AVEO Pharmaceuticals, Inc.

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.

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.

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.