Q4 2024 Coherus BioSciences Inc Earnings Call
Okay.
Operator: Hello, everyone, and welcome to the Coherus fourth quarter year-ending 2024 Financial Results Conference call. At this time, all participants are in a listen-only mode.
Speaker Change: Hello, everyone and welcome to the go here as a fourth quarter year, ending 2024 financial results Conference call.
Speaker Change: At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to participate you wouldn't need to press star one one on your telephone you put in here a message of dicing. Your hand this waste Jupiter All your question simply press Star one again please.
Operator: After the speaker's presentation, there will be a question-and-answer session. To participate, you will need to press star-one-one on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, simply press star-one-one again.
Operator: Please be advised that today's conference is being recorded.
Speaker Change: We advised that today's conference is being recorded nice my pleasure to turn the call over to the head of Investor Relations Jody Fevers. Please proceed.
Jodi Sievers: Now it's my pleasure to turn the call over to the head of investor relations, Jodi Sievers. Please proceed. Thank you, Carmen.
Jodi Sievers: Good afternoon and welcome to Coherus Biosciences' fourth quarter and full year 2024 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Brian McMichael, Chief Financial Officer, Paul Reider, Chief Commercial Officer, Dr. Rosh Dias, Chief Medical Officer, Dr. Theresa Lavallee, Chief Development Officer, and Samir Gaurigalkar, Senior Vice President of Immuno-Oncology Marketing.
Speaker Change: of Officer of Coherus, Brian McMichael, Chief Financial Officer, Paul Reider, Chief Commercial Officer, Dr. Rosh Dias, Chief Medical Officer, Dr. Theresa Lavallee, Chief Development Officer,
Speaker Change: Senior Vice President of Immino Oncology Marketing. 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.
Jodi Sievers: Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus's current expectations about future events. These statements include, but are not limited to, the following. Projections about future revenues, headcount reductions, statements about our ability to satisfy the closing conditions of the EUDENICA divestiture, statements about the use of proceeds from the EUDENICA divestiture, and our projected future cash and cash runway, and statements about future clinical development progress.
Speaker Change: These statements include but are not limited to the following. Projections about future revenues had count reductions. Statements about our ability to satisfy the closing conditions of the U-Demic at that vestiture.
Speaker Change: Statements about the use of proceeds from the dedicated divestiture, and are projected future cash and cash runway, and statements about future clinical development progress.
Jodi Sievers: All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties about achieving the closing of the Budenka divestiture that are discussed in our press release that we issued today, as well as the documents that we filed with the SEC.
Speaker Change: All of these forward-looking statements involve substantial risks in uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements.
Speaker Change: These statements are not guarantees of future performance and are subject to substantial risks and uncertainties.
Speaker Change: including risks that are uncertain to use about achieving the clothing at the Luzanaka digestiture that are not discussed and are discussed in our press release that we issue today, as well as the documents that we file with the FEC.
Jodi Sievers: Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements.
Speaker Change: For the Kim statements provided on the call today are made as a fifth state, and we undertake no duty to update for advice any more of this statement.
Jodi Sievers: All December 31, 2024 financial amounts discussed today have not been audited and are subject to change upon completion of Coherus's audited financial statements for the year ended December 31, 2024 that will be included in Coherus's Form 10-K, which is expected to be filed with the SEC in the coming days.
Speaker Change: worker. All dissemadand Silver. We remain in conversation. We realizeGood evening once again. Again my name is Abby Jackson. I want to start by introducing myself. Thank you for joining us on this hour. We really appreciate your subscription. Today's webinar will be possession equipment ramifications. I hope you will make the time today to enjoy it. If so, you can access this webinar online. You can go online and log into AliX learning support service at
Speaker Change: December 31, 2024, financial amounts discussed today have not been audited and are subject to change upon completion of Coherus's audited financial statements for the year ended December 30, 2024, that will be included in Coherus's form 10K, which is expected to be filed with the SEC in the coming days. And now I'll turn the call over to Danny.
Dennis Lanfear: And now I'll turn the call over to Denny. Thank you, Jodi. And thank you all for joining us today at Coherus's Q4 and full year 2024 earnings call. Today, I'll provide you with a view of the progress we've made in 2024 and our key objectives. And I'll describe to you the path that lies ahead as we focus on maximizing revenues and marketability, expanding its indications, and advancing our proprietary pipeline combination with the market.
Benny: Today I'll provide you with a review of the progress we've made in 2024 and our key objectives.
Benny: I will describe to you the path that lies ahead as we focus on maximizing revenues will work towards expanding its indications.
Benny: Our proprietary pipeline combination with back towards it.
Dennis Lanfear: On our previous calls, I outlined our four-part strategy to position Coherus for future success and innovative in college. This included, first, to drive top-line revenues, second, control the expense line. Thirdly, to advance the innovative pipeline, and lastly, to address the debt overhang on our balance sheet. I'm happy to report that over 2024, we have been successful across all these objectives in support of our overarching strategy. Particularly given last year's strong execution, we are now well positioned in 2025 to complete our strategic transition to a fully integrated, commercial stage, innovative oncology For more information visit www.FEMA.gov We have addressed our balance sheet debt issue and will put about $250 million in cash on the balance sheet at transaction close to continue our development efforts through key data milestone readouts in 2025 and 2026.
Benny: On our previous calls I outlined our four part strategy to position <unk> for future success.
Benny: We live in college.
Benny: This included first to drive topline revenues second to control the expense line.
Benny: Thirdly to advance innovative pipeline and lastly to address the debt overhang on our balance sheet.
Benny: I'm happy to report that over 2024, we have been successful across all of these objectives in support of our overarching strategy.
Benny: Particularly given last year's strong execution, we are now well positioned in 2025 to complete our strategic transition to a fully integrated commercial stage innovative oncology company.
Benny: We have addressed our balance sheet debt issue and we will put about $250 million in cash on the balance sheet at transaction close to continue our development efforts through key data milestones readouts.
Benny: 25 and 2026.
Dennis Lanfear: The most significant change for the company is the divestiture of Eudenica France. And I'm happy to report that we have made substantial progress positioning us to complete this transaction in late Q1 or early Q2. Security Exchange Commission Review, Hartscott-Regina Review, and Cypius Review have all been completed or otherwise approved. The shareholder vote and the special meeting are tomorrow. We are confident that the divestiture will be approved and believe that such approval will constitute both an endorsement of our overarching strategy as well as an appreciation for the strong execution that got us here.
Benny: The most significant change for the company as the divestiture of your Deneke franchise and I'm happy to report that we have made substantial progress positioning us to complete this transaction in late Q1 early Q2.
Benny: The Security Exchange Commission Redo Hart, Scott Rodino review and Cynthia its review have all been completed or otherwise approved.
Benny: The shareholder vote, and a special meeting or tomorrow.
Benny: We are confident that the divestiture will be approved and believe that such approval will constitute both endorsement of our overarching strategy as well as an appreciation for the strong execution that got us here.
Dennis Lanfear: However, it must be said at a more macro level that we are certainly not satisfied with our current stock price. Post-transaction, with the debt overhang behind us, a strong balance sheet and potentially exciting data in front of us, we will focus on enhancing investors' appreciation and understanding of Coherus's value proposition. This will be a key focus of management in 2025 and 2026.
Benny: However, it must be said on a more macro level that we are certainly not satisfied with our current stock price.
Benny: Post transaction with the debt overhang behind us a strong balance sheet and potentially exciting data in front of US we will focus on enhancing investors' appreciation and understanding of careers is value proposition.
Benny: This will be a key focus of management in 2025 and 2026.
Dennis Lanfear: Now back to the divestiture. Apart from the shareholder vote, the primary remaining closing condition at this point is the FDA authorization to sell final packaged product from our additional contract manufacturing organization responsible for our labeling and packaging operations. We've made the required submission and believe it fully conforms with FDA expectations, as well as the FDA's communicated guidance to us. This final step in our strategic transformation follows a series of achievements over the past two years.
Benny: Now back to the divestiture.
Benny: Apart from the shareholder the primary remaining closing conditions at this point is the FDA authorization to sell a final package product from our additional contract manufacturing organization responsible for our labeling and packaging operations.
Benny: We've made the required submission and believe it fully confirms with FDA expectations as well as the FDA has communicated guidance to us.
Benny: This final step in our strategic transformation and follows a series of achievements over the past two years.
Dennis Lanfear: In January 2021, we initiated a deliberate four-year strategic transformation process with the in-licensing of Toropelmeth, our differentiated PD-1 inhibitor from Junichi BioSciences. To be a major commercial player in innovative oncology, we believe it is a strategic necessity to have an approved proprietary PD-1 to anchor an innovative oncology pipeline. Lactorsi is our key foundational asset and will be used in combination with both our own pipeline candidates, as well as our partners, driving development synergies, as well as sales synergies for proprietary combination. Lactrose was launched in Q1 last year and is now standard of care in all lines of nasal pharyngeal care.
Benny: In January 2021, we initiated a deliberate four year strategic transformation process with the in licensing them toward our differentiated PD one inhibitor from June sheet Biosciences.
Benny: A major commercial player in innovative oncology, we believe strategic necessity to have an approved proprietary PD, one to anchor and innovative oncology pipeline.
Benny: Like towards he is our key foundational asset and will be used in combination with both our own pipeline candidates as well as our partners driving development synergies as well as sales synergies from proprietary combinations.
Benny: <unk> was launched in Q1 last year and is now standard of care in all lines of nasal pharyngeal cancer.
Dennis Lanfear: In September 2023, we acquired a promising pipeline of oncology candidates through the acquisition of Surface Oncology for a net $40 million, inclusive of global rights to a first-in-class anti-IL-27 agent, CASTOS-O-KETO, as well as a highly selective cytolytic CCR8 antibody, CHS114. While these assets were underappreciated at the time, the strong inherent biology and early clinical data convinced us that these are differentiated and potentially game-changing, ideally suited for development in combination with lactoris That data is rolling out in front of us now, particularly in liver cancer with castozo, and gives us confidence that we were right, and that future data readouts will further validate the clinical utility of these assets.
Benny: In September 2023, we acquired a promising pipeline of oncology candidates through the acquisition of surface oncology for a net $40 million inclusive of global rights to a first in class anti IL 27 agent.
Benny: So Q2 as well as a highly selective catalytic CCR antibody CHF one four.
Benny: While these assets were underappreciated at the time, the strong inherent biology and early clinical data convinced us that these are differentiated and potentially game changing.
Benny: Daily suited for development in combination with victory.
Benny: That data is rolling out in front of US now, particularly in liver cancer with <unk>. So it gives us confidence that we were right and the future data Readouts will further validate the clinical utility of these assets.
Dennis Lanfear: Having thus secured our Innovative Oncology future with a promising pipeline, last year, in 2024, we divested our Ophthalmology and Humira Biosimilar franchises for about $240 million in total consideration and transferred financial obligation. Over this past year, assuming The Eugenica transaction closes and things happen as planned. We will have divested at least $800 million in assets or commitments, paying off $480 million in debt, all with an average capitalization of around $175 million. Going forward, we're left in good position with $250 million. on the downshade, a differentiated PD-1 enjoying growing sales in a market where it's standard of care, indication-expanding pivotal trials underway for our PD-1 funded by others, and a strong pipeline addressing a $15 billion potential sales opportunity in combination with lectors.
Benny: Having secured our innovative oncology future with a promising pipeline last year in 2024, we divested our ophthalmology and Humira biosimilar franchises for about $240 million and total consideration transferred financial obligations.
Benny: Over this past year assuming.
Benny: The identical transaction closes and things happen as planned we will have divested at least $800 billion in assets, where commitments paid off $480 million in debt all with an average capitalization around $175 million.
Benny: Going forward growth left in good position with $250 million.
Benny: On the balance sheet, a differentiated PD, one enjoying growing sales in a market where it's standard of care.
Benny: Indication expanding pivotal trials underway for our PD, one funded by others.
Benny: Our strong pipeline addressing a $15 billion of potential sales opportunity in combination with <unk>.
Dennis Lanfear: And with that, let me now turn it over to my team for more color and details in each of their areas. First, on the commercial side, you'll hear from Paul Reider, our Chief Commercial Officer, whose team has done an excellent job with Udenica navigating the supply interruption and the subsequent re-entry into the market. Paul's team delivered some strong Udenica numbers for us in Q4, all things considered against obvious headwinds.
Benny: With that let me now turn it over to my team for more color and details in each of their areas.
Speaker Change: On the commercial side, you'll hear from Paul Ritter, our Chief commercial officer, whose team has done an excellent job with your deneke navigating the supply interruption.
Benny: Subsequent reentry into the market.
Benny: Paul team delivered a strong new delicate numbers for us in Q4, all things considered against the obvious headwinds.
Dennis Lanfear: You will also hear today from Samir Gauragalkar, who joined us in Q4 as the new Lactorsi Brand Lead. Sabir is tightly focused on maximizing the potential for the Lactorsi label, NCCN guidelines, as well as customer-patient segmentation, which he will discuss with you.
Samir: You'll also hear today from Samir <unk>, who joined US in Q4 as the new like towards the brand.
Samir: Severe is tightly focused on maximizing the potential for the <unk> label, and CCN guidelines as well as customer patient segmentation, which he will discuss with you.
Dennis Lanfear: Samir will continue to provide his insights on my touristy performance on these calls going forward.
Samir: Samir will continue to provide us insights unlike towards the performance on these calls going forward.
Dennis Lanfear: After commercial, Dr. Theresa Lavallee will discuss our overarching development strategy, and Dr. Rosh Dias, our Chief Medical Officer, will cover our clinical trials and provide additional color on the evolving Adozo CHS114 dataset.
Speaker Change: After commercial Dr Truth live Ali will discuss our overarching development strategy and Dr. Raj <unk>, our Chief Medical Officer, who will cover our clinical trials and provide additional color on the evolving as does our CHS one four datasets.
Dennis Lanfear: Lastly, before we conclude our prepared remarks and go to the question and answer session, Chief Financial Officer Brian McMichael will review the Q4 and 2024 annual numbers and deltas for you, as well as provide some color on matters going forward. Without the transaction closed, we will not be guiding on 2025 expenses at this point. But of course, we'll do so for you on the Q1 call in May.
Speaker Change: Lastly, before we conclude our prepared remarks and go to the question answer session Chief.
Speaker Change: Chief Financial Officer, Brian Mcmichael will review Q4, and 2024 annual numbers and Delta is for you as well as provide some color on matters going forward.
Speaker Change: Without the transaction closed we will not be guiding on 2025 expenses at this point, but of course, we will do so for you on the Q1 call in May.
Paul Reider: And with that, I'll hand it over to Paul and Samir for the commercial review. Thank you, Dane. Good afternoon, everyone.
Speaker Change: And with that I'll hand, it over to Paul and Samir for the commercial review Paul.
Paul Ritter: Thank you Danny and good afternoon, everyone I will now review brand specific updates starting with your deneke.
Paul Reider: We'll now review brand-specific updates, starting with you, Dennis. The net product sales for Q4 were $46.3 million, an increase of 28% compared to $36.2 million for Q4 2023. For fiscal year 2024, eugenic and net sales were $206. an increase of 62% compared to $127.1 million for fiscal year 2020. Pleased to report that Udetica's supply resumed in November with our labeling, Packaging Contract Manufacturing Organization, delivering both backlogged and planned lots to restock the distribution. and begin fulfilling customer demand. In early January, we announced that due to strong demand in Q4 and into Q1 of this year, all three presentations of Udenica were being temporarily allocated.
Paul Ritter: <unk> net product sales for Q4 were $46 3 million, an increase of 28% compared to $36 2 million for Q4 2023.
Paul Ritter: For fiscal year 2024, <unk> net sales were $206 million, an increase of 62% compared to $127 1 million for fiscal year 2023.
Paul Ritter: Pleased to report that <unk> supply resumed in November with our labeling and packaging contract manufacturer organization.
Paul Ritter: Delivering both backlog and planned blocks to restock, the distribution channel and begin fulfilling customer demand.
Paul Ritter: In early January we announced that due to strong demand in Q4 and into Q1 of this year all three presentations of you Detica, we're being temporarily allocated.
Paul Reider: Since then, and based on individual wholesaler historical purchases. Supply allocations to wholesalers and to their end customers for all three presentations of Udenica were removed between the end of January and the end of February. Customers who represented 97% of Udenica volume pre-supply interruption have returned to order in Udenica, reinforcing the strength and resilience of the Udenica brand and the differentiated delivery presentation options that meet the unique needs of providers and patients. Udenica market share of Q4 was 15% with an exit share of 22%. And we remain confident that customers will continue prescribing Udetica with demand and market share acceleration throughout 2020.
Since then and based on individual wholesaler historical purchasing patterns supply allocations to wholesalers into their end customers for all three presentations of you Danica were removed between the end of January and the end of February.
Paul Ritter: Customers, who represented 97% of your identical volume pre supply interruption have returned to ordering you donica reinforcing the strength and resilience of the <unk> brand and the differentiated delivery presentation options that meet the unique needs of providers and payers.
Paul Ritter: <unk>.
Paul Ritter: <unk> market share in Q4 was 15% with an exit share of 22%.
Paul Ritter: Confident that customers will continued prescribing identical with demand and market share acceleration throughout 2025.
Paul Reider: because Udetica is the only brand in the PEG-Fograstin class that offers three product presentations. a differentiated on-body device and broad pair cover.
Paul Ritter: Dedicated is the only brand the Pegfilgrastim class that offers three product presentations, a differentiated on body device and broad payer coverage.
Paul Reider: Finally, as we move toward the closing of the divestiture of the Udenica business, the commercial team remains focused on three key priorities. First, driving Udenica revenue and market share beyond pre-supply interruption level. Second, accelerating while TORSI new patients start. and Samir will discuss momentarily. And third, to ensure that post-transaction, we maintain an optimized commercial. fully enabled continued momentum of our Lactorsi launch and reach the maximum commercial opportunity for Lactorsi as quickly as possible.
Paul Ritter: Finally, as we move toward the closing of the divestiture of <unk> business. The commercial team remains focused on three key priorities.
Paul Ritter: First driving <unk> revenue and market share beyond free supply interruption levels.
Paul Ritter: Second accelerating work towards the new patient starts, which Samir will discuss momentarily.
Paul Ritter: Third to ensure that post transaction.
Paul Ritter: Maintain an optimized commercial team to fully enable continued momentum towards the launch and reached the maximum commercial opportunity for luck towards as quickly as possible.
Samir Gaurigalkar: Now to review the Lactorsi business, I'll turn the call over to... Samir. Thank you, Paul. I'm happy to join the team. Lactosia net revenue was $7.5 million in Q4, a 29% increase quarter over quarter. Net revenue for fiscal year 2024 was $19.1 million. As previously outlined, there are approximately 2,000 locally eligible MPC patients each year. And relapsed locally advanced and first-line metastatic patients represent about two-thirds of the eligible patient population. NPC is a rare cancer and oncologists typically see one to two new patients per year. Our goal is to reinforce LOP-PERSI as the standard of care in all eligible MPC patients.
Sameer: Now to review the walk towards the business I'll turn the call over to Sameer Sameer.
Sameer: Thank you Paul I'm happy to join the team.
Speaker Change: <unk> total net revenue was $7 5 million in Q4, a 29% increase quarter over quarter net revenue for fiscal year 2024 was $19 1 million.
Speaker Change: As previously outlined there are approximately 2000 lakotas the eligible mtc patients each year.
Speaker Change: And relapsed locally advanced and first time metastatic patients represent about two thirds of the eligible patient population.
Speaker Change: MPC, the rare cancer and oncologists typically feed wanted to new patients per year.
Speaker Change: Our goal is to reinforce.
Speaker Change: The standard of care and all eligible MPV basins.
Samir Gaurigalkar: We remain focused on expanding the breadth of lactrose use as well as keeping patients on therapy for as long as appropriate. Since launch, we have made strong progress towards these goals. Nearly 80% of all NCCN institutions have used Loctorazine for at least one patient. and Q4, the number of new accounts purchasing Loctorze grew by 37%. Lactose in new patient starts also continue to grow in Q4, with uptake primarily in the relapsed, locally advanced, and first-line metastatic setting, which is a key driver for long-term revenue growth. We reiterate our belief that La Crosie revenue will follow a steady ramp in the near term, fueled primarily by new patient acquisitions.
Speaker Change: We remain focused on expanding the breadth of block overuse and going to keeping patients on therapy for as long as appropriate.
Speaker Change: Since launch we have made strong progress towards these goals.
Speaker Change: 80% of all <unk> institutions have you a block currently.
Speaker Change: One patient.
In Q4, the number of new accounts purchasing lock currently grew by 37%.
Speaker Change: <unk> New patient starts also continued to grow in Q4 was uptake primarily relapsed locally advanced and first line metastatic setting which is a key driver for long term revenue growth.
Speaker Change: We reiterate our belief that <unk> revenue will follow a steady ramp in the near term fueled primarily by new patient acquisition.
Samir Gaurigalkar: Sustained growth over time will be driven by duration of treatment, and 80% of long-term revenue will come from continuing patients. We estimate that this will take about three to four years to realize the full potential in NPTEL.
Speaker Change: Sustained growth over time will be driven by duration of treatment and 80% of long term revenue will come from continuing patients.
We estimate that this will take about three to four years to realize the full potential and MTV.
Samir Gaurigalkar: Now, regarding Q4, revenue trends were affected by two transient headwinds that impacted Locke-Poisey's share of oil. The first was Eugenica temporary supply interruption. Second, the announcement of eugenic divestiture and the required field force restructuring comprise an additional impediment. This will continue to impact us until the transaction closes, customer assignments are finalized, and the field establishes a new territory footprint and customer relationship. However, long-term lactose will benefit from sustained tailwinds beyond closing of the divestiture and we are well positioned for success.
Speaker Change: Now regarding Q4.
Speaker Change: Revenue trends were affected by two transient headwinds that impacted lock proteus share points.
Speaker Change: The first one <unk> temporary supply interruption.
Speaker Change: Second the announcement of your deneke divestiture and the required field restructuring comprised an additional impediment.
Speaker Change: This will continue to impact us until the transaction closes.
Speaker Change: Consumer assignments are finalized.
Speaker Change: And the field establishes a new territory footprint and customer relationships.
Speaker Change: However, long term lock program will benefit from sustained tailwind beyond closing of the divestiture and we are well positioned for success.
Samir Gaurigalkar: First, in November 2024, NCCN updated NPC guidelines, placing long-coursing in a preferred position for metastatic and locally recurrent NPC patients. Both our sales team and digital promotions are focused on educating customers on the updated guidelines. Initial customer feedback on the guidelines have been very positive, with oncologists telling us they intend to increase the use of nocturology in NPV. Secondly, as an innovative oncology commercial organization, the team's singular focus will be on reinforcing loctorazine as the standard of care and preferred treatment for all MPC patients. Given that NPC is a rare cancer, key tactics include leveraging real-time data to drive HCP and patient identification at the time of diagnosis.
Speaker Change: First in November 2024, and CCM updated MPC guidelines.
Speaker Change: Conversely in a preferred position for metastatic and locally recurred mtc patients.
Speaker Change: Both our sales team and digital promotions are focused on educating customers on the updated guidelines.
Speaker Change: Initial customer feedback on the guidelines have been very positive, but oncology is telling us.
Speaker Change: To increase the use of <unk>.
Speaker Change: Pardon me and NPV.
Speaker Change: Secondly, as an innovative oncology commercial organization the team singular focus will be on Greencore Fremont currently as the standard of care and preferred treatment for all <unk> patients.
Speaker Change: Given that MPC the rare cancer key tactics include leveraging real time data to drive HCP and patient identification at the time of diagnosis.
Samir Gaurigalkar: And we're engaging with key customers to encourage updating of account-level MTC pathways and order sets to align with our label and revise NCCN guidelines, placing Loctorzi in the preferred position. In short, we will continue to deliver on our track record of strong commercial execution in oncology. In Lopurzi, we have a differentiated and highly efficacious drug that has delivered a profound survival advantage and enjoys superior NCCN positioning that is reflective of the strength of our data. We thus expect that La Corse will achieve a dominant market share position in NBC that we estimate to be valued at about $150 to $200 million.
Speaker Change: And we are engaging with key customers to encourage updating account level NPV pathway and order size.
Speaker Change: To align with our label and revised Mtc and guidelines.
Speaker Change: Cosby and the preferred position.
Speaker Change: In short we will continue to deliver on our track record of strong commercial execution and oncology.
Speaker Change: And.
Speaker Change: We have a differentiated and highly efficacious drug that has delivered a profound survival advantage and enjoying superior <unk> positioning is it reflective of the strength of our data.
Speaker Change: We don't expect that we will achieve a dominant market share position at MPC that we estimate to be valued at about $150 million to $200 million.
Theresa Lavallee: In 2025, we are excited to differentiate Lactrose plus or minus chemo as the only MPCN-preferred regimen for metastatic and recurrent MPC patients, and the only FDA-approved PD-1, with proven PFS and OS benefits for patients in this Allow me to call over to Dr. Lavallee, our Chief Development Officer. Theresa? Thank you, Samir. Good afternoon. We are pleased to update you on our continued progress in 2025 with key regulatory and clinical advancements of our promising pipeline focused on our next generation and differentiated PD-1 inhibitor, toropalumab. Lortz et al. recently highlighted that not all PD-1 inhibitors are the same in a review article published in the Frontiers in Oncology journal .
Speaker Change: In 2025, we are excited to differentiate lock, probably plus or minus chemo as the only <unk> preferred regimen for metastatic and recurrent mtc patients and the only FDA approved PD, one with proven PFS and OS benefit for patients in this space.
Speaker Change: I'll now turn the call over to Dr. La Valley, our Chief Development Officer Tricia. Thank you Samir.
Speaker Change: Yeah.
Speaker Change: We are pleased to update you on our continued progress in 2025 with regulatory and clinical advancements are promising pipeline focused on our next generation <unk>.
Speaker Change: <unk> PD one inhibitor.
Speaker Change: Got it.
Lawrence at all recently highlighted.
Speaker Change: Not all PD one inhibitor.
Speaker Change: In a review article published in the frontier in oncology Journal.
Theresa Lavallee: The publication highlighted that TOR-PALIMAP uniquely binds the F2 loop of the PD-1 ectodomain with high potency driven by a very slow offset. Clinically, this pharmacology has revealed differentiation by delivering clinical activity in combination with chemotherapy irrespective of PD-L1 expression level in multiple phase 3 studies. The European Health Authorities recently approved for our Palomab for first-line esophageal squamous cell carcinoma, irrespective of PD-L1 expression. And in contrast, Tizolizumab has recently been approved for first-line esophageal squamous cell carcinoma only for patients whose tumors express PD-L1. The U.S. FDA also recently highlighted the lack of activity of pembrolizumab, nivolumab and tizolizumab in PD-L1 low patients in this indication and gastric cancer in an ODAC meeting last September.
Speaker Change: Publication highlighted that tour of Allomap uniquely binds the <unk> of the PD one <unk>.
Speaker Change: With high potency driven by a very low level off rate.
Speaker Change: Clinically this pharmacology has revealed differentiation by delivering clinical activity in combination with chemotherapy irrespective of PDL, one expression level and multiple phase III studies.
Speaker Change: The European Health authorities recently approved tour, our Allomap first line esophageal squamous cell carcinoma irrespective of PDL one expression.
Speaker Change: And in contrast.
Speaker Change: To the loser.
Speaker Change: That's recently been approved for first line <unk> squamous cell carcinoma.
Speaker Change: Only for patients tumors Express PDL one.
Speaker Change: The U S. FDA also recently highlighted the lack of activity primarily at the Nab.
Speaker Change: Aluminum and timber lithium AD and PD lone low patients in this indication in gastric cancer and in meeting last September.
Theresa Lavallee: Tora Palabev's differentiation and potency positions us well as we look to expand into additional indications in combination with novel eight. Our strategy for expanding toropalumab indications beyond MPC in the U.S. is focused on drug supply collaborations, where we evaluate toropalumab with novel mechanisms This is a production of the Centers for Disease Control and Prevention. both with early and late stage compounds and prioritized tumor types such as head and neck and lung cancer in clinical trials. and internal development efforts on our pipeline of potent and selective antibodies positioned in tumor types with strong biologic rationale to establish proof of concept.
Speaker Change: Tore a pallet of differentiation and potency.
Speaker Change: Well as we look to expand into additional indications in combination with novel agents.
Speaker Change: Our strategy for <unk>.
Speaker Change: Turning to our Palomar indications beyond on PC in the U S. It's focused on trends supply collaboration.
We evaluate tore a polymath with novel mechanisms.
Speaker Change: Both with early <unk>.
And late stage compound and prioritize tumor types, such as head and neck and lung cancer and clinical trials.
Speaker Change: Yes.
Speaker Change: Internal development efforts on our pipeline.
Speaker Change: <unk> selective antibody physician and tumor types with strong biologic rationale to establish proof of concept.
Theresa Lavallee: Importantly, for each clinical indication that advances Kestosaketan or CHS114 into a pivotal study, It also advances Torah Palimax into a potential new indication. From a regulatory perspective, we are progressing to plan with establishing all our drug manufacturing in the United States. Coherus has always focused on the US for development and commercial, including Made in America manufacturing. The clinical trials for Cazdose-Ketog, an IL-27 antagonist, and CHS114, a cytolytic CCRA antibody, are designed to deliver data this year to address the FDA's Project Optimist, and enabling favorable regulatory strategies to advance development, pending positive data, into pivotal studies in 2026 and 2027.
Speaker Change: Importantly for each clinical indication that advances catheter as a key Ken or CHF, one <unk> four into a pivotal study at all selling the asset.
Speaker Change: For a power Mac into a potential new indication.
Speaker Change: Okay.
Speaker Change: From a regulatory perspective, we are progressing to plan with establishing all our drug manufacturing in the United States.
Speaker Change: Coherent has always focused on the U S for development and commercial including American manufacturing.
Speaker Change: The clinical trials for <unk>.
Speaker Change: IL 27 and patented.
Speaker Change: Cash glenmark for ACI analytics CPRE antibody are designed to deliver data this year to address the Fda's project Optimists.
Speaker Change: And enabling favorable regulatory strategy to advance developed humming.
Pending positive data into pivotal studies in 2026 and 2020 Capex.
Rosh Dias: I'll now turn the call over to Dr. Dias to discuss the clinical development and pipeline data. Rosh? Thank you, Theresa, and good afternoon. Over the next few minutes, I'll focus on the progress of the combination studies of our competitively well-positioned assets, CAVDOS-KiTUK and CHS114, in combination with the Torrey-Palomar backbone, which forms the foundation of our internal development strategy. With regards to CASDOVO, our first in class IL-27 targeting antibody, our two areas of current focus are in non-small cell lung cancer and hepatocellular carcinoma. For non-small cell, our ongoing program builds upon the monotherapy responses demonstrated in previously treated PD-L1 refractory squamous cell histology in less-inflamed tumors, most recently presented at ESMO-IO in December 2024.
Speaker Change: I'll now turn the call over to Dr. <unk> to discuss the clinical development and pipeline data.
Speaker Change: Ross.
Speaker Change: Thank you Teresa and good afternoon over the next few minutes I'll focus on the progress of the combination studies of our competitively well positioned assets kept the key tuck in CHF 114 in combination with the Tory patent that backbone, which form the foundation of our internal development strategy.
Speaker Change: With regards to cast a vote a first in class IL 27 targeting antibody our two areas of current focus ironbound small cell lung cancer and <unk> carcinoma.
Speaker Change: The non small cell ongoing program builds upon the monotherapy responses demonstrates in previously treated PD, one refractory squamous cell histology in less inflamed tumors. Most recently presented at ESMO Io in December 2024 hour.
Rosh Dias: Our combination study of Casdosa with Toripalumab continues to guide us to focus on squamous cell histology, where our future focus will be. The first line about cellular carcinoma dates from the Atizo-Bev-Casdova triplet combination study was first presented mid-2023, and the final data was recently presented at ASCO-GI in January 2025. During this time period, overall response rate has increased from 27% to 38%, reflecting an increase in response rate over time. Additionally, the complete response rate has also increased from 0 CRs initially to 5 CRs in the most recent dataset, representing a 17% complete response rate, which reflects a deepening of response also.
Speaker Change: Our combination study of <unk> with Tori Panama continues to guide us to focus on squamous cell histology, where our future focus will be.
Speaker Change: Our fence lines about cellular carcinoma dates from the it team has.
Speaker Change: The triplet combination study was first presented mid 2023 and the final data was recently presented at <unk> Gi in January 25.
Speaker Change: During this time period overall response rate has increased from 27% to 38%, reflecting an increase in response rate over time.
Speaker Change: <unk> a complete response rate has also increased from <unk> initially to <unk> in the most recent data set represents a 17% complete response rate, which reflects a deepening of responsible fab.
Rosh Dias: These figures compare favorably with current treatment benchmarks, in particular, as the prior Phase 3 studies in HCC, in BRAVE-150 and Himalaya, have reported CRAs between 3 and 8%. And importantly, the increase in response rate and the deepening of responses over time is very encouraging as we move forward with our ongoing development program, where we have switched out a TISO for our own PD-1 toripalamab. This three-arm TORI-BEV-CASDOZO combination study in Futsil and HTC is active and ongoing and randomizes a total of 72 subjects to explore two dose levels of CASDOZO in combination with TORI-BEV versus the TORI-BEV doublet to address Project Optimist whilst at the same time aiming to provide us with a strong body of evidence to set us up for further development in Phase 2.3 in this indication.
Speaker Change: These figures compare favorably with current treatment benchmarks in particular as the phase III studies in HCC, Embraer 150, and human that have reported CR rate between three 8% and importantly, the increase in response rate and the deepening of responses over time is very encouraging as we move forward.
Speaker Change: With our ongoing development program, where we have switched out a teaser for our own PD one story part of that.
Speaker Change: Three Torrey best kept out of the combination study in first line HCC is active and ongoing and randomized a total of 72 subjects to explode two dose levels of <unk>.
Speaker Change: In combination with Tori Bev.
Speaker Change: Tony Benn doublet to address project optimists, whilst at the same time aiming to provide us with a strong body of evidence to set us up for further development in phase III in this indication.
Rosh Dias: Our previously reported data has demonstrated activity irrespective of viral and non-viral etiology, which is important, as our ongoing study includes sites globally where HCC historically has had varied etiology.
Speaker Change: Our previously reported data have demonstrated activity irrespective of viral and non viral etiology, which is important as our ongoing study includes sites globally.
Speaker Change: <unk> historically has had very etiologies.
Rosh Dias: We anticipate having data from our ongoing triplet study in the first half of 2016.
Speaker Change: We anticipate having data from our ongoing triplet study in the first half of 'twenty six.
Rosh Dias: With regard to CHS114, our CCR8 cytolytic antibody, our programs continue to progress in both head and neck squamous cell carcinoma and gastric cancer.
Speaker Change: With regard to CHF 114, <unk> antibody program continued progress in both head and neck squamous cell carcinoma and gastric cancer.
Rosh Dias: As a reminder, our Phase 1 program focusing on head and neck is in four cohorts to successfully position us for further development. Firstly, monotherapy dose escalation across advanced solid tumors. Secondly, monotherapy dose expansion of two dose levels of CHS in head and neck with paired biopsies to look at tumor biology. Thirdly, combination dose escalation of TORI and CHS114 in head and neck. And fourthly, further combination dose expansion of TORI plus CHS114 in head and neck cancer to a total of 40 subjects. We have now completed a crawl in the first three cohorts of the study.
As a reminder, our phase one program focusing on the head and neck is in full cohorts to successfully position us for further development.
Speaker Change: Firstly monotherapy dose escalation across advanced solid tumors.
Speaker Change: Secondly, monotherapy dose expansion of two dose levels of CHF in head and neck with paired biopsies to look at tumor biology, thirdly combination dose escalation of Tory and CHS, one month for head and neck and fourthly further combination dose expansion of Torrey plus CHF, one month for head and neck cancer.
Speaker Change: So in total about 40 subjects.
Speaker Change: We have now completed accrual in the first three cohorts of the study. We previously presented the data from the monotherapy dose escalation cohort at <unk> last year, which demonstrated an acceptable safety profile with no dlt's.
Rosh Dias: We previously presented the data from the first monotherapy dose escalation cohort at ASCO last year, which demonstrated an acceptable safety profile with no DLTs. peripheral CCR8 positive T-rex. and a disease stability rate of 47% in very heavily pre-treated patients.
Speaker Change: Peripheral CCR eight positive T Reg depletion and the disease stability rate of 47% in very heavily pretreated patients.
Rosh Dias: We will report safety, early efficacy, and intratumoral biomarker data on the second and third head and neck cohorts of the study in the first half of this year. The fourth cohort of the study, the Combination Dose Expansion Cohort of TORI plus CHF114 in second line head and neck, is open and ongoing.
We will report safety efficacy and intra tumoral biomarker data on the second and third head and neck cohorts of the study in the first half of Acs.
Speaker Change: The fourth cohort of the study the combination dose expansion cohort of <unk> plus CHF one four in second line head and neck is open and ongoing.
Rosh Dias: For gastric cancer, we remain on track to open our global dose expansion phase 1b study in second-line gastric, gastroesophageal, and esophageal adenocarcinoma this quarter to build upon the encouraging TAURI CCRA data presented at AFCA24 in this indication and anticipate data from this study to be available in the first half of 26.
Speaker Change: Perhaps you can say we remain on track to open up level. The dose expansion phase <unk> study in second line gastric gastroesophageal and esophageal adenocarcinoma this quarter to build upon the encouraging Tory CRA data presented at <unk> 24 in this indication.
Speaker Change: Anticipate data from this study to be available in the first half of 2006 with that I'll hand, it over to Bryan Bryan.
Brian Mcmichael: With that, I'll hand over to Brian. Thank you, Rosh, and good afternoon, everyone. Today, I will cover the fourth quarter and annual results and provide an overview of Coherus's transition, culminating with the expected divestiture of Udenica, sets the company up for focus and the execution solely on oncology. I will start with COGS since Paul and Samir already covered revenue. Cost of goods sold decreased $159 million in full year 2023 to $118 million in 2024. The change was primarily driven by $56.9 million lower costs from the divested product, similarly, and $32.9 million lower net inventory write-off.
Bryan Bryan: Thank you Raj and good afternoon, everyone today, I will cover the fourth quarter and annual results and provide an overview of coherent as transition, culminating with the expected divestiture of your deneke sets the company up for focus and execution solely on oncology.
Bryan Bryan: I will start with Cogs since Paul and Samir already covered revenue.
Bryan Bryan: Cost of goods sold decreased $159 million in full year 2000, $23 million to $118 million in 2024.
Bryan Bryan: The change was primarily driven by $56 $9 million lower Cogs from the divested product similarly, and $32 $9 million lower net inventory write offs.
Brian Mcmichael: partially offset by increased volumes of our oncology product. Cogs of $33.9 million in the fourth quarter 2024 reflected the impact during the quarter from temporary supply interruption of Udenica and includes a $12 million charge for the write-down of Udenica inventory that did not meet acceptance criteria. COGS in Q4 2023 was $84.6 million and includes a $47 million charge related to slow-moving eucimery inventory and slow-moving eucimery inventory.
Bryan Bryan: Partially offset by increased volumes of our oncology products.
Bryan Bryan: Cogs at $33 9 million in the fourth quarter 2024 reflected the impact during the quarter from temporary supply interruption of <unk> and includes a $12 million charge for the write down of your deneke inventory that did not meet acceptance criteria.
Bryan Bryan: <unk> and 'twenty and Q4 of 2023 was $84 6 million and includes a $47 million charge related to slow moving.
Bryan Bryan: Inventory.
Bryan Bryan: It is slow moving.
Brian Mcmichael: Turning to optics. Total 2024 GAP, R&D, and FG&A was $261 million. Comparisons of the full year 2024 and the fourth quarter to the same periods in the prior year reflect decreases in both R&D and FG&A due to savings driven by lower headcount and lower costs due to biosimilar divestitures in the first half of 2024. Specifically, research and development expense decreased 15% to $93.3 million in 2024, down from $109.4 million in 2023, and was $21.2 million for the fourth quarter of 2024, down 19% from $26.4 million in the prior year. The decreases were primarily driven by factors mentioned earlier, partially offset by increased investments in our pipeline in 2024.
Bryan Bryan: Inventory.
Bryan Bryan: Turning to Opex totaled.
Bryan Bryan: Total 2024, GAAP R&D and SG&A was $261 million.
Bryan Bryan: Comparisons of the full year 2024 in the fourth quarter to the same periods in the prior year reflect decreases in both R&D and SG&A due to savings driven by lower head count and lower costs due to buyout. The biosimilar divestitures in the first half of 2024.
Bryan Bryan: Specifically research and development expense decreased 15% to $93 $3 million in 2024 down from $109 4 million in 2023 and was $21 2 million for the fourth quarter of 2024 down 19% from $26 4 million in the prior year.
Bryan Bryan: The decreases were primarily driven by factors mentioned earlier, partially offset by increased investments in our pipeline in 2024.
Brian Mcmichael: FD&A expenses decreased 13% to $167.7 million in 2024, down from $192 million in 2023. The fourth quarter 2024 SG&A totaled $41.3 million, which includes $6.7 million in divestiture-related transaction costs, and was down 17% from $49.5 million in Q4 of the prior year. The decreases were primarily driven by the factors mentioned earlier. I'm pleased to report that interest expense in 2024 was $27.2 million, down 33% from $40.5 million in the prior year, and $5.3 million in Q4 2024, which is about half what it was in 2020. The decreases were primarily from paying off our $250 million term loan in the first half of the year.
Bryan Bryan: SG&A expenses decreased 13% or $167 million to $267 7 million in 2024 down from $192 million in 2023.
Bryan Bryan: The fourth quarter 2020 for SG&A totaled $41 3 million, which.
Bryan Bryan: Which includes $6 $7 million and divestiture related transaction costs and was down 17% from $49 5 million in Q4 of the prior year.
Bryan Bryan: The decreases were primarily driven by the factors mentioned earlier.
Bryan Bryan: I'm pleased to report that interest expense in 2024 was $27 2 million down 33% from $45 million in the prior year and $5 3 million in Q4, 2024, which is about half what it was in 2023.
Bryan Bryan: The decrease the decreases were primarily from paying off our $250 million term loan in the first half of the year.
Brian Mcmichael: We ended the year with $126 million in cash and cash.
Bryan Bryan: We ended the year with $126 million in cash and cash equivalents.
Brian Mcmichael: Denny talked about the progress on the Udenica divestiture, so I'd like to provide you a view on our post-transaction projection. We expect headcounts to reduce by 30% from approximately 225 employees, including 50 employees transferring to the buyer in the domestic. The substantial majority of the company's off-balance sheet firm purchase commitments related to UDACA will also transition to the buyer. As previously disclosed in our filings, we expect to use tax attributes to offset all but a minor part of the gain on the transaction. Immediately following the transaction close, which is projected late this quarter or early next quarter, we expect to have $250 million in cash on the balance.
Bryan Bryan: And he talked about the progress on the identical divestiture. So I'd like to provide you a view on our post transaction projections.
Bryan Bryan: We expect head count to reduce by 30% from approximately 225 employees, including 50 employees transferring to the buyer and the divestiture.
Bryan Bryan: A substantial majority of the company is off balance sheet firm purchase commitments related to <unk> will also transition to the buyer.
Bryan Bryan: As previously disclosed in our filings we expect to use tax attributes to offset all of it a minor part of the gain on the transaction.
Bryan Bryan: Immediately following the transaction close which is projected late this quarter or early next quarter, we expect to have $250 million in cash on the balance sheet.
Brian Mcmichael: This amount is net of the expected payoff of $230 million convertible note, as well as a $48 million projected payoff of the Udenica Royalty Office. We expect this cash, combined with collections from Udenica Receivables' net of related chargebacks, rebates, and other fees as of the divestiture close date, as well as proceeds from La Corsi's expecting growing revenues and reimbursements from the Transition Service Agreement with the buyer, to last beyond two years.
Bryan Bryan: This amount is net of the expected payoff of $230 million.
Bryan Bryan: Convertible note as well as a $48 million projected payoff of the identical royalty obligations.
Bryan Bryan: We expect this cash combined with collections from <unk> receivables net of related charge backs rebates and other fees as of the divestiture closed date as well as proceeds from locked cars. These are expecting growing revenues and reimbursements from the transaction transition service agreement with the buyer to last beyond.
Dennis Lanfear: With that, I'll hand the call over to Teddy. Thank you, Brian.
Bryan Bryan: Two years.
Denny: With that ill call ill handle hand, the call over to Denny.
Operator: Operator, that concludes our prepared remarks. We're happy to go to the Q&A session. Thank you so much. And as a reminder, to ask a question, simply press star 1-1 on your telephone and wait for your name to be announced. To withdraw the question, press star 1-1 again. One moment for our first question.
Speaker Change: Thank you Brian.
Speaker Change: That concludes our prepared remarks, we're happy to go to the Q&A session.
Thank you so much and as a reminder to ask a question simply press Star one one on your telephone and wait for your name to be announced to withdraw your question Press Star One again, one moment for our first question.
Kripa Devarakonda: and is from Kripa Devarakonda with Tourist Securities. Please proceed. Hey guys, thank you so much for taking my question. With the shareholder voting tomorrow, just wanted to check if there are any hurdles at all that we can expect, like make sure there are no surprises with respect to the Udenica divestiture. Also, you noted you expect to have $250 million in cash exceeding two years. Does that include the cost savings from the headcount reduction by 30% and that 30% coming from those associated with Udenica, or is there any other optimization in terms of expenses? And then I have a follow-up question.
Speaker Change: And as far as quickly devilry recorder with tourists Securities. Please proceed.
Speaker Change: Hey, guys. Thank you so much for taking my question.
Speaker Change: The shareholder voting tomorrow.
Speaker Change: Just wanted to check is there any hurdles at all.
Speaker Change: That we can expect.
Speaker Change: To make sure there are no surprises with.
Speaker Change: With respect to the <unk> divestiture.
Speaker Change: Also you know you noted you expect to have $2 2 million in cash exceeding two years does that include the cost savings from the headcount reduction by 30%.
Speaker Change: And that 30% coming from those associated with your Danica or is there any other optimization in terms of expenses and then I have a follow up question.
Dennis Lanfear: Thanks for your question, Kripa. With respect to the divestiture, we see no obstacles or impediments in the way of concluding that. We feel that the investors are very supportive of both the execution of the company over the past year or so, as well as the reposition of the company strategically. And we have also, as I outlined in my prepared remarks, completed SEC reviews, CFIUS, Hart-Scott-Regino, and so on. So the only remaining, I would say the primary remaining issue, is the authorization from FDA to begin selling the material for the new contract manufacturer. And we do not believe that was an impediment either.
Thanks for your question.
Speaker Change: With respect to the divestiture, we see no obstacles are impediments in the way of concluding that.
Speaker Change: We feel that the investors are very supportive of both the execution of the company over the past year or so as well as our repositioning the company strategically and we have also as I outlined in my prepared remarks.
Speaker Change: Completed.
Speaker Change: SEC review Cepheid, Scott Rodino and so on.
Speaker Change: The only.
Speaker Change: Remaining I would say the primary remaining issue.
Speaker Change: Is the authorization from the FDA and selling the material new contract.
Speaker Change: Manufacturer.
Speaker Change: And we do not believe that is competitive in either so we believe that pretty much.
Dennis Lanfear: So we believe that it's pretty much going forward as planned.
Speaker Change: Going forward as planned.
Brian Mcmichael: With respect to the two years of savings, and so on, and the 30% headcount reduction, I'll let Brian McMichael, my CFO, give you some additional color. Sure. Thanks. Thanks, Kripa, for the question. So, the $250 million, the way to get to that number is, if you look at our cash as of the end of the year, it was $126 million. The upfront consideration on the transaction is $483 million. And then we expect to pay off the $230 million convertible note, $48 million in royalties. And then you have some other cash flows related to fees and just during Q1.
Mcmichael: With respect to the two year, some savings and so on and the 30% head count reduction I'll, let prime Mcmichael My CFO will give you some additional color sure. Thanks. Thanks for the question so the $250 million.
Speaker Change: The way to get to that number is if you look at our cash as of the end of the area of the $126 million.
Mcmichael: The upfront consideration on the transaction is $483 million.
Mcmichael: And then we expect to pay off the $250 $230 million convertible note.
Mcmichael: $48 million in royalties and then you have some other.
Mcmichael: Cash flows related to fees and just during Q1 and so the 250 represents what we expect cash to be at.
Brian Mcmichael: And so the 250 represents what we expect cash to be as of the – or immediately following those transactions. None of those deductions.
Mcmichael: As of the immediately following those transactions.
Brian Mcmichael: And what about the – what about going forward with the reductions of the savings? So going forward, what you can expect is, as we mentioned, we have around 225 employees as of now. And we expect to get that down to 155 employees. 50 of those employees, we expect approximately to transfer to a court or INTOS. And the rest will work out over the coming. year. Thank you, Kripa.
Mcmichael: Those deductions and what about the what about going forward with the headcount reductions in the savings.
Mcmichael: So net net going forward.
Mcmichael: What you can expect is as we mentioned we have around 225 employees as of now.
Mcmichael: And we expect to get that down to 155.
Mcmichael: Employees 50 of those employees, we expect approximately to transfer to.
Mcmichael: Our quarter end costs.
Mcmichael: And the rest will work out over the coming.
Samir Gaurigalkar: Did you have a follow-on question? Yeah, I was just wondering about Locterze. I think you, you know, you have the modified NCCM guidelines. You have preferred position for Locterze. Congratulations on that. I was just wondering if you have a sense of where the drug is being used now, now that you have, you know, both frontline and second line and guidelines. Thanks for that.
Speaker Change: Year. Thank you Craig but did you have a follow up question.
Speaker Change: Yes, I was just wondering about <unk> I think you have the modified into Kim guidelines you have preferred position.
Speaker Change: Position for luck turnkey because one congratulations on that.
Speaker Change: I was just wondering if you have a sense of where the drug is being used now now that you have both.
Speaker Change: Both frontline and second line in <unk>.
Samir Gaurigalkar: Maybe Samir has a few comments of color he can provide on that. Samir? Yeah, sure, Denny. So just let me give you a little bit of historical context, right? The previous guidelines put out, on the previous guidelines, there were multiple treatment options, including chemo alone, chemo plus other off-label IOs, and chemo plus loft protein. So as a result of that, we believe that fueled the extensive use of chemo only and chemo plus off-label IOs that was happening in the marketplace, right? Going forward, what we've seen is that the guidelines are very clear about recommending chemo plus loft protein as the preferred treatment for first-time metastatic patients and recurrent patients as well.
Speaker Change: Thanks.
Thanks for that maybe Sameer has a few comments from color you can provide that Sameer sure Jami. So let me give you a little bit of historical context, Bryan the previous guideline.
Speaker Change: On the previous guidelines there are multiple treatment options, including chemo alone chemo plus other off label, Iowa, and Chemo plus law. Currently so as a result of that we believe that fueled the extensive use of chemo only and chemo plus off label, Iowa about what's happening in the marketplace right.
Going forward, what we've seen is that the guidelines are very clear about recommending chemo plus bulk appropriate as the preferred treatment for first line metastatic patients Andrew.
Speaker Change: And recurrent metastatic recurrent patients as well.
Samir Gaurigalkar: We've talked to a lot of physicians and market research, and what we've heard is the guidelines have been very well received. Physicians tell us they are expecting to increase the use of loft protein. And then really specifically about your question, where it's being used right now, it's a mix of recurrent locally advanced patients, metastatic first-time patients, and also we have some second-line metastatic patients. But primarily, the majority of patients are right now receiving therapy in the more early lines of therapy. So we have a mix of patients right now, and we expect that to continue because of the broadness of our label.
Speaker Change: We've talked a lot of provisions in market research and what we've heard of the guidelines have been very well received so this will come up they are expecting to increase the use of our proceeds.
Speaker Change: And then it really specifically about your question, where it's being used right now it's a mix of.
Speaker Change: Recurrent locally advanced patients metastatic first line patients and also we have some second line metastatic patients, but primarily the majority of patients are right now receiving therapy into more.
Speaker Change: More early lines of therapy.
Speaker Change: We have a mix of patients right now and we expect that to continue because of the broadness of our label.
Operator: Thank you so much. Thank you.
Speaker Change: Thank you Scott. Thank you so much.
Yigal Nochomovitz: One moment for our next question, please. It comes from Yigal Nochomovitz with Citigroup. Please proceed. Hi, Danny and team. Thank you.
Speaker Change: Thank you one moment for our next question. Please.
Speaker Change: It comes from Yigal <unk> with Citigroup. Please proceed.
Speaker Change: Hi, Denny and team. Thank you.
Dennis Lanfear: Just on the on the labeling and packaging for the second supplier, what exactly is the FDA looking to check the box on there to give you clearance to go through with the transaction? Yeah, so the FDA required that we did certain test runs and validation runs with the new line. The new line required installation of certain equipment. And so whenever you spool up an additional manufacturer, even though it may be like-to-like, whatever, you have to actually perform runs and make sure that the equipment's working. And so we, first of all, had conversations with the FDA establishing how many runs they needed, how many units per run, and so forth.
Speaker Change: Just on the on the labeling and packaging for the second supplier what what exactly is the FDA looking to check the box on there to give you a clearance.
Speaker Change: To go through with.
Speaker Change: The transaction.
Speaker Change: Yes.
Speaker Change: So.
Speaker Change: The FDA required that we did certain test runs and validation runs with the new line of the new line.
Speaker Change: Required installation of certain equipment and so whenever you spool up in additional manufacturer, even though it may be like to like whatever you have to actually perform runs to make sure that equipment's working.
Speaker Change: No.
Speaker Change: First of all I had conversations with the FDA, establishing how many runs they needed units per run and so forth.
Dennis Lanfear: The new contract manufacturer then went off and did that and completed the required validation protocols. And then we went ahead, reviewed that, and then submitted it. So we think that it's relatively straightforward. And we expect probably over the next month or so, we'll hear from the FDA regarding that. Okay, so they don't need to visit the facility, they just need to sign off on that data, is that correct? No, they do not need to visit the facility. They only need to review the data. Correct. Okay. Got it.
Speaker Change: A new contract manufacturer, then went off and did that.
Speaker Change: And completed the required validation protocols and then we went ahead and reviewed that and then submitted it. So we think that its relatively straightforward and we expect probably over the next month or so we will hear from the FDA.
Speaker Change: Regarding that.
Speaker Change: Okay. So they don't need to visit the facility they just need to sign off on the data is that correct.
Speaker Change: No they do not need to.
Speaker Change: Since the Maselli, they only needs to review the data correct, Okay got it.
Rosh Dias: And on the CCR8, actually, I was curious. You have fairly specific timing, second quarter 2026 for the TORI combo and then the Phase 1b study in the second line gastric. Could you just comment on how you're able to arrive at such a specific timing, you know, more than a year away for that study? I'll let Rosh give you a little more color on that, Yigal, but I think the shorter answer is that we have making very good progress with respect to enrolling the patients and splitting them up, and we're also dealing with a contract research organization that we have a very strong history with that's put a strong team on the product.
Speaker Change: And then on the CCR Ed.
Speaker Change: Curious you have fairly specific timing.
Speaker Change: Second quarter 2026 for the <unk>.
Speaker Change: Tori combo and then the <unk>.
Speaker Change: Phase one B study in second line gastric.
Speaker Change: Could you just comment on how youre able to arrive at such a specific timing.
Speaker Change: More than a year away from that study.
Speaker Change: I think I'll, let Raj give you a little more color on that but I think the shorter answer is that we have.
Speaker Change: Making very good progress with with respect to enrolling the patients and splitting them up and we're also dealing with a contract research organization that we have a very strong history with that's put a strong team on the product Raj any further color for Hugo Yes ill just thank you for the question. So just two or three additional so festival.
Rosh Dias: Rosh, any further color for Yigal?
Rosh Dias: Yeah, I'll just say, hi, Yigal, thank you for the question, so just two or three additional comments. So, first of all, you'll recall we already The study is multiple parts, so we've already reported the initial data set, so we have good site engagement from there. The second piece is that we will have more additional data from the second and third parts of the head-and-neck study this year. And then for the expansion, as you quite rightly say, we anticipate both head-and-neck and gastric data towards the end of the first half of next year. And I think, you know, if you look at several of our studies, we have very good site engagement, very good engagement with physicians, and we also, for the gastric study in particular, it's a global study, so I think our feasibilities have been pretty tight, and we have really engaged the right sites, which have these patients.
Speaker Change: <unk>.
Raj: Youll recall, we already.
Raj: This study has multiple parts. So we have already reported the initial datasets that we have good fight engagement from that.
Raj: The second piece is that we will have more additional data from the second and third parts of the head and neck study this year.
Raj: And then for the expansion as you quite rightly say, we anticipate both head and neck and gastric data.
Raj: Towards the end of the first half of next year.
Raj: And I think if you look at several of our studies, we have very good site engagement.
Raj: Very good engagement with physicians.
Raj: And we also for the for that.
Raj: Gastric study in particular, it's a global study.
Raj: So I think our feasibility has been pretty tight and we have.
Raj: Really engage the right sites, which have these patients so our projections are fundamentally based on cyclical.
Rosh Dias: So our projections are fundamentally based on site-to-call projections. The other comment that I would offer you, Yigal, is that management reviews these regularly. We just had another review on this last week, so we realize the importance of getting the data in a timely fashion. We're quite focused on it, and I think execution along these lines is one of our strong points. So happy to keep you informed. Okay, thanks.
Raj: The other comment that I would argue yigal.
Raj: Management reviews. These regularly we just had another review on this last week. So we realized the importance of getting the data type of fashion, we're quite focused on it and I think execution along these lines. This is one of our strong points. So happy to keep you informed.
Samir Gaurigalkar: Last one quickly. On LaTorze, did you take a price increase? And if so, what was the percent? Oh yeah, that's great. Samir, would you like to comment for Yigal on the pricing? or Paul. Yeah, yeah, I'll take that. Hi, Yigal. Yeah, we did take a price increase. It was around 2.46%. Okay, thank you. One moment for our next question, please.
Speaker Change: Okay. Thanks last one quickly unlock towards the did you take a price increase and if so what was the percent.
Speaker Change: Oh, Yes, thats, great estimate would you like to comment for you on the pricing.
Paul Yes, yes, I'll take that Hi, Hugo Yes, we did take a price increase.
Speaker Change: Round, 246%.
Speaker Change: Okay. Thank you.
Speaker Change: One moment for us.
Speaker Change: Question. Please.
Colleen Kusy: And it comes from the line of Colleen Kusy with Baird. Please proceed. Hi, good afternoon. Thanks for taking our questions and congrats on the progress.
Speaker Change: And it comes from the line of <unk> <unk> with Baird. Please proceed.
Speaker Change: Hi, good afternoon, thanks for taking our questions and congrats on the progress.
Rosh Dias: For the head and neck cancer data in the first half of this year, can you just kind of help us set expectations on what to expect there, how many patients, and how much follow-up? Hey, Colleen. Thanks. Rosh, do you want to give a little call to Colleen? Yep, absolutely. Hi, Colleen. So yeah, we're expecting we will be reporting out data in the first half of this year at one of the major conferences. This is from part, a little bit of data from the first part. Also, more data from the second and third part. So essentially, all in all, we'll have around 30, 35 patients worth of data.
Speaker Change: For the head and neck cancer data in the first half of this year can you just kind of help us set expectations.
Speaker Change: And what to expect there how many patients.
Speaker Change: And how much follow up.
Speaker Change: Thank you Kelly and thanks, Bruce do you want to give a little color.
Bruce: Yeah, absolutely hi, Colleen so yes, we're expecting we will be.
Bruce: Reporting out data in the first half of this year at one of the major conferences from part a little bit of data from first part also more data from the second and third so essentially all in all we'll have around 30 35 patients.
Rosh Dias: And what you should expect is safety, early efficacy, and also we've got some intratumoral biomarker data as well that we anticipate presenting as well. Great.
Bruce: Worth of data.
Bruce: And what you should expect is safety early efficacy and also we've got some intra tumoral biomarker data as well that we.
Presenting as well.
Rosh Dias: And then for the Cazdozo-Tori combo in 2nd and 4th line, non-spousal lung cancer, can you just kind of help us set expectations for that data readout as well? Yeah, so we'll have emerging data as we move through the year. I'm not going to comment too much on specific enrollment and results because we still do have subjects who are still on therapy in the stage one of the two-stage, Simon two-stage design. But what I will say is that we anticipate focusing in on squamous specifically moving forwards, which is, of course, as you know, Colleen, where we have seen our signal thus far.
Bruce: Great and then for the curves does a Tory combo in second line non small cell lung cancer can you just can help us set expectations for that data readout as well please.
Bruce: Yes, so we will have emerging data as we move through the year.
Speaker Change: Im not going to comment too much on specific.
Speaker Change: Enrollment and results because we still do have subjects, who are still on therapy.
Speaker Change: The stage one of the two stage Simon two stage design.
Speaker Change: But what I will say is that we anticipate focusing in on squamous specifically moving forward, which is of course as you know clean where we have seen our seasonal thus far.
Michael Nedelcovych: Thank you, Colleen. Thank you.
Great. Thank you for taking my questions.
Speaker Change: Thank you.
Rosh Dias: Our next question. is from Michael Nedelcovych, with T.D. Cowan. Please proceed. Hi, thank you for the question. I have one as it relates to the Chaz Dozo development plan in non-small cell lung cancer. So, it sounds like you're moving forward in squamous. I was just curious, what is the next step? Is it a randomized phase two? Is there any chance you could move to a pivotal in late-line non-small cell lung cancer? And what is contemplated in your CASH runway guidance as it relates to Chaz Dozo development in lung cancer? Thank you.
Speaker Change: Our next question.
Speaker Change: It's Tom Michael is now they'll kovich with TD Cowen. Please proceed.
Speaker Change: Alright, Thank you for the question.
Speaker Change: One as it relates to China.
Speaker Change: Development plan in non small cell lung cancers.
Speaker Change: It sounds like Youre moving forward in squamous I was just curious what is the next step is it a randomized phase two is there any chance you could move to a pivotal.
Speaker Change: In late line non small cell lung cancer and.
Speaker Change: What is contemplated in your cash runway guidance as it relates to cash does the development in lung cancer. Thank you.
Rosh Dias: Hi, Michael. So, I'll take the first part of that question. So, our anticipation is that once we have completed a robust dataset in the combination of TORI-Palomar with CasDozo in non-small cells, as I say, the future focus for that is likely to be on squamous cell, we'll then move on into a Phase II-III. So, the Phase III study will be a standard Phase III and will be against the current standard of care, which is doso-taxel. And we talked a little bit last time about the response rates that one sees typically with doso-taxel. And while I won't comment on what exactly, what bar we're expecting to see, you know what the doso-taxel overall response rates are.
Speaker Change: Hi, Michael So I'll take the first part of that question.
Speaker Change: So our anticipation is that we once we have completed.
Speaker Change: Robust dataset in combination of Torrey powder map with <unk> in non small cell as I say the future focus for that is likely to be on squamous cell. We will then move on into <unk>.
Speaker Change: As <unk> III phase III study.
It will be a standard phase III.
And we will be against the current standard of care, which is docetaxel.
Speaker Change: And we talked a little bit last time about the.
Speaker Change: The response rates at <unk>, typically with Docetaxel and while I won't comment on.
Speaker Change: Exactly what.
Speaker Change: We're expecting to see.
Speaker Change: You know what the Docetaxel overall response rates or so.
Rosh Dias: So, the subsequent Phase III study will be against standard of care doso-taxel. Regarding funding of the Phase 3, that's not within the window of the two-year guidance that we've gone up so far, but I think there's a number of options to proceed with that given the data. And I would also indicate that out three to four years during that such time, we think that we have, to our problem, pretty much at full force in the nasal pharyngeal cancer space with 150 to 200 million. Thank you.
Speaker Change: The subsequent phase III study will be again against setup Fedex Texel.
Speaker Change: Regarding regarding funding of the phase III and thats that within the window. The two year guidance that we have gone on so far but I think theres a number of options to proceed with that given the data and I would also indicate that.
Speaker Change: All three to four years during that such time, we think that we have.
Speaker Change: And to our palmar.
Speaker Change: Pretty much.
Speaker Change: At full force and the nasal pharyngeal cancer space with the $150 million to $200 million.
Speaker Change: Great. Thank you thank.
Michael Nedelcovych: Thank you, Michael.
Speaker Change: Thank you.
Brian Cheng: One moment for our next question that comes from the line of Brian Cheng with J.P. Morgan. Please proceed. Hey guys, thanks for taking our questions this afternoon.
Michael: Thank you Michael for a moment for our next question.
Speaker Change: That comes from the line of Brian Chen with Jpmorgan. Please proceed.
Brian Chen: Hey, guys. Thanks for taking my questions afternoon.
Paul Reider: Maybe the first one is for Paul. On Lacto-RC, can you give us a sense of the stickiness to the product in the real world? And for those doctors who have been using Keytruda off-label in MPC in the past, I'm just wondering if you can talk a little bit more about their current level of awareness, and also willingness to adopt. Yeah, well, thank you. Thank you for your question on that, Brian. I think Samir can probably provide you a little color on that.
Speaker Change: Maybe first one is for Paul unlock towards the or can you give us a sense of that.
Brian Chen: The stickiness to the product in the real world.
Speaker Change: And for those doctors, who have been using keytruda off label.
Brian Chen: Do you see in the past.
Brian Chen: I'm just wondering if you can talk a little bit more about their current level of awareness and also willingness to adopt <unk>.
Brian Chen: Yes.
Speaker Change: Thank you for your question on that Brian I think American probably provides a little color on that.
Samir Gaurigalkar: Yeah, so let me start with the question about the stickiness of loftrosi, right? So what we've seen is the physicians who have used loftrosi since launch have been very satisfied with loftrosi, and they've been advocating on behalf of loftrosi. So we expect that they will continue to have repeat use of loftrosi. The thing is, this is a rare cancer, so physicians don't see more than one to two new patients every year. So by the time a physician who's used loftrosi, by the time they have an opportunity to use it again, it's going to take some time.
Speaker Change: So let me start with a question about the stickiness of our product right. So what we've seen over positions.
Have you got further since launch have been very satisfied with what could be.
Speaker Change: Maybe in advocating on behalf of a project, but we expect that they will continue to have repeat yogurt more broadly.
Speaker Change: Yes.
Speaker Change: Rare cancers, so physicians don't see more than one or two new patients every year. So by the time, a physician who used block towards the by the time, we have an opportunity to use it again, it's going to take some time.
Samir Gaurigalkar: But again, we feel confident that we will get repeat use within our physician population.
Speaker Change: We feel confident that we will get repeat use within our physician population.
Samir Gaurigalkar: Now, regarding Keytruda, right, there is a significant amount of off-label use of Keytruda. Part of it is driven by a lack of awareness in the community about Lactorsi and the data from Lactorsi, and we are overcoming that very actively by engaging with physicians and explaining to them the data and the NCCM guidelines. I'll say this, every time we have a conversation with a physician about our data or NCCM guidelines, it is very well received and people get pretty excited about it. So we feel confident that we will be able to overturn the ongoing off-label use of Lactorsi, especially considering that we're the only PD-1 that has any data in this space.
Now regarding keytruda.
Speaker Change: There is a significant amount of off label use of few truda.
Speaker Change: Part of it is driven by a lack of awareness in the community about off towards the end of the data from both <unk> and <unk>.
Speaker Change: We are overcoming that very actively by engaging with physicians and explaining to them the data and BNP guidelines.
Speaker Change: I will say that every time, we have a conversation with the physician about our data Rmp's guidelines have been very well received.
Speaker Change: And people get pretty excited about it. So we feel confident that we will be able to overturn be ongoing off label use of a poorly, especially considering that we're the only PD one there have any data in that space. So.
Samir Gaurigalkar: So yeah, we're very excited and confident moving forward about making inroads into the Keytruda business as well as the chemo-only business. Thanks, Brian.
Speaker Change: We're very excited and confident moving forward about making inroads into with Keytruda business development chemo only business.
Theresa Lavallee: Did you have a follow-up? Yeah, and then maybe just one quick one related to the phase 1 CCRA-TORI combo data sometime later this year. I just want to get a better sense of what we should expect from the intratumoral biopsy data. Specifically, what would be considered good data that you view as further supportive for your ongoing work in head and neck? Great question. Maybe Dr. Lavallee can handle that one for you, Theresa. Yeah, Brian, thanks for that question. There are a couple things we're looking for. First, we've shown robust depletion of ctR8 positive Tregs in the periphery that's sustained over the dosing cycle.
Brian: Thanks, Brian did you have a follow up.
Speaker Change: And then maybe just one quick one.
Brian: We laid out too.
Brian: The phase one <unk> combo data sometime later this year.
Brian: I just wanted to get a better sense of what we should expect from the intra tumor biopsy data.
Brian: Specifically what would be considered good data.
Brian: Got you.
Brian: Fair enough support and for your ongoing work in head and neck.
Brian: Okay.
Brian: Sure Great question, maybe talk to the valley can handle that one.
Brian: Yes, Brian Thanks for the question.
Brian: There are a couple of things we're looking for our first we've shown robust depletion of Ctr eight positive T regs in the periphery.
Brian: Sustained over that dosing cycle, we want to be able to see that in the tumor.
Theresa Lavallee: We want to be able to see that in the tumor. Secondly, what's been demonstrated in preclinical models is that removal of the immune suppressive cell, the ctR8 positive Treg, there's a broad infiltration of CD8 T cells. So that ratio of immune suppressive to immune activating cell is very important. And a number of studies with PD-1 and CTLA-4 have been done and shown efficacy is associated with high CD8 T-cells in the tumor after treatment. So we're looking for an increase in the CD8 cells to tip the balance to immune deficiency. Got it. Thank you so much.
Brian: Secondly, what's been demonstrated in preclinical models.
Speaker Change: Is that for a new phone.
Speaker Change: The immune suppressive cell the <unk> positive T Reg.
Speaker Change: Broad infiltration of CD eight T cells.
Speaker Change: So that ratio of immune suppressive immune activating Sal is very important.
Speaker Change: And a number of studies with PD, one and <unk> four have been done and shown efficacy is associated with high CD eight T cells in the tumor after treatment.
Speaker Change: Looking for an increase in the CD eight cells can tip the balance to immune debate it.
Theresa Lavallee: Thank you, Theresa. Thanks, Brian. Thank you.
Brian: Got it. Thank you so much. Thank you thanks, Brian.
Douglas Tsao: Our next question is from Douglas Tsao with HC Wainwright. Please proceed. Douglas, your line is open. Oh, sorry about that. I was on mute. My apologies. Thanks for taking the questions and congrats on the progress. I guess just one follow-up for me.
Speaker Change: Thank you. Our next question is from Douglas Tsao with H C. Wainwright. Please proceed.
Speaker Change: Douglas Your line is open.
Speaker Change: Sorry about that I was on mute my apologies.
Speaker Change: Sure.
Speaker Change: The questions and congrats on the progress I guess, just one follow up for me I'm just curious.
Douglas Tsao: I'm just curious, in terms for La Torze and the MDC market, how much continued use is there of off-label I.O. agents given, you know, with the NCNF guidelines out there now? You know, and how long do you think it will take for you to sort of capture all that volume? Thank you. Thanks, Doug. So your question is, how much off-label, other CD1s without label, and how long will it take us before we really embed lactorazine as damp care? Samir? Yeah.
Speaker Change: In terms for a lot towards the in the LTC market. How much continued use is there.
Speaker Change: Off label Io agents.
Speaker Change: With the E and S guidelines out there now.
Speaker Change: How long do you think it will take for you to sort of capture all of that volume. Thank you.
Speaker Change: Yeah. Thanks, Doug. So question is how much off label other PD ones with our label and how long will it take us before we really embed back towards he is Tam severe.
Samir Gaurigalkar: And maybe what are some of the things that you need to do to have that happen? So our business opportunity is divided between the academic and hospital setting and the community setting. In the academic setting, there's a pretty good awareness, especially the head and neck cancer specialists, there's a pretty good awareness of the guidelines and the data for laparoscopy. In the community setting, all of these physicians are seeing lots of different cancer types, and MPC is not top of mind until they actually see a patient, and as I mentioned earlier, they're seeing one to two patients per year, so it's only top of mind when they see a patient.
Speaker Change: Maybe what are some of the things that you need to do.
Speaker Change: Yes.
Speaker Change: Great got it.
Speaker Change: Our business opportunity is divided between the academic and hospitals in the community setting.
Speaker Change: In the academic setting we have a pretty good awareness, especially the head and neck cancer specialist at a pretty good awareness of.
Speaker Change: The guidelines and the data for lock towards the in the community setting all of these physicians are seeing lots of different cancer types and MPC is not top of mind until we actually see a patient and as I mentioned earlier, we're seeing 1% to two patients per year. So it is always top of mind with fear fear patient. So we are very actively working on jewelry.
Samir Gaurigalkar: So we are very actively working on using data to identify physicians at the time of diagnosis of a new patient, so we're having a discussion with them about our data and about the NCCN guidelines at a time when they're thinking about MPC. So really, the answer to your question is it's going to be an ongoing process. We did some market research recently, and there's about a 40% awareness of the NCCN guidelines. Clearly, we want to change that. We want to drive a much higher awareness of the NCCN guidelines, but it will be a steady ramp of the awareness and also the uptake of laparoscopy.
Speaker Change: Data to identify physicians at the time of diagnosis of new patients.
Speaker Change: Having a discussion with them about our data and about the NCC guidelines at a time when they're thinking about NPV.
Speaker Change: So really the answer to your question is it going to be.
Speaker Change: The ongoing process, we did some market research recently and that's about a 40% awareness of the MPC and guidelines clearly we want to change that and we want to drive a much higher <unk> guidelines.
Speaker Change: But it will be a steady ramp of the awareness and also the uptake of Oxford.
Samir Gaurigalkar: Last thing I'll say is just reiterate what I said earlier. When we do have a conversation with a physician who is thinking about MPC, it resonates really well, and they get excited about our PFSOS data and the guidelines. And I guess just as a follow-up, do you anticipate it being an easier task in the academic centers? Is it the community where you have more work to do? Yeah, I think we have to be, we can't just focus on the academic centers. We obviously want to get all the academic centers on board. We want to drive usage in hospital and hospital settings.
Speaker Change: Last thing I'll say I'll, just reiterate what I said earlier when we do have a conversation with the physician who are thinking about MPC, it resonate really well and they get excited about a PFS or OS data and the guidelines.
Speaker Change: Yeah.
Speaker Change: And I guess, just a follow up I think you anticipated muni.
Speaker Change: Easier count.
Speaker Change: Easier task in the academic centers as it is is it the community where you have more work to do.
Speaker Change: Yes, I think we have to be re Kansas focus on ACA.
Speaker Change: Academic centers, we obviously want to get all the academic centers on board, we want to drive usage and hospital and hospital settings, but we wanted to establish ourselves.
Samir Gaurigalkar: But if we want to establish ourselves as a center of care, there's a lot of NPC use, treatment of NPC in the community. So we have to make inroads into the community. And we are committed to doing that both through our sales force, but also through digital channels. So we've got to be successful in both those settings. Okay, great. Thank you. And thank you.
Speaker Change: There is a lot of MPC use treatment of MPC in the community because we have to make in growth into the community.
Speaker Change: And we are committed to doing that both through our sales force, but also through digital channels. So we've got to be successful in both of those settings.
Okay, great. Thank you thanks, Doug.
Operator: And this concludes our Q&A session.
Speaker Change: Thank you.
Dennis Lanfear: I will turn it back to Lanny Lanfear for his final comment. Thank you, Operator, and thank you all for joining us today as Coherus achieves, I should say, is about to achieve really a very strategic milestone, assisting the company as a commercial stage, innovative oncology company with an excellent product, Entorafilmat, and a very, very promising pipeline. We will be at IO360 later this month in Boston and look forward to seeing you all there.
Speaker Change: This concludes our Q&A session I will turn it back to Lenny Lance here for his final comments.
Speaker Change: Thank you operator, and thank you all for joining us today as as co Harris achieved.
Speaker Change: I should say.
Speaker Change: It is about to change really our various strategic milestone positioning the company as a commercial stage innovative oncology company.
Speaker Change: Company with an excellent product into our Pal map in a very very promising pipeline.
Speaker Change: We will be at Io and <unk> later this month in Boston and look forward to seeing you all there and thank you very much.
Operator: Thank you very much. And thank you all for participating in today's conference.
Speaker Change: And thank you all for participating in today's conference you may now disconnect.
Operator: You may now disconnect.
Speaker Change: Good.
Speaker Change: Okay.
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