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DMK Pharmaceuticals (DMK) - 2023 Q3 - Quarterly Report
2023-11-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-36242 DMK PHARMACEUTICALS CORPORATION (Exact name of registrant as specified in its charter) Delaware 82-0429727 ( ...
DMK Pharmaceuticals (DMK) - 2023 Q2 - Quarterly Report
2023-08-20 16:00
UNITED STATES OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36242 ADAMIS PHARMACEUTICALS CORPORATION SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...
DMK Pharmaceuticals (DMK) - 2023 Q1 - Earnings Call Transcript
2023-05-15 22:32
Adamis Pharmaceuticals Corporation (ADMP) Q1 2023 Earnings Conference Call May 15, 2023 5:00 PM ET Robert Uhl - MD, ICR Westwicke David Benedicto - CFO Operator It is now my pleasure to introduce your host, Robert Uhl with ICR Westwicke. Thank you, sir. You may proceed. Thank you, operator. Welcome to the Adamis Pharmaceuticals first quarter 2023 financial results and corporate update conference call. Joining me on the call today are members of the Adamis executive team, including Chief Executive Officer, D ...
DMK Pharmaceuticals (DMK) - 2023 Q1 - Quarterly Report
2023-05-14 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (858) 997-2400 (Registrant's telephone number, including area code) For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36242 ADAMIS PHARMACEUTICALS CORPORATION (Exact name of registrant as sp ...
DMK Pharmaceuticals (DMK) - 2022 Q4 - Earnings Call Transcript
2023-03-17 20:50
Robert Uhl - MD, ICR Westwicke Operator Our format for this call will consist of prepared remarks from Adamis Management and Dr. Versi, followed by a Q&A session. This call is being webcast and will be available for replay in the Investors section of our website at adamispharmaceuticals.com. David Marguglio Adamis Pharmaceuticals Corporation (ADMP) Q4 2022 Results Conference Call March 16, 2023 5:00 PM ET Dr. Eboo Versi - CEO, DMK Pharmaceuticals Robert Uhl Further, nothing in todayÂ's presentation should b ...
DMK Pharmaceuticals (DMK) - 2022 Q4 - Annual Report
2023-03-15 16:00
Financial Performance - Adamis Pharmaceuticals reported that sales of prescription epinephrine products were estimated to exceed approximately $1.75 billion in 2022[37]. - The company incurred approximately $1.6 million in restructuring charges related to the winding down of USC's operations during the third and fourth quarters of 2021[53]. - The total amount received from the USC asset purchase agreement was approximately $5.5 million as of December 31, 2022[50]. - The company recorded impairment charges of approximately $8.6 million for inventory, fixed assets, and intangibles in the third and fourth quarters of 2021[54]. - The company has incurred significant net losses for the years ended December 31, 2022, and December 31, 2021, raising doubts about its ability to continue as a going concern[125]. - The company anticipates continued substantial net losses as it supports commercialization of its approved products and conducts research and development activities[131]. - The company expects to require additional funding to sustain operations and meet obligations for at least the next 12 months[127]. - The company has not generated commercial revenue from marketing or selling any drugs or products, except for SYMJEPI and ZIMHI[139]. Merger and Acquisition - The company announced a merger agreement with DMK Pharmaceuticals, a clinical stage neuro-biotechnology company, on February 24, 2023[23]. - Under the merger agreement, Adamis will issue shares valued at $27 million to DMK shareholders based on the average closing prices of Adamis common stock[24]. - The merger is expected to close in the second quarter of 2023, subject to stockholder approvals and other closing conditions[32]. - The merger will result in a new board composition, including two directors from DMK and three from Adamis[30]. - The proposed merger with DMK Pharmaceuticals is subject to stockholder approval and other customary closing conditions, with risks of delays or failure to complete the transaction[135]. - Adamis is liable for significant transaction costs related to the merger, regardless of its completion[141]. - The trading price of Adamis' common stock may decline based on market assumptions regarding the merger's completion[141]. - The company could face litigation related to the Merger Agreement or any failure to complete the merger[141]. Product Development and Regulatory Challenges - The company halted the development of Tempol after a Phase 2/3 clinical trial did not achieve its primary efficacy endpoint[21]. - The FDA approval process for new drugs includes preclinical studies, IND submission, and clinical trials, which can be lengthy and costly[72][78]. - The FDA aims to complete Priority Review NDAs within six months and Standard Review NDAs within ten months, but these timelines can be extended[79]. - The company intends to pursue Section 505(b)(2) regulatory approval filings with the FDA, which involve significant costs and potential delays in obtaining regulatory approval for its products[161]. - A Section 505(b)(2) NDA allows the company to rely on the FDA's findings of safety and efficacy of previously approved products, potentially providing an alternate path to FDA approval for new formulations[162]. - The company submitted a Section 505(b)(2) NDA for its approved SYMJEPI products and ZIMHI (naloxone) Injection product, with plans to pursue similar filings for future product candidates[162]. - The company faces risks related to patent certifications and potential litigation that could delay FDA approval of its 505(b)(2) applications, which may incur significant expenses[165]. - Regulatory approvals are necessary for product marketing, and the approval process is lengthy, expensive, and uncertain[157]. Market Competition and Challenges - The epinephrine market is competitive, with potential downward pressure on pricing and revenues from SYMJEPI products[37]. - The competitive landscape includes self-administered epinephrine products like EpiPen and Auvi-Q, which have seen price reductions and new generic entrants affecting market dynamics[63]. - The markets for the company's products are highly competitive, with numerous competitors having greater financial and technical resources, which could reduce the company's commercial opportunities[181]. - The company may face significant challenges in developing new pharmaceutical products due to unpredictable market conditions and regulatory pathways[140]. - There is a risk that product candidates may not gain acceptance among physicians and patients, limiting revenue generation and future growth prospects[183]. Legal and Compliance Issues - The company has received grand jury subpoenas related to a criminal investigation, which may divert management's attention and require significant financial resources[133]. - The company is subject to various federal and state laws regulating the marketing and reimbursement of pharmaceutical products, which can significantly impact its ability to successfully market products[105]. - The Patient Protection and Affordable Care Act (ACA) includes federal reporting and disclosure requirements for pharmaceutical manufacturers, which could result in civil monetary penalties for non-compliance[110]. - The Inflation Reduction Act (IRA) enacted in August 2022 may significantly impact the pharmaceutical industry, particularly regarding Medicare drug product reimbursement and manufacturer rebate obligations[112]. - The company must comply with HIPAA and HITECH regulations regarding the privacy and security of health information, which can incur material monetary penalties for violations[109]. - The company is subject to complex data privacy and security requirements, with potential fines and penalties for non-compliance[195]. Operational and Financial Risks - The company lacks commercial-scale manufacturing capability and relies on third-party manufacturers, which poses risks to product supply[152]. - The company relies on third parties for clinical trials, which could lead to delays in obtaining trial results or regulatory approval[145]. - Delays in development efforts could materially affect the company's ability to achieve financial goals[142]. - The COVID-19 pandemic has caused business disruptions that may continue to impact operations and customer relationships[143]. - The company has historically relied on sales of equity or debt securities to fund operations, which may not be available on acceptable terms[128]. - The company has three wholly-owned subsidiaries: Adamis Corporation, USC, and Biosyn, Inc.[122]. Stock and Shareholder Information - The company was notified by Nasdaq on December 28, 2022, regarding non-compliance with the minimum bid price requirement, risking delisting unless compliance is regained by June 26, 2023[208]. - The company has 149,983,265 shares of common stock outstanding as of December 31, 2022, which may be sold publicly, subject to certain limitations[219]. - As of December 31, 2022, the company had reserved 4,431,429 shares for issuance upon the exercise of stock options at a weighted-average exercise price of $4.10 per share[220]. - The company has outstanding warrants to purchase 14,952,824 shares of common stock at a weighted-average exercise price of $1.13 per share[220]. - The company has not paid cash dividends on its common stock in the past and does not expect to do so in the foreseeable future[213]. - Delisting from Nasdaq could lead to significant volatility in the market price of the common stock and impair the ability to raise capital[206]. - If the common stock becomes subject to penny stock rules, it could adversely affect liquidity and trading activity[209]. - Future sales of substantial amounts of common stock could negatively impact the market price and lead to dilution for existing shareholders[217].
DMK Pharmaceuticals (DMK) - 2022 Q3 - Earnings Call Transcript
2022-11-15 03:03
Adamis Pharmaceuticals Corporation (ADMP) Q3 2022 Earnings Conference Call November 14, 2022 5:00 PM ET Company Participants Robert Uhl - Westwicke Partners David Marguglio - Co-Founder, CEO, President & Director David Benedicto - CFO Conference Call Participants Operator Good afternoon, ladies and gentlemen, and welcome to the Adamis Pharmaceuticals' Third Quarter 2020 Financial Results Conference Call. [Operator Instructions]. This call is being recorded on Monday, November 14, 2022. I would now like to t ...
DMK Pharmaceuticals (DMK) - 2022 Q3 - Quarterly Report
2022-11-13 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each class Trading Symbol(s)Name of each exchange on which registered Common Stock ADMP NASDAQ Capital Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36242 ADAMIS PHAR ...
DMK Pharmaceuticals (DMK) - 2022 Q2 - Earnings Call Transcript
2022-08-11 23:00
Adamis Pharmaceuticals Corporation (ADMP) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Robert Uhl - Managing Director, ICR Westwicke David J. Marguglio - Chief Executive Officer David Benedicto - Chief Financial Officer Ron Moss - Chief Medical Officer Conference Call Participants Operator Greetings and welcome to the Adamis Pharmaceuticals' Second Quarter 2022 Financial Results Conference Call. [Operator Instructions] As a reminder this conference is being recorded. It i ...
DMK Pharmaceuticals (DMK) - 2022 Q2 - Quarterly Report
2022-08-09 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36242 ADAMIS PHARMACEUTICALS CORPORATION (Exact name of registrant as specified in its charter) Delaware 82-0429727 (State or other jurisdict ...