Achieve Life Sciences, Inc. (ACHV) 2026 Q1 法說會逐字稿

Greetings, and welcome to the Achieve Life Sciences first quarter 2026 earnings conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

各位好，歡迎參加 Achieve Life Sciences 2026 年第一季財報電話會議與網路直播。（接線員指示）提醒各位，本次會議將被錄音。

I would now like to turn the call over to Nicole Jones, Achieve's Vice President, Strategic Communications and Stakeholder Relations. You may begin.

現在我想把電話會議交給 Achieve 策略溝通與利害關係人關係副總裁 Nicole Jones。您可以開始了。

Thank you, operator. Good morning, everyone, and thank you for joining us today. From Achieve Life Sciences, we are joined by Dr. Andrew Goldberg, Chief Executive Officer, who will deliver the prepared remarks. Joining Dr. Goldberg for the Q&A will be Mark Oki, Chief Financial Officer. A replay will be available later today using the information in the earnings press release or by visiting the Achieve Life Sciences website.

謝謝，接線員。各位早安，感謝今天加入我們。代表 Achieve Life Sciences 與會的有執行長 Andrew Goldberg 醫師，他將發表事先準備的談話。在問答環節，將由財務長 Mark Oki 與 Goldberg 醫師一同參與。今天稍晚可依據財報新聞稿中的資訊收聽重播，或造訪 Achieve Life Sciences 官網。

Today's conference call will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Achieve.

今天的電話會議將包含若干前瞻性陳述，包括關於 Achieve 之目標、策略、信念、預期以及未來潛在營運成果的陳述。

Although management believes these statements are reasonable based on estimates, assumptions and projections of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. Achieve undertakes no obligation to update or revise any of these forward-looking statements. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company.

儘管管理層認為這些陳述係基於今日之估計、假設與預測而屬合理，但這些陳述並非對未來績效的保證。具時效性的資訊在任何電話或網路直播重播時點可能已不再準確。實際結果可能因風險、不確定性及其他因素而出現重大差異，包括但不限於公司向美國證券交易委員會（SEC）提交文件中所列之因素。Achieve 不承擔更新或修訂任何前瞻性陳述之義務。請參閱 Achieve 官網可取得且已向 SEC 提交之文件，了解可能影響公司的因素。

I'll now turn the call over to Dr. Goldberg.

現在我把電話會議交給 Goldberg 醫師。

Thank you, Nicole, and good morning, everyone. I'm honored to step into the role of Chief Executive Officer at such an important time. I joined Achieve to lead a mission-driven company. We are developing a new treatment for cessation of smoking, the leading cause of preventable death, as well as vaping that is putting a new generation at risk. We are going to make sure the public and the people most directly affected get the help they deserve.

謝謝你，Nicole，各位早安。我很榮幸在這個關鍵時刻接任執行長一職。我加入 Achieve，是為了領導一家以使命為導向的公司。我們正在開發一種新的戒菸治療，因為吸菸是可預防死亡的首要原因；同時也針對讓新世代面臨風險的電子菸使用。我們將確保大眾以及最直接受影響的人，能獲得他們應得的協助。

Before turning to the quarter, a word about my background and why I'm here. For the last decade, I've been an investor and governance leader, serving as a director or observer on 19 health care boards, most recently at Veradermics and currently with Tarsus Pharmaceuticals through their national launch of XDEMVY.

在談本季之前，先簡要說明我的背景以及我為何在此。過去十年，我一直是投資人與公司治理領導者，曾在 19 家醫療保健公司董事會擔任董事或觀察員，最近是在 Veradermics，目前則在 Tarsus Pharmaceuticals，並陪伴其完成 XDEMVY 的全國上市。

My expertise is helping companies cross the chasm from late-stage development to commercial with disciplined execution, all in service of bringing next-generation therapies to market for patients. Improving patient care has been the focus of my career. I have spent nearly 20 years as a physician, dual board certified in critical care and emergency medicine. I trained in practice at the Mayo Clinic, Los Angeles General Medical Center, and the VA Health System. I published my first research on tobacco when I was 19.

我的專長是以嚴謹的執行力，協助公司跨越從後期研發到商業化的鴻溝，致力於將下一代療法推向市場、造福病患。改善病患照護一直是我職涯的核心。我擔任醫師近 20 年，並同時取得重症醫學與急診醫學的雙專科認證。我曾在梅約診所（Mayo Clinic）、洛杉磯綜合醫療中心（Los Angeles General Medical Center）以及退伍軍人醫療體系（VA Health System）受訓與執業。我在 19 歲時就發表了第一篇關於菸草的研究。

Through treating critically ill patients with respiratory failure, vascular events and complications of cancer, I've since seen firsthand the total nicotine dependence takes on patients and their families.

在治療呼吸衰竭、血管事件以及癌症併發症等重症病患的過程中，我親眼見證了尼古丁依賴對病患及其家庭造成的全面性影響。

Today, in the United States, nearly 50 million adults use nicotine. Approximately 25 million are smokers, 18 million vape. And though the majority want to quit, most fail because current treatment options fall short. Despite the scale of this problem, there has not been a new FDA-approved smoking cessation therapy in more than 2 decades. And there has never been an approved therapy for vaping cessation.

目前在美國，近 5,000 萬名成年人使用尼古丁。其中約 2,500 萬人吸菸、1,800 萬人使用電子菸。雖然多數人想戒除，但因現有治療選項不足而多以失敗告終。儘管問題規模龐大，超過 20 年來並沒有新的 FDA 核准戒菸療法；而針對戒除電子菸，更從未有任何核准療法。

At Achieve, the strength of the clinical data and the favorable tolerability profile gave me conviction that we have an opportunity to fill that gap between patient need and available solutions and champion a category-defining public health intervention.

在 Achieve，臨床數據的強勁表現與良好的耐受性特徵，讓我確信我們有機會填補病患需求與現有解決方案之間的缺口，並推動一項可定義新類別的公共衛生介入措施。

Before I jump into this quarter's updates, I want to acknowledge Rick Stewart, our Co-Founder and former CEO. Rick was instrumental in building this company from recognizing cytisinicline's potential through NDA acceptance, and we are deeply grateful for his vision, leadership and unwavering dedication to this mission. We would not be where we are today without him.

在我進入本季更新之前，我想致謝共同創辦人暨前任執行長 Rick Stewart。Rick 在打造公司方面居功厥偉，從辨識 cytisinicline 的潛力一路推進至 NDA 受理，我們對他的遠見、領導力以及對此使命的堅定投入深表感激。沒有他，就不會有今天的我們。

We also recently appointed three new Board members: Chris Martin, most recently the Chief Commercial Officer of Verona Pharma; Dr. Lucian Iancovici, Managing Director at TPG; and Dr. Aaron Royston, Managing Partner at venBio. Chris recently led the launch of Ohtuvayre, widely regarded as one of the most successful pulmonary launches in industry history and brings exemplary commercial execution experience to our Board. Dr. Iancovici and Dr. Royston each bring deep expertise in company scaling, investing and board governance and have guided numerous companies through FDA approval.

我們近期也任命了三位新董事會成員：Chris Martin，最近擔任 Verona Pharma 的商務長（Chief Commercial Officer）；TPG 董事總經理 Lucian Iancovici 醫師；以及 venBio 管理合夥人 Aaron Royston 醫師。Chris 近期主導 Ohtuvayre 的上市，該上市案被廣泛視為產業史上最成功的肺科產品上市之一，並為董事會帶來卓越的商業化執行經驗。Iancovici 醫師與 Royston 醫師則在公司擴張、投資與董事會治理方面具備深厚專長，並曾引導多家公司取得 FDA 核准。

I'm pleased to welcome all three to the Board. And earlier this morning, we also announced two of Chris prior colleagues from Verona joining us as key leaders in our commercial team, Mark Zappia as Senior Vice President of Commercial; and Jim Willis as Vice President of Sales and Enablement, where he will lead the field force. Together with Chris, this team brings deep experience from, Ohtuvayre, widely regarded as one of the best launches in industry history, and we are thrilled to have their leadership for what comes next.

我很高興歡迎三位加入董事會。今天稍早，我們也宣布 Chris 在 Verona 的兩位前同事將加入我們，成為商業團隊的關鍵領導者：Mark Zappia 擔任商業資深副總裁（Senior Vice President of Commercial）；Jim Willis 擔任銷售與賦能副總裁（Vice President of Sales and Enablement），並將領導前線團隊。連同 Chris 在內，這個團隊帶來了來自 Ohtuvayre 的深厚經驗；Ohtuvayre 被廣泛認為是產業史上最佳上市案之一。我們非常期待他們在下一階段的領導。

Today, I'd like to touch on three key highlights from the quarter. First, we closed a transformational financing, which positions us for success. This private placement included $180 million in upfront capital, plus up to $174 million from milestone-based warrants that may be exercised at any time prior to and up to 20 trading days following FDA approval. This financing came together because a syndicate of leading specialist healthcare investors chose to support this company's next chapter. And I want to personally thank Frazier Life Sciences, TPG, venBio, Paradigm BioCapital, Marshall Wace and our other new and existing investors for the conviction they have placed in this team and this mission.

今天我想談本季三項重點。第一，我們完成了一項具轉型意義的融資，為成功奠定基礎。此私募包含 1.8 億美元的前期資金，另有最高 1.74 億美元來自里程碑式認股權證；該等權證可於 FDA 核准前任何時間，以及 FDA 核准後最多 20 個交易日內行使。這項融資之所以能成形，是因為一群領先的專業醫療保健投資人選擇支持公司下一篇章。我也想親自感謝 Frazier Life Sciences、TPG、venBio、Paradigm BioCapital、Marshall Wace 以及其他新舊投資人，感謝他們對本團隊與此使命的信念。

Second, we continue to make operational progress. As mentioned last quarter, the company has partnered with US-based Adare Pharma Solutions to manufacture cytisinicline drug product for potential commercial supply. We expect this partnership will help decrease risk related to international importation of pharmaceuticals, including potential tariffs. In the first quarter, we produced our first cytisinicline engineering batch at their facility. In mid-April, the company announced it expects to receive a complete response letter from the FDA on or by our June 20 PDUFA date due to a separate third-party manufacturer having received an official action indicated classification.

第二，我們持續取得營運進展。如同上季所提，公司已與美國在地的 Adare Pharma Solutions 合作，製造 cytisinicline 藥品成品，以供潛在商業供應。我們預期此合作將有助於降低與國際藥品進口相關的風險，包括潛在關稅。在第一季，我們在其廠區生產了第一批 cytisinicline 工程批次（engineering batch）。4 月中旬，公司宣布，由於另一家第三方製造商收到「官方行動指示（official action indicated）」分類，我們預期 FDA 將在 6 月 20 日 PDUFA 日期當日或之前發出完整回覆函（complete response letter）。

It is important to note that these observations relate to general cGMP matters at the facility and are not specific to cytisinicline manufacturing.

需要特別指出的是，這些觀察結果與該廠的一般 cGMP 事項相關，並非針對 cytisinicline 的製造。

The company's plan, as previously stated, is to resubmit the NDA in the fourth quarter of 2026 naming Adare Pharma Solutions as our new and primary manufacturing partner for commercial supply. The company's stated expectation is for a commercial launch in the first half of 2027. I am now ensuring our readiness against that timeline. Third, let's now turn to the continued advancement of our scientific data. In March, we published mechanistic data in nicotine and tobacco research, providing evidence that cytisinicline selectively interacts with the alpha 4 beta 2 nicotinic receptor while exhibiting minimal interaction with the 5-HT3 serotonin receptor, a key mechanism potentially underlying its tolerability.

如先前所述，公司計畫於 2026 年第四季重新提交 NDA，並指定 Adare Pharma Solutions 為我們新的且主要的商業供應製造合作夥伴。公司既定預期為於 2027 年上半年進行商業上市。我目前正確保我們能依該時程做好準備。第三，接著談我們科學數據的持續推進。3 月，我們在《Nicotine & Tobacco Research》發表機轉數據，提供證據顯示 cytisinicline 會選擇性地與 α4β2 菸鹼型受體互動，同時與 5-HT3 血清素受體的互動極少；這可能是其耐受性表現背後的關鍵機制。

These findings help explain the low nausea rates observed in clinical trials.

這些發現有助於解釋在臨床試驗中觀察到的低噁心發生率。

At the Society for Research on Nicotine and Tobacco Conference, our team presented an analysis of over 1,600 Phase III participants, demonstrating consistent efficacy regardless of prior treatment history or previous quit attempt patterns. Importantly, among participants with prior varenicline and bupropion use, those receiving 12 weeks of cytisinicline achieved continuous abstinence rates of 32.4% versus 6% on placebo with an odds ratio of 7.5. This is a particularly difficult-to-treat population, and these results highlight cytisinicline's potential to address a significant unmet need among patients who have failed existing therapies.

在尼古丁與菸草研究學會（Society for Research on Nicotine and Tobacco）年會上，我們團隊發表了對超過1,600名第三期（Phase III）受試者的分析，顯示無論既往治療史或先前戒菸嘗試模式如何，療效皆一致。重要的是，在曾使用伐尼克蘭（varenicline）與安非他酮（bupropion）的受試者中，接受12週cytisinicline治療者的持續戒斷率為32.4%，相較之下安慰劑組為6%，勝算比（odds ratio）為7.5。這是一個特別難以治療的人群，而這些結果凸顯cytisinicline有潛力滿足既有療法失敗患者的一項重大未被滿足需求。

In closing, my focus now is on growing our team and executing the strategy required to launch this important medicine at the scale the opportunity deserves. We understand the stakes and with multiple physician officers and directors at Achieve, we have direct experience with the limited tools currently available to help patients. Our goal is to build a company that our shareholders, the public health community and every patient and family affected by nicotine dependence want to see succeed. That is what this company is for, and what I am here to do. Thank you for joining us this morning.

最後，我目前的重點是擴充團隊並執行所需策略，以符合此機會應有的規模推出這項重要藥物。我們了解其中利害關係；Achieve擁有多位具醫師背景的主管與董事，我們對目前可用於協助患者的有限工具有第一手經驗。我們的目標是打造一家讓股東、公共衛生社群，以及每一位受尼古丁依賴影響的患者與家庭都希望看到成功的公司。這就是這家公司存在的目的，也是我在此要做的事。感謝各位今天早上與我們一同參與。

I look forward to updating you on our continued progress in the months and years to come.

我期待在未來幾個月與幾年中，向各位更新我們持續取得的進展。

(Operator Instructions)

（接線員指示）

Jason Butler, Citizens.

Jason Butler，Citizens。

Hi, thanks for taking the questions and really appreciate all the detail you provided this morning. Can you maybe just give us a few more comments on the commercial strategy and what you think really needs to be achieved in 2026 to be ready for launch next year?

嗨，感謝你們接受提問，也非常感謝今天早上提供的所有細節。你們能否再多談一些商業化策略，以及你們認為在2026年需要達成哪些關鍵事項，才能為明年上市做好準備？

Thank you. I appreciate asking that question. It's something we've obviously been thinking about carefully, especially since I've joined. If you look forward with me for a moment, now we have the capital after a meaningful financing. We're building our team.

謝謝。我很感謝你提出這個問題。這顯然是我們一直在仔細思考的事情，尤其是在我加入之後。若和我一起往前看一下，現在在完成一筆具規模的融資後，我們已有資金。我們正在建立團隊。

And fortunately, now we have the time and above all, the asset. And so my job right now is to make sure we have the right data-driven strategy to bring cytisinicline to patients. I think the team announcements this morning are some of the most visible evidence of that work, and we'll continue to build on that in the months and years to come.

而且幸運的是，現在我們有時間，更重要的是，我們有這項資產。因此，我目前的工作是確保我們有正確、以數據驅動的策略，將cytisinicline帶給患者。我認為今天早上公布的團隊任命，是這項工作最明顯的證據之一；未來幾個月與幾年，我們也會持續在此基礎上推進。

And I think the main change in our strategy going forward is, yes, we plan to commercialize independently with our own field force, and we recruited a fantastic leader today. And so with this team, the asset, what we know about the category, we believe that Achieve is best positioned to bring cytisinicline to patients ourselves, and we'll share more specifics as our decisions firm up.

我認為我們未來策略的主要改變是：是的，我們計畫以自建的業務團隊獨立商業化，我們今天也招募到一位非常出色的領導者。因此，憑藉這個團隊、這項資產，以及我們對該治療領域的理解，我們相信Achieve最適合由我們自己將cytisinicline帶給患者；隨著決策逐步定案，我們會分享更多具體細節。

Great. And then just one follow-up. Just on the medical education side, where do you think awareness is with current CHANTIX prescribers of cytisinicline in the Phase III data? And again, what do you need to do in 2026 to keep building that awareness?

很好。接著一個追問：在醫學教育方面，你認為目前CHANTIX處方醫師對cytisinicline第三期數據的認知程度如何？同樣地，你們在2026年需要做些什麼來持續提升這種認知？

Thank you for that. So we're constrained about what we can communicate in a pre-approval environment, and we take those rules seriously. But what we can do is share our existing clinical data and any new data generated from our trials through the appropriate scientific channels. We expect to present some new data at conferences later that year, including some this month. And as we get closer to approval and the launch, our MedEd team will expand, and we'll continue to update throughout the course of the year.

謝謝你的提問。因此，在核准前的環境下，我們能夠溝通的內容受到限制，我們也嚴肅看待這些規範。但我們能做的是，透過適當的科學管道分享既有臨床數據，以及試驗所產生的任何新數據。我們預期在當年稍晚的會議上發表一些新數據，其中也包括本月的一些。隨著我們更接近核准與上市，我們的醫學教育（MedEd）團隊將擴編，並會在全年過程中持續更新。

Justin Walsh, JonesTrading.

Justin Walsh，JonesTrading。

It would be great if you could provide some color on what additional information will need to go into the NDA resubmission and how Adare is progressing in its manufacturing efforts? And related to this, also it would be great to hear your thoughts on capacity and if you expect Adare will be able to meet potential demand?

如果你們能補充說明NDA重新遞交需要納入哪些額外資訊，以及Adare在製造工作上的進展，會很有幫助。另外，也希望聽聽你們對產能的看法，以及你們是否預期Adare能夠滿足潛在需求。

So we expect any CRL that focus on the OAI classification of a prior third-party manufacturer, which is the basis of for the Adare transition. And so the three words I kind of want to use to characterize our position here are going forward are transparency, proactiveness and importantly, adaptability. So we'll continue to be transparent with our investors and analysts. What we know is that based on observations at that prior third-party manufacturing, they are unrelated to our drug. But although we haven't received that notification yet, the company has already been proactive.

我們預期任何CRL將聚焦於先前三方製造商的OAI分類，而這正是轉由Adare承接的原因。因此，用來描述我們未來立場的三個詞是：透明、主動，且重要的是，具適應性。我們會持續對投資人與分析師保持透明。我們所了解的是，基於對先前三方製造現場所見的觀察，其問題與我們的藥物無關。但即便我們尚未收到該通知，公司已經採取主動作為。

We've already moved our manufacturing to the US, and we've already produced our first batches this quarter.

我們已將製造移轉至美國，並且已在本季生產出第一批批次。

And so our principal goal and my principal goal is completing that tech transfer to Adare on as fast a time line as possible while maintaining our completeness. And so I'm early in my tenure, but we're evaluating every strategy and expenditure as we do this right and we will not hesitate to adjust resourcing where it is needed, including ramping up where we believe that it's necessary. I am personally engaged in this process. I've already visited Adare headquarters in my first week to help ensure that we're ready, and we're committed to getting this done.

因此，我們的主要目標、也是我個人的主要目標，是在維持完整性與周延性的前提下，以盡可能快的時程完成向Adare的技術移轉。我上任時間尚短，但我們正在評估每一項策略與支出，以確保把事情做對；我們也不會猶豫在需要之處調整資源配置，包括在我們認為必要時加速投入。我本人正深度參與此流程；我在第一週就已造訪Adare總部，以協助確保我們做好準備，我們也承諾會把這件事完成。

Importantly, now we have the resources to do so, and we recognize what's at stake. The patients waiting for this medicine can't afford for us to get this wrong. And so we will ramp up where it's needed to get this right. And we're confident that our current US partner who has multiple FDA-approved products already can help us get there.

重要的是，現在我們有資源可以做到這一點，而且我們也認知到其中利害關係。等待這項藥物的患者承受不起我們出錯。因此，我們會在需要之處加大投入，確保把事情做對。我們也有信心，目前這家在美國的合作夥伴已擁有多項FDA核准產品，能協助我們達成目標。

Gary Nachman, Canaccord Genuity.

Gary Nachman，Canaccord Genuity。

Congrats on the next phase for the company. Andrew, before you led this last private placement and decided to take over as CEO, what sort of due diligence did you do on the IP for cytisinicline? And how comfortable you are with the durability of that product? And then just on the last question that you answered, how confident are you with the stated timeline given the transition to manufacturing, and it sounds like that's a fluid process.

恭喜公司進入下一階段。Andrew，在你主導這次私募並決定接任CEO之前，你對cytisinicline的智慧財產權做了哪些盡職調查？你對該產品權利保護的持久性有多放心？另外，關於你剛才回答的上一個問題，考量到製造轉移且看起來是個動態流程，你對所述時程有多大信心？

So let me take the first question on IP. So I've looked at Achieve for, I followed this company for a long time, both as a position and as an investor. And so we've done diligence on the intellectual property on several fold. And I would also add that was done by other investors who have come into this significant financing as well. And we're confident we have the IP to protect our franchise going forward well into the late 2030s and even the 2040s.

我先回答IP的問題。我關注Achieve已經很久了，無論是作為持倉標的或作為投資人。因此，我們已從多個面向對智慧財產權進行盡職調查。我也要補充，參與這次重大融資的其他投資人也做了相關盡調。我們有信心擁有足以保護我們未來產品版圖的IP，期限可延伸至2030年代末，甚至到2040年代。

With respect to your question about the timeline, I'm, again, early in my tenure. We are trying to look under every nook and cranny to ensure that we can meet those timelines. Right now, I've not seen anything to suggest that we will not be able to meet them. And but I can assure you that we'll be transparent with the analysts and our investor community and the market and share any updates as they come forward.

至於你關於時程的問題，我同樣是上任不久。我們正試圖檢視每一個細節，以確保能符合那些時程。目前我尚未看到任何跡象顯示我們無法達成。不過我可以向你保證，我們會對分析師、投資人社群以及市場保持透明，並在有任何進展時分享更新。

Okay. Great. And then just a follow-up. With the likely change in leadership at FDA if Makary leaves, how are you thinking about the evolving dynamics in the vaping market if more vapes end up being approved? And also with respect to the priority voucher for vaping that you got last fall, if you think FDA will be committed to that as a priority?

好的。很好。接著再追問一下。若 Makary 離任導致 FDA 領導層可能出現變動，若未來有更多電子菸產品最終獲得核准，您如何看待電子菸市場動態的演變？另外，關於您去年秋天取得的電子菸優先審查憑證，您認為 FDA 會否仍會把它作為優先事項來推進？

Okay. So I won't speculate on the agency or comment on any of the internal dynamics that have been reported. What I can say is that our interactions with the FDA have been constructive and consistent with the standard submission process. What the CNPV means to us is that the agency is aligned with the public health need to get this therapy to patients as fast as possible. And so we're honored to be a part of the program.

好的。所以我不會對該機構作任何揣測，也不會評論任何已被報導的內部動態。我能說的是，我們與 FDA 的互動一直是建設性的，且符合標準的送件流程。CNPV 對我們而言的意義在於，該機構與公共衛生需求保持一致，希望盡快把這項治療帶給病患。因此我們很榮幸能成為該計畫的一部分。

And remember, we also have breakthrough designation. So not only is this a public health imperative, it's also novel. It's the first ever for the indication, and that's important.

而且請記得，我們也擁有突破性療法認定。因此這不僅是公共衛生上的迫切需求，它同時也具創新性。這是該適應症史上首次，這點很重要。

But I think what separates us from some of the other CNPV recipients is this. Smoking is our lead indication and vaping, the indication with the CNPV is a follow-on program. So the smoking NDA stands on its own 2 feet. We have 2 Phase III double-blind, placebo-controlled trials where not one, but both of our 6- and 12-week courses reached statistical significance. And so we're proud to be a recipient of the voucher, but we're not dependent on it to be successful.

但我認為，使我們與其他一些 CNPV 受領者有所區隔的是這一點：戒菸是我們的主要適應症，而獲得 CNPV 的電子菸適應症則是後續延伸計畫。因此，戒菸的 NDA 本身就站得住腳。我們有兩項第三期、雙盲、安慰劑對照試驗，不是只有其中一個，而是我們 6 週與 12 週兩種療程都達到統計顯著性。因此我們很自豪能獲得該憑證，但我們的成功並不依賴它。

The voucher tells us that the agency understands the urgency, but it does not change the substance of what we're doing.

這張憑證告訴我們，主管機關理解其急迫性，但它不會改變我們正在做的事情之實質內容。

Okay. And then just lastly, how soon do you think it will be before you could start the vaping Phase III? Is there still a lot of work you want to do just going back to the FDA ensuring you just need that single Phase III? Is that something that could happen later this year?

好的。最後一個問題，您認為距離啟動電子菸第三期試驗還需要多久？回到 FDA 那邊，是否仍有很多工作要做，以確認只需要做單一一項第三期？這件事有可能在今年稍晚發生嗎？

Yeah. So, thank you for that. ORCA-V2 will be a randomized placebo-controlled multicenter trial, and we're finalizing that design and aligning on the criteria to ensure the highest probability of success. And so we hope to initiate the study this year, and we'll update the markets on timelines when we're able to do so.

是的，謝謝你的提問。ORCA-V2 將是一項隨機、安慰劑對照的多中心試驗，我們正在定案其設計，並就相關標準達成一致，以確保最高的成功機率。因此我們希望能在今年啟動研究，並在可行時向市場更新時程。

Brandon Folkes, H.C. Wainwright.

Brandon Folkes，H.C. Wainwright。

Congratulations on all the progress. Three for me, if I may. The previous team had mentioned initially focusing on those smokers that need to stop smoking and may have comorbidities. Just given the capital you now have at your disposal, would you be willing to talk about if you contemplate a wider approach at launch? I'll ask my second one because it stays along those lines.

恭喜你們取得所有進展。我有三個問題（如果可以的話）。前一個團隊曾提到，最初會聚焦在那些需要戒菸且可能有共病的吸菸者。考量到你們現在可運用的資金規模，能否談談你們是否會在上市時考慮採取更廣泛的切入方式？我也先問第二個，因為同樣沿著這個方向。

How do you think about patient support programs for the launch, just things such as patient hotlines, et cetera. Can you just help us think about how large of an investment do you contemplate across the commercial organization at launch, I guess, especially in light of if we look back at the CHANTIX launch and sort of the importance of those programs as they were described?

你們如何看待上市時的病患支持計畫，例如病患專線等？能否協助我們理解，在上市時你們預計在商業組織上投入多大的資源？尤其是回顧 CHANTIX 上市時，這類計畫的重要性曾被如此描述。

Thank you for that. So, yes, after our financing, which we closed, we're in a very strong financial position to be able to execute on our goals and our launch preparation. So we have the resources now that we need to execute on a broader commercial strategy. I think the commercial model here matters as much as the budget. Nicotine dependence is uniquely well suited to a disease awareness and diagnosis approach.

謝謝你的提問。是的，在我們完成並結束這次融資之後，我們的財務狀況非常強健，足以執行我們的目標與上市準備。因此我們現在具備所需資源，能夠推動更廣泛的商業策略。我認為在這裡，商業模式的重要性不亞於預算本身。尼古丁依賴特別適合採用疾病認知與診斷導向的方式。

Patients already know they have the problem. We don't need a new diagnostic test. We don't need a long referral pathway, and we don't need extensive titration or monitoring. The vast majority of people with nicotine dependence are already in front of a healthcare provider for other reasons.

病患本來就知道自己有這個問題。我們不需要新的診斷檢測，不需要冗長的轉診流程，也不需要大量的劑量滴定或監測。絕大多數尼古丁依賴者，原本就因其他原因在醫療照護提供者面前就診。

And so the barrier to treatment has not been awareness of the disease to date and with prior attempts. It's been with the lack of an effective and tolerable therapy that prescribers feel confident offering. And so that for us changes a bit of the commercial map. Launch efficacy launch efficiency in this category is not about saturating awareness. Patients already raised their hands.

因此，迄今以及過去嘗試的治療中，治療障礙並不在於對疾病的認知不足，而在於缺乏一個有效且耐受性良好、讓處方醫師有信心開立的療法。這對我們而言會稍微改變商業版圖。在這個類別中，上市的成效與效率並不在於把認知宣傳做到飽和；病患早已舉手表明需求。

It's about where we're going to be focused is about giving prescribers a reason to treat, equipping them with the right therapy and removing that access friction. And that's what our commercial team, Mark, Jim and Chris, who were announced this morning has done before. And so with this team, this asset and category, we believe we can effectively launch at scale.

我們要聚焦的是：給處方醫師一個治療的理由，為他們配備正確的療法，並移除取得治療的摩擦成本。這正是我們的商業團隊——今天早上宣布的 Mark、Jim 和 Chris——過去做過的事。因此憑藉這個團隊、這項資產與這個類別，我們相信可以有效地以規模化方式推動上市。

With respect to your second question around investment in patient support programs, the world now is very different than it was 20 years ago. And with a digital and tele-infrastructure and now everyone with a cellphone in their pocket, the ability to provide support programs for our patients has really never been easier. And so I can foresee a potential future where we're able to offer not just that therapy, but also some of those support programs going forward in order to help our patients and the clinicians meet the goals.

至於你第二個問題，關於在病患支持計畫上的投資，如今的世界與 20 年前非常不同。隨著數位化與遠距基礎設施的成熟，以及每個人都隨身帶著手機，為病患提供支持計畫的能力其實前所未有地容易。因此我可以預見，未來我們不僅能提供療法，也能進一步提供一些支持計畫，協助病患與臨床醫師達成目標。

Great. And one more, if I may. Given your focus on the data, do you anticipate doing any additional small clinical work or any clinical work you would like to do before refiling should you get the CRL?

很好。如果可以的話我再問一個。鑑於你們對數據的重視，若收到 CRL，你們是否預期在重新送件前會再做任何額外的小型臨床研究，或任何你們希望先完成的臨床工作？

So as a physician and a prior researcher, I'm always considering and thinking about new unique studies we can run. I do think that there are unique subsets within the smoking community that are well positioned to study. We've already shared some unique information today and over the last quarter around patients, the success rates in patients who have tried prior therapies before and the impressive efficacy and tolerability in those cohorts. We're also sharing some information later this year on patients with cancer and how this drug improves smoking in that cohort.

作為醫師與前研究人員，我總是在思考我們可以進行哪些新的、獨特的研究。我確實認為，在吸菸族群中有一些獨特的子族群很適合進一步研究。我們今天以及過去一季已分享一些獨特資訊，包含曾嘗試過既有療法的病患之成功率，以及在那些隊列中令人印象深刻的療效與耐受性。我們也將在今年稍晚分享癌症病患的相關資訊，以及這款藥物如何改善該隊列的吸菸情況。

We've already described how we work pretty effectively in patients with COPD. I think there's additional subsets, some small and some, frankly, very large that we can also continue to highlight. The focus will be right now getting the drug approved through our primarily completed clinical program and ramping up our vaping study to get that follow-on indication. But I think you can expect that we will be thorough in generating data going forward. And I think we have an excited and committed research community that's going to help support us in that.

我們也已描述過，我們在 COPD 病患中運作得相當有效。我認為還有其他子族群，有些規模較小，有些坦白說規模非常大，我們也可以持續加以凸顯。眼前的重點將是：透過我們主要已完成的臨床計畫推動藥物核准，並加速推進電子菸研究以取得後續適應症。但我想你可以期待，我們未來在數據產出上會非常周全。我也認為我們有一個令人振奮且投入的研究社群，將協助支持我們。

Nelson Cox, Lake Street Capital.

Nelson Cox，Lake Street Capital。

This is Nelson on for Thomas. I'll ask kind of, both mine upfront, which are follow-ups to previous questions. But on the CNPV, can you kind of walk us through your understanding of the two-year clock? And specifically, does it start at receipt of the voucher or at the initiation of the pivotal vaping study? Or what's kind of the what's the -- how does that work there?

我是 Nelson，代 Thomas 提問。我會把兩個問題一起先問，都是對前面問題的追問。關於 CNPV，你能否帶我們走一遍你對「兩年時鐘」的理解？具體來說，它是從收到憑證時開始計時，還是從啟動關鍵性的電子菸樞紐試驗時開始？或是——那邊的運作方式大概是怎樣？

And then how large of a field team would you anticipate needing to meet your commercial expectations?

另外，你們預期需要多大規模的外勤團隊，才能達成你們的商業化期望？

I don't want to comment on the exact specifications around the voucher. We've received it. We plan on initiating the ORCA-V2 trial as fast as we can, and we will work with the agency in order to try and stay on any needed timelines. With respect to the size of our field force, I think we're going to be smart about how we scale that up. I could see us starting with a reasonable sized field force.

我不想就該憑證的確切規格發表評論。我們已經收到它。我們計劃以最快速度啟動 ORCA-V2 試驗，並將與主管機關合作，盡力遵守任何所需的時程安排。至於我們外勤團隊的規模，我認為我們會以審慎且聰明的方式擴編。我可以想像我們會先從一支規模合理的外勤團隊開始。

I don't want to commit to any specific numbers right now, but I'm confident that we have both the capital and the team to help lead that. And as we branch out into a broader nationwide distribution, we -- our field force will scale in accordance with that. I think the main thing is we want to build both the company and the field force to scale with the magnitude of the opportunity, but we're going to be disciplined about when we start and how we do it.

我目前不想承諾任何具體數字，但我有信心我們同時具備資金與團隊來推動這件事。隨著我們拓展到更廣泛的全國性通路，我們——我們的外勤團隊也會相應擴編。我認為重點在於，我們希望公司與外勤團隊都能隨著機會的規模而擴張，但我們會在何時開始以及如何執行上保持紀律。

John Vandermosten, Zacks.

John Vandermosten，Zacks。

Dr. Goldberg, with respect to the fourth quarter resubmission of the NDA, do you expect a Class I or Class II type of resubmission?

Goldberg 醫師，關於第四季重新提交 NDA，您預期會是 Class I 還是 Class II 類型的重新提交？

I think we'll wait for, we're trying to be proactive here in what we plan. I think right now, we'll wait for the information from the agency and then plan our resubmission at that time, and we'll update the market when we do that.

我想我們會先等待——我們在規劃上正試圖更積極主動。我認為目前我們會先等主管機關提供資訊，然後再於當時規劃重新提交，並在我們這麼做時向市場更新。

Okay. And with respect to the European manufacturer, have you completely severed ties with them? Is that all the way in the past now? Or is that something that may continue as an alternative supply source?

好的。那關於歐洲的製造商，你們是否已經完全切斷與他們的關係？這是否已經完全成為過去？還是未來可能仍作為替代供應來源而延續？

Yeah. So the manufacturer that received the OAI, we plan on no longer using them as part of our path forward. We've replaced them with our new US partner as our primary supplier.

是的。所以，收到 OAI 的那家製造商，我們計劃在未來的推進路徑中不再使用他們。我們已以新的美國合作夥伴取代他們，作為我們的主要供應商。

Got it. And it seems like there's been a lot of messaging recently around new aids for smoking cessation. GLP-1s, mentioned digital tools on your phone, and the FDA approved some flavored vapes, which I assume they're using that for nicotine they're intending that for nicotine cessation and then the psilocybin discussions as well going on about that. Does that drown out or potentially drown out the messaging that you guys will have about smoking cessation and using cytisinicline?

了解。而且看起來最近有很多訊息都在談新的戒菸輔助方式。GLP-1、你們提到的手機上的數位工具，以及 FDA 核准了一些有口味的電子菸，我猜他們是把它用於尼古丁——他們的意圖是用於尼古丁戒除，另外也有關於裸蓋菇素（psilocybin）的討論。這些會不會淹沒、或可能淹沒你們在戒菸以及使用 cytisinicline 方面的訊息傳達？

So I think that the area of smoking cessation has been undercovered for the last 20 years, and that's been because there has not been adequate therapies to meet the needs of patients and there's never been one, as we've discussed for vaping. I think some of the new resurgence in some of these other therapies is frankly helpful. We're going to get more attention to the condition. It's going to help more patients. Ultimately, we have a pretty robust and far along program with our Phase III clinical trials, and we have 52-week data that should be released on safety and both efficacy later this year.

我認為戒菸這個領域在過去 20 年一直被低度關注，原因在於一直沒有足夠的療法能滿足病患需求，而且如我們所討論的，對於電子菸（vaping）也從未有過相應療法。我認為這些其他療法近期的再度興起，坦白說是有幫助的。我們會讓這個疾病狀況獲得更多關注，這將幫助更多病患。最終，我們的計畫相當扎實且已推進很深，已完成第三期臨床試驗，並且我們有 52 週數據，預計將在今年稍晚公布安全性與有效性。

And so we're confident that our asset has an extremely easy to tolerate profile. We're an oral pill, easy to take, standard dosing, no titration, no injections. And so we're confident that we have a strong position in that future landscape.

因此我們有信心，我們的資產具有極佳的耐受性。我們是口服錠劑，容易服用，標準劑量，不需要滴定（titration），不需要注射。因此我們有信心，在未來的競爭版圖中我們將具備強勢地位。

Okay. And then finally, with the new team, is your relationship or objectives with Omnicom going to change at all?

好的。最後，隨著新團隊加入，你們與 Omnicom 的關係或目標會有任何改變嗎？

I think the company has had some fantastic partners to get to where they are today. And we are in full transparency, evaluating every partner as to how we've done on manufacturing to commercial to future data-driven infrastructures. And so we'll continue to evaluate our partners and pick the best ones for the time where we are and the ones that will align us best for the strategy going forward.

我認為公司一路走到今天，擁有一些非常出色的合作夥伴。而且我們以完全透明的方式，正在評估每一位合作夥伴——從製造到商業化到未來以數據驅動的基礎設施——我們過去的執行情況。因此我們會持續評估合作夥伴，選擇最適合我們當前階段的，以及最能與未來策略對齊的合作夥伴。

Boris Tolkachev, Freedom Broker.

Boris Tolkachev，Freedom Broker。

Just a quick one for me. Should we assume that the drug batches for the ORCA-V trial will be already manufactured by Adare Pharma? And should we think that the readiness of this facility is the key to really start the trial?

我這邊一個簡短問題。我們是否應該假設 ORCA-V 試驗用的藥品批次將已由 Adare Pharma 製造？以及我們是否應該認為，該設施的就緒程度是實際啟動試驗的關鍵？

Sorry, if I heard the question correctly, it was about manufacturing readiness for the clinical trial supply?

抱歉，如果我沒聽錯的話，問題是關於臨床試驗供應的製造就緒狀況？

Yeah.

是的。

Okay. So the company has manufactured clinical trial supply before. We've manufactured it for multiple Phase III programs, 52-week programs, including trial supply for our randomized controlled trial for vaping, which we've already completed and published. And so we have the ability to generate clinical trial supply. We have also already ramped up manufacturing.

好的。所以公司以前就製造過臨床試驗用藥。我們為多個第三期計畫、52 週計畫製造過，包括我們已完成並發表的、針對電子菸（vaping）的隨機對照試驗用藥。因此我們具備產出臨床試驗供應的能力。我們也已經提升了製造產能。

We've done our batches already last quarter at our US manufacturer. And so we're working now with our clinical development teams and our CMC teams to source this next trial with appropriate supply, and we're making those decisions right now.

我們在上一季已經在我們的美國製造商完成了批次生產。因此我們目前正與臨床開發團隊以及 CMC 團隊合作，為下一項試驗配置適當供應量，而這些決策我們正在進行中。

And just a last quick one. Maybe you could reiterate what is the what is driving the decision to push the resubmission exactly to Q4? Is it like something conservative? Or is it like a real assumption that you will be ready up to the point?

最後再一個快問。也許你可以重申一下，是什麼驅動你們決定把重新提交精確地推到第四季？這是比較保守的做法嗎？還是你們真的假設到那個時間點就會準備就緒？

Yeah. So it really just comes down to doing the technology transfer completely, doing the analytical method transfer, which we've already completed and all the necessary milestones to build up for a resubmission. We're trying to be accurate in how we portray the timelines.

是的。這主要就是把技術轉移完整做完、把分析方法轉移完成——我們已經完成了——以及完成重新提交所需的所有里程碑。我們希望在對外說明時程時能夠準確。

And we have reached the end of the question-and-answer session. Therefore, I would like to turn the floor back over to Dr. Andrew Goldberg for closing remarks.

問答環節到此結束。因此，我想把時間交還給 Andrew Goldberg 醫師作結語。

Thank you. In closing, I think there are three main things to take away this quarter, and thank you for the questions. First is that we have a strong capital position to execute our strategy of approval and launch. Second is that we have a US-based supply chain that derisks our manufacturing and our launch timing. And third, we have new commercial leadership with directly relevant launch experience joining a team and company that has already done the hard work of getting to NDA acceptance.

謝謝。總結來說，我認為本季有三個重點值得帶走，也謝謝各位的提問。第一，我們擁有強勁的資本部位，足以執行我們的核准與上市策略。第二，我們建立了以美國為基礎的供應鏈，降低了製造與上市時程的風險。第三，我們有新的商業領導團隊加入，具備直接相關的上市經驗，並加入一個已經完成艱鉅工作、成功達到 NDA 受理的團隊與公司。

Achieve is positioned to address one of the largest preventable public health problems we know, and we're building the company to deliver on that opportunity.

Achieve 已就位，可望解決我們所知最大且可預防的公共衛生問題之一，而我們也正在打造公司以把握這個機會。

Thank you for joining us today, and I look forward to speaking again soon.

感謝各位今天與會，我期待不久後再次交流。

Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

謝謝。今天的會議到此結束，您現在可以掛斷電話線。感謝您的參與。