Good morning, and welcome to AVEO Oncology Q1 2022 financial results conference call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. At that time, if you have a question, please press the one followed by the four on your telephone. If at any time during the conference you need to reach an operator, please press star zero. As a reminder, today's conference is being recorded. I will now turn the call over to Hans Vitzthum of LifeSci Advisors. Please go ahead, sir. Good afternoon, and thank you all for joining us on today's call to discuss AVEO's Q1 2022 financial results conference call. I'm joined today by Michael Bailey, Chief Executive Officer, Mike Ferraresso, Chief Commercial Officer, Erick Lucera, Chief Financial Officer, and Jeb Liddell, Chief Operating 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 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 our 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 required by law. With that, I will now turn the call over to AVEO's President and Chief Executive Officer, Michael Bailey. Michael? Thank you, Hans, and thank you to everyone for joining us on today's call. We're excited to share with you the continued progress we made during the Q1 of 2022. Importantly, the end of this quarter marked the one-year anniversary of the approval and commercialization of FOTIVDA, or tivozanib, for patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. As this is our first commercial product, the success of FOTIVDA's launch over the course of this first year was critical to our long-term growth strategy and marks a major milestone in our company's history. Despite pandemic-related restrictions for in-person access to prescribers and other healthcare professionals throughout much of 2021 and early 2022, our sales team has been able to drive a steady increase in commercial uptake of FOTIVDA in each quarter since the launch commenced. In terms of the first quarter of 2022, we reported a 25% increase in prescriptions filled compared with the fourth quarter of 2021. One of the key potential drivers behind this growth is that we believe many physicians who initially used FOTIVDA with later line patients are now moving FOTIVDA to earlier line patients based on their positive experience. In fact, our third-party data indicates that starting in December of 2021, FOTIVDA has been the leader in third-line RCC new patient starts. As you know, new patient starts is an important leading indicator of market penetration. With that said, we are still only a year into this launch, and there is much more work and opportunity ahead of us as we progress towards our goal of establishing FOTIVDA as the standard of care for third-line RCC patients, which we believe would in turn drive our continued growth. Let me conclude my FOTIVDA commercialization comments by reaffirming our 2022 full-year net sales guidance for FOTIVDA of between $100-$110 million. With $20 million of net revenues for FOTIVDA in the first quarter, we remain confident that we can meet our 2022 full-year guidance target. Turning to our clinical trial activity, we have issued several exciting clinical announcements in the first quarter, including positive clinical data updates for FOTIVDA at both ASCO GU in February 2022 and ASCO GI in January 2022. At ASCO GU, we presented five-year follow-up data for progression-free survival and overall survival from our TIVO-3 trial. These data show that long-term PFS rates at 3 and 4 years were consistently higher among patients treated with tivozanib when compared to patients treated with sorafenib. Importantly, this prolonged progression-free survival benefit translated to continued improvement of the overall survival trend favoring FOTIVDA, with a hazard ratio now standing at 0.89. At ASCO GI, we presented top-line efficacy and safety data from the first line cohort of our phase 2 DEDUCTIVE clinical trial, in which patients with advanced unresectable HCC or liver cancer are treated with a combination of 0.89 milligrams of tivozanib plus durvalumab. These top-line results demonstrate that the combination was well-tolerated and showed a 28% partial response rate with a median progression-free survival of 7.3 months and a 1-year overall survival rate of 76%, which we believe positions the combination favorably when compared to other VEGF checkpoint inhibitor combinations in this setting. AVEO continues to enroll patients in the phase 3 TiNivo-2 clinical trial evaluating tivozanib in combination with nivolumab or Opdivo, Bristol Myers Squibb's antibody directed against program death one, as compared to tivozanib monotherapy in patients with advanced refractory RCC who have progressed following prior immune checkpoint inhibitor therapy. If successful, we believe this trial has the potential to expand the market opportunity for FOTIVDA in the larger second-line RCC setting. Bristol Myers is providing nivolumab clinical drug supply pursuant to a clinical trial collaboration and supply agreement. AVEO currently expects enrollment in the TiNivo-2 trial to be completed in the first half of 2023. In addition, we've entered into a clinical trial collaboration and supply agreement to evaluate tivozanib in combination with NKT-2152, NiKang's novel hypoxia-inducible factor or HIF-2α inhibitor, which is an emerging target of interest in RCC. We believe this program is on track to initiate a phase 2 trial in mid-2022. Collectively, we believe that these combination clinical initiatives have the potential to further establish FOTIVDA as the combination VEGF-TKI of choice. It's important to note that all these clinical initiatives are included in the 2022 OpEx guidance, which Erick will be able to provide some additional color on in a moment. Turning to ficlatuzumab, we believe this asset is well-positioned to potentially address a significant unmet medical need that exists for patients with HPV-negative recurrent or metastatic head and neck cancer. Patient population's prognosis is very challenging. Importantly, in Q1, we completed scale-up manufacturing work for ficlatuzumab and expect to complete full-scale drug substance manufacturing for the clinical supply in the second quarter of 2022. This initiative will be followed by standard drug stability studies and drug packaging of the final clinical trial materials while we prepare for the initiation of our potential phase 3 clinical trial in the first half of 2023. In the meantime, we expect to finalize the clinical trial design and consultation with the FDA, as well as continue ongoing partnership discussions. For AV-380, we remain on track to initiate a phase 1b clinical trial in GDF15-expressing cancer patients during the second half of this year, where we hope to generate additional data supporting the safety and the ability of AV-380 to lower elevated GDF15 expression in cancer patients, which we believe is a key driver for the cachexia syndrome. All in all, we are pleased with our continued progress that we have made in advancing our pipeline, as well as the success to date with the FOTIVDA launch, both of which we believe position us well for future value creation. I'd like to turn the call over to Mike Ferraresso to walk us through the more detailed commercial update, including first quarter 2022 metrics. Mike? Thank you, Michael. As Michael mentioned, as we look back over the past year, we're pleased with the commercial launch of FOTIVDA to date. The team has successfully executed our go-to-market strategy to raise awareness, and starting in December of last year, established FOTIVDA as the number one treatment option for new third-line patient starts. With our continued success, we believe FOTIVDA has the potential to become the overall market share leader and standard of care for third-line RCC patients. Let me highlight this point with some of the sales and market data we're monitoring internally. To start, this was the fourth consecutive quarter of growth for FOTIVDA, with U.S. net product revenue of $20.1 million, which reflects a 20% increase in revenue from the fourth quarter of 2021. Finally, during the first quarter, we recorded a total of 977 commercial prescriptions, reflecting a 25% increase in commercial prescriptions compared to the fourth quarter of 2021. Perhaps even more importantly, we remain excited by the level of interest and overall feedback we're receiving from physicians. Many of these physicians have had an opportunity to treat a few patients with FOTIVDA. As Michael mentioned earlier, we'll typically try a new therapy initially in a later-line patient and then move earlier to third-line patients with positive experience. I'm pleased with the growth trajectory that we are currently experiencing, as FOTIVDA now has the leading share of third-line new patient starts, as evidenced by third-party data, which we first achieved in December of 2021 and have continued for the first quarter of 2022. We are hopeful that with continued leadership in third-line new patient starts, this will translate into continued growth and future leadership in the overall total patient market share, establishing FOTIVDA as the third-line standard of care in advanced RCC. In terms of outreach, we're now seeing significant improvement in our in-person access, which we believe will continue to expand our account penetration. Throughout our launch, we've focused on building a new commercial model with extensive in-person and remote capabilities and multi-channel approaches to reach our customers. We have supplemented the field sales team's efforts with extensive marketing outreach, peer-to-peer influence opportunities, and social media initiatives in order to drive awareness in areas facing access restrictions. With a year of launch success behind us and a continued leadership position and share of voice in the relapsed or refractory RCC market, we believe we have validated the capabilities and impact of our innovative commercial model and the team's ability to execute in the landscape of evolving customer access. We believe this commercial model will continue to drive our progress with FOTIVDA within the current label, as well as support any future label expansions and future launches from our pipeline. In closing, we continue to be pleased with the momentum that our commercial team has generated since launch and the encouraging reception FOTIVDA has received from oncologists, patients, and the broader medical community. We look forward to updating you on our continued progress over the coming quarters. I will now turn the call over to Erick Lucera to discuss first quarter 2022 financial results. Erick? Thank you, Mike. Total net revenue for the first quarter of 2022 was $20.9 million, driven by US net product revenue of $20.1 million. Selling, general and administrative expense for the first quarter of 2022 was $17.3 million, a level consistent with the prior three quarters and as compared with $15.1 million in the first quarter of 2021. Research and development expense for the first quarter of 2022 was $10.2 million, compared with $5.8 million in the first quarter of 2021. Looking to our full year guidance for 2022, we continue to expect our commercial spending levels to remain relatively constant during the year. Specifically, we expect commercial spend for 2022 to increase slightly over the last year to approximately $50 million, reflecting the full year expenses of the commercial launch as compared to only three quarters in 2021. Gross margins are expected to remain in the mid- to high-80s%. In addition, we expect general and administrative expenses to remain flat at approximately $20 million for the year. In terms of our research and development expense, we continue to expect it to be in the range of $60-$70 million for 2022. This increase in R&D expense reflects the clinical trial we expect to conduct during the year. As Michael Bailey mentioned earlier, we continue to expect to report $100-$110 million in FOTIVDA US net revenue for the year. We ended the first quarter of 2022 with cash equivalents and marketable securities of $79 million compared with $87.3 million at December 31, 2021. We believe that our cash equivalents and marketable securities as of March 31, 2022, along with expected U.S. net product revenues from the sales of FOTIVDA, will enable us to maintain our current operations for a period of at least 12 months following the filing of our report on Form 10-Q for the quarter ended March 31, 2022. A full overview of the results for the first quarter of 2022 is available on our quarterly report on Form 10-Q. I will now turn the call back over to Michael Bailey. Michael? Thank you, Erick. To close, we continue to establish FOTIVDA as the leading treatment option for new third line RCC patients, and we continue to make great progress towards becoming the overall standard of care in this setting. In addition, we are executing on the clinical front to further expand the market potential for tivozanib into earlier lines of RCC with the TiNivo-2 study. 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'll now open up the line to Q&A. Operator? Thank you very much. If you'd like to register a question, please press the one followed by the four on your telephone. You will hear a three-tone prompt to acknowledge your request. If your question has been answered, to withdraw your registration, it is the one followed by the three. Once again, on the phone, so any questions or comments you may have, it is the one four on your telephone keypad. One moment please for our first question. We do have a few questions queuing up. We'll proceed with our first one from Colleen Kusy with Baird. Go right ahead. Good morning, everyone, and thanks for taking our questions and congrats on the progress this quarter. This is obviously your first full quarter of the year. I'm sure there are some learnings about the dynamics there. Can you talk about anything you saw in the first quarter that might be particular to the January, February, March time frame? You had a higher gross to net this quarter. Can you just talk about what your expectations for the gross to net going forward are? I have a follow-up. Thanks. Yeah. Thanks, Colleen, for the question. This is a very exciting time for us with the first full year of sales in this quarter with a little over $20 million in revenues. Increasing quarter-over-quarter is very encouraging for us. I'm gonna turn it over to Mike Ferraresso to answer your first question. Then we'll turn it over to Erick for the gross to net. Thanks, Michael, and thanks for the question, Colleen. I would say the only significant dynamic we saw, and you honed in on it with the gross to net, is just the reset in co-pays. We did see an increased utilization of our co-pay support to make sure we can keep patients on active treatment through this reset period. We launched last year around the second quarter and certainly saw a lot lower then. That may be an estimate of when things return to more normalcy on the co-pay front. Erick, can you give some guidance on the longer term? Yeah. We've always said that over the long run that we would be getting to a gross to net similar to our peers, and we continue to expect that. As mentioned, last year was a bit of an anomaly because we had no first quarter revenue, so, you know, we can at the end get closer to the peer group. Colleen, I'll just with a couple other dynamics that were mentioned earlier. One is the access is opening up, and we're very encouraged by that, and we hope that will help us continue to drive growth. Then, you know, reiterating this third line, new patient start leadership. This is a really important leading indicator for overall kinda market penetration. We're excited about maintaining that into the first quarter. That's really helpful. Thank you. Yeah, certainly encouraging to see maintained leadership and then new scripts for the third line. I guess, are you able to? Do you have any granularity into the FOTIVDA description where those fall in terms of line of therapy? Like, is third line also the largest share of FOTIVDA scripts that you've been seeing to date this quarter? Yeah. Mike, do you wanna try to tackle that? Yeah. We don't have that granularity as to our current base of business. We'll say, you know, most of your business at this point, your launch is refills, so a lot of it is patients who started in earlier quarters and may or may not have been third line patients. But we are seeing now we have a 25% share in the first quarter of new patient starts in the third line, which is the number one product share. You know, we're very proud of that significant achievement by the team in this short time of our launch. We see that we're well on our way to becoming the overall share leader if we maintain that share. We're seeing reported a 14% share for overall market share in the first quarter, it's less than half of what our new patient share is. Significant room for growth there as we continue to own the space. That's great. Thank you. In prior quarters, you had mentioned, or at least in last quarter, you had mentioned that some of those early discontinuations that you saw earlier in the launch have kinda stopped. Any additional commentary on early discontinuations that you saw in 1Q? Yeah, absolutely. We've seen a positive continuation of the trend. What we shared last quarter, and we can extrapolate this now into the first quarter, is in our first couple quarters of launch, as is common with a relapse refractory oncology drug launch, you get a lot of trial initially in very late line patients, and then if they have a positive experience or more to the extent of the label, and for us really focusing on that third line population. In our first two quarters of launch, we had somewhere between 25% and 30% of patients who discontinued after one cycle. What that tells us is these were very late line patients who really weren't going to benefit from any additional treatment. In the fourth quarter, we saw an improvement. It very much lined up with our movement into the third line share increase, and it dropped to 16%. In the first quarter now we're reporting 15%, so it's again very consistent. As we move to an earlier third line population, we've seen a significant decrease in those early drop-offs. I'll just add to that. I mean, you know, those early patients, they're not all absolutely late line, and we do have a percentage of those that started in the first or the second quarter of 2021 that are still on therapy. You know, the drug is delivering on its promise, and we're very excited about that. Great. Congrats again on all the progress, and thanks for taking our questions. Thanks, Colleen. Thank you very much. We'll get your next question on the line from Stephen Willey with Stifel. Go right ahead. Morning, guys. Can you guys hear me okay? Yeah, can. Okay. Hi, this is Julie on for Steve. I might have missed it in case you guys mentioned it, but I have a few follow-up questions. First one is, would it be possible for you guys to quantify the contribution of inventory shipments to sales realized during this quarter? I'll turn that over to Mike to answer the inventory question. Sure. Our inventory has been very consistent. It fluctuates between about 2 or 4 weeks supply on hand, and so it was right within those bounds at the end of this quarter as well. All of our distributors can readily order product and typically get it the next day, so there's really no incentive for them to build up any inventory. They try to manage in that 2-4-week range. Great. Thank you. My next question would be related to data. Exelixis will be providing top line, their top line CONTACT-03 data in the second half of this year, and this trial appears to serve as a surrogate of the TiNivo-2 trial and presumably have more statistical power due to an increased number of patients. Can you guys speak to how a potentially negative data readout from this trial would influence TiNivo-2? Your question, if I may restate it, you're asking about any impact on CONTACT-03 on the overall- Yeah. TiNivo-2. Is that correct? Yes. Correct. Thank you. Yeah. Just to remind everybody, CONTACT-03 is a very similar study to TiNivo-2, and that was very intentionally done on our part because this will be a great opportunity for us to kinda compare and contrast not only the combination of cabo and checkpoint versus tivozanib and a checkpoint, but also it will give us an opportunity to compare the single agent. We really like this study design for a couple of reasons. One is, you know, we can't really lose. If the combination is not better than the single agent tivozanib, we've really established tivozanib further as a great opportunity or alternative to treating after immune checkpoint inhibitors. If at the end of the day the CONTACT-03 is not successful in the combination arm, I'm not sure there's a huge read-through there for us in that our tolerability profile is very different than cabozantinib. We believe the importance of being able to maintain dose and not have to dose reduce or dose interrupt is a significant advantage. I'll also say, kind of related to that topic, CONTACT-03, cabo is using their full dose, whereas they had the great success in the first line they used a reduced dose. As you recall from our prior call, we the 0.89, the lower dose in this combination. We did that specifically and strategically because we believe tolerability is incredibly important in combination success. I would argue that the FDA is also kind of moving in this direction with their Project Optimus, where they're really looking to try to better balance toxicity and efficacy or risk benefit, if you will. I think you know, we're right on track to be able to have the highest possibility of success here. We'd be very interested to see what happens in CONTACT-03. I don't have data for some time now, but it will be an interesting data set to compare to the TiNivo-2 at the end of the day. Great. If I may, I have one more question. What is the contribution of ficlatuzumab manufacturing scale up to 2020 R&D guidance? Again, I guess I might have missed it. Can you guys quantify that for us? Sure. Erick, do you wanna Yeah. Hi, this is Erick Lucera. As we previously guided before, we're expecting about $10 or so million of manufacturing for the study drug material during the current year. All right. Great. Thank you. That was helpful. Thank you very much. Great question. Proceed to our next question on the line from Andrew Berens with SVB Securities. Go right ahead. Hi, guys. Thanks for taking the questions. I'm sorry if I missed some of this because I came onto the call at the tail end. Can you give us color on the duration of FOTIVDA that you're seeing in the market now? And what other drugs are being used in the third line are comprising the 75% in RCC? And then also, what percentage of third-line patients are not being treated that you see as addressable? And then lastly, what would we expect to see in the HCC second-line setting in regards to duration? Lots of great questions there, Andy, and thank you for them. I'm gonna turn it over to Mike to tackle. I'll start by saying it's early to be able to get a very specific duration of therapy because as you know, even with the updated data we presented at ASCO GU, you have a lot of patients who are really on tivozanib for a very long time, even 3-4 years, as reported just recently. So Mike? Thanks for the question, Andrew. As Michael said, it still is difficult for us to calculate the duration, and it's very encouraging in that, even when we look back to the group of patients who started in Q2 of last year, which is the longest follow-up, we still have a significant portion of those patients still on active treatment. Recalling as well, that was a time when we were getting our initial trial where it was a lot more biased towards later line patients. We believe it's gonna get even enriched as we go forward, and we're getting more third-line patients. We'll need to follow that for a longer period of time. As far as the other drugs in the third line, historically it was Cabo and lenvatinib were the top choices. Essentially, there was a lot of fragmentation amongst therapies beyond that of essentially whatever treatment a patient hadn't had before. Used to see a fair amount of nivolumab historically, but now that most people are getting an immunotherapy in the front line, you're seeing less and less use of nivolumab in that later line setting. For the percent treated, what we look at is DRG's combination of third line plus. As we're stating it, prior to our approval, it was estimated only about 50% of patients who were eligible were going on to active treatment. That's about 5 out of 10,000 patients per year. Since our approval, DRG has revised that percent treated up to 58% and correspondingly increased the size of the market from $350 million to $480 million. We think we're making an impact. We're clearly driving being the leading new patient starts and getting a lot more patients on treatment. We believe that rate has a lot of room to continue to increase. In the first and second line, it's about 85 or 90% going to active treatment. We'd love to see that in the third and fourth line setting. Yeah. Andy, just to answer your last question on what we'd expect to see in the HCC duration after bev-atezo. Importantly, remember, there's no data after bev-atezo at this point, so this is one of the exciting parts about this study. If we look at second line activity as single agent ramucirumab, the duration's somewhere in the 3-5 months. You know, really not great extension of duration of therapy for that second line. The bar is relatively low, but we'll be excited to see what we see in this second cohort of the DEDUCTIVE trial. Great. Thanks for taking all the questions, guys, and congrats. Thank you, Andy. Thank you. We'll get to our next question on the line. It is from Soumit Roy with Jones Research. Go right ahead. Hi, everyone. Congratulations on all the progress. Quick question on the DEDUCTIVE, the Cohort B. Can't remember if you already enrolled those 20 patients and just waiting for data to be available. Yeah, I'm gonna turn that over to Jeb. We've said that we would finish that enrollment during the second half of this calendar year. In terms of the TiNivo-2 enrollment, do you see it's like a steady growth going on, or you see it's picking up as the name is getting more coming out for FOTIVDA and physicians are getting more aware of it? Yeah, we haven't provided any guidance on the shaping of the enrollment. What we've said is that we expect to finish the study in the first half of the calendar year. Got it. Sure. Last question is, could you give us like the NRx, TRX number on the current prescription? Mike, you wanna take that? That's actually not a number that we have easy access to, so we don't get the broken out that way. Most of our business is going through the SP channel, so we just see volume going into an account. We would estimate at this point in our launch, most of our volume is refill, but we're growing both the new and refill quarter-over-quarter. Okay. Thank you so much for taking the questions. Congratulations again. Thank you, Soumit. Thank you. Once again, on the phone, if you'd like to ask a question, it is star one on your telephone keypad. Our next question on the line is from Go right ahead. Thank you. Good morning, gentlemen, and thanks for taking my questions. Probably some of these questions have been already asked, since I'm coming late into this. Yeah, in some of your pre-prepared remarks, you stated that there are certain physicians being comfortable with FOTIVDA or actually trying to use the drug in second line as well. You know, do you have a certain percentage or like what percent of physicians are actually trying to get, you know, use it in the second line as well, which is obviously not on the label, but. Thanks for the question again, RK, and I'll add a little color. Basically what we said, our early patients were kind of fourth, fifth, sixth line, you know, patients who didn't have a lot of in hospice came up. The third line. Now, with that said, there are anecdotes, and we've heard reports of physicians using tivo in the second line. Again, that's the label is after two prior systemic. Theoretically after you've had, let's say, a cabo-nivo, tivo could be a good choice. And again, we've heard anecdotes about that. But what we're really trying to highlight today is our core focus market of third line, which we estimate or Decision Resources estimate about $480 million and growing. We have taken the leadership role in new patient starts, which as we said, is really an important leading indicator to overall market penetration. I don't know, Mike, if you wanna add anything to that or. Yeah, the only color I would add, RK, is as Michael said, we've heard anecdotally, and as he said, it's most commonly if they used to use cabo in the second line setting, and now they're starting up front with cabo-nivo. We have heard some physicians say that within our label of two prior systemic therapies, they would do that. The other thing we've heard is if they get comfort with FOTIVDA and they have a patient who maybe went on a frontline therapy and had some toxicity challenge, candidate for some of the multi targeted TKIs or TKIs with a similar toxicity profile that they already struggled with, that they may adopt in that setting. I would say at this point, as Michael said, we're very focused on third line, and it's been mostly just anecdotes from those with a higher level of experience with the drug and comfort level. I'll just close that thought out, RK, and a good question, that's our key strategic initiative to getting into the second line and hopefully taking leadership share there is really the TiNivo-2 study. We're excited about the progress we've made there. Okay. Regarding the TiNivo-2 study, is there going to be an interim look, or do we need to wait till the end of that study? Yeah, we're gonna have to wait till the end of that study. Interim looks on safety and Okay. You know, that are very typical in a phase 3 study. Unless there's some, the study will proceed to conclusion. Okay. Last question from me, Mike, is do you still have the voucher program, or is it pretty much done with at this point? Because it's almost a year into your commercialization. RK, we do still have physician samples available, and it is intended to be a launch program. As we said, there still are some pockets where physicians have been difficult to launch and things are now opening up. With that said, we're seeing very little need to use the program, so it's likely phasing out soon. Perfect. Thank you. Thank you, gentlemen, for taking my questions, and congratulations again. It's a great start, of course. Thank you very much, RK. Thank you. Mr. Bailey, we have no further questions at this time. I'll now turn the call back to you for any closing remarks. Very good. Well, thank you all for joining us today. Greatly appreciate your continued support and look forward to updating you all on further progress in the coming quarters. With that, we'll end. Thank you very much. Thank you, everyone. That does conclude the conference call for today. We thank you for your participation. As we disconnect your lines, have a good day, everyone.