Adamis Pharmaceuticals Announces Third Quarter 2020 Financial Results and Business Update
Adamis Pharmaceuticals (NASDAQ: ADMP) reported third-quarter results for 2020, with revenues of approximately $4.3 million, a 27% decline year-over-year due to the COVID-19 pandemic. Selling expenses rose to $5.8 million, while research & development expenses decreased to $1.7 million. Cash at quarter-end was $12.4 million, boosted by a recent equity offering. Key milestones include the FDA's decision on ZIMHI by November 15, 2020 and USWM aiming for more growth with SYMJEPI following a transition from Sandoz.
- FDA PDUFA date for ZIMHI is November 15, 2020, signaling potential upcoming approval.
- Cash reserves increased to approximately $12.4 million, supported by a recent equity offering.
- Transition of SYMJEPI to US WorldMeds expected to drive sales growth.
- Revenue decreased by approximately 27% year-over-year due to COVID-19 impacts.
- Selling, general, and administrative expenses increased to $5.8 million.
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
Third Quarter Financial Results
Revenues were approximately
Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 were approximately
Research and development expenses were approximately
Cash and equivalents at the end of the third quarter was approximately
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
FAQ
What were Adamis Pharmaceuticals' Q3 2020 revenues?
What is the significance of the FDA decision on ZIMHI for Adamis?
How did the COVID-19 pandemic affect Adamis Pharmaceuticals' financial results?