On April 15, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, reported financial results for the year ended December 31, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, APR 15, 2021, View Source [SID1234578082]).
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!
"Adamis made significant advancements over the past year and that momentum has carried over into 2021," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "We completed the transition of SYMJEPI to our new commercial partner, US WorldMeds, and we look forward to its continued market penetration and sales growth in 2021. As we announced earlier this week, we recently met with the FDA to discuss the regulatory path forward for ZIMHI in the treatment of opioid overdose, and we intend to resubmit our NDA to the FDA. We also intend to commence our Phase 2/3 clinical trial for Tempol in the second quarter of this year, to evaluate the use of Tempol for the prevention of hospitalization of patients with COVID-19. Earlier this year, we completed an underwritten public offering that raised net proceeds of approximately $48.6 million, which provides the financial flexibility we need to move our programs forward. Adamis has an opportunity to reach several meaningful inflection points that could make 2021 a transformative year for the company."
Product and Pipeline Updates and Other Corporate Developments
SYMJEPI (epinephrine) Injection
In October 2020, the SYMJEPI product line, for use in the emergency treatment of acute allergic reactions, completed its transition to a new commercial partner, US WorldMeds.
In January 2021, the SYMJEPI products became available through the Walgreens Prescription Savings Club. The products are being offered at a discounted price of $99.99 per two-pack, which the company believes is the lowest price for an epinephrine device in the U.S.
ZIMHI (naloxone) Injection
Adamis submitted responses to the FDA to address the deficiencies identified in a complete response letter (CRL) received in November. Adamis recently met with the FDA to discuss the responses. After the meeting, and based on discussions with the agency, Adamis expects to resubmit the Naloxone NDA within the next 45 days.
Recently, the U.S. Patent and Trademark Office allowed one of Adamis’ patent applications relating to ZIMHI. The claims allowed describe a naloxone composition at a dose greater than or equal to five milligrams configured for administration as an injection.
Tempol
In June 2020, Adamis entered into an exclusive worldwide license for a novel patented compound, Tempol, for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19. Additionally, the license also includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer.
In February 2021, the company announced results from a study in collaboration with Stanford University demonstrated that Tempol inhibited the release of multiple cytokines from activated immune cells of COVID-19 patients, which may be a unique mechanism of action for the agent. In-vivo preclinical data from a hamster virus challenge model has shown an attenuation of the lung pathology and more rapid healing in animals treated with Tempol. This animal model has been used successfully to test vaccines and monoclonal antibodies against COVID-19. These results further support the clinical program of testing Tempol in early COVID.
The company’s IND relating to a protocol for a clinical trial of Tempol in COVID-19 patients received FDA clearance in January 2021. Adamis expects to begin the Phase 2/3 trial during the second quarter of 2021 to examine the effects of Tempol on preventing hospitalization in subjects with COVID-19 infection.
Drug Outsourcing Facility
In January, the company announced that it had entered into a non-binding letter of intent with a potential buyer for the sale of substantially all of the assets of its US Compounding, Inc. (USC) registered outsourcing facility subsidiary. Under the terms of the LOI, the buyer would acquire substantially all of the assets of USC, in exchange for a total gross consideration that could range from approximately $10-$20 million, before transaction fees and expenses and other potential post-closing adjustments. Any definitive agreement would be subject to approval by the respective parties, including approval by the board of directors of Adamis, and would likely include customary provisions, including representations and warranties of Adamis and USC, restrictive covenants and indemnification provisions.
2020 Financial Results
Total revenues for the year ended December 31, 2020 and 2019 were $16.5 million and $22.1 million, respectively. The total revenue decrease was primarily attributable to a decline in sales of products by USC due to restrictions and limitations on outpatient surgery and other medical procedures caused by the COVID-19 pandemic, and related impacts of the pandemic on sales and marketing efforts.
Selling, general and administrative expenses for the years ending December 31, 2020 and 2019 were approximately $30.6 million and $25.3 million, respectively. The increase was primarily due to the $7.9 million contingent liability related to the Nephron litigation, offset by the decreases in selling expenses at USC.
Research and development expenses were approximately $8.3 million and $10.4 million for the years ended December 31, 2020 and 2019, respectively. The decrease was primarily due to a decrease in development expense for the company’s pipeline candidates.
Cash and equivalents at the end of the year was approximately $6.9 million. In January and February 2021, the company received approximately $5.9 million and $48.6 million from the exercise of warrants and an equity financing transaction, respectively.
Targeted Potential Milestones
Resubmit the ZIMHI NDA to FDA within the next 45 days
Start of Phase 2/3 clinical trial of Tempol in COVID-19 patients in the second quarter of 2021
Progress from non-binding term sheet to executed purchase agreement for the sale of USC outsourcing division in the second half of 2021
On-going market penetration and increasing sales of SYMJEPI in the U.S. throughout 2021
Approval and commercial launch of ZIMHI
Conference Call
Adamis will host a conference call and live webcast today, April 15, 2021 at 2 p.m. PDT (5 p.m. EDT) to discuss its financial and operating results for the fourth quarter 2020 and year ended December 31, 2020, as well as provide an update on business developments and activities.
If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source