On November 12, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2019 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 12, 2019, View Source [SID1234550985]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Since the full launch in July, Sandoz has implemented several initiatives that we expect will increase sales of SYMJEPITM. We believe the Sandoz team is now targeting allergists and primary care physicians with their retail launch. A new website was launched in the third quarter that provides patients and physicians with product information, instructions for use and provides links to order demonstrator devices and to have SYMJEPI shipped to patients’ homes through PillPack, an Amazon company."

"While we are eager for sales of SYMJEPI to grow, we are also looking forward to a final decision by the FDA on ZIMHITM, our naloxone injection product candidate. If approved, we believe our company will be very well positioned for growth in 2020 as we plan to play an important role in combating the ongoing public health crisis of opioid overdose."

Product Updates

SYMJEPI (epinephrine) Injection

During the third quarter, Adamis’ commercial partner, Sandoz, announced the full launch of our SYMJEPI epinephrine injection product, making both the 0.3mg and 0.15mg doses available in local pharmacies across the U.S. Sandoz increased and continues to expand its commercial initiatives and we expect those efforts to begin translating into a steeper sales growth during the fourth quarter.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and on October 1, 2019, the company announced it had entered into an exclusive distribution and commercialization agreement with Emerge Health to seek registration and commercialize SYMJEPI in Australia and New Zealand.

ZIMHI (naloxone) Injection

Since Adamis’ November 4, 2019 update, the U.S. Food and Drug Administration ("FDA") continues to review the company’s New Drug Application (NDA) for its ZIMHI high-dose naloxone product candidate, and as of the date of this press release the company has not received any notice of action from the FDA. The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose. The company believes that discussions with potential partners for ZIMHI have sufficiently progressed and that while no assurances are possible, the company expects to be able to announce a commercial partner soon after receiving clearance from the FDA.

Drug Outsourcing Facility

During the third quarter of 2019, the company’s wholly owned drug outsourcing facility, US Compounding (USC), continued to grow its revenues by approximately 19% in the third quarter compared to the same quarter last year and approximately 25% year-to-date versus the same nine months of 2018. USC’s increase in revenues was due to the increase in sales of USC’s sterile pharmaceutical formulations resulting in part from an increase in production capacity in order to meet product demand and from marketing personnel efforts.

Third Quarter 2019 Financial Results

Revenues increased approximately 54%, from $3.8 million to $5.9 million, for the three months ended September 30, 2018 and 2019, respectively. Revenues increased by approximately 52%, from $10.9 million to $16.6 million for the first nine months of 2018 compared to the same period in 2019. The increase was primarily attributable to growth in sales of USC’s sterile pharmaceutical products and revenue relating to SYMJEPI.

Selling, general and administrative expenses ("SG&A") decreased approximately 19%, from $6.5 million to $5.3 million for the three months ended September 30, 2018 and 2019, respectively. The decrease in SG&A expenses was primarily due to decreases in wages and benefits.

Research and development expenses ("R&D") decreased approximately 15%, from $3.9 million to $3.3 million for the third quarter of 2018 compared to the same period in 2019. The decrease was primarily due to a decrease in development costs of our product candidates. We anticipate that R&D expenses will continue to decrease in the fourth quarter of 2019.

Cash and equivalents at the end of the third quarter was approximately $12.1 million.

Targeted Near-Term Milestones

•Increasing sales of SYMJEPI in the U.S.
•FDA approval and commercial partner for ZIMHI
•Additional commercial partners for SYMJEPI outside of the U.S.
•Increasing sales and margins at US Compounding

Conference Call

Adamis will host a conference call and live webcast today, November 12, 2019 at 2:00 pm PDT (5:00 pm EDT) to discuss its financial and operating results for the third quarter 2019, as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-800-458-4121

TOLL/International Dial-In: 1-323-794-2093

Conference ID: 1103072

Webcast: View Source

If you are unable to participate in the call live, a telephone playback will be available after approximately 5:00 pm PDT on November 12, 2019. To listen to the replay, call toll free 1-844-512-2921 within the U.S. or 1-412-317-6671 internationally (toll) and enter PIN number 1103072.