Q2 2024 Coherus BioSciences Inc Earnings Call

Unknown Executive: Good day, and thank you for standing by. Welcome to the Coherus Biosciences second quarter 2024 earnings conference call.

Operator: Good day, and thank you for standing by.

Thank you very much for watching this video.

Operator: Welcome to the Coherus BioSciences 2nd quarter, 2024, earnings conference call. At this time, all participants aren't in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star-1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star-1-1 again.

Speaker Change: Good day and thank you for standing by. Welcome to the Coherus Biosciences second quarter 2024 earnings conference call.

Unknown Executive: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 1 on your telephone. You will then hear an automated message advising that your hand is raised. 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 Jami Taylor, Head of Investor Relations. Please go ahead.

Speaker Change: At this time, all participants are in a listening mode.

Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again.

Operator: Please be advised that today's conference is being recorded.

Jami Taylor: I would now like to hand the conference over to Jamie Taylor, Head of Investor Relations. Please go ahead.

Speaker Change: Please be advised that today's conference is being recorded.

Speaker Change: I would now like to hand the conference over to Jami Taylor, ahead of industrial relations. Please go ahead.

Jami Taylor: Thank you, operator. Good afternoon and welcome to Coherus BioSciences' 2nd quarter 2024 earnings conference call. Joining me today to discuss our results are Danny Lanfear, Chief Executive Officer of Coherus. Ryan McMichael, Chief Financial Officer; Paul Reider, Chief Commercial Officer; Dr. Rosh Dias, Chief Medical Officer; and Dr. Theresa LaValley, Chief Development Officer.

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

Jami Taylor: Thank you, operator. Good afternoon and welcome to Coherus Biosciences' second quarter 2024 earnings conference call.

Speaker Change: Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Bryan McMichael, Chief Financial Officer,

Speaker Change: Paul Reider, Chief Commercial Officer, Dr. Rosh Dias, Chief Medical Officer, and Dr. Theresa Lavallee, Chief Development Officer.

Jami Taylor: 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 that are not limited to the following. Expectations for the timing of future clinical studies, expectations about future partnerships, projections of future revenue, and expenses. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements. These statements are not guaranteed to 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 file with the FCC.

Jami Taylor: Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus's current expectations about future events. These statements include, but are not limited to, the following. Expectations for the timing of future clinical studies, expectations about future partnerships, projections of future revenue, and expenses. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statement.

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

Speaker Change: The statements include that are not limited to the following expectations for the timing of future clinical studies, expectations about future partnerships, projections of future revenue and expenses.

Speaker Change: All of these forward-looking statements involved 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: 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 FCC. 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 Denny. Thank you.

Speaker Change: 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 the documents that we filed with the FCC.

Jami Taylor: Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements.

Speaker Change: 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.

Danny Lanfear: And now I'll turn the call over to Danny.

Denny Lanfear: Thank you, Jami. Good afternoon, everyone, and thank you for joining us.

Danny Lanfear: Thank you, Jamie. Good afternoon, everyone, and thank you for joining us. Today, we're pleased to share updates from the second quarter of 2024, a period in which we made definitive progress in executing upon our plan to align all aspects of our business to a focus on oncology. Our strategic focus on oncology is proving its merit. With streamlined operations and a recently streamlined portfolio, we grew total sales 10% year over year in the second quarter, from 59 million to 65 million.

Speaker Change: And now, I'll turn the call over to Denny.

Denny Lanfear: Today, we're pleased to share updates from the second quarter of 2024. This is a period in which we made definitive progress in executing upon our plan to align all aspects of our business to a focus on oncology. Our strategic focus on oncology is proving its merit. With streamlined operations and a recently streamlined portfolio, we grew total sales 10% year-over-year in the second quarter.

Denny Lanfear: Thank you, Jami. Good afternoon, everyone, and thank you for joining us.

Denny Lanfear: Today we're pleased to share updates from the second quarter of 2024, a period in which we made definitive progress in executing upon our plan to align all aspects of our business to a focus on oncology.

Speaker Change: Our strategic focus on ecology is provenance merit.

Speaker Change: With streamlined operations and a recently streamlined portfolio, we grew total sales 10% year-over-year in the second quarter.

Denny Lanfear: $59,265,000. Even without Simmerly, the ophthalmology biosimilar we digested earlier this year, Idenka is delivering impressively as Lactorsi builds very nicely... As our Chief Commercial Officer, Paul Reider, will describe shortly. The three presentations within our Udelica franchise continue to expand our opportunities in the marketplace. As the only brand offering three presentation options, the refilled syringe, the auto-injector, and the on-body injector, we hold a clear competitive advantage that we believe will endure and increase over the long term.

Danny Lanfear: Even without, similarly, the optimality by a similar we divested earlier this year. Identity is delivering impressively as lactoresy builds very nicely. As our Chief Commercial Officer, Paul Reader, will describe shortly, the three presentations within our Identity franchise continue to expand our opportunities in the marketplace. Because the only brand offering three presentation options. Refilled Syringe, Yodoo Injector Anne, Yon Body Injector. We hold a clear competitive advantage that we believe will endure an increase over the long term. Our average selling price remains consistently strong, and our market share is growing. As an oncology company, our mission is to extend the survival of patients with cancer.

Speaker Change: from 59 million to 65 million. Even without, similarly, the ophthalmology bout somewhere we died best as earlier this year.

Speaker Change: Dennis is delivering impressively as like Thursday builds very nicely.

Paul Reider: As our Chief Commercial Officer, Paul Reider, will describe shortly, the three presentations within our Udenica franchise continue to expand our opportunities in the marketplace.

Paul Reider: They're the only brand offering three presentation options.

Paul Reider: Beetle Syringe, The Auto Injector, and The On-Body Injector.

Paul Reider: We hold a clear competitive advantage that we believe will endure and increase over the long term.

Denny Lanfear: Our average selling price remains consistently strong, and our market share is growing. As an oncology company, our mission is to extend the survival of patients with cancer, and central to the fulfillment of that mission is Black Tourism, our first commercial immuno-oncology agency, which demonstrated a profound survival advantage in the data supporting its FDA approval late last year for the treatment of nasopharyngeal carcinoma. The launch of Lactorsi continues to proceed according to plan, and Paul will provide further updates on this during our call today.

Paul Reider: Our average selling price remains consistently strong in our market shares growing.

Paul Reider: As an oncology company, our mission is to extend the survival of patients with cancer.

Danny Lanfear: Central to the fulfillment of that mission is lactorsi. Our first commercial immunoncology agent, which demonstrated a profound survival advantage in the data supporting its FDA approval late last year for the treatment of nasal pharyngeal carcinoma. The launch of lactorsi continues to proceed according to plan, and Paul will provide further updates on this during our call today. Beyond our commercial portfolio, we maintain our strong conviction in our pipeline innovative immunoncology drug candidates. We are advancing clinical studies across areas of clear unmet medical need, including head and neck cancers and small cell lung cancer, and have had a cellular carcinoma.

Paul Reider: Central to the fulfillment of that mission is Lactorsi, our first commercial immuno-oncology agent.

Paul Reider: which demonstrated a profound survival advantage in the data supporting its FDA approval late last year for the treatment of nasopharyngeal carcinoma.

Paul Reider: The launch of Lactorsi continues to proceed according to plan. Paul will provide further updates on this during our call today.

Denny Lanfear: Beyond our commercial portfolio, we maintain our strong conviction in our pipeline of innovative immuno-oncology drug candidates. We are advancing clinical studies across areas of clear unmet medical need, including head and neck cancers, non-small cell lung cancer, and hepatocellular carcinoma.

Paul Reider: Beyond our commercial portfolio, we maintain our strong conviction in our pipeline of innovative immuno-oncology drug candidates.

Paul Reider: We are advancing clinical studies across areas of clear unmet medical need, including head and neck cancers, non-small cell lung cancer, and hepatocellular carcinoma.

Denny Lanfear: Dr. Theresa Lavallee, our Chief Development Officer, and Dr. Rosh Dias, our Chief Medical Officer. Please discuss these studies further on our call today. I'm especially pleased to report today that as a direct result of our continued efforts to manage our cash, reduce both our debt and headcount, Bryan McMichael will report that we ended Q2 with $159 million on the balance sheet, a position as well for the second half of this year and beyond.

Danny Lanfear: Dr. Theresa Lavallee, our chief development officer, and Dr. Rosh Dias, our chief medical officer, will describe these studies further on our call today. I'm especially pleased to report today that, as a direct result of our continued efforts to manage our cash, reduced both our debt and headcount, Brian McMichael will report that we ended Q2 with 159 million on the balance sheet, wishing us well for the second half of this year and be often. I'd like to congratulate Brian on the exceptional skill and leadership he has demonstrated since taking the role of Interim CFO earlier this year.

Speaker Change: Dr. Theresa Lavallee, our Chief Development Officer, and Dr. Rosh Dias, our Chief Medical Officer, will describe these studies further on our call today.

Paul Reider: I'm especially pleased to report today that as a direct result of our continued efforts to manage our cash, reduce both our debt and headcount, Bryan McMichael will report that we ended Q2 with $159 million on the balance sheet, positioning us well for the second half of this year at BEOFT.

Denny Lanfear: I'd like to congratulate Bryan on the exceptional skill and leadership he has demonstrated since taking the role of interim CFO earlier this year. As announced in our press release this morning, Bryan has now been appointed to the Chief Financial Officer role at Coherus, and with my support, the full support of the Board of Directors. Bryan's deep financial expertise honed throughout his time at Gilead Sciences and further demonstrated since his arrival at Coherus a few years ago gives me great confidence.

Speaker Change: I'd like to congratulate Bryan on the exceptional skill in leadership he has demonstrated since taking the role of interim CFO earlier this year.

Danny Lanfear: As announced in our press release this morning, Brian has now been appointed to the chief financial officer role, coherence, and with my support, the full support of the board of directors. Brian's deep financial expertise, owned throughout his time at Gilead Sciences and further demonstrated, some of the arrival at coherence a few years ago, gives me great confidence. My confidence extends to our product portfolio. Like Torzi, plus our competitively positioned pipeline, represents long-term value creation for shareholders. The pace of executing our strategy has been brisk, and we have strong momentum carrying us forward into the quarters ahead. And now, with that, I'll turn the call over to Paul.

Speaker Change: As announced in our press release this morning, Bryan has now been appointed to the chief financial officer role of Harris, and with my support of Paul's support, the Board of Directors.

Paul Reider: Bryan's deep financial expertise honed throughout his time at Gilead Sciences.

Speaker Change: and further demonstrated since his arrival at Coherus a few years ago gives me great confidence.

Denny Lanfear: My confidence extends to our product portfolio. Black Taurzine, plus our competitively positioned pipeline, represents long-term value creation for shareholders. The pace of executing our strategy has been brisk. We have strong momentum carrying us forward into the quarters ahead. And now, with that, I'll turn the call over to Paul. Thank you.

Speaker Change: My confidence extends to our product portfolio. Lactorzine, plus our competitively positioned pipeline, represents long-term value creation for shareholders.

Speaker Change: The pace of executing our strategy has been brisk and we have strong momentum carrying us forward into the quarters ahead. And now with that, I'll turn the call over to Paul.

Paul Reider: Thank you, Denny, and good afternoon, everyone. Our focused execution in oncology is delivering results. I am pleased to report a fifth consecutive quarter of top-line revenue growth for Udetica and strong progress on Lectorsi following its second quarter of commercial launch. Regarding the quarter's performance,

Paul Reider: Thank you, Danny, and good afternoon everyone for a focused execution and oncology. His delivering results. I am pleased to report a fifth consecutive quarter of top-line revenue growth for Udenka, strong progress on log Torzi following its second quarter of commercial launch. Regarding the quarter's performance, total net revenue was 65 million, which included 58.5 million from sales of marketed products and 6.3 million from a non-recurring upfront cash payment received from the outlicencing block Torzi's rights in Canada. U2 Udenka net revenue was 50.9 million in 19 percent increase quarter of a quarter in a 60 percent increase over a Q2 2023.

Paul Reider: Thank you, Denny. Good afternoon, everyone. Our focused execution on oncology is delivering results. I am pleased to report a fifth consecutive quarter of top-line revenue growth for Udenica.

Speaker Change: Strong progress on Lectorsi following its second quarter of commercial launch.

Paul Reider: Total net revenue was $65 million, which included $58.5 million from sales of marketed products and $6.3 million from a non-recurring, upfront cash payment received for the outlicensing of Lactorse's rights in Canada. Q2 Udenic's net revenue was $50.9 million, a 19% increase quarter over quarter, and a 60% increase over Q2 2023. Lactorsi net revenue nearly doubled to $3.8 million in Q2 compared to $2 million in Q1. I'll now speak in more detail about each brand, starting with Lactorsi.

Speaker Change: regarding the quarters performance.

Paul Reider: Total net revenue is 65 million, which includes 58.5 million from sales of marketed products and 6.3 million from a non-recurring upfront cash payment received for the outlice and locked doors he's writes in Canada.

Speaker Change: Q2 Udenic Net Revenue was $50.9 million, a 19% increase quarter over quarter, and a 60% increase over Q2 2023.

Paul Reider: Lawtorsi net revenue nearly doubled to 3.8 million in Q2, compared to 2 million in Q1.

Paul Reider: Lactorsi net revenue nearly doubled to $3.8 million in Q2, compared to $2 million in Q1.

Paul Reider: I'll now speak in more detail about each brand, starting with Lawtorsi. First half, 2024, the top priority was setting up Lawtorsi to become the future standard of care in NPC. We remained very confident in achieving this ambition. Lawtorsi offers unprecedented efficacy for NPC patients. Like all new product launches, it requires substantial groundwork to ensure providers have access to Lawtorsi. Please to report that many operational milestones have been achieved, setting Lawtorsi up for future growth. The examples of these include, first, Lawtorsi was included in NCCN, ASCO, and LINPAT guidelines. The NCCN Lawtorsi is the only PD-1 with a category-1 designation for first-line use, and the only preferred regimen in second-line plus.

Speaker Change: About speaking more detail about each brand starting with Lock Toursy.

Paul Reider: In the first half of 2024, a top priority was setting up Lectorsi to become the future standard of care in. We remain very confident in achieving this ambition. Octorzi offers unprecedented efficacy for NPC patients. Like all new product launches, however, require substantial groundwork to ensure providers have access to Lactaura's. I am pleased to report that many operational milestones have been achieved, setting Lucktowersy up for future growth

Paul Reider: First half of 2024, a top priority was setting up Lectorsi to become the future standard of care at NCC.

Speaker Change: We remain very confident in achieving this ambition.

Paul Reider: on towards the offer's unprecedented efficacy for NPC patients.

Paul Reider: Like all new product launches, requires substantial groundwork to ensure providers have access to Lactorse.

Speaker Change: Police to report that many operational milestones have been achieved, setting locked doors up for future growth.

Paul Reider: Examples of these include: First, Torzi was included in NCCN, ASCO, and ClinPatGuide.org, and NCC Analog Taurasi is the only PD-1 with a Category 1 designation for first-line use, and the only preferred regimen in second line. Second, payer coverage has now been confirmed on nearly 100% of targeted medical benefit lives in health plans, including Medicare fee-for-service, Medicare Advantage, and national and regional commercial coverage. The third, product-specific permanent J-code has been granted by CMS and took effect July 1st, which will enable electronic billing and faster, more predictable reimbursement for providers.

Speaker Change: The examples of these include, first, what towards he was included in NCCN, Osco, and when path guidelines.

Speaker Change: And NCC Analog Torsi is the only PD-1 with a Category 1 designation for first-line use.

Paul Reider: Second, payer coverage has now been confirmed on nearly 100% targeted medical benefit lives in health plans, including Medicare Fee for Service, Medicare Advantage, and National and Regional Commercial Plans. Third, Audit Specific Permanent Chatehood has been granted by CMS and took effect July 1st, which will enable electronic billing and faster or predictable reimbursement for providers. Fourth, among the top academic research hospitals, Lawtorsi is now accessible in all 33 NCCN institutions. With the foundation now set to enable broad access to Lawtorsi, our efforts are solely focused on driving new patient starts in the Lawtorsi eligible patient segments.

Speaker Change: and the only preferred regimen in Second Life Plus.

Speaker Change: Second, payer coverage has now been confirmed on nearly 100% targeted medical benefit lives in health plans including Medicare fee-for-service, Medicare Advantage, and national and regional commercial plans.

Speaker Change: Third, Autx-specific permitting code has been granted by CMS and took effect July 1st, which will enable electronic billing and faster or predictable reimbursement for providers.

Paul Reider: Among the top academic research hospitals, Lactorsi is now accessible in all 33 NCCN institutions. With the foundation now set to enable broad access to Lactorse, our efforts are solely focused on driving new patient starts in the Lactorse-eligible patient sector, which we believe constitutes approximately 2,000 patients. I'll now speak in more detail about the NPC patient populations. This is progress we made in Q2 and our priorities for the second half of the

Speaker Change: Fourth, a month of the top academic research hospitals locked towards his now accessible in all 33 and CCN institutions.

Speaker Change: With the foundation now set to enable broad access to Lactorse, our efforts are solely focused on driving new patient starts in the Lactorse-eligible patient segments.

Paul Reider: We believe constitute approximately 2,000 patients annually.

Paul Reider: I'll now speak in more detail about the NPC patient populations, the progress we made in Q2, and our priorities for the second half of 2020. NPC patients within the Lawtorsi eligible indications include three patient segments. First, those with recurrent, locally advanced disease. Majority of NPC patients are diagnosed in the local or locally advanced setting. Here, patients are diagnosed at early stages and receive radiation or chemo plus radiation as their first treatment, with many patients being cured. These patients drop out of the NPC treatment pool unless they experienced local recurrence at any point in time. That may become Lawtorsi eligible that will receive Lawtorsi plus chemotherapy.

Speaker Change: We believe constitute approximately 2,000 patients annually.

Speaker Change: I'll now speak in more detail.

Speaker Change: The NPC patient populations, the progress we made in Q2, and our priorities for the second half of the 2020 week.

Paul Reider: NPC Patients with a Naloxone-eligible Indication. Includes three patients: First, those with recurrent locally advanced disease. The majority of NPC patients are diagnosed in the local or locally advanced setting. Here, patients are diagnosed at early stages and receive radiation or chemo plus radiation as their first treatment, with many patients being cured. These patients drop out of the NPC treatment pool unless they experience local recurrence at any point in

Speaker Change: NPC Patients within the Lactorse-Eligible Indications

Speaker Change: Include three patient segments.

Speaker Change: First, those with recurrent locally advanced disease.

Speaker Change: Majority of NPC patients are diagnosed in the local or locally advanced setting. Here, patients are diagnosed at early stages and receive radiation or chemo plus radiation as their first treatment, with many patients being cured.

Speaker Change: These patients drop out of the NPC treatment pool, unless the experienced local recurrence at any point in time. That may become locked towards the eligible, that will receive locked towards the plus chemotherapy.

Paul Reider: Then they become Lactorse-eligible and will receive Lactorse plus chemotherapy. These patients account for approximately one-third of the 2,000 who are locked into being the elderly. The second patient segment are those with first line metastatic disease. It could be metastatic recurrence from early stage disease or de novo metastatic. These patients account for approximately one-third of the 2,000 who are locked towards the elderly. Historical treatment for these two patient subpopulations includes chemotherapy or a combination of chemo plus off-label PD-1 treatment.

Paul Reider: These patients account for approximately one-third of the 2,000 who are Lawtorsi eligible. The second patient segment are those with first line metastatic disease, which could be metastatic recurrence from early stage disease or de novo metastatic. These patients account for approximately one-third of the 2,000 who are Lawtorsi eligible. Storical treatment for these two patients' sub-populations includes chemotherapy or a combination of chemo plus off-label PD-1 treatment. Real-world data shows current off-label PD-1 use of approximately 25 percent a second. This is important in the near term from a sales ramp perspective. As we do not expect, the patient is currently on an off-label PD-1 regimen.

Speaker Change: These patients account for approximately one-third of the 2000s were locked towards the eligible.

Speaker Change: The second patient segment are those with first line metastatic disease.

Speaker Change: It could be metastatic recurrence from earthly stage disease or day-no vote metastatic.

Speaker Change: These patients account for approximately one-third of the 2,000 who are lactose-eligible.

Speaker Change: Historical treatment for these two patient subpopulations.

Speaker Change: include chemotherapy, or a combination of chemo plus off-label pd1 treatment.

Paul Reider: Real-world data shows current off-label PD-1 use of approximately 25%. This is important in the near term for the sales ramp; do not expect that patients currently on an off-label PD-1 treatment will be switched to Lactorsi if the patient is already responding to treatment. Now the third patient segment is second line plus with metastatic disease. These patients account for the remaining one-third of Lactorsi-eligible patients and will receive Lactorsi as monotherapy. Patients in the first two segments I described are our primary focus for the following two reasons. First, Based on the results of the JUPITER-2 trial, these are the patients who can derive the greatest survival benefits.

Speaker Change: Real-world data shows current off-label PD-1 use of approximately 25% segments.

Speaker Change: This is important in the near term from a sales ramp perspective.

Speaker Change: We do not expect that patients currently on an off-label PD-1 regimen will be switched to lactorazine if the patient is already responding to treatment.

Paul Reider: We will be switched to log-tore-Z if the patient is already responding to treatment. Now the third patient cited this second line plus with metastatic disease. These patients account for the remaining one third of log-tore-Z eligible patients and will receive log-tore-Z as model therapy. Patients in the first two segments I described are our primary focus for the following two reasons. First, based on the results of the Jupiter-2 trial, these are the patients who can derive the greatest survival benefit. In second, these patients are likely to deliver the longest duration of treatment, which is a key driver of log-tore-Z's revenue ramp over time.

Speaker Change: Now the third patient segment is second line plus with metastatic disease.

Speaker Change: These patients account for the remaining one-third of Lactorsi-eligible patients and will receive Lactorsi as monotherapy.

Speaker Change: Patients, in the first two segments I described, are our primary focus for the following two reasons.

Speaker Change: First, based on the results of the Jupiter 2 trial, these are the patients who can derive the greatest survival benefit. In a second, these patients are likely to deliver the longest duration of treatment, which is a key driver of locked tours he's revenue ramp over time.

Paul Reider: These patients are likely to deliver the longest duration of treatment, which is a key driver of Lactorse's revenue ramp over time. In Q2, the total number of Lactorsi treated patients more than doubled by an estimated 100 new patients. Real world data shows two key fights First, a minority of drug-treated NPC patients are new to treatment in any given quarter, so it will take time for us to acquire these new patients. Second, we are acquiring our targeted patients, with 40% of lactose patients being treated in the locally advanced setting. Approximately 75% of total autopsy patients are being treated in combination with chemotherapy.

Paul Reider: In Q2, the total number of log-tore-Z treated patients more than doubled by an estimated 100 new patients. The real-world data shows two key findings. First, a minority of drug-treated NPC patients are new to treatment in any given quarter, so it will take time for us to acquire these new patients. Second, we are acquiring our targeted patient types. With 40% of log-tore-Z patients being treated in the locally advanced setting, approximately 75% of total log-tore-Z patients being treated in combination with chemotherapy. These real-world data, combined with the current off-label PD-1 use, confirms our view that log-tore-Z will follow a steady revenue ramp in the near term, fueled by new patient acquisition with sustained growth over time driven by duration.

Speaker Change: In Q2, the total number of Lactorsi treated patients more than doubled by an estimated 100 new patients.

Speaker Change: The real-world data shows two key findings.

Speaker Change: First, a minority of drug-treated NPC patients are new to treatment in any given corner, so it will take time for us to acquire these new patients.

Speaker Change: Second, we are requiring our target impatient to each.

Speaker Change: With 40% of locked towards the patients being treated in the locally advanced setting and approximately 75% of total locked towards the patients being treated in combination with chemotherapy.

Paul Reider: These real-world data, combined with the current off-label PD-1 use, confirms our view that Lectorsi will follow a steady revenue ramp in the near term, fuelled by new patient acquisition with sustained growth over time driven by duration. 80% long term value

Speaker Change: These real-world data combined with the current off-label PD-1 use

Speaker Change: Confirms our view that Lectorsi will follow a steady revenue ramp in the near term.

Speaker Change: You'll buy new patient acquisition with sustained growth over time driven by duration.

Paul Reider: 80% of log-tore value is from early-line, continuing patients, which we estimate will take three to four years fully materialized.

Paul Reider: Early line continuing patients, which we estimate will take three to four years to fully materialize. Overall, the launch is progressing well, and we remain confident that Lactorsi will achieve a dominant market share position in the NPC market, which we estimate to be valued at $150 to $200 billion. In the near term, our priorities are focused on three revenue drives: driving new patient share, strong HCP, and patient identification. Ensuring what TORSI messaging is delivered at the time of treatment decision. Optimizing the duration of Lactose E Treatment

Speaker Change: 80% of long-term value.

Speaker Change: Early line continuing patients, which we estimate will take three to four years to fully materialize.

Paul Reider: Overall, the launch is progressing well, and we remain confident that log-tore-Z will achieve a dominant market share position in the NPC market, that we estimate to be valued at 150 to 200 million. In the near term, our priorities are focused on three revenue drivers. Driving new patient share, strong HTTP patient identification, ensuring log-tore-Z messaging is delivered at the time of treatment decision, now optimizing the duration of log-tore-Z treatment.

Speaker Change: Overall, the launch is progressing well, and we remain confident that Lactorse will achieve a dominant market share position, the NPC market that we estimate to be valued at $150 to $200 million.

Speaker Change: In the near term, our priorities are focused on three revenue drivers.

Speaker Change: Driving new patient share, strong HCP, patient identification.

Speaker Change: Ensuring Lactorsi messaging is delivered at the time of treatment decision and optimizing the duration of Lactorsi treatment.

Paul Reider: Now, regarding new data to them, data could deliver another quarter of revenue growth, driven by continued strong execution, fueled by three drivers. First, the commercial launch of the data on body. Second, the data could be only peg full grasp of brand, with three device options to meet the unique needs, providers, and patients. Third, broad payer coverage, which opens access to significantly more patients.

Paul Reider: Now, regarding eugenics... Connecticut delivered another quarter of revenue growth, driven by continued strong execution. Fueled by Three Drivers: First, the commercial launch of Udetica OnBio. Second, Dedicate is the only Pegg-Full-Graston brand with three device options to meet the unique needs of providers and patients.

Speaker Change: Now, regarding eutectic.

Speaker Change: Dennis delivered another quarter of revenue growth, driven by continued strong execution, fueled by three drivers.

Dennis: First, the commercial launch of Udetica on Body.

Speaker Change: Second, dedicated to the only pegs full grass to the brand with three device options to meet the unique needs, providers and patients in third, broad payer coverage, which opens access to significantly more patient lives.

Paul Reider: And third, broad payer coverage, which opens access to significantly more patient lives. As for key performance indicators for the quarter, Udetica Franchise Demand grew 25% quarter-over-quarter. All three product presentations grew in the quarter, with OnBody representing 60% of the total unit growth. Unbody and Auto Injector ended the quarter at 13.5% and 10% of the total FUMIX, respectively. Franchise market share was 29%, an increase of four market share points quarter over quarter. Regarding the launch of Udenica OnBody, we're very pleased with the launch performance to date, and customer receptivity continues to be very positive.

Paul Reider: Live's. As for key performance indicators for the quarter, Udena could franchise demand through 25% quarter. All three product presentations grew in the quarter, with on-body representing 60% of the total unit growth. On-body and auto ejector ended the quarter at 13.5% and 10% of the total units, respectively. Franchise market share was 29%, an increase of four market share points quarter over quarter. Regarding the launch of Udena could on-body, we're very pleased with the launch performance to date, and customer receptivity continues to be very positive. Fueling customer adoption are innovative and differentiated features such as Udena could on-body's five-minute ejection time compared to the 45-minute delivery time for Ulasa on-prone.

Speaker Change: As for key performance indicators for the quarter, Udetic and Franchise Demand grew 25% per quarter. All three product presentations grew in the quarter with on-body representing 60% of the total union growth.

Dennis: On Body and Auto Injector ended the quarter at 13.5% and 10% of the total skew mix respectively.

Speaker Change: Franchise market share was 29 percent.

Speaker Change: An increase of four market share points quarter over quarter.

Speaker Change: Regarding the launch of Udana Khan Body, we're very pleased with the launch performance today and customer receptivity continues to be very positive.

Paul Reider: Fueling Customer Adoption, or Innovative and Differentiated Features, such as eugenic odd bodies, five minute ejection, paired to the 45-minute delivery time for Dulasta On. In summary, our long-term strategy for Udenica is delivering as planned, and we expect continued revenue growth for this second half. I'll now turn the call to Dr. Theresa Lavallee.

Speaker Change: Fueling Customer Adoption, or Innovative and Differentiated Features.

Speaker Change: such as eugenics on body's five-minute ejection time.

Paul Reider: In summary, our long-term strategy for Udena could is delivering as planned, and we expect continued revenue growth this second half of 2024.

Speaker Change: Prepare to the 45-minute delivery time for DoLASTA on-prone.

Speaker Change: In summary, our long-term strategy for U-Datica is delivering out-splanned, and we expect continued revenue growth of this second half in 2024.

Theresa Lavallee: I'll now turn the call to Dr. Theresa Lavallee. Thank you, Paul. Good afternoon, everyone. Firstly, we congratulate our partner at Junethe Bio-Sciences for continued progress with advancing TORA Polymath development. The Committee for Medicinal Products for Human Use, or CHMP, in Europe adopted a positive opinion recommending approval of Lock 4C, a next generation PD-1 inhibitor for the first line treatment of patients with nasopharyngeal carcinoma in combination with cisplatinum and gymsitably. Secondly, for the first line treatment of adult patients with unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with cisplatin and paclitaxel. The CHMP positive opinion is based on data from the phase 3 study Jupiter 2 for an MPC and Jupiter 6 for esophageal squamous cell carcinoma, demonstrating statistically significant and clinically meaningful improvements in survival in these two indications.

Theresa Lavallee: Thank you, Paul, and good afternoon, everyone. Firstly, we congratulate our partner, Jun-Chi Biosciences, for continued progress with the advancing torrapalumab development. The Committee for Medicinal Products for Human Use, or CHMP in Europe, adopted a positive opinion recommending approval of LOC4Z, a next-generation PD-1 inhibitor, for the first-line treatment of patients with nasopharyngeal carcinoma in combination with cisplatinum and gemcitabine. Secondly, for the first-line treatment of adult patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma in combination with cisplatinum and Paclitaxel.

Speaker Change: of now turn the call to Dr. Theresa Lavallee, Theresa.

Theresa Lavallee: Thank you, Paul, and good afternoon, everyone.

Theresa Lavallee: Firstly, we congratulate our partner, Jun-Chi Biosciences, for continued progress with advancing toropalumab development.

Theresa Lavallee: The CH-MP positive opinion is based on data from the Phase 3 studies Jupiter 2 for MPC and Jupiter 6 for esophageal squamous cell carcinoma, demonstrating statistically significant and clinically meaningful improvements in survival in these two indications. Importantly, while Toropalumab has demonstrated efficacy in these studies, its safety profile is consistent with the PD-1 inhibitor class. If approved, this will expand marketing of Toropalma beyond the U.S. into the EU. This potential approval is important to further demonstrate the efficacy and safety of toropalumab, as well as the quality of the drug. The Technical Data Set.

Speaker Change: Committee for Medicinal Products for Human Use, or CHMP, in Europe .

Speaker Change: adopted a positive opinion recommending approval of LOC4Z, a next-generation PD-1 inhibitor, for the first-line treatment of patients with nasopharyngeal carcinoma in combination with cisplatinum and gemcitabine.

Speaker Change: and specifically for the first line treatment of adult patients with unresectable advanced recurrent or metastatic it's off the deal's way to self-carsion human, in combination with his platinum and copper taxol.

Speaker Change: The CH-MP positive opinion is based on data from the Phase 3 study Jupiter-2 for MPC and Jupiter-6 for esophageal squamous cell carcinoma.

Speaker Change: Demonstrating statistically significant and clinically meaningful improvements in survival in these two indications.

Theresa Lavallee: Importantly, while TORA Polymath has demonstrated efficacy in these studies, TORA Polymath's safety profile is consistent with the PD-1 inhibitor class. It's approved this will expand marketing of TORA Polymath beyond the US into the EU. This potential approval is important to further demonstrate the efficacy and safety of TORA Polymath, as well as the quality of the drug and clinical datasets. For our tumor microenvironment targeting pipeline with global rates, and as we look to develop these assets in combination with TORA Polymath, EU approval will facilitate future approval with novel agents. Executing on our combination strategy for TORA Polymath indication expansion.

Speaker Change: Importantly, while Toropalumab has demonstrated efficacy in these studies, Toropalumab's safety profile is consistent with the PD-1 inhibitor class.

Speaker Change: If approved, this will expand marketing of Toropalumab beyond the U.S. into the EU.

Speaker Change: This potential approval is important to further demonstrate the efficacy and safety of toropalumab, as well as the quality of the drug and clinical data sets.

Theresa Lavallee: For our tumor microenvironment targeting pipeline, we have global rights, and as we look to develop these assets in combination with Tor Palomar. EU approval will facilitate future approvals with novel agents, executing on our combination strategy for TAURA-PALIMAP indication expansion. Furthermore, while the U.S. FDA will not accept phase 3 single country data for approval, they have stated on several occasions the data sets will support contribution of components. Development of our novel pipeline and tumor types where toropalumab has data may simplify any phase 3 study design. In China, Tora Palomar now has 10 marketed indications.

Speaker Change: For our tumor microenvironment targeting pipeline, we have global rights, and as we look to develop these assets in combination with TOR-PALIMAB,

Speaker Change: EU approval will facilitate future approvals with novel agents.

Speaker Change: Executing on our combination strategy for TORA-PALOMAB indication expansion.

Theresa Lavallee: Furthermore, while the US FDA will not accept Phase 3 single-country data for approval, they have stated on several occasions the data sets will support the contribution of components, development of our novel type lines and tumor types where TOREPALAMAP has data; they simplify any Phase 3 study design. In China, TOREPALAMAP now has 10 marketed indications following the recent approval of TOREPALAMAP in combination with Pactletaxle for the first-line treatment of recurrent or metastatic triple-negative breast cancer based on the Phase 3 Torchlight data. TOREPALAMAP is a foundational process in the coherus pipeline and now is being evaluated in coherus-sponsored clinical studies with Cascozakita, an anti-AL-27 antagonist, and with CHS 114, an anti-ACCRA antibody preferentially targeting tumor resident immunosuppressive p-regulatory cells.

Speaker Change: Furthermore, while the U.S. FDA will not accept Phase III single-country data for approval, they have stated on several occasions the data sets will support contribution of components.

Speaker Change: Development of our novel pipeline and tumor types where toropalamab has data may simplify any phase 3 study design.

Speaker Change: In China, Toropalumab now has 10 marketed indications following the recent approval of Toropalumab in combination with Paclitaxel for the first-line treatment of recurrent or metastatic triple negative breast cancer based on the phase 3 torchlight data.

Theresa Lavallee: Following the recent approval of Toropalumab in combination with Paclitaxel for the first line treatment of recurrent or metastatic triple negative breast cancer based on phase three torchlight data, chloropalumab is a foundational asset in the Coherus pipeline, and now is being evaluated in Coherus-sponsored clinical studies with Casdozaketag, an anti-IL-27 antagonist, and with CHS114, an anti- In addition to our internal development and our partner Jun-Chi's development, we have several partnership discussions ongoing and look forward to the potential to progress and advance these exciting clinical studies through our internal efforts. As key tech development with Torah Palomath continues. Tomorrow, at the I-O Summit Conference in Philadelphia, there's an oral presentation on the Strong Data Package Supporting Development in HCC.

Speaker Change: Cora Palamad is a foundational asset in the Coherence pipeline.

Speaker Change: And now is being evaluated in Coherus-sponsored clinical studies with Kazdoz Akita, an anti-IL-27 antagonist.

Speaker Change: and with CHS 1-1-4, an anti-CCR-8 antibody, preferentially targeting tumor resident and uses the press of T-Ray Batory cells.

Theresa Lavallee: In addition to our internal development and our partner Jiu Jiu's development, we have several partnership discussions ongoing and look forward to the potential to progress and advance these exciting clinical studies. For our internal efforts, Cascozakita's development with TOREPALAMAP continues.

Speaker Change: In addition to our internal development and our partner GMC's development, we have several partnership discussions ongoing and look forward to the potential to progress and advance these exciting clinical studies.

Speaker Change: for our internal efforts.

Speaker Change: As does the key tech development with Torah Palomath continues.

Theresa Lavallee: Tomorrow, at the IOS Summit Conference in Philadelphia, there's an oral presentation on the strong data package supporting development in HCC. While inhibiting cytokines is a validated approach in inflammatory diseases with multiple approved antibodies, Cascozakita is the first cytokine antagonist to show safety, immune activation, and monotherapy responses in cancer patients. In preclinical models, blocking IL-27 results in immune activation and brain, liver, and lung, preclinical tumor models only show anti-tumor activity in response to IL-27 in addition and liver and lung models. Three different HCC mouse models: carcinogen-induced, NASH-induced, or HEPA-16HCC cell line. Show anti-tumor response to IL-27 inhibition.

Speaker Change: Tomorrow, at the I-O Summit Conference in Philadelphia, there's an oral presentation on the Strong Data Package Supporting Development in HCC.

Theresa Lavallee: While inhibiting cytokines is a validated approach in inflammatory diseases with multiple approved antibodies, Testozokituk is the first cytokine antagonist to show safety. Activation, and Monotherapy Responses in Cancer. In preclinical models, blocking IL-27 results in immune activation in the brain, liver, and lungs. Preclinical tumor models only show anti-tumor activity in response to IL-27 inhibition in liver and lung models. Three different HCC mouse models, carcinogen-induced, NASH-induced, and the HEPA1-6 HCC cell line, show anti-tumor responses to IL-27 inhibition.

Speaker Change: While inhibiting cytokines is a validated approach in inflammatory diseases with multiple approved antibodies.

Speaker Change: Testozaketug is the first cytokine antagonist to show safety.

Speaker Change: Immune Activation

Speaker Change: and Donna Therapy responses in cancer patients.

Speaker Change: In preclinical models, blocking IL-27 results in immune activation in brain, liver, and lung.

Speaker Change: Reclinical tumor models only show anti-tumoractivity in response to iOS 27 in addition in liver and lung models.

Speaker Change: Three different HCC mouse models, carcinogen-induced, NASH-induced, are HEPA1-6 HCC cell lines.

Speaker Change: show anti-tumor response to IL-27 inhibition.

Theresa Lavallee: Further, in liver cancer, Jiu Jiu has recently announced the positive results from a phase three study of TOREPALAMAP in first line at a cellular carcinoma in combination with bevacism app. These results will be important in supporting the randomized phase two study of Cascozakita in combination with TOREPALAMAP and bevacism app in first line HCC for efficacy, safety, and relative contribution data. Our second key pipeline asset, CHS-114, a highly selective cytolithic anti-CCRA antibody, continues to progress in the clinic. Eliminating a immune suppressive T-Rake cells in the tumor has been attempted by the field evaluating several approaches. But with the problem of depleting T-Rake cells broadly leading to autoimmune toxicity and also depleting T-cells and thus limiting anti-tumor activity.

Theresa Lavallee: Further, in liver cancer, Junshi has recently announced positive results from a phase 3 study of toropalumab and first-line hepatocellular carcinoma in combination with bevacizumab. These results will be important in supporting a randomized Phase 2 study of castozic ketones in combination with toropalumab and bevacizumab in first-line HCC for efficacy, safety, and relative contribution data Our second key pipeline asset, DHS114, a highly selective cytolytic anti-CCR8 antibody, continues to progress in the clinic.

Speaker Change: Further, in liver cancer, Jun-Chi has recently announced the positive results from a phase 3 study of toropalumab and first-line adicellular carcinoma in combination with bevacizumab.

Speaker Change: These Rosals will be important in supporting the randomized space to study if Kesto's key task in combination with Toro Palo and App and Devices and App in first line HCC for efficacy, safety, and relative contribution data.

Speaker Change: Our second key pipeline asset, DHS114, a highly selective cytolytic anti-CCR8 antibody, continues to progress in the clinic.

Theresa Lavallee: Eliminating immune suppressive Treg cells in the tumor has been attempted by the field evaluating several approaches, but with the problem of depleting T-reg cells broadly, leading to autoimmune toxicity, and also depleting T cells and thus limiting anti-tumor activity. The CHS114 clinical data demonstrating peripheral depletion of CCR8 positive Treg cells and not depleting Treg cells broadly establishes proof of mechanism in cancer VCR8 positive Treg cells have a high prevalence and density in a number of solid tumors, with the highest levels in head and neck, gastric, and cervical cancer.

Speaker Change: Eliminating immune suppressive Treg cells in the tumor has been attempted by the field evaluating several approaches.

Speaker Change: Besides, with the problem of depleting T-Rexel's broadly leading to autoimmune toxicity and also depleting T-cells and thus limiting anti-tomor activity.

Theresa Lavallee: The CHS-114 clinical data demonstrating peripheral depletion of CT-R-8 positive T-Rake cells and not depleting T-Rake cells broadly establishes proof of mechanism and cancer patients. CT-R-8 positive T-Rake cells have a high prevalence in density and a number of solid tumors. With the highest levels in head-and-neck, gastric, and cervical cancer. For this reason, RCHS-114-DOS expansion in the Phase I study is evaluating head-and-neck cancer and includes pre- and on-treatment biopsies to evaluate T-Rake depletion in the tumor.

Speaker Change: The CNTS-114 clinical data demonstrating peripheral depletion of CTR-8 positive T-Rag cells, and not depleting T-Rag cells broadly establishes proof of mechanism and cancer patients.

Speaker Change: BCR8 positive Treg cells have a high prevalence and density in a number of solid tumors.

Speaker Change: and the highest levels in head and neck, gastric and cervical cancer.

Theresa Lavallee: For this reason, our CHS114 dose expansion in the Phase 1 study is evaluating head and neck cancer and includes pre- and on-treatment biopsies to evaluate Treg depletion in the tumor. At ASCO this year, one of the experimental therapeutics presentations that impressed me most was by Lenovo Medicine, evaluating their CCR8 antibody LM108 in combination with Torapalumab and Advanced Gastric Cancer Patients. We were encouraged by these early clinical data showing an acceptable safety profile and an overall response rate of 36.1 percent, which we believe demonstrates proof of principle for CCRA targeting in combination with toropalumab in a tuber type expected to show benefits.

Speaker Change: For this reason, RCH-114 dose expansion in the Phase I study is evaluating head-in-neck cancer, and includes pre and on treatment biopsies to evaluate T-Rake depletion in the tumor.

Theresa Lavallee: At ASCO this year, one of the experimental therapeutic presentations that impressed me most was by Lenovo Medicines, evaluating their CT-R-8 antibody LM-108 in combination with TORAPILM and advanced gastric cancer patients. We were encouraged by these early clinical data showing an acceptable safety profile and an overall response rate of 36.1%, which we believe demonstrates proof of principle for CT-R-8 targeting in combination with TORAPILM and a tumor type expected to show benefit.

Speaker Change: at ASCO this year. One of these pyramidal therapists' presentations that impressed me most.

Speaker Change: with Vice-Linopa Medicine, evaluating their CCRA antibody LM-108 in combination with Toro Palauna.

Speaker Change: and Advanced Gastric Cancer Patients.

Speaker Change: We were encouraged by these early clinical data showing an acceptable safety profile.

Speaker Change: And...

Speaker Change: and overall response rate of 36.1 percent, which we believe demonstrates proof of principle for CCR8 targeting in combination with toropalumab and a tuber type expected to show benefit.

Theresa Lavallee: Lastly, to update you on the internal development of our discovery agent. I am proud of the CoPIR at CHS-1000 IELT-14 for submitting a quality IND package to the FDA that has been accepted. We plan to advance CHS-1000 to clinic to establish single agent safety and rapidly move into combination with TORAPILM for treatment of fallen tumors. It is designed to block IELT-4 activity and promote an active or pro-inflammatory immune response. The IELT receptor family modulates the activity of the innate and adaptive immune system and plays a role in innate immune cell mechanisms that lead to tumor escape and PD-1 resistance.

Theresa Lavallee: Lastly, to update you on the internal development of our Discovery Agents. I am proud of the Coherus CHS 1000 ILT4 team for submitting a quality IND package to the FDA that has been accepted. And we plan to advance CHS 1000 to the clinic to establish single agent safety and rapidly move it into combination with toropalumab for treatment of solid tumors.

Speaker Change: Lastly, to update you on the internal developments of our discovery agent.

Speaker Change: I am proud of the co-herit CHS-1,000 IELT-14

Speaker Change: for submitting a quality IND package to the FDA that has been accepted.

Speaker Change: And we plan to advance CHS1000 to clinics to establish single-agent safety and rapidly move into combination with toropalumab for treatment of solid tumors.

Speaker Change: It is designed to block IL-T4 activity and promote an active or pro-inflammatory immune response.

Theresa Lavallee: The ILT receptor family modulates the activity of the innate and adaptive immune system and plays a role in innate immune cell mechanisms that lead to tumor escape and PD-1 resistance. This is a promising target and a body that Coherus discovered. I'll now turn the call to Dr. Dias, our Chief Medical Officer. Thank you, Theresa.

Speaker Change: The ILT receptor family modulates the activity of the innate and adaptive immune system. And place a role in innate immune cell mechanisms that lead to tumor escape in pd1 resistance.

Theresa Lavallee: This is a promising target and an antibody that Coherace discovered.

Speaker Change: This is a promising target in a potent antibody that Coherus discovered.

Rosh Dias: I'll now turn the call to Dr. Diaz, our Chief Medical Officer, Raj. Thank you, Theresa. I'm Torzi with the profound survival advantage demonstrated in the interference of your carcinoma and its accompanying approval across all lines of therapy for NPC. You need to form the foundation of our IEO franchise and, in addition, you need to demonstrate efficacy outside NPC, most recently in first line about the cellular carcinoma patient. Is a published phase 2 Tory Palimad, Deb Sismab, later in clinical cancer research, and the phase 3 Hepatoche study, meeting its primary endpoints of PFS and OS of Theresa has pointed out.

Speaker Change: I'll now turn the call to Dr. Dias or Chief Medical Officer, Rosh.

Rosh Dias: Thank you, Theresa. Loctorze, with the profound survival advantage demonstrated in nasopharyngeal carcinoma and its accompanying approval across all lines of therapy for NPCs, continues to form the foundation of our IO franchise and, in addition, continues to demonstrate efficacy outside AI, most recently in first-line hepatocellular carcinoma patients. The published Phase II tauripalumab-deposizumab data in clinical cancer research and the Phase III hepatology study meeting its primary endpoints of PFS and OS, as Theresa has pointed out.

Rosh Dias: Thank you, Theresa. Loptorzi, with the profound survival advantage demonstrated in nasopharyngeal carcinoma and its accompanying approval across all lines of therapy for NPC.

Speaker Change: continues to form the foundation of our IO franchise and, in addition, continues to demonstrate efficacy outside NPC, most recently in first-line hepatocellular carcinoma patients.

Speaker Change: to the published Phase II tauripalumab-depacizumab data in clinical cancer research and the Phase III hepatology study meeting its primary endpoints of PFS and OS, as Theresa has pointed out.

Rosh Dias: We've been clear in our six leading three very distinct strategies for further development of our IF franchise, including development of a lot towards the outside NPC. Firstly, combination with our internal IO pipeline of the competitively well-positioned assets, Joseph Keter and CHS114. Secondly, combinations with external partners at the discovery or close discovery stage, where we would provide locked towards the combination with partner companies, early stage assets, where the partner company would fully fund development. And thirdly, combinations with external partners at the later phase 3 stage of development of novel agents, trials of registration intent, where again, we would provide locked towards the infocombination with partner companies' late stage assets, and where again, the partner company would fully fund development.

Rosh Dias: We've been clear in articulating three very distinct strategies for further development of our AYA franchise, including the development of Lactorsi outside it. Firstly, in combination with our internal IO pipeline of competitively well-positioned assets, such as KETA and CHS. Secondly, combinations with external partners at the discovery or post-discovery stage, where we would provide Loctorzi in combination with partner companies' early stage assets, where the partner company would fully fund development. And thirdly, combinations with external partners at a later phase 3 stage of development of novel agents, trials of registration intent were again, provide a lot of tools for combination with partner companies' late-stage assets, and where, again, the partner company would fully fund The strategic approach enables effective resource allocation focused on our internal pipeline development, and I'm pleased to report that we're making good progress on all three fronts.

Speaker Change: We've been clear in articulating three very distinct strategies for further development of our AYA franchise, including development of Loctaw as the outside NPC.

Speaker Change: Lastly, combination with our internal IO pipeline of the competitively well-positioned assets such as the KETA and CHS114.

Speaker Change: Good morning.

Speaker Change: Secondly, combinations with external partners at the discovery or close to this company stage where we would provide locked towards the combination with partner companies, early stage assets, with a partner company, would fully fund development.

Speaker Change: And thirdly, combinations with external partners at a later phase 3 stage of development of novel agents, trials of registration intent, where again, we would provide locked tools in for combination with partner companies' late stage assets.

Rosh Dias: The strategic approach enables effective resource allocation focus towards our internal pipeline development, and I'm pleased to report that we're making good progress on all three fronts. And so, though, our IO27 target antibody continues to progress to plan in our combination study for locked towards the second to fourth line, non-small for lung cancer. As a reminder, this is intended to be followed by a phase 3 randomized controlled trial and second line non-small for lung cancer. We're also on track to start the first line HCC combination study for locked towards the encoder for this year. We'll link upon the impressive triplet combination data presented at ASCOGI at the start of this year.

Speaker Change: and where again the partner company would fully fund development.

Speaker Change: The strategic approach enables effective resource allocation focused towards our internal pipeline development, and I'm pleased to report that we're making good progress on all three fronts.

Rosh Dias: As we do so, our IL-27 targeting antibody continues to progress as planned in our combination study to look towards the second to fourth line in non-small cell lung cancer. As a reminder, this is intended to be followed by a phase three randomized control trial and the second line in small cell lung cancer. We're also on track to start the first line HCC combination study with Loktharvi in Q4 this year, building upon the impressive triplet combination data presented at ASCO GI at the start of this year.

Speaker Change: As do so, our IL-27-targeting antibody continues to progress to plan in our combination study block towards the second to fourth line, non-small cell lung cancer.

Speaker Change: As a reminder, this is intended to be followed by a Phase 3 randomized control trial in second line non-small cell lung cancer.

Speaker Change: Rosh on track, start first line, HCC combinations that they will look toward the, in order for this year. We'll link up on the impressive tripler combination data presented at Ask a GI at the start of this year.

Rosh Dias: DHS 114, our CCRA targeting antibody, has completed its escalation and is now progressing; Transcription by Transcription Outsourcing, LLC, from the dose escalation portion of the study was presented at ASCO, showing an acceptable safety profile with no dose-limiting toxin. UK Dose Proportionality, Proof of Mechanism with Depletion of Peripheral CCRA Positive Tregs, and a Disease Control Rate Our partner programs incorporating Loctorzi in early stage with ENB therapeutics in collaboration with the Cancer Research Institute in ovarian cancer, as well as the later stage multinational programs in combination with BTL-8 in limited stage for small cell lung cancer and with the Inervio vaccine in the HPV positive early stage head and neck cancer continue to plan, with the latter in particular being in the same physician group of head and neck oncologists. For more information, visit www.

Rosh Dias: CHS114, our CCRA targeting antibody, has completed the escalation and is now progressing with indication expansion, beam 2 head and neck cancer versus monotherapy and in combination locked towards the stage from the escalation portion of the study was presented at ASCO in June, showing an expectable failure profile with no dose linking toxicities. Decade dose proportionality, proof of mechanism with depletion of peripheral CCRA positive T-regs, and a disease control rate of 47% in an advanced solid tumor population that was heavily pre-streated. Our partner programs incorporating locked towards the in early state with ENB therapy 6 collaboration with the cancer research institute, no variant cancer, and one of the late stage multinational programs in combination with BTLA in limited stage, small for lung cancer, and with the inner view of vaccine in the HPV positive early stage, head and neck cancer continued to plan with a latter in particular being in the same position group of head and neck oncologists or to treat NPC.

Operator: Good day and thank you for standing by. Welcome to the Coherus BioSciences 2nd quarter 2024 earnings conference call. At this time, all participants aren't a listen only mode.

Speaker Change: CHS-114 of CCRA targeting antibody has completed the first escalation and is now progressing with indication expansion into head and neck cancer versus monotherapy and the incombination flock to will be.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again.

Speaker Change: This from the dose escalation portion of the study was presented at ASCO in June .

Speaker Change: showing an acceptable safety profile with no dose-limiting toxicities.

Speaker Change: EK Dose Proportionality, Proof of Mechanism with Depletion of Peripheral CCR8-Positive Tregs, and a Disease Control Rate of 47% in an Advanced Solid Tumor Population that was heavily pre-treated.

Operator: Please be advised that today's conference is being recorded.

Jami Taylor: I would now like to hand the conference over to Jamie Taylor, Head of Investor Relations. Please go ahead. Thank you, operator.

Speaker Change: Our partner program is incorporating Loctorzi in early stage with ENB therapeutics.

Jami Taylor: Good afternoon and welcome to Coherus BioSciences 2nd quarter 2024 earnings conference call.

Speaker Change: in collaboration with the Cancer Research Institute, No Variant Cancer.

Jami Taylor: Joining me today to discuss our results are Danny Lanfear, Chief Executive Officer of Coherus. Ryan McMichael, Chief Financial Officer, Paul Reider, Chief Commercial Officer, Dr. Rosh Dias, Chief Medical Officer, and Dr. Theresa LaValley, Chief Development Officer.

Speaker Change: and one at the late stage.

Speaker Change: multinational programs in combination with BTLA in limited stage for small cell lung cancer and with the Inervio vaccine in the HPV positive early stage.

Speaker Change: Head and Neck Cancer continue to plan, with the latter, in particular, being in the same physician group of Head and Neck Oncologists, or to treat NPC.

Rosh Dias: We look forward to announcing further partnerships over the coming months.

Brian Mcmichael: And with that, I've handed over to Brian McMichael, Chief Financial Officer. Brian. Thank you, Roch, and good afternoon, everyone. Following the summary of revenues provided by Paul, I will focus on the rest of the P&L and CAF. Cost of Goods Sold for Q2, 2024, was $28.4 million compared to $24.8 million in Q2 last year. The increase was driven primarily by increased demand-free genica and non-recurring costs related to the summer. Q2 marked the first full quarter following the divestiture of summer league, a product that had a significant gross profit share in the mid 50% range, taken before internal commercial expenses.

Jami Taylor: 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 that are not limited to the following. Expectations for the timing of future clinical studies, expectations about future partnerships, projections of future revenue, and expenses. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance, or achievements to differ from those implied by the forward-looking statements.

Speaker Change: We look forward to announcing further partnerships over the coming months.

Speaker Change: And with that, I'll hand over to Bryan McMichael, Chief Financial Officer, Bryan.

Bryan McMichael: Thank you, Rosh, and good afternoon, everyone. Following the summary of revenues provided by Paul, I will focus on the rest of the P&L and cash. Cost of goods sold for Q2 2024 was $28.4 million compared to $24.8 million in Q2 last year. The increase was driven primarily by increased demand for eugenica and non-recurring costs related to eugenics.

Bryan McMichael: Thank you, Rosh and good afternoon, everyone. Following the summary of revenues provided by Paul, I will focus on the rest of the P&L in cash.

Bryan McMichael: Cost of goods sold for Q2 2024 was $28.4 million compared to $24.8 million in Q2 last year. The increase was driven primarily by increased demand for eugenica and non-recurring costs related to eugenics.

Bryan McMichael: Q2 marked the first full quarter following the divestiture of Thermaly, a product that had a significant gross profit share in the mid 50% range, taken before internal commercial expenses. In addition, the mid-single-digit royalty on Udenica Net Revenues payable to Amgen expired this past July 1st.

Bryan McMichael: Q2 marked the first full quarter following the divestiture of Thermalea, a product that had a significant gross profit share in the mid-50% range, taken before internal commercial expenses.

Brian Mcmichael: In addition, the mid single-digit royalty on identical net revenues payable to Amgen expired this past July 1. R&D expense totaled 22 million and decreased 1.3 million and 6% from Q2 a year ago. The decrease was driven primarily by lower headcap. Additionally, decreases came from cost-not-recurring for programs terminated in previous years and divested products, partially offset by investments in our current pipeline. SGNA totaled $35.2 million and decreased $10 million and 22% compared to Q2 in the prior year. The decrease primarily reflects savings from lower headcount, expenses for divested products that did not recurred, and ongoing cost reduction efforts.

Jami Taylor: These statements are not guaranteed to 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 file with the FCC. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statements.

Bryan McMichael: In addition, the mid-single-digit royalty on Udenica Net Revenues payable to Amgen expired this past July 1.

Bryan McMichael: R&D expense totaled $22 million and decreased $1.3 million and 6% from Q2 a year ago. The decrease was driven primarily by lower headcount. Additionally, decreases came from costs not recurring for programs terminated in previous periods and divested products partially offset by investments in our current pipeline. SG&A totaled $35.2 million and decreased $10 million and 22% compared to Q2 in the prior year. The decrease primarily reflects savings from lower headcount, expenses for divested products that did not recur, and our ongoing cost reduction efforts.

Bryan McMichael: R&D expense totaled $22 million and decreased $1.3 million and 6% from Q2 a year ago. The decrease was driven primarily by lower headcount.

Bryan McMichael: Additionally, decreases came from cost not recurring for programs to earn aid in previous years in domestic products, partially offset by investments in our current pipeline.

Danny Lanfear: And now I'll turn the call over to Danny. Thank you, Jamie.

Danny Lanfear: Good afternoon, everyone, and thank you for joining us. Today, we're pleased to share updates from the second quarter of 2024, a period in which we made definitive progress in executing to plan our plan to align all aspects of our business to a focus on oncology. Our strategic focus on oncology is proving its merit. With streamlined operations and a recently streamlined portfolio, we grew total sales 10% year over year in the second quarter, from 59 million to 65 million.

Bryan McMichael: SG&A totaled $35.2 million and decreased $10 million and 22% compared to Q2 in the prior year.

Speaker Change: The D-creas primarily reflects saying it's from lower-head count, except for that that's the products they did not record, and are ongoing cost reduction efforts.

Brian Mcmichael: Interest expense of $5.3 million decreased, $4.6 million, and 46% compared to Q2 in the prior year. Q2 2024 was the first quarter we started to see savings from the full payoff of our $250 million principal amount term loan, which occurred during the quarter. The Q2 2024 net loss was $12.9 million or 11 cents per due to share, compared to a net loss of $42.9 million or $49 cents per due to share for the same period in 2023. Non-GAAP net loss per share, which excluded the gain on the vest of share of eSemory, was $16.4 million or $0.14 cents per due to share in Q2 2024 compared to $32.8 million or $0.38 cents per due to share for the same period in 2023.

Bryan McMichael: Interest expense of $5.3 million decreased $4.6 million and 46% compared to Q2 of the prior year. Q2 2024 was the first quarter we started to see savings from the full payoff of our $259 principal amount term loan, which occurred during the quarter. The Q2 2024 net loss was $12.9 million, or $0.11 per diluted share, compared to a net loss of $42.9 million, or $0.49 per diluted share, for the same period in 2023.

Bryan McMichael: Interest expense of $5.3 million, decreased of $4.6 million and 46% compared to Q2 in the prior year.

Bryan McMichael: Q2 2024 was the first quarter we started to see savings from the full payoff of our $250 million principal amount term loan, which occurred during the quarter.

Danny Lanfear: Even without, similarly, the optimality by a similar we divested earlier this year. Identicate is delivering impressively as like tourism builds very nicely. As our chief commercial officer, Paul Reader, will describe shortly, the three presentations within our Identicate franchise continue to expand our opportunities in the marketplace. Because the only brand offering three presentation options. Refilled Syringe, Yadu Injector Anne, Yann Body Injector. We hold a clear competitive advantage that we believe will endure an increase over the long term. Our average selling price remains consistently strong, and our market share is growing.

Bryan McMichael: The Q2-2024 net loss was $12.9 million, or $11 per diluted share compared to a net loss of $42.9 million, or $49 per diluted share for the same period in 2023.

Bryan McMichael: Non-GAAP net loss per share, which excludes the gain on the divested share of Yosemite, was $16.4 million or 14 cents per diluted share in Q2 2024 compared to $32.8 million or 38 cents, her diluted chair for the same period in 2023. Cash equivalents and investments in marketable securities were $159.2 million as of June 30, 2024, compared to $117.7 million at year-end. As a reminder, during the quarter, we paid off $250 million in term loans, as I mentioned earlier, entered into a new $38.7 million term loan due May 2029, sold revenue rights for $37.5 million, and received $40 million and $6.3 million in exchange for the sale of eSummary and the out license of the Canadian rights to La Torze, respectively.

Bryan McMichael: non-GAAP net loss per share, which excludes the gain on divestiture of Yosemite, was $16.4 million, or $0.14 per diluted share, in Q2 2024, compared to $32.8 million, or $0.38

Brian Mcmichael: Cash equivalents and investments in marketable securities were $159.2 million as of June 30th, 2024, compared to $117.7 million at your end. As a reminder, during the quarter we paid off $250 million in term loan, as I mentioned earlier, answered into a new $38.7 million term loan due May 2029. Sold revenue rights for $37.5 million and received $40 million and $6.3 million in exchange for the sale of eSemory and the out license of the Canadian rights to locked towards the respectable. Today we are reiterating our expected range of combined 2024 R&D and SGN8 expenses of $250 to $265 million.

Bryan McMichael: Her diluted share for the same period in 2023.

Danny Lanfear: As an oncology company, our mission is to extend the survival of patients with cancer. Central to the fulfillment of that mission is like Torzi, our first commercial immunomacology agent. We should demonstrate that profound survival advantage in the data supporting its FDA approval late last year for the treatment of nasopharyngeal carcinoma. The launch of Lak Torzi continues to proceed according to plan, and Paul will provide further updates on this during our call today.

Bryan McMichael: Cash equivalents and investments in marketable securities were $159.2 million as of June 30, 2024, compared to $117.7 million at year-end.

Bryan McMichael: As a reminder, during the quarter, we paid off $250 million in term loan, as I mentioned earlier, entered into a new $38.7 million term loan due May 2029.

Speaker Change: So old revenue rights for $37.5 million, and received $40 million and $6.3 million in exchange for the facility summary, and the out license of the Canadian rise to a lot towards the respectable.

Danny Lanfear: Beyond our commercial portfolio, we maintain our strong conviction in our pipeline that innovates immunomacology drug candidates. We are advancing clinical studies across areas of clear unmet medical need, including head and neck cancers on small cell lung cancer, and have had a cellular carcinoma.

Bryan McMichael: Today, we are reiterating our expected range of combined 2024 R&D and SG&A expenses of $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes certain business development activity. These strong quarterly results are the outcome of tremendous execution on the part of our team. With that, I will turn the call back over to Denny for closing remarks.

Speaker Change: Today, we are reiterating our expected range of combined 2024 R&D and SG&A expenses of $250 to $265 million.

Brian Mcmichael: This guidance includes approximately $40 million of stock-based compensation expense and excludes certain business development activities.

Danny Lanfear: Dr. Tricilavalli, our chief development officer, and Dr. Raj Dias, our chief medical officer, will describe these studies further on our call today. I'm especially pleased to report today that as a direct result of our continued efforts to manage our cash, reduced both our debt and headcount, Bryan McMichael will report that we ended Q2 with 159 million on the balance sheet, wishing us well for the second half of this year and be often.

Bryan McMichael: This guy includes approximately $40 million of stock-based compensation expense and excludes certain business development activities.

Brian Mcmichael: These strong quarterly results are the outcome of tremendous execution on the part of our team.

Bryan McMichael: These strong quarterly results are the outcome of tremendous execution on the part of our team.

Danny Lanfear: With that, I will turn the call back over to Denny for closing remarks. Thank you, Brian. On the happen report today, we are executing very well on our four-part plan to deliver shareholder value. First, as Paul described, driving the top line. Secondly, as Brian described, controlling our operating expenses. Third, as Theresa and Rosh described, advancing our pipeline of tumor-microenvironment-focused assets. And lastly, making substantial improvements in our capital structure. We're proud of our accomplishments in the second quarter, and we remain dedicated to our mission of extending the survival of cancer patients.

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

Denny Lanfear: I am unhappy to report today that we are executing very well on our four-part plan to deliver shareholder value. First, as Paul described, dragging the top line.

Denny Lanfear: Thank you, Bryan.

Denny Lanfear: On behalf of the report today, we are executing very well on our four-part plan to deliver shareholder value.

Denny Lanfear: Secondly, as Bryan described, controlling our operating expenses. Third, as Theresa and Rosh described, advancing our pipeline of tumor microenvironment focused assets. And lastly, making substantial improvements in our capital structure. We are proud of our accomplishments in the second quarter, and we remain dedicated to our mission of extending the survival of cancer patients. Now, I'm happy to open the line for questions. Operator.

Denny Lanfear: First and Paul the Scrag, drag in the top line.

Danny Lanfear: I'd like to congratulate Bryan on the exceptional skill and leadership he has demonstrated since taking the role of interim CFO earlier this year. As announced in our press release this morning, Bryan has now been appointed to the chief financial officer role or Harris, and with my support, the full support of the board of directors. Bryan's deep financial expertise honed throughout his time at Gilead Sciences and further demonstrated some of the rival at Coheres a few years ago gives me great confidence.

Speaker Change: Secondly, as Bryan's described, controlling our operating expenses.

Speaker Change: Third, as Theresa and Rosh described, advancing our pipeline of tumor microenvironment focused assets.

Speaker Change: And lastly, making substantial improvements in our capital structure.

Denny Lanfear: We're proud of our accomplishments over the second quarter, and we remain dedicated to our mission of extending the survival of cancer patients.

Paul Reider: Now, happy to open the line for questions. I'm Reider. As a reminder, if you'd like to ask a question at this time, 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. Please stand by. Will we compile the Q&A roster?

Speaker Change: Now I'm happy to open the line for questions. Operator?

Unknown Executive: As a reminder, if you'd like to ask a question at this time, please press star 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question will come from the line of Yigal Nochomovitz with Citi.

Danny Lanfear: The confidence extends to our product portfolio, like Torzi plus our competitively positioned pipeline represents long-term value creation for shareholders. The pace of executing our strategy has been brisk, and we have strong momentum carrying us forward into the quarters ahead.

Speaker Change: As a reminder, if you'd like to ask a question at this time, 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.

Paul Reider: And now with that, I'll turn the call over to Paul. Thank you, Danny.

Speaker Change: Thank you very much for watching this video, see you in the next video.

Yigal Nochomovitz: Our first question will come from the line of Yigal Nakomovitz with City.

Asha Gan: Hi, this is Asha Gan for Yigal. Thanks for taking my questions and congrats on the quarter. I just had a few on the Lactorsi launch in NPC.

Paul Reider: Good afternoon, everyone. Our focused execution and oncology is delivering results. I am pleased to report a fifth consecutive quarter of top-line revenue growth for UDECA. Strong progress on luck, Torzi, following its second quarter of commercial launch. Regarding the quarter's performance, total net revenue was 65 million, which included 58.5 million from sales of marketed products at 6.3 million from a non-recurring upfront cash payment, received from the outlicencing block Torzi's rights in Canada.

Yigalna Comovets: Our first question will come from the line of Yigalna Comovets, which city?

Yigal Nochomovitz: Hi, this is Aja Gondregaal. Thanks for taking my questions, and congrats on the quarter. I just had a few on the Laktorsi launch in NPC. Can you give us any color on which types of patients you're treating? Are they primarily really diagnosed patients? Or are you seeing switches from other patients on off-label PD-1s? And on the same topic, where are you with the payer coverage access?

Asha Gan: Can you give us any color on which types of patients you're treating? Are they primarily newly diagnosed patients, or are you seeing switches from other patients on off-label PD1s? And on the same topic, where are you with payer coverage access, and how should we think about the J code as an inflection point for sales growth this year?

Speaker Change: Hi, this is Ozark on Pretty Gal. Thanks for taking my questions and congrats on the quarter. I just had a few on the LockTorsey launch in NPC.

Speaker Change: Can you give us any color on which types of patients you're treating? Are they primarily newly diagnosed patients or are you seeing switches from other patients on off-label PD-1s?

Yigal Nochomovitz: How should we think about the J-code as an inflection point for sales growth this year? Thanks.

Speaker Change: And on the same topic, where are you with the payer coverage access and how should we think about the J code as an inflection point for sales growth this year? Thanks.

Paul Reider: Hey, Aja, thank you very much for your questions. Paul, do you want to cover the issue of the NPC launch? Where do we bump into any switching problems in the second early of the payer coverage question? Yeah, sure. Thanks for your question. So the NPC launch is delivering in line with our expectations. The patients share that we're seeing is really a very heterogeneous mix, as we expected. We've got patients in later lines of therapy. And these patients are getting Laktorsi as monotherapy, but they're going to have shorter durations because they're going to be second, third, fourth line.

Unknown Executive: Hey, Ashik. Thank you very much for your questions. Paul, do you want to cover the issue of the NPC launch and whether we bumped into any switching problems and, secondarily, the payer coverage question?

Paul Reider: U2 UDECA net revenue was 50.9 million, in 19 percent increased quarter of a quarter, in a 60 percent increase over Q2 2023. Block Torsy net revenue nearly doubled to $3.8 million in Q2, compared to $2 million in Q1. I'll now speak in more detail about each brand starting with Block Torsy. First half, 2024, the top priority was setting up Block Torsy to become the future standard of care in NPC. We remained very confident in achieving this ambition.

Paul Reider: Hey, Ashik. Thank you very much for your questions. Paul, do you want to cover the issue of the NPC launch and whether we've bumped into any switching problems, and secondarily, the payer coverage question?

Paul Reider: Yeah, sure. Thanks for your question. So the NPC launch is delivering in line with our expectations. The patient share that we're seeing is really a very heterogeneous mix, as we expected. We've got patients, you know, in later lines of therapy. And these patients are getting Lactorsia as monotherapy, but they're going to have shorter durations because they're going to be second, third, fourth lines. We're also very encouraged to be seeing patients in these early launch periods of early line patients.

Paul Reider: Yeah, sure. Thanks for your question.

Paul Reider: So the NPC launches delivering in line with our expectations. The patients share that we're seeing is really a very heterogeneous mix as we expected. We've got patients in later lines at therapy.

Paul Reider: Block Torsy offers unprecedented efficacy for NPC patients. Like all new product launches, requires substantial groundwork to ensure providers have access to Block Torsy. Please to report that many operational milestones have been achieved, setting Block Torsy up for future growth. The examples of these include, first, Block Torsy was included in NCCN, ASCO, and LINPAT guidelines. In NCCN, Block Torsy is the only PD-1 with a category-1 designation for first-line use, and the only preferred regimen in second-line plus.

Paul Reider: And these patients are getting Lactorsia's monotherapy, but they're going to have shorter durations because they're going to be second, third, fourth line. We're also very encouraged to be seeing patients in these early launch periods of the early line patients.

Paul Reider: We're also very encouraged to be seeing patients in these early launch periods of the early line patients. And these patients are very, very important because these are the patients who will have longer durations of treatment. And these patients continue quarter over quarter that long duration. That's how we see the revenue ramp over the long term. But in the short term, we see it as a steady ramp, as we work through this heterogeneous mix of patients and that patient mix begins to stabilize. As it relates to the payer coverage, we have virtually no payer issues right now.

Paul Reider: And these patients are very, very important because these are the patients who will have longer durations of treatment. And as these patients continue to undergo that long duration, that's how we see the, you know, revenue ramp over the long term. But in the short term, we see it as a, you know, a steady ramp as we work through this heterogeneous mix of patients and that patient mix begins to stabilize.

Speaker Change: and these patients are very, very important.

Speaker Change: because these are the patients who will have longer durations of treatment and as these patients continue quarter of a quarter that long duration, that's how we see the revenue ramp over the long term. But in this short term, we see it as a steady ramp.

Speaker Change: You know, as we work through this heterogeneous mix of patients and that patient mix begins to stabilize.

Paul Reider: As it relates to payer coverage, we have virtually no payer, you know, issues right now. We've got now nearly 100% of the targeted payer medical benefit lives across Medicare Fee-for-Service, national and regional health plans, both on commercial and Medicare Advantage. So, we are very, very pleased with the unrestricted coverage we have in NPC right now. And as it relates to the J-code, your question was, you know, is it going to be an inflection point?

Paul Reider: Second, payer coverage has now been confirmed on nearly 100% targeted medical benefit lives in health plans including Medicare fee for service, Medicare Advantage, and National and Regional Commercial Plants. Third, product-specific permanent check that has been granted by CMS took effect July 1st, which will enable electronic billing and faster, or predictable reimbursement for providers. Fourth, among the top academic research hospitals, Block Torsy is now accessible in all 33 NCCN institutions. With the foundation now set to enable broad access to Block Torsy, our efforts are solely focused on driving new patient starts in the Block Torsy eligible patient segments. We believe constitute approximately 2,000 patients annually.

Speaker Change: As it relates to the payer coverage, we have virtually no payer, you know, issues right now. We've got now nearly 100% of the targeted payer medical benefit lives across Medicare Fee-for-Service.

Paul Reider: We've got now nearly a hundred percent of the targeted payer medical benefit lives across Medicare, if you for service, the national and regional health plans, both on commercial and the Medicare Advantage. So we are very, very pleased with the unrestricted coverage we have in NPC right now. And as it relates to the J-code, your question was, you know, is it going to be an inflection point? You know, the way that we see the J-code here is really enabling the electronic billing and faster, more predictable reimbursement for providers. So I wouldn't necessarily characterize it as a significant immediate revenue inflection, per se, but certainly its availability will remove any operational barrier and any account that, you know, doesn't allow for use of products until the J-code is in effect.

Speaker Change: the National and Regional Health Plans, both on commercial and the Medicare Advantage. So we are very, very pleased with the unrestricted coverage we have in NPC right now.

Speaker Change: And as it relates to the J code, your question was, you know, is it going to be an inflection point?

Paul Reider: You know, the way that we see the J-code here is really enabling electronic billing and faster, more predictable reimbursement for providers. So I wouldn't necessarily characterize it as a significant, immediate revenue inflection per se, but certainly, its availability will remove any operational barrier in any account that doesn't allow for the use of products until the J-code is in effect. I think we're very, I think we're really set from an access standpoint now moving into the second half of the year and feel very encouraged that those, any of those impediments are behind us.

Speaker Change: You know, in the way that we see that J. Code here is really enabling the electronic billing and faster, more predictable reimbursement for providers.

Speaker Change: So I wouldn't necessarily characterize it as a significant, immediate revenue inflection per se, but certainly it's available. It will remove any operational barrier in any account that, you know, doesn't allow for use of products until the J code is in effect.

Paul Reider: I'll now speak in more detail about the NPC patient populations, the progress we made in Q2 and our priorities for the second half of 2020. NPC patients within the Block Torsy eligible indications include three patient segments. First, those with recurrent locally advanced disease. Majority of NPC patients are diagnosed in the local or locally advanced setting. Here, patients are diagnosed at early stages and receive radiation or chemo plus radiation as their first treatment with many patients being cured.

Paul Reider: So... I think we're very, I think we're, we're really set from an access standpoint now moving into the second half of the year. If you'll very encourage that those, any of those impediments are behind us.

Speaker Change: I think we're really set from an access standpoint now moving into the second half of the year, if you'll very encourage that those any of those impediments are behind us.

Paul Reider: Paul, can you just comment if you had, with respect to the issue of the switch. And I think, which was one of our short questions. And then, secondarily, a progress on the MCC and formulas. Yeah, sure. You know, as I mentioned in my prepared remarks, any patient that is currently on an off-label PD-1 or PD-1 chemo regimen, you know, we don't, we don't believe that they're going to switch if the patient is responding to treatment. That being said, what we've seen in the real-world data here in just the first couple of quarters is that we are seeing patients who have been re-challenged after prior PD-1 treatment.

Denny Lanfear: Paul, can you just comment a bit with respect to the issue of the switch, which was one of our six questions and, secondarily, progress on the NCCN formularies. Yeah, sure. You know, as I

Speaker Change: Paul, can you just comment a bit with respect to the issue of the switch, and I think, which was one of our six questions, and the secondarily, progress on the MCCN formularies?

Paul Reider: Yeah, sure. But, as I mentioned in my prepared remarks, any patient that is currently on an off-label PD-1 or PD-1 chemo regimen, we don't believe that they're going to switch if the patient is responding to treatment. That being said, what we've seen in the real-world data here in just the first couple quarters is that we are seeing patients who have been re-challenged after prior PD-1 treatment, and usually, off-label PD-1 was prescribed in the earlier line of treatment in combination with chemotherapy.

Paul Reider: And therefore, you know, by the time the patient was retreated with Lactorse, they had already progressed to a later line. So in these cases, we would expect a shorter duration of Lactorse use. That being said, we're encouraged that doctors are willing to consider retreatment with PD-1 failures and that patients were, you know, or that payers were approving the product. So those are encouraging signs. And then as it relates to access at the NCCN institutions, we've now, you know, got accessibility to Lactorse at all 33 NCCN institutions. So, you know, again, that operational milestone was achieved here in the second quarter.

Paul Reider: Yeah, sure. You know, as I mentioned in my prepared remarks, any patient that is currently on a off-label PD1 or a PD1 chemo regimen, you know, we don't, we don't believe that they're going to switch if the patient is

Paul Reider: These patients drop out of the NPC treatment pool unless the experienced local recurrence at any point in time. That may become Block Torsy eligible that will receive Block Torsy plus chemotherapy. These patients account for approximately one third of the 2,000 who are Block Torsy eligible. The second patient segment are those with first line metastatic disease. These could be metastatic recurrence from the early stage disease or de novo metastatic. These patients account for approximately one third of the 2,000 who are Block Torsy.

Speaker Change: Responding to treatment. That being said, what we've seen in the real world data here in just the first couple quarters is that we are seeing patients who have been re-challenged after prior PD-1 treatment.

Paul Reider: And usually the off-label PD-1 was typically prescribed in the earlier line of treatment in combination with chemotherapy. And therefore, you know, by the time the patient was re-treated with Lactorsy, you know, the patient had already progressed to a later line. So in these cases, you know, we would expect a shorter duration of lactorsy use. That being said, we're encouraged; you know, the doctors are willing to consider re-treatment with PD-1 failures. And that patients were, you know, or that payers were approving the product. So those are those are encouraging signs. And then, as it relates to the access on the NCCN institutions, we've now, you know, got accessibility to lactorsy on all 33 NCCN instances.

Speaker Change: and usually the off-label PD-1 was...

Speaker Change: Typically prescribed in the earlier line of treatment.

Speaker Change: in combination with chemotherapy and therefore

Speaker Change: You know, by the time the patient was re-treated with Lactorse,

Speaker Change: you know, the patient had already progressed to a later line. So in these cases, you know, we would expect a shorter duration of loctorzi use.

Paul Reider: A historical treatment for these two patients' sub-populations include chemotherapy, or a combination of chemo plus off-label PD-1 treatment. Real-world data shows current off-label PD-1 use of approximately 25% second. This is important in the near term for the sales ramp perspective. As we do not expect, the patient is currently on an off-label PD-1 regimen. We'll be switched to lactorsi if the patient is already responding to treatment. Now the third patient segment is second-line plus with metastatic disease. These patients account for the remaining one third of lactorsi eligible patients if we receive lactorsi as monotherapy.

Speaker Change: That being said, we're encouraged, you know, the doctors are willing to consider retreatment with PD1 failures and that patients were, you know, or the payers were approving the product. So those are encouraging signs.

Speaker Change: and then as it relates to the access on the NCCN institutions, we've now got accessibility to locked towards on all 33 NCCN institutions, so again that operational milestone was achieved here in the second quarter.

Paul Reider: So, you know, again, that, that, you know, operational milestone was achieved here in the second quarter.

Brian Chang: Thanks very much. Our next question will come from the line of Brian Chang with JP Morgan.

Brian Cheng: Our next question will come from the line of Brian Cheng with J.P. Morgan.

Speaker Change: Thanks very much.

Speaker Change: Our next question will come from the line of Bryan Cheng with J.P. Morgan.

Brian Chang: Hey guys, thanks for taking our question this afternoon. Maybe just one on the benefit units growth that you saw this past quarter. You mentioned that most of the unit growth came from on body, so which is trying to try to better understand the dynamics here. You know, can you tell us a little bit more about, you know, the biggest contributor that's driving the object across all their presentation this past quarter. And more importantly, how does it change, you think, this momentum that we're seeing today across all three presentations? Thanks.

Paul Reider: Patients in the first two segments I described are our primary focus for the following two reasons. First, based on the results of the Jupiter-2 trial, these are the patients who can derive the greatest survival benefit. In second, these patients are likely to deliver the longest duration of treatment, which is a key driver of lactorsi's revenue ramp over time. In Q2, the total number of lactorsi treated patients more than double by an estimated 100 new patients.

Brian Cheng: Hey guys, thanks for checking out the questions this afternoon. Maybe just one on UBANICA unit growth that you saw this past quarter. You mentioned that most of the unit growth came from on-body, so we're just trying to better understand the dynamics here. Can you tell us a little bit more about the biggest contributor that's driving the uptick across all the presentations this past quarter? And more importantly, how sustained do you think this momentum that we're seeing today across all three presentations will be? Thank you.

Bryan Cheng: Hey guys, thanks for taking our questions this afternoon.

Bryan Cheng: Maybe just one on the Benetech unit growth that you saw this past quarter.

Bryan Cheng: You mentioned that most of the unit growth came from on-body, so we're just trying to better understand the dynamics here.

Speaker Change: You know, can you tell us a little bit more about, you know, the biggest contributor that's driving the uptick across all their presentation this past quarter?

Speaker Change: And more importantly, how sustained do you think this momentum that we're seeing today across all three presentations? Thanks.

Paul Reider: The real-world data shows two key findings. First, a minority of drug-treated NPC patients are new to treatment in any given quarter, so it will take time for us to acquire these new patients. Second, we are acquiring our targeted patient types. With 40% of lactorsi patients being treated in the locally advanced setting, an approximately 75% of total lactorsi patients being treated in combination with chemotherapy. These real-world data, combined with the current off-label PD-1 use, confirms our view that lactorsi will follow a steady revenue ramp in the near term, fueled by new patient acquisition with sustained growth over time driven by duration. 80% of long-term value is from early-line continuing patients, which we estimate will take three to four years fully materialized.

Unknown Executive: Thanks, Bryan. Great question. Paul, do you want to address the issue of the SKU mix and the growth across the quarter for Bryan?

Paul Reider: Thanks, Brian.

Paul Reider: Great question. Paul, do you want to trust the issue of the SKU mix and the growth across the quarter, Brian? Sure.

Paul Reider: Thanks Bryan, great question. Paul, do you want to address the issue of the SKU mix and the growth across the quarter for Bryan?

Paul Reider: Sure. Thanks for your question, Bryan. Let me start just by reiterating, you know, our goal for the Udenica franchise, and that's to maximize the long-term profitability and sustainability of the franchise. You know, Bryan, our investments to bring these innovative device presentations to market combined with our consistent, strong execution is really what's delivering these results. Udenica now is strongly positioned in the peg field grasp of the market. And, you know, we said multiple times that once we launch these new devices, we're going to drive market share gains. And, you know, that's what you're seeing.

Paul Reider: Thanks for your question, Brian. Let me start just by reiterating, you know, our goal for the Udenica franchise, and that's to maximize the long-term profitability and sustainability of the franchise. You know, Brian, and our investments to bring these innovative device presentations to market, combined with our consistent strong execution, is really what's, you know, delivering these results. Udenica now is strongly positioned the peg full grasp the market and, you know, we said multiple times that once we launch these new devices, you know, we're going to drive market share gains. And, you know, that's what you're seeing.

Paul Reider: Sure. Thanks for your question, Bryan. Let me start just by reiterating, you know, our goal for the Udenica franchise, and that's to maximize the long-term profitability and sustainability of the franchise.

Paul Reider: You know, Bryan and our investments to bring these innovative device presentations to market.

Paul Reider: combined with our consistent, strong execution.

Speaker Change: is really what, you know, delivering these results. You Dennis and now is...

Speaker Change: strongly positioned the pegs to grasp the market and we said multiple times that once we launched these new devices, we're going to drive market share gains and that's what you're seeing. We're delivering on that promise.

Paul Reider: We're delivering on that promise, and these market share gains are coming basically in the last five quarters from an 11% share to a 29% share. And we remain confident that Udenica will continue to grow in the second half of 2024. And it's going to be fueled by three growth drivers, Bryan. The first is the commercial launch of OnBody.

Paul Reider: We're delivering on that promise. You know, in these market share gains, you know, are coming basically in the last five quarters from an 11% share to a 29% share. And we remain confident that Udenica will continue to grow in the second half of 2024. And it's going to be fueled by three of these growth drivers, Brian.

Speaker Change: You know, and these market share gains, you know, are coming basically in the last five quarters from an 11% share to 29% share.

Paul Reider: Overall, the launch is progressing well, and we remain confident that lactorsi will achieve a dominant market share position, the NPC market, that we estimate to be valued at 150 to 200 million. In the near term, our priorities are focused on three revenue drivers. Driving new patient share, strong HDP patient identification, ensuring lactorsi messaging is delivered at the time of treatment decision, and optimizing the duration of lactorsi treatment. Now, regarding new data to them, data could deliver another quarter of revenue growth driven by continued strong execution and fueled by three drivers.

Speaker Change: And we remain confident that Udenica will continue to grow in the second half of 2024. And it's going to be fueled by three of these growth drivers, Bryan. The first is the commercial launch of OnBody.

Paul Reider: The first is the commercial launch of On Body. And that's really because we now can compete head to head and access the entire peg full grasp the market. And secondly, the payer coverage, which, you know, nearly doubled in 2024 compared to 2023. So that opens up significantly more patient lives. And then the third is our discipline management of ASP. And that's really important, you know, for our customers, providers, payers, et cetera, hospitals, because it provides them greater predictability, which they value. So moving forward in the second half of the year, you know, we still are very confident that the franchise is going to grow all three product presentations, growing Q2.

Paul Reider: And that's really because we now can compete head-to-head and access the entire peg fill grass to mark. And secondly, payer coverage, which, you know, nearly doubled in 2024 compared to 2023. So that opens up significantly more patient lives. And then the third is our disciplined management of ASP.

Bryan McMichael: and that's really because we now can compete head-to-head and access the entire Peg Philgrass to market.

Bryan McMichael: And secondly, the payer coverage, which, you know, nearly doubled in 2024 compared to 2023. So that opens up significantly more patient lives.

Paul Reider: And that's really important for our customers, providers, payers, et cetera, hospitals, because it provides them with greater predictability, which they value. So moving forward in the second half of the year, we still are very confident that the franchise is gonna grow. All three product presentations grew in Q2, but we see the YonBody device as really being the driving force of the growth in the second half of the year, largely because of its accessibility, you know, to the entire market.

Bryan McMichael: And then the third is our discipline management of ASP, and that's really important, you know, for our customers, providers, payers, et cetera, hospitals, because it provides them greater predictability, which they value.

Paul Reider: First, a commercial launch of UDECA on body. Second, UDECA is the only peg full grasp of brand with three device options to meet the unique needs, providers and patients. Third, broad payer coverage, which opens access to significantly more patient. Live. As for key performance indicators for the quarter, you're dead at a franchise demand through 25% quarter. All three product presentations grew in the quarter, with on-body representing 60% of the total unit growth.

Bryan McMichael: So moving forward in the second half of the year, you know, we still are very confident that the franchise is going to grow. All three product presentations grew in Q2.

Paul Reider: But we see the on-body device is really being the driving force of the growth in the second half of the year, largely because of the accessibility, you know, to the entire market. That being said, you're still seeing nice uptake in the pre-filled syringe and the auto-injector presentations, and we're finding now that customers are really able to now choose amongst the presentations that fit their unique needs and the needs of their patients. So we remain very confident in the second half of the year, and they continue growth of the franchise.

Bryan McMichael: But we see the young body device is really being the driving force of the growth in the second half year, largely because of the accessibility, you know, to the entire market.

Paul Reider: That being said, you're still seeing nice uptake in the pre-filled syringe and the auto-injector presentations. And we're finding now that customers are really able to choose amongst the presentations that fit their unique needs and the needs of their patients. So we remain very confident about the second half of the year and the continued growth of the franchise.

Speaker Change: That being said, you're still seeing nice uptake in the prefilled syringe and the auto-injector presentations and we're finding now that customers are really able to now choose amongst the presentations that fit their unique needs and the needs of their patients.

Paul Reider: On-body and auto ejector ended the quarter at 13.5% and 10% of the total units respectively. Franchise market share was 29%, an increase of four market share points quarter over quarter. Regarding the launch of Yudenaka on-body, we're very pleased with the launch performance to date and customer receptivity continues to be very positive. Fueling customer adoption are innovative and differentiated features, such as Yudenaka on-body's five-minute ejection time, compared to the 45-minute delivery time for Dulasa on-prone.

Bryan McMichael: So we remain very confident in the second half of the year and the continued growth of the franchise.

Paul Reider: Thank you, Scott. Thank you for asking.

Unknown Executive: Great, thank you for asking. Thank you.

Paul Reider: Thank you.

Speaker Change: Thank you for asking us a lot and thank you.

Douglas Tsao: Our next question will come from the line of Douglas Tsao with HC Wainwright. Good afternoon, thanks for taking the questions.

Douglas Tsao: Our next question will come from the line of Douglas Tsao with H.C. Wayne. Good afternoon, thanks for taking the time.

Paul Reider: In summary, our long-term strategy for Yudenaka is delivering as planned and we expect continued revenue growth this second half of 2024.

Douglas Tsao: Our next question will come from the line of Douglas Tsao with H.C. Wainwright.

Douglas Tsao: Good afternoon, thanks for taking the questions.

Douglas Tsao: I'll do that to me and thanks for taking this question.

Douglas Tsao: Hi, Doug. Can you repeat your question? We can't hear you.

Unknown Executive: Hey Doug, can you repeat your question? We can't hear you. It looks like Doug may have disconnected. We'll move to the next question. This question will come from a line from Bilal Jahangiri with Truist Security.

Speaker Change: [inaudible]

Speaker Change: Hey Doug, can you repeat your question? We can't hear you.

Operator: It looks like Doug may have disconnected.

Unknown Executive: It looks like Doug may have disconnected. We'll move to the next question. This question will come from a line from Bilal Jahangiri with Truth Security.

Operator: We'll move to the next question.

Billal Jahangiri: This question will come from the line of Billal Jahangiri with True Securities.

Speaker Change: It looks like Doug may have disconnected. We'll move to the next question.

Speaker Change: This question will come from a line of Bill Al Jahangiris with true insecurities.

Billal Jahangiri: Hi, congrats on the quarter. We had a couple of questions here. We're wondering what differences would you expect to see from using Tori versus Tso in the triplet for HC?

Speaker Change: Hi, congrats on the quarter. We had a couple questions here. We're wondering what differences would you expect to see from using Tori versus Tezo in the triplet for HTC and given that

Theresa Lavallee: I'll now turn the call to Dr. Theresa Lavallee. Theresa. Thank you, Paul, and good afternoon, everyone. Firstly, we congratulate our partner at Junethe Bio-Sciences for continued progress with advancing Tora Palama's development. The Committee for Medicinal Products for Human Use, or CHMP in Europe, adopt it a positive opinion recommending approval of Lockforsey, a next-generation PD-1 inhibitor, for the first line treatment of patients with nasopharyngeal carcinoma, in combination with cisplatinum and gymsitably, and secondly, for the first line treatment of adult patients with unresectable advanced recurrent or metastatic esophageal swayma cell carcinoma, in combination with cisplatinum and pachletaxal.

Theresa Lavallee: And given that a bunch of your pipeline targets are not, don't have precedence of approval in the US, which permutation and indication do you envision as your next phase three after HC? Thank you.

Speaker Change: A bunch of your pipeline targets are not, don't have precedence of approval in the U.S. Which permutation and indication do you envision as your next phase three after HCC?

Theresa Lavallee: Dr. Theresa Lavallee, the company's Chief Development Officer, is with us today. Theresa, can you comment on the question of Tory with the triplet?

Theresa Lavallee: Dr. Treslavali, the company's Chief Development Officer, is with us today. Tresla, can you comment on the question of Tori with the triplet? Yes, so for the HCC study, looking at Tori Palamab plus Bevisismab, Casdosa, Ketug, and obviously in a phase three study, we would compare it with a Tso Bev. The difference is obviously our PDL-1 versus PD-1. The data set for Tori Bev from Junq and a phase three study has been reported positive, but we're waiting to see the data. There was a phase two study that was published showing overall response rate and PFS that was numerically higher than what was seen with the Imbra 150, a Tso Bev phase three study.

Speaker Change: Dr. Theresa Lavallee, the company's Chief Development Officer, is with us today. Theresa, can you comment on the question of Tory Wood's triplet?

Theresa Lavallee: Yeah, so for the HCC study, looking at toropalumab, plaspevacizumab, casdozaketug, and obviously, in a phase three study, we would compare it with TezoBev. The differences are obviously PD-L1 versus PD-1 and the data set for Tori Bev.

Theresa Lavallee: Yeah, so for the HCC study, looking at Tauropalumab, Plaspevacizumab, Casdozaketug,

Speaker Change: and obviously in a phase 3 study we would compare it with a tezobev.

Speaker Change: The difference is, obviously, our PDL1 versus PD1, and the data set for...

Theresa Lavallee: The CHMP positive opinion is based on data from the Phase 3 study Jupiter 2 for an MPC and Jupiter 6 for esophageal swayma cell carcinoma, demonstrating statistically significant and clinically meaningful improvements in survival in these two indications. Importantly, while Tora Palama has demonstrated efficacy in these studies, Tora Palama's safety profile is consistent with the PD-1 inhibitor class. It's approved this will expand marketing of Tora Palama's beyond the US into the EU.

Theresa Lavallee: From June, she has been in a phase three study and has been reported positive, but we're waiting to see the data. There was a phase two study that was published, showing overall response rate and PFS that were numerically higher than what was seen with the IMBRAV 150 Atezobeb Phase 3 study. So based on the data there, we would expect

Speaker Change: Tori Bev

Speaker Change: From June she in a phase 3 study has been reported positive, but we're waiting to see the data There was a phase 2 study that was published

Speaker Change: Showing overall response rate and PFS.

Speaker Change: that was numerically higher than what was seen with the IMBRAV-150 at Tezobev phase 3 study.

Theresa Lavallee: So based on the data there, we would expect Tori to be well suited in position to go against Tso, and then, of course, adding Casdosa, Ketug, should add increased benefit. So really extending the survival for those first line HCC patients without an increase in toxicity, a really good color ability to date.

Speaker Change: So, based on the data there, we would expect

Theresa Lavallee: Kripa Devarakonda, Yigal Nochomovitz, Balaji Prasad, Dennis Lanfear, Douglas Tsao, Robyn Karnauskas, Michael Nedelcovych, Colleen Devarakonda, Jami Taylor, Theresa Lavallee, should add increased benefit. So really extending the survival for those first-line HCC patients without an increase in toxicity, really good And in terms of that, the second question was, could you repeat that? I'm sorry.

Speaker Change: Tori to be well-suited and positioned to go against the Tezo. And then, of course, adding because there's a key tag.

Theresa Lavallee: This potential approval is important to further demonstrate the efficacy and safety of Tora Palama as well as the quality of the drug and clinical datasets for our tumor microenvironment targeting pipeline with global rates, and as we look to develop these assets in combination with Tora Palama. EU approval will facilitate future approval with novel agents, executing on our combination strategy for Tora Palama's invitation expansion. Furthermore, while the US FDA will not accept Phase 3 single country data for approval, they have stated on several occasions the data sets will support contribution of components, development of our novel type lines and tumor types where TORAPalamab has data, they simplify any Phase 3 study design.

Speaker Change: should add increased benefit. So really extending the survival for those first-line HCC patients without an increase in toxicity, really good tolerability to date.

Theresa Lavallee: Was it about the next study that we had? Yeah, what combination or triplet doublet and what indication does your gut feel, I guess? Yeah, so in development right now, we're building off of the activity that's been observed in the early phase studies for Casdoza-Quito, both in non-small cell lung cancers. So, as Rosh mentioned, we're actively enrolling in the second to fourth line non-small cell lung cancer study with Kezda Teig and Tora Palomath. We'd also like to look in other areas of non-small cell lung cancer, given the strong disease linkage there. And then the HCC study is on deck to open later.

Theresa Lavallee: In terms of the second question, was could you repeat that? I'm sorry, was it about the next study that we... Yeah, what combination or triplet doublet and what indication is your gut feel, I guess. Yeah, so in development right now, we're building off of the activity that's been observed in the early phase studies for Casdosa, Ketug, both in nonsmoker lung cancers. So as Rush mentioned, we're actively enrolling in the second or fourth line nonsmosa lung cancer study with Casdosa and Tori Palomath. We'd also like to look in other areas in nonsmoker lung cancer, giving this from disease linkage there, and then the HCC study is on deck to open later this year.

Speaker Change: In terms of that, the second question was, could you repeat that? I'm sorry, was it about the next study that we're

Speaker Change: Yeah, what combination or what triplet, doublet, and what indication is your gut feel, I guess?

Speaker Change: Yes, I'm in development right now. We're building off of the activity that's been observed in the early face that he's forecasted as a key tug.

Rosh Dias: both in non-small cell lung cancers. So, as Rosh mentioned, we're actively enrolling in the second-to-fourth line non-small cell lung cancer study with Kezda Teig and Tora Palomapp.

Speaker Change: We'd also like to look in other areas in non-small cell lung cancer, given the strong disease linkage there. And then the HCC study is on deck to open later this year.

Theresa Lavallee: In China, TORAPalamab now has 10 targeted indications following the recent approval of TORAPalamab in combination with Pachletaxle for the first line treatment of recurrent or metastatic triple negative breast cancer based on the Phase 3 torchlight data. TORAPalamab is a foundational process in the coherus pipeline and now is being evaluated in coherus sponsored clinical studies with Cascozakita and anti-al-27 antagonist and with CHS 114 and anti-CCRA antibody preferentially targeting tumor resident immunosuppressive T-regulatory cells.

Rosh Dias: Rosh has some additional comments with respect to this question for you also. Rosh, go ahead.

Speaker Change: Rosh has some additional comments with respect to this question, pretty awesome.

Rosh Dias: Thanks very much for your question. Just one point to add to your first question on essentially some of the differences between the T-Zo and also Tori.

Rosh Dias: Yes, thanks very much for your question. Just one point to add to your first question on, essentially, some of the differences between Atizo and also TORI. So one thing that we do know is that the ADA, the anti-drug antibodies with Atizo are reasonably high, probably in the 40% range, whereas we also know for TORI-PALMAB, it's in the single-digit range. So I think that's one additional consideration I'd add to what Theresa said.

Rosh Dias: Thanks very much for your question. Just one point to add to your first question on

Rosh Dias: So one thing that we do know, the anti-drug antibodies with a T-Zo is reasonably high, probably in the 40% range; whereas we also know for Tori palmarb, it's in the single digit range. So I think that's one additional consideration that I'd add to what Theresa already mentioned about the T-Zo and the Tori. Great, thank you so much.

Rosh Dias: Essentially some of the differences between Atizo and also Tauri. So one thing that we do know

Rosh Dias: is that the ADA, the anti-drug antibodies with Atitha is reasonably high, probably in the 40% range, whereas

Rosh Dias: To add to what Theresa already mentioned about the TISA and the TORI,

Speaker Change: We also know for Torrey-Palomar, it's in the single-digit range. So I think that's one additional consideration to add to what Theresa already mentioned about the Ateza and the Torrey.

Theresa Lavallee: In addition to our internal development and our partner June she's development, we have several partnership discussions ongoing and look forward to the potential to progress in advance these exciting clinical studies. For our internal efforts, Cascozakita development with TORAPalamab continues. Tomorrow, at the IOS Summit Conference in Philadelphia, there's an oral presentation on the strong data package supporting development in HCC. While inhibiting cytokines is a validated approach in inflammatory diseases with multiple approved antibodies, Cascozakita is the first cytokine antagonist to show safety, immune activation and monotherapy responses in cancer patients.

Speaker Change: Great, thank you so much.

Douglas Tsao: Our next question will come from the line of Douglas Tsao with H.C. Wayne Wright. Hi, good afternoon. Sorry about that earlier.

Douglas Tsao: Our next question will come from the line of Douglas Tsao with H.C. Wainwright.

Speaker Change: [inaudible]

Speaker Change: Our next question will come from the line of Douglas Tsao with H.C. Wainwright.

Douglas Tsao: Hi, good afternoon. Sorry about that earlier. Um, just curious about your perspectives on now that you're all in the NCNN centers, how much of the market is there versus patients being treated in the community setting? And how quickly or how long do you think it will take to penetrate the sort of broader community for the MPC market?

Douglas Tsao: Just curious your perspectives on now that you're all in the N-C-N-N centers, how much of the market is there versus patients being treated in the community setting and how quickly or how long do you think it will take to penetrate the sort of broader community for the N-P-C market? Thanks for the question, Doug.

Douglas Tsao: Hi, good afternoon. Sorry about that earlier.

Douglas Tsao: Curious your perspectives on, now that you're all in the NCNN centers, how much of the market is there versus patients being treated in the community setting and and how quickly or how long do you think it will take to penetrate the sort of broader communities for the MPC market?

Paul Reider: Thanks for the question, Doug. Paul, do you want to give Doug a little insight into the patient proportion split and then CCN and the uptake projection?

Paul Reider: Paul, do you want to give Doug a little insight on the patient portions but an N-C-C-N in the uptake? Sure, thanks for your question, Doug. You know, we believe that about 60% of all the N-P-C in the United States is treated in some kind of academic N-C-C-N type of setting of care. 40% is still in the community, and after the first couple quarters are locked towards the business, is about two-thirds in the hospital. So it's tracking very closely to that in relation to the overall treatment. I think, as it relates to the uptake in the community setting, Doug, with a rare cancer, a lot of these oncologists in the community might be seeing N-P-C, one, maybe two patients a year.

Paul Reider: Thanks for the question, Doug. Paul, do you want to give Doug a little insight on the patient proportion split and then CCNF and the uptake projection?

Paul Reider: Yeah, sure. Thanks for your question, Doug. You know, we believe that about 60% of all NPC in the United States is treated in, you know, some kind of academic NCCN type setting of care. 40%, you know, is still in the community. And, you know, after the first couple quarters, our Lactorsi business is about two-thirds in the hospital, so it's, you know, it's tracking, you know, very closely to that in, you know, in relation to their overall treatment.

Paul Reider: Yeah, sure. Thanks for your question Doug. You know, we believe that about 60% of all the NPCs.

Theresa Lavallee: In preclinical models, blocking IOS 27 results in immune activation and brain liver and lung, preclinical tumor models only show anti-tumor activity in response to IOS 27 in addition and liver and lung models. Three different HCC mouse models are sydogen-induced, mass-induced, or further in liver cancer. June she has recently announced the positive results from a phase three study of TORAPalamab in first line, Paticellular Cartonoma, in combination with Bevisism app. These results will be important in supporting the randomized phase two study of Cascozakita in combination with TORAPalamab in Bevisism app in first line HCC for efficacy, safety, and relative contribution data.

Paul Reider: in the United States is treated in some kind of academic and CCN type of setting of care. 40% still in the community and after the first couple quarters are locked towards the business.

Paul Reider: is about two-thirds in the hospital so it's, you know, it's tracking, you know, very closely to that in, you know, in relation to their, you know, to the overall treatment.

Paul Reider: You know, I think as it relates to uptake in the community setting, you know, Doug, with a rare cancer, a lot of these oncologists in the community might be seeing NPC, you know, one, maybe two patients a year. It's a rare cancer, as you know.

Paul Reider: You know, I think as it relates to the uptake in the community setting, you know, Doug, with a rare cancer, you know, a lot of these oncologists in the community might be, you know, seeing NPC, you know, one, maybe two patients a year. It's a rare cancer, as you know. So...

Paul Reider: It's a rare cancer, as you know. So what we've got to do and our plans are all focused on is continually engaging with these command oncologists; they're treating N-P-C. So when they get that patient that's locked towards the eligible across one of those three patient segments that I described, you know, we've got that locked towards the message and we've got everything set up to get that new patient start. So, you know, that's where, you know, our complete focus is right now in the second half of the year is really to drive the new patient acquisition across both segments: community and the N-C-C-N and academic institutions.

Paul Reider: So, you know, what we've got to do, and our plans are all focused on, is continually engage with these community oncologists that are treating NPC. And so when they get that patient that's Lactorsi-eligible across one of those three patient segments that I described, we've got that Lactorsi message, and we've got everything set up to get that new patient started. So that's where our complete focus is right now in the second half of the year, really driving new patient acquisition across both segments, community and the NCC and academic institutions. And I believe we're going to make great progress there as the year unfolds.

Doug: You know, what we've got, you know, to do and our plans are all focused on.

Speaker Change: is continually engaging with these command colleges, they're treating NPC, and so when they get that patient that's locked towards the eligible across one of those three patient segments that I describe, you know, we've got that locked towards the message and we've got everything set up to get that new patient start.

Theresa Lavallee: Our second key pipeline asset, CHS 114, highly selective cytolitic anti-CCRA antibody, continues to progress in the clinic. Eliminating a immune suppressive T-Rake cells in the tumor has been attempted by the field evaluating several approaches. But with the problem of depleting T-Rake cells broadly leading to autoimmune toxicity and also depleting T-cells and thus limiting anti-tumor activity. The CHS-114 clinical data demonstrating peripheral depletion of CTRA positive T-Rake cells and not depleting T-Rake cells broadly establishes proof of mechanism in cancer patients.

Paul Reider: So, you know, that's where, you know, our...

Paul Reider: Our complete focus is right now in the second half of the year is really to drive the new patient acquisition across both segments, community and the NCC and academic institutions. And I believe we're going to make great progress there as the year unfolds.

Paul Reider: And I believe we're going to make great progress there as the year unfolds.

Paul Reider: Great. That's really helpful. And Paul, maybe just on Eugenica, I'm just curious, you guys have had a really nice recovery in terms of share and a revamp in terms of revenue performance. Are there particular segments where you're having more success with the on-body and auto injector or pre-filter and just your overall portfolio products versus the others, or is it pretty widespread right now?

Paul Reider: Great, that's really helpful. And Paul, maybe just on Yudanaka, I'm just curious, you know, you guys have had a really nice recovery in terms of share and a rebound in terms of revenue performance. I'm just curious, you know, are there particular segments where you're having more success with the on-body and an auto-injector or pre-filtering just your raw portfolio products, eat versus the other, or is it pretty widespread right now? Yeah, Doug, with you, Dennis, we're seeing growth across all segments of the business. When I talked to you last in May on the Q1 call, we were only a few weeks into the call, and most of the uptake at that time was in the clinics. Now we're seeing it across all segments of the business.

Paul Reider: Great, that's really helpful, and Paul, maybe just on Eugenica, I'm just curious, you guys have.

Speaker Change: I had a really nice recovery in terms of share and a revamp in terms of revenue performance. I'm just curious.

Speaker Change: you know are there particular segments where you're having more success with the on-body and an auto injector or pre-filter and just your overall portfolio products you know versus the other or is it pretty widespread right now?

Theresa Lavallee: BCRA positive T-Rake cells have a high prevalence in density and a number of solid tumors with the highest levels in head and neck, gastric and cervical cancer. For this reason, our CHS-114 dose expansion in the Phase I study is evaluating head and neck cancer and includes pre and on treatment biopsies to evaluate T-Rake depletion in the tumor. At ASCO this year, one of the experimental therapeutic presentation that impressed me most was by Lenovo Medicines evaluating their CCRA antibody LM-108 in combination with TORopylem and advanced gas for cancer patients.

Paul Reider: Yeah, Doug, with Udenica, you know, we're seeing growth across all segments of the business. You know, when I talked to you last in May on the Q1 call, we were only a few weeks into the year, and most of the uptake at that time was in the clinics. You know, now we're seeing it across all segments of the business. Autoinjector, if there's one segment where that's probably being used more than the other, it's going to be in the clinics.

Paul Reider: Yeah, Doug, with Udenica, you know, we're seeing growth across all segments of the business.

Speaker Change: You know, when I talked to you last in May on the Q1 call, we were only a few weeks into the call and most of the uptake at that time was in the clinics. You know, now we're seeing it across all segments of the business.

Paul Reider: Auto-injector, if there's one segment where that's probably being used more than the other, it's going to be in the clinics. But essentially, the entire franchise is growing, and on-body we're still only one full quarter in. But we're really, really pleased with the penetration it's making across all the segments. So I think that's where we're going to continue to see the growth in the second half of the year. We're very confident in that. Okay, great.

Paul Reider: Autoinjector. If there's one segment where that's probably being used more than the other, it's going to be in the clinics.

Paul Reider: But essentially, the entire franchise is, you know, growing, and on the body. We're still, you know, only one full quarter in, but we're really, really pleased with the penetration it's making across all the segments. So I think that's where we're going to continue to see growth in the second half of the year. We're very confident in that. Okay, great. Right.

Paul Reider: But essentially the entire franchise is growing and on body we're still only one full quarter end but we're really, really pleased with the penetration that's making across all the segments. So I think that's where we're going to continue to see the growth in the second half of the year. We're very confident in that.

Theresa Lavallee: We were encouraged by these early clinical data showing an acceptable safety profile and an overall response rate of 36.1 percent, which we believe demonstrates proof of principle for CCRA targeting in combination with TORopylem and a tumor type expected to show benefit.

Paul Reider: Okay, great. We're right on the progress.

Paul Reider: It's right on the focus. Thanks, Doug.

Speaker Change: Okay, great. We're right on the progress.

Mike Adelgovich: Our next question will come from the line of Mike Adelgovich with TD Cowan. Great, thank you for the question. I just have one on Tor Palamad.

Mike Nedelkovych: Our next question will come from the line of Mike Nedelkovych with TD Coward.

Speaker Change: Thanks for having me.

Mike Edelgabitch: Our next question will come from the line of Mike Edelgabitch with TD Cowan.

Mike Nedelkovych: Thank you for the question. I just have one on Tor Palomad. Can you remind us what milestones and royalties are owed to Junshi based on your current indication? And what obligations do you have to them relative to the development path for Tor Palomad, so the various combinations that you plan to test? Thank you.

Brian Mcmichael: Can you remind us what milestones and or royalties are owed to Jinxi based on your current indication and what obligations do you have to them relative to the development path for Tor Palamad to the various combinations that you plan to test? Thank you. Oh, great question, Mike. So, Jinxi gets a $25 million approval milestone, which we have paid half, so we paid 12 and a half. The other 12 and a half is doing Q1 2025. Secondarily, Jinxi gets a 20% royalty on net sales, which is pay-as-you-go.

Mike Edelgabitch: Great. Thank you for the question. I just have one on Tor Palamad. Can you remind us what milestones and or royalties are owed to Junshi based on your current indication? And what obligations do you have to them relative to the development path for Tor Palamad, so the various combinations that you plan to test?

Theresa Lavallee: Lastly, to update you on the internal development of our discovery agent.

Theresa Lavallee: I am proud of the Co-PARIS CHS-1000 ILT-14 for submitting a quality IND package to the FDA that has been accepted and we plan to advance CHS-1000 to clinics to establish single agents safety and rapidly move into combination with TORopylem for treatment of solid tumors. It is designed to block ILT-4 activity and promote an active or pro-inflammatory immune response. The ILT receptor family modulates the activity of the innate and adaptive immune system and plays a role in innate immune cell mechanisms that lead to tumor escape and PD-1 resistance.

Denny Lanfear: Great question, Mike. So Jun-Chi gets a $25 million approval milestone, which we have paid half of, so we paid $12.5 million. The other $12.5 million is due in Q1 2025. Additionally, Jun-Chi gets a 20% royalty on net sales, which is pay as you go. With respect to your cost with cost sharing question and the development programs, we are not obligated to share costs, for example, of the Tor Palmeb plus BTLA program, which is going into a segment of small cell lawn.

Speaker Change: Thank you. Oh, great question, Mike.

Speaker Change: Jun-Shi gets a $25 million approval milestone, of which we have paid half, so we paid $12.5 million.

Speaker Change: The other 12-and-a-half is due in Q1, 20-25, thinking they're early in June, she gets a 20% royalty on net sales, which is pay as you go. With respect to your cost with me.

Brian Mcmichael: With respect to your cost with sharing questions and development programs, we are not obligated to share costs, for example, of the Tor Palamad plus BTLA program, which is going into segment a small sell line. So, one of the advantages of our development strategy, as Raj pointed out in his prepared remarks, is that we saw it deliberately to have others develop products and go into pivotal trials and pay for those total trials. And then, when the label gets done by the FDA, we can sell into these commercially. So, our objective is to line up another of these.

Denny Lanfear: So one of the advantages of our development strategy, as Rosh pointed out in his prepared remarks, is that we sought deliberately to have others develop products and go into pivotal trials and pay for those pivotal trials, and then when the label gets done by the FDA, we can sell these commercially. So our objective is to line up a number of these. We have, I think, two now, one with Jun Shi and one with Inovio.

Speaker Change: I was sharing a question in the development programs. We are not obligated to share a cost, for example, of the Toro Palmev Plus BTLA program, which is going into segment of small of one.

Theresa Lavallee: This is a promising target in an antibody that coherace discovered.

Rosh Dias: I'll now turn the call to Dr. Diaz, our chief medical officer, Raj. Thank you, Theresa. I'm TOR-Z with the profound survival advantage demonstrated in the interference of your carcinoma and its accompanying approval across all lines of therapy for NPC. Do you need to form the foundation of our IO franchise and, in addition, do you need to demonstrate efficacy outside NPC? First recently, in first line, about the cellular carcinoma patient, is a published phase two Tory Palimad, Deb Sismab, later in clinical cancer research, and the phase three Hepatoche study, meeting its primary end points of PFS and OS of Theresa has pointed out.

Speaker Change: So, one of the advantages of our development strategy, as Rosh pointed out in his prepared remarks, is that we sought deliberately to have others develop

Paul Reider: products and go into pivotal trials and people's pivotal trials and then when the label gets done by the FDA, we can sell into these commercially.

Brian Mcmichael: We have, I think, two now, one with Jinxi and one with the Novio. We'll continue to focus on that over the next six to twelve months. You'll probably see more of those. But we think this is a very effective strategy for development that reduced costs.

Speaker Change: So our objective is to line up a number of these, we have, I think, two now, one with Eugene Sheen, one with the nobio, we'll continue to focus on that over the next six or twelve months, you'll probably see more of those. But we think this is a very effective.

Denny Lanfear: We'll continue to focus on that over the next 6 to 12 months. You'll probably see more of those. But we think this is a very effective strategy for development that reduces costs. So no, we're not obligated for further development.

Rosh Dias: We've been clear in articulating three very distinct strategies for further development of our IF franchise, including development of a lot towards the outside NPC. Firstly, combination with our internal IO pipeline of the competitively well-positioned assets, Joseph Keeta, and CHS114. Secondly, combinations with external partners at the discovery or close discovery stage, where we would provide locked towards the combination with partner companies, early stage assets, where the partner company would fully fund development.

Brian Mcmichael: So, no, we're not obligated for further development unless we choose to. And, Junxi, have any, there's a royalty extent to potential future approvals and other indications, potentially in combination with your in-house assets. The royalty extends to any Tor Palamad sold in the United States regardless of indication, whether it's NPC, your lawn, or gastric, or whatever. It's just simply straightforward royalty on Tor Palamad sales. You're not allocated to pay any royalty, of course. I didn't need you in she assets.

Speaker Change: and Strategy for Development that Reduce Cost. So, no, we're not obligated for further development unless we choose to.

Denny Lanfear: And does Junxi have any, or does the royalty extend to potential future approvals and other indications, potentially in combination with your in-house assets?

Speaker Change: Got it. And does Junshi have any, or does the royalty extend to potential future approvals and other indications?

Denny Lanfear: The royalty extends to any Torp Palamate sold in the United States, regardless of indication, whether it's MPC or lung or gastric or whatever. It's just a straightforward royalty on Torp Palamate sales. We are not obligated to pay any royalties.

Speaker Change: Dentistry in combination with your in-house efforts.

Speaker Change: Um, the royalty extends to any twerkel map soul in the United States regardless of indication, whether it's NPC, or a long, or a gastric, or whatever, is just simply straightforward royalty on twerkel map sales.

Rosh Dias: And thirdly, combinations with external partners at the later phase three stage of development of novel agents, trials of registration intent, where again, we would provide locked towards the for combination with partner companies late stage assets, and where again, the partner company would fully fund development. This strategic approach enables effective resource allocation focused towards our internal pipeline development, and I'm pleased to report that we're making good progress on all three fronts. Joseph, though, our IL-27 target antibody, continues to progress to plan in our combination study for locked towards the second to fourth line, non-small for lung cancer.

Denny Lanfear: Okay, and then are there any associated milestone payments as well, or is it all those in the ruby here now? There are some additional sales milestones down the road. However, we don't don't feel that those are really relevant because most of those milestones were constructed at a time when we expected to have much larger Thanks a lot.

Speaker Change: You're not obligated to pay any relative interest on any Jun-Chi assets.

Brian Mcmichael: Okay, and then are there any associated milestones? We don't think those are really economically relevant to the modeling.

Speaker Change: Okay, and then are there any are there any associated milestone payments as well, or is it in the ruby here now? There's some additional sales milestones down the road. However, we don't...

Speaker Change: We don't feel that those are really relevant because most of those milestones were constructed at a time when we expected to have much larger

Speaker Change: Indications such as not small, not long, the number of things there, you know, indications will take a bit to get to, so we don't think those are really economically relevant to the modeling.

Mike Adelgovich: Thank you, Mike.

Rosh Dias: As a reminder, this is intended to be followed by a phase three randomized controlled trial and the second line non-small for lung cancer. We're also on track to start the first line HCC combination study for locked towards the in quarter four this year, the link upon the impressive triplet combination data presented at ASCO GI at the start of this year. CHS-114, our CCRA targeting antibody, has completed the fiscalation and is now progressing with indication expansion being to head in their cancer versus monotherapy and in combination with locked towards the stage from the fiscalation portion of the study was presented at ASCO in June, showing an acceptable failure profile with no dose linking toxicities, EK dose proportionality, proof of mechanism with depletion of peripheral CCRA positive T-regs, and a disease control rate of 47 percent, an advanced solid tumor population that was heavily pre-streated.

Speaker Change: Yeah, thanks a lot.

Colleen Kusy: Our next question will come from a line of Colleen Kusy with Baird. Great. Good afternoon. Congrats on the progress. Thanks for taking our questions for you, Dan. Okay, can you go ahead and what's been resonating with prescribers when choosing the on body and what do you think is going to be kind of the big growth drivers for on body adoption. And then I have a couple of development follow-up questions.

Colleen Kusy: Our next question will come from the line of Colleen Kusy with Bayer.

Mike Edelgabitch: Thank you, Mike.

Speaker Change: Our next question will come from the line of Colleen Kusy with Baird.

Colleen Kusy: Great. Good afternoon.

Colleen Kusy: Great, could I turn in, can you go in? What's been resonating with prescribers when choosing the on-body? And what do you think is going to be kind of the big growth drivers for on-body adoption? And then I have a couple of development policies.

Paul Reider: Great. Paul, do you want to talk a little bit about our experience in the field, the reaction to the customer base with on body and the growth drivers for Colleen? Yeah, Colleen.

Paul Reider: Great. Paul, do you want to talk a little bit about our experience in the field, the reaction to the customer base with OnBody and the growth drivers for Colleen?

Colleen Kusy: Congratulations on the progress. Thanks for taking our questions. For you, Danica, can you comment on what's been resonating with prescribers when choosing the on-body and what do you think is going to be kind of the big growth drivers for on-body adoption? And then I have a couple of development follow-up questions.

Paul Reider: Thanks for your question. I think what's really resonating amongst our customers is the innovative and differentiated features of Udenica on body. Probably the most common feedback we've been getting from customers is how much they appreciate the five-minute injection time for Udenica on body compared to the 45-minute injection time for the innovator. That doesn't sound like it would be that important, but for a patient the next day that has to wait for this injection to occur five minutes, it's done and they can then get on with their day and their lives. And so that's been one of the most important differentiated features.

Paul Reider: Yeah, Colleen, thanks for your question. I think what's really resonating, you know, amongst our customers is the innovative and differentiated features of Udenica OnBody. Probably the most

Unknown Executive: Great. Paul, do you want to talk a little bit about our experience in the field, the reaction of the customer base with OnBody, and the Growth Drivers for Colleen?

Paul Reider: Yeah, Colleen, thanks for your question. I think what's really responding, you know, amongst our customers is the innovative and differentiated features of Udeneca OnBody. Probably the most common feedback we've been getting from customers is how much they appreciate the five minute injection time for Udenicom body compared to the 45 minute injection time for the innovator. You know, that doesn't sound like it would be, you know, that important, but for a patient the next day who has to, you know, wait for this injection to occur, you know, five minutes, it's done, and they can then get on with their day and their lives.

Rosh Dias: Our partner programs incorporating locked towards the in the early state with EMB-therapy-6 collaboration with the cancer research institute, no variant cancer, and one of the late stage multinational programs being combination with BTLA in limited stage, smaller lung cancer, and with the no-view of vaccine in the HPV positive early stage, and in their cancer continued to plan with a latter in particular being in the same position group of head and neck oncologists or to treat NPC.

Speaker Change: You know, common.

Speaker Change: You know, feedback we've been getting from customers is how much they appreciate the five-minute injection time for Udenakon body compared to the 45-minute injection time for the innovator. Yeah, that doesn't sound like it would be.

Speaker Change: You know, that important, but for a patient, you know, the next day that has to, you know, wait for this injection to occur, you know, five minutes, it's done and they can then get on with their day and their lives. And so that's been one of the most important differentiated features.

Paul Reider: I think the other drivers to Colleen is really what I mentioned in my prepared remarks. You know, we have, you know, now broad pair coverage. So it's highly accessible to more patients, and equally as important is our stable ASP. So you said everything else aside and having a predictable ASP, which drives, you know, provider reimbursement. It's very, very valuable. So you put the total value proposition together, innovative device features, broad pair coverage, you know, consistent and stable ASP. And now you have a Udenica value proposition that customers, you know, are really driving towards. And so, you know, we are, we are very pleased with, you know, with the launch progress.

Bryan McMichael: We look forward to announcing further partnerships over the coming months, and with that, I've hand over to Brian McMichael, Chief Financial Officer Brian. Thank you, Roch, and good afternoon, everyone. Following the summary of revenues provided by Paul, I will focus on the rest of the PNL and CAF. Cost of Good Sold for Q2, 2024, was $28.4 million compared to $24.8 million in Q2 last year. The increase was driven primarily by increased demand-free genica and non-recurring costs related to the seminary.

Paul Reider: And so that's been one of the most important differentiated features. I think the other drivers, too, Colleen, is really what I mentioned in my prepared remarks. You know, we have, you know, now broad payer coverage, so it's highly accessible to more patients and equally as important is our stable ASP, so you set everything else aside and having a predictable ASP, which drives, you know, provider reimbursement, it's very, very valuable, so you put the total value proposition together, innovative device features, broad payer coverage, you know, a consistent and stable ASP, and now you have a Udenica value proposition that customers, you know, are really driving towards, and so, you know, we are very pleased with, you know, with the launch progress and, you know, we're very confident, you know, in the second half of the year and our continued performance there.

Speaker Change: I think the other drivers too, Colleen, is really what I mentioned in my prepared remarks.

Speaker Change: You know we have now broad pair of coverage so it's highly accessible to more patients.

Speaker Change: And equally as important is our stable ASP.

Speaker Change: So you set everything else aside and having a predictable ASP, which drives...

Speaker Change: Provider reimbursement.

Speaker Change: It's very, very valuable. So you put the total value proposition together, innovative device features, broad pair coverage.

Bryan McMichael: Q2 marked the first full quarter following the divestiture of seminary, a product that had a significant gross profit share in the mid 50% range taken before internal commercial expenses. In addition, the mid-single-digit royalty on identical net revenues payable to Angen expired this past July 1st. R&D expense totaled $22 million and decreased $1.3 million and 6% from Q2 a year ago. The decrease was driven primarily by lower headcap. Additionally, decreases came from cost-not-recurring for programs terminated in previous years and divested products partially offset by investments in our current pipeline.

Speaker Change: You know, a consistent and stable ASP.

Speaker Change: And now you have a eugenic value proposition that customers, you know, are really driving towards. And so, you know, we are very pleased with, you know, with the launch progress and, you know, we're very confident, you know, in the second half of the year and our continued performance there.

Paul Reider: And, you know, we're very confident, you know, in the second half of the year and our continued performance there.

Colleen Kusy: Got it. That's helpful. Thank you.

Colleen Kusy: Got it. That's helpful. Thank you. And then, can you just comment on Casdozo plus Torrey and non-small cell lung cancer, can you comment on when we might be able to expect data from that? And then, for the triplet study that's going to be starting soon in HTC, can you ask, does that have a control arm and what you're hoping to learn from that study before starting phase three?

Theresa Lavallee: And then can you just comment for Casozo plus Torian lung in non-spousal lung cancer.

Speaker Change: Got it, that's helpful, thank you. And then, can you any comment for Kazoza, plus Torian Lung, and non-sponsor Lung cancer? Can you come in and when we might be able to expect data from that? And then, for the triplet study that's going to be starting soon in HCC, can you ask, does that have the control arm and what you're hoping to learn from that study before starting the phase three?

Theresa Lavallee: Can you come in and when we might be able to expect data from that?

Theresa Lavallee: And then for the triplet study that's going to be starting soon in HTC, can you guys, does that have a control arm and what you're hoping to learn from that study before starting the phase?

Theresa Lavallee: And so, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know, you know Thanks, Callie Nullitz, our Chief Medical Officer, Dr. Raj Dias, it takes that one, Rosh?

Colleen Kusy: Thanks, Colleen. I'll let our Chief Medical Officer, Dr. Rosh Dias, take that one. Rosh? Hi, Colleen. Thank you for the question.

Bryan McMichael: SGNA totaled $35.2 million and decreased $10 million and 22% compared to Q2 in the prior year. The decrease primarily reflects savings from lower headcounts, expenses for divested products that did not recurred and are ongoing cost reduction efforts. Interfixed expense of $5.3 million decreased $4.6 million and 46% compared to Q2 in the prior year. Q2 2024 was the first quarter we started to see savings from the full payoff of our $250 million principal amount term loan which occurred during the quarter.

Rosh Dias: Thanks, Kelly Knowledge, our Chief and I collapsed for Dr. Rosh Dias, and take that one, Rosh. Hi, Colleen, thank you for the question. So your first question was on a non-small cell lung cancer. Just as a very quick reminder, obviously schools upon the data that we presented at ESMO, IO, at the end of last year, showing a couple of monitor for responses.

Theresa Lavallee: Hi, Colleen. Thank you for the question. So, your first question was on non-small-cell lung cancer, just a very quick reminder, obviously, to schools upon the data that we presented at ESMO, IO, at the end of last year, showing a couple of monetary responses in PDL-1 refractory subjects. So, the ongoing study is in combination with Tori Palemans, the Tori Palemans, plus Kessos Ketog, in second to fourth line non-small-cell lung cancer. This study is recruiting very well and continues to recruit, and we anticipate results in next year, essentially in 2025. The second question was on about the cellular carcinoma, so we are on track to start the HCC study later this year, which is what we've communicated previously. Obviously, this bill on the very encouraging data presented at ASCO GI earlier this year.

Rosh Dias: This question was about non-small cell lung cancer. Just a very quick reminder, obviously, this falls upon the data that we presented at ESMO-IO at the end of last year, showing a couple of monotherapy responses in PD-L1 refractory subjects. So, the ongoing study is in combination with Torrey-Palomar, so Torrey-Palomar plus Kastos-Ketog. In second to fourth-line non-small cell lung cancer, this study is recruiting very well and continues to recruit, and we anticipate results in the next year, essentially in 2025. The second question was on hepatocellular carcinoma.

Speaker Change: in PDL1 refractory subjects. So the ongoing study is in combination with Tory Palomance, the Tory Palomance, plus Castor's K-Tag.

Speaker Change: In second to fourth line non-small cell lung cancer, this study is recruiting very well and continues to recruit, and we anticipate results in next year, essentially 2025.

Bryan McMichael: The Q2 2024 net loss was $12.9 million or 11 cents per diluted share compared to a net loss of $42.9 million or 49 cents per diluted share for the same period in 2023. Nongat net loss per share which excluded the gain on the vestiture of the summary was $16.4 million or 14 cents per diluted share in Q2 2024 compared to $32.8 million or $38 cents per diluted share for the same period in 2023.

Rosh Dias: So we are on track to start the HCC study later this year, which is what we've communicated previously. Obviously, this builds upon the very encouraging data presented at ASCO GI earlier this year. You asked about the design.

Speaker Change: The second question was on about the server look after Noma, so we are on track to start the HCC study late this year, which is what we've communicated previously, obviously, to discuss on the very encouraging data presented an asker to you earlier this year.

Theresa Lavallee: You asked about the design. So, first of all, we will be looking at a couple of doses for the current standards of care, obviously, the teas of beer and our phase three study. We'll look at the comparison against that current standard of care, but prior to that, we will look at a couple of doses of Casanovo in combination with Tori and then also look at the contribution of components, so probably a third arm as well. And then once we've done that, we'll move on into the phase three, as we've discussed.

Rosh Dias: So first of all, we will be looking at a couple of doses. The current standard of care, obviously, is TZOBEV, and our Phase 3 study will look at the comparison against that current standard of care. But prior to that, we will look at a couple of doses of Casdozo in combination with TORI and then also look at the contribution of components, so probably a third arm as well. And then once we've done that, we'll move on into Phase 3, as we've discussed.

Speaker Change: You asked about the design, so first of all we will be looking at

Colleen Kusy: Great, that's helpful. Thanks for taking our questions.

Bryan McMichael: Cash equivalents and investments in marketable securities were $159.2 million as of June 30th 2024 compared to $117.7 million at your end. As a reminder during the quarter we paid off $250 million in term loan as I mentioned earlier, answered into a new $38.7 million term loan due May 2029. Sold revenue rights for $37.5 million and received $40 million and $6.3 million in exchange for the sale of the summary and the out license of the Canadian rights to locked towards the respectable.

Speaker Change: A couple of doses for the current standard of care, obviously, is the T. diverba and our phase 3 study will look at that.

Speaker Change: Comparison against that kind of standard of care, but prior to that we will look at a couple of doses of Castovo in combination with Tory and then also look at a contribution of components, so probably a third on this well.

Speaker Change: And then once we've done that, we'll move on into the Phase 3, as we've discussed.

Operator: Great, the softball. Thanks for seeing your question.

Operator: On the run, Matt Cullin.

Speaker Change: Great, that's helpful. Thanks for taking our questions. Questions around that, Colleen?

Operator: That concludes today's question-and-answer session.

Speaker Change: www.microsoft.com.ca

Unknown Executive: That concludes today's question and answer session. I'd like to turn the call back to Denny Lanfear for his closing remarks.

Bryan McMichael: Today we are reiterating our expected range of combined 2024 R&D and SGN8 expenses of $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes certain business development activities. These strong quarterly results are the outcome of tremendous execution on the part of our team.

Danny Lanfear: I'd like to turn the call back to Daniela and Fear for closing remarks. Thank you, operator. Thank you all for joining. This is afternoon for our call. As I indicated in my prepared remarks, we are very pleased with the company's progress broadly here in Q2. We're looking forward to another good quarter in Q3, and we look forward to seeing you all at the investment conference.

Speaker Change: That concludes today's question and answer session. I'd like to turn the call back to Denny Lanfear for closing remarks.

Denny Lanfear: Thank you, operator. Thank you all for joining us this afternoon for our call. As I indicated in my prepared remarks, we're very pleased with the company's progress broadly here in Q2. We're looking forward to another good quarter in Q3, and we look forward to seeing you all at the investment conferences. Bye-bye.

Denny Lanfear: Thank you, operator. Thank you all for joining us this afternoon for our call. As I indicated in my prepared remarks, we're very pleased with the company's progress broadly here in Q2. We're looking forward to another good quarter in Q3, and we look forward to seeing you all at the investment conferences. Bye-bye.

Operator: Bye-bye.

Operator: This concludes today's conference call. Goodbye. Thank you for participating. You may now disconnect.

Danny Lanfear: With that I will turn back over to Denny for closing remarks. Thank you, Brian. On the half of the report today, we are executing very well on our four-part plan to deliver sureholder value. First, as Paul described, driving the top line. Secondly, as Brian described, controlling our operating expenses. Third, as Theresa and Rosh described, advancing our pipeline of tumor microenvironment-focused assets. And lastly, making substantial improvements in our capital structure.

Unknown Executive: This concludes today's conference call. Goodbye. Thank you for participating. You may now disconnect.

Speaker Change: This concludes today's conference call. Goodbye. Thank you for participating. You may now disconnect.

Danny Lanfear: We're proud of our accomplishments with the second quarter, and we remain dedicated to our mission of extending the survival of cancer patients.

Paul Reider: Now happy to open the line for questions. I'm Reider. As a reminder, if you'd like to ask a question at this time, please press star 1-1 on your telephone and wait for your name to be announced.

Operator: To withdraw your question, please press star 1-1 again. Please stand by, will we compile the Q&A roster?

Ashwani Gondrigaal: Our first question will come from the line of Yigal Nakomovitz with City. Hi, this is Ashwani Gondrigaal. Thanks for taking my questions and congrats on the quarter. I just had a few on the Laktorsi launch in NPC. Can you give us any color on which types of patients you're treating? Are they primarily newly diagnosed patients? Or are you seeing switches from other patients on off-label PD-1s? And on the same topic, where are you with the payer coverage access? And how should we think about the J-code as an inflection point for sales growth this year? Thanks. Yeah, Shik. Thank you very much for your questions.

Paul Reider: Paul, do you want to cover the issue of the NPC launch, and whether we've bumped into any switching problems in the second early of the payer coverage question? Yeah, sure. Thanks for your question. So the NPC launch is delivering in line with our expectations. The patients share that we're seeing is really a very heterogeneous mix as we expected. We've got patients, you know, in later lines of therapy. And these patients are getting Laktorsi as monotherapy, but they're going to have shorter durations because they're going to be second, third, fourth line.

Paul Reider: We're also very encouraged to be seeing patients in these early launch periods of the early line patients. And these patients are very, very important because these are the patients who will have longer durations of treatment, and these patients continue quarter over quarter of that long duration. That's how we see the revenue ramp over the long term. But in the short term, we see it as a steady ramp, as we work through this heterogeneous mix of patients and that patient mix begins to stabilize.

Paul Reider: As it relates to the payer coverage, we have virtually no payer issues right now. We've got now nearly a hundred percent of the targeted payer medical benefit lives across Medicare for Service, the national and regional health plans, both on commercial and the Medicare Advantage. So we were very, very pleased with the unrestricted coverage we have in NPC right now. And as it relates to the J-code, your question was, you know, is it going to be an inflection point?

Paul Reider: You know, the way that we see the J-code here is really enabling the electronic billing and faster, more predictable reimbursement for providers. So I wouldn't necessarily characterize it as a significant immediate revenue inflection per se, but certainly its availability will remove any operational barrier and any account that, you know, doesn't allow for use of products until the J-code is in effect. So... I think we're very, I think we're, we're really set from an access standpoint now moving into the second half of the year. If you'll very encourage that there was any of those impediments are behind us.

Paul Reider: Paul, can you just comment if you had, with respect to the issue of the switch and I think which was one of our short questions and then secondarily a progress on the NCCN formulas? Yeah, sure. As I mentioned in my prepared remarks, any patient that is currently on a off-label PD-1 or PD-1 chemo regimen, we don't believe that they're going to switch if the patient is responding to treatment. That being said, what we've seen in the real world data here in just the first couple quarters is that we are seeing patients who have been re-challenged after prior PD-1 treatment.

Paul Reider: And usually the off-label PD-1 was typically prescribed in the earlier line of treatment in combination with chemotherapy and therefore by the time the patient was re-treated with lactorsi, the patient had already progressed to a later line. So in these cases, we would expect a shorter duration of lactorsi use. That being said, we're encouraged, the doctors are willing to consider re-treatment with PD-1 failures. And that patients were, you know, or that payers were approving the product.

Paul Reider: So those are encouraging signs. And then as it relates to the access on the NCCN institutions, we've now, you know, got accessibility to lactorsi on all 33 NCCN institutions. So, you know, again, that operational milestone was achieved here in the second quarter. Thanks very much.

Brian Chang: Our next question will come from the line of Brian Chang with JP Morgan. Hey guys, thanks for taking our question this afternoon. Maybe just one on the benefit units growth that you saw this past quarter. You mentioned that most of the unit growth came from on body, so which is kind of trying to better understand the dynamics here. You know, can you tell us a little bit more about, you know, the biggest contributor that's driving the uptake across all their presentation this past quarter. And more importantly, how's it staying do you think this momentum that we're seeing today across all three presentations? Thanks. Thanks, Brian. Great question.

Paul Reider: Paul, do you want to trust the issue of the SKU mix and the growth across the quarter, Brian? Sure. Thanks for your question, Brian. Let me start just by reiterating, you know, our goal for the Udenica franchise. And that's to maximize the long-term profitability and sustainability of the franchise. You know, Brian and our investments to bring these innovative device presentations to market combined with our consistent strong execution is really what's, you know, delivering these results.

Paul Reider: Udenica now is strongly positioned in the peg full grasp the market. And, you know, we said multiple times that once we launched these new devices, you know, we're going to drive market share gains. And, you know, that's what you're seeing. We're delivering on that promise. You know, in these market share gains, you know, are coming basically in the last five quarters from an 11% share to 29% share. And we remain confident that Udenica will continue to grow in the second half of 2024.

Paul Reider: And it's going to be fueled by three of these growth drivers, Brian. The first is the commercial launch of on-body. And that's really because we now can compete head to head and access the entire peg full grasp the market. And secondly, the payer coverage, which, you know, nearly doubled in 2024 compared to 2023. So that opens up significantly more patient lives. And then the third is our discipline management of ASP. And that's really important, you know, for our customers, providers, payers, et cetera, hospitals, because it provides them greater predictability, which they value.

Paul Reider: So moving forward in the second half of the year, you know, we still are very confident that the franchise is going to grow, all three product presentations grew in Q2. But we see the on-body device is really being the driving force of the growth in the second half of the year, largely because of the accessibility, you know, to the entire market. That being said, you're still seeing nice uptake in the pre-filled syringe in the auto-injector presentations and we're finding now that customers are really able to now choose amongst the presentations that fit their unique needs and the needs of their patients. So we remain very confident in the second half of the year and they continue growth of the franchise.

Unknown Executive: All right, thank you for asking. Thank you.

Douglas Tsao: Our next question will come from the line of Douglas Tsao with HC Wayne, right? Good afternoon. Thanks for taking the questions. Hi, Doug. Can you repeat your question we can't hear you? It looks like Doug may have disconnected.

Operator: We'll move to the next question.

Billal Jahangiri: Next question will come from the line of Billal Jahangiri with true securities. Hi, congrats on the quarter. We had a couple of questions here.

Theresa Lavallee: We're wondering what differences would you expect to see from using Tory, Versa Pizzo in the triplet for HTC? And given that a bunch of your pipeline targets are not don't have precedence of approval in the US, which permutation and indication do you envision as your next phase three after HTC?

Theresa Lavallee: Dr. Treslovali, the company's chief development officer is with us today. Treslo, can you comment on the question of Tory with the triplet? Yes, so for the HTC study, looking at Torah Palemab plus Bevisismab, Cazdoza Ketug, and obviously in a phase three study, we would compare it with a Tazo Bev. The difference is obviously our PDL-1 versus PD-1. And the data set for Tory Bev from June, see in a phase three study has been reported positive, but we're waiting to see the data.

Theresa Lavallee: There was a phase two study that was published showing overall response rate and PSS that was numerically higher than what was seen with the imbra 150 a Tazo Bev phase three study. So based on the data there, we would expect Tory to be well suited in position to go against Tazo, and then of course adding Cazdoza Ketug should add increased benefit. So really extending the survival for those first line HTC patients without an increase in toxicity, a really good color ability to date.

Theresa Lavallee: And in terms of the second question was, could you repeat that? I'm sorry, was it about the next study that we have? Yeah, one combination or what triplet, doublet, and what indication is your gut feel, I guess. Yeah, so in development right now, we're building off of the activity that's been observed in the early phase studies for Cazdoza Ketug, both in Nonsmosa lung cancers. Giving the strong disease linkage there, and then the HTC study is on deck to open later this year.

Theresa Lavallee: Thank you very much for your question. Just one point to add to your first question on essentially some of the differences between the T-Zo and also Tori. So one thing that we do know that the ADA, the anti-drug antibodies with a T-Zo, it is reasonably high, probably in the 40% range, whereas we also know for Tori, Palmyr, but it's in the single digit range. So I think that's one additional consideration I'd add to what Tori has already mentioned about the T-Zo and the Tori. Great, thank you so much.

Douglas Tsao: Our next question will come from the line of Douglas H.C. Wayne Wright. Hi, good afternoon. Sorry about that earlier. Just curious your perspectives on now that you're all in the N-C-N-N centers. How much of the market is there versus patients being treated in the community setting? And how quickly or how long do you think it will take to penetrate the sort of broader community for the N-C-N market?

Paul Reider: Thanks for the question, Doug. Paul, do you want to give Doug a little insight on the patient portions, but an N-C-N in the uptake direction? Yeah, sure. Thanks for your question, Doug. You know, we believe that about 60% of all the N-P-C in the United States is treated in some kind of academic N-C-C-N type of setting of care. 40% is still in the community. And after the first couple quarters are locked towards the business, it's about two-thirds in the hospital.

Paul Reider: So it's tracking very closely to that in relation to the overall treatment. I think as it relates to the uptake in the community setting, Doug with a rare cancer, a lot of these oncologists in the community might be seeing N-P-C, one, maybe two patients a year. It's a rare cancer, as you know. So what we've got to do, and our plans are all focused on, you know, is continually engaging with these command oncologists, they're treating N-P-C. And so when they get that patient that's locked towards the eligible across one of those three patient segments that I described, you know, we've got that locked towards the message, and we've got everything set up to get that new patient start.

Paul Reider: So, you know, that's where, you know, our complete focus is right now and the second half of the year is really to drive the new patient acquisition across both segments, community, and the N-C-C-N and academic institutions. And I believe we're going to make great progress there as dear unfolds.

Paul Reider: Great, that's really helpful. And Paul, maybe just on Yudanaqa, I'm just curious. You know, you guys have had a really nice recovery in terms of share and a rebound in terms of revenue performance. I'm just curious, you know, are there particular segments where you're having more success with the on-body and an auto-injector or pre-filter, just your raw portfolio products in versus the other or is it pretty widespread right now? Yeah, Doug with you, Dennis, we're seeing growth across all segments of the business.

Paul Reider: When I talked to you last in May on the Q1 call, we were only a few weeks into the call and most of the uptake at that time was in the clinics, now we're seeing it across all segments of the business. Auto-injector, if there's one segment where that's probably being used more than the other, it's going to be in the clinics. But essentially the entire franchise is growing and on-body, we're still only one full quarter in, but we're really, really pleased with the penetration it's making across all the segments. So I think that's where we're going to continue to see the growth in the second half of the year. We're very confident in that.

Unknown Executive: Okay, great. That's on the focus. Thanks, Doug.

Mike Adelgovich: Our next question will come from the line of Mike Adelgovich with TD Cowan. Great, thank you for the question. I just have one on Toro Palamab. Can you remind us what milestones and or royalties are owed to Jinxi based on your current indication? And what obligations do you have to them relative to the development path for Toro Palamab so the various combinations that you plan to test? Thank you.

Danny Lanfear: Oh, great question, Mike. So, Jinxi gets a $25 million approval milestone, which we have paid, so we paid 12 and a half. The other 12 and a half is doing Q1 2025. Similarly, Jinxi gets a 20% royalty on net sales, which is paid as you go. With respect to your cost with sharing questions and development programs, we are not obligated to share costs, for example, of the Toro Palamab plus BTLA program, which is going into a segment of small cell month.

Danny Lanfear: So, one of the advantages of our development strategy, as Raj pointed out in his prepared remarks, is that we saw it deliberately to have others develop products and go into pivotal trials and pay for those trials. And then when the label gets done by the FDA, we can sell into these commercially. So, our objective is to line up a number of these. We have, I think, two now, one with Jinxi and one with the Novio.

Danny Lanfear: We'll continue to focus on that over the next six to 12 months. You'll probably see more of those. But we think this is a very effective strategy for development that reduced costs. So, no, we're not obligated for further development, unless we choose to. And the Jinxi have any, there's the royalty extent to potential future approval of other indications, potentially in combination with your in-house assets. The royalty extends to any Toro Palamab, so in the United States, regardless of indication, whether it's NPC, or lung, or gastric, or whatever, is just simply straightforward royalty and Toro Palamab sales.

Danny Lanfear: You're not allocated to pay any royalty, of course, I didn't need you, and she assets. Okay, and then are there any associated milestones during the fiscal year now? There's some additional sales milestones down the road. However, we don't feel that those are really relevant because most of those milestones were constructed at a time when we expected to have much longer larger indications, such as not small sell long and a number of things there. You know, indications will take a bit to get to, so we don't think those are really economically relevant to the modeling. Thanks a lot.

Mike Adelgovich: Thank you, Mike.

Colleen Kusy: Our next question will come from a line of Colleen Kusy with Baird. Great.

Paul Reider: Good afternoon. Congrats on the progress. Thanks for taking our questions for you, Dan. Okay, can you go in? What's been resonating with prescribers when choosing the on body? And what do you think is going to be kind of the big growth drivers for on body adoption? And then I have a couple of development follow up questions. Great. Paul, do you want to talk a little bit about our experience in the field, the reaction to the customer base with on body and the growth drivers for calling?

Paul Reider: Yeah, Colleen, thanks for your question. I think what's really resonating, you know, amongst our customers is the innovative and differentiated features of Udenica on body. Probably the most common feedback we've been getting from customers is how much they appreciate the five minute injection time for Udenica on body compared to the 45 minute injection time for the innovator. You know, that doesn't sound like it would be, you know, that important, but for a patient, you know, the next day that has to wait for this injection to occur, you know, five minutes.

Paul Reider: It's done and they can then get on with their day and their lives. And so that's been one of the most important differentiated features. I think the other drivers to Colleen is really what I mentioned in my prepare remarks. You know, we have, you know, now broad pair coverage. So it's highly accessible to more patients and equally as important is our stable ASP. So you said everything else aside and having a predictable ASP, which drives, you know, provider reimbursement, it's it's very, very valuable.

Paul Reider: So you put the total value proposition together, innovative device features, broad pair coverage, you know, consistent and stable ASP. And now you have a Udenica value proposition that customers, you know, are really driving towards. And so, you know, we are, we are very pleased with, you know, with the launch progress. And you know, we're very confident, you know, in the second half of the year and our continued performance there. Got it.

Paul Reider: That's helpful. Thank you. And then can you just comment for Casozo plus Torian lung in non-sposal lung cancer? Can you come in and when we might be able to expect data from that? And then for the triplet study that's going to be starting soon in HTC. Can you guys does that have a control arm and what you're hoping to learn from that study before starting the phase? Thanks, Callie Nullitz, our Chief Medical Officer, Dr. Raj Dias, and take that one, Rosh?

Paul Reider: Hi, Colleen, thank you for the question. So, your first question was on non-small-so lung cancer, just a very quick reminder, obviously, the schools upon the data that we presented at ESMO, IO, at the end of last year, showing a couple of monetary responses in PDL1 refractory subjects. So the ongoing study is in combination with Tori Palemans, the Tori Palemans, plus Kestos Ketag, in second to fourth line non-small-so lung cancer. This study is recruiting very well and continues to recruit, and we anticipate results in next year, essentially in 2025.

Paul Reider: The second question was on about the cellular carcinoma, so we are on track to start the HCC study later this year, which is what we've communicated previously, obviously, the schools on the very encouraging data presented at ASCO GI earlier this year. You asked about the design. So, first of all, we will be looking at a couple of dentuses, so the current standards of care, obviously, is the teaser of BERB and ARB phase 3 study, we'll look at the comparison against that current standard of care, but prior to that, we will look at a couple of doses of Kestos in combination with Tori, and then also look at the contribution of components, so probably a third arm as well. And then, once we've done that, we'll move on into the phase 3, as we've discussed. Great, the softball.

Unknown Executive: Thanks for taking here a question. That concludes today's question and answer session. I'd like to turn the call back to Daniela in fear for closing remarks. Thank you, operator. Thank you all for joining. This is afternoon for our call. As I indicated in my prepared remarks, we're very pleased with the company's progress broadly here in Q2. We're looking forward to another good quarter in Q3, and we look forward to seeing you all at the investment conferences. Bye-bye. This concludes today's conference call. Goodbye. Thank you for participating. You may now disconnect.