Q4 2023 Coherus BioSciences Inc Earnings Call

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Good day, and thank you for standing by. Welcome to the Q4 2023 Coherus earnings conference call. At this time, all participants are in a listen-only mode.

Speaker Change: Good day and thank you for standing by welcome to the Q4 2023 core areas.

Speaker Change: <unk> Sciences, Inc. Earnings Conference call at this time, all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please be advised that today.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jami Taylor, Head of Investor Relations for Coherus. Thank you, operator.

Speaker Change: Comprehensive is being recorded I would now like to hand, the conference over to your speaker today, Jamie Taylor head of Investor Relations for Agco here.

Jami Taylor: Good afternoon, and welcome to Coherus Biosciences' fourth quarter and full year 2023 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus. Brian McMichael, Interim Chief Financial Officer; Paul Reider, Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa Lavallee, Chief Development Officer. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, the following:

Jami Taylor: Thank you operator, good afternoon, and welcome to coherence Biosciences fourth quarter and full year 2023 earnings conference call joining.

Jami Taylor: Joining me today to discuss our results are Denny Lanfear, Chief Executive officer of Cookie Rs.

Ryan Thank Michael interim Chief Financial Officer.

Speaker Change: Reeder, Chief Commercial Officer, Ross Dias, Chief Medical Officer, and Theresa Live Alley, Chief Development Officer.

Speaker Change: Before we get started I would like to remind you that today's call includes forward looking statements regarding coherence with current expectations about future events.

Speaker Change: These statements include but are not limited to the fall away.

Jami Taylor: Our Ability to Advance Our Pipeline, Projections of Future Growth, Revenue, Expensive, Headcount, and Debt Levels, and the Timing of Any Return to Profitability or Cash Flow Positivity. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results. Transcript by Transcription Outsourcing, LLC. These statements are not guaranteed for future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process that are discussed in our press release that we issued today, as well as the documents that we filed with the SEC. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statement. With that, I'll turn the call over to Denny.

Speaker Change: Our ability to advance our pipeline projections of future growth revenue expenses headcount and debt levels and the timing of that he returned to profitability or cash flow positivity.

Speaker Change: 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.

Speaker Change: Including risks and uncertainties inherent in the clinical drug development process.

Speaker Change: Discussed in our press release that we issued today as well as the documents that we file with the SEC.

Speaker Change: Forward looking statements provided on the call today are made as of this date.

Speaker Change: And we undertake no duty to update or revise any forward looking statement.

Dennis M. Lanfear: Thanks, Jami, and thank you all for joining us on the call today. I'm pleased to report to you today strong fourth quarter results rounding out an important year of transition for Coherus as we sharpened our focus on innovative oncology, assisting the company to reach new levels of efficiency and growth in 2024 and beyond. Our strategy and our mission are clear: to extend the lives of cancer patients. Today, we are delivering on this strategy in every way.

Speaker Change: With that I'll turn the call over to Tony.

Tony: Thanks, Jamie and thank you all for joining us on the call today I am pleased to report to you today as strong fourth quarter results rounding out an important year of transition for our courtyard.

Tony: We sharpened our focus on innovative oncology.

Tony: Listing the company for new levels of efficiency and growth in 2024 and beyond our.

Tony: Our strategy and our mission are clear to extend the lives of cancer patients.

Today, we are delivering on this strategy in every front zany coke years for long term sustainable growth that's in oncology company.

Dennis M. Lanfear: Positioning Coherus for long-term sustainable growth as an oncology company. We believe this strategy creates long-term shareholder value as we develop and deliver next-generation oncology treatments for patients. We continue on the path that we set forward last year.

Tony: Believe this strategy creates long term shareholder value as we develop and deliver next generation oncology treatments for patients.

Tony: We continue on the path that we set forward last year, which.

Dennis M. Lanfear: Which is to first drive sales growth and revenues across the oncology portfolio with new product launches for Udenica and Lactorsa, Secondly, simultaneously reduce our spend in any, Third, realign our balance sheet by reducing our debt, and advance our high-potential pipeline focused on the tumor microenvironment and those complementary to our PD-1. We experienced double-digit sales growth in 2023, and I'll let Paul Reider, our Chief Commercial Officer, discuss continued progress in Lebanon and shared growth in just a moment. Let me start with the spending and headcount reduction. 2024.

Tony: Which is the first drive sales growth in revenues across the oncology portfolio with new product launches of new deneke like tourism.

Tony: Secondly, simultaneously reduce our spend at any cost.

Tony: Alright.

Tony: Our balance sheet by reducing our debt and advance our high potential pipeline.

Tony: On the tumor microenvironment and those are complementary with our PD one.

Tony: We experienced double digit sales growth in 2023.

I'll, let Paul <unk>, our Chief commercial officer discuss continued progress on Lebron and share growth in just a moment.

Paul: Let me start with the spending and head count reductions.

Paul: 24.

Dennis M. Lanfear: Last year, we began a multifaceted process of driving new, efficient headcount reductions, product divestitures, and business process integration for greater efficiency. Today, as part of this plan to position us for sustainable growth, we are announcing a 30% headcount reduction. 2024, and cost reductions as part of our transformation. We are projecting an SG&A plus R&D spend for 2024 of $250 million to $265 million, which is reduced from 301 million in 2023, itself being reduced from about $400 million in 2022. This reduction was the result of a rigorous evaluation of every role within the company, with the objective to reduce or eliminate FTE spend wherever possible.

Paul: Now last year, we began a multifaceted process of driving new efficiencies through head count reductions product divestitures and business process integration for greater efficiencies.

Paul: Today as part of this plan to position us for sustainable growth.

Paul: We're announcing a 30% head count reduction for 2024 and cost reductions as part of our transformation.

Paul: We are projecting and SG&A plus R&D spend for.

Paul: For 2020 for $250 million to $265 million.

Paul: Which is reduced from $301 million in 2023.

Paul: Which itself was reduced from about $400 million in 2022.

Paul: This reduction was the result of a rigorous evaluation of every role within the company with the objective to reduce or eliminate FTE spend wherever possible.

Dennis M. Lanfear: These actions demonstrate that we remain highly committed to returning to profitability as soon as possible. Cash Flow Positivity 2024 remains our goal. Now, as previously stated, monetization of ex-U.S. rights is one of the cash management levers we seek to use to preserve our capital.

Paul: These actions demonstrate that we remain highly committed to returning to profitability as soon as possible.

Paul: And cash flow positivity by 'twenty four remains our goal.

Paul: Now as previously stated monetization of ex U S rights is one of the cash management levers, we seek to use to preserve our capital.

Dennis M. Lanfear: Accordingly, we agreed with Jun Xi to defer and reduce the $25 million approval milestone payment scheduled for this quarter, Q1 2024. This payment is now bifurcated into two parts. $12.5 million to be paid next quarter to 2024, and an additional payment of $12.5 million, paid in Q1 2025, such second tranche to be potentially reduced by proceeds, for the Monetization of Canadian Torque Helmets. This reflects our strong partnership and high level of cooperation with Junxi. With respect to the realignment of our balance sheet and reduction of debt, we are pleased with the financial outcome of the divestiture of our ophthalmology fund. Our efforts to strengthen our balance sheet and overall capital structure are progressing well. And we recently announced a renegotiated agreement with FarmerCount Advisor to pay down $175 million in term loan debt.

Paul: Accordingly.

Paul: We have agreed with June sheet to defer and reduce $25 million approval milestone payment.

Paul: Scheduled for this quarter Q1 2024.

Paul: This payment is now bifurcated into two parts.

Paul: All $5 million to be paid next quarter Q2, 2024 and.

Paul: An additional payment of $12 5 million.

Paul: Paid in Q1 2025.

Paul: Such second tranche to be potentially reduced by proceeds from the monetization of Canadian <unk>.

Paul: This reflects our strong partnership and high level of cooperation with June Shane.

Paul: With respect to realignment of our balance sheet a reduction of debt. We are pleased with the financial outcome for the divestiture of our ophthalmology franchise.

Paul: Our efforts to strengthen our balance sheet and overall capital structure are progressing well.

Paul: And we recently announced the renegotiated agreement with farmers kind of advisors.

Paul: $175 million in term loan debt.

Dennis M. Lanfear: Decreasing our term loan interest payment burden by roughly 70% moving into the remainder of 2024. The ophthalmology divestiture also allows us to streamline operations. Today, Coherus is a leaner, more efficient, more nimble organization, capable of competing in the marketplace with even greater focus, agility, and intensity, tightly focused on being a sustainable and growing company.

Paul: Increasing our term loan interest payment burden by roughly 70% moving into the remainder of 2024.

Paul: The ophthalmology divestiture also allows us to streamline operations.

Paul: <unk> is a leaner more efficient more nimble organization capable of competing in the marketplace with even greater focus agility and intensity.

Paul: We focused on being a sustainable and growing oncology company.

Dennis M. Lanfear: With Lactorsi, we are gaining predictable and growing high-margin revenues from our innovative product and are able to realize the synergies of having two adjacent oncology. I want to congratulate our R&D and regulatory team for their success in securing three product approvals in 2023 from the FDA. This is a major accomplishment for any company, especially one of our size. The FDA approvals of the Udenica autoinjector, the Udenica on-body injector, and Lactorsi for nasopharyngeal cancer have positioned us for further commercial success in 2024, capitalizing on synergies. Each of these products aligns to our vision of oncology leadership, and each paves the way for the impressive slate of tumor microenvironment-focused immuno-oncology assets in our As Dr. Dias will describe shortly, first-in-class and potential best-in-class drug candidates have the potential to deliver on our vision of extending patient survival and driving long-term shareholder value creation. Now, with that, I'll turn it over to my Chief Commercial Officer, Mr. Paul Reider. Paul.

Paul: With like towards the were gaining predictable and growing high margin revenues from our innovative product.

Paul: We're able to realize the synergies of having two adjacent oncology products.

Paul: I want to congratulate our R&D and regulatory teams for their success in securing three product approvals in 2023 from the FDA.

Paul: This is a major accomplishment for any company, especially one of our size.

Paul: The FDA approvals of the identical auto injector, you Danica on body injector and like towards the it makes up your NGL cancer have positioned us for further commercial success in 2024.

Paul: <unk> on synergies.

Paul: Each of these product lines to our vision of oncology leadership, each paves the way for that.

Paul: Impressive slate of tumor microenvironment focused immuno oncology assets in our development pipeline.

Paul: As Dr. Diane will describe shortly first in class and potential best in class drug candidates have the potential to deliver on our vision of extending patient survival and driving long term shareholder value creation.

Paul: Now with that I'll turn it over to my Chief Commercial Officer, Mr. Paul Reader partners.

Paul Reider: Thank you, Denny. Good afternoon, everyone. We ended 2023 with strong momentum for the business and Dynastiture of the Ophthalmology Franchise. Let's use this momentum in 2024.

Paul Reider: Thank you Denny and good afternoon, everyone.

Paul Reider: We ended 2023 with strong momentum to the business.

Paul Reider: The divestiture of the ophthalmology franchise will use this momentum in 2024 are hyper focused on our oncology business drive topline growth of our core oncology assets <unk> and <unk>.

Paul Reider: A hyper focus on our oncology business to drive top-line growth of our core oncology assets, Udetica and Lactors. For the fourth quarter, combined net product revenue was $91.4 million, an increase of 23% over Q3. Full Year 2023 Net Product Revenue is $256.66, a 22% increase over 2022. I'll now speak to each brand, and we'll begin with oncology, starting with eugenics. I'm excited to announce that in Q4, Udetica eclipsed 1 million units sold since its launch, a significant and important milestone demonstrating our customers' belief in Udenica and Coherus's continued commitment to cancer. Now that both the Udenica auto-injector and on-body presentations are launched, our strategy moving forward is to deliver profitable revenue and market share growth. Fueled by 3 drives, First.

Paul Reider: For the fourth quarter combined net product revenue was $91 4 million an increase of 23% over Q3.

Paul Reider: Full year 2023, net product revenue was $256 6, million% to 22% increase over 2022.

Paul Reider: I'll speak to each brand and we will begin with oncology starting with <unk>.

Paul Reider: I'm excited to announce that in Q4, two deneke eclipsed 1 billion units sold since its launch a significant and important milestone and demonstration of our customers' belief the new deneke Incoherences continued commitment to cancer patients.

Paul Reider: Now the <unk> auto injector antibody body presentations are launched our strategy moving forward is to deliver profitable revenue and market share growth.

Paul Reider: Fueled by three drivers.

Paul Reider: Udinecate is the only Paxil-Gaston brand with three device options to meet the unique needs of providers and patients. This strengthens our competitive position and allows us to compete on factors other than price. Second, the launch of Udenica OnBody, a novel and proprietary state-of-the-art delivery system, Peg Philgraston, enabling us to compete now within the entire Peg Philgraston market. And third, we come into 2024 with payer coverage of nearly two times that of 2023, opening up access to significantly more patients. Disciplined execution of the strategy is delivering a third consecutive quarter of Udenica revenue and demand. Q4 net sales were $36.2 million, an increase of 10% quarter over quarter. Total unit demand grew 7% quarter over quarter, driven by increased payer coverage.

Paul Reider: First.

Paul Reider: As the only Pegfilgrastim brand with three device options to meet the unique needs of providers and patients.

Paul Reider: This strengthens our competitive position and allows us to compete on factors other than price.

Paul Reider: Second the launch of <unk> on body.

Paul Reider: <unk> and proprietary state of the art delivery system for <unk>.

Paul Reider: <unk>.

Paul Reider: Enabling us to compete now within the entire Pegfilgrastim market.

Paul Reider: And third we come into 2024 with payer coverage nearly two times that of 2023.

Paul Reider: Opening up access to significantly more patient lives.

Paul Reider: Our disciplined execution of the strategy is delivering a third consecutive quarter of <unk> revenue and demand growth.

Paul Reider: Q4, net sales were $36 2 million, an increase of 10% quarter over quarter.

Paul Reider: Total unit demand grew 7% quarter over quarter, driven by increased payer coverage continued growth of the pre filled syringe presentation and accelerated adoption of auto injector.

Paul Reider: Continued growth of the pre-filled syringe presentation and accelerated adoption of autoinjectors. Customer enthusiasm for the Udenica auto injector presentation led to a 129% demand growth quarter over quarter and CIS Commercial Launch in May of 2023. 727 accounts have ordered the autoinjector presentation.

Paul Reider: Customer enthusiasm for the <unk> auto injector presentation.

Paul Reider: <unk> led to a 129% demand growth quarter over quarter.

Paul Reider: Since commercial launch in May of 2023, 727 accounts have ordered the auto injector presentation.

Paul Reider: Udeneca OnBody was launched last month in February. High Customer Demand for a unique and differentiated on-body device, coupled with confirmed payer coverage, is leading to encouraging demand uptake in these first few weeks of launch, with 138 accounts already ordering a body.

Paul Reider: Jessica on body was launched last month in February.

High customer demand customer demand for a unique and differentiated on body device, coupled with conferred payer coverage is leading to encouraging demand uptake in these first few weeks of launch.

Paul Reider: 138 accounts already ordering on body.

Paul Reider: Based on data from Acuvia, rolling four-week Udenica market share as of March 1st was 26%, representing an increase of, 2015 Market Shoot, versus the same time period in 2023. Udetica is now a franchise and the only PECFIL Grasp of Brand with three presentation offerings now becoming the total solution for oncology providers. With respect to our nine core assets, I'll start with you, Simran. In Q4, we sold 3,800 cartons, generating net sales of $2.2 million.

Paul Reider: Based on data from <unk> Rolling four week <unk> market share.

Paul Reider: As of March one.

Paul Reider: It was 26%.

Paul Reider: Presenting an increase of 15 market share points versus the same time period in 2023.

Paul Reider: <unk> is now a franchise and the only Pegfilgrastim brand with three presentation offerings now, becoming the total solution for oncology providers.

Speaker Change: With respect to our non core assets start with your summary.

Speaker Change: Q4, we sold 3800 cartons generating net sales of $2 2 million.

Paul Reider: All year 2023 net sales were $3.6 billion. We continue to expect slower growth for Humira biosimilars through 2024 until the implementation of the inflation reduction. Regarding similarly, net revenue in Q4 grew to $52.4 million, an increase of 31% quarter-over-quarter; full year 2023 net revenue is $125.4 million, proceeding our guidance of at least $100 million. Similarly, market share within the random ismat class is 34%, an increase of six market share points quarter over quarter. Let me conclude now with Locke-Torzi, our other core oncology. Lactorazine plus chemo is the first and only FDA-approved treatment for recurrent prometastatic NPC in all lines of therapy. We launched January 2nd, and it's going well, with demand uptake tracking to expectation.

Speaker Change: Full year 2023, net sales were $3 6 million.

Speaker Change: We continue to expect slower growth for Humira biosimilars through 2024 until the implementation of the inflation reduction Act 125.

Speaker Change: Regarding similarly net revenue in Q4 grew to $52 4 million, an increase of 31% quarter over quarter.

Speaker Change: Full year 2023, net revenue was $125 4 million exceeding our guidance of at least $100 million.

Speaker Change: Similarly market share within the Ranibizumab class was 34% in Q4, an increase of six market share points quarter over quarter.

Speaker Change: Let me conclude now let's walk towards our other core oncology asset.

Speaker Change: <unk> plus chemo is the first and only FDA approved treatment for recurrent or metastatic mtc in all lines of therapy.

Speaker Change: Launched January 2nd and it's going well with demand uptake tracking to expectations.

Paul Reider: For Q4, we recorded $600,000 in sales based on initial wholesaler stocking to support the commercial watch. NPC is a rare cancer, and we estimate that the U.S. NPC market is valued at up to $200 million. Consisting of approximately 2,000 recurrent or metastatic MPC patients who are diagnosed each year and are split evenly between those in first line versus second, with Lactorsi's broad indication. In all lines of therapy, we are executing a plan to establish lactorse plus chemo as a new standard of care, and that is our ambition. Make Lock TORSI available to as many NPC patients as quickly as possible. Our conviction in achieving this ambition is bolstered by the following. First, we have strong advocacy from the nation's leading opinion leaders.

Speaker Change: For Q4, we recorded $600000 in sales.

Speaker Change: Initial Hawaii wholesaler stocking to support the commercial launch.

Speaker Change: <unk> is a rare cancer and we estimate that the U S. MPC market is valued at up to $200 million in peak <unk>.

Speaker Change: <unk> of approximately 2000, recurrent or metastatic mtc patients diagnosed each year.

Split evenly between those with first line versus second line plus.

Speaker Change: With work towards these broad indication in all lines of therapy, we are executing our plan to establish locked towards E plus chemo as a new standard of care and our ambition.

Speaker Change: Let's take a look towards the available with many NPC patients as quickly as possible.

Speaker Change: Our conviction in achieving this ambition is bolstered by the fall.

Speaker Change: First we have strong advocacy from the nation's leading opinion leaders and advocacy.

Paul Reider: During the multidisciplinary Head and Neck Cancer Symposium, well, just two weeks ago, I held over 50 one-on-one in-person meetings with the nation's top opinion leaders, and over 90% of them affirmed universally that Lactorse plus chemo will become the new standard of care at MPC based on its FDA-approved indication and the strength of the phase three data that includes significant improvements on progression-free and overall survival. Second, La Torze is achieved.

Speaker Change: During the multi disciplinary head neck cancer Symposium will just two weeks ago.

Speaker Change: He held over 50 101 in person meeting with the nation's top opinion leaders.

Speaker Change: Over 90% of them occurred.

Speaker Change: Universally that lock towards the plus chemo will become the new standard of care at MPC based on its FDA approved indication and the strength of the phase III data that includes significant improvements both progression free and overall survival.

Speaker Change: Second look towards he has achieved preferred listing on both the <unk> and FCC NNPC guidance.

Paul Reider: Preferred list, on both the ASCO and NCCN NPC Guide. Rosh will speak to this further, but Lactorsi is the only PD-1 with a Category 1 designation from NCCN for first-line use, a clear differentiator for Lactorsi, and a core message in the Lactorsi promotional message. Third, we've confirmed payer coverage now on label, with payers representing approximately 95% of targeted lives. This includes Medicare fee-for-service. Fourth, the innovative tools we deploy to identify MPC patients are bearing fruit. We've invested in and deployed real-time claims associated with the NPC ICP10 code, as well as electronic medical record data sources. Unknown Executive, Ashwani Verma, McDavid Stilwell, Bhavin Patel, Jason Gerberry, Coherus. First, a Lactorse sales call with that doctor, and second, hyper-targeted branded digital advertising to that oncologist. In terms of early impact, over 60% of accounts that have ordered Lactorsi thus far were sourced from the use of these tools.

Speaker Change: Raj will speak to this further.

Raj: <unk> is the only PD one with a category one designation with the FCC and for first line use a clear differentiator for <unk> and our core message and the lock towards the promotional message campaign.

Raj: Third we've confirmed payer coverage down to label with payers, representing approximately 95% of targeted lives.

Raj: <unk> Medicare fee for service.

Raj: Fourth the innovative tools, we deploy to identify mtc patients are bearing fruit.

Raj: We've invested in and deployed real time claims associated with MPC, ICD 10 codes as well as electronic medical record data sources.

To help identify appropriate mtc patients identified of course these tools alert our field teams in real time, when an oncologist hasnt Mtc patients, which then triggers to actions first block towards the sales call with that Doctor.

Raj: Paper targeted branded digital advertising to that oncologists.

Raj: In terms of early impact over 60% of accounts in order to work towards the thus far.

Raj: Sourced from the use of these tools.

Paul Reider: Last and most important, oncologists are prescribing authority. Since launch, we've had 59 accounts, order locked towards, both clinics and hospitals. With respect to the 33 NCCN-designated cancer centers, 55%... have already added Lactorsi to formulary with the remaining centers in P&T review. And I'm confident we'll have successful outcomes with these centers as well. In summary, we're excited to become a trusted partner within the headnet community to bring new hope for greater survival for NPC patients. With that, I'll now hand it over to you.

Raj: Last and most important oncologists are prescribing locked worthy.

Raj: Since launch we've had 59 accounts order locked horsey priced both clinics and hospitals.

Raj: With respect to the 33 end CCN designated cancer centers.

Raj: 5% have already added look towards to formulary with the remaining centers in PMT review.

Raj: I am confident we will have successful outcomes with new centers as well.

In summary, we're excited to become a trusted partner within the head neck community.

Raj: To bring new hope for greater survival for Mtc patients nationwide.

Raj: With that I'll now hand, it over to Raj.

Rosh Dias: Thanks very much, Paul, and good afternoon, everyone. The past few months have been an exciting time for Loptorsi, which remains the foundational element of our immuno-oncology portfolio. Following FDA approval on October 27, last year, final overall survival data from the Pivotal Registration Study Jupiter-2 were published in JAMA in November, showing a hazard ratio for survival of 0.63 favoring loctorzean, which represents a 37% risk reduction in mortality in patients living with advanced NPCs. This overall survival advantage is not only statistically significant but also very clinically meaningful as NPC patients have not, up until now, had any approved treatment options Within six weeks of approval, LOCTORSI was also included in the NCCN Guidelines for NPC by the NCCN Head and Neck Panel with a very strong position.

Raj: Thanks, very much Paul and good afternoon, everyone.

Raj: Last few months have been an exciting time volatility, which remains the foundational element of our immuno oncology portfolio.

Raj: I think FDA approval on October the 27th last year final overall survival data from the pivotal registration study Jupiter two was published in Jama in November starting a hazard ratio for survival of 0.63 favoring the towards the <unk>, which represents a 37% risk reduction in mortality in patients living with.

Raj: Advanced Mtc.

Raj: This overall survival advantage is not only statistically significant but also very clinically meaningful as MPC patients have not up until now at any approved treatment options for their disease.

Raj: Within six weeks of approval activity was also included in the SEC guidelines for MPC by the SEC in head and neck panel with a very strong positioning in first line disease. <unk> is listed as a preferred therapy and the only checkpoint inhibitor with category, one designation, which does reflect the highest level of evidence and also the uniformity.

Rosh Dias: First-line disease, loctorzi, is listed as a preferred therapy and the only checkpoint inhibitor with Category 1 designation, which does reflect the highest level of evidence and also the uniformity of the panel members' decisions. For the second line and beyond, Loctorazine is the only agent listed as a preferred therapy. And both designations are very reflective of both the strength of the data and the clear unmet medical needs.

Raj: Of the panel members decision.

Second line and beyond look towards the only agent listed as a preferred therapy in both designations are very reflective of the strength of the data and the clear unmet medical need.

Rosh Dias: Outside NPC, several additional positive phase 3 datasets have been published over the past few months, all in high-tier journals. For example, a Neotorch Study in JAMA showing a positive and profound event-free survival benefit favoring toripalumab in perioperative, locally advanced non-small cell lung cancer. Torchlight in Nature Medicine with a positive progression-free survival benefit in triple negative breast cancer, and Renotorch in the Annals of Oncology showing a PFS benefit in renal cell carcinoma. In addition, positive randomized phase 2 data in locally advanced gastroesophageal junction carcinoma have also been published recently in Nature Medicine. It's been very consistent in our communication that our strategic approach to tumors outside NPC will be to develop tori palimab in combinations of partnerships, and therefore these positive data sets across additional tumor types set us up well for partnerships, not only in NPC but also beyond. Tori Pallema forms the backbone for investigation in combination with other novel investigative agents.

Raj: Outside NPC several additional positive phase III data sets have been accomplished over the past few months all in high tier journals, including the near towards study in China take a positive a profound event free survival benefit favoring towards pilot and Peri operative locally advanced non small cell lung cancer towards light in nature.

Raj: I'd say with the positive progression free survival benefit in triple negative breast cancer and renal in the analyst of oncology showing a PFS benefit in renal cell carcinoma. In addition positive randomized phase two data in locally advanced Gastroesophageal Junction carcinoma has also been published recently in nature Medicine.

Raj: <unk> been very consistent in our communication that our strategic approach in tumors outside MPC will be in developing Tory panamax and combination of the partnerships and therefore these positive datasets across additional tumor types sets us up well for partnerships not only in APC, but also beyond the toric pilot nonperforming.

Raj: But for investigation in combination with other novel investigational agents.

Rosh Dias: A recent example of this was our Inovio partnership, where we announced that we will be supplying Toripalumab, in combination with Inovio's DNA-based vaccine directed against HPV-positive tumors, for investigation in a registration-enabling study in locally-advanced head-and-neck squamous cell carcinoma, a tumor type that is complementary to our current indication in HPV. Regarding our clinical stage pipeline By targeting both the T-cell with TORI-PALIMAP and also the tumor microenvironment with our novel agents, the aim will be to make the tumor microenvironment more favorable to anti-tumor effects and therefore realize potential additive benefits.

Raj: A recent example of this was our <unk> partnership, where we announced that we will be supplying towards probably Matt the combination with <unk> DNA based vaccine directed against HPV positive tumors for investigation in a registration enabling study in locally advanced head and neck squamous cell carcinoma, a tumor type that is complementary to our core.

Raj: Current indications in APC.

Raj: Regarding our clinical stage pipeline, we remain excited about the potential to combine our novel agents on top of the Tory Panama backbone by targeting both the T cell with Tori pilot map and also the tumor microenvironment without novel agents. The aim will be to make the tumor micro environment more favorable to antitumor effect and.

Raj: Before realized potential additive benefit.

Rosh Dias: Regarding Casdozo-Ketog, our first-in-class and only clinical-stage anti-IL-27 molecule, we presented data at ESMO-IO in December in advanced non-small-cell lung cancer, where Casdozo demonstrated monotherapy responses in PD-L1 refractory non-small-cell lung cancer with no safety concerns. These encouraging data position us well for further investigation of Cazdozo in this tumor type in combination with TORI, and we are currently enrolling patients in a new arm of our Cazdozo Phase 1B study, evaluating Cazdozo in combination with TORI-Palimab in patients with advanced non-small cell lung cancer. The study is currently open, and we have patients active in the study, and we anticipate presenting data from this study either later this year or early next year. For hepatocellular carcinoma, we presented CASDOVA data in first-line HTC at ASCO-GI in January, with CASDOVA in combination with Atizo and Bev demonstrating an overall response rate of 38% by resist and 43% by M-resist, including complete responses in three subjects.

Raj: Regarding cast as a key took our first in class and early clinical stage anti IL 27 molecule, we presented data at ESMO Io and defend that in advanced non small cell lung cancer, what kind of doses demonstrated monotherapy responses in PD, one refractory non small cell lung cancer with no safety concerns.

Raj: These encouraging data position us well for further investigation of <unk> in this tumor type in combination with Tori and we are currently enrolling patients in a new arm in our cost of the phase <unk> study evaluating <unk> in combination with Tori panamax in patients with advanced non small cell lung cancer.

Raj: This study is currently open and we have patients active on study and we anticipate presenting data from this study either late this year or early next year.

Raj: We'll have better cellular carcinoma, we presented the data in first line HCC at <unk> Gi in January with Cabo in combination with <unk> and <unk> demonstrating an overall response rate of 38% by resist at 43% by M resist including complete responses in three subjects.

Rosh Dias: Recall earlier data that we presented from this study last year showed an overall response rate of 27% with only partial responses, so this increase in response rate, together with deepening of the responses, is very encouraging. Moving forward, we will be investigating Casdozo in combination with Torrey Palomap and Bevacizumab in first-line HCC, which we anticipate will start later this year. I particularly encourage that the clinical activity observed with our IL-27 antagonist Cazdozo has, in addition to clinical response, demonstrated immune activation in liver and lung patients. Biomarker work from these two clinical studies revealed an Association of Higher Levels of IL-27 Expression in Tumors and Cazdova Response. Continue to evaluate if IL-27 expression is informative for indication selection or if it can improve patient outcomes as a predictive biomarker. Other tumor types besides lung cancer and HCC that have high levels of IL-27 expression include head and neck cancer, gastric cancer, and triple negative breast cancer.

Raj: Recall earlier data that we presented from the study last year showed an overall response rate of 27% with any partial responses.

Raj: This increase in response rate together with deepening of responses is very encouraging moving forward, we will be investigating <unk> in combination toward <unk> and Demcizumab in first line HCC, which we anticipate will start later this year.

Raj: We're particularly encouraged that the clinical activity observed with our IL 27 antagonist <unk> has in addition to clinical response demonstrates to immune activation in liver and lung patients.

Raj: The biomarker work from these two clinical studies have revealed.

Raj: In association of higher levels of IL 27 expression in key Mezz and catheter as a response, we will continue to evaluate <unk> seven expression is informative for indication selection or if it can improve patient outcomes as a predictive biomarker.

Raj: The tumor types, besides lung cancer and HCC that have high levels of IL 27 expression in head and neck cancer gastric cancer and triple negative breast cancer.

Rosh Dias: Dr. Wozniak has demonstrated activity in several of these tumor types and supports the potential for additional synergies of the Casdozo-Tauri combination treatment in some of these additional tumor types. Finally, CHS114, our CCR8 antibody, is nearing completion of the dose escalation stage of our Phase 1 study without any safety concerns. Non-clinical data presented at CIDC last year highlight the potential for targeting CCRA to deplete Tregs in the tumor microenvironment to enhance anti-tumor response in head and neck squamous cell.

Raj: <unk> has demonstrated activity in several of these tumor types. It supports the potential for additional synergies of the cat.

Raj: Tori combination treatment and some of these additional candidates.

Raj: Finally, CHF one one for CRA antibody is nearing completion of the dose escalation stage of our phase one study without any safety concerns.

Raj: The clinical data presented that fits the last year.

Raj: Highlights at the potential for targeting <unk> deplete T regs in the tumor microenvironment to enhance antitumor response in head and neck squamous cell.

Rosh Dias: Once dose escalation is complete, we plan to expand the study to explore CHS114 in combination with toripalimab in patients with head and neck cancer where the biology of the target shows strong disease linking. I'll now turn it over to Theresa. Thank you, Rosh, and good afternoon, everyone.

Raj: Once dose escalation is complete we plan to expand the study to explore CHF 114 in combination with Tori piloting that in patients with head and neck cancer, where the biology of the target showed strong disease linkage.

Raj: Now I'll turn it over to Teresa.

Teresa: You Raj and good afternoon, everyone.

Theresa M. Lavallee: I want to once again thank the FDA for taking the approval action in a timely manner and much faster than the BASUFA six-month time period for the eugenica on-body supplement after our resubmission in October. With both the eugenica on-body approval and approval of Lactorsi for all lines of therapy and all patient subsets of nasopharyngeal carcinoma, the Coherus oncology franchise Loctorazine is a next-generation PD-1 inhibitor with potent activation of T-cells, including demonstrating significant activity in tumors that are less inflamed. Our Lactors-E mechanism of action paper, recently published in Cancer Immunology and Immunotherapy, describes its potent activity on T-cells that is attributed to both high binding affinity for PD-1 and its binding at a unique epitope, the FG Lactorsi is the foundation of our I-O franchise, and we are excited to explore clinical opportunities to extend patient survival with novel combinations, particularly with agents that target mechanisms of PD-1 resistance due to immune suppression in the tumor microenvironment. Immunosuppressive M2 macrophages have been well characterized for their ability to dampen the immune system.

Teresa: I'd like to once again, thank the FDA for taking the approval action in a timely manner.

Teresa: Faster than the pursuit for six months time period for the organic on body.

Teresa: After a resubmission in October.

Speaker Change: With both the organic on body <unk>.

Speaker Change: And a peripheral nerve block towards the for all lines of therapy in all patient subsets of nasopharyngeal carcinoma.

Speaker Change: <unk> oncology franchise is well positioned.

Speaker Change: <unk> is a next generation PD, one inhibitor with potent activation of T cells, including demonstrating significant activity in tumors that are <unk>.

Speaker Change: <unk> locked towards the mechanism of action paper recently published in cancer Immunology immunotherapy described Houghton activity on T cells that is attributed to both high binding affinity for PD, one and its binding at a unique epitope.

Speaker Change: F kilo as PD one.

Speaker Change: Slide towards the as the foundation of our Io franchise, and we are excited to explore clinical opportunities to extend patient survival with novel combinations.

Speaker Change: Kelly with agents that target mechanisms at PD one resistant.

Speaker Change: Again suppression in the tumor microenvironment.

Speaker Change: Immune suppressive <unk> macrophages have been well characterized dampen the immune system.

Theresa M. Lavallee: Our CHS 1000 program, an anti-ILT4 antibody, is on track for IND submission in the second quarter of this year. We'll be presenting the preclinical data from our CHS 1000 program at AACR in April. The poster presentation presents the non-clinical characterization of CHS1000, showing it as an IL-T4-selective and potent antibody that promotes an inflammatory immune response. Tumor types with high expression of IL-T4 include lung, head and neck, liver, breast, and ovarian cancer.

Speaker Change: Our CHS 1000 program.

Anti IL <unk> four antibody.

Speaker Change: On track for IND submission in the second quarter of this year.

Speaker Change: We will be presenting the preclinical data from our CHS 1000 program at ACR in April.

Speaker Change: Poster presentation.

Speaker Change: On the non clinical characterization of CHS 1000, and it is in Iot for selective and potent antibody that promotes an inflammatory immune response.

Speaker Change: Give or take with high expression of IL <unk> includes Latin.

Speaker Change: Nick.

Deferred breast and ovarian cancer.

Theresa M. Lavallee: In addition to advancing new latentacy indications with combination treatments using the Coherus pipeline targeting the TME, we have a number of exciting novel external combinations and discussions. Another important partnering initiative is exploring novel combinations with CazDozo and CHS114. Given their safety profiles, strong line-of-sight to tumor indications, and immune modulation in cancer patients, there are several rational combinations, such as bi-specific antibodies, including T-cell engagers, ADCs, targeted therapies, and even CAR T therapies.

In addition to advancing new lock towards the indications with combination treatments using the coherent pipeline marketing teams. The T&D, we have a number of exciting novel external combinations in discussions.

Speaker Change: Another important partnering initiatives is.

Speaker Change: Is exploring novel combinations with <unk> and <unk>.

Speaker Change: Glen Lake for.

Speaker Change: Given their safety profiles.

Speaker Change: Line of sight to tumor indications and immune modulation in cancer patients. There are several rational combinations such as bi specific antibodies, including T cell engagement.

Speaker Change: ADC targeted therapies and even car T therapies.

Brian Mcmichael: I'll now turn the call over to Brian. Thank you, Theresa, and good afternoon, everyone. I'll briefly review the results for the quarter and the full year. As Paul covered revenues, I will start with costs and expenses. Cost of goods sold increased significantly for the year to $159 million compared to $70.1 million in the prior year, driven primarily by our non-core products.

Speaker Change: I'll now turn the call to Brian.

Brian: Thank you Teresa and good afternoon, everyone.

Brian: Briefly reviewing the results for the quarter and the full year.

Brian: As Paul covered revenues I will start with cost and expenses.

Brian: Cost of goods sold increased significantly for the year to $159 million compared to 71 in the prior year, driven primarily by our noncore products.

Brian Mcmichael: Specifically, in Q4 2023, we recorded a $47 million charge for the write-down of slow-moving eucimery inventory and related firm purchase commitments. In addition, similarly, COGS included a low to mid 50% royalty on gross profit. Gross margins for the fourth quarter were 8%, excluding the $47 million write-down. Gross margins for the quarter would have been 59%, including the royalty on similarly gross profits mentioned earlier and the mid-single-digit royalty we pay to Udenica. We pay our new debt, and that's it. We ended the year with RMD expenses totaling $109.4 million, down $89.9 million from the prior year.

Brian: Specifically in Q4 2023, we recorded a $47 million charge for the write down of slow moving new cemetery inventory and related firm purchase commitments. In addition, similarly Cogs included a low to mid 50% royalty on gross profits.

Brian: Gross margin for the fourth quarter was 8%.

Brian: Excluding the $47 million write down.

Brian: Gross margin for the quarter would've been 59%, including the royalty on similarly gross profit as mentioned earlier and a mid single digit royalty we pay to <unk>.

Brian: We pay on new Deneke net sales.

Brian: We ended the year with a R&D expense totaling $109 4 million.

Brian: Down $89 9 million from the prior year.

Brian Mcmichael: R&D expense for Q4 2023 was $26.4 million, a decrease of $2.7 million from the same period in the prior year. The decline is reflected in the price. Dispensers in 2022 that did not reoccur in 2023, namely, the $35 million digit option fee in Q1 2022 and other descoped co-development costs which achieved the cost of preparing for launches of new products that happened during 2023 and savings with reduced headcount and to be a very important part of the 2021 launch of the new launch of the new launch of the new launch of the new launch of the new launch of For the quarter, FT&A expense was $49.5 million, down $4.1 million and 8% compared to a year ago.

Brian: <unk> expense for Q4, 2023 was $26 4 million a decrease of $2 $7 million from the same period in the prior year.

Brian: The declines reflected expenditures in 2022 that did not reoccur in 2023.

Brian: Emily to $35 million ticket option fee in Q1, 2022, and other de scoped co development costs, which in shape.

Brian: Cost of preparing for launches of new products that happened during 2023 and savings with reduced head count.

Brian: SG&A expense for the year was $192 million down from $198 5 million in the prior year.

Brian: For the quarter SG&A expense was $49 5 million down $4 1 million and 8% compared to a year ago and.

Brian Mcmichael: The decrease is primarily reflected savings from lower headcount, partially offset by other costs. For the fourth quarter of 2023, we reported a net loss of $79.7 million, or $0.71 per share, compared to a net loss of $58.9 million, or $0.76 per share for the same period in 2022. Cash and cash equivalents and investments in marketable securities were $117.7 million as of December 31, 2023, compared to $192 million at December 31, 2022. Our 2023 results included $40.5 million of interest expense. We expect to reduce our cash flow borrowing costs by more than $24 million on an analyzed basis following the partial pay down using proceeds from the divestiture. In addition, we expect to save at least $25 million on an annualized basis in OPEX due to headcount reductions associated with the divestiture and the reduction in force.

Brian: The decrease is primarily reflected savings from lower head count partially offset by other costs.

Brian: For the fourth quarter 2023, we reported a net loss of $79 7 million or.

Brian: Or <unk> 71 per share compared to a net loss of $58 9 million or <unk> 76 per share for the same period in 2022.

Brian: Cash and cash equivalents and investments in marketable securities were $117 7 million as of December 31, 2023, compared to $192 million at December 31, 2022.

Brian: Our 2023 results included $45 million of interest expense, we expect to reduce our cash flow borrowing costs by more than $24 million on an annualized basis. Following the partial pay down using proceeds from the similarly divestiture in.

Brian: In addition, we expect to save at least $25 million on an annualized basis in opex due to head count reductions associated with the divestiture and the reduction in force.

Brian Mcmichael: After factoring in these savings, in addition to those expected from the termination of the TJIP program that we announced in January, Coherus is introducing a 2024 guidance range of combined R&D and SG&A expenses of $250 million to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of strategic acquisitions, collaborations, and investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified.

Brian: After factoring in these savings in addition to those expected from the termination of the tissue program that we announced in January.

Brian: This is introducing a 2020 quarter guidance range of combined R&D and SG&A expense of $250 million to $265 million.

Brian: This guidance includes approximately $40 million of stock based compensation expense and excludes the effects of strategic acquisitions collaborations and investments the exercise of rights or options related to collaboration programs and any other transactions or circumstances, not yet identified or quantified.

Brian: With that I'll turn the call back over to Denny.

Brian Mcmichael: With that, I'll turn the call back over to Denny. Thank you, Brian. Operator, we're ready to open the line up for questions. Thank you. Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again.

Dennis M. Lanfear: Thank you, Brian operator, we're ready to open the lineup for questions. Thank you.

Brian: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Dennis M. Lanfear: One moment for questions.

Dennis M. Lanfear: Our first question comes from Robyn <unk> with <unk> Securities You May proceed.

Hey, this is Michelle on for Robyn. Thanks for taking my question. So I have one on <unk>.

Operator: One moment for questions. Our first question comes from Robyn Karnauskas. With two insecurities, you may proceed. Hey, this is Nishant. I'm on behalf of Robyn.

Phil.

Michelle: Anika you continue to increase market share, it's up 7% quarter with Walker.

Nishant: Thanks for taking our question. So I have one on Eugenica and one on Lactordi. So with Eugenica, you continue to increase market share. It's up 7% point quarter over quarter. But, however, the sales are up by 10%. Can you provide more color?

Michelle: But how long are the sales are up by 10% can you provide more color.

Michelle: That was the tech belt net selling price reduction this quarter.

Michelle: And for <unk>, you mentioned the lumpy Greenville can you provide more color as in weather.

Michelle: The drug is being used more in frontline and second line study. Thank you.

Speaker Change: Thank you. Thank you very much Paul we'll be happy to address your question with respect to your identity and then.

Nishant: How much was the effect of the NET selling price reduction this quarter? And for Lactordi, you mentioned the launch is going well. Can you provide more color as in whether, you know, the drug has been used more in a frontline or second line setting? Thank you. Thank you. Thank you very much. Paul will be happy to address your question with respect to Udenica and then, secondarily, the question of the launch of FirstLine versus SecondLine for a black jersey. Yeah, hi, Michonne.

Speaker Change: Secondarily. The question of launch of first line versus second line or a black Turkey Paul.

Paul: Yeah, Hi, Sean Thanks for your question.

Sean: Yes, so the.

Speaker Change: The effect of the net selling price quarter over quarter.

The mid single digit range.

Speaker Change: And as I mentioned in my remarks.

Speaker Change: Our focus now that we've launched and have all three presentations.

Paul Reider: Thanks for your question. Yeah, so the, the effect of the net selling price quarter over quarter was in the, you know, the mid single digit range. And as I mentioned in my remarks, our focus now that we've launched all and have all three presentations is that we're now going to drive the franchise, Unknown Executive, Ashwani Verma, McDavid Stilwell, Bhavin Patel, Jason Gerberry, Colleen Karnauskas, Michael Nedelcovych, Colleen Karnauskas, Michael Nedelcovych, Coherus BioSciences Inc Unknown Executive, Ashwani Verma, McDavid Stilwell, Bhavin Patel, Jason Gerberry, Coherus BioSciences Inc Unknown Executive, Ashwani Verma, McDavid Stilwell, Bhavin Patel, Jason Gerberry, Coherus BioSciences Inc Unknown Executive, Ashwani Verma, McDavid Stilwell, Bhavin Patel, Jason Gerberry, Coherus Unknown Executive, Ashwani Verma, McDavid Stilwell, Bhavin Patel, Jason Gerberry, Coherus BioSciences Inc, I think you have an ancillary. As an ancillary response to your question, Nishan, perhaps Dr. Dias would like to comment on the selection of lactorazine as a PD-1 for patients diagnosed with MPC.

We're now going to drive the franchise too.

Speaker Change: Profitable market share and revenue growth.

Speaker Change: And that's that's going to be our plan in 2024 and beyond we're going to do that because we have now all three presentations can access the entire market we've locked in rate payer coverage.

Speaker Change: We've been able to have a competitive asp's. So we're looking forward to a successful 2024 with you deneke franchise regarding look towards again your question about <unk>.

Speaker Change: Getting first line or second line, we're just a couple of months into it will be better able and on our first quarter call to give you more specifics, but what are but what our intelligence tells us Dallas, we're getting patients across all lines of therapy.

Speaker Change: And that's not unexpected given that we've got the indication for all lines of treatment.

Speaker Change: Many of the patients that are.

Speaker Change: <unk> gotten chemo in second line, they're going to they're going to get lock towards the immediately now so so we're getting it in both both lines, which is great and the launch is going very well so.

Speaker Change: Thanks, Larry.

Speaker Change: As an ancillary response to your question John.

Speaker Change: Perhaps <unk> like to comment on the selection of locked tours.

Speaker Change: As a PD one up for patients diagnosed with MPC.

Rosh Dias: Yeah, happy to. So, um, I can tell you as a physician that I doctors tend to be very evidence-based and data driven. What I will say is that Loctorze has three things that other checkpoint inhibitors do not have.

John: Yeah happy to so.

I can tell you that the physician.

Speaker Change: Doctors tend to be very evidenced based and data driven.

Speaker Change: What I will say is that look towards the has <unk>.

Speaker Change: Anything into that other checkpoint inhibitors do not have first of all we have data from a randomized control study and not only do we have data that we have overall survival data, which is actually the gold standard in oncology to look for and I mentioned, the 37% risk reduction in terms of.

Rosh Dias: First of all, we have data from a randomized control study. And not only do we have data, but we also have overall survival data, which is actually the gold standard that oncologists look for. And I mentioned the 37% risk reduction in terms of survival advantage. Secondly, of course, we have a label, and other checkpoint inhibitors do not have a label, and not only do other checkpoint inhibitors not have labels, but there are no other indicated therapeutic agents for NPC.

Speaker Change: Survival advantage with the additional volatility.

Speaker Change: Of course, we have a label and other checkpoint inhibitors do not have a label and not only that actually not only do other checkpoint inhibitors and I'll have labor there is no other indicated.

Therapeutic agents for MPC and thirdly.

Rosh Dias: And thirdly, I'll say to Denny's point, we also have preferred positioning in terms of NCCN guidelines. We are the only Category 1 listed agent for First Line in terms of immunotherapy, and I think that really does reflect the strength of the data and the confidence in the data in this area. Thank you, Rosh.

Speaker Change: <unk> stated that each point, we also have preferred positioning in terms of Mtc and guidelines.

Speaker Change: Category one.

Speaker Change: <unk> agent Footwall.

Speaker Change: For slide in terms of immunotherapy and I think that really does reflect the strength of the data and.

Speaker Change: The confidence in the data in this in this area of unmet need.

Rosh Dias: Thank you for your questions, John. Thank you. One moment for questions. Our next question comes from Yigal Nochomovitz with Citigroup. You may proceed. Hi, Denny and team, thank you for taking the questions on the liver cancer study. I'm just curious.

Speaker Change: Thank you Raj. Thank you for your question Sean.

Speaker Change: Thank you.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Yigal <unk> with Citigroup you May proceed.

Yigal: Hi, Denny and team. Thank you for taking the questions.

Yigal: The on the liver cancer study I'm, just curious I think the key comp there as Embraer 150.

Yigal Dov Nochomovitz: I think the key comp there is InBrave 150. Nominally, you are, you are above those numbers. Of course, the numbers are small. I'm just curious if you could comment as to how much better you think you'd need to be than the InBrave 150 benchmark to be on a go go forward decision with your triple combo. Thank you. Thank you, Yigal. Dr. Dias can address that. Yeah, so you're absolutely right. The EMBRAVE data with the TISA BEV is actually the only indication; the TISA BEV is the licensed indication right now.

Yigal: Nominally you are you are above those numbers of course the numbers are small.

Yigal: Just curious if you could comment as to how much better you think you'd need to be then and the embraer one safety benchmarks too to be on a go go forward decision with your Triple combo. Thank you.

Speaker Change: Thanks Hugo.

Speaker Change: <unk> can address that.

Speaker Change: So yes.

Speaker Change: You're absolutely right.

Speaker Change: We embraced data with a teaser bev is actually.

Speaker Change: <unk> is the license application right now so we've shown a response rate as I said, a 38%, 43% with and resist I think we'll be looking at that that this is the kind of range, we're actually looking for but the development.

Rosh Dias: So we've shown a response rate, as I said, of 38%, 43% with M-Resist. I think we'll be looking at this is the kind of range we're actually looking for further development, right? So I think the data that we presented at ASCO GI in January is exactly what we were looking for, and we will be following up with a further study that's going to start later this year. If we're looking at the triplet combination,

Speaker Change: Development rights, So I think with the data that we presented at <unk> Gi in January is.

Speaker Change: It is exactly what we were looking for and we will be.

Speaker Change: We will be following up with that.

Speaker Change: A further study thats going to start later this year.

Speaker Change: We're looking at that triplet combination.

Rosh Dias: Yeah, if I can add to that, Yogi, I think in a 30 patient study, the numbers are higher, but it's not an apples to apples comparison. So we were excited, as Rosh mentioned, in both the deepening of response and the improvement in response, and the study continues to evaluate data, but important in a 30 patient phase 2 study is also to look at how those responses track with IL-27 biology. So while the numbers again are small, very provocative that we see an association of IL-27 expression with response. Additionally, this is a program that has shown preclinically that there is strong activity in HCC in multiple models. The biology of IL-27 coming from the tissue resident macrophages, so liver macrophages, Cooper cells, is really one known to dampen the immune response.

Speaker Change: Yeah, and if I can add to that.

Speaker Change: I think in a 30 patient study the numbers are higher but it's not an apples to apples comparison.

Speaker Change: We're excited as Ross mentioned in both the deepening of response and the improvement in response in this study is.

Speaker Change: You evaluate data and.

Speaker Change: Importantly in a 30 patient phase two study is also to look at how those responses track with IL 27 biology.

Speaker Change: So when will the numbers again are small very provocative that we see in association.

Speaker Change: IL 27 expression with response.

Speaker Change: Additionally.

Speaker Change: This is a program that has shown pre clinically that there is strong activity in HCC and multiple models.

Speaker Change: <unk> of IL 27 coming from that.

Speaker Change: That tissue resident macrophages, so liver macrophages herself, it's really one camp.

Speaker Change: Dampen the immune response and that activity that was specific in preclinical models to liver cancer and lung cancer translate it.

Theresa M. Lavallee: And that activity that was specific in preclinical models to liver cancer and lung cancer translated to humans. So I think that, with the biomarker data in the responding patients, showing modulation of the IL-27 pathway in association with response, and the high levels of IL-27 expression, we are incredibly excited to do the TORI-ASDOZO-VEV combination. And maybe one last thing I'll add. Safety is always important.

Speaker Change: So I think that with the biomarker data in the responding patients.

Speaker Change: Joey modulation of the IL 27 pathway in association with response and the high levels of IL 27 expression.

Speaker Change: Incredibly excited to Cuba, Torii as sales Bev combination.

Speaker Change: And maybe one last thing I'll add.

Theresa M. Lavallee: We showed a very, you know, there's a very clean safety profile as well. Very important. Thank you, Yigal. Okay, can I have another one? I was just curious about one on CH114.

Speaker Change: <unk> always important.

Speaker Change: We showed a very there's.

Speaker Change: A very clean safety profile as well.

Speaker Change: Thank you Hugo.

Speaker Change: Okay.

Speaker Change: And the other one I was just curious on.

Speaker Change: On one on CH.

Yigal Dov Nochomovitz: Yeah, Theresa, you mentioned the dose escalation, and then you're going to do the combo with Tori. I think in your slide deck in early January, you indicated there'd be some data in the first half of the year for phase one. I wasn't sure if that was still the expectation or if you could just help understand that, please.

Speaker Change: One for Teresa.

Speaker Change: Teresa you mentioned the <unk>.

Speaker Change: Dose escalation and then youre going to do the combo with Tori.

Speaker Change: I think in your slide deck in early January you indicated there'd be some data in the first half of the year for the phase one.

Speaker Change: Wasn't sure if that was still.

Speaker Change: The expectation or just help us understand that please thank you.

Theresa M. Lavallee: Thank you. Yes, we plan to present the dose escalation in the first half of the year at a major medical conference. Packing.

Speaker Change: Yes.

Speaker Change: We plan to present dose escalation in the first half of the year at a major medical conference.

Theresa M. Lavallee: Thank you. Okay. Thank you. One moment for questions. Our next question comes from Colleen Kusy with Baird. You may proceed.

Speaker Change: Thank you okay.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Colin <unk> with Baird You May proceed.

Colleen Margaret Kusy: Hi, thanks for taking our questions. I think revenue guidance is something you've given in the past. It looks like you're not providing revenue guidance for 2024. So can you just talk a little bit about that decision?

Colin: Hi, Thanks for taking our questions I think revenue guidance is something you've given in the past and it looks like.

Colin: You are not providing revenue guidance for 2024. So can you just talk a little bit about that decision and what you think some of the levers are for revenue growth this year.

Dennis M. Lanfear: And what do you think some of the levers are for revenue growth? Hi, thanks, Colleen. I'll take that one and let Paul backfill.

Speaker Change: Alright, Thanks, Kelly I'll take that one and let Paul backfill.

Dennis M. Lanfear: I think the primary issue is that we have recently launched Udenica OnBody. We're very excited about the enthusiasm that's been received in the market, but the ultimate trajectory of that across 2024 is not yet known. It's only been out in the market for about a month.

Speaker Change: I think the primary issue is that we have freshly launched that you deneke on body. We're very excited about the enthusiasm thats been received in the market, but the ultimate trajectory of that across 2024. It is not yet known it's only been out in the market for about a month as Paul pointed out, though we have seen a $100.

Dennis M. Lanfear: As Paul pointed out, though, we have seen a 129% increase with respect to the auto injector uptake, and the trailing four-week data for Udenica itself is up north of 25% up from Q4. So that's all very, very compelling. I think that would give us greater certainty with respect to the trajectory and the steepness of the trajectory.

Speaker Change: 9% increase with respect to the auto injector uptake.

Speaker Change: The trailing four week data or your dedicated itself is up north of 25% up from Q4. So that's all very very compelling.

Speaker Change: Think that would give us greater certainty with respect to the trajectory.

Dennis M. Lanfear: Once we get a little further into Q1 and get that below us, all the indicators are positive. But I think, certainly on the next call, we'll be able to give you some additional information on that. With respect to Lactorsi, as Paul indicated, we're very pleased with the launch. Our digital strategy over the last two years of basically developing a relationship with the patient has been very, very good, and we are very pleased with the uptake, very pleased with the P&T committees and how well we're doing there, you know, but I think that's going to take a little bit of time. You know, it takes a month or two to get on a formulary for a P&T committee in a major hospital somewhere on the East Coast or something.

Speaker Change: And the steepness that trajectory once we get little further into Q1 and get that below us and all the indicators are positive, but I think certainly on our next call will be able to give you. Some additional information on that with respect to lock towards the as Paul indicated we're very pleased with the launch our digital strategy over the last few years.

Speaker Change: <unk>.

Speaker Change: Basically.

Speaker Change: Developing a relationship with the patient.

Speaker Change: It's very very good and we are very pleased that the uptake very pleased that TNT committees and how well we're doing there.

Speaker Change: But I think thats going to take a little bit of time. It takes a month or two to get on formulary for a PNT committee of the major hospital someplace in.

Dennis M. Lanfear: So we're happy to do that. But we just would like a little, probably another quarter under our belts before we go ahead and do projections with respect to revenue. But on the topic of revenue, though, I would make one key point for you: the quality of the revenues is just as important, if not more important, as the size of the revenues.

Speaker Change: The east coast or something so we are happy to do that but we just would like to alert probably another quarter under our belts before we go ahead, and we do projections with respect to revenue.

Speaker Change: But on the topic of revenue, though I would make one keep.

Speaker Change: What would make one key point for you is the quality of the revenues is just as important if not more important is the size of the revenues.

Dennis M. Lanfear: And we expect that the margins and the quality of revenues, for example, with Lacto-Rosie and Udenica, will lead to greater profitability as we go into the backside of the year. And as Paul said, that's really where we're focused. We want to drive the top line, but we also really think that the quality of the revenues, especially with a product like Lacto-Rosie, is going to be far better, more stable, and more sustainable than your typical biosimilar. Transcribed by https://otter.ai. That's helpful.

Speaker Change: We expect that the margins and the quality of the revenues for example, but like towards the end you Deneke will lead to greater profitability as we go into the backside of the year and as Paul said, that's really where we're focused we want to drive the top line, but we also really the quality of the revenues, especially with a product like <unk>.

Speaker Change: It is going to be far better more stable and more sustainable than your typical biosimilar.

Colleen Margaret Kusy: Thank you. And maybe a follow up on some of your comments and just a quick clarification on cash flow positivity. I think you said the goal is cash flow positivity in 2024. Can you clarify? Is that guidance for cash flow positivity in 2024 or not specifically, maybe dependent on revenue or other factors? Without being able to predict revenues, I can't really predict cash flow positivity. But I would just make the key point that I think that we've made substantial progress with respect to reducing our SG&A and R&D costs, even in the face of several launches over the past 12 months. We have reduced our headcount over the past two years, from 22 to 23 to 24, from 360 to 290, and now we are targeting 215 FTEs by the end of this year.

Speaker Change: That's helpful. Thank you and maybe a follow up on your comments and just a quick clarification on cash flow positivity. I think you said the goal is cash flow positive in 224 can you just clarify is that guidance for cash flow positive in 2024 or not specifically may be dependent on revenue.

Speaker Change: Yes.

Speaker Change: Yes, without being able to predict revenues I can't really predict cash flow positivity, but no I would just make the key point that I think that we've made substantial progress with respect to reducing our SG&A and R&D line, even in the face of several launches over the past 12 months.

Speaker Change: We have reduced our head count over the past two years from 'twenty two to 'twenty three to 'twenty four from 360 to 290 and now targeting 215 ftes by the end of this year I mentioned, our our overall SG&A reductions. So I think that we are running a very very efficient.

Dennis M. Lanfear: I mentioned our overall SG&A reductions. So I think that we are running a very, very efficient organization as we focus on oncology. At the same time, we're driving revenues higher, as you can see. And then lastly, we're making very good progress reducing our interest costs. Brian summarized that for us.

Speaker Change: <unk> organization as we focus on oncology at the same time, we're driving the revenues higher as you can see and then lastly, we're making very good progress, reducing our interest cost Brian recapitulated that for us, but 70, 70% reduction in our fixed term loan.

Dennis M. Lanfear: But a 70% reduction in our fixed term loan interest costs, where we're paying SOFR plus aid, I think that that's really very significant. So we're going to continue in this direction. And just where those two lines cross, we can't quite predict, but that's our North Star and our guiding light for where we're going. That's helpful.

Speaker Change: Interest costs were paying software plus as I think that's really very significant so we're going to continue in this direction and just where those two lines cross we can't quite predict but thats, our northstar and our guiding light where we're going.

Michael Thomas Nedelcovych: Thanks for taking our questions. Thank you. One moment for questions. Our next question comes from Michael Nedelcovych with TD Cowan. You may proceed. Hi, thanks for the question. So you have a wealth of opportunities in terms of various combinations and various tumor types and indications where those combinations might be tested. Can you give us a sense of pipeline priorities and when those priorities might translate into discrete go-no-go trials or even digital trials?

Speaker Change: That's helpful. Thanks for taking my questions.

Speaker Change: Sure.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Michael <unk> with TD Cowen You May proceed.

Michael: Hi, Thanks for the question.

Michael: Do you have a wealth of opportunities in terms of various combinations in various tumor types and indications.

Michael: Of those combinations might be tested can you give us a sense of pipeline priorities and when those priorities might translate into.

Michael: Discrete go no go trials or even pivotal trial.

Michael: Yes.

Theresa M. Lavallee: Thanks for the question, Michael. I'll let Dr. Lavallee address that. Theresa?

Speaker Change: Thanks for the question Michael is that Dr. La Vallee address that Teresa, Yeah, and Michael Thanks.

Michael Thomas Nedelcovych: Yeah, Michael, thanks. Where, as we've talked about with the CAS-DOSO lung cancer study, is it open? I mean, that's a home run kind of strategy, a high bar, but given the monotherapy activity of CAS-DOSO, which was not expected to see in cancer patients, the TORI combination should show data by the end of this year or early next year. We're also looking at earlier lines of treatment based off of the TORI positive data trials, such as Neotort. Further Explore Lung Cancer

Teresa: As we've talked about we think has got us as a lung cancer study is open.

Teresa: That said at home run kind of strategy a high bar given the monotherapy activity of <unk>, which was not expected to see in cancer patients that Tori combination chip shell by data by the end of this year early next year. We're also lucky.

Teresa: At earlier lines of treatment based on the tour a positive data trials, such as <unk> and <unk>.

Theresa M. Lavallee: The HCC study we plan to open later this year, so data next year. As we mentioned, the 114, the CCR8 antibody, will be presented in next quarter. So I think the news flow from that plus a number of partnerships, we've already announced the Inovio one, you'll see other ones, and that will be generating data next year. It'll also be presented. And the, you know, the part that isn't appreciated about Torah Palamab is Junxi continues to develop it, and now all of their studies are multi-regional clinical trials, which would make it acceptable to the FDA.

Teresa: Further explored lung cancer.

Teresa: <unk> study we plan to open later this year as that data next year as we mentioned the one line floor. The ctr eight antibody will be presenting.

Teresa: And next quarter.

Teresa: I think the news flow from that plus a number of partnerships with already announced <unk> Wang guilty other wins and that will be generating data next year.

Teresa: Have been presented.

Speaker Change: And I'm.

Speaker Change: I'm sorry that is it appreciated about tour a column ad.

Speaker Change: Is GMC continues to develop it and as now all the Zurich studies or multi regional clinical trials, which would make it.

Speaker Change: And acceptable to the FDA and today have a phase III ongoing with their pipeline.

Theresa M. Lavallee: And so they have phase three ongoing with their pipeline, so we'll be watching while we're not part of that study or funding that study. Clearly, as it gets registered, we have the market share, so we'll be watching for that. And that study opened last year. So typical small cell lung cancer phase three metrics.

Speaker Change: So we'll be watching but were not part of that study are funding that steady clearly as it gets registered we have the market share that we will be watching for that and that steady opened last year. So typical small cell lung cancer phase III metrics later in the next couple of years.

Theresa M. Lavallee: So later in the next couple of years. Thanks, Michael. Thank you. One moment for questions. Our next question comes from Chris Schott with JPMorgan Chase. He may proceed. Hi, this is Ethan Brown on behalf of Chris Schott.

Speaker Change: Thanks, Michael.

Speaker Change: Thank you.

Speaker Change: One moment for questions.

Speaker Change: Our next question comes from Chris Shaw with.

Chris Shaw: JP Morgan Chase you May proceed.

Chris Shaw: Hi, This is Ethan brown on for Chris Schott, Thanks for taking our question.

Christopher Thomas Schott: Thanks for taking our questions. Just to start off, can you maybe offer some color on how you're thinking about OpEx looking past 2024, given, on the one hand, you have the pipeline that you're trying to progress and then balancing that against the company's past profitability? And then I have one more question after that. I'll let Brian McMichael take a shot at that, Brian.

Ethan Brown: Just to start off can you maybe offer some color on how youre thinking about opex looking past 2024 given.

Ethan Brown: On one hand, you have the pipeline that youre trying to progress and then balancing that against the company's path to profitability.

Speaker Change: And then I have one more question after that.

Speaker Change: I'll, let Brian Mcmichael I'll take a shot at that Brian.

Brian Mcmichael: Yeah, so we're not providing guidance beyond 24 at this time. As we sort out some of the things we're working on with our capital structure, we'll have a better idea of how we'll move forward from there. And that'll inform how we move forward in 2020. Yeah, I would say after we achieve profitability and cash flow positivity, we intend to stay profitable, if that's your question. I would offer you one other point, which is that we expect Lactorse to reach peak sales in two and a half to three years, and we further expect a continued increase in market share for Udenica, you know, over the short to medium term. So both of those things will continue to drive top line for us, and furthermore, we'll continue to show a very high degree of discipline with respect to controlling our expenses in SG&A, as That's very helpful.

Speaker Change: Yes.

We're not providing guidance beyond 24 at this time.

Speaker Change: <unk>.

Speaker Change: Now as we get it.

Brian Mcmichael: As we sort out some of the things we're working on with our capital structure, we'll have a better idea of how we'll move forward from there.

Brian Mcmichael: And that will inform how we move forward in 2026.

Brian Mcmichael: I would say after we achieve.

Brian Mcmichael: The ability and cash flow positive I think we intend to stay profitable if that's your question right.

Speaker Change: I would like to add.

Speaker Change: Would offer you one other for you one other point, which is like towards the we expect locked doors to reach peak sales and $2 five to three years and we further expect a continued increase in market share for your deneke over the.

Speaker Change: The short to medium term so both of those things will continue to drive top line for US and further we will continue to show very high degree of discipline with respect to controlling our expenses and SG&A as you've seen already.

Christopher Thomas Schott: And then just pivoting over to you, Denica, is there any color you can offer on how much sales at this point are coming from the auto injector versus the traditional presentation? And maybe more broadly, just your expectations for pricing looking to 2024? And maybe more specifically, if you think Coherus is now more insulated versus other players, given you have the whole suite of products approved and in the market? Yeah, that's a, you know, that's a very, very, Very, very good question, Barry. It's a very observant nuance.

Speaker Change: That's very helpful. Thank you and then with <unk>.

Speaker Change: Pivoting over to you Dennis.

Is there any color you can offer on how much sales at this point is coming from the auto injector versus the traditional presentation and maybe more broadly just your expectations for pricing looking into 2024, and maybe more specifically if you think.

Dennis: Harris is now more insulated versus other players given you have the whole suite of products approved and in the market.

Dennis: Yes.

Speaker Change: That's a very very.

Speaker Change: <unk>.

Speaker Change: Very very good question, a very it's a group of derivative newest I'll, let I'll, let Paul address that particular issue.

Paul Reider: I'll let Paul address that particular issue, the three presentations and our ability to have a sustainable franchise in the market and support prices. Yeah, hey, Chris, thanks for your question. So, you know, our whole strategy, with eugenica, with the three presentations, is to give the customers choice, so that they can choose the presentation that meets the unique needs of the patient and the doctor. And that's something no other brand can do that.

Speaker Change: 80 presentations and our ability to have a sustainable franchise in the market and support pricing Paul.

Paul: Hey, Chris Thanks for your question, so our whole strategy with you Danica.

Paul: With the three presentations is to give the customers choice.

Paul: So that they can choose the presentation that meets the unique needs of the patient and the Doctor and Thats no. Other no other brand can do that.

Paul Reider: We saw pretty impressive growth with the auto injector in the fourth quarter, driven largely by the clinic market. And that's because now we have nurses that have had great experience with it, liked it, and it's starting to now get its foothold in the workflow in the offices. As it relates to the percent of the AI business to the total eugenica, it was still under 10%.

Paul: We saw.

Paul: Pretty pretty.

Paul: Impressive growth with auto injector in the fourth quarter, driven largely in the clinic market.

Paul: And Thats because now we've got nurses that were using it a great experience with it liked it and it's starting to now get its foothold into the into the workflow in the offices as it relates to the percent of the AI business to the total <unk> it was still under 10%.

Paul Reider: So the workhorse continued to be the pre-filled syringe presentation, but as we see in 2024, that's all going to take a new shape now that we have our on-body device launched, as well as the auto injector and the pre-filled syringe. But as I mentioned in my remarks, Chris, moving forward in year six of this brand's life cycle, we're getting that second wave of growth, and our focus is really going to be around driving profitable revenue and market share growth. And we are confident we're going to do that in 2024. Ethan, the other point that I would make is we played the long-term game here with eugenica and the market. As Paul said, we're six years in. We invested significantly, both in the auto injector, some $25 million in years past. It took us at least three or four years to bring the on-body. You know, that was probably a $35 billion investment.

Paul: So the workhorse continued to be the pre filled syringe presentation, but as we see a 2024, that's all going to take a new shape now that we have our on body device launched as well as the <unk> auto.

Paul: Auto injector and the Prefilled syringe.

As I mentioned in my remarks, Chris.

Paul: Moving forward in year six of this brand's lifecycle.

Paul: We're getting that second wave of growth and our focus is really going to be around driving profitable revenue and market share growth and we're confident we're going to do that in 2024.

Paul: And the other the other point that I would make is we played the long term game here with the tanker market as Paul said, we're six years and we invested significantly in both in the auto injector some $25 billion in years past it took us at least three or four years to bring forward. The on body that was probably a $35 billion investment.

Dennis M. Lanfear: We underwent a number of years where we had very strong discipline around pricing and ASP management. We consider ourselves good stewards of ASP. In the interim, you know, others have exited the market with aggressive pricing, and we're still there. The new market entrants really haven't had an impact on the business.

We underwent a number of years, where we had very strong discipline around pricing and ASP management consider ourselves good stewards of ASP.

Paul: In the interim others have exited the market with aggressive pricing, we're still there the new market entrants really hasnt had an impact on the business and I think that the significant market share increase like the trailing 25% and our look forward here for 2024 shows that our long term strategy is paying off we're the only folks that.

Dennis M. Lanfear: And I think that significant market share increased, like the four-week trailing 25%. And our look forward here for 2024 shows that our long-term strategy is paying off. We're the only folks that have three presentations.

Dennis M. Lanfear: We're positioned for market stability and sustainability as we go forward now with Peg Toprassen, and that's where we want to be. Thank you guys for your questions. Thank you. And as a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. One moment for questions. And I'm not showing any further questions.

Paul: The three presentations, we're positioned for markets stability and sustainability.

Paul: As we go forward now with Pegfilgrastim, and Thats, where we want to be.

Paul: Okay.

Speaker Change: Thank you guys for questions.

Speaker Change: Thank you and as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.

Speaker Change: One moment for questions.

Dennis M. Lanfear: I'll now like to turn the call back over to Denny Lanfear for any closing remarks. Thank you, operator, and thank you all for joining us on our Q4 full year 2023 call this afternoon. We're pleased with our progress on all fronts, to drive our sales higher, strictly control our expenses, reduce our debt, and advance our pipeline. We are entering 2024 with strong upward momentum and a clear organizational focus on extending survival for patients with cancer. We look forward to seeing you all at the upcoming investor conferences and on our next call. Thank you for your participation. You may now disconnect. Goodbye. PHONE RINGS

Speaker Change: And im not showing any further questions I will now like to turn the call back over to Denny Lanphier for any closing remarks.

Dennis M. Lanfear: Thank you operator, and thank you all for joining us on our Q4 full year 2023 call. This afternoon. We are pleased with our progress on all fronts to drive our sales higher strictly control our expenses reduce our debt and advanced our pipeline.

Dennis M. Lanfear: During 2024 with strong upward momentum and a clear organizational focus on extending survival for patients with cancer. We look forward to seeing you all at the upcoming investor conferences in our next call. Thank you.

Okay.

Speaker Change: Thank you for your participation you may now disconnect.

Speaker Change: Goodbye.

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