Veru Inc.

Good morning, ladies and gentlemen, and welcome to Veru Incorporated's Investor Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fish, Veru Incorporated's Executive Director of Investor Relations and Corporate Communications.

Please go ahead. Good morning. The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, regulatory interactions, finances, and development and product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or developments that differ materially are contained in our 10Q and 10K SEC filings, as well as in our press releases from time to time. I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc.' 's Chairman, CEO, and President.

Good morning. With me in this morning's call are Dr. Gary Barnett, the CSO, Michelle Greco, the CFO and CAO, Michael Purvis, the EVP of General Counsel and Corporate Strategy, and Sam Fish, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Vera is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for oncology. The company has a commercial sexual health program called UREV. which includes two FDA-approved products, Entafi, a new treatment for benign prosthetic hyperplasia, and FC2 female condom internal condom for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. The revenue from the sexual health program is being used partially to fund the clinical development of our late-stage therapeutic candidates, which aim to address multibillion-dollar premium market opportunities. This morning, we will provide an update on our COVID-19 subisobulin clinical program, the clinical development of our oncology drug pipeline, and the commercialization of our products in the UREP program. We will also provide financial highlights for our fiscal fourth quarter and our fiscal year 2022 year-end. First, I will update you on the status of subisobulin in investigational drug candidate for the treatment of hospitalized adult COVID-19 patients at high risk for ARDS. We reported positive results from the Phase 3 COVID-19 clinical trial, which was a double-blind, multi-center, multinational, randomized 2-to-1 placebo-controlled study evaluating daily oral 9-milligram doses of Sibisbulin for up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19 patients who were at high risk for ARDS and death. both the placebo and subisobulin treatment groups were allowed to receive standard of care treatment, which could include dexamethasone, remdesivir, anti-IL-6 receptor antibodies, and or JAK inhibitors. The primary efficacy endpoint of our Phase III trial was the proportion of patients who die on study up to day 60. Key secondary endpoints measured included a proportion of patients alive without respiratory failure, days in the ICU, days on mechanical ventilation, days in the hospital, and viral load. On April 8, 2022, the Independent Data Monitoring Committee conducted a planned interim efficacy analysis in the first 150 patients randomized in the Phase 3 COVID-19 study. After reviewing the unblinded clinical data, the Independent Data Safety Monitoring Committee unanimously recommended that the Phase III study be halted early due to clear clinical efficacy benefit. The Independent Data Monitoring Committee also remarked that no safety concerns were identified. In this interim analysis, subisobulin treatment demonstrated a statistically significant 24.9 percentage point absolute reduction and a 55.2 percent relative reduction in all-cause mortality by day 60. That was the primary efficacy endpoint of the study. and that p-value was 0.0042. The efficacy was further supported by the consistency of the mortality benefit across subgroup analyses of the primary endpoint. Clinically meaningful reductions in deaths with subisobulin treatment compared to placebo was observed regardless of the standard of care treatment received, baseline WHO ordinal score, sex, age, baseline comorbidities, BMI, or geographic location. In the full final data set of 204 randomized patients, the all-cause mortality benefit was similar to the positive clinical results observed in the interim efficacy analysis population, with subisobulin treatment resulting in a 51.6% relative reduction in deaths compared to placebo treatment, and that p-value is 0.0046. Data from the key secondary efficacy endpoints demonstrated that subisobulin treatment resulted in a significant reduction in days in the ICU, days on mechanical ventilation, days in the hospital compared to placebo. Subisobulin also had an acceptable safety profile. Significantly fewer adverse and serious adverse events were reported for subisobulin compared to placebo. There were also fewer treatment discontinuations due to adverse events in the subisobulin group compared to placebo. The Phase III reported safety profiles suggest that subisobulin treatment may have resulted in fewer COVID-19-related morbidities, especially respiratory failure, pneumothorax, acute kidney injury, cardiac arrest, septic shock, and hypotension. We're proud that the Phase III clinical trial interim efficacy and full study safety results were published in the New England Journal of Medicine evidence in July. which recognizes both the importance of a trial focused on COVID-19 treatment during the ongoing pandemic and the potential clinical benefit of sibizabulin in hospitalized, moderately severe COVID-19 patients. We plan to submit a manuscript of the overall 204 randomized subjects to a prestigious peer-reviewed medical journal soon. In addition, we are extremely pleased that the clinical results in the Phase III trial of sibizabulin in COVID-19 patients was highlighted in two medical conference presentations this fall. including a late-breaker oral presentation and ID week. Next, I will share with you our U.S. and ex-U.S. regulatory situation and progress regarding subvisibility and COVID-19. On May 10, 2022, we had a pre-emergency use authorization meeting with FDA. In this meeting, the FDA agreed that no additional efficacy studies would be required to support an emergency use authorization, or EUA, or an NDA. FDA also agreed that no additional safety data would be required to support an EUA, but that a collection of safety data under the EUA would satisfy the safety requirements for an NDA. Based on that FDA feedback from that meeting, on June 6, 2022, we submitted a request for an EU application to FDA. On November 9, 2022, the US FDA's Pulmonary Allergy Drugs Advisory Committee met with the company to review its request for EUA of subisobulin. Although the advisory committee had a vote of eight to five that the known or potential benefits of subisobulin when used for the treatment of adult patients hospitalized with COVID-19 high risk of ARDS do not outweigh the known or potential risks of subisobulin, there was additional discussion by the advisory committee around the possible clinical trial design aspects for a potential confirmatory phase three clinical trial as a post-EUA authorization requirement. FDA will consider the input of the advisory committee as part of the review, but the FDA makes the final decision on the emergency use authorization application. We're in contact with the FDA as they continue to review our request for the EUA. As it relates to our ex-U.S. regulatory updates, on July 27, 2022, we announced that the European Medicine Agency, which is also known as EMA's Emergency Task Force, had informed the company that it has initiated a review of sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The review will assess the 31 EU member states who may consider allowing the use of the medicine before a formal marketing authorization is granted. This review of sabizabulin is the first to be triggered under Article 18 of the new EU regulation that expanded the role of the EMA during public health emergencies in 2022. We have been in active communication with the Emergency Task Force as they complete their review of sabizabulin. Once the Emergency Task Force completes their review, they will submit their formal recommendation to the EMA's Committee for Medicinal Products for Human Use, also known as CHMP. The CHMP then reviews the recommendation and renders an opinion whether sabizabulin qualifies for emergency use in Europe. On December 2nd, 2022, we had discussions with the Health Emergency Preparedness and Response Authority, also known as HERA, H-E-R-A, which is part of the European Commission. HERA is responsible for joint procurement framework contracts, which offers 36 participating countries the possibility to jointly procure medical drugs and countermeasures as an alternative or to complement to procurement at the national level. The Joint Procurement Framework contracts have been previously signed with Gilead, Hoffman LaRoche, GSK, and most recently on November 23rd with Pfizer. With respect to the United Kingdom, on July 25th, 2022, we announced that the UK's Medicine and Healthcare Products Regulatory Agency, again, also known as MHRA, considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the company's subvisivulin treatment in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome when the application is submitted. In August of 2022, Australia's Therapeutic Goods Administration, TGA, granted the company an expedited provisional registration regulatory pathway for subvisivulin treatment in hospitalized COVID-19 patients at high risk for ARDS. On November 28, 2022, Bureau submitted a regulatory package to the ACCESS Consortium national groups, which includes UK, Australia, and Switzerland. And the ACCESS Consortium is a coalition of these regulatory authorities with therapeutic products that work together to promote greater regulatory collaboration and alignment of regulatory requirements. Also, on November 28th, we submitted a regulatory data package for Subisibulin to Health Canada. We have submitted regulatory data packages and requests for emergency use authorizations on an international level to the European Union, the U.K., Australia, Switzerland, and Canada, as well as South Korea. We are also in various stages of discussions with regulatory agencies in other countries to obtain regulatory emergency expedited authorizations in the near term, including Israel, Singapore, Egypt, and South Africa. Turning now to subisobulin's commercialization preparation update, in anticipation of the need for potential commercial subisobulin drug product, we have scaled up manufacturing processes and have commercial drug supply on hand to address anticipated drug needs following a potential FDA authorization in the U.S., as well as potential authorizations and approvals in other ex-U.S. countries and territories. As an update for the commercialization of Subicibulin in the U.S., Joel Batten, our Executive Vice President and General Manager of Vero's U.S. Infectious Disease Franchise, was hired in May of 2022. Mr. Batten has assembled an experienced leadership team to commercialize Subicibulin in the U.S. This dedicated team consists of 16 employees and 52 contractors that are focused on commercial launch, market access, and medical affairs. We have also executed contracts with wholesalers for specialized hospital facilities. distribution services for Subisibulin. We are ready for the launch of Subisibulin to hospitals across the U.S. if we are granted emergency use authorization. We also have established Vero International to commercialize Subisibulin to the rest of the world. Jason Davies joined us in August of 2022 as the Executive Vice President, General Manager of Europe, the Middle East and Africa, Latin America, Canada, UK, and the Asian Pacific for Vero's infectious disease franchise for Vera International. Most recently, Mr. Davies held positions as the EMEA Head of Launch Excellence and Pharmaceutical Portfolio at Janssen, which is a Johnson & Johnson company, where he's responsible for creating and leading a new organization to enhance launch strategy and execution across all of Janssen's EMEA's pharmaceutical portfolio. Over the course of his career, Mr. Davies spent approximately 20 years in several commercial positions of increasing responsibility spread across the Janssen business units, including pharmaceutical business unit P&L responsibility, sales, marketing, market access, integration and strategy, with a focus on pharmaceuticals for virology and infectious disease. Viru, Mr. Davis, is responsible for developing and leading all aspects of international launch strategy. including government purchase agreements, as well as the go-to-market commercial partner and distribution strategy for severe disease and COVID-19, if authorized, as well as planned future indications for other viral ARDS-related diseases. If we receive an emergency use authorization from the U.S., EU, or in another large market, we plan to initiate in a post-emergency use authorization setting any potential additional clinical studies that regulatory agencies request to evaluate subisobulin for the treatment of hospitalized, moderate to severe COVID-19 adult patients at high risk for ARDS and death. We're also excited to expand the investigation of subisobulin into other infectious disease indications based on the candidate's novel mechanism of action. As we have preclinical data in vivo scientific data, that demonstrates that sabizabulin has activity against H1N1 variant of influenza A, also known as swine flu. We plan to conduct a Phase III clinical study to evaluate sabizabulin in hospitalized adult patients with influenza A who had high risk for ARDS. Influenza A virus causes up to 52,000 deaths and 710,000 hospitalizations each year in the U.S. alone. We also plan to conduct a Phase III clinical study of sabizabulin for the treatment of hospitalized adult patients with viral ARDS, kind of an all-comers, which would include respiratory syncytial virus, which alone causes 14,000 deaths and 177 hospitalizations each year in the U.S. As outlined above, zabizabulin, as a novel antiviral and anti-inflammatory agent, is positioned to potentially become a valuable treatment option for multiple infectious diseases that can lead to ARDS, a life-threatening lung condition that has a high mortality rate. I will now briefly discuss the progress of our oncology drug portfolio focused on advanced breast and prostate cancers. In advanced breast cancer, we're actively enrolling two Phase III clinical trials. The first is the R-Test Registrational Clinical Study in approximately 210 patients to evaluate anobisarm monotherapy for third-line treatment of AR-positive, ER-positive cancer. HER2-negative metastatic breast cancer. The second one is the ENABLER2 registration clinical study in approximately 186 patients to evaluate the efficacy and safety of a novus arm and a bemacyclic combination therapy versus an alternative estrogen blocking agent in subjects with AR-positive, ER-positive, HER2-negative metastatic breast cancer who have failed first-line therapy with papocyclic, which is a CDK4-6 inhibitor, plus an estrogen blocking agent and who have sufficient AR expression in their breast cancer tissue. We have a clinical trial collaboration and supply agreement with Lilly for the ENABLER II Phase III clinical study. And under terms of the non-exclusive clinical trial collaboration supply agreement, Viru is responsible for conducting the clinical trial, while Lilly is supplying abemacyclib for this study. Viru maintains full exclusive and global rights to Novosarm. In the advanced prostate cancer, we're actively enrolling a Phase III and a Phase II clinical trial. We're actively enrolling an open-label, randomized 2-to-1 multi-center Phase III veracity clinical study, evaluating subisobulin 32 milligrams versus an alternative antireceptor-targeted agent for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer who've had tumor progression after previously receiving at least one antireceptor-targeted agent. The primary endpoint is radiographic progression-free survival, enrollment for the Phase III of veracity clinical studies on track and ongoing. Our second clinical study in prostate cancer is evaluating VIR-100, a GnRH antagonist three-month depot formulation in the Phase II dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. Although the study is ongoing, the promising preclinical data demonstrate that that Vero 100 has the ability to both induce and maintain castration for three months. Vero has a commercial sexual health division called UREV, which includes two FDA products, FC2 and Entatvi. We have built the infrastructure to allow for broad market access to FC2 across the U.S. As a result, FC2 is now available through multiple sales channels. We have partnered with fast-growing and highly reputable telemedicine platform companies, to bring our FC2 product to patients in the most cost-effective and highly convenient manner. While the telemedicine sector has underperformed across the board this past year, we're anticipating improvement in revenues after a couple of down quarters. Our strategy to drive FC2 sales is as follows. One, we will seek additional telemedicine and internet pharmacy service partnerships. Two, we have created and launched our own dedicated direct-to-patient telemedicine an internet pharmacy services platform. We're pleased with its growing source of revenue to date and are committed to expanding its customer base and reach, and the website can be reached at fc2condoms.com. We also expect to see continued increase in our U.S. public sector sales through our new agreements with the New York Department of Health and with new distribution partnerships with Global Protection as well as at Faxes. We also have Intatfeet, An FDA-approved new treatment for benign prostatic hyperplasia and currently prescribed benign prostatic hyperplasia medicines may lead to the most common side effect of sexual adverse events. And TAFI has demonstrated its faster and more effective treatment option for benign prostatic hyperplasia than finasteride alone, and it has not caused a side effect of impotence. We launched this product during the fourth fiscal quarter with a focus on payer agreements, as well as executing distribution, wholesaler, and Medicare contracts. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?