Seagen Inc. (SGEN) on Q2 2022 Results - Earnings Call Transcript
Operator: Good day and welcome to the Seagen Second Quarter 2022 Financial Results Conference Call. 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. Douglas Maffei: Thank you, operator and good afternoon, everyone. I'm pleased to welcome you to Seagen'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 Investors Section, Events and Presentations page. Speakers on today's call will be Roger Dansey, Interim Chief Executive Officer and Chief Medical Officer; Todd Simpson, Chief Financial Officer; and Chip Romp, Executive Vice President, Commercial U.S. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour. 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 Seagen is contained under the caption Risk Factors included in the company's quarterly report on Form 10-Q for the quarter ended March 31, 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. Roger Dansey: 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 seasoned 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. Seagen has a rich history of oncology innovation and I would like to acknowledge Clay Siegall 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 4 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 2 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 PADCEV. 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. PADCEV 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 EV-301 trial. Furthermore, we continue to expand our commercial footprint internationally and booked our first sales of PADCEV 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 EV-103 trial. This study evaluated PADCEV 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 sBLA to the FDA later this year to support potential accelerated approval in the United States. Further clinical development for PADCEV continues. The global Phase III EV-302 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 2 Phase III trials assessing PADCEV in combination with KEYTRUDA in muscle-invasive bladder cancer. In addition, we are progressing the Phase I EV-104 trial which is investigating PADCEV monotherapy administered intravesically in BCG nonresponsive non-muscle invasive bladder cancer patients. And finally, we are exploring PADCEV's potential utility beyond bladder cancer with our Phase II EV-202 trial which is studying the effect of PADCEV 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 TUKYSA 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 TUKYSA's performance in the second quarter despite the competitive headwinds, while working towards additional European launches in 2022 and Merck is progressing regulatory submissions and reimbursement activities intended to expand TUKYSA's reach in their territories. At the ESMO GI meeting earlier this month, we presented results from the MOUNTAINEER trial that assessed TUKYSA plus trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer. The combination of TUKYSA 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 III MOUNTAINEER-03 trial which adds TUKYSA and trastuzumab to standard of care chemotherapy in the frontline CRC setting. This is intended to serve as a confirmatory trial in the U.S. for HER2-positive CRC and could also support global submissions. In metastatic breast cancer, we recently completed global enrollment in HER2CLIMB-02. This study is investigating TUKYSA in combination with Kadcyla, compared with Kadcyla monotherapy in the first- or second-line metastatic setting, including patients with brain metastases. I will now move on to TIVDAK, 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 TIVDAK was strong and reflect the high unmet medical needs, the significant clinical data and exceptional commercial execution from the Seagen and Genmab teams. The innovaTV 301 Phase III 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 innovaTV 205 Phase II study evaluating TIVDAK and KEYTRUDA in the frontline metastatic cervical cancer setting. The combination demonstrated a confirmed overall response rate of 41% and a median duration of response that was not reached after a median follow-up of 19 months. In addition, updated data from the combination of TIVDAK 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 public results. And innovaTV 205 is now investigating TIVDAK plus carboplatin and KEYTRUDA plus or minus Avastin in the frontline setting. Results from these triplet and quadrupled combinations will inform our next steps. Next to highlight is ADCETRIS which, through our collaboration with Takeda, has become a foundation of care for CD30 expression lymphomas and is approved in over 75 countries. Two important Phase III ADCETRIS trials were featured as oral presentations at ASCO last month. The first was ECHELON-1 which showed that ADCETRIS in combination with AVD significantly improved overall survival compared with ABVD in patients with advanced Hodgkin lymphoma. The ADCETRIS 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, AHOD1331 in pediatric patients with high-risk Hodgkin lymphoma. The study met its primary endpoint of event-free survival with ADCETRIS plus chemotherapy reducing the risk of disease progression by 59% when compared to a chemotherapy regimen that included bleomycin. The pediatric patients' data were included in an sBLA which has already been granted priority review by FDA with a target action date of November 16, 2022. These 2 studies emphasize the meaningful difference that ADCETRIS could make in patients' lives. Disitamab 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 I 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 Polivy in first-line DLBCL in the United States based on their Phase III POLARIX trial. I will now briefly touch on our ongoing legal proceedings with Daiichi Sankyo. As many of you are aware, we received a positive jury verdict in April that Daiichi Sankyo had willfully infringed our 039 patent and we were awarded past damages of $41.8 million for sales of ENHERTU 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 Seagen, based on the jury's award. We intend to now request the court to award a royalty for future sales of ENHERTU 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 ENHERTU 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? Todd Simpson: Thanks, Roger and thanks to everyone for joining us on the call. Our financial results continue to reflect significant advancements made across the business. Today, I'll briefly summarize our results and then discuss a few updates to our financial outlook for the remainder of 2022. Total revenues were $498 million in the second quarter and $924 million for the first half of 2022. Product sales were $432 million in the second quarter and $815 million for the first half of the year, each representing approximately 25% growth over the same period in 2021. These results reflect continued growth across our commercial portfolio. Of note, PADCEV sales in the second quarter of 2022 included $19 million in sales to another company for a combination clinical trial that they are conducting. Royalty revenues were $39 million in the second quarter and $67 million for the first half of 2022. Growth in the second quarter was 8% compared to the prior year and driven by ADCETRIS sales by Takeda as well as sales of Polivy by Roche and BLENREP by GSK, both of which are ADCs that use Seagen's technology. Collaboration revenues were $27 million in the second quarter and $42 million for the first half of 2022. These reflect royalties on sales of PADCEV by Astellas in its territories as well as other collaboration activities, including a milestone from AbbVie in the second quarter of this year. Cost of sales were $106 million in the second quarter and $194 million in the first half of 2022. This included cost of product sales and royalties for each of our 4 brands, profit share amounts owed to our collaboration partners, Astellas and Genmab as well as noncash amortization of acquired technology for Takeda. R&D expenses were $304 million in the second quarter and $602 million in the first half of 2022. This reflected continued investment to expand the potential of our approved products and to advance our pipeline programs. SG&A expenses were $220 million in the second quarter and $394 million in the first half of 2022. This was driven by commercialization efforts, including investments to support country launches of TUKYSA in Europe, the ongoing TIVDAK launch in the U.S. and other corporate activities. Regarding our financial guidance, we are increasing our ADCETRIS sales guidance to a new range of $750 million to $775 million, reflecting strong performance year-to-date. We are maintaining our guidance for PADCEV and TUKYSA and we are not providing guidance for TIVDAK at this time. Chip will provide more context on market dynamics related to each of our brands in a moment. Based on progress made by our existing collaborators and a new collaboration, we are increasing our guidance for collaboration revenues to a new range of $50 million to $60 million. Our guidance for royalty revenues remain unchanged, although we are monitoring the effects of foreign currency fluctuations. With regard to expenses, we are maintaining our guidance ranges. We ended the second quarter with $1.9 billion in cash and investments. Our financial performance and strong balance sheet allow us to continue investing in our portfolio and business. With that, I'll now turn the call over to Chip for an overview of our commercial performance. Chip Romp: Thank you, Todd. I'm pleased to provide an update on our commercial performance which set a new quarterly product sales record of $432 million, driven by our 4 approved brands. We are pleased with the performance of our commercial portfolio of best, or first-in-class, drugs that have become important treatment options and now have treated approximately 120,000 patients across the globe. ADCETRIS second quarter sales were $124 million, a 50% increase over the second quarter of 2021. Excluding clinical trial supply orders, growth was up 27% over the second quarter of last year and 15% over the first quarter of this year. Underlying growth continues to be primarily driven by use in the post checkpoint setting, where PADCEV is a U.S. standard of care. We are pleased with the recent positive top line data reported from the EV-103 Cohort K trial. As a reminder, there are approximately 20,000 total addressable patients in the frontline metastatic setting in the U.S., with about 80% of these being drug-treated. 40% to 50% of these patients are ineligible for cisplatin-based chemotherapy which represents the population studied in Cohort K. Moving on to TUKYSA. Second quarter sales were $89 million, a 7% increase over the second quarter of 2021. You will recall that our 2022 outlook for TUKYSA assumes the impact of competitive pressure from ENHERTU U.S. launch in the second-line setting and inclusion in guidelines and pathways. This remains our expectation despite seeing modest impact in the first half of the year. With ENHERTU's approval in this setting in May, we continue to anticipate a shift in how these regimens are sequenced. With increased use of ENHERTU, resulting in a delay of patient flow into the third-line plus setting where TUKYSA is mostly used. We continue to be confident in TUKYSA's strong value proposition in the second-line plus setting, especially for patients with CNS involvement. In addition, following the positive MOUNTAINEER study results, we look forward to a potential label expansion in the U.S. into the second-line plus setting in combination with trastuzumab in metastatic colorectal cancer patients at some point in 2023. Although a modestly sized patient population, it represents a high unmet medical need as existing approved colorectal cancer therapies typically offer limited response rates. ADCETRIS second quarter sales were a record $202 million, an 11% increase over the second quarter of 2021. Post ASCO, we are actively promoting the unprecedented overall survival data from the ECHELON-1 trial and are pleased with the positive reaction we are seeing from prescribers. And finally, TIVDAK sales were $17 million for the second quarter. While this initial indication in metastatic cervical cancer patients represents a modest opportunity, we are very pleased with the positive reception from physicians and patients we've seen to date. The Seagen and Genmab commercial teams are managing the eye care visit requirements with best practices being shared between clinics. We continue to promote this important treatment option for patients with such high unmet need. Now, I'll hand the call back to Roger. Roger Dansey: Thank you, Chip. Regarding recent media reports, focused on potential M&A, we do not comment on market speculation and we will not respond to questions on this topic during the Q&A session. In closing, I am very proud of our second quarter financial and commercial performance as well as our development accomplishments throughout the year. We recently reported pivotal data from trials for ADCETRIS, PADCEV and TUKYSA that are each intended to support potential label expansions. Seagen is well positioned to continue advancing our mission to deliver cutting-edge innovation that positively impacts the lives of people with cancer. With that, we'll open for your questions. Operator, please open the line for Q&A. Operator: Our first question comes from Salveen Richter from Goldman Sachs. Salveen Richter: Any updates here on the timing for an arbitration decision? And any color you can provide on why the judge has not yet rolled on future old royalties in the infringement case? Roger Dansey: Salveen, thank you for the question. As we see it right now and our best estimate is around midyear and that continues to be our guidance with regard to timing. Just to remind you, the arbitration proceeding is controlled by the arbitration judge. And the time line is his to control. We don't actually have any specific influence on that. But we are in the midyear period and so we are expecting that result to come out midyear. Todd Simpson: And then Salveen, with respect to the Texas matter. The normal process, it's now that the judge has entered the jury's award. We'll file motions with the court for the judge to now consider future damages. So just procedurally, that takes a little bit of time but that's something that we are working on right now and expect to happen shortly. Operator: The next question comes from Matthew Harrison from Morgan Stanley. Matthew Harrison: I guess can I just ask on Cohort K? I think one of the key factors people are trying to understand is potential duration of follow-up in that study and what that implies in terms of potential durability? So I don't know if you're willing to just tell us what the median duration of follow-up was at the time that you reported those results. And then just secondly, on 202 for PADCEV, can you just remind us of the different cohorts? And which cohorts maybe you're potentially most excited about? Roger Dansey: Thank you. Thanks for the question. We're very pleased with the Cohort K. I think we're excited to present the data, we'll get it to a medical meeting as soon as we can. But as I'm sure you understand, we are limited in how much we can talk about in the press release. We need to maintain the data confidentiality until it gets presented at a meeting. We can't share a median follow-up number with you. But what I can say is just in broad strokes, the study started to enroll in January of 2020 and we declared last patient enrolled in October of last year. And we've now presented the data in the July time frame. So you can get some sort of sense of the age of the trial. I think we're confident in its maturity, otherwise, we would not have cut the data at this point but you'll just unfortunately have to stay tuned until we can get it in front of you at the medical meeting. With regards to 202, there are a number of cohorts. We're unfortunately not going to be able to share with you which cohorts have got top line results. But there are the Nectin-4-expressing tumors, including things like head and neck cancer, lung cancer, breast cancer, I believe, gastric cancer and perhaps some others. Operator: The next question comes from Cory Kasimov from JPMorgan. Cory Kasimov: I want to follow up on Cohort K as well, from a regulatory point of view. Can you kind of discuss the type of discussions you've had with the FDA prior to the release of data from Cohort K that this particular study with robust results in hand which you seem to have now, could be enough to form the basis of an accelerated approval, especially with PADCEV monotherapy is technically the control? Roger Dansey: Thanks for the question, Cory. Just to remind you that from the basis of Cohort A which was the first data set that we presented with this combination, we were able to go on a breakthrough therapy designation and that's an interaction obviously, with the agency in order to get into that place. And Cohort K, the trial that we've just read out on, was a subsequent effort beyond Cohort A with a specific intent of the -- data supports to look for accelerated approval. So without going into any of the FDA details, I think the sequence of events is obviously, we generated that initial data. We had conversations with the agency, we were granted breakthrough therapy designation. We then designed Cohort K and executed it, including, as you say, the monotherapy whose primary purpose is to supply a sense of contribution of components for the combination of PADCEV and KEYTRUDA. Operator: The next question comes from Gena Wang from Barclays. Gena Wang: Regarding your ADCETRIS combo with pembrolizumab in solid tumor initial data later this year. Wondering if you can give a little bit more color, how many patients in what kind of solid tumors? And then what would be the threshold you'll be looking for? Roger Dansey: Yes. Gena, thanks for the question. It's a very interesting area that we're exploring with ADCETRIS. And the population, just to remind folks, these are patients who have previously responded in the main to a PD-1 or PD-L1 inhibitor and then have subsequently progressed. And the scientific basis for this is that ADCETRIS is a -- amongst other things, a T regulatory cell modulator. It so happens that T regulatory cells which may be one of the mechanisms by which resistance to PD-1 inhibition occurs could be over-expressed in tumors. And if you reduce or eliminate that population, that may allow a recovery of sensitivity to the PD-1 inhibition by the PD-1 inhibitors. And the 2 diseases that we're interested in and for good reason, one is in melanoma. Because PD-1 inhibition is at the core of melanoma therapy. And then the other is lung cancer. So both of these tumors are immune-responsive, certainly on the initial period. And so those are the 2 cohorts that we've studied initially. We can't give you any further details as regards to numbers and exactly when we may present the data. But it is an area of interest for us. And so please stay tuned for those results when we can get them out to you. Operator: The next question comes from Andrew Berens from SVB Securities. Andrew Berens: Congrats on the multiple beats and raises. Two questions for me. I was just wondering how we should interpret your comments about some of the EV-202 basket trial towards reading out but they're not being a top line release about the findings. Should we look at ? And then a question on arbitration on the district trial. It sounds like the district court's decision on the future royalties could take some time. Is that something you think that the arbitrator might want to see in his deliberation? Roger Dansey: Andy, thank you, number one, for congratulations. We really are proud of this effort that the quarter was outstanding on many levels. So thank you for that comment. With regard to understanding EV-202, this is very recent information. Astellas is running the trial and so the information is available. It does need to be reviewed and in terms of where will we present the data and the timing and all of that. So just stay tuned on that aspect. I expect that we will onboard in a reasonable period with a plan there. With regard to the matters around the arbitration, perhaps I'll ask Todd to make a comment. Todd Simpson: Sure. So Andy, thanks for the question. Again, remember, there are 2 separate matters. The Texas case is a patent infringement. They're the jury award and 8% royalty and we're now asking for the judge to award us future damages. We think that, as I mentioned earlier, we'll take a matter of months, some additional time. The arbitrage on the other hand, is a question of ownership improvements to our ADC technology that we believe are embedded in some of the work that Daiichi did with our assistance. So it's a separate matter. We don't think they're necessarily tied together. And just -- based on what we know -- and which isn't certainly everything. We do expect that the arbitration will read out for anything further from the Texas court. Andrew Berens: Okay. The reason I was asking is just there will be damages potentially awarded from the arbitration. And I was just wondering whether the arbitrator looks at the 8% that you got retroactively and maybe proactively too. Todd Simpson: It's a good question. I think it's perhaps one of the things that will be looked at but we've provided a whole different damage case to the arbitration judge that we think will be sufficient in order for him to make a ruling. Operator: The next question comes from Michael Schmidt from Guggenheim. Michael Schmidt: Roger, I had one on EV-302 which you said is the confirmatory study for Cohort K. And my question is on, what is the regulatory bar for overall survival now in frontline bladder cancer with BAVENCIO maintenance being routinely used and PADCEV obviously as well in later-stage patients. And how confident are you in the EV-302 trial design and powering assumptions now with Cohort K data being available to you? Roger Dansey: Well, Michael, thank you. That's a great question. With regard to the outcome that we could expect on the experimental arm of EV-302, we do have the luxury now of 2 data sets which, as we indicated, in the press release, are generally consistent with each other. So confidence around the experimental arm in terms of its reproducibility and its likely outcomes is based on that data. And so the question becomes how will the control arm perform? And just to remind you -- but as you know, BAVENCIO intervention and avelumab addition as a maintenance therapy is not for everyone. So the patients have to either respond or do not progress in order to get to avelumab opportunity. And EV-302 enrolls everyone. There is no -- the populations are not the same. Obviously, there will be avelumab use in the trial. There will be other PD-1 inhibitor use. Again, as a sort of sequence to after therapy. And so from our perspective, if you're asking the question, are we confident that we have adequate power to show the outcome that we could expect as a differential for ? I think the answer is yes, we are confident. We think the trial is big enough, reminding you that it's a global trial of some, I think, 800 to 900 patients. And we have good visibility into what the experimental arm should do. And it is a question of how the control arm will perform. Operator: The next question comes from Geoff Meacham from Bank of America. Geoff Meacham: I guess I had more of a commercial question. I wanted to kind of take your vis-Ã -vis what happened or what's changed commercially for PADCEV and TUKYSA in particular versus what your original assumptions were to start the year? And then the second part of that is just on the ADCETRIS side of things. Just wondering what the feedback was on the recent data on OS for ECHELON-1. And maybe what kind of commercial impact you think that could have down the road? Roger Dansey: Yes. Thanks, Geoff and thanks again for congrats. With regard to -- I think I understood your question as being the -- at the beginning of the year, we obviously gave guidance and we had some parameters under which we determined that guidance. And how do you see that compared to where we are right now and in terms of how we're thinking about the . I think that's what I heard. I'll ask Chip to respond, please. Chip Romp: Sure. Geoff, thanks for the question. So we're pleased with the quarter. It was a very strong quarter across all of our brands. At the end of the day, it kind of reaffirms our thinking around guidance. We think we're on track with regard to our guidance recommendation which was at the beginning of the year. PADCEV had a very strong quarter at 15% growth over the first quarter. And in addition to that, we sold very strong ADCETRIS growth, as you mentioned. We do attribute this to the E-1 data that we released the OS data. We've seen significant response to that data. Physicians are pleased with it and I think it has reaffirmed some of the messaging that we've been getting over the last couple of years. In addition to that, we did see a rebound in patient diagnosis in Q2 with regard to newly diagnosed HL patients which was close to pre-pandemic levels. The pandemic had an impact on ADCETRIS. So we spoke to that in the past. With regard to TUKYSA. TUKYSA has held up very well. It is a valued treatment option for physicians and particularly for patients with CNS involvement. And so we're pleased with the performance of the TUKYSA. We continue to maintain our guidance on it and we'll continue to monitor the market closely. Todd Simpson: Yes. Maybe I'll just add. Some of the dynamics that we included in our guidance are as follows. So first for TUKYSA, as Chip mentioned, we were expecting to see ENHERTU approval, we're really happy with the way the brand has performed in the first half of the year. We've only now seen ENHERTU approved. It was approved, I guess, late in the second quarter. So we're still watching the effect of that. But as we talked about when we gave our guidance, we do see a little bit of a disruption in how the drugs are sequenced in that setting. So we'll continue to watch and see how that plays out. But again, I think we're really pleased with how the first half of the year has gone. And then with respect to PADCEV, we were expecting growth from Cohort 2. We were also looking at the use of BAVENCIO maintenance and how that informs patients that come on to the label for PADCEV. So all in all, things are playing out the way we thought they would when we gave guidance. And again, as I think Chip said, we're really happy with how the brands have performed in the first half of the year. Operator: The next question comes from Gregory Renza from RBC Capital. Gregory Renza: Great. Congratulations on the quarter. Maybe, Roger, perhaps more of a higher-level question. You acknowledge the Interim CEO role at the top of the call. Perhaps, I could just ask you to comment a bit about what you're learning about the organization, the culture and the progress to date as you think about Seagen's future from the interim CEO standpoint? Roger Dansey: Greg, thank you for the congrats and thanks for this question. I have to say, Greg, I am energized. I mean this company is really terrific. The workforce -- all of the employees are really focused on a sincere mission which is to try and make a difference in the lives of cancer patients. And we've obviously had -- we had an excellent execution for the first half of this year. And it is -- I get energized honestly by the employees, their enthusiasm, their commitment and their desire to make a difference and it's a very collaborative environment. So as a work experience, now sitting in this Interim CEO position, I have nothing but positive things to think and say about the role. And the company, it has a soul. There is a culture in this company which is very attractive which we absolutely plan to maintain and retain as we grow and as we essentially scale for what is ahead of us. And my focus right now as Interim CEO is on keeping the business moving on the straight trajectory. Operator: The next question comes from Stephen Willey from Stifel. Stephen Willey: Congratulations. So maybe just a follow-up, I guess, on the last question. So -- and I know, Roger, you are holding the Interim CEO role here. Congratulations. But I think there is an ongoing search for a permanent CEO. I'm just wondering if you could provide any commentary just with respect to where that process is and what time lines might look like? And then I just have a quick guidance follow-up. Roger Dansey: Yes. Thanks for the question and it's an important one. So as I think we've indicated, the Board has initiated a search. This is a great opportunity for anyone who happens to land the role. And so in terms of timing, we have -- our sales are set, we have plans in place. This is not necessarily an urgent thing to do. We are in great shape. So I think we have the time to look for the ideal candidate. The candidate will fit in with the type of company that we are and the mission that we're on. And so there is no clear guidance as to timing other than to indicate that the process has begun and we look forward to reviewing candidates as they come through. Stephen Willey: Okay, that's helpful. And then maybe just quickly for Todd. It doesn't look like the infringement awards included in any updated guidance and just curious if that's a function of that being subject to some kind of appeal? Or if you could just provide any commentary on that? Todd Simpson: Yes. Thanks for the question. So it's not included in our guidance. While we've had a positive jury verdict. There have been legal maneuvering to try to have this overturned. And nicely, I think the court continues to find in our favor. So we're feeling very good about the award but we haven't recorded anything yet in terms of payments or damages. There's an accounting framework, if you will, that we need to apply which we're doing and it hasn't gotten to the level where we've recorded anything and therefore, it's not included in our guidance, as you mentioned. Operator: The next question comes from Andy Hsieh from William Blair. Andy Hsieh: Really glad to see the strong commercial performance and clinical success this quarter. So regarding Disitamab vedotin, I'm just curious about how you think about exploring the opportunity there, maybe for a white space perspective and also kind of taking into account other therapies out there that could fulfill that unmet medical need? Roger Dansey: Thanks, Andy and it's a great question. So as we've indicated before, Disitamab vedotin has a novel HER2-directed antibody on the front end which has been optimized, we believe, for an ADC-type construct and it uses technology. So we're very familiar with the payload and the drug linker. With regard to the opportunity, in the broad potential for EV. We, obviously, were fortunate enough to have data in hand from our partner, RemeGen in China, generated in China in diseases such as urothelial cancer and in breast cancer and to some extent, in gastric cancer. And just to remind you, they have approval in a number of diseases in China. With regard to where are we going? We've already declared pretty clearly and we have already opened the first trial in urothelial cancer -- and our clinical trial footprint is focused on collecting data, enrolling patients from a Western population which will be more amenable to review by agencies such as the FDA. So we are committed to urothelial cancer and our first trial is looking for an accelerated approval approach. And as you know, going down that path, then basically entails a confirmatory trial because that's what's required for an accelerated approval. And so we will be conducting at least 2 trials in urothelial cancer, on monotherapy. We haven't disclosed what our plans are with regard to what our confirmatory trial could look like. And obviously, as we always do, when we conduct a randomized Phase III, it's not just a confirmatory trial, it gives opportunity. It's positive to seek approval basically around the world. So bladder cancer is in scope. The second area is -- certainly is breast cancer. And obviously, the results that were presented within HER2 recently are outstanding and points the way to the potential for an ADC which is not dependent upon some form of addiction to the pathway. The pathway itself doesn't necessarily have to signal. It just has to be there, such that the ADC can then internalize. And that's why an ADC has the possibility of working in HER2-low population. So we're very interested in that. And one of the differentiators we have which we believe is important. And in fact, Cohort K, I think, speaks to this is there is something important going on when you combine a vedotin ADC with a PD-1 inhibitor. Certainly, that is our belief. And that is an element that I think we will explore with EV in various diseases, including potentially breast and gastric cancer and so on, wherever we think it's appropriate to consider something like a PD-1 inhibitor. And then lastly, I would say, just to remind you, we do have TUKYSA. So we have another HER2 asset that is available and we are thinking through what could a development program look like that would incorporate a combination of TUKYSA . So there's lots of work ahead of us. I think we're excited for the program. There's lots of opportunity. We're trying to be thoughtful about how to navigate, what is the competitive landscape. So we will bring more plans forward as they mature. Operator: The next question comes from Joe Catanzaro from Piper Sandler. Joe Catanzaro: Maybe just one follow-up on Cohort K. So Roger, you mentioned that there's a monotherapy arm within that trial. Just wondering if you guys have taken a cut of those monotherapy data, yet? And if so, when would you expect to present those data? And if not, when would you expect to take a data cut? Roger Dansey: Thanks for the question. So in a -- it's a randomized trial. So both arms are contemporaneous. And anytime we do an analysis in that circumstance, even though there is no inferential statistics between the 2 arms, they are still randomized. We take a complete data cuts. And so we will be presenting all of the data we have and it is a rich data set and it will include the monotherapy and the combination at a medical meeting that we can get to as soon as possible. Operator: The next question comes from Jay Olson from Oppenheimer. Jay Olson: Thanks for the update and congrats on the quarter. Can you comment on any read across from Roche's TIGIT antibody to your TIGIT program? And remind us, what are some of the important differences between your SEA-TGT and tiragolumab? And maybe comment more broadly on any plans to expand your SEA technology platform? Roger Dansey: Jay, thank you for the congrats and the question. It's a great one. So from the point of view of what is the level of conviction around the pathway, the TIGIT pathway, there was obviously enormous initial excitement and certainly, Roche generated their randomized outcome which was very encouraging initially in the Phase II. We haven't seen the data. So it's really hard for us to actually make a judgment about the treatment effect that may have been seen. But the science is strong and we really like our molecule. It's preclinically differentiated. And it's basically because the backbone is in an activated state with regard to being . And what it does is essentially increases the potency of all the interactions that the backbone may have with various other cell types. And so we've got a lot of preclinical data that I think shows that we have a differentiated TIGIT that maybe -- if that preclinical component turns out to be useful in the clinic, may put us in a very strong position. With regard to where we are, we are still in Phase I. We are in -- we are focusing on determining what a dose that we would -- dosing schedule that we would take forward. And we are also exploring signals in various diseases such as gastric cancer and lymphomas which we think is an interesting area for us to look at. And we've also begun -- and we have a collaboration with Pfizer with their PD-1 inhibitor, just to evaluate what our TIGIT together with the PD-1 inhibitor may look like. So we take the point that the TIGIT landscape is perhaps not as positive as it was before. But I think the point that I've made, we're still committed to evaluating the drug. We have the potential for the differentiation. The Phase I sets us up to try and get an understanding of whether that actually does occur. And then obviously, the opportunity depending on what we see from our Phase I will present itself to move forward. Operator: The next question comes from Zhiqiang Shu from Berenberg. Zhiqiang Shu: Great. I'd like to add my congrats as well, very strong quarter. I would like to ask regarding Cohort K data in terms of the accelerated approval. Absent the trial, the agreement with the FDA on the first-line patients who are not eligible for treatment. So do you see any risk regarding the accelerated approval at eligible patients and the potential approval for us. Roger Dansey: We couldn't hear your question. There was a fair amount of background noise. So I'll do my best for . I think what you're asking is quite an eligible population versus the population we've studied. I mean from the point of view of the expected outcome from our side, we believe strongly that we will get -- if the data are compelling to the agency and they agree that this is something that should be approved, we expect the indication to manage the population that we enrolled. And just to remind you, it's a cisplatin-ineligible population. And the definition of cisplatin eligibility is clearly stated in the protocol. And we project that is about somewhere between 40% and 50% of patients with frontline metastatic urothelial cancer . So I don't know if I've answered your question but I didn't hear it all but that's our expectation is that will be cisplatin-ineligible. And that doesn't limit you to carboplatin-eligible. It's just cisplatin-ineligible. Zhiqiang Shu: You did answer the question. Operator: The next question comes from Ren Benjamin from JMP Securities. Reni Benjamin: Congratulations on a great commercial and clinical quarter. Maybe just looking at ADCETRIS. I definitely wouldn't have predicted that ADCETRIS would outperform in terms of revenues, maybe some of the other products. Can you talk a little bit about what kind of market share you have across the indications? And which ones kind of remaining have the potential for significant growth? And just thinking about the commercial products with TUKYSA, as you think about sequencing, do you have a sense as to the clinical benefit TUKYSA might provide when it's used subsequently to ENHERTU relapsed or refractory patients? Roger Dansey: Yes. Thanks again and I appreciate the comments on the quarter. With regard to some quick comments and then I'll hand it over to Chip to make the commercial response. ADCETRIS is an amazing drug. I mean, here we are, it's been on the market for 10 years. We've now shown survival in its primary indication which is Hodgkin lymphoma and we continue to develop the drug. We are interested in seeing whether we can find a place for ADCETRIS in a relapsed DLBCL population. So it is an amazing drug. And I think I can just actually make some comments about TUKYSA which is, do we know what TUKYSA profile looks like post ENHERTU? I think that the answer to that is no because we haven't got data. The expectation would be because TUKYSA is a tyrosine kinase inhibitor, mechanistically completely different from anything like an ADC and provided pathways post-signaling is still relevant to the tumors addicted to that path than using TUKYSA at any stage regardless of prior exposure and it should potentially bring value. But we don't have data, I don't think to support to demonstrate that. Chip, would you want to comment on the commercial? Chip Romp: Yes. Sure, Roger. So ADCETRIS did have a very strong quarter. The overall survival data is meaningful data. It's important data for both physicians and patients. The teams have been executing very well and getting that information out. We feel that there's continued opportunity for growth with regard to ADCETRIS and its labeled indication in frontline. We are a standard of care in frontline therapy now. So I think there's a good platform for us to continue to build off of. With regard to TUKYSA. TUKYSA is viewed as a really important option for physicians and particularly for patients with CNS involvement. We spoke on other calls in the past regarding the dynamic nature of the breast cancer market associated with entries into it. We continue to monitor that market very, very closely but we are pleased with how TUKYSA has held up with regard to its revenue production. We continue to look for additional opportunities with regard to that from a development standpoint as well and we'll continue to execute across the label that we have. Operator: The next question comes from Ami Fadia from Needham. Ami Fadia: Great. Congratulations on the quarter and the clinical data. Just a clarification or a follow-up on ADCETRIS. Given its position in both first-line and second-line, what do you see as the growth opportunity in Hodgkin lymphoma from here? You do have a couple of programs in the clinic. And if you could talk to which one excites you more in terms of growth? And then a follow-up on Daiichi Sankyo arbitration, when we get the decision, are we also going to get a decision on what the remedy would be and sort of quantification of whether it's royalty or any other sort of payment that would be due to Seagen? Or will that be something that gets determined down the line? Roger Dansey: Thanks for the question and thanks for the comments. So with regard to ADCETRIS, I think I'll give a quick set of comments to you. ADCETRIS continues to grow, as you can see. And so there's still opportunity in front-line Hodgkin lymphoma in the advanced setting for Stage III, IV. As you know, now with an overall survival signal, commercially, Chip's team will be looking to make sure that any physician that needs to know the data and understands what the possibilities are with ADCETRIS as part of the front-line therapy is aware of that. So that does represent some growth. Of course, the pediatric component which we've indicated we have submitted for potential approval. If we're successful there, it's a modest opportunity but it remains an opportunity nevertheless and an important one and this is in high-risk Hodgkin lymphoma. We are very interested in earlier-stage Hodgkin lymphoma and we are interested in novel regimens. So we wouldn't describe these as label-enabling but we are certainly looking at the combination of ADCETRIS plus nivolumab together with an . So we've got a lot of effort going on. We're looking to what -- to look to see what is the next generation of therapies. And we believe that in ADCETRIS, a PD-1 combination may well lead the pack in terms of what possibly could be considered for later development. With regard to DS, I think I'll turn it over to Todd for a quick comment. Todd Simpson: Yes. So thanks for the question. It's a good question. It's one, unfortunately, we don't have a clear answer to. Obviously, what would be nice would be a ruling in our favor with awarding us ownership of the IP and a pathway forward with respect to what that means in terms of damages. Unfortunately, we don't know how the judge is going to rule and we don't know to the degree the ruling will kind of cover all the unknowns. It could be quite clear and easy or it could be a matter of Seagen has ownership, you guys go figure out what that means from a product standpoint. So it's a great question. Thanks for it. We just need to kind of wait and see what happens here. Roger Dansey: Yes. But we believe we have a strong case in our hands. We're hoping for a very clear and really interpretable outcome. Operator: Due to time constraints, this concludes our question-and-answer session. I would like to turn the conference back over to Doug Maffei for any closing remarks. Douglas Maffei: Thank you, operator and thanks, everybody, for participating in our call this afternoon. Have a great rest of your day. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.SGEN Ratings Summary
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Seagen Reports Q3 Miss, Revenues Beat, 2022 Guidance Raised
Seagen (NASDAQ:SGEN) reported its Q3 results, with EPS of ($1.03) coming in worse than the Street estimate of ($0.95). Revenue was $510 million, compared to the Street estimate of $459.58 million.
The company raised its fiscal 2022 net product sales guidance (including Adcetris, Tukysa, and Padcev) to $1.580–1.615 billion from $1.500–1.565 billion driven by strong Adcetris momentum and less-than-expected impact on Tukysa in 2022.
The company also confirmed the submission of an sBLA to FDA in October for Padcev+Keytruda in 1L la/mUC. CEO search efforts continue and the timing of several catalysts from the pipeline has been updated.
