Novan Inc (NOVN) 2023 Q1 法說會逐字稿

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

您好，歡迎參加 Novan 公司季度業績更新電話會議及網路直播。 （操作說明）請注意，本次網路直播應本公司要求錄製，會議結束後，將在公司網站上提供回放。在此，我想提醒各位聽眾，本次網路直播中的發言可能涉及管理階層的意圖、信念、預期或未來預測。這些都是前瞻性陳述，涉及風險和不確定性。

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. 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 these contemplated by such forward-looking statements are discussed in the periodic reports Novan files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. 

本次電話會議中的前瞻性聲明均符合聯邦證券法的安全港條款，並基於Novan目前的預期，實際結果可能與預期有重大差異。因此，您不應過度依賴任何前瞻性陳述。可能導致實際結果與此類前瞻性陳述預期結果存在重大差異的部分因素已在Novan向美國證券交易委員會提交的定期報告中進行了討論。這些文件可在公司網站的「投資者」專欄和美國證券交易委員會的網站上查閱。我們建議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 has not independently verified and makes no representation as to the adequacy, fairness, accuracy or completeness of or that any independent source has verified. Any information obtained from third-party sources. Joining us on today's call from the Novan 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.

此外，本次網路直播中包含的某些資訊涉及或基於從第三方來源獲得的研究、出版物、調查和其他數據以及公司本身的估算和研究。儘管本公司認為截至本次演示之日，這些第三方來源的資訊可靠，但本公司並未對其進行獨立核實，也不對其充分性、公正性、準確性或完整性，或任何獨立來源已核實的資訊作出任何聲明。所有資訊均來自第三方來源。今天參加電話會議的Novan領導團隊成員包括：董事長、總裁兼執行長Paula Brown Stafford；執行副總裁兼營運長John A. Donofrio；以及財務長John M. Gay。

I would now like to turn the call over to Paula Brown Stafford. Please proceed.

現在我將把電話交給寶拉·布朗·斯塔福德。請繼續。

Thank you, Andrew, and thanks to everyone for joining us this morning. Novan is building a premier medical dermatology company that is focused on developing and commercializing innovative therapies for diseases of the skin. Our priority is our NDA for berdazimer gel, 10.3% for the treatment of molluscum, molluscum contagiosum. It is under review at the FDA with a PDUFA goal date of the 5th of January 2024. We are in the review cycle, and we have less than 8 months remaining. Since January, we have had a number of noteworthy accomplishments.

謝謝安德魯，也謝謝各位今天早上的參與。 Novan 致力於打造一家頂尖的皮膚病醫療公司，專注於開發和商業化創新療法，治療各種皮膚疾病。我們目前的首要任務是向美國食品藥物管理局 (FDA) 提交的用於治療傳染性軟疣（包括傳染性軟疣）的 10.3% 濃度貝達唑凝膠的新藥申請 (NDA)。該申請正在 FDA 審查中，預計 PDUFA 目標日期為 2024 年 1 月 5 日。我們正處於審查週期中，距離審查結束還有不到 8 個月的時間。自 1 月以來，我們取得了一系列值得關注的成就。

Our entire team remains excited about our progress, our momentum and what lies ahead. Our NDA was submitted in early January. This represents the most significant milestone Novan has achieved to date and something of which we are extremely proud. In March, our filing was accepted for review with no known potential issues. And we have provided our PDUFA goal date, as I mentioned as well as other expected milestone dates for a standard review cycle. We continue our dialogue with the agency while we move forward with preparing toward our commercial supply of drug substance in anticipation of a potential approval. 

我們整個團隊對目前的進展、勢頭以及未來的發展前景都感到無比振奮。我們的新藥申請（NDA）已於1月初提交。這是Novan迄今取得的最重要里程碑，我們為此感到無比自豪。 3月份，我們的申請被受理，目前未發現任何潛在問題。正如我之前提到的，我們已提交了處方藥使用者付費法案（PDUFA）的目標日期，以及標準審查週期內的其他預期里程碑日期。我們將繼續與監管機構保持溝通，同時推進藥品原料商業化供應的準備工作，以期獲得最終批准。

Berdazimer gel, 10.3% is a novel, topical nitric oxide releasing medication for viral skin infections. Berdazimer sodium, our active pharmaceutical ingredient is a new chemical entity. Our NDA is based on a Phase III program that demonstrated clinical evidence of efficacy with robust clinical data from our B-SIMPLE4 trial and a favorable safety profile for patients with molluscum. Our clinical trial data from B-SIMPLE4 were published in JAMA Dermatology in July of last year.

Berdazimer凝膠（10.3%）是一種新型的局部性一氧化氮釋放藥物，用於治療病毒性皮膚感染。 Berdazimer鈉是我們的活性藥物成分，是一種新的化學實體。我們的新藥申請是基於一項III期臨床試驗，該試驗透過B-SIMPLE4試驗提供了可靠的臨床數據，證實了其療效，並顯示出良好的安全性，適用於傳染性軟疣患者。 B-SIMPLE4試驗的臨床試驗數據已於去年7月發表在《美國醫學會皮膚病學雜誌》（JAMA Dermatology）上。

So if approved, this product would satisfy an important patient care need, largely displacing in-office procedures that are often cumbersome, painful and time-consuming. Molluscum is highly contagious. It is 1 of the 5 most prevalent skin diseases worldwide and the third most common viral skin infection in children, most of them less than 10 years old, and if left untreated, it could last up to 48 months. Through recent market research, we received caregiver feedback that speaks to the impact of the disease, really on the psyche of the patient. And to give you a sense of the real-world experiences, as you can see in these quotes here, at least children feeling depress, hopeless, bullied, a need to build their self-confidence. 

因此，如果獲得批准，該產品將滿足一項重要的患者護理需求，很大程度上取代那些通常繁瑣、痛苦且耗時的診室治療程序。傳染性軟疣具有高度傳染性，是全球五大常見皮膚病之一，也是兒童（其中大多數為10歲以下兒童）第三大常見病毒性皮膚感染。若不及時治療，病情可持續長達48個月。透過近期的市場調查，我們收到了護理人員的回饋，這些回饋反映了該疾病對患者心理的影響。為了讓您更直觀地了解實際情況，正如您在此處看到的引述，至少有兒童會感到沮喪、絕望、遭受霸凌，並且需要建立自信。

And last week, we actually received an e-mail from a parent. We get these quite frequently. And this one, it was just a striking e-mail and at the end it said, I am looking for a sign of hope. We think we're that sign. 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. We believe the lack of at-home options results in many undiagnosed cases. The current standard of care is in-office procedures, freezing, cutting, blistering and off-label and OTC offerings that have no proven efficacy.

上週，我們收到了一位家長的電子郵件。我們常收到這類郵件。這封郵件尤其令人印象深刻，結尾寫道：「我正在尋找希望的曙光。」我們認為我們就是那束希望的曙光。目前，市場對一種可供患者自行使用或由護理人員協助使用的局部外用療法需求旺盛。市場潛力大，目前美國有600萬患者，每年新增患者約100萬人。我們認為，缺乏居家治療方案導致許多病例未被確診。目前的標準治療方法是診間手術、冷凍、切開、水泡療法以及未經證實療效的非處方藥和非適應症用藥。

Per U.S. claims data, over 70% of patients with molluscum go untreated. 19% of molluscum patients seek treatment from a dermatologist. 72% visit their pediatrician, but approximately 90% of these pediatricians have a wait-and-see approach. Whereas 65% of dermatologists will treat molluscum, but it's typically with a treatment that's an in-office procedure. So this is how we view the future. We believe that berdazimer gel, 10.3% has the potential to become a first-line therapy. Dermatologists and communities would likely lead the way and what we expect is that pediatricians would follow. 

根據美國醫療保險索賠數據，超過70%的傳染性軟疣患者未接受治療。 19%的傳染性軟疣患者會尋求皮膚科醫師的治療。 72%的患者會去看兒科醫生，但其中約90%的兒科醫生採取觀察等待的態度。而65%的皮膚科醫師會治療傳染性軟疣，但通常會採用門診手術治療。這就是我們對未來的展望。我們相信，10.3%的伯達齊默凝膠有潛力成為第一線治療方案。皮膚科醫生和社區可能會率先採用，我們預計兒科醫生也會跟進。

There's no FDA-approved treatment today for molluscum. But a wait-and-see approach is not a standard of care that patients or caregivers seem to benefit from today. So in the next 7.5 months, the FDA could approve 2 potential treatment solutions that we believe would complement one another. We believe if approved, berdazimer gel could be prescribed by pediatrician as a prescription product that would most likely be covered by insurance at the pharmacy.

目前尚無FDA核准的傳染性軟疣治療方法。但「觀察等待」並非目前患者或照護者普遍認為有效的治療方案。因此，FDA可能在未來7.5個月內批准兩種我們認為可以互補的潛在治療方案。我們相信，如果獲得批准，兒科醫生可以開立伯達齊默凝膠處方，並且很可能在藥房獲得醫療保險報銷。

Whereby, if approved, a new drug device combo could be used as an in-office procedure by dermatologists across multiple visits, if covered by medical insurance. So there's room for both in the market, if approved, one, a prescription, one, a drug device used in the office.

如果獲得批准，這種新型藥物器械組合療法可以在醫保覆蓋範圍內，由皮膚科醫生在多次就診中進行診室內治療。因此，如果獲得批准，市場上可以同時存在這兩種產品：一種是處方藥，另一種是診室內使用的藥物器械。

Our research shows that health care providers are ready for a safe and effective treatment and specifically berdazimer gel, if approved. As you see here, very -- there's a very high potential, very high adoption rates are expected within 12 months of approval across the 3 primary HCP types who are seeing molluscum patients today. So we're planning for success. Our NDA is in the review cycle at the FDA, and we're currently expecting the review to be complete by the goal date of January 5, which is, again, less than 8 months away. So as we respond to FDA information requests, we're also planning toward a potential launch. 

我們的研究表明，醫療保健提供者已經準備好接受一種安全有效的治療方法，特別是如果獲得批准，那就是伯達齊默凝膠。正如您所看到的，該產品具有非常高的潛力，預計在獲得批准後的12個月內，目前接診傳染性軟疣患者的三大主要醫療保健專業人員群體都將獲得非常高的採用率。因此，我們正在為成功做好準備。我們的新藥申請（NDA）正在接受美國食品藥物管理局（FDA）的審查，我們目前預計審查將於1月5日的目標日期前完成，也就是不到8個月的時間。因此，在回應FDA的資訊請求的同時，我們也在為可能的上市做準備。

So specifically, we look to build awareness and excitement for our potential product among our customers as well as employees and potential future employees. We work to educate health care providers about the disease and the treatment options. We look to deliver the best possible access program. We want to prepare our existing commercial organization. We continue to protect our proprietary platform technology with patents nationally and globally.

具體而言，我們致力於提升現有客戶、員工及潛在員工對我們潛在產品的認知與興趣。我們努力向醫療保健提供者普及疾病知識和治療方案。我們力求提供最佳的准入方案。我們希望為現有商業團隊做好準備。我們將繼續透過國內外的專利來保護我們的專有平台技術。

Now the extent of these efforts remains dependent on funding available to the business. So our go-to-market strategy starts with the opportunity in the dermatologist offices. They recognize the value. Their patients recognize the value. They are eager. So we expect pediatricians will look to them and follow. We will mostly market to non-derm HCPs digitally. Once we prove out our marketing playbook with the dermatologists, we would look and expect to have the foundation to expand beyond dermatologists. The opportunity for berdazimer gel is compelling.

目前，這些努力的規模仍取決於公司可用的資金。因此，我們的市場推廣策略首先著眼於皮膚科醫生診所的市場機會。他們認可產品的價值，他們的患者也認可產品的價值，並且他們對此充滿熱情。所以我們預計兒科醫生會效法他們的做法。我們將主要透過數位化管道向非皮膚科醫護人員行銷。一旦我們與皮膚科醫生合作驗證了我們的行銷方案，我們就會著手並期望以此為基礎，將市場拓展到皮膚科醫生以外的領域。伯達齊默凝膠的市場機會非常誘人。

So I'll now hand the call over to our Chief Operating Officer, John Donofrio, to provide an update on our commercial business for the first quarter of 2023.

現在我將把電話交給我們的營運長約翰·多諾弗里奧，讓他介紹一下我們2023年第一季的商業業務狀況。

Thank you, Paula. Good morning, everyone. I'm pleased to report our promoted products delivered strong prescription growth compared to Q1 2022. This is the fifth consecutive quarter of strong commercial team execution, delivering growth across our promoted product portfolio as compared to prior periods. Our team successfully launched new promotional campaigns for RHOFADE and Wynzora moved to digital platforms and selling tools across our portfolio.

謝謝Paula。大家早安。我很高興地向大家匯報，與2022年第一季相比，我們推廣產品的處方量實現了強勁增長。這是我們商業團隊連續第五個季度保持強勁的執行力，與以往相比，我們推廣產品組合的整體業績均有所成長。我們的團隊成功地為RHOFADE和Wynzora推出了新的推廣活動，並將這些活動推廣到我們產品組合中的各種數位平台和銷售工具上。

Complementing our strong total prescription growth compared to Q1 2022, we have also experienced a significant increase in underlying demand in new prescriptions for both RHOFADE and MINOLIRA and increased ACP rider activity for Wynzora. Wynzora, which was launched in mid-2021, compete in the market that has many treatment options for psoriasis. As such, this is a positive trend in a very competitive market. For the quarter, we continued to grow our prescribing base and market share for our core promoted products. 

與2022年第一季相比，我們的處方總量實現了強勁增長，同時，RHOFADE和MINOLIRA的新處方潛在需求也顯著增加，Wynzora的ACP附加條款活動也有所增加。 Wynzora於2021年中期上市，其所處的乾癬治療市場擁有眾多選擇。因此，在競爭激烈的市場中，這是一個正面的趨勢。本季度，我們核心推廣產品的處方量和市佔率持續成長。

Q1 RHOFADE total prescription volume of 40,149 was less than 100 prescriptions short of an all-time high set in Q4 2022. This represents an 11% growth over Q1 2022, 18% growth in new prescriptions and all-time highs in both new prescribers and total prescribers of 8,000 and 9,000 respectively. As noted in previous calls, Wynzora was impacted in the second half of 2022 by new competitive launches that have challenged the use of topical steroids in the U.S. for plaque psoriasis. However, our new promotional efforts and execution have returned Wynzora to growth of 9% in Q1 2023 versus Q1 2022. 

2023年第一季度，RHOFADE的總處方量為40,149張，僅比2022年第四季創下的歷史最高紀錄少不到100張。這比2022年第一季增加了11%，新處方量增加了18%，新處方醫生和處方醫生總數分別達到8,000人和9,000人，均創歷史新高。如同先前的電話會議所述，2022年下半年，Wynzora受到競爭對手新產品上市的影響，這些新產品對美國斑塊狀乾癬局部類固醇的使用構成了挑戰。然而，我們新的推廣措施和執行力已使Wynzora在2023年第一季恢復成長，較2022年第一季成長了9%。

MINOLIRA continues to outperform the declining minocycline market for acne, strong growth of 19% in total prescriptions and 18% growth in new prescriptions versus Q1 of 2022. Our strong prescription growth during the quarter was partially offset by 2 factors impacting our net profitability. We experienced a supply disruption in March for RHOFADE. This issue was quickly resolved and distribution channels restocked and solid demand and pull-through in mid-April.

在痤瘡治療領域，米諾環素類藥物MINOLIRA持續跑贏下滑的市場，總處方量較2022年第一季強勁增長19%，新處方量增長18%。本季強勁的處方量成長被兩個影響淨利潤的因素部分抵消。 3月份，RHOFADE的供應出現中斷。此問題已迅速解決，分銷通路已恢復供貨，4月中旬市場需求強勁，銷售狀況良好。

In addition, as it relates to our gross to net deductions, we experienced an increase in payer rebates as we moved from nonpreferred to preferred coverage, higher patient assistant copay costs due primarily to a coverage mix shift of higher deductible plans and the result of patients' annual coverage deductible resets. We continue to work towards the implementation of tactical and strategic actions to reduce the impact of gross to net adjustments on profitability. Overall, we're excited with the total prescription growth performance, including new and total prescribers for our promoted brands. Thank you.

此外，就我們的毛利與淨利差額而言，由於我們從非優選保險轉向優選保險，支付方返利有所增加；患者輔助支付成本也較高，這主要是由於保險組合中高免賠額計劃的增加，以及患者年度保險免賠額重置所致。我們將繼續努力實施戰術和戰略措施，以降低毛利與淨利差額調整對獲利能力的影響。整體而言，我們對處方總量的成長表現感到滿意，包括我們推廣品牌的新增處方醫生和處方醫師總數。謝謝。

And I will now hand it over to John Gay, our Chief Financial Officer.

現在我將把發言權交給我們的財務長約翰·蓋伊。

Thanks, John, and thank you to everyone for joining our call today. Before we review the activity for the quarter ended March 31, 2023, I will remind you that when I refer to prior year figures for the quarter ended March 31, 2022, it includes 20 days of activity based upon our March 11 acquisition last year and the related timing of the consolidation of our commercial business within our financial statements. As such, the comparability of the current year versus prior year first quarter should be noted as it relates to this 20-day stub period in the prior year. I'd also like to let our listeners know that we are not yet providing guidance as it relates to Q2 and full year 2023 revenues or EBITDA.

謝謝約翰，也謝謝各位今天參加我們的電話會議。在回顧截至2023年3月31日的季度業績之前，我想提醒各位，當我提及截至2022年3月31日的季度數據時，其中包含了去年3月11日收購後20天的業績，以及相關商業業務併入財務報表的時間安排。因此，在比較本年度與上年同期第一季業績時，應考慮到去年同期這20天的業績影響。此外，我還想告知各位聽眾，我們目前暫不提供2023年第二季及全年營收或EBITDA的業績指引。

For the 3 months ended March 31, our net product sales of $2.4 million included in our commercial businesses total revenue was comprised of $1.1 million for RHOFADE, $0.5 million for Wynzora and $0.3 million for MINOLIRA with other products in our portfolio contributing $0.4 million. The increase in our net product revenue for the 3 months ended March 31, 2023, as compared to the 3 months ended March 31, 2022, was due to the timing of the EPI Health acquisition, offset by the impacts of a manufacturing delay with the supplier for our RHOFADE commercial product. RHOFADE was on backorder beginning in March 2023 until mid-April of this year.

截至3月31日止的三個月內，我們的淨產品銷售額為240萬美元，計入商業業務總收入，其中RHOFADE銷售額為110萬美元，Wynzora銷售額為50萬美元，MINOLIRA銷售額為30萬美元，其他產品組合貢獻了40萬美元。與截至2022年3月31日止的三個月相比，截至2023年3月31日止的三個月內，我們的淨產品收入有所增長，這主要歸功於EPI Health收購的時間安排，但部分被RHOFADE商業產品供應商的生產延遲所抵消。 RHOFADE自2023年3月起一直處於缺貨狀態，直到今年4月中旬才恢復供貨。

This temporary stock out of RHOFADE impacted the overall net product revenue during the first quarter of 2023 as there was a 28% decrease in the number of units sold in Q1 2023 from Q1 2022. I will note that this decrease of units sold is calculated based upon the total units sold in the first year -- prior year first quarter, including units sold by EPI Health prior to the acquisition by Novan. However, I'm pleased to report that the volume of units sold to our customers in mid-April 2023 rebounded when RHOFADE was restocked. 

RHOFADE的暫時缺貨對2023年第一季的整體淨產品收入造成了影響，2023年第一季的銷售量較2022年第一季下降了28%。需要說明的是，這一銷量下降是基於第一年（即上年同期）的總銷量計算的，其中包括Novan收購EPI Health之前該公司的銷量。不過，我很高興地報告，隨著RHOFADE的重新到貨，2023年4月中旬出售給客戶的銷售回升。

License and collaboration revenue on a consolidated basis was $0.6 million for the 3 months ended March 31, 2023. This amount relates primarily to the Sato agreement for the out-license of SB206 recorded in the research and development operations business. Total cost of goods sold recorded in the commercial business was $1.3 million for the 3 months ended March 31, 2023. 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.

截至2023年3月31日止三個月，合併後的許可和合作收入為60萬美元。該金額主要與佐藤公司就SB206對外許可達成的協議有關，該協議已計入研發營運業務。截至2023年3月31日止三個月，商業業務的銷售成本總額為130萬美元。銷售成本包括從第三方製造商購買成品的成本、基於銷售額的特許權使用費和里程碑付款以及其他第三方智慧財產權授權費用。

For the 3 months ended March 31, 2023, we recognized net product revenue related royalty expense of $0.7 million within cost of goods sold. This amount included our current obligation to third parties in addition to amounts related to the accounting presentation for the MC2 licensing agreement. R&D business incurred research and development expenses of $4.8 million for the 3 months ended March 31, 2023 and 2022. Included in the fluctuation from the prior year quarter was a $1 million net decrease in the SB206 program related to the SB206 NDA submission in January of '23, offset by a $1 million increase in expense related to a regulatory milestone payment, which became due to Ligand Pharmaceuticals during the first quarter of 2023.

截至2023年3月31日止三個月，我們在銷售成本中確認了與產品淨收入相關的特許權使用費支出70萬美元。該金額包括我們對第三方的當期義務，以及與MC2授權協議會計處理相關的金額。研發業務在截至2023年及2022年3月31日止三個月期間產生了480萬美元的研發費用。與上年同期相比的波動包括SB206項目因2023年1月提交SB206新藥申請而導致的100萬美元淨減少，但被與2023年第一季度應付給Ligand Pharmaceuticals的監管里程碑付款相關的100萬美元支出增加所抵消。

On a consolidated basis, SG&A expenses were $10 million for the 3 months ended March 31, 2023 and 2022. Included in the fluctuation from the prior year was a $4 million net decrease and transaction-related expenditures in connection with the EPI Health acquisition, offset by an increase of $3.7 million of selling, general and administrative expenses incurred to support the conduct of our commercial business operations. Consolidated net loss was $14.1 million for the 3 months ended March 31, 2023, compared to $13.4 million for the prior year comparable period.

截至2023年3月31日及2022年3月31日止三個月，合併後的銷售、一般及行政費用均為1,000萬美元。與上年同期相比的變動包括400萬美元的淨減少以及與收購EPI Health相關的交易支出，但被為支持公司商業運營而增加的370萬美元銷售、一般及行政費用所抵消。截至2023年3月31日止三個月，合併淨虧損為1,410萬美元，而上年同期為1,340萬美元。

As it relates to our balance sheet, as of the end of the quarter, we had a total cash balance of $12.5 million and accounts receivable totaling $13.8 million. In the first quarter of 2023, 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 in Japan, and we have continued to use our $15 million accounts receivable back factoring facility, 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，截至本季末，我們的現金餘額總額為1,250萬美元，應收帳款總額為1,380萬美元。 2023年第一季度，我們完成了一項註冊直接發行，募集資金總額為600萬美元。我們收到了佐藤公司支付的500萬美元預付款，該款項與RHOFADE在日本的對外授權協議相關。此外，我們繼續使用1500萬美元的應收帳款反向融資額度，該額度可提供高達我們商業業務合格應收帳款總額70%的營運資金。

We will need additional funding to support our planned and future operating activities related to our berdazimer gel, 10.3% product candidate and our business in general. We believe that our existing cash and cash equivalents as of March 31, 2023, plus expected receipts associated with product sales from our commercial part portfolio will provide us with liquidity to fund our planned operating needs into the late second quarter of 2023. The variability in our operating forecast, driven primarily by commercial product sales, timing of operating expenditures and unanticipated changes in net working capital may impact our cash runway.

我們需要額外的資金來支持我們與10.3%候選產品berdazimer凝膠相關的計劃和未來營運活動，以及我們整體業務的營運。我們相信，截至2023年3月31日，我們現有的現金及現金等價物，加上我們商業產品組合的預期銷售收入，將為我們提供足夠的流動資金，以滿足我們計劃的營運需求，直至2023年第二季末。我們的營運預測存在波動，主要受商業產品銷售、營運支出時間表以及淨營運資本意外變化的影響，這可能會影響我們的現金儲備。

We continue to be laser focused on obtaining the additional funds necessary to get to a potential approval and launch of berdazimer gel, 10.3%, if approved, including evaluating strategic opportunities while at the same time, conserving cash by delaying or deferring certain expenditures. We have been pursuing and will continue to pursue additional capital through a broad range of financing strategies and other strategic alternatives.

我們將繼續全力以赴籌集必要的額外資金，以期最終獲得批准並推出10.3%的伯達齊默凝膠（berdazimer gel）。如果獲得批准，我們將評估各種策略機遇，同時透過延遲或延期某些支出來節省現金。我們一直在尋求並將繼續透過多種融資策略和其他策略選擇來籌集額外資金。

With that, I'll hand it back to Paula.

說完，我就把它還給寶拉。

Thank you, John and John. I truly believe that Novan is in a position to succeed with a potential approval and an infrastructure to support a potential product launch. We are highly focused on driving towards the potential approval of berdazimer gel, 10.3% on aligning our commercial infrastructure to support a potential launch on the continued growth of our marketed products and improving the gross to net profitability.

謝謝John和John。我堅信，Novan公司具備成功的能力，只要獲得潛在批准並擁有支援產品上市的基礎設施。我們目前高度重視推動berdazimer凝膠的潛在批准，同時致力於調整商業基礎設施以支持產品上市，並持續推動現有產品的銷售成長，提高毛利率和淨利率。

And as John mentioned, we continue to aggressively pursue additional potential capital or strategic relationships to provide the funding necessary to progress the development of necessary to progress the development of berdazimer gel. And these activities include the evaluation of options such as debt, equity, in-license, out-license acquisition or sale of an asset, a business unit or the company. In closing, we at Novan are committed to building a premier medical dermatology company. We remain focused on executing and delivering results, and we're excited for our future. So thank you.

正如約翰所提到的，我們正積極尋求更多潛在資金或策略合作關係，以籌集推進伯達齊默凝膠研發所需的資金。這些活動包括評估各種方案，例如債務融資、股權融資、引進許可、對外許可、收購或出售資產、業務部門或公司。最後，Novan致力於打造一流的皮膚病醫療公司。我們將繼續專注於執行和交付成果，並對未來充滿信心。謝謝。

And operator, you may now open the line for questions.

接線員，現在可以開始接受提問了。

(Operator Instructions) The first question comes from Oren Livnat with H.C. Wainwright.

（操作說明）第一個問題來自 Oren Livnat 和 H.C. Wainwright。

I have a few. Just on the API business, I understand it's been a little volatile for different reasons the last few quarters. Aside from the destocking, in particular, this quarter, can you give us an update on the progress with the prior issue you called out with regards to pharmacies, maybe inappropriately pushing patients to co-pay cards rather than through existing insurance coverage? And are you able to quantify the, I guess, dollar hit this quarter from that destocking? Should we expect that to fully reverse in Q2 such that sales will exceed maybe underlying demand by the same amount?

我有一些問題。就API業務而言，我了解到過去幾個季度由於各種原因，業務波動較大。除了本季的去庫存之外，您能否更新一下您之前提到的關於藥房的問題進度？藥局可能不當地引導患者使用自付費用卡而不是透過現有保險支付。您能否量化一下本季去庫存造成的實際損失？我們是否可以預期這種情況會在第二季完全逆轉，銷售額將超過潛在需求相同的幅度？

Yes, we have been able, as we noted, working with the pharmacies and seeing the issues that we saw in the second half of 2022. We have seen some improvement, but we do believe that the first quarter seasonality with the higher deductible plans reset and also seen a shift to higher deductible plans has muddied that picture a little bit for Q1. We feel like it's a seasonality. We've seen that across the industry with not only competitors, but other companies. And we feel like that will even out, if you will, over the next couple of quarters. We've also begun implementing working closely with our pharmacy -- network pharmacy partners in order to have better data and metrics as we mentioned, in the second half of the year, and that's continued into Q1. So yes, and I'll hand it over to John, and he can provide a little bit more on the impact of the stock out.

是的，正如我們之前提到的，我們一直在與藥局合作，並關注我們在2022年下半年遇到的問題。我們看到了一些改善，但我們認為，第一季高免賠額計畫的重置以及向高免賠額計畫的轉變，都對第一季的整體情況造成了一定的影響。我們認為這是一種季節性現象。我們在整個產業都觀察到了這種情況，不僅是競爭對手，其他公司也存在類似情況。我們認為，這種情況會在接下來的幾季逐漸趨於穩定。正如我們之前提到的，為了獲得更好的數據和指標，我們在下半年開始與我們的藥房合作夥伴（即合作藥房）密切合作，這一舉措也延續到了第一季。所以，是的，接下來我將把發言權交給約翰，他可以就股票退出帶來的影響做更詳細的說明。

So related to your question, we did talk a little bit about in the prepared remarks about the decline in units sold. I think to the point of your question, we did see that rebound in mid-April. So a lot of it was a timing issue. And so I think both from a TRx perspective, that growth trajectory continues as it relates to our demand on the sales side that was recouped effectively in April as it relates to continued profitability, I think that will be really twofold. One, it will be addressing some of the gross to net volumes that John just mentioned. But as it relates to total units sold, you see that recovering.

關於您的問題，我們在事先準備好的發言稿中確實談到了銷量下滑的情況。我認為，就您提出的問題而言，我們在四月中旬確實看到了反彈。所以，這很大程度是時機問題。我認為，從TRx的角度來看，這種成長動能將持續保持，這得益於我們四月份銷售的需求恢復，以及持續的獲利能力。我認為這主要體現在兩個方面。首先，它將解決約翰剛才提到的毛銷量與淨銷量之間的差異。其次，就總銷量而言，您會看到它正在復蘇。

Okay. And I know you're not giving guidance for 2Q or beyond. Are you able to sort of characterize what you view the, I guess, you'd call it a normalized size of this franchise, whether it's RHOFADE alone or the whole thing, adjusting for seasonal and onetime pushes and pulls? Do you look at this as a $20 million business, the $25 million in terms of like current run rate? Or is that not something you're able to sort of characterize right now? And I have one follow-up after that.

好的。我知道您不會給予第二季或以後的業績指引。您能否大致描述一下您認為這個系列節目的正常規模是多少？無論是單獨指《RHOFADE》還是整個系列，並考慮季節性因素和一次性因素的影響？您認為以目前的營運速度，這個系列節目的年收入是2000萬美元還是2500萬美元？或者您現在還無法給出確切的估計？之後我還有一個後續問題。

Yes. I think, Oren, to that question. If you look at kind of where we ended up last year on a consolidated basis, we'll just talk about kind of the total net product revenue, right, because the ROE is by far the biggest component of that. We do expect to see growth year-over-year. Now part of that will be because of the full year of activity. But we do expect to see continued growth in the sales, if you will, of our commercial business. As it relates to a run rate, I think as it relates to net product revenues, I think we'll continue to see TRxs grow and sold grow. I think the challenge will be addressing some of these gross to net components. But I think we ended last year roughly $16 million and that product revenue, I think we will see that this year. What percentage, I think will largely be dependent upon the gross to that matter that we discuss.

是的。奧倫，關於這個問題，我想說的是，如果我們回顧去年的合併業績，我們只討論總淨產品收入，因為淨資產收益率（ROE）是其中最重要的組成部分。我們預計將同比增長。部分成長將得益於全年業務活動。但我們也預期商業業務的銷售額將持續成長。就年化成長率而言，我認為就淨產品收入而言，我們將繼續看到處方量和銷售額的成長。我認為挑戰在於如何平衡毛利潤和淨利潤。但我認為我們去年的淨產品收入約為1600萬美元，今年我們預計也能達到這個水準。至於具體百分比，我認為這很大程度取決於我們討論的毛利率。

Okay. And just lastly, to move to SB206, which is obviously the most important thing here. I guess -- well, firstly, related to API, do you just look at it as a bridging strategy essentially to SB206 now? Or should -- are you looking at that as a growing business for the next couple of years beyond this year in your view? And then just on SB206 specifically, did you receive a day 74 letter or I assume you did. And did that -- any changes to your expectations for what you need to do to prepare for approval or activities you need to do after approval to ramp up before launch?

好的。最後，我們來談談SB206，這顯然是最重要的。我想——首先，關於API，您目前是將其視為SB206的過渡策略嗎？還是應該將其視為未來幾年（甚至更遠）的一項持續成長的業務？另外，關於SB206，您是否收到了第74天的通知函？我假設您收到了。收到通知函後，您對審核准備工作或審核後啟動階段的預期是否有任何變更？

I'll start with that one, Oren, and then John can talk about the bridge. So SB206, we in our -- basically our day 60 letter, they gave us all the information that you would typically get in a day 74. So we were thrilled to get all that information in one and get it ahead of time. So we are -- and in that they provided interim dates that are typical on a standard review that get you to the January 5 PDUFA date. So we have all the information we need from them. We will this summer, we'll -- they will have an internal mid-cycle review. And we'll get that input late second, early third quarter, we'll get that input from the agency. So in terms of what we have to do now, we, as I mentioned, are really focusing our effort on the approval and spending less on the prelaunch activities due to our financial situation. So -- but we are preparing our drug substance supply so that we would be in a position to launch in the first half of next year. So there are things that we need to do this year from a manufacturing standpoint to be ready for that. Yes.

我先從這個說起，奧倫，然後約翰可以談談橋樑部分。關於SB206，我們在——基本上是第60天的信函中——他們提供了通常需要到第74天才能獲得的所有資訊。我們很高興能一次獲得所有這些信息，而且是提前獲得。他們還提供了中期日期，這些日期在標準審查中很常見，可以確保我們能夠達到1月5日的PDUFA日期。所以我們已經從他們那裡獲得了所需的所有資訊。今年夏天，他們將進行一次內部中期審查。我們將在第二季末或第三季初收到來自監管機構的回饋。至於我們現在必須做的事情，正如我所提到的，由於我們的財務狀況，我們正在集中精力推進審批，減少上市前活動的支出。但我們正在準備原料藥供應，以便我們能夠在明年上半年上市。所以，從生產製造的角度來看，我們今年需要做一些準備。是的。

And Oren to the first part of your question as it relates to kind of the activity of EPI Health and bridging. And at the end of the day, when we do the acquisition of EPI Health is really twofold rationale. One was to give us the infrastructure to launch SB206 as it relates to the sales force and the relationships. That was a key value proposition as it relates to that acquisition because as folks know, to do that, either build internally or to outsource, if you will, is very expensive. The other benefit, obviously, is that we acquired a great sales team, infrastructure, leadership, management and the (inaudible) RHOFADE is a great product, and we fully expect to be able to use our life cycle management for that product and others in our current portfolio to provide value to shareholders. Now as Paula noted, the long view of Novan is SB206. And at the same time, we do have a current portfolio that we're going to execute against. And we think it does provide value. But again, at the end of the day, the long-term value of one SB206.

奧倫，關於你問題的第一部分，也就是與EPI Health的業務活動和銜接相關的部分。歸根究底，我們收購EPI Health的真正原因有二。一是為我們提供啟動SB206所需的銷售團隊和關係網路等基礎設施。這是此次收購的關鍵價值主張，因為眾所周知，無論是內部建設還是外包，實現這些目標都非常昂貴。另一個顯而易見的好處是，我們獲得了一支優秀的銷售團隊、基礎設施、領導層和管理團隊，而且RHOFADE（聽不清楚）是一款非常棒的產品，我們完全有信心利用我們對該產品以及現有產品組合中其他產品的生命週期管理，為股東創造價值。正如寶拉所指出的，Novan的長期目標是SB206。同時，我們也有現有的產品組合需要執行。我們認為這些產品組合確實能夠創造價值。但歸根結底，一項 SB206 法案的長期價值是什麼？

The next question comes from Jeff Jones with Oppenheimer.

下一個問題來自奧本海默公司的傑夫瓊斯。

You just gave a lot of detail, but a couple of follow-ups here. On MINOLIRA, it looked like sales took a hit as well looking at 4Q to 1Q. Any comment there? And then on the BD front in terms of discussions with Sato around rights beyond Japan. I know there was a clock on those discussions. Can you give us an update on that?

您剛才提供了很多細節，但還有幾個後續問題。關於MINOLIRA，從第四季到第一季的銷售情況來看，似乎也受到了影響。對此您有什麼看法？另外，關於藍色光盤方面，您提到與佐藤先生就日本以外地區的發行權進行的談判。我知道這些談判是有時間限制的。您能為我們提供一下最新的進展嗎？

Jeff, thanks for the question. In regards to MINOLIRA, if you know, we look at the overall market dropped about 14%. And we declined about 1.5%, if you will. So we look at it as just the market overall decline from Q4 to Q1, and we still feel strongly. Also, again, on the net side, as John mentioned, we saw the same implications of the high deductibles and resets. But from a TRx perspective, that's what we're seeing. We still saw a strong prescriber base as compared to Q4, and so it was more driven just by the market itself for the quarter.

Jeff，謝謝你的提問。關於MINOLIRA，如果你了解的話，我們看到整體市場下跌了約14%。而我們自身下跌了約1.5%。所以我們將其視為第四季到第一季整體市場的下滑，但我們仍然對其充滿信心。此外，正如John所提到的，從整體來看，我們也看到了高免賠額和重置的影響。但從處方藥的角度來看，情況確實如此。與第四季相比，我們的處方醫生基礎依然穩固，因此本季的下滑更多是由市場本身驅動的。

Got it. So market in gross to net.

明白了。所以是毛利率換算成淨利率。

From a net, yes. Net revenue perspective. I'll hand it to John for the second part.

從淨收益的角度來看，是的。從淨收入的角度來看。第二點我得承認約翰說得對。

I'll take it. That's okay. So regarding the out-license or they're in-license of RHOFADE into other countries, that clock is not up yet. So we -- that goes into the end of the second quarter. So we'll provide an update at a later point on that.

我接受。沒問題。至於RHOFADE向其他國家的授權許可問題，目前還沒有最終決定。這要到第二季末才能完成。之後我們會提供最新進展。

The next question comes from Jonathan Aschoff with ROTH.

下一個問題來自 ROTH 的 Jonathan Aschoff。

Guys, might the R&D expense drop over the rest of this year, such that year-over-year R&D spend is flat. I believe you mentioned that it would be at least on the fourth quarter call.

各位，今年剩餘時間的研發支出會不會下降，進而使年比研發支出持平？我記得你們在第四季財報電話會議上提到至少會這樣。

Jonathan, yes, you're correct. We expect R&D to be flat compared to last year. And again, the rationale there being is a lot of the activity that we're currently in the process of doing as it relates to the NDAs to mission and administering any responses back from the FDA and preparing the facility that we'll run through R&D. So to answer your question, yes, we expect R&D to be flat year-over-year. And we saw it flat in Q1, although a different reason.

喬納森，是的，你說得對。我們預計研發支出將與去年持平。原因在於，我們目前正在進行大量與新藥申請相關的活動，包括處理FDA的回覆、準備研發設施等等。所以，回答你的問題，是的，我們預計研發支出將與去年持平。第一季的研發支出也與去年持平，儘管原因有所不同。

And are all console stability batches submitted?

所有主機穩定性測試批次都提交了嗎？

Yes. I will take the opportunity to say, you may not have -- there's sort of one line in the queue. We did have an issue with the consoles name. It was conditionally approved by the agency. However, we will not be moving forward with that name. So we have sent in and we have other name options with the agency in terms of getting -- it would be contingently accepted again until we had an approval if we have an approval. But just we won't be using the consoles name anymore.

是的。我想藉此機會說明一下，您可能不知道——目前只有一個排隊的隊列。我們之前確實遇到了主機名稱的問題。雖然官方已經初步批准了這個名稱，但我們不會再繼續使用。我們已經提交了其他備選名稱，並向官方諮詢過——如果最終獲得批准，我們會再次有條件地接受這些備選名稱。但我們不會再使用主機的原名了。

Okay. Back to 206. So will you have the exact same headcount for sales, let's say, in 8-ish months or now you're saying it'll be over the first half of '24 before you can effectively really launch given you'll do less until you'll do less prior to approval, just given the cash position. So will you have the same head count? And would a greater focus on consoles compromise the legacy EPI product sales at all, you think, next year?

好的。回到206號問題。假設8個月左右，你們的銷售團隊人數會跟現在一樣嗎？還是說，考慮到資金狀況，在獲得批准之前，你們會減少投入，所以要到2024年上半年才能真正有效地啟動專案？那麼，你們的團隊人數會和現在一樣嗎？另外，你們認為明年如果更專注於遊戲主機，會不會對EPI傳統產品的銷售造成影響？

Yes. I'll start and if John wants to add. But where we are in headcount is that based on our cash position, we actually have a freeze on hiring for our sales associates. But we're still covering that 40 to 42 territories with the heads that we have. So we won't be increasing that. It was always our plan with SB206. We believe that going upwards 50% to 60% in that range would be the best thing for a launch, but we aren't launching in 2023. And in terms of the positioning is that what you would end up with is berdazimer gel in the first position in RHOFADE in the second and then going on from there.

是的，我先開始，如果約翰想補充的話。就我們目前的人員配置而言，鑑於我們的現金狀況，我們實際上已經凍結了銷售人員的招募。但我們現有的人員仍然涵蓋了40到42個區域。所以我們不會增加人手。這始終是我們SB206的計畫。我們認為，在這個範圍內增加50%到60%的人員配置對產品上市來說是最佳方案，但我們不會在2023年上市。至於產品定位，最終的結果是：Berdazimer凝膠排在第一位，RHOFADE排在第二位，然後依序遞增。

Yes, I just think -- to follow up just on Paula's point, when you look at the legacy EPI brands, we're going to target the same physicians. So that footprint of representatives will complement as we launch berdazimer. Also, we have a strong rider base, both RHOFADE, Wynzora and MINOLIRA and we feel confident that, that rider base will remain strong and then and continue to move forward and grow those products even with the launch. It's a very complementary selling point with all 3 current products and then with berdazimer. Obviously, I think the top 3 berdazimer, RHOFADE and Wynzora will all do very well. And MINOLIRA in an oral antibiotic market will be moved to fourth position at that particular point.

是的，我只是想補充Paula的觀點，當我們審視現有的EPI品牌時，我們會瞄準相同的醫生群體。因此，當我們推出berdazimer時，現有的銷售代表網絡將起到互補作用。此外，我們擁有強大的客戶基礎，包括RHOFADE、Wynzora和MINOLIRA，我們相信，即使在新藥上市後，這部分客戶基礎仍將保持強勁，並繼續推動這些產品的成長。這與現有的三款產品以及berdazimer的銷售優勢非常互補。顯然，我認為berdazimer、RHOFADE和Wynzora這三款產品都將表現出色。而MINOLIRA在口服抗生素市場中，屆時將躍升至第四位。

Okay. You guys mentioned something about $700,000 booked into COGS. Does that mean there's another $550,000 that needs to be booked this quarter as it relates to the $1.25 million to a third party, you have to pay from Sato's $5 million?

好的。你們提到有70萬美元計入銷售成本。這是否意味著本季還需要計入另外55萬美元，因為這筆錢與支付給第三方的125萬美元有關，而這筆錢需要從佐藤的500萬美元中支付？

Sato, we've recorded that accrual, if you will, in COGS at the end of Q4. So as it relates to my prepared remarks and COGS of roughly 1.3. $700 million of that is really the rest is what I would say is product COGS as it relates to the acquisition of materials for selling. But to your point, that prior milestone was recorded in Q4.

佐藤，我們已經在第四季末的銷售成本中計入了這筆應計項目。至於我之前準備的發言，大約13億美元的銷售成本中，7億美元其實是剩餘部分，也就是與採購銷售材料相關的產品銷售成本。但正如您所說，先前的里程碑事件已計入第四季度。

And I guess it's safe to say that any sort of view towards in-licensing any new products is deemphasized for the time being yes?

所以我想可以肯定地說，目前任何引進新產品的想法都被弱化了，對嗎？

I think that's probably a fair assumption.

我認為這可能是個合理的假設。

The next question comes from Jeff -- excuse me, Dolliver from Brookline Capital Markets.

下一個問題來自 Jeff——抱歉，是 Brookline Capital Markets 的 Dolliver。

Great. A couple of questions. First, there was the comment in the slide deck about streamlining the commercial team, but it looks like the size of the commercial team has remained steady. What changes did you implement in the quarter?

好的。我有幾個問題。首先，投影片提到要精簡商務團隊，但看起來商務團隊的規模保持穩定。請問本季你們做了哪些調整？

I'm not sure what you're referring to in terms of the size of the commercial team because the commercial team has decreased in size by -- compared to the fourth quarter.

我不確定你指的是商業團隊的規模，因為與第四季相比，商業團隊的規模已經減少了——。

In the number of territories.

領土數量。

Okay. Yes. So we've said that we cover 42 territories, and that's generally been with 40 to 42 people. We're currently around 37%.

好的。是的。我們之前說過，我們的業務涵蓋42個地區，通常需要40到42人。目前我們的人員配備率約為37%。

And then with regard to the marketing initiatives that you've commenced for the promoted products, what are you doing differently versus last year?

那麼，關於您為推廣產品所進行的行銷活動，與去年相比，您有哪些不同之處？

Yes. So we -- in Q1, we launched brand-new campaigns for both RHOFADE and Wynzora, which you've seen the uptick in performance. We also moved to digital platforms and selling tools for our representatives has been a real nice addition into the marketplace. We definitely executed on our strategy to build Wynzora awareness and usage hitting all-time highs in total rider for Q1 and we definitely focus on our messaging for fast week 1 results as a differentiator in a very busy and competitive psoriasis market. And we've also continued the momentum and strong growth on RHOFADE with all-time highs in new prescriptions. And our goal is still established the medical need of persistent patient erythema and making sure you're treating that with a prescription product. So those initiatives from a marketing perspective, why we tried to ensure we're being fiducially responsible to the shareholders has been received very well in Q1, and you can see that in the prescription group.

是的。第一季度，我們為RHOFADE和Wynzora都推出了全新的推廣活動，您也看到了業績的提升。我們還拓展了數位化平台，並為我們的銷售代表提供了銷售工具，這在市場上是一個非常好的補充。我們切實執行了提升Wynzora知名度和使用率的策略，第一季總處方量創歷史新高。我們將重點放在「第一週見效」這一優勢，以此在競爭激烈的乾癬市場中脫穎而出。 RHOFADE也維持了強勁的成長勢頭，新處方量創歷史新高。我們的目標仍然是確立患者持續性紅斑的醫療需求，並確保他們使用處方藥物進行治療。從行銷的角度來看，這些舉措，以及我們努力確保對股東履行信託責任的努力，在第一季都得到了很好的反響，您可以在處方藥業務的業績中看到這一點。

That's great. And the last question relates to the change in formulary position and granted that it's only a couple of months of data. But when you focus on, say, prescriptions versus rebate, from -- and putting aside the seasonal effects, are you seeing a net benefit in revenue from agreeing to higher rebates in exchange for the better formulary positions?

太好了。最後一個問題與藥品目錄排名變化有關，雖然目前只有幾個月的數據。但是，如果只關注處方量與回扣，並且撇開季節性因素不談，您是否看到，為了獲得更好的藥品目錄排名而接受更高的回扣，最終能帶來淨收入增長？

Yes, thank you for the question. So we are excited that we did on one of the major plans moved from nonpreferred to preferred coverage effective January 1. So obviously, we're paying higher rebates, but we'll see better coverage and lower co-pay card costs. We did not see that in Q1 as much as we expected, and we think a lot of that is due just to the shift in high deductibles and also with the reset plans. So it wasn't as clear to see. But on the individual basis, we have seen the benefit. And we believe we'll continue to see that through Q2, Q3 and Q4. So it will continue to improve as we work through pull-through of downstream accounts as well. The dynamic of it being effective January 1 and being pulled through and through all the thousands of downstream accounts is also a part that will increase over the upcoming months. So yes, so we're pleased with it. We feel like moving to a preferred position definitely puts RHOFADE to this particular life cycle in a great position, and the pull-through will continue as we go through the year.

是的，謝謝您的提問。我們很高興地宣布，我們的一項主要計劃已於1月1日起從非優選計劃升級為優選計劃。顯然，這意味著我們需要支付更高的回扣，但同時也能享受更全面的保障和更低的自付卡費用。第一季度，我們並沒有看到預期的效果，我們認為這主要是由於高免賠額的調整以及計劃重置所致，所以效果並不十分明顯。但就個人而言，我們已經看到了好處。我們相信，這種益處將在第二、三、四季持續顯現。隨著我們逐步將優惠政策推廣到下游帳戶，情況還會繼續改善。此外，由於新計劃於1月1日生效，並將逐步推廣到成千上萬的下游帳戶，因此未來幾個月的效果也會更加顯著。所以，是的，我們對此感到非常滿意。我們認為，進入優先位置絕對會讓 RHOFADE 在這個特定的生命週期中處於非常有利的地位，而且這種勢頭會在今年繼續下去。

The next question comes from John Vandermosten with Zacks.

下一個問題來自 Zacks 的 John Vandermosten。

All right. I want to ask a question on your marketing efforts that you'll make, assuming approval of SB206. Are there any social media or similar approaches that you can use to improve awareness. And I'm wondering what the most effective medium is that you can use to increase awareness of molluscum and even the products that you currently are marketing.

好的。我想問一個關於SB206法案通過後，你們將採取哪些行銷措施的問題。你們是否會利用社群媒體或其他類似方式來提升大眾認知度？另外，我想知道，對於提高大眾對傳染性軟疣以及你們目前正在推廣的產品的認知度而言，最有效的宣傳媒介是什麼？

Yes. So John, thank you. Great question. So we -- before launch, we'll be using our medical affairs organization to make sure there's awareness of molluscum and some of the points Paul mentioned in the previous slides. And then when we look to go forward as far as our marketing efforts, we have developed a great initial launch strategy and promotional plan that will continue to evolve. We'll use the same tools that we're currently using in our existing platform, but absolutely, we'll use digital and social media types of avenues to not only promote the product, but promote the awareness of the disease state as we've noted, to ensure that this absolutely gets treated as a disease, and there's a prescription medication available. We also believe this will help not only in the dermatology market where we have a strong foothold and good relationships, but it will help us our initial launch into pediatrics and as we grow to evolve further down that road. So absolutely.

是的。約翰，謝謝你。問得好。在產品上市之前，我們會利用我們的醫學事務部門，確保公眾對傳染性軟疣以及保羅在前幾張幻燈片中提到的一些要點有所了解。展望未來的行銷工作，我們已經制定了一套完善的初期上市策略和推廣計劃，並且會不斷改進。我們會沿用現有平台使用的工具，但肯定會利用數位媒體和社交媒體等管道，不僅推廣產品，還會提高公眾對這種疾病的認知，正如我們之前提到的，確保傳染性軟疣被當作一種疾病來對待，並且有處方藥可用。我們相信，這不僅有助於我們在皮膚科市場站穩腳跟並建立良好關係，還有助於我們初步進軍兒科市場，並隨著我們在該領域的進一步發展而不斷拓展。所以，當然。

Okay. And when you think about splitting the effort between awareness for providers and awareness for patients, how do you look at the effort there, I guess, 50-50 or maybe 75%, 25%? How do you think about that?

好的。那麼，當您考慮將精力分配在提高醫護人員意識和提高病患意識時，您認為應該如何分配呢？ 50-50，還是75%、25%？您是怎麼考慮的？

Yes. I think that will primarily be driven off of resources and funding as well. I think primarily, the beginning part will be around awareness at the physician level. And as we evolve and grow, the opportunity to expand that to patients and also caregivers of patients is a fantastic opportunity. And again, I think cash resources will be a primary driver from that perspective. But our market research does show that, that ability to reach the patient and the patient caregiver can absolutely impact this opportunity.

是的。我認為這主要取決於資源和資金。我認為初期階段主要在於提高醫師的認知度。隨著我們不斷發展壯大，將認知度擴展到患者及其照顧者是一個絕佳的機會。同樣，我認為資金支持將是推動這一目標實現的主要因素。但我們的市場調查也表明，能否有效觸達患者及其照顧者，對實現這一目標至關重要。

Great. And regarding RHOFADE in Japan with Sato, what is the development time line and process for that going forward?

好的。關於佐藤在日本的 RHOFADE 項目，接下來的開發時間表和流程是什麼？

Yes. So the process is that -- and that is really for them to share for a timetable, but there is some development effort that is necessary in country before they launch. So they are begetting that process now getting ready to do the small development effort that they need there to then commercialize. So it won't be immediate.

是的。具體流程是這樣的——至於時間表，他們需要自己公佈——但在正式推出之前，需要在目標國家進行一些研發工作。所以他們現在正在啟動這個過程，準備進行必要的研發工作，以便最終實現商業化。因此，產品不會立即上市。

Got it. And I was looking at analyst estimates for the psoriasis category. It looks like they're going to be about up 3% to a little over $30 billion. And I'm wondering, there's a few new entries into the category. And I'm wondering is it becoming more competitive? Or is there more potentially complementary among the medicines there in these combination approaches, I guess, being used to more effectively treat. What are your thoughts on that?

明白了。我正在查看分析師對銀屑病市場的預測。看起來市場規模將成長約3%，略高於300億美元。我想知道，這個領域出現了一些新藥。我想知道，競爭是否會變得更加激烈？或者說，在這些聯合療法中，藥物之間是否具有更強的互補性，從而能更有效地治療銀屑病？您對此有何看法？

Yes. And when you think about the competition, it's not only there's more entrants, which we have noted is great for the market itself because as we know, there's usually numerous prescriptions written to address the disease state. Part of it is just the size and the amount of investment coming in from these new companies. It's both larger pharma companies with biologics and then the nonsteroidal companies that have invested a significant amount of investment, both from a field size perspective, you've seen DTC kind of campaigns coming out and additional types of promotional.

是的。說到競爭，不僅僅是進入市場的新公司更多了——我們注意到這對市場本身是好事，因為眾所周知，針對同一種疾病通常會開出很多處方——部分原因還在於這些新公司的規模和投資額。既有大型製藥公司在生物製劑領域投入巨資，也有非類固醇類藥物公司投入大量資金。從市場規模來看，我們看到了面向消費者的直接行銷活動和其他類型的推廣活動。

So it's more around the size of the resources and investment in here. And again, I think it's been great. We believe it's been great for the market itself. It's the awareness and the opportunities. But as we've stated, steroid use and especially a combination product with a steroid in the vitamin D analog have an extreme place and benefit to these patients, and that awareness only highlights the fast-acting need to address psoriasis. And we feel like with Wynzora, that meets all patient needs from that spectrum and the increased competition and awareness is good for the marketplace.

所以，關鍵在於資源和投資的規模。再次強調，我認為這非常棒。我們相信這對市場本身來說是件好事。這體現在人們對銀屑病的認知和機會。正如我們之前所說，類固醇的使用，尤其是將類固醇與維生素D類似物結合使用的產品，對這些患者來說具有極其重要的意義和益處，而這種認知的提高也凸顯了快速治療銀屑病的迫切需求。我們認為，Wynzora能夠滿足所有患者的需求，而日益激烈的競爭和公眾認知的提升對市場發展是有益的。

This concludes our question-and-answer session. I would like to turn the conference back over to Paula Brown Stafford for any closing remarks.

問答環節到此結束。現在我將會議交還給寶拉·布朗·斯塔福德女士，請她作總結發言。

Thank you all. Thank you, analysts, for your very good questions. I appreciate those. In conclusion, we believe the opportunity for berdazimer gel is compelling. And Novan remains focused on executing and delivering results, and we're excited for our future. Thank you for being with us.

謝謝大家。感謝各位分析師提出的寶貴問題，我非常感激。總而言之，我們認為berdazimer凝膠的市場前景十分廣闊。 Novan將繼續專注於執行計劃並取得成果，我們對未來充滿信心。感謝各位的參與。

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

會議已結束。感謝您參加今天的報告。您可以斷開連線了。