Coherus Bioscien Stock Price, News & Analysis

The FDA has delayed its review of Coherus BioSciences' Biologics License Application (BLA) for toripalimab due to travel restrictions in China preventing necessary site inspections. The application was not acted upon by the December 23, 2022 PDUFA date. Coherus and Junshi Biosciences are in discussions with the FDA to expedite the inspection process. Toripalimab is intended for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC), a condition with significant unmet medical needs. The FDA has awarded Priority Review and Breakthrough Therapy designations to toripalimab.

Coherus BioSciences (Nasdaq: CHRS) reported Q3 2022 net sales of $45.4 million, a decline from $82.5 million in Q3 2021. This drop stemmed from reduced sales volume of UDENYCA® and lower prices amid increased competition. The FDA approved CIMERLI™ in August 2022, which launched on October 3, 2022, and is projected to generate over $100 million in 2023 sales. Coherus anticipates the launch of several new products in 2023 and is targeting profitability by 2024. The net loss for Q3 was $86.7 million, up from a $38.5 million loss in the same quarter last year.

Coherus BioSciences (CHRS) has announced its third quarter 2022 financial results will be released on November 8, 2022, after market close. Following the release, management will host a conference call at 5:00 p.m. Eastern Time to discuss the results and provide a business update. Investors can access the press release and related materials on the official website before the call. A replay of the webcast will be available post-call. Pre-registration is required for call access, ensuring a timely connection.

Coherus BioSciences and Junshi Biosciences announced significant improvements in overall survival (OS) and progression-free survival (PFS) in their phase 3 trial of toripalimab combined with chemotherapy for treatment-naïve advanced non-small cell lung cancer (NSCLC) without EGFR/ALK mutations. The trial showed a median PFS of 8.4 months compared to 5.6 months for chemotherapy alone, and a 2-year OS rate of 51.2% versus 33.9%. No new safety concerns were reported. This data supports further development of toripalimab in combination with other immunotherapies.

CIMERLI is the first FDA-approved biosimilar interchangeable with Lucentis for all indications, with a 12-month exclusivity on interchangeability. Launching on October 3, 2022, it offers the same efficacy and safety as Lucentis, allowing for confident transitions for existing patients. The product is priced at $1,360 for the 0.5 mg dose, providing a 30% discount compared to Lucentis. Coherus aims to capture a significant market share by leveraging its dedicated sales team and CIMERLI Solutions™ for patient support and reimbursement.

Coherus BioSciences (Nasdaq: CHRS) announced participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 10:00 am ET. Senior management will engage in a fireside chat, which will be available via an audio webcast on the company's investor page. Interested parties are encouraged to access the webcast in advance to ensure a timely connection. The archived webcast will be accessible on the Coherus website for 30 days following the event.

Coherus BioSciences (Nasdaq: CHRS) announced the grant of stock options for an aggregate of 234,000 shares to 22 new employees, effective August 24, 2022. The options have a per-share exercise price of $12.90, matching the closing trading price on the grant date. This action is part of the Company’s 2016 Employment Commencement Incentive Plan aimed at attracting new talent.

Coherus BioSciences (CHRS) reported a Q2 2022 net revenue of $60.2 million, down from $87.6 million in Q2 2021, mainly due to decreased sales of UDENYCA®. The FDA approved CIMERLI™ for commercial launch in October 2022 and set a PDUFA date of December 23, 2022, for toripalimab's BLA. The company has $275 million in cash and is preparing for the launch of several products, including YUSIMRY™. Net loss for Q2 2022 was $50.2 million, widening from a loss of $29.9 million in Q2 2021. R&D and SG&A expense guidance has been revised down to $375-$395 million.

Coherus BioSciences announced FDA approval for CIMERLI™ (ranibizumab-eqrn), an interchangeable biosimilar to Lucentis®, for all five FDA-approved indications, marking its third product approval. With expected sales starting in October 2022, CIMERLI™ aims to enhance treatment access in the $7 billion anti-VEGF ophthalmology market. The COLUMBUS AMD trial confirmed CIMERLI™'s clinical equivalence to Lucentis®, showing comparable safety and efficacy. Coherus plans additional product launches, including YUSIMRY™, a Humira® biosimilar, in 2023.