Q1 2024 Coherus BioSciences Inc Earnings Call

Operator: Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to Coherus BioSciences Inc.'s first quarter 2024 earnings conference call.

Ladies and gentlemen, thank you for standing by at this time I would like to welcome everyone to go Haywire Biosciences, Inc. First quarter 'twenty 'twenty four earnings conference call.

Operator: All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star number one. Thank you. I would now like to turn the conference over to Jami Taylor.

Speaker Change: Lines have been placed on mute to prevent any background noise.

Jami Taylor: They just because you would like there will be a question and answer session. If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad.

Jami Taylor: If he would like to withdraw your question again, Brett This started what thank you Howard.

Jami Taylor: I'd now like to turn the conference over to Jamie Taylor head of Investor Relations. Please go ahead.

Jami Taylor: Thank you, operator. Good afternoon, and welcome to Coherus Biosciences' first quarter 2024 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Bryan McMichael, our Interim Chief Financial Officer, Paul Reider, our Chief Commercial Officer, Rosh Dias, Chief Medical Officer, and Theresa Lavallee, our Chief Development Officer.

Jami Taylor: Thank you operator, good afternoon and welcome to go here is Biosciences first Florida 'twenty 'twenty four earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive officer of coherent Brian Mcmichael, our interim Chief Financial Officer.

Jami Taylor: Well Freda, our chief commercial Officer Raj.

Jami Taylor: Brush Dias, Chief Medical Officer, and Theresa Live Ali our Chief Development Officer.

Jami Taylor: Before we get started, I'd 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: our ability to advance our pipeline, projections of future growth, and revenue expenses at county debt levels. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements.

Jami Taylor: Before we get started I'd like to remind you that today's call includes forward looking statements regarding so curious just current expectations about future events.

Jami Taylor: Statements include but are not limited to the following our ability to advance our pipeline projections of future growth revenue expenses and cash.

Jami Taylor: Debt levels.

Jami Taylor: All of these forward looking statements involve substantial risks and uncertainties that are beyond our control and could cause the actual results performance or achievements to differ from that's implied by the forward looking statements.

Jami Taylor: These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process that are discussed in our press release that we issued today, as well as in the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statement. And now, I'll turn the call over to Steny. Thank you, Jami. Good afternoon,

Jami Taylor: These statements are not guarantees of future performance and are subject to substantial risks and uncertainties.

Steny: <unk> risks and uncertainties inherent in the clinical drug development process. There are discussed in our press release that we issued today as well as in the documents we filed with the SEC.

Steny: Forward looking statements provided on the call today are made as at this stage and we undertake no duty to update or revise any forward looking statement and now I'll turn the call over to Denny.

Dennis M. Lanfear: Thank you, Jami. Good afternoon, everyone, and thank you for joining us on our call today. As we open the call, let me emphasize two things. First, the strength of our first quarter results.

Steny: Thank you Jamie and good afternoon, everyone and thank you for joining us on our call today.

Steny: As we open the call let me emphasize two things.

Steny: First the strength of our first quarter results.

Dennis M. Lanfear: And secondly, the strategic initiatives we are successfully executing to position our company for long-term success. As you are aware, in the fourth quarter of 2023, we received two U.S. FDA approvals for products vital to our commercial portfolio: First Lactorse for nasopharyngeal carcinoma, a rare and devastating cancer for which it is the only FDA-approved therapy, and Udenica OnBodyInject.

Steny: Secondly, the strategic initiatives we are.

Dennis M. Lanfear: Successfully executing to position our company for long term success.

Dennis M. Lanfear: As you are aware in the fourth quarter of 2023, we received two U S FDA approvals for products vital for our commercial portfolio.

Dennis M. Lanfear: First like towards me for nasopharyngeal carcinoma, rare and devastating cancer for which.

Dennis M. Lanfear: The only FDA approved therapy.

Speaker Change: Ed you've deneke on body injector and innovative drug delivery mechanism with novel features that opens up large portions of the pegfilgrastim market that we previously could not access.

Dennis M. Lanfear: Innovative Drug Delivery Mechanism with Novel Features that opens up large portions of the Pegg-Philgraston market that we previously could not access. In the last three months, we launched both products, leveraging synergies derived from our company's focus on ecology. My Chief Commercial Officer, Paul Reider, will describe these launches in more detail in just a moment. Meanwhile, I'll share with you the enthusiasm with which both products have been received in the market and the revenue growth each has experienced this quarter.

Paul Reider: And the last three months, we launched both products leveraging synergies derived from our company's focus on oncology.

Paul Reider: My Chief Commercial officer, Paul Reader will describe these launches in more detail just a moment to share with you the enthusiasm with which.

Dennis M. Lanfear: <unk> had been received in the market and the revenue growth each has experienced this quarter.

Dennis M. Lanfear: Recently launched innovative products are fully aligned to our company's mission of extending the survival of cancer. On the development side, in just a moment, Dr. Theresa Lavallee and Dr. Rosh Dias will describe how our R&D pipeline is advancing to the plant, with impressive data consistently presented at major medical conferences, and more to come.

Paul Reider: Recently launched innovative products are fully aligned to our company's mission extending the survival of cancer patients.

Speaker Change: On the development side, just a moment, Dr <unk> and Dr. Raj.

Dennis M. Lanfear: Describe how our R&D pipeline is advancing to plan.

Dennis M. Lanfear: It's impressive data consistently presented at major medical conferences and more to come.

Dennis M. Lanfear: Across every key dimension, the company is executing well and on plan. Regarding strategic initiatives, we have focused on exercising our strategic optionality to strengthen the company's balance sheet and enhance long-term value for our shareholders, consistent with our mission. This is particularly relevant.

Dennis M. Lanfear: Across every key dimension company is executing well and to plan.

Dennis M. Lanfear: Regarding the strategic initiatives, we are focused on exercising our strategic optionality to strengthen the company's balance sheet and enhance long term value for our shareholders consistent with our mission.

Dennis M. Lanfear: This is particularly relevant to the commitment we have demonstrated strengthening coherence is capital structure with strong progress has been made.

Dennis M. Lanfear: Commitment, we have demonstrated that strengthening Coherus' capital structure has made strong progress. I'll highlight just two of the recent steps in development. Early in the first quarter, we announced the Divestiture Assembly, a non-core, non-ecology asset for $170 million upfront cash payment, plus an additional $17.8 million in cash for inventory. This divestiture has allowed us to pay down a large portion of our $250 million term loan debt while reducing interest costs, reducing headcount and overhead costs, and significantly improving our gross margin.

Dennis M. Lanfear: I'll highlight just two of the recent steps and development.

Dennis M. Lanfear: Early in the first quarter, we announced the divestiture of somebody a noncore non oncology asset for $170 million upfront cash payment plus an additional $17 8 million in cash for inventory.

Dennis M. Lanfear: This divestiture has allowed us to pay down a large portion of our $250 million term loan debt.

Dennis M. Lanfear: Reducing interest costs, reducing headcount and overhead costs and significantly improving our gross margins.

Dennis M. Lanfear: Today, we announce a new non-dilutive debt and royalty financing, which fully repays the remaining $75 million, otherwise due in October of 2025. With this transaction completed, we have now reduced our structured term loan debt by 85% over the recent three-month period, while the remaining $37.5 million and moving the due date out five years to 2029 with no springing maturity. The timeline for debt maturity under this agreement extends beyond that, the development horizon of our product. And with that, let me turn the call over to Paul Reider. Paul. Thank you.

Dennis M. Lanfear: Today, we announced a new non dilutive debt royalty financing, which fully repaid the remaining $75 million with otherwise due in October 2025.

Paul Reider: With this transaction completed.

Paul Reider: Now reduced our structured term loan debt by 85% over the recent three month period.

Paul Reider: While the remaining $37 5 million.

Paul Reider: Moving the due date out to five years to 2029.

Paul Reider: No springing maturity.

Paul Reider: Timeline for debt maturity under this agreement extends beyond that the development horizon of our products.

Paul Reider: Let me turn the call over to Paul Reader Paul.

Paul Reider: Thank you, Danny, and good afternoon, everyone. With the ophthalmology divestiture, we are now an oncology-centered commercial organization which supports our overarching business objectives, ongoing oncology launches, Lactorsi, Udenica OnBody, and Udenica AutoInjector enable a singular focus on driving top line. We are executing the plan. We're pleased with our progress. Regarding the quarter's performance... Total Net Product Revenue was $76.7 million, a 137% increase over Q1 2020. For our core oncology brands, Q1 Udenica net revenue was $42.7 million, an 18% increase quarter over quarter, and a 63% increase over Q1 2023. Toursy Net Revenue was $2 million in the quarter, still early in launch and in line with our expectations, with new patient Krull Momentum Builder. And for our non-core products, if you want net revenue for Yosemite, 3.9 million, 77% growth quarter over quarter. And finally, Simmer.

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

Paul Reider: With the ophthalmology divestiture, we are now.

Paul Reider: Apologies centered commercial organization, which supports our overarching business objectives.

Paul Reider: Ongoing oncology launches like towards the deneke on body <unk> auto injector.

Paul Reider: <unk> singular focus on driving driving topline revenue.

Paul Reider: We're executing to plan.

Paul Reider: Pleased with our progress.

Paul Reider: Regarding the quarter's performance total net product revenue was $76 $7 million and 137% increase over Q1 2023.

Paul Reider: For our core oncology brands Q1, <unk> net revenue was $42 7 million, an 18% increase quarter over quarter and a 63% increase over Q1 2023.

Paul Reider: But towards the net revenue was $2 million in the quarter still early and Lora and in line with our expectations and with new patient accrual momentum building.

Paul Reider: Before our noncore products Q1, net revenue for <unk> was $3 9 million, 77% growth quarter over quarter.

Paul Reider: And finally similarly.

Paul Reider: Given the deal closed on March 1st, net revenue for the quarter was $28.2 million and only reflects sales for January and February. I'll now speak in more detail about our core oncology assets, starting with Lactors. The commercial launch of Lactorazine now establishes Coherus in the immuno-oncology therapeutic area and serves as the foundation upon which we will commercialize our exciting pipeline of IO products. My Toursie has a broad label and is approved in combination.

Paul Reider: Given the deal closed on March 1st net.

Paul Reider: Revenue for the quarter was $28 2 million only reflects sales for January and February.

Paul Reider: I will now speak in more detail about our core oncology assets, starting with luck torsi.

Paul Reider: The commercial launch of luck towards it now establishes careers in the immuno oncology therapeutic area serves as the foundation upon which we will commercialize our exciting pipeline of Io products.

Paul Reider: <unk> has a broad label and it is approved in combination with FIS Jim for first line treatment of adults with metastatic or recurrent locally advanced NPC.

Paul Reider: CISGEM for first-line treatment of adults with metastatic or recurrent locally-advanced NPCs, and as a single agent for adults with recurrent unresectable or metastatic disease progression on or after platinum-containing chemotherapy. Today, the standard of care is chemotherapy.

Paul Reider: And as a single agent for adults with recurrent or unresectable or metastatic MPC with disease progression on or after platinum containing chemotherapy.

Paul Reider: But today the standard of care chemotherapy. So our ambition is to establish look towards <unk> <unk> plus chemo as the new standard of care and offer MPC patients the hope for greater survival based on the final overall survival or survival results.

Paul Reider: And so our ambition is to establish Lactorazine plus chemo as the new standard of care and offer NPC patients the hope of greater survival based on the final overall survival results from the JUPITER-2 trial, in which lactose plus chemo resulted in a 37% reduction in the risk of death versus chemotherapy alone. Educating NPC treating oncologists on these clinical data remains a top priority, and it's being amplified by the advocacy of the nation's leading NPC opinionators, who have affirmed the strength of the Lactorsi clinical data and its position as the new standard of care. Since launch, we've achieved a series of milestones necessary to enable broad prescribing over the course of 2024 and beyond. I'll highlight four examples.

Paul Reider: The Jupiter two trial in which look towards <unk> plus chemo resulted in a 37% reduction in the risk of death versus chemotherapy alone.

Paul Reider: Educating MPC treating oncologists on these clinical data remain a top priority and it is being amplified by the efficacy of the nation's leading MPC opinion leaders, who have affirmed the strength of the walk towards the clinical data and its position as the new standard of care.

Paul Reider: Since launch we've achieved these series of milestones necessary to enable broad prescribing over the course of 2024 and beyond.

Paul Reider: Now highlights for example.

Paul Reider: First... Lactorsi was included in NCCN, ASCO, and CLINPATH guidelines. In NCCN, Lactorsi is the only PD-1 with Category 1 designation for first-line use and the only preferred regimen in second-line plans. Second, payer coverage has been confirmed now on greater than 85% of medical benefit lives in health plans, including Medicare fee-for-service, Medicare Advantage, and national and regional commercial plans. Third, among the top academic research hospitals, TORSI was added to the formulary at 55% of the 33 NCCN institutions with the remaining institutional reviews scheduled. Formulary position is highly expected to be achieved in all NCCN institutions by the end of Q2 2021. [inaudible] Product specific permanent J code has been granted by CMS, and will take effect July 1st, 2024.

Paul Reider: First <unk>.

Paul Reider: Look towards it was included in FCC in Pasco and Clinton past guidelines may 9th CCN a tour.

Paul Reider: This is the only PD one category one designation for first line use and the only preferred regimen in second line plus.

Paul Reider: Second payer coverage has been confirmed now greater than 85% medical benefit lives health plans, including Medicare fee for service.

Paul Reider: <unk> advantage and national and regional commercial plans.

Paul Reider: Third among the top academic research hospitals.

Paul Reider: Towards it was added to the formulary on 55% of the 33, HCC and institutions with the remaining institutional reviews scheduled.

Paul Reider: Formulary position is highly expected to be achieved with all NCC and institutions by the end of Q2 2024.

Paul Reider: Finally.

Paul Reider: Product specific permanent J code has been granted by CMS will take effect July one 2024, this will enable more efficient billing processes.

Paul Reider: This will enable a more efficient billing process. This would be the time for reimbursement for providers. Based on Torsi's labeled indication, we estimate approximately 2,000 patients will fall within the addressable market opportunity for Lactorsi. With the hospital formulary conversion process underway, the enthusiasm with which the community is bracing for the product, we're building momentum as the launch continues. In Q1, approximately 80 patients received Lactor-Z treatment across all lines of therapy, in combination with chemo or as monotherapy, which was in line with our expectations. We're pleased that the launch has progressed. I'll turn it to you, Dennis.

Dennis: Speed the time to reimbursement for providers.

Paul Reider: Based on work towards these labeled indication we estimate approximately 2000 patients will fall within the addressable market opportunity for log towards.

Dennis: If a hospital formulary conversion process underway, the enthusiasm with which the community is bracing the product we're building momentum as the launch continues.

Dennis: In Q1, approximately 80 patients receive look towards the treatment across all lines of therapy Combi.

Dennis: Combination with chemo, whereas mono therapy, which was in line with our expectations.

Dennis: We are pleased that the largest progressing to plan.

Dennis: Now turning to Delek.

Paul Reider: Udenica delivered another quarter of revenue growth driven by continued strong execution. The strength of our execution is fueled by three drivers. First, the commercial launch of Udetica OnBody, a novel and proprietary, state-of-the-art delivery system for pegfibers, enabling Udenica to now compete across the entire PECFO market. Second, Dedicate is the only Pegfograsten brand with three device options to meet the unique needs of providers and patients strengthens our competitive position. It allows us to compete on factors other than Third, we come into 2024 with payer coverage nearly two times that of 2023, opening up access to significantly more patient lives.

Dennis: <unk> delivered another quarter of revenue growth driven by continued strong execution.

Paul Reider: The strength of our execution is fueled by three drivers.

Paul Reider: The commercial launch of <unk> on body, a novel and proprietary state of the art delivery system for Pegfilgrastim, enabling new deneke to now compete across the entire pegfilgrastim market.

Paul Reider: <unk> is the only pegfilgrastim brand with three device options to meet the unique needs of providers and patients.

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

Paul Reider: Third we come into $2 20 to 2024 with payer coverage nearly two times that of 2023 opening up access to significantly more patient lives.

Paul Reider: As for key performance indicators for the quarter, Udenica franchise demand grew 36% quarter over quarter, driven primarily by the prefilled syringe and auto injector presentation. In addition, franchise market share was 25%, an increase of 10 market share points quarter over quarter. Regarding the launch of Udenica OnBody, customer receptivity has been very positive. Providers are pointing to Udenica OnBody's five minute injection, which is approximately 90% faster medication delivery than NuLast or OnPro. This is noted as a key differentiator.

Paul Reider: As for key performance indicators for the quarter, you did make a franchise dominion grew 36% quarter over quarter, driven primarily by the pre filled syringe and the auto injector presentations and.

Paul Reider: In addition franchise market share was 25% an increase of 10 market share points quarter over quarter.

Paul Reider: Regarding the launch of <unk> on body customer receptivity has been very positive specifically providers are pointing to you dedicate ore bodies five minute injection time, which is approximately 90% faster medication delivery the neulasta on pros.

Paul Reider: This was noted as a key differentiator in this differentiation is translating into strong customer adoption.

Paul Reider: And this differentiation is translating into strong customer adoption. Summary, Udenica Franchise now offers providers and patients the total solution, and we expect continued unit and revenue growth with a focus on improving margins over the course of 2020. I'll now turn the call to Dr. Rosh Dias, our Chief Medical Officer. Thanks very much.

Paul Reider: Summary, you Danica franchise now offers providers and patients the total solution and we expect continued unit and revenue growth with a focus on improving margins over the course of 2024.

Speaker Change: I'll now turn the call Dr. Raj <unk>, our Chief Medical Officer Raj.

Rosh Dias: Thanks very much, Paul, and good afternoon, everyone. Otorzi or Toripalumab, with a profound survival advantage demonstrated in nasopharyngeal carcinoma, together with additional positive efficacy datasets published across a variety of tumor types, continues to form the foundational element of our community oncology portfolio. As an I.O. company with an approved and highly efficacious PD-1, this affords us the opportunity to pursue three distinct strategies for further development from a wider variety of tumor types.

Speaker Change: Thanks, very much Paul and good afternoon, everyone I'll towards the inventory pattern that with the profound survival advantage demonstrated nasopharyngeal carcinoma together with additional positive efficacy data sets published across a variety of tumor types.

Rosh Dias: Can you just follow the foundational element of our immuno oncology portfolio.

Rosh Dias: As an Io company with an approved and highly efficacious PD, one affords us the opportunity to prosecute three distinct strategies for further development across a wide variety of tumor types.

Rosh Dias: Firstly, combinations with our own internal pipeline, which consists of three competitively well-positioned assets, tightly focused development plans, all of which are progressing according to plan. For example, Dozo Ketoc, our IL-27 targeting antibody, DHS-114, our CCR-8 targeting antibody, and our anti-IL-T4. Secondly, development opportunities where TORI-PALIMAT is studied in combination with novel compounds with nearer term registration opportunities, fully funded by partner companies in Phase 3 registration enabling studies, such as the Inovio vaccine combination study in head and neck squamous cell carcinoma sponsored by Inovio, where we're providing TORI-PALIMAT supply, and the ongoing Junshi BTLA-TORI-PALIMAT combination study in limited stage small cell Let me first start with Cazdozo.

Rosh Dias: Fleet combinations with our own internal pipeline, which consists of three competitively well positioned.

Rosh Dias: Tightly focused development plans all of which are progressing according to plan.

Rosh Dias: Key tech.

Rosh Dias: <unk> thousand seven targeting antibody CHS 114, <unk> targeting antibody and anti <unk> four <unk>.

Rosh Dias: Secondly development opportunities with Tory Parliament studied in combination with novel compounds with nearer term registration opportunities funded by partner companies in phase III registration, enabling studies such as the <unk> vaccine combination study in head and neck squamous cell carcinoma, Spanspek novia, while we're providing toward panamax.

Rosh Dias: The supply and demand Gen sheet Vitiello, Tory piling that combination study limited stage small cell lung cancer.

Rosh Dias: Thirdly development opportunities Cytori piloting that with partner companies that have earlier phase novel compound for which they are looking for a PD one partner.

Rosh Dias: We remain excited about the potential of Casdozo in both non-small cell lung cancer, where we have demonstrated monotherapy activity in PD-L1 refractory subjects in the advanced setting, and also in hepatocellular castration, where we have demonstrated encouraging overall response rates in the first-line advanced setting. We're taking forward the non-small cell lung cancer data with our Phase 2 study that is currently ongoing and is active in the U.S., and we remain on track to report data towards the end of this year or early next year.

Rosh Dias: With respect to our internal pipeline, let me first start with <unk>.

Rosh Dias: We remain excited about the potential of <unk> in both non small cell lung cancer, where we've demonstrated monotherapy activity in PD, one refractory subjects in the advanced setting and also in hepatocytes carcinoma, while we have demonstrated encouraging overall response rates in the first line advanced setting.

Rosh Dias: We're taking forward the non small cell lung cancer data in our phase II study that is currently ongoing and is active in the U S and while we remain on track to report out data towards the end of this year or early next year are.

Rosh Dias: Our second development program with Cazdozo in advanced stage also remains on track to start in the second half of this year, building upon the promising data presented earlier this year at ASCO GI. Now, turning to CHS114, our CCR8 cytolytic antibody.

Rosh Dias: Our second development program with <unk> in advanced HCC also remains on track to start in the second half of this year building upon the promising data presented earlier this year at <unk> Gi.

Rosh Dias: Turning to CHS, one for PCR rate.

Rosh Dias: Antibody, we've continued to make good progress through dose escalation and are now moving onto the next stage of the study and expansion into head and neck squamous cell carcinoma, where the disease linkage is particularly strong.

Rosh Dias: We've continued to make good progress through dose escalation and are now moving on to the next stage of the study with expansion into head and neck squamous cell clusters, where the disease leakage is particularly strong. We're excited that NAVSTRACT has been accepted for presentation at ASCO in a few weeks' time, which will further detail data from the dose escalation portion of the trial. Theresa will speak more about the status of our ILT4 program and will highlight data presented at the recent AACR meeting.

Rosh Dias: Is that an abstract has been accepted for presentation at <unk> in a few weeks' time, we fulfill the detailed data from the dose escalation portion of the trial.

Rosh Dias: Teresa will speak more about the states about Iot full program and will highlight data presented at the recent ACR meeting.

Rosh Dias: Next, with respect to our pivotal partnered programs with nearer term registration opportunities, our partnership with Inovia continues with the phase three registration enabling study in HPV positive locally advanced head and neck squamous cell carcinoma currently actively in development. In addition, the Torrey-Palomar BTLA phase three combination study in limited stage to treat more cell lung cancer led by our partners Junshi continues to progress in the U.S. The potential of TORI-PALOMAB to act as a foundational element novel combination

Rosh Dias: Next with respect to our pivotal partnership programs with nearer term registration opportunities our partnership with <unk> continues with phase III registration, enabling study in HPV positive locally advanced head and neck squamous cell carcinoma. Currently actively in development. In addition, Torrey pilot Dcla phase.

Rosh Dias: <unk> combination study and limited limited stage small cell lung cancer led by Jim sheet continues to progress in the U S and also other multi regional sites and it serves as a further example, the potential of Torrey pilot map to act as a foundational elements novel combinations.

Rosh Dias: Finally, with respect to earlier stage novel combinations, delighted to announce yesterday that Tori Palamad was selected by Cancer Research Institute as the PD-1 backbone for exploration with EMD Therapeutics' Endothelin B inhibitor within a platform ovarian cancer study exploring novel combinations in this patient population that historically has been underserved by immunotherapy. Selection of tauripalumab by CRI provides further validation of our strategic trials approach of utilizing tauripalamab as an investigational PD-1 backbone, and others. Thank you. I'll now turn the call over to Dr. Lavallee, our Chief Development Officer, Theresa.

Rosh Dias: Finally, with respect to earliest stage novel combinations, we were delighted to announce yesterday.

Theresa: That Tori polymath was selected by cancer Research Institute as the PD, one backbone for exploration.

Theresa: <unk> Therapeutics Endothelin B inhibitor within our platform ovarian cancer study exploring novel combinations in this patient population historically has been underserved by immunotherapy.

Theresa M. Lavallee: Selection of Torrey, Panama by Cri provides further validation of our strategic trials approach utilizing a Tory Palomar is an investigational PD one backbone.

Theresa M. Lavallee: Outside in D C.

Theresa: I'll now turn the call over to Doug to the Valley, our Chief Development Officer.

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

Theresa: Thank you Raj and good afternoon, everyone.

Theresa M. Lavallee: I'm pleased to update you on additional progress in our efforts to pursue development of our tumor microenvironment or <unk> pipeline.

Theresa M. Lavallee: We have two approaches.

Theresa M. Lavallee: Nominations broadly with immune activators with partners.

Theresa M. Lavallee: And the internal development plans focus on combination with <unk>.

Theresa M. Lavallee: The CAS-DOSA-Q-TEC clinical data on non-small cell lung cancer in HCCE that were presented in December 2023 and January 2024 have demonstrated clinical efficacy in early clinical studies. Importantly, the studies show a favorable safety profile, blending Cazdozoid accommodation treatment. And that's equal and important.

Speaker Change: Okay. Thank you.

Theresa M. Lavallee: <unk> clinical data in non small cell lung cancer.

Theresa M. Lavallee: See that represented in December 2023 in January 2024, as demonstrated clinical efficacy in early clinical studies.

Theresa M. Lavallee: Importantly, the study show a favorable safety profile.

Theresa M. Lavallee: <unk> <unk> combination treatments.

Theresa M. Lavallee: And of equal importance.

Theresa M. Lavallee: Immune Activation in Cancer Patients. In the Casdozo Phase 1 study, the biomarker data show that at Casdozo doses of 10 mg per kg or higher, but not at 3 mg per kg or lower, that IL-27 signaling is inhibited, and furthermore, NK and T cells are activated. While rebalancing the immune system with anti-cytokine antibodies is well-established in inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis, this approach has not yet been successfully demonstrated for the treatment of cancer. Doza Ketug is an antagonist in First in Class.

Theresa M. Lavallee: And activation in cancer patients.

Theresa M. Lavallee: In the <unk> phase one study.

Theresa M. Lavallee: Oh marker data shadow it casts.

Theresa M. Lavallee: Joseph doses of 10 mix per kg or higher but not at three <unk> per kg or lower.

Theresa M. Lavallee: IL 27 signaling inhibit and further NK and T cells are activated.

Theresa M. Lavallee: While rebalancing the immune system with anti cytokine antibodies is well established in inflammatory diseases, such as rheumatoid arthritis clamatorial disease in psoriasis.

Theresa M. Lavallee: This of credit has not yet and successfully demonstrated for the treatment of cancer.

Speaker Change: Thanks, Jonathan key tag is an antagonist and first in class.

Theresa M. Lavallee: It blocks Aisle 27, which is in the Aisle 23, Aisle 12, and Aisle 6 family of cytokines, a family that has multiple approved antibody drugs in inflammatory diseases. Our scientific advisor, Dr. Christopher Hunter, from the University of Pennsylvania, was honored for his research on Aisle 27 with the Distinguished Lecture at the American Association of Immunologists Congress in Chicago on May 4th. In Dr. Hunter's lecture, he described the basic research in mouse models to understand the immune regulatory role of IL-27 and how the absence of IL-27 results in immune pathology due to an overactive immune system, specifically dysregulated and activated T cells and NK cells. Interestingly, these effects are most notable in liver, lung, and brain tissue.

Theresa M. Lavallee: Blocks, IL 27, which.

Theresa M. Lavallee: Thank you <unk> and the IL 23, IL 12, IL six family of cytokines.

Theresa M. Lavallee: A family that has multiple approved antibody drugs and inflammatory diseases.

Theresa M. Lavallee: Our scientific advisor Dr. Christopher <unk> from the University of Pennsylvania was honored for his research on IL 27, with a distinguished lecture at the American Association of Immunologist Congress in Chicago I made for it.

Theresa M. Lavallee: In Doctor Hector Slack sure. He described the basic research in mouse models to understand the immune regulatory role of IL 27.

Theresa M. Lavallee: The absence of IL 27 results in EMEA and <unk>.

Theresa M. Lavallee: Ofer <unk> system.

Theresa M. Lavallee: Typically gets regulated and activated T cells and NK cells.

Theresa M. Lavallee: Interestingly these effects are those net of the ball levered.

Theresa M. Lavallee: And brain tissue.

Theresa M. Lavallee: The translation of this work to cancer and treatment of patients with casdoza-ketog showing anti-tumor activity in lung and liver cancer is very exciting. A strong line of sight for tumor indications where IL-27 biology is critical for regulating immune responses allows Coherus to have a focused development plan. I'm also proud to say that at the recent ACR meeting... Our team presented IND-enabling studies for IL-T4 antibody CHS1000. BHS-1000 is our first internally discovered and developed bio drug candidate. We will remain on.

Theresa M. Lavallee: And translation of this work to cancer and treatment of patients with cast as a key tag.

Theresa M. Lavallee: Anti tumor activity in lung and liver cancer is very exciting.

Theresa M. Lavallee: This strong line of sight for accumulate indications, where IL 27 biology is critical for regulating immune response.

Theresa M. Lavallee: Laos Caviar is to have a focus development financing.

Theresa M. Lavallee: Also proud to say that at the recent ACR meeting our team presented a handy, enabling studies for Iot for antibody CHS with housing.

Theresa M. Lavallee: CHS 1000, as our first internally discovered and developed <unk>.

Theresa M. Lavallee: Candidate.

Theresa M. Lavallee: We remain on track for FDA feedback on the A&D in second quarter 2024.

Theresa M. Lavallee: I will now turn the call to Brian Mcmichael.

Bryan J. McMichael: Thank you, Theresa, and good afternoon, everyone. Since Denny covered the updates to our capital structure and Paul covered revenues, I will focus on the rest of the P&L and cash. Cost of goods sold during Q1 2024 was $34.6 million. Excluding the impact of the inventory write-down in Q4, FOGS would have decreased $3 million or 8% from Q4 2023. R&D decreased $5.7 million and 17% from Q1 a year ago, primarily reflecting savings from reduced headcount and reduced development costs on biosimilars, partially offset by investments in our IO pipeline.

Speaker Change: Thank you Teresa and good afternoon, everyone.

Bryan J. McMichael: Since then he covered the updates to our capital structure and Paul covered revenues I will focus on the rest of the P&L and cash.

Bryan J. McMichael: Cost of goods sold during Q1 2024 was $34 6 million.

Bryan J. McMichael: Excluding the impact of the inventory write down in Q4.

Bryan J. McMichael: What is what would have decreased $3 million or 8% from Q4 2023.

Bryan J. McMichael: R&D decreased $5 7 million and 17% from Q1, a year ago, primarily reflecting savings from reduced head count and rich.

Bryan J. McMichael: And reduced development costs on Biosimilars, partially offset by investments in our Io pipeline.

Bryan J. McMichael: FG&A increased to $7.4 million and 15% driven by a net $6.8 million charge in Q1 2024 associated with the non-cash write-off of NZV930, which is now a license obtained in the surface oncology acquisition that was terminated by Novartis. The first quarter 2024, we reported net income of $102.9 million, or 83 cents per diluted share, compared to a net loss of $75.7 million, or 96 per share diluted share for the same period in 2023, non-GAAP net loss per share which excludes the gain on divestiture, The net charge associated with the termination from Novartis mentioned earlier was $35.8 million or $0.32 per diluted share in Q1 2024 compared to $59.5 million or $0.75 per diluted share for the same period in 2023.

Bryan J. McMichael: G&A increased $7 $4 million at 15% driven by a net.

Bryan J. McMichael: $6 $8 million charge in Q1 2024 associated with the noncash write offs of <unk> 930, which is an out license obtained in the surface oncology acquisition that was terminated by Novartis.

Bryan J. McMichael: For the first quarter 2024, we reported net income of $102 9 million or 83 per diluted share compared to a net loss of $75 $7 million were <unk> 96 per share diluted share for the same period in 2023.

Bryan J. McMichael: non-GAAP net loss per share, which excludes the gain on divestiture and then.

Bryan J. McMichael: Net charge associated with the termination from Novartis mentioned earlier was $35 8 million or <unk> 32 cents per diluted share in Q1, 2024 compared to $59 $5 billion or 75 cents per diluted share for the same period in 2020.

Bryan J. McMichael: Three.

Bryan J. McMichael: Cash and cash equivalents and investments in marketable securities were $259.8 million as of March 31, 2023, compared to $117.7 million at year end. As noted earlier, we used the cash on hand to pay $175 million in principal after the quarter ended. Today we are reiterating our expected range of combined 2024 R&D and SG&A expenses of $250 million to $265 million. This guidance includes approximately $40 million in stock-based compensation and excludes business development activities, and other unforeseen activities. With that, I will turn the call back over to Denny for his closing remarks. Thank you, Bryan.

Bryan J. McMichael: Cash and cash equivalents and investments in marketable securities were $259 $8 million as of March 31, 2023, compared to $117 7 million at year end.

Bryan J. McMichael: As noted earlier, we used cash on hand to pay $175 million in principles after the quarter ended.

Bryan J. McMichael: Today, we are reiterating our expected range of combined 2020 for R&D and SG&A expenses of $250 $250 million to $265 million.

Bryan J. McMichael: This guidance includes approximately $40 million of stock based compensation and excludes business development activities.

Bryan J. McMichael: And other unforeseen activities.

Denny: With that I will turn the call back over to Dennis for closing remarks.

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

Denny: Thank you Brian as we have emphasized throughout our remarks today, we are executing well on our plan to deliver shareowner value.

Dennis M. Lanfear: First driving the top line of our revenues.

Dennis M. Lanfear: Can barely controlling our operating expenses.

Dennis M. Lanfear: We are making great progress advancing our pipeline of tumor microenvironment focus assets and lastly, as I disclosed improving our capital structure.

Dennis M. Lanfear: I am fully confident in both the progress we are making and of course, we have a churn.

Dennis M. Lanfear: Oncology company.

Dennis M. Lanfear: We're now happy to open the line for questions.

Operator: Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, press star 1 to join the queue. Your first question comes from the line of Yigal Nochomovitz with SITI. Your line is open.

Speaker Change: Thank you Duston. Your line is now open for questions. If you have dialed in and who would like to ask a question. Please press star one on your telephone keypad duration and joined the queue.

Yigal Dov Nochomovitz: I would like to withdraw your question simply press Star one again.

Yigal Dov Nochomovitz: If you had called upon to ask your question and I listened in via loudspeakers device.

Yigal Dov Nochomovitz: These pick up your handset and ensure that your phone is not on mute.

Yigal Dov Nochomovitz: When asking your question again, west Taiwan to join the queue.

Yigal Dov Nochomovitz: Your first question comes from the line of Yigal <unk> with <unk>. Your line is open.

Ashwani Verma: Hi guys, this is Ashwin Mubarak. I'm from Yigal. Thanks for taking my questions and congrats on the quarter. I joined a little bit late, so I apologize if I missed this, but how are you thinking about the contribution of each presentation of Udenica to the revenue mix for the quarter? And more importantly, what is that going to look like? Moving forward, I kind of assume that weighting will increase towards the new presentations, but I'm wondering how you're thinking about it.

Yigal Dov Nochomovitz: Hi, guys. This is Austin laboratory for Hugo Thanks for taking my questions and congrats on the quarter.

Ashwani Verma: I joined a little bit late so I apologize if I if I missed this but how are you thinking about the contribution.

Ashwani Verma: Each presentation have you done I go to the revenue mix for the quarter and more importantly, how does that how is that going to look like.

Ashwani Verma: Moving forward I kind of assume that weighting will will increase towards the new presentations, but what I'm wondering how you're thinking about it.

Dennis M. Lanfear: Hi, thank you very much for your question. Paul Reider will be happy to further describe the contribution revenues for the three presentations that we now have on the market.

Speaker Change: Alright. Thank you very much for your question Paul Reader will be happy to further describe the contribution revenues for the three presentations that we now have on the market Paul.

Speaker Change: Good luck.

Paul Reider: So, in the first quarter, the refilled syringe still represented the largest share of our scubics, around 90%. The auto injector is around 8%. And the on body came in around 2%. Recalling that, you know, we launched mid-quarter, so we only had about half of the quarter left on the on body. So that's the breakdown of the skew mix. It varies a little bit by segment. So clinics and hospitals, you know, tend to customize the skew that works best for them, which is exactly how we are now competitively positioning the franchise.

Dennis M. Lanfear: No.

Paul Reider: Yes, so the in the first quarter.

Paul Reider: Deep Prefilled syringe still represented the largest share of our.

Paul Reider: Our SKU mix was around 90%.

Paul Reider: The auto injector, it's around 8% in the.

Paul Reider: Bodies came in around 2%.

Paul Reider: Recalling that we launched mid quarter. So we only had about half of the quarter. The on body. So that's the breakdown of the SKU mix.

Paul Reider: And we're the only franchise that can offer providers and patients three different options to meet the unique needs of each individual patient or how they deliver peg full grasp of. So, you know, you can see how that differentiation is translated into market share growth of 10% points, quarter over quarter to 25%. And, and so we're going to continue to drive that differentiation as the remainder of the year unfolds.

Paul Reider: It varies.

Paul Reider: A little bit by segment, so clinics and hospitals.

Paul Reider: Oster buys.

Paul Reider: The skew that works best for them, which is exactly how we're now competitively positioning the franchise and we're the only franchise that could offer providers and patients three different options.

Paul Reider: Beauty needs.

Paul Reider: Of each individual patient or how they do.

Paul Reider: Deliver pegfilgrastim.

Paul Reider: So you could see how that differentiation has translated into market share growth.

Paul Reider: 10% points quarter over quarter to 25% and and so we're going to continue to drive that differentiation is the remainder of the year unfolds.

Paul Reider: Well, how do we see Mark being chair of each of the presentations evolving through the rest of the year? Do you have any line of sight on that?

Paul Reider: And how do we see the.

Paul Reider: Market share of each of the presentations evolving through the rest of the year do you have any line of sight on that.

Paul Reider: Yeah, I think, I think, you know, it's still early in the on body launch. So we're, you know, gaining feedback from customers as to where it's fitting in. I can tell you right now that, you know, it's moving primarily in the clinic segment and also different segments of hospitals, but I think we're still going to see, throughout this year, at least the pre-filled syringe, still holding a good percentage of the SKU mix with the remainder being auto injector and in the on- We would expect that to continue throughout the year.

Speaker Change: But yes, I think Kevin I think.

Paul Reider: It's still early in the on body large so we are we.

Paul Reider: We are gaining feedback from customers.

Paul Reider: Where it's fitting in I can tell you right now.

Paul Reider: It's moving primarily in the clinic segment. It also.

Paul Reider: Different segments of the hospitals.

Paul Reider: I think we're still going to see.

Paul Reider: Throughout this year at least the pre filled syringe still holding a good percentage of the SKU mix with the remainder being auto injector it.

Paul Reider: And the <unk> body, but.

Paul Reider: But the on body growth has largely been in the clinic segment, we would expect that to continue throughout the year.

Ashwani Verma: Thank you for your question. Got it. That's super.

Speaker Change: Thank you for your question.

Ashwani Verma: Got it. That's super helpful.

Speaker Change: Got it that's super helpful.

Operator: The next question comes from the line of Cripa de Veraconda with Truist Securities. Your line is open.

Ashwani Verma: Next question comes from the line of Creeper, Nevada, Glenda with <unk> Securities. Your line is open.

Unknown Executive: Hey guys, thank you so much for taking the time to answer my question. For on Lock Tour Z, you know, you mentioned that the launch is going well. Can you maybe provide some color on whether the drug has been used more on the front line or... in a second line setting? And also, I think, you know, it's a new launch, and it's, you know, relatively rare to see. So we mentioned it could take time to get on the formularies. You talked about 55%. Being on 55% of the 33 NCCN hospitals, is this in line with your expectations? Thank you.

Speaker Change: Hey, guys. Thank you so much for taking my question.

Unknown Executive: Or unlocked Harvey I know you mentioned that the launch is going well can you maybe provide some color on whether the drop has been used more in frontline or <unk>.

Unknown Executive: Second line setting and also I think.

Unknown Executive: Non gender no relatively rare disease. So we mentioned it can take time to get on the formularies.

Unknown Executive: You talked about 55%.

Unknown Executive: Being on 55% of the 33 end CCN.

Unknown Executive: Hospitals is this in line with your expectations. Thank.

Speaker Change: Thank you.

Unknown Executive: Kripa, thank you for your question. Paul, I'd be happy to talk a little bit about frontline versus second line utilization and the 55% NCCN conversion. Paul. Yeah, thanks for your question.

Speaker Change: Thank you for your question, Paul Happy to come a little bit about frontline versus second line utilization at the 55% as ACN of conversion Paul.

Paul Reider: Yeah, thanks for your question. So going back to the labeled indication, or Lactorsi, it's indicated in the earlier stage of recurrent locally advanced patients. And we are seeing Lactorsi used in those patients. It's typically, in that case, combined with chemotherapy. What we also saw, as expected, was the contribution of lactorazine in the metastatic setting in both the front line and the second line plot. And in those cases, if it's frontline, it was being combined with chemotherapy consistent with the JUPITER-2 trial and our labeled indication, and more as monotherapy when it's second line plus. So, as expected, it's being positioned all throughout the indicated uses.

Paul Reider: Yes. Thanks for your question so.

Paul Reider: Going back to the labeled indication or look towards the syndicated in the.

Paul Reider: The earlier stage of the recurrent locally advanced patients.

Paul Reider: We are seeing lock towards the use in those.

Paul Reider: Those patients it's typically in that case.

Paul Reider: Combined with chemotherapy.

Paul Reider: We also saw as expected was contribution of lock towards the in both the metastatic setting and both the frontline and second line plus.

Paul Reider: And in those cases, the pits frontline it was being combined with chemotherapy consistent with the Jupiter two trial at our labeled indication and more as mono therapy. When it's second line plus so as expected it's being positioned all throughout the indicated uses.

Paul Reider: The only thing, and I think you mentioned this, was that when in the second line and the later lines of therapy, you know, these patients' duration is likely going to be less. And if when we have eligible patients, though, that are already on an off-label PD-1, those will be difficult for Lactorse to capture. So the value of the franchise will occur over the next three years as we build up the large majority of the new standard of care in the frontline setting.

Paul Reider: The thing that I think you mentioned this was like in.

Paul Reider: In the second line in the later lines of therapy. These patients duration is likely going to be less and when we have.

Paul Reider: Eligible patients those data already on and off label PD one.

Paul Reider: Those will be difficult for lock towards E. Two to capture so the value of the franchise will occur over the next three years as we build up the.

Paul Reider: The large majority of the new standard of care in the in the frontline setting.

Paul Reider: As for the formularies, yeah, that's very much in line with our expectations. Academic medical centers have processes, you know; it takes time to go through those formularies. And as I mentioned, we would expect all the remaining NCCN institutions to be completed by the end of the year.

Paul Reider: As for the formularies, yes.

Paul Reider: Very much in line with our expectations academic medical centers have processes. It takes time to go through those formularies and.

Paul Reider: As I mentioned, we would expect all the remaining NCC and institutions to be completed by the end of the year.

Speaker Change: Alright, Thank you Chris.

Paul Reider: Okay.

Operator: The next question comes from the line of Mike Nedelcovych with TD Cowen. Your line is open.

Speaker Change: Next question comes from the line of Matt, Mike Labelle calls each with TV Cowen Your line is open.

Michael Thomas Nedelcovych: Thank you for the questions. I have two.

Michael Thomas Nedelcovych: Thank you for the question ties to the first is also on <unk>.

Michael Thomas Nedelcovych: The first is also on Lactorsi. Your progress in gaining formulary access is impressive. Is that basically the lever that's needed to be pulled in order to displace any residual off-label prescription of other checkpoint inhibitors, or is there additional work that needs to be done from a marketing or physician education perspective? So that's one question. And then my second question is on UCIMRI. I think in the past you've suggested that 2025 could be an inflection year for a biosimilar like UCIMRI based on some of the IRA provisions. Are you still thinking about it that way? Does UCIMRI have a bright future ahead, or what is your latest thinking on its outlook?

Michael Thomas Nedelcovych: Sure.

Michael Thomas Nedelcovych: In gaining formulary access is impressive is that basically the latter that's needed to be pulled in order to displace any residual off label prescription of other checkpoint inhibitors or is there additional work that needs to be done from a marketing or physician education perspective.

Michael Thomas Nedelcovych: That's one question and then my second question is on <unk>.

Michael Thomas Nedelcovych: In the past you've suggested that 2025 could be an inflection year for a biosimilar like <unk> based on some of the IRI.

Michael Thomas Nedelcovych: <unk> provisions are you still thinking about it that way does eastern rehab.

Michael Thomas Nedelcovych: Future ahead, or what is your latest thinking on your <unk> outlook.

Michael Thomas Nedelcovych: Yes.

Dennis M. Lanfear: Great, thank you for the question. I'll let Dr. Rosh Dias first address the issue of the therapy selection decision that physicians now have with the launch of Lacto-Rosie, and then Paul can secondarily talk about Yosemite. Rosh. Yeah, thanks very much for the questions.

Speaker Change: Great. Thank you for the question I'll, let Dr Raj dialysis.

Rosh Dias: Firstly address the issue of the therapy selection decision that physicians now have with.

Rosh Dias: The launch of <unk> and then Paul can secondarily talk about your summary of brush, yes, thanks very much for the question.

Rosh Dias: For the questions, I would say doctors tend to be pretty evidence-driven. And we have three things that no other PD-1 has. First of all, we have an indication. Secondly, we have a profound survival advantage in the first-line setting, 37% risk reduction of death, and again, that's in the context of negative trials with other PD-1s in nasopharyngeal carcinoma. And then the third thing we have is also preeminent positioning on the NCCN.

Rosh Dias: I would say doctors tend to be pretty.

Rosh Dias: Evidence driven and we have three things that no. Other PD. One has first of all we have an indication.

Rosh Dias: Secondly, we have a profound survival advantage.

Rosh Dias: In the first line setting 37% risk reduction of debt.

Rosh Dias: And again, that's in the context of negative trials with other PD ones in nasopharyngeal carcinoma, and then the third thing. We have is also a preeminent positioning on the Ccs first line. We are the early category one designated Io therapy and in second line and beyond.

Rosh Dias: We have the <unk>.

Rosh Dias: We are the only per se Richmond actually.

Rosh Dias: As we start seeing patients I think these three things are key and all his team is continuing to.

Rosh Dias: Message on those three things.

Paul Reider: Thank you. Paul, do you want to comment a little about our expectations for UCMRI going to 2025 with IRA? For Denny. Thanks for your question, Mike. Yeah, the 2020 one.

Rosh Dias: Thank you Paul do you want to comment a little above our expectations for each similar going into 2025 with IRI.

Paul Reider: Sure, Denny. Thanks for your question, Mike.

Paul Reider: Sure Denny Thanks for your question, Mike, Yes, 2025.

Paul Reider: Yeah, the 2025... Formulary negotiations are ongoing. Yosemarie and Coherus are actively engaged in that process. So we continue to believe, you know, that that will be the point where we see, you know, even greater inflection of biosimilars in the adalumumab space. So, I think we're, you know, we're well positioned there based on our price point and the value that this product brings to healthcare systems in patients. Thank you.

Paul Reider: Formulary negotiations are ongoing.

Paul Reider: Your summary, and coherence are actively engaged in that process. So.

Paul Reider: We continue to believe.

Paul Reider: Okay.

Paul Reider: EBITDA will be the I think the point, where we see.

Paul Reider: Even greater inflection of Biosimilars and the AD Illumina space.

Paul Reider: So I think we're well positioned there based on our our price point and the value that this product brings to the health care systems and patients.

Speaker Change: Thank you.

Speaker Change: Thank you for your question.

Paul Reider: Again, if you would like to ask a question press star one on your telephone keypad.

Operator: Again, if you would like to ask a question, press star 1 on your telephone keypad. Your last question comes from the line of Balaji Prasad with Barclays. Your line is open.

Paul Reider: Your last question comes from the line of Matthew <unk> with Barclays. Your line is open.

Unknown Executive: Good afternoon. This is Xiao on behalf of Balaji.

Operator: Don Nolan shall formalized multi can help us.

Unknown Executive: Thanks for taking our question. Just a quick follow-on question on the Udenica franchise. Amnio recently announced that they're licensing a PEG-fil-grastim on-body injector and pre-filled auto-injector, and they expect to submit the BRA in the first quarter of 2025. And there are a few other players that are trying to get into this market. So, what is your expectation for the PEG-fil-grastim on-body injector? And do you have any plans or mechanism to build and defend your market shares against those potential new entrants? Thank you.

Xiao: A quick follow on question on that you've done the call franchise.

Unknown Executive: Since the announcement that the license.

Unknown Executive: So question on body injector and pre fill the auto injector and the expenses associated to the <unk> first quarter. All study 75, and there are two other players start to get into this landscape. So what are your expectations for the <unk> on body.

Unknown Executive: Inscape and the entire market for the next two to three years and do you have any.

Unknown Executive: Plans metabolism.

Unknown Executive: And viewed and defend your market shares again against those potential reinsurance. Thank you.

Dennis M. Lanfear: I'm sorry, I want to understand. We're having a difficult time hearing you. I want to understand your question. Is your question with respect to future entrants in the on-body space with the infografton market or with auto injectors?

Speaker Change: Okay I'm sorry.

Speaker Change: We're having a difficult time hearing you I understand your question.

Dennis M. Lanfear: Is your question with respect to future entrants in the on body space.

Dennis M. Lanfear: With the pegfilgrastim market or with auto injectors.

Unknown Executive: have progressed in the market, especially the on-body injector and the pre-filled auto-injector. Amnio recently announced that they have something in their plan, and they plan to fail BLA in the first quarter of 2025.

Dennis M. Lanfear: Southwestern markets like specialty the on body injector and the auto field pre field auto injector as Amnio recently announced at odds you know the <unk>.

Unknown Executive: Something in plan and the plan to file a BLA in first quarter of 275 so.

Paul Reider: Oh, would you like to address how we view the competition in the agrograssive market for future auto manufacturers? Yeah, well, first of all, you know, we've been operating in this Peckfield-Graston market now for six years, and we maintain, you know, one of the leadership positions here. So what we're going to continue to do, Douglas Tsao, Robyn Karnauskas, Michael Nedelcovych, Colleen Kusy, Jason Gerberry, Bryan McMichael, Colleen Karnauskas, Michael Nedelcovych, Colleen Tsao, Robyn Karnauskas, Michael Nedelcovych, the high quality and reliability of this brand.

Unknown Executive: Paul would you like to address how we view the competition in the yes. Thanks, Congrats on markets for future Auto injectors, Yeah, well first of all we've been we've been operating in this pegfilgrastim market now we are in our sixth year.

Paul Reider: Maintain.

Paul Reider: One of the leadership positions here so.

Paul Reider: We're going to continue to do is focus on our business and the positioning of <unk>, which is to be the total solution for providers and patients. So we're doing this as I mentioned because.

Paul Reider: Today, we've got all three.

Paul Reider: Presentations, it's tried and true.

Paul Reider: And well established in the market Secondly, we've got strong payer coverage and.

Paul Reider: So that's being recognized by payers.

Paul Reider: You Deneke brand as a go to brand because of all of these benefits that we bring to not only the consistency in the marketplace. The predictor predictability, but also the high quality and reliability of this brand.

Paul Reider: So.

Paul Reider: We'll be prepared for any competition.

Speaker Change: If anybody else comes but we believe we will continue to be well positioned to compete and win whatever that landscape unfolds. Thank you Paul the other point that I would that I would make is consistent with Paul's remarks, our on body injector represents an innovative.

Paul Reider: So we'll be prepared for any competition if anybody else comes along, but we believe we'll continue to be well positioned to compete and win, whatever that landscape unfolds. Thank you, Paul. The other point that I would make is consistent with Paul's remarks.

Dennis M. Lanfear: Our on-body injector represents an innovative, de novo, highly sophisticated device with a five minute injection time. And the enthusiasm with which it has been received by the market, the physicians, and the patients is due to that. However, we believe there are significant technical hurdles to such an approach.

Dennis M. Lanfear: Oh, a highly sophisticated device with a five minute injection time, and the enthusiasm with which it has been received by the market the physicians and the patients is due to that we believe there is significant technical hurdles to such an approach and we investigated a number of approaches before settled.

Dennis M. Lanfear: And We investigated a number of approaches before settling on this one, so we think this is very important. We think we have got it right. But lastly, as Paul said, we are the first competitors in the Peg Phil Griffith market. And our track record over the last six years demonstrates that. We are the only team with all three presentations, each filling a particular need in the market. So I believe that we're confident in our ability to compete and remain successful and grow our share in this market.

Dennis M. Lanfear: Non thus far and so we think this is a very important we think we got it right, but lastly, as Paul said, we are first competitors and Pegfilgrastim market and our track record over the last six years demonstrates that we are the only team with all three presentations each filling a particular need in the market. So I believe the word <unk>.

Dennis M. Lanfear: <unk> and our ability to compete and remain successful and grow share in this market.

Speaker Change: Thank you.

Operator: Another question comes from the line of Douglas Tsao with HC Wainwright. Your line is open.

Dennis M. Lanfear: Another question comes from the line of Douglas Tsao with H C.

Douglas Dylan Tsao: Your line is open.

Douglas Dylan Tsao: Hi, good afternoon, and thanks for taking the questions and congrats on the progress. You know, obviously, there are a number of sort of gates that you need to clear in terms of the ramp up for Lactorsi, in particular, getting on to formulary. You know, how quickly do you think you can get through those and sort of, you know, have access to the majority of the market? And what other steps do you think we might need to clear before we really start to see an acceleration in the revenue trajectory?

Douglas Dylan Tsao: Hi, good afternoon, and thanks for taking my questions and congrats on the progress.

Douglas Dylan Tsao: Obviously.

Douglas Dylan Tsao: There are a number of sort of gates that you need to clear in terms of the ramp up for a lot towards the in particular.

Douglas Dylan Tsao: Getting on to formulary.

Douglas Dylan Tsao: Yes.

Douglas Dylan Tsao: How quickly do you think you can get through those and sort of you know.

Douglas Dylan Tsao: <unk> access it at sort of the most of the majority of the market and what other steps do you think we might need to you might need to clear before we really start to see an.

Douglas Dylan Tsao: An acceleration in the revenue trajectory.

Dennis M. Lanfear: Thanks. Thanks for your question, Doug. Paul, would you like to comment a little bit on the gating of...

Speaker Change: Thanks, Thanks for your question Doug.

Paul Reider: What would you like to comment little bit on the gating of the adoption of <unk> and how we do that yes.

Paul Reider: Yeah, thanks for your question, Doug. Yeah, obviously, payer coverage is the first one. And you know that that's well established.

Paul Reider: Thanks for your question, Doug, Yes, so obviously the payer coverage was the first one.

Paul Reider: That's well established and I don't I don't.

Paul Reider: Really foresee.

Paul Reider: Any further hurdles.

Paul Reider: On the payer side.

Paul Reider: The second gate is now that we've got the <unk>.

Paul Reider: CCN guidelines.

Paul Reider: What we have to ensure now is in each of the accounts that the guidelines that are translated into the order sets. So again. This this enables the doctor at the time of.

Paul Reider: And I don't I don't really foresee any further hurdles, you know, on the payer side. The second gate is, you know, now that we've got the NCCN guidelines, what we have to ensure now in each of the accounts are the guidelines that are translated into the order set. So, again, this enables the doctor at the time of prescribing so that when they click through the order set, the lactorse chemo combination is there.

Paul Reider: Prescribing.

Paul Reider: When they click through the order said that look towards the chemo combination is there that's ongoing that will typically.

Paul Reider: That's ongoing, but that will typically, you know, settle in here over this next quarter. You know, then, Doug, I really think, you know, the next gate is just, you know, sorting out all of the current patients that are on, you know, current off-label PD-1 and establishing new patients with leukemia as the new start and getting anybody that's on chemo today or not on a PD-1, you know, treated with leukemia.

Paul Reider: Settle in here over this next quarter.

Paul Reider: Then Doug I really think the.

Paul Reider: The next gate is just sort of washing out all of the current patients that are on current off label PD ones.

Paul Reider: And in establishing the new patients with <unk> as the new start and getting anybody that's on chemo today, no auto and a PD one.

Paul Reider: Treated with <unk> and Thats, just going to take continued effort in terms of promotion both through our sales team from their kols from the podium.

Paul Reider: And that's just going to take a continued effort, you know, in terms of promotion, both through our sales team from the KOLs on the podium and through the referral networks, but also through our digital efforts. And we're going to continue to invest in and deploy those so that at the time of decision, the oncologist knows that leukemia and chemo are the regimen of choice for those patients. But, you know, again, it's a rare disease.

Paul Reider: And through the referral networks, but also through our our digital efforts and we're going to.

Paul Reider: To invest and deploy those so that at the time of decision the oncology oncologist knows locked.

Paul Reider: Block towards the and chemo is the regimen of choice for those patients, but again, it's a it's a rare disease.

Paul Reider: You know, it's going to ramp up, which is why we think peak is going to occur around, you know, year three of this. But we feel very confident we're going to achieve that. But for all the reasons...

Paul Reider: It's going to ramp up which is why we think peaks going to occur.

Paul Reider: Her around year three of those but we feel very confident we're going to we're going to achieve the growth for all the reasons that well just elucidated.

Paul Reider: For all the reasons that Paul just outlined, we see the growth of this market as a steady ramp up to peak market share and penetration, probably out around year three. So this isn't a market such as a replacement enzyme market or something where you can get out to these patients and just find them immediately and convert them. These patients are in various stages of therapy, and they may have been exposed to another PD-1 antibody.

Paul Reider: We see the growth of this market as a steady ramp up to peak market share and penetration probably out around year three so this isn't a market.

Paul Reider: Such as the replacement enzyme market or something where you can get out to these patients and just find their mail and convert that these patients are in various stages of therapy. They may have been exposed to another PD. One we're going to catch the patients that are on chemotherapy. Those are all eligible they all benefit some patients we will have.

Paul Reider: We're going to catch the patients that are on chemotherapy. Those are all eligible. They will all benefit. Some patients, we will have to wait for them to progress to the second line. But the key issue is, as Rosh Dias pointed out, we are the only first-line therapy from the FDA. We've gotten a position on all of the formularies. We're doing very, very well with the MCCM. But I would say when the building blocks are in place for the market, we see a steady ramp forward in the future.

Paul Reider: Have to wait for them to progress to second line, but the key issue is as Raj pointed out.

Paul Reider: We are the only first line of therapy from the FDA, we've gotten position on all of the formularies, we're doing very very well with the CCM, but I would say with the building blocks are in place for the market, but we see it we see a steady ramp forward.

Paul Reider: Future.

Douglas Dylan Tsao: Okay, great. Maybe a follow-up question on the Udenica franchise? I'm just curious, you know; we're starting to see uptake of both your on-box device as well as the auto-injector. I'm just curious if you have any insight in terms of how physicians are using those two, you know, dosage forms or product types. You know, are there sort of themes in terms of the types of patients that are getting the on-body versus the auto-injector and vice versa? Thank you.

Speaker Change: Okay, Great and maybe a follow up question on the <unk> franchise I'm. Just curious you know, we're starting to see uptake of both beyond of your boxing device as well as.

Douglas Dylan Tsao: The auto injector I'm just curious if you have any insight in terms of how physicians are using.

Douglas Dylan Tsao: The two those two.

Douglas Dylan Tsao: Dosage forms or product types.

Douglas Dylan Tsao: Are there sort of themes in terms of the types of patients that are getting the on body versus the auto injector and vice versa.

Dennis M. Lanfear: Paul, I guess Doug's question is, what sort of patient settings would they go for in the auto?

Douglas Dylan Tsao: Paul I guess I guess the question is what sort of take patients settings, where they go for the auto injector with patient settings for the antibody and so on yes.

Paul Reider: Yeah, Doug, so you know, let me frame this in a couple different ways. First, let's take the clinics. So the clinic segments are going to gear more towards all three of the presentations because they have patients who like to come back to the office the next day; they like the high touch, you know, connectivity with their nurse and with their doctor. And so therefore, the pre-filled syringe or the auto injector is positioned for those patients.

Paul Reider: Yes, Doug so.

Paul Reider: Let me let me frame this in a couple of different ways first let's take the clinics so the clinic segments.

Paul Reider: To gear more towards all three of the presentation because they are patients I would like to come back to the office. The next day, they like the high touch.

Paul Reider: Connectivity with their with their nurse and with their Doctor and so therefore, the pre filled syringe or the auto injector are.

Paul Reider: Our position for those patients, but some patients in the clinic.

Paul Reider: But some patients in the clinic, you know, they want their injection experience at home. Therefore, we give them the option of the on-body device, you know, with a well-designed five-minute injection. But if the patient wants to self-inject and not wear the device, they can choose, you know, the auto-injector and, under 10 seconds, inject themselves at the time and place that they like. So, that's really how we position ourselves by the patients and by the providers.

Paul Reider: Want to do or injection experience at home and therefore, we give them the auction.

Paul Reider: The on body device.

Paul Reider: With.

Paul Reider: Well.

Paul Reider: Well designed five minute injection.

Paul Reider: But if the patient wants to self inject where the device. They can choose the auto injector in under 10 seconds inject themselves at the time and place that they like so that's really how we're positioning by the patients and by the.

Paul Reider: By the provider to hospitals.

Paul Reider: The hospitals, you know, they tend to go a little bit more with the on-body device or the pre-filled syringe. So, we've had good uptake with the auto-injector in the hospital, but not nearly as much in the clinic because they prefer either the pre-filled syringe or the on-body as the at-home reference. So, that's kind of how we're seeing it. And again, being the only franchise with all three options really sets us apart from competitive differentiation, and I think you see that in our market share growth. Okay, great. Thanks.

Paul Reider: They tend to go a little bit more with the on body device or the Prefilled syringe. So we've had we've had.

Paul Reider: Good uptake with auto injector in the hospital, but not nearly as much of the clinic because they prefer either the pre pre filled syringe or the on body as the at home reference.

Paul Reider: So that's kind of how we're seeing it again being the only.

Paul Reider: Franchise with all three options really sets us apart from our competitive differentiation and I think you see that in our market share growth.

Paul Reider: Okay, great.

Speaker Change: Okay great.

Operator: Question comes from the line of Colleen Kusy with Beard. Your line is open.

Paul Reider: Question comes from the line of Squalamine Goosey with Baird. Your line is open.

Colleen Margaret Kusy: Thanks, good afternoon, and thanks for taking our questions. So I realize you're not providing guidance at this point but just how to think about what the growth drivers for Eudeneca will be in 2024. Is it growing on the body? Is it, you know, just focusing on the pre-filled syringe and auto injector? Just kind of thoughts around growth for Eudeneca this year and then, sorry if I miss this in the prepared remarks, but if you could just speak towards the potential for reaching cash flow positivity and if that goal is still set for 2024.

Colleen Margaret Kusy: Thanks, Good afternoon, and thanks for taking our questions.

Colleen Margaret Kusy: So for realizing youre not providing guidance at this point, but.

Colleen Margaret Kusy: How to think about.

Colleen Margaret Kusy: What the growth drivers for <unk> will be a 2024 is it is it growing the on body is that just focusing on the pre filled syringe and auto injector just kind of thoughts around grocery you Danica. This year and then sorry, if I missed this in the prepared remarks, but.

Colleen Margaret Kusy: If you could just speak towards the <unk>.

Colleen Margaret Kusy: Potential reaching cash flow positivity in of that call is still set for 2024. Thank you.

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

Speaker Change: Great. Thank you Kelly.

Speaker Change: I will let Paul handle the growth drivers for Heath Deneke first and then I'll handle your secondary question with respect to 2020 for Paul.

Paul Reider: Yeah, thanks for your question. Yeah, I think we fully expect the on-body to be the predominant driver of our growth in 2024. You know, as Denny mentioned, the approval of that product now opens up segments of the market that have been difficult to penetrate with our prefilled syringe and auto injectors. So, you know, we're really looking for that skew, that presentation to drive market share growth for the remainder of the year.

Paul Reider: Yes, Thanks for your question.

Speaker Change: Yes, I would say.

Paul Reider: We fully expect the Gabon body.

Paul Reider: To be the predominant driver of our growth in 2024.

Paul Reider: Jenny mentioned that the approval of that product now opens up segments of the market.

Paul Reider: That has been difficult to penetrate with our Prefilled syringe, an auto injector. So we're really looking for that that skew that presentation to drive market share growth for the remainder of the year.

Paul Reider: It'll be buoyed and facilitated by our payer coverage, which I mentioned was, you know, doubled this year versus last year. And that payer coverage extends to all three product presentations, so it's not inhibited by payer coverage, you know, by each of those presentations. So where we've got it, we've got all three.

Paul Reider: It will be it will be buoyed and facilitated by our payer coverage, which I mentioned was.

Paul Reider: Doubled this year versus last year and that payer coverage extends to all three product presentations so really.

Paul Reider: Not inhibited by payer coverage.

Paul Reider: By each of those presentations, so where we've got it we've got all three and we will leverage that.

Paul Reider: As we continue to execute.

Dennis M. Lanfear: Thanks, Paul. With respect to your secondary question, I would first say... 2024 is shaping up to be a more predictable year than 2023, and so far as 2023, we had to focus a lot on getting approvals. You know, we focused on getting the on-body approval. We did that successfully. We went and got Lactorse approved by the FDA. That took a little time.

Speaker Change: Thanks, Bob with respect to your secondary question.

Dennis M. Lanfear: I would first say.

Dennis M. Lanfear: With.

Dennis M. Lanfear: 'twenty 'twenty four is shaping up to be.

Dennis M. Lanfear: A more predictable year than 2023, and so far as the 2023, we had to focus a lot on getting approvals, we focused on getting the on body approval. We did it successfully.

Dennis M. Lanfear: Got like towards the approved and the FDA that was that took a little time, we got that done and then we rolled into the launches, particularly the launch of the <unk>.

Dennis M. Lanfear: We got that done. And then we rolled into the launches, you know, particularly the launch of the on-body, the launch of the auto-injector, and now the launch of Lactorse. So the trajectory over 2024 is continued revenue growth. We'll see more Lactorse as we go on in the year, quarter to quarter, and we believe that we'll also see continued growth with respect to Udenica for the reasons that Paul just laid out. The issue is like how steep will that growth curve be, how much growth? What we are constrained by is the rare word, looking backwards, right?

Dennis M. Lanfear: <unk> launch of the auto injector and <unk> launch like towards the sort of the trajectory over 2020 for his continued revenue growth, we will see more <unk> as we go out of the year.

Dennis M. Lanfear: But we believe they will also see continued growth with respect to identical for the reasons that Paul just lay it out this shows how steep will that growth curve b, how much growth and what.

Dennis M. Lanfear: But we're constrained by is there a rearward looking.

Dennis M. Lanfear: <unk> looking backwards, we're very early in these launches we've just gotten out there with respect to <unk>, we're making very good progress on the formularies, but.

Dennis M. Lanfear: We're very early in these launches. We've just gotten out there with respect to lactorse. You know, we're making very good progress on the formularies, but it's a rare disease. Now we have to acquire patients and so on, but I think we're off to a very good start. So we don't want this to be a forecast with respect to our forward-looking, although clearly, as I indicated, growth will continue. So it's a question of when and how that will go up, but that remains very clearly in our sights, to move forward in that direction. Growth is something that we're happy with.

Dennis M. Lanfear: But it is a rare disease that we have to acquire the patients and so on but I think we're off to a very good start so we don't want.

Dennis M. Lanfear: <unk>.

Dennis M. Lanfear: Yes.

Dennis M. Lanfear: Forecast with respect to our forward looking although clearly as I indicated growth will continue so it's a question of when and how they will go up but that remains very clearly in our sites is to move forward in that direction, but the growth is something that we're happy with.

Colleen Margaret Kusy: Great, thanks for taking our questions.

Speaker Change: Great. Thanks for taking my question.

Speaker Change: Thank you Colleen.

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

Colleen Margaret Kusy: There are no further questions at this time, Mr. Daniel Nancy I'll turn the call back over to you.

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

Dennis M. Lanfear: Thank you operator, thank you all for joining us on our call today and thank you for the opportunity to enumerate for you of the progress we've made.

Dennis M. Lanfear: All of our key overtures, particularly with respect to driving our sales and advancing our tumor microenvironment focused pipeline and we look forward to price new of our progress at our next call. Thank you.

Operator: With this conference call, you may now disconnect.

Speaker Change: Today's conference call you may now disconnect.

Operator: Okay.

Operator: Okay.

Operator: <unk>.