CHRS - NASDAQ

Coherus Oncology, Inc.

CHRS·NASDAQ

$1.57

+7.1%

HealthcareBiotechnology

Coherus Oncology, Inc., a biopharmaceutical company, researches, develops, and commercializes immunotherapies to treat cancer in the United States. The company develops UDENYCA, a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor; LOQTORZI, a novel next-generation programmed death receptor-1 inhibitor; and Casdozokitug, an investigational recombinant human immunoglobulin isotype (IgG1) monoclonal antibody targeting interleukin 27. It also develops CHS-114, an investigational highly specific human afucosylated IgG1 monoclonal antibody, a chemokine receptor highly expressed on Treg cells in the tumor microenvironment (TME); and CHS-1000, Anti-ILT4 monoclonal antibody for solid tumors. In addition, the company offers GSK4381562, an antibody targeting CD112R to treat tumor cells; YUSIMRY, a biosimilar to Humira for inflammatory diseases characterized by increased production of tumor necrosis factor (TNF) in the body, such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, and ulcerative colitis; and CIMERLI, a Lucentis biosimilar to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. It has a collaboration agreement with Junshi Biosciences for the co-development and commercialization of toripalimab; agreement with Surface and Adimab LLC; license agreements with Bioeq AG and Genentech, Inc. and Surface and Vaccinex, Inc.; and out-licensing agreement with Novartis Institutes for Biomedical Research, Inc. and GlaxoSmithKline Intellectual Property No. 4 Limited. The company was formerly known as Coherus BioSciences, Inc. and changed its name to Coherus Oncology, Inc. in May 2025. The company was incorporated in 2010 and is based in Redwood City, California.

Statements Value Model

At a Glance

Live Snapshot

Market Cap$192.80M

EPS-1.4500

P/E Ratio-1.09

Earnings Date07/30/2026

Earnings Call Transcript

CHRS • 2024 • Q1

Operator

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to Coherus BioSciences, Inc. First Quarter 2024 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Jamie Taylor, Head of Investor Relations. Please go ahead.

Jami Taylor

Thank you, operator. Good afternoon, and welcome to Coherus BioSciences First Quarter 2024 Earnings Conference Call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Bryan McMichael, our Interim Chief Financial Officer; Paul Reider, our Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa LaVallee, our Chief Development Officer. Before we get started, I'd like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, the following, our ability to advance our pipeline, projections of future growth, revenue, expenses, headcount, and debt levels. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process that are discussed in our press release that we issued today, as well as in the documents that we file with the SEC. 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 statement. And now, I'll turn the call over to Denny.

Dennis Lanfear

Thank you, Jami. Good afternoon, everyone, and thank you for joining us on our call today. As we open the call, let me emphasize 2 things. First, the strength of our first quarter results and secondly, the strategic initiatives we are successfully executing to position our company for long-term success. As you are aware, in the fourth quarter of 2023, we received 2 US FDA approvals for products vital for our commercial portfolio. First, LOQTOR

Paul Reider

Thank you, Denny, and good afternoon, everyone. With the ophthalmology divestiture, we are now an oncology-centered commercial organization which supports our overarching business objectives. The ongoing oncology launches like, LOQTOR

Rosh Dias

Thanks very much, Paul, and good afternoon, everyone. LOQTOR

Theresa Lavallee

Thank you, Rosh, and good afternoon, everyone. I'm pleased to update you on additional progress and our efforts to pursue development of our tumor microenvironment, or TME, focused pipeline. We have 2 approaches, combinations broadly with immune activators with partners, and the internal development plans focused on combination with LOQTOR

Bryan McMichael

Thank you, Theresa, and good afternoon, everyone. Since Denny covered the updates to our capital structure and Paul covered revenues, I will focus on the rest of the P&L and cash. Cost of goods sold during Q1 2024 was $34.6 million. Excluding the impact of the inventory write-down in Q4, COGS would have decreased $3 million or 8% from Q4 2023. R&D decreased $5.7 million and 17% from Q1 a year ago, primarily reflecting savings from reduced headcount and reduced development costs on biosimilars partially offset by investments in our IO pipeline. SG&A increased to $7.4 million and 15%, driven by a net $6.8 million charge in Q1 2024 associated with the non-cash write-off of N

Dennis Lanfear

Thank you, Bryan. As we have emphasized throughout our remarks today, we are executing well on our 4-part plan to deliver shareholder value. First, driving the top line of our revenues and secondarily, controlling our operating expenses. We are making great progress advancing our pipeline of tumor microenvironment focused assets and lastly, as I disclosed, improving our capital structure. I'm fully confident in both the progress we are making and, of course, we have charted as an innovative oncology company. Operator, we're now happy to open the line for questions.

Operator

[Operator Instructions] Your first question comes from the line of Yigal Nochomovitz with Citi.

Unknown Analyst

This is [ Ashley Mubarak ] coming on for Yigal. I joined a little bit late, so I apologize if I missed this, but how are you thinking about the contribution of each presentation of UDENYCA to the revenue mix for the quarter? And more importantly, how's that going to look like moving forward? I kind of assume that weighting will increase towards the new presentations, but I'm wondering how you're thinking about it.

Dennis Lanfear

Thank you very much for your question. Paul Reider will be happy to further describe the contribution revenues for the 3 presentations that we now have on the market. Paul?

Paul Reider

Yes. So the -- in the first quarter, the prefilled syringe still represented the largest share of our SKU mix. It was around 90%. The autoinjector is around 8%, and the ONBODY came in around 2% recalling that, we launched mid-quarter. So we only had about half of the quarter of the ONBODY. So that's the breakdown of the SKU mix. It varies a little bit by segment. So clinics and hospitals tend to customize the SKU that works best for them, which is exactly how we are now competitively positioning the franchise. And we're the only franchise that can offer providers and patients 3 different options to meet the unique needs of each individual patient or how they deliver pegfilgrastim. So you could see how that differentiation has translated into market share growth. [ 10 percent points ] quarter-over-quarter to 25%. And so we're going to continue to drive that differentiation as the remainder of the year unfolds.

Unknown Analyst

Paul, how do we see the market share of each of the presentations evolving through the rest of the year? Do you have any line of sight on that?

Paul Reider

Yes. I think it's still early in the ONBODY launch. So we are gaining feedback from customers as where it's fitting in. I can tell you right now that it's moving primarily in the clinic segment and also different segments of the hospitals. But I think we're still going to see throughout this year, at least, the prefilled syringe still holding a good percentage of the SKU mix, with the remainder being auto injector and the ONBODY. But the ONBODY growth has largely been in the clinic segment. We would expect that to continue throughout the year.

Dennis Lanfear

Thank you for your question.

Operator

Next question comes from the line of Kripa Devarakonda with Truist Securities.

Kripa Devarakonda

For -- on LOQTOR

Dennis Lanfear

Kripa, thank you for your question. Paul would be happy to comment a little bit about frontline versus second line utilization and the 55% NCCN conversion. Paul?

Paul Reider

Yeah. Thanks for your question. So, going back to the labeled indication or LOQTOR

Operator

Next question comes from the line of Mike Nedelcovych with TD Cowen.

Michael Nedelcovych

I have 2. The first is also on LOQTOR

Dennis Lanfear

Great. Thank you for the question. I'll let Dr. Rosh Dias firstly address the issue of the therapy selection decision that physicians now have with the launch of LOQTOR

Rosh Dias

Yes. Thanks very much for the question. So, I would say doctors tend to be pretty evidence-driven and we have 3 things that no other PD-1 has. First of all, we have an indication. Secondly, we have a profound survival advantage in the first-line setting, 37% risk reduction of death. And again, that's in the context of negative trials with other PD-1s in nasopharyngeal carcinoma. And then the third thing we have is also a preeminent positioning on the NCCN. So, first line, we are the only category 1 designated IO therapy and in second line and beyond, we have the -- we are the only preferred regimen, actually. So I think as we start seeing patients, I think these 3 things are key, and Paul's team is continuing to message on those 3 things.

Dennis Lanfear

Thank you. Paul, do you want to comment a little bit on our expectations for YUSIMRY going to 2025 with IRA?

Paul Reider

Sure, Denny. Thanks for your question, Mike? Yes, for 2025 formulary negotiations are ongoing. And YUSIMRY and Coherus are actively engaged in that process. So we continue to believe that that will be the -- I think, the point where we see even greater inflection of biosimilars in the adalimumab space. So I think we're well-positioned there based on our price point and the value that this product brings to the health care systems and patients.

Operator

[Operator Instructions] Your last question comes from the line of Balaji Prasad with Barclays.

Unknown Analyst

This is [ Shau ] on for Balaji. Just a quick follow-on question on the UDENYCA franchise. Amneal recently announced that they are licensing pegfilgrastim ONBODY injector and pre-filled autoinjector, and they expect to submit the [ BRA ] in first quarter of 2025. And there are a few other players that are trying to get into this landscape. So what is your expectation for the pegfilgrastim ONBODY injector landscape and the entire market for the next 2 to 3 years? And do you have any plans or mechanism to build and defend your market shares against those potential new entrants?

Dennis Lanfear

I'm sorry. Want to understand -- we're having a difficult time hearing you. Want to understand your question. Is your question with respect to future entrants in the ONBODY space with the pegfilgrastim market or with autoinjectors?

Unknown Analyst

Pegfilgrastim market, like -- especially the ONBODY injector and the auto-filled -- pre-filled auto injector as Amneal recently announced that they have something in plan and they plan to file a BRA in first quarter of 2025.

Dennis Lanfear

Paul, would you like to address how we view the competition in pegfilgrastim market for future autoinjectors?

Paul Reider

Yes. Well, first of all we've been operating in this pegfilgrastim market now -- we're in our sixth year and maintain one of the leadership positions here. So what we're going to continue to do is focus on our business and the positioning of UDENYCA, which is to be the total solution for providers and patients. And we're doing this, as I mentioned, because today, we've got all 3 presentations. It's tried and true and well established in the market. Secondly, we've got strong payer coverage. And so that's being recognized by payers that UDENYCA brand is a go-to brand because of all these benefits that we bring to not only the consistency in the marketplace, the predictability, but also the high quality and reliability of this brand. So we'll be prepared for any competition if anybody else comes. But we believe we'll continue to be well-positioned to compete and win, whatever that landscape unfolds.

Dennis Lanfear

Thank you, Paul. The other point that I would make is consistent with Paul's remarks, our ONBODY injector represents an innovative de novo, highly sophisticated device with a 5-minute injection time. And the enthusiasm with which it has been received by the market, the physicians and the patients is due to that. We believe there are significant technical hurdles to such an approach, and we investigated a number of approaches before settling on this one. So we think this is very important. We think we got it right. But lastly, as Paul said, we are first competitors in the pegfilgrastim market, and our track record over the last 6 years demonstrates that we are the only team with all 3 presentations, each filling a particular need in the market. So I believe that we're very confident in our ability to compete and remain successful and grow share in this market.

Operator

Another question comes from the line of Douglas Tsao with H.C. Wainwright.

Douglas Tsao

Obviously, there are a number of sort of gates that you need to clear in terms of the ramp-up for LOQTOR

Dennis Lanfear

Thanks for your question, Doug. Paul, would you like to comment a little bit on the gating of the adoption of LOQTOR

Paul Reider

Yes. Thanks for your question, Doug. Yes. So, obviously, the payer coverage was -- is the first one, and that's well established. And I don't really foresee any further hurdles on the payer side. The second gate is now that we've got the NCCN guidelines, what we have to ensure now is in each of the accounts that the guidelines that are translated into the order sets. So again, this enables the doctor at the time of prescribing that when they click through the order set that LOQTOR

Dennis Lanfear

Doug, for all the reasons that Paul just elucidated, we see the growth of this market as a steady ramp up to peak market share and penetration, probably out around year 3. So this isn't a market such as a replacement enzyme market or something where you can get out to these patients and just find them immediately convert them. These patients are in various stages of therapy. They may have been exposed to another PD-1. We're going to catch the patients that are on chemotherapy. Those are all eligible. They'll all benefit. Some patients, we will have to wait for them to progress to second line. But the key issue is, as Rosh Dias pointed out, we are the only first-line therapy from the FDA. We've gotten a position on all of the formularies. We're doing very, very well with the NCCN, but I would say with the building blocks are in place for the market, we see a steady ramp forward over the future.

Douglas Tsao

Okay. Great. And maybe a follow-up question on the UDENYCA franchise. I'm just curious, we're starting to see uptake of both of your ONBODY device as well as the autoinjector. I'm just curious if you have any insight in terms of how physicians are using the 2 -- those 2 dosage forms or product types. Are there sort of themes in terms of the types of patients that are getting the ONBODY versus the auto-injector and vice versa?

Dennis Lanfear

Paul, I guess the question is, what sort of patient settings would they go for the autoinjector, what patient settings for the ONBODY and so on.

Paul Reider

Yes, Doug. So let me frame this in a couple of different ways. First, let's take the clinics. So the clinic segments are going to gear more towards all 3 of the presentations because they have patients who like to come back to the office the next day. They like the high-touch connectivity with their nurse and with their doctor. And so therefore, the prefilled syringe or the autoinjector are positioned for those patients. But some patients in the clinic, they want their injection experience at home. Therefore, we give them the option of the ONBODY device with a well-designed 5-minute injection. But if the patient wants to self inject, and not wear the device, they can choose the auto-injector and under 10 seconds inject themselves at the time and place that they like. So that's really how we're positioning by the patients and by the provider. The hospitals, they tend to go a little bit more with the ONBODY device or the prefilled syringe. So we've had good uptake with autoinjector in the hospital, but not nearly as much in the clinic, because they prefer either the prefilled syringe or the ONBODY is the at-home preference. So that's kind of how we're seeing it. And, being the only franchise with all 3 options really sets us apart from a competitive differentiation. And I think you see that in our market share growth.

Operator

Question comes from the line of Colleen Kusy with Baird.

Colleen Hanley

So for -- realizing you're not providing guidance at this point, but just how to think about what the growth drivers for UDENYCA will be in 2024? Is it growing the ONBODY? Is it just focusing on the prefilled syringe and autoinjector? Just kind of thoughts around growth for UDENYCA this year. And then, sorry if I missed this in the prepared remarks, but if you could just speak towards the potential of reaching cash flow positivity and if that goal is still set for 2024.

Dennis Lanfear

Thank you, Colleen. I'll let Paul handle the growth drivers for UDENYCA first, and then I'll handle your secondary question with respect to 2024. Paul?

Paul Reider

Yes, thanks for your question. Yes, I think we fully expect the ONBODY to be the predominant driver of our growth in 2024. As Denny mentioned that the approval of that product now opens up segments of the market that have been difficult to penetrate with our prefilled syringe and autoinjectors. So we're really looking for that SKU, that presentation to drive market share growth for the remainder of the year. It'll be buoyed and facilitated by our payer coverage, which I mentioned was doubled this year versus last year. And that payer coverage extends to all 3 product presentations. So, really not inhibited by payer coverage by each of those presentations. So, where we've got it, we've got all 3 and we will leverage that as we continue to execute.

Dennis Lanfear

Thanks, Paul. With respect to your secondary question, I would first say 2024 is shaping up to be a more predictable year than 2023. Insofar 2023, we had to focus a lot on getting approvals. We focused on getting the ONBODY approval. We did that successfully. We went and got LOQTOR

Operator

There are no further questions at this time. Mr. Dennis Lanfear, I turn the call back over to you.

Dennis Lanfear

Thank you, operator. Thank you all for joining us on our call today. And thank you for the opportunity to enumerate for you the progress we've made across all of our key overtures, particularly with respect to driving our sales and advancing our tumor microenvironment focused pipeline. And we look forward to [ pricing you ] of our progress at our next call. Thank you.

Transcript from May 9, 2024