Seagen Inc.

Please note this event is being recorded. I would now like to turn the conference over to Ms. Peggy Pinkston, Senior Vice President of Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. I'd like to welcome all of you to CJIN's second quarter 2021 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 Romp, Executive Vice President, Commercial U.S., and Roger Danzy, Chief Medical Officer. Following our prepared remarks, we'll open the line for questions. 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 2021 financial outlook, anticipated product sales, revenues, costs, and expenses, and potential clinical and regulatory milestones, including data readouts, regulatory submissions, and 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 the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by CGEN is contained under the on Form 10-Q for the quarter ended March 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, and good afternoon, everyone. This was an exceptional quarter for our business in terms of commercial performance as well as regulatory and clinical progress. We're pleased to report the highest ever net product sales across each of our approved medicines, as well as the highest sequential quarter-over-quarter dollar growth in product sales in our history. These results reflect strong commercial execution across PADSET, TUKAISA, and ETC. Our financial strength is driven by product sales, as well as royalties and multiple strategic collaborations. We ended the quarter with $2.5 billion in cash and investments and have no debt. This positions us to expand our programs, advance our research and development, and continue investing in our business. We remain focused on maximizing the opportunity and value of our approved drugs and developing additional transformative cancer therapies for patients around the world. We look forward to sharing key business, regulatory, commercial, and development updates on the call today. We are focused on three strategic priorities that empower our ability to drive innovation, growth, and substantial benefit for our stakeholders, including employees, oncologists, our communities, shareholders, and most notably, cancer patients. Our first strategic priority is to maximize the global potential of our three approved medicines through robust clinical development and exceptional commercial execution. The first product I would like to highlight is PADSEV, a first-in-class ADC that has quickly become standard of care in previously treated metastatic urothelial cancer. Earlier this month, FDA granted PADSEP regular approval in the US based on data from the Phase III EV301 trial, which demonstrated an overall survival advantage for patients treated with PADSEP versus chemotherapy. Full approval is important for the commercial team as inclusion of the OS data allows for promotion of PADSEP's demonstrated clinical benefit. PADSEP was also granted a second indication making it the first and only FDA-approved therapy for urothelial cancer patients who are cisplatin ineligible and have previously received one or more therapies. As a meaningful proportion of bladder cancer patients cannot tolerate cisplatin-based chemotherapy, there is an urgent need for more treatment options such as PATSET. In addition to supporting regular approval in the U.S., The EV301 data supports global regulatory submissions, which we and our partner, Astellas, continue to move forward. Another key product is Tucaisa, a best-in-class HER2 tyrosine kinase inhibitor, which has become an important standard of care in the U.S. for the treatment of second and later line HER2-positive breast cancer patients with and without brain metastasis. Tucaisa is now approved in 36 countries and in addition to the U.S., has launched in Germany, France, Switzerland, and Austria. We are actively engaging with country-specific authorities to gain reimbursement and broader access for Tocasa outside the U.S. We're pleased by early uptake, healthcare provider feedback, and the fact that Tocasa has already been included in key treatment guidelines. Tukeiza's broad clinical development program includes evaluation in HER2-positive breast cancer, as well as colorectal and gastric cancers, and in other HER2-amplified or mutant tumors. We expect our strategic commercial collaboration with Merck to further accelerate Tukeiza's global reach in regions outside of the U.S., Canada, and Europe. The third product I'll highlight is ETCETRIS, which is the established foundation of care in multiple CD30-expressing lymphomas. ETCETRIS is a remarkable product that is commercially available in 76 countries and serves as the bedrock of our core business, enabling us to continue investing in our pipeline and other products. A decade after approval, Etcetera has just reported its highest ever quarterly sales, which serves as further evidence of the significant benefit it offers to patients. We are committed to maximizing Etcetera's reach and continuing to advance a comprehensive clinical development program in Hodgkin lymphoma, diffuse large B-cell lymphoma, and solid tumors. In addition, our partner, Takeda, is pursuing approvals for frontline Hodgkin lymphoma and peripheral T-cell lymphoma in its territories. Our second strategic priority is to advance late-stage programs towards securing approvals for new products. Tisotomatvidotin, or TV, is currently under priority review by FDA, seeking accelerated approval for recurrent or metastatic cervical cancer with a PDUFA action date of October 10th. TB is positioned to be our fourth commercial product as we look to expand our portfolio further. And together with our partner, GenMab, we are currently on track with launch preparations. This is an important development in the treatment of cervical cancer, which in the recurrent or metastatic setting has a significant unmet medical need. Our third strategic priority is to expand our deep and diverse early stage pipeline through continued innovation encompassing antibody drug conjugates, immuno-oncology agents, R&D investments, corporate development, and strategic partnerships. In closing, I'd like to recognize our employees and partners around the world who, despite challenging conditions over the past 17 months, have worked tirelessly to progress our programs and build our business. We have now begun the process of appropriately and safely returning our U.S.-based workforce to the office in a phased approach. Next, I'll turn the call over to Todd, who will provide an overview of our financial results. Then Chip will discuss our commercial performance. After that, Roger will provide an update on clinical development activities and our pipeline. Todd? Great. Thanks, Clay, and thanks to everyone for joining us on the call this afternoon. Our financial results reflect significant advancements made across the business. Today, I'll summarize our financial results for the second quarter and year to date, which are in line with our expectations for the full year. Total revenues were $388 million in the second quarter and $720 million for the year to date in 2021. Product sales from our three oncology franchises totaled $347 million in the second quarter, representing 15% sequential quarterly growth and 44% growth over the second quarter of 2020. This reflects revenues across our diverse commercial portfolio, which now has international reach. Royalty revenues were $36 million in the second quarter and $64 million for the year to date in 2021. Growth over 2020 reflects increasing sales of Etcetera Spice Takeda, as well as royalties on sales of Polivie by Roche and BlendRep by GSK. As expected, collaboration revenues were modest at $5 million in the second quarter and $7 million for the year to date in 2021. Costs of sales increased to $78 million in the second quarter and $142 million for the first half of 2021. This included product cost of sales and royalties for each of our three brands, the PADSEV gross profit share to Astellas, which was $39 million in the second quarter and $71 million for the year to date, as well as non-cash amortization of acquired technology costs for Takaiba. R&D expenses were $235 million in the second quarter and $465 million for the first half of 2021. These are increases over 2020 and reflect increased investment across our early and late stage pipeline. SG&A expenses were $165 million in the second quarter and $325 million for the first half of 2021. These are increases over 2020 reflecting investments to support European Takaiba launches and our global expansion efforts. Lastly, we are maintaining our 2021 financial guidance, and we're pleased with our performance in the first half of the year. We have significant financial strength, which allows us to continue investing in our pipeline in business. Now we'll turn the call over to Chip for an overview of our commercial performance. Thank you, Todd. Performance across the commercial portfolio was strong in Q2, and we believe we are emerging from the pandemic with positive momentum. We are well positioned to drive continued growth with the recent PatSub label expansion, additional country launches for Kikisa, and the potential approval of TV. We are seeing a meaningful increase in the number of in-person sales calls by our field team, and our commercial infrastructure and capabilities are in place to maximize future product launches. Accessorist delivered a record quarter, a noteworthy accomplishment for a 10-year-old brand. Etc. sales were $182 million, a 9% increase over Q2 2020, and a 12% increase in volume over last quarter. Our field sales force is returning towards normal call activity levels with mostly face-to-face interactions. We are now actively promoting the landmark five-year Echelon 1 progression-free survival data in frontline osteomyeloma, as featured in the Lancet hematology publications. This is meaningful data to physicians and patients and solidifies the eccentrics regimen as the best option for frontline stage 3 or 4 Hodgkin lymphoma patients. Moving on to PADSEV, second quarter sales were $82 million, a 44% increase over the second quarter of 2020, and an 18% increase over last quarter. We are pleased with the conversion to full approval for PADSEV, and a new indication for cisplatin-eligible metastatic uretherial cancer patients who have previously received one or more lines of therapy. Our ability to now promote this new indication should drive incremental uptake, representing a meaningful but modest opportunity. As we've discussed in past quarters, the metastatic uretherial cancer setting continues to evolve, and we are confident that PADSET is well-positioned to remain the standard of care. Transitioning to Tecaisa, second quarter sales were $83 million, an increase of 18% over the last quarter. Our U.S. launch has been very successful, and we continue to see high levels of utilization in patients with and without brain mets. In patients with brain mets, Tecaisa is the most utilized product in second and later lines for HER2-positive breast cancer. In Europe, early uptake has been very encouraging, notably with recent launches in France and Germany. The strength of evidence, including demonstrated overall survival benefit from the HER2 CLIMB trial, along with favorable clinical guidelines, gives us confidence as we execute our reimbursement strategy in Europe. And finally, we are pleased that the PDBLA received priority review, and if approved, this would be an important new drug for women with previously treated metastatic cervical cancer. The team will be ready ahead of the October 10th PDUFA date with a dedicated sales force in place. We are starting the second half of the year with great momentum across our portfolio of first-in-class or best-in-class products and look forward to potentially adding another important medicine soon to our proven commercial model. Now I'll turn the call over to Roger to talk about our robust development activities.