- The stock price of Adamis Pharmaceuticals Corp (NASDAQ: ADMP) fell by over 15% pre-market today. This is why it happened.
The stock price of Adamis Pharmaceuticals Corp (NASDAQ: ADMP) – a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease – fell by over 15% pre-market today. Investors are responding negatively to the company announcing the financial results for the 9 months ended September 30, 2021 and provided a business update.
Product and Pipeline Updates and Other Corporate Developments
ZIMHI
— On October 18, 2021, Adamis announced that the U.S. FDA had approved the Company’s ZIMHI (naloxone HCL Injection, USP) 5 mg/0.5 mL product.
— ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.
— According to the preliminary data from the CDC, overdose deaths in the U.S. exceeded 100,000 for the twelve months ending April 2021.
— The company’s U.S. commercial partner, US WorldMeds is preparing to commercially launch ZIMHI in the first quarter of 2022.
SYMJEPI
— In October 2020, US WorldMeds completed the transition of control of the commercial operations of SYMJEPI from Sandoz, Inc.
— The U.S. market for epinephrine exceeded $1.7 billion in annual sales for the 12-month period ending September 30, 2021, according to Symphony Health market data.
— Despite the marketing challenges posed by the pandemic and related lockdowns, Symphony Health data indicates SYMJEPI unit sales increased approximately 98% for nine months ending September 30, 2021, versus the first nine months of 2020.
TEMPOL
— Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity.
— Recently, the National Institutes of Health (NIH) highlighted Tempol as a potential home treatment for COVID-19.
— In September, the first patient was enrolled into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 and the Company is expanding the number of clinical study sites, including several potential sites outside the U.S.
— Adamis licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus infection, influenza and COVID-19.
— In addition to the work in COVID, the company is exploring additional indications for the use of Tempol including, but not limited to the treatment of methamphetamine use disorder.
US COMPOUNDING
— In July 2021, the company sold assets relating to its US Compounding human compounding pharmacy business. And under the terms of the sale, the company expects to receive monthly payments over a 12-month period in an amount equal to one to two times the amount collected for sales of products to certain identified customers included in the sale.
— By the end of October, USC had ceased manufacturing both human and veterinary pharmaceutical products and the employment of all USC employees has ended.
— The company is now engaged in a process of selling or otherwise disposing of the remaining assets of the business.
Financial Results
— Reflecting discontinued operations accounting principles, revenues for the nine months ended September 30, 2021 and 2020 were approximately $3.4 million and $2.1 million, respectively. This increase in revenue was primarily attributable to US WorldMeds’ marketing initiatives for SYMJEPI.
— Selling, general and administrative expenses for the nine months ending September 30, 2021 and 2020 were approximately $13.2 million and $9.6 million, respectively. This increase was primarily attributable to an increase in legal fees.
— Research and development expenses were approximately $9.1 million and $6.6 million for the nine months ending September 30, 2021 and 2020, respectively. This increase was primarily due to development related to ZIMHI and Tempol.
— Cash and equivalents as of September 30, 2021 was approximately $28.7 million. And based on the operating capital that Adamis provided to USC over the last four quarters, the company estimates the shutdown of the USC business may reduce those cash expenditures by approximately $1.2 million per quarter starting in the fourth quarter of 2021, excluding expenses associated with the winding down of USC’s business. Plus over the next 4 quarters, the company estimates to receive additional cash amounts relating to the sale of certain USC assets.
KEY QUOTE:
“Adamis made significant advancements over the past year. We resubmitted our NDA for ZIMHI to the FDA. We initiated and began enrolling patients in a Phase 2/3 clinical trial to evaluate the use of Tempol for the treatment of COVID-19. Under our new commercial partner, we have seen significant sales growth for SYMJEPI. Most significantly, in October we received an early approval for ZIMHI for the treatment of opioid overdose and commercial introduction is expected during the first quarter of 2022.”
— Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.
