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Edited Transcript of DCPH.OQ earnings conference call or presentation 5-Nov-20 9:30pm GMT

·47 min read

Q3 2020 Deciphera Pharmaceuticals Inc Earnings Call Nov 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Deciphera Pharmaceuticals Inc earnings conference call or presentation Thursday, November 5, 2020 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Daniel C. Martin Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer * Jennifer Robinson Deciphera Pharmaceuticals, Inc. - VP of IR * Matthew L. Sherman Deciphera Pharmaceuticals, Inc. - Executive VP & Chief Medical Officer * Steven L. Hoerter Deciphera Pharmaceuticals, Inc. - President, CEO & Director * Thomas Patrick Kelly Deciphera Pharmaceuticals, Inc. - Executive VP, CFO & Treasurer ================================================================================ Conference Call Participants ================================================================================ * Allison Marie Bratzel Piper Sandler & Co., Research Division - Research Analyst * Eun Kyung Yang Jefferies LLC, Research Division - MD & Senior Equity Research Analyst * Eunshuk Shim Canaccord Genuity Corp., Research Division - Associate * Jessica Macomber Fye JPMorgan Chase & Co, Research Division - Analyst * Reni John Benjamin JMP Securities LLC, Research Division - MD & Equity Research Analyst * Waleed Abdel-Naby * Yue-Wen Zhu Guggenheim Securities, LLC, Research Division - Associate ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good afternoon, everyone, and welcome to the Deciphera Pharmaceuticals Third Quarter 2020 Financial Results Conference Call. (Operator Instructions) Please be advised that today's call is being recorded. (Operator Instructions) At this time, I would now like to turn the call over to Jen Robinson, Vice President, Investor Relations. Jen? -------------------------------------------------------------------------------- Jennifer Robinson, Deciphera Pharmaceuticals, Inc. - VP of IR [2] -------------------------------------------------------------------------------- Thank you, operator. Welcome, and thank you for joining us today to discuss Deciphera's third quarter 2020 financial results. I'm Jen Robinson, Vice President, Investor Relations at Deciphera. With me this afternoon to discuss the financial results and provide a general corporate update are Steve Hoerter, President and Chief Executive Officer; Dan Martin, Chief Commercial Officer; Matt Sherman, Chief Medical Officer; and Tucker Kelly, Chief Financial Officer. Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this conference call include our expectations for our preclinical and clinical programs, our commercialization of QINLOCK and 2020 guidance. Forward-looking statements made on this call involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include those set forth in our most recent quarterly report on Form 10-Q as well as our other SEC filings. We assume no obligation to update or revise any forward-looking statements. Following this call, a replay will be available on the company's website, www.deciphera.com. With that, I will now turn the call over to Steve Hoerter, President and Chief Executive Officer of Deciphera. Steve? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Jen. Good afternoon, everyone, and thank you for joining us on today's call. This year has been an incredibly exciting one for Deciphera. A year in which we received regulatory approval for and launched our first medicine, QINLOCK, and also made significant progress advancing our pipeline of new product candidates. That we were able to accomplish so much this year in spite of the challenges of the pandemic is a testament to the dedication and hard work of the team here at Deciphera and the investigators we work with around the world. We are well positioned for a strong finish to 2020 and eager to continue our mission in 2021. The third quarter marks the first full quarter of results from our ongoing launch of QINLOCK in the United States. QINLOCK, which was approved by the FDA in May of this year, was designed to address the broad spectrum of mutations that are one of the hallmarks of gastrointestinal stromal tumor or GIST. In a moment, Dan Martin, our Chief Commercial Officer, will share with you highlights from the launch and outline how we have been successful in establishing QINLOCK as the standard of care in our approved indication. We are focused on exploring the full potential of QINLOCK to benefit people with GIST. And on today's call, Matt Sherman, our Chief Medical Officer, will review recent data updates from the QINLOCK development program, which reinforce the potential best-in-class profile of QINLOCK in this disease. Our near-term focus for further clinical development remains in the second-line treatment setting, and we are on track to complete target enrollment by the end of this year in the Phase III INTRIGUE study, in which we are comparing QINLOCK to sunitinib in the second line. We believe QINLOCK has the potential to play an even broader role in the treatment of GIST. And we look forward to sharing with you our vision for further clinical development in the coming months. One of our goals this year was to expand access to QINLOCK for people with GIST outside the United States. To that end, we announced today that we recently submitted a marketing authorization application, or MAA, to the European Medicines Agency. The submission was validated by the EMA last month, which signals the beginning of the formal review process. We look forward to working with the EMA to bring this potential new treatment option to patients in the European Union. We also announced today that we intend to establish a direct commercial presence in key markets in Europe to commercialize QINLOCK if approved. This nimble organization will be positioned for future expansion as we develop and seek approval for additional Deciphera medicines in the coming years. In Europe, we believe the commercial opportunity in GIST is concentrated in the 5 largest markets, France, Germany, Italy, Spain and the U.K. Within these countries, the treatment of patients with GIST is often centralized at tertiary treatment centers, which we believe allows us to build an efficient and targeted commercial infrastructure. As we lay the building blocks in Europe, we continue to make strides for the commercialization of QINLOCK in other areas of the world as well. Over the summer, we received approvals for QINLOCK in both Canada and Australia. I'm pleased to announce that we have recently entered into exclusive distribution agreements in both of these territories. And in China, our partner, Zai Lab, filed the new drug application for QINLOCK in July, targeting a potential approval next year. We look forward to working with our partners around the world to bring QINLOCK to patients with advanced GIST. Finally, we continue to advance multiple clinical stage programs that have the potential to be future approved medicines. Earlier this year, we presented initial compelling data with rebastinib in combination with paclitaxel, in patients with heavily pretreated endometrial and ovarian cancers. And later this month, we are excited to present additional clinical data for DCC-3014 in tenosynovial giant cell tumor. As our clinical stage pipeline comes into focus, our novel switch control kinase inhibitor discovery platform continues to provide opportunities for future growth. I'll now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss the exciting results for the first full quarter of QINLOCK commercial sales. Dan? -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [4] -------------------------------------------------------------------------------- Thank you, Steve. Good afternoon. Today, I'm pleased to share results from our first full quarter of QINLOCK sales. In Q3, we achieved U.S. net product revenue of $14.7 million, bringing total U.S. net product revenue for the first 4.5 months of launch to $19.5 million. While it is important to remember that it is still early in our launch, we continue to be very pleased with the way the launch has progressed. Several important factors contributed to our Q3 results. First, we have continued to see strong prescriber demand for QINLOCK. In addition to robust month-over-month sales growth, insights from our recent launch tracking surveys showed strong product awareness, message recall, product perceptions and intent to prescribe among physicians who have fourth-line GIST patients. Further, a large majority of these physicians indicate they now view QINLOCK as the standard of care treatment for these patients. Importantly, these metrics tend to be strongest among physicians who report being detailed by our sales team, underscoring the importance of physician reach and access in this promotionally sensitive disease area. Second, we saw continued new prescriber growth across both academic and community settings. Thanks to the tireless work of our commercial team to navigate the unprecedented and ongoing challenges of COVID-19, the number of new QINLOCK prescribers more than doubled during Q3. Since launch, more than 250 GIST treaters, representing more than 200 unique institutions, have prescribed QINLOCK. As expected, while just treaters within academic institutions comprise the majority of our early adopters, our data suggests new prescriber growth is shifting toward the community setting. While new academic prescribers grew by more than 80% in Q3, new community prescribers grew by nearly 150%. During the quarter, more than 50% of the QINLOCK prescribers and QINLOCK-treated patients came from community accounts. Third, our market access team continued to deliver broad patient access to QINLOCK in Q3. We have been very pleased with our progress in securing payer coverage for QINLOCK in patients with fourth-line GIST. We have also been very pleased with the performance of our channel partners and our patient support center. Finally, the percentage of patients in Q3 that received free drug under our patient assistance program, or PAP, was at the low end of our estimate of approximately 20% to 30%. However, we anticipate that the PAP percentage may be somewhat higher in Q4 as it's not uncommon for patients to experience increased affordability challenges late in the year. Additionally, the PAP percentage may be higher in Q1 of next year, given that the Medicare Part D benefit resets on January 1, requiring patients to pay for their deductible and their portion of the coverage gap before reaching the catastrophic coverage tier. Before turning the call over to Matt, I would like to highlight factors that may impact our results over the next several quarters. As I mentioned previously, we expect the majority of our future new prescriber growth to come from the community setting, where fourth-line GIST patients are much more widely dispersed and physician awareness and knowledge of GIST is much lower when compared to the academic setting. Analysis of claims data indicates that community oncologists who treat fourth-line GIST patients may see only 1 such patient every 12 to 18 months. Thus, while we are very pleased with the results we have seen in both academic and community institutions to date, we recognize that future growth and product awareness and new patient starts, may be more challenging and come more slowly as we work to further penetrate the community setting. And this dynamic may be particularly challenging given the hurdles to physician access created by COVID-19, which we expect to continue as the pandemic persists and potentially intensifies over the next several quarters. I will now turn the call over to Matt to discuss the progress of our clinical programs. Matt? -------------------------------------------------------------------------------- Matthew L. Sherman, Deciphera Pharmaceuticals, Inc. - Executive VP & Chief Medical Officer [5] -------------------------------------------------------------------------------- Thank you, Dan. QINLOCK serves as a great example of how we have effectively and efficiently discovered, developed and now commercialized a product generated from our research platform. While Dan's team has been focused on helping fourth-line GIST patients access QINLOCK in the U.S., our clinical and medical affairs teams have continued to generate and publish additional data on QINLOCK and our pipeline programs. As Steve mentioned earlier, our strategic priority is to maximize the potential of QINLOCK in GIST, and to generate additional clinical data for this program and for our other development product candidates to reach key value inflection points on the way to potential registrational studies and regulatory approval. For QINLOCK, we're keenly focused on the completion of the ongoing Phase III INTRIGUE study in second-line GIST. The study is on track to reach full enrollment by year-end, and we expect to be able to provide additional guidance on [depending of] the primary endpoint at that time. We remain confident in the likelihood of success with INTRIGUE based on the strong data we have seen in the Phase I and Phase III studies THAT demonstrate the broad clinical activity in patients with GIST. At the recent ESMO Virtual Congress, we presented new data in 2 mini-oral presentations related to QINLOCK that continue to demonstrate the strong clinical benefit for second-line through fourth-line plus GIST patients. The first mini-oral presentation provided longer-term follow-up results from the INVICTUS study in fourth-line GIST, that reinforced the exceptional progression-free survival and overall survival benefit observed at the time of the initial database log. The updated data provided an additional 9 months of follow-up and demonstrated that treatment with QINLOCK continued to provide clinically meaningful benefit, with the PFS maintained at 6.3 months. And importantly, the median OS benefit improved from an initial 15.1 months to an overall survival that has now not been reached. In addition, the updated safety findings were consistent with the previous primary analysis results, demonstrating that QINLOCK was generally well tolerated. The second mini-oral presentation in ESMO provided exciting data from the ongoing Phase I study at QINLOCK in patients with second-line through fourth-line plus GIST who dose escalated to 150 milligrams twice daily. In the Phase I study, patients were permitted to dose escalate to QINLOCK 150 milligrams twice daily after disease progression of 150 milligrams once daily. These data showed that across all 3 patient groups, treatment with 150 milligrams twice daily provided an additional clinically meaningful PFS benefit. Comparison of TEAEs reported in these 2 dosing periods demonstrated that QINLOCK was similarly well tolerated. Feedback from key opinion leaders on these data has been very positive, and we believe these data have the potential to impact clinical practice. At the upcoming Connective Tissue Oncology Society, or CTOS, Virtual Meeting, we will be presenting new QINLOCK data from the INVICTUS trial. These data include an oral presentation discussing the extensive heterogeneity of KIT and PDGFR-alpha mutations as well as a poster discussing QINLOCK's demonstrated activity across all KIT and PDGFR-alpha mutations in patients in the INVICTUS study. QINLOCK was specifically designed as a drug that can broadly inhibit KIT and PDGFR-alpha mutated kinases, making it particularly suited to address GIST, a disease that is characterized by a broad spectrum of mutations in these kinases. We have also explored QINLOCK's utility in the treatment of additional non-GIST mutations in the ongoing Phase I study, including Systemic Mastocytosis, or SM. We have decided, with input from our lead investigators, not to invest in further studies in SM at this time. While we have seen clinical activity in SM and the safety and tolerability were consistent with what we've reported in GIST, given the overall [condition of the] landscape and the strength of the opportunities we have with QINLOCK and GIST and with our other product candidates, we believe it is best to focus our resources in areas in which we're able to have the greatest impact. As we continue to advance our development activities across the portfolio, we are very excited about the potential for both DCC-3014, our potent and selective inhibitor of CSF1R and rebastinib, our potent and selective TIE2 inhibitor. We are developing DCC-3014 for the treatment of tenosynovial giant cell tumor, or TGCT, which has significant morbidity for these patients and is driven by a genetic translocation in certain cells within the tumor, causing an overproduction of CSF1, the ligand for the CSF1 receptor. The only approved systemic therapy for patients with TGCT is pexidartinib, a small molecule inhibitor in CSF1R, which is subject to a REMS program due to hepatotoxicity, an adverse event that has got to be an off-target effect. We believe that DCC-3014 has the potential to be a best-in-class CSF1 receptor inhibitor that will fulfill the unmet medical need for an effective and well-tolerated treatment for patients with TGCT. In an oral presentation at CTOS later this month, we are excited to present results for more than 20 TGCT patients across multiple dose levels and dose cohorts from the dose escalation portion of the Phase I study. In addition, we are on track to select a recommended Phase II dose and to initiate the expansion cohort of the Phase I/II study in TGCT patients. Turning to rebastinib. Our potent and selective TIE2 inhibitor, which is currently being studied in combination with chemotherapy. TIE2 is a target primarily expressed in endothelial cells and TIE2 expressing macrophages or tests, and plays an important role in angiogenesis is part of the angiopoetin TIE2 signaling access. We were very pleased with the recent data presented at ASCO and ESMO from the 2 Phase IB/II studies in combination with paclitaxel and with carboplatin. In particular, we presented data showing strong preliminary activity in patients with endometrial and platinum-resistant ovarian cancer and Part 2 of the paclitaxel combination study. Data presented at the ESMO Virtual Congress 2020 in platinum-resistant ovarian cancer demonstrated encouraging efficacy with an objective response rate of 38%, confirmed and unconfirmed, and the global benefit rate of 88% at 8 weeks in heavily pretreated patients. All patients received prior platinum- and taxane-based therapy, 90% of patients received bevacizumab, 62% received a PARP inhibitor and 31% received immunotherapy. In addition to these data, we presented compelling data from the individual cohort at the ASCO 2020 virtual program showing promising preliminary antitumor activity and favorable tolerability, with an objective response rate of 39%, confirmed and unconfirmed, and a clinical benefit rate of 72% at 8 weeks, also in heavily pretreated patients. We look forward to providing updated results from these ongoing Phase Ib/II studies as well as additional guidance on our clinical and regulatory plans for rebastinib. Finally, we continue to be excited about the prospects for DCC-3116, our potential first-in-class ULK kinase inhibitor designed to treat mutant RAS cancers. We are aiming to submit the IND in the fourth quarter this year, but this event may shift to the first quarter 2021. We are making great progress across each of our programs in our pipeline. And we believe that this is just the beginning of making a meaningful difference in the treatment of patients with cancer and rare diseases. I will now turn the call over to Tucker Kelly, our Chief Financial Officer, to review the financial results. Tucker? -------------------------------------------------------------------------------- Thomas Patrick Kelly, Deciphera Pharmaceuticals, Inc. - Executive VP, CFO & Treasurer [6] -------------------------------------------------------------------------------- Thanks, Matt. I'd like to review the highlights from our third quarter 2020 financial results, which includes our first complete quarter of QINLOCK product sales. Total revenue for the quarter was $15.5 million, which includes $15.2 million of net product sales of QINLOCK, and $300,000 of collaboration revenue. Net product revenue included $14.7 million in U.S. product sales as well as approximately $500,000 in product sales of QINLOCK outside the U.S. under early access programs. The gross to net adjustment in Q3 was slightly lower than our prior guidance of approximately 15%. I would note that this adjustment is likely to increase in Q4 and in Q1 as we accrue for anticipated Medicare Part D rebates required for existing QINLOCK-treated patients who will reenter the coverage gap in January. Cost of sales for the 3 months ended September 30, 2020, was immaterial, as the majority of the manufacturing costs related to QINLOCK sales were incurred prior to FDA approval and thus, were recorded as R&D expense. Cost of sales will not be significant until the initial pre-launch inventory is depleted and additional inventory is manufactured and sold. In the third quarter of 2020, our total operating expenses, excluding cost of sales, were $79 million compared to total operating expenses of $76 million in the second quarter. Research and development expenses were approximately $49 million, and selling, general and administrative expenses were approximately $30 million for the third quarter of 2020. We expect our operating expenses will increase modestly in the coming quarters as we continue to invest in the development of our clinical pipeline, the commercial launch of QINLOCK in the U.S. and prepare for a potential commercial launch in Europe. We ended the third quarter in a strong financial position and remain well capitalized, ending the quarter with cash, cash equivalents and marketable securities of approximately $584 million, which we expect will be sufficient to fund our operations into the second half of 2022. With that, I'll now turn the call back over to Steve. -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [7] -------------------------------------------------------------------------------- Thank you, Tucker. I'm extremely proud with what our team has accomplished so far this year. We have delivered on our promise to bring an important new medicine to patients with cancer with the approval and successful initial launch of QINLOCK in the United States, and are now working to bring this novel product to patients with advanced GIST around the world. Meanwhile, we continue to advance the rest of our pipeline based on our novel switch control kinase inhibitor platform, and we look forward to presenting updated data on DCC-3014 at the CTOS meeting later this month. Operator, I'd now like to open the call for Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from the line of Jessica Fye with JPMorgan. -------------------------------------------------------------------------------- Jessica Macomber Fye, JPMorgan Chase & Co, Research Division - Analyst [2] -------------------------------------------------------------------------------- Congrats on the quarter. Curious if you can give a little more color about the QINLOCK dynamics. For example, is it possible to provide an average number of patients on QINLOCK in the quarter? And how many were on therapy as of quarter end? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Yes. Jess, it's Steve. Thanks for the question. I'll ask Dan Martin who's on the call to address your question. Dan? -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [4] -------------------------------------------------------------------------------- Jess, thanks for the question. It's a good one. So really, I think we're just going to remain focused on what we think were the key themes this quarter. We've been really pleased to see the continued strong demand, not only in terms of the numbers themselves, the revenue numbers themselves, but also any number of measures from our various launch tracking surveys. The new prescriber growth that we saw as well as broad access, we've been really pleased with how payer policies have come into place for QINLOCK in the fourth line. And in terms of specific metrics, our goal is on these calls to provide color that's relevant to convey our launch progress and expectations moving forward. And we'll definitely continue to assess what information to share on future calls to help convey those insights, but we're not sharing specific patient numbers at this time. -------------------------------------------------------------------------------- Jessica Macomber Fye, JPMorgan Chase & Co, Research Division - Analyst [5] -------------------------------------------------------------------------------- Okay. Maybe if you cannot answer that, I'm curious with the rapid uptake you're seeing in the community, what percent of QINLOCK use you estimate is in fourth line versus potentially earlier lines of therapy? -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [6] -------------------------------------------------------------------------------- Yes. Thank you. Another good question. Before launch, we had done quite a bit of claims, analytics to help us estimate just that. And before launch, before we had experience selling our first product in that market, we thought that, overall, about 30% of GIST treatment across all lines of therapy, occurs in the academic setting, with about 70% broadly distributed throughout the much larger just in terms of number of physicians and institutions community setting. At the time, we also thought that, that tended to flip a bit with maybe 60% of late line, fourth line or later patients being treated in the academic setting. But interestingly, even then, our analytics would suggest that 40% or so of very late-line patients received care in the community. And what we're seeing -- well, before I comment on what we're seeing, I think one other important thought was, or one other important question was, with a new product that is highly efficacious and has a favorable tolerability profile, would more community treaters hold on to those late-stage patients as opposed to maintaining the same referral pattern they had historically? And so while we don't -- still early days and we don't have answers to all those questions, what we -- yes, what we are seeing is slightly more than that 40% that we expected to occur in the community setting for late-line GIST, we're seeing slightly more than 50% thus far, which we've been encouraged to see. But like I said in my prepared remarks, I think it's really important and one thing we want to highlight is, and we've said this on prior calls, although the majority of our early adopters were in the academic setting, and we've seen some nice growth in early days in the community setting, we expect moving forward, just because of the nature of the structure of the market, that future growth will need to increasingly come from the community setting. And that's a setting where patients are much more widely dispersed. As I mentioned in my prepared remarks, a lot of patients -- excuse me, a lot of prescribers in the community setting may treat only 1 patient every 12 to 18 months with late-line GIST. And so given that and the lower awareness and lower knowledge, we're cognizant of the fact that continued growth, which will depend on our ability to continue to penetrate in that setting, the community setting, may be more challenging and come somewhat more slowly, particularly in light of the ongoing challenges of the pandemic, which I think we all know is likely to persist and perhaps even intensify in the coming quarters. So that's how we're thinking about sort of source of business just overall and for QINLOCK as we look ahead. -------------------------------------------------------------------------------- Jessica Macomber Fye, JPMorgan Chase & Co, Research Division - Analyst [7] -------------------------------------------------------------------------------- Got it. And if I can sneak in 1 more for Steve. In prepared remarks, I think you alluded to a broader potential for QINLOCK in GIST. And it kind of sounded like you weren't solely talking about second line. So can you elaborate on what you meant there? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [8] -------------------------------------------------------------------------------- Yes. Thanks, Jess. It's a good question. We're very committed with QINLOCK to fully exploring the potential of the drug in just even beyond where we're now currently standard of care on the fourth line, as Dan was describing, and also beyond the INTRIGUE study in the second-line setting. We know we have a very active drug in this disease, and we think there may well be other places where we could explore the drug's utility. We're not ready to share details about that vision and that strategy. We'll do that over the course of the coming months, but we are fully committed to conducting further clinical study of this drug in GIST. -------------------------------------------------------------------------------- Operator [9] -------------------------------------------------------------------------------- Our next question comes from the line of Chris Raymond with Piper Sandler. -------------------------------------------------------------------------------- Allison Marie Bratzel, Piper Sandler & Co., Research Division - Research Analyst [10] -------------------------------------------------------------------------------- This is Allison Bratzel on for Chris. So first one on the QINLOCK dynamics. I think last quarter, you'd called out a slight revenue benefit from QINLOCK inventory build. So just hoping you could provide any color on whether there is any inventory impact this quarter or even just directionally help us understand how the magnitude or direction of any inventory impact in Q3 compares to Q2? And maybe a similar question on new patient -- or new commercial patient adds from the expanded access program and how that played into the Q3 revenue number? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [11] -------------------------------------------------------------------------------- Yes. Thanks for the question, Allison. I'll ask Dan Martin to take both of those. -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [12] -------------------------------------------------------------------------------- Yes. Thanks, Allison. Good questions. So the first one related to inventory build. Inventory build was not a significant contributor to our Q3 revenue performance. And then on the EAP front, as we've shared previously, there were a number of patients who converted from our EAP program to commercial product at the time of approval. And our Q3 revenues did include -- continue to include a modest contribution from those patients, but we haven't provided specific numbers. But yes, Q3 did include a modest contribution from those patients who were still on therapy. -------------------------------------------------------------------------------- Allison Marie Bratzel, Piper Sandler & Co., Research Division - Research Analyst [13] -------------------------------------------------------------------------------- Okay. And maybe just one more on the -- some of the data you had at ESMO, specifically the data on ripretinib from the Phase I, the intra-patient dose escalation. That was really supportive of treating patients past progression and updosing them to the BID dose. And really, the later-line patients seeing a nice benefit on PFS2. So just hoping you could maybe talk to how that compares with the early launch experience and your messaging for QINLOCK. And basically, how willing are physicians to treat path progression in those later-line GIST patients? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [14] -------------------------------------------------------------------------------- Dan, would you like to take that? -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [15] -------------------------------------------------------------------------------- Sure, absolutely. So good question. Yes. We mentioned that data a number of times. I think that's really interesting data. We've also said previously, though, that how a drug is used in the commercial setting is impacted by any number of factors. And as it relates to the BID dosing, first, I'll want to underscore that we are entirely focused on launching QINLOCK in the fourth line in -- consistent with our label. And that goes for indication, it goes for our -- the recommended dose in our label. But we've seen a small number of prescriptions for BID, but the vast majority has been at the 150 QD. And when I say a lot of things contribute to how a drug gets used in the commercial setting, one of them that's really important is payer policies. And we've been really pleased to see the payer coverage come along really nicely for QINLOCK. But those policies have very much been consistent with label, including the dose from the dose perspective. So while certainly interesting data and certainly, our KOLs tell us that there's interest in it, from a commercial point of view, it's been a pretty modest contribution to revenues to date. -------------------------------------------------------------------------------- Operator [16] -------------------------------------------------------------------------------- Our next question comes from the line of Peter Lawson with Barclays. -------------------------------------------------------------------------------- Waleed Abdel-Naby, [17] -------------------------------------------------------------------------------- This is Waleed on for Peter. Congrats on a great quarter. Just had a couple of questions here. I was wondering if you could provide any sort of details on the QINLOCK usage this quarter. Are you seeing any potential off-label use in earlier lines of GIST? And then I've got a question on the upcoming data for TGCT at CTOS. Wondering if you've got sort of expectations as to what you would be considering to be positive results from that study? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [18] -------------------------------------------------------------------------------- Sure, Waleed. It's Steve. Thanks very much for the question. So maybe what I'll do is take the TGCT question first and then ask Dan to take the first question that you had. So with respect to 3014, as Matt mentioned in his prepared remarks, we're looking forward to having additional data from the Phase I in just over 20 patients. That'll be presented in an oral presentation at the Connective Tissue Oncology Society conference coming up in a couple of weeks. As you know, this Phase I study is a dose-escalation study. So what you can expect to see is data from a variety of different dose cohorts, doses and schedules of 3014 in patients with TGCT. What we do know is that our drug 3014 is very potent and very selective against the target. This is a disease, as you know, that's driven by a genetic translocation that results in overproduction of the ligand for the receptor. So based on the biology and based on our knowledge of the mechanism, we would expect to see 3014 have activity in this patient population, as we previously reported at CTOS last year. So we're looking forward to presenting the data here coming up in a couple of weeks. And as Matt mentioned, we remain on track to get to a recommended Phase II dose and also to open the expansion cohort. Dan, would you like to take Waleed's question related to off-label use? -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [19] -------------------------------------------------------------------------------- Sure, absolutely. So as I -- similar to as I mentioned a moment ago, we, of course, are not out promoting anything other than our labeled indication. And the payer policies that we're seeing come online have very consistently been aligned with our labeled indication. It is difficult. We've shared before it's difficult to estimate the proportion of patients who may be receiving QINLOCK in earlier lines of therapy, frankly, because the data sources are imperfect. But what we are seeing in the data that we have is that a significant majority of QINLOCK patients have been fourth line or fourth line plus. The -- that's not surprising to us, again, because, again, the point about payer policies being consistent with label. And then again, we're not out promoting that data. So the large majority, consistent with the fourth-line indication. -------------------------------------------------------------------------------- Operator [20] -------------------------------------------------------------------------------- Our next question comes from the line of Eun Yang with Jefferies. -------------------------------------------------------------------------------- Eun Kyung Yang, Jefferies LLC, Research Division - MD & Senior Equity Research Analyst [21] -------------------------------------------------------------------------------- So the first question is on Phase III INTRIGUE data time line. So based on what you saw in the Phase I in second-line for ripretinib for PFS and certain historical PFS. When do you think you would expect to see the data once you finish the enrollment by end of this year? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [22] -------------------------------------------------------------------------------- Yes, Eun. It's Steve. Thanks very much for the question. It's a great question. As Matt mentioned in his prepared remarks, we're looking forward to getting to completion of enrollment in INTRIGUE here by the end of the year. And when we get to a completion of enrollment in the study, our intention at that time is to be able to share more detail about the time line for the study to read out. As you know, from our Phase I experience in the second-line cohort, we've seen a very robust PFS in that patient population that we studied at close to 11 months PFS. And when you look at the Sutent label, one would expect a PFS in the range of 5.5 months to 6 months. So it's premature for us at this stage to talk about when we think the study will read out. But certainly, as we get to full enrollment, here before the end of the year, which is our target, we'll then be in a position to share more. -------------------------------------------------------------------------------- Eun Kyung Yang, Jefferies LLC, Research Division - MD & Senior Equity Research Analyst [23] -------------------------------------------------------------------------------- Great. And then as you move into second line with the INTRIGUE study. So once it's approved in second line, do you expect the use of ripretinib in fourth line will be dramatically reduced? Or do you think that there is a potential that, in some patients, ripretinib could be recycled in the fourth line? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [24] -------------------------------------------------------------------------------- Yes. Eun, it's Steve. I'll ask Dan to address that here in a second, as the team and Dan have done a ton of market research and speak to the clinicians all the time about their view of ripretinib and QINLOCK in the treatment of this disease as the treatment paradigm evolves. I mean I think what's also relevant here in a way are the data that we presented at ESMO, where we dose escalated patients to 150 BID and saw additional meaningful benefit by treating patients beyond, after progression with a higher dose of the drug. So it seems clear that ripretinib has the potential at least to be a real backbone of treatment for patients and for patients to receive prolonged benefit from the drug in that context. But Dan, maybe you want to comment further about how you see the market evolving in a world of a positive INTRIGUE readout and how physicians may evolve the treatment approach and paradigm. -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [25] -------------------------------------------------------------------------------- Sure, absolutely. So what we hear from our KOLs is certainly real interest in seeing QINLOCK get to that second-line setting. They all tell us that that's where they see the principal use for QINLOCK and they're really excited to see the results of INTRIGUE as a result, as you would expect. There's -- when we look through the claims data, when we talk to our KOLs, we don't see a dramatic amount of retreatment in the space. As you know, there's some data for imatinib with retreatment, but we just -- we haven't seen a ton of that. And so it remains to be seen whether or not ripretinib, QINLOCK would be looked at as a valuable option in a retreatment setting. As we've said before, there's a lot of things that go into how a drug will be used, obviously, data that gets generated, how things appear in guidelines, payer policies and the like. So it's still a bit early for us to have a good sense for that, but definitely, what our KOLs tell us is they're looking forward to potentially having QINLOCK available in the second line. -------------------------------------------------------------------------------- Eun Kyung Yang, Jefferies LLC, Research Division - MD & Senior Equity Research Analyst [26] -------------------------------------------------------------------------------- Great. And the last question is on the market, the commercial strategy. So Steve, in your prepared remarks, you are preparing to launch and list the major European countries. But emerging markets are like really a big opportunity for new therapies. So I want to ask you outside the U.S. and major European countries and Zai Lab categories, what's your plan for commercial strategy for ripretinib? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [27] -------------------------------------------------------------------------------- Thanks, Eun. That's a good question. So as you know, you referenced it, we have our collaboration with Zai in Greater China. That NDA has been filed, and there's the potential for action on that application next year. And of course, we also announced today that we're working through a couple of distributors in other territories, so Specialised Therapeutics in Australia and other Pacific Rim countries. And then we also announced our distribution agreement with Medison for Canada and Israel. Beyond those territories, however, our approach from a commercial point of view would be to take a similar approach, that is to work through distributors in key territories. And we'll start to make our way around the world with QINLOCK in terms of making sure the patients have access to it in a commercial setting upon approval. And that is something that we're committed to. So we're looking forward to continuing to identify partners in the right priority territories as we seek to make the drug available further. -------------------------------------------------------------------------------- Operator [28] -------------------------------------------------------------------------------- Our next question comes from the line of Michael Schmidt with Guggenheim. -------------------------------------------------------------------------------- Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division - Associate [29] -------------------------------------------------------------------------------- This is Charles Zhu on for Michael Schmidt. Congrats on the strong quarter. A couple on DCC for the TGCT. I fully understand that you and others have highlighted the market opportunity for TGCT as an annual 1,300 patients or so, at least for the diffuse type with a much larger prevalence, given its long lethal. On that front, however, what's your sense of how many patients are truly candidates for pharmaceutical intervention relative to the current role and potential cure rates of surgery, even repeat surgery and/or radiation? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [30] -------------------------------------------------------------------------------- Yes, Charles. It's Steve. Thanks for the question with respect to 3014. As you know, the target indication for us for 3014 and TGCT is for patients that are not amenable to surgery. And we know that, as you referenced, there are about 1,300 new patients in the U.S. each year with the diffuse form of the disease. And these are patients with a high recurrence rate, who generally, at some point in the course of their disease, I think the estimates are between 30% and 50% of those patients have recurrence. But at some point, those patients, as we understand it, run out of surgical options to manage their disease and then would become candidates for a systemic therapy. So that is the population we're targeting. We also know that there are patients with the localized form of the disease that are also not amenable to surgery for whatever reason. And then also would be candidates for drug therapy, for systemic therapy. -------------------------------------------------------------------------------- Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division - Associate [31] -------------------------------------------------------------------------------- Got it. Makes sense. And I guess, also based on the research you've done so far around pexidartinib and other off-label drugs such as imatinib for this disease, what's your sense around a potential treatment duration in these patients? And is it possible to convert these patients, I guess, from previously unamenable to surgery into [suitable] patients for potential curative surgery? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [32] -------------------------------------------------------------------------------- Yes. It's a good question with respect to the potential for neoadjuvant treatment in this disease context. And there may well be a role for CSF1R inhibition in such patients to shrink tumors to make them potentially resectable, whereas perhaps prior to treatment, that might not have been resectable. So that, I think, remains an open question. This is a disease category where there just haven't been systemic treatments until the approval of pexidartinib last year. And what we continue to hear from physicians is that they have concerns about using pex in their patients. And in fact, patients have concerns about using pex as a result of the black box warning for hepatotoxicity. And the REMS that is associated with that. So we believe there remains a significant other medical need for a drug that is effective and well tolerated in the treatment of this disease. And I think part of our task, assuming continued success, is going to be to ensure that we're able to access patients at the right time in their disease course for a systemic treatment like ours. -------------------------------------------------------------------------------- Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division - Associate [33] -------------------------------------------------------------------------------- Congrats again on a strong quarter. -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [34] -------------------------------------------------------------------------------- Thanks, Charles. -------------------------------------------------------------------------------- Operator [35] -------------------------------------------------------------------------------- Your next question comes from the line of Ren Benjamin with JMP Securities. -------------------------------------------------------------------------------- Reni John Benjamin, JMP Securities LLC, Research Division - MD & Equity Research Analyst [36] -------------------------------------------------------------------------------- Congratulations guys on a great quarter. Can you provide us maybe a little bit more color on the commercial plans in the EU? Maybe I missed it, but how many people are we talking about? Are there -- is there going to be a centralized kind of sales force? Just any sort of idea as to how that build-out will occur? Or will they occur just based on -- by country-by-country approval? Any sort of color there? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [37] -------------------------------------------------------------------------------- Yes, Ren. It's Steve. I'd be happy to take your question about Europe. As I mentioned in the prepared remarks, we think the majority of the opportunity is in the 5 largest markets, as you'd expect. And we don't have any reason to believe that the prevalence of GIST or the incidence of GIST in Europe as a percent of population is any different than what we see in the U.S. So based on that, we think across the 5 largest markets, there are probably between 4,000 and 6,000 new patients with GIST that are diagnosed each year. So as we think about our build in Europe, it will very much be a stagger build based on market access. So as you know, when -- each of these markets are generally single-payer markets. And so depending on the country, a manufacturer like us would have to go through pricing and reimbursement negotiations. And sometimes that can take a matter of a few months, and sometimes that can take as long as a year. So depending upon how long that process takes to get to a price and to get to reimbursement in the system, that would then be the trigger for us to consider a build related to that country. As I also mentioned in the prepared remarks, Ren, we -- our estimate is that these patients tend to be treated centrally at tertiary centers. So there's probably an opportunity here, as we look at it, for us to build more of a hub model across Europe, where we have the majority of our head count sitting in a regional center within a field-based personnel in key markets. And so I'm sure as we get to a potential approval in Europe, which, as you know, the filing has now gone in, it's been validated, so we think that the earliest potential action on the application could be by the end of next year. So as we get closer, I'm sure we'll be sharing some more detail about how we view the build and what we see in terms of numbers. But it's certainly going to be a staggered build and we'll, of course, continue to be thoughtful about what the size of that organization ends up looking like to access the opportunity. -------------------------------------------------------------------------------- Reni John Benjamin, JMP Securities LLC, Research Division - MD & Equity Research Analyst [38] -------------------------------------------------------------------------------- Got it. And then I think it was Matt, you might have mentioned that the SM opportunity is -- you guys are no longer investing in that. Can you talk a little bit, I guess, about what was it? Was it because enrollment was kind of tough or you were not seeing the kind of efficacy that you were hoping for? And ultimately, will we see, based on the patients that you have enrolled, what the data looked like? Or it really doesn't make any sense to even do that further at all? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [39] -------------------------------------------------------------------------------- Yes. Thanks for the question, Ren. And as we've been saying for a number of months now, even well over a year, our real focus of development for QINLOCK or ripretinib is in GIST. And as Matt noted in his prepared remarks, we have seen modest clinical activity in the fewer than 20 patients that we treated in that SM cohort. But we didn't see sufficient activity to warrant further development in this disease. And that's particularly given the context of the evolving treatment landscape in SM and frankly, the compelling investment opportunities that we see in other parts of the portfolio, not only in QINLOCK or ripretinib, but also in our other clinical-stage assets as those start to really come into focus. And so as a result, we've decided to focus our investment resources, both people and dollars, in other areas for now. I'm sure when the time is right, at some stage, we'll publish the data from the SM cohort. I don't have any specific details I can share with you at this time though. -------------------------------------------------------------------------------- Reni John Benjamin, JMP Securities LLC, Research Division - MD & Equity Research Analyst [40] -------------------------------------------------------------------------------- Got it. And then just one final one regarding the IND for 3116. I think I heard it right, that it was shifted to the first quarter. Anything -- is it just you guys are -- have enough to focus on right now? Or did anything kind of pop up, that's making you have to make that shift? -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [41] -------------------------------------------------------------------------------- No, we remain really excited about 3116. This is targeting the initiating factor in autophagy, which is thought to play a role in mutant RAS cancers. So really large patient populations and significant tumor types like lung and bladder cancer. So we remain really excited about the program. The team has been working coal hard to advance us to file the IND. This is a goal that we have for the end of the year. That was our initial milestone. And as Matt indicated, there's a possibility that this shifts into quarter 1. But this is really just a function of timing being an end-of-year sort of goal, but we remain really excited about the program and very focused on it. -------------------------------------------------------------------------------- Operator [42] -------------------------------------------------------------------------------- And your last question comes from the line of Arlinda Lee with Canaccord Genuity. -------------------------------------------------------------------------------- Eunshuk Shim, Canaccord Genuity Corp., Research Division - Associate [43] -------------------------------------------------------------------------------- It's Ben Shim for Arlinda. And congrats on the great quarter. Many of my questions have already been answered. I kind of have a high-level question for you. For the benefit of us outsiders, can you walk us through how, on a day-to-day basis, you're getting more penetration in the community setting? And how is it different in the pandemic environment? And to what extent can you communicate the potential for earlier lines of treatment? Since you guys are already there, can you kill 2 birds with 1 stone as it were? And I have a couple of follow-ups. -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [44] -------------------------------------------------------------------------------- Yes. Thanks for the question, Ben. I'll ask Dan Martin to take that first part of your question, then we'll come back for your follow-ups. -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [45] -------------------------------------------------------------------------------- Yes. Thank you. Good question. So the -- really the crux of our effort to penetrate the community setting is just being incredibly highly targeted and leveraging our analytics strength to identify where are the physicians who are most likely to have a late-line, fourth-line GIST patient. As I mentioned before, patients are much more widely dispersed. It's much more diffuse in the community setting. And so making sure that you are spending your sales and marketing efforts in the right place is critically important. And so of course, in addition to communicating, all the things that we do irrespective of setting, communicating the best-in-class profile, communicating the fact that it's the only approved agent for the fourth line, et cetera, really making sure that we are laser-targeted in our efforts is critically important. Now, as it relates to COVID-19, this is an ongoing challenge. I think it is for just about every company. It's an ongoing challenge because of any number of reasons. Patient -- the data continues to show that broadly, patient numbers remain somewhat depressed in oncology. And there's a lot going on at these provider institutions. One of the things that is a challenge is virtual fatigue. I think a lot of people can appreciate the sort of virtual fatigue that happens. And so we continue to invest in training and resources for our field force to make sure that they are having the most robust and engaging conversations with physicians about QINLOCK and about their on-label patients. So there's no magic bullet, no magic potion here. A lot of it is just continuing to work every day, and the team has done a fabulous job, a fabulous job navigating that. But as we think about moving further and further into the community setting and with the ongoing pandemic, which may intensify in the coming quarters, it is something that we are cognizant of and think that continued growth in those new patient starts may be a bit more challenging and come a bit more slowly. So I hope that answers your question. I missed the second part of your question, and I wasn't sure if that was a commercial one or not. You mentioned something about second line? -------------------------------------------------------------------------------- Eunshuk Shim, Canaccord Genuity Corp., Research Division - Associate [46] -------------------------------------------------------------------------------- Yes. What can -- to what extent can you communicate or may you communicate the potential for earlier lines since you guys are already there and not having to go back? -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [47] -------------------------------------------------------------------------------- When you say already there, you mean at the physician -- with the physician? -------------------------------------------------------------------------------- Eunshuk Shim, Canaccord Genuity Corp., Research Division - Associate [48] -------------------------------------------------------------------------------- Yes, at the physician level, yes. -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [49] -------------------------------------------------------------------------------- Okay. Sure. So the answer is we can't, not promotionally. The data on second line, the KOLs are obviously already aware of that data from the publications and such, really excited about it and really looking forward to INTRIGUE results. And the potential movement of QINLOCK up in the order of therapy. But from a promotional perspective, we stick to the labeled indication. -------------------------------------------------------------------------------- Eunshuk Shim, Canaccord Genuity Corp., Research Division - Associate [50] -------------------------------------------------------------------------------- Got you. Okay. That makes sense. And maybe a question for Tucker. Can you give us some color when the accrued pre-launch inventory will be worked through at the, let's say, current run rate? Are we talking quarters? -------------------------------------------------------------------------------- Thomas Patrick Kelly, Deciphera Pharmaceuticals, Inc. - Executive VP, CFO & Treasurer [51] -------------------------------------------------------------------------------- Yes, absolutely. As you know, we did have a little bit when you'll see the financial results in the earnings release and in the Q. There was a little bit of COGS expense in this quarter, but it will be a number of quarters before we work off the prelaunch inventory and regarding expenses R&D. -------------------------------------------------------------------------------- Eunshuk Shim, Canaccord Genuity Corp., Research Division - Associate [52] -------------------------------------------------------------------------------- Okay. That's very helpful. And I think you guys mentioned something, was there any material changes in payer mix for the quarter? I'm sorry if I missed the question, probably your statement. -------------------------------------------------------------------------------- Daniel C. Martin, Deciphera Pharmaceuticals, Inc. - Chief Commercial Officer [53] -------------------------------------------------------------------------------- I can take that. It's Dan. No, no material change that we've seen in payer mix. -------------------------------------------------------------------------------- Eunshuk Shim, Canaccord Genuity Corp., Research Division - Associate [54] -------------------------------------------------------------------------------- Okay, great. Congrats on the quarter. -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [55] -------------------------------------------------------------------------------- Thank you, Ben. -------------------------------------------------------------------------------- Operator [56] -------------------------------------------------------------------------------- Thank you. I'm not showing any further questions. I'll now turn the call back over to Steve Hoerter for closing remarks. -------------------------------------------------------------------------------- Steven L. Hoerter, Deciphera Pharmaceuticals, Inc. - President, CEO & Director [57] -------------------------------------------------------------------------------- Great. Thank you, Bridget. I appreciate that, and thanks to everybody on the call for joining us on the call today and for your continued support. We're looking forward to keeping you all updated on our continued progress with QINLOCK as well as with the balance of our development programs. Have a great evening, everyone. -------------------------------------------------------------------------------- Operator [58] -------------------------------------------------------------------------------- Ladies and gentlemen, this does conclude the program. You may now disconnect. Everyone, have a great day.