Karyopharm Therapeutics Inc.

Good morning. My name is Vaishnavi, and I'll be your conference operator for today. At this time, I would like to welcome everyone to the Carrier Farm Therapeutics Fourth Quarter and Full Year 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, Carrier Farm Senior Vice President, Investor and Public Relations. Please go ahead.

Thanks so much, and thank you all for joining us on today's conference call to discuss Carrier Farms' fourth quarter and full year 2020 financial results and business update. This is Ian Karp, and I'm joined today by Dr. Michael Kaufman, our Chief Executive Officer, Mr. Mike Mason, Chief Financial Officer, Mr. John Demery, Chief Commercial Officer, Dr. Jayden Shah, Chief Medical Officer, and Mr. Stephen Michener, Chief Business Officer. On the call today, Mike will provide an overview of key recent corporate developments and an update on our commercial progress. and then Mike Mason will provide an overview of the fourth quarter and full year 2020 financial results. We will conclude with a Q&A portion of the call. Earlier this morning, we issued a press release detailing Carrier Farm's results for the fourth quarter and full year of 2020. This release, along with a slide presentation that we will reference, are available on our website at carrierfarm.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the State of Harbor provisions under the Private Securities Litigation Reform Act of 1995, as outlined on slide three. 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 materially differ from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our most recent quarterly report on Form 10-Q, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only, but we may elect to update these forward-looking statements at some point. 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. With that, I'll now turn the call over to Michael Kaufman, Chief Executive Officer.

Thank you, Ian, and good morning, everyone. 2020 was a pivotal year for Cary Farm, and I'm extremely proud of the significant progress our team has made towards our commercial, clinical development, and operational objectives with the ultimate goal of having positive impact on the lives of patients battling cancer. Most notably, our year was marked by two U.S. FDA approvals for Expovio, first in June for the treatment of patients with relapsed or refractory diffused large B-cell lymphoma, or DLBCL, And then in late December, once weekly Expovio received additional approval in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. We expect to carry the momentum of these important achievements into 2021 and have already started the year with several recent accomplishments as outlined on slide four. Expovio net product revenue for the fourth quarter and full year of 2020 were 20.2 million and 76.2 million respectively. More than 170 and 700 new physicians and accounts prescribed Expovio for the first time in Q4 and in 2020 overall, respectively. These achievements are particularly encouraging, keeping in mind that Expovio was only first approved for use by the FDA in July of 2019. And of course, for most of 2020, we've all been impacted in some shape or form by the ongoing COVID-19 pandemic. The expansion and launch of Expovio into the second and third line treatment settings significantly increases the addressable patient population for Expovio and represents a meaningful growth opportunity for carry of harm in both the near and long term. Separately, in December, the addition of three Expovio treatment regimens for multiple myeloma to the National Comprehensive Cancer Network's clinical practice guidelines in oncology represented another key achievement that we believe will help further expand Expovio's utilization. For our pipeline progress, we recently announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion recommending the conditional approval for Nexpovio, the brand name for Selenexer in Europe, in combination with dexamethasone for the treatment of myeloma in adult patients with heavily pretreated disease, an indication nearly identical to the approved indication that Expovio received in the 2019 accelerated approval issued by the FDA in the United States. I will talk a bit more about our expecting steps for Europe in just a few minutes. Additionally, we were excited to secure our first regulatory approval outside the United States in Israel for both myeloma and DLBCL, which we announced last week. Turning now to other program updates from our ongoing hematological and solid tumor clinical studies. Our Phase III Siendo study evaluating expovial endometrial cancer passed its planned interim futility and upsizing analysis, and we look forward to the top-line results expected in the second half of this year. In addition, the first patient in the Phase 2-3 Export DLBCL-030 study evaluating Expovio in patients with DLBCL has now been treated, and this study will serve as a confirmatory study for Expovio's accelerated approval in DLBCL granted last year. Finally, on the financial front, we ended the quarter with a strong cash position of approximately $276.7 million that, along with expected future revenues, we anticipate will be sufficient to fund our planned operations into late 2022. Let me now turn to slide five to provide additional details on Expovio sales performance through 2020. In the first three quarters of 2020, we generated steady increased sales for Expovio due to both the unique attributes of Expovio as well as the hard work of our dedicated commercial team. Net sales for both the full year of 2020, as well as for the fourth quarter specifically, were largely driven by prescription demand from both academic and community-based oncologists for patients with penta-refractory multiple myeloma. The 5% decrease in product sales in the fourth quarter as compared to the third quarter was a result of the impact from both the recent surge in US COVID-19 cases as well as some increased competition for patients. More specifically, as we turn to slide six, we believe the surge in COVID-19 cases impacted both patient visits to their healthcare providers as well as in-person access for KarioPharm's commercial team to its physician customers. Additionally, increased competition from recently launched drugs in pentarefractory myeloma and in refractory DLBCL settings also contributed to some additional sales pressure in the quarter. However, we are seeing a meaningful rebound in demand and new patients start since the expanded approval, further reinforcing our confidence in the future growth potential for Expovio. As mentioned previously, The addition of multiple Expovio combination regimens to the NCCN guidelines and the expanded FDA approval of Expovio provided strong tailwinds for sales growth in December, following declines in October and November. We're still in the very early stages of the launch of Expovio into the second and third line settings, but we expect to see significant increase in annual sales largely driven by both earlier use and longer duration of treatment in patients with myeloma. Moving now to slide seven, the graph here shows the prescription refill rate for Expovio over 2020 for both the first and second refills for those patients eligible for these refills. These numbers have remained encouraging throughout 2020 and are significantly higher as compared to our initial launch period in 2019. These refill rates, coupled with an average of nearly three treatment cycles per patient as of the end of 2020, further reinforce the positive feedback we have received from physicians and patients regarding their experiences and uses of Expovio. Importantly, the patient discontinuation rate due to side effects remain relatively low at 13%, which we believe is a testament to more and more physicians gaining comfort in helping their patients prevent and manage the side effects of Expovio with proper prophylactic and supportive therapies, as well as dose modification. In addition to the expanded label for Expovio in the U.S., we believe that future International expansion of Expovio in Europe will be another key strategic area of growth for CarioPharm, which I'll now highlight on slide eight. The CHMP positive opinion for Nexpovio, which was issued at the end of January, could lead to our first regulatory approval in Europe and recognizes the positive clinical benefit risk profile of oral Nexpovio. We look forward to the European Commission's final decision on an Expovio submission, which is expected in April 2021. We intend to submit a second regulatory filing based on the data from the Phase 3 Boston study with the goal of further expanding the global reach of Nexpovia to additional patients in need of new treatment options. And encouragingly, even before a possible European regulatory approval, the European Hematology Association and European Society for Medical Oncology recently updated their treatment guidelines for myeloma in November of 2020 and added Selenexer, Velcade, dexamethasone regimen to their second-line recommendations and Selinexa with dexamethasone to the third-line plus treatment guidelines. In parallel to the regulatory experts, we're also continuing to evaluate potential collaborations with partners in Europe and Japan. We're committed to making Expovio available in Europe if approved in April with the greatest opportunity to come potentially before the end of 2021 when we would hope to receive an expanded approval in Europe based on the data from our phase three Boston study. I'd be remiss if I did not mention updates on a number of additional exciting pipeline opportunities that we are pursuing for Expovio, which can be seen on slides nine and 10. We have a robust clinical development plan for Expovio in both hematological malignancies and solid tumors. This includes our phase three Ciendo study in patients with endometrial cancer, where we expect to have a top line data readout before the end of this year. I'll note that there are two additional new important clinical trials we plan to initiate in 2021, which we believe will help further define the broad clinical utility of Expovio as a potential partner of choice with other active anti-cancer agents. First, we expect to initiate a new randomized phase three study evaluating Expovio in combination with Pomalyst and dexamethasone in patients with previously treated myeloma. If the results of this trial are positive, this regimen would represent a potent oral drug option to patients with refractory disease. Next, we plan to initiate a new phase two study evaluating Expobio in combination with Keytruda in patients with newly diagnosed or recurrent metastatic melanoma. We're particularly excited about this study based on some encouraging data from the MD Anderson investigator sponsored trial evaluating this combination regimen, which was presented at the annual ESMO conference in 2020. With that, I'll now turn the call over to Mike Mason to review the quarterly financials. Mike?