Veru Inc. (NASDAQ:VERU) Q4 2022 Earnings Call Transcript

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.

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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?

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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 €œnearly 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?

Q&A Session

Operator: Thank you. Our first question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.

Brandon Folkes: Hi. Thanks for taking my questions and congratulations on all the progress. So, I guess no surprise where I’m going to start, but just, you know, I’ll ask my, I guess, two questions upfront, because they kind of roll into each other. So, maybe just firstly, can you talk about how much interaction you’ve had with the FDA post the ad comment anyway to put into context the nature of those interactions? And then secondly, given the proposal to run a potential confirmatory Phase 3 trial, I’m not saying that’s going to happen, but just how quickly could you get such a trial up and running provided within the range of maybe, you know, what you’re expecting a trial to look like? Maybe what was proposed? And on that nature, I guess, any risk or how should we think about, sort of the one topic of maybe getting U.S. patients, and U.S. standard of care, is there a rush to get it done this winter? Thank you very much.

Mitchell Steiner: Okay. So, first question has to do with getting a sense of how much interaction we’re having with the FDA post AdCom? And as I said in my prepared comments that we’re in contact with the FDA, we are in contact with the FDA on an ongoing basis. And so, this is not radio silence by any means. So, what I can tell you is that we have been actively in communication with the FDA. So, that’s an important point because as you know with PDUFA dates, if you don’t hear from the FDA, you worry. But we don’t have a PDUFA date, but we’re hearing from the FDA. So, that’s number one. So, what I can tell you, as I said in my prepared remarks, they are continuing to review the EUA post AdCom. As it relates to the question, I believe the question around the Phase 3 clinical trials, I guess your assumption is, if we have to do the Phase 3 not onto an EUA, , you mean just doing it or with an EUA, it doesn’t matter.

Brandon Folkes: It doesn’t matter. I’m just trying to think about, if they do ask for additional U.S. exposures, I think, you know, which some of those committee members raised, you know, how quickly can you get that up and running, and, you know, does it need to be this winter versus maybe going to the southern hemisphere or having to wait for next year?

Mitchell Steiner: Yes. Well, first of all, if you look at the pattern, we had our surge during the summer just like Australia. It doesn’t seem so far that COVID is really necessarily following the surge concept of the viruses where they tend to happen based on coming together during the winter months. It appears that you’re still going to have it even the summer months when people are going in for air conditioning, I guess, with crowds. But with that said, the strategy this time is to have more clinical sites than just U.S., South America, and Bulgaria. I wouldn’t say there’s a rush except the fact that the people dying and standard of care. One of the things that works in our favor is that literally thousands of companies have done clinical trials trying to find a drug for COVID-19 and have failed.

And now we’re down to a handful of drugs that have emergency use authorization, a full authorization that have a modest at best mortality benefit. Remdesivir has no mortality benefit. And as the only antiviral in this setting and the anti-inflammatory agents at best with baricitinib, you’re getting at about 5.7% absolute benefit in mortality. And so, there is an unmet need as the FDA said during the AdCom for a new agent. So, I think because we have the data that we have, Phase 3 study, published study, full study to be published, that we have a real opportunity with less noise and competition for patients, more clinical sites and with good scientific data showing the mortality benefit that this trial should enroll much more quickly and our goal is to enroll it as quickly as we can.

But the truth in the matter is it still takes about three to six months to get most of your clinical sites up and running and the endpoint will be 60 days. So, we still have to have two months of follow-up after a patient is on the study. And we’re even contemplating, adding in as a follow-up, not as a primary endpoint. Long COVID, as you know, long COVID is becoming the next major issue that people are dealing with COVID. So, we’re going to have a lot of fun with this additional trial in order to answer some of the questions we could not have answered during the ongoing pandemic because we just didn’t know those were questions to ask. So, I think you can look for us to be pretty aggressive in getting that study done. As we to the question of €“ well, your second question has to with standard care and rush to get it done.

I kind of answered that. So, standard of care now, the best we’re doing is still dealing with 300, 350 deaths a day on average and now the hospitalizations are going back up, and the lag behind hospitalizations with deaths again, and I think we’re also dealing with immunity waning, people are just not getting the booster no matter how much people are asking for boosters. And then we’re seeing quite frankly that these antibody drugs, particularly the ones on Lilly that was the only hope that immunocompromised patients had is gone. And so, they’re at risk. So, I think what we’re seeing is this evolving situation is pointing to standard of care is just not adequate. And the rush, the rush is that you’ve got a loved one that’s dying and what do you want to do about that.

And so, I think that as physicians to have this additional tool will be very important.

Brandon Folkes : Thanks, Mitch. I appreciate all the color. Definitely makes sense. Congrats on the progress.

Mitchell Steiner: Thank you.

Operator: Our next question comes from Leland Gershell from Oppenheimer. Please go ahead.

Leland Gershell: Mitch, thank you for the update and for taking our questions. Just to get into specifics to the extent you’re able to with respect to the ongoing FDA discussions, can you say that you are continuing to discuss the design of what may be a confirmatory trial that would be performed under the EUA? Is that a part of the ongoing discussion content?

Mitchell Steiner: What I can tell you, which is public, is the FDA stated in their background package that the design that they laid out was agreed upon by the sponsor. So, it’s there. And so, that’s not the top discussion point because that’s been agreed upon. I think I can’t say much more than that except right now in the black box of the FDA, they’re checking their boxes that they need to check.

Leland Gershell: Can you comment if there are any particular boxes that are left to check that you’re working to check?

Mitchell Steiner: I can’t say much more.

Leland Gershell: Okay. And then with respect to the other countries, has there been any change in in their interest since the advisory committee and whether there has or not or whether you can comment or not, are you aware of any dependence on what the EUA decision outcome will have in terms of what those ex-U.S. decisions maybe versus independent, it could be independent emergency authorizations and other places irrespective or prior to an FDA decision?

Mitchell Steiner: Yes. So, let me see if I can give you some color on that. So, the question is basically, have you noticed any changes in the interactions that we’re having with other governments that are reviewing our application based on the advisory committee? And the answer is no. In fact, what we see is intense discussions with other regulatory agencies outside the U.S. To put this in perspective and using Remdesivir as an analog, especially the last six months that was reported by Gilead, almost 52% to 53% of their revenue, they reported I think revenue of $1.9 billion for the first half of the year. It was coming from outside the U.S. and a big bulk of that was coming from Europe. The point I’m trying to make is that when you’re looking at the COVID-19 drug, the split of 65% in the U.S. and 35% outside the U.S. doesn’t make sense.

It’s very different. And when you look at that, the major markets then turn out to be Europe, and all the countries that follow Europe. So, if Europe gives you an emergency use authorization similar, than 80% of the countries outside of Europe will use that authorization as part of their review or in lieu with their review, okay, because €“ and it makes sense. So, if you get U.S., you get Europe, you get both. And those are the major markets you’re good to go and have significant revenue, but I will tell you that there has not been at all any change in the interactions that we’ve had with, as I mentioned in the prepared comments, with multiple agencies, and the multiple agencies remain engaged and active in their review. And so, no, the answer is no.

The answer is, it appears to be quite independent. And as I mentioned, the FDA is still reviewing the application. So, I’m not quite sure what to make out of the AdCom.

Leland Gershell: Okay. And then just one question on the other development programs. Just with our test and veracity, I believe you’d indicated around the time that those trials were getting going that we could see enrollment starting to complete, kind of in this timeframe. Just wanted to ask about enrollment progress with those. And if you do see either of both trials perhaps completing enrollment by year-end or what that timeframe is looking like?

Mitchell Steiner: Yes. So, the timeframe still looks like data in €“ end of next year kind of timeframe and they’re event driven. And so, enrollment is still consistent with that, but that’s all I can say at this point.

Leland Gershell: Okay, great. Thanks for taking the questions.

Mitchell Steiner: Thank you.

Operator: Our next question comes from Chris Howerton from Jefferies. Please go ahead.

Chris Howerton: Hey, good morning. Thanks for taking the questions. I guess, two from me. One would be, with respect to the FC2 and ENTADFI part of your business, what measures are you going to take in your own internal hub to, kind of combat some of the challenges that your partner had for the telemedicine and I guess to give you confidence that that will be a sustainable business? And then I guess I’m just curious if you can give us some more color around liquidity and your cash runway in a scenario where sabizabulin has launched? What would be your cash needs to launch such a drug? And in a scenario where maybe there’s a longer delay, how do you see your current cash reserves being deployed against your plan? Thank you.

Mitchell Steiner: Okay. Thank you for your questions. So, the first one on FC2 and that part of the business, I’m going to answer and I’m going to have Michele answer the question on liquidity. As it relates to FC2, so, we’ve had two down quarters, and the telemedicine market, we have two customers that in the telemedicine space that make up a significant portion of that revenue. And they had a down year, we get to have a down year. If you look across telemedicine, you already know you can see that they’re still going through some pains right now. With that said, I’m happy to report the way we’re handling that to maximize our revenue is threefold. One is to make sure we do everything in our power to have our partners. And I will tell you that indications at this point is that whatever that hiccup was this last two quarters is turning around.

So, they’re figuring it out as well. And so our expectation is to see an increase in revenue, increase in orders, and wherever that new normal is, they’re back. So, they’ve gone from struggling to headwinds to looks like they, sort of figured it out. And again, time will tell, but it feels good that at least our main customers will get back, which means we will start to see significant revenue come back, but what we didn’t sit on our hands, we went ahead and realized that what would be better than depending on customers to buy product from us would be to have a telemedicine hub of our own. And that really has played out very, very nicely because it puts us in control of our destiny. And so, what we’ve done €“ what that means is, you have to put all the components together, you have to have the doctors, you have to have the website, we have the product, and you have to have the ability to fill prescription and you have to have the ability to deal with insurance and all that’s in place.

And what we’re finding is there is a direct correlation between marketing spend and people buying the product and wanting the prescriptions. So, I’m happy to report that that looks incredibly viable and will really supplement the revenue going forward. And it took us about a year to put it together, but it’s been pressure tested and now we’re going to expand that. So, we’re again seeing an opportunity for revenue from that standpoint. ENTADFI is early days because most of it has been trying to get insurance, Medicare and wholesaler contracts in place because of the FDA wanting certain release criteria that we didn’t agree upon until later in the year. We really didn’t have, but fiscal year €“ fourth quarter fiscal year 2022 is an opportunity to launch.

And so, a little behind there, but we’ll try to do our best to make up. So, the Urev is $39 million in revenue this past year that’s real money that our investors don’t have to come up with that we can use to help invest and move our pipeline. With that, I’ll turn it over to Michele to talk about liquidity in the event that we launched sabizabulin.

Michele Greco: Sure. So, in the event we launched sabizabulin, you know I’d like to point out that our drug spend was around $70 million this year. And slightly over half of that was related to COVID. Our COVID-trial included in that was over 60% of those costs. We’re related to building up the material to get our drug ready, so that when we’re ready to launch, we have the drug ready. You can see as I noted, we built the team and so we had those expenses that ran through this past year in our fourth quarter. We built the team in the U.S. We put all the vendor contracts in place. We have the people up and going. We have our strategy ready to deliver. So, from a liquidity standpoint, we’ve already invested in this drug and we’re ready to go.

We’re not going to be needing to get additional liquidity other than what we generate from our business. As Mitch indicated, there’s a lot of things that we’re doing on the Urev side to get things up and going there and working on increasing some of those revenues. In the event that we don’t launch the COVID drug, as the company €“ as we’ve demonstrated over the years, we’re very good at managing our cash and managing and prioritizing all of our drugs under development. Those are the levers that we have to work on is, you know how quickly we push different drugs through the trial and how much we can slow them down. So, for us from a liquidity standpoint, we’re looking good between our balance sheet and what we can get from Urev and how we can manage our business.

Liquidity isn’t a concern for us, whether we launch the drug or if the drug isn’t launched this year.

Mitchell Steiner: Thank you.

Chris Howerton : That’s wonderful. Thanks so much.

Mitchell Steiner: Thank you.

Operator: Our next question comes from Yi Chen from H.C. Wainwright. Please go ahead.

Yi Chen: Thank you for taking my questions. When do you expect the FDA to issue its final decision on the EUA application? And do you think it could occur before the end of 2022?

Mitchell Steiner: I will tell you that €“ and you can appreciate this, because I’ve given up on guessing when the FDA is going to make a decision. Okay? I just €“ FDA does what the FDA does, and I just scratch my head because we’re dealing with an agent that has an incredible mortality benefit. And so, I can’t answer that question at all or give you any sense at all because, you know, my guidance initially was that we expect this sooner. And so, it’s not €“ there’s a great need out there and even the FDA said so. So this €“ I just can’t give any more color than that. And we just have to look at FDA work through their process. And this is true also for the other regulatory agencies. And €“ but what I can tell you is that they’re all €“ and they’re all sincerely doing their work.

Yi Chen: Okay. So, for the fiscal fourth quarter, there appears to be a sharp decline in terms of revenue from FC2. So, could you comment on the current trend of the U.S. prescription for FC2? And how much revenue contribution you expect to get from the launch of ENTADFI going forward? And also, could you also comment on whether the operating expenses will be on the level €“ on the same level as observed in the fiscal fourth quarter going forward? Thank you.

Mitchell Steiner: Yes. So, if you don’t mind, may I ask Michele to answer those three questions. The first question being the FC2 decline, and second being related to the contribution, and third related to operating expenses. Relative contributions ENTADFI, and the third one is operating expenses. My color to the first question is, we’re already seeing the turnaround. So, we believe that the fourth quarter is going to €“ is hopefully going to represent the bottom. And now, with all these other levers have been increasing revenue in place plus seeing actual life coming back to telemedicine, it feels like we’re going to see more revenue, but I’ll let Michele answer. Michele?

Michele Greco: Sure. As Dr. Steiner indicated, yes, we’re working with our customers. We’ve added some customers this year and we’re projecting that we’re going to be seeing a turnaround here. The turnaround is an instant, but the turnaround is coming for the FC2 business, both in the U.S. in the prescription channel. In the global public sector in the U.S., we did add a new distributor this year that’s really helping drive those increased sales. And then in the global public sector, in the global public sector, it’s a matter of timing related to these tenders, don’t always flow a strict cadence agencies and when that happens. But right now, the South Africa tender is €“ we’re starting to see sales that are coming back under their newest tender.

ENTADFI, is going to slowly . Again, a lot of that is getting some of the back office infrastructure in place and then it’s to allocate some money and marketing dollars to spend, to push that launch. And right now, as I indicated in discussing liquidity, we’re managing our cash spend. And we’re looking at the trade-offs and what we’re doing with our cash spend. And so, that’s going to be a trade-off, we’re going to look at as to how much we’re going to put behind marketing spend for ENTADFI versus what we’re going to be doing with that cash to spend for a launch for COVID. As far as the level of operating expenses, as Mitch indicated, we Joel Batten and he brought on his team, all primarily in our fourth quarter of 2022. So, the increase in our SG&A expense in the fourth quarter is driven by building out that team.

We’ve started now to build out an international team, but that’s just starting. And so, our operating expenses, if we go ahead with the launch are going to be closer to those expenses that you look at in the fourth quarter of this past fiscal year, and to continue there and then to build as we build out a commercial team ex-U.S.

Yi Chen: Okay. Thank you.

Operator: Ladies and gentlemen, this concludes our question-and-answer session. I’d like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks.

Mitchell Steiner: I appreciate everyone who joined us on today’s call, and I look forward to updating you all on our progress at our next Investor Call. Thank you.

Operator: The digital replay of the conference call will be available beginning approximately noon Eastern Time today, December 5, by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 4646397. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today’s discussion.