On March 29, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), beginning at 9:30 a.m. Eastern Daylight Time reported that , is hosting a meeting with analysts and investors to present the Company’s corporate strategy to build a leading innovative immuno-oncology ("I-O") franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics (Press release, Coherus Biosciences, MAR 29, 2022, View Source [SID1234611106]). A simultaneous webcast and slides for the meeting are available on the Events and Presentations page of the Coherus website.
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"Executing on our strategy, by 2026 we believe that our commercial product portfolio will generate more than $1.2 billion in annual net sales and that our R&D productivity will position Coherus as a new leader in immuno-oncology," said Denny Lanfear, CEO of Coherus. "We believe having proprietary rights to a well-developed and commercialized PD-1 is required for long-term success in immuno-oncology, especially for companies developing PD-1 combinations who wish to earn label claims and commercialize them. Our foundational I-O asset, toripalimab, is an efficacious and differentiated PD-1 inhibitor developing a consistently strong clinical profile in studies across multiple tumor types. If approved, toripalimab will provide our commercial point of entry into the rapidly growing checkpoint inhibitor and PD-1 combination market. For the first time, today we are providing details of our PD-1 combination programs, including our clinical-stage anti-TIGIT antibody candidate and our internal preclinical programs targeting immune-suppressive mechanisms in the tumor microenvironment."
Lanfear added, "We believe that we will successfully execute on both our near-term product launches and our innovative immuno-oncology pipeline development to position Coherus for long-term growth and significant shareholder value creation over our planning period."
Immuno-Oncology R&D Update: Positioned for Growth Across a Broad Portfolio
At the meeting, Theresa LaVallee, PhD, Chief Development Officer, is providing 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 NPC in 2021 as well as in monotherapy in the second or third-line treatment of recurrent or metastatic NPC, and a Biologics License Application ("BLA") for these indications is currently under priority review by the United States Food and Drug Administration ("FDA") with a Prescription Drug User Fee Act target action date of April 30, 2022. Coherus and partner Junshi Biosciences are working closely with the FDA to complete the review process including the scheduling of any required inspections in China. Dr. LaVallee is also presenting details about the potential to pursue additional indications for toripalimab, including through possible expansion of several ongoing pivotal studies into multi-regional clinical trials with enrollment of patients in the United States.
Dr. LaVallee and Dr. Sanjay Khare, Senior Vice President of Immuno-oncology R&D, are presenting, for the first time, an overview of Coherus’ earlier stage 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 is planning to enroll new patient cohorts in the United States to evaluate CHS-006 + toripalimab for treatment of several solid tumor indications that may include non-small cell lung cancer, small cell lung cancer, esophageal cancer, and hepatocellular carcinoma.
Coherus is pursuing two early-stage development candidates designed to improve anti-PD-1 clinical benefit by transforming an unfavorable tumor microenvironment ("TME") to 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 immuno-oncology R&D investments will lead to ongoing identification of promising pipeline assets and the submission of at least one new IND application for immuno-oncology development candidates per year beginning in 2023.
Commercial Update: Preparing to launch as many as four new products through mid-2023
Paul Reider, Chief Commercial Officer, is presenting an overview of the Company’s plans for up to four new product launches in the next 15 months.
Toripalimab launch readiness is on track and will benefit from the high 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 Lucentis biosimilar, 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 into the $8B anti VEGF market and to drive adoption among retina specialists that the Company believes will be receptive to using 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. With projected 2022 U.S. Humira net sales of more than $18 billion, the Humira market represents a uniquely large and attractive opportunity. Coherus has made significant investments in manufacturing capacity and expects to be a low-cost, high-volume adalimumab manufacturer. Coherus expects this investment to result in launch-year manufacturing capacity of approximately 1.2 million units, or about 10% of the overall adalimumab market, equal to the Company’s target market share. After additional YUSIMRYTM scale-up efforts, the current manufacturing site has the potential to supply as much as 30% of the overall U.S. adalimumab market, three times Coherus’ target market share.
Coherus is planning a potential 2023 launch, assuming approval by the FDA, of its UDENYCA (pegfilgrastim-cbqv) on-body injector ("OBI") presentation. The UDENYCA OBI would enable Coherus to compete directly against Neulasta Onpro, which has approximately a 50% share of the overall pegfilgrastim market. Coherus believes the on-body segment of the pegfilgrastim market represents a $1 billion market opportunity and that a UDENYCA OBI would generate significant new growth for the UDENYCA franchise in 2023 and beyond.
Financial Update: Economies of scale within the Coherus business model
Chief Financial Officer, McDavid Stilwell, is presenting an overview of the Company’s cost structure as well as a projected range of annual net sales for 2026.
Coherus projects combined R&D and SG&A expenses in 2022 to be in the range of $415 million to $450 million, excluding license fee and potential milestone payments to partner Junshi Biosciences. The projected increase in combined R&D and SG&A expenses compared to 2021 is driven primarily by costs the Company expects to incur with the anticipated launches of two new products, toripalimab and CIMERLITM, as well as manufacturing and development costs for additional presentations of UDENYCA and of YUSIMRYTM, which Coherus is planning to launch in 2023.
Since Coherus’ commercial organization is already operating at scale, Coherus expects additional new product launches will largely leverage existing infrastructure, with some additional capabilities added to support launches outside of oncology. R&D expenses are expected to trend higher from 2024 through 2026 as Coherus initiates new clinical trials for CHS-006, CHS-1000 and CHS-3318. Full year 2026 operating expenses are expected to increase by only 15 to 25 percent compared to 2022 operating expenses.
Mr. Stilwell is also providing an estimate of the long-term revenue potential of the Company’s diversified product portfolio, assuming all four new products are approved and launched, with a range for 2026 net sales of $1.2 billion to $2.2 billion.