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spk02: Ladies and gentlemen, today's conference is scheduled to begin shortly. Please continue to stand by and take up your patience. Ladies and gentlemen, today's conference is scheduled to begin shortly. Please continue to stand by and take up your patience. Thank you. Thank you. Thank you. Thank you. Good day and thank you for your standby. Welcome to Aveo's third quarter 2021 financial results and business update. At this time, all participants are in listen on the mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. If you require any further assistance, please press star zero. As a reminder, this conference call is being recorded. I would now like to turn the call over to Mr. Eric Lucera, Chief Financial Officer. Please go ahead.
spk04: Good afternoon, and thank you all for joining us on today's call to discuss Aveo's third quarter 2021 financial results and business update. I'm joined today by Michael Bailey, Chief Executive Officer, Mike Ferrareso, Chief Commercial Officer, and Dr. Michael Neal, Chief Medical Officer. Before we begin today's call, let me remind you that during this discussion, we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to important risks and uncertainties, including those that are detailed in today's press release and in the risk factors section of our most recent quarterly report on Form 10-Q, which is on file with the SEC, that may cause actual results to differ materially from those results expressed in such statements. Furthermore, we caution you that these forward-looking statements represent are views only as of today, and we do not assume any obligation to update these statements, whether as a result of new information, future events, or otherwise, except as may be required by law. With that, I will now turn the call over to our President and Chief Executive Officer, Michael Bailey. Michael.
spk06: Thank you, Eric, and thank you to everyone for joining us on today's call. The third quarter marked our second full quarter as a commercial stage company. and we are excited to share with you the continued progress we have made since the launch of Fatibda, or Tivozanib, our first commercial product, as well as the progress we've made with the rest of our pipeline and our financial results for the quarter. We are pleased to report our second full quarter of Fatibda sales, which reflect a strong commercial uptake compared to the second quarter of 2021 and since Fatibda was launched on March 22nd. To note, we saw 113% increase in net product revenue and 119% increase in prescriptions filled in the third quarter as compared to the second quarter. Fatibda's commercial performance validates its potential to serve as a standard of care for relapsed refractory RCC patients. As many of you already know, Fatibda is an oral, once a day, VEGFR TKI approved in the U.S. for the treatment of adults with relapsed or refractory advanced renal cell carcinoma, or RCC, following two or more prior systemic therapies. This approval was based on the Phase III TiVo III study, the first positive RCC Phase III study in this highly refractory setting, and the first Phase III RCC study to incorporate a predefined subpopulation of patients who had received prior immunotherapy, which reflects the new standard of care in earlier lines of treatment. It is important to note that prior to Fertitta, therapies used in these settings were often chosen based on extrapolation of clinical data from treatment in earlier line settings, as well as from clinical data that did not include a predefined subpopulation of patients who received prior immunotherapy. Furthermore, Due to a lack of data in this refractory setting, coupled with tolerability concerns of other available treatment options, we know that a large percentage of patients historically opted out of continuing on to later line therapy. Turning to our pipeline, in the third quarter, we achieved an important milestone with the start of enrollment of our pivotal Phase III Kenevo II trial of Fatibda and Abdevo in patients who previously received IO therapy. We will now be able to assess Fatibda's potential in a registration-directed study in earlier lines of therapy and in the immunotherapy combination setting. For Ficlituzumab, we made great progress over the quarter with fast-track designation granted by the US FDA for our potential registration study, which we expect to start in the first half of 2023. We believe these recent developments further support the belief that Ficotuzumab has the opportunity to address a serious unmet need and serve as an important treatment option for patients with HPV-negative head and neck cancer, a patient population whose prognosis is very challenging. I would like to turn the call over to Mike Ferraresso now to walk us through a more detailed commercial update, including third quarter metrics. Mike? Thank you, Michael. As Michael mentioned, we are very encouraged with the launch to date, and I'm excited to share with you results from our second full quarter of sales. For the third quarter of 2021, U.S. net product revenue was 14.3 million, which reflects a 113% increase from last quarter. Since launching Cotivda in late March, year-to-date U.S. net product revenue is 22.1 million. Of note, Q3 sales were representative of true end-user demand. We estimate that as of the end of the third quarter, there was approximately two weeks of inventory available on the channel, underscoring that our net revenue total was achieved with a lean inventory level. Finally, during the third quarter, we recorded a total of 619 commercial prescriptions, reflecting a 119% increase compared to the second quarter. Since launch, approximately 260 accounts have ordered as of September 30th, a 90% increase compared to 137 accounts having ordered as of June 30th. As we expand our prescriber base, we are seeing decreased need for launch patient experience samples, and we're scaling back the program as planned, with 75 patient kits distributed in Q3 compared to 180 in the second quarter. Let me take a minute to discuss the commercial team that is helping drive these results. Our team is comprised of individuals who are deeply experienced in oncology with a proven track record in reaching and impacting customers both in person and when required remotely. With the increase of the Delta variant in the third quarter, COVID restrictions have, of course, posed a continuing challenge for gaining in-person access to treating oncologists. That said, our teams are executing well and we're seeing steady progress toward reaching all of our key customers in person or using technology to engage them remotely. As I mentioned, we have received orders from over 260 unique accounts to date, which just scratches the surface of our 3,000-plus targeted accounts. In addition to the field sales team, we have supplemented their efforts with extensive marketing outreach, spanning a wide variety of formats in order to increase awareness in areas facing access restrictions. We continue to invest in new opportunities to enhance our awareness, from traditional print advertising to social media and other digital formats. As reported by Acuvia, we continue to have a leading share of voice in the relapse refractory RCC setting, and this is great evidence of the effectiveness of our efforts. Fotivda is broadly available through a limited network of specialty pharmacies and specialty distributors. By limiting our distribution network, We believe we are able to improve the customer experience for those receiving Cotivda at home through our specialty pharmacy partners, as well as for those who receive Cotivda directly from their treatment facility. We have designed our network to allow oncology practices who dispense directly to their patients to do so not only for the first month of treatment, but for the duration of treatment. We believe our model is unique within the RCC space. Our comprehensive support services provided through the Aveo Access Center of Excellence, also known as the ACE Patient Support Hub, helps to support prompt access to Protivda for on-label patients. We continue to be very successful in securing coverage with minimal payer issues. We are pleased with the significant progress that a commercial team has made since launch and the encouraging reception Protivda has received from oncologists and patients as well as the broader medical community. We look forward to updating you on our continued progress over the coming quarters. With that, I would now like to turn the call over to Dr. Mike Needle to review the clinical opportunities within our pipeline.
spk05: Thank you, Mike. Beyond the launch of Flotibda, we are pleased with the progress we have made this past quarter in the clinic, starting with Dr. Vazanid immunotherapy combination programs. In the third quarter, enrollment opened for the pivotal phase three Tenevo 2 trial of Tevo in combination with Novolumab or Updevo, Bristol-Myers Squibb's anti-PD1 therapy in patients with advanced relapsed refractory RCC following prior immunotherapy. The pivotal trial is being conducted under our clinical trial and collaboration agreement with Bristol-Myers Squibb. Bristol-Myers Squibb will be providing Nivolumab clinical drug supply for the study, and we will serve as a study sponsor and will be responsible for costs associated with trial execution. The pivotal trial is following up on the positive results previously reported from the Phase I-II Tenevo trial, where the combination of Tavazanib and Nivolumab demonstrated a high objective response rate and disease control rate, long progression-free survival, and a favorable tolerability profile in treatment-naive and previously treated patients with advanced RCC. With the introduction of immunotherapy combinations as the new standard of care for first-line RCC, there is an increased need to establish optimal sequencing and treatment options in the second-line setting following prior immunotherapy. We believe that the combination of Tavazanib and the Volumab could serve as a meaningful therapeutic option in this growing patient population, and we look forward to updating you on the progress of this trial. Moving on to Ficletuzumab, our HDF CMET IgG1 antibody. In September, the U.S. Food and Drug Administration, or FDA, granted Ficletuzumab fast-track designation for the treatment of patients with relapsed or refractory recurrent head and neck squamous cell carcinoma. We are pleased to receive fast-track designation from the FDA as their decision further underscores the potential for ficletuzumab to address a serious unmet need and serve as a meaningful therapeutic option for patients with HPV negative relapsed or recurrent head and neck squamous cell carcinoma. In regard to timing for the start of the ficletuzumab registrational trial in human papillomavirus, HPV negative, head and neck squamous cell carcinoma, we expect to commence manufacturing of ficletuzumab clinical supply in the second quarter of 2022, subject to availability of key raw materials and manufacturing also used in the COVID-19 vaccine manufacturing. With the initiation of the registrational trial now anticipated in the first half of 2023, with the receipt of fast track designation, We believe ficletuzumab has potential to advance as an important new treatment option for patients with head and neck squamous cell carcinoma. We are continuing our discussions with the FDA to identify the optimal registration trial design for the program, as well as speaking with potential partners as we look forward to providing further updates on our progress. I will now turn the call over to Eric to discuss third quarter 2021 financial results.
spk04: Thank you, Mike. Total revenue for the third quarter of 2021 was $15.2 million, and U.S. net product revenue for the third quarter of 2021 was $14.3 million. Selling, general, and administrative expense for the third quarter of 2021 was $15.1 million, a level consistent with the prior two quarters and is compared with $5.8 million in Q3 of 2020. We continue to expect that our total G&A spend for the year will be approximately $20 million and that our total commercial spend for the year will be approximately $40 million for a total spend of $60 million. We continue to expect gross margins to be in the mid to high 80th percentile. Research and development expense for the third quarter of 2021 was $7.5 million compared with $5.9 million in the third quarter of 2020. We continue to expect R&D expense to be approximately $30 million for the year. We ended the third quarter of 2021 with cash, cash equivalents and marketable securities of 94 million, compared with 102.9 million at the end of the second quarter. As we expect our spending levels to remain relatively constant for the fourth quarter, we also anticipate net cash burn to continue to decline as we expect revenues to increase. We believe that our existing cash, cash equivalents and marketable securities as of September 30th, 2021, along with Expected net product revenues from the commercial launch of Fativda in the United States will enable us to maintain our current operations for a period of at least 12 months following the filing of our quarterly report on Form 10-Q for the third quarter. A full overview of the results for the third quarter 2021 is available in our quarterly report on Form 10-Q. And I will now turn the call back over to Michael Bailey. Michael?
spk06: Thank you, Eric. To close, we believe we are well positioned for continued success with the commercial launch of the TIVDA here in the U.S., as well as the continued advancement of the balance of our pipeline programs. We look forward to providing updates on our progress in the coming quarters as we continue on our mission of improving the lives of patients with cancer. We will now open the line to Q&A. Operator?
spk02: Thank you, sir. As a reminder, if you have a question at this time, please press star 1 on your telephone keypad and wait for your name to be announced. If your question has been answered or you wish to remove yourself from the queue, press the pound key. We'll pause for just a moment to compile the Q&A roster. Again, that's star 1 to ask a question. Your first question comes from the line of Stephen Willie with Stifel. Please go ahead.
spk08: Yeah, good afternoon. Thanks for taking the questions. Maybe you can speak a little bit to some of the patients that you're seeing being prescribed drug in terms of just most recently failed therapy, if there's any kind of patterns that appear to be emerging with respect to the specific type of patient who's being prescribed TiVo. I was also wondering if you've seen any evidence of patients receiving TiVo as a second-line therapy, just given the fact that the label does presumptively allow for second-line use in the context of frontline combination regimen.
spk07: Thanks for the question, Steve. I'm going to pass this over to Mike Ferrazza.
spk06: Great. Thanks, Steve. We don't always have visibility into the patient types, so it's going to take some more time for our data sets to get more robust to have greater granularity. But in the data we do get, we're certainly seeing a mix of patients. So we're getting a mix from those, as you described, coming off a frontline combination. Those who are a typical third-line patient, we're also seeing later-line patients who would have likely opted out of treatment or gone on to hospice. So We're seeing a broad mix, and again, we don't have full visibility yet, but we will continue to build a more robust data set going forward and be able to provide more granularity in the future. Okay.
spk08: And did you say previously that your target number of accounts was 3,000? Correct. We have over 3,000 target accounts.
spk06: We've penetrated to this point about 260, so we see a tremendous amount of opportunity to continue to expand our prescriber base and grow our business.
spk08: Okay. And I guess, how do you think about the kinetics of closing that gap between the number targeted and the target number? And is this something that you think you can achieve over the course of the next one, two, three quarters? Go ahead, Mike.
spk06: Yeah, it's a great question, Steve. I think the biggest challenging question for anyone launching a drug right now is COVID and the way it's impacting our access. I mean, we're very pleased that we grew our prescriber account base by 90% quarter over quarter. We continue to make penetration to new accounts and expand our reach. it certainly is more challenging with COVID and we think ultimately it certainly will take us longer to reach everyone and reach our full penetration than if we were in a non COVID era. But again, the team's executing well and we're really pleased with the quarter on quarter progress that we've made.
spk08: Very good. And then just lastly, do you have any data points on just the proportion of, uh, ordering accounts that are, that have reordered? I guess specifically those in between kind of specifically those who had ordered as of the end of 2Q and whether or not you saw a high reordering amongst those accounts in the third quarter.
spk06: Mike? Yeah, so I don't have specific metrics on that, but we certainly are really pleased with the growth we're seeing both in new prescriptions and refills and You know, I think as we look at the TEVO3 study, we had 18% of patients progression-free at two years, so we think it's going to take quite a while for us to truly know what our real-world long-term refill rate and duration of treatment is going to be, but we're pleased with what we're seeing so far.
spk08: All right. Thanks for taking my questions.
spk06: Thanks, Steve.
spk02: Thank you. Your next question comes from the line of Colleen Cousy with Beard. Please go ahead.
spk09: Great, thanks so much for taking questions and congrats on the quarter. Piggybacking off of Steve's last question, do you have any insight into the refill rate in terms of what patients are getting how many refills?
spk07: Yeah, Mike, do you want to talk about that?
spk06: Sure, Colleen. Yeah, it is challenging. So, you know, as I was sharing, we don't have that visibility into all of our business, we get it in a small subset. So as our data gets more robust over time, we get better and better accuracy and get a comfort level where we have updates we can provide in the future. So we're pleased so far. We're certainly seeing a good mix of refills and new patient starts. Again, we're really pleased with new account growth, and we'll continue to track these things. As I said, it's probably going to take quite a while until we can really say what our real-world duration of treatment is. Just because there was such a significant tail of patients on the drug in a very long time in our clinical trial setting, we have to see how that translates into the real-world setting. So, again, we'll keep tracking, and when we get robust enough data, we'll be happy to share that in the future.
spk09: Makes sense. Thanks. And for the sampling program, would you expect that to go to increase again as you're continuing to expand into the remaining 2,000-ish accounts or how to think about with regard to what the sampling program is going to be?
spk07: Yeah, thanks, Kelly.
spk06: Mike, can you take that one too? Sure. So, yeah, our sampling program, we've always planned it to be a launch sampling program or patient experience program. So, we've already seen a significant drop from 180 samples distributed in the second quarter to 75 in the third quarter. We don't have any plans to shut it down at this point because, you know, as we've discussed, there are still a lot of accounts to access and it still can be a powerful tool. But I will say you wouldn't expect all 3,000 accounts to take a sample. There's many treatment settings that are not allowed to take a sample. Those that do any dispensing themselves and other institutions don't, they prohibit it. So it's not a program that's for everyone. So I think we'll continue to see it. decreasing over time, but we're not shutting it down just yet because we think there are still our accounts who would benefit from a sample that we've yet been able to access and reach.
spk09: Okay, thanks. That's helpful. And on the TANIMA 2 study, maybe if you can talk about expectations for enrollment there, kind of how many centers you're targeting, and if you think COVID will kind of impact getting those up online.
spk07: Yeah, thanks, Colleen. Hey, Dr. Mike, do you want to answer that one?
spk05: It was hard for me to hear. Could you please repeat the question?
spk09: Yeah, sorry. On the Teneva 2 study, if you could just talk about what your expectations are for enrollment there, how many centers, and what you expect the COVID impact will be on getting those centers online.
spk05: Sure. Well, we are targeting close to 200 centers. It's hard to, the COVID bit is such a moving target. You think it's getting better and then there's a setback. And it's obviously different in different parts of the world at different times. So it is, it's very difficult for us to predict. And I mean, I'm not sure what else I can say. Yeah.
spk07: I'll add one thing, Mike. I mean, as Mike said, it's about 200 sites. That's not too dissimilar from Pivo 3. You know, it's early in the opening and the enrollment process, so, you know, we're keeping a close eye on it. But just as a benchmark, you know, Pivo 3 enrolled at about 15 to 18 months with about a similar number of patients, but recognized also, as Mike pointed out, that was not during COVID. So that's why we want to just Let's see how things go, mostly how things go with COVID and how that ultimately impacts the initial uptake on enrollment. We'll keep you posted. Great. That makes sense. Thanks for taking the questions.
spk02: Great.
spk07: Thanks, Colin.
spk02: Thank you. Your next question comes from the lineup, R.K. Remenkunt with H.C. Wainwright. Please go ahead.
spk03: Thank you. Good afternoon, Michael, Mike, and Eric. And just a couple of quick questions. You said, you know, you're trying to target 3,000 accounts, and right now you've got orders from 260 accounts. So how many accounts have you, you know, interacted with out of which the 260 have been successful?
spk07: Yeah, great question, RK. Mike, you want to talk a little bit about reach?
spk06: Yeah, thanks for the question, RK. So we haven't put that metric out, but I'll give you a sense of what the world is like out there in general right now, as reported by Acuvia and others. There's probably somewhere between 25 and 30%, maybe 35% of oncology accounts that are open to engage with industry right now that are allowing sales reps to get in there. So I think that's maybe a helpful insight. Certainly there's other ways we try to engage, but the in-person interactions are certainly the most impactful. And usually it takes a few visits, a few meetings with a customer to walk them through the drug, how you get access to it, give them comfort with reimbursement, all the things they need to know to start a new therapy. So it's going to take us a while because your access is restricted and how often you can get in there, the frequency also gets restricted. So we're continuing to make great progress. Again, we're really pleased to grow our account base 90% quarter on quarter, despite the access challenges that we have. And, you know, it's difficult to predict where COVID is going, but we're hopeful that the Delta variant seems to be settling down and that access trends may start to once again improve and open up and make it easier for us to expand our reach.
spk03: Thank you. Thank you very much. Um, so you, um, you said, um, you had about 619 scripts in the third quarter. So obviously the third quarter did quite well, um, or very well actually. Um, so how should, uh, any commentary at all that you can give us regarding what you have been seeing, um, in the last 35 days since this quarter started, um, especially on the back of the comments that, you know, uh, COVID seems to be, you know, I'm regressing a bit.
spk07: Yeah, okay, good question. We are going to be providing going forward as the launch matures is really just kind of sticking to quarterly updates. So, you know, we had provided with the first quarter of that extra month, but we've shifted to quarterly updates and we'll be looking forward to giving those to you at future calls.
spk03: Perfect. Thank you. Thank you, gentlemen. Thanks for taking my questions.
spk07: Thanks, Arquette.
spk02: Thank you. And that concludes our question and answer session for today. I will now turn the call over back to Mr. Michael Bailey for closing remarks.
spk07: Well, thank you all for joining us today. We appreciate your continued support and look forward to updating you on further progress in the coming quarters.
spk02: And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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