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spk02: Good afternoon. Thank you for standing by. Welcome to CTI Biopharma's third quarter 2022 earnings call. During today's presentation, all parties will be in listen-only mode. This conference is being recorded today, November 7, 2022. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. I'd now like to turn the conference over to Dr. Adam Craig, CEO and President of CTI Biopharma. Please go ahead.
spk04: Thank you, Liz, and welcome to this afternoon's conference call. Joining me today are David Kersky, Chief Financial Officer, and Jim Fong, Chief Commercial Officer. Following formal remarks, the conference will be open for questions. Before we begin, Please note that during this call, we will be making forward-looking statements based on current expectations. Such statements are within the meaning of the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the types of statements identified as forward-looking in our 2021 Annual Report on Form 10-K that was filed on March 31, 2022. and our subsequent periodic reports filed with the SEC, which are available on our website in the investor section. Such forward-looking statements, which are indicated by terms such as expect, intend, and seek, represent our views as of the date of this call, are not guarantees of future performance, and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. including many that are beyond our control. These statements include our expectations regarding cash runway, market adoption of Vonjo, and the future success of our product launch. For further description of these and other risks and uncertainties that may cause actual results to differ materially from those expressed in the forward-looking statements, as well as the risks related to our business, please see our periodic reports filed with the SEC. Today, I'm delighted to share our accomplishments with the launch of Vonjo as we work towards becoming the market leader in cytopenic myelofibrosis by offering a safe, simple, and effective therapy for patients with an important medical need. As a reminder, the FDA approved Vonjo Procritinib in February for the treatment of adults with myelofibrosis with a platelet count below 50 times 10 to 9 per liter. In the United States, of the approximately 21,000 patients with myelofibrosis, two-thirds have cytopenias, that is, thrombocytopenia and or anemia, resulting either from disease or commonly from toxicity of other approved therapies such as roxalignib. Severe thrombocytopenia, defined as a blood platelet count below 50 times 10 to the 9 per liter, occurs in one-third of the overall MF population and has a particularly poor prognosis, with an overall median survival of just 15 months. The commercial launch of Vonjo in the United States continues to exceed our internal projections. Today, we are pleased to report $18.2 million in net product revenue for the third quarter, reflecting a 48% increase in sales compared to the second quarter. Vonjo is being actively prescribed to patients with platelet counts less than 50 times 10 to 9 per liter, and we understand that Vonjo is also being used spontaneously in patients with higher platelet counts. The growth in the uptake of Vonjo has occurred both in the community and academic settings, reflecting growing awareness among healthcare providers that Vonjo is differentiated from existing MF therapies, and they can be considered a new standard of care for the treatment of cytopenic MF. The inclusion of Vonjo in the NCCCN clinical practice guidelines in oncology for myeloprolifted neoplasms earlier this year has further reinforced Vonjo's meaningful role in the treatment of MS. Our medical affairs team continues to educate health care providers on these guidelines, where Vonjo is the only approved JAK inhibitor recommended by the NCCCN, regardless of platelet count. Over the last six months, we've continued to learn more about the potential mechanisms of action of Vondra in cytopenic MF. In September, at SOHO22, we presented new data that showed procritinib to be a highly potent inhibitor of ACVR1. ACVR1 mediates hepcidin production, and its inhibition is thought to lead to improvements in transfusion independence and anemia in MF patients. Our analyses demonstrate that treatment with Bondro at the approved dose of 200 mg twice daily led to improvements in transfusion independence and anemia when compared to best available therapy in invaluable patients treated on the Phase III Persist-2 study. We've heard from healthcare providers that a clinically meaningful anemia benefit could be an important factor in the decision-making with respect to the treatment of cytopenic myelofibrosis. As our understanding of this benefit expands, we look forward to presenting additional data on this topic during an oral presentation at ASH 2022 next month. I'll now turn the call over to our Chief Commercial Officer, Jim Fong, to discuss the highlights of our Vonjo launch. Jim.
spk07: Thank you, Adam. As Adam just mentioned, we are pleased to announce $18.2 million in net product revenue for Vonjo this quarter. a 48% growth compared to the second quarter. We are very pleased by the robust uptake of Vonjo in just our second full quarter of launch and are confident in our ability to deliver strong growth over the coming quarters. Vonjo is a simple, safe, and effective new treatment option that addresses the urgent need of existing MF patients. Our ongoing launch momentum stems from the effective execution of the Vonjo launch plan by our sales, marketing, market access, and medical affairs teams who are deeply committed to making Vonjo the market leader in cytopenic myelofibrosis. Our commercial strategy continues to focus on our three core Vonjo launch objectives. One, build Vonjo awareness among myelofibrosis healthcare providers. Two, drive adoption and utilization with our top accounts and high potential prescribers. And three, ensure optimal patient access via securing effective payer coverage as well as our patient support services called CTI access. Our promotional efforts and activities are driving growth in Vonjo brand awareness among our target HCP audiences. Recent market research studies indicates we have already achieved brand awareness that's equal to or exceeding in Rebic, which has been on the market for several years. We continue to invest heavily in peer-to-peer programs that are designed to educate our ATPs about BonJo, identify the appropriate patients, and ultimately support BonJo demand. Our field teams have executed approximately 160 peer-to-peer programs through the end of the third quarter, programs that had reached more than 1,800 HCPs. This strong HCP participation underscores the broad interest in cytopenic myelofibrosis, and more specifically, in Vonjo's differentiated clinical value proposition to address the unique needs of these patients. We are also seeing steady growth in new prescribers, new patients, new prescriptions, and refills across all lines of therapy in both community and academic settings. Approximately 80% of our accounts have reordered Vonjo multiple times. Feedback from the field and market research indicate that future prescription growth will result from the early identification of second-line cytopenic myelofibrosis patients. With respect to patient access, Our payer team continues to successfully optimize coverage decisions with payers for VONGO as both commercial and Medicare plans now have approximately 70% and 90% coverage, respectively. In addition, our patient services team has effectively minimized coverage denials and affordability issues and provided VONGO bridge therapy for those patients waiting for coverage. Thus, the vast majority of patients who are prescribed VONGO receive it. In summary, I am very pleased with Avonjo's launch progress and growth in the third quarter, where we've recorded $18.2 million in net revenue, a reflection of the clear unmet need that exists for cytopenic MF, our customers' excitement for Avonjo's differentiated clinical profile, and our team's strong execution in the field. I will now turn the call over to David to review our quarterly financials. David?
spk06: Thank you, Jim. Moving on to financial highlights. As of September 30, 2022, cash and cash equivalents totaled $81.6 million as compared to $65.4 million as of December 31, 2021. The increase in cash and cash equivalents was primarily attributed to the proceeds received from our at-the-market offering facility and the $60 million payment received from DRI Healthcare Trust. that we received upon approval. This increase strengthens our financial position and extends our cash runway through at least the next 12 months. Net product sales were $18.2 million and $32.9 million for the three and nine months ended September 30, 2022, respectively. Operating loss was $12.2 million $23.4 million for the three months ended September 30th, 2021 and 2022 and 2021 respectively. And $66.2 million and $60 million for the nine months ended September 30th, 2022 and 2021 respectively. Net loss for the three months ended September 30th, 2022 was $15.7 million, or $0.13 for basic and diluted loss per share, compared to a loss of $24.2 million, or $0.26 for basic and diluted loss per share for the same period in 2021. Net loss for the nine months ended September 30, 2022, with $75.1 million, or 69 cents for basic and diluted loss per share, compared to a net loss of $60.1 million, or 70 cents for basic and diluted loss per share for the same period in 2021. So with that, I will now turn it back to Adam.
spk04: Thank you, David, and thank you, Jim. So in summary, we're making strong progress with the commercial launch of Onjoe. Fondro is a safe, simple, and effective therapy that is differentiated from existing older therapies. Fondro's role as a potent ACVR1 inhibitor and its clinical benefits on anemia continues to be studied, and we look forward to presenting new data and oral presentation at ASH next month. As our market penetration increases, we are successfully moving towards our goal of becoming the market leader in the treatment of cytopenic MF. That concludes our formal remarks. Liz, please open the call for questions.
spk02: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster.
spk03: The first question. The first question will come from Boris Peeker with Cowen.
spk01: Hey, thank you for taking my question. This is Hanfei Fu calling for Boris Peeker. Congrats for the strong quarter again. Can you comment on the anemia data presented at SOHO and in comparison to the update you could have presented at ASH? What additional data will you get in the meeting compared to the after? And how should we think about the difference between pacortinib and the mominotinib? Thanks.
spk04: Yeah, sure. Well, thank you for the question. So the most important component of this data is we've shown pacortinib to be an ACBR1 inhibitor. Previously, that had not been demonstrated. And in fact, the data that will come out to ASH shows quite conclusively that we're the most potent ACV1R inhibitor amongst the JAK inhibitors that are approved. And we will show ASH four times more potent than momelotinib. So that mechanism then allows us to understand something we've known for a while, which is that procritinib does have an anemia benefit. We publish data on this. in the John Mascarenas abstract, a manuscript that came out in the PASSIST-2 trial. But what we've looked at recently is the impact of transfusion independence, because that's a very important outcome, and that's the outcome that sero-oncology used to assess the effects of momolotinib. And what we found is whilst the data is not collected in exactly and analyzed in exactly identical ways, we've really shown that we are as good as momolotinib with respect to anemia benefit. And that's very important because many of the patients in which we treat who have thrombocytopenia also have anemia. So we see the data is very important in leveling the playing field with momolotinib. And given the fact that we have much better data in the cytopenic MS setting across the board with SVR and TSS rates, we continue to believe that we are and should be the treatment of choice for patients with cytopenic MF. Next question, please, Liz.
spk02: Please stand by for the next question. The next question is from Boris Beaker with Cowan.
spk03: Your line is live. I have asked for the question.
spk04: Yeah, can we go on to the next one, please? Thank you for your question, but let's move on to the next one, please.
spk02: Please stand by for the next question. The next question is from Kelly. She's with Jefferies. Kelly, your line is live.
spk05: Thanks. Congrats on a great quarter. Firstly, can you comment on Vonjo's new patient start in Q3 and how does it compare to Q2?
spk04: I also have follow-up. Thank you, Kelly, for your question. Jim's not going to give specific answers, but he can give general answers there. Jim?
spk07: Yeah. Hi. We're really encouraged and really pleased with the growth in new patient starts, and we continue to see that as we move on into even this quarter. So, yeah, we're really excited about that as physicians gain more experience and confidence with our asset.
spk05: Great. Thanks. How many days in Q3 were impacted by the recent 10% drug price increase? And entering Q4, do you expect a seasonality effect due to holidays that could boost the sales from overstocking? Thanks.
spk04: I'll answer the first bit. So the price increases came in early August. As you mentioned seasonality, we should say there was some seasonality in this quarter. I think that's important to say. The majority of companies with their own oncolytics do experience seasonality over the summer months, and we did like everyone else. Jim, your thoughts on seasonality for the rest of the year?
spk07: Yeah, no doubt that the holidays certainly impact some of the demand as patients don't typically want to go in to see their oncologist, but we believe that the strong growth in new starts and new prescriptions leading up into the fourth quarter here should carry us through to another strong fourth quarter.
spk04: And of course, Kelly, we also have ASH, which is a great forum where we can meet with many of our prescribers and interact with them and share with them our thoughts on the anemia data through the medical affairs team. Thank you. Next question, please.
spk03: Please stand by for the next question.
spk02: The next question comes from Ken Shields with SVB Securities. Your line is open.
spk09: Hey, guys. Congrats on a great quarter. So I was just wondering if you guys had any color on, I guess, the degree of off-label usage that could be being used spontaneously, as well as maybe any color generally on breakdown between first-line, second-line, or potentially third-line settings. Thanks.
spk04: Yes, so I'll answer that. Thanks, Ken. It's nice to have you on the call. As I've said, I think I've said to you and others, the majority of our patients have plate accounts less than 50,000, but it's a very significant minority. It's not a small number of patients at all. It's a considerable number of patients who are treated spontaneously at the discretion of the treating physician, and obviously we cannot promote in that area. With respect to first line, second line, we're where we are we thought we would be with respect to first line. The first line population is an incident population, so it takes some time for that group of patients to grow in our patient mix. Where we're getting the majority of our patients at the moment, as Jim said, it's a very important area of growth for us, is in the second line setting, because they're prevalent patients, and there continues to be a very high degree of dissatisfaction with ruxolitinib, particularly low dose ruxolitinib. And that's an opportunity for us to grow the market in that area.
spk07: Yeah, and Ken, I'll just add their color, too, is, well, you know, the NCCN guidelines obviously give us a two-way recommendation in the second line above 50,000. And so we've heard anecdotally in the field, as well as in market research, that physicians are certainly leveraging the NCCN guidelines in that second line above 50,000 to use our product based on their medical judgment, you know, spontaneously.
spk09: Okay, thanks.
spk02: Please stand by for the next question. The next question comes from Bert Haslett with BTIG. Your line is open.
spk12: Thank you. Thank you for taking the question. My first one and second one question was just asked. I'd like to know how you think about the Salesforce infrastructure and whether it's right size, not only for today, but for the... the arrival of potential additional competition in the MF space. Thanks. Thanks.
spk04: Jim will answer the call.
spk07: Yep. But as you know, obviously, this is a rare disease and a pretty well-defined disease state because of in-size work. And so we know that there's approximately 4,700 ACPs that treat about over 80% of the patients and about 1,200 accounts. And so we have size or field force to adequately cover that alignment. So we're very comfortable with where we are. And certainly, adding more people, given the finite number of ACPs and accounts, really doesn't make a lot of sense. In addition, we will be the only company solely focused on one asset that sells in the model fibrosis space. So that will be 100% of our commitment and our investment of our resources, unlike other players in this space.
spk04: And it's important, thank you, Jim, to mention that we don't, with respect to our costs over the coming year, we don't expect a a large increase in our cost for sales and marketing because we think the headcount will remain very stable. There may be a small increase, well, an increase for inflation, but we're not anticipating a large increase in sales and marketing costs. Thank you. Thank you.
spk03: Please stand by for the next question. The next question comes from .
spk02: Your line is open.
spk10: Hey, thank you very much. Congrats on the quarter. And if I can, I'd like to ask two questions. One, around the anemia data. Very interesting anemia data that you put out there, especially at Houston a few months ago. Can you talk about what you think it will take for this data to percolate within the medical community broadly? How do you get physicians to sort of broadly recognize Vondra's anemia benefits? Or is this already happening?
spk04: Yes. We cannot promote anemia data, but we can educate and share it through our medical affairs team, which is what we're doing very actively. I had the opportunity to sit in on an advisory panel just a week ago where the ASH anemia data was shared online. confidentially to a group, and the reaction is very positive and people are talking about it. We should say, Ben, people in the field have reported since launch anemia benefit with this drug. We hear it anecdotally again and again. So when we share the analysis from PASSIST-2 and the kinase profile data on ACVR-1, many of the people we see, it's a missing link, the missing piece of the puzzle. When they see it, it all makes sense. So it is very well received, universally very well received. And as I said in my opening, in my remarks, I do think it will become part of the decision-making process of treating physicians. But obviously, we cannot promote the we can only educate around the anemia data.
spk07: Hey, Ben. That's great. Ben, the other thing I'll just add to that is, you know, the original PERSIST-2 manuscript does outline the anemia benefit with procretinib. And so our field force right now is able to share that currently from the PERSIST-2 manuscript. The additional analysis from SOHO and upcoming at ASH is what Adam is talking about. But just so you know, our field force is actively out there educating physicians about the anemia benefit that was published in the original PERSIST-2 manuscript.
spk10: That's very helpful. Thank you. And actually, Jim, if I could also ask you another question. I think you mentioned earlier that in terms of payer access or getting access to drug, basically anyone who gets prescribed it gets the drug. But maybe just feedback with regards to patients that have platelets above 50,000 at baseline. Is there any color you can provide there in terms of the access that those patients are getting?
spk07: Yeah, great question. As I mentioned earlier, right, the NCCN guidelines have been very, very beneficial for healthcare providers who choose to spontaneously use procritinib in that setting above 50,000, particularly in the second line. And so, again, what we've heard anecdotally from the physicians is that the NCCN guidelines have been very effective in getting prioritizations and letters of medical necessity approved to the payers and getting coverage for Bonjo above 50,000 platelet counts.
spk10: Okay, that's great. Thank you very much. Thank you, Ben.
spk02: Please stand by for the next question. The next question is from Rene Benjamin with JMP. Your line is open.
spk11: Hey, good afternoon, guys. Thanks for taking the questions and congratulations on a great quarter. Maybe I can just start off, you know, how many accounts have you grown or reached compared to the last quarter? you know, coming into the third and kind of where do you want to be by the end of the year? I think Jim mentioned in his prepared remarks as well that there's like 1,200 accounts total and you've reached about 1,800 HCPs. I'm kind of trying to follow the trajectory as to, you know, where we might be by the end of this year.
spk04: Yeah, I'll let Jim answer. Again, as I said earlier, Ren, we're not going to give specific numbers today except for revenue. The most important thing for us is to grow quarter on quarter, and I believe that's what we're doing, and that's what we continue to do for next year, healthy growth quarter on quarter. I don't think we've even began to tap the potential of this drug. I think we've had a good start. We're very happy to exceed our internal projections, but growth is what we're aiming for. I'll let Jim answer your question, but I don't think he's going to give you any specifics. Jim?
spk07: Yeah, sorry, Rand. But just know that we're really pleased with both the new prescriber and new accounts that are part of that target population I just mentioned that have really adopted the product. And as I mentioned before, the good news is that we're seeing multiple orders from 80% of them. And so that shows you that there's repeat usage as well as refills happening. So those are all good signs that we look for a successful launch.
spk11: Got it. So just sticking with this for a second, are there accounts that are not coming on board? And if they're not coming on board, what are some of the reasons and how do you overcome them? Yes.
spk07: Yeah, we actually were not seeing that as a big issue. All of our key accounts have ordered the product. It's just a matter of, like we said before, having the ability to educate them and them gaining experience and then having a positive experience enough to reorder the product. So it's really, we're not, that's not a big issue for us. We're not concerned about that.
spk11: Got it. And then I guess just finally for me, you know, as we As we look at kind of the real-world application and usage of Procritinib, how is it tracking compared to clinical trials, you know, not just from a perspective of duration or response, but maybe also from a safety perspective? Because that was something that was something we had always thought about.
spk04: Yeah, let me answer that. So we don't have all the data on how it's tracking because we're only six months, really, seven months into the launch. But that is something we're looking at. I am in my role as interim chief medical officer able to see the safety data, the pharmacovigilance data. And I'm pleased to say the drug is well tolerated. We've not identified any new signals or any areas of concern. The data is reviewed regularly with the team. It was reviewed a couple of weeks ago. And so far, very pleased in the real world. I would say the drug is tolerated better than we found in the clinical trials. That's probably a reflection of a broader range of patients. Our clinical trials were pretty specific in who we enrolled. In a broader population, I'm very happy with how the drug is being tolerated in the safety profile to date. Yeah, Ren, I'll hear it.
spk11: Congratulations. Yep, thank you. Sorry, go ahead, Jim. I interrupted you.
spk07: Oh, no, I was just going to say, you know, to that point, we are not seeing those early discontinuations that happen when the drug is not tolerated. That happens in the first few weeks of therapy. We're not seeing that when they discontinue. It's typically due to progressive disease because these patients were such poor prognosis patients. So that's, you know, a great sign for us.
spk11: Perfect. Thank you very much and congrats. Thanks, Ryan. Thanks, Jim. Next question, please.
spk02: Please stand by for the next question. The next question comes from Gil Bloom with Needham. Your line is open.
spk11: Good afternoon, everyone, and let me add my congratulations for a strong quarter. Thank you. At what point do you think you guys are going to start providing us with guidance for sales? I mean, we have a couple of quarters in now.
spk04: Yeah, I think as we move into next year, we will be able to start providing guidance. We're only six months into the launch, Gil, and as we've spoken about with you and with others, there's a lot of variability at the beginning of the launch, particularly with respect to the GTM. We are finding the gross to net number is now stabilizing, and I think once it stabilizes and Jim is on a clear trajectory, then we can provide some guidance next year. I don't think we will be providing guidance for the the remaining of this year, but certainly in 2023, I think we will, particularly if the GTN continues to be stable. I think that's the biggest variable that we encounter on a weekly basis.
spk11: Excellent. Maybe a quick housekeeping question. As you've already noted, the SG&A is going to go up maybe a little bit and stabilize. Should we expect a continuation of drop in R&D expenses
spk06: Gil, I think what we're seeing is a stabilizing of the expense run rate in those areas. And as we've talked about in the past, it took a while to build up the commercial infrastructure, including marketing, but it's starting to stable. And as we are entering into our budget process, it really is, there's no need to expand. There will be some costs associated with inflation, but that's the extent of it.
spk11: All right, excellent. And I look forward to strong quarters in the future. Thank you.
spk02: Please stand by for the next question.
spk03: The next question is from Thomas Flatton with Lake Street.
spk02: Your line is open.
spk08: Hey, congrats, and thanks for taking the question. Adam, just with mamelotinib coming and the strength of the anemia data that you have in hand, have you guys considered and perhaps rubbished a labeling strategy for that, maybe even elevating one of the tertiary endpoints in Pacifica to a secondary endpoint, something like that?
spk04: Yeah, we are looking at how we can use the Pacifica data to generate anemia benefit data, but But that's still going to be several years away, Thomas. The other area we may be able to get it in will be the NCCN guidelines. The NCCN is revising their guidelines now. We do expect them to come out, version 4, the early part of next year. And then if there is an opportunity in 2023 to include some anemia data, we will submit it and see if it can be included. So I think there's two strategies. I think the NCCN approach is the one that's most likely to be successful in the shorter term.
spk08: Got it. And just perhaps only anecdotally, but for those low-dose RUX patients that are being switched over to pacritinib, is there any consistency in theme? Is it side effect-driven? Is it efficacy-driven? Or are they just you know, so overwhelmed by the availability of procritinib, they're taking patients off of low-dose Rux, even if they're not having any particular issues with it. I'm just curious if you could color in some of that.
spk04: I'll let Jim answer that. Jim?
spk07: Hi, Thomas. Yeah, what we're seeing is it's across the board, whether it's the progression of the disease on low-dose Rux because certainly it's not a proper dose, or the spleen is still a problem, or symptoms are still a problem, or they're breaking through. That's when they're switching, or there's tolerability. Despite them being on low-dose Rux, we still see counts going down after a while. And so largely it's progressive disease because the drug is not effective at that dose. and or tolerability. But we are starting to see some physicians who are taking people off because they believe they can get a better response on procritin than what they're getting now.
spk08: And then just one final one, if I may. You know, this idea of cytopenic myelofibrosis and the co-occurrence of thrombocytopenia and anemia, I get that that's probably well recognized in the academic centers. Is that well recognized in the community? Do you have to do a lot of education just around that co-occurrence or do people recognize that kind of just intrinsically?
spk07: No, you're right, Thomas. You know, that term and all that has really been a big driver for us to try to get across, and that's why I mentioned the 160 programs we've already done through the third quarter, largely in the community setting with over 1,800 ACPs where we have introduced and educated on cytopenic malafibrosis. So you're right, it's largely already accepted within the academic setting, but we're continuing to educate the community providers on this specific part of the disease data and really segmenting the population that's ideal for procretinib.
spk08: Excellent. Thanks for taking the questions. Thank you, Todd.
spk02: At this time, I would like to turn it back to Dr. Craig for closing remarks.
spk04: Thank you, everyone, for your questions. Thank you for joining us today. We look forward to our conversations over the coming days, weeks, and months.
spk02: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
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