Better Therapeutics Inc (BTTX) 2023 Q3 法說會逐字稿

Therapeutics third quarter 2023 business update call. (Operator Instructions) Once again, please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mark Heinen, Chief Executive Officer (sic - "Chief Financial Officer"). Please go ahead.

治療學 2023 年第三季業務更新電話會議。 （操作員指示）再次提醒您，今天的會議正在錄製中。我現在想將會議交給今天的發言人、執行長（原文如此，「財務長」）馬克‧海寧 (Mark Heinen)。請繼續。

Thank you, operator. Good morning, everyone, and welcome to the Better Therapeutics conference call. Our press release was issued this morning and can be found in the investors section of our corporate website, bettertx.com. Joining me on the call today is Frank Karbe, our President and Chief Executive Officer; Dr. Mark Berman, our Chief Medical Officer; and Diane Gomez-Thinnes, our Chief Commercial Officer. During today's call, we will provide a business update and a financial overview of the third quarter of 2023. A Q&A session will follow our prepared remarks.

謝謝你，接線生。大家早安，歡迎參加 Better Therapeutics 電話會議。我們的新聞稿於今天上午發布，可以在我們公司網站 bettertx.com 的投資者部分找到。今天和我一起參加電話會議的是我們的總裁兼執行長 Frank Karbe；我們的首席醫療官 Mark Berman 博士；以及我們的首席商務官 Diane Gomez-Thinnes。在今天的電話會議中，我們將提供 2023 年第三季的業務更新和財務概覽。在我們準備好的發言之後將進行問答環節。

Before we begin, I'd like to remind everyone that any statements we make, or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans, and expectations that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events and results may differ materially from those expressed or implied by any forward-looking statements. With that, I'll pass the call over to Frank. Frank?

在我們開始之前，我想提醒大家，我們所做的任何聲明或本次電話會議中提供的非歷史事實的資訊都是前瞻性聲明，這些聲明基於我們當前的信念、計劃和期望，這些聲明是根據1995 年《私人證券訴訟改革法案》的安全港條款。實際事件和結果可能與任何前瞻性陳述明示或暗示的內容有重大差異。這樣，我會將電話轉給弗蘭克。坦率？

Thank you, Mark and good morning, everyone. Thanks for joining us on the call today. I am delighted to start this call with the exciting news that AspyreRx is now available for commercial use. We've started receiving prescriptions and have patients on active treatment. Of the past quarter, we have made substantial progress following the news in July that the FDA authorized AspyreRx as a Class II medical device, indicated to treat adults with type 2 diabetes. Our team completed development work to prepare the product for commercial release, establish the necessary organizational infrastructure to launch a regulated prescription product into the market, and continued engaging payers to obtain coverage.

謝謝你，馬克，大家早安。感謝您今天加入我們的電話會議。我很高興以 AspyreRx 現已可用於商業用途的令人興奮的消息開始本次電話會議。我們已經開始接受處方並讓患者接受積極治療。在 7 月 FDA 授權 AspyreRx 作為 II 類醫療器械，用於治療成人 2 型糖尿病的消息傳出後，我們在過去的一個季度取得了實質進展。我們的團隊完成了產品商業發布的開發工作，建立了必要的組織基礎設施以將受監管的處方產品推向市場，並繼續吸引付款人以獲得承保。

Our first opportunity to engage directly with healthcare providers was at this year's American College of Lifestyle Medicine's annual meeting a couple of weeks ago. And it was exciting to see the strong interest in AspyreRx. I believe we're truly at an inflection point, with a possibility of commercial success now within our grasp.

我們第一次有機會直接與醫療保健提供者接觸是在幾週前的今年美國生活方式醫學學院年會上。看到人們對 AspyreRx 的濃厚興趣真是令人興奮。我相信我們確實正處於一個轉折點，商業成功的可能性現在就在我們的掌握之中。

Now a few months ago, I laid out the three areas we need to de-risk in order to successfully advance Better Therapeutics. It's one, obtain FDA authorization, which of course we have; two, demonstrate commercial traction; and three, improve our financial position. In October, we raised approximately $3 million through our at-the-market or ATM facility at an average price per share of $0.42. We intend to further strengthen our financial position in the coming weeks and extend our runway sufficiently to first, demonstrate meaningful commercial traction, particularly in our initial launch geographies, to inform the full commercial potential of AspyreRx; and then second, advance discussions with payers and secure initial coverage. As you will hear from Diane, we are confident both can be accomplished.

幾個月前，我列出了我們需要降低風險的三個領域，以便成功地推進更好的治療。一是獲得 FDA 授權，我們當然有；二、展示商業吸引力；第三，改善我們的財務狀況。 10 月份，我們透過市場或 ATM 融資，以每股 0.42 美元的平均價格籌集了約 300 萬美元。我們打算在未來幾週內進一步加強我們的財務狀況，並充分擴展我們的跑道，以首先展示有意義的商業吸引力，特別是在我們最初推出的地區，以充分發揮 AspyreRx 的商業潛力；其次，推進與付款人的討論並確保初步覆蓋。正如您將從黛安那裡聽到的那樣，我們相信這兩件事都能實現。

I will now recap other accomplishments in the third quarter and October of this year. In September, we announced the completion of enrollment of 1,000 participants in our clinical programs evaluating the long-term effectiveness of AspyreRx in type 2 diabetes.

現在我將回顧今年第三季和十月的其他成就。 9 月，我們宣布臨床計畫已完成 1,000 名參與者的入組，以評估 AspyreRx 對第 2 型糖尿病的長期有效性。

Also in September, our patent, Managing Lifestyle and Health Interventions with Predictive Analytics, was issued in the European Union. Now this is our second patent issued for four patent families filed by Better Therapeutics covering the breadth of our novel method of delivering cognitive behavioral therapy, innovative use of patient engagement data, and AI methods such as machine learning, to predict outcomes and adjust treatment.

同樣在 9 月，我們的專利「利用預測分析管理生活方式和健康幹預措施」在歐盟獲得授權。現在，這是我們為Better Therapeutics 提交的四個專利族頒發的第二項專利，涵蓋了我們提供認知行為治療的新方法、患者參與數據的創新使用以及機器學習等人工智慧方法來預測結果和調整治療。

In October, we announced the preprint publication of the results of our LivVita liver study in Gastro Hep Advances, a peer-reviewed journal produced by the American Gastroenterological Association or AGA. Authors concluded the totality of positive efficacy, safety, and usability data indicates the potential of Better Therapeutics' digitally delivered CBT to help address the significant unmet clinical needs observed in metabolic dysfunction-associated steatotic liver disease or MASLD, and metabolic dysfunction-associated steatohepatitis or MASH. Now these others newer terms now for NASH and NAFLD.

10 月，我們宣佈在美國胃腸病學協會 (AGA) 出版的同行評審期刊 Gastro Hep Advances 上發表 LivVita 肝臟研究結果的預印本。作者的結論是，積極的療效、安全性和可用性數據的整體表明，Better Therapeutics 的數位化 CBT 有潛力幫助解決在代謝功能障礙相關的脂肪肝病 (MASLD) 以及代謝功能障礙相關的脂肪性肝炎或糊狀物。現在這些其他新術語現在用於 NASH 和 NAFLD。

Also in October, we announced new data from a subgroup analysis that revealed that adjunctive use of AspyreRx with standard of care, including GLP-1 receptor agonist, leads to a substantially greater clinical improvement compared to control participants who used GLP-1s but did not incorporate AspyreRx into their regimen. We plan on submitting this data for peer review and publication.

同樣在10 月，我們公佈了一項亞組分析的新數據，該數據顯示，與使用GLP-1 但未使用GLP-1 的對照組參與者相比，輔助使用AspyreRx 與標準護理（包括GLP- 1 受體激動劑）相比，可帶來更大的臨床改善。將 AspyreRx 納入他們的治療方案中。我們計劃提交這些數據以供同行評審和出版。

With healthcare providers prescribing AspyreRx and patients engaging in the CBT treatment, we have now transitioned from an R&D organization to a fully integrated commercial one. Our focus for the remainder of the year is to further lay the foundation for successful commercial launch. And in doing so, we have the benefit of incorporating lessons learned from those that came before us.

隨著醫療保健提供者開出 AspyreRx 處方以及患者參與 CBT 治療，我們現在已經從研發組織轉變為完全一體化的商業組織。我們今年剩餘時間的重點是進一步為成功的商業發布奠定基礎。這樣做的好處是，我們可以吸取前人的經驗教訓。

We are pursuing a very targeted go-to-market strategy, with the objective to demonstrate meaningful commercial traction in our initial launch geographies to inform the full commercial potential of AspyreRx, which would then allow us to rapidly expand our commercial footprint to other parts of the country. Over the past few months, we have, and we continue to prioritize our market access activities, with a goal to achieve payer coverage. These discussions have progressed in a positive direction, and combined with overall feedback received thus far, we are confident payer coverage will be obtained.

我們正在推行一項非常有針對性的進入市場策略，目的是在我們最初推出的地區展示有意義的商業吸引力，以充分發揮AspyreRx 的商業潛力，使我們能夠迅速將我們的商業足跡擴展到其他地區。國家。在過去的幾個月裡，我們已經並將繼續優先考慮我們的市場准入活動，目標是實現付款人覆蓋。這些討論已朝著積極的方向進展，結合迄今為止收到的整體回饋，我們有信心獲得付款人的覆蓋。

As with any new product launch, particularly in a new category like PDTs, payer coverage, of course, will take time to ramp up. But in the meantime, to ensure physicians can gain clinical experience with AspyreRx and that eligible patients have affordable access to AspyreRx, we're offering a self-pay option for a limited period of time.

與任何新產品的發布一樣，特別是在 PDT 等新類別中，支付者覆蓋範圍當然需要時間來擴大。但同時，為了確保醫生能夠獲得 AspyreRx 的臨床經驗，並且符合條件的患者能夠負擔得起 AspyreRx 的費用，我們在有限的時間內提供自付費用選項。

Now I'll address the question of revenue guidance. Our plan is to begin sharing guidance once we have obtained a solid understanding of our launch dynamics, which we expect to take at least two to three quarters of commercial experience. Now with that, I'll hand it over to Diane to provide a commercial update. Diane?

現在我將解決收入指導的問題。我們的計劃是，一旦我們對我們的發布動態有了充分的了解，我們就開始分享指導，我們預計這需要至少兩到四分之三的商業經驗。現在，我將把它交給黛安來提供商業更新。黛安？

Thanks, Frank. It is exciting to be at this point, launching AspyreRx into the market and continuing to build out our commercial footprint to drive awareness and educate providers. And with that, I thought I'd start by sharing initial reactions since our market release. The news of AspyreRx's commercial availability was picked up by over 20 news outlets, and this included AspyreRx being featured in the medical breakthroughs in diabetes section in the October-November issue of AARP.

謝謝，弗蘭克。此時此刻，將 AspyreRx 推向市場並繼續擴大我們的商業足跡以提高知名度並教育提供者是令人興奮的。說到這裡，我想我應該先分享自我們的市場發布以來的初步反應。 AspyreRx 商業上市的消息被 20 多家新聞媒體報道，其中包括 AspyreRx 在美國退休人員協會 (AARP) 10 月至 11 月號的糖尿病醫學突破部分中得到專題報導。

We debuted AspyreRx at the American College of Lifestyle Medicine's 2023 annual meeting in Denver, giving us the opportunity to engage with hundreds of healthcare providers, share our clinical data, demonstrate our product, and educate providers on how to prescribe as AspyreRx. Providers reacted positively to AspyreRx, seeing its main benefits as helping patients make lifestyle changes in provider resource-constrained environment, complementing existing diabetes care management programs, and addressing a gap in care in a scalable way.

我們在丹佛舉行的美國生活方式醫學學院2023 年年會上首次推出了AspyreRx，這讓我們有機會與數百家醫療保健提供者互動、分享我們的臨床數據、展示我們的產品，並教育提供者如何開立AspyreRx 處方。提供者對 AspyreRx 反應積極，認為其主要好處是幫助患者在提供者資源有限的環境中改變生活方式，補充現有的糖尿病護理管理計劃，並以可擴展的方式解決護理方面的差距。

A combination of the pivotal clinical trial data, including A1c efficacy reductions in adverse events, and fewer increases in anti-hyperglycemic medications, were cited as compelling reasons to prescribe AspyreRx. And this reinforced our findings from our market research that we completed last quarter. And providers are pleased to hear about our efforts to seek coverage by payers and were complimentary of our affordable self-pay options for patients until broader insurance coverage is available.

關鍵臨床試驗數據的結合，包括不良事件中糖化血紅蛋白療效的降低，以及抗高血糖藥物的增加較少，被認為是開出 AspyreRx 處方的令人信服的理由。這強化了我們上季完成的市場研究的結果。醫療服務提供者很高興聽到我們為尋求付款人承保所做的努力，並對我們為患者提供負擔得起的自付選項表示讚賞，直到提供更廣泛的保險承保範圍。

I will now share our progress with payers. Since our authorization in July, we have engaged with 21 payers, which includes both national and regional payers. And thus far, 13 of those engagements have progressed to clinical presentations, with two more scheduled before Thanksgiving. And so far, seven have advanced to deeper product and clinical discussions, furthering potential coverage decisions.

我現在將與付款人分享我們的進展。自 7 月獲得授權以來，我們已與 21 個付款人接洽，其中包括國家和地區付款人。到目前為止，其中 13 項活動已進入臨床演示階段，另外兩項活動計劃在感恩節前進行。到目前為止，七家已進入更深入的產品和臨床討論，進一步推動了潛在的核保決策。

In general, there is great receptivity and willingness from payers to engage with us. Managing costs associated with type 2 diabetes is a top priority for payers due to the escalating costs associated with this disease, and they are seeking solutions. And given the positive feedback, we recently onboarded additional payer field resources to broaden our outreach. While payers may have different processes, we have been successful in meeting with key decision makers and gaining support to facilitate reviews with broader clinical teams.

總的來說，付款人對與我們合作的接受度和意願很高。由於與第 2 型糖尿病相關的費用不斷上升，管理與第 2 型糖尿病相關的費用是付款人的首要任務，他們正在尋求解決方案。鑑於正面的回饋，我們最近聘請了額外的付款人現場資源來擴大我們的覆蓋範圍。儘管付款人可能有不同的流程，但我們已成功與關鍵決策者會面並獲得支持，以促進更廣泛的臨床團隊的審查。

We have also published our price in all major Compendia, and we expect to be able to announce a payer agreement by year end. Overall, payers continue to be impressed by the size and the design of our randomized controlled trial, including the diversity in the hard-to-treat uncontrolled patient population, the study's clinically meaningful endpoint, and the quality of clinical evidence that we generated. They have reacted positively when hearing about our development of health economic models. And we recently submitted our comparative effectiveness analysis for peer-reviewed publications. As a reminder, a CEA evaluates the long-term or lifetime economic impact of an intervention with an incremental cost effectiveness ratio, which describes the cost per quality-adjusted life-year gains. And we look forward to having this manuscript reviewed.

我們還在所有主要 Compendia 上公佈了我們的價格，並且我們預計能夠在年底前宣布付款人協議。總體而言，付款人仍然對我們隨機對照試驗的規模和設計印象深刻，包括難以治療的非對照患者群體的多樣性、研究具有臨床意義的終點以及我們產生的臨床證據的品質。當他們聽到我們發展健康經濟模式時，反應正面。我們最近提交了同行評審出版物的比較效果分析。提醒一下，CEA 透過增量成本效益比來評估幹預措施的長期或終身經濟影響，該比率描述了每個品質調整後的生命年收益的成本。我們期待對這份手稿進行審查。

Moving to an update on the VA, we have submitted our Federal Supply Schedule application and are waiting to be assigned a contract negotiator. And once on FSS, AspyreRx would be available to be prescribed to veterans that receive care via the VA network. And as a reminder, according to Veterans Affairs, diabetes affects nearly 25% of the VA patient population.

關於 VA 的最新情況，我們已經提交了聯邦供應計劃申請，正在等待指派合約談判代表。一旦加入 FSS，AspyreRx 就可以開立透過 VA 網路接受護理的退伍軍人處方。提醒一下，據退伍軍人事務部稱，糖尿病影響著退伍軍人事務部近 25% 的患者群體。

With our product now market, we are focused on building out our commercial organization to support the initial phase of our launch. Our new head of sales is on board, and together, we are placing field sales personnel in our focused initial geographies to begin educating targeted providers about AspyreRx. We are also deploying medical science liaisons into our target markets to support scientific exchange meetings and engage with key opinion leaders.

隨著我們的產品現已上市，我們專注於建立我們的商業組織以支持我們發布的初始階段。我們的新銷售主管已就任，我們將一起在我們重點關注的初始地區安排現場銷售人員，開始向目標供應商提供有關 AspyreRx 的教育。我們也在目標市場部署醫學聯絡員，以支援科學交流會議並與關鍵意見領袖互動。

And for prescribers outside these geographies, we have internal virtual resources, our customer service group, and Phil, our pharmacy partner, who can support prescribing with interested providers. As a reminder, our initial launch geographies and early adopter targets are informed by type 2 diabetes patient volumes and associated prescription counts, the providers associated with these patients, and an overlap with top health systems and payers.

對於這些地區以外的處方者，我們擁有內部虛擬資源、我們的客戶服務團隊和我們的藥房合作夥伴 Phil，他可以支持向感興趣的提供者開處方。提醒一下，我們最初的推出地域和早期採用者目標是根據 2 型糖尿病患者數量和相關處方數量、與這些患者相關的提供者以及與頂級醫療系統和付款人的重疊情況確定的。

A heat map of the highest concentration of targeted providers has informed the locations and initial focus for our sales teams in the Northeast stretching down the Mid-Atlantic and out to the Midwest. We have identified a total of 4,300 target providers tied to about 15 million diabetes prescriptions a year, an increase from pandemic-era data we previously acquired. This cohort represents innovator and early adopter segments of providers who are more willing to prescribe new medications and devices to treat type 2 diabetes and are already actively using technology, including apps, in their practices.

目標供應商最集中的熱圖為我們東北部銷售團隊的位置和最初關注點提供了信息，這些團隊一直延伸到大西洋中部，一直延伸到中西部。我們已經確定了總共 4,300 家目標提供者，與每年約 1,500 萬張糖尿病處方相關，這比我們之前獲得的大流行時期數據有所增加。該群體代表了醫療服務提供者的創新者和早期採用者群體，他們更願意開立新藥物和設備來治療 2 型糖尿病，並且已經在實踐中積極使用包括應用程式在內的技術。

Together with over 200 leads from the recent ACLM meeting, we are focused on driving provider awareness and adoption as we begin to expand our sales reach with targeted provider, including in the VA; invest further in our medical affairs organization; activate a targeted provider omnichannel approach to include digital awareness campaigns; and establish our presence at key diabetes conferences for the first half of 2024. To support physician prescribing, we are tracking availability in electronic health record systems since submitting AspyreRx information to all major Compendia. And physicians are already successfully e-prescribing.

與最近 ACLM 會議上的 200 多名潛在客戶一起，隨著我們開始擴大與目標提供者（包括 VA）的銷售範圍，我們致力於提高提供者的認知度和採用率；進一步投資我們的醫療事務組織；啟動有針對性的提供者全通路方法，包括數位意識活動；並在 2024 年上半年的重要糖尿病會議上建立我們的影響力。為了支持醫生開處方，自從向所有主要 Compendia 提交 AspyreRx 資訊以來，我們一直在追蹤電子健康記錄系統的可用性。醫生已經成功地進行電子處方。

Before I finish, I will touch briefly on a couple of recent developments in the industry that acknowledge prescription digital therapeutics are gaining awareness among key stakeholders to open up future growth opportunities. In October, the FDA announced the formation of a Digital Health Advisory Committee to support safe and effective regulation of digital health technologies while encouraging innovation. This committee will advise on FDA policies and regulations, providing relevant expertise to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with the use of digital health technologies. In addition, the FDA recently issued draft guidance titled, Regulatory Considerations for Prescription Drug Use-Related Software, which provides the agency's views and intends to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions.

在結束之前，我將簡要介紹該行業的一些最新發展，這些發展承認處方數位療法正在獲得主要利益相關者的認識，從而開闢未來的成長機會。 10 月，FDA 宣布成立數位健康諮詢委員會，支持數位健康科技的安全有效監管，同時鼓勵創新。該委員會將就 FDA 的政策和法規提供建議，提供相關專業知識，以提高 FDA 對與使用數位醫療技術相關的益處、風險和臨床結果的理解。此外，FDA 最近發布了題為《處方藥使用相關軟體監管注意事項》的指南草案，該指南提供了該機構的觀點，並打算在做出藥物標籤決策時考慮藥品和數位治療解決方案的綜合有效性。

Next, on CMS, regarding the bipartisan bill to provide Medicare and Medicaid patients access to prescription digital therapeutics, in September, the House Energy and Commerce Committee held a subcommittee hearing in which they reviewed the PDT bill. In addition, a Congressional Budget Office Board has been requested for the PDT Act this year. We were also pleased to hear, at the most recent Academy of Managed Care Pharmacy Nexus meeting, that the pending bill and the new FDA Digital Health Advisory Committee are top policy priorities for AMCP.

接下來，在 CMS 上，關於為 Medicare 和 Medicaid 患者提供處方數位治療的兩黨法案，眾議院能源和商業委員會於 9 月舉行了一次小組委員會聽證會，其中他們審查了 PDT 法案。此外，今年也要求國會預算辦公室委員會制定《PDT 法案》。我們也很高興地在最近舉行的管理護理藥局 Nexus 學會會議上獲悉，待決法案和新的 FDA 數位健康諮詢委員會是 AMCP 的首要政策優先事項。

Before passing on to Mark, let me finish by saying AspyreRx is now commercially available and providers are prescribing through our pharmacy partner, PhilRx. We have had positive reactions among providers, highlighted by feedback we received at our first industry conference. And we are confident with the level of engagement we have had with payers and the progress we are making towards gaining commercial coverage for AspyreRx, and we expect to announce at least one agreement by year end. Mark Heinen, our Chief Financial Officer, will now review our third-quarter 2023 financial results. Mark?

在交給 Mark 之前，我想最後說一下，AspyreRx 現已上市，供應商正在透過我們的藥房合作夥伴 PhilRx 開處方。我們在供應商中得到了積極的反應，我們在第一次行業會議上收到的回饋凸顯了這一點。我們對與付款人的接觸程度以及我們在獲得 AspyreRx 商業覆蓋方面所取得的進展充滿信心，我們預計將在年底前宣布至少一項協議。我們的財務長 Mark Heinen 現在將審查我們 2023 年第三季的財務表現。標記？

Thank you, Diane. I'll begin with a discussion of our operating expenses for the third quarter of 2023. Our overall operating expenses declined to $5.3 million in the third quarter compared to $7 million in the second quarter of this year, and $11 million in the third quarter of last year. The lower operating expenses are primarily the result of the cost-saving initiatives we announced earlier this year.

謝謝你，黛安。我將首先討論 2023 年第三季的營運支出。第三季我們的整體營運支出降至 530 萬美元，而今年第二季為 700 萬美元，2023 年第三季為 1,100 萬美元。去年。營運費用降低主要是我們今年稍早宣布的成本節約措施的結果。

Research and development expenses were $1.8 million for the quarter compared to $5.5 million for the same period in 2022. The decrease was primarily due to a $2 million decline in clinical study costs as we completed the BT-001 pivotal trial in the third quarter of 2022, and a $1.8 million decline in personnel-related costs as a result of the restructuring in the first quarter of 2023 and other cost-saving initiatives. Sales and marketing expenses were $1.4 million this quarter compared to $1.6 million for the same quarter last year. Personnel-related costs increased $200,000 as we prepared for the October commercial launch of AspyreRx. This was offset by a $300,000 decline in real-world evidence costs as we completed the enrollment in the study.

本季的研發費用為 180 萬美元，而 2022 年同期為 550 萬美元。減少的主要原因是我們在 2022 年第三季完成了 BT-001 關鍵試驗，臨床研究成本減少了 200 萬美元由於2023 年第一季的重組和其他成本節約舉措，人員相關成本減少了180 萬美元。本季銷售和行銷費用為 140 萬美元，去年同期為 160 萬美元。當我們為 10 月 AspyreRx 的商業發布做準備時，與人員相關的成本增加了 20 萬美元。當我們完成研究的註冊時，實際證據成本減少了 30 萬美元，抵消了這一影響。

G&A expenses for the quarter were $2.1 million compared to $4 million for the same period in 2022. The decrease was the result of a $1.1 million decline in personnel and consulting costs related to the cost-saving initiatives I previously mentioned, and a $700,000 decrease in business insurance costs.

本季的一般管理費用為210 萬美元，而2022 年同期為400 萬美元。這一下降是由於與我之前提到的成本節約舉措相關的人員和諮詢成本減少了110 萬美元，以及與我之前提到的成本節約措施相關的人員和諮詢成本減少了70 萬美元。商業保險費用。

Interest expense for the quarter was $500,000 compared to $400,000 for the same period last year. The increase was a result of higher interest rates associated with our secured term loan agreement with Hercules Capital.

本季的利息支出為 500,000 美元，而去年同期為 400,000 美元。這一增長是由於我們與 Hercules Capital 的擔保定期貸款協議相關的利率上升所致。

Net loss was $5.9 million compared to $11.4 million in Q3 last year. On a per-share basis, net loss was $0.15 for the quarter compared to $0.48 last year. The decline in loss per share is related to the previously mentioned cost-saving initiatives and an increase in weighted average shares outstanding.

淨虧損為 590 萬美元，而去年第三季的淨虧損為 1,140 萬美元。以每股計算，本季淨虧損為 0.15 美元，去年同期淨虧損為 0.48 美元。每股虧損的下降與先前提到的成本節約措施和加權平均流通股的增加有關。

Moving to our balance sheet, cash and cash equivalents were $6.6 million on September 30, 2023, compared to $15.7 million on December 31, 2022. In addition, in October 2023, we raised $2.9 million through our ATM facility. So on a pro forma basis, taking into account the ATM utilization, cash and cash equivalents was $9.5 million at the end of the third quarter. Our lower cash burn and the recent utilization of our ATM extends our cash runway into the first quarter of 2024, allowing us to make several key fourth-quarter milestones. I'll now hand the call back over to Frank for some closing remarks.

從我們的資產負債表來看，2023 年9 月30 日的現金和現金等價物為660 萬美元，而2022 年12 月31 日為1,570 萬美元。此外，2023 年10 月，我們透過ATM 設施籌集了290 萬美元。因此，按預計計算，考慮到 ATM 利用率，第三季末現金和現金等價物為 950 萬美元。我們較低的現金消耗以及最近 ATM 的使用將我們的現金跑道延長至 2024 年第一季度，使我們能夠實現第四季度的幾個關鍵里程碑。現在我將把電話轉回給弗蘭克，讓他做一些結束語。

Thank you, Mark. Before we wrap up, I want to address what the upcoming milestones are that Mark just alluded to. As we've shared, we have advanced conversations with a number of regional and national payers to gain commercial payer coverage. And we expect to be able to announce our first agreement by the end of the fourth quarter this year, with more expected to follow, of course, in Q1 and beyond.

謝謝你，馬克。在結束之前，我想談談馬克剛剛提到的即將到來的里程碑。正如我們所分享的，我們與許多地區和國家付款人進行了深入對話，以獲得商業付款人的覆蓋範圍。我們預計能夠在今年第四季末宣布我們的第一份協議，當然，預計第一季及以後還會有更多協議。

Following the successful completion of the LivVita liver study and publication of the results in the peer-reviewed journal, Gastro Hep Advances, we intend to submit a request to the FDA for Breakthrough Device Designation for an investigation of PDT in MASLD and MASH, also by the end of this year. Currently, there is no FDA-approved treatments for these diseases, which affects approximately one in four Americans. Similar to type 2 diabetes, behavioral change is foundational to addressing the root cause of these conditions.

在成功完成 LivVita 肝臟研究並在同行評審期刊 Gastro Hep Advances 上發表結果後，我們打算向 FDA 提交突破性設備指定請求，以對 MASLD 和 MASH 中的 PDT 進行研究，也通過今年年底。目前，FDA 還沒有批准治療這些疾病的治療方法，這些疾病影響了約四分之一的美國人。與第 2 型糖尿病類似，行為改變是解決這些疾病的根本原因的基礎。

To support the commercialization of AspyreRx, we expect to announce a business development partnership by the end of this year. And lastly, we expect to further strengthen our financial position before the end of the year, to extend our runway so that we can demonstrate meaningful commercial traction both in terms of payer coverage as well as market adoption of AspyreRx.

為了支持 AspyreRx 的商業化，我們預計在今年年底前宣佈建立業務開發合作夥伴關係。最後，我們希望在今年年底前進一步加強我們的財務狀況，擴大我們的跑道，以便我們能夠在付款人覆蓋範圍以及 AspyreRx 的市場採用方面展現出有意義的商業吸引力。

I recognize our market capitalization and share price are significantly depressed, and how frustrating that is for our shareholders. But the fact is that we have made substantial progress over the past year in getting FDA authorization for our first product and making it commercially available. We are confident we can obtain payer coverage, and we're excited by the initial feedback from providers. And as we look ahead, we believe we will be able to demonstrate the commercial potential of AspyreRx over the next few quarters.

我意識到我們的市值和股價嚴重低迷，這對我們的股東來說是多麼令人沮喪。但事實是，在過去的一年裡，我們在第一個產品獲得 FDA 授權並將其商業化方面取得了實質進展。我們有信心獲得付款人承保，並且我們對提供者的初步回饋感到興奮。展望未來，我們相信我們將能夠在未來幾季展示 AspyreRx 的商業潛力。

There remains a huge unmet medical need in type 2 diabetes. Our product has a broad label and has utility across the entire disease spectrum. It fits into the existing provider workflow. Our mode of action is already embedded in the type 2 diabetes treatment guidelines. We have solid clinical evidence. And our HEOR models suggest that AspyreRx has the potential to demonstrate cost savings for payers and health systems. Our primary focus now is on successfully executing our commercial launch and getting our product to the millions of patients who can benefit from it.

2 型糖尿病仍有龐大的未滿足的醫療需求。我們的產品具有廣泛的標籤，並且適用於整個疾病譜。它適合現有的提供者工作流程。我們的行動模式已納入第 2 型糖尿病治療指引中。我們有確鑿的臨床證據。我們的 HEOR 模型顯示 AspyreRx 有潛力為付款人和衛生系統節省成本。我們現在的主要重點是成功執行我們的商業發布，並將我們的產品提供給數百萬可以從中受益的患者。

I'm proud of our team and grateful for their dedication to our mission and persistence in pursuing it, which is what got us to this point in our evolution. And with that, we're now ready to take your questions. Thank you.

我為我們的團隊感到自豪，並感謝他們對我們使命的奉獻和堅持不懈的追求，這就是我們發展到今天這一點的原因。至此，我們現在準備好回答您的問題了。謝謝。

(Operator Instructions) Thomas Flaten, Lake Street Capital Markets.

（操作員說明）Thomas Flaten，湖街資本市場。

Hey, good morning, everyone. I appreciate you taking the questions. Diane, you mentioned that you've hired a new Head of Sales and your placing field reps. Could you maybe quantify that in regard to your goal, and also maybe layer in the MSL coverage you have currently versus what your goals are?

嘿，大家早安。感謝您提出問題。黛安，您提到您已經聘請了一位新的銷售主管和您的現場代表。您是否可以根據您的目標來量化這一點，並且可以將您目前擁有的 MSL 覆蓋範圍與您的目標進行分層？

Go ahead, Diane.

繼續吧，黛安。

Hey, Thomas, good morning. Thank you for the questions. Yes, we're really pleased with where we are in placing our team, as you saw from our heat map there. And our plan is really to build teams that we've built the momentum with our targeted providers, payers, and health systems. And we are strategically placing these first resources in priority geographies.

嘿，托馬斯，早安。謝謝你的提問。是的，我們對我們團隊的定位非常滿意，正如您從我們的熱圖中看到的那樣。我們的計劃實際上是建立我們與目標提供者、付款人和衛生系統建立勢頭的團隊。我們正在策略性地將這些首要資源配置在優先地區。

And so when we look at this initial team this quarter, we are really looking at about 10 to start, made up of sales, (technical difficulty) seasoned health experience, some medical science liaisons. And of course, as I referenced, we have also outsourced an additional payer resource group that will aid us in starting our efforts in the marketplace.

因此，當我們本季審視這個初始團隊時，我們實際上正在尋找大約 10 個團隊來啟動，其中包括銷售人員、（技術難度）經驗豐富的健康經驗人員以及一些醫學科學聯絡人。當然，正如我所提到的，我們也外包了一個額外的付款人資源小組，這將幫助我們在市場上工作。

And maybe on that strategic placement, how are you guys thinking about placing those, post coverage in that territory? Or are you assuming that those will align over the coming, I don't know, 6 to 12 months?

也許在這個戰略佈局上，你們如何考慮在該地區放置這些帖子報道？或者您假設這些將在未來（我不知道）6 到 12 個月內保持一致？

Yeah, a great question. So as we've been talking over the last year, our strategy has always been to be extremely focused, really carefully managing our resources. And so the work that we've done has really been to identify where the highest concentration of high-volume targeted providers are. We expect to be the early adopters of AspyreRx, given all of the research and the segmentation work that we've done. So it was really important to start where we are utilizing our resources efficiently in these marketplaces, as you saw on the map.

是的，一個很好的問題。因此，正如我們去年一直在談論的那樣，我們的策略始終是高度專注，並非常仔細地管理我們的資源。因此，我們所做的工作實際上是確定大容量目標提供者最集中的地方。鑑於我們所做的所有研究和細分工作，我們希望成為 AspyreRx 的早期採用者。因此，正如您在地圖上看到的那樣，從我們在這些市場中有效利用資源的地方開始非常重要。

But I also wanted to clarify, from a coverage perspective, that our engagements have actually been across the country. We continue to be really encouraged by the number of conversations, the level of conversations we've had immediately, post-FDA authorization. So those engagements are across the country and not limited to these geographies. And as we advance with our payer coverage efforts, clearly, that's an opportunity for us to ensure that we are mapping our sales focus to those efforts as well.

但我還想澄清，從覆蓋的角度來看，我們的活動實際上是在全國範圍內進行的。 FDA 授權後我們立即進行的對話數量和對話水平繼續讓我們感到鼓舞。因此，這些活動是在全國範圍內進行的，而不僅限於這些地區。顯然，隨著我們推進付款人覆蓋工作，這對我們來說是一個機會，確保我們將銷售重點也映射到這些工作上。

Got it. And a quick one for Mark Heinen. I believe payments against the Hercules loan were scheduled to start November 1. Could you just confirm that's happening? Over what time period those repayments are being made?

知道了。馬克海寧 (Mark Heinen) 的快速發言。我相信 Hercules 貸款的付款計劃於 11 月 1 日開始。您能否證實這一情況正在發生？這些還款是在什麼時間內進行的？

Go ahead, Mark.

繼續吧，馬克。

Yeah, sure, Thomas, thanks. Thanks for the question. Yes, they restarted on November 1. Although as we've mentioned in the past, Hercules has been a great partner to us, and we continue to have discussions with them about potential future amendments to the agreement.

是的，當然，托馬斯，謝謝。謝謝你的提問。是的，他們於 11 月 1 日重新啟動。儘管正如我們過去提到的，Hercules 一直是我們的重要合作夥伴，我們將繼續與他們討論未來可能對協議進行的修改。

Got it. Excellent. Appreciate you guys taking the questions. Thank you.

知道了。出色的。感謝你們提出問題。謝謝。

Thank you, Thomas.

謝謝你，托馬斯。

Rahul Rakhit, LifeSci Capital.

拉胡爾·拉希特（Rahul Rakhit），LifeSci Capital。

Hey, guys. Thanks for taking the questions. I was just wondering if maybe you guys could give us an update on what you're thinking or what is the set ASP and out-of-pocket costs for AspyreRx?

大家好。感謝您提出問題。我只是想知道你們是否可以向我們提供最新的想法，或者 AspyreRx 的設定 ASP 和自付費用是多少？

Hey, Rahul, good morning. Thanks for your question. Yes, we absolutely can talk to that. Diane, do you want to take that?

嘿，拉胡爾，早安。謝謝你的提問。是的，我們絕對可以討論這一點。黛安，你想接受這個嗎？

Sure. As a reminder, in prior calls, we did set our wholesale acquisition cost or list price at $750 for a 90-day treatment, for one cycle of treatment of AspyreRx. As you heard from our prepared remarks today, and had previously announced, we do have a self-pay option that is available for patients if they are not covered by their insurer. And so that price is $65 for a one 90-day treatment period. And feedback from providers has actually been complementary on this price point, recognizing what has been central to our mission here at Better Therapeutics, which is about providing its AspyreRx at an affordable price, with a commitment to ensure the broadest access for new innovation.

當然。提醒一下，在先前的電話會議中，我們確實將 AspyreRx 一個治療週期的 90 天治療的批發採購成本或標價定為 750 美元。正如您從我們今天準備好的發言中聽到的以及之前宣布的那樣，如果患者的保險公司沒有承保，我們確實有一個自付選項可供患者選擇。因此，90 天治療期的價格為 65 美元。供應商的回饋實際上在這個價格點上是互補的，認識到我們 Better Therapeutics 使命的核心是什麼，即以實惠的價格提供 AspyreRx，並承諾確保最廣泛的新創新。

And so that is the price that we've set from the self-pay option. And I do think that it's important to note here that while we are not yet aware of what payers will set for their co-pay, we do expect that this is a reasonable assumption for co-pay for a tier 2 drug. paper appear to drop, and I really appreciate that color.

這就是我們透過自付費選項設定的價格。我確實認為，這裡值得注意的是，雖然我們尚不知道付款人將為他們的共同支付設定什麼，但我們確實希望這是對二級藥物的共同支付的合理假設。紙張似乎會掉落，我真的很喜歡這種顏色。

Got it. Really appreciate that color, thanks. And Diane, while I have you, you mentioned that you got in deeper conversations with certain payers around coverage. Could you maybe outline for us the remaining steps in this process that need to happen for you guys to get to the point of a coverage decision from where you are currently?

知道了。真的很喜歡這個顏色，謝謝。黛安，當我採訪你時，你提到你與某些付款人就保險範圍進行了更深入的對話。您能否為我們概述一下此過程中的剩餘步驟，以便您可以從目前的位置做出承保決定？

Yes -- go ahead, Frank. Do you want to start?

是的——繼續吧，弗蘭克。你想開始？

No, you go, Diane.

不，你走吧，黛安。

Okay. Great question, Rahul. I'll start by saying that, you know, getting to payer coverage, it is a process. And it does involve multiple steps and it takes time. And each payer has their own process, but we continue to be encouraged by the fact that the front end of our funnel, meaning that the total number of payers that we're engaging with in discussions, continues to grow pretty steadily here.

好的。好問題，拉胡爾。我首先要說的是，你知道，獲得付款人保險是一個過程。而且它確實涉及多個步驟，並且需要時間。每個付款人都有自己的流程，但我們繼續對漏斗前端的事實感到鼓舞，這意味著我們正在參與討論的付款人總數在這裡繼續穩定增長。

And what we see is that when we have the opportunity to review AspyreRx and the clinical data -- as I mentioned, we're being successful in getting to some of these key decision makers, we have success in advancing those conversations. Payers find AspyreRx compelling for several of the reasons previously outlined related to the quality of data that we've generated.

我們看到的是，當我們有機會審查 AspyreRx 和臨床數據時——正如我所提到的，我們成功地接觸了其中一些關鍵決策者，我們成功地推進了這些對話。付款人發現 AspyreRx 具有吸引力，原因有幾個，這些原因與我們產生的資料品質有關，之前已概述過。

But that said, the PDT category as a whole is still very novel. And while payers recognize that the prescription digital therapeutics are here and offer a long-term proposition, there are some that are more willing than others to be a leader in that innovation and jump right in. So for us, we continue to be really encouraged by advancing these reviews, with additional broader team members, to payers working to figure out how to operationalize. And we're really engaged with them on thinking through all of that.

但話雖如此，PDT類別整體而言還是非常新穎的。儘管付款人認識到處方數位療法已經存在並提供了長期主張，但有些人比其他人更願意成為創新領域的領導者並立即加入。因此，對我們來說，我們繼續受到真正的鼓勵通過與更多更廣泛的團隊成員一起向正在努力弄清楚如何實施的付款人推進這些審查。我們確實與他們一起思考所有這些問題。

And Rahul, I might just said -- you've seen the slide that we presented this morning that gives you sort of summary of the funnel? And as Diane said, I mean, we're encouraged by the front end of the funnel continuing to grow, meaning we are continuing to engage with more and more payers. And we're encouraged by how these discussions have progressed over the last few months. And as you can see, a number of payers have now progressed to the latest status in the process. And some are approaching the final steps, which is why we're confident that we'll be able to announce the first agreement this quarter.

拉胡爾，我可能只是說 - 您已經看過我們今天早上展示的幻燈片，它為您提供了漏斗的摘要？正如黛安所說，我的意思是，我們對通路前端的持續成長感到鼓舞，這意味著我們將繼續與越來越多的付款人接觸。我們對過去幾個月這些討論的進展感到鼓舞。正如您所看到的，許多付款人現在已進入流程的最新狀態。其中一些正在接近最後步驟，這就是為什麼我們有信心在本季宣布第一份協議。

That's helpful as well. I appreciate that. And then I guess just one more for me, if I can. I don't know if we've spoken about this yet, but the recent PDURS guidance from the FDA, how has that, if at all, impacted your conversations with potential partners? And are you also just seeing generally greater urgency from some of the pharma players in this space to create these partnerships, now that they've seen this guidance from the FDA? Thanks for taking questions.

這也很有幫助。我很感激。如果可以的話，我想再給我一個。我不知道我們是否已經討論過這個問題，但是 FDA 最近發布的 PDURS 指南，如果有的話，對您與潛在合作夥伴的對話有何影響？您是否也看到該領域的一些製藥公司在看到 FDA 的指導後普遍更加迫切地建立這些合作夥伴關係？感謝您提出問題。

Yeah, thanks for that question, Rahul. This is the guidance you're referring to, right? That opens up the possibility of expanding drug labeling to include the increased benefits patients may experience by also using a prescription digital therapeutic. And we think that has a number of benefits. If we strengthen drug labeling, it has potential to raise awareness about the concurrent benefits that PDTs can provide, alongside pharmacotherapies. And that, of course, enables providers to improve clinical outcomes.

是的，謝謝你提出這個問題，拉胡爾。這就是您所指的指導，對嗎？這開啟了擴大藥物標籤的可能性，以包括患者透過使用處方數位療法可能體驗到的更多益處。我們認為這有很多好處。如果我們加強藥物標籤，就有可能提高人們對 PDT 與藥物療法同時提供的益處的認識。當然，這使提供者能夠改善臨床結果。

And this differentiation in the label may be particularly relevant in, let's say the GLP-1 market. It's a massive market with a lot of competition in this category. And we have a data set that we have announced publicly a few weeks ago that shows the added benefit that AspyreRx can provide when combined with standard of care, including GLP-1s. And we think that offers an opportunity to differentiate labels in this highly competitive marketplace. And we think this provides the basis for having some productive discussions with the pharmaceutical players in this space.

標籤上的這種差異可能與 GLP-1 市場特別相關。這是一個巨大的市場，該類別的競爭非常激烈。我們幾週前公開宣布的數據集顯示了 AspyreRx 與包括 GLP-1 在內的標準護理相結合時可以提供的額外益處。我們認為這為品牌在這個競爭激烈的市場中脫穎而出提供了機會。我們認為這為與該領域的製藥公司進行一些富有成效的討論奠定了基礎。

Wow, that's helpful. Yeah, I guess I was wondering, with the full select data set coming up later this weekend, questions around whether payers are going to be strict on covering GLP-1s or not. Also, just what's the longevity of the impacts of those drugs are without sustainable behavioral modifications, if there's some urgency here or -- and a large opportunity for you guys to insert yourselves there?

哇，這很有幫助。是的，我想我想知道，完整的選擇資料集將於本週末晚些時候公佈，關於付款人是否會嚴格覆蓋 GLP-1 的問題。另外，如果沒有可持續的行為改變，這些藥物的影響能持續多久，如果這裡有一些緊急情況，或者你們有很大的機會介入那裡？

Yeah, I think there's a number of benefits that just goes beyond just what we talked about, maybe differentiating the label. I think that the key benefit ultimately is to provide better clinical outcomes. And that can come through a variety of different ways. I think it is well known that many patients do not fully achieve their therapeutic dose of the GLP-1s that they're on; we might be able to help with that.

是的，我認為有很多好處超出了我們所討論的範圍，也許可以使標籤與眾不同。我認為最終的關鍵好處是提供更好的臨床結果。這可以透過多種不同的方式實現。我認為眾所周知，許多患者沒有完全達到他們所服用的 GLP-1 的治療劑量；我們或許可以提供協助。

And keep in mind, when you combine a pharmaceutical drug with a PDT, there's not only maybe the benefit that, let's say the behavioral therapy can provide, there's also the benefit that the product itself can provide, for example, in maybe supporting medication adherence. So there's a number of things that ultimately, we believe have the potential to generate better clinical outcomes than other products alone.

請記住，當您將藥物與 PDT 結合使用時，不僅可能有行為療法可以提供的好處，還有產品本身可以提供的好處，例如，可能支持藥物依從性。因此，我們相信，有很多東西最終有可能比單獨的其他產品產生更好的臨床結果。

Awesome, makes sense. Thank you.

厲害了，有道理。謝謝。

Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may now disconnect. And have a wonderful day.

女士們、先生們，目前沒有其他問題了。感謝您參加今天的會議。程式到此結束。您現在可以斷開連線。祝你有美好的一天。

Thank you very much, everyone. Bye-bye.

非常感謝大家。再見。