SpringWorks Therapeutics, Inc.

After the speaker's remarks, there will be a question and answer session. Please limit your questions to one. Thank you. I would now like to hand the conference over to Samantha Sandler, Senior Director of Investor Relations at SpringWorks Therapeutics. Samantha, you may now begin the conference.

Thank you, and good morning, everyone. Welcome to SpringWorks Therapeutics' second quarter 2024 earnings conference call. This morning, we issued a press release which outlines our financial and operational results for the second 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, Bhavish Asher, Chief Commercial Officer, Dr. Jim Cassidy, Chief Medical Officer, Frank Perrier, Chief Financial Officer, and Dr. Badraveen 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. This 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.

Thank you, Sam, and thank you all for joining this morning. I'm pleased to share our second quarter results and 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 encouraged by the strong momentum of our U.S. launch. In the second quarter of 2024, we reported $40.2 million in net product revenue. This robust and continued growth is driven by the transformative clinical benefits from OXIVIO, high demand from patients and physicians across treatment settings, and strong commercial execution. Since our FDA approval last November, OXIVIO has rapidly become the standard of care systemic therapy for patients with desmoid tumors. As Bhavesh will discuss in more detail, we are seeing steady growth in new patient starts, as well as strong persistence from those who previously initiated OXIVIO therapy. Importantly, patients are reporting rapid and meaningful symptomatic relief, which is contributing to their overall improved quality of life and their enthusiasm for OXIVIO for their treatment. We are pleased with our early launch experience and believe that we have only reached a small proportion of people with desmoid tumors who can benefit from OXIVIO. Our confidence in the overall patient population has continued to increase as we have gained further insights from the launch and from emerging desmoid tumor specific claims data. our conviction remains high in the opportunity we have in front of us to serve an increasing number of desmoid tumor patients. Turning to our investigational MEK inhibitor, mirtimetinib, in the second quarter, we completed our NDA submission to the FDA for the treatment of children and adults with neurofibromatosis type 1 associated plexiform neurofibromas, or NF1PN. Our NDA submission is based on positive data from our Pivotal Phase 2b Renew Trial, which support the potential for miridometinib to be a best-in-class therapy for both children and adults living with these devastating lifelong tumors. 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 pediatric patients. Challenges with administration and tolerability limit the use of currently available options for children, and there are no FDA-approved therapies for adults. We look forward to working with the FDA throughout our NDA review process and to advancing our commercial preparations in anticipation of our second medicine introduced to patients in 2025. We are also excited about the opportunities in our emerging portfolio. We have several important efforts in development to serve additional patient populations with high unmet needs, including patients with ovarian granulosa cell tumors, multiple myeloma, and MAPK mutant solid tumors. In addition, we recently began enrollment in our phase one study of our investigational TID inhibitor, SW682, in hippo mutant solid tumors. which represent up to 10% of cancers. Finally, we have durable IP protections for our lead molecules and a robust balance sheet that we expect to fund us through profitability. I'll now hand the call to Bhavesh to discuss our progress with Oxivio for patients with desmoid tumors. Bhavesh?