On August 10, 2018 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2018 and a business update (Press release, Adamis Pharmaceuticals, AUG 10, 2018, View Source [SID1234528712]).
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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "Recently, we have announced several significant achievements for our company. The Sandoz partnership for the commercialization and distribution of Symjepi in the U.S. will likely prove to be the most transformative for the Company. Under the agreement, Sandoz will take responsibility for sales and marketing. We believe the financial terms of the agreement could provide for a meaningful recurring revenue to Adamis. We have also expanded our pipeline with our sublingual tadalafil (Cialis) product candidate, which is in development."
Dr. Carlo added, "The successful underwritten public offering of common stock has provided the necessary resources to advance our pipeline. We were fortunate to have had multiple fundamental health care funds lead that offering. These recent advancements have put Adamis in a strong position for growth."
Company Highlights and Product Updates
Some of the company’s product updates and accomplishments since the beginning of the second quarter of 2018 include the following:
Symjepi (epinephrine) Injection 0.30mg – The company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell Symjepi in the U.S. Key terms include: Sandoz to pay a supply price to Adamis for product, Adamis 50% profit split and Sandoz right of first negotiation for territories outside the U.S.;
APC-8000 (sublingual tadalafil) – The company is developing a new fast-dissolving sublingual tablet containing tadalafil (Cialis) and intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) before year-end;
APC-6000 (naloxone) – We continue to advance our naloxone product candidate for opioid overdose, and plan to file an NDA with the FDA before year-end. This is our second product using our FDA-approved injection device;
APC-1000 (beclomethasone) – The FDA cleared Adamis to begin Phase 3 pivotal studies with our beclomethasone metered dose inhaler and we are planning to begin patient recruitment in Q4;
APC-4000 (fluticasone) – Fluticasone will be our first product candidate using our patented dry powder inhaler device platform purchased from 3M. We continue to work on proof of concept studies with the objective of demonstrating proper dosing of the steroid;
Balance sheet – We strengthened our cash position with an underwritten equity offering that raised net proceeds of approximately $37.6 million.
Second Quarter Financial Results
Revenues were approximately $3.9 million and $3.8 million for the three months ended June 30, 2018 and 2017, respectively. The increase in revenues for the three months ended June 30, 2018 compared to the comparable period of 2017 reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations resulting in part from price increases and marketing personnel efforts.
Net loss from operations for the three months ending June 30, 2018 and 2017, respectively, was approximately $9.7 million and $4.9 million. The increase in net loss primarily resulted from an increase in both selling, general and administrative ("SG&A") expenses and research and development ("R&D") expenses.
SG&A expenses for the three months ended June 30, 2018 and 2017 were approximately $6.4 million and $5.7 million, respectively. The increase was primarily due to adding personnel, increases in compensation and benefits expense, as well as, increases in the cost of maintaining licenses, registrations and intellectual property.
R&D expenses were approximately $4.8 million and $1.2 million for the three months ended June 30, 2018 and 2017, respectively. The increase was the result of the expense of advancing several late-stage candidates in our product pipeline.
At June 30, 2018, the Company had cash and cash equivalents of $4.4 million. On August 6, 2018, the Company announced the closing of an underwritten public offering resulting in net proceeds of approximately $37.6 million.
Future Milestones for 2018
Commercial launch of Symjepi (epinephrine) Injection 0.3mg in the U.S. – timing of launch and commercial strategy will be at Sandoz’s sole discretion;
FDA approval of lower dose Symjepi (epinephrine) Injection 0.15mg;
Announcement of ex-U.S. strategy for Symjepi;
Filing an NDA for naloxone injection;
Filing an NDA for the sublingual tadalafil (Cialis) tablet;
Commencement of Phase 3 studies for beclomethasone in asthmatics;
Growing net revenue of outsourcing facility (U.S. Compounding) by 30% over 2017.