Adamis Pharmaceuticals (ADMP) is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease and allergy. the company is currently developing several products in the allergy and respiratory markets, including its Epinephrine Injection pre-filled syringe, or PFS, product for use in the emergency treatment of acute allergic reactions, including anaphylaxis; albuterol (APC-2000) and fluticasone (APC-4000) Dry Powder Inhaler, or DPI, products for the treatment of bronchospasm and asthma, respectively; and a steroid hydrofluoroalkane, or HFA metered dose inhaler product (APC-1000) for the treatment of asthma. Adamis's goal is to create low cost therapeutic alternatives to existing treatments. Consistent across all specialty pharmaceuticals product lines, the company intend to submit Section 505(b)(2) New Drug Applications, or NDAs, or Section 505(j) Abbreviated New Drug Applications, or ANDAs, to the U.S. Food and Drug Administration, or FDA, whenever possible, in order to potentially reduce the time to market and to save on costs, compared to those associated with Section 505(b)(1) NDAs for new drug products. Its U.S. Compounding, Inc., or USC, subsidiary, which is registered as a drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act, as amended and the U.S. Drug Quality and Security Act, or DQSA, compounds sterile prescription drugs, and certain nonsterile drugs, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.

Recent Developments

Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe

On June 15, 2017, the U.S. Food & Drug Administration, or FDA, approved the Company’s Epinephrine Injection USP, 1:1000 (0.3 mg Pre-filled single dose syringe), or PFS, product for the emergency treatment of allergic reactions (Type I) including anaphylaxis. The FDA approved also the trade name of “Symjepi™” for the product. The approval was pursuant to the FDA’s review of the Company’s New Drug Application, or NDA, which was amended and resubmitted in December 2016, pursuant to the Food, Drug & Cosmetic Act, as amended, relating to the Epinephrine PFS product. Symjepi provides two single dose syringes of epinephrine (adrenaline), which is used for emergency, immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to certain foods, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis. The company are in the process of exploring commercialization options and are in discussions with potential partners regarding commercialization of the product, and in the interim, the company expect to build inventory levels in preparation for an anticipated launch before the end of this year, although the actual timing of a commercial launch will depend on a number of factors. If the company enter into an agreement with a commercialization partner, the timing of a commercial launch of a product will depend in part on the plans of any such partner, and as a result there are no assurances regarding the date of commercial launch of the product.


Adamis Pharmaceuticals is continuing development of the APC-1000 product candidate, a steroid hydrofluoroalkane, or HFA, metered dose inhaler product for asthma. Following discussions with the FDA and additional consideration of the development pathway for the product, the company has decided to conduct additional development work for APC-1000. its product development timelines are subject to a number of risks and uncertainties, which can delay the actual development time. Its development plans concerning its allergy and respiratory products, including APC-1000, are affected by developments in the marketplace, including the introduction of potentially competing new products by its competitors. For example, certain products that previously have been available by prescription only have been approved by the FDA and introduced for sale over-the-counter without a prescription at a lower price than competing prescription products, and other new allergy or respiratory products have been or could in the future also be approved as “branded generic” products or as over-the-counter products. Such products could be sold at lower prices than prescription products, could adversely affect the willingness of health insurers or other third party payors to reimburse patients for the cost of prescription products, and could adversely affect its ability to successfully develop and market product candidates in its pipeline. As a result, its product development plans could be affected by such considerations. The anticipated dates for development and introduction of products in its allergy and respiratory product pipeline will depend on a number of factors, including the availability of adequate funding to support product development efforts. Adamis Pharmaceuticals believe that should it decide to pursue such applications, the company would be required to submit data for an application for approval to market APC-1000 pursuant to Section 505(b)(2), although there are no assurances that this will be the case. Adamis Pharmaceuticals believe that the next pivotal trial for APC-1000 would be a Phase 3 pivotal trial, although there are no assurances that this will be the case or concerning the timing of any regulatory filings that the company may make relating to commencement of clinical trials regarding the APC-1000 product. Total time to develop the APC-1000 product, including manufacture of the product, clinical trials and FDA review, is expected to be approximately 24-30 months from inception of full product development efforts, assuming adequate funding and that there are no unforeseen regulatory issues or other delays.

Going Concern and Management Plan

Adamis Pharmaceuticals's independent registered public accounting firm has included a “going concern” explanatory paragraph in its report on its consolidated financial statements for the years ended December 31, 2016 and 2015 indicating that Adamis Pharmaceuticals has sustained substantial losses from continuing operations and have used, rather than provided, cash in its continuing operations, and incurred recurring losses from operations and have limited working capital to pursue its business alternatives. As of June 30, 2017, the company had cash of approximately $11.7 million, including approximately $1.0 million in restricted cash, an accumulated deficit of approximately $99.2 million, and liabilities of approximately $10.1 million. As noted below under the heading “Liquidity and Capital Resources” and in Note 9 to the financial statements appearing elsewhere herein, in April 2017, the company completed an underwritten public offering of shares of common stock resulting in estimated net proceeds, after underwriting discounts and estimated offering expenses, of approximately $16.0 million. In addition, in July 2017, the company received approximately $10.6 million of proceeds from the exercise of certain warrants. However, the company will need additional funding for future operations and the expenditures that will be required to conduct clinical, development and regulatory activities relating to its product candidates, commercially launch any products that may be approved by applicable regulatory authorities, market and sell products, satisfy existing obligations and liabilities, and otherwise support its intended business activities and working capital needs. Such additional funding may not be available, may not be available on reasonable terms, and could result in significant additional dilution to its stockholders. If the company do not obtain required additional equity or debt funding, its cash resources will be depleted and the company could be required to materially reduce or suspend operations, which would likely have a material adverse effect on its business, stock price and its relationships with third parties with whom the company has business relationships, at least until additional funding is obtained.

The above conditions raise substantial doubt about its ability to continue as a going concern. The condensed consolidated financial statements included elsewhere herein for the three and six months ended June 30, 2017, were prepared under the assumption that the company would continue its operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. In preparing these condensed consolidated financial statements, consideration was given to its future business as described elsewhere herein, which may preclude it from realizing the value of certain assets. Its unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. Without additional funds from debt or equity financing, sales of assets, sales or out-licenses of intellectual property or technologies, or from a business combination or a similar transaction, after expenditure of its existing cash resources the company would exhaust its resources and would be unable to continue operations.

Its management intends to attempt to secure additional required funding through equity or debt financings, sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions, and through revenues from sales of compounded sterile formulations. However, there can be no assurance that the company will be able to obtain any required additional funding. If the company is unsuccessful in securing funding from any of these sources, the company will defer, reduce or eliminate certain planned expenditures, delay development or commercialization of some or all of its products and reduce the scope of its operations. If the company do not have sufficient funds to continue operations, the company could be required to seek bankruptcy protection or other alternatives that could result in its stockholders losing some or all of their investment in it.

Created by Asif Farooqui on 2019/09/06 05:40
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