Adamis Pharmaceuticals Corporation

Greetings and welcome to the Adamus Pharmaceuticals Corp fourth quarter and full year 2020 conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host, Robert Uhl, Westwick ICR. Thank you, Robert. You may begin.

Thank you, operator. Good afternoon, everyone, and welcome to Adamas Pharmaceuticals' fourth quarter 2020 earnings conference call. Thank you for joining us today for the update, and we welcome our shareholders, analysts, and all others interested in Adamas. Joining me today is Adamas' president and CEO, Dr. Dennis J. Carlo, Chief Financial Officer Rob Hopkins, Chief Medical Officer Dr. Ron Moss, and Chief Business Officer David Margulio. The format for this call will consist of prepared remarks from management followed by Q&A. This call is being webcast and will be available for replay in the investor section of our website, AdamusPharmaceuticals.com. In today's call, we will make certain forward-looking statements regarding our business based on current expectations and current information. Those statements speak only as of today. and except as required by law, we do not assume any duty to update in the future any forward-looking statement made today. Of course, any forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements that we make today. Additional information concerning factors that affect our business and financial results is included in our most recent annual report on Form 10-K with the Securities and Exchange Commission and in other subsequent filings that we make with the SEC. These are available on the SEC's website. With that, I will now hand the call over to Dr. Dennis Carlo, President and CEO.

Thank you, Robert. Well, a lot has happened since our last earnings call in November. Certainly, the complete response letter the FDA delivered to us shortly after the call relating to our Zinhai data, NDA, was a surprise to say the least. But I am pleased to say that we had a very productive meeting with the agency on April 8th, during which time we came to a consensus with the FDA on the path forward. Based on our discussion and the agency's responses, There is no need to file an appeal, so we will not be filing an appeal. The review committee encouraged us to resubmit the NDA and we intend to do so within the next 45 days. Although they would not provide a specific timeline, they are sensitive to the impact of the opioid crisis and committed to work closely with us to hasten their review. Even as recently as a few days ago, the CDC reported that overdose deaths have dramatically surged during the pandemic. Now I'd like to move on to epinephrine. As we mentioned on our last call, US World Meds completed the transition of commercial responsibility for Symgepi from Sandoz at the end of October. Since US World Meds took the reins, we have seen a significant uptick in commercial efforts. One early success was Walgreens adding Symgepi to the Prescription Savings Club in January, which now has 750,000 subscribers. On the retail side, U.S. World Med has fielded a sales force to call on high prescribing doctors, while at the same time, they are seeking additional contracting opportunities on the institutional side, which includes now the Department of Defense, the Indian Health System, and the VA system. And in addition, Kroger stores are using some Jeffy as their epinephrine of choice accompanying their COVID vaccine program. So with this, we believe when we believe or expect to see those efforts translated into increase sales during the year and yet. Just need a temple. We're very encouraged by the results, both in animal studies as well as Stanford University study on the effects of temple on immune cells from coven 19 patients. Temple was shown to suppress cytokines from covert 19 simulated cells. Based on the information and data that was generated, we filed an investigational new drug application. After receiving clearance from the FDA in late February, we are preparing to begin a Phase 2-3 blinded placebo-controlled study examining the effects of Temple in COVID-19 patients early in the infection and on preventing hospitalization in subjects with COVID-19. We expect to begin the study this quarter. Dr. Moss will provide more details on the trials in a few minutes. As I previously mentioned, in addition to potential as a treatment for COVID-19, Temple has shown in Phase II studies to have a positive impact in reducing radiation dermatitis in patients undergoing treatment for cancer. We are currently working on additional formulation development and GMP manufacturing processes to support an IND to begin a Phase II-III pivotal study for the treatment of radiation-induced dermatitis, which of course is a very large commercial opportunity. I would now like to turn it over to our CFO, Rob Hopkins, to provide some highlights from the fourth quarter financials.