SpringWorks Therapeutics, Inc.

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 SpringWorks Therapeutics Third 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 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 SpringWorks Therapeutics. Kim, you may now begin the conference.

Thank you and good morning everyone. Welcome to the SpringWorks Therapeutics third quarter 2024 earnings conference call. 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.springworkstx.com. Joining me today are Saqib Islam, Chief Executive Officer, Babash Ashar, Chief Commercial Officer, Dr. Jim Cassidy, Chief Medical Officer, Frank Perrier, Chief Financial Officer, and Dr. Badruddin Idrees, Chief Operating Officer. Before we begin, I would 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 report filed with the SEC. Your caution is 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 Sajid.

Thank you, Kim, and thank you all for joining this morning. 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. Starting with Oxivio for patients with desmoid tumors, we are very pleased with the continued strong momentum of our US launch. In the third quarter, we reported $49.3 million in net product revenue, which represents a 23% growth quarter over quarter. This strong and steady growth is driven by robust demand, both from new patient starts as well as existing patients who are continuing to experience meaningful anti-tumor activity, and substantial improvements in their quality of life on OXIVIO. As we approach the one-year mark of our launch, we are very pleased with our progress in making OXIVIO the standard of care systemic therapy for patients with desmoid tumors. Our commercial execution to date has been exceptional, and our market research shows we have only reached a small portion of people with desmoid tumors who can potentially benefit from Onvivio. In a few moments, our chief commercial officer, Bhavesh, 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. In these data, you will see high enthusiasm for OXIVIO, increasing likelihood and desire to treat, and an addressable patient population that appears to be meaningfully larger than we initially estimated. 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. Four key drivers underscore our confidence and a significant opportunity in front of us. First, this quarter we successfully introduced 150 milligram and 100 milligram strength tablets of Onfivio in blister packaging to increase patient convenience, adherence, and renewal times. Second, we now have real-world data that strongly suggests that the addressable patient population is larger than we initially had estimated. We have continued to see very high satisfaction from physicians and expect that the majority will increase their usage of OXIVIO in the coming year. And fourth, we have continued to generate data on the benefits of longer-term treatment with OXIVIO. 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 Oxivio's opportunity to benefit patients with desmoid tumors and are poised for success to help this patient community going forward. Turning to mirtometinib, there is a substantial unmet need for the approximately 40,000 people living with NF1PN in the United States alone, 30,000 of whom are adults and 10,000 are children. Our NDA for adults and children with NF1PN was granted priority review and launch preparations are on track ahead of our February 28th, the due for date. Data from our pivotal phase 2b renewed trial form the basis of our NDA and provide the potential for mirtamitinib to become the first FDA approved treatment for adults with NF1PN and a best in class option for children. Our team is excited by the opportunity to deliver a medicine that has the potential to provide deeper responses than existing therapies, a manageable tolerability profile, improved quality of life, and a dispersible tablet formation for children and adults unable to swallow a pill. We look forward to continuing to work with the FDA throughout the NDA review process while simultaneously advancing our commercial preparations in anticipation of a potential approval in early 2025. In parallel, we are advancing our efforts to bring our innovative therapies to patients globally, with EU regulatory reviews for Onxivio and Mirtimetinib underway. With the potential for both approvals to come in 2025, we have onboarded European commercial and medical leadership to further advance these efforts and prepare to bring our medicines to market. Beyond our work in desmoid tumors and NF1PN, we continue to advance our emerging portfolio, which Jim Cassidy will provide an update on later in the call. Lastly, we have a strong balance sheet that we expect to fund us through profitability, which we are on track to achieve in the first half of 2026. I'll now turn the call to Bhavesh to discuss our progress with Onxivio for patients with desmoid tumors and our prelaunch preparations for mirtometinib for patients with NF1PN. Saves?