Evoke Pharma Inc (EVOK) 2024 Q4 法說會逐字稿

Good afternoon, and welcome to the Evoke Pharma fourth quarter and full-year 2024 earnings conference call. (Operator Instructions) Please be advised that today's call is being recorded.

下午好，歡迎參加 Evoke Pharma 2024 年第四季和全年財報電話會議。（操作員指示）請注意，今天的通話正在錄音。

I would now like to turn the call over to Daniel Kontoh-Boateng. Thank you, sir. You may begin.

現在我想把電話轉給丹尼爾康托-博阿滕。謝謝您，先生。你可以開始了。

Good afternoon, and thank you for participating in Evoke Pharma's conference call today. With me today are Matt D'Onofrio, Evoke's Chief Executive Officer; Chris Quesenberry, GIMOTI's Chief Commercial Officer from EVERSANA; and Mark Kowieski, Evoke's Chief Financial Officer.

下午好，感謝您今天參加 Evoke Pharma 的電話會議。今天與我一起出席的還有 Evoke 執行長 Matt D'Onofrio、來自 EVERSANA 的 GIMOTI 首席商務官 Chris Quesenberry 以及 Evoke 財務長 Mark Kowieski。

By now, you should have a copy of the press release we issued earlier. If not, it is available on the Investor Relations page of our website at evokepharma.com. We encourage everyone to read today's press release as well as Evoke's annual report on Form 10-K, which is now filed with the SEC. The company's Form 10-K and earnings release are also available on Evoke's website.

現在，您應該已經收到我們之前發布的新聞稿的副本。如果沒有，請造訪我們網站 evokepharma.com 的投資者關係頁面。我們鼓勵大家閱讀今天的新聞稿以及 Evoke 的 10-K 表格年度報告，該報告現已提交給美國證券交易委員會 (SEC)。該公司的 10-K 表格和收益報告也可在 Evoke 的網站上查閱。

Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks, uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Evoke's press releases and SEC filings, including its annual report on Form 10-K and subsequent filings.

請注意，今天電話會議上討論的某些資訊屬於《私人證券訴訟改革法案》安全港條款的涵蓋範圍。我們提醒聽眾，在本次電話會議中，管理階層將做出前瞻性陳述。由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述所明示或暗示的結果有重大差異。這些前瞻性陳述受到 Evoke 新聞稿和 SEC 文件（包括其 10-K 表格年度報告和後續文件）中包含的警示性聲明的限制。

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Evoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

本次電話會議包含時間敏感訊息，這些資訊僅在本次直播之日準確。Evoke 不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後的事件或情況的義務。

With that, I would now like to turn the call over to Matt D'Onofrio. Matt?

說完這些，我現在想把電話轉給馬特多諾弗里奧 (Matt D'Onofrio)。馬特？

Thank you, Daniel. Good afternoon, everyone. Thanks for joining today. I want to start with a patient story to keep our focus on why we're working so tirelessly to help persons suffering from gastroparesis. This quote here is from a real person, a patient that underscores why we do what we do at Evoke Pharma.

謝謝你，丹尼爾。大家下午好。感謝您今天的加入。我想先講一個病人的故事，讓我們專注在為什麼我們要如此不懈地幫助胃輕癱患者。這句話出自一個真實的人，一個病人，它強調了為什麼我們在 Evoke Pharma 做我們所做的事情。

A physician recently described to us a 23-year-old patient who had been to the ER eight times in the prior six months to him receiving our medication. He had lost his job, had moved back in with his parents and he had dropped below 100 pounds. He and his mother were desperate for solution.

一位醫生最近向我們描述了一位 23 歲的患者，他在接受我們的藥物治療之前的六個月內已經去過急診室八次。他失去了工作，搬回父母家住，體重也降到了 100 磅以下。他和他的母親迫切地想要找到解決辦法。

One month after starting of GIMOTI, he had not returned to the hospital. He had started regaining weight and he had only experienced one episode of vomiting when he missed a dose. That's the kind of life-changing impact we aim to deliver. Stories like these drive us forward and reinforce our mission to make a meaningful difference in the lives of gastroparesis patients.

開始使用 GIMOTI 一個月後，他就沒有再去過醫院。他的體重已開始恢復，並且只在漏服藥時出現過一次嘔吐。這就是我們想要實現的改變生活的影響。類似這樣的故事推動我們前進，並強化了我們的使命，為胃輕癱患者的生活帶來有意義的改變。

2024 was another growth year for Evoke Pharma. It was a year where we executed on our strategy, gained traction in the market and delivered strong financial results. We achieved $10.2 million in total revenue, reflecting a 97% year-over-year increase, surpassing our prior $9.5 million to $10 million guidance. In Q4 alone, we saw revenue of $3.3 million, a 24.6% sequential increase.

2024 年是 Evoke Pharma 的另一個成長年。這是我們執行策略、在市場上取得進展並取得強勁財務業績的一年。我們的總收入達到了 1,020 萬美元，年增 97%，超過了我們之前 950 萬至 1,000 萬美元的預期。光是第四季度，我們的營收就達到 330 萬美元，季增 24.6%。

A major driver of this growth was the expansion of GIMOTI's prescriber base and improved prescription fulfillment. The transition to Aspen pharmacies played a crucial role in this, significantly accelerating the delivery time of GIMOTI and rapid adjudication of insurance authorizations for patients. This, along with our growing provider engagement, led to a 46% increase in prescribers year over year, bringing our total cumulative prescriber base to 2,553.

這一增長的主要驅動力是 GIMOTI 處方人員基礎的擴大和處方履行能力的提高。向 Aspen 藥局的過渡在其中發揮了至關重要的作用，大大加快了 GIMOTI 的交付時間并快速裁決了患者的保險授權。再加上我們與供應商的持續合作，我們的處方數量比去年同期增加了 46%，使我們的累積處方數量達到 2,553 人。

Additionally, fill rates increased 72% year over year and patient enrollments grew 22%. Our corporate position continues to improve with two additional Orange Book listed patents that were allowed in 2024 and recently posted to the FDA website. We now have six listed patents related to GIMOTI into 2030. Additionally, the recent Vanda CRL and FDA's posted notice on domperidone discontinuation via the compassionate use program further emphasize the critical need for GIMOTI.

此外，填充率年增 72%，患者登記人數增加 22%。我們的公司地位繼續提升，另外兩項橙皮書列出的專利於 2024 年獲得批准，並於最近發佈在 FDA 網站上。我們目前擁有六項與 GIMOTI 相關的 2030 年專利。此外，最近 Vanda CRL 和 FDA 透過同情用藥計畫發布的關於停用多潘立酮的通知進一步強調了 GIMOTI 的迫切需求。

GIMOTI remains the only approved product to treat this disease that has any evidence of improvement over prior standard of care oral metoclopramide. We continue to capture stories of patients that are not adequately treated with oral medications and find relief with GIMOTI, the only non-oral and reliable FDA-approved nasal treatment for gastroparesis.

GIMOTI 仍然是唯一獲準用於治療這種疾病的產品，並且有證據表明其比先前的標準治療口服甲氧氯普胺有改善。我們繼續記錄那些口服藥物治療不充分的患者的故事，他們透過 GIMOTI 找到了緩解的方法，GIMOTI 是唯一獲得 FDA 批准的可靠的非口服胃輕癱鼻腔治療方法。

Evoke remains the only company positioned to elevate treatment for this devastating disease. Now I'll turn to Chris to recap our commercial progress over the course of 2024 and plans moving forward into 2025.

Evoke 仍然是唯一一家致力於提高這種毀滅性疾病治療水平的公司。現在，我請克里斯回顧我們在 2024 年的商業進展以及 2025 年的計畫。

Thanks, Matt, and good afternoon, everyone. To reinforce Matt's summary of 2024, in addition to improving the efficiency of our processes with our Aspen partner pharmacy, we had a number of milestone moments in 2024 that helped us to achieve the growth that Matt described. We expanded our pharmacy distribution network to create redundancy in key markets and mitigate loss of out-of-network strips in other markets. We continue to build evidence supporting the utilization of GIMOTI and challenge the use of oral metoclopramide as the standard of care for patients with gastroparesis. And we improved our execution in the field and overall by launching a fully integrated omnichannel program powered by artificial intelligence and launched a new marketing campaign focused on switch.

謝謝，馬特，大家下午好。為了強化 Matt 對 2024 年的總結，除了與 Aspen 合作藥局一起提高流程效率之外，我們在 2024 年還經歷了許多里程碑時刻，幫助我們實現了 Matt 所描述的成長。我們擴大了藥房分銷網絡，以在主要市場創造冗餘，並減輕其他市場網絡外的損失。我們將繼續收集支持使用 GIMOTI 的證據，並對使用口服甲氧氯普胺作為胃輕癱患者護理標準提出質疑。我們透過推出由人工智慧驅動的完全整合的全通路計畫提高了我們在該領域和整體的執行力，並啟動了一項專注於轉換的新行銷活動。

Our message is being heard and recognized in various channels, including awards and presentations at congresses, attendance at sponsored speaking programs and publications of our data. Beyond commercial execution, we have also made meaningful strides in clinical validation. Our healthcare resource utilization, or HRU data has continued to reinforce the value proposition of GIMOTI. At ACG in October of 2024, we presented data evaluating the impact of GIMOTI, our FDA-approved metoclopramide nasal spray in patients with diabetic gastroparesis who are simultaneously taking GLP-1 receptor agonist. This research highlights GIMOTI's role as a potential supportive therapy for GLP-1 users experiencing gastroparesis symptoms.

我們的訊息透過各種管道被聽到和認可，包括在會議上獲獎和演講、參加贊助演講計劃以及發布我們的數據。除了商業執行之外，我們在臨床驗證方面也取得了有意義的進展。我們的醫療資源利用率或 HRU 數據不斷強化 GIMOTI 的價值主張。2024 年 10 月，在 ACG 上，我們展示了評估 GIMOTI（我們經 FDA 批准的甲氧氯普胺鼻噴劑）對同時服用 GLP-1 受體激動劑的糖尿病胃輕癱患者的影響的數據。這項研究強調了 GIMOTI 作為 GLP-1 胃輕癱患者的潛在支持療法的作用。

Furthermore, given the frequent questions and interest from providers on this topic, we are now integrating this data into our educational efforts. ACG was a defining moment for us. Not only did we receive the Presidential Poster award, but our larger booth presence allowed us to engage with hundreds of physicians, double the number of interactions from last year, many of whom were learning about GIMOTI for the first time and a good number who specifically sought us out. This underscores what we already believe. We are just scratching the surface in terms of market penetration.

此外，鑑於提供者經常詢問並關注此主題，我們現在將這些數據整合到我們的教育工作中。ACG 對我們來說是一個決定性的時刻。我們不僅獲得了總統海報獎，而且我們更大的展位讓我們有機會與數百名醫生進行交流，互動次數是去年的兩倍，其中許多人是第一次了解 GIMOTI，還有相當一部分人是專門來找我們的。這強調了我們已然相信的事。就市場滲透而言，我們才剛開始觸及表面。

Awareness remains a top priority. And with EVERSANA's expanded efforts, we are well positioned to accelerate broad provider education and drive adoption.

提高認識仍然是重中之重。隨著 EVERSANA 的努力不斷擴大，我們已做好準備，加速廣泛的供應商教育並推動採用。

Again, to emphasize the impact of working with Aspen over the past year, this transition has been one of the most effective commercial strategies we've implemented. It has not only streamlined prescription fulfillment, but has also improved the overall patient experience, reducing frustration and improving adherence. Aspen's high patient retention rates helps to ensure that more patients stay on therapy, which is critical for improving outcomes and supporting provider confidence in prescribing GIMOTI.

再次強調，為了強調過去一年與 Aspen 合作的影響，這次轉型是我們實施的最有效的商業策略之一。它不僅簡化了處方的執行，還改善了整體患者體驗，減少了挫折感並提高了依從性。Aspen 的高患者保留率有助於確保更多患者繼續接受治療，這對於改善治療結果和支持提供者對開立 GIMOTI 的信心至關重要。

The result of these adjustments to strategy and tactical moves is that we were able to double revenue in 2024 from 2023. And in fact, we've doubled revenue 2x over the last two years. We are making an impact in the market and showing that we can impact both providers' behaviors as well as our own processes to continue to build on the performance of GIMOTI. We took particularly big strides in the second and fourth quarter of last year and plan to continue progress towards growing business and market share as well as breadth of prescribing for GIMOTI. In fact, as we continue to add new prescribers to the ranks of GIMOTI, the depth of prescribing continues to grow.

這些策略和戰術調整的結果是，我們能夠將 2024 年的收入比 2023 年翻倍。事實上，過去兩年我們的收入翻了一番。我們正在對市場產生影響，並表明我們可以影響供應商的行為以及我們自己的流程，以繼續鞏固 GIMOTI 的績效。我們在去年第二季和第四季取得了特別大的進步，並計劃繼續努力擴大業務和市場份額以及擴大 GIMOTI 的處方廣度。事實上，隨著我們不斷將新的處方者加入 GIMOTI 隊伍，處方的深度也在不斷增長。

On average, we add between 65 and 75 new prescribers each month who generally write for their first prescription, and yet we still continue to see the depth of prescribing per physician continue to grow and is now at nearly 6.5 scripts per prescriber. We believe neither of these trends show signs of slowing and underscores the fact, again, that we have only scratched the surface for this brand in this market, and there is and continues to be significant upside potential. When we look at patients and the average number of months on therapy, the trends are remarkably similar to the ones you see on this graph. They continue to grow, and they show no signs of abating either.

平均而言，我們每月新增 65 至 75 名開立處方的新醫生，他們通常都會開出第一張處方，但我們仍然看到每位醫生的開立處方量持續增長，目前每位開立處方的醫生開立處方量接近 6.5 張。我們認為，這兩種趨勢都沒有放緩的跡象，並再次強調，我們才剛剛觸及這個品牌在這個市場上的表面，而且還有並將繼續存在巨大的上升潛力。當我們觀察患者和接受治療的平均月數時，趨勢與您在此圖表上看到的趨勢非常相似。它們繼續增長，並且沒有減弱的跡象。

I'm excited because we continue to see signs of repeat patients with prescription renewals, strong refill rates and overall fill rates that are cumulatively catching up to cumulative prescriptions since launch. Let's now look at the efficacy of key components of our program. There are several improvements we have made within our processes, communication, and education in coordination with our pharmacy partner, Aspen. They have leading capabilities in communicating and onboarding patients, reporting and transparency and tools for providers to support access for patients to important medications like GIMOTI.

我很興奮，因為我們不斷看到重複患者的跡象，他們的處方不斷更新，續藥率很高，而且總體配藥率累計趕上了自推出以來的累計處方量。現在讓我們來看看我們計劃的關鍵組成部分的功效。我們與藥房合作夥伴 Aspen 合作，在流程、溝通和教育方面做出了多項改進。他們在與患者溝通和入院、報告和透明度以及為供應商提供支持患者獲得 GIMOTI 等重要藥物的工具方面擁有領先的能力。

We are focused on streamlining the process and integrating it into the providers' workflow as much as possible. A significant indicator of those efforts is seen a meaningful rise in conversion rates over the course of the year. The quality of those same adjustments is reflected in the improvement in the conversion rate for each payer type throughout the year. In addition to improvements with the processes with Aspen, we added capacity and coverage by expanding our distribution network by seven dispensing pharmacies. These partnerships have helped us patch holes in a payer system that, in some instances, requires pharmacies to be part of a PBM's network of pharmacies or in others requires them to be within the state where the prescription is filled.

我們專注於簡化流程並盡可能將其整合到提供者的工作流程中。這些努力的一個重要指標是，轉換率在一年內顯著上升。這些調整的品質反映在每個付款人類型的轉換率全年的提高。除了透過 Aspen 改進流程之外，我們還透過擴大七家配藥藥房的分銷網絡來提高容量和覆蓋範圍。這些合作關係幫助我們修補了付款系統中的漏洞，在某些情況下，該系統要求藥房成為 PBM 藥房網路的一部分，或者在其他情況下要求它們位於配藥的州內。

We added these pharmacies throughout the year, which contributed to a 30% faster speed to therapy for patients, which is essentially the time between the prescription intake and the receipt by the patient of GIMOTI, a significant reduction in out-of-network prescriptions and increased overall conversion and reimbursement. This yielded a growth in year-over-year expenses by 72%.

我們全年增加了這些藥房，使患者的治療速度提高了 30%，這基本上是從處方到患者收到 GIMOTI 之間的時間，大大減少了網絡外處方，並提高了整體轉化和報銷。這導致支出比去年同期增加了 72%。

Importantly, when patients get their prescriptions filled, it increases both their confidence and prescriber confidence, which is a very important currency for us. No matter what the market, data is king, and the gastroparesis market is not different. While we have a nasal route of administration that demonstrated faster bioavailability and clinical trial efficacy that shows relief of symptoms, previously, we couldn't answer two critical questions that physicians had.

重要的是，當患者拿到處方藥時，他們的信心和開處方者的信心都會增加，這對我們來說是非常重要的。無論哪個市場，數據為王，胃輕癱市場也不例外。雖然我們有一種經鼻給藥途徑，顯示出更快的生物利用度和臨床試驗效果，表明可以緩解症狀，但以前，我們無法回答醫生的兩個關鍵問題。

First, does the nasal route of administration really matter? And second, are you any better than oral metoclopramide. Our retrospective real-world data and perhaps one of the largest studies of patients with gastroparesis was a significant step towards answering those questions. We demonstrated that GIMOTI was significantly better than oral metoclopramide in reducing ER visits and hospitalizations. Emphasizing the point, nearly 2/3 of patients in the GIMOTI group previously took oral metoclopramide.

首先，鼻腔給藥途徑真的很重要嗎？其次，你比口服甲氧氯普胺好嗎？我們回顧的真實世界數據以及可能是對胃輕癱患者最大規模的研究之一，是朝著回答這些問題邁出的重要一步。我們證明 GIMOTI 在減少急診就診和住院方面明顯優於口服甲氧氯普胺。值得強調的是，GIMOTI 組中近 2/3 的患者之前曾服用口服甲氧氯普胺。

So by switching from oral to the nasal route of administration, the patients achieved better results. In fact, it somewhat answers a third important question, which is if a patient is not doing well on oral metoclopramide, would they see benefit by switching to GIMOTI. We think the answer is yes. So armed with these data, we feel confident that we can move GIMOTI from a product providers are willing to try to a product they rely upon. So we've taken this message to the market, and we've initiated a definitive switch campaign and then supercharge that with an omnichannel campaign powered by artificial intelligence that we launched at the beginning of Q4 last year.

因此，透過從口服給藥途徑改為鼻腔給藥途徑，患者獲得了更好的治療效果。事實上，它在某種程度上回答了第三個重要問題，即如果患者口服甲氧氯普胺效果不佳，那麼改用 GIMOTI 是否會有益。我們認為答案是肯定的。因此，有了這些數據，我們有信心將 GIMOTI 從供應商願意嘗試的產品轉變為他們依賴的產品。因此，我們將這一訊息傳達給了市場，並發起了一場明確的轉換活動，然後透過去年第四季初推出的由人工智慧驅動的全通路活動來增強這項活動。

Our message is reaching a broader audience with a faster cadence and a more reliable presence than ever before. We believe we have high commitment within our sales team and a significant engagement with our providers. In fact, we've been able to improve our reach to targeted physicians to 60%, make more than 2,000 additional calls that we wouldn't have been able to make beforehand and send content over e-mail that was engaging enough to compel a 16% open rate versus an industry average of 2%.

我們的訊息正以比以往更快的節奏和更可靠的方式傳達給更廣泛的受眾。我們相信我們的銷售團隊具有高度的責任感，並且與我們的供應商有著密切的合作。事實上，我們已經能夠將對目標醫生的覆蓋率提高到 60%，多打了 2,000 多個電話（這些電話是我們之前無法撥打的），並且透過電子郵件發送了足夠吸引人的內容，從而使郵件開啟率達到 16%，而行業平均開啟率為 2%。

Qualitatively, we know we're having an impact because more providers are seeking GIMOTI out rather than us introducing GIMOTI to them and providers are asking more questions and digging deeper into our data.

從品質上講，我們知道我們正在產生影響，因為更多的供應商正在尋求 GIMOTI，而不是我們向他們介紹 GIMOTI，而供應商正在提出更多問題並更深入地挖掘我們的數據。

As I transition from accomplishments in 2024 that doubled net revenue, we need to dig deeper into 2025 to achieve our own performance expectations. We aim to build on this momentum we've earned and not rest on those achievements.

當我從 2024 年淨收入翻倍的成就轉變時，我們需要更深入地挖掘 2025 年以實現我們自己的績效預期。我們的目標是繼續鞏固我們已取得的勢頭，而不是停留在已取得的成就上。

As I've said, we have only scratched the surface, and there are so many more patients who we can potentially help. One area where there's still significant room for impact is on the pharmacy side and doing so in a strategic and thoughtful manner. Within gastroenterology, the landscape has been changing pretty dramatically and thousands of providers are now part of very large GI practice organizations.

正如我所說，我們才剛開始，我們還有更多的患者需要幫助。藥局方面仍有很大影響空間，需要以策略性和深思熟慮的方式進行。在胃腸病學領域，情況發生了巨大的變化，現在有數千名醫療服務提供者加入了非常大的胃腸病學實踐組織。

These organizations are purpose-built to economize on share operational needs and to scale to offer services to patients, hospital systems and payers.

這些組織的目的是節省共享營運需求並擴大規模為病患、醫院系統和付款人提供服務。

Based on their size, they have increasing cloud and many of them have preferred specialty pharmacies they work with, and our goal is to meet them where they're at. We have many common goals and objectives, primarily centered on improved patient care and wanting a streamlined process. By adding pharmacies here and in this way, we believe it will be additive to our business. As we grow volume and continue to obtain prior authorizations, we're going to invest in improving this process as well.

根據他們的規模，他們的雲不斷增加，其中許多都有他們合作的首選專業藥房，我們的目標是在他們所在的地方與他們會面。我們有許多共同的目標和目的，主要集中在改善患者護理和簡化流程。我們相信，透過在這裡以這種方式增加藥局，我們的業務將會增加。隨著我們業務量的增加和持續獲得事先授權，我們也將投資改善這項流程。

And I'm really excited to announce that we recently added four field reimbursement managers or FRMs and a leader to serve as a resource to prescribers in the prior authorization process or currently only 50% of them are being completed. We have demonstrated, though, that we can improve the completion rate with our sales team, but that took them off the task of selling. By deploying FRMs, we hope to solve a pain point for prescribers, the task of obtaining prior authorizations, which to take them away from patient care, and we solve a pain point for ourselves by increasing the completion and quality of prior authorizations.

我很高興地宣布，我們最近增加了四名現場報銷經理或 FRM 和一名領導，為處方人員提供事先授權流程的資源，目前只有 50％ 的流程正在完成。然而，我們已經證明，我們可以提高銷售團隊的完成率，但這使他們無法完成銷售任務。透過部署 FRM，我們希望解決處方人員的一個痛點，即獲取事先授權的任務，這使他們不再專注於患者護理，而我們透過提高事先授權的完整性和品質來解決我們自己的一個痛點。

We expect this to impact conversions, gross to net and again, overall confidence in prescribing. And we're going to continue to invest in evidence generation and education to reinforce that GIMOTI should be the standard of care. We will continue to feature our healthcare resource reduction data prominently. As I mentioned earlier, recently, we have provided data to the growing discussion about GLP-1 use and the association with symptoms like nausea, vomiting and gastroparesis.

我們預計這將影響總收入與淨收入的轉換率，以及對處方的整體信心。我們將繼續投資於證據生成和教育，以強調 GIMOTI 應該成為護理標準。我們將繼續重點展示我們的醫療資源減少數據。正如我之前提到的，最近，我們為有關 GLP-1 的使用及其與噁心、嘔吐和胃輕癱等症狀的關聯的日益激烈的討論提供了數據。

In a sub-analysis of our HRU data in 92 patients, we showed that patients taking GIMOTI fared better than patients taking oral metoclopramide across different healthcare visits. While these data are limited, we believe GIMOTI can be an option for patients on a GLP-1 who have diabetes and suffer from gastroparesis. This pillar of evidence will continue to be an important part of GIMOTI and will further entrench the brand in the market today and serve to differentiate GIMOTI against future entrants.

在對 92 名患者的 HRU 數據進行的子分析中，我們發現服用 GIMOTI 的患者在不同的醫療保健訪問中的表現優於服用口服甲氧氯普胺的患者。雖然這些數據有限，但我們相信 GIMOTI 可以成為患有糖尿病和胃輕癱的 GLP-1 患者的一種選擇。這項證據支柱將繼續成為 GIMOTI 的重要組成部分，並將進一步鞏固該品牌在當今市場的地位，並使 GIMOTI 有別於未來的進入者。

In summary, we are ambitious about our plans and goals for 2025. We set some solid groundwork and have made adjustments to capitalize on our opportunities and diminish our challenges. Our aim is to continue to build on our performance. We are strategically partnering with select pharmacies, improving the prior authorization process, expanding our share of voice and improving our execution, adding to the reasons to believe in GIMOTI through evidence and data and continuing to challenge ourselves on where else GIMOTI might add value to patients and providers.

總而言之，我們對 2025 年的計畫和目標充滿野心。我們打下了堅實的基礎，並做出了調整以利用機會並減少挑戰。我們的目標是繼續提高我們的業績。我們正在與精選藥局建立策略合作夥伴關係，改善事先授權流程，擴大我們的發言權並提高我們的執行力，透過證據和數據增加相信 GIMOTI 的理由，並繼續挑戰自己，看看 GIMOTI 還能在哪些方面為患者和提供者增加價值。

With that, I'll turn the call over to our Chief Financial Officer, Mark, to go over the financials.

說完這些，我將把電話轉給我們的財務長馬克，讓他來討論一下財務狀況。

Thanks, Chris. Once again, thank you for all joining us this afternoon. I'll get right into Evoke's financials for the fourth quarter and full year-end 2024 results. As Matt mentioned, for the fourth quarter of 2024, net product sales were approximately $3.3 million compared with $1.7 million during the fourth quarter of 2023, and the net loss was approximately $1.2 million or $0.49 per share compared with $2 million or $7.13 per share for the fourth quarter of 2023.

謝謝，克里斯。再次感謝大家今天下午的參加。我將直接介紹 Evoke 第四季和 2024 年全年的財務表現。正如馬特所提到的，2024 年第四季度，淨產品銷售額約為 330 萬美元，而 2023 年第四季為 170 萬美元；淨虧損約為 120 萬美元或每股 0.49 美元，而 2023 年第四季為 200 萬美元或每股 7.13 美元。

For the year ended December 31, 2024, net product sales were approximately $10.2 million compared with approximately $5.2 million for the year ended December 31, 2023, and the net loss was approximately $5.4 million or $2.81 per share compared with a net loss of $7.8 million or $27.97 per share for the year ended December 31, 2023. The year-over-year increase in revenue was due to the higher net product sales in 2024, resulting from enhanced prescription fulfillment through the Aspen pharmacy network, robust commercialization efforts and increased provider awareness through marketing of head-to-head real-world data demonstrating GIMOTI healthcare resource utilization benefits over oral metoclopramide.

截至 2024 年 12 月 31 日止年度，淨產品銷售額約為 1,020 萬美元，而截至 2023 年 12 月 31 日止年度約為 520 萬美元，淨虧損約為 540 萬美元或每股 2.81 美元，而截至 2023 年 12 月 31 日為每股 27.70 萬美元的淨虧損 270 萬美元。營收年增率是由於 2024 年淨產品銷售額增加，這得益於透過 Aspen 藥局網路增強了處方履行能力、大力開展商業化努力以及透過行銷面對面真實世界數據提高了供應商意識，證明了 GIMOTI 醫療資源利用優勢優於口服甲氧氯普胺。

There were no research and development expenses incurred during the fourth quarter of 2024 compared to $23,000 for the fourth quarter of 2023. For the full year of 2024, research and development expenses were approximately $16,000 compared with approximately $0.2 million for the prior year. For the fourth quarter of 2024, selling, general and administrative expenses were approximately $4.4 million compared to $3.5 million for the fourth quarter of 2023. For the year ended December 31, 2024, SG&A expenses were approximately $15.1 million versus approximately $12.2 million for the year ended December 31, 2023.

2024 年第四季沒有發生研發費用，而 2023 年第四季為 23,000 美元。2024 年全年研發費用約為 16,000 美元，而前一年約為 20 萬美元。2024 年第四季的銷售、一般和行政費用約為 440 萬美元，而 2023 年第四季為 350 萬美元。截至 2024 年 12 月 31 日止年度，銷售、一般及行政費用約為 1,510 萬美元，而截至 2023 年 12 月 31 日止年度約為 1,220 萬美元。

The increase in SG&A costs year over year resulted primarily from higher marketing and EVERSANA profit sharing costs. We expect that SG&A expenses will increase in the future as we continue to progress with the commercialization of GIMOTI and we reimburse EVERSANA from the sales of GIMOTI. Total operating expenses for the fourth quarter of 2024 were approximately $4.5 million compared to $3.6 million for the same period of 2023. For the year ended December 31, 2024, total operating expenses were approximately $15.5 million compared with approximately $12.6 million for the full year of 2023.

銷售、一般及行政費用較去年同期增加主要是由於行銷和 EVERSANA 利潤分享成本增加。我們預計，隨著 GIMOTI 商業化的不斷推進以及我們從 GIMOTI 的銷售額中償還 EVERSANA，未來銷售、一般及行政費用 (SG&A) 支出將會增加。2024 年第四季的總營運費用約為 450 萬美元，而 2023 年同期為 360 萬美元。截至 2024 年 12 月 31 日止年度，總營運費用約為 1,550 萬美元，而 2023 年全年約為 1,260 萬美元。

As of December 31, 2024, cash and cash equivalents were approximately $13.6 million. We believe, based on our current operating plan that our existing cash and cash equivalents, including proceeds raised from financings in 2024 as well as future cash flows from net product sales of GIMOTI will be sufficient to fund our operations into the first quarter of 2026.

截至 2024 年 12 月 31 日，現金及現金等價物約為 1,360 萬美元。我們相信，根據我們目前的營運計劃，我們現有的現金和現金等價物（包括 2024 年融資籌集的收益以及 GIMOTI 淨產品銷售的未來現金流）將足以資助我們到 2026 年第一季的營運。

It's worth reiterating that one of the biggest financial milestones of 2024 was our $14.3 million capital raise, which was achieved through equity financings and warrant exercises. This funding has allowed us to ensure Nasdaq compliance and extend our cash runway into Q1 2026, giving us the financial flexibility we need to execute operations smoothly and expand market access.

值得重申的是，2024 年最大的財務里程碑之一是我們透過股權融資和認股權證行使實現的 1,430 萬美元融資。這筆資金使我們能夠確保符合納斯達克的規定，並將我們的現金流延長至 2026 年第一季度，從而為我們順利開展營運和擴大市場准入提供了所需的財務靈活性。

We have a strong financial outlook for 2025. As noted in our press release, we are projecting net revenue guidance of approximately $16 million, which represents a 60% increase over 2024 net revenue. This projection is built on the momentum we've established, improved reimbursement pathways and increasing prescription fills.

我們對 2025 年的財務前景充滿信心。正如我們的新聞稿中所述，我們預計淨收入約為 1,600 萬美元，比 2024 年淨收入成長 60%。這項預測建立在我們已經建立的勢頭、改進的報銷途徑和增加的處方藥量的基礎上。

Of course, as with any guidance, this outlook also considers external factors outside our control, such as macroeconomic conditions, supply chain constraints and inflationary pressures. That said, we remain highly confident in our ability to execute and continue delivering strong results.

當然，與任何指導一樣，這項展望也考慮了我們無法控制的外部因素，例如宏觀經濟條件、供應鏈限制和通膨壓力。儘管如此，我們仍然對我們的執行能力和持續取得強勁成果充滿信心。

And with that, we'll open the call to questions. Operator?

接下來，我們將開始提問。操作員？

(Operator Instructions) Yale Jen, Laidlaw & Company.

（操作員指示）Yale Jen，Laidlaw＆Company。

Congrats on good quarter. We have two questions here. The first one, I just want to look at the competitive landscape that you have the Vanda drug [CIS] complete response letter and also the compassion use of being pulled out from the FDA. How do you see that impact on the competitive landscape? And what do you feel that the compassion use -- the scope of compassion use drug and how much that could potentially be in the -- you can capture some of those.

恭喜本季取得良好業績。這裡我們有兩個問題。第一個問題，我只想看看你們的競爭格局，包括 Vanda 藥物 [CIS] 完整回應函以及被 FDA 撤銷的同情使用許可。您如何看待這對競爭格局的影響？您認為同情用藥——同情用藥的範圍以及其潛在作用有多大——您可以了解其中的一些嗎？

Sure, sure. I'll make a comment and then maybe, Chris, you can chime in. It's really hard to know exactly what will happen in terms of the domperidone component. We don't know when it will finally run out. We know that we said sometime this year.

當然，當然。我會發表評論，然後也許克里斯，你可以插話。就多潘立酮成分而言，很難確切知道會發生什麼。我們不知道它什麼時候會最終用完。我們知道我們在今年某個時候說過。

Obviously, there are patients that are out there taking it through that mechanism. The exact number is not reported anywhere, so we don't know.

顯然，有些患者正在透過這種機制服用該藥物。確切的數字並未在任何地方報道，所以我們不知道。

We also know that some patients getting illegally shipped in from Canada or other countries externally, which would probably continue as well. We recognize that there's just a big need for product, and it's most likely going to end up in some way falling into our laps in terms of those patients are probably going to end up having to turn to an alternative like GIMOTI. I'll stop with that, and maybe, Chris, you can further chime in.

我們也知道，有些病人從加拿大或其他國家非法運送進來，這種情況可能還會持續下去。我們認識到對產品的需求很大，而且它很可能會以某種方式落入我們的手中，因為那些患者最終可能不得不轉向像 GIMOTI 這樣的替代品。我就講到這裡，克里斯，也許你可以進一步加入討論。

I agree, Matt. It's not clear the volume. But what is clear is that yet another option is no longer available for patients sometime later this year. That continues to cement Evoke as a leader in this market. And as patients and their providers turn to options, then we will be there as an option for them.

我同意，馬特。音量不清楚。但可以肯定的是，今年稍後患者將不再有其他選擇。這進一步鞏固了 Evoke 在該市場的領先地位。當患者及其醫療服務提供者尋求治療選擇時，我們就會為他們提供選擇。

Okay. Great. That's very helpful. Maybe a follow-up question here that I remember a few quarters -- in the prior quarters, you guys are talking about increased Medicaid pharmacies in different states. Any update on that at that front?

好的。偉大的。這非常有幫助。也許這裡有一個後續問題，我記得幾個季度——在前幾個季度，你們正在談論不同州增加醫療補助藥房。有這方面的最新消息嗎？

Yes. Chris, why don't you take this one?

是的。克里斯，你為什麼不接受這個？

Yes. So that strategy, as I mentioned earlier, has helped us. And you saw earlier in the slide that the conversion rate of Medicaid and Medicare scripts has increased over the year. And part of that reason is because we have brought on board those seven additional dispensing pharmacies. Medicaid, as an example, has gone from about 2% of our business at the early part of 2024 to now between 5% and 7%, depending upon the month.

是的。正如我之前提到的，該策略對我們有所幫助。您在幻燈片中看到，醫療補助和醫療保險處方的轉換率在一年內增加。部分原因是我們已新增了 7 家配藥藥局。以醫療補助為例，其比例已從 2024 年初的 2% 上升至現在的 5% 至 7% 之間（具體比例取決於月份）。

So it's growing. And as we demonstrate to providers that we can fill those prescriptions, we believe that will continue to grow.

所以它正在增長。當我們向供應商證明我們可以配這些處方時，我們相信這個數字將會繼續成長。

(Operator Instructions) And there are no further questions on the line at this time. So this concludes the Q&A portion for today's call. I would now like to turn the call back over to Matt D'Onofrio for any additional or closing remarks.

（操作員指示）目前線路上沒有其他問題。今天電話會議的問答部分到此結束。現在，我想將電話轉回給馬特·多諾弗里奧 (Matt D'Onofrio)，請他發表任何補充或結束語。

Sure. Before we conclude the call, I want to take a moment to reflect on where we are heading. Looking ahead into 2025 and beyond, our strategy remains clear, expand pharmacy partnerships to continue improving access, increase provider awareness and engagement to drive broader adoption of GIMOTI, leverage real-world data to strengthen payer discussions and reinforce GIMOTI's value, continue improving prescription fulfillment rates to reduce leakage and abandonment and as per our mindset since Evoke's inception, maintain a disciplined approach to capital allocation, ensuring we maximize the return on every dollar invested in commercialization.

當然。在我們結束通話之前，我想花點時間思考我們接下來要去的地方。展望 2025 年及以後，我們的策略仍然明確，擴大藥房合作夥伴關係以繼續改善藥物獲取途徑，提高供應商意識和參與度以推動更廣泛地採用 GIMOTI，利用真實世界數據加強付款人討論並強化 GIMOTI 的價值，繼續提高處方履行率以減少洩漏和放棄，並按照我們自 Evoke 成立以來的每一筆思維方式，保持嚴格的資金在商業上的資本化。

We've built strong momentum, and we are in a great position to capitalize on the foundation we've laid over the past year. With the right commercial infrastructure, strong strategic partnerships and growing clinical validation, we believe GIMOTI is on its way to becoming the standard of care for gastroparesis treatment. We are looking forward to sharing our progress over the course of the year, and thank you for your continued support.

我們已經建立了強勁的勢頭，並且我們處於有利地位，可以利用過去一年來奠定的基礎。憑藉正確的商業基礎設施、強大的策略合作夥伴關係和不斷增長的臨床驗證，我們相信 GIMOTI 將成為胃輕癱治療的標準。我們期待分享我們在這一年中取得的進展，並感謝您一直以來的支持。

This concludes today's Evoke Pharma fourth quarter and full-year 2024 earnings call and webcast. You may disconnect your line at this time, and have a wonderful day.

今天的 Evoke Pharma 第四季和 2024 年全年收益電話會議和網路直播到此結束。此時您可以斷開線路，祝您有美好的一天。