Adamis Pharmaceuticals Corp (ADMP) 2023 Q1 法說會逐字稿

Greetings, and welcome to Adamis Pharmaceuticals' First Quarter 2023 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Adamis Pharmaceuticals 2023 年第一季財務業績電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Robert Uhl with ICR Westwicke. Thank you, sir. You may proceed.

現在我很高興向您介紹主持人，ICR Westwicke 的 Robert Uhl。謝謝您，先生。您可以繼續。

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, David J. Marguglio; and Chief Financial Officer, David Benedicto. And once again, DMK Pharmaceuticals CEO, Dr. Eboo Versi, will also join the call.

謝謝你，接線生。歡迎參加 Adamis Pharmaceuticals 2023 年第一季財務業績和公司最新動態電話會議。今天和我一起參加電話會議的是 Adamis 執行團隊的成員，包括執行長 David J. Marguglio；和財務長大衛·貝內迪克托。 DMK Pharmaceuticals 執行長 Eboo Versi 博士也將再次加入此次電話會議。

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.

我們這次電話會議的形式將包括 Adamis 管理層和 Versi 博士準備好的發言，然後是問答環節。本次電話會議正在進行網路直播，並將在我們網站 adamispharmaceuticals.com 的投資者部分重播。

In today's call, we will make certain forward-looking statements regarding our business based on current information and expectations. Those statements speak only as of today, and except as required by law, we do not assume any duty to update in the future any forward-looking statements made today. Of course, any forward-looking statements involve risks and uncertainties and our actual results could differ materially from those anticipated by any forward-looking statements that we make today.

在今天的電話會議中，我們將根據當前資訊和預期就我們的業務做出某些前瞻性聲明。這些陳述僅代表今天的情況，除非法律要求，否則我們不承擔任何責任在未來更新今天所做的任何前瞻性陳述。當然，任何前瞻性陳述都涉及風險和不確定性，我們的實際結果可能與我們今天所做的任何前瞻性陳述的預期有重大差異。

Additional information concerning factors that could affect our business and financial results is included in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission and in other subsequent filings that we make with the SEC. These are available on the SEC's website at sec.gov or on Adamis' website.

有關可能影響我們業務和財務表現的因素的更多資​​訊包含在我們向美國證券交易委員會提交的最新 10-K 表格年度報告以及我們向美國證券交易委員會提交的其他後續文件中。這些資訊可在 SEC 網站 sec.gov 或 Adamis 網站上取得。

Now let me hand the call over to David Marguglio, CEO of Adamis.

現在讓我將電話轉交給 Adamis 執行長 David Marguglio。

Thank you, Robert, and thanks to everyone for joining our call this afternoon. Today has certainly been an exciting day for all of us here at Adamis. As you may know, earlier, we hosted a special meeting of stockholders during which stockholders approved both measures that will enable us to proceed with the merger with DMK Pharmaceuticals.

謝謝羅伯特，也謝謝大家今天下午加入我們的電話會議。對於 Adamis 的所有人來說，今天無疑是個令人興奮的日子。如您所知，早些時候，我們召開了一次特別股東會議，股東們在會議上批准了兩項措施，使我們能夠繼續與 DMK Pharmaceuticals 合併。

Following this stockholder meeting, the Adamis Board of Directors met to review the voting results. After the Board meeting, we filed our 10-Q with financial results for the first quarter ending March 31, from which David Benedicto will provide a summary of in a few moments.

本次股東大會結束後，阿達米斯董事會召開會議審查投票結果。董事會會議結束後，我們提交了 10-Q 報告，其中包含截至 3 月 31 日的第一季的財務業績，David Benedicto 稍後將提供其中的摘要。

During the Board meeting, among other matters, the Board discussed the necessity for meeting the minimum bid price requirement to avoid being delisted from NASDAQ. The Board determined that it is in the best interest of the company and its stockholders to avoid delisting, and therefore, authorized the company to effect a reverse split in the near future to be able to reach the closing price of over $1 a share for at least 10 consecutive trading days prior to the NASDAQ-imposed deadline of June 26.

在董事會會議期間，除其他事項外，董事會還討論了滿足最低買入價要求以避免從納斯達克退市的必要性。董事會認為避免退市符合公司及其股東的最佳利益，因此授權公司在不久的將來進行反向分拆，以便能夠以每股 1 美元以上的價格實現收盤價納斯達克規定的截止日期6月26 日之前至少連續10 個交易日。

We notified NASDAQ of our plan and in the coming days, we intend to further describe the timing and the ratio for the reverse stock split. Following the reverse split and upon the satisfaction or waiver of the remaining closing conditions, we intend to close the merger with DMK. This merger has been the result of countless hours of work over the last 6 months by the employees of both companies as well as our respective auditors, lawyers and other advisers. I believe I speak for everyone involved when I say that this merger is truly an exciting milestone in the history of both companies, and we have great expectations for the future of the combined company.

我們已向納斯達克通報了我們的計劃，在接下來的幾天裡，我們打算進一步描述反向股票分割的時間和比例。在反向分拆並滿足或放棄剩餘成交條件後，我們打算完成與 DMK 的合併。這次合併是兩家公司的員工以及我們各自的審計師、律師和其他顧問在過去 6 個月裡無數個小時工作的結果。我相信，當我說這次合併確實是兩家公司歷史上令人興奮的里程碑時，我代表了所有參與者，我們對合併後公司的未來抱有很大的期望。

Before turning it over to our incoming CEO, Dr. Eboo Versi, to provide a glimpse of that future, I will ask David Benedicto to summarize the first quarter 2023 financials. David?

在將其交給我們即將上任的執行長 Eboo Versi 博士之​​前，我將請 David Benedicto 總結一下 2023 年第一季的財務狀況。大衛？

Thank you. As David mentioned this afternoon, we filed our Form 10-Q for the quarter ending March 31, 2023. I would like to describe a few key items from those financials, but I encourage you to review the full 10-Q for additional details and disclosures.

謝謝。正如David 今天下午提到的，我們提交了截至2023 年3 月31 日的季度的10-Q 表格。了解更多詳細信息，披露。

Revenue for the first quarter ending March 31, 2023, increased by 26% to approximately $1.5 million versus approximately $1.2 million for the same period in 2022. The increase in revenues was primarily due to product sales of ZIMHI to US WorldMeds. No revenues relating to SYMJEPI were reported for the first quarter of 2023 or 2022, due to its manufacturing hold and the voluntary product recall that was announced in March 2022.

截至 2023 年 3 月 31 日的第一季營收成長 26%，達到約 150 萬美元，而 2022 年同期約為 120 萬美元。由於 SYMJEPI 的生產暫停以及 2022 年 3 月宣布的自願產品召回，2023 年或 2022 年第一季沒有報告與 SYMJEPI 相關的收入。

Selling, general and administrative expenses for the 3 months ending March 31, 2023, and 2022 were approximately $4.8 million and $3.4 million, respectively. The increase was primarily a result of increased legal, audit and advisory fees associated with both the merger and the financing transaction, which closed in March.

截至2023年3月31日和2022年3月31日的三個月的銷售、一般和管理費用分別約為480萬美元和340萬美元。這一增長主要是由於與三月完成的合併和融資交易相關的法律、審計和諮詢費用增加。

Research and development expenses were lower for the first quarter at approximately $1.3 million, compared to $4.2 million in the first quarter of 2022. The decrease was primarily related to the wind down of Tempol clinical trial and product development work.

第一季的研發費用較低，約 130 萬美元，而 2022 年第一季的研發費用為 420 萬美元。

Net loss from continuing operations decreased by approximately 12% to approximately $9 million from approximately $2.2 million for the quarters ending March 31, 2023 and 2022, respectively. Lastly, cash and cash equivalents at March 31, 2023, totaled approximately $3.1 million.

截至2023年3月31日及2022年3月31日的季度，持續營運淨虧損分別從約220萬美元下降至約900萬美元，下降約12%。最後，截至 2023 年 3 月 31 日，現金和現金等價物總計約 310 萬美元。

I would now like to hand it over to Dr. Eboo Versi. Dr. Versi?

現在我想把它交給 Eboo Versi 博士。韋爾西博士？

Thank you, David. I would like to thank both Adamis and DMK stockholders for their approval and support, and I look forward to completing this merger in the coming days. To accelerate the integration, teams from both companies have been meeting regularly to level set and align on strategic objectives.

謝謝你，大衛。我要感謝 Adamis 和 DMK 股東的批准和支持，我期待在未來幾天內完成這次合併。為了加速整合，兩家公司的團隊定期舉行會議，以設定並協調策略目標。

On Adamis' last earnings call, I described DMK's lead compounds, the stage of development and the indications and regulatory paths we intend to pursue. Today, I want to spend some time discussing my vision for the combined company, which will focus on saving lives and treating patients with substance use disorder.

在 Adamis 的上次財報電話會議上，我描述了 DMK 的先導化合物、開發階段以及我們打算尋求的適應症和監管路徑。今天，我想花一些時間討論我對合併後公司的願景，該公司將專注於拯救生命和治療藥物濫用障礙患者。

Whereas Adamis' focus was on saving lives through the development of rescue treatments for opioid overdose and anaphylaxis, I intend to use ZIMHI as the foundation upon which to establish the new company as the leader in the treatment of substance abuse.

Adamis 的重點是透過開發阿片類藥物過量和過敏反應的救援治療方法來拯救生命，而我打算以 ZIMHI 為基礎，將新公司建立為藥物濫用治療領域的領導者。

An American dies every 5 minutes from an opioid overdose, and 85% of these are due to fentanyl that is plaguing our country. Given the high potency of fentanyl, I believe that intranasal NARCAN or its generic equivalents are unable to revive patients with a single dose.

每 5 分鐘就有一名美國人死於阿片類藥物過量，其中 85% 是由於困擾我們國家的芬太尼造成的。鑑於芬太尼的高效力，我相信鼻內 NARCAN 或其仿製藥無法單劑量使患者甦醒。

Recently, Dr. Strauss of the FDA presented data that suggested that against fentanyl, rapid dosing with naloxone is the most effective reversal treatment. This is precisely what ZIMHI achieves. NARCAN, the leading naloxone product franchise reported revenues in excess of approximately $374 million for 2022. And I believe we can, over time, achieve a significant share of this market without being -- while being even more effective at preventing deaths from fentanyl overdose.

最近，FDA的Strauss博士提出的數據表明，針對芬太尼，快速服用納洛酮是最有效的逆轉治療。這正是 ZIMHI 所達成的目標。 NARCAN 是領先的納洛酮產品系列，報告2022 年收入超過約3.74 億美元。導致的死亡。

Neither of Adamis' commercial products have even approached the market share, I believe they can. One of my first initiatives as CEO of the combined companies will be to make increasing sales my top priority by taking an active role in commercial efforts to achieve greater market penetration.

Adamis 的兩種商業產品都沒有達到市場份額，我相信它們可以。作為合併後公司的首席執行官，我的首要舉措之一就是透過在商業努力中發揮積極作用以實現更大的市場滲透，從而將增加銷售額作為我的首要任務。

I've already identified several strategies to improve the sales of ZIMHI, which we intend to roll out in the near future. Not only do you, the stockholders, deserve the long-awaited price appreciation that I believe should come from putting more meaningful sales numbers on the board, but caregivers also deserve the benefit of these important and differentiated products to save lives.

我已經確定了幾項提高 ZIMHI 銷售的策略，我們打算在不久的將來推出這些策略。你們，股東，不僅應該得到期待已久的價格升值，我認為這應該來自於在董事會上公佈更有意義的銷售數字，而且護理人員也應該從這些重要且差異化的產品中受益，以拯救生命。

While seeking to change the sales trajectory for ZIMHI and SYMJEPI, we will look for opportunities to further the development of our lead clinical stage compound DPI-125, as a treatment for opioid use disorder. The same characteristics and mechanism of action that we believe should make DPI-125 a useful tool in the fight against addiction could also make it a game-changing alternative to all currently marketed opioids used for treating pain. If we can do that, there exists the possibility for this company, not only to create shareholder value, but also to play a significant role in trying to substantially reduce or end this current opioid crisis.

在尋求改變 ZIMHI 和 SYMJEPI 的銷售軌蹟的同時，我們將尋找機會進一步開發我們的主要臨床階段化合物 DPI-125，作為阿片類藥物使用障礙的治療方法。我們認為 DPI-125 的相同特性和作用機制應該使 DPI-125 成為對抗成癮的有用工具，也可能使其成為目前市售的所有用於治療疼痛的阿片類藥物的改變遊戲規則的替代品。如果我們能做到這一點，那麼該公司不僅有可能創造股東價值，而且有可能在努力大幅減少或結束當前的鴉片危機方面發揮重要作用。

The clinical programs that will be required to potentially gain marketing approval for DPI-125 in multiple indications will require investment and time. DMK has a track record of attracting nondilutive funding in the form of government grants, and I propose to continue these activities to fund our programs.

為 DPI-125 的多種適應症獲得上市批准所需的臨床項目需要投資和時間。 DMK 擁有吸引政府補助形式的非稀釋性資金的記錄，我建議繼續這些活動來資助我們的計畫。

The merged company has several valuable assets that are not central to our core mission of treating substance use disorder. My plan is to seek opportunities to develop or codevelop these additional assets with nondilutive dollars and advance them through proof of concept from which they can then be outlicensed to generate cash from upfront milestones and royalty payments. By increasing the sales of our marketed products, getting outlicense revenues and by increasing to get nondilutive funding, I expect to defray the costs of our clinical programs and to increase shareholder value.

合併後的公司擁有幾項寶貴的資產，這些資產並不是我們治療藥物濫用障礙的核心使命的核心。我的計劃是尋找機會用非稀釋性資金開發或共同開發這些額外資產，並通過概念驗證來推進它們，然後可以從中獲得許可，從預付款和特許權使用費中產生現金。透過增加我們行銷產品的銷售、獲得許可收入以及增加非稀釋性資金，我希望能夠支付我們臨床項目的成本並增加股東價值。

Lastly, I would like to say how excited and privileged I am to have this opportunity to unleash the potential that our combined company has in saving lives while increasing shareholder value.

最後，我想說，能夠有這個機會釋放合併後的公司在拯救生命和增加股東價值方面的潛力，我感到非常興奮和榮幸。

David, I will now pass the call back to you.

大衛，我現在將電話轉給你。

Thank you, Dr. Versi. I think you had described the new vision very well. At this point, we'll open it up to some questions. Robert?

謝謝你，韋爾西博士。我認為您很好地描述了新願景。此時，我們將提出一些問題。羅伯特？

All right. Thank you. For the first one, have sales to date for ZIMHI matched the company's expectations?

好的。謝謝。對於第一個問題，ZIMHI 迄今為止的銷售額是否符合公司的預期？

No, in fact, I'd say they're well below our expectations. However, we still believe ZIMHI represents a huge unmet need and it's a very large and growing market. So part of the strategy, as Dr. Versi just described, moving forward will be to introduce new strategies to increase the marketing and sales efforts, which we believe will be instrumental in boosting market share and unit sales.

不，事實上，我想說它們遠低於我們的預期。然而，我們仍然相信 ZIMHI 代表著巨大的未滿足需求，而這是一個非常大且不斷成長的市場。因此，正如 Versi 博士剛才所描述的，策略的一部分是引入新的策略來加大行銷和銷售力度，我們相信這將有助於提高市場份額和銷售量。

Great. Thank you. Here's one for Dr. Versi. You mentioned 3 avenues for cash generation: increased sales of existing products, outlicensing and royalty revenue, and grants. Does this mean that a follow-on equity offering or other financing is not part of your plans?

偉大的。謝謝。這是給 Versi 博士的一份。您提到了產生現金的 3 個途徑：增加現有產品的銷售、向外授權和特許權使用費收入以及補助金。這是否意味著後續股權發行或其他融資不屬於您的計畫？

As with all small public biopharma companies, until we reach profitability, we will continue to consider raising capital through the sale of equities. However, the financing strategy will be to prioritize growing revenue from the commercial products as these will be key to our long-term growth of the company. In addition, we want to focus on getting nondilutive capital in the form of government and nongovernment grants as well as codevelopment and outlicense opportunities.

與所有小型上市生物製藥公司一樣，在我們實現盈利之前，我們將繼續考慮透過出售股權籌集資金。然而，融資策略將優先考慮商業產品收入的成長，因為這將是我們公司長期成長的關鍵。此外，我們希望專注於以政府和非政府撥款以及共同開發和向外許可機會的形式獲得非稀釋資本。

Okay. Great. Thank you. What is the next step in the clinical development of DPI-125? Is initiation of the next clinical trial anticipated for later this year? And what indication will you be pursuing?

好的。偉大的。謝謝。 DPI-125臨床開發的下一步是什麼？預計下一次臨床試驗將於今年稍後啟動嗎？您將追求什麼跡象？

To date, the development of DPI-125 has completed a dose escalation first-in-human Phase I study, which showed that the drug was well tolerated and had no serious adverse effects. The next planned human studies will attempt to confirm what has been demonstrated in preclinical studies in terms of better safety from respiratory depression and reduction in abuse liability. Once these key characteristics have been demonstrated, we intend to develop DPI-125 as a treatment for opioid use disorder and eventually as a treatment for acute and chronic pain.

截至目前，DPI-125的研發已完成劑量遞增首次人體I期研究，結果顯示該藥耐受性良好，且無嚴重不良反應。下一個計劃中的人體研究將試圖證實臨床前研究中在呼吸抑制方面的更好安全性和減少濫用傾向方面已證明的內容。一旦這些關鍵特性得到證實，我們打算開發 DPI-125 作為阿片類藥物使用障礙的治療方法，並最終作為急性和慢性疼痛的治療方法。

All right. Here's another one for you, Dr. Versi. You have previously mentioned that DMK brings to the merger a portfolio of over 750 novel molecules. Can you tell us why these are valuable and what your plans are for extracting this value?

好的。這是給您的另一份，Versi 博士。您之前曾提到，DMK 為合併帶來了超過 750 種新型分子的產品組合。您能告訴我們為什麼這些很有價值以及您計劃如何提取這種價值嗎？

Yes, sure. There is scientific literature that suggests that these compounds could be useful in alcohol use disorder, depression and anxiety, heart disease, cancer, neuroprotection and wound healing to mention some of them. More recently, tools have been developed that can screen such compounds relatively cheaply to identify these targets. We intend to use these techniques to find high-value indications. If these newly discovered potential treatments are core to our mission, we will develop them ourselves. If not, we will outlicense them to generate additional cash to fund our priority programs.

是的，當然。有科學文獻表明，這些化合物可用於治療酒精使用障礙、憂鬱症和焦慮症、心臟病、癌症、神經保護和傷口癒合等。最近，已經開發出可以相對便宜地篩選此類化合物以識別這些目標的工具。我們打算使用這些技術來尋找高價值的適應症。如果這些新發現的潛在治療方法是我們使命的核心，我們將自己發展它們。如果沒有，我們將授權他們產生額外的現金來資助我們的優先項目。

All right. Thank you. You have previously mentioned having a product to treat Parkinson's disease. What are your plans for this product?

好的。謝謝。您之前提到過有一種治療帕金森氏症的產品。您對該產品有何規劃？

Yes. I am very excited about this molecule as results from preclinical investigations, including nonhuman primate studies, suggest that it can be used as monotherapy and also as adjunctive therapy with levodopa. One, levodopa is the gold standard treatment for Parkinson's disease, and it is very effective. However, after a few years, some patients become intolerant of this and have to resort to brain surgery called DBS. I believe that this product could prevent the need for such surgery and the FDA could grant it orphan drug status, making it potentially a very valuable product for partnerships.

是的。我對這種分子感到非常興奮，因為包括非人靈長類動物研究在內的臨床前研究結果表明，它可以用作單一療法，也可以用作左旋多巴的輔助療法。一、左旋多巴是治療帕金森氏症的黃金標準，而且非常有效。然而，幾年後，一些患者變得無法忍受，不得不訴諸腦部手術，稱為 DBS。我相信該產品可以避免此類手術的需要，而 FDA 可以授予其孤兒藥地位，使其成為合作夥伴關係中非常有價值的產品。

All right. Can you provide a timeline of the key expected events for the company over the next several months?

好的。您能否提供公司未來幾個月預計發生的主要事件的時間表？

Sure. I'll take that. So next steps will be to effect a reverse stock split, as I indicated earlier, and then to proceed with the close of the merger transaction and the integration of the 2 companies. And as far as a specific timeline, I think it's realistic that, that can all be achieved in the next 30 days.

當然。我會接受的。因此，正如我之前指出的，下一步將是實施反向股票分割，然後繼續完成合併交易和兩家公司的整合。至於具體的時間表，我認為這是現實的，這一切都可以在未來30天內實現。

All right. Terrific. Thank you all. That brings us to the end of our call today. Thank you again for joining and for your interest in Adamis Pharmaceuticals. Have a nice evening, everyone.

好的。了不起。謝謝大家。今天的電話會議到此結束。再次感謝您的加入以及對 Adamis Pharmaceuticals 的興趣。祝大家有個愉快的夜晚。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與，祝您有美好的一天。