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spk22: Good day and welcome to the CGEN second quarter 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I'd now like to turn the conference over to Doug Maffei. Vice President of Investor Relations. Please go ahead.
spk02: Thank you, Operator, and good afternoon, everyone. I'm pleased to welcome you to CGEN's second quarter 2022 financial results conference call. This afternoon, we issued a press release with our results. The press release and supporting slides are available on our website in the investor section, events and presentations page. Speaker on today's call will be Roger Danzi, Interim Chief Executive Officer and Chief Medical Officer, Todd Simpson, Chief Financial Officer, and Chip Romp, Executive Vice President, Commercial US. Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A. Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2022 financial outlook, anticipated product sales, revenues, costs, and expenses, future developments related to legal matters, potential clinical and regulatory milestones, including data readouts and regulatory submissions, potential marketing and reimbursement approvals, and commercial performance. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty in forecasting sales, revenues, costs and expenses, impacts related to the COVID-19 pandemic and the uncertainty associated with legal disputes, and with the pharmaceutical development and regulatory approval process. More information about the risks and uncertainties faced by CGEN is contained under the caption, Risk Factors, included in the company's quarterly report on Form 10-Q for the quarter ended March 31st, 2022, filed with the Securities and Exchange Commission, and the company's subsequent reports filed with the SEC. Now, I'll turn the call over to Roger.
spk07: Thank you, Doug. Good afternoon, everyone, and welcome to our second quarter earnings call. I was recently appointed interim CEO, and I am honored and privileged to lead such an extraordinary company. Along with my Cgen colleagues, I am deeply committed to continuing our mission of bringing transformative medicines to market that make a meaningful difference in the lives of people with cancer. Cgen has a rich history of oncology innovation, And I would like to acknowledge Clay Seagal as our founder, who was integral to building the company that we have become. Today, we are pleased to announce total quarterly revenue of $498 million. This represents growth of 28% compared to the same quarter last year. This growth reflects robust commercial sales across our four approved products, as well as strength in royalties and collaboration revenue. we continue to progress our assets with more than 17 programs across our approved medicines and pipeline. We remain focused on two strategic priorities. Our first priority is maximizing the global potential of our products through commercial execution, supporting robust clinical development programs for future label expansions, and leveraging our strategic partnerships to broaden our geographic reach. Our second strategic priority is to advance our deep and diverse pipeline as we look to bring additional medicines to market in the coming years. Our financial strength and solid balance sheet drive internal and external investment to support our priorities. Beginning with PADSEV, our first-in-class ADC for metastatic urothelial cancer, net product sales were strong in the second quarter. This was driven by continued uptake in labeled indications, along with clinical trial supply orders, which Todd will discuss. PAD-SEV has become standard of care in the United States for patients in the post-PD-1, PD-L1 setting. It has now been approved in nearly 40 countries based on the overall survival advantage demonstrated in the global EV301 trial. Furthermore, We continue to expand our commercial footprint internationally and booked our first sales of PADSEC in Brazil during the quarter. We also secured approvals in Singapore and Australia through our partner, Astellas, who we continue to work with to commercialize this important therapy. We were excited earlier this week to release positive top-line data from cohort K of the EV103 trial. This study evaluated PANSEV in combination with Keytruda in frontline cisplatin ineligible patients with unresectable, locally advanced, or metastatic urothelial cancer. Results from this trial showed a confirmed overall response rate per independent radiographic review of 64.5%. The median duration of response was not reached. The combination had a manageable and tolerable safety profile. These are patients with a very high unmet medical need, and we are encouraged by these important results. We look forward to presenting additional data from this trial at an upcoming medical conference, and we also plan to discuss these results with regulatory authorities with the intention of submitting an SPLA to the FDA later this year to support potential accelerated approval in the United States. Further clinical development for PADSEP continues. The global phase III EV302 trial in the frontline metastatic setting is on track to complete enrollment this year. This trial enrolls both cisplatin eligible and ineligible patients, irrespective of PD-L1 expression, and is intended to serve as a confirmatory trial in support of an accelerated approval. In collaboration with Merck, enrollment is also ongoing in two phase III trials assessing PADSEV in combination with Keytruda in muscle-invasive bladder cancer. In addition, we are progressing the Phase 1 EV104 trial, which is investigating PADSEV monotherapy administered intravesically in BCG non-responsive, non-muscle-invasive bladder cancer patients. And finally, we are exploring PADSEV's potential utility beyond bladder cancer with our Phase 2 EV202 trial, which is studying the effects of PADSEV monotherapy in other Nectin-4-expressing solid tumors. Our partner, Astellas, who is conducting this trial, has obtained top-line results in some cohorts, and we will be jointly reviewing the results and discussing future direction. Turning to Takaiza, which is our best-in-class tyrosine kinase inhibitor and is approved for HER2-positive metastatic breast cancer patients with and without brain metastases. We are pleased with Tukayza's performance in the second quarter, despite the competitive headwinds. We are working towards additional European launches in 2022, and Merck is progressing regulatory submissions and reimbursement activities intended to expand Tukayza's reach in their territories. At the ESMO GI meeting earlier this month, we presented results from the Mountaineer trial that assessed Tukayza plus trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer. The combination of ducasa and trastuzumab resulted in a confirmed overall response rate of 38% with a median duration response of 12.4 months. The safety profile further demonstrated that the combination was tolerable with only 6% of patients needing to stop therapy due to adverse events. Based on the strength of these data, we have submitted a supplemental NDA under the accelerated approval program in the United States, which has the potential for approval in 2023. We are also conducting the phase three Mountaineer O3 trial, which adds to Kaiser and trastuzumab to standard of care chemotherapy in the frontline CRC setting. This is intended to serve as a confirmatory trial in the US for HER2 positive CRC and could also support global submissions. In metastatic breast cancer, We recently completed global enrollment in HER2-CLIM-O2. This study is investigating to Kaiser in combination with CAD-SILA compared with CAD-SILA monotherapy in the first or second line metastatic setting, including patients with brain metastases. I will now move on to TIVDAC, our first in class tissue factor directed ADC approved in the United States for recurrent or metastatic cervical cancer patients. Second quarter net product sales of TIVDAC were strong and reflect the high unmet medical needs, the significant clinical data, and exceptional commercial execution from the CGEN and GENMAD teams. The innovative 301 Phase 3 monotherapy study is enrolling well and is intended to serve as the confirmatory trial in the U.S. and to enable global regulatory applications. At ASCO last month, We presented encouraging data from our innovative 205 phase 2 study, evaluating TIVDAC and Keytruda in the frontline metastatic cervical cancer setting. The combination demonstrated a confirmed overall response rate of 41% and a median duration response that was not reached after a median follow-up of 19 months. In addition, updated data from the combination of TIVDAC and carboplatin in the frontline setting showed a confirmed ORR of 55% with a median duration response of 8.6 months. We are encouraged by these doublet results, and Innovative 205 is now investigating TIVDAC plus carboplatin and Keytruda plus or minus Avastin in the frontline setting. Results from these triplet and quadruplet combinations will inform our next steps. Next to highlight is ETCETRUS, which, through our collaboration with Takeda, has become a foundation of care for CD30-expressing lymphomas and is approved in over 75 countries. Two important Phase III ETCETRUS trials were featured as oral presentations at ASCO last month. The first was Echelon 1, which showed that ETCETRUS in combination with AVD significantly improved overall survival compared with AVBVD in patients with advanced Hodgkin lymphoma. The etc. combination reduced the risk of death by 41% with a p-value of 0.009. These results were recently published in the New England Journal of Medicine, and we also plan to submit the data to FDA this year for possible inclusion in the label. The second presentation was from the Phase III Children's Oncology Group Study, AHRD 1331, in pediatric patients with high-risk Hodgkin lymphoma. The study met its primary endpoint of event-free survival with etcetras plus chemotherapy reducing the risk of disease progression by 59% when compared to a chemotherapy regimen that included leomycin. The pediatric patient data were included in an SPLA, which has already been granted prior to review by FDA with a target action date of November 16, 2022. These two studies emphasize the meaningful difference that ETCETRUS could make in patients' lives. Dacitimab vedotin, or DV, is a late-stage novel HER2-directed ADC that utilizes our vedotin-based technology. Our clinical development program is evaluating monotherapy and combination approaches in a variety of cancers. We recently began enrolling into the Phase II pivotal monotherapy trial in second line HER2-expressing metastatic urothelial cancer. We plan to initiate additional pivotal studies in bladder cancer and HER2 low breast cancer over the next several months. We are also considering development in other HER2-expressing solid tumors, including gastric cancer. Turning to our earlier stage pipeline, given our robust IND engine, we are advancing a growing number of drug candidates in phase one clinical trials across a range of solid tumors and hematologic malignancies. Our ADC collaborators continue to make progress with programs that utilize our technology. AbbVie initiated a Phase III trial in non-small-cell lung cancer with their CMET-directed ADC, and Roche has now filed an application for approval of Polivi in first-line DLBCL in the United States based on their Phase III Polarix trials. I will now briefly touch on our ongoing legal proceedings with Daichi Sankyo. As many of you are aware, we received a positive jury verdict in April that Daichi Sankyo had willfully infringed our 039 patent and we were awarded past damages of $41.8 million for sales of Inher2 through the trial date. Despite the jury's verdict, Daiichi Sankyo requested the court to find our patent unenforceable. We are pleased the court recently ruled against Daiichi on their request and entered judgment in favor of CJEN based on the jury's award. We intend to now request the court to award a royalty for future sales of Inheritu through the end of the patent term. In another favorable decision recently, The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office has again denied Daiichi's request to institute a post-grant review proceeding against our 039 patent. We now await the arbitration outcome regarding ownership of the ADC technology used by Daiichi in Inher2 and its other pipeline ADC products, which we believe represents the most meaningful element of these legal matters. As a pioneer and leader in ADCs, it is vitally important for us to defend our intellectual property as we continue to drive ADC innovation. Next, I'll turn the call over to Todd, who will discuss our financial results, and Chip will provide an update on our commercial performance. Todd.
spk20: Thanks, Roger, and thanks to everyone for joining us on the call. Our financial results continued 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 periods in 2021. These results reflect continued growth across our commercial portfolio. Of note, passive 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 Etcetera sales by Takeda, as well as sales of Polivi by Roche and BlendRef by GSK, both of which are ADCs that use cGen 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 PADSEV 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 four brands, profit share amounts owed to our collaboration partners, Astellas and GenMap, as well as non-cash amortization of acquired technology for Tecaiza. 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 Takaiza in Europe, the ongoing TIVDEC launch in the US, and other corporate activities. Regarding our financial guidance, we are increasing our Etcetera sales guidance to a new range of $750 to $775 million, reflecting strong performance year to date. We are maintaining our guidance for PAD7 Takaiza and we are not providing guidance for TavDAC 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 to $60 million. Our guidance for royalty revenues remains 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.
spk16: 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 four 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. PADSEV's 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 PADSEV is a U.S. standard of care. We are pleased with the recent positive top-line data reported from the EV103 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. Forty to 50% of these patients are ineligible for cisplatinum-based chemotherapy, which represents the population studied in cohort K. Moving on to Dikisa, second quarter sales were $89 million, a 7% increase over the second quarter of 2021. You will recall that our 2022 outlook for Tecasa assumes the impact of competitive pressure from NHER2's 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 NHER2's approval in this setting in May, we continue to anticipate a shift in how these regimens are sequenced, with increased use of NHER2, resulting in a delay of patient flow into the third-line-plus setting, where Teqaisa is mostly used. We continue to be confident in Teqaisa'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. At Cetrus, 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, TIVDEC 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 CGEN and GEDMAP 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 Raja.
spk07: 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 Etcetris, PADSEV, and to Kaiser, that are each intended to support potential label expansions. CGEN 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.
spk22: Thank you. We'll now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. At this time, we'll pause momentarily to assemble our roster. Our first question comes from Salveen Richter from Goldman Sachs. Please go ahead.
spk15: Thanks for taking my question. Any updates here on the timing for an arbitration decision and any color you can provide on why the judge has not yet ruled on future owed royalties in the infringement case? Thank you.
spk04: Hi, Salveen. Thank you for the question.
spk07: As we see it right now, our best estimate is around mid-year, 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 timeline is his to control. We don't actually have any specific influence on that. But we are in the mid-year period. And so we are expecting that result to come out mid-year.
spk20: And then, Selby, with respect to the taxes matter, The normal process is 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.
spk15: Thank you.
spk22: The next question comes from Matthew Harrison from Oregon Stanley. Please go ahead.
spk01: Great. Good afternoon. Thanks for taking the questions. 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, you know, 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 PADSET, can you just remind us of the different cohorts and which cohorts maybe you're potentially most excited about? Thanks.
spk07: Matthew, thanks for the question. You know, we're very pleased with 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, you know, we are limited in how much we can talk about in a press release. 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 timeframe. 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, you know, 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.
spk14: Thank you.
spk22: The next question comes from Corey Kasimov from J.P. Morgan. Please go ahead.
spk05: Hey, good afternoon, guys. Thank you for taking my question. 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 PADSEV monotherapy is technically the control. Thank you.
spk07: Thanks for the question, Corey. You know, 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 to 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 if the data supports to look for accelerated approval. So without going into any of the FDA details, in the sequence of events, 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 this, including, as you say, the monotherapy, whose primary purpose is to supply a sense of contribution of components for the combination of PAD7 and Keytruda.
spk05: That's helpful. Thank you, Roger.
spk22: The next question comes from Jenna Wang from Barclays. Please go ahead.
spk18: Thank you for taking my questions. Regarding the citrus combo with PEMBRO in solid tumor initial data later this year, wondering if you can give a little bit more color how many patients and in what kind of solid tumors and what would be the threshold you'd be looking for?
spk07: Yeah, Gina, thanks for the question. It's a very interesting area that we're exploring with etc. 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 etc. is, amongst other things, a key regulatory cell modulator. by which resistance to PD-1 inhibition occurs could be overexpressed 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 two 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 two 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
spk03: for those results when we can get them out to you.
spk18: Thank you.
spk22: The next question comes from Andrew Behrens from SVB Securities. Please go ahead.
spk09: Hi, guys. 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 EV202 basket trial cohorts reading out, but they're not being a top line release about the findings. Should we look at tea leaves or the Ouija board? And then a question on arbitration and the district trial. It sounds like the district court's decision on future royalties could take some time. Is that something you think that the arbitrator might want to see in his deliberation?
spk07: Andy, thanks. Thank you, number one, for the congratulations. We really are proud of this effort. The quarter was outstanding. So thank you for that comment. With regard to understanding EV202, this is very recent information. Stelis is running the trial, and so the information is available. It does need to be reviewed, and then some next steps 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... on board in a reasonable period with a plan there. With regard to the matters around arbitration, perhaps I'll ask Todd to make a comment.
spk20: Sure. So, Andy, thanks for the question. Again, remember there are two 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 arbitration, 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, which isn't certainly everything, We do expect that the arbitration will read out for anything further from the Texas court.
spk09: Okay. The reason I was asking is just there'll be damages potentially awarded from the arbitration. And I was just wondering whether the arbitrator looks at the 8% that he got retroactively and maybe proactively too.
spk20: 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.
spk09: Okay. Thanks for letting me ask more than one question. Appreciate it.
spk22: The next question comes from Michael Schmidt from Guggenheim. Please go ahead.
spk17: Hey, thanks for taking my question. Roger, I had one on EV302, which you said is the confirmatory study for cohort K. And my question is, what is the regulatory bar for overall survival now in frontline bladder cancer with, you know, above N2 maintenance being routinely used and PADSF obviously as well in later stage patients? And how confident are you in the EV302 trial design and powering assumptions now with cohort K data being available to you? Michael, thank you.
spk07: That's a great question. With regard to the outcome that we could expect on the experimental arm of EV302, we do have the luxury now of two datasets, 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 a control arm perform? And just to remind you, but as you know, a Bivencio intervention and a Velumab addition as a maintenance therapy is not for everyone. So, you know, the patients have to either respond or do not progress in order to get to an Avelumab opportunity. And, you know, EV302 enrolls everyone. 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 sequenced event 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 OS, 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. you know, we have good visibility into what the experimental arm should do, and it is a question of how the control arm will perform.
spk17: Okay, very helpful. Thank you so much, and congrats on the quarter. Thank you.
spk22: The next question comes from Jeff Meacham from Bank of America. Please go ahead.
spk13: Hey, guys. I also wanted to offer my congrats on the quarter. I guess I had more of a commercial question and wanted to kind of take your temperature vis-a-vis, you know, what's happened or what's changed commercially for PADSEV and Jukaisa in particular versus what your original assumptions were to start the year. And then the second part of that is just on the incestuous side of things, just wondering, you know, 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. Thank you.
spk07: Thanks, Jeff, and thanks again for the congrats. With regard to, I think I understood your question as being at the beginning of the year, we obviously gave guidance, and we had some parameters under which we determined that guidance. And how do we see that compared to where we are right now in terms of how we're thinking about the brands or behavior? I think that's what I heard. I'll ask Chip to respond, please.
spk16: Sure. Jeff, thanks for the question. So, you know, 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. Pat said it had a very strong quarter at 15% growth over the first quarter. And in addition to that, we saw very strong et cetera growth, as you mentioned. We do attribute this to the E1 data that we released, the OS data. We've seen a 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 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 it, et cetera, so we spoke to that in the past. With regard to Tysa, Teqaisa 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 Teqaisa. We continue to maintain our guidance on it, and we'll continue to monitor the market closely.
spk20: And maybe I'll just add, you know, some of the dynamics that we included in our guidance are as follows. So first for Takai's and Chip mentioned, we were expecting to see an in her to approval. We're really happy with the way the brand has performed in the first half of the year. We've only now seen. in HER2 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 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 PADSEV, you know, we were expecting growth from cohort two. We were also looking at the use of Levencio as frontline maintenance and how that informs patients that come on to the label for PADSEV. So, you know, 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.
spk22: The next question comes from Gregory Renza from RBC Capital. Please go ahead.
spk00: Great. Thank you very much for taking my question, and congratulations on the quarter. Maybe, Roger, perhaps more of a higher-level question. You acknowledged 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 CIGEN's future from the interim CEO standpoint. Thank you very much.
spk07: Again, thank you for the congrats and thanks for this question. I have to say, you know, Greg, I am energized. I mean, this company is really terrific. The workforce, all of the employees are really focused on on a sincere mission, which is to try and make a difference in the lives of cancer patients. And we've obviously had an excellent execution for the first half of this year. And 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 this great trajectory.
spk00: Thanks, Roger.
spk22: The next question comes from Stephen Willie from Stiefel.
spk12: Please go ahead. Yeah, thanks for taking the question and congratulations. So maybe just a follow-up, I guess, on the last question. So 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 timelines might look like. And then I just have a Quick guided follow-up.
spk07: 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, 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, you know, for the ideal candidate. The candidate will fit in with the type of company that we are and, you know, 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, you know, we look forward to reviewing candidates as they come through.
spk12: 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. Thanks.
spk20: Yeah, thanks for the questions. While we've had a positive jury verdict, there have been legal maneuverings to try to have this overturned. Nicely, I think the court continues to find in our favor. 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. gotten to the level where we've recorded anything, and therefore it's not included in our guidance, as you mentioned.
spk12: Great.
spk22: Thanks for taking the questions. The next question comes from Andy Say from William Blair. Please go ahead.
spk11: Great. Thanks for taking my question. Really glad to see the strong commercial performance and clinical success this quarter. So regarding the system at Vidotin, I'm just curious about how you think about you know, exploring the opportunity there, you know, maybe for a white space perspective, and also kind of taking into account other therapies out there that could fulfill that medical need. Thank you.
spk07: Thanks, Andy. And it's a great question. So, you know, as we've indicated before, the sitamab vedotin has a novel, you know, HER2-directed antibody on the front end. for an ADC-type construct, and it uses the donor technology. So we're very familiar with the payload and the drug linker. With regard to the opportunity, there is a broad potential for DV. We obviously were fortunate enough to have data in hand from our partner, Remagen, 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 uracilial 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 And so we will be conducting at least two trials in neurothelial cancer, one monotherapy. We haven't disclosed what our plans are with regard to what a confirmatory trial could look like. And obviously, as we always do, when we conduct a randomized phase three, it's not just a confirmatory trial. It gives opportunity, if positive, to seek regulatory approval basically around the world. So bladder cancer is in scope. The second area is breast cancer. And obviously the results that were presented within HER2 recently are outstanding and point 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 populations. 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 DV 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 Tukeza. So we have another HER2 acid that is available, and we are thinking through what could a development program look like that would incorporate a combination of Tukeza and We're trying to be thoughtful about how to navigate what is the competitive landscape.
spk03: So we will bring more plans forward as they mature.
spk13: Thanks, Roger.
spk22: The next question comes from Joe Catanzaro from Piper Sandler. Please go ahead.
spk10: Hey, guys. Thanks so much for taking my questions. 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?
spk07: Thanks. Thanks for the question. So, you know, it's a randomized trial, so both arms are contemporaneous, and any time we do an analysis in that circumstance, even though there is no inferential statistics between the two arms. They are still randomized. We take a complete data cut. 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.
spk10: Okay. Got it. That's clear. Thanks so much.
spk22: The next question comes from Jay Olson from Oppenheimer. Please go ahead.
spk04: Well, hey, 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 C-TIGIT and Tirogolumab and maybe comment more broadly on any plans to expand your seed technology platform. Thank you.
spk07: Yeah, 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 that randomized outcome, which was very encouraging initially in the phase two. We haven't seen the data, so it's really hard for us to actually make any judgment about the treatment effects that may have been seen. But the science is strong, and we really like our molecule. It is preclinically differentiated. And it's basically because the backbone is in an activated state with regard to being defucosylated. And what it does is it 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 digit that maybe if that preclinical component turns out to be useful in the clinic, may, you know, put us in a very, you know, strong position. With regard to where we are, we are still in phase one. We are in, you know, we are focusing on determining what a dose and schedule that we would take forward. And we are also exploring signals in various diseases, you know, 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 look like. So yeah, we take the point that the TIDGET landscape is perhaps not as positive as it was before, but I think the points that I've made, we're still committed to evaluating the drug. We have the potential for the differentiation. The phase one 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 one, will present itself to move forward.
spk04: Thank you very much.
spk22: The next question comes from Ziqiang Xu from Barenburg. Please go ahead. Ziqiang Xu Great.
spk08: Thank you. I'd like to add my congrats as well. Very straightforward. I'd like to ask cohort K data in terms of the accelerated approval. At the end of the trial, the agreement with the FDA on the accelerated approval was reached in April 2020. And then in August 2021, the first-line patients who are not eligible for any platinum treatment. So do you see any risk regarding the accelerated approval only being granted to couple platinum eligible patients and the potential approval for all platinum eligible systems? will be weighted towards the EUB 302 data to read out.
spk07: Thank you. I actually have a question. There was a fair amount of background noise, so I'll do my best for the parts that I did. I think what you're asking is quite a nuanced question around the definition, for example, in a Pembrolizumab label of a platinum-eligible population. the population we've studied. From the point of view of the expected outcome from our side, we believe strongly that if the data are compelling to the agency and they agree that this is something that should be approved, we expect the indication to match the population that we enrolled. And just to remind you, it's a cisplatin ineligible population. And the definition of cisplatin ineligibility is clearly stated in the protocol. And we project that is about somewhere between 40% and 50% of patients with frontline metastatic ulothelial cancer who will need therapy. So I don't know if I've answered your question, but I didn't hear it all. But our expectation is it will be cisplatin ineligible. And that doesn't limit you to carboplatin eligible.
spk03: It's just cisplatin ineligible.
spk08: I'm glad that you did answer my question.
spk22: The next question comes from Ren Benjamin from JMP Securities. Please go ahead.
spk21: Hey, good afternoon, guys. Thanks for taking the questions, and congratulations on a great commercial and clinical quarter. Maybe just looking at Cetrus, I definitely wouldn't have predicted that Cetrus would outperform in terms of revenues, maybe some of the other products. Can you talk a little bit about you know, 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 Tecaiza, as you think about sequencing, do you have a sense as to the clinical benefits Tecaiza might provide when it's used subsequently to, you know, in HER2 relapsed or refractory patients? Thanks.
spk07: Yeah, 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. Etsetris is an amazing drug. I mean, here we are. It's been on the market 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 Etsetris in a relapsed DLBCL population. So it is an amazing drug. some comment about Teqizah, which is, do we know what Teqizah's profile looks like post in HER2? I think that the answer to that is no, because we haven't got data. The expectation would be because, you know, Teqizah is a tyrosine kinase inhibitor that is mechanistically completely different from anything like an AUT. And provided that the pathway is still signaling, is still relevant, and the tumor is addicted to that path, then using DeKaiser at any stage, regardless of prior exposure, you know, should potentially bring value. But we don't have data, I don't think, to support, you know, to demonstrate that that's the case. Jim, would you like to comment on the commercial?
spk16: Yeah, sure, Roger. So we essentially 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 in getting that information out. We feel that there's continued opportunity for growth with regard to et cetera, and it's 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 Tecisa, Tecisa 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 Tecasa 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. Great. Thanks, guys.
spk22: The next question comes from Ami Fadia from Needham. Please go ahead.
spk19: Great. Thanks for taking my question, and congratulations on the quarter and the clinical data. Just a clarification or a follow-up on it. Centris, given its position in both first line and second line, what do you see as the growth opportunity in Hodgkin Team FOMA 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, thank you, arbitration. When we get the decision, are we also going to get a decision on, you know, what the remedy would be and sort of quantification of, you know, whether it's royalty or any other sort of payment that would be due to CJEN, or will that be something that gets determined down the line? Thank you.
spk07: So thanks for the question, and thanks for the comments. So with regard to Tetris, I think I'll give a quick set of comments to you. Tetris continues to grow, as you can see. And so there's still opportunity in frontline hospital and pharma in the advanced setting, so that's stage three, four. 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 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 signal seeking. looking at the combination of a Tetris Plus and a Volumab together with an anthracycline and Dacaldazine, ANAD. So we've got a lot of effort going on looking to see what is the next generation of therapies. And we believe that an Tetris PG-1 combination may well lead the path.
spk20: 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. quite clear and easy, or it could be a matter of CGEN has ownership. You guys go figure out what that means from a product standpoint. So, you know, it's a great question. Thanks for it. We just need to kind of wait and see what happens here.
spk03: Yeah, but we believe we have a strong case, and we're hoping for a very clear and readily interpretable outcome.
spk19: Got it. Thank you.
spk22: Due to time constraints, this concludes our question and answer session. I'd like to turn the conference back over to Doug Maffei for any closing remarks.
spk03: Thank you, Operator, and thanks, everybody, for participating in our call this afternoon. Have a great rest of your day.
spk22: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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