,769 | 94,162,637 | 77,630,020 | ||||||||||||
| Coherus BioSciences, Inc. Condensed Consolidated Balance Sheets (in thousands) (unaudited) | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 102,891 | $ | 63,547 | ||||
| Investments in marketable securities | 14,857 | 128,134 | ||||||
| Trade receivables, net | 260,522 | 109,964 | ||||||
| Inventory | 130,100 | 115,051 | ||||||
| Intangible assets, net | 71,673 | 5,931 | ||||||
| Other assets | 49,561 | 58,220 | ||||||
| Total assets | $ | 629,604 | $ | 480,847 | ||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Accrued rebates, fees and reserve | $ | 169,645 | $ | 54,461 | ||||
| Term loans | 246,481 | 245,483 | ||||||
| Convertible notes | 226,888 | 225,575 | ||||||
| Other liabilities | 180,015 | 92,746 | ||||||
| Total stockholders' deficit | (193,425 | ) | (137,418 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 629, 604 | $ | 480,847 | ||||
| Coherus BioSciences, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (unaudited) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Cash, cash equivalents and restricted cash at beginning of the period | $ | 80,711 | $ | 287,245 | $ | 63,987 | $ | 417,635 | ||||||||
| Net cash used in operating activities | (12,937 | ) | (99,953 | ) | (174,884 | ) | (241,124 | ) | ||||||||
| Purchases of investments in marketable securities | — | (127,382 | ) | (19,507 | ) | (127,382 | ) | |||||||||
| Proceeds from maturities of investments in marketable securities | 36,212 | — | 144,360 | — | ||||||||||||
| Proceeds from sale of investments in marketable securities | — | — | 13,282 | — | ||||||||||||
| Cash and cash equivalents acquired from Surface Acquisition | — | — | 6,997 | — | ||||||||||||
| Option payment to Junshi Biosciences | — | — | — | (35,000 | ) | |||||||||||
| Milestone based license fee payments | (1,051 | ) | (2,429 | ) | (1,051 | ) | (2,429 | ) | ||||||||
| Other investing activities, net | 42 | (87 | ) | 559 | (2,039 | ) | ||||||||||
| Net cash provided by (used in) investing activities | 35,203 | (129,898 | ) | 144,640 | (166,850 | ) | ||||||||||
| Proceeds from 2027 Term Loans, net of debt discount & issuance costs | — | — | — | 240,679 | ||||||||||||
| Proceeds from issuance of common stock under ATM Offering, net of issuance costs | (105 | ) | 6,358 | 18,093 | 6,358 | |||||||||||
| Proceeds from issuance of common stock under Public Offering, net of issuance costs | — | — | 53,625 | — | ||||||||||||
| Proceeds from issuance of common stock upon exercise of stock options | 524 | 60 | 694 | 691 | ||||||||||||
| Proceeds from purchase under the employee stock purchase plan | 472 | 665 | 1,809 | 2,320 | ||||||||||||
| Taxes paid related to net share settlement | (326 | ) | (123 | ) | (3,587 | ) | (3,744 | ) | ||||||||
| Repayment of 2022 Convertible Notes and premiums | — | — | — | (109,000 | ) | |||||||||||
| Repayment of 2025 Term Loan, premiums and exit fees | — | — | — | (81,750 | ) | |||||||||||
| Other financing activities | (199 | ) | (367 | ) | (1,034 | ) | (1,228 | ) | ||||||||
| Net cash provided by financing activities | 366 | 6,593 | 69,600 | 54,326 | ||||||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 22,632 | (223,258 | ) | 39,356 | (353,648 | ) | ||||||||||
| Cash, cash equivalents and restricted cash at end of the period | $ | 103,343 | $ | 63,987 | $ | 103,343 | $ | 63,987 | ||||||||
| Reconciliation of cash, cash equivalents, and restricted cash | ||||||||||||||||
| Cash and cash equivalents | $ | 102,891 | $ | 63,547 | $ | 102,891 | $ | 63,547 | ||||||||
| Restricted cash balance | 452 | 440 | 452 | 440 | ||||||||||||
| Cash, cash equivalents and restricted cash | $ | 103,343 | $ | 63,987 | $ | 103,343 | $ | 63,987 | ||||||||
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net loss, and the related per share measures, which exclude from net loss, and the related per share measures, stock-based compensation expense, certain acquisition-related expenses, amortization of intangible assets, contingent consideration, loss on debt extinguishment and restructuring charges related to our reduction in workforce. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business.
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
Coherus BioSciences, Inc.
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| GAAP net loss | $ | (79,653 | ) | $ | (58,870 | ) | $ | (237,892 | ) | $ | (291,754 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense(1) | 10,797 | 11,726 | 42,161 | 50,737 | ||||||||||||
| Loss on debt extinguishment | — | — | — | 6,222 | ||||||||||||
| Restructuring charges related to reduction in workforce(1) | — | — | 4,876 | — | ||||||||||||
| Acquisition-related costs(2) | 545 | — | 5,093 | — | ||||||||||||
| Contingent consideration | (920 | ) | — | (920 | ) | — | ||||||||||
| Amortization of intangible assets | 313 | — | 456 | — | ||||||||||||
| Non-GAAP net loss | $ | (68,918 | ) | $ | (47,144 | ) | $ | (186,226 | ) | $ | (234,795 | ) | ||||
| GAAP net loss per share, basic and diluted | $ | (0.71 | ) | $ | (0.76 | ) | $ | (2.53 | ) | $ | (3.76 | ) | ||||
| Non-GAAP net loss per share, basic and diluted | $ | (0.62 | ) | $ | (0.60 | ) | $ | (1.98 | ) | $ | (3.02 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 111,492,596 | 77,955,769 | 94,162,637 | 77,630,020 | ||||||||||||
| (1) | In the year ended December 31, 2023, stock-based compensation of $1.0 million was classified within Restructuring charges related to reduction in workforce. | |
| (2) | Beginning in the third quarter of 2023, the Company began excluding acquisition-related costs in its non-GAAP financial information. To conform to this change, $1.9 million of acquisition-related costs incurred during the quarter ended June 30, 2023 has been excluded from SG&A expense for the year ended December 31, 2023. |
| Last Trade: | US$1.11 |
| Daily Change: | 0.29 35.12 |
| Daily Volume: | 8,709,519 |
| Market Cap: | US$127.880M |
August 08, 2024 June 27, 2024 May 30, 2024 | |
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