Adamis Pharmaceuticals Announces Third Quarter 2020 Financial Results and Business Update

SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced financial results for the third quarter ended September 30, 2020 and provided a business update.

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, “We are excited to have US WorldMeds in full control of our SYMJEPI product now that the transition from Sandoz has been completed. We expect to see the full impact of this transition going forward and I expect 2021 to be the breakout year for this product. We and our commercial partner eagerly await the FDA’s decision on our ZIMHI NDA which has a target PDUFA date of November 15th. We remain very excited about the remainder of this year and beyond.”

Product Updates

SYMJEPI (epinephrine) Injection

On July 1, 2020, Adamis’ new commercial partner, USWM began promoting SYMJEPI® (epinephrine) Injection 0.3mg and SYMJEPI® (epinephrine) Injection 0.15mg products through its field sales force in the U.S. USWM expects to focus its sales efforts on the high-prescribing allergists, pediatricians, and primary care physicians. The transition of sales and distribution from Sandoz to USWM was completed on October 31, 2020 and now USWM is fully responsible for sales and distribution of SYMJEPI.

The company’s Australian partner, Emerge Health, which was acquired by Chiesi Farmaceutica in June, continues to work through the regulatory process with the Therapeutic Goods Administration (TGA) in Australia and the company expects a decision from the TGA sometime in the first half of 2021.

ZIMHI (naloxone) Injection

The FDA has provided a target action date (PDUFA) of November 15, 2020 with respect to the company’s resubmitted New Drug Application (NDA) relating to ZIMHI. The company continues to work with its commercial partner, as USWM prepares for the commercial launch of ZIMHI.

Tempol

Since licensing this product, the company has made some progress on the development of Tempol. Unfortunately, few therapies have been successful so far for the treatment of COVID-19. In preliminary results from a study in collaboration with Stanford University, Tempol inhibits the release of multiple cytokines from activated immune cells of COVID-19 patients. This new data now provides the additional scientific rationale needed to conduct clinical studies in early COVID-19 patients with Tempol. We are currently identifying sites that could conduct this trial. With the additional data from this study, the company continues to explore its options for government and other forms of funding to potentially support additional testing of Tempol.

Discussions with various groups continue to evolve on the funding and design of a large clinical study to examine the effects of Tempol for the treatment of radiation induced dermatitis. One of these groups, which was previously under the direction Dr. Stephen Hahn (current FDA commissioner), conducted successful clinical studies of Tempol for the treatment of radiation induced alopecia.

Drug Outsourcing Facility

Year to date, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the COVID-19 outbreak. Revenues decreased by approximately 21% for the nine months ended September 30, 2020, compared to the same period in the prior year.

Third Quarter Financial Results

Revenues were approximately $4.3 million and $5.9 million for the three months ended September 30, 2020 and 2019, respectively. This decrease in revenues of approximately 27% year over year was primarily due to the COVID-19 pandemic which has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians' offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC’s customers for certain of USC’s products.

Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 were approximately $5.8 million and $5.3 million, respectively.

Research and development expenses were approximately $1.7 million and $3.3 million for the three months ended September 30, 2020 and 2019, respectively. The decrease was primarily due to completing work on ZIMHI and a decrease in development costs of our other product candidates.

Cash and equivalents at the end of the third quarter was approximately $12.4 million. This amount includes proceeds from an equity offering completed in September which provided net proceeds of approximately $10.7 million.

Targeted Milestones

• FDA approval and U.S. commercial launch of ZIMHI;
• Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
• Ex-US partnerships for SYMJEPI and ZIMHI.
  

Conference Call

Adamis will host a conference call and live webcast on Monday, November 9, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-855-327-6838

TOLL/International Dial-in: 1-604-235-2082

Conference ID: 10011804

Webcast: http://public.viavid.com/index.php?id=142367

In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on November 9, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 10011804.

About Adamis Pharmaceuticals

Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The company’s SYMJEPI (epin