On August 17, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, AUG 17, 2020, View Source [SID1234563750]).
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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,
"Although we continue to be negatively impacted by the pandemic and government required operating restrictions, we are very excited about several developments during the last quarter. First, we finalized our agreement with Sandoz, Inc. to take back U.S. commercial rights for our SYMJEPI products. More importantly, we executed a new agreement with US WorldMeds, LLC (USWM) under which they have assumed U.S. rights to market and distribute the SYMJEPI products and, upon FDA approval which we believe will occur this year, will have commercial rights for our ZIMHITM product. I strongly feel USWM’s commitment to detail SYMJEPI to allergists and high-prescribing physicians will be a catalyst to bring broad awareness and usage within the billion plus dollar anaphylaxis market."
"Also, during the last quarter we acquired rights develop a novel drug compound, Tempol, for certain indications including COVID-19 infections. We believe Tempol could be a powerful therapeutic agent in combating COVID-19 and are committed to working with the FDA and other agencies with a goal to begin testing Tempol in patients as soon as practicable. I believe there are a number of exciting near-term milestones for Adamis and I am very excited about the second half of 2020 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.
In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and during the last quarter, through its Australian partner, Emerge Health, Adamis submitted a regulatory dossier to seek clearance to begin marketing both SYMJEPI products in the Australian market.
ZIMHI (naloxone) Injection
On May 11, 2020, Adamis 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 agreement, USWM obtained U.S.
Tempol
In June, the company entered into a license agreement with Matrix Biomed, Inc. (Matrix) to license rights under patents, patent applications and related know-how of Matrix related to Tempol, an investigational drug in the fields of COVID-19 infection, asthma, respiratory syncytial virus influenza infection and as a therapeutic for reducing radiation-induced dermatitis in patients undergoing treatment for cancer.
Since licensing this product, the company has submitted to the FDA a Pre-Investigational New Drug (IND) package, and the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled Phase II study examining Tempol in COVID-19 patients. The company’s goal is to apply for and obtain funding from certain government agencies and programs to enable the necessary trials to determine the efficacy of Tempol as a therapeutic treatment for COVID-19.
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 novel coronavirus outbreak. Revenues decreased by approximately 19% year to date compared to the same period in the prior year.
Second Quarter Financial Results
Year to date revenues were approximately $8.6 million and $10.7 million for the six months ended June 30, 2020 and 2019, respectively, a decrease of approximately 20% at the end of June of 2020 compared to the comparable period of 2019. The COVID-19 pandemic 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 ("SG&A") for the six months ended June 30, 2020 and 2019 were approximately $11.7 million and $15.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses and to a lesser extent by decreases in patent, consulting, outside services, professional fees, depreciation and other related expenses.
Research and development expenses were approximately $5.1 million and $5.0 million for the six months ended June 30, 2020 and 2019, respectively.
Cash and equivalents at the end of the second quarter was approximately $7.9 million.
Targeted Milestones
●Work with USWM to finalize transition of SYMJEPI commercial responsibility from Sandoz;
●FDA approval and U.S. commercial launch of ZIMHI;
●Return USC division back to pre-COVID-19 levels;
●Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
●Begin Phase 2 trial for Tempol in COVID-19 patients
Conference Call
Adamis will host a conference call and live webcast on Thursday, August 20, 2020 at 1:30 pm Pacific Time to discuss its financial and operating results for the second 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: 13708688
Webcast: View Source
In addition, a telephone playback of the call will be available after approximately 4:30 pm PT on August 20, 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 13708688.