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Seagen Inc.
4/28/2022
Good day and welcome to the Segan first quarter 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. And to withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Clay Segal. Please go ahead, sir.
Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to CJIN's first quarter 2022 financial results conference call. This afternoon, we issued a press release with our results, and that press release and supporting slides are available on our website in the investor section, events, and presentations page. Speakers on today's call will be Clay Segal, President and Chief Executive Officer, Todd Simpson, Chief Financial Officer, Chip Bromp, Executive Vice President, Commercial U.S., and Roger Danzy, Chief Medical Officer. Following our prepared remarks, we'll open the line for questions, and we aim to keep this call to one hour, and so ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today. Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2022 financial outlook, anticipated product sales, revenues, costs, and expenses, future developments related to legal matters, and potential clinical and regulatory milestones including data readouts, regulatory submissions, and potential marketing and reimbursement approvals. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty in forecasting sales, revenues, and expenses, impacts related to the COVID-19 pandemic, and the uncertainty associated with legal disputes and with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by CGEM is contained under the caption Risk Factors, included in the company's annual report on Form 10-K for the year into December 31, 2021, filed with the Securities and Exchange Commission, and the company's subsequent reports filed with the SEC. And now I'll turn the call over to Clay.
Thank you, Peg. Good afternoon, everyone, and welcome to our first quarter call. We are pleased to report total revenues of $426 million for the first quarter. This includes net product sales of $383 million, representing 27% growth over the first quarter of last year. This growth reflects strong product sales across all commercial brands. As we look to deliver continued innovation and develop transformative therapies, we remain focused on two strategic priorities. Our first priority is working to maximize the global potential of our products through commercial performance and robust clinical development programs designed to support future label expansions while also leveraging our strategic partnerships. I'll begin with PADSET, which has become a standard of care in the U.S. for previously treated metastatic urothelial cancer. Earlier this month, We and our partner, Astellas, secure approval in both the EU and UK for PADCF in previously treated locally advanced or metastatic urothelial cancer. The approvals are based on the EV301 trials, notably the impressive overall survival benefit. This marks an important milestone for patients in these regions who have previously had limited treatment options offering poor survival rates. We previously secured approvals in the U.S., Canada, Switzerland, Israel, and Japan, and continue to progress regulatory submissions across Asia, Pacific, and the Americas. We and Estellas are engaging with individual country authorities to secure reimbursement for PADSEV, which can take up to two years, depending on the country. PADSEV's robust clinical development program spans monotherapy and combinations with Keytruda and earlier lines of therapy. EV103 cohort K data, which are anticipated in the second half of this year, along with other data from the EV103 trial, could potentially support accelerated approval in the U.S. for patients with first-line metastatic urothelial cancer next year. We are also evaluating PADSEP in combination with Keytruda in muscle-invasive bladder cancer and as monotherapy in non-muscle-invasive disease. These represent areas of significant unmet need in large addressable patient populations. Tucaisa has become an important option for the treatment of second and later line HER2-positive breast cancer patients with and without brain metastasis. Overall survival data and inclusion in key treatment guidelines reflect CHICAZA's exceptional clinical value. CHICAZA delivered strong results this quarter, although we continue to expect competitive challenges in the U.S. this year, which are factored into our annual guidance. We are working to enable additional European launches in 2022, and our strategic collaboration with Merck is expanding CHICAZA's reach outside of Europe and the Americas. Tukeisa's broad development program includes clinical trials in HER2-positive breast cancer, colorectal cancer, gastric cancer, and other HER2-amplified or mutant tumors. Data from the Phase II Mountaineer trial are expected in the second half of this year and could potentially support accelerated approval in the U.S. next year for patients with HER2-expressing colorectal cancer. Although a relatively modest patient population, it represents a high unmet medical need as existing approved colorectal cancer therapies offer limited efficacy. TIBDAC is a tissue factor targeted ADC approved in the U.S. for recurrent or metastatic cervical cancer patients and represents an important new therapy in a disease with historically poor outcomes. Launched last September in collaboration with GENMAB, The strong uptake has been driven by differentiated clinical data, positive reception from the oncologist community, and our focus on commercial execution. We have presented promising combination data in earlier lines of cervical cancer, which may represent clinical advancements and much larger market opportunities. Roger will provide further details on TIVDAC's clinical development program, which is designed to maximize its future opportunity in cervical cancer and other solid tumors while supporting global regulatory applications. ETCETRUS has now been approved in over 75 countries, and ETCETRUS regimens are a U.S. standard of care in frontline Hodgkin lymphoma and peripheral T-cell lymphoma. More than a decade after its first launch, we and our partner, Takeda, continue to bring this important medicine to patients around the globe. Groundbreaking overall survival data from the Phase 3 Echelon 1 trial in newly diagnosed advanced hot skin lymphoma further demonstrate the therapeutic value of its citrus and its importance for these patients. In addition, a Phase III Children's Oncology Group study demonstrated an improvement in event-free survival for high-risk pediatric patients with Hodgkin lymphoma. Both the Echelon 1 data and the Phase III pediatric data will be presented at ASCO in June and will be submitted to FDA this year. Lastly, we are progressing a comprehensive clinical development program to maximize the potential for Tetris to benefit patients. Our second strategic priority is to advance our deep and diverse pipeline as we look to bring additional drugs to market in the coming years. Decidimat-vidotin, or DV, is a late-stage novel ADC that utilizes our vidotin-based technology. DV is active across a broad range of HER2-expressing solid tumors and demonstrates rapid internalization. Our clinical development program prioritizes monotherapy and combination approaches in breast, bladder, gastric, and other cancers. We recently initiated a pivotal trial in previously treated metastatic urothelial cancer intended to support accelerated approval in the U.S. Turning to our earlier stage pipeline, we are advancing several ADCs to both novel and validated targets. We also have four programs that use our proprietary sugar-engineered antibiotic technology. Overall, we are progressing more than 17 programs and products across our pipeline in a range of solid tumors and hematologic malignancies. Our ADC collaborators are also making important progress with programs that utilize our technology. Roche recently reported that the CHMP recommended European Commission approval for Pallavi in combination with other anti-cancer therapies for frontline diffuse large B-cell lymphoma. GlaxoSmithKline is commercializing BlendRep for patients with relapsed multiple myeloma and is advancing several clinical trials. And AbbVie was granted breakthrough therapy designation for their CMET ADC, tolicituzumab-vidotin, based on data from their Phase II study for non-small cell lung cancer. As we look to the future, our plan is to continue building upon our four commercial products, advancing our deep and diverse pipeline, and expanding our geographic footprint. We have over 50 strategic partnerships, including our recent collaboration with Sanofi. Based on our cash position of approximately $2 billion and no debt, we are strongly positioned to utilize cutting-edge innovation to make a positive impact on the lives of people with cancer today and tomorrow. Next, I'll turn the call over to Todd, who will discuss our financial results. Then Chip will provide an update on our commercial performance. After that, Roger will detail our clinical development activities and pipeline. Todd?
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