OptiNose Inc (OPTN) 2022 Q4 法說會逐字稿

Good day and thank you for standing by, welcome to the OptiNose's Fourth Quarter 2022 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持，歡迎來到 OptiNose 的 2022 年第四季度收益電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Jonathan Neely, Vice President of Investor Relations. Please go ahead.

我現在想把會議交給今天的演講者，投資者關係副總裁 Jonathan Neely。請繼續。

Good morning and thank you for joining us today as we review OptiNose's fourth quarter 2022 performance and our plans for the remainder of the year. I'm joined today by our Chairman, Joe Scodari; our CEO, Dr. Ramy Mahmoud; and our Chief Commercial Officer, Paul Spence. Joe is contribution to the prepare remarks portion of today's call. Ramy, Paul, and I will host the question-and-answer session.

早上好，感謝您今天加入我們，因為我們回顧了 OptiNose 2022年第四季度的業績以及我們今年剩餘時間的計劃。今天我們的主席 Joe Scodari 加入了我的行列；我們的首席執行官 Ramy Mahmoud 博士；以及我們的首席商務官 Paul Spence。 Joe 參與了今天電話會議的準備發言部分。拉米、保羅和我將主持問答環節。

The slides will be presented on this call can be viewed on our website, optinose.com in the Investors section. 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 by such statements.

幻燈片將在本次電話會議上展示，可以在我們的網站 optinose.com 的“投資者”部分查看。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特此確定為前瞻性陳述。前瞻性陳述受風險和不確定因素的影響，這些風險和不確定性可能導致實際結果與此類陳述所表明的結果存在重大差異。

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 of OptiNose's most recent Form 10-K and Form 10-Q that are filed with the SEC and available at their website, sec.gov, and on our website at optinose.com.

關於這些因素和前瞻性陳述的更多信息在我們今天發布的收益發布的前瞻性陳述部分的警示性說明部分以及 OptiNose 最新的 10-K 表格和表格的風險因素部分和其他地方進行了討論10-Q 已提交給美國證券交易委員會，可在其網站 sec.gov 和我們的網站 optinose.com 上查閱。

You are cautioned not to place undue reliance on forward-looking statements. The 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.

請注意不要過分依賴前瞻性陳述。本次電話會議中的前瞻性陳述僅在本次電話會議的原始日期或此類陳述中指明的任何更早日期發表，我們不承擔更新或修改任何這些陳述的義務。

We will now make prepared remarks, and then we will move to a question-and-answer session. With that, I will now turn the call over to Joe Scodari. Joe?

我們現在將進行準備好的發言，然後我們將進入問答環節。有了這個，我現在將把電話轉給 Joe Scodari。喬？

Thanks, Jonathan, and good morning everyone. You've all had the opportunity to interact with Ramy over the years in his prior positions as President and Chief Operating Officer of the company, but given the recent decision to name him CEO, I'm taking this opportunity to introduce him and to share some perspectives about him on behalf of the Board of Directors. As you know, Peter recently made the decision to step down as CEO in that context, the Board in front of the question of CEO succession, obviously a very important decision for any company, private or public. As the Board discussed this decision, we recognize that we were in this somewhat unique position for a company of our size to have a ready now candidate to promote into the position.

謝謝，喬納森，大家早上好。多年來，在 Ramy 擔任公司總裁兼首席運營官之前，你們都有機會與他互動，但鑑於最近任命他為 CEO 的決定，我藉此機會介紹他並與大家分享代表董事會對他的一些看法。如您所知，在這種情況下，董事會在 CEO 繼任問題之前，彼得最近做出了辭去 CEO 職務的決定，這對任何公司（無論是私營公司還是上市公司）來說顯然都是一個非常重要的決定。在董事會討論這一決定時，我們認識到，對於我們這種規模的公司來說，我們處於這個有點獨特的位置，現在有一個現成的候選人可以晉升到這個位置。

As you know, Ramy has been a part of building OptiNose from its very beginning and has been a very close working partner with Peter. The fact that he can step into the CEO position given that history is an incredible benefits of the company, its shareholders, the management team, all of our people and the customers and patients we serve. I've known Ramy for more than 20 years dating from the time that we overlap while we were both employed by Johnson & Johnson. In this case, while Ramy served as a member of the management team at Janssen Pharmaceutical and I served as a company group chairman and later worldwide chairman of the pharmaceutical sector.

如您所知，Ramy 從一開始就參與了 OptiNose 的構建，並且一直是 Peter 非常親密的工作夥伴。事實上，鑑於歷史，他可以擔任首席執行官一職，這對公司、股東、管理團隊、我們所有的員工以及我們服務的客戶和患者來說都是一個令人難以置信的好處。我認識 Ramy 已有 20 多年了，從我們都受僱於強生公司開始，我們就有交集了。在這種情況下，Ramy 擔任 Janssen Pharmaceutical 管理團隊的成員，而我擔任公司集團主席，後來擔任製藥部門的全球主席。

During that period in the very robust succession planning planning processes within J&J, Ramy was consistently viewed as a rising star with significant upward potential for senior leadership role both within and beyond medical affairs in R&D. Over the past 5 years as chairman of the board for OptiNose's I've had the chance to work more closely with him and further recognized his leadership skills. We all recognize Ramy (inaudible) lighting the development of expanse for chronic rhinosinusitis but he brings much more to the senior leadership roles he is occupied and the Board is confident he will do so as the company's CEO.

在那段時間裡，在強生內部非常強大的繼任計劃規劃流程中，Ramy 一直被視為一顆冉冉升起的新星，在研發的醫療事務內外都具有擔任高級領導職務的巨大上升潛力。在過去的 5 年裡，作為 OptiNose 的董事會主席，我有機會與他更密切地合作，並進一步認識到他的領導才能。我們都認識到 Ramy（聽不清）點燃了慢性鼻竇炎的廣泛發展，但他為他所擔任的高級領導角色帶來了更多，董事會相信他將作為公司的首席執行官這樣做。

It's rare to see a senior executive in our industry that is trained as an MD served in the military and combines a history of highly productive drug development with exceptional executive and leadership skills. Ramy has been an integral part of building OptiNose into what it is today. And notwithstanding the challenges the industry and the company has faced in the last few years, Ramy is ready now to lead the company into its next chapter of growth. With the filing of the supplemental NDA for the chronic rhinosinusitis indication now behind us, Ramy will lead the effort to ensure the company is ready to launch XHANCE for this very important application.

在我們的行業中，很少有高級管理人員接受過 MD 培訓並在軍隊服役，並將高產藥物開發的歷史與卓越的執行和領導技能相結合。 Ramy 一直是將 OptiNose 打造成為今天的樣子的不可或缺的一部分。儘管行業和公司在過去幾年面臨挑戰，但 Ramy 現在已準備好帶領公司進入下一個增長篇章。隨著針對慢性鼻竇炎適應症的補充 NDA 的提交現已結束，Ramy 將領導努力確保公司準備好為這一非常重要的應用推出 XHANCE。

As you know, there's currently no FDA approved therapy for this disease and a high level of patient satisfaction with the therapeutic options currently available. The planning is already underway to get the company into the position to successfully launch XHANCE into a marketplace with significant unmet medical need in the not too distant future. I can speak on behalf of the entire Board of Directors when I say that we are thrilled that this executive transition has already occurred from the prior to the new CEO.

如您所知，目前尚無 FDA 批准的針對這種疾病的治療方法，而且患者對目前可用的治療選擇的滿意度很高。該計劃已經在進行中，以使公司能夠在不久的將來成功地將 XHANCE 推向一個醫療需求未得到滿足的市場。我可以代表整個董事會發言，我們很高興這一高管交接已經從前任 CEO 手中接過。

We anticipate we did not miss a beat and that Ramy will lead this team to the next level of success while maintaining the culture and values that have contributed to the company winning awards for being a great place to work.

我們預計我們不會錯過任何一個節拍，Ramy 將帶領這個團隊取得更高的成功，同時保持為公司贏得獎項而成為理想工作場所的文化和價值觀。

Thank you all for listening. And now I'll turn it over to Ramy. Ramy.

謝謝大家的聆聽。現在我將把它交給拉米。拉米。

Thank you very much, Joe, for your kind remarks, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our fourth quarter update. Before we get started with our business update, I would like to introduce our new Chief Commercial Officer, Paul Spence. Paul has recently -- most recently the Senior Vice President of the U.S. Pharmaceutical Commercial Organization at Aimmune Therapeutics Therapeutics, a division of Nestle Health Sciences, and has nearly 30 years of experience in the life science and pharmaceutical industry as a commercial leader, including responsibility for marketing, sales, market access and commercial operations. His history of relentless focus on commercial execution and lengthy experience building successful commercial organizations and brands out of products with profiles similar to XHANCE is a big part of why we believe he will be successful in his role as the new leader of our commercial team.

喬，非常感謝你的客氣話，也感謝今天早上收聽我們的每一個人。感謝您加入我們的第四季度更新。在我們開始更新業務之前，我想介紹一下我們的新任首席商務官 Paul Spence。 Paul 最近 - 最近擔任雀巢健康科學部門 Aimmune Therapeutics Therapeutics 美國製藥商業組織高級副總裁，作為商業領導者在生命科學和製藥行業擁有近 30 年的經驗，包括責任用於營銷、銷售、市場准入和商業運營。他不懈地專注於商業執行的歷史，以及利用與 XHANCE 類似的產品建立成功的商業組織和品牌的長期經驗，是我們相信他將成功擔任我們商業團隊新領導者的重要原因。

So starting on Slide 3. We'll go into more detail in a moment, but I'd like to highlight 3 key takeaways from today's presentation. First, we remain enthusiastic about the potential addition of an indication to treat patients who have chronic sinusitis. Claims data suggests that CS is currently being diagnosed by health care providers approximately 10x more frequently than nasal polyps. And in the current health care environment, our off-label use is increasingly constrained by payers, we believe the new indication could enable us to access a multifold larger patient audience and therefore, drive significant growth.

所以從幻燈片 3 開始。我們稍後會詳細介紹，但我想強調今天演示文稿中的 3 個關鍵要點。首先，我們仍然熱衷於可能增加治療慢性鼻竇炎患者的適應症。索賠數據表明，目前醫療保健提供者診斷 CS 的頻率大約是鼻息肉的 10 倍。在當前的醫療保健環境中，我們的標籤外使用越來越受到付款人的限制，我們相信新的適應症可以使我們接觸到更多的患者群體，從而推動顯著增長。

Second, we announced the submission of our supplemental new drug application in February for XHANCE as a treatment for patients with chronic sinusitis. This was consistent with our previous guidance and is an important milestone on the road to a potential approval of the new indication in December 2023.

其次，我們宣佈在 2 月份提交了 XHANCE 的補充新藥申請，用於治療慢性鼻竇炎患者。這與我們之前的指南一致，是在 2023 年 12 月可能批准新適應症的道路上的一個重要里程碑。

Third, we have refocused our strategy to prioritize the potential launch of XHANCE as the first ever FDA-approved drug treatment for CS. Because of important differences in patient prevalence, frequency of diagnosis and payer dynamics, we believe the potential for return on investment that can be produced by promoting XHANCE following the potential label expansion for CS is significantly greater than the return available from promotion of XHANCE as a treatment for nasal polyps. Because of this, we have -- as we enter 2023, structured our business to reduce the use of cash during 2023 and to increase our focus on profitability while preserving the infrastructure and capabilities that will be important to a rapid and successful launch in CS following the potential approval. These principles have shaped our expectations for 2023, and we will discuss those expectations later in the presentation.

第三，我們重新調整了我們的戰略重點，優先考慮可能推出 XHANCE 作為有史以來第一個 FDA 批准的 CS 藥物治療。由於患者患病率、診斷頻率和付款人動態方面的重要差異，我們認為在 CS 的潛在標籤擴展之後通過推廣 XHANCE 可以產生的投資回報潛力明顯大於將 XHANCE 作為一種藥物進行推廣所獲得的回報。治療鼻息肉。正因為如此，當我們進入 2023 年時，我們對業務進行了結構調整，以減少 2023 年的現金使用，並更加關注盈利能力，同時保留基礎設施和能力，這對於 CS 之後的快速成功啟動至關重要潛在的批准。這些原則塑造了我們對 2023 年的期望，我們將在稍後的演講中討論這些期望。

Turning to Slide 4. We believe the future approval of XHANCE as the first and only FDA-approved treatment for CS has potential to increase the number of patients for whom the product can be promoted by tenfold because claims data suggests that an order of magnitude more patients are currently diagnosed and treated for chronic sinusitis that are diagnosed and treated for nasal polyps. We expect the greatly expanded universe of potential patients to include those that are currently carried or by physicians in our existing commercial footprint, which would significantly grow our potential within the scope of our current activities.

轉到幻燈片 4。我們相信，XHANCE 的未來批准作為第一個也是唯一一個 FDA 批准的 CS 治療方法有可能將產品可以推廣的患者數量增加十倍，因為索賠數據表明，更多的數量級目前診斷和治療慢性鼻竇炎的患者被診斷和治療鼻息肉。我們預計潛在患者的範圍將大大擴大，包括目前在我們現有的商業足跡中攜帶或由醫生攜帶的患者，這將在我們當前的活動範圍內顯著提高我們的潛力。

We also expect the expanded universe of patients to include patients who are cared for by physicians outside of our current commercial reach. And we are already exploring a number of ways that future outreach to those physicians and patients as possible, including through commercial partnerships, alternative selling models, modest future expansion of our direct selling efforts or by other means.

我們還期望擴大的患者範圍包括由我們目前的商業範圍之外的醫生照顧的患者。我們已經在探索未來盡可能接觸這些醫生和患者的多種方式，包括通過商業合作夥伴關係、替代銷售模式、未來適度擴大我們的直銷工作或其他方式。

The fact that claims data show a very large number of patients are being diagnosed with CS today up to 10 million office visits per year are coded for chronic sinusitis related diagnoses, gives us optimism that it will not be necessary to engage in educational efforts around the prevalence or recognition of chronic sinusitis. The diagnosis is already being made and documented frequently, much more frequently than nasal polyps in the course of ordinary clinical practice. In addition, you are aware that we believe payer friction is one of the chief hindrances to product uptake and the fact that a diagnosis of chronic sinusitis is commonly documented in routine practice may help address one of the most important challenges to uptake created by payers today.

事實上，索賠數據顯示今天有大量患者被診斷出患有 CS，每年有多達 1000 萬次就診被編碼為慢性鼻竇炎相關診斷，這讓我們樂觀地認為，沒有必要圍繞這一領域開展教育工作慢性鼻竇炎的流行或識別。在普通臨床實踐過程中，診斷已經被頻繁地做出和記錄，比鼻息肉更頻繁。此外，您知道我們認為付款人之間的摩擦是產品採用的主要障礙之一，而慢性鼻竇炎的診斷通常記錄在日常實踐中這一事實可能有助於解決當今付款人對吸收造成的最重要挑戰之一.

Specifically, one of the challenges payers create for physicians prescribing XHANCE today, particularly allergists or primary care providers who do not routinely perform nasal endoscopy is asking for attestation to an on-label diagnosis which today, of course, is a diagnosis of nasal polyps. The new CS indication may be better aligned with current physician practice behaviors and with payer requirements in addition to addressing a larger patient population.

具體來說，付款人為今天開 XHANCE 處方的醫生，特別是不定期進行鼻內窺鏡檢查的過敏症專科醫生或初級保健提供者帶來的挑戰之一是要求證明標籤上的診斷，當然，今天是鼻息肉的診斷。除了解決更大的患者群體外，新的 CS 適應症可能更符合當前的醫生實踐行為和付款人要求。

As a reminder, today, approximately 80% of commercial lives are in a plan that covers XHANCE. And of those, approximately half are in a plan that requires a primary -- I'm sorry, excuse me, are in a plan that requires a prior authorization that includes physician attestation to an on-label diagnosis. While we believe more patients could be diagnosed with nasal polyps that are currently being diagnosed and that some physicians could independently choose to write XHANCE more broadly for patients with insurance plans that don't require attestation to a nasal polyp diagnosis.

提醒一下，今天，大約 80% 的商業生活都在涵蓋 XHANCE 的計劃中。其中，大約一半的計劃需要初級——抱歉，對不起，計劃需要事先授權，其中包括醫生對標籤上診斷的證明。雖然我們相信更多的患者可能被診斷出患有目前正在被診斷出的鼻息肉，並且一些醫生可以獨立地選擇為不需要證明鼻息肉診斷的保險計劃的患者更廣泛地編寫 XHANCE。

Having a meaningful number of patients in plants that require a attestation, we believe is deterring many physicians from Whiting XHANCE broadly or at all. And of course, our promotional efforts today are constrained to nasal polyps. With a CS indication, we believe there's significant potential for more physicians to be willing to write for a broader group of their patients because it will be comparatively much more straightforward to attest to a diagnosis that they are routinely documenting today.

我們認為，在需要證明的工廠中有大量患者，這正在阻止許多醫生廣泛或根本不使用 Whiting XHANCE。當然，我們今天的宣傳工作僅限於鼻息肉。有了 CS 適應症，我們相信有很大的潛力讓更多的醫生願意為更廣泛的患者群體寫作，因為證明他們今天例行記錄的診斷相對來說要簡單得多。

Turning to Slide 6. On February 16, we submitted our supplemental new drug application in pursuit of the additional XHANCE indication for treatment of patients with chronic rhinosinusitis. This is a novel indication for which no drug has ever been approved by FDA. Accordingly, the specific language of this potential future indication is a bit uncertain and maybe chronic sinusitis, chronic rhinosinusitis, chronic rhinosinusitis without nasal polyps or other similar language. From a promotional perspective, we view these terms as interchangeable.

轉到幻燈片 6。2 月 16 日，我們提交了補充新藥申請，以尋求治療慢性鼻竇炎患者的額外 XHANCE 適應症。這是一種新的適應症，FDA 從未批准過任何藥物。因此，這個潛在的未來適應症的具體語言有點不確定，可能是慢性鼻竇炎、慢性鼻-鼻竇炎、無鼻息肉的慢性鼻-鼻竇炎或其他類似的語言。從促銷的角度來看，我們認為這些術語可以互換。

Focusing on what's next. We are now in a 74-day window during which FDA will decide whether to accept the sNDA submission for filing. Based on the submission date, we expect that to occur by the start of May. If accepted, the standard FDA review period for this type of application is 10 months, 10 months from the submission date, which would result in an expected FDA action date in mid-December 2023.

專注於下一步。我們現在處於 74 天的窗口期，在此期間 FDA 將決定是否接受 sNDA 提交的備案。根據提交日期，我們預計會在 5 月初完成。如果被接受，FDA 對此類申請的標準審查期為 10 個月，即自提交日期起 10 個月，這將導致 FDA 的預期行動日期為 2023 年 12 月中旬。

I will not review data from the reopen program in detail during prepared remarks. However, we have included summaries of the co-primary endpoints in an appendix to today's presentation. We opened with a landmark program and a major accomplishment for our organization and for the field. If there are any questions, we'll be happy to address those during the Q&A session.

在準備好的評論中，我不會詳細審查重新開放計劃的數據。但是，我們在今天的演示文稿的附錄中包含了共同主要終點的摘要。我們以具有里程碑意義的計劃和我們組織和該領域的重大成就開場。如果有任何問題，我們很樂意在問答環節中解決。

Turning to Slide 8. While our fourth quarter and full year 2022 results were aligned with the expectations that were set in our last call, we are not satisfied with these results. Accordingly, we've made significant changes to our organization as well as to how we plan to operate moving forward. Our initial changes already implemented, will focus on reducing total expenses while concentrating our commercial investments for growth on our most productive territories and programs.

轉到幻燈片 8。雖然我們的第四季度和 2022 年全年業績與我們在上次電話會議中設定的預期一致，但我們對這些結果並不滿意。因此，我們對我們的組織以及我們未來的運營計劃進行了重大改變。我們已經實施的初步變革將側重於減少總開支，同時將我們的商業投資集中在我們最俱生產力的領域和項目上以實現增長。

In addition, our new Chief Commercial Officer, Paul Spence, and his team are evaluating and acting on a number of key factors that we believe underlie the revenue trends observed in the second half of 2022. He's taken on this challenge energetically and with an eye on both improving the tactical quality of our commercial execution and on a variety of potential strategic changes during the coming months.

此外，我們的新任首席商務官 Paul Spence 和他的團隊正在評估一些關鍵因素並採取行動，我們認為這些因素是 2022 年下半年觀察到的收入趨勢的基礎。他充滿活力地迎接了這一挑戰，並著眼於這一挑戰關於提高我們商業執行的戰術質量以及未來幾個月內各種潛在的戰略變化。

Specific examples of areas receiving attention include improving the efficiency with which active physician interest in prescribing XHANCE is converted to fill the prescriptions that drive net revenue. The rate at which prior authorization paperwork is submitted the structure and implementation of our co-pay program and the size and management of our pharmacy distribution network and our payer strategy. Our commercial team is aware that these and other areas where we are evaluating and considering action this year have potential ramifications not only for our promotional efforts in nasal polyps in 2023, but also for how we are setting the organization up for a successful launch of the much larger new CS indication.

受到關注的領域的具體例子包括提高積極醫生對開 XHANCE 的興趣轉化為開處方的效率，從而推動淨收入。提交預先授權文件的速度我們共同支付計劃的結構和實施以及我們藥房分銷網絡的規模和管理以及我們的付款人策略。我們的商業團隊意識到，我們今年正在評估和考慮採取行動的這些領域和其他領域不僅對我們 2023 年在鼻息肉方面的宣傳工作有潛在影響，而且對我們如何建立組織以成功啟動更大的新 CS 指示。

I'd like to note that we'll be looking for evidence of performance improvement before we allow our commercial changes to influence our outlook for the full year 2023. As for results, in fourth quarter 2022, there were approximately 27,700 new prescriptions for XHANCE, a decrease of 7% compared to fourth quarter 2021. We while a market defined by INS prescriptions written by any physician for any condition, a large component of which our prescriptions for allergic rhinitis increased by 5% over the same period. For the full year 2022, there were approximately 113,100 new prescriptions for XHANCE, a slight increase compared to full year 2021, while the INS market I just described increased by 7% over the same period.

我想指出，在我們允許我們的商業變化影響我們對 2023 年全年的展望之前，我們將尋找性能改進的證據。至於結果，在 2022 年第四季度，XHANCE 有大約 27,700 個新處方，與 2021 年第四季度相比下降了 7%。我們的市場由任何醫生針對任何情況開出的 INS 處方定義，其中很大一部分我們用於過敏性鼻炎的處方在同一時期增加了 5%。 2022 年全年，XHANCE 的新處方約為 113,100 個，與 2021 年全年相比略有增加，而我剛才描述的 INS 市場同期增長了 7%。

Turning to Slide 9. In fourth quarter 2022, there were approximately 86,200 total prescriptions for XHANCE, a decrease of 8% compared to fourth quarter 2021. While the market, which includes INS prescriptions written by any physician for any condition, a large component of which our prescriptions for allergic rhinitis increased by 3% over the same period. For the full year 2022, there were approximately 341,000 total prescriptions for XHANCE, a 2% increase compared to full year 2021, while the INS market previously described increased by 4% over the same period.

轉到幻燈片 9。2022 年第四季度，XHANCE 的處方總數約為 86,200，與 2021 年第四季度相比減少了 8%。雖然市場包括任何醫生針對任何情況開出的 INS 處方，但很大一部分其中我們用於過敏性鼻炎的處方在同一時期增加了 3%。 2022 年全年，XHANCE 的總處方量約為 341,000 份，較 2021 年全年增長 2%，而此前描述的 INS 市場同期增長 4%。

Turning to Slide 10. XHANCE market share of 5.7% in fourth quarter of 2022 decreased when compared to the 5.9% share in fourth quarter 2021. In the future, we may eliminate or replace this measure because the denominator will be used to calculate this fraction has limitations. As a reminder, the denominator for this share includes all intranasal steroid prescriptions written by an audience of approximately 21,000 physicians, which includes a substantial number of prescriptions for indications such as allergic rhinitis and which does not include prescriptions for the several biologics that are indicated to treat nasal polyps.

轉到幻燈片 10。與 2021 年第四季度的 5.9% 份額相比，2022 年第四季度 XHANCE 市場份額為 5.7% 有所下降。未來，我們可能會取消或替換這一措施，因為分母將用於計算這一分數有局限性。提醒一下，這一份額的分母包括由大約 21,000 名醫生的聽眾編寫的所有鼻內類固醇處方，其中包括大量針對過敏性鼻炎等適應症的處方，但不包括用於適應症的幾種生物製劑的處方治療鼻息肉。

Breadth and depth of physician prescribing, as measured by the total number of physicians who have patients filling XHANCE prescriptions had mixed results from fourth quarter '21 to fourth quarter '22. Regarding breadth, in fourth quarter of '22, there were 8,104 physicians who had a patient fill at least 1 prescription for XHANCE, an increase of 8% compared to fourth quarter of 2021. Regarding depth, the number of physicians who had more than 15 XHANCE prescriptions filled by their patients in a quarter, decreased by 8% from fourth quarter '21 to fourth quarter '22 with approximately 1,450 physicians in this segment.

從 21 年第四季度到 22 年第四季度，按照讓患者填寫 XHANCE 處方的醫生總數來衡量，醫生處方的廣度和深度有好壞參半。在廣度方面，22 年第四季度，有 8,104 名醫生至少為 XHANCE 開過一張處方，比 2021 年第四季度增加了 8%。在深度方面，有超過 15 名的醫生數量XHANCE 患者在一個季度開出的處方從 21 年第四季度到 22 年第四季度減少了 8%，該部門約有 1,450 名醫生。

I will now turn the call over to Jonathan to discuss fourth quarter and full year financial performance and guidance.

我現在將電話轉給喬納森討論第四季度和全年的財務業績和指導。

Thank you, Ramy. Turning to Slide 12. As we reported, OptiNose recognized $20.9 million of XHANCE's net revenue in the fourth quarter of 2022, a decrease of 7% compared to fourth quarter 2021 net revenues of $22.5 million. The primary driver of the year-over-year decrease in the fourth quarter is the prescription demand that Ramy just discussed. Full year 2022, XHANCE net revenue was $76.3 million, an increase of 4% compared to the prior year.

謝謝你，拉米。轉到幻燈片 12。正如我們報導的那樣，OptiNose 在 2022 年第四季度確認了 XHANCE 淨收入的 2090 萬美元，與 2021 年第四季度的 2250 萬美元淨收入相比下降了 7%。第四季度同比下降的主要驅動因素是 Ramy 剛才討論的處方藥需求。 2022年全年，XHANCE淨收入為7630萬美元，較上年增長4%。

Turning to Slide 13. Based on available prescription data purchased from third parties and on data we received directly from our preferred pharmacy network, XHANCE average net revenue per prescription for the fourth quarter of 2022 was $242, an increase of 1% compared to $240 of revenue per prescription in fourth quarter of 2021. Full year 2022, average net revenue per prescription was $224 and reflects an increase of approximately 2% compared to $219 for the full year of 2021.

轉到幻燈片 13。根據從第三方購買的可用處方數據以及我們直接從首選藥房網絡收到的數據，XHANCE 2022 年第四季度每張處方的平均淨收入為 242 美元，與之前的 240 美元相比增長了 1% 2021 年第四季度每個處方的收入。2022 年全年，每個處方的平均淨收入為 224 美元，與 2021 年全年的 219 美元相比增長了約 2%。

As we discussed on prior calls, we made a change to our co-pay assistance program at the start of 2022 that was intended to increase average net revenue per prescription by reducing the number of proportion of prescription fills by commercially insured patients and plans that have a high deductible. We believe this change had the intended effect reduced our co-pay assistance expense and increased average net revenue per prescription in the early part of the year.

正如我們在之前的電話中所討論的那樣，我們在 2022 年初對我們的共同支付援助計劃進行了更改，該計劃旨在通過減少商業保險患者和計劃的處方配藥比例來增加每個處方的平均淨收入高免賠額。我們認為，這一變化的預期效果是減少了我們的共同支付援助費用，並增加了今年年初每個處方的平均淨收入。

We believe the increase in average net revenue per prescription due to the change in co-pay assistance helped offset effects of an increasing proportion of our prescription volumes through government plans and increases to contracted rebates and commercial plans, both of which has the effect of decreasing average net revenue per prescription.

我們認為，由於共同支付援助的變化，每個處方的平均淨收入增加有助於抵消通過政府計劃增加我們處方量比例的影響以及合同回扣和商業計劃的增加，這兩者都有減少的影響每個處方的平均淨收入。

Turning to Slide 15. Today, we announced our initial financial guidance for 2023. Our guidance reflects our commitment to refocus our strategy to prioritize the potential launch of XHANCE as the first ever FDA-approved drug treatment for chronic rhinosinusitis. And I hope the message our investors take home today is that we are focused as a company on preserving cash that we believe will generate a higher return if used to support a CS launch while maintaining the infrastructure necessary to rapidly and successfully launch the new indication upon approval.

轉到幻燈片 15。今天，我們宣布了 2023 年的初步財務指導。我們的指導反映了我們重新調整戰略重點的承諾，即優先考慮可能推出 XHANCE 作為 FDA 批准的第一個治療慢性鼻鼻竇炎的藥物。我希望我們的投資者今天要傳達的信息是，作為一家公司，我們專注於保留現金，我們相信，如果用於支持 CS 的推出，同時維持快速成功推出新適應症所需的基礎設施，將會產生更高的回報。贊同。

First, for the full year of 2023, we expect total operating expenses to be in the range from $90 million to $95 million, of which approximately $8 million is stock-based compensation. This is a reduction of approximately $30 million or 25% compared to the $123 million reported for the full year of 2022 and reflects actions taken to reduce both employee-related and third-party expenses. Approximately half of the $30 million reduction is attributable to sales and marketing, and the remainder is available to general and administrative expenses and reduced research and development that follows from the conclusion of the reopen program. As part of [XHANCE] intended to reduce total operating expenses for full year 2023, the company reduced its number of territory managers by approximately 15% at the end of 2022.

首先，對於 2023 年全年，我們預計總運營費用將在 9000 萬美元至 9500 萬美元之間，其中約 800 萬美元是基於股票的薪酬。與 2022 年全年報告的 1.23 億美元相比，減少了約 3000 萬美元或 25%，反映了為減少員工相關費用和第三方費用而採取的行動。減少的 3000 萬美元中約有一半用於銷售和營銷，其餘部分用於一般和行政費用以及重新開放計劃結束後減少的研發費用。作為 [XHANCE] 旨在減少 2023 年全年總運營費用的一部分，該公司在 2022 年底將其區域經理人數減少了約 15%。

Second, bearing in mind the level of sales and marketing expense reductions and our second half 2022 prescription trends, our expectation for XHANCE net revenue for the full year of 2023 is between $62 million to $68 million. It is important to note that we are not assuming revenues from a CS launch in our full year 2023 guidance.

其次，考慮到銷售和營銷費用的減少水平以及我們 2022 年下半年的處方藥趨勢，我們對 XHANCE 2023 年全年淨收入的預期在 6200 萬美元至 6800 萬美元之間。重要的是要注意，在我們的 2023 年全年指導中，我們沒有假設 CS 發布的收入。

Third, as part of our expectation for full year 2023, we expect first quarter 2023 XHANCE net revenue to be approximately $10 million. The year-over-year decrease to XHANCE net revenue for the first quarter of 2023 is a consequence of an expected increase in gross to net deductions and an expected decrease in unit ship. The expected increase in gross to net deductions in the first quarter of 2023 includes increased rebates and changes in business mix that also influenced our full year 2023 net revenue expectations and average net revenue per prescription. We expect average net revenue per prescription to be approximately $200 for the full year of 2023.

第三，作為我們對 2023 年全年預期的一部分，我們預計 2023 年第一季度 XHANCE 淨收入約為 1000 萬美元。 XHANCE 2023 年第一季度淨收入同比下降是由於預計總扣除額增加至淨扣除額以及預計單位船舶減少。 2023 年第一季度總扣除額與淨扣除額的預期增長包括回扣增加和業務組合變化，這也影響了我們 2023 年全年淨收入預期和每個處方的平均淨收入。我們預計 2023 年全年每個處方的平均淨收入約為 200 美元。

Finally, as we noted in our earnings press release this morning, all of our financial obligations under the amended and restated Pharmakon note purchase agreement have been classified as current liability under GAAP. Each quarter, we perform forward-looking analysis to evaluate the alignment of the projected performance of our current business, our current liquidity in terms of our debt agreement.

最後，正如我們在今天上午的收益新聞稿中指出的那樣，根據 GAAP，我們在修訂和重述的 Pharmakon 票據購買協議下的所有財務義務都被歸類為流動負債。每個季度，我們都會進行前瞻性分析，以評估我們當前業務的預期業績與我們當前債務協議流動性的一致性。

Under GAAP, the projections we are permitted to use in the analyses are generally based only on the business that we have today. That is XHANCE approved as a treatment for chronic rhinosinusitis with nasal polyps. On that accounting basis, we believe it is probable that it will not be -- that we will not be able to maintain compliance with certain financial and liquidity covenants in the agreement. It is important to note that this assessment does not account for revenues from a CS approval, the potential to add a partner for primary care and other events that could lead to us achieving a alliance in the future.

根據 GAAP，我們被允許在分析中使用的預測通常僅基於我們今天的業務。這是 XHANCE 批准用於治療慢性鼻竇炎伴鼻息肉的藥物。在這個會計基礎上，我們認為很可能不會——我們將無法維持對協議中某些財務和流動性契約的遵守。重要的是要注意，此評估不考慮 CS 批准的收入、增加初級保健合作夥伴的可能性以及可能導致我們在未來實現聯盟的其他事件。

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

我現在將把電話轉回給 Ramy 作結束語。拉米？

Thank you, Jonathan. Before moving to Q&A, and as we turn our attention fully forward to 2023, I'd like to take a moment to reiterate our strategic focus this year. First, we believe achieving the first ever chronic sinusitis indication will be a crucial driver of future value for patients and for our company. It's therefore our top priority.

謝謝你，喬納森。在開始問答之前，隨著我們將注意力完全轉向 2023 年，我想花點時間重申一下我們今年的戰略重點。首先，我們相信實現有史以來第一個慢性鼻竇炎適應症將成為患者和我們公司未來價值的關鍵驅動力。因此，這是我們的首要任務。

Second, we are dissatisfied with our commercial results in 2022. Mindful of the importance of the cash we have today and of the potentially greater value of commercial investment following the future potential CS indication, we have taken and will continue to take action to efficiently generate XHANCE revenue with the current indication.

其次，我們對 2022 年的商業業績不滿意。考慮到我們今天擁有的現金的重要性以及未來潛在的 CS 指示後商業投資的潛在更大價值，我們已經並將繼續採取行動以有效產生具有當前指示的 XHANCE 收入。

Third, we must prepare our organization to seize the potential opportunity created by a new chronic sinusitis indication by planning for a successful launch aimed at rapidly making the product available to millions of patients in need. This will require a range of efforts during 2023 to position ourselves for an inflection in 2024.

第三，我們必須讓我們的組織做好準備，抓住新的慢性鼻竇炎適應症帶來的潛在機會，計劃成功推出旨在迅速為數百萬有需要的患者提供該產品的產品。這將需要在 2023 年做出一系列努力，以便為 2024 年的拐點做好準備。

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

有了這個，我想感謝你今天早上的關注，並打開問答電話。

(Operator Instructions) Our first question comes from Brandon Folkes with Cantor.

（操作員說明）我們的第一個問題來自 Brandon Folkes 和 Cantor。

Maybe just from me, how quickly can you ramp the CS label uptake, just given sort of would go back to the revenue covenants in the first quarter of 2024? And then similarly, can you just elaborate a bit more on the first quarter headwinds you're seeing in 2023? And what could those different 2024 with the CS indication in the label?

也許就我而言，你能以多快的速度提高 CS 標籤的採用率，只要有點像回到 2024 年第一季度的收入契約？然後類似地，您能否詳細說明您在 2023 年看到的第一季度逆風？標籤中帶有CS指示的那些不同的2024會是什麼？

Brandon, thank you. So obviously, we're not sharing a CS forecast for 2024 at this time. But I'll just share a couple of general thoughts about the nature of the launch for CS. The first thing I'll say is that this is the launch of a new indication, not a de novo launch of a new product into the market. So we have the advantage of physicians who are already in established relationships with our commercial organization. We have the advantage of the distribution channels that are already in place with the advantage of many of the prescribers that we'll be talking to already having a general familiarity with the product, all of which may not be the same because we are launching a product de novo into the marketplace. So those things, I think, will facilitate the adoption of the product more rapidly than it might be if we were launching new.

布蘭登，謝謝你。很明顯，我們目前不會分享 2024 年的 CS 預測。但我只想分享一些關於 CS 發布性質的一般想法。我要說的第一件事是，這是新適應症的推出，而不是將新產品重新推向市場。因此，我們擁有已經與我們的商業組織建立關係的醫生的優勢。我們擁有已經存在的分銷渠道的優勢，以及我們將要與之交談的許多處方醫生的優勢，他們已經對產品有了普遍的了解，所有這些可能都不一樣，因為我們正在推出一個產品從頭進入市場。因此，我認為，這些事情將比我們推出新產品時更快地促進產品的採用。

On the other hand, it's never a good idea to underestimate the potential impact of payer barriers. We are aware of that, and we'll be working to address that. And and as I noted earlier, there's a variety of reasons to think that the CS indication actually will be much easier to prescribe than the nasal polyp indication for the reasons I discussed earlier. So those are just general thoughts that I think could suggest the rapid and successful launch of CS in 2024.

另一方面，低估支付壁壘的潛在影響絕不是一個好主意。我們知道這一點，我們將努力解決這個問題。正如我之前提到的，有多種理由認為 CS 適應症實際上比鼻息肉適應症更容易開處方，原因我之前已經討論過了。所以這些只是我認為可以建議 CS 在 2024 年快速成功推出的一般想法。

I don't know Paul or Jonathan, if you wish to add anything?

我不認識保羅或喬納森，如果你想補充什麼？

I think that's good -- I think in terms of typical first quarter cadence for 2024, I think each year, we talk a little bit about the start of the year resets on out-of-pocket expenses for patients. I think typically, that results in a lower revenue per prescription in the first quarter as patients meet that out-of-pocket minimum. And there's kind of greater reliance on our co-pay assistance program during that period. I think our expectations at the beginning of next year would be similar to what they are each year in terms of that dynamic.

我認為這很好——我認為就 2024 年第一季度的典型節奏而言，我認為每年我們都會談論一些關於年初重置患者自付費用的問題。我認為通常情況下，這會導致第一季度每張處方的收入降低，因為患者達到了自付費用的最低要求。在此期間，我們更加依賴我們的共同支付援助計劃。我認為我們在明年年初的預期與每年的動態相似。

Our next question comes from Gary Nachman with BMO Capital Markets.

我們的下一個問題來自 BMO Capital Markets 的 Gary Nachman。

So with a lot of the evaluation of the commercial components and strategies that you highlighted that you're doing this year, it sounds like you're taking a close look at everything. So what are the areas where you think you need to have the greatest change and how long it will take to affect those changes? And then with the reduction in territory managers by 15%, where does that put the size of the sales force currently?

因此，通過對您今年所做的強調的商業組件和策略的大量評估，聽起來您正在仔細研究所有內容。那麼，您認為哪些領域需要做出最大的改變，需要多長時間才能影響到這些改變？然後，隨著區域經理人數減少 15%，目前銷售人員的規模會怎樣？

So Gary, I'll start, and then I'll ask Paul if he has any additional comments to add. And thank you, Gary, for your question.

那麼 Gary，我會開始，然後我會問 Paul 他是否有任何其他意見要補充。加里，謝謝你提出的問題。

The first thing I'll address is the last question. The current number of territories that we have deployed is 77. And we think that allows us to cover the sort of most potential, the physicians with the greatest potential from our current universe. Understanding, of course, the product has been on the market for several years, and we have a better sense of physicians who are prescribing today than we had when we initially launched.

我要解決的第一件事是最後一個問題。我們目前部署的地區數量是 77 個。我們認為這使我們能夠涵蓋當前宇宙中最具潛力的醫生。當然，了解該產品已經上市多年，與我們最初推出時相比，我們對今天開處方的醫生有更好的了解。

So with regard to the areas of action, you observed that it sounded to you, I think, like we were acting in every area of commercial. And I'm kind of glad that you reached that conclusion because we sort of opened the full book to reevaluate all aspects of our commercialization. So nothing is off the table for consideration. Having said that the areas that I specifically mentioned as examples are areas where we think a greater focus or attention is likely to produce the greatest potential for a change, the greatest difference during 2023.

所以關於行動領域，你觀察到這聽起來對你來說，我認為，就像我們在商業的每個領域都在行動一樣。我很高興你得出了這個結論，因為我們打開了整本書來重新評估我們商業化的各個方面。所以沒有什麼是可以考慮的。話雖如此，我作為例子特別提到的領域是我們認為更大的關注或註意力可能會產生最大變革潛力的領域，即 2023 年最大的差異。

The time line for the expectation for change varies depending on which of those areas we're talking about. So some of those things, Paul and his team have already acted to look for changes. Some of those things have been subjected to fairly intensive analysis, and we expect action to be following here later during March or during the spring. And the time frame for seeing the difference in the market, again, varies by which of those tactics we're talking about.

預期變化的時間線因我們所討論的領域而異。所以其中一些事情，保羅和他的團隊已經採取行動尋求改變。其中一些事情已經過相當深入的分析，我們預計將在 3 月晚些時候或春季採取行動。同樣，看到市場差異的時間框架因我們所討論的策略而異。

Paul, would you like to add anything?

保羅，你想補充什麼嗎？

Yes, Gary, thank you for the question. So to start the year, there's actually several areas that are receiving particular tension, as Ramy had mentioned. A particular note, we just came from our national sales meeting, where we were focused on several things. One most importantly, was improving the efficiency with which active written XHANCE prescriptions are converted to filled dispense prescriptions that ultimately are going to drive greater revenue. In particular around that, stronger patient positioning and improving the quality and speed of PA submission was a lot of our attention last week as we were together. In addition, the structure and implementation of our co-pay program, the size and management of our pharmacy distribution network and our payer access strategy are all receiving particular tension as well.

是的，加里，謝謝你的提問。所以在今年開始時，實際上有幾個領域正面臨著特別緊張的局面，正如拉米所提到的那樣。特別要注意的是，我們剛剛參加了全國銷售會議，我們在會上專注於幾件事。最重要的是，提高了有效的書面 XHANCE 處方轉換為填充配藥處方的效率，這最終將帶來更大的收入。特別是圍繞這一點，上週我們在一起時，加強患者定位以及提高 PA 提交的質量和速度是我們關注的焦點。此外，我們共同支付計劃的結構和實施、我們的藥房分銷網絡的規模和管理以及我們的付款人准入策略也都受到了特別的壓力。

Yes. No, it did. I mean it sounds like things are going to be evolving over the course of the year. And I'm sure we'll get updates on all these different areas. But when it comes to thinking about the CS launch, do you have any sense of how much of an effort you're going to need behind that at this point? And just Ramy, you talked about some of the discussions you might be having with potential co-promote partners. And what some other sales alternatives might be? You mentioned that in the prepared remarks.

是的。不，確實如此。我的意思是聽起來事情會在這一年中發生變化。我相信我們會得到所有這些不同領域的更新。但是當談到 CS 的發佈時，您是否知道此時您需要付出多少努力？拉米，你談到了你可能與潛在的共同推廣合作夥伴進行的一些討論。還有哪些其他銷售選擇？你在準備好的評論中提到了這一點。

Yes, sure. Gary, and thanks for that question. So we are doing a lot during 2023 to prepare to be able to have a rapid and successful launch as we head into next year with the new indication should we receive that in December. And some of those things require this kind of lead time. So Paul alluded to payer access. Payer access as ramifications not just now, obviously, as ramifications for 2024. And matter fact many of the negotiations happening now are specific to contracts, which will come into force at the beginning of 2024. So there's a lot of things we have to do now to be ready for next year.

是的，當然。加里，謝謝你提出這個問題。因此，我們在 2023 年做了大量工作，以準備在明年 12 月收到新指示時能夠快速成功地啟動。其中一些事情需要這種提前期。所以保羅提到了付款人訪問。顯然，付款人訪問不僅是現在的後果，而且是 2024 年的後果。事實上，現在正在進行的許多談判都是針對合同的，這些合同將於 2024 年初生效。所以我們有很多事情要做現在為明年做準備。

The overall commercial investment, the size and distribution, sort of footprint of our direct selling structure and sort of some of the other major selling efforts, I don't expect that to change substantially in size. It's not so much about having to ramp up the size of it going into '24. It's more about changing the content and the strategy and the manner of execution in order to shift the focus to this newer, more commonly diagnosed easier to see sort of widespread uptake indication. So it's not an issue so much of size as of style or quality of the work that we'll be doing. If that's sort of what you were getting at with regard to the plans for our commercial infrastructure.

整體商業投資、規模和分佈、我們直銷結構的足跡以及其他一些主要的銷售努力，我預計這些規模不會發生重大變化。進入 24 世紀並不是必須增加它的規模。它更多的是改變內容、策略和執行方式，以便將焦點轉移到這種更新的、更常見的診斷更容易看到的廣泛吸收跡像上。因此，這不是我們將要做的工作的大小問題，而是我們將要做的工作的風格或質量問題。如果這就是您對我們的商業基礎設施計劃的看法。

Is that getting up the issue you're asking about, Gary?

這就是你要問的問題嗎，加里？

Yes. No, I mean that's helpful. But as far as potential co-promotes and then you said other types of selling alternatives for chronic sinusitis. And if you're not going to change the size of the footprint, then there's other ways that you'd be able to tap into that larger market, I presume.

是的。不，我的意思是這很有幫助。但就潛在的共同推廣而言，你說了其他類型的慢性鼻竇炎銷售替代品。如果你不打算改變足蹟的大小，那麼我想還有其他方法可以讓你進入更大的市場。

Right. Well, so Gary, here's -- the way we're thinking about this is that there's a substantially increased potential within our current specialty audience. And that's what I was talking about before. But as you said, there's a lot of potential outside of our current specialty audience also. And we have to think creatively about the ways in which our company can realize the benefits of getting the product in the hands of patients who need it in that much larger audience. The most obvious way, and one we would like to see, if possible, of course, is if we're able to engage in some kind of commercial partnership with an organization that has an existing infrastructure that allows promotion into that primary care audience. And we are planning to continue to actively pursue conversations with organizations that have the necessary infrastructure and an interest in a product that creates leverage with that infrastructure. So that would be one way of our organization seeing potential benefit from that.

正確的。好吧，加里，這是——我們考慮這個問題的方式是，我們當前的專業觀眾中的潛力大大增加了。這就是我之前所說的。但正如您所說，在我們當前的專業觀眾之外也有很多潛力。我們必須創造性地思考我們公司可以通過哪些方式實現將產品送到需要它的患者手中的好處，這些患者需要它的人數要多得多。最明顯的方式，當然，如果可能的話，我們希望看到的一種方式是，如果我們能夠與擁有現有基礎設施的組織建立某種商業夥伴關係，從而可以推廣到初級保健受眾。我們計劃繼續積極尋求與擁有必要基礎設施並且對利用該基礎設施創造影響力的產品感興趣的組織進行對話。因此，這將是我們組織從中看到潛在好處的一種方式。

I also alluded to the possibility that there are other ways we might see those benefits. Ways that might not involve having to share value in the same way as we might have to in a primary care partnership. And those ways are a little less certain, but worthy of exploration right now during our lead time up to the new indication. For example, there appear to be emerging models in the marketplace for mechanisms of reaching out directly to patients and sort of using nontraditional promotional mechanisms to engage those patients, get them access to providers able to make an appropriate diagnosis. And if appropriate, prescribe the product for them. And to fill that prescription in ways that include our current pharmacy network or potentially other mechanisms for fulfillment that may increase efficiency and outreach for a broader population that's not sort of within our current specialty universe.

我還提到了我們可以通過其他方式看到這些好處的可能性。可能不需要像我們在初級保健合作夥伴關係中那樣必須分享價值的方法。這些方法不太確定，但值得在我們準備新適應症期間進行探索。例如，市場上似乎出現了直接接觸患者的機制的新興模型，並使用非傳統的促銷機制來吸引這些患者，讓他們接觸到能夠做出適當診斷的提供者。如果合適，為他們開產品。並以包括我們當前的藥房網絡或其他潛在的實現機制的方式來填寫該處方，這些機制可能會提高效率並擴大我們當前專業領域之外的更廣泛人群的範圍。

I don't want to define what that looks like yet. Because, as I said a minute ago, it's something that we are beginning to actively explore, it looks like there are some potential mechanisms by which this may be possible. And I want to be clear that we are not close minded. We are open-minded to a variety of potential mechanisms for getting the hand -- the product in the hands of patients who may need it that are outside of our specialty care -- outside of our specialty care universe.

我不想定義它看起來像什麼。因為，正如我剛才所說，這是我們正在開始積極探索的東西，看起來有一些潛在的機制可以使這成為可能。我想明確一點，我們並非心胸狹隘。我們對各種潛在的機制持開放態度——在我們的專業護理領域之外——將產品交到可能需要它的患者手中，這不在我們的專業護理範圍內。

And then just last one, a little bit more on the net revenue per prescription coming down to $200 from $240 if you guys are going to be focusing more on profitability this year? Is that mostly volume-driven? Or are there different programs that you're factoring into that? And should we expect you if this is just going to be a transition year with the CS indication to get it back up to the levels we saw last year?

然後是最後一個，如果你們今年要更加關注盈利能力，那麼每個處方的淨收入會從 240 美元下降到 200 美元？這主要是數量驅動的嗎？還是您考慮了不同的程序？如果這只是一個過渡年，CS 指示將它恢復到我們去年看到的水平，我們是否應該期待你？

Yes. That's a really good question. And it is a significant decrease in our projected average net revenue per prescription.

是的。這真是個好問題。我們預計每個處方的平均淨收入顯著下降。

Jonathan, would you like to comment on that?

喬納森，你想對此發表評論嗎？

Yes, sure. I mean, Gary, thanks for the question. So the guidance that we put out of approximately $200 for average net revenue per prescription, it incorporates some changes in business mix as well as higher gross to net deductions within lines of business. And I believe that I think in a rising interest rate environment that may lead to customers carrying less inventory at the end of 2023 than they did in 2021-2022. Yes, I think some of where we ended up, I think, in 2022 was the result I think, of some benefits that you wouldn't necessarily plan for at the start of the year.

是的，當然。我的意思是，加里，謝謝你提出這個問題。因此，我們提出的每個處方平均淨收入約為 200 美元的指導，它包含了業務組合的一些變化以及業務線內更高的總扣除額與淨額扣除額。而且我認為，我認為在利率上升的環境下，可能會導致客戶在 2023 年底持有的庫存少於 2021-2022 年。是的，我認為我們在 2022 年取得的某些成果是我認為的一些好處的結果，你不一定會在年初計劃這些好處。

As a reminder, last year, we started out with guidance for the year of approximately $210 per TRx. And so we ended up the year at approximately $224. So I think in terms of looking at business trends around mix of business, also making some choices to contract a little bit further into certain government lines of business, which is driving mix into those lines of business, which are relatively less profitable but still good lines of business that can have halo effect with physicians who also serve commercial patients. Those things are all kind of in the mix for our initial guidance here for an expectation of $200 per TRx.

提醒一下，去年，我們開始時的年度指導約為每 TRx 210 美元。因此，我們在這一年結束時的收入約為 224 美元。因此，我認為在觀察業務組合的業務趨勢方面，還做出一些選擇，進一步收縮某些政府業務線，這正在推動這些業務線的混合，這些業務線的利潤相對較低，但仍然不錯可以對同時為商業患者提供服務的醫生產生光環效應的業務線。這些東西都混合在我們這裡的初始指導中，預計每個 TRx 為 200 美元。

But it sounds like this might be more of the new normal. So even with CS, it will be more in this level? Or could it get back up a little bit, even if not to the $224?

但聽起來這可能更像是一種新常態。所以即使有CS，也會更多在這個級別？還是它可以回升一點，即使不會回升到 224 美元？

Yes. I think -- probably the other thing that I would note is that at the start of the last 2 years, we made some changes to our co-pay assistance program. In 2021, we made a change to the co-pay assistance program that was focused on reducing the number of proportion of prescriptions that were coming from patients who are in commercial plans that did not cover XHANCE.

是的。我認為 - 我可能會注意到的另一件事是，在過去兩年的開始，我們對共同支付援助計劃進行了一些更改。 2021 年，我們對共同支付援助計劃進行了更改，重點是減少來自商業計劃中未涵蓋 XHANCE 的患者的處方數量。

In 2022, we made a change to the co-pay assistance program. Again, kind of intended to reduce the number of proportion of prescriptions, but this time from patients who are in commercial plans with a high deductible, which cover XHANCE. Both of those kind of lines of businesses are relatively less profitable for us or in certain cases, can actually be unprofitable lines of business for us. We haven't made a similar kind of profitability, optimizing change to co-pay assistance at the start of 2023. But that doesn't mean that we can't look at things like that as we move forward.

2022 年，我們對共付額援助計劃進行了更改。同樣，有點旨在減少處方數量的比例，但這一次來自商業計劃中具有高免賠額的患者，其中包括 XHANCE。這兩種業務對我們來說利潤相對較低，或者在某些情況下，實際上對我們來說可能是無利可圖的業務。我們還沒有取得類似的盈利能力，在 2023 年初優化共同支付援助的變化。但這並不意味著我們在前進的過程中不能看待這樣的事情。

Our next question comes from Glen Santangelo with Jefferies.

我們的下一個問題來自 Jefferies 的 Glen Santangelo。

I just wanted to talk about the balance sheet a little bit. I mean you're ending the year with $94 million in cash and sort of based on that new revenue guidance of $68 million versus the outlook for operating expense that you're providing. I mean you kind of gave us enough of the pieces here. But I was wondering if you could just sort of summarize that and give us your expected sort of cash burn in 2023?

我只想談談資產負債表。我的意思是，您將以 9400 萬美元的現金結束這一年，並且基於 6800 萬美元的新收入指導與您提供的運營費用前景相比較。我的意思是你在這裡給了我們足夠多的作品。但我想知道您是否可以總結一下並告訴我們您預計 2023 年的現金消耗情況？

Glen, thank you for the question. I'll turn that one over to Jonathan also.

格倫，謝謝你的提問。我也會把那個交給 Jonathan。

Yes, sure. Thanks, Glen. Yes, I think you kind of hit the nail on the head. I think we've given you enough pieces to maybe put the math together yourself or yourselves. But obviously, we ended the year with $94 million in cash. As you pointed out, we structured our business to reduce use of cash in 2023. Again, while preserving the infrastructure and capability is important to a rapid and successful launch in CS following potential approval. The midpoint of our revenue and operating expense ranges, they imply approximately a $20 million improvement to operating income relative to full year 2022.

是的，當然。謝謝，格倫。是的，我認為你有點一針見血。我認為我們已經為您提供了足夠多的部分，您可以自己或自己組合數學。但很明顯，我們在這一年結束時擁有 9400 萬美元的現金。正如您所指出的，我們在 2023 年調整了業務結構以減少現金使用。同樣，在保留基礎設施和能力的同時，對於在獲得潛在批准後快速成功地啟動 CS 非常重要。我們的收入和運營費用範圍的中點，意味著與 2022 年全年相比，運營收入增加約 2000 萬美元。

And I think the way we're structured this business, we expect that similar improvement to the use of cash. And so then as a note for folks if you don't have the press release open or the 10-K opened later on, our use of cash in 2022 was approximately $67 million.

而且我認為我們構建這項業務的方式，我們希望對現金的使用有類似的改進。因此，如果您沒有打開新聞稿或稍後打開 10-K，請注意，我們在 2022 年使用的現金約為 6700 萬美元。

Right. So correct sort of assuming that burn kind of comes down in the $30 million to $40 million range?

正確的。那麼正確的假設是燒錢在 3000 萬到 4000 萬美元之間？

Yes, I mean, I think the -- kind of the midpoint of the operating expense and revenue view would imply approximately $20 million, if you want to kind of range it out with the high and low end of those things, it's probably somewhere between $15 million and $25 million improvement. I think as an organization, we would try to aim for the higher end of that range, not pair up low case revenues with high case operating expenses. So I think we would strive to be approximately 20%, but maybe a little bit better than 20% within those ranges.

是的，我的意思是，我認為 - 運營費用和收入觀點的中點意味著大約 2000 萬美元，如果你想用這些東西的高端和低端來衡量它，它可能介於兩者之間1500 萬美元和 2500 萬美元的改進。我認為作為一個組織，我們會努力瞄準該範圍的高端，而不是將低案例收入與高案例運營費用配對。所以我認為我們會努力達到大約 20%，但在這些範圍內可能比 20% 好一點。

Jonathan, that's fine. Then just sort of as a follow-up. I did want to talk about sort of where that will leave you, right? I mean I think the company has always been pretty much leaning towards the opportunity to enter into some type of commercial partnership, right, in anticipation of the CS indication. I mean, any thoughts with respect to timing around that? I mean you're sort of laying out a time frame for hopefully a PDUFA in mid-December. I mean, have those conversations started? Do you think we could expect to see something in the second half of the year? Or do you think that's kind of more would come in 2024 post approval?

喬納森，沒關係。然後只是跟進。我確實想談談你會離開哪裡，對吧？我的意思是，我認為該公司一直非常傾向於有機會建立某種類型的商業合作夥伴關係，對吧，期待 CS 指示。我的意思是，關於時間安排有什麼想法嗎？我的意思是您正在為 PDUFA 在 12 月中旬制定一個時間表。我的意思是，這些對話開始了嗎？你認為我們可以期待在今年下半年看到什麼嗎？或者您認為在 2024 年獲得批准後會有更多嗎？

So Glen, I'll comment on that. So it's very difficult in advance of reaching an agreement to say exactly when an agreement might be reached. I can say that we have in the past, and I certainly intend right now during 2023 to engage in a variety of conversations with organizations that may have interest in promoting the product into the large audience that we're not reaching with our own commercial footprint. Whether those organizations will prove to be interested in closing an arrangement prior to the PDUFA date, whether they may be interested in seeing the PDUFA approval before closing an arrangement and what exactly the terms of such an arrangement might be, those are uncertain. I don't know the answer to those questions yet. But with regard to whether we'll be engaged in active conversations during the course of this year, the answer is definitely yes.

那麼格倫，我會對此發表評論。因此，在達成協議之前很難準確說明何時可以達成協議。我可以說我們過去有過，現在我當然打算在 2023 年與可能有興趣將產品推廣到我們自己的商業足跡無法觸及的大量受眾的組織進行各種對話.這些組織是否會證明有興趣在 PDUFA 日期之前結束安排，他們是否有興趣在結束安排之前看到 PDUFA 批准以及此類安排的確切條款可能是什麼，這些都是不確定的。我還不知道這些問題的答案。但關於我們是否會在今年期間進行積極對話，答案是肯定的。

Our next question comes from David Amsellem with Piper Sandler.

我們的下一個問題來自 David Amsellem 和 Piper Sandler。

So I guess I'll just sort of sort of touch to maybe an obvious question, but I think an important one. You're entertaining a co-promote here. I know that's something you talked about going back to the IPO. But just given where things are with the business and given the potential challenges regarding interest in owning a piece of the asset here. Why don't you just entertain a sale of the company? And do you think that may be the better alternative here just given all the moving parts? How do you think about that?

所以我想我可能只是有點觸及一個明顯的問題，但我認為這是一個重要的問題。你在這裡招待共同推廣。我知道這就是你談到的回到 IPO 的事情。但只要考慮到業務的發展情況，以及對擁有這裡資產的興趣的潛在挑戰。你為什麼不考慮出售公司呢？考慮到所有活動部件，您認為這可能是更好的選擇嗎？你怎麼看？

So David, I'll comment on that and then Jonathan I'll invite you to comment if you have anything to add. But for all the reasons that you've described, David, and others, we are evaluating a wide range of strategic options. And I think sales of the company is within the range of options that we're considering. It always has been and it will continue to be. It's certainly not the only possibility we're considering. As I said earlier, we are actively planning to engage in conversations about a primary care promotional partnership and plan to do everything necessary to continue to operate the company independently. But in no way does that preclude the possibility of conversations about M&A type transaction either. So we will continue to entertain all strategic options as we go forward through 2023.

大衛，我將對此發表評論，然後喬納森，如果您有任何要補充的內容，我會邀請您發表評論。但出於您所描述的所有原因，大衛和其他人，我們正在評估廣泛的戰略選擇。而且我認為公司的銷售在我們正在考慮的選擇範圍內。它一直是，並將繼續如此。這當然不是我們正在考慮的唯一可能性。正如我之前所說，我們正積極計劃參與有關初級保健推廣合作夥伴關係的對話，併計劃盡一切必要繼續獨立運營公司。但這也不排除就併購類型交易進行對話的可能性。因此，到 2023 年，我們將繼續考慮所有戰略選擇。

And then as a follow-up, as you look at the launch in CS, you've talked about the potential for greater penetration within your existing prescriber base. So is it fair to say that, that's where at least early on in the rollout, that's where most of your growth is going to come from. And if that is certainly the case, then what is the urgency to entertain a primary care partnership ahead of approval or around the approval?

然後作為後續行動，當您查看 CS 的發佈時，您談到了在現有處方者基礎中實現更大滲透的潛力。因此，可以公平地說，這至少是在推出初期的地方，也是您大部分增長的來源。如果情況確實如此，那麼在批准之前或批准前後建立初級保健合作夥伴關係的緊迫性是什麼？

So David, the the potential for the product, we think, is very substantial within our current sort of commercially contacted our direct selling audience and indirect selling. Our specialty audience has a lot of new potential with the new indication. And we do intend to go after that assertively with our own infrastructure. But that doesn't mean that there's not a lot of additional potential outside of the audience that we're currently calling on. And we really don't have the resources to go after that, certainly not with a traditional direct selling model.

因此，大衛，我們認為，在我們目前與直銷受眾和間接銷售的商業聯繫中，該產品的潛力非常可觀。我們的專業觀眾有很多新適應症的新潛力。我們確實打算用我們自己的基礎設施堅定地追求這一目標。但這並不意味著我們目前正在呼籲的觀眾之外沒有很多額外的潛力。而且我們真的沒有資源去做那件事，當然不是傳統的直銷模式。

So it means that if we are able to reach a primary care partnership starting on Day 1 after the approval, there is potential in a very large audience that we're just not going to be able to efficiently access ourselves. And primary care partnership would give us a vehicle for being able to increase the potential value available to us and increase the number of patients who are able to be treated. So it would be incremental value, very much worth having for a variety of reasons that we'd like to see. But that doesn't mean that we're not going to see substantial incremental value within our current audience.

因此，這意味著如果我們能夠在獲得批准後的第一天就開始建立初級保健合作夥伴關係，那麼我們可能無法有效地接觸到大量的受眾。初級保健合作夥伴關係將為我們提供一種工具，使我們能夠增加我們可用的潛在價值並增加能夠接受治療的患者數量。因此，這將是增量價值，出於我們希望看到的各種原因，非常值得擁有。但這並不意味著我們不會在當前受眾中看到實質性的增量價值。

So I'm not sure though, if I've answered your question, David. Did that address what you asked?

所以我不確定，如果我已經回答了你的問題，大衛。那是否解決了您的問題？

It did. I guess I'm just struggling with the urgency to find a primary care partner. I mean don't you call on a certain basket of high-volume general practitioners already? And if so, how many do you call them?

它做了。我想我只是在為尋找初級保健合作夥伴的緊迫感而苦苦掙扎。我的意思是，你不是已經拜訪了一定數量的高容量全科醫生嗎？如果是這樣，您稱他們為多少？

Yes. No, David, I think it's appropriate for us to have a sense of urgency around finding a primary care partner. And that's not because there's not a lot of potential in our current audience, there is. But the sooner we can get a primary care partner, the sooner we can access an otherwise untapped large potential audience.

是的。不，大衛，我認為我們應該對尋找初級保健合作夥伴有一種緊迫感。這並不是因為我們當前的觀眾沒有太多潛力，而是有。但是我們越早找到初級保健合作夥伴，我們就能越早接觸到大量未開發的潛在受眾。

And while it's true that we do have a small number of, I'll call it, a specialist like primary care physicians in our call non-universe. It's a very small number in comparison to the number of primary care physicians that one might ideally choose to engage if you had a primary care promotional infrastructure. What's our current number right now?

雖然我們確實有少數人，但我稱之為專家，比如我們稱之為非宇宙的初級保健醫生。如果您擁有初級保健宣傳基礎設施，與理想情況下可能選擇聘用的初級保健醫生的數量相比，這是一個非常小的數字。我們現在的電話號碼是多少？

Yes. I mean, David, just for a sense of scale. I think when you think about the number of specialty like primary care physicians and our current call on the universe. We're talking about a number that's a few thousand as opposed to when you look at the broader opportunity in primary care, I think historically. We've looked at -- there's potentially an audience of somewhere around 50,000 physicians who are kind of the higher-value prescribers in the chronic sinusitis space. And so it's just a completely different order of magnitude in terms of the number of physicians that somebody with appropriate infrastructure that would be leverageable that this opportunity could reach if we were to partner with them.

是的。我的意思是，大衛，只是為了規模感。我想當你想到初級保健醫生等專業的數量以及我們目前對宇宙的呼喚時。我們談論的是一個幾千的數字，而不是當你看到初級保健中更廣泛的機會時，我認為從歷史上看。我們已經看過 - 可能有大約 50,000 名醫生的聽眾，他們是慢性鼻竇炎領域價值較高的處方醫生。因此，就醫生的數量而言，如果我們與他們合作，擁有適當基礎設施的人可以利用這個機會可以達到一個完全不同的數量級。

I show no further questions at this time. I would now like to turn the conference back to Ramy for closing remarks.

我現在沒有進一步的問題。我現在想把會議轉回 Ramy 作閉幕詞。

I'd like to thank you all very much for joining us this morning for our review of the full year performance in 2022 and our forward look into what we expect may be coming in 2023. And we look forward to talking to you again in a few months with our first quarter results.

非常感謝大家今天早上加入我們，回顧 2022 年的全年業績，並對 2023 年的預期進行展望。我們期待再次與您交談幾個月我們的第一季度業績。

I hope everyone has a wonderful day.

我希望每個人都有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。