Earnings call transcript: Coherus BioSciences Q2 2025 misses EPS, stock dips

Coherus BioSciences Inc reported a second-quarter 2025 earnings per share (EPS) of -$0.34, falling short of the forecasted -$0.26, resulting in a negative surprise of 30.77%. Despite a slight revenue beat, with actual revenue at $10.25 million versus the expected $10.16 million, the company’s stock declined by 3.49% in after-hours trading. According to InvestingPro analysis, the company appears undervalued based on its Fair Value calculation, though analysts anticipate sales decline in the current year.

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Key Takeaways

• Coherus BioSciences missed EPS forecasts by a significant margin.
• Revenue slightly exceeded expectations, providing a minor positive note.
• The company maintains a strong cash position, ending the quarter with $238 million.
• Stock price fell by 3.49% following the earnings announcement.
• Projected cost savings from headcount reductions are expected to support future operations.

Company Performance

Coherus BioSciences demonstrated growth in revenue, driven by the performance of its PD-1 inhibitor, Loktorzi, which saw a 36% quarter-over-quarter and 65% year-over-year increase. The company’s last twelve months revenue reached $272.25 million, with a healthy gross profit margin of 56.38%. However, the overall financial performance was marred by the EPS shortfall, with InvestingPro data showing an EBITDA of -$77.8 million, indicating operational challenges.

Financial Highlights

• Revenue: $10.25 million, up 36% quarter-over-quarter and 65% year-over-year.
• Earnings per share: -$0.34, missing the forecast by 30.77%.
• Cash and investments: $238 million, providing a runway through 2026.
• Projected SG&A for 2025: $90-$100 million.

Earnings vs. Forecast

The actual EPS of -$0.34 was below the forecasted -$0.26, resulting in a significant miss of 30.77%. Revenue slightly exceeded expectations, with a positive surprise of 0.89%, but this was not enough to offset the negative impact of the EPS miss.

Market Reaction

Following the earnings release, Coherus BioSciences’ stock price fell by 3.49% in after-hours trading, closing at $0.884. This decline reflects investor concerns over the company’s profitability and future earnings potential. The stock has experienced significant pressure, down 35.95% year-to-date, trading well below its 52-week high of $2.43. InvestingPro’s comprehensive analysis indicates an Overall Financial Health score of 2.5, labeled as "GOOD," suggesting potential resilience despite current challenges.

Outlook & Guidance

Coherus BioSciences projects peak revenues for Loktorzi by 2028 and aims for $40-$50 million in Loktorzi revenue in 2025. The company is exploring ex-US licensing opportunities and focusing on combination therapies to enhance its oncology portfolio. Analyst consensus provides a range of price targets from $1.10 to $7.00, reflecting diverse views on the company’s potential.

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Executive Commentary

"Our goal is to deliver a step change in survival for cancer patients," stated Denny Lamphere, CEO of Coherus BioSciences. He emphasized the company’s strong balance sheet, which is expected to support operations through 2026, and highlighted the potential of their pipeline assets.

Risks and Challenges

• Potential operational inefficiencies impacting profitability.
• Increased competition in the oncology market.
• Dependence on the success of Loktorzi and pipeline assets.
• Economic pressures affecting healthcare spending.
• Regulatory challenges in expanding market approvals.

Q&A

During the earnings call, analysts inquired about partnership strategies for pipeline assets, the community oncologist education approach, and potential biosimilar competition. The company addressed these concerns by detailing clinical trial progress and enrollment strategies.

Full transcript - Coherus BioSciences Inc (CHRS) Q2 2025:

Jordan, Conference Operator: Thank you for standing by. My name is Jordan, and I’ll be your conference operator today. At this time, I’d like to welcome everyone to the Coherus Oncology Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question and answer session.

Thank you. I’d now like to turn the conference over to Jody Sievers, Head of Investor Relations for Coherus Oncology. You may begin.

Jody Sievers, Head of Investor Relations, Coherus Oncology: Thank you, Jordan. Good afternoon, and welcome to Coherus Oncology’s second quarter twenty twenty five earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coherence Brian McMichael, Chief Financial Officer Doctor. Rosh Dias, Chief Medical Officer Doctor. Teresa Lovalli, Chief Scientific and Development Officer Sameer Goria Galker, Executive Vice President, Commercial.

Before we get started, I would like to remind you that today’s call includes forward looking statements regarding Coherus’ current expectations about future events. Actual results may vary significantly, and we undertake no duty to update or revise any forward looking statement. Please see the press release we issued today and our quarterly report on Form 10 Q for more information on risks and uncertainties. And now I’ll turn the call over to Denny.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thank you, Jody, and welcome all. In Q2 twenty twenty five, we completed our strategic repositioning and renamed our company Coherus Oncology to better reflect our mission. Today, in addition to reviewing the progress we made in growing our commercial revenue and advancing our clinical oncology programs ahead of key data readouts in the ’6, I want to take the opportunity to introduce you to our new company and highlight what sets us apart. Today, I’ll be focusing for you on three main points of Coherence Oncology. First, who we are as a company in terms of science, products, and mission.

Second, what we are doing clinically and strategically to advance that mission through combinations of products and collaborations with partners. And third, why our proven track record in deals and partnerships and in development gives us confidence we will successfully execute globally on our plans, creating significant value for our US focused business. First, let’s talk about who we are. Coerus Oncology is a commercial stage innovative company built on deep science focused on developing cutting edge cancer therapies. Our goal is to deliver a step change in survival for cancer patients using new generation, first in class and best in class therapeutics.

Our science is reading through to clinical results and patient benefit. For example, our next generation PD-one inhibitor Toropalumab has a unique FG loop binding site and significantly higher potency compared to standard of care PD-1s. This has translated to demonstrated efficacy in low PD L1 cancers. While other standard of care PD-one treatments have lost approval for low PD L1 esophageal cancer in The US, Torpalbam has been approved across all PD L1 levels for first line esophageal in The EU, validating its genuine mechanistic and clinical differentiation. Approved for use in recurrent or metastatic nasopharyngeal cancer, Lactorsi, which is the brand name for Toripalumab, demonstrated in a pivotal study a compelling thirty seven percent improvement in overall survival versus standard of care, earning top ranking on NCCN guidelines.

We translated this to increase adoption by physicians and patients fueling commercial growth. Lactorsy net revenue in the second quarter grew 36% over Q1 twenty twenty five to $10,000,000 Nasopharyngeal cancer represents 150,000,000 to $200,000,000 market opportunity for us. However, the larger commercial case for Lactorsi lies in combination therapy with both our own pipeline product candidates as well as other companies’ products. In the latter case, we supply the drug but do not fund the trials, potentially expanding the lactorazy label very cost effectively. Now let me move on to the development strategy for the pipeline assets for just a moment.

The step change in cancer patient survival we seek requires multiple mechanism of action working in concert to attack tumors. Our pipeline assets have complementary MOAs to Lactorsi, and we are actively advancing combination studies across prioritized indications. Collaborations are key to combinations as we don’t want to overlook any potential significant therapeutic benefit in combining any of our assets with another company’s approved or experimental agents. Thus, developing strategic partnerships is an integral part of our overarching development strategy and dovetails with our efforts to license the pipeline ex U. S, as I will describe later.

This results in a very capital efficient indication expansion strategy for our products and sets us apart from other companies as we do not constrain ourselves to just using our own portfolio. Let me now briefly review each of our pipeline product candidates. First, CHS-one hundred fourteen, our anti CCR8 Treg depleter, and then casdozoketog, our anti IL-twenty seven antagonist in terms of first, how they were scientifically brought forward. Second, why they’re so promising. Third, rationale for the development path we’ve chosen.

Then Doctor. Dias, our Chief Medical Officer will review the ongoing studies and the upcoming data readouts expected in the ’6. First, CHS-one hundred fourteen, our potential best in class CCRA Treg depleter. Now normally T regulatory cells act as brakes on the body’s immune response, preventing autoimmune disease. In cancer, particularly with solid tumors, Tregs help tumors evade the immune system, allowing them to grow unchecked.

While the existence and role of Tregs was known years before, in 2016 researchers found that Treg cells in the tumor microenvironment had a unique receptor CCR8 on their surface. This sparked a rush to create antibodies that target CCRA with the objective to eliminate these specific Tregs and not others and boost the immune system’s response against tumors. This was viewed as a potential major breakthrough goal in the years long battle against cancer. CHS-one 114 was developed with great care to specifically target only CCR8, ensuring it doesn’t bind to other receptors outside the tumor microenvironment, which would cause side effects and limit its use. However, CCR8 is a GPCR receptor and targeting such receptors is notoriously difficult as there’s so little protein on the cell surface for binding, making antibody development very challenging.

The development process for CHS-one 114 was rigorous and candidate agents were screened against over 5,200 known off target sites to ensure selectivity. The result of this effort is the only known anti CCRA Treg depleting agent with no off target binding, which may avoid unexpected toxicity. Two key points here. First, some CCRA competitors are accounting off target binding in their development programs and some are finding dose limiting toxicities. Secondly, CHS-one hundred fourteen’s high selectivity makes it potentially best in class giving us competitive advantage in terms of development timing and market entry.

It’s important to note that we are the only independent US biotech developing a CCRA and the US FDA approval is highly valuable ex US in terms of partnering, which is a key focus for us. We are working efficiently and aggressively of course to bring CHS-one hundred fourteen to market for key indications in The US as quickly as possible. And we’re making good progress. With our head and neck trial, Coherus Oncology is the first US company to demonstrate that anti CCRA treatment can deplete Tregs and tumors. 01/2014 treatment also led to increased CD8 positive T cell infiltration in the head and neck cancer patient tumors.

I would also note that in combination with Lactorsi, in this same study, we saw a partial response and significant reduction of target and non target lesions in a fourth line patient. Of course, given the promise of the mechanism of action, targeting CCR8 has become very competitive. However, the upside is that this class of treatments is gaining broad validation across various tumors and settings, particularly in combination with a PD-one. Importantly, given the MOA, there is also the potential for broad combinability of anti CCRAs across other efficacious modalities such as T cell engagers, ADCs and so on. This is the subject of our partnering efforts both in The US and Ex US.

We currently have clinical studies in head and neck, gastric and esophageal cancer, which we will review directly. However, I wish to point out that Doctor. Alexander Rodinski, Chairman of Immunology at Memorial Sloan Kettering and key member of our Coherus Oncology Scientific Advisory Board recently published two important preclinical papers characterizing the immune suppressive role of Tregs in colorectal cancer, an area of burgeoning unmet need. We are currently developing clinical plans to address this increasingly common disease affecting younger patients as recently reported by the Journal of American Medical Association. We believe that in 2026 anti CCR8s will start to realize their therapeutic promise and become a new treatment backbone used broadly across many solid tumor types.

Let me now refresh you on cas dozoketog, a unique first in class opportunity in our pipeline. Cas dozoketog is the only known anti IL-twenty seven treatment currently in development, and IL-twenty seven plays a key role in the immune responses within barrier tissues such as liver and lung. It is well known that cytokines and the immune system are tightly linked to cancer and it has been demonstrated that IL-twenty seven’s role in mediating the immune response is the basis for its mechanism of action. Mechanistically, within the tumor microenvironment, IL-twenty seven facilitates tumor growth in three ways. First, by inducing checkpoint expression such as PD-1s, LAG-3s, and others on the surface of T cells inhibiting the immune response.

Secondly, by reducing pro inflammatory cytokines weakening the immune response. Lastly, affecting natural killer cells, preventing them from attacking tumors. This makes IL-twenty seven a novel and distinctive target with immunomodulatory mechanism that is synergistic with checkpoints, attacking immune resistance from a complementary direction. What’s important for you to think about here is that the translation of the data from our model systems to the human clinical trials is impressive, giving us a clear path forward for development. Across preclinical mouse models, IL-twenty seven was shown to have an important role in turning off T cells and NK cells in lung and liver.

These are the two key tissue types we have chosen to investigate for therapeutic effect. And compelling efficacy has been demonstrated in first line liver cancer patients as previously disclosed.

Coherus Oncology: Coherence Oncology has global rights to cas dozo ketone and hepatocellular carcinoma is a global disease with particular incidents in Asia and other regions, including Europe and MENA. This makes the ex US licensing efforts of cas dozoketog a priority for us. And we believe the success of such efforts will follow from strong clinical data. Such partnering across regions can be expected to provide three things. First, validation of the value of our pipeline.

Second, non dilutive financing for ongoing clinical development. And third, cost offsets for larger pivotal clinical trials to come later. Doctor. Dayas will now provide clinical development rationale and update letting you know what you can expect next year as the data reads out. Then Samir Gargalker, our Executive Vice President of Commercial will provide NPC market color as well as a summary of the large market opportunity of the pipeline product candidates.

Rush?

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: Thank you, Denny, and good afternoon, everyone. I’ll start with a review of our clinical program for CHS-one hundred fourteen before moving on to casidos keto. Given the biology, CHS-one hundred fourteen has potential utility in multiple areas, and we have active trials across several tumor types. Firstly, in second line head and neck squamous cell carcinoma, where the rationale for expiration is several fold. First, this is a tumor type that is well supported by high target expression in terms of the prevalence and density of CCR8 positive Tregs in

Coherus Oncology: the

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: tumor. Additionally, this is an indication synergistic with the current indication for Loptozzi in NPC, a subtype of head and neck cancer. And furthermore, clinically, we’ve been very encouraged by the confirmed partial response demonstrated earlier in the head and neck program in a very late line patient previously refractory to prior PD-one inhibition, with this data being presented at AACR a few months ago, and which firmly supports continued development in head and neck. Our head and neck squamous cell trial explores two biologically active doses of CHS-one hundred fourteen in combination with Toripalumab in the second line setting, which is currently an area of very high unmet medical need with the goal of declaring a dose for continued development, whilst at the same time developing further efficacy and safety data and aiming to address FDA’s Project OPTIMAUS. This trial is active and ongoing, and we remain on track to develop efficacy to deliver efficacy and safety data in the 2026 previously communicated.

The second priority tumor type for CHS-one hundred fourteen is second line gastric cancer, which again is supported by the biology and has demonstrated proof of principle of the CCR8 class in combination with toripalumab specifically as communicated in data presented at ASCO twenty four. The approach here is to include patients with gastric, GEJ, and esophageal adenocarcinoma, and again, to explore two biologically active doses in combination with Toripalumab in forty second line patients. This trial is active and ongoing in The U. S. And Asia Pacific sites, and we anticipate safety and efficacy results over the course of next year as previously discussed.

The third tumor type we’re pursuing is an esophageal squamous cell carcinoma, where we’re looking at both a first line and a second line population. As a reminder, Loktorzi has demonstrated activity irrespective of PD L1 levels in the first line setting, And we’re exploring TORY-one hundred fourteen combination with chemo in first line ESCC. Concurrently, we’re also pursuing second line esophageal squamous cell with the TORY-one hundred fourteen combination as a fast to market strategy as the current standard of care constitutes a large area of unmet medical need. Both cohorts are active and ongoing in The U. S.

And Asia Pacific sites, and we anticipate safety and efficacy results over the course of next year. Candozoketerg, our first in class IL-twenty seven targeting antibody, is progressing in our first line hepatocellular carcinoma study. As a reminder, the current ongoing Phase II study is a three arm 72 patient study exploring two biologically active doses of Caldozo in combination with toripalumab and bevacizumab compared to toribevolone, which in addition to generating further efficacy and safety data, aims to address FDA’s Project OPTIMAIS dose optimization requirement, whilst at the same time addressing contribution of components as we move through the development pathway. As a reminder, this ongoing study builds upon the very encouraging data presented at ASCO GI in January, demonstrating a thirty eight percent overall response rate and a seventeen percent complete response rate with the addition of Castozo to the current standard of care, Atezo and Bev, where historically the overall response rate has been around thirty percent and the complete response rate around eight percent. In our study, we’ve shown a deepening of responses over time and responses irrespective of viral or nonviral etiology.

This trial is currently active and ongoing in The US and the Asia Pacific region, and we anticipate safety and efficacy data in the ’6 as previously communicated. Finally, building upon the monotherapy activity previously demonstrated in late line non small cell lung cancer with squamous histology, Caldoza is also under development in squamous non small cell with a randomized Phase II study sponsored by a prominent investigational group currently in the planning stages and expected to commence next year. With that, I will hand things over to Samir. Samir?

Sameer Gargalker, Executive Vice President, Commercial, Coherus Oncology: Thank you, Rosh. Q2 marked the first quarter when we operated as a dedicated innovative oncology company. This enabled us to maintain a singular focus on educating physicians on Loktorzi as a differentiated and highly efficacious PD-one for NPC patients. Our goal is to establish Loktorzi as the standard of care and preferred regimen for all eligible NPC patients. We are happy to report strong progress towards that goal.

Net revenue in Q2 was $10,000,000 a 36% increase quarter over quarter, and a 65% increase year over year. Q2 performance was driven primarily by strong demand from new patients and some positive impact from wholesaler inventory rebuild, following a drawdown in Q1. Our execution in Q2 was driven by a Lactorsi only sales force, supplemented by robust digital marketing efforts. We were focused on educating physicians on the updated NCCN guidelines, and we are pleased with the reactions that we have seen. Over 90% of the 33 NCCN institutions have now used Loktorzi in their NPC patients.

The number of new purchasing accounts has grown by 20%, an indicator of the increasing breadth of use. And we saw a 22% increase in accounts using Loktorzi in a subsequent patient after initial trial indicating greater depth of use. Among academic KOLs and head and neck specialists, we have seen a significant move towards adopting Loktorzi in both the first line and the second line plus setting. This adoption comes at the expense of off label IOs and chemo only use, both of which are non preferred in the updated NCCN guidelines. Feedback from KOLs have been very positive, and we hear a strong preference for the brand over non preferred regimens.

While we are pleased with the results of our promotional efforts, significant growth opportunity remains primarily in the community setting. Over half of the addressable patients are managed in this segment, but adoption is generally slower in community oncology than in the academic centers. There are more than three times as many target community oncologists versus academic HCPs, but these physicians typically see a much smaller number of NPC patients each year. As a result, advances in NPC treatment and NCCN guidelines are not top of mind for these physicians. So, in second half twenty twenty five, we are using a combination of Salesforce, digital, and data to unlock the community opportunity.

First, we are launching a refreshed messaging platform this month that clearly articulates a strong efficacy and superiority versus chemo only. Second, we’re developing highly engaging KOL driven digital content to help educate community oncologists. And third, we’re doubling down on our investment in real time data to drive intelligent targeting of HCPs and patients at the time of diagnosis. With a strong focus on commercial execution, we expect that Loxozy revenue will follow typical rare disease dynamics, with a steady ramp fueled by new patient acquisition and broad adoption in the community setting. I’d like to end this session by saying that we remain on track to achieve our 2025 revenue goals of between 40,000,000 and $50,000,000 and to achieve a dominant share in the NPC market, which is estimated to be in the range of 150,000,000 to $200,000,000 While Loxozy will fuel our near term growth, we’re excited about the impressive commercial potential of our two pipeline assets.

A key point I want to note at this point is that all of our clinical trials for both CHS-one hundred fourteen and casdozo are paired with Loktorzi. As a result, each new indication approval would represent a label expansion for Loktorzi, and we would realize revenue from both the novel agent and Loktorzi. Through our Loktorzi commercialization efforts, we continue to build a best in class oncology organization with proven launch capabilities. At the time of potential approval of our pipeline indications, we will be well positioned to benefit from this commercial expertise, as well as our relationships across the oncology community. For casdozo, HCC represents a US market opportunity of about $4,000,000,000 and the potential for significant improvement in patient care.

If the data readouts continue to be positive for casdozo, the commercial organization will be well positioned to support the potential for a new standard of care for patients in this area of high unmet medical need. For CHS one one four, as Denny mentioned, we believe we may have a best in class non partnered US asset. Second line head and neck cancer for this molecule is a market of about $4,500,000,000 while second line gastric cancer represents 3,500,000,000.0 and esophageal cancer comes in at just under $1,000,000,000 In isolation, any of these potential indications for our pipeline assets represent a significantly large U. S. Commercial opportunity, With the potential for multiple indications compounded by incremental ex US markets, we are very excited about our innovative immuno oncology portfolio.

While we remain in the near term focused on maximizing the NPC indication, our commercial organization stands ready to support the next phase of our growth in the coming years. With that, I’ll now pass the call to our CFO, Brian McMichael.

Brian McMichael, Chief Financial Officer, Coherus Oncology: Thank you, Sameer, and good afternoon, everyone. Today I will limit my discussion to key financial updates and refer you to our earnings press release for the second quarter and year to date 2025 figures and detailed results. I’m happy to report that Coherus has made strong progress on its operational and financial transition fully consistent with our plans outlined in last quarter’s call. Following the close of the divestiture in April we used a portion of the $483,000,000 in upfront cash proceeds to complete the payoff of substantially all the $230,000,000 convertible notes as well as buy down the UDENYCA royalty obligation. We ended Q2 with $238,000,000 in cash and investments and we project sufficient cash to provide runway through 2026 beyond key data readouts.

Cash burn continues to moderate as per plan quarter to quarter in 2025 as we wind down the transition service agreement activities associated with the divestiture and settle pre close remaining liabilities. A majority of the $97,000,000 in accrued rebates fees and reserves of the balance sheet down from $148,000,000 last year will be settled over the coming quarters through 2025 and 2026. I’m also pleased to report in Q2 we achieved additional progress on our managing of our costs and cost structure and expenditures. We now expect to save approximately $30,000,000 on an annualized basis from Q2 headcount reductions up from $25,000,000 communicated in Q1. This includes the employees transition in the divestiture and other reductions initiated during Q2.

We remain on track per plan to be at 150 FTEs or less by year end which will yield an additional approximate $5,000,000 in annualized savings over the Q1 guidance. Exiting the legacy business has allowed us to simplify our operations and reduce operating costs, particularly as they relate to supply chain and commercial activities. Net of non reimbursed transition service costs, SG and A incurred solely for Coherus programs and expenses for the full year 2025 is projected to be between 90,000,000 and $100,000,000 R and D expenses will be a function of data readouts and our ongoing portfolio prioritization process, and we’ll be able to provide more detail on that later in the year. With that, I’ll hand it over to Denny.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thank you, Brian. Let me close with a few key points that reflect the strength of our company. Our focus on our drugs, our data, and our deals with effective execution making it happen. The science behind our drugs is first rate, next generation, first in class, and arguably best in class addressing very large markets. Our data, our science is already and continues to translate strong clinical data, step change survival benefit the patients.

Strong clinical execution is keeping us on track to turn over key data cards in the first half of next year, meeting your expectations. Then there’s our deals. Excellent deal execution defined our strategic transformation into a focused innovative oncology company, and it will now unlock significant pipeline value through ex US licensing deals, which will do three things over the next six, twelve, and eighteen months. First, validate our science and our products. Secondly, monetize our global rights with upfronts.

And third, offset our global development costs for the future. And in The U. S, we will see collaborations that expand our labels cost efficiently through combinations with development partners. Strong execution across all three of these dimensions will deliver value to shareholders and is enabled by world class advisors and board members working integrally with our team. We expect our strong balance sheet to support operations through ’twenty six, well beyond our key clinical catalysts.

Operator, we’re happy now for you to open the line for questions.

Jordan, Conference Operator: Just one moment while we compile the roster. First question comes from the line of Brian Chang from JPMorgan. Your line is live.

Brian Chang, Analyst, JPMorgan: Hey, guys. Thanks for taking our question this afternoon. Maybe let’s start off with, the pipeline. As you think through your CCRA program, your 114 program in your overall approach in a near term. Can you just talk about how important it is to identify a partner to perhaps regional partners to accelerate some of the progress that you have made in the near term?

If there is interest in that, when do you think it’ll be a good time to look for a partner here? Thanks. And then we have a follow-up.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Yeah, thanks Brian for that. First of all, Ross, do you want to recap for us when we will see the data cards turned over for 01/2014?

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: Yeah, absolutely. Thanks Brian for the question. So, we will, for both molecules actually, we anticipate seeing both efficacy and safety data in the first half of next year. But specifically for CHS-one 114 for our head and neck program, we again will see efficacy and safety data in the first half of the year building, of course, on the data sets that I’ve, the very encouraging data sets actually that I’ve previously communicated. For gastric and esophageal for 01/2014, we anticipate safety in the first half of the year and then efficacy in the second half of year.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thanks. So Brian, we’re funded through those studies with the product. But as I indicated in my prepared remarks, we expect partners to work collaboratively with us and help us offset these development costs. And I think the issue of the timing really strikes also to the development of others. Teresa, do you want to add a comment?

Teresa Lovalli, Chief Scientific and Development Officer, Coherus Oncology: Yeah, thanks Brian. I think there’s a couple of key data sets as we look. Ross outlined, we’ll be getting to a recommended phase two dose. So that simplifies the development and I think makes it more attractive for partners in other regional areas. Additionally, what we showed at AACR, besides just Treg depletion and clinical response, we showed a marked infiltration of CD8 T cells, which really has caught the attention of several folks because that clearly lends itself to combinations with other modalities outside of Toropalimab such as T cell engagers.

And so I think what we’re having is active conversations with people to look for the right partner both to test other tumor types as well as other combinations. And then folks that are prioritized are tumor types where we expect to see efficacy and look at other regions. So all of those conversations are ongoing, but I think it would be really important for us to find a partner that can run with us and not complicate the speed at which we want

Denny Lamphere, Chief Executive Officer, Coherus Oncology: to move this program. And I would add two other points for you, Brian. First of all, the CCRA Treg depleter class is under vigorous development as you know globally. And there are data sets being put forward at various meetings. And we would expect that, and we would expect those data sets sometime over the next six to twelve months, say, to accelerate.

We think 2026 will be the year that CCRAs come to the fore. The second point, as Teresa indicated, is that we’re very open minded with respect to combining our CCRA with others drugs. We’re not constraining ourselves just to our own portfolio. We think there’s broad applicability for the mechanism of action here, and we intend to take advantage of that.

Brian Chang, Analyst, JPMorgan: Great. And then maybe just one quick one on lexthorothy. Just based on the trajectory and also some of the dynamics you’re hearing from doctors, how confident are you on your path towards the $150,000,000 to $200,000,000 goal for the franchise? Are there any indicators that you’re now seeing that gets you confident in yourself moving toward that goal? Thanks.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thanks, Brian. Samir, you want to handle that?

Sameer Gargalker, Executive Vice President, Commercial, Coherus Oncology: Yeah, thank you, Brian. First of all, let me just kind of answer that. So, we feel pretty confident. We expect that we’ll get to peak revenues by 2028. And just one piece of anecdotal evidence that gives us confidence.

After the NCCN guidelines got updated, we saw a pretty strong uptake in the academic setting, in the hospitals and head and neck specialists. They’re the ones who are waiting for the guidelines updates, and once the guidelines got updated, we communicated the data to them. They really jumped on the bandwagon. So, what we need to do now is do the same thing and educate the community on our datasets. So, we feel pretty confident, Ryan.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thanks, Brian.

Jordan, Conference Operator: Your next question comes from the line of Michael from TD Cowen. Your line is live.

Coherus Oncology: Hi, thank you for the question. I have two. My first question is on the anti CCR8 program. You mentioned competitor readouts that could serve as sort of stocking horses for your molecule. Are you aware of any as you survey the competitive landscape that would that you would consider proof of concept for the mechanism?

So perhaps a randomized trial? That’s my first question. And then my second question is actually on the competitive landscape for your anti IL-twenty seven. I know you have the potential here to be first in class. Have you seen any follow on molecule any follow on programs from competitors?

Are there other anti IL-twenty seven molecules in development that perhaps we don’t know about?

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thank you, Michael. Thoughtful and very pertinent questions. Tricia, do want to address the competitive profile both on the two molecules, CCRA and casdozo?

Teresa Lovalli, Chief Scientific and Development Officer, Coherus Oncology: Yeah, I’ll start with the second one first for casdozo, the key type. We are not aware of anyone else going into clinical development with an IL-twenty seven antagonist. We have garnered a lot of interest from partners with the HCC CR rate, So continue those discussions. For the CCRA, what I find compelling is every time we see a data card turned over, we’re seeing efficacy. We saw at ASCO this year that Lenovo presented data in pancreatic cancer showing a twenty two percent overall response rate, I believe, in combination with Torapalumab, which is quite impressive in refractory pancreatic cancer.

Additionally, Shinobi with their IgG1 wild type antibody, so a less potent molecule than ours, showed a complete response and a PR in colorectal cancer. A tumor type that really has MSS colorectal cancer has been underserved. So as we see each data readout come, it’s looking quite interesting. The only randomized study that has been reported publicly is Lenovo advancing in MSI high colorectal cancer. So we actively troll clinicaltrials.gov and the reporting of these molecules, as we’ve heard a lot of buzz in the community, and expect to see updates in the next year from other folks, as well as our own programs.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Just to dovetail on Teresa’s remarks, Michael, there is of course robust development activity across a number of big pharmas. No one’s talking very much right now, but we suspect over the next six or twelve months, there’s going to be quite a bit of data come to the fore, certainly maybe next year by ASCO.

Coherus Oncology: Thank you so much.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thank you.

Jordan, Conference Operator: Your next question comes from the line of Colleen Hussie from Baird. Your line is live.

Colleen Hussie, Analyst, Baird: Great. Good afternoon. Thanks for taking our questions. A few from us. You spoke about on the commercial side making some investments into the community that’s largely untapped right now.

Can you just walk us through those? And when you expect those might bear out into the sales trajectory? And then we have

Jody Sievers, Head of Investor Relations, Coherus Oncology0: a couple of follow ups, please.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Samir, you want to handle that?

Sameer Gargalker, Executive Vice President, Commercial, Coherus Oncology: Yeah. Thank you, Colleen. So, community one of the dynamics of the community is that there’s we have to target at least three times as many physicians in the community as the academic setting. And the number of patients in the community is very dispersed. So, each physician sees maybe one or two patients a year.

But at the same time, we can’t ignore the community, because half the patients are in the community. So, what’s going to happen is we’re focusing now refocusing our efforts on the community, both from the Salesforce standpoint, digital standpoint, and we’re also purchasing a lot of data to identify the physicians with the patients at the time of diagnosis. So, that whole multi pronged approach is underway. But I think because of those dynamics, the time for us to really get to peak sale is going to be about those three to four years, because making a difference in the community is going to be an ongoing process.

Colleen Hussie, Analyst, Baird: Great. That’s helpful. Thank

Brian McMichael, Chief Financial Officer, Coherus Oncology: you. And do have I follow know on question, Colleen?

Colleen Hussie, Analyst, Baird: Yep. I know historically, and you spoke to you out licensed Lactorsi in a capital efficient way to potentially expand the indications there. Is there anything on the horizon from any partners we should be aware of in terms of potential data readouts? And then on the strategy, what sort of deals do think you’d prioritize for Lactorsi licensing in the future?

Denny Lamphere, Chief Executive Officer, Coherus Oncology: I’ll handle the first one and I’ll let Teresa handle the second one. To be clear, we have not out licensed LOCK2RZ. What we have done is we have entered into collaborative strategic arrangements whereby we supply Lactorsi for others clinical trials. The strategy being that as they develop those products, we will eventually get a label that we can promote against. And we do that, the only cost to us really is just supply of the drug, which is not very significant.

So this is very cost effective.

Teresa Lovalli, Chief Scientific and Development Officer, Coherus Oncology: Yeah, on the last call we talked about STORM Therapeutics having the study ongoing and enrolling in both head and neck cancer and lung cancer, two tumor types that complement the data sets we have in hand for Tory. I mean, I can’t speak for how they would disclose data, but knowing that team, I would anticipate some update next year. The other studies are on track to start. And additionally, we would look towards more announcements later this year. We’re now only announcing them when first patient is dosed, so we don’t have to wait a long time for data.

So hopefully next year we’ll see some data readouts.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: The other point I would make pursuant to your question is a point though that Teresa makes frequently, is that if you are a company developing a new therapeutic, you wanna make sure that you have a highly active next generation PD-one. You’re not constrained to using the standard of care which will go biosimilar in a few years in 2020 or whatever. So the interest that we have had in terms of partnering and co development, I think is driven from that, is locked towards these outstanding efficacy and safety profile.

Colleen Hussie, Analyst, Baird: Great, that’s really helpful. And then last one for us, Just on the randomized Phase II for CASDOZA, Torii, Bev and frontline HCC. Can you just comment on how enrollment is going there?

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Rush, how is enrollment going?

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: Yes. Thanks for the question, Colleen. So, yes. Recruitment is going well. We are recruiting in The US and in The Far East.

So, these are active trials that, again, we’re on track to report data for in the first half of next year, both for efficacy and safety. Just recall though that with HCC in particular, responses can take a little bit of time to mature and become more kind of deeper as well, which is what we saw in our earlier trial. So bear that in mind as well. But we’re on track with improvement.

Jody Sievers, Head of Investor Relations, Coherus Oncology0: Great. Thanks for taking our questions.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thanks, Colleen.

Jordan, Conference Operator: Your next question comes from the line of Lee Chen from H. C. Wainwright. Your line is live.

Jody Sievers, Head of Investor Relations, Coherus Oncology0: Hi, this is Li Chen for Doctor. Tau. Thanks for taking our questions and congratulations on the quarter. So maybe to start with, I’m curious to know if you still follow the first line HCC patients treated with the triplet of CASL, atezo, and BAV, and if there’s any insight into the durability there? Or maybe when should we expect those data to be presented?

And I have a follow-up.

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: So, the data set that you referred to is would be a tither triplet data. And we did present the final data in January at ASCO GI. And that was the data that I referred to in my prepared remarks with an overall response rate of 38%, a CR rate of 17%, which compares obviously favorably with current benchmarks. So, that trial is the ATISO trial. The trial that we’re reporting that’s ongoing right now and that we will report out next year, early next year, terms of initial data, is the Toripalumab casdozo, bevacizumab triplet, right?

So we’ve switched obviously to our own PD-one, and that’s the patient study that I described.

Jody Sievers, Head of Investor Relations, Coherus Oncology0: I see. So I guess I’m asking for PFS and OS data from the initial results. So, it sounds like you don’t plan to report?

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: Yes. So, data was reported in January. And in terms of durability, a couple of things I’ll mention. Number one, there was a deepening of response over time and also obviously an increase in response rate. And secondly, for those responses, there was durability.

The majority of those responses were six months or more.

Teresa Lovalli, Chief Scientific and Development Officer, Coherus Oncology: But the PFS was reported as eight point Exactly. Nine So higher than INBROV 150 and the OS data is still maturing.

Jody Sievers, Head of Investor Relations, Coherus Oncology0: Great. Thanks for the clarification. And my second question is regarding the next phase of development in first line SCC. How do you think about the comparator arms for the Phase III? Do you think the data in first half twenty six will be enough for decision making?

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: Well, I think we’ll have so we’ll have initial data in terms of efficacy and safety, as I’ve mentioned, in the first half of the year. But again, in HCC, it can take a little bit of time for the data to mature, meaning it can take a little bit of time for the data, the full effect to be realized, right, in terms of depth of response. So once we have that, the next stage we anticipate will be a next stage trial, phase two, phase three, with compared to the current standard of care, the majority of, in the majority of countries worldwide, the current standard of care is Atezo Veb. So, that’s what we anticipate will be the comparison. And again, some of those benchmarks that I mentioned earlier of thirty eight percent for us, for overall response rate compared to thirty percent for Atezo Bev.

And also seventeen percent CR rate for our combination versus around eight percent for the CR rate. That gives us confidence at this stage.

Jody Sievers, Head of Investor Relations, Coherus Oncology0: Right. Thanks again for the questions. And congratulations.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thank you.

Jordan, Conference Operator: Your final question comes from the line of Jason McCarthy from Maxim Group. Your line is live.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Hey guys, thanks taking the question. So thinking longer term, given your extensive knowledge of biosimilars, do you foresee any risk of off label competition when KEYTRUDA comes off patent and begins to face pricing pressure from biosimilars? Thank you for your question, Jason. I’ll let Raj take a look at that. Raj?

Dr. Rosh Dias, Chief Medical Officer, Coherus Oncology: So, yeah, thanks for the question. So, in NPC specifically, a few points I’ll mention. First of all, I think it’s very well appreciated that Toripalumab is a differentiated PD-one on its molecular characteristics, as well as on some of its clinical characteristics as well. For NPC specifically, we remain the only approved and available therapy within The US. So, the approval is with us.

Secondly, we have really the only positive data compared to pembro and NEVA do not have positive data in NPC. And thirdly, we are the only preferred therapy on NCCN guidelines with first line categorization for, essentially category one designation in first line specifically. So yes, we do not anticipate any effect from that perspective. I

Denny Lamphere, Chief Executive Officer, Coherus Oncology: would say unequivocally none. You know, there’s a failed phase two study. We are the only label PD-one, and think that there’s a good appreciation by physicians of the power of strong data, and our data is very, very strong for nasopharyngeal cancer.

Teresa Lovalli, Chief Scientific and Development Officer, Coherus Oncology: And you have to remember that biosimilars only get the label for the reference product. So it would be

Denny Lamphere, Chief Executive Officer, Coherus Oncology: They would not have a label.

Jody Sievers, Head of Investor Relations, Coherus Oncology0: Yeah.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Yeah. But thanks for the question. Your

Jordan, Conference Operator: final question comes from the line of Douglas Tsao from H. C. Wainwright.

Jody Sievers, Head of Investor Relations, Coherus Oncology1: Hi, good afternoon. Can Thanks for taking the you hear me? Yes, we hear you, Doug. Hey, thanks for squeezing me in. And I hope I didn’t miss it, but I did want to ask about the impact of the guidelines.

I think you touched on sort of the difference between the Centers of Excellence as well as in the community setting. And I’m just curious, are the guidelines sort of permeating or the impact of the guidelines permeating out into the community and it’s just taking a little bit longer? Or is it really they are not necessarily following them as closely as what you’re seeing in the major academic centers?

Denny Lamphere, Chief Executive Officer, Coherus Oncology: That’s a good question on the guidelines. Samir, can you just recap the guidelines for Doug, just briefly and how we do it?

Sameer Gargalker, Executive Vice President, Commercial, Coherus Oncology: Yeah, we’re very excited about the guidelines. The guidelines put us in a category one preferred position, Loxozy plus chemotherapy. So we’re the only ones in that preferred position. So after the guidelines got in were put in place, we did a lot of work with the hospital setting, KOLs, and head and neck specialists, and we were able to really move the needle. And we’ve gotten a lot of hospital specialists and head and neck specialists using Loptoxy because they’re the ones who see a lot of patient volume.

The issue in the community is it’s not so much that they don’t follow the guidelines, they only see a very small number of patients every year, and they just go by what they remember from last time. And it takes a while for them to head and neck basically, or nasopharyngeal carcinoma is not top of mind for them. So it’s our job to keep detailing them and educating them until those guidelines get really established in their practice. So it’s going to be a process, but we’re really focused on executing that process. And we believe that we will make an impact to the community as well.

Jody Sievers, Head of Investor Relations, Coherus Oncology1: Okay, great. Thank you so much. And congrats on the progress.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thanks, Doug.

Jordan, Conference Operator: There are no questions. That concludes the Q and A session. I’ll turn the call back over to Denny Lansier for closing remarks.

Denny Lamphere, Chief Executive Officer, Coherus Oncology: Thank you. Thank you all for joining us on our call. I think as you can see in today’s call, we’ve really hit our stride with regards to the execution, both clinically and commercially and otherwise with the company. Strong balance sheet will keep us moving through next year while we turn over the data cards. And we look forward to seeing you guys at the Barrett and the HCW conferences the second week of New York.

Thank you.

Jordan, Conference Operator: This concludes today’s conference call. You may now disconnect.

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