Q1 2024 SpringWorks Therapeutics Inc Earnings Call

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Operator: Good morning, my name is Tawanda, and I will be your conference operator today. At this time, I would like to welcome everyone to the Springworks Therapeutics First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. Please limit yourself to one question each.

Wanda: Good morning, My name is to Wanda and I would be your conference operator today.

Wanda: At this time I would like to welcome everyone to the spring works Therapeutics first quarter 2024 earnings conference call.

Wanda: At this time all participants are in a listen only mode.

Wanda: After the Speakers' remarks, there will be a question and answer session.

Wanda: Please limit yourself to one question each thank you.

Operator: Thank you. I would now like to hand the conference over to Samantha Sadler, Senior Director of Investor Relations at Springworks Therapeutics. Samantha, you may now begin the conference.

Wanda: I would now like to hand, the conference over to Samantha Sadler Senior director of Investor Relations at Spring works Therapeutics. Samantha you May now begin the conference.

Samantha Sadler: Thank you, and good morning everyone. Welcome to Springworks Therapeutics' first quarter 2024 earnings conference call. This morning, we issued a press release that outlines the topics we plan to discuss today. You can access the press release as well as the slides that we'll be reviewing today by going to the investors and media section of our website at www.springworkstx.com.

Samantha Sadler: Thank you and good morning, everyone. Welcome to spring works Therapeutics first quarter 2024 earnings conference call.

Samantha Sadler: This morning, we issued a press release, which outlines the topics we plan to discuss today.

Samantha Sadler: You can access the press release as well as the slides that we'll be reviewing today by going to the investors and media section of our website at Www Dot spring work, Yeah Dot com.

Samantha Sadler: Joining me today are Saqib Islam, Chief Executive Officer, and Babesh Asher, Chief Commercial Officer. Dr. Jim Cassidy, Chief Medical Officer, and Frank Perrier, Chief Financial Officer. Dr. Badreddin Edris, Chief Operating Officer, is also on the line and available during Q&A. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements that are subject to a number of risks and uncertainties. These may cause our actual results to differ materially, including those described in our reports filed with the SEC. You are cautioned not to place any undue reliance on these forward-looking statements, and Springworks disclaims any obligation to update such statements. I will now turn the call over to Saqib.

Speaker Change: Joining me today are stock of Islam, Chief Executive Officer.

Samantha Sadler: Bob.

Samantha Sadler: Sure Chief commercial officer Dr.

Samantha Sadler: Dr. Jim Cassidy, Chief Medical Officer, and Frank <unk>, Chief Financial Officer Dr.

Samantha Sadler: Dr. Aberdeen Andrey.

Samantha Sadler: <unk> operating officer is also on the line and available during Q&A.

Samantha Sadler: Before we begin I'd like to remind you that some of the statements made during the call. Today are forward looking statements that are subject to a number of risks and uncertainties.

Samantha Sadler: These may cause our actual results to differ materially.

Samantha Sadler: <unk> those described in our reports filed with the SEC.

Samantha Sadler: You are cautioned not to place any undue reliance on these forward looking statements and <unk> disclaims any obligation to update such statements.

Socket: I will now turn the call over to socket.

Saqib Islam: Thank you, Sam, and thank you all for joining us this morning. Today, I'm pleased to share our first quarter performance, as well as our progress towards accomplishing our key objectives for 2024 and beyond. A top priority for Springworks is to continue to execute on our successful U.S. launch of Oxivio for desmoid tumors, and we are very pleased with our strong start. In the first quarter of 2024, our first full quarter on the market, we reported $21 million in net product revenue.

Socket: Thank you Sam and thank you all for joining this morning.

Socket: I'm pleased to share our first quarter performance as well as our progress towards accomplishing our key objectives for 2024 and beyond.

Socket: A top priority for spring works is to continue to execute on our successful U S launch about video for desk My tumors and we are very pleased with our strong start.

Socket: In the first quarter of 2024, our first full quarter on the market, we reported $21 million in net product revenue.

Saqib Islam: This performance underscores the high unmet need for patients with desmoid tumors, the transformative benefits of OXIVIO for these patients, and strong execution across our commercial efforts. We are encouraged by the strong adoption to date and believe there is a meaningful opportunity ahead of us to serve desmoid tumor patients at all stages of their treatment. We are focused on delivering OXIVIO to the broad desmoid tumor community and believe that we are establishing a new standard of care for the treatment of this disease.

Socket: This performance underscores the high unmet need for patients with Desmoid tumors, the transformative benefits of <unk> to these patients and strong execution across our commercial efforts.

Socket: We are encouraged by the strong adoption to date and believe there is a meaningful opportunity ahead of us to serve guests more tumor patients at all stages of their treatment journey.

Socket: We are focused on delivering <unk> to the broad does more tumor community and believe that we are establishing a new standard of care for the treatment of this disease.

Saqib Islam: A second key priority for us is the significant opportunity we see for mirtimetinib, our MEK inhibitor, to help a large number of patients with neurofibromatosis type 1 associated plexiform neurofibromas, or NF1PN. We believe myrtimetinib is a potentially best-in-class treatment for both children and adults with these debilitating tumors.

Socket: Our second key priority for US is the significant opportunity, we see for mirrored imatinib or mec inhibitor to help a large number of patients with neurofibromatosis type one associated plexiform, Neurofibroma, where Nf one P M.

Socket: We believe mirrored imatinib as a potentially best in class treatment for both children and adults with these debilitating tumors.

Saqib Islam: We initiated our rolling NDA submission in March of this year, which we expect to position us to have our second approved product by 2025. We are also continuing to progress our broader targeted oncology pipeline, which presents multiple opportunities to advance the standard of care across different patient populations. Our ongoing studies are targeting a variety of indications, including ovarian granulosa cell tumors, multiple myeloma, MAPK mutant solid tumors, and HIPPO mutant solid tumors, which we will be discussing this morning.

Socket: We initiated our rolling NDA submission in March of this year, which we expect to position us to have our second approved product by 2025.

Socket: We are also continuing to progress our broader targeted oncology pipeline, which presents multiple opportunities to advance the standard of care across different patient populations.

Socket: Our ongoing studies are targeting a variety of indications, including ovarian granulosa cell tumors multiple myeloma map.

Socket: <unk> mutant solid tumors, and <unk> mutant solid tumors, which we will be discussing this morning.

Saqib Islam: Finally, we are in a strong financial position with a balance sheet that is expected to fund our operations through profitability. I'll now turn this call over to Bhavesh, our Chief Commercial Officer, to discuss our commercial progress this year. Bhavesh? Thank you.

Socket: Finally, we are in a strong financial position with a balance sheet that is expected to fund our operations through profitability.

Socket: I'll now turn this call over to Bob <unk>, our Chief commercial officer to discuss our commercial progress this year.

Socket: Yes.

Bhavesh Asher: I'm pleased to share an update on the Axevio launch in the United States. In our initial months of market, we have been intensely focused on delivering OXIVIO as the first and only FDA-approved therapy for adults living with desmoid tumors and establishing a new standard of care for these patients. Our field team has been actively engaging with physicians who manage desmoid tumor patients across treatment sites. As Saqib highlighted, in the first quarter of 2024, which was our first full quarter of Auxiliary Commercialization, we generated $21 million in net product revenue driven by strong commercial execution and high demand from both physicians and patients.

Bob: Thank you.

Bob: I'm pleased to share an update on the October launch in the United States.

Bob: And our initial months of market, we have been intensely focused on delivering octavio as the first and only FDA approved therapy for adults living with desert tumors and establishing a new standard of care for these patients.

Bob: Field team has been actively engaging with physicians, who manage desmoid tumor patients across treatment sites.

Bob: Ah socket highlighted in the first quarter of 2024, which was our first full quarter of Octavio commercialization.

Bob: We generated $21 million and net product revenue driven by strong commercial execution and high demand from both physicians and patients.

Bhavesh Asher: We've seen robust adoption given the large unmet need in this patient population who previously only had suboptimal off-label treatment options available to them. Also contributing to the rapid uptake was high awareness of the availability of oxidio as the only approved medicine developed specifically for the treatment of Desmond Tumor. We have strong engagement and advocacy from desmotumor experts at Sarcoma Centers of Excellence, many of whom were investigators in a phase three device.

Bob: We've seen robust adoption given the large unmet need in this patient population, who previously only had suboptimal off label treatment options available to them.

Bob: Also contributing to the rapid uptake with high awareness of the availability about Silvio as the only approved medicine developed specifically for the treatment of <unk> tumors.

Bob: We have strong engagement and advocacy from designate tumor experts at sarcoma centers of excellence many of them were investigators in our phase III <unk> study.

Bhavesh Asher: They've led the way in prescribing Obsidio to their patients, with physicians at 77% of these institutions already having prescribed Obsidio. We are also pleased to see early use of OXIVIO by physicians in other academic centers, as well as community practice. Importantly, patients prescribed at Sibio have been able to access the product efficiently. We have seen broad reimbursement across peer types, supported by the clear clinical value of our product and also the NCCN guidelines listing Obsidio as a Category 1 Preferred Treatment.

Bob: Dave led the way in prescribing octavio to their patients with physicians at 77% of these institutions already having prescribed octavio.

Bob: We are also pleased to see early use of <unk> by physicians and other academic centers as well as community practices.

Bob: Importantly patients prescribed the CBO had been able to access the product efficiently.

Bob: We have seen broad reimbursement across payer types supported by the clear clinical value of our medicines and also the NCC and guidelines listing octavio as of <unk>.

Bob: Category, one preferred treatment.

Bhavesh Asher: We're also encouraged by early feedback on patients' response to auxiliary therapy. In the few months since launch, we're hearing consistent feedback on symptom relief, in particular reports of quick reductions in patients' pain levels after initiating treatment. In the fullness of time on therapy, we expect tumor shrinkage to be consistent with what was demonstrated in the device.

Bob: We're also encouraged with early feedback on patients' response to oxygen therapy.

Bob: In a few months since launch we're hearing consistent feedback on symptom relief in particular reports so quick reductions in patients pain levels after initiating treatment.

Bob: In the fullness of time on therapy, we expect tumor shrinkage to be consistent with what was demonstrated in the study.

Bhavesh Asher: In a recent survey of 75 oncologists, we received overwhelmingly positive feedback from those who have used Oxyvio coupled with a high degree of anticipation from others to use the medicine. 76% of oncologists surveyed have already prescribed Oxivir or indicated that they plan to prescribe it. Importantly, all those that experienced using it indicated satisfaction, and 98% of them reported that they're likely to use OXIVIO as a frontline treatment. This gives us confidence in our ability to become the go-to systemic treatment for up to 1,650 newly diagnosed patients annually in the U.S.

Bob: In a recent survey of 75 oncologists, we received overwhelmingly positive feedback from those who have used octavio coupled with a high degree of anticipation from others to use the medicine.

Bob: 76% of oncologists surveyed have already prescribed or indicated that they plan to prescribe octavio.

Bob: Importantly, all of those with experience using it indicated satisfaction without <unk> and 98% of them reported that they are likely to use octavio as a frontline treatment.

Bob: This gives us confidence in our ability to become the go to systemic treatment for the up to <unk> hundred 50 newly diagnosed patients annually in the U S.

Bhavesh Asher: Furthermore, in just four months on market, the vast majority who have prescribed Oxidio already prefer it over other unapproved systemic treatment options, which have been known to have inconsistent efficacy and challenging tolerability. This is consistent with our pre-approval market research and highlights that Auxilio's real-world experience is aligning with the promise shown in our clinical trial. These early metrics are encouraging, and our performance to date has reinforced our confidence in our strategy for sustained growth, which is focused on three pillars.

Bob: Furthermore, in just four months on market the vast majority who have prescribed octavio already prefer it over other unapproved systemic treatment options, which have been known to have inconsistent efficacy and challenging tolerability.

Bob: This is consistent with our pre approval market research and highlights that activity is real world experience is aligning with the promise shown in our clinical trials.

Bob: These early metrics are encouraging and our performance to date has reinforced our confidence in our strategy for sustained growth, which is focused on three pillars.

Bhavesh Asher: First, continuing to drive depth of prescribing at Centers of Excellence and other high volume institutions. Second, expanding the breadth of prescribing at other academic and community centers. And finally, maintaining strong access for patients and supporting appropriate utilization. With the momentum we've built since launch, we believe we are strongly positioned for long-term success. Desmoid tumor treatment guidelines have evolved in favor of systemic treatment as the first line intervention for most tumor locations.

Bob: First.

Bob: Continuing to drive depth of prescribing at centers of excellence and other high volume institutions.

Bob: In <unk>.

Bob: Expanding the breadth of prescribing and other academic and community centers and finally, maintaining strong access for patients and supporting appropriate utilization.

Bob: With the momentum we've built since launch we believe we are strongly positioned for long term success.

Bob: First there is no tumor treatment guidelines have evolved in favor of systemic treatment as the first line intervention for most tumor locations.

Bob: There is strong awareness of these guidelines with support the opportunity for an FDA approved therapy like octavio to be used earlier in the treatment paradigm.

Bob: With its strong clinical profile.

Bob: NCC in category, one preferred treatment listing.

Bob: And high brand awareness, we believe octavio is well positioned to be prescribed to a broad pool of dezmon tumor patients across their treatment journey.

Bhavesh Asher: There is strong awareness of these guidelines, which support the opportunity for an FDA-approved therapy like Oxidio to be used earlier in the treatment paradigm, with a strong clinical profile, NCCM Category 1 Preferred Treatment Listing, and High Brand Awareness. We believe Oxivio is well positioned to be prescribed to a broad pool of desmotumor patients across their treatment journey.

Bhavesh Asher: Strong adoption of desmoid-tumor-specific ICD-10 codes since their introduction in October 2023 strengthens our confidence in the size of the actively managed population of 5,500 to 7,000 desmoid-tumor patients. The growing use of these codes also enables real-time patient identification, which is especially helpful in supporting our efforts in the community setting, where we need to be in the right place at the right time to support physicians with educational resources and the availability of obstetric remifetrile as an effective and approved treatment option for adult patients. In addition, insurers are broadly reimbursing our citizens.

Bob: Second strong adoption of definitely tumor specific ICD 10 codes since their introduction in October 2023 strengthens our confidence in the size of the actively managed population of 5500 to 7000 desmoid tumor patients.

Bob: The growing use of these codes also enables real time patient identification, which is especially helpful. In supporting our efforts in the community setting.

Bob: Where we need to be in the right place at the right time to support physicians with educational resources and the availability of Octavio as an effective and approved treatment option for adult patients.

Bob: In addition, insurers are broadly reimbursing octavio.

Bhavesh Asher: Since approval, OXIVIO has been reimbursed by payers representing 98% of commercially covered lives, and we're encouraged by how quickly OXIVIO has been added to formal commercial coverage policies. We have also rapidly secured access for Medicare and Medicaid patients. Enhancing the patient experience with OXIVIO is also a top goal. We're excited to share that the FDA has recently approved our supplemental NDA for 150 milligram and 100 milligram Obsevio tablets in new blister packs.

Bob: Since approval Octavio has been reimbursed by payers, representing 98% of commercially covered lives and we are encouraged by how quickly Octavio has been added to formal commercial coverage policies.

Bob: We have also rapidly secured access for Medicare and Medicaid patients.

Bob: Enhancing the patient experience with Octavio is also a top focus.

Bob: We're excited to share that the FDA has recently approved our supplemental NDA for 150 milligram and 100 milligram Octavio tablets and new blister packs.

Bhavesh Asher: The introduction of this new product format is expected to increase patient convenience and adherence by reducing the number of pills a patient has to take daily and by making morning and evening dosing simpler. The Blister Packs will be commercially available in the middle of May.

Bob: The introduction of this new product format is expected to increase patient convenience and adherence by reducing the number of pills a patient has to take daily.

Bob: And if I'm, making morning and evening dosing simpler.

Bob: The blister packs will be commercially available in the middle of May.

Unknown Executive: [inaudible] We have continued to invest in our IP portfolio and currently have 21 FDA Orange Book listed patents providing protection into 2043. Our first quarter performance strengthens our conviction in Observio becoming the systemic therapy of choice for adult patients with Desmond Tumor. We are still in the early days of our launch, and we believe that we have reached only a small proportion of the patient population that can benefit from treatment without surgery. I'll now hand over to Dr. Jim Cassidy, our Chief Medical Officer, to discuss the progress we're making across our development programs. Jim?

Bob: Lastly.

Bob: We have continued to invest in our IP portfolio and currently have 21, FDA Orange book listed patents, providing protection into 2043.

Bob: Our first quarter performance strengthens our conviction in octavio, becoming the systemic therapy of choice for adult patients with <unk> tumors.

Bob: We are still in the early days of our launch and we believe that we have reached only a small proportion of the patient population that can benefit from treatment with octavio.

James Cassidy: I'll now hand over to Dr. Jim <unk>, our Chief Medical officer to discuss the progress, we're making across our development programs.

James Cassidy: Jim.

James Cassidy: I'm glad to provide updates on our pipeline, starting with how we're maintaining positive momentum for our two lead programs. For Desmond Tumors, the European Medicines Agency validated our marketing authorisation application for Narragastat for the treatment of adults with Desmond Tumors in February. This is an important step towards potentially bringing the first approved therapy to desmoid tumor patients in the EU. We're also pleased that additional data from the Phase 3 to 5 trial will be presented at ASCO. These results reinforce the robust and clinically meaningful safety and efficacy profile of marigaspat in adult patients with desmoid tumors. Thank you for joining us for NF1 PM.

James Cassidy: Thanks Tavis.

James Cassidy: I am glad to provide updates on our pipeline starting with how we are maintaining positive momentum for our two lead programs.

James Cassidy: And David My tumors, the European Medicines agency validated our marketing authorization application for Amerigas.

James Cassidy: Treatment of adults with definitely tumors in February.

James Cassidy: This is an important step towards potentially bringing the first approved therapy today is Mike tumor patients in the EU.

James Cassidy: We're also pleased that additional data from the phase III <unk> trial will be presented at Astro. These results reinforce the robust and clinically meaningful safety and efficacy profile of Madagascar, and adult patients with asthma tumors.

James Cassidy: In the first quarter, we held a successful pre-NDA meeting with the FDA and initiated a rolling NDA submission. We expect to complete that submission by the end of June, bringing us closer to our goal of having a second approved medicine by 2025. We're delighted that data from the Phase 2b renewed trial of mirtimetinib were accepted for an oral presentation at ASCO. These data are the cornerstone of our NDA filing, and we expect the results to be published in a peer-reviewed journal this year.

James Cassidy: So I'm going to move the maintenance oriented <unk> TN in the first quarter, we held a successful pre NDA meeting with the FDA and initiated a rolling NDA submission we.

James Cassidy: We expect to complete that submission by the end of June bringing us closer to our goal of having a second approved medicine by 2025.

James Cassidy: We're delighted that data from the phase two the renew trial of metal Mednet were accepted for an oral presentation at <unk>.

James Cassidy: These data are the cornerstone of our NDA filing and we expect the results to be published in a peer reviewed journal this year.

James Cassidy: Beyond the US, we've had positive engagements with EU regulators and are advancing our preparations to submit a marketing authorisation application for methamphetamine to the European Medicines Agency in the second half of 2024. Turning to the Renew study, we're enthusiastic that modern methamphetamine has the potential to be a best-in-class therapy for children and a first-in-class medicine for adults with NF There are approximately 40,000 people living with NF1PN in the United States, and many of these patients have needs that are not addressed by current options.

James Cassidy: Beyond the U S. We've had posted engagements with EU regulators and are advancing our preparations to submit a marketing authorization application from our commitment to the European medicines agency in the second half of 2024.

James Cassidy: Turning to the renew study we're enthusiastic that <unk> has the potential to be a based in class therapy for children and the first in class medicine for adults with any of one P. M.

James Cassidy: Ultimately 40000 people living with any <unk> in the nation States.

James Cassidy: And many of these patients have needs that are not addressed by current options.

James Cassidy: The positive top-line results from our pivotal Phase 2b Renew trial demonstrated evidence of mother metanin's differentiation and potentially transformative benefit for these patients. Metamethamib showed compelling anti-tumour activity with robust objective response rates confirmed by blinded independent central review and deep responses in both the paediatric and adult cohorts. The depth of response we saw in the trial in both children and adults was unprecedented in studies of other MEK inhibitors, particularly given the hard-to-treat patients we enrolled.

James Cassidy: The positive topline results from our pivotal phase <unk> trial demonstrated evidence of met amendments differentiation and potentially transformative benefit for these patients.

James Cassidy: Maintenance showed compelling antitumor activity was robust objective response rates confirmed by blinded independent Central review.

James Cassidy: Deep responses in both the pediatric and adult cohorts.

Bhavesh Asher: The depth of response, we saw in the trial in both children and adults were unprecedented in studies of other make inhibitors, particularly given the hot.

James Cassidy: We enrolled.

James Cassidy: It's been difficult to achieve deep responses, especially in adults with NF1pn, so the robust volumetric changes we saw provide strong evidence of the unique activity profile of mirdymethanib in this disease. In both children and adults, merrimethinib also demonstrated a manageable safety profile with a vast majority of A's being grade 1 or 2, supporting the potential for extended treatment duration. Plexiform neurofibromas are highly morbid tumors that have a profound physical and emotional impact on patients and their caregivers.

James Cassidy: It's been difficult to achieve deep responses, especially in adults with <unk>. So that robust volumetric changes. We saw provides strong evidence of the unique activity profile of <unk> in this disease.

James Cassidy: In both children and adults.

James Cassidy: <unk> also demonstrated a manageable safety profile with the vast majority of he's being grade one or two supporting the potential for extended treatment durations.

Saqib Islam: Plexiform unified Bloomers are highly morbid tumors.

James Cassidy: <unk> physical and emotional impact on patients and their caregivers.

James Cassidy: So the fact that myrmometanib treatment resulted in statistically significant improvements in patient-reported outcomes, including pain, was also very meaningful. NF1PN is a devastating and lifelong disease that typically requires chronic therapy. Reducing the treatment burden in a real-world setting is critically important, and we believe that mirdometinib's optimized dosing regimen, which provides a built-in treatment holiday and a convenient, paediatric-friendly dispersible formulation, could further improve the patient experience and potentially enhance compliance. Overall, we believe that Murder Method provides the potential for class-leading efficacy and safety in NF1p and paediatric Transitioning to our emerging portfolio, we continue to make strong progress expanding the opportunity set in our pipeline.

James Cassidy: So the fact that <unk> treatment resulted in statistically significant improvements in patient reported outcomes, including team was also very meaningful.

James Cassidy: And if <unk> is demonstrating and life long disease that typically requires chronic therapy.

James Cassidy: Reducing the treatment burden.

James Cassidy: What I would say is critically important and we believe that <unk> optimized dosing regimen, which provides a bill in treatment of holiday and a convenient pediatric friendly disbursal formulation.

James Cassidy: It further improves the patient experience and potentially enhance compliance.

James Cassidy: Overall, we believe that <unk> provides the potential for class, leading efficacy and safety and in <unk> in pediatric patients and can establish our significant first in class therapy for adults.

James Cassidy: Transitioning to our emerging portfolio, we continue to make strong progress expanding the opportunity set in our pipeline.

James Cassidy: Our phase two trial of Madagascar in patients with ovarian granulosa cell tumors is fully enrolled, and we expect to report initial data in the second half of 2024. Ovarian granulosa cell tumors account for approximately 5% of all ovarian cancers, and similar to desmoid tumors, this is a meaningful patient population with a significant unmet need as there is no approved therapy for these patients. In multiple myeloma, we've clinically validated Nargastat's ability to potentiate BCMA-directed agents across modalities, and we are continuing to evaluate combination regimens in collaboration with industry-leading partners.

James Cassidy: Our phase II trial of <unk> in patients with ovarian granulosa cell tumors is fully enrolled and.

James Cassidy: And we expect to report initial data in the second half of 2024.

James Cassidy: We didn't lose a cell tumors account for approximately 5% of ovarian cancers and similar today as Mike tumors. This as a meaningful patient population with a significant unmet need.

James Cassidy: There is no approved therapy for these patients.

James Cassidy: In multiple myeloma with clinically validated <unk> ability to potentiate <unk> directed agents across modalities and.

James Cassidy: And we are continuing to evaluate combination regiments in collaboration with industry leading partners.

James Cassidy: Similar to our approach with Narragassetat, we are pursuing expansion opportunities for merdimethanid, including monotherapy and combination therapy applications in rare oncology and biomarker-defined solid tumors. This includes ongoing combination studies with dromerafenib and advanced solid tumors with MAP kinase mutations and Beijing's liforafenib and N-RAS solid tumors. We're also excited about the opportunity, as you said, for brimerafenib, an investigational next-generation raft diver inhibitor that is being developed by MapCure, our joint venture with Beijing.

James Cassidy: Similar to our approach with natural gas is that we are pursuing expansion of opportunities from a commitment include.

James Cassidy: Including monotherapy and combination therapy applications, and real oncology and biomarker defined solid tumors.

James Cassidy: This includes ongoing combination studies with <unk> in advanced solid tumors with map kinase mutations in <unk>, <unk> and Ross solid tumors.

James Cassidy: We're also excited about the opportunities ahead for <unk> and.

James Cassidy: An investigational next generation RAF dimer inhibitor.

James Cassidy: That is being developed by Mark here.

James Cassidy: Venture with Beijing.

James Cassidy: We believe that up to 7% of solid tumors harbor oncogenic BRAF aberrations that could potentially be targetable with bromer afenib. This includes mutations and fusions where currently approved therapies aren't effective or where resistance occurs. Expansion is ongoing in patients with BRAF V600 mutated solid tumors that had progressed in prior BRAF MEK therapy and those with BRAF class 2 or fusion mutant solid tumors. It's encouraging that we've already demonstrated responses during dose escalation in each of these patient populations.

James Cassidy: We believe the up to 7% of solid tumors Harbor oncogenic BRAF aberrations.

James Cassidy: Could potentially be tolerable with Bernard <unk>.

James Cassidy: This includes mutations and fusions, where currently approved therapies are effective or wear resistance occurs.

James Cassidy: Those expansion is ongoing in patients with BRAF <unk> hundred mutated solid tumors.

James Cassidy: Based on prior BRAF MC.

James Cassidy: And those with BRAF class II fusion mutant solid tumors.

James Cassidy: It's encouraging that we've already demonstrated responses during the dose escalation and each of these patient populations.

James Cassidy: Additional data from the monotherapy study are expected in the second half of 2024. In the first quarter, we initiated a Phase 1B combination study of brimarafenib and Amgen's panetumumab in colorectal and pancreatic cancer patients with known MAP kinase pathway mutations, and patient dosing is currently underway. As I just noted, a phase one culmination study with Mernon Merton is also ongoing. Additionally, we're pleased that FW682, our novel oral potent investigational Pantene inhibitor, is progressing into the clinic.

James Cassidy: Additional data from the monotherapy study are expected in the second half of 2024.

James Cassidy: In the first quarter.

James Cassidy: We initiated a phase <unk> combination study of <unk> with Amgen's panel to map in colorectal and pancreatic cancer patients with known map kinase pathway mutations.

James Cassidy: Patient dosing is currently underway.

James Cassidy: As I just noted a phase one combination study with <unk> that is also ongoing.

James Cassidy: Additionally, we are pleased that SW 682.

James Cassidy: <unk> novel oral potent investigational Pan <unk> inhibitor is progressing into the clinic.

James Cassidy: This program is designed to treat tumors with Hickel pathway mutations, which can occur in up to 10 percent of cancers, including mesothelioma and head and neck cancer. We believe that there is a meaningful opportunity for Springworks to create a best-in-class program for hypo-driven cancers. Our IND for SW682 was cleared in January, and our Phase 1 study is on track to initiate in the second quarter. Lastly, we've continued to enhance our drug discovery and translational medicine capabilities. We have several preclinical programs under development and look forward to sharing more as our work advances. Now, Frank Pirrie, our Chief Financial Officer, will share our first quarter financial results. Frank?

James Cassidy: This program is designed to treat tumors with tyco, possibly mutations which can occur in up to 10% of cancers, including me as to the online head and neck cancer.

Frank Pirrie: We believe that there is a meaningful opportunity for spring looks to create based in class program for hypo driven cancers.

Frank Pirrie: Brian D for SW 62 was cleared in January and our Phase. One study is on track to initiate in the second quarter.

Frank Pirrie: Lastly, we have continued to enhance our drug discovery and translational medicine capabilities, we have several preclinical programs under development and look forward to sharing more as our work advances.

Frank Pirrie: I know Frank <unk>, our Chief Financial Officer will share our first quarter financial results Frank.

Frank Perrier: Detailed first quarter 2024 financial results can be found in our press release, but I'll summarize a few highlights. Starting with our revenues, we were pleased to record $21 million of OXIVIO net product revenue in the first quarter. Our total operating expenses increased compared to the first quarter of 2023, driven by commercial activities to support the U.S. launch of Oxivio. We continue to maintain a strong financial position with $573 million in cash, cash equivalents, and marketable securities on our balance sheet as of the end of the first quarter. We have a clear path to profitability and a long-range operating plan that supports multiple product launches and gives us the flexibility to invest in opportunities across With that, I'll turn the call back over to Saqib.

Frank Pirrie: Thank you Jim.

Frank Pirrie: Detailed first quarter 2024 financial results can be found in our press release, but I'll summarize a few highlights here.

Frank Perrier: Starting with our revenues, we were pleased to record $21 million of ACA Silvio net product revenue in the first quarter.

Frank Perrier: Our total operating expenses increased compared to the first quarter of 2023, driven by commercial activities to support the U S launch of Octavio.

Frank Perrier: We continue to maintain a strong financial position with $573 million in cash cash equivalents and marketable securities on our balance sheet as of the ended the first quarter.

Saqib Islam: We have a clear path to profitability and a long range operating plan that supports multiple product launches and gives us the flexibility to invest in opportunities across our portfolio.

Saqib Islam: With that I'll turn the call back over to soccer.

Saqib Islam: To close, it has been a successful start to the year for Springworks. We're delivering on our commitment to establish OXIVIO as the standard of care treatment for adults with desmoid tumors. As Bhavik highlighted, we are quite encouraged by the growth we are seeing, which is driven by both the breadth and depth of prescribers and the broad satisfaction of patients who are using the medicine. Awareness is high.

Saqib Islam: Thank you Frank to close it has been a successful start to the year for spring works.

Saqib Islam: We are delivering on our commitment to establish <unk> as the standard of care treatment for adults with desk more tumors.

Saqib Islam: As Bob has highlighted we are quite encouraged by the growth, we're seeing which is driven by both the breadth and depth of prescribers and the broad satisfaction of patients who are using the medicine.

Saqib Islam: Feedback from physicians has been overwhelmingly positive. And importantly, patients are experiencing significant benefits from Oxivio, most notably rapid reduction in their pain. In addition, payers across all segments of the reimbursement landscape are recognizing the value of OXIVIO and providing broad access to patients. We are pleased with our strong execution to date, but recognize that we are still in the very early stages of our U.S. launch, with many more patients to serve.

Saqib Islam: Awareness is high.

Saqib Islam: Back from physicians has been overwhelmingly positive and importantly patients are experiencing significant benefits from octavio.

Saqib Islam: Most notably rapid reduction in their pain symptoms.

Saqib Islam: In addition, payers across all segments of the reimbursement landscape are recognizing the value of <unk> video and providing broad access to patients.

Saqib Islam: We are pleased with our strong execution to date, but recognize that we are still in the very early stages of our U S launch with many more patients to serve.

Saqib Islam: Our data show that there is a broad pool of approximately 5,500 to 7,000 actively managed desmoid tumor patients living in the United States today, and the commercial performance of OXIVIO thus far, as well as further insights we have gathered from the launch, reinforces our confidence in the overall patient population. We have high conviction that OXIVIO has the opportunity to deliver significant benefits to patients across their treatment journey, be they newly diagnosed or having previously been treated with other approaches. And we look forward to providing updates on our progress over the course of the year.

Saqib Islam: Our data show that there is a broad pool of approximately 5500 to seven actively manage desmoid tumor patients living in the United States today.

Saqib Islam: And the commercial performance of <unk> video, thus far as well as further insights we have gathered from the launch reinforces our confidence in the overall patient population.

Saqib Islam: We have high conviction that octavio has the opportunity to deliver significant benefits to patients across their treatment journeys.

Saqib Islam: He's a newly diagnosed are having previously been treated with other approaches and we look forward to providing updates on our performance over the course of the year.

Saqib Islam: We're also advancing mirtimetinib towards regulatory approval as a potentially best-in-class treatment for children and adults with NF1PN. Physicians and patients have consistently highlighted their strong desire for a new therapy that offers better tumor and symptomatic control, an improved tolerability profile that enables patients to stay on therapy, and a more convenient patient experience to enhance long-term compliance and treatment outcomes. We believe that Renew results represent best-in-class data for both pediatric and adult patients, the latter of whom do not currently have an approved treatment option.

Saqib Islam: We're also advancing <unk> towards regulatory approval as a potentially best in class treatment for children and adults with Nf One P M.

Saqib Islam: Physicians and patients have consistently highlighted their strong desire for a new therapy that offers better tumor and symptomatic control.

Saqib Islam: An improved tolerability profile it enables patients to stay on therapy, and a more convenient patient experience to enhance long term compliance and treatment outcomes.

Saqib Islam: We believe that renew results represent best in class data for both pediatric and adult patients.

Saqib Islam: Matter of whom do not currently have an approved treatment option.

Saqib Islam: Our data demonstrate Myrta Mettner's potentially differentiated risk-benefit profile, with unprecedented depth of response and manageable safety, all of which point toward a significant opportunity for mirtimetinib to help a large number of people living with NF1PN who are in need of safe and effective therapy.

Saqib Islam: Our data demonstrated Milton Mendes potentially differentiated risk benefit profile.

Saqib Islam: With unprecedented depth of response and manageable safety, all of which point toward a significant opportunity for merit.

Saqib Islam: To help a large number of people living with Nf on pn or a need of safe and effective therapy.

Saqib Islam: Beyond our lead programs, we're also committed to progressing our broader pipeline. We have already generated proof of concept data in monotherapy and combination settings against several different diseases, and we are preparing for multiple catalysts over the course of this year. Finally, we have robust intellectual property protections for our lead assets and a strong balance sheet to further support our long-term aspiration. We expect 2024 to be another meaningful year for Springworks and the patients we aim to serve as our team continues to deliver on our mission of changing the lives of people suffering from devastating diseases.

Saqib Islam: Beyond our lead programs, we're also committed to progressing our broader pipeline.

Saqib Islam: We've already generated proof of concept data in monotherapy and combination settings against several different diseases and we are preparing for multiple catalysts over the course of this year.

Saqib Islam: Finally, we have robust intellectual property protection for our lead assets and a strong balance sheet to further support our long term aspirations.

Saqib Islam: We expect 2024 to be another meaningful year for spring works and the patients. We aim to serve as our team continues to deliver on our mission of changing the lives of people suffering from devastating diseases.

Saqib Islam: As always, I would like to thank the patients and investigators who participate in our clinical trials, our patient advocacy partners and industry collaborators, and our team at Springworks. We're now happy to take questions. Operator. Thank you.

Saqib Islam: As always I would like to thank the patients and investigators who participated in our clinical trials, our patient advocacy partners and industry collaborators and our team of spring workers.

Saqib Islam: We're now happy to take questions operator.

Operator: We will now open the call for questions. To ask a question, please press star 11 on your telephone and then wait to hear your name announced. To withdraw your question, please first start 1-1 again. We ask that you limit yourself to one question each. Please stand by while we compile the Q&A roster. Our first question comes from the line Anupam Rama with J.P. Morgan. Your line is open.

Saqib Islam: Thank you.

Speaker Change: We will now open the call for questions.

Operator: Asked a question. Please press star one on your telephone and then wait to hear your name announced.

Operator: Drawing your question. Please press star one again.

Operator: We ask that you limit yourself to one question each please standby, while we compile the Q&A roster.

Unknown Executive: Thanks, Anupam. Babish, I'll let you answer that question. Yeah, thanks for the question.

Anupam Rama: Our first question comes from the line of <unk> Rama with Jpmorgan. Your line is open.

Anupam Rama: Hey, guys. Thanks, so much for taking the question and congrats on the early innings of the exit loss share.

Anupam Rama: Was wondering forgive you could you provide any color on inventory dynamics that youre seeing in the quarter and how youre thinking about this moving forward. Thanks, so much.

Unknown Executive: Thanks, Pat upon Babish I'll, let you answer that question, yes. Thanks for the question. So our distributors are holding minimal inventory levels and this is fairly standard for any specialty product and but.

Bhavesh Asher: Yeah, thanks for the question. Our distributors are holding minimal inventory levels, and this is fairly standard for any specialty product. But our first quarter revenues, I would say, are primarily driven by demand, both across new patients as well as refills for patients who are continuing treatment. And at the physician level, we're not seeing any stockpiles. They're typically ordering just in real time as patients are prescribed them, or they're refilling their existing prescription. Going forward, we don't expect to see a change in this. Distributors hold very minimal levels, and so we do not expect to see any significant changes in treatment.

Bhavesh Asher: Our first quarter revenues I would say are primarily driven by demand both across new patients as well as refills for patients who are continuing treatment.

Bhavesh Asher: And at the physician level, we're not seeing any stocking that typically ordering just in real time as patients are prescribed or they are refilling their existing prescription going forward, we don't expect to see a change in this.

Bhavesh Asher: But as do hold very minimal levels and so we do not expect to see any significant changes in trends.

Operator: Please stand by for our next question. Our next question comes from the line of Yaron Werber with TV Cohen. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Yaron Benjamin Werber: Our next question comes from the line of Iran. Weber with TD Cowen Your line is open.

Unknown Executive: Hi team, congrats on a really, really great to see this launch. So maybe just a quick question, can you give us a little bit of a sense of what we've done a lot of physician checks, and they're saying that pretty clearly as patients come in, this is not just for new patients, but they're also actively switching and are interesting and continue to switch away from chemo and obviously TKIs. What are you seeing in the market, and can you quantify a little bit how much there was sort of prevalence pool switching versus incidence in the quarter in terms of sales? Thank you. Okay, thanks.

Yaron Benjamin Werber: Hi team congrats on a really really great to see the service launch.

Unknown Executive: So maybe just a quick question can you give us a little bit of a sense, we've done a lot of physician checks and theyre, saying that.

Unknown Executive: Pretty clearly as patients come in this is not just for new patients, but they are also actively switching and are interested in continuing to switch away from chemo and obviously teekay is what are you seeing in the market and can you quantify a little bit how much your soda prevalence pool switching versus incidence in the quarter in terms of sales. Thank you.

Saqib Islam: Okay, thanks, Yaron. I think it's an important question. And certainly, let me start by saying that everything we have seen thus far gives us confidence. And, in fact, heightened confidence in our numbers with respect to expectations for patients, right. So the number you're referring to patients currently on treatment, we talked about six to 7000 currently on treatment in the US, and newly diagnosed, we expect about 1650 annually in the US.

Speaker Change: Okay. Thanks, Karen.

Saqib Islam: I think it's an important question and certainly let me start by saying that everything we've seen thus far gives us confidence.

Saqib Islam: And in fact heightened confidence.

Saqib Islam: On our numbers.

Saqib Islam: With respect to expectations on patients right. So the number you're referring to of patients currently on treatment. We talked about six to 7000 currently on treatment in the U S and newly diagnosed we expect about 650 annually in the U S. So everything we've seen thus far confirms that confirms those numbers and perhaps at the high end.

Saqib Islam: So everything we've seen thus far, you know, confirms those confirms those numbers, and perhaps at the high end, from where we have seen patients of all stripes, both newly diagnosed, as well as those in the prevalent pool. Where we stand at the moment is, you know, Babish talked about, you know, prescriber behavior, which we are seeing as the standard of care. And that's driving our confidence in getting to a large percentage of that currently treated group.

Saqib Islam: <unk> from where from our experienced thus far though we have seen patients of all stripes, both newly diagnosed as.

Saqib Islam: As well as those in the prevalent pool.

Saqib Islam: Where we stand at the moment is.

Saqib Islam: Bob has talked about.

Saqib Islam: The prescriber behavior, which we are seeing is the standard of care and that's driving our confidence in getting to a large percentage of that currently treated group.

Saqib Islam: So we're seeing those patients come in they tend to come in.

Saqib Islam: All through the course of the year as people finish treatments that theyre currently on and make that switch, but the enthusiasm from Clint.

Saqib Islam: So we're seeing those patients come in; they tend to come in all through the course of the year as people finish treatments that they're currently on and make that switch. But the enthusiasm from clinicians certainly bolsters our view there. Now, secondly, I bring up, you know, if you think of these, the newly diagnosed patients, the survey work we've done, which shows that, you know, we very much expect to be the first line of treatment for these newly diagnosed patients.

Saqib Islam: Clinicians certainly bolsters our view there now secondly, I bring up if you think of these.

Saqib Islam: Newly diagnosed patients the survey work, we've done which shows that we very much expect to be the first line of treatment for these newly diagnosed patients. So our confidence in that group is high to your specific question. We've seen some of all we expect the newly diagnosed to be temporarily driven over the course of the year or somebody.

Saqib Islam: So our confidence in that group is high. So your specific question, we've seen some of all, we expect the newly diagnosed to be temporarily driven over the course of the year. If somebody gets diagnosed, that's where we expect to be the frontline treatment, and we expect to be the standard of care for patients as they terminate other, you know, off-label treatments over time.

Saqib Islam: Gets diagnosed that's where we expect to be the frontline treatment and we expect to be the standard of care for patients as they are.

Saqib Islam: Terminate.

Saqib Islam: The other off label treatments over time.

Saqib Islam: Okay.

Operator: Please stand by for our next question. Our next question comes from the line of Corrine Johnson with Goldman Sachs. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Operator: Our next question comes from the line of Corrine Johnson with Goldman Sachs. Your line is open.

Unknown Executive: Good morning, guys. I think you alluded to this on the call, but maybe you could spend a bit more time contextualizing what you're seeing with respect to both the breadth and depth of utilization of Oxivio across the target prescriber population, and in particular where you anticipate and what you anticipate with respect to growth in those two directions over the course of the year. Thanks. Thank you, Corinne.

Corrine Johnson: Hey, guys.

Unknown Executive: You alluded a bit to this on the call, but maybe you could spend a bit more time contextualize and what youre seeing with respect to both the breadth and depth of utilization of <unk> across the target prescriber population and in particular, where are you anticipating what you anticipate with respect to growth in those two directions over the course of the year. Thanks.

Saqib Islam: Thank you, Corinne. Listen, I think, you kind of come back to our view and certainly have confidence in the overall opportunity in terms of the number of patients to help. I do think that where we sit, as far as the drivers of all of that is, you know, we've got a situation; we've got high unmet need for desmoid tumors and high awareness of Oxidio among patients and physicians as the first and only approved therapy.

Corinne: Thank you Karen I listen I think you kind of come back to.

Saqib Islam: Our view certainly have confidence in the overall opportunity in terms of the number of patients to help.

Saqib Islam: I do think that where we sit as far as the drivers of all of that is.

Saqib Islam: You've got a situation, we've got high unmet need and desert tumors in heidrick <unk> among patients and physicians as the first and only approved therapy, we have a broad label with no restrictions, we've got very strong physician engagement and.

Saqib Islam: We have a broad label with no restrictions. We've got very strong physician engagement, and we've got a robust reimbursement environment for us. So that's where we begin. As we think of where early adoption has been, we have been very pleased with the breadth of our prescribers, both in the centers of excellence, which is where you would expect to see early penetration, given their familiarity with the DEFY study, their familiarity with oxidio, but also, very much so, you know, we've been very pleased to see it in the community setting as well.

Saqib Islam: And we've got a robust reimbursement.

Saqib Islam: Environment for us So that's where we begin as we think of where the early adoption has been we've been very pleased with the breadth of our prescribers. Both at the centers of excellence, which is where you would expect to see early penetration given their familiarity with the <unk> study that familiarity with <unk>, but also very much so.

Saqib Islam: No.

Saqib Islam: We've been very pleased to see it in the community setting as well.

Saqib Islam: I think the combination of both of those breadth and are confident that the depth is that a place where we're really only scratching the surface. So we've seen some from all of this prescriber base.

Saqib Islam: And I think the combination of both of those breadths and our confidence that the depth is at a place where we're really only scratching the surface. So we've seen some from all of this prescriber base and have a high conviction that we're only starting. Thank you, Chris.

Saqib Islam: At a high conviction that we're only starting thank.

Chris: Thank you Brent.

Operator: Please stand by for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open. Thank you.

Chris: Thank you.

Speaker Change: Please standby for our next question.

Saqib Islam: Sure, Peter. You know, I think we touched on that a little bit in the previous question, but, you know, we are getting some of both. We are certainly getting patients who are switching. Now, some of them have switched immediately, kind of in the middle of the course of their treatment. And that's what we would have expected.

Operator: Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Speaker Change: Great. Thank you thanks for taking the questions congrats on the launch as well.

Saqib Islam: Wonder if you can make any comment around the mixture of patients between patients do you think that kind of switched from existing therapies versus new patients.

Saqib Islam: Sure Peter I think we touched on that a little bit on the prior question, but we are getting some of both we are certainly getting patients who are switching now some of them have switched immediately kind of in the middle of the course of their treatment.

Saqib Islam: Others are appropriately waiting for them to finish a line of treatment.

Saqib Islam: Before they get on <unk> and Thats, what we would have what we would've expected. In addition, we are seeing patients who are first diagnosed.

Saqib Islam: In addition, we are seeing patients who are first diagnosed with their desmoid tumor coming to Oxivio, and we expect to be the frontline treatment based on the feedback we have thus far from physicians. And certainly, I think we continue to see the opportunity in both of those areas, but it is tough for us at this early stage to quantify, you know, in our first four months of sales, which patients fall into which category.

Saqib Islam: With their desk more tumor coming to <unk>, and we expect to be the frontline treatment.

Saqib Islam: Just on the feedback we have thus far from.

Saqib Islam: From physicians and certainly I think.

Saqib Islam: We continue to see the opportunity in both of those areas, but tough for us at this early stage to quantify.

Saqib Islam: Of our first four months of sales, which patients fall into which category. Thank.

Speaker Change: Thank you Peter.

Operator: Please stand by for our next question. Our next question comes from the line of Alec Stranahan with Bank of America. Your line is open.

Speaker Change: Thank you.

Saqib Islam: Please standby for our next question.

Operator: Our next question comes from the line of Alec Stranahan with Bank of America. Your line is open.

Unknown Executive: Hey, guys, thanks for taking our questions and congratulations on the progress of the launch so far. Apologies if I missed this, but within that 21 million number, I guess, how many of the December patients or the patients that initiated therapy in December does that include? And any, you know, forward-looking guidance, whether the blister pack will help get patients on therapy, or is that more a compliance-to-therapy consideration? Thank you. Well, I think, you know.

Alec Warren Stranahan: Hey, guys. Thanks for taking my questions and congrats on the progress of the launch so far.

Unknown Executive: I apologize if I missed this but.

Unknown Executive: Within that $21 million number I guess, how many.

Unknown Executive: Are the patients that initiated therapy in December.

Unknown Executive: Does that include.

Unknown Executive: And any.

Unknown Executive: Forward looking guidance, whether the blister pack.

Unknown Executive: We will helps.

Unknown Executive: The the getting patients on therapy or is that more a compliance.

Unknown Executive: The therapy consideration. Thank you.

Unknown Executive: Well, I think, you know, if you're asking a question about patient renewal, I think that, you know, we expect and we continue to experience the renewals that you would see with the first and only approved treatments in the market and a high degree of confidence for patients to stay on treatment. You know, the data that we have shown that I can point to from our phase two and phase three of patients staying on treatment for an extended duration would certainly imply that you've got, you know, the vast majority of those patients from our December numbers continuing to build and, as we would expect, stack into this quarter and the quarters that we would have going forward.

Unknown Executive: Well I think.

Unknown Executive: Youre asking a question about patient renewals I think that we expect and we continue to experience.

Unknown Executive: The renewals.

Unknown Executive: Would see with the FERC and only approved treatments in the market and a high degree of confidence for patients.

Unknown Executive: Two.

Unknown Executive: To stay on treatment.

Unknown Executive: The data that we have shown that.

Unknown Executive: That I can point to from a phase II and phase III of patients staying on treatment for an extended duration would certainly imply that you've got.

Unknown Executive: The vast majority of those patients.

Unknown Executive: From the.

Unknown Executive: Our December numbers.

Unknown Executive: Continuing to build and as we would expect stack.

Unknown Executive: As it relates to the blister pack, listen, we do this as an innovation for patients. It is a convenience for them. We think it is a meaningful opportunity to once more put patients at the center of everything we do and allow them the convenience of taking fewer pills in a more organized fashion. And we think it is going to be meaningful and will benefit compliance and certainly benefit patients going forward. Thank you, Ellen.

Unknown Executive: Into this quarter and the quarters that we would have going forward as it relates to the blister pack listen we do this as an innovation for patients. It is a convenience fee.

Unknown Executive: For them, we think that is a meaningful opportunity to once more put the patient at the center of everything we do in <unk>.

Unknown Executive: Allow them the convenience of taking fewer pills in a more organized fashion and we think it is going to be meaningful and.

Speaker Change: It will benefit compliance and certainly benefit patients going forward. Thank you Allen.

Ellen: Thank you.

Speaker Change: Please standby for our next question.

Operator: Please stand by for our next question. Our last question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Unknown Executive: Our last question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Unknown Executive: Hey guys, good morning. Thanks for taking our questions and congrats on the great early launch. I think a lot of the feedback is very consistent with what we've heard in our own survey work, but yeah, Saqib, perhaps just a question on reimbursement. I know that death by tumors is a very low Medicare market, and Medicare percentage population, but have there been any seasonal headwinds in the first quarter that could alleviate over the rest of the year? Do you have any visibility on any sort of early seasonality? I know it's early in the launch, but just curious.

Michael Schmidt: Hey, guys. Good morning, Thanks for taking our questions and congrats on the great early launch I think a lot of that feedback so very consistent with what we've heard it now on survey work, but yes.

Unknown Executive: Thanks so much.

Unknown Executive: Perhaps just a question on reimbursement I know of that definitely tumors is a very low Medicare market Medicare percentage.

Unknown Executive: Population, but.

Unknown Executive: Have there been any CSR headwinds in the first quarter that kit.

Unknown Executive: Alleviate over the rest of the year do you have any visibility on any early seasonality I know it's early in the launch but just curious thanks, so much sure.

Unknown Executive: Sure. Thank you, Alec.

Saqib Islam: Sure. Thank you, Alex so well I will take the first part of that question and then pass it over to Bob to take the risks I would say that from where we stand at the moment.

Saqib Islam: So, I will take the first part of that question and then pass it over to Babish for him to take the rest. I would say that from where we stand at the moment, you're correct that this is largely a commercial payer population, as you think of the age of the patients who are first diagnosed with a desmoid tumor. So, it's largely commercially focused. Now, we've been incredibly pleased with where we stand from a reimbursement standpoint, and I think a lot of good work has gone into that from the team. And Babish, I'll let you thank you. Yes or no, look.

Babish: You are correct that this is largely a commercial payer population as you think of the age of the patients who are first diagnosed with the desk more tumor. So it's largely commercially focused that we've been incredibly pleased with where we stand from a reimbursement standpoint.

Babish: I think a lot of good work has gone into that from the team and Bob I'll. Let you talk about that thank you, yes, or no look with full months into launch we are in a very strong position from an access standpoint, the vast majority of our adult patients with desmid tumors have coverage and very strong coverage rate, we've achieved broad access across all segments commercial Medicare Medicaid.

Bhavesh Asher: Thank you. Yeah, so no, look, with four months into launch, we're in a very strong position from an access standpoint. The vast majority of our adult patients with desmode tumors have coverage and very strong coverage. We've achieved broad access across all segments, commercial, Medicare, and Medicaid. And, you know, even from a mixed perspective, the mix has been pretty much what you would expect based on the age range for desmotumor patients, with a majority skewing towards commercial, and no surprises about the payer mix, nor any surprises about the quick availability of access for these patients. So all in line with expectations.

Bhavesh Asher: And even from a mixed perspective, the mix has been pretty much what you would expect based on the age range for Desmond tumor patients with majorities skewing towards commercial and no surprises towards the payer mix and neither are any surprises towards the.

Bhavesh Asher: Quick availability of access for these patients so all in line with expectations.

Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.

Operator: Okay.

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Operator: Okay.

Operator: Okay.

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Operator: Mhm.

Operator: Okay.