Coherus BioSciences (NASDAQ:CHRS)
Q4 2021 Earnings Call
Feb 17, 2022, 5:00 p.m. ET
- Prepared Remarks
- Questions and Answers
- Call Participants
Good day and thank you for standing by. Welcome to the fourth quarter and full year 2021 Coherus BioSciences earnings conference call. [Operator instructions] Please be advised that today’s conference may be recorded. [Operator instructions] I would now like to hand the conference over to your host today McDavid Stilwell, chief financial officer.
Please go ahead, sir.
McDavid Stilwell — Chief Financial Officer
Thank you, operator. Good afternoon everyone and thank you for joining us. We issued our press release earlier announcing our 2021 fourth quarter and full year results. This release can be found on the Coherus BioSciences’ website.
Today’s call include forward-looking statements regarding Coherus’ current expectations about future events. These statements include, but are not limited to, our ability to advance our product candidates through development and registration, the status of our product candidate clinical profile, our timing and ability to commercialize our products and product candidates in the future. Our R&D and SG&A expense guidance for 2022 and our ability to meet the same. Our projections about margin, as well as our ability to draw down amounts under our new credit facility, all of which involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from the results, performance, or achievements complied by the forward-looking statements.
These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in our press release that we issued today, as well as in the documents that we file with the Securities and Exchange Commission, including those in our annual report on Form 10-K and quarterly reports on Form 10-Q. The forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements. With me on today’s call are Denny Lanfear, CEO of Coherus; Paul Reider, chief commercial officer; and Theresa LaVallee, chief development officer. And I will now turn the call to Denny.
Denny Lanfear — Chief Executive Officer
Thank you, McDavid, and thank you all for joining us this afternoon. Today, I’ll describe how over the past year, we’ve delivered on our objective to transform Coherus into an innovative immuno-oncology company supported by income from a diversified portfolio of FDA-approved products. I’ll begin today with a brief review of our achievements toward our strategic initiative in immuno-oncology, detailing the progress of our foundational assets toripalimab and of our preclinical and clinical-stage innovative combination agents. Then I’ll review recent progress to grow and diversify our commercial portfolio.
Now with respect to our immuno-oncology programs, you may recall that in November, we announced the FDA granted priority review for the BLA for toripalimab for the treatment of nasopharyngeal carcinoma. An indication with no FDA-approved cancer immunotherapy options and for which toripalimab has breakthrough therapy and orphan drug designation. The BLA review is progressing well toward the target action date of April 30, which is about 10 weeks from now. Toripalimab clinical profile continues to strengthen across indications.
In December, we announced that toripalimab plus chemotherapy demonstrated a statistically significant overall survival benefit and a prespecified interim analysis on the CHOICE-1 clinical trial for the first-line treatment of advanced non-small cell lung cancer. This built on other first-line indications in esophageal squamous cell carcinoma and nasopharyngeal carcinoma, where we have seen a robust benefit both the progression-free survival and overall survival. We’ve also made progress with our clinical-stage — mid-stage I-O strategy. In January, we initiated the process to exercise our option and license JS006, a TIGIT targeted antibody developed by Junshi BioSciences our partner, which they are evaluated in a study combination with toripalimab.
Dr. Theresa LaVallee, our new chief development officer, will provide additional details about JS006 and our development plans for you in just a moment. Our immuno-oncology preclinical research and development team is proving to be highly productive. In January, we announced that we are advancing an internally generated pipeline of PD-1 combination candidates and we expect to file the first IND in mid-2023.
With toripalimab nearing its first potential approval, a TIGIT target immune checkpoint blocker entering mid-stage development, and our in-house early stage immuno-oncology candidates successfully advancing toward human clinical trials, Coherus is evolving into an innovative immuno-oncology company with a broad pipeline of product candidates and the potential to drive long-term growth over this decade. I’d now like to introduce Dr. Theresa LaVallee, our recently appointed chief development officer, who brings more than 25 years of drug discovery and development experience and is recognized for her immuno-oncology expertise. Most recently, Dr.
LaVallee was Vice President of Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy, where she provided scientific leadership for the clinical strategy for development of novel immuno-oncology therapies and help establish the Institute’s translation and regulatory organization. Part of that, from 2008 to 2013, Dr. LaVallee was a member of the immuno-oncology team, developing checkpoint inhibitors and related diagnostics at AstraZeneca. Theresa?
Theresa Lavallee — Chief Development Officer
Thank you, Denny. It is exciting to join Coherus as the company gains momentum and its transition to an innovative immuno-oncology leader. I believe our broadening product portfolio with early, mid- and late-stage complementary I-O products is well-positioned to clinically succeed in; immuno-oncology. Commercially, our oncology-focused organization has proven that Coherus can be very successful in highly competitive fields.
Coherus has both the in-house expertise and assets needed to support a successful transformation. Antibody development for PD-1 combinations and co-formulations requires world-class analytics, protein science, and bioinformatics capabilities. We have that at our Camarillo, California site, a 25,000 square foot facility we moved in to two years ago. On the development side, our clinical and regulatory teams have repeatedly demonstrated the ability to develop drugs that gain FDA approval.
Our Scientific Advisory Board has recognized I-O experts from academia and industry is actively involved in our target and [Inaudible] selection, playing a key role, for example, in selecting toripalimab from a due diligence review of more than 10 PD-1 product candidates, as well as setting the TIGIT assets from Junshi. For Coherus, these investments are paying off. Toripalimab, our foundational immuno-oncology asset is establishing an excellent safety and efficacy profile in the ongoing clinical trials. The toripalimab BLA for nasopharyngeal carcinoma, an unmet medical need with no approved immunotherapies is under priority review by the FDA with an action date of April 30.
Denny mentioned earlier that toripalimab’s clinical profile continues to strengthen across indications. Case in point, the positive progression-free survival, overall survival data from the JUPITER-6 study in esophageal squamous cell carcinoma, which showed a significant overall survival benefit even in low PD-01 patients. We have and will continue to engage the FDA on the potential for submission later this year of a supplemental BLA for…