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spk03: 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.
spk04: 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.
spk10: 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.
spk07: Roger? Thank you, Chip, and good afternoon, everyone. I'm happy to share recent clinical development updates for our approved medicines and our pipeline. I'll start with PADSAFE. FDA originally granted PADCED accelerated approval for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PTL-1 inhibitor and a platinum-containing chemotherapy. Continued approval was contingent upon confirmation of the clinical benefits in the EB301 pivotal trial. FDA has now granted PADCED regular approval based on the trial's success which demonstrated improved survival among patients who received PADSEV compared to those who received chemotherapy. Further, the PADSEV-US prescribing information now includes a new indication for the treatment of metastatic urothelial cancer patients who are ineligible for cisplatin and have previously received one or more prior lines of therapy. The new indication was also granted regular approval and is based on cohort 2 of the EB201 trial. These results were recently published in Lancet Oncology and were updated with additional follow-up in a presentation at ASCO. 51% of patients achieved a confirmed objective response with a median duration of response of 13.8 months. These data are clinically meaningful in the setting of high unmet need, where patients are older and are suffering from multiple comorbidities, commonly including poor kidney function. We are pleased with the broad nature of the second indication, which does not specifically require prior PD-1 or PD-L1 treatment. Additionally, the new label has been updated with important safety information, which further informs physicians on how to safely use PADCET. The clinically compelling PADCET data have enabled substantial regulatory progress outside of the United States, with marketing applications currently under review in the EU, Australia, Canada, Japan, Brazil, Switzerland, and Singapore. I'll turn now to first-line metastatic urothelial cancer. At ASCO, we presented updated durability and other long-term outcomes from cohort A of the EV103 trial, evaluating PADCF plus Keytruda in cisplatin-ineligible patients. The data showed a continued objective response rate of 73% and median duration of response extending to 25.6 months. Encouragingly, median TFS was 12.3 months and median OS was 26.1 months. The safety profile of this combination was generally consistent with previous findings. We are using the same regimen in cohort K, which is intended to support accelerated approval, and we expect a complete enrollment of this cohort by the end of the year. In addition, we continue to enroll patients into the Phase III EV302 global trial, which includes both cisplatin-eligible and ineligible patients, evaluating PADSF plus Keytruda compared to a platinum-containing chemotherapy regimen. Our broad PADSEV development program also includes two Phase III trials in patients with muscle invasive disease. Both trials test PADSEV in combination with Keytruda. The Keynote B15 or EB304 trial is enrolling cisplatin-eligible patients, and Keynote 905 or EB303 trial is enrolling cisplatin-ineligible patients. In the next few months, we expect to initiate a dose-finding trial of single-agent PADSEV in non-muscle-invasive bladder cancer. PADSEV will be administered intravesically in BCG non-responsive patients. Nectin-4 is highly expressed in non-muscle-invasive bladder cancer, and there is promising preclinical data to support the potential opportunity for PADSEV to be active in this setting. We are also evaluating PADSEV in a basket trial of high nectin-4-expressing solid tumors, including lung, breast, head and neck, gastric, and esophageal cancer, and we await initial data to inform our next steps. Turning now to Tukeiza. At ASCO, we presented long-term data from a HER2 time trial. The primary analysis upon which Tukeiza was approved was conducted with 14 months of follow-up. This presentation extended the time of follow-up to 29.6 months. The updated median overall survival increased to 24.7 months for the Jukaisa arm, with benefit maintained across all pre-specified patient subgroups. There has also been a recent update to the NCCN treatment guidelines for patients with CNS involvement. Tucaza plus Trastuzumab and Cadsidabine is now the only regimen in the setting with a Category 1 level of evidence. In earlier stages of breast cancer, we are evaluating Tucaza plus Cadsila versus Cadsila alone in first- and second-line metastatic patients in the HER2-CLIM-O2 trial. We in Merck intend for this trial to support global approvals, including in China. In high-risk adjuvant breast cancer, enrollment continues in the randomized COMPASS HER2-RD trial, evaluating to Kaiser plus Capsylo versus Capsylo alone, which is being run by the Alliance Cooperative Group. In GI cancers, we remain on track to complete enrollment in the Mountaineer trial by the end of 2021. This trial is intended to support an accelerated approval in the United States for patients with advanced HER2-positive colorectal cancer. Also, we are advancing to Kaiser in several studies, including in combination with oxaliplatin-based chemotherapy in first-line GI cancers, in a basket trial for solid tumors of HER2 alterations that include mutations, and in combination with HER2 for HER2-positive breast cancer. Moving on now to et cetera, we are pleased that the ECHELON1 five-year manuscript was published in Lancet Hematology during the second quarter. As we have discussed, results demonstrated robust and durable remissions in patients with newly diagnosed advanced Hodgkin lymphoma who received the Tetris in combination with ABD. Importantly, we also saw fewer second malignancies and more pregnancies in patients on the Tetris arm of the trial. We continue to execute our Tetris clinical development program that includes Echelon 3, our Phase 3 trial in relapsed diffuse large B-cell lymphoma, which compares Tetris plus Revlimid and Rituxan versus Revlimid and Rituxan. In frontline advanced as well as early stage Hodgkin lymphoma, we are evaluating a Tetris in combination with Novolumab, Edremicin, and Dicarbazine. And in solid tumors, we are evaluating Atetras as an immunomodulatory agent in combination with Keytruda. I'll turn now to TB, which we are developing in collaboration with GenMab. The BLA currently under review is seeking accelerated approval of TB for the treatment of women with previously treated recurrent or metastatic cervical cancer. The BLA is supported by data from the Innovative 204 trial, which was recently published in Lancet Oncology. In addition, we are enrolling the Innovative 301 Global Phase 3 trial in a similar population that is intended to serve as the confirmatory trial in the United States and to support global regulatory applications. We believe TB could make a meaningful difference for women with cervical cancer where there is such a high unmet to bring TB into earlier lines of metastatic or recurrent cervical cancer, and for that purpose, we are conducting the innovative 205 trial in first or second line. In this trial, we are evaluating TB in combination with chemotherapy or Keytruda, and we expect to report data at a medical meeting before the end of the year. Turning now to Liduratuzumab and Vidotin, we are working with our partner Merck, focusing on optimizing dose and schedule, asthma and therapy, and in combination with Keytruda in breast cancer. We plan to present data from LV later this year. Next, I'd like to highlight the breadth and depth of our early stage pipeline. We are advancing seven programs in phase one clinical trials across a range of solid tumors and hematologic malignancies. These include the ADCs SGN CD228A, B6A, and STMV, and we expect to submit INDs for at least two more ADC programs this year. In addition, we have four effective function-enhanced antibodies utilizing our SEA technology, including SEA CD40, CD70, BCMA, and TIGIS. With regard to SEA CD40, earlier this year we completed enrollment in a clinical trial, evaluating it as part of a combination regimen for the treatment of pancreatic cancer. We expect to report clinical data from the trial sometime either later this year or early next year as the data mature. We are also planning to initiate a basket trial to evaluate SEA CD40 and other solid tumors. In closing, we have achieved many important milestones and have made significant headway across our pipeline in the first half of 2021. We look forward to providing you with further updates on future calls, and now I will turn the call back over to Clay.
spk10: Thank you, Roger. I'm proud of the remarkable progress we have made in growing and evolving our business and technology, enabling us to develop exceptional oncology therapies. Today, we have a deep and diverse pipeline. a multi-product commercial portfolio and additional potential approvals on the horizon. Strategic partnerships, our expanded global infrastructure and substantial financial power fuel our ability to advance our portfolio, including our early and mid-stage pipelines. Our robust clinical development program and proven commercial engine demonstrate our ability to compete in the marketplace, and we are poised to maximize new assets and future launches. With our solid foundation, we are operating from a position of strength and are confident in our ability to continue delivering cutting-edge innovation and transformative medicines for cancer patients worldwide. Operator, please open the line for Q&A.
spk03: We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Andrew Behrens with SVB Learing. Please go ahead.
spk06: Hi, congrats on the strong execution, guys, this quarter. I know you've given some guidance about the addressable markets by line of therapy for PAD7 in the past, so I was wondering if you could tell us how much you think the label expansion to the second line increases the addressable market now, and how saturated do you think PAD7 is in the third line?
spk10: Thank you for the questions and the comments, Andy. You know, we're really pleased with the broad label that we got for PASF. You know, there was the 301 study confirmed the existing label, and then the cohort two, as we called it, gave us a new population of patients that were cis-ineligible. We believe that some of these patients were likely getting unpromoted use of the drug in that setting. It's very hard to know how many, but certainly we don't think it was zero. So, you know, we'll continue to monitor the impact of this new indication on, you know, the commercial uptake of this, but we feel really great about, you know, the new labels.
spk06: Okay. How saturated do you think it was in the third line setting that was originally approved then?
spk10: You know, I think we're, you know, we got to, you know, standard of care pretty quickly there. And docs really embraced using it. And, you know, I don't think we were 100% saturated. It's hard to give guidance on it for what's, you know, happening. It's also... You know, it feels like we're coming out of COVID a little bit, although with the new variants, who knows? And, you know, so it's really hard to give exacting guidance. But I think we have room to continue moving upstream with PADSEP. It's a great drug, and doctors are embracing it.
spk06: Okay. Thanks for the call. I appreciate it.
spk10: Sure. Chip, would you like to give a little color on this? So, absolutely. I think it's just important that this is a dynamic market. And with the advancements in treatment with regard to maintenance, we are seeing, you know, more and more patients become eligible for PASV earlier in their treatment journey than they would have in the past.
spk03: Our next question comes from Salveen Richer with Goldman Sachs. Please go ahead.
spk02: Good afternoon. Congrats on the nice quarter. Could you comment on the trajectory of your products in the second half, given there is suggestion of negative growth for etc. into Kaiser for your guidance? And then what drove the inflection for etc. this quarter?
spk10: Okay. Well, thanks very much for the questions on everything. You know, we're not trying to provide down guidance on anything. It's just hard to really know exactly what will happen as we either get out of COVID or not. And so we just want it to be prudent with our guidance, and we watch things very close on this. Todd, do you want to give a little bit of color on what we're thinking about in terms of financials and guidance? Sure. So thanks for the question, Salveen. First, I'll start off by saying, you know, of a very strong quarter, which we're delighted about. Q2 typically is a strong quarter for us, especially compared to Q1. And when you annualize first half of the year and compare that to our guidance, we think our guidance is appropriate, which is why we've maintained it. But there's a lot going on, and we're really pleased with what we're seeing. The year's off to a great start. It's terrific to get our field teams, for the most part, back into the field, which is where they can do their best work. And there are a lot of things that we're tracking. For example, with Etcetera's, You know, we're now promoting to the five-year data. We're looking at, you know, return of patients in the clinic out of the pandemic, but it's frankly a little too early to tell exactly what's going on. For PADSA, we're looking forward to now promoting to the cohort two label, which, you know, as you heard on the call, is incremental because we're probably getting some of those patients before. And then with Takaiza, you know, we're delighted to now complement the U.S. launch with now launches starting in Europe, most notably in France and Germany. So, again, you know, we're really pleased with how the year has gotten off to a start and feel like we're in a good position going into the second half.
spk02: Great. Thank you.
spk03: Our next question comes from Kenan McKay with LBC Capital Markets. Please go ahead.
spk09: Thanks for taking the question and congrats to the team on the really terrific quarter here. This is awesome to see after the seasonal weakness in Q1 and COVID impacts there. Maybe on the commercial side of things for Clay or for Chip, can you maybe talk to U.S. trends versus ex-U.S. and European trends and perhaps how that Q2 outperformance related to easing of COVID-19 restrictions and, you know, any commentary you can give on early signs of how that's continuing into Q3. And I'd love to hear any commentary you can give around U.S. versus Europe, especially as it relates to the geographic expansion for Kaiser.
spk10: Sure. Ken, thanks for the comments and the questions. Chip, can you try to talk a little bit about U.S. trends and what you're seeing with all three brands and as it relates to COVID-19? And we'll start there, and then we'll get into the U.S. versus European. Oh, absolutely, Clay. So, you know, as far as et cetera goes, I think this is an opportunity to show how the five-year data is resonating with physicians. Five years is an important and meaningful endpoint for for physicians. This shows the durable aspect of the original trial that we did on et cetera. I think in addition to that, we have some publications that are put out in June in Lancet Hematology, which represent this data set. I think we're getting traction with that now on et cetera. I think as far as passive goes, I spoke earlier about the dynamic nature of the market. What we're seeing is As the market continues to change, more maintenance therapy is being used and PADSAP is being used in earlier lines as a result of that. We are excited to have the new label to where we can promote versus flattened and eligible patients, and we think we will get traction from that. And then with regard to Kysa, Kysa has demonstrated an overall survival benefit in the HER2 CLIMB trial. This really resonates with physicians. It's helped us to continue to gain share in patients with and without brain mets. Now, concerning the European question of the U.S. trans-European, we're really excited with going into Europe. We have broad approval throughout all of Europe, but we only have a few countries that we have reimbursement to date. So, you know, most of our sales are coming from the U.S. because there's only a few countries in there. But we expect over time to get all those countries reimbursement. You know, it just takes a little longer to get reimbursement in Europe. There's no issue, no problem. This is all what we expected and you've seen before with other products. And so things are going well there, but it's really hard to give you a definitive answer on the – you know, ex-U.S. trends with Kaiser since we're pretty early in the game there.
spk09: Totally get it. Maybe just a follow-up, Clay, or perhaps for Roger. The potential for PADSF to move into pre-muscle invasive bladder cancer with intravascular dosing is super interesting, given the potential to transform that market and maybe even alleviate the reliance on on suspect me. And you have that linker that maybe uniquely enables you to perform that intervesicular delivery. Can you maybe talk a little bit about how you're thinking about going forward potentially into that market there? I know it's early, but I'd love to understand at least whether you're thinking about combinations either with BCG or checkpoints or simply planning to evaluate that monotherapy activity before making any decisions. Thank you and congrats again.
spk10: Great question, Ken. Really good question. Yes, we're very interested. And Roger, can you take this and see the best way to address that?
spk07: Yeah, thanks, Clay. And thanks for the great question. I think we've got strong preclinical evidence to move forward. The value proposition of giving something like CACID into the bladder because the main body of people who treat patients with superficial bladder cancer is urology. and urologists you know that's their their bread and butter so it's a really good sort of it's a good match uh for the disease states um because you know the we expect the systemic exposure of pads have to be very limited so the safety profile could be you know quite promising and you know as i said in my prepared remarks uh nexon 4 is expressed in non-muscle invasive bladder cancer And I think, Kenan, all of the things that you raised, like where could we go with this and what populations could we address, I think those are all at least theoretically on the table, but we have to start at square one. which is let's take the people who failed BCG and see if we can reverse their disease state. So that is our, you know, starting point. We need to prove that TATV can, in fact, you know, have impact on those late sort of non-muscle-invasive bladder patients. And once we've got that and we can determine what its profile looks like, then I think the development in non-muscle-invasive bladder cancer can go as far as we like. As you know, Pembrolizumab is approved. There are some other agents that are approved. The goal is to clear the disease. And so depending on the efficacy profile, adding another agent would be a reasonable thing to do.
spk03: Our next question comes from Jeff Meechan with Bank of America. Please go ahead.
spk11: Hey, guys. It's asking for Jeff. Thanks for the questions. Just a couple on the commercial launch for TV. Basically, just want to get some more color on what needs to be done and what exactly has been done to prep for that, and maybe how the emerging variants kind of play into your thoughts and what that launch might look like in the U.S. And any learning you can take from the mid-pandemic to keep the launch over the TV would be helpful as well. Thanks.
spk10: Sure. We're really excited about, you know, potentially getting a fourth product, I think potentially because it's not approved yet by FDA. But we're, you know, we submitted a file. We're working hard with them to try to get this thing on the market to help patients. The due date is, I think, October 10th. And, you know, we're working hard toward that. There's, you know, a lot of work to do behind the scenes that, you know, nobody knows that companies do when they're trying to launch a product. Chip, can you talk a little bit about the commercial and what we're seeing and whether you think there's any, you know, anything going on with the COVID variants? But in general, you know, can you talk a little bit about how we're thinking about this launch? Yeah, absolutely, Clay. So the teams have been working for over a year now, getting the right structure, the right technology, roles in place associated with this. We have a fully staffed and dedicated sales force, which is going to work in co-promotion with GenMab in the U.S. So we've got a corporate partner that we're looking forward to partnering when the product becomes approved. In addition to that, you know, this is an important kind of unmet medical need. Metastatic cervical cancer is a devastating disease, and I think there's going to be an opportunity for improvement potentially in outcomes with a product like this. As far as the COVID commentary goes, most of our field sales force is now out making face-to-face calls, or most of our calls, I should say, are face-to-face. We're continuing to monitor what happens. It's an unforeseen future with regard to these variants. But what we do have is a model of a full virtual launch behind us. We can leverage that experience should things in the future change, and we will do that. But our plans right now are really to build upon the successful launches that we've had and leveraging the right parts of that infrastructure when necessary.
spk11: Thank you.
spk03: Our next question comes from Michael Schmidt with Guggenheim. Please go ahead.
spk13: Hey, guys. Thanks for taking my questions, and congrats on the quarter as well from me. I had a couple of pipeline questions. Maybe first on the LIV1A data that we saw the title for the upcoming ESMO presentation, Roger, on the weekly dosing schedule. Just wondering what you're looking for in this data and how it will guide next development steps in breast cancer. And then on the CD40 antibody data, Pancreatic cancer is obviously a huge potential market opportunity, but it also has been difficult in terms of drug development historically. What do you need to see in this single-arm study that really gives you confidence in this combination to potentially succeed in a future phase three trial? Thanks so much.
spk07: Thanks for the question. You know, LV is, as we have said, you know, a few times now, we are continuing to work on optimizing dose and schedule. And the first, you know, piece of data that we will be sharing will come up at ESMO. And we're still working. You know, we're working with our partners. It's an active agent. Of that, there is no doubt, both as monotherapy and in combinations. And, you know, we're trying to find the sweet spot of what is the right dose and what is the right scheduling. So that's our plan. You'll see some data coming up as well. With regard to CD40, it's a great question. You know, just from a science, firstly, we have a well-defined CD40 agonist. We understand the dosing as a monotherapy. We have some activity as a monotherapy. So that part is clear. With regard to the scientific concept of combining a CD40 agonist together with chemotherapy and the PD-1 inhibitor, that's exciting. And that doesn't necessarily have to limit itself to pancreatic cancer. And that's why we're indicating that we're interested in pursuing a basket trial in tumors that may, in fact, be more immune manipulable than something like pancreatic cancer. With regard to what data do we need to see? As you pointed out, pancreatic cancer has been a very difficult disease to develop drugs in, and people have been misled with small numbers and focusing on sort of early endpoints. to find out in large trials that one doesn't show any improvement over standard of care. So I think we're interested, without going into the details of what exactly we would like to see, we are interested in all endpoints, which will include what does the response rate look like on the front end, how much disease control you know can we get that will be measured by pss and most importantly what does the survival curve look like and i think all three of those elements you know need to be part of our evaluation you know once we have the data great thanks so much roger our next question comes from corey casanova with jp morgan please go ahead
spk01: Hey, good afternoon, guys. Thanks for taking the question. Wanted to follow up on the SEACD40 program. And I guess, first of all, what determines whether we'll see that S40 data later this year versus early next? Is it getting kind of that early look at those survival curves, as you were just talking about, Roger? And when we do see the data, I believe, like with pancreatic, the expansion cohorts go up to 75 patients per indication. But are all the pancreatic patients on the same combination, or are there a variety of combinations being evaluated? Thank you.
spk07: Thanks for the question. With regard to the last piece, we have focused the same combination. So it's the standard chemotherapy plus pancreatic. our Pembrolizumab plus our CD40. So the triplet in that component is, in fact, the same. With regard to timing, you're exactly right. We need enough maturity on all the endpoints in order for us to make our best estimate as to whether this is worthwhile taking into a pivotal trial, or we need to do more work. And so in terms of the timing of when that data will be available, it sits on the cusp of the year. And so it's very hard for us to predict, you know, will we be able to share the information in 2020 or will it, you know, will it go into, sorry, not 2020, I'm a year behind, 2021, or will it be in 2022? But we're monitoring very closely. And as soon as we believe we have mature enough data, you know, we'll We'll get it out in the public domain. Okay, thank you.
spk03: Our next question comes from Gina Wang with Barclays. Please go ahead.
spk05: Thank you for taking my questions. So I have one question regarding the Daiichi litigation. I know the arbitration decision should be any time now. I'm just wondering how will you share the decision with us and how would the decision impact the next steps and also the other ongoing litigation?
spk10: So thanks very much for the question on our litigation. I'd like to say, first of all, that over our history of 24 years, we are not a litigious company. We have only taken action that's appropriate to defend our IP and our contractual rights. So this is not something I hope you'll see from us on a routine basis. The arbitration hearing was conducted in June. And we expect a decision sometime later this year from the arbitrator. And, you know, things are proceeding according to the schedule that was set by the arbitrator. So right now we think everything is proceeding in an expected standard way. And, you know, nothing is unusual from what we've seen. But, you know, and we're going forward there. We will provide updates, you know, as soon as we have them and, you know, when we're permitted to in the process. So we're not going to hold something I want you to know that we feel very confident in our position. And we feel like it's very important to defend our legal rights and protect the innovation that we work on so hard and deliver for patients. And so that's really where it is. And you asked a question on what's the next step. Well, it depends on what comes out of the arbitration. So it's hard really to predict the next step. But we feel very good about our case. You have to also, I'm sorry about the other litigation, there's also a patent infringement lawsuit that that's not going to court until sometime next year. So that's a little different. That's not in front of an arbitrator. That's actually in a court. And so that's ongoing as well. And we feel good about that one as well.
spk05: Great. Thank you.
spk03: Our next question comes from with Barenburg. Please go ahead.
spk00: Great. Thanks very much for taking my questions and congrats again on the great quarter. I have two questions. One is related to citrus. So obviously it's a strong quarter after a second quarter. I was wondering, this growth, is it a reflection of the pandemic is behind us, or is it a result of the five-year data that compelled the physician to prescribe the drug? That's the first question I'll ask Citrus. And the second question is related to your TIDGET antibody. I think you shared some very interesting clinical data last year at the R&D day. I was wondering, do you plan to share more data on this program and in light of, you know, the new developments in the field, how's your thinking around this asset evolving? Thanks very much.
spk10: Sure. Let's start with the et cetera question. You know, yes, indeed, we had a strong quarter. We're really excited. I think, you know, there might be something about the pandemic starting to wane, although we will continue to monitor that. And then Wow, I'm sorry. I must be allergic to your question. And then there's the five-year data that Chip referred to. So I think, you know, Chip, you may want to comment here with more color. I think it's a little bit of both, not just one or the other. Chip, what are you thinking? So I would agree with you, but I can speak to the Fiverr data with regard to feedback from our physicians and customers. They have found this data to be compelling. You asked a question about Tidget. So, you know, Tidget, we have a differentiated Tidget, and, you know, Roger's development team is developing it, and, you know, you know, I think they, you know, plan to put out data at appropriate times. Roger, do you want to provide any color on that?
spk07: Yeah, sure. And it's a great question. You know, I think we, certainly preclinically, we see our teachers as a best in task. I mean, we absolutely understand that this is a competitive environment. And so, you know, we're working hard on coming up with a development plan that will, you know, have the opportunity or give our TIGIT the opportunity to showcase itself and move as quickly as possible, if it's appropriate, into pivotal trials. So what I can say is that the TIGIT development team is excited by the opportunity. We're enrolling well. We're working on things like defining dose and schedule, which is what one does in a phase one trial, and thinking very carefully about where we would like to expand our evaluation, including, obviously, in combinations. So no details to disclose, but lots of thought is going on into that program.
spk00: Great. Thanks very much.
spk03: Our next question comes from Jay Olson with Oppenheimer. Please go ahead.
spk08: Oh, hey, congrats on the quarter and thank you for taking the questions. Can you talk about what lines of therapy you're seeing in the U.S. and Europe for Tukaiza and if there's any spontaneous, unpromoted use in first line? And then can you also talk about any impact you might be seeing from Trodelvy to PAD7 in bladder cancer and any feedback that you're getting from doctors related to the efficacy and safety profiles or how these two compare in clinical practice? Thank you.
spk10: Sure. On the DeKaiza front, Chip, can you address like words used in lines, and then I'll come back to the second question. Yeah, sure. You know, what I can tell you is that we are seeing continued utilization and growth in SHARE across all lines of therapy in the label second line and beyond in both patients with and without brain metastasis. It's also important, and it's now the most utilized product in second line and later for HER2-positive metastatic breast cancer patients with brain mets. So it's broad growth. Okay. As far as the second question, you know, Tridelby is not approved in bladder cancer at this point. So, you know, you're asking sort of ahead of time what it is. And we have some fantastic data and survival data. You know, we're not expecting much impact from Tridelby. I think that largely would be used after. PatSep, I think PatSep has such premier data. We're focused on also frontline and getting that. But even in the setting where we are with survival data, you know, you'd be hard-pressed for a doc to use that ahead of another product. But I'm glad that Tridelby exists, and I hope they get approval and can be there for patients that, you know, need it. PatSep doesn't, you know, it doesn't cure every patient, and, you know, other therapies are needed. So it's fine.
spk08: Great, thanks again for taking the question.
spk03: Again, if you'd like to ask a question, please press start and 1. Our next question comes from Andy Shea with William Blair. Please go ahead.
spk12: Great, yeah, thanks for taking my question. I'm really glad to see the commercial inflection across the three key products this quarter. Clay, in your prepared remarks, you mentioned this phrase, which I found very interesting. You said ADCs and immuno-oncology. So I'm just curious if you're hinting that we could expect modalities beyond the sugar-engineered antibodies or traditional kind of antibody linker payload construct of ADCs in your development pipelines?
spk10: So first of all, our SCA products we refer to as our immuno-oncology products. We also do a lot of immuno-oncology work in combination with our agencies, as you know from all the work we've done with Keytruda, Avivo, and many others, actually. It's not limited just to those two. So we do take into account immuno-oncology. We're always looking at other ways to append things to antibodies. And you can be guaranteed that in our lab, we are looking at some very interesting approaches you know, things that we won't be talking about on a conference call now, but can come out in not too distant future. So we have some exciting things that are in the horizon. So buckle up and stay tuned. Great. Thank you.
spk03: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.
spk04: Okay, thank you, operator, and thanks, everybody, so much for joining us this afternoon. Have a good evening.
spk03: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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