Evoke Pharma Inc (EVOK) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to the Evoke Pharma fourth quarter and full year 2022 earnings conference call. (Operator Instructions) Please be advised that today's call is being recorded. I will now turn the call over to Daniel Kontoh-Boateng. Thank you, and you may begin.

下午好，歡迎來到 Evoke Pharma 第四季度和 2022 年全年收益電話會議。 （接線員說明）請注意，今天的通話正在錄音中。我現在將把電話轉給 Daniel Kontoh-Boateng。謝謝，你可以開始了。

Good afternoon and thank you for participating in Evoke Pharma's conference call today. With me today are David Gonyer, Chief Executive Officer; Chris Quesenberry, GIMOTI's Chief Commercial Officer from Eversana; and Matthew J. D'Onofrio, Evoke's Chief Business Officer.

下午好，感謝您今天參加 Evoke Pharma 的電話會議。今天和我在一起的是首席執行官 David Gonyer；來自 Eversana 的 GIMOTI 首席商務官 Chris Quesenberry；以及 Evoke 的首席商務官 Matthew J. D'Onofrio。

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.

到現在為止，您應該有一份我們之前發布的新聞稿。如果沒有，可以在我們網站 evokepharma.com 的投資者關係頁面上找到。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。公司的 10-K 表格和收益發布也可以在 Evoke 的網站上找到。

Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigations 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 risk and uncertainties associated with the company's business.

請注意，今天電話會議上討論的某些信息包含在《私人證券訴訟改革法》的安全港條款中。我們提醒聽眾，在此次電話會議期間，管理層將發表前瞻性陳述。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中明示或暗示的結果存在重大差異。

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. 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.

這些前瞻性陳述符合 Evoke 的新聞稿和 SEC 文件中包含的警示性聲明，包括其 10-K 表格年度報告和後續文件。此電話會議包含時間敏感信息，這些信息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之後發生的事件或情況的義務。

With that, I would now like to turn the call over to David Gonyer. Dave?

有了這個，我現在想把電話轉給 David Gonyer。戴夫？

Thank you, Daniel, and thanks, everyone, for joining us today. I'll start by outlining the important progress Evoke made in 2022 in meeting key strategic goals. I'll also review key events and metrics in the fourth quarter of 2022 and thus far in 2023. I'll then turn the call over to Chris and Matt who will discuss commercial operations and financials.

謝謝你，丹尼爾，也感謝大家今天加入我們。首先，我將概述 Evoke 在 2022 年實現關鍵戰略目標方面取得的重要進展。我還將回顧 2022 年第四季度和 2023 年到目前為止的關鍵事件和指標。然後我會將電話轉給 Chris 和 Matt，他們將討論商業運營和財務。

As I mentioned in today's release, Evoke's fiscal year 2022 was a period of significant growth and progress on several key fronts. Year-over-year revenues, new GIMOTI prescribers, prescription fills, and patient enrollments, all showed substantial improvements in 2022 compared to 2021.

正如我在今天的新聞稿中提到的，Evoke 的 2022 財年是幾個關鍵領域取得顯著增長和進步的時期。與 2021 年相比，2022 年的同比收入、新的 GIMOTI 處方者、處方填寫和患者註冊均顯示出顯著改善。

Looking back in 2021, we focused our attention to GIMOTI's value proposition in the marketplace. There was, and is, a clear unmet need in the market for a non-oral treatment for symptoms associated for diabetic gastroparesis, which for those who are new to the story, is a stomach paralysis caused by the nerve damage that can result from uncontrolled high blood sugars. In such cases, the stomach doesn't empty properly, and food and medications may take a long time to leave the stomach and move into the intestines where they need to be to be absorbed.

回顧 2021 年，我們將注意力集中在 GIMOTI 在市場上的價值主張上。對於糖尿病胃輕癱相關症狀的非口服治療，市場上過去和現在都有明顯未滿足的需求，對於那些剛接觸這個故事的人來說，這是一種由不受控制的神經損傷引起的胃麻痺高血糖。在這種情況下，胃不能正常排空，食物和藥物可能需要很長時間才能離開胃並進入需要被吸收的腸道。

Far too many of the approximately 2 to 3 million patients being treated with traditional oral therapeutics for this debilitating disease end up in the ER or take more invasive steps to address their symptoms, of which, oral medications simply don't help improve or could have even made symptoms worse. These symptoms can include nausea, vomiting, bloating, abdominal pain, and are often accompanied by hydration, malnutrition, and erratic blood sugars.

在大約 2 到 3 百萬接受傳統口服療法治療這種使人衰弱的疾病的患者中，有太多人最終進入急診室或採取更多侵入性措施來解決他們的症狀，其中口服藥物根本無助於改善或可能有甚至使症狀惡化。這些症狀可能包括噁心、嘔吐、腹脹、腹痛，並且通常伴有水合作用、營養不良和血糖不穩定。

GIMOTI is our nasal spray formulation of metoclopramide proven to be an effective medication for treating diabetic gastroparesis. GIMOTI is the only FDA approved non-oral outpatient therapy for gastroparesis and received FDA approval in June of 2020, and then entered the market in the fourth quarter of 2020.

GIMOTI 是我們的甲氧氯普胺鼻腔噴霧劑，已被證明是治療糖尿病胃輕癱的有效藥物。 GIMOTI 是唯一獲得 FDA 批准的胃輕癱非口服門診治療藥物，於 2020 年 6 月獲得 FDA 批准，並於 2020 年第四季度進入市場。

After establishing GIMOTI's viability in the marketplace in 2021 by addressing unmet need, in 2022, we focused on the following. First, increasing the awareness of and accessing -- access to GIMOTI as a groundbreaking new treatment for diabetic gastroparesis among patients and their healthcare providers or HCPs, and those are primarily gastroenterologists.

在 2021 年通過解決未滿足的需求確立 GIMOTI 在市場上的生存能力後，我們在 2022 年重點關注以下內容。首先，提高對 GIMOTI 作為糖尿病胃輕癱患者及其醫療保健提供者或 HCP（主要是胃腸病學家）的突破性新療法的認識和獲取。

And we did this through face-to-face educational interactions with HCPs by our commercial partner, Eversana and their sales team. Building channel partnerships in conjunction with Eversana to improve access to GIMOTI, these include vitaCare, our pharmacy partner, wholly owned by GoodRx; and also, UpScriptHealth, the consumer telehealth platform; and increasing state Medicaid coverage for GIMOTI.

我們通過我們的商業合作夥伴 Eversana 及其銷售團隊與 HCP 進行面對面的教育互動來做到這一點。與 Eversana 建立渠道合作夥伴關係以改善對 GIMOTI 的訪問，其中包括我們的藥房合作夥伴 vitaCare，由 GoodRx 全資擁有；以及消費者遠程醫療平台 UpScriptHealth；並增加 GIMOTI 的州醫療補助覆蓋範圍。

Second, we succeeded in making progress toward our ultimate objective of having GIMOTI become the standard of care for treating diabetic gastroparesis by presenting compelling real-world data at leading medical and scientific forums.

其次，我們通過在領先的醫學和科學論壇上展示令人信服的真實世界數據，成功實現了讓 GIMOTI 成為治療糖尿病胃輕癱護理標準的最終目標。

And finally, in 2022, we focused on fortifying and enhancing our intellectual property estate to deter potential generic competitors ensure that GIMOTI is the only such product available in the market for as long as possible. And Chris will provide more detail on these areas by expanding on some specific milestones.

最後，在 2022 年，我們專注於鞏固和加強我們的知識產權，以阻止潛在的仿製藥競爭對手，確保 GIMOTI 是市場上唯一可用的此類產品。 Chris 將通過擴展一些特定的里程碑來提供有關這些領域的更多詳細信息。

Until GIMOTI, there had been nothing new to treat gastroparesis in over 40 years since the approval of oral metoclopramide and no pharmaceutical company voiced in the marketplace. The immense challenge that we have undertaken in upending medical consensus that has been in place more than four decades, simply does not happen overnight.

在 GIMOTI 之前，自口服甲氧氯普胺獲批以來的 40 多年裡，沒有任何新的治療胃輕癱的方法，也沒有製藥公司在市場上發言。我們在顛覆已有 4 多年的醫學共識方面所面臨的巨大挑戰，絕非一蹴而就。

Happily, though, we're making impressive progress in convincing the diabetic gastroparesis treatment community that GIMOTI's nasal spray metoclopramide formulation is an important and needed treatment for patients instead of current oral tablet option.

不過，令人高興的是，我們在說服糖尿病胃輕癱治療社區方面取得了令人矚目的進展，即 GIMOTI 的鼻腔噴霧甲氧氯普胺製劑是一種重要且需要的患者治療方法，而不是目前的口服片劑選擇。

To that point, GIMOTI was added to the new gastroparesis guidelines by the American College of Gastroenterology as recommended first line therapy. This is a very important milestone for GIMOTI and Evoke.

至此，美國胃腸病學會將 GIMOTI 作為推薦的一線療法添加到新的胃輕癱指南中。這對 GIMOTI 和 Evoke 來說是一個非常重要的里程碑。

In September of last year, we announced that GIMOTI was nominated for Healio's Annual Disruptive Innovators Award under their Industry Breakthrough category. GIMOTI was selected among other novel gastroenterology products from major pharmaceutical companies. Healio is an online source for in-depth specialty clinical information and offers a wide industry accepted news.

去年 9 月，我們宣布 GIMOTI 被提名為 Healio 年度顛覆性創新者獎的行業突破類別。 GIMOTI 從主要製藥公司的其他新型胃腸病學產品中脫穎而出。 Healio 是提供深入專業臨床信息的在線資源，並提供廣泛的行業認可新聞。

The Disruptive Innovators Award hosted by Healio is an annual event to honor the trailblazers, movers, and industry personnel that are creating a difference in the field of gastroenterology. And as a nominee for the award, GIMOTI was recognized for its role in changing the face of gastroenterology and shifting the status quo towards the betterment of the field.

由 Healio 主辦的顛覆性創新者獎是一年一度的活動，旨在表彰在胃腸病學領域創造差異的開拓者、推動者和行業人員。作為該獎項的提名人，GIMOTI 因其在改變胃腸病學面貌和改變現狀以改善該領域方面的作用而受到認可。

In May 2022, Evoke participated at DDW or Digestive Disease Week, which is the largest global conference for gastroenterology. And we were pleased to present a poster of distinction to the scientific and clinical experts and key opinion leaders from around the world. The study provided real-world statistics using the largest claims database available, which covers over 80 million lives in the US, to assess the incidence of tardive dyskinesia or TD for patients taking metoclopramide over a 10-year period.

2022 年 5 月，Evoke 參加了 DDW 或消化疾病週，這是全球最大的胃腸病學會議。我們很高興向來自世界各地的科學和臨床專家以及主要意見領袖展示一張傑出的海報。該研究使用最大的索賠數據庫提供了真實世界的統計數據，該數據庫涵蓋了美國超過 8000 萬人的生活，以評估 10 年期間服用甲氧氯普胺的患者遲發性運動障礙或 TD 的發生率。

Results for patients that had received metoclopramide demonstrated a lower risk of developing TD than stated in previously reported studies. The data revealed an incidence of TD among gastroparesis treated patients -- gastroparesis patients treated with metoclopramide of just 0.1%. The poster data supports the safety profile of metoclopramide, and the aim of the study was to update the medical literature with current information about the incidence of TD in patients with and without gastroparesis and those taking metoclopramide.

接受甲氧氯普胺治療的患者的結果顯示發生 TD 的風險低於先前報導的研究。數據顯示胃輕癱治療患者中 TD 的發生率——接受甲氧氯普胺治療的胃輕癱患者僅為 0.1%。海報數據支持甲氧氯普胺的安全性，該研究的目的是用有關胃輕癱和非胃輕癱患者以及服用甲氧氯普胺的患者 TD 發病率的最新信息更新醫學文獻。

By supporting the largest ever real-world study on the important issue, this important issue, we hope to help HCPs and organizations understand the incidence of TD, recognize patients who might be at higher risk, and revisit the benefit versus the risk of this important compound in patients with gastroparesis.

通過支持有史以來最大規模的關於這個重要問題的真實世界研究，這個重要問題，我們希望幫助 HCP 和組織了解 TD 的發病率，識別可能處於較高風險中的患者，並重新審視這個重要問題的收益與風險胃輕癱患者的複方。

In addition to the new ACG guidelines in GIMOTI's first-line recommendations, two recent announcements also revealed how we're chipping away at the medical consensus I mentioned earlier. In January of this year, we announced that another of our studies will be presented as an abstract at the Academy of Managed Care Pharmacy or AMCP Annual Meeting taking place this week in San Antonio.

除了 GIMOTI 一線建議中的新 ACG 指南外，最近的兩個公告還揭示了我們如何削弱我之前提到的醫學共識。今年 1 月，我們宣布我們的另一項研究將在本周於聖安東尼奧舉行的管理式護理藥房學院或 AMCP 年會上以摘要形式呈現。

The abstract entitled, real-world healthcare resource utilization of patients treated with metoclopramide nasal for diabetic gastroparesis. It's a study of nearly 300 patients using GIMOTI that revealed a reduced need to visit the ER or take more invasive steps to treat their condition. These results have been extremely well received with key opinion leaders.

標題為“甲氧氯普胺鼻腔治療糖尿病胃輕癱患者的真實世界醫療保健資源利用”的摘要。這是一項對近 300 名使用 GIMOTI 的患者進行的研究，結果表明他們減少了去急診室或採取更多侵入性措施來治療病情的需要。這些結果得到了關鍵意見領袖的高度評價。

Last month, together with Eversana, we reported that yet another abstract was not only accepted, but selected for the plenary lecture presentation at the upcoming Digestive Disease Week in Chicago from May 6 to May 9.

上個月，我們與 Eversana 一起報導了另一篇摘要不僅被接受，而且還被選入即將於 5 月 6 日至 9 日在芝加哥舉行的消化疾病週的全體演講中。

This abstract entitled, reducing real-world healthcare resource utilization for patients with diabetic gastroparesis treated with metoclopramide nasal spray versus oral metoclopramide provides compelling healthcare resource utilization data on the effectiveness of GIMOTI as a potentially needle moving solution in the treatment of gastroparesis.

這篇題為“使用甲氧氯普胺鼻腔噴霧劑與口服甲氧氯普胺治療的糖尿病胃輕癱患者減少真實世界醫療保健資源利用”的摘要提供了令人信服的醫療保健資源利用數據，說明 GIMOTI 作為一種潛在的針頭移動解決方案治療胃輕癱的有效性。

For the remainder of 2023 and beyond, we'll continue our strategy of highlighting the benefits of GIMOTI at important medical meetings and continue to generate new data.

在 2023 年剩餘時間及以後，我們將繼續我們的戰略，在重要的醫學會議上強調 GIMOTI 的好處，並繼續生成新數據。

Next, as I referred to earlier, fortifying and enhancing Evoke's intellectual property estate is a vital component of our strategy to make GIMOTI brand synonymous with the new treatment paradigm for diabetic gastroparesis. A prime example is the recent successful litigation against generic pharma giant, Teva Pharmaceuticals.

接下來，正如我之前提到的，鞏固和加強 Evoke 的知識產權是我們使 GIMOTI 品牌成為糖尿病胃輕癱新治療模式代名詞的戰略的重要組成部分。一個典型的例子是最近針對仿製藥巨頭 Teva Pharmaceuticals 的成功訴訟。

Last year, we received a Paragraph IV certification notice letter from Teva. This notice indicated that Teva had submitted an abbreviated new drug application, or ANDA, to FDA seeking approval to manufacture and sell a generic version of GIMOTI prior to the expiration of certain Orange Book listed patents protecting GIMOTI.

去年，我們收到了 Teva 的 Paragraph IV 認證通知函。該通知表明，Teva 已向 FDA 提交了一份簡化的新藥申請（ANDA），尋求在保護 GIMOTI 的某些橙皮書所列專利到期之前批准生產和銷售 GIMOTI 的仿製藥。

We initiated a patent infringement lawsuit against Teva and vigorously defended our intellectual property rights protecting the product. And as a result, Teva withdrew its Paragraph IV for its generic ANDA and will not pursue approval until GIMOTI's last Orange Book listed patent expires. And this is currently, 2030, but may be extended, pending other filed patents.

我們對 Teva 提起專利侵權訴訟，並積極捍衛我們保護產品的知識產權。因此，Teva 撤回了其仿製藥 ANDA 的第 IV 段，並且在 GIMOTI 的最後一個橙皮書上市專利到期之前不會尋求批准。目前是 2030 年，但可能會延長，等待其他已申請的專利。

In addition, no further ANDA filer will be eligible to receive 180 day generic exclusivity for an ANDA that references GIMOTI. This first to file regulatory path is typically a highly sought after by generic firms. Consequently, this matter has ended, and we believe the successful outcome reflects the strength of our intellectual property. And furthermore, this strengthens our resolve to defend our rights, particularly against larger, well-resourced companies.

此外，對於引用 GIMOTI 的 ANDA，沒有更多的 ANDA 申報者有資格獲得 180 天的通用獨占權。這種首先申請監管的途徑通常受到仿製藥公司的高度追捧。因此，這件事已經結束，我們相信成功的結果反映了我們知識產權的實力。此外，這加強了我們捍衛我們權利的決心，尤其是針對資源充足的大型公司。

During 2022, we also bolstered GIMOTI's intellectual property estate with key milestones, I'll briefly summarize. In December, USPTO issued Evoke a patent under the title, Treatment of Moderate and Severe Gastroparesis. This patent expires in 2038 and covers the methods for treating moderate to severe gastroparesis with metoclopramide via the internasal route of administration.

在 2022 年期間，我們還通過關鍵里程碑來支持 GIMOTI 的知識產權，我將簡要總結一下。去年 12 月，美國專利商標局授予 Evoke 一項名為“治療中度和重度胃輕癱”的專利。該專利將於 2038 年到期，涵蓋通過鼻內給藥途徑使用甲氧氯普胺治療中度至重度胃輕癱的方法。

The grant of this patent confirms that we -- what we observed in our Phase 2 trial results from utilizing nasal metoclopramide to treat the patients suffering from moderate to severe gastroparesis. In November, the USPTO issued a Notice of Allowance for a patent application entitled, nasal formulations of metoclopramide, which would expire in December 2029. This patent application is a continuation of several other US patents filed by the company over the last decade.

該專利的授予證實了我們——我們在 2 期試驗中觀察到的結果是使用鼻用甲氧氯普胺治療患有中度至重度胃輕癱的患者。 11 月，美國專利商標局發布了一項名為甲氧氯普胺鼻腔製劑的專利申請的許可通知，該專利申請將於 2029 年 12 月到期。該專利申請是該公司在過去十年中提交的其他幾項美國專利的延續。

And in July, the Canadian Intellectual Property Office granted evoke a key patent for a previously submitted application entitled, nasal formulations of metoclopramide. This pattern corresponds to the two other FDA Orange Book listed patents under the same title that expire in 2029 and 2030. The patent covers the methods of use of nasal delivery of metoclopramide for treating diabetic gastroparesis. This Canadian patent expires in 2029 and provides patent protection in another potential market for our novel gastroparesis treatment.

7 月，加拿大知識產權局授予喚起一項先前提交的名為甲氧氯普胺鼻腔製劑申請的關鍵專利。該模式對應於 2029 年和 2030 年到期的另外兩項 FDA 橙皮書列出的同名專利。該專利涵蓋了使用甲氧氯普胺經鼻給藥治療糖尿病性胃輕癱的方法。這項加拿大專利將於 2029 年到期，並在另一個潛在市場為我們的新型胃輕癱治療提供專利保護。

We're pleased with the progress we made in 2022 and thus far in 2023 to further establish our proprietary concept of delivering effective medication through the nasal pathway to treat symptoms associated with diabetic gastroparesis. We are eager to further our goal to capitalize on this large and growing market opportunity in the US and abroad. Our intellectual property portfolio now includes FDA Orange Book listed patents and other patents in the EU, Japan, Canada, and Mexico.

我們對我們在 2022 年和 2023 年迄今取得的進展感到高興，以進一步確立我們通過鼻腔途徑提供有效藥物治療糖尿病胃輕癱相關症狀的專有概念。我們渴望進一步實現我們的目標，以利用美國和國外這個巨大且不斷增長的市場機會。我們的知識產權組合現在包括 FDA 橙皮書列出的專利以及歐盟、日本、加拿大和墨西哥的其他專利。

Before turning the call over to Chris, I want to provide a little color on the fourth quarter 2022 financial and operating results. And Matt will take us through key components of our financials for the quarter and the year as well.

在將電話轉給克里斯之前，我想提供一些有關 2022 年第四季度財務和運營結果的信息。 Matt 還將帶領我們了解本季度和本年度財務的關鍵組成部分。

As mentioned in today's press release, the fourth quarter saw a slight $36,000 decrease in our net product sales in the third quarter, even though we had an 8% increase in GIMOTI prescription fills. The reason for this decline after three quarters of sequential revenue growth in 2022 is straightforward.

正如今天的新聞稿中所提到的，第四季度我們的產品淨銷售額在第三季度略微下降了 36,000 美元，儘管我們的 GIMOTI 處方藥增長了 8%。在 2022 年連續三個季度的收入增長之後出現這種下降的原因很簡單。

First, Q4 has more holidays and fewer working days than` Q3. Those holidays coincide with the end of the month, which tend to be our stronger weeks, and there were also pharmacy closures due to weather events during that time.

首先，Q4比Q3節假日多，工作日少。這些假期恰逢月底，這往往是我們比較旺盛的幾週，而且在那段時間裡，由於天氣原因，藥店也關閉了。

And lastly, we experienced a slightly higher number of prescriptions provided to uninsured or underinsured patients. In such circumstances, its Evoke's practice to offer GIMOTI at a discount to those patients in urgent need of gastroparesis symptom relief. We expect to return to positive sequential revenue growth in 2023 as the sales mix returns to levels we saw in the first three quarters of 2022.

最後，我們向未投保或投保不足的患者提供的處方數量略多。在這種情況下，Evoke 的做法是向那些急需緩解胃輕癱症狀的患者提供折扣的 GIMOTI。隨著銷售組合恢復到 2022 年前三個季度的水平，我們預計 2023 年收入將恢復正連續增長。

Finally, the number of cumulative GIMOTI prescribers increased by approximately 25% to 1,017 HCPs at December 31, 2022 from 812 through December 31, 2021. This metric continues to increase, reaching 205 prescribers at the end of January of this year, the highest month on record. And finally, as I've mentioned, prescriptions fills in the fourth quarter of 2022 increased by 8% compared to the previous quarter. Prescription fills for all of 2022 increased by 178% compared to 2021.

最後，截至 2022 年 12 月 31 日，累積的 GIMOTI 處方者數量從 812 人增加到 2021 年 12 月 31 日的 1,017 人，增加了約 25%。該指標繼續增加，在今年 1 月底達到 205 人，這是最高月份記錄在案。最後，正如我所提到的，2022 年第四季度的處方藥比上一季度增長了 8%。與 2021 年相比，2022 年全年的處方藥配藥量增加了 178%。

With that, I'll turn the call over to Chris. Chris?

有了這個，我會把電話轉給克里斯。克里斯？

Thank you, Dave. 2022 was a year of tremendous progress for Evoke, GIMOTI, and Eversana. I'd like to add my support to what Dave described as last year's significant progress of physician awareness and patient access to GIMOTI as a needed solution for relief of diabetic gastroparesis [symptoms].

謝謝你，戴夫。 2022 年是 Evoke、GIMOTI 和 Eversana 取得巨大進步的一年。我想對 Dave 所說的去年醫生意識和患者使用 GIMOTI 作為緩解糖尿病胃輕癱 [症狀] 所需解決方案的重大進展表示支持。

Our Evoke team within Eversana, and in the field, as well as our partners at vitaCare and UpScriptHealth, continues to execute on our strategy to make GIMOTI the standard of care for patients suffering with diabetic gastroparesis and to improve access to GIMOTI for appropriate patients.

我們在 Eversana 和現場的 Evoke 團隊，以及我們在 vitaCare 和 UpScriptHealth 的合作夥伴，繼續執行我們的戰略，使 GIMOTI 成為糖尿病胃輕癱患者的護理標準，並改善適當患者獲得 GIMOTI 的機會。

There's has not been without challenges that, many turns, yet our team remains focused and steadfast to alter the clinical inertia and habit that has been status quo in this market. Patients deserve better. Broadening and deepening healthcare practitioner trial and adoption of GIMOTI was and will continue to remain our priority focus, and we have made steady progress.

並非沒有挑戰，許多轉折，但我們的團隊仍然專注並堅定地改變這個市場現狀的臨床慣性和習慣。患者值得更好的。擴大和深化 GIMOTI 的醫療保健從業者試驗和採用過去是並將繼續是我們的優先重點，我們已經取得了穩步進展。

Q4, by many metrics, was our best ever. We nearly doubled our new prescribers in 2022, growing 96%. In the fourth quarter alone, we increased new prescribers 43% over Q3. And our total cumulative new prescribers continue to expand to 1,017. Repeat prescribers grew 774% in 2022 versus '21. And in Q4, we expanded our Q3 total by 14%.

從許多指標來看，第四季度是我們有史以來最好的。到 2022 年，我們的新開處方者幾乎翻了一番，增長了 96%。僅在第四季度，我們的新開處方者就比第三季度增加了 43%。我們的累計新開處方者總數繼續擴大到 1,017 人。與 21 年相比，重複開處方者在 2022 年增長了 774%。在第四季度，我們將第三季度的總數擴大了 14%。

As prescribers grew, so did dispenses at 8% improvement over Q3. Full year dispense growth was 178% versus 2021 (technical difficulty) [continue to see] excellent continuation by our patients with a 79% refill rate for those that have scripts remaining on their treatment.

隨著開處方者的增加，配藥也比第三季度增加了 8%。與 2021 年（技術難度）相比，全年配藥增長率為 178%（技術難度）[繼續看到]我們患者的出色持續性，對於那些仍在接受治療的患者，再填充率為 79%。

Lastly, refills for GIMOTI is a metric we are closely watching. Refills grew 34% in Q4 compared to Q3, and 219% year over year. The primary driver of performance in Q4 and in 2022 was interactions with healthcare providers. Face-to-face interactions in the post-COVID era continues to be the most important lever.

最後，GIMOTI 的筆芯是我們密切關注的指標。與第三季度相比，第四季度的筆芯增長了 34%，同比增長了 219%。第四季度和 2022 年績效的主要驅動力是與醫療保健提供者的互動。後 COVID 時代的面對面互動仍然是最重要的槓桿。

We see a pattern emerging, where when a healthcare provider in a practice prescribes GIMOTI and has a positive experience, they tend to prescribe more. And those that are in the practice with them begin to adopt GIMOTI as well. It is evidence that our total practice approach is paying dividends.

我們看到了一種正在出現的模式，當醫療保健提供者在實踐中開出 GIMOTI 處方並獲得積極體驗時，他們往往會開出更多處方。那些與他們一起實踐的人也開始採用 GIMOTI。這證明我們的全面實踐方法正在帶來回報。

In addition, we conducted peer-to-peer educational programs last year. Those programs reached 673 total attendees where the rationale and benefits of GIMOTI were discussed, including relevant patient case experience. These programs increased the knowledge of our audience, and we saw a significant impact on prescribing, increasing 44% from prior to attending a program. We plan to double our programming this year to reach a broader audience.

此外，我們去年開展了點對點教育計劃。這些計劃共有 673 名與會者討論了 GIMOTI 的基本原理和好處，包括相關的患者案例經驗。這些計劃增加了我們觀眾的知識，我們看到了對處方的重大影響，比參加計劃之前增加了 44%。我們計劃今年將節目增加一倍，以覆蓋更廣泛的受眾。

To further combat status quo thinking, we leveraged the publication of the updated ACG Guidelines for gastroparesis by producing our own summary of the guidelines and highlighting the position of GIMOTI and oral metoclopramide as first-line pharmacotherapy. This has generated significant conversations and added credibility to our messaging.

為了進一步打擊現狀思維，我們利用更新版 ACG 胃輕癱指南的發布，製作了我們自己的指南摘要，並強調了 GIMOTI 和口服甲氧氯普胺作為一線藥物療法的地位。這產生了重要的對話並增加了我們消息傳遞的可信度。

We also continue to conduct patient market research; track their awareness, trial, and utilization patterns. Our last wave confirms feedback we were hearing from providers and demonstrated that roughly 50% of users do not see any symptom improvement from existing oral treatment options, whether they're liquid or tablet form.

我們還繼續進行患者市場調查；跟踪他們的意識、試用和使用模式。我們的最後一波證實了我們從提供者那裡聽到的反饋，並證明大約 50% 的用戶沒有看到現有口服治療方案有任何症狀改善，無論是液體還是片劑形式。

38% of respondents discontinued their gastroparesis medications, primarily due to either side effects or lack of symptom improvement. Of those respondents who were aware of GIMOTI prior to this survey, 43% are current users. And 100% of those current GIMOTI users reported seeing at least some symptom improvement with diminished nausea being the most cited symptom improvement.

38% 的受訪者停止了他們的胃輕癱藥物治療，主要是由於副作用或症狀沒有改善。在本次調查之前了解 GIMOTI 的受訪者中，43% 是當前用戶。 100% 的當前 GIMOTI 用戶報告說至少看到了一些症狀改善，其中噁心減少是最常提到的症狀改善。

Finally, patients rated GIMOTI as more favorable than competing treatments on all attribute related to tolerability and efficacy, compared to other treatments. We are encouraged by these results and yet we recognize there is still a significant gap in conversations between patients and providers around whether current therapies are working, what alternative treatments are available, and how these treatments differ?

最後，與其他療法相比，在與耐受性和療效相關的所有屬性方面，患者認為 GIMOTI 比競爭療法更受歡迎。我們對這些結果感到鼓舞，但我們認識到，在患者和提供者之間關於當前療法是否有效、有哪些替代療法可用以及這些療法有何不同的對話中仍然存在顯著差異？

Another contributor to success in 2022 was changing our distribution approach. In May of last year after a four-month pilot, we switched distribution to vitaCare prescription services. The switch to vitaCare significantly improved prescribing of GIMOTI, allowing HCPs to e-prescribe GIMOTI directly. Additionally, we saw the time from the submission of prescription to the delivery of GIMOTI to a patient's home, what we call, speed to therapy, improve.

2022 年取得成功的另一個因素是改變我們的分銷方式。去年 5 月，經過四個月的試點後，我們將分銷改為 vitaCare 處方服務。改用 vitaCare 顯著改善了 GIMOTI 的處方，使 HCP 可以直接通過電子方式開 GIMOTI 處方。此外，我們還看到了從提交處方到將 GIMOTI 送到患者家中的時間，我們稱之為治療速度、改善。

Reliable access to GIMOTI, especially with a low out-of-pocket expense for patients, is a primary driver for their initial and ongoing use. When patients get access to GIMOTI, we see and hear positive feedback. With the vitaCare process, our refill rates have continued to improve and is at 79%, the highest we've seen since launch.

可靠地獲得 GIMOTI，尤其是患者的自付費用較低，是他們最初和持續使用的主要驅動力。當患者使用 GIMOTI 時，我們看到並聽到了積極的反饋。通過 vitaCare 流程，我們的補充率持續提高，達到 79%，這是我們自推出以來看到的最高水平。

Another opportunity for GIMOTI is coverage by insurance plans. We continue to build on our success and access with 110 payers approving at least one Rx since launch. Before, 69% of dispensers were covered by either a commercial or government insurance, and that is relatively stable from prior quarters. We are committed to expanding access to GIMOTI. Part of that commitment comes in continuing to build on the value proposition for GIMOTI to demonstrate further evidence.

GIMOTI 的另一個機會是保險計劃的承保範圍。我們繼續在我們的成功和訪問的基礎上再接再厲，自推出以來已有 110 位付款人批准了至少一種 Rx。之前，69% 的分配器由商業或政府保險承保，與前幾個季度相比相對穩定。我們致力於擴大 GIMOTI 的訪問範圍。該承諾的一部分來自於繼續建立 GIMOTI 的價值主張，以展示更多證據。

Dave outlined two important new study that we've recently submitted to medical congresses, which have both been accepted. These studies leverage our exclusive pharmacy data for GIMOTI patients and link it compliantly to claims database, which allows us to understand the utilization of healthcare resources such as physician office visits, hospital outpatient visits, hospital inpatient visits, and emergency room visits.

戴夫概述了我們最近提交給醫學大會的兩項重要的新研究，這兩項研究均已被接受。這些研究利用我們針對 GIMOTI 患者的獨家藥房數據，並將其與索賠數據庫合規鏈接，這使我們能夠了解醫療保健資源的利用情況，例如醫生辦公室就診、醫院門診就診、醫院住院就診和急診就診。

These real-world data complement clinical trial data, which affirm the safety and efficacy of a product in a controlled setting and go beyond that to examine impact of treatment on various stakeholders like providers, patients, and payers, varied clinical and diverse demographic settings.

這些真實世界的數據補充了臨床試驗數據，這些數據肯定了產品在受控環境中的安全性和有效性，並超越了這些數據來檢查治療對各種利益相關者（如提供者、患者和付款人）、不同臨床和不同人口背景的影響。

Now, prior to commenting on the new studies, the previous tardive dyskinesia study we conducted, which was presented at last year's Digestive Disease Week, remains an important clinical update for physicians to be aware of with the use of metoclopramide.

現在，在對新研究發表評論之前，我們之前進行的遲發性運動障礙研究（在去年的消化疾病週上發表）仍然是重要的臨床更新，醫生需要了解甲氧氯普胺的使用情況。

Whereas, various prior small studies published decades ago, noticed an incidence rate of 10% or higher with TD for metoclopramide, this groundbreaking analysis examining claims data across 80 million patients in the US showed a much lower incidence at 0.1% of all gastroparesis patients taking metoclopramide over the 10-year survey.

鑑於幾十年前發表的各種小型研究注意到甲氧氯普胺 TD 的發生率為 10% 或更高，這項開創性的分析檢查了美國 8000 萬患者的索賠數據，顯示發生率低得多，佔所有服用胃輕癱患者的 0.1%胃復安超過 10 年的調查。

These data have received significant attention at several large congresses, helping physicians and patients to understand and assess risk-benefit for use of metoclopramide with the updated information. We plan to submit these data on the incidence of tardive dyskinesia in patients with gastroparesis for publication shortly.

這些數據在幾個大型會議上受到了極大的關注，幫助醫生和患者了解和評估使用甲氧氯普胺的風險效益以及更新的信息。我們計劃很快提交這些關於胃輕癱患者遲發性運動障礙發病率的數據以供發表。

The upcoming AMCP study -- the utilization of healthcare resources of 294 patients 6 months before and 6 months after initiation of GIMOTI. The study showed patients starting GIMOTI demonstrated fewer all-cause and diabetic gastroparesis related healthcare resource utilization for office, ER, inpatient, and outpatient visits for the six-month intervals following initiation of treatment, achieving statistical significance for the diabetic gastroparesis related physician office visits and hospital outcome visits. And a numerical improvement for emergency visits.

即將進行的 AMCP 研究——294 名患者在 GIMOTI 開始前 6 個月和開始後 6 個月的醫療資源利用情況。研究表明，開始使用 GIMOTI 的患者在開始治療後的六個月時間間隔內，在辦公室、急診室、住院和門診就診方面的全因和糖尿病胃輕癱相關醫療保健資源利用較少，在糖尿病胃輕癱相關醫生辦公室就診方面取得了統計學意義和醫院結果訪問。以及緊急訪問的數字改進。

For all-cause related HRU, there was a statistically significant reduction in physician office visits. It's important to note that about half these patients tracked were on oral metoclopramide for a mean duration of 8.1 months prior to switching to GIMOTI. The scientific poster for AMCP should be available on the Evoke Pharma corporate website in the coming days.

對於全因相關的 HRU，醫生就診次數在統計上顯著減少。值得注意的是，這些被追踪的患者中約有一半在改用 GIMOTI 之前平均口服甲氧氯普胺持續 8.1 個月。 AMCP 的科學海報將在未來幾天內在 Evoke Pharma 公司網站上發布。

And the next study to be delivered at the plenary session for Digestive Disease Week, 257 patients on GIMOTI compared to a mass-control 257 patients with documented utilization of oral metoclopramide over six months in parallel. These data will provide insight to the question, how does GIMOTI compare to the standard of care for gastroparesis in a real-world setting.

下一項研究將在消化疾病週的全體會議上進行，257 名接受 GIMOTI 治療的患者與 257 名質量控制患者相比，有記錄顯示在六個月內同時使用口服甲氧氯普胺。這些數據將提供對這個問題的洞察力，即 GIMOTI 與現實環境中胃輕癱的護理標準相比如何。

These data are really important to understand as studies suggest that patients with diabetic gastroparesis are admitted to the hospital an average of four times a year, and 30% of them are -- having to be readmitted within 30 days. Cost of the healthcare system is significant and the impact on patients and their families is considerable. We are excited to share these first-in-class data, believe they will add important new information for patients, providers, and payers alike.

了解這些數據非常重要，因為研究表明，患有糖尿病性胃輕癱的患者平均每年入院四次，其中 30% 必須在 30 天內再次入院。醫療保健系統的成本很高，對患者及其家人的影響也很大。我們很高興分享這些一流的數據，相信它們將為患者、提供者和付款人等增加重要的新信息。

In summary, I'd like to reinforce we are making positive strides in improving adoption and performance of GIMOTI. By many measures, Q4 was our best quarter to date. We have tackled barriers and continue to address them proactively and with urgency. We continue to invest in value-generating areas and believe those will bear fruit in 2023.

總之，我想強調的是，我們在提高 GIMOTI 的採用率和性能方面正在取得積極進展。從許多方面來看，第四季度是我們迄今為止表現最好的一個季度。我們已經解決了障礙，並將繼續積極主動地解決這些障礙。我們繼續投資於產生價值的領域，相信這些領域將在 2023 年取得成果。

Our goal remains to position GIMOTI as the standard of care for patients with diabetic gastroparesis. This year, we'll be focused on building on the confidence in GIMOTI and in the programs and services surrounding GIMOTI. If we're going to change the status quo, then confidence is the currency with [which we have to deal in].

我們的目標仍然是將 GIMOTI 定位為糖尿病胃輕癱患者的護理標準。今年，我們將專注於建立對 GIMOTI 以及圍繞 GIMOTI 的計劃和服務的信心。如果我們要改變現狀，那麼信心就是我們必須用來交易的貨幣。

With that, I'll turn the call over to Matt (technical difficulty).

有了這個，我會把電話轉給馬特（技術困難）。

Thanks, Chris. Let's turn quickly to financials. As Dave mentioned, for the fourth quarter 2022 net product sales were approximately $796,000, compared with $361,000 during the fourth quarter of 2021. And the net loss was approximately $1.8 million or $0.54 per share, compared with $1.7 million or $0.61 per share for the fourth quarter of 2021.

謝謝，克里斯。讓我們快速轉向財務。正如戴夫所說，2022 年第四季度產品淨銷售額約為 796,000 美元，而 2021 年第四季度為 361,000 美元。淨虧損約為 180 萬美元或每股 0.54 美元，而第四季度為 170 萬美元或每股 0.61 美元2021 年季度。

For the year ended December 31, 2022, net product sales were approximately $2.5 million, compared with the approximately $1.6 million for the year ended December 31, 2021. And the net loss was approximately $8.5 million or $2.62 per share, compared with a net loss of $8.5 million or $3.18 per share for the year ended December 31, 2021. And the annual net losses per share reflect the company's June 2022 1-for-12 reverse stock split.

截至 2022 年 12 月 31 日止年度，產品淨銷售額約為 250 萬美元，而截至 2021 年 12 月 31 日止年度約為 160 萬美元。淨虧損約為 850 萬美元或每股 2.62 美元，相比之下淨虧損為截至 2021 年 12 月 31 日止年度為 850 萬美元或每股 3.18 美元。每股年度淨虧損反映了公司 2022 年 6 月的 12 股拆股。

The year over year increase in revenue was due to higher net product sales in 2022, resulting from increased face-to-face interactions with physicians, primarily gastroenterologists and other healthcare providers with our sales partner, Eversana. Greater numbers of physicians within larger groups prescribing GIMOTI after the first physician adoption and more increased sales through our vitaCare prescription services partner.

收入同比增長是由於 2022 年產品淨銷售額增加，這是由於與我們的銷售合作夥伴 Eversana 與醫生（主要是胃腸病學家和其他醫療保健提供者）的面對面互動增加。在第一位醫生採用 GIMOTI 後，更大群體中更多的醫生開出 GIMOTI 處方，並且通過我們的 vitaCare 處方服務合作夥伴增加了銷售額。

Research and development expenses totaled $27,000 for the fourth quarter of 2022, compared with $36,000 for the fourth quarter of 2021. And for the full year 2022, research and development expenses were approximately $0.3 million, compared with approximately $0.6 million for the prior year. Since receiving FDA approval of GIMOTI in June of 2020, Evoke's research and development costs continued to decrease and shift to commercialization and selling costs.

2022 年第四季度研發費用總計 27,000 美元，而 2021 年第四季度為 36,000 美元。2022 年全年研發費用約為 30 萬美元，上年同期約為 60 萬美元。自 2020 年 6 月獲得 FDA 對 GIMOTI 的批准以來，Evoke 的研發成本持續下降，並轉向商業化和銷售成本。

For the fourth quarter of 2022, selling, general and administrative expenses were approximately $2.3 million, compared with $1.7 million for the fourth quarter of 2021. For the year ended December 31, 2022, selling general and administrative expenses were approximately $9.6 million versus approximately $8.9 million for the year ended December 31, 2021.

2022 年第四季度，銷售、一般和管理費用約為 230 萬美元，而 2021 年第四季度為 170 萬美元。截至 2022 年 12 月 31 日止年度，銷售、一般和管理費用約為 960 萬美元，而 2021 年第四季度約為 8.9 美元百萬為截至 2021 年 12 月 31 日止年度。

Increase in SG&A costs year over year resulted primarily from shifting personnel costs from research and development to commercialization costs, along with higher marketing, royalty and Eversana profit sharing costs.

SG&A 成本同比增加主要是由於人員成本從研發成本轉移到商業化成本，以及更高的營銷、特許權使用費和 Eversana 利潤分享成本。

We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of GIMOTI and we reimburse Eversana from the net profits attained from the sales of GIMOTI.

我們預計，隨著我們繼續推進 GIMOTI 的商業化進程，未來的銷售、一般和管理費用將會增加，我們會從 GIMOTI 的銷售中獲得的淨利潤中償還 Eversana。

Total operating expenses for the fourth quarter of 2022 were approximately $2.3 million, compared with $1.8 million for the same period of 2021. And for the year ended December 31, 2022, total operating expenses were approximately $10.3 million, compared with approximately $9.8 million for the full year of 2021.

2022 年第四季度的總運營費用約為 230 萬美元，而 2021 年同期為 180 萬美元。截至 2022 年 12 月 31 日止年度，總運營費用約為 1030 萬美元，而去年同期約為 980 萬美元。 2021 年全年。

As of December 31, 2022, cash and cash equivalents were approximately $9.8 million. We believe, based on our current operating plan, that our existing cash and cash equivalents as well as future cash flows from net product sales of GIMOTI will be sufficient to fund our operations at least in the third quarter of 2023.

截至2022年12月31日，現金及現金等價物約為980萬美元。我們相信，根據我們目前的運營計劃，我們現有的現金和現金等價物以及 GIMOTI 產品淨銷售產生的未來現金流量至少在 2023 年第三季度足以為我們的運營提供資金。

And finally, Evoke currently holds the majority of its cash at Pacific Western Bank within the ISC, or insured cash sweep, accounts. These accounts move funds into separate FDIC insured accounts of up to $250,000 each -- per day and is available as needed.

最後，Evoke 目前在 Pacific Western Bank 的 ISC 或保險現金清掃賬戶中持有大部分現金。這些賬戶將資金轉移到單獨的 FDIC 保險賬戶中，每個賬戶每天最高可達 250,000 美元，並且可以根據需要使用。

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

有了這個，我們將打開問題的電話。操作員？

Thank you, sir. (Operator Instructions) Yale Jen, Laidlaw & Company.

謝謝你，先生。 （操作員說明）Yale Jen, Laidlaw & Company。

Good afternoon, and thanks for taking the questions. And congrats on the quarters. A couple of just from -- the first one is that you mentioned that for the fourth quarter you have more under and uninsured patients. And what do you -- you anticipate that to reduce in 2023? Or was there any sign to suggest that of the first three months of this year?

下午好，感謝您提出問題。並祝賀宿舍。有幾個來自——第一個是你提到第四季度你有更多的未投保和未投保的患者。您預計 2023 年會減少什麼？或者有任何跡象表明今年的前三個月有這種情況嗎？

Thanks, Yale, for the question. No. So far in this first quarter, we haven't -- we saw a little maybe trickle in January. But since then, we haven't.

謝謝，耶魯，提出這個問題。不。到目前為止，在第一季度，我們還沒有——我們在 1 月份看到了一些可能的涓涓細流。但從那以後，我們沒有。

And yes, this is Matt. I don't think there's any predictive quantities around it. Other than, as you know, sometimes around year end and beginning of the year, change in plans and those things can cause hiccups around reimbursement for individuals as they move from one insurer to another. So I think there's maybe a very slight seasonal effect that you can see in the end of the year timeframe, but nothing otherwise.

是的，這是馬特。我認為它周圍沒有任何預測量。除了，如您所知，有時在年底和年初前後，計劃的變化和那些事情可能會導致個人從一家保險公司轉移到另一家保險公司時的報銷問題。所以我認為你可能會在年底的時間框架內看到非常輕微的季節性影響，但除此之外別無其他。

Okay. The second question is that -- maybe related, which is, the cost of goods for the fourth quarter, again, is substantially higher than the previous three quarters. What have caused that? And do you anticipate this cost of goods ratio to continue for the 2023?

好的。第二個問題是 - 可能相關，即第四季度的商品成本再次大大高於前三個季度。是什麼原因造成的？您預計 2023 年這種商品成本比率會持續嗎？

Yale, yeah. So I appreciate your question. I guess we don't view this as being substantially out of whack, considering the increase in total product that was being sold. And it's possible, I suppose, that based upon some of the earlier product that had been manufactured prior to launch that may have been expensed prior to launch itself, that may have added to it slightly. But otherwise, we wouldn't expect there to be anything significant there.

耶魯，是的。所以我很欣賞你的問題。考慮到所售產品總量的增加，我想我們並不認為這有很大的不正常。我想，有可能是基於一些在發布前製造的早期產品，這些產品可能在發布前就已支出，可能會略微增加。但除此之外，我們不會期望那裡有任何重要的東西。

So are you suggesting that the current cost of goods ratio -- the margin probably will be similar in 2023?

那麼，您是在暗示當前的商品成本比率——2023 年的利潤率可能會相似？

Yes.

是的。

Okay. And two more quick ones. The first one is that, whilst the GIMOTI has been added to the ACG Guidelines, does that impact on the future, I guess, sales as well as our reimbursement? And typically, adding to the guideline will have positive impact I guess, what's your thoughts?

好的。還有兩個快速的。第一個是，雖然 GIMOTI 已添加到 ACG 指南中，但我想這是否會影響未來的銷售以及我們的報銷？通常，添加到指南中會產生積極影響，我想，您有什麼想法？

So certainly, being added to the ACG Guidelines is a very positive step for product and many physicians look to the guidelines for guidance in terms of how to deal with new therapies. So it's definitely a positive. And as I mentioned, as we are out there with our field sales organization talking to physicians, physicians appreciate the fact that we've been added to the guidelines and added to that first-line physician. And so it's added a lot of credibility and built confidence in physician prescribing. It still remains to be seen whether that coupled with some of the evidence generation that we are building will help us to get access for payers.

因此，當然，被添加到 ACG 指南中對產品來說是一個非常積極的步驟，許多醫生在如何處理新療法方面尋求指南的指導。所以這絕對是積極的。正如我所提到的，當我們與我們的現場銷售組織一起與醫生交談時，醫生們很高興我們已經被添加到指南中並被添加到一線醫生中。因此，它增加了很多可信度，並建立了醫生開處方的信心。這與我們正在構建的一些證據生成是否會幫助我們獲得付款人的訪問權還有待觀察。

Okay. Maybe the last question here is that the -- earlier -- I think this last year, you guys have mentioned that you might have to do a Phase 4 study, does that still -- could that be the case in 2023? And if so, would that impact on the R&D expenses for 2023? And thanks for the -- for answering those questions.

好的。也許這裡的最後一個問題是 - 早些時候 - 我認為去年，你們提到你可能必須進行第 4 階段研究，是否仍然 - 2023 年會是這種情況嗎？如果是這樣，這會影響 2023 年的研發費用嗎？感謝您回答這些問題。

Yes, no problem. Yes, we're still talking to FDA about working through that trial. It's still taking time to get agreement to what that trial will look like. So we don't have any expectations, at least in the first half, probably at the end of 2023, if any.

是沒有問題。是的，我們仍在與 FDA 討論如何完成該試驗。就該試驗的形式達成一致仍需要時間。所以我們沒有任何期望，至少在上半年，可能在 2023 年底，如果有的話。

Okay, great. Thanks a lot. I really appreciate it. And thanks.

好的，太好了。多謝。對此，我真的非常感激。謝謝。

Thanks, Yale.

謝謝，耶魯。

(Operator Instructions) All right. We have no further questions in the queue, so this does conclude that portion of today's call. I would now like to turn the call back over to Dave Gonyer for any additional or closing remarks.

（操作員說明）好的。隊列中沒有其他問題，因此今天的電話會議部分就此結束。我現在想將電話轉回給 Dave Gonyer，以徵求任何補充意見或結束意見。

Great. Thank you. I just wanted to close by saying that our effort to make GIMOTI the standard of care for diabetic gastroparesis got a major boost last year in the areas that we outlined today. I just wanted to remind everyone that GIMOTI is a novel product still in its launch phase, and such times come with both exhilarating growth and handling times like the slight decrease in Q4 revenues that we saw, though prescriptions were 8% higher.

偉大的。謝謝。最後，我只想說，去年，我們為使 GIMOTI 成為糖尿病胃輕癱護理標準所做的努力在我們今天概述的領域得到了重大推動。我只是想提醒大家，GIMOTI 是一種仍處於發布階段的新產品，這種時候伴隨著令人振奮的增長和處理時間，比如我們看到的第四季度收入略有下降，儘管處方量增加了 8%。

Nonetheless, our trajectory is on a steep positive curve, and we look forward to executing on our strategic plan and reporting the results for the remainder of the 2023. Thank you very much for your time.

儘管如此，我們的軌跡正處於陡峭的正曲線上，我們期待著執行我們的戰略計劃並報告 2023 年剩餘時間的結果。非常感謝您的時間。

Ladies and gentlemen, this concludes today's Evoke Pharma fourth quarter and full year 2022 earnings call and webcast. You may disconnect your line at this time and have a wonderful day.

女士們，先生們，今天的 Evoke Pharma 第四季度和 2022 年全年收益電話會議和網絡廣播到此結束。您可以在此時斷開您的線路並度過美好的一天。

On behalf of our client, I would like to thank you for joining. This concludes our program.

我代表我們的客戶，感謝您的加入。我們的程序到此結束。