On May 10, 2018 Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) reported financial results and a business update for the first quarter ended March 31, 2018 (Press release, Adamis Pharmaceuticals, MAY 10, 2018, View Source [SID1234526502]).
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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, said, "We have made a substantial amount of progress on several fronts since the beginning of the year. The development of our product pipeline continues to move forward and we have several target milestones that we hope to reach later this year. We believe the completion of these milestones will increase shareholder value. As for our progress on Symjepi , we continue to be pleased with developments regarding our discussions with potential commercialization partners. We believe that we are closer to concluding the process of naming our licensing partner and we remain focused on bringing this product to market."
Company Highlights and Product Updates
Some of the company’s product updates and accomplishments since the beginning of 2018 include the following:
Symjepi (epinephrine) Injection 0.15mg – The FDA determined that the company’s NDA for Symjepi (epinephrine) Injection 0.15mg was sufficiently complete to permit a substantive review and indicated that no potential review issues were identified as of the date of the agency’s communication in February. Approval is expected in the second half of this year.
Symjepi human factors data – Adamis presented human factors data for Symjepi at the American Academy of Allergy Asthma and Immunology joint congress with the World Allergy Organization, and another human factors study was published in the Annals of Allergy, Asthma and Immunology.
APC-1000 (Beclomethasone HFA) – Our product candidate received approval from the FDA to proceed with Phase 3 clinical studies. We continue to make progress in this area.
APC-6000 (Naloxone PFS) – We are working toward filing a New Drug Application (NDA) later this year and have completed pharmacokinetic (PK) studies.
Sales of several products sold by our U.S. Compounding, Inc. subsidiary have been increasing including Adamis’ unique compound to manage ulcers in horses. One horse that was receiving U.S. Compounding’s product recently came in first in the 2018 Kentucky Derby.
Second Quarter Financial Results
Revenues were approximately $3.2 million and $3.0 million for the three months ended March 31, 2018 and 2017, respectively. The increase in revenues (4.6%) for the three months ended March 31, 2018 compared to the comparable period of 2017 reflected an increase in the volume of sales of USC’s compounded pharmaceutical formulations resulting in part from increased sales and marketing personnel and efforts. The company’s revenues for the first quarter of 2018 increased approximately 11.9% compared to the revenues for the fourth quarter of 2017.
At March 31, 2018, the Company had cash and cash equivalents of $10.1 million. Net cash used in operating activities for the three months ended March 31, 2018 and 2017, was approximately $7.9 million and $3.5 million, respectively. Net cash used in operating activities increased primarily due to the increase in operating losses; increase in accounts receivable, inventories and prepaid expenses; and a decrease in accounts payable and accrued expenses as compared to 2017.
Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2018 and 2017 were approximately $6.5 million and $5.6 million, respectively. The increase in SG&A expenses was primarily due to new hires, compensation and stock option expenses, increases in accounting, audit and other professional fees, patent expenses, selling expenses and market research expenses related to Symjepi (epinephrine) and our APC-6000 product candidate.
Research and development expenses were approximately $2.2 million and $1.5 million for the three months ended March 31, 2018 and 2017, respectively. The increase in research and development expenses for the three months ended March 31, 2018, compared to the comparable period of the prior year was due in part to an increase in development costs of our product candidates and compensation and stock option expenses, in part due to new hires.
Net loss for the first quarter of 2018 was approximately $7.6 million, compared to net loss of approximately $5.8 million for the same period in 2017.
Future Milestones
Some of the company’s goals for the 2018 year include the following:
Finalizing and announcing the commercialization strategy for Symjepi (epinephrine) Injection 0.3mg;
FDA approval for Symjepi TM (epinephrine) Injection 0.15mg;
Initiate pivotal Phase 3 studies of APC-1000 in asthmatics;
Complete a "proof of concept" study with dry powder inhaler platform using fluticasone;
Filing an NDA for Naloxone injection;
Increase sales of compounded medications from our U.S. Compounding, Inc. subsidiary by at least 30%.