On August 2, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2023, and recent business highlights (Press release, Coherus Biosciences, AUG 2, 2023, View Source [SID1234633645]):

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RECENT BUSINESS HIGHLIGHTS

CIMERLI

CIMERLI (ranibizumab-eqrn) net product sales more than quadrupled to $26.7 million compared to the prior quarter following the April 1, 2023 implementation of the permanent, product-specific Q-code.
UDENYCA

Coherus launched a single-dose, prefilled autoinjector (AI) presentation of UDENYCA (pegfilgrastim-cbqv) on May 22, representing the first pegfilgrastim presentation innovation in eight years.
The U.S. Food and Drug Administration (FDA) review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA On-body Injector (OBI), is ongoing. Coherus plans to launch UDENYCA OBI directly upon potential approval later this year.
Toripalimab

The FDA completed inspection of the toripalimab manufacturing site in China in May, and has scheduled the clinical site inspections in China to begin in the second half of August 2023. Coherus anticipates potential FDA approval and U.S. commercial launch of toripalimab in the second half of 2023.
The final analysis of the JUPITER-02 clinical trial (NCT03581786) presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for nasopharyngeal carcinoma (NPC) patients who were treated with toripalimab in combination with chemotherapy versus chemotherapy alone. Median OS was 33.7 months in the chemotherapy-only treatment arm, and median OS was not reached in the toripalimab arm, with a hazard ratio of 0.63, representing a 37% reduction in risk of death (95% CI 0.45-0.89; p=0.0083).
YUSIMRY

Coherus launched YUSIMRY, a Humira biosimilar, with a citrate-free and sting-free formulation delivered via a state-of-the-art autoinjector on July 3rd. YUSIMRY is now available for sale nationwide through retail, mail order and specialty pharmacy channels.
Surface Oncology Merger and Novel Immuno-oncology Pipeline

Coherus announced that it had entered into a definitive agreement and plan of merger on June 16, 2023 that would result in the acquisition of Surface Oncology, Inc. ("Surface Oncology"), if completed. The merger is expected to significantly advance Coherus’ next-generation immuno-oncology pipeline focused on the tumor micro-environment with clinical stage anti-IL-27 and anti-CCR8 development programs. The merger is expected to close following the Surface Oncology special meeting of stockholders scheduled on September 7, 2023.
Patient enrollment continues in the U.S.-based Phase 1/2a dose expansion clinical trial evaluating CHS-006, a TIGIT-targeted antibody, in combination with toripalimab in patients with advanced solid tumors (NCT05757492).
Coherus plans to file an Investigational New Drug ("IND") application by year end for CHS-1000, a novel ILT4-targeted antibody.
"In the second quarter, we had strong execution on our strategy to build an innovative immuno-oncology company funded by revenues from FDA-approved products, and we made good progress across all areas of our business. Compared to the prior quarter, net revenues increased by 81% to $58.7 million, and we expect continued revenue growth in the second half of this year driven by continued success with CIMERLI, the UDENYCA autoinjector and YUSIMRY new product launches, as well as the launches of UDENYCA On-body Injector and of toripalimab for the treatment of NPC later this year, if approved," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "Coherus is successfully diversifying into a multi-product commercial organization with growing revenues supporting the development of our next-generation immuno-oncology franchise."

Mr. Lanfear added, "We look forward to closing the merger with Surface Oncology in the third quarter, reprioritizing our portfolio, and ultimately advancing a highly competitive, next-generation immuno-oncology clinical pipeline of innovative therapeutics focused on the tumor microenvironment. We will be well positioned to deliver the next step change in cancer treatment, with the goal of driving enhanced therapeutic benefit to patients beyond the outcomes achieved with checkpoint inhibitors alone."

SECOND QUARTER 2023 FINANCIAL RESULTS

Net revenue was $58.7 million during the three months ended June 30, 2023 and included $31.7 million of net sales of UDENYCA and $26.7 million of net sales of CIMERLI, which was launched in October 2022. Net revenue for the three months ended June 30, 2022, consisting primarily of UDENYCA net sales, was $60.2 million. Net revenue was $91.2 million and $120.3 million for the six months ended June 30, 2023 and 2022, respectively. Net revenue in the first half of 2023 was reduced by a $1.7 million charge for a contingent liability related to resolving a dispute regarding certain UDENYCA sales from October 2020 through December 2021. The declines were primarily due to a reduction in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition. These factors were partially offset by increasing revenue from CIMERLI sales during the first two quarters of 2023.

Cost of goods sold (COGS) for the three months ended June 30, 2023 and 2022 was $24.8 million and $11.3 million, respectively, and $41.7 million and $20.6 million during the six months ended June 30, 2023 and 2022, respectively. The increases compared to prior year periods primarily result from COGS associated with CIMERLI which was launched in October 2022. 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. COGS for the first half of 2023 also includes $3.0 million in contract modification fees with one of our manufacturers and $2.3 million in write-offs of inventory that was damaged during processing at one of our manufacturers. In addition, gross margins were unfavorably impacted due to product mix resulting from increased volumes of CIMERLI sold following the product specific Q-code implementation on April 1st and the launch of UDENYCA AI in May 2023.

Research and development (R&D) expense for the three months ended June 30, 2023 and 2022 was $23.3 million and $41.6 million, respectively. For the six months ended June 30, 2023 and 2022, R&D expense was $57.4 million and $124.5 million, respectively. The decline in R&D expense compared to the prior year periods primarily resulted from the reduction in scope of the toripalimab collaboration agreement 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.

Selling, general and administrative (SG&A) expense was $45.1 million and $51.3 million during the three months ended June 30, 2023 and 2022, respectively, and $94.3 million and $100.0 million during the six months ended June 30, 2023 and 2022, respectively. The decline in SG&A expense compared to the prior year periods primarily reflects lower headcount.

Net loss for the second quarter of 2023 was $42.9 million, or $(0.49) per share on a diluted basis, compared to a net loss of $50.2 million, or $(0.65) per share on a diluted basis for the same period in 2022. Net loss for the first half of 2023 was $118.6 million, or $(1.42) per share on a diluted basis, compared to a net loss of $146.2 million, or $(1.89) per share on a diluted basis for the first half of 2022.

Non-GAAP net loss for the second quarter of 2023 was $32.8 million, or $(0.38) per share on a diluted basis, compared to non-GAAP net loss of $36.3 million, or $(0.47) per share on a diluted basis for the same period in 2022. Non-GAAP net loss for the first half of 2023 was $92.3 million, or $(1.11) per share on a diluted basis, compared to non-GAAP net loss of $113.3 million, or $(1.46) per share on a diluted basis for the first half 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 $144.7 million as of June 30, 2023, compared to $191.7 million at December 31, 2022.

2023 Revenue and R&D and SG&A Expense Guidance

Coherus expects its 2023 net product revenue will exceed $275 million, including at least $100 million of CIMERLI net revenue.

Coherus projects combined R&D and SG&A expenses for 2023 to be in the range of $315 to $335 million. This guidance range includes stock-based compensation expense and excludes the Surface Oncology acquisition cost as well as any potential collaboration upfront payments to Klinge Pharma for the in-license of its Eylea biosimilar program or milestones payments to Junshi Biosciences due upon U.S. approval of toripalimab.

This financial guidance also excludes the effects of any potential future 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, August 2nd, 2023, starting at 5:00 p.m. Eastern Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI3fdbdc05783442f89d11db6b94e74a28

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Webcast Link: View Source

A replay of the webcast will be archived on the "Investors" section of the Coherus website at View Source