Veru Inc. (NASDAQ:VERU) Q4 2022 Earnings Call Transcript December 5, 2022
Veru Inc. misses on earnings expectations. Reported EPS is $-0.51 EPS, expectations were $-0.3.
Operator: Good morning ladies and gentlemen, and welcome to Veru Inc.'s Investor Conference Call. All participants will be in listen-only mode. 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 Fisch, Veru Inc's, Executive Director of Investor Relations, and Corporate Communications. Please go ahead.
Sam Fisch: 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 to differ materially are contained in our 10-Q and 10-K 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.
Mitchell Steiner: Good morning. With me on this morning's call are Dr. Gary Barnett, CSO; Michele Greco, the CFO and CAO; Michael Purvis, EVP, General Counsel and Corporate Strategy; and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Veru 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 its commercial sexual health program, called Urev, which includes two FDA approved products: ENTADFI, a new treatment for benign prostatic 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 multi-billion dollar premium market opportunities. This morning, we will provide an update on our COVID-19 sabizabulin clinical program, the clinical development of our oncology drug pipeline, and the commercialization of our products in the Urev 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 sabizabulin, an investigational drug candidate for the treatment of hospitalized adult COVID-19 patient and high-risk for ARDS. We reported positive results from the Phase 3 COVID-19 clinical trial, which was a double-blind, multicenter, multinational randomized, 2:1, placebo controlled study evaluating daily oral 9 milligram dose of sabizabulin for up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19 patients who had high risk for ARDS and death.
Both the placebo and sabizabulin treatment groups will allow to receive standard of care treatment, which could include Dexamethasone, Remdesivir, anti-IL6 receptor antibodies and/or JAK inhibitors. The primary efficacy endpoint of our Phase 3 trial was a 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 3 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, sabizabulin treatment demonstrated a statistically significant 24.9 percentage point absolute reduction and a 55.2% 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, the sabizabulin 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 sabizabulin treatment resulting in a 51.6% relative reduction in deaths compared to placebo treatment and that P value 0.0046. Data from the key secondary efficacy endpoints demonstrated that sabizabulin treatment resulted in a significant reduction in days in the ICU, days on mechanical ventilation, days in the hospital compared to placebo. Sabizabulin also had an acceptable safety profile significantly fewer adverse and serious adverse events were reported for sabizabulin compared to placebo. There were also fewer treatment discontinuations due to adverse events in the sabizabulin group, compared to placebo.
The Phase 3 reported safety profiles suggest that sabizabulin treatment may have resulted in fewer COVID-19 related morbidities, especially respiratory failure, pneumothorax, acute kidney injury, cardiac arrest, septic shock and hypertension. We're proud that the Phase 3 clinical treatment, clinical trial interim efficacy, and full study safety results were published in the New England Journal of Medicine evidenced 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 sabizabulin in hospitalized moderate to severe COVID-19 patients. We plan to submit a manuscript of the overall 204 randomized subjects to prestigious peer-reviewed medical journals soon.
In addition, we are extremely pleased that the clinical results in the Phase 3 trial with sabizabulin and COVID-19 patients was highlighted in two medical conference presentations this fall, including the late breaker oral presentation at IDWeek. Next, I will share with you our U.S. and ex-U.S. regulatory situation and progress regarding sabizabulin 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 of EUA or an NDA. FDA also agreed that no additional safety data would be required to support an EUA, but that the collection of safety data under the EUA, which satisfied the safety requirements for an NDA.
Based on an FDA feedback from that meeting on June 6, 2022, we submitted a request for an to FDA. On November 9, 2022, the U.S. FDA's Pulmonary-Allergy Drugs Advisory Committee met with the company to review its request for EUA of sabizabulin. Although the Advisory Committee had a vote of 8-5 the known or potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known or potential risks of sabizabulin. There was additional discussion by the Advisory Committee around the possible clinical trial design aspects to a potential confirmatory Phase 3 clinical trial as a post EUA authorization requirement. FDA will consider the input of the advisory committee's part of their review, but the FDA makes a final decision on the emergency use authorization application.
We're in contact with the FDA as they continue to review our request with the EUA. As it relates to our ex-U.S. regulatory update on July 27, 2022, we announced at 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 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 to 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 that you may 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 2, 2022, we had discussions with the Health Emergency Preparedness and Response Authority also known as HERA, which is part of the European Commission. HERA is responsible for joint procurement framework contracts, which offers 36 participating countries the possibility of jointly procure medical drugs and countermeasures as an alternative was a complement to procurement at the national level. The joint procurement framework contracts have been previously signed with Gilead, Hoffmann-La Roche, GSK, and most recently on November 23 with Pfizer.
With respect to the United Kingdom, on July 25, 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 sabizabulin treatment in hospitalized COVID-19 patients at high-risk acute respiratory distress syndrome when the application is submitted. In August of 2022, Australia's Therapeutic Goods Administration to TGA granted the company an expedited provisional registration regulatory pathway for sabizabulin treatment in hospitalized COVID-19 patients in high-risk ARDS. On November 28, 2022, Veru submitted a regulatory package to the Access Consortium National Groups, which includes U.K., 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 28, we submitted a regulatory data package for sabizabulin to Health Canada. To recap, we have submitted regulatory data packages and request 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 or expedited authorizations in the near-term, including Israel, Singapore, Egypt, and South Africa. Turning now to sabizabulin's commercialization preparation update. In anticipation to the need for potential commercial sabizabulin drug product, we have scaled up manufacturing processes and have commercial drug by on-hand to address anticipated drug needs following a potential FDA authorization in the U.S., as well as potential authorizations and approvals and other ex-U.S. countries and territories.
As an update for the commercialization of sabizabulin U.S. Joel Batten, our Executive Vice President and General Manager of Veru's U.S. Infectious Disease Franchise was hired in May of 2022. Mr. Batten has assembled an experienced leadership team to commercialize sabizabulin in the U.S. This dedicated team consists of 16 employees and 52 contractors that have focused on commercial launch, market access, and medical affairs. We have also executed contracts with wholesalers with specialized hospital, distribution services for sabizabulin. We are ready for the launch of sabizabulin into hospitals across the U.S. if we are granted emergency use authorization. We also have established Veru International to commercialize sabizabulin 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, U.K., and Asia Pacific for Veru's infectious disease franchise for Veru International. Most recently, Mr. Davies held positions us the EMEA Head of Launch Excellence in pharmaceutical portfolio at Janssen, which is Johnson & Johnson Company, where he is 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.
, 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 sabizabulin COVID-19 if authorized as well as planned future indications for other viral ARDS-related diseases. We received 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 at regulatory agencies request to evaluate sabizabulin for the treatment of hospitalized, moderate-to-severe COVID-19 adult patients in high risk ARDS and death. We're also excited to expand the investigation of sabizabulin 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 3 clinical study to evaluate sabizabulin in hospitalized adult patients with influenza A, who had high risk ARDS. Influenza A virus causes up to 52,000 deaths and 710,000 hospitalizations in the U.S. alone. We also plan to conduct a Phase 3 clinical study of sabizabulin for the treatment of hospitalized adult patients with viral ARDS, kind of , which would include Respiratory Syncytial Virus, which alone causes 14,000 deaths and 177 hospitalizations each year in the U.S. As outlined above, sabizabulin has a novel anti-viral 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 3 clinical trials, the first is the ARTEST registrational clinical study in approximately 210 patients to evaluate Enobosarm monotherapy for third line treatment of AR positive ER positive HER2-negative metastatic breast cancer. Second one is the ENABLAR-2 registration clinical study in approximately 186 patients to evaluate the efficacy and safety of Enobosarm and Abemaciclib 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 palbociclib, which is a CDK4/6 inhibitor, plus an estrogen-blocking agent and who have sufficient AR expression in a breast cancer tissue.
We have a clinical trial collaboration and supply agreement with Lilly for the ENABLAR-2 Phase 3 clinical study and on the terms of the non-exclusive clinical trial collaboration supply agreement, Veru is responsible for conducting the clinical trial while Lilly is supplying a Abemaciclib for this study. Veru maintains full exclusive and global rights to Enobosarm. In the advanced prostate cancer, we are actively enrolling a Phase 3 and a Phase 2 clinical trial. We are actively enrolling an open label randomized 2:1 multi-center Phase 3 veracity clinical study evaluating sabizabulin 32 milligrams versus an alternative anti-receptor 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 androgen receptor targeted agent.
The primary endpoint is radiographic progression free survival, enrollment for the Phase 3 VERACITY clinical study is on-track and ongoing. Our second clinical study in prostate cancer is evaluating VERU-100, a GnRH antagonist three-month depot formulation in a Phase 2 dose finding clinical study for the treatment of hormone sensitive advanced prostate cancer. Although the study is ongoing, the promising pre-clinical data demonstrate that VERU-100 has the ability to both induce and maintain castration for three months. Veru has a commercial sexual health division called Urev, which includes two FDA approved products FC2 and ENTADFI. 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 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 are 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 and 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 agreement with the New York Department of Health and with new distribution partnerships with global protection, as well as . We also have ENTADFI, an FDA approved new treatment for benign prostatic hyperplasia and currently prescribed benign prosthetic hyperplasia medicines may lead to the most common side effect of sexual adverse events. ENTADFI has demonstrated its faster and more effective treatment option with benign prosthetic hyperplasia than finasteride alone and it has not caused the 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 Michele Greco, CFO, CAO, to discuss the financial highlights. Michele?
Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, once again, we have a lot of ongoing activity at Veru. Now, let's review the results for the fiscal year ended September 30, 2022. Overall, net revenues for fiscal year 2022 were $39.4 million, compared to $61.3 million in the prior year. The U.S. prescription business net revenues decreased to $30.2 million from $46.5 million in the prior year. The reduction is due to some business challenges experienced by our telemedicine customers during the year, which resulted in a slowdown in orders. Net revenue for the global public health sector business was $9.1 million, compared to $13.9 million in the prior year. The decrease in sales in the global public sector during the year is due primarily to 9.7 million units sold to Brazil, and 4.9 million more units sold to South Africa in the prior year for tenders, which have ended and therefore did not repeat in the current year.
Overall, gross profit was $30.6 million or 78% of net revenues, compared to $47.9 million or 78% of net revenues in the prior year. The reduction in gross profit is driven primarily by the reduction in sales in our U.S. FC2 prescription business. Operating expenses increased to $113.8 million, compared to the prior year of $53.4 million. The increase of $60.4 million is primarily due to research and development costs, which increased $37.9 million to $70.6 million from $32.7 million in the prior year and the increase in selling, general, and administrative expenses of $22.5 million from $20.7 million in the prior year to $43.2 million in the current year. The increase in research and development cost is due to the increased number of clinical trials.
This year, we had four Phase 3 clinical trials and two Phase 2 clinical trials ongoing. While in the prior year, we had three Phase 3 clinical trials and three Phase 2 clinical trials ongoing. The increase in selling, general, and administrative expenses is primarily due to the increase in headcount related to the preparations for the commercial launch of ENTADFI and potentially sabizabulin for COVID-19, as well as the launch of the company's own direct-to-patient telemedicine and pharmacy services portal for FC2, resulting in increased compensation, increased stock compensation, and increased sales and marketing expenses. Operating loss for the year was $83.2 million, compared to operating income in the prior year of $13 million. The change of $96.2 million is primarily due to the gain on sale of PREBOOST of $18.4 million in the prior year period.
The increase in research and development costs and selling, general and administrative expenses during the current year and the reduction in net revenues and gross profit during the year. Non-operating expenses were $316,000, compared to $8.7 million in the prior year, which primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing. For the year, we recorded a tax expense of $236,000 compared to a tax benefit of $3.1 million in the prior year. The tax benefit recorded in the prior year is primarily due to the increased value of the UK net operating losses, due to an increase in the UK tax rates from 19% to 25%. The company has net operating loss carry forwards for U.S. federal tax purposes of $112.5 million with $29.7 million expiring in years through 2042 and $82.8 million, which can be carried forward indefinitely.
And the company has U.K. net operating loss carry-forwards of $63.1 million, which did not expire. The bottom line results for the fiscal year 2022 was a net loss of $83.8 million or $1.05 per diluted common share, compared to net income in the prior year, which included the gain on sale of PREBOOST of $7.4 million or $0.09 per diluted common share. Now, turning to the balance sheet. As of September 30, 2022, our cash balance was $80.2 million and our accounts receivable balance was $3.6 million. Our net working capital was $63.3 million on September 30, 2022, compared to $136 million on September 30, 2021. As a reminder, during fiscal year 2021, we sold PREBOOST for $15 million in cash and $5 million in notes receivable and completed an underwritten public offering, resulting in net proceeds of $108 million.
During the fiscal year ended September 30, 2022, we used cash of $47.5 million for operating activities. The expected future revenues from sabizabulin for COVID-19 is authorized. The continued revenue from sales of FC2 in the U.S. prescription channel and the global public sector and future revenue from ENTADFI added to our healthy balance sheet should continue to be the primary sources of funds we use for commercial activities and to invest in our promising pharmaceutical clinical development programs as we continue to focus on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers. Now, I'd like to turn the call back to Dr. Steiner.
Mitchell Steiner: Thank you, Michele. COVID-19 cases continue to persist worldwide and hospitalizations and death rates are rising as we head into the winter season. The emergence of COVID-19 variants BQ.1 and BQ.1.1 have contributed to this new surge and these mutated strains have the ability to evade immunity, meaning that these variants can affect anyone, including vaccinated individuals. In fact, for the first time, more vaccinated people than unvaccinated people are dying from COVID-19. This waning immunity is partly because of the new variants, but also from booster vaccine fatigue. Unfortunately, Americans have died from COVID-19 to date. A series of recent articles, including one by Ariana Eunjung Cha and Dan Keating published in the Washington Post entitled COVID-19 becomes a plague of the elderly.
Reviving a debate over acceptable laws, points out nearly 9 of 10 deaths are now in people 65 or older, the highest rate since the pandemic began. With the current standard of care treatment, approximately 300 people are still dying each day. This is unacceptable. We need to do better. We must reduce the risk of death from COVID-19, including in this vulnerable population of individuals over the age of 65, an effective and safe oral therapeutic to treat hospitalized moderate to severe COVID-19 patients with high risk ARDS that prevents death is still desperately needed. We strongly believe that sabizabulin, an oral therapy with dual antiviral and anti-inflammatory properties can serve as this new treatment modality that addresses and overcomes the threat of death that hospitalized moderate-to-severe COVID-19 patients continue to face.
While multiple regulatory agencies across the sabizabulin as a potential option for emergency used settings, we are eagerly and proactively preparing multiple work streams in the background. For instance, manufacturing drug supply and scale up activities are in place. Our U.S. and international commercial infrastructure is ready to provide access to sabizabulin to hospitalized patients at high risk ARDS and death . We continue to live in the world facing a public health emergency as we enter the fourth year of the COVID-19 pandemic. In summary, we continue to advance our core late clinical stage breast cancer and prostate cancer programs with three actively enrolling Phase 3 clinical studies. Our legacy sexual health business comprised of two FDA approved products continues to generate revenue, and if authorized, we expect to have substantial near term revenue from sabizabulin 9 milligrams for hospitalized COVID-19 patients and high risk ARDS.
With that, I'll now open the call to questions. Operator?
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