On May 8, 2023 Coherus BioSciences, Inc. ("Coherus", "the Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2023 and recent business highlights (Press release, Coherus Biosciences, MAY 8, 2023, View Source [SID1234631133]):

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RECENT BUSINESS HIGHLIGHTS

CIMERLI

On April 1st, the permanent, product-specific Q-code assigned to CIMERLI (ranibizumab-eqrn) by the U.S. Centers for Medicare & Medicaid Services (CMS) became active, enabling more efficient, electronic billing processes and reducing time to reimbursement for providers. Demand increased sharply as expected in April, with over 7,000 units of CIMERLI shipped, exceeding in one month 70% of Q1 unit sales.
UDENYCA

The FDA approved a single-dose, prefilled autoinjector (AI) presentation of UDENYCA (pegfilgrastim-cbqv) on March 3, 2023, which represents the first presentation innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative treatments that expand access and address the needs of patients undergoing cancer treatment. Coherus plans to launch UDENYCA AI later this month.
The FDA review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA on-body injector (OBI), is ongoing, and Coherus plans to launch UDENYCA OBI directly upon potential approval later this year.
Toripalimab

The U.S. Food and Drug Administration (FDA) has notified the Company that it plans to conduct the required inspection of the toripalimab manufacturing facility in China later in May 2023. The inspections, previously hindered by COVID-related travel restrictions, are part of the FDA’s review of the biologics license application (BLA) for toripalimab, a PD-1 inhibitor for the treatment of nasopharyngeal carcinoma (NPC). Coherus anticipates potential FDA approval and commercial launch of toripalimab in the U.S. in Q3 2023.
Positive toripalimab clinical data will be presented at the upcoming 2023 ASCO (Free ASCO Whitepaper) Annual Meeting including the final overall survival analysis for JUPITER-02 in NPC, updated overall survival analysis for CHOICE-01 in advanced non-small cell lung cancer (NSCLC), interim analysis of event-free survival for NEOTORCH in Stage II/III NSCLC, and clinical data for TORCHLIGHT in advanced triple-negative breast cancer.
YUSIMRY

Preparations are underway for commercial launch in Q3 2023 of YUSIMRY, a Humira biosimilar with a citrate-free and sting-free formulation delivered via a state-of-the-art autoinjector. Coherus has invested in robust, large-scale manufacturing capabilities to ensure ample supply upon launch.
The FDA recently approved YUSIMRY prior approval supplements for the autoinjector presentation and for large-scale drug supply manufacturing.
Novel Immuno-oncology Pipeline

Patient recruitment is underway in the U.S.-based Phase 1/2 clinical trial of CHS-006, a TIGIT-targeted antibody in combination with toripalimab in patients with advanced solid tumors (NCT05757492).
Coherus expects to file an IND by year end for CHS-1000, a novel ILT4-targeted antibody.
"With the approval of the UDENYCA autoinjector, the activation of the CMS-assigned Q-code and the other product launches planned across our diversified portfolio, we are well positioned for accelerated revenue growth for the remainder of 2023 and beyond. We continue to sharply focus on commercial execution, and are already beginning to see the impact of the Q-code on CIMERLI sales at the start of the second quarter," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "Innovative presentations offering differentiated value, such as the UDENYCA autoinjector launching this month, as well as the UDENYCA on-body injector presentation, with anticipated approval and launch later in the year, will offer patients and physicians unprecedented choice in their treatment options, driving market share gains and long-term value for the franchise."

Mr. Lanfear continued, "Inspections of the toripalimab manufacturing facilities are scheduled for later this month, with clinical site inspections to follow. NPC patients currently have no FDA approved therapies, and toripalimab has the potential to be the new standard of care for across multiple lines of treatment, if approved. We are planning for approval and launch in the third quarter."

FIRST QUARTER 2023 FINANCIAL RESULTS

Net revenue was $32.4 million during the three months ended March 31, 2023 and included $26.2 million of net sales of UDENYCA and $6.2 million of net sales of CIMERLI, which was launched in October 2022. Net sales of UDENYCA for the first quarter of 2023 were reduced by a $1.7 million charge for a contingent liability related to resolving a dispute regarding certain sales from October 2020 through December 2021. Net revenue was $60.1 million during the three months ended March 31, 2022. The decline was primarily due to a decrease in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition.

Cost of goods sold (COGS) was $16.9 million and $9.4 million during the three months ended March 31, 2023 and 2022, respectively. 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 quarter of 2023 also includes $3.0 million in contract modification fees with one of our manufacturers and $2.7 million in write-offs of inventory that was damaged during processing at one of our manufacturers.

Research and development (R&D) expense for the three months ended March 31, 2023 was $34.2 million. R&D expense for the three months ended March 31, 2022 was $82.9 million, which included a $35 million option exercise fee paid to Junshi Biosciences to license CHS-006, a clinical-stage TIGIT-targeted antibody, as well as development and manufacturing costs for clinical and preclinical pipeline programs.

Selling, general and administrative (SG&A) expense for the three months ended March 31, 2023 was $49.2 million compared to $48.8 million for the same period in 2022. The increase was primarily due to $1.3 million in restructuring charges from our reduction in force that occurred in the first quarter of 2023.

Net loss for the first quarter of 2023 was $75.7 million, or $(0.96) per share on a diluted basis, compared to a net loss of $96.1 million, or $(1.24) per share on a diluted basis for the same period in 2022.

Non-GAAP net loss for the first quarter of 2023 was $59.5 million, or $(0.75) per share on a diluted basis, compared to non-GAAP net loss of $77.0 million, or $(1.00) per share on a diluted basis for the same period in 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 $128.1 million as of March 31, 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 includes approximately $50 million of stock-based compensation expense and excludes 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: Monday, May 8th, 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/BI12e6d284dae8440e91891f2cef4f2097

Please dial-in 15 minutes early to ensure a timely connection to the call.

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