การแถลงผลประกอบการไตรมาส 2 ปี 2026 ของ Alpha Cognition (ACOG): ยอดขาย ZUNVEYL เพิ่มขึ้น 71%

ประเด็นสำคัญ

• รายได้สุทธิจากการขายผลิตภัณฑ์ ZUNVEYL อยู่ที่ประมาณ 6.0 ล้านดอลลาร์ เพิ่มขึ้น 71% จากประมาณ 3.5 ล้านดอลลาร์ในไตรมาส 1/2026 ส่วนรายได้รวมอยู่ที่ 6.1 ล้านดอลลาร์ เทียบกับ 1.7 ล้านดอลลาร์ในปีก่อนหน้า
• อุปสงค์รวมอยู่ที่ประมาณ 8,294 ขวด เพิ่มขึ้น 37% เมื่อเทียบกับไตรมาสก่อนหน้า ผู้บริหารระบุว่าไม่มีการกักตุนสินค้าคงคลังอย่างมีนัยสำคัญ ซึ่งแสดงให้เห็นว่าการเพิ่มขึ้นดังกล่าวสะท้อนถึงอุปสงค์ที่แท้จริง
• อัตรากำไรขั้นต้นจากการขายผลิตภัณฑ์ตามมาตรฐาน GAAP อยู่ที่ประมาณ 94% ขาดทุนสุทธิลดลงเหลือ 8.8 ล้านดอลลาร์ หรือ 0.40 ดอลลาร์ต่อหุ้น จาก 13.2 ล้านดอลลาร์ หรือ 0.82 ดอลลาร์ต่อหุ้น ในไตรมาสเดียวกันของปีก่อน
• การเปิดรับใช้ยาของผู้สั่งจ่ายยาและสถานดูแลขยายตัวกว้างขึ้น ZUNVEYL มีผู้สั่งจ่ายยา 1,347 รายในระหว่างไตรมาส และมีแพทย์ผู้สั่งจ่ายยาสะสม 1,908 ราย ขณะที่จำนวนบ้านพักคนชราที่มีการสั่งจ่ายยาเพิ่มขึ้น 20% จากไตรมาสก่อนหน้า สู่ระดับ 1,095 แห่ง
• การเข้าถึงระบบชำระเงินยังคงเป็นข้อจำกัดหลักในระยะสั้น การเปิดใช้อย่างกว้างขวางในบัญชียาหลักคืบหน้าช้ากว่าที่ผู้บริหารคาดไว้ แม้ว่าบริษัทจะระบุว่าอุปสงค์ยังคงเติบโตอย่างต่อเนื่องโดยไม่ต้องได้รับการอนุมัติเพิ่มในบัญชียาหลักก็ตาม
• Alpha Cognition ได้ปรับลดคาดการณ์ค่าใช้จ่ายในการดำเนินงานเต็มปี 2026 ลงสู่ระดับ 50 ล้าน–54 ล้านดอลลาร์ จากเดิม 54 ล้าน–58 ล้านดอลลาร์ และยังคงเป้าหมายที่จะบรรลุกำไรจากการดำเนินงานในปี 2027

ผลประกอบการทางการเงินที่สำคัญ

นอกจากนี้ Alpha Cognition ยังได้ปิดบัญชีชำระหนี้ก่อนกำหนดสำหรับภาระผูกพันด้านค่ารอยัลตีของ Galantos โดยผู้บริหารระบุว่ารายการดังกล่าวช่วยขจัดต้นทุนค่ารอยัลตีในอนาคต ทำให้โครงสร้างเงินทุนเรียบง่ายขึ้น และเพิ่มสัดส่วนการรับรู้ผลประโยชน์ทางการเงินในระยะยาวของบริษัทจาก ZUNVEYL

ผลการดำเนินงานทางธุรกิจและการปฏิบัติการ

ปริมาณใบสั่งยาต่อเดือนของ ZUNVEYL เพิ่มขึ้นอย่างต่อเนื่องตลอดไตรมาส โดยเดือนมิถุนายนเป็นเดือนที่มีอุปสงค์แข็งแกร่งที่สุดในไตรมาส 2 ผู้บริหารกล่าวเสริมว่าแรงส่งนี้ยังคงดำเนินต่อไปในไตรมาส 3 พร้อมเน้นย้ำว่าบริษัทไม่ได้ให้คาดการณ์รายได้

มียอดขายประมาณ 8,294 ขวดในระหว่างไตรมาส 2 เพิ่มขึ้น 37% เมื่อเทียบกับไตรมาสก่อนหน้า ร้านขายยาและผู้ค้าส่งทำการสั่งซื้อตามอุปสงค์เป็นหลัก และผู้บริหารระบุว่าไม่มีผลประโยชน์จากการกักตุนสต็อกอย่างมีนัยสำคัญ

ทีมเชิงพาณิชย์ได้เข้าพบผู้สั่งจ่ายยา 3,905 ราย ผ่านทีมงานภาคสนามส่วนหน้าประมาณ 60 คน ผู้สั่งจ่ายยาประจำไตรมาสแตะระดับ 1,347 ราย ขณะที่ผู้สั่งจ่ายยาสะสมเพิ่มขึ้นเป็น 1,908 ราย ทำให้บริษัทเข้าใกล้เป้าหมายปี 2026 ที่ตั้งไว้ประมาณ 2,000 ราย ประมาณ 76% ของผู้ให้บริการทางการแพทย์มีการสั่งจ่ายยาซ้ำ และผลิตภาพเพิ่มขึ้นเป็นประมาณหกใบสั่งยาต่อผู้สั่งจ่ายยาหนึ่งราย

บ้านพักคนชราที่มีการสั่งจ่ายยา ZUNVEYL เพิ่มขึ้น 20% จากไตรมาสก่อนหน้า สู่ระดับ 1,095 แห่ง ซึ่งรวมถึงสถานดูแลที่เพิ่มขึ้นใหม่ 346 แห่ง ประมาณ 81% ของสถานดูแลที่มีการสั่งจ่ายยาได้ทำการสั่งซื้อซ้ำ ผู้บริหารได้ระบุบ้านพักคนชราที่มีความสำคัญสูงประมาณ 5,000 แห่ง และแพทย์ชั้นนำประมาณ 3,000 ราย เป็นโอกาสหลักในการดูแลระยะยาว ซึ่งแสดงให้เห็นว่ายังมีโอกาสอีกมากสำหรับการเปิดรับใช้อย่างกว้างขวางและลึกซึ้งยิ่งขึ้น

ผู้บริหารระบุว่าการสั่งจ่ายยาซ้ำเป็นผลมาจากความสามารถในการทนต่อยา ผลทางสติปัญญา และประโยชน์ด้านพฤติกรรมที่ผู้ให้บริการทางการแพทย์สังเกตเห็น นอกจากนี้ยังประเมินว่าผู้ป่วยรายใหม่หรือผู้ที่ไม่เคยได้รับการรักษามาก่อน และผู้ป่วยที่เปลี่ยนมาจากยารักษาอื่น มีสัดส่วนรายละประมาณครึ่งหนึ่งของธุรกิจ

โครงการทางคลินิกและหลักฐานเชิงประจักษ์

การศึกษา BEACON ให้ผลลัพธ์เบื้องต้นในเชิงบวก หลังจากเริ่มใช้ ZUNVEYL ผู้ให้บริการทางการแพทย์รายงานว่าผู้ป่วยมีความสามารถทางสติปัญญา อาการทางจิตประสาท และกิจกรรมในชีวิตประจำวันปรับตัวดีขึ้น พร้อมทั้งลดการใช้ยาหลายชนิดร่วมกัน บริษัทได้ยื่นผลการศึกษานี้เพื่อนำเสนอในการประชุมทางการแพทย์ในอนาคต

คาดว่าข้อมูลเบื้องต้นจากการศึกษา CONVERGE ซึ่งเป็นการศึกษาย้อนหลัง จะได้รับการเปิดเผยในไตรมาส 3/2026 ผู้บริหารกล่าวว่าการศึกษานี้จะประเมินความต่อเนื่องในการใช้ยา ความสม่ำเสมอในการกินยา การใช้ยาหลายชนิดร่วมกัน ความสามารถในการทนต่อยา ลักษณะของผู้ป่วย และกิจกรรมในชีวิตประจำวันในการรักษาโรคอัลไซเมอร์ประเภทต่าง ๆ ซึ่งคาดว่าสิ่งพิมพ์ที่เกี่ยวข้องจะได้รับการเผยแพร่ต่อสาธารณะในปี 2027

การศึกษา RESOLVE กำลังเปิดรับผู้เข้าร่วมตามที่ผู้บริหารคาดการณ์ไว้ โดยตั้งเป้าจะเสร็จสิ้นในไตรมาส 2/2027 และคาดว่าจะทราบผลข้อมูลในช่วงฤดูร้อนหรือฤดูใบไม้ร่วงปี 2027 ขึ้นอยู่กับวันที่เสร็จสิ้น

Alpha Cognition ยังกำลังดำเนินการศึกษาเภสัชจลนศาสตร์เปรียบเทียบสำหรับรูปแบบยาอมใต้ลิ้น โดยคาดว่าจะทราบผลในไตรมาส 3/2026 ผู้บริหารประเมินว่าผู้ป่วยที่มีปัญหาในการกลืนอาจคิดเป็นประมาณ 10%–20% ของผู้ป่วยโรคอัลไซเมอร์ทั้งหมด ผลลัพธ์ทางเภสัชจลนศาสตร์จะเป็นตัวกำหนดกรอบเวลาสำหรับโครงการทางคลินิกขั้นต่อไป

แนวทาง/คาดการณ์จากผู้บริหาร

Alpha Cognition ได้ปรับลดคาดการณ์ค่าใช้จ่ายในการดำเนินงานเต็มปี 2026 ลงสู่ระดับ 50 ล้าน–54 ล้านดอลลาร์ จากเดิม 54 ล้าน–58 ล้านดอลลาร์ ช่วงตัวเลขใหม่นี้สะท้อนถึงประสิทธิภาพในการดำเนินงานที่เพิ่มขึ้น ขณะที่ยังคงจัดสรรเงินทุนแก่โครงการเชิงพาณิชย์และการสร้างหลักฐานเชิงประจักษ์อย่างต่อเนื่อง

ผู้บริหารยังคงเป้าหมายที่จะบรรลุกำไรจากการดำเนินงานในปี 2027 โดยบริษัทเชื่อว่าฐานะเงินทุนในปัจจุบัน ยอดขาย ZUNVEYL ที่คาดว่าจะได้รับ รวมถึงรายได้ตามเป้าหมายความสำเร็จ (milestones) และค่ารอยัลตีที่อาจเกิดขึ้น สามารถสนับสนุนแผนงานดังกล่าวได้

บริษัทคาดว่ารายจ่ายในปี 2027 จะยังคงอยู่ในช่วงใกล้เคียงกันแม้ว่างบประมาณยังไม่ได้ข้อสรุปก็ตาม การศึกษาทางคลินิกบางโครงการมีกำหนดสิ้นสุดภายในไตรมาส 2/2027 แต่การลงทุนเชิงพาณิชย์เพิ่มเติมอาจมาชดเชยส่วนที่ประหยัดได้ ทั้งนี้ คาดว่าคาดการณ์ค่าใช้จ่ายสำหรับปี 2027 จะได้รับการเปิดเผยในช่วงปลายไตรมาส 4/2026 หรือต้นปี 2027

ความเสี่ยงและประเด็นที่ต้องจับตา

การเข้าถึงระบบชำระเงินยังคงเป็นอุปสรรคสำคัญที่สุดในระยะสั้น การเปิดใช้อย่างกว้างขวางในบัญชียาหลักยังไม่เกิดขึ้นในขนาดที่เคยคาดการณ์ไว้ และสัดส่วนธุรกิจที่ทำสัญญาเปิดกว้างของบริษัทยังคงอยู่ที่ประมาณ 16% ผู้บริหารอ้างถึงต้นทุนแผน Medicare Part D ที่เพิ่มขึ้นซึ่งเชื่อมโยงกับพระราชบัญญัติลดเงินเฟ้อ (Inflation Reduction Act) ว่าเป็นปัจจัยที่ส่งผลต่อการตัดสินใจของผู้ชำระเงิน

ผู้บริหารอธิบายว่าการขยายการเข้าถึงที่ล่าช้าลงเป็นเรื่องของกรอบเวลามากกว่าจะเป็นข้อจำกัดด้านอุปสงค์ อย่างไรก็ตาม กรอบเวลาของการบรรจุเข้าบัญชียาหลักยังคงมีความไม่แน่นอน อัตราการเบิกจ่ายยังคงอยู่ที่ประมาณ 74% และผู้บริหารคาดว่าตัวเลขทางเศรษฐกิจจะใกล้เคียงเดิมจนถึงสิ้นปีหากไม่มีการเพิ่มเข้าบัญชียาหลักรายการใหญ่

บริษัทยังไม่มีการประเมินที่แม่นยำเกี่ยวกับระยะเวลาการรักษาเฉลี่ย หรืออัตราการรักษาผู้ป่วยต่อเนื่องในช่วง 6 เดือนและ 12 เดือน ผู้บริหารระบุว่าข้อมูลการดูแลระยะยาวอาจทำให้การวัดความสม่ำเสมอในการใช้ยาเป็นไปได้ยาก และกำลังปรับปรุงการวิเคราะห์อย่างต่อเนื่อง

ไฮไลต์ช่วงถาม-ตอบกับนักวิเคราะห์

• การสั่งจ่ายยาซ้ำ: ผู้บริหารระบุว่าโดยทั่วไปผู้ให้บริการทางการแพทย์ต้องใช้เวลาเก็บประสบการณ์กับผู้ป่วยสองถึงสามเดือนก่อนจะเพิ่มการใช้ ZUNVEYL ส่วนอัตราผู้สั่งจ่ายยาซ้ำที่ 76% เป็นผลมาจากความสามารถในการทนต่อยา ประสิทธิผล และผลต่อพฤติกรรมที่สังเกตเห็น
• การขยายตัวนอกเหนือจากการดูแลระยะยาว: บริษัทยังคงมุ่งเน้นการขยายตลาดการดูแลระยะยาวให้เกิดประโยชน์สูงสุด การขยายเข้าสู่ตลาดประสาทวิทยาผู้ป่วยนอก (retail neurology) ในอนาคตจะขึ้นอยู่กับการบรรลุกำไรจากการดำเนินงานและการได้รับการครอบคลุมในบัญชียาหลักที่กว้างขึ้น เนื่องจากค่าใช้จ่ายร่วม (copay) ที่สูงอาจทำให้ผู้ป่วยละทิ้งใบสั่งยามากขึ้น
• กรอบเวลาของผู้ชำระเงิน: ผู้บริหารยังคงหวังว่าจะมีความคืบหน้าเรื่องบัญชียาหลักในครึ่งหลังของปี 2026 แต่ไม่ได้ให้กรอบเวลาที่แน่นอน โดยระบุว่าการได้รับการอนุมัติจากผู้ชำระเงินในอนาคตถือเป็นโอกาสเติบโตส่วนเพิ่ม (upside) เนื่องจากเติบโตในปัจจุบันเกิดขึ้นได้โดยไม่ต้องอาศัยการขยายการครอบคลุม
• การหยุดใช้ยาของผู้ป่วย: ผู้บริหารกล่าวว่าสาเหตุหลักที่สังเกตพบ ได้แก่ การเสียชีวิตของผู้ป่วย การเข้ารักษาตัวในโรงพยาบาลชั่วคราว การย้ายสถานดูแล และปัญหาเรื่องการเบิกจ่าย ไม่ใช่เรื่องความสามารถในการทนต่อยาหรือการขาดประสิทธิผลตามที่รายงาน
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Operator

Thank you. are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require operator assistance during a conference, please press star zero on your telephone keypad. As a This conference is being recorded. It is now my pleasure to introduce your host, Henry Du, interim CFO, VP Accounting and Finance. Thank you. You may begin.

Henry Du

Thank you, Saatchi. Good afternoon, everyone, and thank you for joining us today for Alpha Cognition's second quarter 2026 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results. On the call with me are Alpha Cognition Chief Executive Officer Michael McStadden and Chief Operating Officer Lauren D'Angelo. Today's call is being made available via the investor section of the company's website at www.alphacognition.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Alpha Cognition's current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the risk factors section of the company's latest SEC filings.

Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on August 13, 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Off-ball cognition declines any obligation to update these forward-looking statements, except as required by APA's.

Unknown Speaker

I'll now turn the call over to Michael. Michael? Thank you, Henry. Good afternoon, everyone. Welcome to today's call. The second quarter of 2026 represents another important quarter of commercialization for Zunville, the first new oral Alzheimer's treatment approved in more than 15 years. It was a strong quarter of execution with clear sequential growth in Zunville, Zumbel demand, expansion and prescriber adoption, increase nursing home penetration, and continue progress with evidence generation to clinically support Zumbel. We continue to execute with discipline and confidence, and I believe this quarter demonstrates that Zimbel's commercial trajectory is tracking well with our expectations as we continue to scale the brand and the long-term care segment. Q2, we generated approximately $6 million in net product revenues, representing approximately 71% quarter-over-quarter growth versus Q1, 2026. While we're pleased with Zunbell's trajectory, we're still in the early phases of the product's commercial phase and remain optimistic that we'll continue to see signs of success. sustained product performance and adoption in the long-term care setting.

Looking at the quarter, monthly prescription volumes strengthened consistently with high single-digit sequential growth each month. All KPIs were positive, including prescriber number increases, nursing home prescriptions, and repeat prescriptions. Overall, we believe we're on track with our 2026 strategic priorities as we continue to drive prescription growth and build a durable path toward operating profitability in 2027. Turning to our clinical and medical programs, we continue to advance our evidence generation priorities in Q2, which we believe will strengthen Zumbel's positioning with both payers and healthcare providers over the long term. During the second quarter, the company reported positive top-line results from the Beacon study. We initiated conversion. a retrospective data review in long-term care, and we initiated resolve with site selected, sites activated, and initial patient enrollment underway. Of note, the BEACON study demonstrated that following initiation of Zumbel, providers observed improvements in cognition, improvements in neuropsychiatric symptoms, and improvements in activities of daily living, along with reductions in polypharmacy.

These are all meaningful outcomes for long-term care practitioners treating patients with Based on these positive findings, our medical team has submitted the data for presentation at several upcoming medical meetings. We look forward to announcing additional details as presentations are accepted and confirmed. We expect converged top line data in Q3. We believe this will provide the company two nursing home data sets that can be utilized stakeholders of the changes in cognition, neuropsychiatric behaviors, and ADLs they might expect to see when utilizing Zumbel in the nursing home setting. Henry will provide financials in detail in a moment, and Lauren will provide a more comprehensive commercial update thereafter. But first, let me make a few high-level remarks on our financial position. Our operating spend of $13.5 million this quarter continues to reflect a deliberate investment in our commercial capabilities and in studies that support our positioning. with healthcare providers and payers.

As I said last quarter, I want to be direct about the way we're thinking about this investment. Our net product loss this quarter reflects the company's intentional scaling. We're deploying capital against our highest return opportunities in the business, including expanding prescriber reach, building real-world advocacy, evidence to support Zimvel, and unlocking additional payer access. These are investments that will drive the company to achieve operating profitability in 2027 and beyond, and we continue to remain on track with these targets. I'll now turn it over to Henry.

Henry Du

Thank you, Michael. Good afternoon again, everyone. As I review our second quarter of 2026 financial results, please also refer to the press release and 10Q to be filed this afternoon. For the second quarter of 2026, Zunvale generated approximately $6 million in net product revenue, compared with approximately $3.5 million in the first quarter, representing approximately a 71% sequential growth quarter over quarter. Total revenue for the quarter was $6.1 million, compared to $1.7 million in the prior quarter year period, driven primarily by Zunvale product sales. From a margin perspective, Gap's gross product margin was approximately 94% for the second quarter, based on net product sales of $6 million and cost of product sales of approximately $0.4 million. Regarding spending, total operating expenses for the second quarter were $13.5 million, including $11.5 million of SG&A and $2 million of R&D expense. SG&A reflects continued investment behind the commercial infrastructure, payer engagement, marketing resources, and public company operations.

While R&D reflects continued investment in evidence generation and development programs required to build Zenville for the long term. Net loss in the second quarter was $8.8 million, or 40 cents per share. with a net loss of 13.2 million or 82 cents per share in the prior year period. As of June 30th, 2026, the company had $41.4 million in cash and cash equivalents and $57.9 million in total current assets. Total current liabilities were $6.4 million, resulting in working capital of approximately $51.5 million. During the quarter, we also completed the early settlement of our Galantos formal royalty obligation. This transaction simplifies our capital structure, eliminates future royalty burden on the product economics, increases our long-term participation in the value created by Zenvale. We believe this was a prudent use of capital and a strategic step that improves the future cash flows and strengthens the economics of the franchise as the brand continues to grow.

We continue to believe our current capital position, together with expected future sales of Zendale and potential milestones and royalties, can support our plan towards operating profitability in 2027. Lastly, based on the strong commercial performance of Zendel and our continued focus on operating discipline, we are lowering our four-year 2026 operating steps guidance from our previous range of $54 million to $58 million to a new range of $15 million to $54 million. While we remain committed to supporting the growth of Zendale and advancing key evidence generation initiatives, we have identified opportunities to operate more efficiently across the organization. This revised outlook reflects our confidence in our ability to balance growth investments with career expense management. With that, I will now turn the call over to Lauren to discuss commercial progress. Lauren?.

Lauren D’Angelo

Thank you, Henry. I'm pleased to provide a detailed update on our Q2 2026 commercial performance. Depending on the momentum we described last quarter, Q2 was a period of meaningful execution across prescriber adoption, nursing home penetration, and payer engagement. And the data tell a compelling story of durable and accelerating commercial traction. Let me start with the headline. Q2 demand generated approximately 6 million net product sales, representing 71% sequential growth over Q1. That result was driven by approximately 8,294 bottles, up roughly 37% quarter over quarter. Turning to adoption, in Q2, the commercial team reached 8,194 total commercial customers and called on 3,905 prescribers, reflecting the reach of our now right-sized, approximately 60-person productive field organization and the continued refinement of our targeting approach.

HCP writers, prescribers who wrote at least one Zunvale prescription, grew 20% 27% quarter over quarter to 1,347 and cumulative life to date writers reaching 1,908. This keeps us firmly on track to meet or surpass our 2026 goal of approximately 2,000 cumulative writers. As I've said in the past, depth matters is not the only thing that matters. much as breadth. Of our 1,024 Q2 writers, approximately 76% placed repeat prescriptions, and productivity per writer continued to climb, rising to approximately six prescriptions per writer. Evidence that adoption is deepening, not just widening. That sustained repeat behavior is one of the strongest signals that Zunville is moving from initial trial into routine clinical practice. We see the same pattern at the facility level.

Homes with Zunville prescriptions grew 20% quarter over quarter to 1,095, including 346 new homes added during the quarter. Of homes with with prescriptions, roughly 81% placed repeat orders, consistent with the durable facility level adoption we described in Q1. monthly trajectory shows how momentum built through the quarter, each month delivering sequential growth, with June our strongest demand month to date. That exit velocity establishes clear momentum as we move into Q3. Payer access remains our most significant near-term opportunity, and candidly, our most significant near-term friction point. Implementation across the downstream plan clients in Q2 was roughly consistent with Q1. We want to be very direct about that. The broad formulary activation we anticipated has not yet materialized at scale, and access expansion... is tracking slower than the axis curve we outlined last quarter.

Critically, we view this as a timing dynamic, not a demand constraint. The clearest evidence is that our Q2 demand grew approximately 37 percent in bottles and 71 percent in net sales, even without any expansion in payer access. Underlying prescription growth and an 81% facility repeat rate are being driven by genuine clinical pull, not by a formulary tailwind. That means payer conversion remains almost entirely ahead of us as upside. Reinforcing that access to the work is our real-world evidence program, BEACON, CONVERGE, and RESOLVE. We expect these studies to deliver meaningful promotional value, supporting peer-to-peer education, strengthening payer discussions, and building physician confidence around tolerability, polypharmacy management, and caregiver burden. That evidence is already fueling our education efforts.

Since March, we have conducted more than 240 peer-to-peer programs, reaching 1,058 attendees and 325 prescribers. We also maintained a strong scientific presence at key congresses, including the NADONA and MPA, Reinforcing Zunvale's Credibility Among High-Value Prescribers. In summary, Q2 2026 reflected strong commercial execution with growing demand, improving conversion, high repeat utilization, broader prescriber adoption, and deeper facility penetration. While payer access has not yet expanded, the strength of demand underscores the clinical pull behind Zunvale and the opportunity ahead. As access improves, we believe we are well positioned for continued acceleration. I'll now hand it back to Michael for closing remarks.

Unknown Speaker

Thank you, Lauren. Let me briefly summarize what I believe are the key takeaways from the quarter. First, Sunbelt's growing. We delivered approximately 71% sequential growth from Q1 to Q2, and monthly prescriptions increased from April through June. The commercial trajectory is accelerating. Secondly, adoptions deepening. We had over 1,300 HCP riders, over 1,000 repeat riders, 1,000 nursing homes with prescriptions, and almost 900 homes with repeat prescriptions. Repeat utilization remains one of the most important indicators of good product adoption. And third, we're executing on our commercial and company strategy with discipline. Our commercial organization is in place.

Our focus is on deploying capital against high return opportunities in the business. And our evidence generation continues to advance. The company's enrolling was all converges underway and beacon was completed ahead of schedule. And the company will have publications from that study to present to the medical community this fall. So we're excited about the balance of the 2026 year. The foundation we built for Zumbel is strengthening. Our commercial indicators are moving in the right direction.

We remain focused on discipline execution. With that operator, we'll now take questions.

Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. The first question is from Ram Selvaraju from H.C. Wainwright. Please go ahead.

ช่วงถาม-ตอบ

Raghuram Selvaraju

Thanks so much for taking our questions and congratulations on a very solid quarter. I was wondering if you could comment on the following three aspects at this point in the launch. Firstly, when you look at the repeat prescribers and the percentage of repeat prescribers that you have seen write prescriptions in multiple months, Can you give us an additional granularity on that specific element of prescribing behavior, particularly what it may be that converts the repeat prescriber into not only writing more than one script, but sticking with the product over a lengthy period of time? And if at this point we have enough data to indicate. what the characteristics of that group of prescribers are. Secondly, I was wondering if you could give us a sense of, at this point in time, given where you are with the launch, when you believe you might expand sales and marketing outreach beyond long-term care into the specialist neurologist population, and then lastly, Lastly, with respect to formulary access, I was wondering if you could elaborate a little bit further on when you anticipate that emerging as a tailwind above and beyond the pull-through demand that you're seeing. Thank you.

Lauren D’Angelo

Thanks, Ram. Very solid. Good three questions there. I'll start with your first one around our repeat prescriber rate, what we're seeing in terms of what's causing that repeat group to continue writing Zunville. I think it really comes down to there experience with the drug. We've talked previously on many quarters that, you know, you start out with Brett, you call on a significant amount of physicians. Once you convince them to try the drug, it takes two to three months for them to really get that experience to monitor the one or two patients. And then, of course, you know, they'll start repeating once they've experienced positive effects from Zunvale. What we're seeing is these are significant repeat rates. 76% of providers are writing again.

That's some of the highest I've seen in my experience. And we believe, based on all of the feedback we've gotten from our customers, is that it's really through First, they want to make sure this drug is tolerable because obviously their experience with the generics in the decades past has not been great as it relates to tolerability. Once they see that Zunville is a very tolerable drug, they're then looking obviously at the efficacy and they see significant difference. cognition, that core foundation of why they use these drugs in the first place. And then as we've talked about in the past, they're seeing significant benefit across the behavior. So those are really the three things. Those are the three factors that are causing these physicians to write again and that feedback is consistent. consistent across the board. As it relates to when we'll step outside of long-term care and potentially go into retail or that neurology space, we're really focused right now on maximizing the long-term care opportunity.

We obviously believe there's tremendous upside and opportunity in the long-term care space. And as we get to operating profitability next year, that's when we would look to start evaluating whether it's time to go into the neurology space. Another key aspect of that expansion into neurology is the payer lens, which obviously goes to your next question. You don't want to launch into retail without solid formulary coverage because you'll see significant abandonment rates in the retail setting when the co-pay is too high. So it's really operating profitability and payer coverage that would determine at what point in time we will expand into neurology. And then finally, your question or... payer. You know, we are, again, actively engaged with all of the key payers that really matter to the long-term care business.

We're having consistent conversations. We're focused on increasing our demand so that, you know, we increase the likelihood that we can gain formulary coverage. What we're seeing across the board, not just specifically to Zunvale, but really across the industry and the Medicare Part D space is the impact of the Inflation Reduction Act. That is having a significant impact on the plan and the additional cost that they have to pick up. So that's why, you know, we've got to continue continuing. driving demand. We're hopeful that we will see something as we've always communicated, you know, the second half of the year. But it's not a matter of if, it's a matter of when, because the payers definitely recognize the demand and the growth that we're driving, and we will continue to have those conversations to make sure that, obviously,.

Raghuram Selvaraju

we start to obtain formulary coverage. And then just very quickly, I was wondering if you could maybe provide us with your sense of when converged data becomes available, to what extent that constitutes a potential game changer in trending the curve upwards, as well as when you anticipate being able provide data from the RESOLVE study. I know you've guided towards when the study would be completed, but when data would be available. And then if you could also comment on the size of the market opportunity that you expect to be addressable with the sublingual formulation and whether you would consider the possibility a revenue guidance range for 2027, along with possibly also instituting an expense guidance range for that year.

Unknown Speaker

A lot to unpack there. First, I'll start with Converge. So we anticipate top-line data for Converge in Q3 of 2026. The significance of Converge is the quantitative retrospective data analysis on the entire Alzheimer's market, and it will provide data on persistence at adherence, polypharmacy with all drugs, as well as a number of other elements like ADL improvement, tolerability, types of patients that are being profiled for each of the drugs, et cetera. That data will result in multiple publications. They likely will not be public until 2027. We'll begin writing data post-study and then submitting those for publication thereafter. We also believe that with Converge quantitative data, and beacon qualitative data, that there's an opportunity to analyze that data pharmaco-economically, which will provide additional information that we believe will be useful for payers and decision makers that have a financial interest in how Alzheimer's drugs are used.

Resolve studies underway. it's recruiting to our expectations we anticipate that study will complete and Q2 of next year, we'll have data in the summer fall, depending on when in Q2 the data resolve is provided. from a sublingual perspective, we're really excited about the sublingual opportunity. We believe that the opportunity represents about 10 to 20% of patients with Alzheimer's disease. Data indicates that about 10 to 20% of patients with Alzheimer's have either aphasia or dysphagia, meaning they cannot swallow or have difficulty swallowing, and the treatment choice is based choices for those patients currently are very limited. We believe a sublingual has the opportunity to take significant share from existing therapies and from a patch that's often used on the torso or the arm of these patients. which is quite difficult and challenging to administer and for the patients to utilize that drug. We have a gating item for the sublingual product. We're running a comparative PK study this quarter. We anticipate that data will be available in Q3, and that will determine timeline for clinical program for sublingual.

And then for revenue guidance, currently we haven't commented on when we'll provide revenue guidance. We will provide expense guidance for 2023. and will likely do that the very beginning of 2027 or the latter part of Q4.

Operator

Thank you very much. The next question is from Nav Rahman from Maxim Group. Please go ahead.

Unknown Speaker

Hi, everyone. Congrats on the quarter and the progress, and thanks for taking my questions. I just have two quick questions. In the quarter, did you have or see any outsized stocking or material stocking in the quarter that could have impacted sales? And also, if the current reimbursement and coverage is going slower, than anticipated. What do you expect your grossing nets to be by the end of the year or through the year? Thanks.

Lauren D’Angelo

Yes, both really good questions. So as it relates to material stocking, no, we did not have a significant increase in stocking. Our pharmacy and our wholesalers are now at a point where they're pretty much purchasing on demand. So what you see this quarter is pure demand growth, and we feel very strongly about that. because we can follow the trends in the data. As it relates to our reimbursement, obviously right now we're holding strong at about 74 percent. So obviously If we do not see any significant formulary ads by the end of the year, we would stay pretty consistent. We'll pick up some of the IRA penalty, but it will stay within a pretty similar GTN by the end of the year.

Operator

Thanks. Thanks for taking my questions. Sure. The next question is from Chase Knickerbocker from Craig Hallam Capital Group. Please go ahead.

Unknown Speaker

Good afternoon everyone. Thanks for taking the questions. This is Jake on for Chase. We've seen another nice month in Scripps in July. Could you maybe just speak a bit to what you have seen from a demand perspective so far in the third quarter? Sure. And what level is plan, pull through, and payer dynamics playing a role here versus just is it just commercial execution from your team?.

Lauren D’Angelo

Sure, so Q2 results and demand were increasing month on month and June was our strongest demand as of Q2. What I can tell you, I know we don't provide guidance, is that that momentum has continued. It is all, in my opinion, we have had no formulary wins. our 16% contracted open book of business is consistent since last quarter. So we believe that the strong demand in Q2 is pure commercial execution. We've gotten a lot smarter with targeting the right customers. We're now at the ideal 60-person customer facing Salesforce. So we believe that, you know, that is really what's driving the demand.

That's why we like to say that any formulary wins that will come in the future, it's all upside for us, because we've got strong growth, and we continue to have strong growth in Q3.

Unknown Speaker

Thanks for that color, Lauren. And then lastly, could you just speak to how adherence is trending now that we're more than a year into launch? How have you seen this change over time and what do you calculate patient retention is at six or 12 months, however you want to present it?.

Lauren D’Angelo

Sure. So we're still tracking adherence rates, you know, because long-term care is a little bit different how you look at the data. So, you know, it's hard for me to give you a number in terms of the average time on drug, you know, how much is new business versus refill business. But what we do see is patients do stay on drug longer in the long-term care facility, you know, versus a retail segment, obviously because they're, you know, they're being cared for every day. I hate to give you a number because we're still working through that adherence rate. But what I can tell you is Q2 was driven by significant new growth as well as those refills from previous quarters. Hopefully in the future I'll be able to give you a more accurate number around adherence.

Operator

Yes, that would be very helpful. Thank you for taking the questions. Sure. The next question is from Ryan Deschner from Raymond James. Please go ahead. Ryan Deshner, your line is open.

Ryan Deschner

Yes, we can hear you, Ryan. I have apologies for that. Two great questions for me. the first, can you comment on specific geographies or types of prescribers or really any other attributes where you're seeing the most growth this quarter and going into next quarter? And then as you're collecting feedback from prescribers who switch patients over to Zenvale, what have the primary drivers for switching over been as of recent and how refractory are the patients that you're putting on drugs in terms of number of therapies that they've already been on? How is that looking so far?.

Lauren D’Angelo

Sure. So as it relates to the growth, you know, across the nation for Q2, we've seen growth across every region. where we're seeing obviously the largest volume is coming from those key markets that have the largest opportunity. But overall, I'm pleased to say that across the country, we're seeing pretty significant growth and there's not one specific area that's doing far better than let's say another area of the country. I think we're finally getting to a point with our 60 person sales team, you know, where we're we're gaining momentum. Every region is gaining traction. So that's really exciting. Your second question around what is the feedback then and what's causing that reason for shifting. There's several reasons. We're talking to customers every day, and the feedback continues to overwhelm us with the positive impact that Zunville is having on patients. We see a lot of new patients who haven't been on drug in a while because they had already failed Dinepazil.

They already failed maybe one or two generics. and there's been no other alternative for them. So the physician is re-energized to try something else for these patients because they were not able to tolerate some of these drugs previously. We also see a significant amount of switching. And I think some of that is due to tolerability. It's due to, you know, which obviously, is insomnia on some of the other drugs. It could be the GI issues on some of the other drugs. but also the behavioral impact. So I think physicians have started to get experience with Zunvale, they're seeing a positive impact across behaviors, and so patients that are on another drug, they've seen behavioral impact with patients already on Zunvale, so it's causing them to switch those patients over to Zunvale just to from their peer experience with other patients.

I don't know if that answers your question, but those two areas are probably the biggest reasons for switch or to try ZunVeil.

Operator

That's very helpful. Thanks so much. The next question is from Dave Storms from StoneGate. Please go ahead.

David Storms

Good afternoon. Thank you for taking my questions. I just wanted to start with maybe some of the prescribers that have only been one-time prescribers thus far. Do you feel the need to maybe go back and retrace your steps there, or is there still so much runway in front of you that you're more focused on the white space there?.

Lauren D’Angelo

That's a great question. So, one of the challenges with long-term care data is we call them ghostwriters. So, even though it might show in the data that they've only written one prescription, they've actually written more. The order was just entered under another doctor. So, we don't have a lot of physicians who have tried one and dropped off and they're not using. the drug anymore. What I can tell you though that I think ties to your question is that we have segmented the market and we have obviously bucketed our physicians and our writers into our first tier, our second tier where they've written several scripts but they're maybe not writing it for 30% of patients, and then we've got a third tier. And the good news in what we're seeing in Q2 is that every single tier is improving. So if you'll remember in previous quarters, we talked a lot about those early, you know, physicians who have only tried one or two.

They need two to three months to get experience with the drug. We're seeing that wave of physicians now move into significant repeat. writing. And so it's kind of a constant cycle where we'll continue to call on a tier three, where, you know, they're getting that two to three month experience with the drug, they will move into the next tier. And so in every single tier, we've seen significant improvement. It's just time and experience with Zunvale. And we expect that that trend will continue.

David Storms

That's really great, Collier. I appreciate that. And then maybe just one more modeling question. With the SG&A expense guidance decreasing, is there any more you could give us there, just maybe how sticky that might be, how much of it could be applied into 2027? Just maybe any more color there would be helpful.

Unknown Speaker

Yes, I can comment on that. We anticipate some consistency, uh, Dave, and to 2027, but we haven't finalized our 2027 numbers. We have a number of studies ongoing this year which increase expenditures. Those will be concluding in Q2 of next year, but our commercial efforts and opportunities may offset that into 2027. So I ask you to bear with the company as we finalize our 2027 budget and spending plan and we'll provide those data. But it'll be in a similar range for next year.

Operator

Perfectly fair. Thank you for taking my questions. The next question is from William Wood from B Reilly Securities. Please go ahead.

Unknown Speaker

I was curious in terms of the patients that don't or come off drug and so on that churn where they don't continue persistence, what is the main driver for the patient to either to get off? drug? Is it adverse events or just lack of efficacy? Or alternatively, what's driving the prescriber to stop prescribing it? And then also in terms of long-term home care base, it looks like you've got a continued very nice expansion there. But I was curious in terms of percentage of total base that you're looking at. And I know that you're looking at a lot of home care base, but I you've been potentially building into. I know it's still early times, but just curious how much of an expansion you have sort of room to grow on that sort of top line full expansion there. Thank you. Sure, no, both of those.

Lauren D’Angelo

a really great question. So now I can tell you that we're talking to customers daily, we're getting significant feedback, and we are following those patients that discontinue Zunvale. What I can tell you, now it doesn't mean that it's not happening, I'm not speaking to the universe, but we have not had or heard of patients, especially within our data, that are coming due to tolerability or lack of efficacy. We've actually heard the very opposite. This drug works, and this drug works really well, and I think the feedback has been overwhelmingly positive. Of course, the downside of long-term care is these patients are very frail, and so you will see death for patients. You'll also see patients who leave the long-term care facility and they have a fall. So they get put into the hospital.

So you might have some break. We will recapture those patients when they come back into the home. But the time that they, you know, it looks like a discontinue in the data when they're actually checking, going into the hospital. So those are really probably the two biggest factors. And then, of course, if there's a formulary change or we. you know, the prior authorization wasn't completed, then our reimbursement team will follow up and ensure that that patient gets put back on drugs. So those would be the main reasons why you would see a patient come off Zunvale. To your question about opportunity and our base – From my perspective and the company's perspective, we have significant opportunity in long-term care.

You know, if you look at just the highest volume Alzheimer patients across the country and you split these out into homes, there's about 5,000 homes, right, that are at your Tier 1 targets. Right. that provides significant opportunity for Zunvale. And then, of course, there's about 3,000 top, top-tier physicians. So right now, you know, we've got about 1,000 writing, you know, so not only do we need to increase the depth of those providers, but we also have significant more prescribers that we need. need to activate on Zunvale. So from our perspective,.

Unknown Speaker

tons of upside opportunity from a market opportunity. Got it. And one last one, if I may. In terms of just the patients who are switching or are starting drugs, do you find that you're getting more patients that are refractory to other drugs or more switchers that are actively looking for drugs? So sort of pulling from a non-drug user or.

Lauren D’Angelo

a drug user. It's a minor difference there. Yes, we're seeing about 50-50. So if you look at the data, of course, in long-term care, you know, there's many, many patients who have already tried these drugs. You know, these drugs have been out for decades. There's nothing available to them. So they've been off drugs for some time. So they look like a treatment naive. but they're actually tried something previously likely. So we are actually, we're getting many, we'll call them treatment naive, but patients who were not on drugs, but we're also seeing a significant amount of switches. So those patients who are already either already still on it today, they're having tolerability issues, they're experiencing significant changes. significant insomnia, many of them already have behavioral issues, those patients, that patient profile right there is probably our highest switch because that is obviously, you know, with Dunville being core foundation and impacting all of those areas in a positive way, it's a pretty easy switch for a physician.

So I'd say about half of our business is coming from patients who have probably tried and failed. They're no longer on treatment right now, but we're, you know, the doctor is then adding Zunvale or they're being directly switched from a generic acetylcholinesterase inhibitor due to those issues that I described.

Unknown Speaker

Got it. Very helpful. Thank you for taking our questions and congrats on the quarter. Thanks.

Operator

There are no further questions at this time. I'd like to turn the floor back over to Michael McFadden for closing comments.

Unknown Speaker

Thanks everybody for attending the call and those who are listening to the call. We're excited about the quarter. We had a strong quarter highlighted by our growth. and bottles, prescribers, adoption, our progress in payer and evidence generation, and the focus on high target opportunities for the company that we believe will continue the growth in quarters to come. Thank you for listening to the call. If you have interest in speaking with the company further, you can reach out to our IR on website. Thank you so much.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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