This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk16: Good morning. My name is Jason, and I will be your conference operator today. At this time, I'd like to welcome everyone to the CarioFarm Therapeutics First Quarter 2021 Financial Results Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Mr. Ian Karp, CarioFarm's Senior Vice President, Investor and Public Relations.
spk13: Great. Thank you. And thank you all for joining us on today's conference call to discuss carrier farms, first quarter financial results and business update. And let me be the first one to officially welcome our new president and chief executive officer, Mr. Richard Paulson to our quarterly earnings call. This is Ian Karp. And today, in addition to both Michael Kaufman and Richard Paulson, I'm also joined by Mr. Mike Mason, our chief financial officer, Mr. John Demery, chief commercial officer, and Mr. Steven Michener, chief business officer. On the call today, Michael will provide an overview of key recent corporate developments and an update on our commercial progress, followed by an update on one of our key pipeline opportunities in endometrial cancer. Mike Mason will then provide an overview of the first quarter financial results. We will conclude with some thoughts from Richard on KaryoFarm's future, and then we will move to the Q&A portion of the call. Earlier this morning, we issued a press release detailing KaryoFarm's results for the first quarter of 2021 and the appointment of Richard Paulson as our next president and CEO. These releases, along with a slide presentation that we plan to reference on today's call, are available on our website at cariofarm.com. Before we begin our formal statements, I'll remind you that various remarks we make today constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and as outlined on slide number three. These include statements about our future expectations, clinical development and regulatory matters and timelines, the potential success of our products and product candidates, including our expectations related to the commercialization of Expovio and Nexpovio, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. And when we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Michael Kaufman, co-founder of CarioPharm and our first CEO. And now please turn to slide number four.
spk15: Thank you, Ian, and good morning, everyone. Let me begin first by saying how thrilled I am to also be joined here today with Richard Paulson, our company's new CEO, and we'll begin on slide four. When Dr. Sharon Shackham and I started CarioPharm over 12 years ago, our mission was really quite simple. We wanted to do everything we possibly could to make a difference in the lives of patients battling cancer. More specifically, we sought to develop novel drugs that exploited a fundamental pillar of oncogenesis. namely the reactivation of tumor suppressor proteins by inhibiting their export out of the cell nucleus, which, as you may know, is actually where the name CarioPharm comes from. Now with our lead medicine, Expovio, having received three separate FDA approvals and one marketing authorization in Europe, over 450 employees and a robust pipeline of programs across both hematologic and solid tumor indications, I could not be more proud of the work we've accomplished on behalf of patients, their families, and healthcare providers. But as our company is increasingly focused on commercial execution and competing in the global cancer marketplace, the time is right for a new leader, particularly one with a strong track record for building successful oncology commercial brands. Richard, of course, is no stranger to Kariopharm, having served on our board of directors since February 2020. And prior to his new role here, Richard served as Chief Executive Officer of Ipsen North America and is the former Vice President and General Manager of Oncology at Amgen. Richard will provide some of his thoughts regarding Kario Farms' future at the end of today's review of our Q1 2021 earnings and business update. Please now turn to slide five. Total revenues were $23.3 million, with Expovio net product sales of $21.7 million in the quarter. Importantly, Expovio prescription demand increased 17% in Q1 2021, as compared to Q4 2020 following the expanded FDA indication granted in December of 2020. We also saw more than 160 new physicians or accounts prescribing Expovio for the first time in the quarter. This quarterly growth occurred when many myeloma brands were flat or declining. Moving to our pipeline progress, we recently announced that in March of 2021, the European Commission granted conditional marketing authorization for Nexpovio in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Additionally, we also announced that we have now submitted the clinical data from our Phase 3 Boston study as part of a Type 2 variation marketing authorization application, formally requesting an expansion of our indicated label in Europe. This submission has now been validated, and we expect to have a decision on this application from the European Commission in the fourth quarter of 2021. Turning now to some other program updates from our ongoing hematological and solid tumor clinical studies, We are pleased to see the first set of data from our Phase III SEAL study evaluating Expobio in patients with de-differentiated liposarcoma were recently published, and the first patients have now been dosed in a Phase III study in diffuse large B cell lymphoma. Finally, on the financial front, we ended the quarter with a strong cash position of approximately $233.6 million that, along with expected future revenues, we anticipate will be sufficient to fund our planned operations into late 2022. Let's now turn to slide six, where I'll provide additional details on Expovio's recent sales performance. First quarter net Expovio sales increased by 7% as compared to the fourth quarter of 2020, while prescriptions increased by approximately 17%. This increase was primarily driven by multiple myeloma new patient starts. Additionally, we've seen strong payer coverage since the expanded approval we received from the FDA in December. I will note that much of the difference between the sales growth and prescription growth was driven by higher gross-to-net discounts, which are fairly typical in the first quarter of the year, as commercial and Medicare patients' out-of-pocket payment requirements reset for the new year. There were also some additional stocking within our distributor network at the end of 2020 in preparation for the launch of Expovio's expanded indication. While we expected higher demand growth, we are encouraged that sales and prescription demand returned to growth in the first quarter and we remain confident in Expovio's long-term commercial potential and our ability to further increase utilization. Richard's top priority in the coming weeks and months ahead of us will be to help our organization further accelerate the growth trajectory for Expovio in the U.S. market. We believe some of this will occur naturally, as we expect to see the benefit of longer duration of Expovio treatment in the second half of 2021, and we also believe our teams will have better access to customers in the second half of the year, which will increase promotional impact. Please now turn to slide seven. Here you can see a chart of monthly Expovio prescriptions for the first three months of 2021. Importantly, we saw a significant increase in March and we'll be working hard to further expand utilization and penetration into the earlier line treatment setting in the near future. Moving now to slide eight, the graph here shows the prescription refill rate for Expovio for both the first and second refills for those patients eligible for these refills. These numbers have remained encouraging throughout 2020 and into 2021 and are significantly higher as compared to our initial launch period in 2019. These refill rates, coupled with an average of nearly three treatment cycles per patient, further reinforce the positive feedback we've received from patients and physicians regarding their experience and uses of Expobio. Importantly, we do expect the average duration of treatment to increase throughout 2021 as more and more patients are being treated with a once-weekly Expovio dose and as part of a combination triplet regimen. Additionally, patient discontinuation rates due to side effects remains relatively low at 12%, which we believe is a testament to more and more physicians gaining comfort in helping their patients prevent and manage side effects from Expovio with proper prophylactic therapies and dose modifications. On slides 9 and 10, you can see our most current robust clinical development plan for Expobio in both hematological malignancies and solid tumors. This includes our phase 3 C endo study in patients with endometrial cancer, where we expect to have top-line data before the end of this year, and which I'll highlight in more detail in a few moments. I will note that there are two important clinical trials we expect to initiate in 2021, which we believe will help further define the broad clinical utility of Expovio as a potential partner of choice with other active anti-cancer agents. First, we expect to start a new randomized phase three study evaluating expofio in combination with pomalyst and dexamethasone in patients with previously treated myeloma that will begin in 2021. If the results of this trial are positive, this regimen could represent a potent all-oral drug option to patients with refractory myeloma. Next, we plan to initiate a new phase two study evaluating expofio in combination with ketrudib in patients with newly diagnosed or recurrent metastatic melanoma. We're particularly excited about this study based on some encouraging data from an investigator-sponsored trial from MD Anderson evaluating this combination regimen, which was presented at the annual ESMO conference in 2020. Moving to slide 11, I'll highlight the potential opportunity of expovia on patients with endometrial cancer, where we're currently conducting our phase 3 SIANDO study. Endometrial cancer is the most common gynecologic cancer in the U.S., with over 65,000 new cases and, unfortunately, over 12,000 new deaths in 2020. While most women are diagnosed with early stage disease and have a good prognosis after surgery alone, approximately 14,000 patients each year in the United States have advanced or metastatic disease and are treated with combination chemotherapy in the frontline setting. When their disease progresses, these patients are typically treated with additional chemotherapy, immunotherapy, and or targeted agents. However, currently, there are no approved drugs in the maintenance setting for patients who've had a response to their frontline chemotherapy. This is the setting in which we're currently studying Expobio in the Siendo study. A similar approach was taken with PARP inhibitors for patients with ovarian cancers, and their use in this maintenance setting in that disease has been quite dramatic. To put our potential opportunity in endometrial cancer in perspective, assuming about two-thirds of frontline patients respond to chemotherapy, there could be 3,000 or so patients treated each year in the maintenance setting by capturing approximately 30% of this market. Now, as we move to slide 12, you will see highlights from a previous phase 2 study published in 2019, which evaluated Selenexer in 114 patients with heavily pretreated and actively progressing gynecologic cancers. including 23 patients with heavily pretreated endometrial cancer who previously received a median of two and up to five fire lines of therapy. In this population with growing cancer, patients treated with single-agent selenexer demonstrated a disease control rate of 35% and a confirmed partial response rate of 9%. The most common side effects were similar to other cell and extra studies and included nausea, fatigue, decreased appetite, vomiting, weight loss, anemia, thrombocytopenia, dysgousia, and blurred vision, and were primarily grades one and two and reversible. On the right-hand side of the slide, you can see a waterfall plot of the best percent change in the sum of all the target lesions from screening for 19 evaluable patients with endometrial cancer. This encouraging clinical data in a population with highly refracted progressive endometrial cancer gave us the confidence to conduct the Ciendo study in the frontline maintenance setting, which is summarized on slide 13. Ciendo's enrolled in approximately 248 patients, randomized two to one, to receive either 80 milligram Selenex or once weekly or matching placebo. Eligible patients included those who have completed a single line of at least 12 weeks of Taxane-Platinum combination chemotherapy and achieved either a partial or complete response. The primary endpoint of the trial is improvement in progression-free survival from the time of randomization until death or disease progression. In November of 2020, we announced the trial had passed its planned interim futility analysis, and so the study continues as planned with no modifications, and we expect the top-line data by the end of this year. We remain highly encouraged by this study and the opportunity for patients should the trial meet its primary endpoint, and we look forward to providing additional updates in the future. With that, I'll now turn the call over to Mike Mason to review the quarterly financials. Mike? Thank you, Michael.
spk07: Since we issued a press release earlier today with the full financial results, I will just focus on the highlights, which begin on slide 15. Net product revenue for the first quarter of 2021 was $21.7 million compared to $16.1 million for the first quarter of 2020. The estimated gross net discount for Expovio in Q1 2021 was slightly higher at 21%, in the top of our expected range of 15 to 20%. License and other revenue for the first quarter of 2021 was 1.5 million compared to 2.1 million for the first quarter of 2020. R&D expenses for the first quarter of 2021 were 37.1 million compared to 34 million for the first quarter of 2020. The increase in R&D expenses in 2021 compared to 2020 was primarily attributable to costs incurred related to our ongoing clinical trials and regulatory activities. Selling, general, and administrative expense for the first quarter of 2021 was $37.7 million compared to $30.7 million for the first quarter of 2020. The increase in SG&A expenses compared to the prior year was due primarily to activities to support the U.S. commercialization of Expovia. On slide 16, you can see that cash, cash equivalents, restricted cash, and investments as of March 31, 2021 sold 233 compared to $276.7 million as of December 31, 2012. Finally, based on our current operating plans, Carrier Farm expects non-GAAP R&D and SGN expenses, which exclude stock-based compensation expense, for the full year 2021 to be in the range of $280 million to $300 million. The company expects that its existing cash, cash equivalents, and investments, and the revenue it expects to generate from Expovia product sales and other licensed revenues, be sufficient to fund its planned operations into late 2022. We are not providing revenue guidance for 2021 today, as we remain in the initial launch phase of Expobio and its expanded indication, but do expect to see meaningful growth in 2021 relative to 2020, with a ramp of sales increasing in the second half of the year, as we expect to see the benefit of a longer duration of treatment for multiple myeloma patients being prescribed Expobio earlier in their treatment course and or in combination with Velcade. I'll now turn the call over to Richard for some of his thoughts about Carrier Farm's future. Richard.
spk06: Thank you, Mike. Let me begin by saying how excited I am to be leading the Carrier Farm organization in such inspiring times. Of course, Carrier Farm is not new to me, as I have served on its board of directors since February of 2020. And first, I would like to acknowledge and thank Dr. Michael Kaufman for his immense contributions to the scientific and initial commercial success achieved by Carrier Farm. Dr. Kaufman, both as a clinician and drug developer, has truly enabled our company to reach amazing scientific and clinical achievements. During my tenure on the board, I have been extraordinarily impressed with what this amazing company has been able to do in such a short period of time. Now, with three separate FDA approvals and one conditional European marketing authorization granted, all having been achieved in just the past few years. Of course, all of these approvals were preceded by many years of careful and thoughtful clinical development for Expovia. And CarioPharm remains deeply rooted in innovative science with a passion for improving the lives of patients battling cancer, something that is very near and dear to me as a passion I work towards. Importantly, I believe the best is yet to come for both CarioPharm and for the patients we aim to serve. However, I know that a lot of work still remains. As CarioPharm has now effectively transitioned to a commercial stage organization, I am excited to lead the company in its next chapter as we seek to expand Expovio's impact across indications and geographies. I look forward to leveraging my experience in global product commercialization and organizational leadership to help further advance CarioPharm's impact in helping improve patient outcomes And I'm excited to work alongside of both Michael and Sharon on behalf of our patients, employees, partners, and shareholders. Regarding my initial priorities, in the near term, I think we have a great opportunity to expand our breadth and depth in the multiple myeloma treatment landscape, where we have really just begun to scratch the surface regarding where we can compete and help patients. And as we continue to generate additional combination data with other myeloma drugs, we believe Expovio has the opportunity to become an increasingly important backbone therapy. And moving beyond multiple myeloma, I believe Expovio can become a portfolio in a pill with the potential to have clinically meaningful utility across a host of cancers, including many solid tumor indications, both as a single agent and importantly, as a future combination partner of choice with other cancer medicines, allowing for synergistic opportunities to further help patients battling cancer. Now, before we open the call up to your questions, let me highlight a few of the key commercial, clinical, and regulatory milestones that we've already achieved so far in 2021 and others that we expect for the remainder of the year and shown on slide 17. we have made significant progress in Europe, where we recently received conditional marketing authorization for an Expovio and have submitted a Type 2 variation application based on the Phase 3 Boston study, which was recently validated by the EMA. Next, while we have made some progress increasing Expovio sales in the U.S., we are far from content here and remain committed to further penetrating the U.S. market throughout the remainder of this year and beyond. This is where I intend to spend much of my time in the weeks and months ahead. And finally, in the second half of this year, we expect top-line data from the Phase III Siendo study in endometrial cancer, the initiation of multiple clinical trials, and the presentation of additional combination data with Expobio and other cancer therapies at a variety of medical meetings. I look forward to updating the investment community on our continued progress in the months and quarters ahead. And with that, I would now like to ask the operator to open the call-up to question and answer portion of today's presentation. Operator?
spk16: Thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. Please ask one question and one follow-up. Our first question comes from Brian Abrahams from RBC Capital Markets. Please go ahead.
spk12: Hi there. Thanks for taking my questions. And I guess first off, congratulations to Michael and Sharon on all your accomplishments. I want to wish you the best of luck in your new roles. And congratulations to Richard as well.
spk04: Thanks, Brian.
spk12: Yeah, so first off, I'm curious if you can maybe provide a little bit more color around Expovio use patterns in the U.S. in the earlier line population. Can you help characterize the blend of the penta-refractory versus earlier line Boston population being put on drug based on your market research? What's your sense as to how Expovio is fitting into the current competitive landscape across lines versus in previous quarters? And then I have a follow-up. Thanks.
spk15: I'll turn that to John Demery, our commercial officer.
spk02: Thanks, Michael. Sales growth we saw, Brian, was across lines of therapy, with the majority coming from later line patients. It's hard to tell for sure if prescription data we receive from our specialty pharmacies and distributors does not capture in what line of therapy patients are receiving Expobio. However, from secondary market research data we purchase, our own market research with prescribers and ad boards, our sense is that is coming from later lines, e.g. fourth line and later lines. So many of those patients are now receiving the triplet combination with Expobio and another myeloma backbone instead of just Expobio plus dexamethasone, which was more common in the past, indicating we're getting trial of the new triplet indication, and we would expect them to try it in later lines and then move it up into earlier lines if they have success. So while the majority of patients are still in later lines, we are making inroads with some physicians who are starting to prescribe Expovio to their second and third line patients.
spk12: Got it. That makes a lot of sense. And then maybe just as a follow-up, just maybe a bigger picture strategic question for Richard. Selenix obviously has shown signals in a number of different tumor types. Where do you see the most promising opportunities for the drug and Do you see any opportunity to further refine the development strategy or even maybe partner in some of these combo indications that you mentioned to split economics to enable any further cost savings on the R&D side? Thanks.
spk06: Thank you, Brian. You know, we'll get into that in the future and share with you and the other analysts. But, you know, I think in the near term, we have a great opportunity to really expand our breadth and depth in multi-myeloma treatment landscapes. And as you know, we've just begun there and John talked to that as we're starting to move into earlier lines where we can compete and help more patients. And as you heard from Michael, we are generating new data in the, uh, in the XPG study as we continue to generate that additional combination data with other myeloma drugs. You know, I do believe we have the opportunity to be a backbone, uh, in many areas. And as we move forward, and as we heard a little bit around Siendo moving beyond multiple myeloma, I really believe this opportunity to be a portfolio and a pill is clinically meaningful for us and will allow us to have a utility across a host of cancers. So we'll have to explore moving forward how we bring that to life. But when you look at many solid tumor indications, you know, both as a single agent and importantly, as you touched on, as a combination partner of twice other cancer medicines, it's going to allow us to really synergistically bring Expovio to more patients battling cancer moving forward.
spk16: Got it. Thanks so much. The next question comes from Mari Raycroft from Jefferies. Please go ahead.
spk11: Good morning, everyone, and I would like to add my congrats to Michael Cherone and Richard, too. Maybe first question is just if you can talk more about the higher gross to net discounts in 1Q compared to 4Q20. Can you say what the discount was in 1Q, and will this continue going forward, or how should we think about it?
spk07: Sure, yeah. we've guided that we'd end up in a range of 15% to 20% from gross, and that we ended up just slightly north of that in Q1 at 21%. And pretty typical, you know, with the first quarter with the copay resets, et cetera. So we do expect that to come down into our, you know, into our range of 15% to 20% as we think about, you know, for the entire year with some lumpiness, you know, quarter to quarter.
spk11: Got it. That's helpful. And then as far as access for the sales team goes, Can you provide any more specifics or quantify how much access they have currently and where you aim to get in the second half of 21?
spk02: Sure.
spk11: John will take that.
spk02: Yeah, so in terms of access to customers, COVID has been a challenge. It's created an impact for patients, for HCPs, and the entire industry. And we do still have some access challenges. We do see that growing. It's growing at a different pace in different parts of the country. The last secondary data report that we saw suggested that about 20% to 25% of our interactions are in-person, and 75% to 85% of our interactions are still virtual. We're providing our teams tools to engage with their customers in both the virtual and in-person environments so they continue to drive the Boston message as we go forward. We expect as we go throughout the remainder of the quarter and about the remainder of the year, grow substantially.
spk11: Got it. Okay. Thank you for taking my question.
spk08: Thank you.
spk16: The next question comes from Peter Laws from Berkeley. Please go ahead.
spk10: Hey, thank Michael. I've just always been a pleasure speaking with you and best of luck with the next steps. And maybe the first question just for Richard, just on, I guess we get really transfixed on the first hundred days. So just if you could walk us through what you're thinking for, the initial steps at KarioPharm?
spk06: Thanks, Peter. You know, in the initial steps, I think over the next 100 days, I mean, really what I'm super excited about with KarioPharm is the opportunity to help patients. You know, as you know, Expobio, I think, is uniquely positioned with its broad mechanisms of action and its ability to be combined with a variety of other cancer drugs. Now, it's going to enable us to make a tremendous impact on patients battling cancer. You know, in the near term, as we touched on, our focus is to continue to move up past the initial launch of expovial and ventral refractory multiple myeloma. The initial launch was successful, but as we expand into earlier line settings, it's more complex, and it's going to require us to really expand our breadth and depth. So that is a key area of focus for me in the near term. And then also, should the phase 3 Siendo study in endometrial cancer prove successful, we will need to start launch preparations early. in the next little while. So as this is potentially a significant commercial opportunity for us moving forward, we're going to need to see how we bring that to life over the near term. So those are a couple areas of my near-term focus. And finally, as we're in the process of discussing and evaluating potential partners in Europe and Japan, with the recent marketing authorization to EU, as well as the acceptance of the MAA for Boston indication, which is where we know much of our value to us, and potential partners will be generated, we need to continue to explore those partnership opportunities. And the immediate priority is around ensuring we bring Expobio to the EU and multiple myeloma. However, potential partners have also expressed a very high interest in our solid tumor pipeline. So as we touched on, making sure we find the right strategy moving forward in Europe is also going to be a key focus.
spk10: Thank you. And then just from your prior experience, Richard, what parallels do you have with drugs similar to Selenexa?
spk06: Thanks, Peter. You know, in the past, I've had the opportunity to bring drugs to market in multi-myeloma, specifically working on Kyprolis. And I think, as we know, in many areas, when you first launch in later stages of the disease and then work to move up, You know, you need to continue to work with physicians to help them better understand the medicine, help them understand how to initiate and manage patients.
spk04: And that's a process that takes time, but one which we're committed to moving forward. Perfect. Thank you so much.
spk16: Congratulations. Thank you. The next question comes from Eric Joseph from J.P. Morgan. Please go ahead.
spk03: Thanks for taking the questions. Good morning and congrats again on the role, Richard. I will do my best to not call you Paul Richardson. Just a couple questions on recent prescription trends and looking forward here. Exiting first quarter, growth seems pretty strong. I guess, can you comment on demand trends through April so far, and are you able to perhaps guide us a little bit on second quarter expectations? And then just a follow-up on sort of where you're seeing use right now. You note that with the once-weekly, sorry, with most of the demand being for the once-weekly regimen suggested as a combination use, is there an expectation that it might kind of accrue to longer average duration on therapy, or is it really more about trying to, you know, expand into earlier line use where we might see the benefit of, you know, longer time on therapy occurring for sales? Thanks for taking the question.
spk15: Eric, it's Michael. Listen, we're not going to comment on this quarter's growth at all at this point, and we'll update you, obviously, when we can. But I will turn it over to John for the second part of the question.
spk02: Looking at our dosing mix, thanks for your question there, Eric. Just as an example, last year in Q1, over 50% of our new patients were being started on the twice a week 80 milligram dose or 160 milligrams per week, which was the starting dose in the storm population. In this most recent quarter, only 15% of patients were started on that dose, with the remaining 85% being started on a once weekly dose, most commonly either 100 milligrams or 80 milligrams And while we can't be exactly sure which line of treatment these prescriptions are being generated in, syndicated market research we purchased suggests many of them are being prescribed with other multiple myeloma drugs such as Velcade from the Boston study or with Pomalyst or Darzalex, which are in the NCCN guidelines, or with Kyprolis, which has been studied in the STOP trial. So we continue to see the triplet use expand, most likely in the later line populations now, and we do expect that to move earlier as patients get more comfortable using Expobia with the different triplet combinations. Of course, I mentioned a couple of different drugs listed in NCCN. As a company, we will only promote the XBD indication, which is our own label indication.
spk04: Okay, got it. Thanks for taking the question.
spk16: The next question comes from David Leibowitz from Morgan Stanley. Please go ahead.
spk14: Thank you very much for taking my question. Is it fair to say that almost all the incremental increase in prescriptions is from the expanded label, or is there some incremental increase from the DLBCL and maybe some additional from the initial indications?
spk02: I think it's fair to say that the 17% demand growth was driven primarily by new patient starts in multiple myeloma, with most of that being an increase in triplet usage, so driven by the new indication that we've seen.
spk14: How do you expect, I guess, if there's any way to qualitatively, I guess, estimate how the shift in in the environment as patients are starting to see their doctors a little bit more actively with vaccinations going up as the year goes on, how could that number shift going forward? And how should we look at that when we model as far as what type of demand could change going forward?
spk02: I think it was interesting to see in the first quarter when you look at all the multiple myeloma brands that have reported this quarter to date, as Michael mentioned, it seems to be a down quarter in terms of multiple myeloma. We would expect as patients are vaccinated that patients would return to see their physicians, that they will be getting these therapies. So we would expect the market to return to growth. We would expect to benefit from that market growth as well as, obviously, incremental growth above that with the continued launch and success in driving uptake in earlier lines with the Boston indication.
spk14: Thanks for answering my questions.
spk04: Thanks for your question.
spk16: The next question comes from Jonathan Chang from SVB LearLink. Please go ahead.
spk00: Good morning, and thanks for taking my questions. First question, given it sounds like the majority of revenue currently is still coming from the later line storm setting or the later line setting period, can you speak to reasons for confidence that you'll be able to successfully penetrate to earlier line settings and see that benefit for longer duration of treatment in the second half of those numbers?
spk15: Maybe I'll start and then I'll turn it to John and Richard may have a comment. The main driver here is education of physicians. Physicians for the last five years have assembled a series of multiple different triplet therapies, typically, that they use in first, second, third, fourth line settings, and they're comfortable with those. We're a new entry. While this is not the unmet medical need that we had when we went into penta-refractory, we do have one of the simplest, if not the simplest, triplet therapy in terms of administration, time required for a patient to come into clinic, and so on of all the drugs. So what you're doing now is having to educate doctors that there's a new kid on the block and that it's quite simple, it's easy. And with the proper prophylaxis, it can be very manageable with patients on this combination, as you know, for over two years now. So that's the main driver here. And I think, as John mentioned, with our sales force getting back face-to-face, We will be able to change practice and guide physicians that there is a new option out there. John, do you want to?
spk02: Yeah, I think Michael's point about education is critical. And we're also deploying a number of new tools to help continue to reinforce and drive that education. So we're deploying interactive content that can be used in person or via virtual engagements by both our Salesforce and our marketing team. In addition, we recently made significant investments in our digital ecosystem to improve that physician education, including website enhancements, KOL videos, banner ads, search engine marketing, search engine optimization, digital media, social networking, competitive media pilots, and plan to continue to expand this substantially going forward to drive that education that Michael spoke to as being critical. We're also investing in significant peer-to-peer education via both live and digital channels. And finally, beyond just branded, we're continuing to enhance disease state education around the role of XB01 inhibition in cancer, including in multiple myeloma. So a number of things that we're doing to continue to drive that education in the second half of the year, second quarter and second half of the year.
spk00: Got it. Thank you. And just one follow-up to that. Can you give us a sense of what you can and can't track in teasing out where these sales are coming from?
spk08: Thank you.
spk04: This is Ian.
spk13: Jonathan, not much has really changed there for those who have been following our story for some time. Essentially, we're able to track from our distributor network, certainly for about half of our business that goes through special distributors, we can see essentially just what dose of drug is being prescribed and how much per account. And then for the other half of our business, we're able to see a bit more data where we can see are these new patients, are they refills, and that's where we get our refill data from. And we can see are these multiple myeloma patients or are these DLBCL patients. But none of this data unfortunately gives us specifically what line of treatment these patients are from. And it doesn't tell us what specifically combination drugs are being prescribed. So all of that information we garner through general market research or intelligence with our sales force, et cetera.
spk04: The next question comes from Ed Waite from HC Wainwright. Please go ahead.
spk05: Good morning and congratulations to Richard and a thank you and congratulations to Michael and Sharon as well. So just two pipeline questions. The first is on export 035 and 034 in myelofibrosis. I was just wondering if we can get a status update and perhaps when we can see data from those studies And the second question is on the solid tumor studies and just wanted to get an update there on GBM, non-small cell lung cancer, and colorectal cancer. Any kind of updates you can give us there on status and timing to data would be appreciated as well. Thank you.
spk15: Hi, Ed. We will update on the, I know the 34 and 35 myelofibrosis studies are on clinicaltrials.gov. When we have our first patients enrolled, we will announce those as typical. We won't be able to give much in the way of data expectation, just given the accrual rates and so on and so forth. But we're quite encouraged about the underlying basis for doing those studies. And hopefully this year, you guys will see some data in that regard. For the solid tumor studies, the same thing applies. The colorectal and lung studies are ongoing. And we hope to provide updates in medical meetings when appropriate, hopefully this year. And for the GBM study, similar. Although I think we've just initiated, as you know, some of the new cohorts and frontline combination and in relapsed in combination with lamustine. So those will take a little bit longer and I would expect maybe next year to see them, but we'll have to see.
spk08: Great.
spk04: The next question comes from Colleen Cossey from Baird.
spk16: Please go ahead.
spk09: Hi, good morning. Thanks so much for taking our questions and congrats to the whole team. If you could comment on what the inventory stocking level is as of the end of 1Q, and then when you're thinking about competition in the layer lines with multiple myeloma, what are some of the features of Exposio that really resonates with the prescribers when thinking relative to competitors?
spk07: Mike Mason will discuss the inventory. Sure. As Michael mentioned earlier on the call, you know, we had 17% demand growth, but 7% ex-factor growth. And part of that was gross to net. And part of the other difference was some stocking that happened in December of 2020. If you recall, we got the Boston approval in mid-2020. and stocking in December. We didn't see much of a benefit of that in Q1, so that led us somewhere around four-ish weeks of inventory, which is pretty consistent with what we've had in prior quarters. Great.
spk16: John will take the second part.
spk02: In terms of what customers are looking for, you ask in later lines with therapy, actually, our goal with the Boston data is to move into earlier lines of therapy And what we've seen there in multiple myeloma, many physicians believe it's important to treat with different mechanisms as early as possible in the patient's course of disease. And that's one of the key advantages Expobio brings is a novel mechanism of action that is synergistic with proteasome inhibitors like Velcade and the indicated XVD regimen. We also know that they're very focused on efficacy, and we're able to communicate with the XVD regimen rapid and sustained PFS benefit, as well as clinically significant durable responses, all attributes that are very important to the customers. And I do think it's important to note, when you look at the landmark Boston study, it's the only trial out there to date to study Velcade weekly, the way it's actually used by clinicians in clinical practice. And despite using that weekly dose or half the dose of other trials, still produced very strong data for patients. So those are some of the attributes that our physicians are looking for, and we're highlighting as we work to move XDD up into earlier lines of therapy.
spk09: Great. Thank you. That's really helpful. And if I can quickly ask a follow-up. If CNO data are positive, how much incremental investment would you expect you'll need to make in your commercial infrastructure to expand into solid tumors?
spk02: Yeah, go ahead, John. So we're actually doing that assessment right now to look at overlap of accounts and the size of the commercial platform and footprint that we would need to fully maximize that. So that's something that we'll be able to provide more data to you at a later point in time.
spk09: Great. Thank you.
spk16: The next question comes from our Linda Lee from Canaccord. Please go ahead.
spk01: Hi, guys. Thanks for taking my question. I guess I was curious about on the education front, I'm curious what you guys are encountering as what the disconnect is or the hurdle is for prescribers to prescribe more into the Boston trial or Boston patient population. Thank you.
spk15: I'll start, and John can add. I don't think there's really a disconnect. Again, I think it really has to do with that you do things that you're used to doing. Doctors are very much... you know, they're confident with what regimens they had prior to the Boston approval. They've been working on them and honing them for the last five years, which is really the last time that a major second line in new indication or new drug came out. And so they're just comfortable. It's a little like, you know, before we all use seatbelts, nobody really wanted to put it on, but you eventually get used to it and then it becomes second nature. So what we have to do is make the Boston regimen second nature to physicians. And that's going to take a little bit of time. But I don't think there's a problem here at all. When the doctors, typically most doctors, when they use this regimen, they're pleasantly surprised. When they use proper prophylaxis, we get a number of doctors calling us and saying, well, the patient didn't have any nausea. And we asked them what they did, and they said, well, I used what you suggested, and that's how it all works. So we know how to prevent the side effects from this drug, a lot of them. They are reversible, and we just have to change people's habits sometimes.
spk02: I think Michael's absolutely right. Some physicians have a habit based on the storm data. As you know, the once-weekly dosing regimen in the Boston is better tolerated and shows a higher level of efficacy. So it's just getting physicians to try that new regimen versus the original regimen we launched with and continue that education process.
spk04: There are no more questions in the queue.
spk16: This concludes our question and answer session. I'd like to turn the conference back over to Richard Paulson for any closing remarks.
spk06: I'd like to thank everybody again for joining today's call, and we look forward to updating you on our progress as soon as we can. Thank you, operator. We'll close the call.
spk16: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Disclaimer