Q3 2024 SpringWorks Therapeutics Inc Earnings Call

Good morning, My name is Tanya and I will be your conference operator today at this time I would like to welcome everyone to the spring works Therapeutics third quarter 2024 earnings Conference call. At this time all participants are in a listen only mode. After the Speakers' remarks, there will be a question and answer.

Speaker Change: Session. Please limit your questions to one each thank you I would now like to turn the conference over to Kim Diamond Vice President of corporate Communications at Spring works Therapeutics. Kim you May now begin the conference.

Kim Diamond: Thank you and good morning, everyone welcome to the spring works Therapeutics third quarter 2024 earnings Conference call.

Kim Diamond: This morning, we issued a press release, which outlines our financial and operational results for the third quarter you can access the press release as well as the slides that we will be presenting today by going to the investors and media section of our website at www Dot frameworks, TX Dot com.

Kim Diamond: Joining me today are socket Islam, Chief Executive Officer, Bob <unk>, Chief Commercial Officer, Dr. Jim Cassidy, Chief Medical Officer, Frank Perrier, Chief Financial Officer, and Dr. Poverty, a tree Chief operating officer.

Kim Diamond: Before we begin I would like to remind you what some of the statements made during the call. Today are forward looking statements that are subject to a number of risks and uncertainties.

Kim Diamond: These may cause our actual results to differ materially including those described in our reports filed with the SEC.

Kim Diamond: You are cautioned not to place any undue reliance on these forward looking statements and spring works disclaims any obligation to update such statements I will now turn the call over to socket.

Speaker Change: Thank you Ken and thank you all for joining this morning.

Socket: I'm pleased to share our third quarter results as well as an update on how we are delivering on our objective to make a profound impact on the lives of patients with devastating diseases.

Socket: Starting with our video for patients with tumors. We are very pleased with the continued strong momentum of our U S launch.

Socket: The third quarter, we reported $49 3 million in net product revenue, which represents a 23% growth quarter over quarter.

Socket: With strong and steady growth is driven by robust demand both from new patient starts as well as existing patients or continuing to experience meaningful antitumor activity and substantial improvement in their quality of life on auxiliary.

Socket: As we approach the one year Mark of our launch we are very pleased with our progress in making <unk> a standard of care systemic therapy for patients with Geismar tumors.

Socket: Our commercial execution to date has been exceptional and our market research shows we have only reached a small portion of people with does more tumors, who can potentially benefit from a video.

Socket: In a few moments.

Socket: Commercial officer, Bob <unk> will highlight key metrics from the launch, including those related to patients prescribers and evolving treatment trends that inform our view of the significant opportunity ahead of us.

Socket: In these data you'll see high enthusiasm for our <unk>, increasing likelihood and desire to treat and an addressable patient population, but appears to be meaningfully larger than we initially estimated.

Socket: Our conviction is further reinforced by insights we have gained from our early launch and measures we have taken to position ourselves for long term success.

Socket: All key drivers underscore our confidence in the significant opportunity in front of US first this quarter. We successfully introduced a 150 milligram and 100 milligram strength tablet about video and blister packaging to increased patient convenience adherence and renewal times.

Socket: Second we now have real world data that strongly suggests that the addressable patient population is larger than we initially had estimated.

Socket: Third we have continued to see very high satisfaction from physicians and expect that the majority will increase their usage of I'll give you in the coming year.

Socket: And fourth we have continued to generate data on the benefits of longer term treatment without video.

Socket: We will review all four of these factors over the course of this morning's presentation to highlight our increased confidence that we have only scratched the surface of auxiliary opportunity to benefit patients with definitely tumors.

Socket: Poised for success to help this patient community going forward.

Socket: Turning to mirror net net there is a substantial unmet need for the approximately 40000 people living with N F. One P M in the United States alone.

Socket: 30000 of whom are adults and 10000 of our children.

Socket: Our NDA for adults and children with <unk> was granted priority review and launch preparations are on track ahead of our February 28 different date.

Socket: Data from our pivotal phase to be renewed trial on the basis of our NDA and provide the potential for <unk> to.

Socket: To become the first FDA approved treatment for adults with Nf one P M and a best in class option for children.

Socket: Our team is excited by the opportunity to deliver a medicine that has the potential to provide deeper responses in existing therapies in manageable tolerability profile improve quality of life and it just first of all tablet formation for children and adults unable to swallow a pill.

Socket: We look forward to continuing to work with the FDA throughout the NDA review process.

Socket: Simultaneously advancing our commercial preparations in anticipation of a potential approval in early 2025.

Socket: In parallel we are advancing our efforts to bring our innovative therapies to patients globally.

Socket: With EU regulatory reviews for our video and near the nickname underway.

Socket: With the potential for both approvals to come in 2025, we are Onboarding European commercial and medical leadership.

Socket: Other advanced these efforts and prepare to bring our medicines to market.

Socket: Beyond our work in des Moines tumors, and then F. One PM, we continue to advance our emerging portfolio, which Jim Cassidy will provide an update on later in the call.

Socket: Lastly, we have a strong balance sheet, we expect to fund us through profitability, which we are on track to achieve in the first half of 2026.

Speaker Change: I'll now turn the call to Bob to discuss our progress with oxygen for patients with tumors and our prelaunch preparations premier to Latam for patients with <unk> Pn.

Speaker Change: Yes.

Speaker Change: Thank you socket.

Speaker Change: Nearly a year into our launch Octavio has continued to consolidate and expand its leadership position as the most prescribed systemic therapy for adults with Desmond tumors.

Speaker Change: In the third quarter, we generated $49 3 million in net product revenue, representing a 23% growth over the second quarter we.

Speaker Change: We've seen strong adoption of <unk> in newly diagnosed patients and then those seeking their next line of therapy after unsatisfactory outcomes with previous interventions.

Speaker Change: We're also seeing continued depth of prescribing amongst physicians at centers of excellence and an increase in prescribing amongst the community physicians.

Speaker Change: As we expected the month of July was a transition period as patients switched to the 150 and 100 milligram blister packs, which were developed to enhance the patient experience and improve adherence.

Speaker Change: While the transition to this new product form cause some short term delays due to the need for new prescription for some patients. The transition is now largely complete and we expect to see the positive benefits of the blister packs in the coming quarters, including the impact of flat pricing across doses.

Speaker Change: In addition, and as is common with many therapies, we experienced some summer seasonality that impacted new patient starts in July how.

Speaker Change: However, we were pleased to see strong demand return in August and September with each month successively representing our best performance since launch.

Speaker Change: Importantly, octavio is providing meaningful clinical benefit in a real world setting that are consistent with our robust data in our FDA approved label and we are seeing limited discontinuation, which we expect will be further supported by the new long term data from defy which show that with long.

Speaker Change: Term use patients are experiencing further reduction in tumor size and sustained symptomatic relief.

Speaker Change: Contributing to their overall improved quality of life and desire to stay on therapy.

Speaker Change: These positive treatment experiences combined with our focused commercial execution and real time patient identification efforts make us confident that we are well positioned for continued growth in the fourth quarter and beyond.

Speaker Change: As we approach the one year, Mark and a launch we're now in a position to share some learnings and metrics from the past year, all of which increase our understanding of key prescribing and patient dynamics and underscores our confidence in the magnitude of the commercial opportunity.

Speaker Change: First.

Speaker Change: I'll touch on the patient population in September over 800 unique patients filled a prescription for <unk>.

Speaker Change: As you might recall, we've observed median durations of treatment between three and four and a half years in our clinical trials.

Speaker Change: While it's still too early to know what a median treatment duration will be in a real world setting. We are pleased by the low rates of discontinuation. We are seeing thus far and believe that the new long term follow up data from defy.

Speaker Change: Port extended treatment durations and enable patients to continue receiving the life changing benefits of our medicine.

Speaker Change: Now it's important to note that the number of patients filling a script in any given month under represents the total number of actively treated patients since not all of them refill exactly on time.

Speaker Change: The introduction of the blister packs gives us greater visibility into dosing and administration patterns and given their flat pricing. The blister packs also allow us to capture commensurate value at the dose best suited for each patient.

Speaker Change: We're already seeing the timing and predictability of refills improve with the adoption of the blister packs.

Speaker Change: As of the end of September approximately 65% of axis of your patients are on the blister pack and are experiencing the convenience reduced pill burden and improved compliance that this product format offers.

Speaker Change: We expect to complete the transition to a blister packs by the end of the year.

Speaker Change: We're gratified with the increasing number of patients who have had the opportunity to serve but we believe that we've only scratched the surface and here's why.

Speaker Change: Growing use of the Desmarais specific ICD 10 code, which was launched right before our FDA approval in October 2023 is better informed our understanding of the overall market size.

Speaker Change: Based on our prior analysis, we originally calculated that they were 5500 to 7000 desmoid tumor patients Underactive management each year in the U S out of a diagnosed prevalent population of approximately 30000 patients.

Speaker Change: Through August of this year, approximately 10000 unique desmoid tumor patients have already been identified through the new diagnosis code data.

Speaker Change: This strongly suggests that our earlier estimate of patients under active management was markedly conservative.

Speaker Change: Although not every patient captured by these codes may require active treatment immediately.

<unk> afforded by Dezmon tumor specific code enables our team to reach prescribers as theyre, making treatment decisions.

Speaker Change: We also know that these desmond tumor specific codes have not yet been fully adopted as is the case with any new ICD 10 rollout. So we expect these numbers will continue to grow and we will revise our estimates accordingly in the future.

Speaker Change: Moving on to the physician community.

Speaker Change: As of quarter end, we see in our data that providers at approximately 420 treatment centers have prescribed octavio, which is far beyond the approximately 90 sarcoma centers of excellence.

Speaker Change: Physicians at these centers, where our earliest adopters and Octavio is firmly established as a systemic standard of care therapy for desert tumors in these centers.

Speaker Change: One of our key goals has been to reach physicians and patients outside of the centers.

Speaker Change: Strong commercial execution, coupled with high awareness and robust demand.

Speaker Change: Loud us to broaden our reach to community physicians.

Speaker Change: As it stands today, 57% of Auxilium prescribers are practicing in the community setting.

Speaker Change: Lastly, robust and broad payer coverage has been an area of strength since our FDA approval and remains strong with the introduction of the blister packs when patients prescribed <unk> they have been able to access it efficiently due to strong reimbursement.

Speaker Change: Our feedback from physicians started off positive and has only continued to improve.

Speaker Change: And our market research, we ask physicians, how well the treatments they use perform on a number of important attributes.

Speaker Change: On this chart you can see that <unk> far outperforms across every attribute.

Speaker Change: Most notably from an efficacy perspective, but also along the dimension of Tolerability improvements in pain and overall quality of life.

Speaker Change: Positive feedback <unk> profile translates into strong physician intent to prescribe spin.

Speaker Change: Specifically from a research approximately 90% of prescribers surveyed said that they are likely to use <unk> as a frontline treatment.

Speaker Change: Second our research indicates that nearly all physicians surveyed not only expect to continue using octavio.

Speaker Change: About 60% of them also expect to increase their usage in the coming year.

Speaker Change: Collectively this supports the potential for strong growth ahead.

Speaker Change: I would now like to share some evolving treatment dynamics that further underpin our confidence in the desert tumor opportunity starting with overall attitudes towards how and when to intervene for patients with desert tumors, which point to the urgency to treat at the earliest sign of progression.

Speaker Change: We are seeing increasing levels of alignment with guideline based treatment, which favor systemic therapy over surgery for patients who require active treatment.

Speaker Change: More recently, we've also observed a growing emphasis on prescribers initiating treatment based on a range of clinical symptoms of progression.

Speaker Change: Not only radiographic evidence of progression.

Speaker Change: In fact, 87% of physicians surveyed indicated likelihood to use <unk> for symptomatic patients without radiographic progression.

Speaker Change: As shown on this slide 67% of doctors view, new or worsening pain, 75% view worsening symptoms overall and 51% considered decline in function as factors for initiating treatment.

Speaker Change: Each of these responses is higher than what we saw at this time last year and we expect that the sentiment will continue to grow amongst the treating community and drive urgency to treat.

Speaker Change: As a reminder, octavio as label covers treatment based on either symptomatic or radiographic progression. So with this shifting treatment landscape dynamics, we expect that more patients will become candidates for video earlier in the course of their disease.

Speaker Change: We also continue to make important progress to bring <unk> to patients outside the U S.

Speaker Change: In the EU, our marketing authorization application is currently under review and we anticipate approval in the first half of next year.

Our plan for the EU launch is to begin with Germany, and then expand to other countries.

Speaker Change: To support these efforts, we have established European headquarters in Switzerland, and hired commercial and medical leadership as well as medical science liaisons with other key personnel and field team members in the process of being on boarded.

Speaker Change: We're also conducting comprehensive pricing and market access work in each of these key European markets to facilitate a successful series of launches.

Speaker Change: The European market represents an attractive opportunity for us with a proportionate number of demo tumor patients to that in the U S.

Speaker Change: We see a number of characteristics that are conducive to a successful launch.

Speaker Change: First prescribers recognize the high unmet need with available treatment options, which are limited given that there are currently no EMA approved therapies and access to off label treatments is not broad.

Speaker Change: Further while surgeries considered for some patients. It has selected less frequently for the treatment of designate tumors in some European countries.

Our survey work indicates high enthusiasm for the potential approval of <unk>.

Speaker Change: Based on a blinded profile more than 90% of oncologists unlikely to prescribe and believe that Octavio offers clinical benefits not offered by other therapies.

Speaker Change: Importantly, several key opinion leaders and sites already have experienced with octavio through to Fi as well as through our compassionate use program, which is more than 250 active patients.

Speaker Change: And finally, the care of days my tumors is relatively centralized in Europe, enabling the use of an efficient commercial footprint.

Speaker Change: Turning briefly to Japan, we've had several successful discussions with the <unk> over the course of the preceding months and we expect to initiate a bridging study next year.

Speaker Change: We are very pleased with the commercial performance of <unk> to date in the U S and are confident in the significant opportunity for growth ahead of us on a global basis.

Speaker Change: To recap just a few of the tailwind supporting continued strong growth.

Speaker Change: There is a large and growing patient population, which is larger than our original estimates.

Speaker Change: An increasing propensity to treat with systemix based on treatment guidelines.

Speaker Change: A shift towards initiating treatment based on symptoms rather than radiographic criteria.

Speaker Change: Strong physician preference for octavio across efficacy safety and quality of life metrics as well as long term data that support durable benefits with continued use of <unk>.

Speaker Change: We are gratified that octavio is changing the lives of patients with asthma tumors.

Speaker Change: And look forward to serving many more patients in the months and years ahead.

Turning now to <unk>, we are very excited about the significant opportunity ahead of us to make a profound impact on lives of patients and families living with this chronic and highly debilitating disease.

Speaker Change: There are approximately 100000 people in the United States living with Nf one.

Speaker Change: These individuals have a 30% to 50% lifetime risk of developing plexiform, neurofibroma, which are tumors that grow along peripheral nerve sheets and can cause severe disfigurement pain and functional impairment.

Speaker Change: We estimate that there are approximately 40000 patients with Nf one P N in the U S. Today, 75% of whom are adults, who currently do not have an FDA approved therapy.

Speaker Change: As there is no specific demographic leaning for this disease, we estimate that there are proportionate number of people living with Nf <unk> pn outside of the United States as well.

Speaker Change: While <unk> inhibitors have emerged as a validated class of treatment for <unk> Pn. There is currently no standard of care.

Speaker Change: No formal treatment guidelines and a highly fragmented treatment landscape with significant use of off label therapies, even for pediatric patients for whom there is an approved medicine.

Our market research shows that only a small portion of Nf one patients have been treated with a targeted therapy and that this community is desperately in need of new options.

Speaker Change: Data from our phase III renew trial support <unk> potential to be a differentiated therapy for both adults and children with Nf One P M.

Speaker Change: The renew trial results that were presented at <unk>. This year and the additional data that will be presented in a few weeks at the society of neuro oncology meeting with Jim will share in a few moments emphasize robust efficacy across both the adult and pediatric cohorts.

Speaker Change: These results show not only significant reductions in the size of Pn tumors with robust objective response rate as confirmed by blinded independent Central review, but also very deep responses, which we believe represent an important differentiator for us.

Speaker Change: In addition, both adults and children experienced early and sustained improvements in health related quality of life over the course of treatment with <unk>, including clinically significant reductions in pain.

Speaker Change: These outcomes are very meaningful since in many cases, the primary goal of treatment is to improve pain and other P and associated Morbidities.

Martin Imatinib: Martin Imatinib also demonstrated a manageable safety profile in both children and adults with low rates of grade III related adverse events and low discontinuation rates due to aes.

Martin Imatinib: We believe <unk> tolerability profile supports the potential for extended treatment durations, which is important in a chronic disease like <unk>, where there are high rates of recurrence after stopping therapy.

Martin Imatinib: Lastly, we believe that <unk> convenient dosing regimen, which provides a built in treatment holiday and a pediatric friendly dispersal tablet for oral suspension could further optimize the patient experience and potentially enhance compliance.

Martin Imatinib: With our NDA accepted under priority review and our marketing authorization application validated by the EMA. We are moving full steam ahead with commercial preparations.

Martin Imatinib: We are leveraging our commercial infrastructure and learnings from the successful Octavio launch to serve patients with <unk> Pn.

Martin Imatinib: We've spent the past several years collecting important insights from treating physicians and working to thoroughly understand the needs of the Nf one pm patient and caregiver community.

Martin Imatinib: These efforts have been especially critical on behalf of adult patients who have had to face this devastating disease without an approved therapy.

Martin Imatinib: Our disease State education campaign, entitled Coping isn't care focuses on educating and empowering young adult patients to advocate for themselves and to engage in ongoing treatment.

Martin Imatinib: This campaign has received high engagement and positive feedback from patients and physicians alike.

Martin Imatinib: We've also developed a launch plan that focuses on the aspects that differentiate <unk> from other systemic treatments based on a robust efficacy and safety data in patients of all ages.

Martin Imatinib: As we did for those of desert tumors, we will offer comprehensive patient services through our spring works care connection program, which is designed to support the unique needs of patients with <unk> pn and ensure that eligible patients have access to therapy.

Martin Imatinib: We've also hired and started training our sales team, which consists of 35 field representatives.

Martin Imatinib: Their initial focus will be on the 70, or so Nf clinical network centers across the United States, many of which have experience with <unk> from our renew trial as well as other key treatment sites in both the academic and community setting.

Martin Imatinib: These teams will be equipped with comprehensive resources and data to assist with patient identification.

Martin Imatinib: And enable them to target physicians, who are currently managing patients with Nf one P M.

Martin Imatinib: We are incredibly excited by the opportunity ahead of us to serve <unk> patients and we will share more on our commercial plans as we get closer to our February 28 <unk> date.

Speaker Change: With that I'll turn the call over to Jim to discuss the recent data highlights and provide an update on our emerging pipeline programs.

Martin Imatinib: Jim.

Thank you.

I'm pleased to take you through some of our recent data on important updates on our pipeline programs.

Martin Imatinib: With Madagascar that long term follow up data from our phase III <unk> trial will be presented in a late breaking oral session at the connective tissue oncology Society. This weekend.

These results utilizing in August 2024 data cutoff and with a median duration on therapy of approximately three years, so that longer term treatment with Nat gas that was associated with some of the reductions in tumor size and increase in the objective response rate with additional partial responses and complete responses.

Martin Imatinib: Sustained improvements in desmoid tumor symptoms, including pain.

Martin Imatinib: And a consistent safety profile compared to the April 'twenty 'twenty to be utilized.

Martin Imatinib: We utilized for the primary results of the trial.

Martin Imatinib: Given the debilitating chronic nature of days lung tumors. These results are very important for clinicians and patients.

They're very valuable insights on the longer term use of our medicine.

Martin Imatinib: Although the final data to be presented at <unk> include an oral presentation of a post talk analysis assessing the effect of that I guess that in subgroups of patients with days my tumors.

Martin Imatinib: Risk factors associated with poor prognosis.

Martin Imatinib: And a poster on patients with beta <unk> and <unk> mutations.

Martin Imatinib: We're very pleased the growing evidence from defy continues to support the significant benefit.

Martin Imatinib: If you can provide for a broad range of patients with <unk> tumors.

Turning to motor Mednet were pleased that our phase two be renew trial was recently published in the journal of clinical oncology and that new data from our renewed will be presented at the upcoming society for neuro oncology meeting.

Martin Imatinib: The first dataset being presented at Snow is a review of patients achieving deep responses on the demand that we observed impressive depth of response and renew.

Martin Imatinib: Both children and adults, which was confirmed by blinded independent Central review.

Speaker Change: That's a response.

Speaker Change: By many questions on patients to be an important indicator of a treatment success.

Speaker Change: Especially in the tumor and a critical site like the head and neck region.

Speaker Change: As highlighted in our abstract 62% of adults and 52% of children, who achieved an objective response.

Response, which we defined as greater than 50% reduction in tumor volume from baseline.

Speaker Change: Patients who had a deep response.

Speaker Change: Longer than those who did note and importantly, our data identify no baseline characteristics.

Which patients will achieve a deep response.

Speaker Change: The ability of patients to stay on therapy is an important factor.

We believe that Zip code.

Speaker Change: This differentiated tolerability profile and tablet for oral suspension formulation offers patients a meaningful chance to achieve long term disease control tumor shrinkage and symptomatic improvement.

Speaker Change: Also to be presented at snow is analysis of patient health related quality of life automotive maintenance patients.

Speaker Change: Patients with <unk> Pn.

Speaker Change: Significant morbidities, which include pain and other symptoms that negatively impact quality of life.

Speaker Change: Addressing the symptoms as an important goal of treatment.

Speaker Change: New trial patients under the method of experienced clinically meaningful improvements in that health related quality of life with the early and.

Speaker Change: Sustained during the course of treatment.

Speaker Change: Nearly half of the patients achieved clinically meaningful improvements that stake of 13, which was the pre specified analysis point.

Speaker Change: The improvements were noted in subscales, measuring patient's physical emotional and social experience as well.

Speaker Change: Next I will cover a few highlights from our earlier stage programs and collaborations.

Speaker Change: Beyond days my tumors natural gas that is being studied as a monotherapy.

Speaker Change: Phase II trial in patients with a median and you lose the sale tumors.

Speaker Change: We expect the top line data from this trial to be released in the first half of 2025.

Speaker Change: The phase III in June sponsored study of <unk>.

Speaker Change: In children and young adults with low grade glioma is ongoing.

Speaker Change: Exciting data from 23 patients enrolled in this study will be presented in an oral presentation at <unk>.

Speaker Change: The jays promising clinical activity in patients with recurrent or progress in low grade glioma across a variety of Matt Kay possibly aberrations.

Speaker Change: Our combination studies of <unk>.

Speaker Change: <unk> and <unk> are also ongoing on the next set of data from the monotherapy trial.

Speaker Change: And patients with map key operation is on track for release in the second half of 2025.

Speaker Change: Lastly, the phase one trial of SW 682 in patients with <unk> mutant tumors is underway with dose escalation and currently ongoing.

Speaker Change: At the recent Triple meeting held in Barcelona, We presented two preclinical dataset elaborating on the potential lows SW 682, as both a monotherapy and combination with Revlimid and.

In patients with head and neck cancer and also as a combination partner with <unk> inhibitors in patients with non small cell lung cancer.

Speaker Change: Now I'll turn it over to Frank to discuss our financial results.

Frank: Thank you Jim.

Frank: I'll now summarize a few highlights from our third quarter 2024 financial results.

Frank: Starting with revenues, we recorded $49 $3 million of <unk> net product revenue in the third quarter.

Frank: This brings our 2024 year to date <unk> net product revenue to $110 $5 million.

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

Frank: And the anticipated U S launch of mirrored Imatinib.

Frank: We have a strong balance sheet with $498 million in cash cash equivalents and marketable securities as of the end of the third quarter.

Frank: We believe that our current balance sheet will be sufficient to fully fund our operations through profitability, an important milestone, which we expect to achieve in the first half of 2026.

Frank: Lastly, we have a durable operating plan designed to fund multiple global product launches.

Frank: And to enable the continued investment and expansion opportunities across our pipeline.

Speaker Change: With that I'll hand, the call back over to soccer.

Speaker Change: Thank you Frank we.

Speaker Change: We are very pleased with our 2024 accomplishments to date and have several important milestones ahead of us.

Speaker Change: Our long term follow up data from our defined trial being presented to US are highly supportive of the benefits of extended treatment duration with a video in des Moines tumors and we believe the data from our renew trial being presented at snow reinforced the differentiated profile of <unk> for patients with Nf One P M.

Speaker Change: Looking ahead, we have multiple readouts in our emerging portfolio expected in the first half of 2025 as well and are continuing to advance our early stage discovery programs.

Speaker Change: To close we are very pleased that Octavio has rapidly become the standard of care for adults with desk what tumors as we discussed. This morning, there is a large and growing population of desperately tumor patients in need of the transformative benefits that our video offers and outperform.

Speaker Change: <unk> to date represents exceptional progress in terms of market uptake patient focused product innovation physician experience and data supporting long term use for <unk> and evolving treatment preferences that highlight the growing importance of earlier intervention and systemic therapies for this disease.

Speaker Change: We have strong conviction that we are just getting started and serving this community in the United States and have a significant opportunity on a global basis as well.

Speaker Change: We are working with urgency to bring mirrored unmet need to children and adults with <unk> in the U S. Following our <unk> date of February 28, and have begun our expansion to serve patients in Europe, starting next year.

Speaker Change: In parallel we are advancing our emerging portfolio to serve additional patients living with devastating diseases.

Speaker Change: We are confident that our strong foundation will support our continued success as we deliver on our mission to make a profound impact on patients' lives.

Speaker Change: As always I would like to thank the patients and investigators who participate in our clinical trials, our patient advocacy partners and collaborators and our team of spring workers working on behalf of patients in multiple community settings, where.

Speaker Change: We are now happy to take questions.

Speaker Change: Later.

We will now open the call for questions to ask a question. Please press star one one to remove yourself from the queue. Please press star one again, please limit yourself to one question and our first question will come from Andy.

Speaker Change: <unk> Rama of Jpmorgan Your line is open.

Speaker Change: Hey, guys. Thanks, so much for taking the question.

Speaker Change: Could you give us a little bit more color on how the blister pack transition progressed over <unk> and how we should think about.

Speaker Change: Sort of that remaining 35% progressing through <unk> and <unk>.

Speaker Change: Just trying to understand what have been the biggest sort of challenges to the transitions and how do you guys have been working through those and getting around some of the challenges. Thanks. So much.

Speaker Change: Thanks, a lot about so listen we made the choice to make the transition this quarter knowing that it was going to pose some challenges over the course of the quarter and we're very happy with where we've come out and so.

Speaker Change: What it means what it meant over the course of the quarter as we saw about a two week delay for many patients and getting their prescriptions refilled as they transition from bottle.

Speaker Change: Her pack refills and so over the course of that time, we saw the impact of that largely in July.

Speaker Change: We finished as we said on the call with our strongest months ever in August.

Speaker Change: And even a stronger month in September and I think it positions us really well now.

The reason we made this transition quite frankly for patients, it's a reduced pill burden.

Speaker Change: So we don't result in improved compliance and adherence and improve convenience for those patients first frameworks. It improves our tracking of dose reductions and we've gone flat pricing between 100 milligrams and 150 milligrams and so where that positions us going forward is to accelerate and Thats what were seeing.

Speaker Change: Over the over the course of the third quarter, that's what we expect to see going forward.

Speaker Change: And I think as you mentioned on the pump where about two thirds through that transition with the bulk of the patients who actually were going to benefit from that transition in the third quarter.

Speaker Change: Yeah.

Speaker Change: Well through that now and expect to be through it by the end of the year.

Speaker Change: Yes.

Yeah.

Speaker Change: And our next question comes from Iran. Werber of TD Cowen Your line is open.

Speaker Change: Hi, This is Gino honestly round.

Speaker Change: Thanks for taking my question you mentioned on the call that your ICD 10 data suggests that you have underestimated the tumor population could you elaborate a little bit on this and specifically what does your ITT. Gen 10 data indicate to you about the size of the overall opportunity and does my Q&A. Thank you.

Speaker Change: Sure. Thank you for the question. So just to level set right. These 10000 patients were identified.

Speaker Change: Between the introduction of the designated tumor specific ICD 10 codes in October 2023, and August of this year. So just a little under one year.

Speaker Change: The number is meaningfully higher than the 50 507000 patients that we've spoken about in the past and we know it's actually an undercount since new codes actually takes several years to become fully adopted.

Speaker Change: Proof of this factors that in our data we are seeing many desmoid tumor patients being prescribed octavio still being quoted on the old code, which was sort of a general soft tissue neoplasms deep $48, one ICD 10 code.

Speaker Change: And for a chronic and debilitating disease like doesn't with tumors, it's not a matter of when they will get prescribed on therapy.

Speaker Change: Thank you.

Speaker Change: And our next question will be coming from Peter Lawson of Barclays. Your line is open.

Speaker Change: Great. Thanks for taking my question.

Speaker Change: Just on the thanks for the demand.

Speaker Change: Demand dynamics wondering if you could kind of dig in a little bit around that.

Speaker Change: What is <unk>.

Speaker Change: Look like beyond September did you see military.

Speaker Change: Growth in Q3.

Speaker Change: How does that continue through Q4 thank.

Speaker Change: Thank you.

Speaker Change: Sure. Thank.

Speaker Change: Thank you Peter listen I think we are as we said we are poised for acceleration from here and within the quarter you saw that our largest San first month was August and then that was superseded by our largest ever month in September within that quarter.

Speaker Change: Adjusting for certainly.

Speaker Change: The decision we made to get it to do the blister packs with the impact of that in July, but if we step back let's think about where we are.

Speaker Change: In this journey to get to the larger group of patients. We already have 800 Guinea prescriptions in September.

Speaker Change: We've been steadily adding a consistent number of patients throughout the throughout the year with no reduction from where we are now to where we were.

Speaker Change: And we're starting to see the benefits of the blister pack both in the third quarter and then going forward here right.

Speaker Change: With parity pricing between the 100 milligram and 150 milligram dose.

Speaker Change: Add to that the fact that.

Speaker Change: This is a larger addressable markets into one we anticipated.

Speaker Change: As we think of 10000, ICD 10 claims already processed within within a year and that we believe is an under account that that patient population going forward combine that with the fact that the physician satisfaction is not just very high but the likelihood to treat is higher and the large majority of those physicians.

Speaker Change: <unk> to be using it or going forward quite frankly, a question here on the treatment use of <unk> for desktop tumor patients is not if but when.

Speaker Change: As patients need the treatment, we believe they will come to us if not at the outset. We are certainly seeing them steadily being added to our patient roles over the course of the year now I think the.

The important element to all of it so not only are we seeing it's a bigger patient population physicians are getting more familiar with the medicine and are much more likelihood to treat we have patients on a blister pack, which is going to improve.

Speaker Change: Retail rates and certainly the pricing neutral to us but on top of that.

Speaker Change: We're going to be sharing data at <unk>.

Speaker Change: Next weekend showing the benefits of continued treatment. So not only is there a kind of the rationale benefit.

Speaker Change: Having a reduction in pain, but we are seeing.

Speaker Change: Continued reduction in tumor size continued benefits on patient reported outcome scores.

Speaker Change: Increased.

Speaker Change: Complete responses partial responses from the benefit from the data that we have from our open label extension. That's now out to three years. So put that together, we feel great about the fourth quarter, but even well beyond the fourth quarter, Peter going forward, knowing that we made the conscious decision in the third quarter et cetera.

Speaker Change: Set ourselves up for it going forward.

Speaker Change: Yes.

Speaker Change: Our next question will be coming from Corinne Johnson of Goldman Sachs. Your line is open.

Corinne Johnson: Thanks, Good morning.

Speaker Change: Helpful commentary on that last question soccer, but im hoping you could expand a little bit on that it sounds like all the trends are kind of putting in the right direction. So is there any reason to expect that trends into October November December.

Speaker Change: A reverse of what you've seen thus far which is month over month growth every quarter and can you just help clarify what you're seeing now as we get into this fourth quarter.

Yes, I see nothing here certainly over the long term trend it does not.

Speaker Change: Well for us in terms of stacking patients getting better refill rates, certainly pricing, obviously being set and now getting to people showing that benefit to physicians for longer term dosing. So the stacking of patients the acceleration that I see.

Speaker Change: Currently we expect to see I don't see any abatement there.

Speaker Change: Thanks.

Speaker Change: Yes.

And our next question will be coming from David near Carton of Wedbush Securities. Your line is open.

Speaker Change: Hey, Thanks for taking our question, if we could dig into the patients being treated at.

Speaker Change: At the moment are they who come onto I was giving you a treatment are they.

Speaker Change: Typically active progresses are they transitioning from watch and wait to active treatment are they switching from other treatments, maybe if you could dig into that and if that's.

Speaker Change: Yes.

Speaker Change: Jing over summer to include more maybe more watchful waiting or vice versa.

Speaker Change: If you could comment on that that'd be great.

Speaker Change: Hello. Thank you for the question obviously, we're very pleased with the number of patients we see at the end of September.

Speaker Change: Specific to your question. We are we are seeing patients across the treatment continuum.

Speaker Change: Data right, we are seeing newly diagnosed patients we see patients who came off.

Speaker Change: Watch for waiting we're seeing switch patients from <unk> chemotherapy and.

Speaker Change: As you've seen from the data we presented also patient.

Speaker Change: Patients who had surgery have seen regrows tumors. So we've seen a mix across your back there is no particular leaning towards any specific group. So so David what I would add to that is kind of what I was saying before is that we really believe it's not a function of if a plant.

Speaker Change: With this patient group and as with most rare diseases with greater awareness greater familiarity with the medicine from the prescriber community, we expect to see a greater urgency to treat all of the clinical data, including what was shared setose actually argues for that and so.

Speaker Change: What we see as weak as we've seen in many other situations rare diseases, you cross that threshold of awareness and it will continue to add patients and particularly in this disease.

Speaker Change: Patients do go through other treatments before they get to us and we expect more and more to come to us first.

Speaker Change: And our next question will be coming from Alec Stranahan Bank.

Speaker Change: Bank of America. Your line is open.

Speaker Change: Hey, guys. Thanks for taking our questions.

Speaker Change: Bob as you mentioned limited view of discontinuation to date.

Speaker Change: Do you have a sense of how prescribers are approaching this.

Speaker Change: And maybe what the patient profiles, where who did discontinue and that follow up what percentage of patients have had dose reductions and are maybe drug holidays also being considered for some patients perhaps in the context of ovarian dysfunction.

Speaker Change: Yes so.

Speaker Change: I think.

Speaker Change: Greater there's confusion as Ive said <unk> been generally though.

Speaker Change: And what wed expect given the clinical trial experience, indicating that patients are having a positive experience octavio.

Speaker Change: And they're able to stay on therapy right.

So overall I think.

I'm trying to recall part of the question.

Speaker Change: We've seen fewer than 10% of patients overall.

Speaker Change: On CBOE discontinued you're roughly a year into launch at this point in time.

Speaker Change: From a dose reduction perspective.

Speaker Change: Now with the transparency afforded by the bottles. We did not have full visibility was starting to get more visibility with patient switching to the 100 and 150 milligram blister packs and based on the conversion data we've seen so far we see a majority of patients are still under 150 milligram, which actually.

Speaker Change: Portends, well for me being able to tolerate <unk> therapy at the maximum dose.

Speaker Change: But we.

Speaker Change: We do see a proportion of patients at the 100 milligram dose as well.

Speaker Change: Get much better transparency into that overall mix by the end of Q4, when the transition is complete and what I'd say is you.

Speaker Change: Use the reference of the <unk> study, where you had about 40% of patients.

Speaker Change: Clinical protocol dose reduce down so as we think of the opportunity for the blister packs going forward, we haven't seen that yet we'll have greater clarity as Bob says.

Speaker Change: <unk> got people on the 100 milligram dose, but if that is the amount that goes down that is the capture so we see possible through the introduction of a blister pack in the 100 milligrams.

Speaker Change: Got it.

Speaker Change: And our last question will be coming from Rosie Leo.

Speaker Change: Guggenheim Your line is open rosy.

Speaker Change: Hi, guys. This is <unk> on for Michael Schmidt. Thanks, Ricky.

Speaker Change: And your question, so I guess <unk> Xavier looking forward to 2025, how should we think about the trajectory for the second year of OXXO the launch relative to the first year and perhaps.

The longer term effects of the new formulation.

Speaker Change: So some things up a little bit on with respect to my button up your pizza coming up at the end of February and I guess, how should we think about that sure hi Geoffrey.

Speaker Change: Saturday there for that launch relative to <unk>.

So thank you Rajiv and listen I think I'll come back to where we are I think we are positioned incredibly well for 2025 and beyond Brian all of the stage has been set and let me take you through the parameters. Once again right already we talked about unique 800 unique prescriptions going forward, but what gives us that.

Speaker Change: Confidence going forward from here is the fact that it is a larger patient population, we talked about the 10000, plus ICD 10 claims, which we think is.

Speaker Change: And under call our enthusiasm physicians with <unk>, we are already the systemic standard of care and we expect that only to improve with doctors, indicating their desire to use it more going forward. We now will be by the end of the year as we get into 2025 through the blister pack transition.

Speaker Change: So youll be able to benefit from better refill rates.

Speaker Change: The better compliance for patients who are now required to take your films and certainly.

Speaker Change: As I said parity between 100, and 150 milligram dosing for US and then certainly that benefit of longer term duration of dosing and now we've got clinical data not just patient data will clearly benefit from a pain reduction standpoint, but clinical data supporting why those patients are benefiting from.

Speaker Change: Continued dosing here.

Speaker Change: So I think we are in a very good position for 2025 and beyond and the ability to stack patients have a medicine that these patients do need better awareness of what is out there.

Speaker Change: Now with the transition of the blister pack largely behind US, we think we're very well positioned going forward.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: And this concludes today's call. Thank you for joining you may now disconnect.

Speaker Change: Yeah.

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