Deciphera Pharmaceuticals, Inc.

Thank you, Operator. Welcome, and thank you for joining us today to discuss Decipher's third quarter 2022 financial results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. With me this morning to discuss the financial results and provide a general corporate update are Steve Herter, President and Chief Executive Officer, Dan Martin, Chief Commercial Officer, Matt Sherman, Chief Medical Officer, Mark Rieda Duarte, Head of International, and Tucker Kelly, Chief Financial Officer. Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this conference call include our expectations for our preclinical and clinical programs, our commercialization of Kinloch, and 2022 guidance. Forward-looking statements made on this call involve substantial risks and uncertainties that could cause the actual results to differ materially from those expressed or implied by the forward-looking statements, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent quarterly report on Form 10-Q, as well as our SEC filings. We assume no obligation to update or revise any forward-looking statements. Following this call, a replay will be available on the company's website, www.deciphera.com. With that, I will now turn the call over to Steve Herter, President and Chief Executive Officer of Deciphera. Steve?

Thank you, Jen, and good morning, everyone. Thank you for joining us today as we provide an update from the third quarter, review our financial results, and discuss upcoming corporate milestones. We achieved another record for Kinloch revenue in the third quarter, reflecting our success delivering this breakthrough medicine to patients in the United States and around the world. Our efforts to expand the global reach of Kinloch continued as we submitted a reimbursement application to authorities in Italy and initiated the market access process in Spain. We are proud of the difference Kinloch has made in the lives of fourth-line GIST patients around the globe, and we remain committed to ensuring this important medicine reaches the patients who need it most. We made significant progress in the third quarter across our clinical stage portfolio and presented exciting new data updates from the Vimseltinib and DCC3116 programs at the European Society of Medical Oncology, or ESMO, Congress in Paris. At ESMO, we presented the initial phase one dose escalation data for DCC3116, our first-in-class ALK inhibitor targeting the autophagy pathway. in patients with advanced metastatic tumors with a mutant RAS or RAF gene. We demonstrated three key outcomes in the Phase I data. DCC 3116 demonstrated dose-dependent pharmacokinetics, a favorable tolerability profile, and strong target inhibition across all dose levels tested. Since the presentation at ESMO, we completed enrollment in the Phase I single-agent dose escalation portion of the study. and selected the starting dose for these cohorts. We announced today that we opened enrollment of these dose escalation combination cohorts with the first patient treated last week. At ESMO, we also presented updated data from the Phase 1-2 study of Vimseltinib, our orally administered inhibitor of CSF1 receptor for the treatment of patients with tenosynovial giant cell tumor, or TGCT, not amenable to surgery. The updated data underscored the best-in-class potential of imseltinib, demonstrating strong clinical activity, positive patient-reported outcomes, and a favorable tolerability profile. Finally, we announced today that we have nominated BCC3084, a selective inhibitor of BRAF and C-RAF kinases, as the next clinical candidate to enter our portfolio. Discovered using the same proprietary kinase inhibitor platform that has brought us Kenlock, Vimseltinib, and DCC3116, we believe DCC3084 has the potential to be best in class and demonstrates our ability to discover novel agents for the treatment of cancer. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to share more details on our strong U.S. commercial performance. and then to Margarita Duarte, our head of international, to provide an update on Kinloch's ongoing fourth-line launch in Europe, which has continued its positive momentum throughout the year. Dan? Thanks, Steve.

In Q3, we continue to execute on our commercial goals for Kinloch in the U.S., reinforcing its position as the clear standard of care and fourth-line gist, while continuing to grow our prescriber footprint and position experience with Kinloch. During the quarter, we achieved $24.5 million in total net product revenue in the U.S., which represents a 23% increase from Q3 of last year. Our key performance metrics continue to reflect strong commercial execution. In Q3, our sales and marketing teams again drove strong unit demand volume across all business segments. Our launch-to-date prescriber base has continued to grow at a very consistent pace quarter over quarter, exceeding 750 positions through Q3 2020. with the majority of new prescribers again coming from the community setting. Our market access team has continued to deliver excellent payer access with 100% payable claims for on-label patients during the quarter. And we again saw strong persistency and time on therapy. The percentage of patients receiving free drug under our patient assistance program or PAP was at the high end of our 20 to 30% estimated range as anticipated. Consistent with what we saw in 2021, we expect the PAT percentage in Q4 of this year to again be at the high end of our estimated annual range of 20 to 30%. Turning to themselves in it, as the clinical team continues to rapidly enroll patients in the phase three motion study, our commercial team continues to prepare for the potential launch of our second marketed product. Given the limitations of existing therapies, there is a clear unmet medical need for TGCT patients who are not amenable to surgery. In market research, physicians and patients consistently cite the desire for an effective therapy without having to sacrifice safety and tolerability. Our recent market research with TGCT treaters further supports the potential for vimseltinib to establish a new standard of care. We conducted detailed interviews with TGCT treaters to gain their feedback on the vimseltinib data generated to date and on how it compares to existing treatment options. After reviewing product profiles for Vinsultinib, Paxartinib, and Imatinib, TGCT treaters consistently rated the Vinsultinib profile as highly compelling across all key product attributes. When asked which of the three products they would be most likely to recommend to their TGCT patients, every physician interviewed selected Vinsultinib, commonly citing what they perceived to be best-in-class efficacy and safety. This feedback from TGCT treaters further underscores why we believe in Sultanate has the potential to deliver a best-in-class profile and the opportunity to provide tremendous clinical benefit to TGCT patients globally. I will now turn the call over to Margarita Duarte, our head of international, to discuss the results from the third quarter of the commercial launch of Kinloch in Germany and the progress we're making in other European countries and around the world. Margarita?