Novan Inc (NOVN) 2022 Q4 法說會逐字稿

Hello, and welcome to the Novan, Inc. Full Year 2022 Update Conference Call and Webcast. (Operator Instructions) Note that this webcast is being recorded at the company's request and that a replay will be available on the company's website following the end of the event.

您好，歡迎來到 Novan, Inc. 2022 年全年更新電話會議和網絡廣播。 （操作員說明）請注意，該網絡廣播是應公司要求錄製的，活動結束後將在公司網站上提供重播。

At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on Novan's current expectations, and actual results could differ materially.

此時，我想提醒我們的聽眾，在本次網絡廣播中發表的言論可能表明管理層的意圖、信念、期望或未來預測。這些是前瞻性陳述，涉及風險和不確定性。本次電話會議的前瞻性陳述是根據聯邦證券法的安全港條款作出的，並基於 Novan 當前的預期，實際結果可能存在重大差異。

As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Novan files with the Securities and Exchange Commission. These documents are available on the Investors section of the company's website on the Securities and Exchange Commission's website. We encourage you to review these documents carefully.

因此，您不應過分依賴任何前瞻性陳述。 Novan 向美國證券交易委員會提交的定期報告中討論了一些可能導致實際結果與此類前瞻性陳述所預期結果存在重大差異的因素。這些文件可在美國證券交易委員會網站上公司網站的投資者部分獲得。我們鼓勵您仔細閱讀這些文件。

Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company's own estimates and research. While the company believes these third-party sources to be reliable as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy or completeness of that or of any independent source that has been verified, any information obtained from any third-party sources.

此外，本網絡廣播中包含的某些信息涉及或基於研究、出版物、調查和從第三方來源獲得的其他數據以及公司自己的估計和研究。雖然公司認為這些第三方來源在本報告發布之日是可靠的，但並未經過獨立驗證，也不對這些來源或任何已驗證的獨立來源的充分性、公平性、準確性或完整性做出任何陳述, 從任何第三方來源獲得的任何信息。

Joining us on today's call from Novan's leadership team are Paula Brown Stafford, Chairman, President and Chief Executive Officer; John A. Donofrio, Executive Vice President and Chief Operating Officer; and John M. Gay, Chief Financial Officer. I would now like to turn the conference over to Paula Brown Stafford, Chairman, President and Chief Executive Officer. Please proceed.

與我們一起參加今天來自 Novan 領導團隊的電話會議的有主席、總裁兼首席執行官寶拉·布朗·斯塔福德 (Paula Brown Stafford)； John A. Donofrio，執行副總裁兼首席運營官；以及首席財務官 John M. Gay。我現在想將會議轉交給主席、總裁兼首席執行官 Paula Brown Stafford。請繼續。

Thank you, operator. Before I begin my formal presentation, I would like to take a moment to recognize 2 important individuals to me and to the full Novan team, both individuals recently passed away. First, Dr. John Palmer, one of our original Board members and shareholders passed away in November; and second, Mr. Bob Ingram, previous chair before myself of the Novan Board, a decade long member and shareholder and an icon in the pharmaceutical industry passed away this past weekend. I ask for just a moment of silence in their memory.

謝謝你，運營商。在我開始正式演講之前，我想花點時間來認識 2 位對我和整個 Novan 團隊很重要的人，他們最近都去世了。首先，John Palmer 博士，我們最初的董事會成員和股東之一於 11 月去世；其次，鮑勃英格拉姆先生，在我之前擔任 Novan 董事會主席，十年之久的成員和股東以及製藥行業的偶像在上週末去世了。我請求在他們的記憶中默哀片刻。

Thank you. And now I would like to thank our stakeholders and analysts for joining our annual earnings webcast and general business update. Novan is building a premier medical dermatology company that is focused on developing and commercializing innovative therapies for diseases of the skin. In January, we submitted our NDA for berdazimer gel 10.3% for the treatment of molluscum contagiosum. Our filing has been accepted for review, and we were provided our PDUFA goal date of January 5, 2024. We are in the review cycle with 9 months remaining. Hence, we anticipate a potential FDA approval in the first quarter of 2024, if not before.

謝謝。現在，我要感謝我們的利益相關者和分析師參加我們的年度收益網絡廣播和一般業務更新。 Novan 正在打造一家一流的醫學皮膚病學公司，專注於開發和商業化針對皮膚疾病的創新療法。一月份，我們提交了用於治療傳染性軟疣的 berdazimer 凝膠 10.3% 的 NDA。我們的申請已被接受審查，我們的 PDUFA 目標日期為 2024 年 1 月 5 日。我們處於審查週期，還剩 9 個月。因此，我們預計 FDA 可能會在 2024 年第一季度獲得批准，甚至更早。

Importantly, we could be the first FDA-approved prescription treatment solution for molluscum. Over the course of 2022 and in the first quarter of 2023, we have achieved a number of noteworthy accomplishments. We remain excited about our progress, our momentum and what lies ahead. Our NDA was filed and accepted for review with no known potential issues.

重要的是，我們可能成為第一個 FDA 批准的軟體動物處方治療方案。在 2022 年和 2023 年第一季度，我們取得了一些值得注意的成就。我們仍然對我們的進步、勢頭和未來感到興奮。我們的 NDA 已提交並接受審查，沒有已知的潛在問題。

This followed our submission in January, which followed the completion of our CMC and analytical testing, which we had shared with you, which was required for submission. Prior to that, in July, the results from our pivotal Phase III trial were published in JAMA Dermatology. And to start 2022, we acquired EPI Health, which had marketed products and a commercial capability to launch berdazimer gel 10.3%, if approved. We firmly believe that Novan remains a compelling investment opportunity.

這是在我們於 1 月份提交之後，在完成我們與您分享的 CMC 和分析測試之後，這是提交所必需的。在此之前，7 月，我們關鍵的 III 期試驗結果發表在《美國醫學會皮膚病學雜誌》(JAMA Dermatology) 上。從 2022 年開始，我們收購了 EPI Health，如果獲得批准，該公司擁有上市產品和推出 10.3% berdazimer 凝膠的商業能力。我們堅信 Novan 仍然是一個引人注目的投資機會。

So speaking of berdazimer, bedazimer sodium, our active pharmaceutical ingredient is a new chemical entity. And berdazimer gel 10.3% is a novel topical nitric oxide releasing medication for viral skin infections. Our NDA is based on a Phase III program that demonstrated clinical evidence of efficacy and a favorable safety profile.

所以說到貝達齊默，貝達齊默鈉，我們的活性藥物成分是一種新的化學實體。 berdazimer 凝膠 10.3% 是一種用於病毒性皮膚感染的新型外用一氧化氮釋放藥物。我們的 NDA 基於 III 期計劃，該計劃證明了療效的臨床證據和良好的安全性。

As I mentioned, clinical trial data from the B-SIMPLE4 trial were published in 2022 in JAMA Dermatology. And if approved, this product would satisfy an important patient care need, largely displacing in-office procedures that are often cumbersome, painful and time consuming.

正如我所提到的，B-SIMPLE4 試驗的臨床試驗數據已於 2022 年在 JAMA Dermatology 上發表。如果獲得批准，該產品將滿足重要的患者護理需求，在很大程度上取代通常繁瑣、痛苦和耗時的辦公室程序。

Molluscum contagiosum has no standard treatment of care today. More than 70% of molluscum patients go untreated. The market is prime for a topical self-administered or caregiver administered therapy. The market potential is large with 6 million patients in the U.S. today and approximately 1 million new patients annually. Approximately 90% of pediatricians have a wait-and-see approach.

傳染性軟疣目前還沒有標準的治療方法。超過 70% 的軟疣患者未得到治療。局部自我管理或護理人員管理療法的市場是主要的。市場潛力巨大，目前美國有 600 萬患者，每年約有 100 萬新患者。大約 90% 的兒科醫生持觀望態度。

We believe the lack of at-home options results in many undiagnosed cases. Berdazimer gel 10.3% has the potential to become a first-line therapy for molluscum. Dermatologists and communities will lead the way, and we expect pediatricians to follow. As I mentioned, there are no FDA approved treatments today. Our NDA is in the review cycle, and we are expecting the review to be complete by the goal date of January 5, 2024, again, just 9 months away. As we respond to FDA information requests, we are also investing in a successful launch in 2024. Specifically, we are planning to build awareness and excitement for our potential product among our customers, and our employees to educate health care providers about the disease and the treatment options, to deliver the best possible access program.

我們認為，缺乏在家就診的選擇會導致許多未確診的病例。 Berdazimer 凝膠 10.3% 有潛力成為治療軟疣的一線藥物。皮膚科醫生和社區將引領潮流，我們希望兒科醫生能夠效仿。正如我所提到的，目前還沒有 FDA 批准的治療方法。我們的 NDA 正處於審查週期，我們預計審查將在 2024 年 1 月 5 日這一目標日期之前完成，同樣只有 9 個月的時間。在我們響應 FDA 信息請求的同時，我們還投資於 2024 年的成功發布。具體來說，我們計劃在我們的客戶和我們的員工中建立對我們潛在產品的認識和興奮，以教育醫療保健提供者有關疾病和治療選擇，以提供最佳的訪問程序。

Based on our market research, we expect favorable access with payers. To prepare our existing commercial organization, and to protect our proprietary platform technology with patents, both nationally and globally. We are committed to the medical dermatology community with our diverse portfolio of promoted products and with strong development pipeline.

根據我們的市場研究，我們預計付款人會獲得有利的准入。準備我們現有的商業組織，並在國內和全球範圍內通過專利保護我們的專有平台技術。我們致力於為醫學皮膚科社區提供多樣化的推廣產品組合和強大的開發渠道。

Our commercial unit is built to expand disease states within the medical dermatology areas such as molluscum, and to other specialty areas such as pediatrics. I'll now hand the call over to our Chief Operating Officer, John Donofrio, to provide an update on the successes of our commercial unit in 2022. John?

我們的商業部門旨在將疾病狀態擴展到醫學皮膚病學領域（如軟疣）和其他專業領域（如兒科）。我現在將電話轉給我們的首席運營官 John Donofrio，以提供我們商業部門在 2022 年取得成功的最新情況。約翰？

Thank you, Paula, and good morning, everyone. Our commercial organization provides an established foundation for the potential berdazimer launch with an ideal complement to our R&D and manufacturing expertise. Our commercial capabilities include an integration -- integrated platform with supply chain, patient access and distribution with the sales and marketing team ready to scale for the future.

謝謝寶拉，大家早上好。我們的商業組織為潛在的 berdazimer 上市奠定了堅實的基礎，並完美補充了我們的研發和製造專業知識。我們的商業能力包括一個集成——與供應鏈、患者訪問和分配的集成平台，銷售和營銷團隊準備為未來擴展。

We start with supply chain management of our third-party suppliers, along with an optimized demand management process and distribution capabilities to both wholesalers and direct network pharmacies. Our market access strategy focuses on favorable insurance coverage volume, complemented with patient affordability programs to ensure patients have affordable access to our medications. Our dedicated marketing team has significant experience in dermatology with demonstrated success with brand and disease state messaging and education.

我們從第三方供應商的供應鏈管理開始，以及優化的需求管理流程和對批發商和直接網絡藥店的分銷能力。我們的市場准入戰略側重於有利的保險覆蓋範圍，輔之以患者負擔能力計劃，以確保患者能夠負擔得起我們的藥物。我們敬業的營銷團隊在皮膚病學方面擁有豐富的經驗，並在品牌和疾病狀態信息傳遞和教育方面取得了成功。

Our team has extensive launch experience across numerous therapeutic areas, both in competitive selling and medical education, providing a solid foundation for our potential future launches. We have also built strong professional relations engagement with our health care practitioners and key opinion leaders across the country.

我們的團隊在眾多治療領域擁有豐富的上市經驗，包括競爭性銷售和醫學教育，為我們未來的潛在上市奠定了堅實的基礎。我們還與全國各地的醫療保健從業者和主要意見領袖建立了牢固的專業關係。

Our sales organization consists of 4 regions and 42 territories with the ability to reach more than 4,000 health care practitioners across the country. We're extremely excited to prepare for the potential launch berdazimer gel 10.3%. While we're excited about the future, let's review our promoted product growth in 2022.

我們的銷售組織由 4 個地區和 42 個地區組成，能夠覆蓋全國 4,000 多名醫療保健從業者。我們非常高興能夠為潛在的 berdazimer 凝膠 10.3% 上市做準備。在我們對未來感到興奮的同時，讓我們回顧一下我們在 2022 年推廣的產品增長情況。

I'm pleased to report that our promoted products delivered strong double-digit prescription growth for the full calendar year. All 3 brands exceeded targets established at acquisition and each outperformed the growth in their respective markets. We are also pleased to see similar strong double-digit prescription growth for the fourth quarter, demonstrating our continued focus on execution of our commercial plans, strong prescriber base and solid promoted product portfolio.

我很高興地報告，我們推廣的產品在整個日曆年實現了強勁的兩位數處方增長。所有 3 個品牌都超過了收購時設定的目標，並且每個品牌都超過了各自市場的增長。我們也很高興看到第四季度類似的強勁兩位數處方藥增長，表明我們繼續專注於執行我們的商業計劃、強大的處方藥基礎和穩固的推廣產品組合。

I will now provide additional highlights in each of our promoted products. Rhofade is the #1 prescribed treatment for persistent facial erythema, PFE or facial redness, owning approximately 90% of the market. Our growth strategy is to continue the expansion of the PFE market, increase the number of rosacea patients treated for redness. Q4 prescription volume of 40,791 prescriptions was just shy of an all-time high set in Q2 and total prescriptions for December exceeded 15,000, the highest-ever monthly total for the brand.

我現在將在我們的每個促銷產品中提供更多亮點。 Rhofade 是治療持續性面部紅斑、PFE 或面部發紅的首選藥物，佔據了大約 90% 的市場份額。我們的增長戰略是繼續擴大 PFE 市場，增加因發紅而接受治療的酒渣鼻患者的數量。第 4 季度的處方量為 40,791 張，略低於第 2 季度創下的歷史新高，12 月份的處方總數超過 15,000 張，是該品牌有史以來最高的月度總數。

We're also extremely excited about the opportunities outside the U.S. for Rhofade starting in Japan with strong potential to expand in other markets. As we complete our first full year on the market with Wynzora, we have established a strong psoriasis prescribers. We have a partnership in collaboration with MC2 Therapeutics for the sales and marketing of Wynzora in the U.S. for plaque psoriasis.

我們也對 Rhofade 從日本開始在美國以外的機會感到非常興奮，並具有在其他市場擴張的強大潛力。當我們完成 Wynzora 在市場上的第一個完整年度時，我們已經建立了強大的銀屑病處方。我們與 MC2 Therapeutics 合作，在美國銷售和營銷 Wynzora 治療斑塊狀銀屑病。

As we covered in our previous calls, new competitor launched in Q3 have challenged the use of topical steroids for psoriasis. You can see the impact on reduction of total prescriptions from Q2 and we have primarily remained flat for the second half of the year. However, despite the strong competition, Wynzora managed to finish Q4 with no loss in market share within the topical psoriasis market. And today, Wynzora outperforms all competitors on average number of total prescriptions provider or productivity. We are confident in the continued use of topical steroids for the treatment of plaque psoriasis going forward and the benefits that Wynzora brings to patients who need and desire quick relief. Our growth strategy continues to focus on increasing brand awareness and they can't continue expansion of our rider base.

正如我們在之前的電話會議中所述，第三季度推出的新競爭對手挑戰了使用局部類固醇治療牛皮癬。您可以看到第二季度對處方藥總量減少的影響，我們在下半年基本持平。然而，儘管競爭激烈，Wynzora 仍成功完成了第四季度，在外用銀屑病市場中的市場份額沒有損失。而今天，Wynzora 在總處方供應商平均數量或生產力方面優於所有競爭對手。我們對未來繼續使用局部類固醇治療斑塊狀銀屑病以及 Wynzora 為需要和希望快速緩解的患者帶來的好處充滿信心。我們的增長戰略繼續專注於提高品牌知名度，他們無法繼續擴大我們的騎手基礎。

Minolira is an oral minocycline for the treatment of acne, offering weight-based flexible dosing for patients with the first-ever biphasic delivery system. We've seen significant growth in prescriptions since increasing our promotional efforts on the brand this year. We delivered our largest growth in Minolira prescriptions during the third quarter and are extremely pleased with the 68% growth in Q4 versus last year.

Minolira 是一種用於治療痤瘡的口服米諾環素，採用有史以來第一個雙相給藥系統，可為患者提供基於體重的靈活劑量。自今年加大對該品牌的促銷力度以來，我們看到處方藥的數量有了顯著增長。我們在第三季度實現了 Minolira 處方藥的最大增長，並對第四季度與去年相比增長 68% 感到非常滿意。

The reduction in Q3 all-time high was part due to seasonality and competitive supply challenges in Q3. Minolira strong growth in 2022 was a highlight in the overall market that declined 10% throughout the year. Overall, we're extremely pleased with the performance and continued prescription growth of our promoted brands. Thank you, and I'll now hand it over to John Gay, our Chief Financial Officer.

第三季度歷史高位的下降部分是由於第三季度的季節性和競爭性供應挑戰。 Minolira 在 2022 年的強勁增長是整個市場的一個亮點，全年下降了 10%。總的來說，我們對我們推廣品牌的表現和處方藥的持續增長感到非常滿意。謝謝，我現在將其交給我們的首席財務官 John Gay。

Thank you, John. Our December 31, 2022 year-end represents our first fiscal year in which we have fully consolidated results from our commercial business. I'll remind you that when I refer to year-to-date figures, this represents 295 days of activity based upon our March 11 acquisition.

謝謝你，約翰。 2022 年 12 月 31 日的年終是我們全面整合商業業務業績的第一個財政年度。我會提醒你，當我提到年初至今的數字時，這代表了基於我們 3 月 11 日收購的 295 天的活動。

I would like to let our listeners know that we are not yet in a position to provide guidance as it relates to Q1 and full year 2023 revenues or EBITDA. As of December 31, our year-to-date commercial business reported total revenues of $21 million. Net product sales included in our commercial businesses total revenue was $11.5 million for Rhofade, $1.6 million for Wynzora and $1.6 million for Minolira with other products in our portfolio contributing $1.1 million year-to-date.

我想讓我們的聽眾知道，我們還無法提供與第一季度和 2023 年全年收入或 EBITDA 相關的指導。截至 12 月 31 日，我們年初至今的商業業務報告的總收入為 2100 萬美元。我們的商業業務總收入中包含的淨產品銷售額為 Rhofade 1150 萬美元，Wynzora 160 萬美元，Minolira 160 萬美元，我們產品組合中的其他產品今年迄今貢獻了 110 萬美元。

In addition, our commercial business also reported licensing and collaboration revenue of $5.2 million, comprised primarily of the $5 million out-license agreement for Rhofade signed in December of 2022 for the Japanese territory with Sato Pharmaceuticals.

此外，我們的商業業務還報告了 520 萬美元的許可和合作收入，主要包括 2022 年 12 月與 Sato Pharmaceuticals 就日本領土簽署的 500 萬美元 Rhofade 的許可外協議。

For our broader product portfolio, Rhofade prescriptions have continued to grow with a year-over-year increase of 33%. We continue to see market opportunity for improvement in Wynzora, which John mentioned, launched in Q3 of 2021. In addition, Minolira prescriptions have continued to grow with a year-over-year increase of 61%.

對於我們更廣泛的產品組合，Rhofade 處方藥繼續增長，同比增長 33%。我們繼續看到 John 提到的 Wynzora 於 2021 年第三季度推出的市場改進機會。此外，Minolira 的處方量繼續增長，同比增長 61%。

As of December 31, 2022, our year-to-date R&D business reported total revenues of $2.7 million. This amount related to the Sato agreement related to the Japanese territory out-license on 2 of our product candidates, including berdazimer gel 10.3%.

截至 2022 年 12 月 31 日，我們年初至今的研發業務總收入為 270 萬美元。該數額與日本領土有關的 Sato 協議對我們的 2 個候選產品進行許可，包括 10.3% 的 berdazimer 凝膠。

I will now provide a bit more detail on our fiscal year 2022 financial results, which expands on the information filed this morning with our earnings release and in our annual report on Form 10-K. Total cost of goods sold was $7.4 million for the year ended 2022. Cost of goods sold includes the cost of procuring finished goods from our third-party manufacturers sales-based royalty and milestone expenses and other third-party IP licensing costs.

我現在將提供更多關於我們 2022 財年財務業績的詳細信息，這些業績擴展了今天上午隨我們的收益發布和我們的 10-K 表格年度報告提交的信息。截至 2022 年止年度，已售商品總成本為 740 萬美元。已售商品成本包括從我們的第三方製造商採購成品的基於銷售的特許權使用費和里程碑費用以及其他第三方 IP 許可成本。

For the year ended December 31, 2022, we recognized net product revenue related royalty expense of $4 million within cost of goods sold. This amount included our current obligations to third parties in addition to amounts related to the accounting presentation for the MC2 license agreement of $1.4 million. In addition, $1.25 million was included in cost of goods sold as part of the Sato Rhofade license and collaboration upfront payment for the Japanese out-license agreement due to a third party.

截至 2022 年 12 月 31 日止年度，我們在銷貨成本中確認了 400 萬美元的淨產品收入相關特許權使用費。該金額包括我們目前對第三方的義務，以及與 MC2 許可協議的 140 萬美元會計報表相關的金額。此外，125 萬美元計入作為 Sato Rhofade 許可的一部分的商品銷售成本和應付給第三方的日本對外許可協議的合作預付款。

Our R&D business incurred research and development expenses of $16 million for the year ended December 31, 2022, compared to $20.4 million in the prior year. The decrease of $4.6 million was primarily driven by decreased clinical costs associated to the timing of the B-SIMPLE4 trial totaling $7.7 million, offset by an increase of $3.1 million of costs related to regulatory activities, stability testing, CMC and material costs to support our berdazimer gel 10.3% NDA filing.

截至 2022 年 12 月 31 日止年度，我們的研發業務產生了 1600 萬美元的研發費用，而上一年為 2040 萬美元。減少 460 萬美元的主要原因是與 B-SIMPLE4 試驗時間相關的臨床成本減少，總計 770 萬美元，被與監管活動、穩定性測試、CMC 和支持我們的材料成本相關的成本增加 310 萬美元所抵消berdazimer 凝膠 10.3% NDA 備案。

On a consolidated basis, SG&A expenses were $34.1 million for the year ended December 31, 2022, and compared to $12.3 million for the prior year. The increase of $21.8 million was primarily due to $13.7 million of selling, general and administrative expenses and courage to support the conduct of our commercial operations acquired during the year, $4.7 million of transaction-related expenditures related to the EPI Health acquisition, $1.1 million on investment costs related to the SB206 prelaunch strategy and commercial preparation and $2.3 million of facility and depreciation, personnel and other general and administrative costs.

在綜合基礎上，截至 2022 年 12 月 31 日止年度的 SG&A 費用為 3410 萬美元，而上一年為 1230 萬美元。增加 2,180 萬美元主要是由於 1,370 萬美元的銷售、一般和行政費用以及支持我們年內收購的商業運營的勇氣，470 萬美元與 EPI Health 收購相關的交易相關支出，110 萬美元與 SB206 發射前戰略和商業準備相關的投資成本，以及 230 萬美元的設施和折舊、人員及其他一般和行政成本。

For the year ended December 31, 2022, we also had net $2.9 million of other income, which is composed of a $4.3 million gain on debt extinguishment related to the promissory note issued in March of 2022 in connection with the EPI Health acquisition, partially offset by $1.4 million of interest expense incurred prior to the settlement of that promissory note in July of 2022.

截至 2022 年 12 月 31 日止年度，我們還有 290 萬美元的其他收入淨額，其中包括與 2022 年 3 月發行的與 EPI Health 收購有關的期票相關的 430 萬美元債務清償收益，部分抵消在 2022 年 7 月結算該期票之前發生的 140 萬美元利息費用。

On a consolidated basis, total revenue was $23.7 million for the year ended 2022 compared to $3 million for the prior year. Consolidated net loss was $31.3 million for the year ended 2022 compared to $29.7 million for the prior year. Our commercial business net loss for the year ended 2022 was $1.8 million, and our R&D business net loss for the year was $29.5 million.

在綜合基礎上，截至 2022 年的年度總收入為 2370 萬美元，而上一年為 300 萬美元。截至 2022 年的綜合淨虧損為 3130 萬美元，而上一年為 2970 萬美元。我們截至 2022 年的商業業務淨虧損為 180 萬美元，我們的研發業務淨虧損為 2950 萬美元。

As it relates to our balance sheet, as of the end of the year, we had a total cash balance of $12.3 million and accounts receivable totaling $22 million. Since December 31, 2022, we closed a registered direct offering for gross proceeds of $6 million, we received the Sato upfront payment of $5 million related to the Rhofade out-license agreement and we have continued to use our $15 million accounts receivable-backed factoring facility executed in December of 2022, which provides working capital in an amount that is up to 70% of our commercial businesses gross eligible receivables.

就我們的資產負債表而言，截至年底，我們的現金餘額總額為 1230 萬美元，應收賬款總額為 2200 萬美元。自 2022 年 12 月 31 日以來，我們完成了 600 萬美元總收益的註冊直接發售，我們收到了與 Rhofade 對外許可協議相關的 Sato 預付款 500 萬美元，我們繼續使用 1500 萬美元的應收賬款支持保理於 2022 年 12 月執行的貸款，提供的營運資金高達我們商業業務合格應收賬款總額的 70%。

We will need additional funding to support our planned and future operating activities in our berdazimer gel 10.3% product candidate and our business in general. We believe that our cash balance as of December 31, 2022, plus expected receipts associated with product sales from our commercial product portfolio, and the proceeds of the March 2023 registered direct offering will provide us with adequate liquidity to fund our planned operating needs into the latter part of the second quarter of this year.

我們將需要額外的資金來支持我們在 berdazimer 凝膠 10.3% 候選產品和我們的總體業務中計劃和未來的運營活動。我們認為，我們截至 2022 年 12 月 31 日的現金餘額，加上與我們商業產品組合的產品銷售相關的預期收入，以及 2023 年 3 月註冊直接發售的收益，將為我們提供足夠的流動資金，為我們的計劃運營需求提供資金今年第二季度下半年。

Variability in our operating forecast was driven primarily by commercial product sales, timing of operating expenditures and unanticipated changes in net working capital may impact our cash runway. We are tirelessly working to obtain the additional funds necessary to get to a potential approval and launch of a berdazimer gel 10.3% that approved including evaluating potential strategic opportunities, while at the same time, conserving cash by delaying or deferring certain expenditures.

我們經營預測的變化主要是由商業產品銷售、經營支出的時間安排和淨營運資金的意外變化可能影響我們的現金跑道所驅動的。我們正在不懈地努力獲得必要的額外資金，以獲得潛在的批准和推出 10.3% 的 berdazimer 凝膠，包括評估潛在的戰略機會，同時通過延遲或推遲某些支出來節省現金。

We have been pursuing and will continue to pursue additional capital through a broad range of financing strategies and other strategic alternatives. Other potential funding activities may include equity financings convertible debt or capital from other sources or traditional debt financing. With that, I will turn it back to Paula.

我們一直並將繼續通過廣泛的融資戰略和其他戰略選擇尋求額外資本。其他潛在的融資活動可能包括股權融資、可轉換債務或其他來源的資本或傳統債務融資。有了這個，我會把它轉回寶拉。

Thank you, John Gay, and thank you, John Donofrio. Listeners, you've heard an update regarding our lead asset berdazimer gel 10.3%. Our commercial operations and our financial update and status. Novan is in a solid position to succeed with a potential approval and the infrastructure to support a launch. We are therefore focused on driving towards the potential approval of berdazimer gel. On aligning our commercial infrastructure to support a potential launch on continued growth of our marketed products, Rhofade, Wynzora and Minolira; and on pursuing additional ex-U.S. out-licensing opportunities. So in closing, we at Novan remain focused and excited for our future. Thank you. And operator, you may now open the line for questions.

謝謝你，John Gay，也謝謝你，John Donofrio。聽眾們，您已經聽說了有關我們的主要資產 berdazimer 凝膠 10.3% 的最新消息。我們的商業運營以及我們的財務更新和狀態。 Novan 憑藉潛在的批准和支持發射的基礎設施，處於成功的堅實位置。因此，我們專注於推動 berdazimer 凝膠的潛在批准。調整我們的商業基礎設施以支持我們上市產品 Rhofade、Wynzora 和 Minolira 持續增長的潛在發布；並尋求更多的前美國對外許可的機會。因此，最後，我們在 Novan 對我們的未來保持專注和興奮。謝謝。接線員，您現在可以打開問題熱線。

(Operator Instructions) And the first question comes from Jonathan Aschoff with ROTH.

（操作員說明）第一個問題來自 ROTH 的 Jonathan Aschoff。

Congrats on the increasing sales. You guys have definitely talked about some of the special items that have led to, I guess, like a 74% COGS for the fourth quarter. But what can you say about gross-to-net for 2023? And also should R&D drop substantially in that year -- I mean, in this year versus last year?

祝賀銷量增加。你們肯定談到了一些特殊項目，我猜，比如第四季度 74% 的銷貨成本。但是，對於 2023 年的毛收入比，您有什麼看法？研發在那一年也應該大幅下降——我的意思是，今年與去年相比？

Yes. Thanks, Jonathan. This is John Gay. Thanks for the question. So to your point, make sure I touch on all of them COGS, you're correct. There is some atypical activity for the current quarter as it relates to the Sato agreement. As it relates to your question on gross-to-net, I'll give a little bit of background, as you know, but I think it might be helpful. The components of gross-to-net or GTN deductions is going to be categorized in 2 parts. First, the actual activity based upon the number of prescriptions filled for our patients in a given period. And second, estimates used to project future activity for prescriptions not yet filled for patients. That's the channel inventory wholesalers or for our pharmacy direct customers. But both components, both those GTN components, consider them as -- if you think about the most significant line items to those deductions, is comprised of payer rebates, copay coupons and reserves or products. Each period, we update our gross-to-net deductions for both parts, both the actual and the estimated. The actual activity can vary based upon the numbers and method of how prescriptions are effectively filled by our customers. For example, what an insurance program, they're covered, Bob, what health care plan they're on and which PBM is utilized. In addition, the mix of coverage of PBM versus coupon will vary by the underlying patients. So this product mix and changes period-over-period will impact the actual GTN deduction and may move up or down over time. .

是的。謝謝，喬納森。這是約翰·蓋伊。謝謝你的問題。因此，就您的觀點而言，請確保我觸及所有 COGS，您是對的。本季度有一些與佐藤協議有關的非典型活動。由於它與您關於淨額的問題有關，如您所知，我將提供一些背景知識，但我認為這可能會有所幫助。總淨額或 GTN 扣除額的組成部分將分為兩部分。首先，實際活動基於給定時期內為我們的患者開出的處方數量。其次，估計用於預測尚未為患者配藥的處方的未來活動。那是渠道庫存批發商或我們的藥房直接客戶。但是，這兩個組件，這兩個 GTN 組件，都將它們視為——如果你考慮這些扣除中最重要的項目，包括付款人回扣、共同支付優惠券和儲備金或產品。每個時期，我們都會更新實際和估計兩部分的總扣除額與淨額扣除額。實際活動可能會根據客戶有效配藥的數量和方法而有所不同。例如，什麼保險計劃，他們承保，Bob，他們參加什麼醫療保健計劃以及使用哪種 PBM。此外，PBM 與優惠券的覆蓋範圍組合將因潛在患者而異。因此，這種產品組合和周期性變化將影響實際的 GTN 扣除額，並可能隨著時間的推移而上升或下降。 .

The estimated activity was that part of the gross-to-net can also vary based on how we utilize historical trends, paired with assumptions to project future deductions based on channel inventory, open lots and other factors. So during the fourth quarter, you're right, we saw TRx increase for certain products for Rhofade, for example, but we also saw a decline in the period-over-period gross margin for that. This was based upon the gross-to-net deductions based on actual activity. As it relates to the payers and coupon mix and our estimates, which is based upon historical trends and year-end accounting adjustments. So both the commercial and finance teams are working closely with our partners to work towards optimizing both the payer and coupon mix, if you will, and we'll continue to focus on improvements in the near term. John Donofrio, would you have any thoughts on that?

估計的活動是毛對淨額的一部分也可能因我們如何利用歷史趨勢而有所不同，並結合基於渠道庫存、未清倉和其他因素的假設來預測未來的扣除額。因此，在第四季度，你是對的，例如，我們看到 Rhofade 的某些產品的 TRx 有所增加，但我們也看到該產品的同期毛利率有所下降。這是基於基於實際活動的毛淨扣除額。因為它涉及付款人和息票組合以及我們的估計，這是基於歷史趨勢和年終會計調整。因此，商業和財務團隊都在與我們的合作夥伴密切合作，努力優化付款人和優惠券的組合，如果你願意的話，我們將在短期內繼續關注改進。 John Donofrio，你對此有什麼想法嗎？

Yes. Great. Thanks, John. Jonathan, thanks for the question, too. I think as you know, probably the industry issue across the board with some challenges. And we have seen some increased rebates and some challenges at the pharmacy. But we've already started to implement in 2023, a better partnership with the PBMs to ensure that the coverage that we have acquired is actually pulled through at the pharmacy level. We've also looked at a co-pay card redesign to ensure the business rules that we set in place to make sure there's access, but also profitability on our scripts and implement it. And we're also looking to implement a e-hub service to help facilitate the scripts and ensure that our scripts go through to follow the coverage that we've won and earned, as we focus on 2023. So I think there's some critical operational programs that have already been started. or that will be implemented in Q2 to ensure you see that kind of being just a bump for Q4 versus an ongoing trend.

是的。偉大的。謝謝，約翰。喬納森，也感謝你提出這個問題。我認為，如您所知，行業問題可能會面臨一些挑戰。我們在藥房看到了一些回扣的增加和一些挑戰。但我們已經在 2023 年開始實施，與 PBM 建立更好的合作夥伴關係，以確保我們獲得的覆蓋範圍實際上在藥房層面得以實現。我們還研究了共同支付卡的重新設計，以確保我們設置的業務規則已到位，以確保可以訪問，但也可以在我們的腳本上實現盈利並實施它。我們還希望實施電子中心服務，以幫助簡化腳本並確保我們的腳本通過以遵循我們已經贏得和贏得的覆蓋範圍，因為我們專注於 2023 年。所以我認為有一些關鍵的運營已經啟動的程序。或者將在第二季度實施，以確保您看到第四季度與持續趨勢相比只是一個顛簸。

Okay. And the second part of that -- the second part of that question was the R&D drop. Should that be substantial this year versus 2022?

好的。第二部分——這個問題的第二部分是研發下降。與 2022 年相比，今年應該是可觀的嗎？

Yes. So obviously, with the reduction of the clinical trial. So it will -- we ended up the year down as it relates to prior periods, clearly, because of the cost nature of the clinical trials. But we will continue to have R&D expense as it relates to the activities associated with the regulatory process, right? So as we continue to move toward the PDUFA goal date at January of next year, we will continue to have R&D costs associated with that or what cost that will be categorized as R&D. Because, obviously, prior to approval, those -- the nature of those expenditures will be categorized as R&D. I think it's fair to say that we will continue to have a relatively consistent R&D spend as we move toward the regulatory approval process.

是的。很明顯，隨著臨床試驗的減少。所以它會 - 我們結束了這一年，因為它與前期相關，顯然，由於臨床試驗的成本性質。但是我們將繼續有研發費用，因為它與監管過程相關的活動有關，對嗎？因此，隨著我們繼續朝著明年 1 月的 PDUFA 目標日期邁進，我們將繼續有與之相關的研發成本或將被歸類為研發的成本。因為，很明顯，在批准之前，那些 - 這些支出的性質將被歸類為研發。我認為可以公平地說，隨著我們走向監管審批程序，我們將繼續保持相對穩定的研發支出。

Okay. Does the year-end '22 cash of $12.3 million include the $5 million that was booked in the fourth quarter? Or does it not include that?

好的。 22 年末的 1230 萬美元現金是否包括第四季度登記的 500 萬美元？或者它不包括那個？

It is not included, Jonathan. We had it as an account receivable, but we did collect that in January.

它不包括在內，喬納森。我們把它作為應收賬款，但我們確實在一月份收回了它。

And how much of it is paid out to a third party?

其中有多少是支付給第三方的？

1 point...

1分...

$25 million.

2500 萬美元。

25%.

25%。

Okay. And how much of the $15 million facility has been used?

好的。 1500 萬美元的設施中有多少已經使用？

So at the end of the year, we had $10.3 million as it relates to what had gone through as of the balance sheet date. But you can see in our statement of cash flows, we had almost $20 million of usage, it's $18 million or so in the fourth quarter.

所以在今年年底，我們有 1030 萬美元，因為它與截至資產負債表日所發生的事情有關。但是你可以在我們的現金流量表中看到，我們使用了近 2000 萬美元，第四季度約為 1800 萬美元。

Okay. But there's no subsequent events footnote in the 10-K about usage subsequent to the fourth quarter end?

好的。但是 10-K 中沒有關於第四季度結束後使用情況的後續事件腳註嗎？

Well, that's correct. We continue to utilize it at our discretionary, but that's correct. So I think it's fair to say that just the nature of commercial business, and the nature of our payables and accounts receivable cycles and timing with our customers and vendors. It's advantageous to have a working capital on. So we do continue to utilize it, and it's all again subject to our gross sales and activity from a TRx perspective.

嗯，這是正確的。我們繼續酌情使用它，但這是正確的。所以我認為可以公平地說，商業業務的性質，我們的應付賬款和應收賬款週期的性質以及與我們的客戶和供應商的時間安排。有營運資金是有利的。所以我們確實繼續使用它，從 TRx 的角度來看，這一切都再次取決於我們的總銷售額和活動。

Next question comes from Oren Livnat with H.C. Wainwright.

下一個問題來自 Oren Livnat 和 H.C.溫賴特。

I was hoping to talk bigger picture as you look forward to the SB206 potential approval in January. Can you just talk about what you're able to do with the EPI business in place in terms of, I guess, priming the pump, so to speak, as like you said, are only theoretically 9 months away and you've got boots on the ground already. What are your reps able to do now before our products approved in terms of education, if anything, in terms of awareness building molluscum. And also, when we think about a potential catalyst and another in-office procedure for Verrica's product getting approved in July potentially, what kind of impact do you think that has on awareness in the space? And do you think that helps or hurts you guys heading into January approval hereon. And then I have a follow-up.

當您期待 1 月份 SB206 的潛在批准時，我希望談論更大的前景。你能談談你能用 EPI 業務做些什麼嗎，我想，啟動泵，可以這麼說，就像你說的，理論上只有 9 個月的時間，你已經有了靴子已經在地上了。在我們的產品在教育方面獲得批准之前，您的代表現在能夠做什麼，如果有的話，在提高軟體動物意識方面。而且，當我們考慮 Verrica 產品可能在 7 月獲得批准的潛在催化劑和另一個辦公室程序時，您認為這對空間意識有什麼樣的影響？你認為這會幫助還是傷害你們進入 1 月批准的階段。然後我有一個後續行動。

Okay. Thanks, Oren. So our reps, we are not able to train them or prime the pump because we do not have an approved product our sales reps are aware and are excited to potentially have something to begin to talk to their health care providers about, but they cannot do so until it's approved. So if you will, the only way to prime the pump is through education and we do that with our medical affairs group. And so we actually have 4 individuals in our medical affairs group and 3 of them are dedicated to really SB206 and that is around publications presentations at meetings, be it abstracts or posters or full-on presentation. So we were active at the AAD, the American Academy of Dermatologist meeting, which was just 2 weeks ago. And we were very active there and had a late breaker presentation that Dr. John Browning, one of our KOLs presented and that was very exciting for us. So that's how we can get out and build awareness. But with reference to Verrica, they will build awareness for the disease of molluscum if they are approved.

好的。謝謝，奧倫。所以我們的代表，我們無法培訓他們或啟動泵，因為我們沒有經過批准的產品，我們的銷售代表知道並且很高興有可能開始與他們的醫療保健提供者談論一些事情，但他們做不到所以直到它被批准。因此，如果您願意，啟動泵的唯一方法是通過教育，我們與我們的醫療事務小組一起這樣做。因此，我們的醫療事務組實際上有 4 個人，其中 3 個人致力於真正的 SB206，即圍繞會議上的出版物介紹，無論是摘要、海報還是全面介紹。因此，我們積極參加了 2 週前舉行的美國皮膚病學會會議 AAD。我們在那裡非常活躍，我們的 KOL 之一 John Browning 博士做了一個遲到的突破性演講，這讓我們非常興奮。這就是我們走出去並建立意識的方式。但關於 Verrica，如果獲得批准，他們將提高對軟疣疾病的認識。

So they have a PDUFA date in late July. But again, this is for a procedure. And as I said, we believe that we would be once if approved, we would likely be the first-line therapy because it is a prescription (inaudible) gel, topical treatment once a day versus a procedure that is potentially requiring 3 or 4 doctors visits. But we believe because roughly 70% of patients today go untreated because there is no FDA-approved treatment. We believe that there are patients that will begin to hear and be offered this. It's really not a new procedure. It's a new way of delivering the same product center but we have a novel new chemical entity that, again, is a prescription benefit as opposed to a medical benefit. So those are some of the differences.

所以他們在 7 月下旬有一個 PDUFA 日期。但同樣，這是一個程序。正如我所說，我們相信一旦獲得批准，我們可能會成為一線療法，因為它是一種處方（聽不清）凝膠，每天一次局部治療，而不是可能需要 3 或 4 名醫生的程序訪問。但我們相信，因為目前大約有 70% 的患者未接受治療，因為沒有 FDA 批准的治療方法。我們相信有些患者會開始聽到並得到這個。這真的不是一個新程序。這是一種提供相同產品中心的新方式，但我們有一個新穎的新化學實體，它再次是一種處方福利，而不是醫療福利。所以這些是一些差異。

Okay. And just when you talk about preparing with your existing commercial infrastructure for that launch, can you remind us, I guess, how much -- yes, how much of that SB206 market is addressable with your current infrastructure versus how much you think you would need to scale up more and add on to your capabilities to actually launch it?

好的。就在您談論為該發布準備現有的商業基礎設施時，我猜您能否提醒我們，有多少 - 是的，有多少 SB206 市場可以通過您當前的基礎設施解決，而不是您認為您需要多少擴大規模並增加您的實際啟動能力？

Yes. No, it's a good question. Thank you, Oren. We will begin with the dermatologists because as I mentioned in my statement that we believe that the dermatologists will be the first to prescribe berdazimer gel if approved. And we believe that in a community, the pediatricians know the dermatologists to whom they refer their patients for the treatment because generally, pediatricians don't offer the in-office procedures. And after they begin to see that the dermatologist is offering a prescription. They will look to the dermatologists as the key opinion leader in their community and then the pediatricians will follow. There are a large number of pediatricians in the U.S. It's a very difficult market to call on with reps. And we are planning for digitally informing them once the product is approved and that's the way we would do that. And so it wouldn't necessarily be increasing our number of reps at this point. And so preparing the field also means looking at the payer access and preparing for that and then preparing ourselves to train a sales force. We are limited by our funds or lack thereof. And so this preparedness is an investment that we will make as funds are available.

是的。不，這是個好問題。謝謝你，奧倫。我們將從皮膚科醫生開始，因為正如我在聲明中提到的那樣，我們相信如果獲得批准，皮膚科醫生將是第一個開出 berdazimer 凝膠的人。我們相信，在一個社區中，兒科醫生知道他們將患者轉介給哪些皮膚科醫生進行治療，因為一般來說，兒科醫生不提供辦公室程序。在他們開始看到皮膚科醫生正在開處方之後。他們會將皮膚科醫生視為他們社區中的主要意見領袖，然後兒科醫生將緊隨其後。美國有很多兒科醫生。這是一個很難拜訪銷售代表的市場。我們計劃在產品獲得批准後以數字方式通知他們，這就是我們這樣做的方式。因此，此時不一定會增加我們的代表數量。因此，準備該領域還意味著查看付款人訪問權限並為此做好準備，然後準備好培訓銷售人員。我們受限於我們的資金或缺乏資金。因此，這種準備是我們將在資金可用時進行的一項投資。

Okay. Can I just segue to one more follow-up on payer prep. Can you just remind us what's your thinking on pricing? I know it's early, but have you done any more -- since the data is out since you filed, have you been doing more payer outreach and research and refining your thinking around likely net monthly pricing around the product?

好的。我可以再進行一次關於付款人準備的後續行動嗎？您能否提醒我們您對定價的看法？我知道現在還早，但你有沒有做更多的事情——自從你提交後數據就已經出來了，你有沒有做更多的付款人外展和研究，並完善你對產品可能的每月淨定價的想法？

Yes. We did some market research in August of last year, and we continue to have some discussions. But in terms of payer research, it was from August and it was pretty much in line with maybe a bit of an increase from what we had seen in 2019, when we went out and did that research. So we've updated it, and we haven't given guidance, but I know our analysts have been looking at anything between $500 and $1,000 per kit.

是的。我們在去年八月做了一些市場調查，我們繼續進行一些討論。但就付款人研究而言，它是從 8 月開始的，與我們在 2019 年外出進行研究時所看到的情況相比，可能略有增加。所以我們已經更新了它，我們還沒有給出指導，但我知道我們的分析師一直在關注每個套件 500 美元到 1,000 美元之間的任何東西。

Sorry, go ahead, didn't mean to interrupt.

抱歉，繼續，沒有打擾的意思。

Yes. I was just saying on the kit is for 4 weeks of treatment.

是的。我只是在試劑盒上說要進行 4 週的治療。

So the next question comes from Jeff Jones with Oppenheimer.

所以下一個問題來自 Jeff Jones 和 Oppenheimer。

Congratulations on the quarter. I guess 2 questions. In terms of cash needs to -- which you've spoken to in terms of where you get later -- latter part of 2Q. What are you looking at to get through the year? And what does that allow you to do in terms of building up for sales and marketing perhaps for launch? And then any update on discussions with Sato or others around further ex-U.S. partnering for Rhofade?

祝賀這個季度。我猜2個問題。就現金需求而言——你已經談到了你以後得到的地方——第二季度的後半部分。你希望通過什麼來度過這一年？在建立銷售和市場營銷方面（也許是發布），這讓您可以做什麼？然後是與佐藤或其他人圍繞進一步的美國以外的討論的任何更新。與 Rhofade 合作？

Thanks, Jeff. I'll take the first question as it relates to cash need and (inaudible) prep. If you look at back at kind of the historical activity that we had during 2022, we were utilizing about $8 million to $10 million of cash on a quarterly basis. Going forward, in Q1 that should probably look similar, really, as it relates to from year 4 for the rest of the year, it's going to be dependent upon to Paula's comment just a moment ago, the amount of activity that we do to prepare the market, if you will. So that number could vary. But I think it's fair to say that if we look at that activity, I think the prior year numbers, call it, 8% to 10% on a quarterly basis, we can probably bring that down a couple of million on a quarterly utilization just based on some of the cost conservation measures that we're doing. And also paired with the amount of activity we're able to do as it relates to preparing the field. So again, that can be variable, again, dependent upon our access to capital. And then as it relates to Sato ex-U.S.?

謝謝，傑夫。我會回答第一個問題，因為它與現金需求和（聽不清）準備有關。如果你回顧一下我們在 2022 年的歷史活動，我們每季度使用大約 800 萬到 1000 萬美元的現金。展望未來，在第一季度可能看起來很相似，真的，因為它與今年剩餘時間的第 4 年相關，這將取決於 Paula 剛才的評論，我們為準備所做的活動量市場，如果你願意的話。所以這個數字可能會有所不同。但我認為可以公平地說，如果我們看一下這個活動，我認為前一年的數字，稱其為每季度 8% 到 10%，我們可能可以將每季度的利用率降低幾百萬基於我們正在採取的一些成本節約措施。並且還與我們能夠進行的與準備現場相關的活動量相結合。同樣，這也可能是可變的，這取決於我們獲得資本的機會。然後它與來自美國的佐藤有關？

Yes. So in ex U.S., we have active discussions going on in many countries in Asia Pacific, Europe, Canada, others. So there is interest. I was going to qualify that. But there is interest in Rhofade because it is a very good product, and a number of companies and countries are interested in that. So we continue to progress those discussions. And as always, as we can or when we can, we will share the detail of those discussions and those potential agreements. Thanks for asking.

是的。因此，在美國以外，我們在亞太地區、歐洲、加拿大和其他國家/地區的許多國家/地區進行了積極的討論。所以有興趣。我打算證明這一點。但人們對 Rhofade 很感興趣，因為它是一種非常好的產品，許多公司和國家對此感興趣。所以我們繼續推進這些討論。與往常一樣，我們將盡可能或在可能的時候分享這些討論和那些潛在協議的細節。謝謝你的提問。

Just a quick follow-up on Sato. I believe they had a limited time to exercise rights in certain additional territories, how much time was left on that? Or has that expired?

只是對佐藤的快速跟進。我相信他們在某些額外領土上行使權利的時間有限，還剩下多少時間？還是已經過期了？

It has not expired and we've got a couple of months to go before that expires. But we are aware and we'll proceed elsewhere for some reason that doesn't move forward. So there is interest in addition to Sato.

它尚未過期，我們還有幾個月的時間才能過期。但我們知道，我們會因為某些無法推進的原因而在其他地方繼續。所以除了佐藤還有興趣。

And the next question comes from Jennifer Kim with Cantor Fitzgerald.

下一個問題來自 Jennifer Kim 和 Cantor Fitzgerald。

I have 2 here. Maybe on the first following up on a prior comment. The digital investments that you're currently planning, what degree of additional investment would go into that? And is there a way to think about your potential reach through digital investment or an analog to other similar approaches to launches?

我這裡有2個。也許在第一次跟進之前的評論時。您目前正在計劃的數字投資，將投入多大程度的額外投資？有沒有一種方法可以通過數字投資或類似於其他類似發布方法來考慮您的潛在影響力？

And then my second question is, I know you're not in a position to provide guidance just yet, but is there anything you can say on, I guess, expectations on the cadence of growth over time? And maybe when you believe you'll be in a position to provide guidance?

然後我的第二個問題是，我知道你現在還不能提供指導，但是你有什麼可以說的嗎，我想，隨著時間的推移對增長節奏的期望？也許當您相信自己能夠提供指導時？

Thank you, Jennifer. I'll take the first. John, I'll take the -- John Gay will take the second [or result still good to be the], I think in terms of the digital investment and the investment for the potential launch of berdazimer gel is for us is measuring over time and balancing over time, the funds available and the win, et cetera. I think one thing to say is that it's not just sales and marketing, but it's also manufacturing. So it's to be able to launch in 2024 and hopefully, in the first half of 2024, we need to manufacture product. And so I'll put that spend ahead of some of even the sales and marketing to make sure that we have the product available, and then put that spend into 2024, if we don't have it to spend in 2023. So it's a matter of how much you put in is how much you get out. And so we will continue to evaluate and balance our funds with the investment in our potential launch.

謝謝你，詹妮弗。我要第一個。約翰，我會接受 - 約翰蓋伊會接受第二個[或者結果仍然很好]，我認為就數字投資和潛在推出 berdazimer 凝膠的投資而言，我們正在衡量隨著時間的推移隨著時間的推移，可用資金和獲勝等方面的平衡。我認為有一件事要說的是，這不僅僅是銷售和營銷，而且還包括製造。所以它能夠在 2024 年推出，希望在 2024 年上半年，我們需要製造產品。因此，我會把這筆支出放在銷售和營銷之前，以確保我們有可用的產品，然後把這筆支出放到 2024 年，如果我們在 2023 年沒有的話。所以這是一個投入多少就是退出多少。因此，我們將繼續評估和平衡我們的資金與對我們潛在發射的投資。

So Jennifer, I'll take the first part of that. The second part of your question and maybe ask John Donofrio to weigh in. But as it relates to guidance, like you said, we continue to evaluate that. Now keep in mind, it's been roughly 9 months from a fiscal period that we've shown consolidated results. So I think we're still working through that and both internally the Board on how to approach potential guidance as it goes forward. That being said, as it relates to product or TRx growth in prescription growth, we continue to focus on that. And maybe John, you gave some comments on that going forward?

詹妮弗，我先講第一部分。你的問題的第二部分可能會請 John Donofrio 參與。但正如你所說，它與指導有關，我們會繼續對其進行評估。現在請記住，從我們顯示綜合結果的財政期開始大約有 9 個月。因此，我認為我們仍在努力解決這個問題，並且在董事會內部都在研究如何處理未來的潛在指導。話雖這麼說，因為它與處方增長中的產品或 TRx 增長有關，我們繼續關注這一點。也許約翰，你對未來發表了一些評論？

Yes. I think as you could tell, in for just the momentum we've had throughout the years across our products. We've had a few ups and downs in the psoriasis space, but we continue to be the market leader and expand a persistent patient erythema and we expect to continue to do that. That's what our goals and our objectives are for 2023. I think to Paula and John both point the continued investment around that. We've demonstrated that, that will also be dependent on funds going forward. But we do expect to still grow that market and still see significant opportunity in the oral antibiotic market with Minolira. And again, we feel like we've leveled out with the noise of the new -- the competitors in the topical psoriasis market, and we expect to see a rebound in that. So we're -- again, we're not giving guidance per se, but our brand plans, our tactics, we talked about SB206 in berdazimer plans. We have plans for all 3 products. They've all been initiated over in a national sales meeting in early March and are being active. So we would expect to continue that momentum that we've seen.

是的。我認為正如您所說，這正是我們多年來在產品方面所擁有的勢頭。我們在牛皮癬領域經歷了一些起伏，但我們仍然是市場領導者並擴大了持續性紅斑患者，我們希望繼續這樣做。這就是我們 2023 年的目標。我認為保拉和約翰都指出了圍繞這一點的持續投資。我們已經證明，這也將取決於未來的資金。但我們確實預計該市場仍將增長，並且仍會看到 Minolira 在口服抗生素市場的重大機遇。再一次，我們覺得我們已經與新的噪音——局部牛皮癬市場的競爭對手——保持平衡，我們預計會看到反彈。所以我們——再一次，我們本身並沒有提供指導，而是我們的品牌計劃、我們的策略，我們在 berdazimer 計劃中談到了 SB206。我們對所有 3 種產品都有計劃。他們都是在 3 月初的全國銷售會議上發起的，並且很活躍。因此，我們希望繼續保持我們所看到的勢頭。

And the next question comes from come Kemp Dolliver of Brookline Capital Markets.

下一個問題來自 Brookline Capital Markets 的 Kemp Dolliver。

This is based on backing into the numbers and could be off, but Wynzora fees look like they are down or sequentially or just in broad terms, fairly depressed versus the last few quarters. Could you talk -- a, is that correct? And then b, could you just discuss what's going on behind that?

這是基於對數字的支持並且可能會關閉，但 Wynzora 費用看起來像是下降或連續下降或只是從廣義上講，與過去幾個季度相比相當低迷。你能談談——a，這樣對嗎？然後 b，你能談談這背後發生的事情嗎？

Yes. Ken, this is John. Thanks for your question. So the Wynzora fees, keep in mind a couple of things. One, subsequent to the acquisition, the accounting presentation and treatment of Wynzora did evolve a little bit over time. So if you're looking period-over-period, there could be some artificial changes. But effectively, agreement with Wynzora the way that it works is that the agreement is that we're the distributor and the commercial partner for MC2 for that product. So we effectively recognize all the revenue because we get cash as it relates to the product sales. But we do effectively remit any option if you will, back to MC2 because effectively, and we shared that as a COGS because effectively that's the way that this agreement works, right? So the net-net, if you will, is the residual 15%. So as it relates to changes in the fees as a part of the MC2 area that goes through COGS, that can vary based upon Wynzora and net product revenue. But then again, like I said, we've also had some presentation changes during the quarter. I'm sorry, during the year, I should say.

是的。肯，這是約翰。謝謝你的問題。所以 Wynzora 費用，請記住幾件事。第一，在收購之後，Wynzora 的會計報表和處理確實隨著時間的推移發生了一些變化。因此，如果您逐個查看，可能會有一些人為的變化。但實際上，與 Wynzora 達成協議的方式是，我們是該產品的 MC2 的分銷商和商業合作夥伴。因此，我們有效地確認了所有收入，因為我們獲得了與產品銷售相關的現金。但是，如果您願意，我們確實會有效地放棄任何選項，因為有效地返回 MC2，並且我們將其作為 COGS 共享，因為實際上這就是該協議的運作方式，對吧？因此，如果您願意，淨值就是剩餘的 15%。因此，作為通過 COGS 的 MC2 區域的一部分，它與費用變化有關，這可能會因 Wynzora 和產品淨收入而異。但話又說回來，就像我說的，我們在本季度也進行了一些演示更改。對不起，在這一年裡，我應該說。

Okay. But looking at the underlying script trend is still a reliable measure of what the fees would be on a normalized basis.

好的。但是查看基本腳本趨勢仍然是衡量正常化費用的可靠指標。

Yes.

是的。

Okay. Great. And just shifting to Rhofade and the activity there. I think the one question in my mind with regard to how that's impacting you is looking at the competitors' data, it looks like they're doing the typical thing at the launch, a lot of sampling, very depressed net-to-gross. And despite the fact you do have rebate agreements in place, you are somehow having to respond. And is -- and the discussion around coupons in the pharmacy and the like, don't seem to -- may be at the full explanation of that, but I'm just trying to understand in that context of this initial period of virtually free product out there, if that's real -- and the final analysis that just responding to that is what you're dealing with.

好的。偉大的。只是轉移到 Rhofade 和那裡的活動。我認為關於這如何影響你的一個問題是查看競爭對手的數據，看起來他們在發佈時做了典型的事情，大量的抽樣，非常沮喪的淨毛比。儘管您確實有回扣協議，但您還是不得不做出回應。並且是 - 圍繞藥房優惠券等的討論，似乎沒有 - 可能是對此的完整解釋，但我只是試圖在這個幾乎免費的初始階段的背景下理解那裡的產品，如果那是真的——最後的分析就是你正在處理的只是對此做出回應。

Yes. This is John Donofrio. I'll take that. I think you hit a few points in just the gross-to-net dynamic of payer rebates have increased, not only for new market entrants, but also for products on the market like Rhofade. We continue to still have strong coverage across all the major players that's been with Rhofade for a while. But we have seen increased rebates percentages. I think where the challenge and opportunity is still what's going on at the pharmacy. And we've seen less scripts being adjudicated through that coverage through numerous reasons. And I think we've identified that. We're working with the payers and the pharmacies to ensure that those scripts that are coming through are not getting rejected and they're following the business rules and the contractual obligations have been set up. And I think that's a primary driver of some of the correction you've seen. And -- but we continue to see good coverage as far as our competitors go really knowing competes in the redness market per se. The new products are all still going up to anti-inflammatory. And yes, they've come out with heavy sampling and heavy discounts. And we did mention in my commentary to Rhofade, at this point of its life cycle still has very, very, very favorable copay card rules and we're looking to assess that and ensure that we meet the optimal that we still have patient affordability, which is still important but that we could bring optimal value back to Novan. So that's being assessed as well. And as you know, there's a lot of analogs out there of what that means, and we think we're very comfortable with some of those opportunities going forward, especially with Rhofade. But the solid rider base that we do have.

是的。這是約翰·多諾弗里奧。我會接受的。我認為你在付款人回扣的毛淨比動態增加中達到了幾點，不僅對於新的市場進入者，而且對於市場上的產品，如 Rhofade。我們繼續對所有與 Rhofade 合作一段時間的主要參與者進行強有力的報導。但我們已經看到回扣百分比有所增加。我認為挑戰和機遇仍然存在於藥房中。由於多種原因，我們看到通過該報導裁定的劇本越來越少。我認為我們已經確定了這一點。我們正在與付款人和藥房合作，以確保通過的那些腳本不會被拒絕，並且他們遵守業務規則並且已經建立了合同義務。我認為這是你所看到的一些修正的主要驅動力。而且——但就我們的競爭對手真正了解紅色市場本身的競爭而言，我們繼續看到良好的報導。新品都還在往上消炎。是的，他們推出了大量樣品和大幅折扣。我們在對 Rhofade 的評論中確實提到，在其生命週期的這一點上，它仍然有非常、非常、非常有利的共付卡規則，我們正在尋求評估並確保我們達到最佳狀態，即我們仍然有患者的負擔能力，這仍然很重要，但我們可以將最佳價值帶回 Novan。所以這也在評估中。正如你所知，這意味著很多類似的東西，我們認為我們對未來的一些機會感到非常滿意，尤其是 Rhofade。但是我們確實擁有堅實的騎手基礎。

Yes. And the increase rebate -- the increased rebate levels, is that something that's carrying through in 2023 as part of your annual discussion with the plans. Is that correct?

是的。增加回扣——增加回扣水平，是在 2023 年進行的，作為您與計劃進行年度討論的一部分。那是對的嗎？

Yes, we're baked for 2023. So we're already having conversations for 2024, but our contracts will go through 2023. So yes, -- so the experience we have in 2022, no changes for 2023 for the rebate percentage.

是的，我們已經為 2023 年準備好了。所以我們已經在討論 2024 年，但我們的合同將持續到 2023 年。所以是的，我們在 2022 年的經驗，2023 年的回扣百分比沒有變化。

And the next question comes from John Vandermosten with Zacks.

下一個問題來自 Zacks 的 John Vandermosten。

Paula and John, regarding gross margin, we saw a lot of volatility in 2022 for a number of reasons that you mentioned. How should we think about it for this year product gross margin for 2023? Will it be as volatile? And then if we look at kind of the full year percentage there, what way directionally should we think about that going product gross margin?

Paula 和 John，關於毛利率，由於您提到的多種原因，我們在 2022 年看到了很大的波動。對於2023年的今年產品毛利率，我們應該如何思考？它會如此不穩定嗎？然後，如果我們看一下那裡的全年百分比，我們應該從什麼方向考慮該產品的毛利率？

So thanks, John. And once there's a little bit of a breakup, but I think you're asking about the gross margin on a product basis. And the volatility we've seen and then what it looks like going forward. Yes. I think, again, if you think about it, like I said in the prepared remarks, that margin is impacted by a couple of different things. True product COGS, if you will, our COGS number, like I said, includes the royalties and milestones, et cetera. But if you think about 3 product COGS, I mean that's going to be a pretty consistent margin, if you will, as it relates to product COGS as part as a percent of our gross margin of NPR net product revenue. So that's roughly at [88%] or so. So we would expect that to continue as it relates to the product portion of COGS on a go-forward basis. And we will see some variability, it will be, again, in the royalties in potential milestones.

所以謝謝，約翰。一旦有一點分手，但我認為你是在問產品基礎上的毛利率。以及我們所看到的波動，以及未來的走勢。是的。我想，再一次，如果你考慮一下，就像我在準備好的評論中所說的那樣，利潤率受到幾個不同因素的影響。真正的產品 COGS，如果你願意的話，我們的 COGS 數字，就像我說的，包括版稅和里程碑，等等。但如果你考慮 3 個產品 COGS，我的意思是這將是一個相當一致的利潤率，如果你願意的話，因為它與產品 COGS 相關，作為我們 NPR 淨產品收入毛利率的一部分。所以這大約是 [88%] 左右。因此，我們預計這種情況會繼續下去，因為它與 COGS 的產品部分有關。我們將看到一些可變性，這將再次出現在潛在里程碑的特許權使用費中。

Great. And when we look at selling, general and administrative, and how would we split that between, I guess, sales and marketing and general and administrative for this year?

偉大的。當我們查看一般和行政銷售時，我想我們將如何在今年的銷售和營銷以及一般和行政之間進行分配？

Yes. So if you think about, again, bifurcating, if you will, the SG&A from the -- our commercial business. It was about almost not quite $14 million. And quarter-over-quarter, that spend has stayed Q4 to Q3 has been kind of been relatively consistent. As it relates to what part of that relates to marketing, et cetera, that is also staying consistent again as it relates to our activities. It's probably I don't know the exact percentage, but I would say it's fair to say that we expect our G&A as it relates to our SG&A, I should say, for the EPI Health business to say between $4 million and $5 million on a quarterly basis.

是的。因此，如果您再次考慮將 SG&A 從我們的商業業務中分叉，如果您願意的話。這幾乎不是 1400 萬美元。與上一季度相比，第四季度到第三季度的支出一直保持相對穩定。因為它涉及到營銷等方面的哪一部分，所以它也與我們的活動保持一致。我可能不知道確切的百分比，但我想說的是，我們預計我們的 G&A 與我們的 SG&A 相關，我應該說，對於 EPI Health 業務來說，在 400 萬到 500 萬美元之間每季。

Okay. And then final question on when we finally -- if we see approval for SB206, how will that incrementally affect sales and marketing expense as that's rolled out. I mean I know you have a lot of excess capacity, but there might be some other demands that need to be made. How should we think about that in 2024, assuming approval?

好的。然後是關於我們何時最終的最後一個問題——如果我們看到 SB206 的批准，隨著它的推出，這將如何逐步影響銷售和營銷費用。我的意思是我知道你們有很多產能過剩，但可能還需要提出一些其他要求。假設獲得批准，我們應該如何考慮到 2024 年？

Yes. I mean I think there will obviously be some increase, but part of the main benefit of having the acquisition of EPI Health is that it will greatly reduce the amount of marketing spend that will be necessary for 206.

是的。我的意思是我認為顯然會有一些增加，但收購 EPI Health 的部分主要好處是它將大大減少 206 所需的營銷支出。

I was going to say, too, the sales, I think, stays the same, it's the marketing that might be what increases as we try to market. And as I mentioned earlier, it's going to be relative to the funds that we have, how much we are able to market the product ahead or at launch.

我也想說，我認為銷售額保持不變，隨著我們嘗試營銷，營銷可能會增加。正如我之前提到的，這將與我們擁有的資金有關，我們能夠在多大程度上提前或在發佈時推銷產品。

And the next question is a follow-up from Oren Livnat with H.C. Wainwright.

下一個問題是 Oren Livnat 和 H.C. 的後續問題。溫賴特。

You mentioned earlier on the call, John, we discussing R&D that a top priority is certainly progressing the manufacturing activities, so you're ready to launch if and when the time comes. Can you just talk -- can you guys talk about, in general, what is left to do on that front? Is it just crossing T's and dotting I's and manufacturing, keeping things in compliance? Or are you going to actually ramp up and build launch quantities ahead of January? And is that in your financial plan? And I guess also just risk derisking wise, are there anything left to do that, in your mind, represents, I guess, risk gates you pass with regards to manufacturing? Are there things that need to be verified still in terms of scale up or inspections with the FDA?

你早些時候在電話中提到，約翰，我們討論研發的首要任務肯定是推進製造活動，所以你準備好在時機成熟時啟動。你能不能談談——你們能不能談談，總的來說，在這方面還有什麼要做的？它只是穿越 T 並點綴 I 和製造，使事情合規嗎？或者你們真的要在 1 月之前增加並建立發射數量？這在你的財務計劃中嗎？而且我想也只是冒險明智地降低風險，在你看來，還有什麼可以做的，我猜，代表你在製造方面通過的風險門？在擴大規模或與 FDA 檢查方面，是否還有需要驗證的事項？

Thanks, Oren. We are on track for the January 5 PDUFA goal date and the normal course of that standard review. We hear producing in Durham, North Carolina, our drug substance, and we have submitted what we need to submit and we are on track. I mean there are usual processes that you go through in terms of process validation, et cetera. And so all of that is ongoing. No risk that we are aware of. And we continue to progress and want to move toward manufacturing or a potential launch. And in terms of that derisking and how much do you do ahead of an approval the mid-cycle review would come sometime this summer. And I think once we get through that, we'd like to be in a position to begin to manufacture product that would be available for a launch. I think John wanted to add.

謝謝，奧倫。我們正朝著 1 月 5 日的 PDUFA 目標日期和標準審查的正常過程邁進。我們聽說在北卡羅來納州達勒姆生產我們的原料藥，我們已經提交了我們需要提交的材料，我們正在走上正軌。我的意思是，在流程驗證等方面，您會經歷一些通常的流程。所以所有這些都在進行中。沒有我們知道的風險。我們繼續進步，並希望轉向製造或潛在的發射。就這種去風險化以及在批准之前你做了多少，中期審查將在今年夏天的某個時候進行。而且我認為一旦我們完成了這一點，我們希望能夠開始製造可用於發布的產品。我想 John 想補充一下。

I was just to your point as it relates to the cost in future that on. I mean, obviously, anything that we do from preparing for launch, in addition to what Paula just mentioned, as it relates to product preparedness, that is going to kind of be rolled up in R&D expenses to my earlier point on an earlier question. Which is why we're going to see effectively the same level of R&D spend next year than we did this year. But at Paula's point, that amount of cost will be able to get us to a point of the initial launch.

我只是想表達你的意思，因為它與未來的成本有關。我的意思是，很明顯，除了 Paula 剛才提到的與產品準備相關的內容之外，我們從準備發布所做的任何事情都會在研發費用中累積到我之前在一個較早的問題上的觀點。這就是為什麼我們明年會看到與今年有效相同水平的研發支出。但在 Paula 看來，這筆費用足以讓我們達到最初發布的目的。

Thank you. And this concludes the question-and-answer session. I would like to turn the call over to Paula Brown Stafford for any closing comments.

謝謝。問答環節到此結束。我想將電話轉給 Paula Brown Stafford 以徵求任何結束評論。

Okay. Thank you, operator, and thank you all for joining, for really good questions this morning, an extended call. Novan is in a solid position to succeed with this potential launch. We're on track for our January 5 PDUFA date. So we remain focused and excited for our future. And appreciate you being on the journey with us. So thank you. Have a great day.

好的。謝謝接線員，感謝大家今天早上的加入，提出了非常好的問題，延長了通話時間。 Novan 有能力通過這次潛在的發射取得成功。我們正在為 1 月 5 日的 PDUFA 約會做準備。因此，我們對未來保持專注和興奮。感謝您與我們一起踏上旅程。所以謝謝。祝你有美好的一天。

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

謝謝。會議現已結束。感謝您參加今天的演講。您現在可以斷開線路。