On May 18, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the first quarter ended March 31, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, MAY 18, 2020, View Source [SID1234558236]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,

"We are pleased to have resubmitted our ZIMHI New Drug Application to the FDA to get us back on track for regulatory review. We are also very excited to be partnering with US WorldMeds to commercialize both our SYMJEPI and ZIMHI products here in the U.S. Certainly, Adamis has been negatively affected by the COVID-19 outbreak and the various degrees of lockdowns, and it remains to be seen how quickly everyone can get back to a new normal. However, we continue to operate and progress on a number of objectives. We will continue these efforts to mitigate the financial impact of the pandemic."

Product Updates

SYMJEPI (epinephrine) Injection

Earlier this month, the company announced that it had entered into an agreement with Sandoz Inc. providing for the mutually agreed return to Adamis of the marketing, promotion, and distribution rights to the company’s SYMJEPI (epinephrine) Injection 0.3mg, SYMJEPI (epinephrine) Injection 0.15mg products currently marketed and available in the United States, and the termination of the commercialization agreement between Adamis and Sandoz, following a transition period, supported by a transition services agreement that is currently being negotiated. Adamis also simultaneously entered into an exclusive distribution and commercialization agreement with USWM, LLC (USWM) for the United States commercial rights for the SYMJEPI products as well as the Company’s ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate.

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

ZIMHI (naloxone) Injection

Adamis has entered into an exclusive distribution and commercialization agreement with USWM for the U.S. commercial rights for ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate. Under the terms of the Adamis/USWM agreement, US WorldMeds obtained U.S. rights to commercialize and distribute the SYMJEPI products, upon the termination of Sandoz’s commercial rights, and ZIMHI, if approved by the U.S. Food and Drug Administration, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million. Additionally, after deducting the supply price and certain other deductions, including an allocation for US WorldMeds sales and distribution expenses from net sales of the products, Adamis and US WorldMeds will share equally in the net profits, as defined in the agreement.

Earlier today, the company announced the resubmission of the company’s New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its ZIMHI product candidate. The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter ("CRL").

Drug Outsourcing Facility

During the first quarter of 2020, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), decreased by approximately 6% in the first quarter compared to the same quarter in the prior year. Revenues from the sale of pharmaceutical formulations by USC were adversely affected by slowing demand due to the novel coronavirus outbreak. The company is seeking to mitigate the impact with the development and launch of products for which there has been a recent increase in demand.

First Quarter Financial Results

Revenues were approximately $4.7 million and $4.9 million for the three months ended March 31, 2020 and 2019, respectively. The decrease of approximately 5.0% in the first quarter of 2020 compared to the comparable period of 2019 was impacted by the effect of the pandemic on demand for USC’s products.

Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2020 and 2019 were approximately $6.1 million and $8.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses, and to a lesser extent by decreases in operational expenses relating to the ceasing of sales of certain USC products, and decreases in patent, consulting, outside services, professional fees, PDUFA fees, depreciation and other related expenses.

Research and development expenses were approximately $2.0 million and $2.2 million for the three months ended March 31, 2020 and 2019, respectively, a decrease of approximately 7.3%. The decrease was primarily due to a decrease in development costs of our product candidates.

Cash and equivalents at the end of the first quarter was approximately $10.5 million. In February 2020, the company completed a registered direct offering of common stock, and a concurrent private placement of warrants, resulting in estimated net proceeds of approximately $6.2 million.

Targeted Milestones

•Transition SYMJEPI commercial responsibility from Sandoz to US WorldMeds;
•FDA approval and U.S. commercial launch of ZIMHI;
•Develop and launch new USC products to help offset the impact of pandemic; and
•Complete a Phase III ulcer study in horses.

Conference Call

Adamis will host a conference call and live webcast on Monday, May 18, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-877-423-9813

TOLL/International Dial-in: 1-201-689-8573

Conference ID: 13703885

Webcast: View Source

In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on May 18, 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 13703885.