Net sales

Coherus BioSciences (CHRS) forecasts net sales of $1.2-2.2 billion in 2026

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Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), beginning at 9:30 a.m. Eastern Daylight Time, is hosting a meeting today with analysts and investors to discuss the company’s corporate strategy. company aiming to create a leading innovative immuno-oncology (“IO”) funded by cash generated from net sales of its diversified portfolio of FDA-approved therapeutic products. A simultaneous webcast and slides from the meeting are available on the Events and presentations page from the Coherus website.

“By executing our strategy, by 2026 we believe our commercial product portfolio will generate over $1.2 billion in annual net sales and our R&D productivity will position Coherus as a new leader in immuno-oncology,” said Denny Lanfear, CEO of Coherus. . “We believe that owning proprietary rights to well-developed and marketed PD-1 is necessary for long-term success in immuno-oncology, especially for companies developing PD-1 combinations that wish to obtain claims on the immuno-oncology. label and market them. Our foundational IO active, toripalimab, is an effective and differentiated PD-1 inhibitor developing a strong and consistent clinical profile in studies across multiple tumor types. If approved, toripalimab will be our commercial entry point into the rapidly growing combination checkpoint inhibitor and PD-1 market. For the first time, we are today providing details of our PD-1 combination programs, including our clinical-stage anti-TIGIT antibody candidate and our in-house preclinical programs targeting immunosuppressive mechanisms in the tumor microenvironment.

Lanfear added, “We believe we will successfully execute our near-term product launches and innovative immuno-oncology pipeline development to position Coherus for long-term growth and significant shareholder value creation over the course of the year. of our planning period.

Immuno-Oncology R&D Update: Positioned for Growth in a Broad Portfolio

During the meeting, Theresa LaVallee, PhD, Director of Development, provided an update on the Company’s clinical-stage immuno-oncology R&D programs. Toripalimab was granted Breakthrough Therapy Designation in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPCs in 2021 as well as as monotherapy in the second- or third-line treatment of recurrent or metastatic NPCs, and an application for Biologics License (“BLA”) for these indications is currently under priority review by the U.S. Food and Drug Administration (“FDA”) with a Target Action Date of the Prescription Drug User Fee Act of April 30, 2022. Coherus and its partner Junshi Biosciences are working closely with the FDA to complete the review process, including scheduling all required inspections in China. Dr. LaVallee also presents details on the possibility of pursue additional indications for toripalimab, including the possible extension of several ongoing pivotal studies to clinical trials m multi-regional with patient recruitment in the United States.

Dr. LaVallee and Dr. Sanjay Khare, Senior Vice President of Immuno-oncology R&D, present, for the first time, an overview of Coherus’ immuno-oncology R&D programs:

  • CHS-006 (anti-TIGIT antibody) is being evaluated in an ongoing clinical trial. In 2023, Coherus expects to receive clinical data informing dose selection and plans to enroll new patient cohorts in the United States to evaluate CHS-006 + toripalimab for the treatment of multiple solid tumor indications that may include the non-small cell lung cancer, cellular lung cancer, esophageal cancer and hepatocellular carcinoma.
  • Coherus is pursuing two candidates in early-stage development designed to improve the clinical benefit of anti-PD-1 by transforming an unfavorable tumor microenvironment (“TME”) into a more favorable TME. Coherus expects to file Investigational New Drug (“IND”) applications with the FDA in 2023 for CHS-1000, an antibody targeting ILT4, and in 2024 for CHS-3318, an antibody targeting CCR8.

Coherus expects its R&D investments in immuno-oncology to lead to the continued identification of promising assets and the submission of at least one new IND application for development candidates in immuno-oncology per year. from 2023.

Commercial Update: Preparing to launch up to four new products through mid-2023

Paul Reider, Chief Commercial Officer, provides an overview of the company’s plans for up to four new product launches over the next 15 months.

  • Preparation for the launch of toripalimab is on track and will benefit from the strong overlap in customer accounts between UDENYCA® and toripalimab. If approved, toripalimab will be the first and only PD-1 inhibitor registered in the United States for the treatment of advanced nasopharyngeal carcinoma.
  • CIMERLITM (ranibizumab-ranq), a biosimilar of Lucentis®, is under FDA review with a target action date of August 2, 2022. If approved, Coherus is preparing to launch CIMERLITM in the second half of 2022 in the $8 billion anti-VEGF market and to drive adoption among retina specialists who the Company believes will be receptive to the use of an anti-VEGF biosimilar.
  • The FDA approved Coherus’ Humira® biosimilar, YUSIMRYTM (adalimumab-aqvh), in December 2021, and Coherus plans to launch YUSIMRYTM in the United States on or after July 1, 2023. billion dollars, the Humira® market represents an exceptionally large and attractive opportunity. Coherus has made significant investments in its manufacturing capacity and expects to be a low-cost, high-volume manufacturer of adalimumab. Coherus expects this investment to result in manufacturing capacity of approximately 1.2 million units for the launch year, or approximately 10% of the overall adalimumab market, or the equivalent of the Company’s target market share. After additional efforts to scale YUSIMRYTM, the current manufacturing site has the potential to supply up to 30% of the overall US adalimumab market, three times Coherus’ target market share.
  • Coherus anticipates a potential 2023 launch, pending FDA approval, of its UDENYCA® (pegfilgrastim-cbqv) on-body injector (“OBI”) presentation. UDENYCA®’s OBI would allow Coherus to directly compete with Neulasta® Onpro®, which holds approximately 50% of the global pegfilgrastim market. Coherus believes that the over-the-body segment of the pegfilgrastim market represents a billion dollar market opportunity and that a UDENYCA® OBI would drive significant new growth for the UDENYCA® franchise in 2023 and beyond.

Financial point: economies of scale in the Coherus business model

Chief Financial Officer McDavid Stilwell provides an overview of the company’s cost structure along with a projected range of annual net sales for 2026.

The Coherus projects combined R&D and SG&A spending in 2022 to be between $415 million and $450 million, excluding licensing fees and potential milestone payments to partner Junshi Biosciences. The expected increase in combined R&D and SG&A expenses compared to 2021 is mainly due to the costs the Company expects to incur with the planned launches of two new products, toripalimab and CIMERLITM, as well as manufacturing costs. and development for additional presentations of UDENYCA® and YUSIMRYTM, which Coherus plans to launch in 2023.

Given that Coherus’ commercial organization is already operating at scale, Coherus expects additional new product launches to largely leverage the existing infrastructure, with some additional capabilities added to support launches outside of it. of oncology. R&D spending is expected to increase from 2024 to 2026 as Coherus launches new clinical trials for CHS-006, CHS-1000 and CHS-3318. Operating expenses for the full year of 2026 are only expected to increase by 15-25% compared to operating expenses in 2022.

Stilwell also provides an estimate of the long-term revenue potential of the company’s diverse product portfolio, assuming all four new products are approved and launched, with a 2026 net sales range of $1.2 billion. at $2.2 billion.