Karyopharm Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to the DynaVax Technologies first quarter 2022 financial results. As a reminder, this conference call is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific instructions at that time. I would now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations. You may begin.

Thank you. Good afternoon, and welcome to the DynaVax first quarter 2022 financial results and corporate update conference call. In addition to our press release issued today, a supplementary slide presentation that accompanies today's call is available in the event section of our website. Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including but not limited to potential market size and market share. impact of ACIP recommendations, financial guidance and trends, expected regulatory filings or approvals of our collaborators, clinical readouts, and potential future uses of CPG-1018 adjuvant. These statements involve risks and emergencies, and our actual results may differ materially. These results, these risks are summarized in today's press release. and detailed in the risk factors section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today, and we undertake no obligation to update these statements. Joining me on the call today are Brian Spencer, Chief Executive Officer, Don Casal, Senior Vice President of Commercial, Rob Jansen, Chief Medical Officer, and our Chief Financial Officer, Kelly McDonald. I will now turn the call over to Ryan.

Thank you, Nicole, and thank you all for joining us today. We are very excited to have this opportunity to review the progress we've made in our business during the first quarter. I will provide some corporate highlights and a brief review of our COVID-19 adjunct supply business before I turn it over to Don, Rob, and Kelly to provide a bit more insight into their respective areas. Following a year of record revenue in 2021, we are off to a great start in 2022. Our team has demonstrated strong execution in driving growth of Hepatitis B and executing on our adjuvant supply business for COVID-19 vaccines, driving total revenue of $114 million in the first quarter, which was up 37% from the same period last year. For Hepatitis B, we are seeing positive momentum driven by market growth as we emerge from the pandemic, along with our continued successful engagement across our customer segment. Through our efforts, we have achieved $21 million in product sales in the first quarter, providing us continued confidence in our expectation for annual revenue growth. Additionally, we continue to focus increasing effort on driving awareness of the expanded ACIP recommendation, which we believe will result in significant market growth over the coming years. In addition to HEPA-SAP-B, our global portfolio of CPG-1018 adjuvant supply agreements for COVID-19 vaccines, generated $92 million as the largest driver of revenue in the first quarter. We're very proud of our efforts to support the development of multiple COVID-19 vaccines. Our COVID-19 supply partners have received multiple emergency use authorizations, and additional regulatory applications are under review, with decisions anticipated in the second and third quarter of this year spanning multiple countries and regions. Additionally, our partners continue to expand their clinical data to support broad utilization of their vaccines. This includes additional clinical trials to support heterologous boosting, elderly and pediatric indications, and research to evaluate new variant-based vaccines. Based on the impressive phase three data sets across our COVID-19 partnership portfolio, we believe the combination of high efficacy and immunogenicity with favorable safety and tolerability provides a very competitive profile as COVID-19 vaccine landscape evolves to a recurring booster market. We expect revenues of at least $550 million from our adjuvant supply business in 2022, and our supply partners' continued progress provides opportunity for future revenues as the endemic COVID-19 vaccine market develops. We are also leveraging CPG1018's profile in our clinical pipeline to develop new and improved vaccines. We have advanced two programs into the clinic, Tdap and Shingles, both of which are on track to generate additional clinical data this year that we anticipate will highlight our high-value pipeline designed to produce best-in-class products targeting large markets. Our performance this quarter puts us on track to achieve annual revenue growth in 2022 for both Heplis FV and CPG 1018 adjuvant supply, which is expected to enable a second consecutive year of profitability. This strong financial performance has resulted in sufficient capital for us to bring HEPA-CEP-B to profitability, develop our existing pipeline, and to continue to advance CPG-1018. We are committed to taking advantage of all the strengths we have, including our commercial, manufacturing, and development expertise, our advancing clinical pipeline, our strong balance sheet, and our team's commitment to deliver value for public health and our shareholders. I'll now turn the call over to Dawn to provide more details on HEPA-CEP-B performance.