Seagen Inc.

Good day and welcome to the CGEN second quarter 2022 financial results conference call. All participants will be in 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. To withdraw your question, please press star then two. Please note this event is being recorded. I'd now like to turn the conference over to Doug Maffei. Vice President of Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. I'm pleased to welcome you to CGEN's second quarter 2022 financial results conference call. This afternoon, we issued a press release with our results. The press release and supporting slides are available on our website in the investor section, events and presentations page. Speaker on today's call will be Roger Danzi, Interim Chief Executive Officer and Chief Medical Officer, Todd Simpson, Chief Financial Officer, and Chip Romp, Executive Vice President, Commercial US. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A. 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, potential clinical and regulatory milestones, including data readouts and regulatory submissions, potential marketing and reimbursement approvals, and commercial performance. 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, costs 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 CGEN is contained under the caption, Risk Factors, included in the company's quarterly report on Form 10-Q for the quarter ended March 31st, 2022, filed with the Securities and Exchange Commission, and the company's subsequent reports filed with the SEC. Now, I'll turn the call over to Roger.

Thank you, Doug. Good afternoon, everyone, and welcome to our second quarter earnings call. I was recently appointed interim CEO, and I am honored and privileged to lead such an extraordinary company. Along with my Cgen colleagues, I am deeply committed to continuing our mission of bringing transformative medicines to market that make a meaningful difference in the lives of people with cancer. Cgen has a rich history of oncology innovation, And I would like to acknowledge Clay Seagal as our founder, who was integral to building the company that we have become. Today, we are pleased to announce total quarterly revenue of $498 million. This represents growth of 28% compared to the same quarter last year. This growth reflects robust commercial sales across our four approved products, as well as strength in royalties and collaboration revenue. we continue to progress our assets with more than 17 programs across our approved medicines and pipeline. We remain focused on two strategic priorities. Our first priority is maximizing the global potential of our products through commercial execution, supporting robust clinical development programs for future label expansions, and leveraging our strategic partnerships to broaden our geographic reach. Our second strategic priority is to advance our deep and diverse pipeline as we look to bring additional medicines to market in the coming years. Our financial strength and solid balance sheet drive internal and external investment to support our priorities. Beginning with PADSEV, our first-in-class ADC for metastatic urothelial cancer, net product sales were strong in the second quarter. This was driven by continued uptake in labeled indications, along with clinical trial supply orders, which Todd will discuss. PAD-SEV has become standard of care in the United States for patients in the post-PD-1, PD-L1 setting. It has now been approved in nearly 40 countries based on the overall survival advantage demonstrated in the global EV301 trial. Furthermore, We continue to expand our commercial footprint internationally and booked our first sales of PADSEC in Brazil during the quarter. We also secured approvals in Singapore and Australia through our partner, Astellas, who we continue to work with to commercialize this important therapy. We were excited earlier this week to release positive top-line data from cohort K of the EV103 trial. This study evaluated PANSEV in combination with Keytruda in frontline cisplatin ineligible patients with unresectable, locally advanced, or metastatic urothelial cancer. Results from this trial showed a confirmed overall response rate per independent radiographic review of 64.5%. The median duration of response was not reached. The combination had a manageable and tolerable safety profile. These are patients with a very high unmet medical need, and we are encouraged by these important results. We look forward to presenting additional data from this trial at an upcoming medical conference, and we also plan to discuss these results with regulatory authorities with the intention of submitting an SPLA to the FDA later this year to support potential accelerated approval in the United States. Further clinical development for PADSEP continues. The global phase III EV302 trial in the frontline metastatic setting is on track to complete enrollment this year. This trial enrolls both cisplatin eligible and ineligible patients, irrespective of PD-L1 expression, and is intended to serve as a confirmatory trial in support of an accelerated approval. In collaboration with Merck, enrollment is also ongoing in two phase III trials assessing PADSEV in combination with Keytruda in muscle-invasive bladder cancer. In addition, we are progressing the Phase 1 EV104 trial, which is investigating PADSEV monotherapy administered intravesically in BCG non-responsive, non-muscle-invasive bladder cancer patients. And finally, we are exploring PADSEV's potential utility beyond bladder cancer with our Phase 2 EV202 trial, which is studying the effects of PADSEV monotherapy in other Nectin-4-expressing solid tumors. Our partner, Astellas, who is conducting this trial, has obtained top-line results in some cohorts, and we will be jointly reviewing the results and discussing future direction. Turning to Takaiza, which is our best-in-class tyrosine kinase inhibitor and is approved for HER2-positive metastatic breast cancer patients with and without brain metastases. We are pleased with Tukayza's performance in the second quarter, despite the competitive headwinds. We are working towards additional European launches in 2022, and Merck is progressing regulatory submissions and reimbursement activities intended to expand Tukayza's reach in their territories. At the ESMO GI meeting earlier this month, we presented results from the Mountaineer trial that assessed Tukayza plus trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer. The combination of ducasa and trastuzumab resulted in a confirmed overall response rate of 38% with a median duration response of 12.4 months. The safety profile further demonstrated that the combination was tolerable with only 6% of patients needing to stop therapy due to adverse events. Based on the strength of these data, we have submitted a supplemental NDA under the accelerated approval program in the United States, which has the potential for approval in 2023. We are also conducting the phase three Mountaineer O3 trial, which adds to Kaiser and trastuzumab to standard of care chemotherapy in the frontline CRC setting. This is intended to serve as a confirmatory trial in the US for HER2 positive CRC and could also support global submissions. In metastatic breast cancer, We recently completed global enrollment in HER2-CLIM-O2. This study is investigating to Kaiser in combination with CAD-SILA compared with CAD-SILA monotherapy in the first or second line metastatic setting, including patients with brain metastases. I will now move on to TIVDAC, our first in class tissue factor directed ADC approved in the United States for recurrent or metastatic cervical cancer patients. Second quarter net product sales of TIVDAC were strong and reflect the high unmet medical needs, the significant clinical data, and exceptional commercial execution from the CGEN and GENMAD teams. The innovative 301 Phase 3 monotherapy study is enrolling well and is intended to serve as the confirmatory trial in the U.S. and to enable global regulatory applications. At ASCO last month, We presented encouraging data from our innovative 205 phase 2 study, evaluating TIVDAC and Keytruda in the frontline metastatic cervical cancer setting. The combination demonstrated a confirmed overall response rate of 41% and a median duration response that was not reached after a median follow-up of 19 months. In addition, updated data from the combination of TIVDAC and carboplatin in the frontline setting showed a confirmed ORR of 55% with a median duration response of 8.6 months. We are encouraged by these doublet results, and Innovative 205 is now investigating TIVDAC plus carboplatin and Keytruda plus or minus Avastin in the frontline setting. Results from these triplet and quadruplet combinations will inform our next steps. Next to highlight is ETCETRUS, which, through our collaboration with Takeda, has become a foundation of care for CD30-expressing lymphomas and is approved in over 75 countries. Two important Phase III ETCETRUS trials were featured as oral presentations at ASCO last month. The first was Echelon 1, which showed that ETCETRUS in combination with AVD significantly improved overall survival compared with AVBVD in patients with advanced Hodgkin lymphoma. The etc. combination reduced the risk of death by 41% with a p-value of 0.009. These results were recently published in the New England Journal of Medicine, and we also plan to submit the data to FDA this year for possible inclusion in the label. The second presentation was from the Phase III Children's Oncology Group Study, AHRD 1331, in pediatric patients with high-risk Hodgkin lymphoma. The study met its primary endpoint of event-free survival with etcetras plus chemotherapy reducing the risk of disease progression by 59% when compared to a chemotherapy regimen that included leomycin. The pediatric patient data were included in an SPLA, which has already been granted prior to review by FDA with a target action date of November 16, 2022. These two studies emphasize the meaningful difference that ETCETRUS could make in patients' lives. Dacitimab vedotin, or DV, is a late-stage novel HER2-directed ADC that utilizes our vedotin-based technology. Our clinical development program is evaluating monotherapy and combination approaches in a variety of cancers. We recently began enrolling into the Phase II pivotal monotherapy trial in second line HER2-expressing metastatic urothelial cancer. We plan to initiate additional pivotal studies in bladder cancer and HER2 low breast cancer over the next several months. We are also considering development in other HER2-expressing solid tumors, including gastric cancer. Turning to our earlier stage pipeline, given our robust IND engine, we are advancing a growing number of drug candidates in phase one clinical trials across a range of solid tumors and hematologic malignancies. Our ADC collaborators continue to make progress with programs that utilize our technology. AbbVie initiated a Phase III trial in non-small-cell lung cancer with their CMET-directed ADC, and Roche has now filed an application for approval of Polivi in first-line DLBCL in the United States based on their Phase III Polarix trials. I will now briefly touch on our ongoing legal proceedings with Daichi Sankyo. As many of you are aware, we received a positive jury verdict in April that Daichi Sankyo had willfully infringed our 039 patent and we were awarded past damages of $41.8 million for sales of Inher2 through the trial date. Despite the jury's verdict, Daiichi Sankyo requested the court to find our patent unenforceable. We are pleased the court recently ruled against Daiichi on their request and entered judgment in favor of CJEN based on the jury's award. We intend to now request the court to award a royalty for future sales of Inheritu through the end of the patent term. In another favorable decision recently, The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has again denied Daiichi's request to institute a post-grant review proceeding against our 039 patent. We now await the arbitration outcome regarding ownership of the ADC technology used by Daiichi in Inher2 and its other pipeline ADC products, which we believe represents the most meaningful element of these legal matters. As a pioneer and leader in ADCs, it is vitally important for us to defend our intellectual property as we continue to drive ADC innovation. Next, I'll turn the call over to Todd, who will discuss our financial results, and Chip will provide an update on our commercial performance. Todd.