Karyopharm Therapeutics Inc.

Good morning. My name is Patrice and I'll be your conference operator today. At this time, I would like to welcome everyone to the CarioPharm Therapeutics First Quarter 2020 Financial Results Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Mr. Ian Karp, CarioPharm's Vice President, Investor and Public Relations.

Thank you, Patrice, and thank you all for joining us on today's conference call to discuss Carrier Farms' first quarter 2020 financial results and business update. This is Ian Karp, and I'm joined today by Dr. Michael Kaufman, Chief Executive Officer, Dr. Sharon Shacham, President and Chief Scientific Officer, Mr. Mike Mason, Chief Financial Officer, Mr. John Demery, Chief Commercial Officer, Mr. Christopher Permiano, Chief Business Officer and General Counsel, Dr. Jayden Shaw, Chief Medical Officer, and Mr. Perry Monaco, Senior Vice President of Sales. On the call today, Dr. Kaufman and John will provide an overview of key recent corporate developments and an update on our commercial progress. Mike Mason will then highlight the first quarter 2020 financial results, and we'll conclude with the Q&A portion of the call. Earlier this morning, we issued a press release detailing Carrier Farm's results for the first quarter of 2020. This release, along with a slide presentation that we plan to reference, are available on our website at carrierfarm.com. Before we begin our formal comments, I will remind you that various remarks we will make today constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation and Reform Act of 1995. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, including our expectations related to the commercialization of Expovio, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those disclosed in the risk factor section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we may make in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. In addition, please note that any references we make to clinical trial data during today's discussion refer to interim unaudited site data unless otherwise specified. I'll now turn the call over to Dr. Michael Kaufman.

Thank you, Ian, and good morning, everyone. Despite these challenging times, I just want to have a couple of words that I'm extremely proud to be part of this organization. It has been a remarkable several months now. Keep in mind that we are actively in dialogue with FDA on our supplementary NDA for our SADL study in patients with relapsed or refractory diffuse large B-cell lymphoma. and we've been working extremely hard to deliver the highest quality supplementary NDA for the Boston trial for patients who have previously created multiple myeloma. We're very pleased to report that this NDA will be submitted before the end of this month. And in the meantime, and following some extremely strong scientific preclinical and clinical observations, we've developed an internal virology program focused on the SARS-CoV-2, which causes COVID-19. In less than six weeks from conception internally, along with several independent external scientific reports, we've initiated a randomized phase two study of patients with severe COVID-19. What's even more remarkable about this program is the strength of the scientific foundation on which it's built. And this foundation has supported the rapid regulatory approvals and excited a large number of hospitals across the world to join the study in short order. Now, of course, it's still too early to know if low-dose Selinexa will prove effective against SARS-CoV-2, but we remain cautiously optimistic, and I frankly could not be prouder of our employees and partners around the globe who worked with remarkable urgencies to initiate this study and help us make a difference during these unprecedented times. Now, in the setting of these specific challenges created by the COVID-19 pandemic, we've still been extremely productive on the commercial, clinical, and corporate development fronts, and we expect this to be yet another transformational year for our company. For those following along the slide presentation, please now turn to slide four. First quarter Expovio sales were $16.1 million, with total revenues reaching $18.1 million. We did experience a 9% decrease in Expovio sales compared to the fourth quarter of 2019, but the decline was primarily due to minimal channel inventory built in the first quarter as compared to the previous two quarters, as well as market effects from the COVID-19 pandemic, which primarily impacted the volume of new patient starts in the quarter. Importantly, we did see more than 150 new physician accounts prescribe Expovio for the first time in the quarter, and we saw demand for Expovio accelerate in April. The most significant event in the quarter was the positive top-line results from the Phase III Boston study, a randomized trial of once-weekly selenexer, bortezomib, and dexamethasone against standard twice-weekly bortezomib and dexamethasone. The trial met its primary endpoint with a statistically significant increase in progression-free survival. This is now the first randomized phase 3 trial to demonstrate clinically significant activity of once-weekly Expovio in combination with once-weekly Bortezomib over a current standard of care anti-myeloma treatment in patients who had previously received one to three prior therapies. We believe these results represent a significant advance with a highly convenient once-weekly regimen, our so-called Boston SVD regimen, for patients with previously treated myeloma. The study results will be disclosed in an oral presentation at the upcoming ASCO 2020 virtual scientific program at the end of May. And as mentioned, we expect to submit a supplemental new drug application to the U.S. FDA by the end of this month, a bit earlier than originally planned. In addition, our SMDA for Expovio in patients with relapsed or refractory DLBCL after at least two prior lines of therapy received priority review from the Thank you for joining us today. in Australia, South Korea, and additional Asian Pacific markets, excluding Japan. Under the terms of the amended agreement, we will receive an upfront payment of $12 million in the second quarter of 2020 and are eligible for additional future milestone payments and royalties. Certain countries included in the expanded antigen territory became available at no cost to Cariopharm following our reacquisition of the exclusive development and commercial rights from Mono Pharmaceuticals last month. Importantly, in addition to the U.S. and Europe, we now retain full rights to Selenexer and Eltenexer in Japan, following our reacquisition of these rights from ONO, again, at no cost to Carrier Park. Please now turn to slide 5, where I will ask John Demery, our newly appointed Chief Commercial Officer, to provide some additional details on ExpoVO sales performance during the quarter. John?