Coherus Oncology Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 12, 2025

Key Takeaways

  • Coherus is now a commercial-stage innovative oncology company with an FDA-approved next-generation PD-1 inhibitor, Lactorsi, and two proprietary pipeline products (CHS-114 and casdozokito) progressing in early- to mid-stage clinical trials.
  • Management projects Lactorsi NPC sales to reach $150–200 million annually over the next three years, driven by strong NCCN guidelines and partner-funded label-expansion trials in head-and-neck and small-cell lung cancer.
  • CHS-114, the only known highly selective anti-CCR8 antibody, demonstrated >50% tumor Treg depletion, marked CD8+ T-cell infiltration, and a partial response in fourth-line head and neck cancer, with FDA alignment on Phase 2 dosing via a Type D meeting.
  • Casdozokito combination data in first-line hepatocellular carcinoma showed a 38% overall response rate and 17% complete response, and a Phase II trial of casdozokito plus Lactorsi and bevacizumab is underway, with data expected in H1 2026.
  • In Q1, Lactorsi patient demand grew 15% despite flat revenue of $7.3 million due to seasonal inventory drawdown, while the company strengthened its balance sheet with $483 million in divestiture proceeds and expects $25 million in annualized cost savings.
AI Generated. May Contain Errors.
Earnings Conference Call
Coherus Oncology Q1 2025
00:00 / 00:00

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Operator

Good day, and thank you for standing by. Welcome to the Coherus Biosciences First Quarter twenty twenty five Earnings Conference Call. At this time, participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

Operator

I would now like to hand the conference over to your speaker today, Jody Sievers, Head of Investor Relations. Please go ahead.

Jodi Sievers
Vice President of Investor Relations & Corporate Communications at Coherus BioSciences

Thank you, Shannon. Good afternoon, and welcome to Coherus Biosciences first quarter twenty twenty five earnings conference call. Joining me today to discuss our results are Denny Lamphere, Chief Executive Officer of Coherus Brian McMichael, Chief Financial Officer Doctor. Raj Dayas, Chief Medical Officer Doctor. Theresa Lavalli, Chief Scientific and Development Officer and Sameer Gurukaukar, Executive Vice President, Commercial.

Jodi Sievers
Vice President of Investor Relations & Corporate Communications at Coherus BioSciences

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. These statements include, but are not limited to, the following: expectations about repurchasing Coherus' remaining convertible notes projections of cost savings from headcount reductions timing for Coherus to release data from its clinical trials and projections of future expenses. 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 that are discussed in our press release that we issued today, as well as our quarterly report on Form 10 Q. 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 hand the call over to Denny.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Jody, and thank you everyone for joining us today on our Q1 twenty twenty five earnings call. First, let me say that with our biosimilar divestitures behind us and our promising innovative oncology business in front of us, we are fully focused on innovative oncology. We are now a commercial stage innovative oncology company, with an FDA approved next generation PD-one inhibitor, Lactorsi, as well as two highly promising proprietary pipeline products moving quickly through early to mid stage clinical trials and demonstrating positive data for large markets. Our strategy is anchored around three core pillars that drive both our near term revenue growth as well as our long term innovation as we strive to extend the survival of cancer patients. The first pillar is Torapalumab, our next generation PD-one inhibitor, brand name Lactorsine, which is the only FDA approved and available treatment for metastatic recurrent locally advanced nasopharyngeal carcinoma in all lines of therapy and the standard of care in MPC.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Demonstrated to be efficacious in a number of cancers and active in low PD L1 tumor types, Torpalimab derives its differentiation from its unique binding epitope on PD-one, the FG loop of the receptor. We have demonstrated that this results in differential and superior signaling within the T cell. Clinically, in at least three phase three studies, Toropalumab in combination with chemotherapy has shown efficacy irrespective of PD L1 status. These properties make Toropalb ideal as a combination agent for other cancer therapeutics, which I will discuss directly. The Lactorsi growth is now focused on increasing the breadth and depth of market penetration, driven by strong NCCN guidelines, as well as the duration of treatment in patients to maximize patient benefit.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Uncumbered by the strategic diversions in the last two quarters, that is the divestiture and the supply interruption issues, as well as the field team remapping efforts, it's now clear that our commercial team will be able to deliver consistent growth going forward. Sameer Goregalker, our Executive Vice President Commercial, will be describing this for you in greater detail in just a moment. We project lactorzi in just the NPC indication alone will grow to about 150,000,000 to $200,000,000 annually over the next three years, providing non dilutive funding for the development pipeline, as well as being an important source of revenue going forward as we seek to expand its indications and non NPC sales. Once we exceed about $15,000,000 per quarter, we will cover our commercial costs and begin to contribute to corporate expenses, progressively moving to cover R and D costs with revenues. A key development focus is on expanding the indications for lactorzine in combination with other agents, including our own, to extend patient survival across tumor types, which creates a market opportunity for current pipeline candidates of over 15,000,000 annually.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

A key part of this is an elegant, efficient, and aggressive indication expansion strategy based on partnerships, whereby we supply drug to various partners who then fund all other clinical trial costs themselves. Once approved, these partner combination agent labels will specify torpalimab. We have put several of these agreements in place, which include pivotal trials such as with INOVIO in HPV positive head and neck cancer, as well as a number of earlier stage assets. Our objective is to be the preferred partner of choice for companies needing a safe and highly efficacious next generation PD-one inhibitor. More such arrangements are in the process.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Additionally, our partner Genxi has a pivotal study underway with Torpala in combination with BTLA in small cell lung cancer subtype, which would also provide an additional approved indication. We are also developing additional indications for Toripalumab in combination with our proprietary pipeline, which includes casdozoketogue, a first in class anti IL-twenty seven antibody, and CHS-one 14, our CCR8 cytolytic antibody in several cancers. Particularly, we believe that the broad therapeutic promise of selective Treg depletion in a tumor microenvironment facilitating the infiltration of CDA positive T cells to attack the tumor may finally be realized with a sufficiently selective CCR8 cytolytic antibody such as CHS-one 14. Ourselves and others believe the anti CCR8 class could see broad applicability across a number of solid tumors, turning cold tumors hot and constituting an emerging cancer therapeutic superclass synergistic with other modalities such as T cell engagers, ADCs, bispecifics, and others. Accordingly, our development efforts with CHS-one hundred fourteen constitute the second pillar of our value creation strategy.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

We believe that CHS-one hundred fourteen is potentially best in class, as it is highly selective in the product of an extensive product candidate selection process that resulted in the only CCR8 agent with no off target binding. What is most striking about this program, and what gives us such confidence, is the translational read through from binding to Treg depletion to CD8 plus T cell tumor infiltration to clinical efficacy. We recently presented the first US clinical data with a CCRA at AACR last week, showing visually compelling biomarker data illustrating the elimination of Tregs, infiltration and inflammation of the TME by CD8 plus T cells. Remarkably, in this study, there was also a partial response showing tumor shrinkage in a very advanced fourth line head and neck cancer patient, which Doctor. Dias will discuss directly.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

We believe that our very thorough and deliberate scientific translational approach and developing datasets position Coherus as the thought leader expert in this rapidly evolving field. Of such high promise. The third pillar of our development value creation strategy focuses on pioneering novel treatment paradigms in the first line hepatocellular carcinoma, a significant unmet need with large market potential. These efforts are centered on cas doso ketone, our first in class anti IL-twenty seven. Earlier this year, we announced very compelling data in first line liver cancer, where five out of twenty eight patients, some seventeen percent, had complete response in a phase two efficacy study of cassoketog combined with atezo and beva.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

This compares very favorably to the standard of care alone, or even other studies in this indication. Building on this very positive data, we are now conducting a Phase II trial evaluating casidosokitoid with lactorazine and bevacizumab. We expect data in the first half of next year. Also in liver cancer, our partner Junshi is conducting a phase three pivotal study with Lactorsi combined with lenvatinib, which should read out in the next three to six months. If successful, we will seek to engage the FDA regarding potential approval approaches.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

In summary for the development and value creation strategy now, let me make two key points for you. First, as you know, we felt it essential as an innovative oncology company to have an approved and proprietary PD-one inhibitor. It is now apparent why. Such an approach first allows great latitude and cost savings while developing your own synergistic combination agents. This offers the opportunity for others to embrace your PD-one, co develop it with their own assets at minimal cost to Coherus as we realize expanded legal indications and result in higher revenues.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Additionally, when your PD-one is combined and approved with your own proprietary agents, you set up the opportunity to realize sales multiples by realizing revenues on both agents. Because as your novel agents get approved, you can mark your PD-one right alongside. My second key point is that clinical data readouts that are occurring in 2025 support these product candidates with safety, initial efficacy, and proof of mechanism data that builds momentum as we look forward to initial key data readouts for these studies projected in the first half twenty twenty six. Today you will hear next from Doctor. Teresa Lavalle, our Chief Scientific and Development Officer, who will be followed by Doctor.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Raj Dias, our Chief Medical Officer. Doctor. Dayas will provide you with an update on clinical trial rationale, study designs, and progress to date. Then you will hear from Sameer Gurgaugkar, our Executive Vice President of Commercial. Samir joined us late last year to lead the Lactore franchise and will give you a detailed rundown on the key market drivers impacting revenues, uptake, and the like.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Following that, I will turn the call over to Brian McMichael, our Chief Financial Officer. Brian will review the closeout of Q1, the divestiture of the UDENYCA business, and financial impact of these discontinued operations. He will also review the Q1 overall numbers and provide SG and A guidance looking forward through the end of twenty twenty five. Now with that, I'll turn the call over to Doctor. Lavalli to review the scientific rationale of our pipeline product candidates and the expansion strategy for Lictorsi.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Teresa will particularly focus on the biology of the emergent CCRA class, including CHS-one 14, which is a preeminent candidate given its high selectivity. Theresa?

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Thank you, Denny, and good afternoon. We are pleased to update you on our continued progress in 2025 with key regulatory and clinical translational advancements of our promising pipeline in combination with our next generation and differentiated PD-one inhibitor, Torapalumab. There are three key components of Coherent's value creation scientific and development strategy, and I will focus my remarks today on what we view is of high potential impact our CTRA targeted antibody, CHS-one 14. First, let me review for you what Denny alluded to earlier, our elegant and efficient toripalumab label expansion strategy. Our strategy for expanding toripalumab indications beyond MPC in The United States is first to put in place drug supply collaborations where we evaluate toripalumab with other novel drugs across a variety of mechanisms.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

We have prioritized collaborations with strong MOA rationale and clinical safety and efficacy data evaluating tumor types such as head and neck and lung cancer in clinical trials. These are tumors that overlap with our existing commercial call points. The second area of Torapalumab indication expansion is combination therapy with our own pipeline of potent and selective antibodies positioned in tumor types with strong biologic rationale to establish proof of concept. For each clinical indication that advances kazdosahedrug CHS-one hundred fourteen into a pivotal study, that study also advances Torapalumab into a potential new indication as a combination regimen. These efforts include Capdoza Key Tug in liver and lung cancers and CHS-one hundred fourteen across a wide variety of solid tumor types.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Given our recent head and neck cancer presentation at AACR, today I will focus on CHS-one hundred fourteen as we believe CCR8 to be an emerging target that may address unmet medical needs for a variety of tumor types and combination agents, and our compound, CHS-one hundred fourteen, has the requisite pharmacology and clinical proof of mechanism needed for success. For background, T regulatory cells, or Tregs, are known for their ability to suppress effector T cell function in the tumor microenvironment and are associated with PD-one resistance. Genetic defects with complete knockout of all Tregs in humans leads to inflammation and autoimmunity. Effective drug targeting of Tregs in cancer patients requires antibody based strategies that target selective expression of a protein on Tregs and tumors and not in normal tissue, and secondly, selective target Tregs and not normal CD8 and CD4 T cells, immune cells needed for antitumor immunity. CCR8 was identified from single cell sequencing experiments of Tregs in tumors and is a G protein coupled receptor that is upregulated preferentially on tumor resident Tregs and has limited expression in other tissues or on other cells, including CD8 and CD4 T cells.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

While there are over four fifty drugs targeting GPCRs and approximately one third of all FDA approved drugs target this class of receptors. Only about five antibody drugs targeting GPCRs have been approved so far, highlighting the challenges in generating and developing therapeutic antibodies for these receptors. GPCRs are seven transmembrane spanning receptors with a limited amount of protein on the outside of the cell, which makes them difficult targets to generate antibodies with selectivity. Said another way, having an antibody drug candidate that has no off target binding or non CCR8 protein binding is a challenge. To date, CHS-one 14 is the only known selective CCR8 antibody.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

As we profiled some of the competitor antibodies, we identified off target binding, including one that binds J chain. This off target binding has the potential to lead to gut toxicity. Let me now discuss the dosing and clinical biomarker data for CHS-one hundred fourteen that has shown targeting CCR8 results in selective depletion of CCR8 positive Tregs, but not CD8 or CD4 T cells. Furthermore, the safety profile has not shown autoimmunity and has a manageable safety profile to date. Two critical aims for advancing the development of CHS-one hundred fourteen is addressing FDA's Project Optimist sufficiently to define a recommended phase two dose and establishing that the drug candidate does what it is intended to do, deplete Tregs in the tumor.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

At the AACR meeting last month, we presented the results from our ongoing clinical trial in a head and neck cancer expansion phase evaluating treatment with CHS-one hundred fourteen alone or in combination with Torapalumab at two pharmacologically active doses. I will highlight the CHS-one hundred fourteen monotherapy dosing and biomarker aspects of the study, and Doctor. Dayas will further elaborate on the clinical safety and efficacy data. Importantly, in paired tumor biopsies, we show that following treatment with CHS-one hundred fourteen, there is greater than 50% depletion of CCRA positive Tregs. These data strongly support the CHS-one hundred fourteen doses as being pharmacologically relevant.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

And this targeted therapy leads to selective depletion of Tregs in tumors. We are pleased to say that we recently had a Type D meeting with FDA to review these data and gained alignment on the acceptability of the approach and doses for addressing Project Optimus and defining a recommended phase two dose. We are on track for defining the dose early in 2026. The second aspect of the biomarker studies that I want to call out as being a surprise and exciting is that this CHS-one hundred fourteen mediated Treg depletion was accompanied by a marked increase in tumor infiltrating CD8 T cells. We did not expect Treg depletion to promote this level of CD8 T cell recruitment in the tumor.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Why this is important is that it is evidence that Treg depletion with CHS-one hundred fourteen is a potentially promising combination for immunotherapies broadly. Internally, we are focused on combination with Torapalumab and addressing mechanisms of PD-one resistance with the aim of bringing treatment to many of the seventy percent of cancer patients that are underserved by PD-one inhibitors. Moreover, this impressive increase in tumors immune infiltrate supports combination with T cell engagers, bispecific antibodies, ADCs, radioligands, and CARs to name a few. We own global rights for CHS-one hundred fourteen, and these exciting and compelling clinical data can support discussions with potential partners to evaluate CHS-one hundred fourteen with agents other than Toropalimab while we work to rapidly advance our sponsored clinical studies. Doctor.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Gaius will update you further on clinical data for cabozoketog and CHS-one hundred fourteen. Raj?

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Thank you, Theresa. Let me focus on the significant progress we've seen with our internal pipeline of CHS-one hundred fourteen and casdosahed ketog, which we're developing in combination with Toripalumab. We're very excited about the positive data with CHS-one hundred fourteen, our highly selective CCR8 cytolytic antibody, as it's part of an emerging class of moieties with significant potential to impact solid tumor therapies across a number of modalities. The promise, as Theresa explained, is to turn cold tumors hot, enabling immune response and overcoming PD-one resistance. We're exploring CHS-one hundred fourteen in head and neck squamous cell carcinoma as well as gastric cancer, both tumor types where CCR8 density and prevalence are high, and therefore a strong supporting biological rationale exists for therapeutic impact.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Data is now emerging that validates that rationale. At AACR two weeks ago, we presented CHS114 data from our head and neck squamous cell program, which was, to our knowledge, the first US focused trial data presented to date within the CCR8 class. We reported data from twenty one patients with advanced head and neck squamous cell carcinoma in late lines of therapy. Twelve of the twenty one received CHS-one hundred fourteen monotherapy, and seven received combination therapy of CHS-one hundred fourteen with toripalumab. We're very excited and encouraged to report that of the first seven patients receiving combination therapy, there was one confirmed partial response.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

This advanced very late in therapy fourth line patient with oropharyngeal squamous cell carcinoma had lung metastases and low immunogenicity features and had received prior therapy with multiple agents, including a prior PD-one, a TKI, and a taxane. Impressively, this patient achieved a 40% reduction in target lesions as well as response in non target lesions. The fact that we saw this response is impressive for several reasons. First, this was in a very late line patient who had endured substantial and multiple prior therapies and was additionally refractory to prior PD-one treatment. This is important to note because the head and neck squamous cell patient population anytime after failure of a first line agent tends to have very limited additional treatment options in the second line setting and even more limited in even later lines.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Additionally, the fact that we achieved a partial response in fourth line suggests that the CHS-one hundred fourteen toripalumab combination may have reversed PD-one resistance, in effect turning a cold tumor hard. Deep and sustained partial response in this resistant population sets us up very well as we move into the earlier line setting. And our focus moving forward is in the second line setting, specifically in less refractory patients. Secondly, this clinical observation is scientifically consistent with the biomarker data that Therese has outlined, which showed impressive Treg depletion and immune activation, suggesting that the clinical data follows the biology of the tumor. This is consistent with a robust and deliberate biologically driven approach we follow throughout our program.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Safety was also acceptable and manageable with overall treatment emergent AEs being generally well balanced for monotherapy and combination, which is a very important consideration in this late line population that tends to have a worse performance status. In the CHS-one 14 study, in addition to the partial response observed, we also reported stable disease in two subjects in the combination arm and four subjects in the monotherapy arm. Considering that this was in a heavily pretreated population that was refractory to prior therapies and in a target where one may not typically expect monotherapy activity, these positive results are highly encouraging. At ASCO twenty twenty four last year, we presented data from the dose escalation portion of this trial reporting a forty seven percent stable disease rate in a heavily pretreated population. These most recent findings are consistent with those data reinforcing biological and scientific rationale.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

We're now actively accruing an additional 40 head and neck squamous cell patients to an expansion cohort of this study in an earlier line of therapy that is second line patients using CHS-one hundred fourteen in combination with Toripalumab, and we anticipate reporting results of data in the first half of next year. We've also opened a CHS-one hundred fourteen study in a second tumor type, second line gastric cancer, where again, there is strong biological rationale and where clinical proof of concept exists. This 40 patient study will explore the same two biologically active CHS-one hundred fourteen dose levels in combination with toripalumab. This multinational study includes both US and ex US sites with an anticipation of results in 2026. As you've heard from Teresa, the Treg depletion mechanism is synergistic and complementary with other modalities as well as across other tumor types.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Accordingly, we're in the process of evaluating additional tumor types and modalities to explore with CHS-one hundred fourteen both on our own and with potential partners. Regarding casidos keto, our first in class IL-twenty seven antagonist, our focus remains on both non small cell lung cancer and hepatocellular carcinoma. For non small cell, our focus is in squamous cell carcinoma specifically, where we have seen our signal to date and we anticipate reporting further news on this program over the coming months. For HCC, our multinational study in first line exploring the triplet combination of casdozo in combination with toripalumab and bevacizumab is active and is currently accruing patients. As a reminder, study builds upon the very exciting data presented at ASCO GI in January, which reported an overall response rate of thirty eight percent with a seventeen percent CR rate with casdozo and bev in combination with Atezo.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Importantly, this compares very favorably with current standard benchmarks in this setting where no other agents have reported CR rates in double digits in the phase three setting. Our safety profile was consistent with Atezo bev alone. We're currently actively accruing patients in the toripalumab triplet study exploring two biologically active doses of casdozo in combination with tori and bev compared to toribev alone in a total of 72 subjects. The objective is to address Project Optimus and provide contribution of components as we advance the development pathway to Phase IIIII. With that, I'll hand over to Samir. Samir?

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Thank you, Raj. Over the course of Q1, the commercial team has been focused on two priorities. First, concurrent with the UDENYCA divestiture, we remapped territories, updated customer assignments, and assessed a talent pool for the highly clinical sales demanded by Loughtoresi. We are happy to report that our Salesforce restructure work is complete, and all field staff were in place in their new assignments immediately following the divestiture. While the restructure is a short term headwind, our Lactroly only sales team is now laser focused on driving rapid growth in appropriate NPC patients.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Second, we drove HCP education on the new NCCN guidelines, which accurately reflect the strength of our data and place Loptoirzi in a preferred position for recurrent and metastatic patients. There are still a significant number of patients receiving non preferred chemo only and off label IO treatments. Thus, we continue our efforts to educate physicians on the survival benefit of Loporzine in combination with chemotherapy. While Q1 was a transitional quarter in the middle of a significant corporate transformation, we are excited to share that patient demand grew 15%. Revenue was flat at 7,300,000.0 due to a seasonal inventory drawdown despite strong demand growth.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Demand growth came from an increase in new patient starts and an increase in duration of treatment. New patient starts came from two sources. First, if new accounts and oncologists starting using Loptoxy for the first time in their NPC patients. We're happy to see an increasing breadth of Loptoxy use in both the academic and community setting. Over 400 accounts now have experience with the brand.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

The second source of new patient starts was depth, a repeat use in accounts with prior Loptoirizy experience. Feedback from physicians who have tried Lactorsi have been very positive. And in Q1, we saw a growing number of accounts using Lactorsi on a subsequent patient. Duration of treatment also continued to increase. Earlier stage patients would be expected to stay on therapy longer, and we see about two thirds of our business coming from relapsed locally advanced and first line metastatic setting.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

While it's too early to comment on the average duration of therapy, growth in duration is progressing according to our expectations. As a singularly focused oncology commercial organization, we will further establish Loptoresi as the standard of care for all eligible MPP patients. Our commercial execution centers on three priorities. First, enabling the sales force to leverage real time data to drive patient and HCP identification at the time of diagnosis. Second, expanding the breadth and depth of adoption by educating oncologists on our strongly differentiated clinical profile and preferred NCCN guidelines.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

And finally, engagement with key customers to encourage updating MPC pathways and order sets to reflect our label and preferred NCCN recommendations. In summary, we continue to expect that Loptoirzia will achieve a dominant share the NPC market that we estimate to be valued at 150,000,000 to $200,000,000 With that, I'll now turn the call over to Brian McMichael, our Chief Financial Officer. Brian?

Bryan McMichael
CFO at Coherus BioSciences

Thank you, Samir, and good afternoon, everyone. Today I will discuss the successful closing of the UDENYCA divestiture, which occurred at the beginning of Q2, and the related discontinued operations presentation reflected in Coherus' financial reporting. I will then conclude with the first quarter twenty twenty five results. In accordance with the relevant accounting rules, the results of the biosimilar business, which comprises UDENYCA, Simerly, and YUCIMRI, have been collapsed into a single discounted operations line in Coherus' P and L. The balance sheet includes a similar treatment.

Bryan McMichael
CFO at Coherus BioSciences

This presentation is retroactive, so comparative periods such as Q1 twenty twenty four have been recast. The remainder of the P and L comprises continuing operations, including Loktorzi, the IO pipeline, and transition services transactions for divestitures. The proceeds from the Udentica divestiture and the use of a portion of those proceeds will not be reflected in our financial reporting until we report our Q2 results. As a reminder, we received $483,000,000 of upfront cash in April. Also in April, we repurchased $170,000,000 principal amount of our convertible notes in privately negotiated transactions.

Bryan McMichael
CFO at Coherus BioSciences

We expect to purchase the remaining $60,000,000 of convertible notes by mid May, provided that they are tendered by the holders of those notes. Finally, also in April, we paid $48,000,000 to buy the remaining royalty on UDENYCA in conjunction with the close of the divestiture. The net cash from these transactions is almost $200,000,000 after deducting transaction fees and taxes and is in addition to the $82,000,000 in cash Coherus had on its balance sheet at 03/31/2025. The majority of the $60,000,000 in accounts receivable and $148,000,000 in accrued rebates, fees, and reserves reflected on the 03/31/2025 balance sheet were related to UDENYCA and were not transferred in the divestiture. Most of these balances are expected to be settled in a front loaded fashion over the remainder of the year.

Bryan McMichael
CFO at Coherus BioSciences

Following the divestiture, we expect to achieve approximately $25,000,000 in annualized savings from lower headcount, with more than half already being realized due to the transfer of approximately 40 employees at deal close in April. We anticipate realizing the full annualized savings benefit by year end. We further expect additional savings in SG and A due to lower commercial and other costs. Costs associated with reimbursed transaction services paid fully by acquirers are expected to be several million dollars through the end of this year. Net of non reimbursed transaction services service costs, SG and A incurred solely for Coherence programs and expenses for full year 2025 is projected to be between 90,000,000 and $100,000,000 R and D expense will be a function of data readouts and our portfolio prioritization process, and we'll be able to provide more detail on this later in the year.

Bryan McMichael
CFO at Coherus BioSciences

Turning to the results for the quarter compared to Q1 last year, starting with COGS because Samir already covered revenue. COGS from continuing operations was $2,700,000 an increase from $1,400,000 in Q1 last year due to increased Loktorzi sales. As a reminder, there is a royalty of the low 20% range on net sales of Loktorzi. We do not expect tariffs to have a significant impact on Coherus' margins. R and D from continuing operations was $24,400,000 a decrease of just over $4,000,000 or 14% from Q1 last year.

Bryan McMichael
CFO at Coherus BioSciences

The change reflects savings from reduced co development with Junshi, partially offset by increased investments in Clogiris' internal programs CHS-one hundred fourteen and Castozokitu. SG and A from continuing operations was $26,000,000 a decrease of $14,200,000 or 35% from Q1 last year. Dollars '6 point '8 million of the decrease was due to non recurring charges for the net write down of acquired outlicenses in Q1 last year. The remainder of the decrease was primarily due to savings from lower headcount. The net loss from discontinued operations for the quarter was $9,200,000 as compared to net income of $170,900,000 in Q1 last year.

Bryan McMichael
CFO at Coherus BioSciences

The primary driver for the difference was the $153,600,000 gain on sale of the Similee ophthalmology franchise in March 2024. In addition, net revenues from discontinued operations were $32,100,000 in Q1 twenty twenty five and $74,800,000 in Q1 twenty twenty four, driven by divestitures in 2024 and wholesaler allocations allowed following the Q4 twenty twenty four supply interruptions that were not lifted until the February. With that, I'll hand the call back over to Denny.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Brian. With our strategic transformation now complete, we are well positioned to execute on our mission to bring innovative therapies that extend the survival of cancer patients while building a sustainable oncology franchise that delivers long term value for our shareholders. We're happy to open the line for questions. Operator?

Operator

Thank you. Our first question comes from the line of Kripa Devrakhanja with Truist Securities. Your line is now open.

Kripa Devarakonda
Kripa Devarakonda
Vice President - Biotechnology Equity Research at Truist Securities

Hey guys, thank you so much for taking my question and congratulations on all the progress, especially with CFS114 presentation at AACR. I have a question on locturizine. Given the drug's preferred position with the NCCN guidelines, what do you think needs to happen? I know you provided a lot of color during your prepared remarks, but what do you think really needs to happen to see a significant inflection point? As you're running more Tory trials and ahead of substantial data next year, do you think the awareness around Tory is increasing amongst providers?

Kripa Devarakonda
Kripa Devarakonda
Vice President - Biotechnology Equity Research at Truist Securities

And then maybe a big picture question in the context of all the macro elements headwinds that the industry is facing. A lot of changes at FDA. I would just love to hear your comments on the recent changes and if you're concerned about any of them. Thanks.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Kripa. Let start with the last point first. I'll let Doctor. Lavalli address the issue of the FDA changes. Theresa?

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Sure. Thanks for that question. Obviously, we spend a lot of time observing what changes are occurring and also trying to keep our fingers on the pulse. But the aspects that I think are to our advantage is as the FDA has staff that's turning over, you're losing some of the experience there. And so having well thought through, quality packages with strength of development really is an advantage to people with strong development expertise.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

So I think that we always do that. My goal is to have the packages we submit very readable, describing how this is in line with the guidance, and exactly what we're doing and why. Our experience to date has not seen anything. We were surprised to get a Type D meeting instead of just written responses only for our dosing discussion. And the other thing I'll say is going through challenges is something that I think we've done repeatedly.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

So getting Tori approved through COVID travel restrictions to China was not your usual rule book, but we just will find a way to get it done.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Just to dovetail Theresa's remarks before Sameer addresses your secondary question, Gripa, we were the first ones out of the gate with pegfilgrastim biosimilars, and they were handing out a lot of complete response letters at the time. We were there when the FDA changed direction with respect to the applicability of Chinese data. And I think this is a business really where you just have to adapt and do good science, as Teresa said, and deal very straightforward with the FDA. And we have a very strong track record of doing so. Now regarding your questions about Torii and the inflection point for the cells, and secondarily any issues in how the clinical trial program can increase awareness. I'll let Samir address that. Samir?

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Thank you for the question, Trippa. So let me make a couple of points here. So what we're really excited about Q1 was we saw 15% growth in end user demand. So these are real physician level patient demand that we saw increasing in Q1. We also saw an increase in the breadth.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

We define that as the number of new accounts starting block towards E, we had about 75 new accounts starting in Q1 that had never used Loptoirzi in the past. We also had 25% of the former users have used Loptoirzi again for subsequent use. And what we're seeing is when we ask physicians who have used Lactorsi in the past, they are very satisfied with the product, and the next time they have a new patient, they usually start them on the product. So those are all the great things that we saw in Q1. That being said, I do want to kind of reemphasize what we discussed in the last earnings call and also I alluded to today.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

The supply interruption was real. Our sales force in Q4 lost a bit of momentum because the focus had to change on UDENYCA in Q4. And in Q1, we did have the restructure of the sales force, their territories were remapped, and the reps had new customer relationships to build. So that did impact the momentum a little bit, but despite that, we did see a 15% growth in the demand, right? These are going to be transitional and temporary events.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

In Q2 and onwards, our sales force will be firing on all cylinders, and we expect to see an acceleration in the growth.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

And one last point I'll make is, as we've said in the past, NPC is a rare cancer, so it will be a steady ramp up. We expect to get market leadership in terms of share in the near future, this year or next year. But until a physician has an NPC patient, which happens once or twice a year, they're not actually thinking about So it is going to take a steady ramp up here for us to get there.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Kripa.

Kripa Devarakonda
Kripa Devarakonda
Vice President - Biotechnology Equity Research at Truist Securities

Thank you so much.

Operator

Our next question comes from the line of Brian Chang with JPMorgan. Your line is now open.

Brian Cheng
Brian Cheng
Senior Biotech Analyst at J.P. Morgan

Hi, guys. Thanks for taking our call this afternoon. Can you clarify what you meant by patient demand for Leporzi? I just want to confirm if that 15% that you quoted is referring to the number of patients that are in commercial supply? I have a quick follow-up. Thank you.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Yeah. So we look at revenue and demand as two different things, right? So wholesalers purchasing our product, we have that going in inventory. And then the end user, which is the actual clinics buying the product from the wholesaler, that's the demand. And the demand is usually a direct indicator of actual patient growth, because in this disease state, physicians are not stocking inventory on their shelves.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

So two things to remember, right? The revenue reflected by actual demand and inventory, and the end user demand is actual true patient demand. Thanks, Brian. Your follow-up?

Brian Cheng
Brian Cheng
Senior Biotech Analyst at J.P. Morgan

And then one quick one just on the Salesforce restructure here. Can you talk a little bit more about whether there will be still be impact in the second quarter? As we model out the rest of the year, how should we think about just the projection for LUTORIZI for the remainder of the year and also into 2026? Thank you.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Yeah, thanks for that question. So, we believe that the sales force restructure impact was still primarily in Q1. We did a lot of work during the restructure phase of retraining the sales force, reestablishing relationships. So we believe that Q2 is going to be a time for us to grow the business, time for us to grow demand. So we expect that Q2 and Q3 will be time for growth for the brand.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Yeah, I would just add, Brian, that on the August call we reported Q2. We'll probably have some interesting projections for you on how we'll land for the year and how the sorting out sales team went.

Operator

Thank you. Our next question comes from the line of Mike Nettalkovich with TD Cowen. Your line is now open.

Michael Nedelcovych
Director - Equity Research at TD Cowen

Hi, thank you for the questions. I have two. One is a follow-up on Lactorsi. You noted that it could take some time to take share in NPC in part because Lactorsi is not stocked, at all institutions. Should we take that to mean that PD-1s like Keytruda and Opdivo are still being used off label to a high degree in NPC?

Michael Nedelcovych
Director - Equity Research at TD Cowen

And then my second question is about, the CCR8 landscape. Theresa, you noted that you guys have thoroughly surveyed the competitive landscape here and found that most competitor molecules are less selective. But I'm curious if on the efficacy side, are there any molecules that you think have served as stocking horses that help to prove out the mechanism and provide proof of concept for CCR rate targeting or have none really gotten far enough or they're too, it's too difficult to interpret the data because of the selectivity issue? Thank you.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thanks for that, Michael. Let's take the last one first. Teresa?

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Yeah. Two things on the selectivity. In our screen, there was only one antibody identified that exclusively bound CCRA. That is very unusual to only have one in a full lead identification screen. We've screened some competitors and some have reported out their screening.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

And no one else has demonstrated selectivity to date. So that is where we ask for people to please provide that evidence. In fact, there was a poster at ACR where one of the competitors showed two off target findings. In terms so they all do bind CCR8. So the mechanism is still relevant.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

It's just whether or not there could be issues with pharmacokinetics or toxicity. Lenovo Medicine last year at ASCO presented data with their CCR8 antibody LM108 in combination with Toropalumab, no less, in gastric cancer. And to me, this data was very exciting for the class because in the overall second line and greater gastric cancer population who have progressed on PD-one, they showed a thirty six percent response rate. In second line only, which was eleven patients, a small number, but they showed a sixty three percent response rate. And why scientifically I find that incredibly exciting is that there are a very high density and prevalence of CCR8 positive Tregs in gastric cancer.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

So there are many mechanisms of PD-one resistance. Getting a sixty three percent response rate suggests that Tregs are the prominent mechanism for PD-one resistance in gastric cancer. So we think that that really bodes well for these tumor types, which is a large number of solid tumors that have a high density and prevalence of CCR8 positive Tregs. So super excited to see in the safety cohort, one PR in the head and neck study, and now are waiting for that 40 patients that Raj described.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Theresa. Michael, regarding your question, how we view the sort of old habit of KEYTRUDA use or PD-one use and how we're gonna address that regarding using the new NCCN guidelines. I'll let Samir offer you a little more color for you.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Sure. So, the KEYTRUDA in chemo only use is real. It's real, especially in the community setting, less so in the academic setting. And this is despite the NCCN guidelines recommending a chemo combination, including Lactrocy as a preferred regimen. And the reason this happens is, frankly, it's a matter of habit, right? That's the reason it's happening.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

But when we talk to physicians, it's a very clear story. The story is simply we are the only brand, only IO with an OS survival benefit that's been demonstrated in a phase III trial, and we're the only NCCN approved preferred regimen for these patients. So the story is really simple. And when we talk to physicians, we are able to get the physicians on board. But what happens is, after we talk to physicians, there's a time lag between that conversation with the physicians and by the time a patient is available for that office.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

So just to reiterate, this is going be a steady ramp up because of the delay from the time that we have the conversation and the time that a patient becomes available.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Sameer. Thank you, Mike.

Operator

Our next question comes from the line of Colleen Kuzzi with Baird. Your line is now open.

Colleen Kusy
Senior Research Analyst at Robert W. Baird & Co

Great. Good afternoon. Thanks for taking our questions and congrats on all the progress. Can you talk a little more about the Type D meeting you had with the FDA for CHS-one hundred fourteen? Sounds like you aligned on Project OPTIMISS, but any other interesting feedback coming out of that meeting?

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Colleen. Theresa?

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Yeah, I mean, the focus of that I mean, so our approach is to collaborate with the FDA and not just show up with data, but really have a conversation about our approaches and how we do things. So the Type D meetings in particular are very focused on single topics. And that was I mean, Optimus is something a lot of people have struggled with. And so really walking them through the data we have and the data we plan to bring to them early next year, and ensuring that this would meet what they're looking for was important, and I think very exciting that they found it acceptable.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

A positive development.

Theresa Lavallee
Chief Scientific & Development Officer at Coherus BioSciences

Yeah, mean, of course, it always depends on the data, which is what they'll always say. But they didn't say, go do five other things or change this.

Colleen Kusy
Senior Research Analyst at Robert W. Baird & Co

That's helpful. Thank you. And then following the restructuring of the Salesforce, can you speak to the level of interest in potentially adding another commercial stage asset to further leverage the existing infrastructure?

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you. That's a very interesting topic. Certainly, I would offer you this. We think that it's probably another twelve months or so before Samir and his team really get the doctors trained and focused, and I think routinely writing all the scripts with Vogturzy. But we are keen to put something else in the bag at some point in the future to enhance sales.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

That's one bogey that we focus on I think, a lot as we go through various strategic options and so on. But I think the sales force has about a year, I would say, maybe a little more, getting the MPC market moving up the escalators.

Colleen Kusy
Senior Research Analyst at Robert W. Baird & Co

Got it. Thanks for taking our questions.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, Colleen.

Operator

Our next question comes from the line of Douglas Tsao with H. C. Wainwright. Your line is now open.

Doug Tsao
Analyst at H.C. Wainwright & Co.

Hi, good afternoon. Thanks for taking the questions. Just one as a follow-up in terms of educating physicians. I'm just curious, it the is sort of does it take convincing a physician in terms of the value of the PD-one, or is it sort of demonstrating the value of lactoressi, meaning do they have some skepticism because of other PD-1s not demonstrating efficacy? And so you need to convince them there and the differentiation of the asset? Thank you.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you. Well, let me get that one first, Doug. I'll let Doctor. Dias address that. I'd one say that the clinical data is irrefutable, and the positioning on the NCCN guidelines reflects that. Raj, can you talk about how physicians view the data that we're presenting?

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

If you were a physician prescribing to your patient, what lens you would use?

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Yeah. Thanks for the question, Doug. So, a couple of points I'll make. So first of all, up until now, you know there's been no approved therapies and no data actually in this tumor type. So this is a real area of unmet medical need. So we've come along with the first real data, the first positive data.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

And as you know, what LOPTORZIA has shown is over chemotherapy alone, we have shown a really profound survival benefit. That is the gold standard. So whenever a doctor hears this data, they're very impressed with the data. It is impressive data. Again, it's a thirty seven percent risk reduction.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

Now that's now accompanied by premier listing on the NCCN. So there are no real objections to the data whatsoever. Just remember, this is a rare disease. So it takes some time for patients to really show up for this. But again, when they hear the data, there's no real objections based on the strength of data itself, but also the NCCN positioning as well.

Rosh Dias
Chief Medical Officer at Coherus BioSciences

And impressively also their experience so far when they've had a patient, when they've used it, we are generally hearing very positive experience taking that forward.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Yeah. I just want make one more comment. Just one thing I'd like us to remember is just three months ago, the NCCN guidelines basically were saying you can use either loss forty plus chemo, you could use chemo, or you could use the off label IOs to your discretion, right? That was three months ago. But now it's completely changed.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

It's only been three months since the NCCN unequivocally said that you should be using LOCTORGY plus chemo. So our real educational efforts and those guidelines have really taken off in the last three months, and we do expect that it's going to pay off in the coming months and quarters.

Doug Tsao
Analyst at H.C. Wainwright & Co.

Just as a follow-up. Can I get a follow-up?

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Sure.

Doug Tsao
Analyst at H.C. Wainwright & Co.

You know, I think, Ross, you referenced sort of positive experience of physicians being experienced. I'm just curious, when they talk to you, are they speaking?

Doug Tsao
Analyst at H.C. Wainwright & Co.

I'm sort of curious, what are they speaking to when they say that they're having good experiences early on? Are they seeing patients with extended survival, partial responses? I'm just curious if you could sort of characterize what doctors are seeing. Thank you very much.

Sameer Goregaoker
EVP - Commercial at Coherus BioSciences

Yeah, generally, they're saying that what the data I mean, it's going be variable from patient to patient, right, depending on whether it's a metastatic patient or a recurrent, locally advanced patient. But generally, what they're saying is the data that we show them in the clinical trials, they're able to see those experiences in their actual patients. Thanks, Doug.

Operator

You. Would now like to turn the call back over to Denny Lanphear for closing remarks.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

Thank you, operator, and thank you all for joining us today. Regarding our upcoming presentation schedule, next week we will be attending the H. C. Wainwright BioConnect Conference at NASDAQ in New York. Then, on May 27, we'll be presenting at the TD Common sixth Annual Virtual Oncology Innovation Summit.

Dennis Lanfear
Dennis Lanfear
Chairman, President & CEO at Coherus BioSciences

And later on in June, we'll be at the Jefferies Global Healthcare Conference in New York. We'll see you all there. Thank you.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect. Goodbye.

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