OptiNose Inc (OPTN) 2024 Q2 法說會逐字稿

Hello, and welcome to the OptiNose second-quarter 2024 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，歡迎參加 OptiNose 2024 年第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄製中。

It is now my pleasure to introduce Vice President of Investor Relations, Jonathan Neely.

現在我很高興向大家介紹投資者關係副總裁喬納森‧尼利 (Jonathan Neely)。

Good morning. Thank you for joining us today as we review OptiNose's second-quarter 2024 performance and our plans for the remainder of the year. I'm joined today by our CEO, Dr. Ramy Mahmoud; and our Chief Commercial Officer, Paul Spence. Slides that will be presented on this call can be viewed on our website, optinose.com, in the Investors section.

早安.感謝您今天加入我們，我們將回顧 OptiNose 2024 年第二季的業績以及我們今年剩餘時間的計畫。今天我們的執行長拉米·馬哈茂德 (Ramy Mahmoud) 博士也加入了我的行列。以及我們的首席商務官 Paul Spence。您可以在我們的網站 optinose.com 的投資者部分查看本次電話會議中將展示的幻燈片。

Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements. All statements that are not historical facts are hereby identified as forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated in such statements.

在我們開始之前，我想提醒您，我們在本次電話會議期間的討論將包括前瞻性陳述。所有非歷史事實的陳述均被認定為前瞻性陳述。前瞻性陳述存在風險和不確定性，可能導致實際結果與此類陳述中所示的結果有重大差異。

Additional information regarding these factors and forward-looking statements is discussed under the Cautionary Note on Forward-Looking Statements section of the earnings release that we issued today, as well as under the Risk Factors section and elsewhere in OptiNose's most recent Form 10-K and 10-Q that are filed with the SEC and available at their website, sec.gov; and our website at optinose.com.

有關這些因素和前瞻性陳述的更多資訊將在我們今天發布的收益報告的「前瞻性陳述的警示說明」部分以及 OptiNose 最新的 10-K 表格中的「風險因素」部分和其他部分進行討論。 10-Q 已向SEC 備案並可在其網站sec.gov 上取得；以及我們的網站 optinose.com。

You are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements during this conference call speak only as of the original date of this call or any earlier date indicated in such statement. And we undertake no obligation to update or revise any of these statements. We will now make prepared remarks, and then we will move to a question-and-answer session.

請您注意不要過度依賴前瞻性陳述。本次電話會議期間的前瞻性陳述僅代表本次電話會議的原始日期或此類陳述中指明的任何較早日期。我們不承擔更新或修改任何這些聲明的義務。我們現在將發表準備好的發言，然後進入問答環節。

With that, I will now turn the call over to Ramy.

現在，我將把電話轉給拉米。

Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our second-quarter 2024 update.

謝謝喬納森，也感謝今天早上收聽我們節目的所有人。感謝您加入我們的 2024 年第二季更新。

Starting on slide 3. We're pleased to report a promising start to our chronic sinusitis launch and good progress in the quarter. I'll start with a brief outline of what we'll cover during our call today.

從投影片 3 開始。我們很高興地報告我們的慢性鼻竇炎產品的推出有一個良好的開端，並且在本季度取得了良好的進展。我將首先簡要概述我們今天的電話會議將討論的內容。

First, I'll review three key takeaways from today's call. Second, our Chief Commercial Officer, Paul Spence, will discuss our early efforts to educate our ENT and allergy specialist physician audience on XHANCE's new clinical profile and some encouraging early signals of progress that will enable future uptake.

首先，我將回顧今天電話會議的三個關鍵要點。其次，我們的商務長Paul Spence 將討論我們早期為讓耳鼻喉科和過敏專科醫師受眾了解XHANCE 的新臨床概況以及一些令人鼓舞的早期進展信號而做出的努力，這些信號將有助於未來的採用。

Next, Jonathan Neely, our VP of Investor Relations and Business Development, will review our second-quarter 2024 performance and our financial guidance for full-year 2024. Finally, we'll return to wrap up the call and take your questions.

接下來，我們的投資者關係和業務發展副總裁 Jonathan Neely 將回顧我們 2024 年第二季的業績和 2024 年全年的財務指引。最後，我們將返回結束通話並回答您的問題。

Turning to slide 4. I'd like to highlight three key takeaways from today's presentation. First, I'd like to reiterate the significant long-term potential of the opportunity in front of us, which we believe has potential to reshape our business for years into the future.

轉到投影片 4。我想強調今天演講中的三個重點。首先，我想重申我們面前的機會具有巨大的長期潛力，我們相信這有可能在未來幾年重塑我們的業務。

Claims data suggests that chronic sinusitis is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. Reshaping our business by launching XHANCE in chronic sinusitis started in the second quarter.

索賠數據表明，目前醫療保健提供者診斷出慢性鼻竇炎的頻率至少是鼻息肉的 10 倍。從第二季開始，我們開始在慢性鼻竇炎領域推出 XHANCE，重塑我們的業務。

In April, we held a national sales meeting to complete training of our sales team. And they are now engaged with a full set of new materials and have been interacting with the universe of both familiar and new prescribers.

4月，我們召開了全國銷售會議，完成了銷售團隊的訓練。他們現在正在研究全套新材料，並與熟悉的和新的處方者的世界進行互動。

As a reminder, our plan is to launch with our current sales force infrastructure, arming our sales team with a suite of new chronic sinusitis promotional materials accompanied by digital and nonpersonal promotion and by educational efforts based on the new label, with the objective of attaining peak-year sales of at least $300 million and producing positive income from operations for full-year 2025.

提醒一下，我們的計劃是啟動現有的銷售隊伍基礎設施，為我們的銷售團隊配備一套新的慢性鼻竇炎宣傳材料，並輔以數位和非個人推廣以及基於新標籤的教育工作，目標是實現高峰年銷售額至少達 3 億美元，並在 2025 年全年產生正營運收入。

Over the course of the prior five quarters, since I accepted responsibility for this position, our focus has been on seeking approval for the new first-and-only chronic sinusitis indication, on greatly increasing our operating efficiency, on stabilizing XHANCE's revenue, and on preparing our organization for the greatly expanded opportunity in chronic sinusitis.

在過去的五個季度中，自從我接受這個職位的職責以來，我們的重點一直是尋求新的第一個也是唯一的慢性鼻竇炎適應症的批准，大大提高我們的運營效率，穩定XHANCE 的收入，以及讓我們的組織為慢性鼻竇炎的巨大機會做好準備。

Our success in these areas means that initial launch efforts by our commercial team in the second quarter of this year are building on a significantly stronger base than we had at the start of 2023. From a financial perspective, this includes a stronger balance sheet, lower expenses, and improving average net revenue per prescription.

我們在這些領域的成功意味著我們的商業團隊在今年第二季的初步發布工作將建立在比 2023 年初更強大的基礎上。從財務角度來看，這包括更強大的資產負債表、更低的費用以及提高每張處方的平均淨收入。

During the first few quarters of launch, we are aiming to sustain our operating efficiency gains, while building on the strength and foundation to begin to penetrate the greatly expanded total addressable market, resulting from our first-and-only new CS indication. Over the initial quarters after launch, we expected gradually improving insurance coverage and are pleased that late in second quarter, XHANCE was added to large Express Scripts' national formularies. You'll hear more about that in a moment.

在推出的前幾個季度，我們的目標是維持營運效率的提高，同時建立實力和基礎，開始滲透因我們第一個也是唯一一個新的 CS 指標而大幅擴大的總體目標市場。在推出後的最初幾個季度，我們預計保險覆蓋範圍將逐漸改善，並且很高興在第二季度末，XHANCE 被添加到大型 Express Scripts 的國家處方中。稍後您會聽到更多相關資訊。

In the second quarter, we also empowered our sales force to use new and differentiated clinical data and new promotional materials to engage prescribers and begin the educational interactions that should facilitate gradual adoption of XHANCE as a regular part of clinical practice for treating this underserved disease.

在第二季度，我們還授權我們的銷售人員使用新的、差異化的臨床數據和新的宣傳材料來吸引處方者，並開始教育互動，以促進逐漸採用XHANCE 作為治療這種服務不足的疾病的臨床實踐的常規部分。

In addition, as we previously noted, earlier this year, we began to transition much of our prescription fulfillment to a central intake pharmacy or HUB. And during the first few quarters of launch, we expect to continue work to optimize the effectiveness of that fulfillment channel.

此外，正如我們之前指出的，今年早些時候，我們開始將大部分處方履行轉移到中央攝入藥房或 HUB。在推出的前幾個季度，我們預計將繼續努力優化該履行管道的有效性。

Overall, we believe we're making progress on laying the necessary foundation to be able to realize the significant long-term potential of XHANCE in our new market. Today, we're reporting on the first quarter of our launch and have achieved revenue consistent with our expectations. Our Chief Commercial Officer, Paul Spence, will provide some encouraging updates about initial progress by his team in just a moment.

總的來說，我們相信我們正在為實現 XHANCE 在新市場的巨大長期潛力奠定必要的基礎方面取得進展。今天，我們將報告第一季的發布情況，並實現了與我們預期一致的收入。我們的首席商務官 Paul Spence 將立即提供有關其團隊初步進展的一些令人鼓舞的最新資訊。

We continue to believe the first few quarters after launch will produce gradual growth while we progressively implement insurance coverage changes and steadily educate target prescribers on clinical data related to the new indication. We continue to believe that consistent commercial plan execution on multiple fronts will lead to future acceleration of the growth trajectory in the much larger market that has now been opened for XHANCE.

我們仍然相信，推出後的前幾季將產生逐步成長，同時我們將逐步實施保險範圍變更，並穩步向目標處方者提供與新適應症相關的臨床數據方面的教育。我們仍然相信，在多個方面持續執行商業計劃將導致 XHANCE 現已開放的更大市場的未來加速成長軌跡。

Lastly, during the first half of this year, we have been more successful than we originally anticipated in our efforts to focus on profitable business and move away from lower profit and unprofitable business. As a result, we are increasing our expectation for XHANCE net revenue per prescription for full-year 2024 to at least $250, compared to our previous expectation of at least $230, an increase of at least 20% compared to 2023.

最後，今年上半年，我們在專注於獲利業務、遠離利潤較低和無獲利業務的努力方面比我們最初預期的更加成功。因此，我們將 XHANCE 2024 年全年每張處方淨收入的預期提高至至少 250 美元，而先前的預期為至少 230 美元，與 2023 年相比增長至少 20%。

We're also narrowing our full-year 2024 XHANCE net revenue guidance range to $85 million to $90 million from $85 million to $95 million previously. The new range represents revenue growth of 20% to 27% compared to full-year 2023 revenues of $71 million.

我們也將 2024 年全年 XHANCE 淨收入指引範圍從先前的 8,500 萬美元至 9,500 萬美元縮小至 8,500 萬美元至 9,000 萬美元。與 2023 年全年 7,100 萬美元的收入相比，新系列的收入增長了 20% 至 27%。

The narrowing of the revenue range reflects removal of revenues associated with lower profit and unprofitable business, for which we have intentionally reduced co-pay support. We believe focusing on growth in profitable lines of business will result in a healthier, more sustainable business over the long term. It's important to note that the combined effect of these two changes is directionally offsetting, which leaves our expectations for cash runway and operating income largely unchanged.

收入範圍的縮小反映了與利潤較低和無利可圖的業務相關的收入的去除，為此我們有意減少了自付費用支援。我們相信，從長遠來看，專注於獲利業務的成長將帶來更健康、更永續的業務。值得注意的是，這兩項變動的綜合影響是方向性抵銷的，這使得我們對現金跑道和營業收入的預期基本上保持不變。

Finally, with respect to operating expense, we continue to plan for full-year 2024 to be modestly incremental to full-year 2023 in support of promotional launch efforts as previously communicated. I'd now like to turn the call over to Paul Spence to review initial launch performance and recent commercial highlights. Paul?

最後，關於營運費用，我們繼續計劃 2024 年全年相對 2023 年全年適度增加，以支持先前溝通的促銷活動。我現在想將電話轉給 Paul Spence，回顧最初的發布表現和最近的商業亮點。保羅？

Thank you, Ramy. Turning to slide 6. To set the context, we are leveraging four major tactics to launch XHANCE into this major new market opportunity. These include in-person promotion by our sales force, nonpersonal promotion, peer-to-peer education, and presence at medical meetings.

謝謝你，拉米。轉到投影片 6。為了設定背景，我們正在利用四種主要策略將 XHANCE 推向這一重大的新市場機會。其中包括我們銷售人員的面對面促銷、非個人促銷、同儕教育以及出席醫療會議。

The XHANCE launch into chronic sinusitis required a significant shift in our commercial model, most especially, around the opportunity to expand the number of new XHANCE prescribers. Some estimate that with new products and indications, it require 10 to 12 calls on new physicians before they fully understand and believe in a product's clinical information and then identify appropriate patients to trial the new medication and change behavior.

XHANCE 進軍慢性鼻竇炎領域需要我們的商業模式發生重大轉變，尤其是圍繞擴大新 XHANCE 處方者數量的機會。有些人估計，對於新產品和適應症，需要 10 到 12 次拜訪新醫生，他們才能完全理解並相信產品的臨床信息，然後確定合適的患者來試驗新藥物並改變行為。

In second quarter, we started that climb to the hill. Successful product trials across our new physician targets will be a precursor for consistent adoption and continued growth over time. Our efforts thus far are already getting the ball rolling with both naive XHANCE prescribers. And those HCPs, we believe, prescribed very little due to prior restrictions around the nasal-polyps-only indication. And we expect gradually accelerating product uptake in the second half of this year.

在第二季度，我們開始爬山。我們新的醫生目標的成功產品試驗將成為持續採用和持續成長的先兆。到目前為止，我們的努力已經讓兩位天真的 XHANCE 處方者開始行動。我們認為，由於先前對僅鼻息肉適應症的限制，這些 HCP 的處方很少。我們預計今年下半年產品的吸收將逐漸加速。

Since the CS launch, more than half of the sales calls have been made to HCPs who we categorize as naive to prescribing XHANCE or as having a history of infrequently prescribing prior to the CS approval. New and total prescription growth with both groups has started out positive and we believe, is responding to a combination of sales costs, peer-to-peer education programs, and sampling.

自 CS 推出以來，超過一半的銷售電話是打給 HCP 的，我們將他們歸類為對開 XHANCE 處方天真的人，或者在 CS 批准之前有很少開處方的歷史的人。兩個群體的新處方和總處方增長一開始都是積極的，我們相信，這是銷售成本、同儕教育計劃和抽樣綜合作用的結果。

Our market research suggests that within this group of HCPs, the allergy and primary care prescribers appear to be having a stronger initial response to our communication about the new CS indication and efficacy of XHANCE. In addition, market research validates that these HCP targets use efficacy as their number one preference driver in the CS space.

我們的市場研究表明，在這組 HCP 中，過敏和初級保健處方醫生似乎對我們關於 XHANCE 新的 CS 適應症和功效的溝通有更強烈的初步反應。此外，市場研究證實，這些 HCP 目標將效能作為其在 CS 領域的第一偏好驅動因素。

And therefore, our primary strategic communication focus is to educate them about XHANCE's differentiated efficacy. We expect the adoption of XHANCE by this group of high-potential HCPs to gradually continue to grow in the second half and that we will advance the number of both new and more frequent prescribers of XHANCE.

因此，我們主要的策略溝通重點是讓他們了解 XHANCE 的差異化功效。我們預計下半年這批高潛力 HCP 對 XHANCE 的採用將逐漸繼續增長，並且我們將增加新開 XHANCE 處方者和更頻繁開處方者的數量。

The balance of our direct selling resources are deployed against high-CS-volume ENT and allergy specialists with a history of prescribing XHANCE. We continue to listen to and work closely with these HCPs and their staff to support their efforts to bring XHANCE to significantly more CS patients via strong clinical evidence, personal experience with the product XHANCE, and streamlined prescribing process.

我們的直銷資源的平衡是針對具有開 XHANCE 處方歷史的高 CS 量耳鼻喉科和過敏專家進行部署。我們繼續傾聽這些 HCP 及其員工的意見並與他們密切合作，支持他們透過強有力的臨床證據、產品 XHANCE 的個人經驗和簡化的處方流程，將 XHANCE 帶給更多的 CS 患者。

For example, we've deployed new field support resources via the HUB that we expect to help advance HCP staff proficiency within the XHANCE's patient support program and to ease the process of working with the HUB. We believe this, in combination with important educational efforts on new XHANCE clinical information, will begin to translate into this group of prescribers choosing XHANCE for treatment of more CS patients over time.

例如，我們透過 HUB 部署了新的現場支援資源，我們希望這些資源能夠幫助提高 HCP 員工在 XHANCE 患者支援計畫中的熟練程度，並簡化與 HUB 的合作流程。我們相信，隨著時間的推移，這與新 XHANCE 臨床資訊的重要教育工作相結合，將開始轉化為這群處方者選擇 XHANCE 來治療更多的 CS 患者。

In parallel, we are also focused on increasing the productivity of our promotional efforts by improving overall commercial coverage and access to XHANCE. We're constantly working to streamline the process for managing prior authorization paperwork and the overall prescription fulfillment process and continuing to offer a patient-friendly co-pay support program to ensure the experience for HCPs and patients is as smooth and accessible as possible.

同時，我們也致力於透過改善整體商業覆蓋範圍和 XHANCE 的存取來提高促銷工作的效率。我們不斷努力簡化管理事先授權文書工作和整體處方履行流程的流程，並繼續提供患者友好的共付支持計劃，以確保醫療保健專業人員和患者的體驗盡可能順利和方便。

We're moving and reducing obstacles to filling and refilling prescriptions for both patients and doctors alike. We'll ensure that more CS patients can receive and stay on XHANCE therapy, maintaining their symptom control throughout the year.

我們正在為患者和醫生移動並減少配藥和補充處方的障礙。我們將確保更多 CS 患者能夠接受並持續接受 XHANCE 治療，全年保持症狀控制。

Turning to slide 7. At the end of June, we announced the addition of XHANCE to large Express Scripts' national formularies. Including in this is national preferred, flex, and basic formularies. These are among the largest commercial formularies in the US, with more than 24 million lives. This also marks the first time that XHANCE had held preferred Tier 2 coverage on a national formulary.

轉到投影片 7。6 月底，我們宣布將 XHANCE 加入大型 Express Scripts 的國家處方集中。其中包括國家首選、靈活和基本處方集。這些是美國最大的商業處方藥之一，擁有超過 2400 萬人的生命。這也標誌著XHANCE首次在國家處方集中獲得優先二級保險。

We believe this is an important milestone for patients who suffer from chronic sinusitis and for our business, as this improvement will make it easier and more affordable for patients in these plans to get XHANCE, which is the only approved medication for the treatment of this disease.

我們相信，這對於患有慢性鼻竇炎的患者和我們的業務來說都是一個重要的里程碑，因為這項改進將使這些計劃中的患者更容易、更實惠地獲得XHANCE，這是唯一批准用於治療這種疾病的藥物。

From a business perspective, the new ESI preferred formulary coverage requires only a simple step, that the patient has previously used a standard-delivery nasal steroid. Prescribers will not have to complete prior authorization paperwork. This is expected to improve prescribing and fulfillment at the pharmacy.

從商業角度來看，新的 ESI 首選處方覆蓋範圍只需要一個簡單的步驟，即患者之前使用過標準給藥的鼻用類固醇。處方者無需完成事先授權文件。預計這將改善藥房的處方和履行。

Further streamlining the prescription fulfillment process and improving the quality of our insurance coverage over time will also help prepare the market for potential future commercial initiatives that we've discussed in the past, such as sales force expansion in specialty offices, the addition of a primary care partnership, and further consumer engagement, which can expand our reach to more than 30 million total patients with chronic sinusitis.

隨著時間的推移，進一步簡化處方履行流程並提高我們的保險承保品質也將有助於為我們過去討論過的潛在未來商業舉措做好市場準備，例如擴大專業辦公室的銷售隊伍、增加主要護理合作夥伴關係以及進一步的消費者參與，這可以將我們的覆蓋範圍擴大到超過3000 萬名慢性鼻竇炎患者。

As mentioned earlier, the XHANCE CS launch presents a significant change in our commercial strategy and requires a shift in the XHANCE business from a small dense group of prescribers to now a much larger group of HCPs with big future potential in CS. It takes time to deliver the necessary number of engagements with high-potential HCPs, especially including both those new to XHANCE and those not new, but are new to the chronic sinusitis data, in order to move their interest in prescribing of XHANCE.

如前所述，XHANCE CS 的推出代表了我們商業策略的重大變化，需要 XHANCE 業務從一小群密集的處方醫生轉變為現在更大的 HCP 群體，在 CS 領域具有巨大的未來潛力。與高潛力 HCP 進行必要數量的接觸需要時間，特別是包括那些剛接觸 XHANCE 的人以及那些雖然不是新人但對慢性鼻竇炎數據不熟悉的人，以激發他們對開 XHANCE 處方的興趣。

We expect this to gradually accelerate over the first few quarters of our launch. And I believe we're seeing early patterns suggesting green shoots of growth that increased my confidence and future potential of XHANCE.

我們預計這一速度將在推出後的前幾季逐漸加速。我相信我們看到了早期的模式，顯示成長的萌芽，這增強了我對 XHANCE 的信心和未來潛力。

Finally, you may recall earlier this year, we launched a central intake pharmacy model or a HUB to prepare for the growth that we expect from XHANCE's new indication. During Q2, we transitioned a significant portion of our business from a historical preferred pharmacy network now to the HUB.

最後，您可能還記得今年早些時候，我們推出了中央攝入藥房模型或 HUB，為我們預期 XHANCE 新適應症的增長做好準備。在第二季度，我們將大部分業務從歷史上首選的藥房網路轉移到了 HUB。

In addition to offering the necessary scalability for our anticipated growth and providing improved protection for business continuity, we believe the HUB has the potential to provide more comprehensive and consistent patient support and prescription fulfillment services.

除了為我們的預期成長提供必要的可擴展性並為業務連續性提供更好的保護外，我們相信 HUB 有潛力提供更全面、一致的患者支援和處方履行服務。

This transition has been slight -- has had a slight headwind as we continue to optimize the process at the HUB and as HCP offices become familiar with working with this new fulfillment channel. However, we believe this transition will become a tailwind as we begin to realize the efficiencies that the HUB can offer.

隨著我們繼續優化 HUB 的流程以及 HCP 辦事處逐漸熟悉這個新的履行管道，這種轉變是輕微的 - 遇到了輕微的阻力。然而，我們相信，隨著我們開始意識到 HUB 可以提供的效率，這種轉變將成為一種順風。

I would like to now turn it over to Jonathan Neely to review our second-quarter financial performance and financial guidance for the full '24 year. Jonathan?

我現在想將其交給喬納森·尼利 (Jonathan Neely) 來審查我們第二季度的財務業績和整個 24 年的財務指導。喬納森？

Thanks, Paul. Turning to slide 9. We are encouraged by our second-quarter 2024 financial results. Regarding revenue, OptiNose recognized $20.5 million of XHANCE net revenue in the second quarter, a 5% increase compared to the second quarter of 2023 net revenues of $19.5 million.

謝謝，保羅。轉到投影片 9。我們對 2024 年第二季的財務表現感到鼓舞。在營收方面，OptiNose 在第二季確認了 XHANCE 淨收入 2,050 萬美元，比 2023 年第二季 1,950 萬美元的淨收入成長了 5%。

Based on available prescription and inventory data purchased from third parties and own data, which we received directly from our HUB and preferred pharmacy network, the estimated XHANCE average net revenue per prescription for the second quarter of 2024 was $309, a 44% increase compared to $214 of estimated average net revenue per prescription in the second quarter of 2023.

根據從第三方購買的可用處方和庫存數據以及我們直接從HUB 和首選藥房網絡收到的自有數據，預計XHANCE 2024 年第二季度每張處方的平均淨收入為309 美元，與去年同期相比成長了44%預計 2023 年第二季每個處方的平均淨收入為 214 美元。

As discussed on our first-quarter earnings call, the year-over-year increase is driven by favorable business mix resulting from changes we made to our co-pay support program. I will discuss this in more detail when reviewing our expectations for full-year 2024.

正如我們在第一季財報電話會議上所討論的那樣，同比增長是由我們對自付費用支援計劃進行的改變帶來的有利業務組合推動的。我將在回顧我們對 2024 年全年的預期時更詳細地討論這一點。

Finally, as we reported earlier, OptiNose recognized $25.1 million of SG&A plus R&D expenses in the second quarter of 2024. This is an increase of approximately $4 million compared to the second-quarter 2023 expenses of $21.1 million.

最後，正如我們之前報導的那樣，OptiNose 在 2024 年第二季度確認了 2510 萬美元的 SG&A 加上研發費用。與 2023 年第二季的 2,110 萬美元費用相比，增加了約 400 萬美元。

Turning to slide 10. Our results for first-half 2024 similarly reflect the improvements to net revenue per prescription and the initial investments to support the CS launch.

轉到投影片 10。我們 2024 年上半年的業績同樣反映了每個處方淨收入的改善以及支持 CS 推出的初始投資。

Regarding revenue, OptiNose recognized $35.4 million of XHANCE net revenue in the first half of 2024, a 13% increase compared to the first half of 2023 net revenues of $31.3 million. XHANCE net revenue per prescription for the first half of 2024 was $269, a 51% increase compared to $178 of estimated average net revenue per prescription in the first half of 2023.

在收入方面，OptiNose 在 2024 年上半年確認了 XHANCE 淨收入 3,540 萬美元，比 2023 年上半年 3,130 萬美元的淨收入增加了 13%。XHANCE 2024 年上半年每張處方的淨收入為 269 美元，與 2023 年上半年每張處方的估計平均淨收入 178 美元相比增長了 51%。

Finally, as we reported earlier, OptiNose recognized $46.8 million of SG&A plus R&D expenses in the first half of 2024. This is approximately $1 million increase compared to the first-half 2023 expenses of $45.6 million.

最後，正如我們之前報導的那樣，OptiNose 在 2024 年上半年確認了 4,680 萬美元的銷售、行政管理費用和研發費用。與 2023 年上半年 4,560 萬美元的支出相比，這大約增加了 100 萬美元。

Turning to slide 12. Our full-year 2024 operating expense guidance remains unchanged. We expect total operating expenses to be between $95 million to $101 million, of which approximately $6 million is expected to be stock-based compensation. What is changing is our expectation for both full-year 2024 XHANCE net revenue and full-year 2024 revenue per prescription.

轉到投影片 12。我們的 2024 年全年營運費用指引維持不變。我們預計總營運費用將在 9,500 萬美元至 1.01 億美元之間，其中約 600 萬美元預計將用於股票薪酬。正在改變的是我們對 2024 年全年 XHANCE 淨收入和 2024 年每個處方收入的預期。

As we have discussed previously, we expect average net revenue -- net product revenues per prescription to increase in 2024 compared to 2023, primarily as a result of the revisions that we made to our co-pay assistance program in 2023 and early 2024, intended to enhance average net revenue per prescription by reducing co-pay support to and thus prescriptions filled by patients and commercial insurance plans that either do not cover XHANCE or are in commercial insurance plans that have high deductibles, as these prescriptions have limited or no profitability.

正如我們之前討論的那樣，我們預計2024 年平均淨收入（每個處方的淨產品收入）將比2023 年有所增加，這主要是由於我們在2023 年和2024 年初對共同支付援助計劃進行了修訂，旨在透過減少對患者和不承保XHANCE 或包含在具有高免賠額的商業保險計劃中的患者和商業保險計劃的處方的共同支付支持，從而提高每張處方的平均淨收入，因為這些處方的盈利能力有限或沒有盈利能力。

The magnitude of the benefit derived from these revisions to our co-pay assistance program was greater than we expected in the first half of 2024. And as a result, today, we are increasing our expected average net product revenues per prescription estimate for the full-year 2024, while narrowing our expected range for full-year 2024 XHANCE net revenues.

我們對自付額援助計畫的這些修訂所帶來的效益程度大於我們在 2024 年上半年的預期。因此，今天，我們提高了 2024 年全年每處方平均淨產品收入的預期，同時縮小了 2024 年全年 XHANCE 淨收入的預期範圍。

Specifically, we now expect XHANCE net revenues per prescription to exceed $250 for the full-year 2024, which represents an increase of at least 20% compared to $209 for the full year of 2023. Previously, we expected XHANCE average net revenues per prescription to exceed $230 for the full year of 2024.

具體來說，我們現在預計 2024 年全年 XHANCE 每個處方的淨收入將超過 250 美元，與 2023 年全年的 209 美元相比增加至少 20%。此前，我們預計 2024 年全年 XHANCE 每個處方的平均淨收入將超過 230 美元。

Finally, our guidance for XHANCE net revenue for the full year of 2024 is now between $85 million to $90 million. Compared to full-year 2023, this is a growth of 20% to 27%. Previously, we expected XHANCE net revenue for the full-year 2024 to be between $85 million to $95 million.

最後，我們對 XHANCE 2024 年全年淨收入的指導目前在 8,500 萬美元至 9,000 萬美元之間。與 2023 年全年相比，成長了 20% 至 27%。此前，我們預計 XHANCE 2024 年全年淨收入在 8,500 萬美元至 9,500 萬美元之間。

The narrowing of the guidance range for the full year of 2024 XHANCE net revenues is primarily driven by our expectation for net revenue from prescriptions that have limited or no profitability, for which we have intentionally reduced the level of co-pay support. These revised expectations are offsetting. And as a result, our projections for operating income and cash runway are largely unaffected.

2024 年 XHANCE 淨收入指引範圍的縮小主要是由於我們對盈利能力有限或沒有盈利能力的處方淨收入的預期，為此我們有意降低了自付費用支持水平。這些修改後的預期正在抵銷。因此，我們對營業收入和現金跑道的預測基本上不受影響。

We continue to expect that our existing cash and cash equivalents will be sufficient to fund our operations and debt service obligations through 2025 and that we will produce positive income from operations for full-year 2025.

我們仍然預計，我們現有的現金和現金等價物將足以為我們的營運和償債義務提供到 2025 年的資金，並且我們將在 2025 年全年產生正的營運收入。

I will now turn the call back over to Ramy for closing remarks. Ramy?

現在我將把電話轉回給拉米，讓他發表結束語。拉米？

Thanks, Jonathan. Turning to slide 14. Before moving to take questions, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business for years into the future.

謝謝，喬納森。轉到投影片 14。在回答問題之前，我想重申我們面前的機會的重要性，我們相信這個機會有可能在未來幾年重塑我們的業務。

We're pleased with the success we had in executing our prelaunch operating strategy. In 2023, we achieved increased operating efficiency while stabilizing revenue in the comparatively niche nasal polyp indication. At the same time, we preserved capital and focused our organization on preparation to seize the much larger opportunity that would be created by approval of XHANCE as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine.

我們對執行啟動前營運策略所取得的成功感到高興。2023年，我們在相對利基的鼻息肉適應症方面實現了營運效率的提高，同時穩定了收入。同時，我們保留了資金，並將我們的組織重點放在準備工作上，以抓住XHANCE 獲得批准作為針對成人門診醫學診斷的最常見疾病之一的第一種處方療法所創造的更大機遇。

We are still in the early innings of our launch. But we've already begun to see the desired improvements in insurance coverage following our new indication and are laying the groundwork necessary to expand our prescriber base for the future.

我們仍處於發布的初期階段。但在我們的新適應症之後，我們已經開始看到保險覆蓋範圍出現預期的改善，並正在為擴大未來的處方者基礎奠定必要的基礎。

Although we expect it will naturally take some time to realize the benefits of our initial efforts, we continue to believe that the size of this opportunity, coupled with a stronger balance sheet, position us well to build a profitable ENT- and allergy-focused business by tapping into the significantly expanded net revenue potential with an efficient base of commercial capabilities.

儘管我們預計自然需要一些時間才能實現我們最初努力的好處，但我們仍然相信，這個機會的規模，加上更強大的資產負債表，使我們能夠很好地建立一個以耳鼻喉科和過敏為重點的獲利業務透過利用有效的商業能力基礎，挖掘顯著擴大的淨收入潛力。

In addition, we believe the chronic sinusitis indication will facilitate commercial partnerships or other approaches to accessing additional value in the primary care space that's incremental to what we can access on our own in the specialty segment.

此外，我們相信慢性鼻竇炎適應症將促進商業合作夥伴關係或其他方法在初級保健領域獲得額外價值，這些價值是我們在專業領域自行獲得的價值的增量。

With that, I'd like to thank you very much for your attention and open the call up for Q&A.

在此，我非常感謝您的關注並開始問答環節。

(Operator Instructions) David Amsellem, Piper Sandler.

（操作說明）David Amsellem、Piper Sandler。

Hi. Thanks. This is Schuyler, on for David. So curious, what are your assumptions for your path to profitability? In other words, what level of sales do you think you need to get to in order to reach breakeven?

你好。謝謝。這是斯凱勒，替大衛發言。很好奇，您對獲利之路有何假設？換句話說，您認為需要達到什麼水準的銷售才能達到損益兩平？

And what are your overall thoughts on balancing the sales force versus extending cash runway? And then similarly, how do you feel about your revenue covenant in third quarter? Are you concerned at all about not meeting that minimum? Thanks.

您對平衡銷售隊伍與擴大現金跑道的整體想法是什麼？同樣，您對第三季的營收契約有何看法？您是否擔心未達最低要求？謝謝。

Schuyler, thanks for the question. I'll take the second of your three questions, and I'll ask Jonathan to speak to the first and the third.

斯凱勒，謝謝你的提問。我將回答你三個問題中的第二個，然後我將請喬納森回答第一個問題和第三個問題。

Your second one was around the sales force. And I'll just reiterate what we had said before that our plan is to launch with our current sales force infrastructure. So at least through third quarter, probably through the remainder of the year and potentially significantly longer, we don't expect to make material changes to our current sales force infrastructure.

第二個是關於銷售人員的。我只想重申我們之前說過的話，我們的計劃是利用我們目前的銷售人員基礎設施來啟動。因此，至少到第三季度，可能到今年剩餘時間，甚至可能更長的時間，我們預計不會對我們目前的銷售人員基礎設施進行重大改變。

Jonathan, do you want to address the first and third questions?

喬納森，你想回答第一個問題和第三個問題嗎？

Sure. I might ask you to remind me the third one by the time we get there. But in terms of the pathway to profitability, I think what we've highlighted for everybody is that for this year, we're expecting revenue growth of somewhere between 20% to 27%. And over the long term, we think that the peak revenue potential for this product inside of our current commercial infrastructure is approximately $300 million.

當然。當我們到達那裡時，我可能會要求你提醒我第三件事。但就獲利之路而言，我認為我們向大家強調的是，今年我們預計營收成長在 20% 到 27% 之間。從長遠來看，我們認為該產品在我們目前商業基礎設施內的最高收入潛力約為 3 億美元。

And so that's going to imply kind of multiple years of strong growth ahead of us. And so we think that if you were to look at product with 90% -- approximately 90% gross margins and the types of operating expense structure that we have today, that there's a clear pathway to profitability for the full year of 2025.

因此，這將意味著我們未來幾年將實現強勁成長。因此，我們認為，如果你看看毛利率為 90%（約 90%）的產品以及我們今天擁有的營運費用結構類型，就會發現 2025 年全年有一條明確的獲利途徑。

In terms of the third question, can you remind me the third question? I was taking some notes on the first one.

關於第三個問題，你能提醒我第三個問題嗎？我正在對第一個進行一些筆記。

Yeah. No, just if you're confident on the revenue covenant in the third quarter?

是的。不，如果您對第三季的收入承諾有信心？

Yeah. I mean, I think the third-quarter revenue covenant, I think we're probably already on a trailing 12-month basis, I think, ahead of that. And so again, I think we're expecting growth for this year.

是的。我的意思是，我認為第三季的收入契約，我認為我們可能已經在過去 12 個月的基礎上，我認為，提前了。再說一次，我認為我們預計今年會出現成長。

And so I think we're on a pathway to maintain compliance. As a reminder, I think that number is $72.5 million for the third quarter. And for the fourth quarter, the target is trailing 12-month sales of $75 million.

所以我認為我們正在走一條保持合規的道路。提醒一下，我認為第三季的數字是 7,250 萬美元。第四季的目標是 12 個月的銷售額 7,500 萬美元。

Great, helpful. Thank you.

太棒了，有幫助。謝謝。

Thomas Flaten, Lake Street Capital Markets.

托馬斯·弗拉頓（Thomas Flaten），湖街資本市場。

Good morning. Appreciate you taking the questions. Jonathan, on the average net revenue per prescription for the first half, you're already at $269. And that number tends to stay similar across the third and fourth quarter.

早安.感謝您提出問題。喬納森，就上半年每個處方的平均淨收入而言，您已經達到 269 美元。這個數字在第三季和第四季往往保持相似。

So $250 seems a bit conservative. Should I read it that way, or do you think there's upside to that number? And I know you said it would exceed $250, but it seems like $250 is a very conservative number.

所以250美元似乎有點保守。我應該這樣解讀嗎？我知道你說過會超過 250 美元，但 250 美元似乎是一個非常保守的數字。

Thanks, Thomas, for the question. Yeah. So I mean, again, I think we're trying to build into our expectation for average net revenue per prescription some flexibility for the lower profit or not profitable kind of volumes to rebound in conjunction with the launch.

謝謝托馬斯提出這個問題。是的。因此，我的意思是，我認為我們正在努力在對每個處方的平均淨收入的預期中建立一定的靈活性，以便利潤較低或不盈利的銷量隨著上市而反彈。

Clearly, I think, through the first half, we haven't seen that volume kind of come back into the business. And it also, I think, allows us some operational flexibility related to co-pay assistance and other programs that could be used to stimulate additional demand as we move through the second half.

顯然，我認為，整個上半年，我們還沒有看到業務量回升。我認為，它還使我們在共同支付援助和其他計劃方面具有一定的營運靈活性，這些計劃可用於在下半年刺激額外需求。

But I think our -- so yeah, we're at $269 on a year-to-date basis. And there is some room up against the $250, but it allows us some flexibility.

但我認為我們的——是的，我們今年迄今的價格為 269 美元。250 美元還有一些上漲空間，但它給了我們一定的靈活性。

Yeah. Tom, I'll just -- this is Ramy. I'll just remind you that in first half, we also have the sort of strange one-time event of the Change Healthcare disruption in the switch.

是的。湯姆，我只是──這是拉米。我只想提醒您，在上半年，我們還發生了一種奇怪的一次性事件，即交換機中的 Change Healthcare 中斷。

And as a consequence of that, we saw sort of an artificial one-off suppression of unprofitable volumes, with an emphasis on profitable volumes that we might not otherwise have seen. So we're trying to think carefully about the effect of that sort of one-time event also.

結果，我們看到了對無利可圖的交易量的人為一次性抑制，重點是我們可能不會看到的盈利量。因此，我們也試圖仔細考慮此類一次性事件的影響。

Great. And then maybe for Paul. I'm just curious, in the dialogue you've had with payers to expand the coverage to the new indication, qualitatively, what have those engagements been like? Has there been any pushback? Is it more of just a paper processing issue?

偉大的。然後也許是保羅。我只是很好奇，在您與付款人就將覆蓋範圍擴大到新適應症的對話中，從質量上講，這些活動是什麼樣的？有沒有遇到什麼阻力？這不只是紙張處理問題嗎？

Yeah, no, thanks for the question, Thomas. What I'd say is that payers are seeing the increased demand in prescribing as a result of the new indication and our efforts. And as a result, more and more are approaching us about that indication and the opportunity for improved access and improved coverage across the board.

是的，不，謝謝你的提問，托馬斯。我想說的是，由於新的適應症和我們的努力，付款人看到了處方需求的增加。因此，越來越多的人向我們詢問這一跡像以及改善接入和全面改善覆蓋範圍的機會。

Other than that, we continue to work with our own processes and HCPs around paperwork and supporting their staff and the HCPs and the patients in doing it. But overall, HCPs or our payers are noticing the demand increasing as a result of the indication and our efforts.

除此之外，我們繼續與我們自己的流程和 HCP 圍繞文書工作進行合作，並支持他們的員工、HCP 和患者這樣做。但總體而言，HCP 或我們的付款人注意到，由於指示和我們的努力，需求增加。

Excellent. Thanks much!

出色的。非常感謝！

Thank you.

謝謝。

Thank you. I'll now hand the call back over to CEO, Ramy Mahmoud, for any closing remarks.

謝謝。現在，我將把電話轉回執行長拉米·馬哈茂德 (Ramy Mahmoud)，讓其發表結束語。

Great. Yeah. Thank you very much. So I'll just close by reiterating that we're in a formative phase of our business right now. We've made a major transition from preparing ourselves and sort of laying the groundwork to be able to seize the opportunity associated with our new indication to beginning the execution process on the gradual ramp-up over time with the new indication.

偉大的。是的。非常感謝。因此，我最後要重申，我們目前正處於業務的形成階段。我們已經做出了重大轉變，從做好準備並奠定基礎以便能夠抓住與新適應症相關的機會，到隨著時間的推移開始逐步提升新適應症的執行過程。

And we believe we're making progress on those foundational activities in the initial couple of months here. We look forward to getting back with you again in a few months to tell you a little bit more about our progress during the second-quarter launch. Thank you again for joining today.

我們相信，在最初的幾個月裡，我們正在這些基礎活動上取得進展。我們期待在幾個月後再次與您聯繫，向您詳細介紹我們在第二季發布期間的進展。再次感謝您今天的加入。

Ladies and gentlemen, thank you for participating. This does conclude today's program, and you may now disconnect.

女士們、先生們，感謝您的參與。今天的節目到此結束，您現在可以斷開連線了。