Coherus BioSciences Reports First Quarter 2024 Financial Results and Provides Business Update
Coherus BioSciences reported net revenue of $77.1 million in Q1 2024, with significant increases in UDENYCA sales and LOQTORZI launch. The company entered into a partnership for toripalimab development, replaced term loan with new debt, and presented positive clinical data. Despite increased expenses, Coherus showed a strong financial performance, with net income of $102.9 million and cash reserves of $259.8 million.
Net revenue of $77.1 million in Q1 2024, driven by strong UDENYCA sales and successful LOQTORZI launch.
Partnership with CRI for toripalimab development in ovarian cancer, demonstrating commitment to expanding immunotherapy pipeline.
Agreement with ENB Therapeutics for combination study with LOQTORZI, showcasing strategic collaborations for innovative treatments.
Successful replacement of $75 million term loan with new debt and royalty financing, enhancing capital structure.
Positive clinical data presentation at 2024 ASCO Annual Meeting for CHS-114, a potential oncology treatment, indicating pipeline advancement.
Net income of $102.9 million in Q1 2024, a significant improvement compared to previous year's net loss.
Robust cash reserves of $259.8 million as of March 31, 2024, showing financial strength and stability.
Increase in COGS and R&D expenses in Q1 2024, impacting profit margins despite revenue growth.
Selling, general, and administrative expenses rose due to one-time charges and higher processing fees, affecting overall operational costs.
Non-GAAP net loss of $35.8 million in Q1 2024, highlighting underlying financial challenges despite reported net income.
Guidance for combined R&D and SG&A expenses for 2024 in the range of $250 to $265 million, indicating continued operational costs and potential financial pressure.
Insights
The disclosed net revenue of $77.1 million signifies a robust year-over-year increase, primarily leveraged by the sales surge in UDENYCA® and the market introduction of LOQTORZI®. The divestiture of CIMERLI® to Sandoz notably contributed to a one-time gain which significantly bolstered the net income to $102.9 million for the quarter. This kind of gain is non-recurring and investors should consider the underlying operational performance excluding such one-time events when assessing the company's ongoing profitability.
It is also noteworthy that the replacement of the existing debt with new financing extends the debt maturity to May 2029, offering a more comfortable liquidity position in the medium term. However, the new royalty financing agreement could potentially impact future revenue. The decrease in R&D expenses is indicative of strategic cost control, though it's pertinent to ensure that it does not come at the expense of long-term innovation and pipeline development.
The increase in UDENYCA® sales and the launch of LOQTORZI® indicate a successful expansion within the oncology market segment. The 25% market share for the UDENYCA franchise can be seen as a testament to Coherus BioSciences' competitive positioning within the biosimilar market. Nonetheless, the growth trajectory should be monitored closely for sustainability, especially as the market for biosimilars becomes increasingly competitive.
The strategic partnership with CRI and ENB Therapeutics for the development of toripalimab in ovarian cancer may bring additional value to the company's pipeline. The implications of the novel immuno-oncology pipeline's progression are twofold: it may unlock long-term growth opportunities if successful, but it also increases the R&D risk profile. Investors should balance the potential of pipeline advancements with the inherent risks of clinical development.
– Net revenue of
– CRI and ENB Therapeutics development partnership for toripalimab in ovarian cancer –
– New debt and royalty financing replaces
– Conference call today at 5:00 p.m. Eastern Time –
REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended March 31, 2024 and recent business highlights:
RECENT BUSINESS HIGHLIGHTS
UDENYCA® RESULTS and ONBODY™ LAUNCH UPDATE
- UDENYCA net product sales were
$42.7 million in Q1 2024, an increase of18% compared to$36.2 million in Q4 2023 and a63% increase compared to the$26.2 million in Q1 2023. Total unit demand grew36% in Q1 2024 compared to Q4 2023 and represented a108% increase compared to Q1 2023. - UDENYCA Autoinjector presentation unit demand grew
158% in Q1 2024 compared to Q4 2023. - UDENYCA ONBODY, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv, was launched in February 2024. High customer demand and confirmed payer coverage drove early robust uptake.
- Based on data from IQVIA, UDENYCA franchise market share for Q1 2024 was
25% , an increase of 10 market share points in Q1 2024 compared to Q4 2023.
LOQTORZI® LAUNCH UPDATE
- LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic NPC, commercially launched on January 2, 2024.
- Academic research hospital formulary position achieved on
55% of the 33 NCCN institutions, with the remaining institutional reviews scheduled or in process. Formulary position is expected to be achieved with all NCCN institutions by the end of Q2 2024. - Payer coverage has been confirmed on >
85% of medical benefit lives in health plans including Medicare Fee for Service, Medicare Advantage, and national and regional commercial plans respectively. - LOQTORZI net sales in Q1 of
$2.0 million , tracking to early launch stage expectations, with patient accrual momentum building. - Product-specific, permanent J Code has been granted by the Centers for Medicare and Medicaid Services and will take effect July 1, 2024.
NOVEL IMMUNO-ONCOLOGY PIPELINE ADVANCES
- Coherus entered into an agreement with the Cancer Research Institute (CRI) to supply LOQTORZI for a combination study with ENB-003, a first-in-class small molecule inhibitor of endothelin B receptor. Endothelin B receptor is implicated in tumorigenesis and tumor immune suppression for several solid tumors including ovarian cancer. CRI is overseeing the iPROC study.
- Clinical data from the dose escalation stage of the Phase 1 study of CHS-114, a highly selective antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-CCR8 antibody, will be presented at the 2024 ASCO Annual Meeting in June.
“The strength of our company’s first-quarter performance reflects our ongoing commitment to driving top-line revenues, controlling operating expenses, advancing our pipeline, and improving our capital structure,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. “The progress we reported today aligns with these objectives, consistent with our overarching mission to become a sustainable and growing oncology company improving outcomes for cancer patients.”
FIRST QUARTER 2024 FINANCIAL RESULTS
Net revenue was
Cost of goods sold (COGS) was
Research and development (R&D) expense was
Selling, general and administrative (SG&A) expense for the three months ended March 31, 2024 was
Gain on Sale, net for the divestiture of the ophthalmology franchise, which closed during the three months ended March 31, 2024, was
Net income for the first quarter of 2024 was
Non-GAAP net loss for the first quarter of 2024 was
Cash, cash equivalents and investments in marketable securities were
2024 R&D and SG&A Expense Guidance
Coherus projects combined R&D and SG&A expenses for 2024 to be in the range of
Conference Call Information
When: Thursday, May 9, 2024, starting at 5:00 p.m. Eastern Daylight Time
To access the conference call:
Dial: (800) 715-9871 (toll-free USA and Canada); (646) 307-1963 (international)
Conference ID: 4442005
Webcast: https://edge.media-server.com/mmc/p/jqq7phbt/
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 is expected to 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 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 a response from the FDA on our IND filing expected in the second quarter 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 an FDA response to its IND for CHS-1000; Coherus’ future projections for R&D expense and SG&A expense; and Coherus’ expectations about revenues and long term growth.
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’ quarterly filing on Form 10-Q for the fiscal quarter ended March 31, 2024 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 quarter ended March 31, 2024 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
IR@coherus.com
For Media:
Jodi Sievers
VP, Corporate Communications
media@coherus.com
| Coherus BioSciences, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) | |||||||
| Three Months Ended | |||||||
| March 31, | |||||||
| 2024 | 2023 | ||||||
| Net revenue | $ | 77,063 | $ | 32,436 | |||
| Costs and expenses: | |||||||
| Cost of goods sold | 34,586 | 16,874 | |||||
| Research and development | 28,470 | 34,154 | |||||
| Selling, general and administrative | 56,532 | 49,153 | |||||
| Total costs and expenses | 119,588 | 100,181 | |||||
| Loss from operations | (42,525 | ) | (67,745 | ) | |||
| Interest expense | (11,116 | ) | (9,712 | ) | |||
| Gain on Sale Transaction, net | 153,647 | — | |||||
| Other income (expense), net | 2,869 | 1,728 | |||||
| Income (loss) before income taxes | 102,875 | (75,729 | ) | ||||
| Income tax provision | — | — | |||||
| Net income (loss) | $ | 102,875 | $ | (75,729 | ) | ||
| Net income (loss) per share: | |||||||
| Basic | $ | 0.91 | $ | (0.96 | ) | ||
| Diluted | $ | 0.83 | $ | (0.96 | ) | ||
| Weighted-average number of shares used in computing net income (loss) per share: | |||||||
| Basic | 112,749,306 | 79,268,853 | |||||
| Diluted | 125,529,971 | 79,268,853 | |||||
| Coherus BioSciences, Inc. Condensed Consolidated Balance Sheets (in thousands) (unaudited) | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 259,775 | $ | 102,891 | |||
| Investments in marketable securities | — | 14,857 | |||||
| Trade receivables, net | 251,951 | 260,522 | |||||
| TSA receivables, net | 32,194 | — | |||||
| Inventory | 127,623 | 130,100 | |||||
| Intangible assets, net | 57,104 | 71,673 | |||||
| Other assets | 34,898 | 49,561 | |||||
| Total assets | $ | 763,545 | $ | 629,604 | |||
| Liabilities and Stockholders’ Deficit | |||||||
| Accrued rebates, fees and reserve | $ | 155,775 | $ | 169,645 | |||
| TSA payables and other accrued liabilities | 30,770 | — | |||||
| Term loans | 247,452 | 246,481 | |||||
| Convertible notes | 227,220 | 226,888 | |||||
| Other liabilities | 184,172 | 180,015 | |||||
| Total stockholders’ deficit | (81,844 | ) | (193,425 | ) | |||
| Total liabilities and stockholders’ deficit | $ | 763,545 | $ | 629,604 | |||
| Coherus BioSciences, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (unaudited) | |||||||
| Three Months Ended | |||||||
| March 31, | |||||||
| 2024 | 2023 | ||||||
| Cash, cash equivalents and restricted cash at beginning of the period | $ | 103,343 | $ | 63,987 | |||
| Net cash used in operating activities | (46,766 | ) | (68,732 | ) | |||
| Proceeds from maturities of investments in marketable securities | 6,200 | 17,500 | |||||
| Proceeds from sale of investments in marketable securities | 8,688 | — | |||||
| Cash received from Sale Transaction | 187,823 | — | |||||
| Other investing activities, net | 52 | 26 | |||||
| Net cash provided by investing activities | 202,763 | 17,526 | |||||
| Proceeds from issuance of common stock under ATM Offering, net of issuance costs | 1,507 | 6,835 | |||||
| Proceeds from issuance of common stock upon exercise of stock options | 291 | 103 | |||||
| Taxes paid related to net share settlement | (745 | ) | (2,781 | ) | |||
| Other financing activities | (166 | ) | (353 | ) | |||
| Net cash provided by financing activities | 887 | 3,804 | |||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 156,884 | (47,402 | ) | ||||
| Cash, cash equivalents and restricted cash at end of the period | $ | 260,227 | $ | 16,585 | |||
| Reconciliation of cash, cash equivalents, and restricted cash | |||||||
| Cash and cash equivalents | $ | 259,775 | $ | 16,145 | |||
| Restricted cash balance | 452 | 440 | |||||
| Cash, cash equivalents and restricted cash | $ | 260,227 | $ | 16,585 | |||
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 income (loss), and the related per share measures, stock-based compensation expense, certain acquisition-related expenses, amortization of intangible assets, gain on divestiture, impairments 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 Income (Loss) to Non-GAAP Net Loss (in thousands, except share and per share data) (unaudited) | |||||||
| Three Months Ended | |||||||
| March 31, | |||||||
| 2024 | 2023 | ||||||
| GAAP net income (loss) | $ | 102,875 | $ | (75,729 | ) | ||
| Adjustments: | |||||||
| Stock-based compensation expense(1) | 7,319 | 11,333 | |||||
| Gain on Sale Transaction, net | (153,647 | ) | — | ||||
| Impairment of out-license asset and remeasurement of CVR liability, net | 6,772 | — | |||||
| Restructuring charges related to reduction in workforce(1) | — | 4,876 | |||||
| Amortization of intangible assets | 930 | — | |||||
| Non-GAAP net loss | $ | (35,751 | ) | $ | (59,520 | ) | |
| GAAP | |||||||
| Net income (loss) per share, basic | $ | 0.91 | $ | (0.96 | ) | ||
| Net income (loss) per share, diluted | $ | 0.83 | $ | (0.96 | ) | ||
| Shares used in computing basic net income (loss) per share | 112,749,306 | 79,268,853 | |||||
| Shares used in computing diluted net income (loss) per share | 125,529,971 | 79,268,853 | |||||
| Non-GAAP | |||||||
| Net loss per share, basic and diluted | $ | (0.32 | ) | $ | (0.75 | ) | |
| Shares used in computing basic and diluted net loss per share | 112,749,306 | 79,268,853 | |||||
(1) In the quarter ended March 31, 2023, stock-based compensation of
FAQ
What was Coherus BioSciences' net revenue in Q1 2024?
What partnership did Coherus enter for toripalimab development?
What financial update did Coherus provide in Q1 2024?
What was the impact of expenses on Coherus' financial results in Q1 2024?
