Harrow Inc (HROW) 2023 Q4 法說會逐字稿

Good morning, and welcome to Harrow's fourth quarter and year-end 2023 earnings conference call. My name is Drew, and I will be your operator for today's call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the call over to Jamie Webb, Director of Communications and Investor Relations for Harrow.

早安，歡迎參加 Harrow 第四季和 2023 年底財報電話會議。我叫德魯，我將擔任今天電話的接線生。（操作員指示）謹此提醒，本次會議正在錄製中。我現在想將電話轉給哈羅公關和投資者關係總監傑米·韋伯 (Jamie Webb)。

Thank you, operator. Good morning, and welcome to Harrow's fourth quarter and year end 2023 earnings conference call. Before we begin today, let me remind you that the Company's remarks may include forward-looking statements within the meaning of federal securities law. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Antero's control, including risks and uncertainties described from time to time in its SEC filings such as the risks and uncertainties related to the Company's ability to make commercially available is the FDA approved products and compounded formulations and technologies and FDA approval of certain drug candidates in a timely manner or at all.

謝謝你，接線生。早安，歡迎參加哈羅公學第四季和 2023 年底的財報電話會議。在今天開始之前，讓我提醒您，公司的言論可能包括聯邦證券法含義內的前瞻性陳述。前瞻性陳述受到眾多風險和不確定性的影響，其中許多風險和不確定性超出了Antero 的控制範圍，包括在其SEC 文件中不時描述的風險和不確定性，例如與公司商業化能力相關的風險和不確定性。 FDA 及時或根本批准了產品和複合製劑和技術，並且 FDA 批准了某些候選藥物。

For a list and description of those risks and uncertainties, please see the Risk Factors section of the Company's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Erroneous results may differ materially from those projected herein disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

有關這些風險和不確定性的清單和描述，請參閱公司向美國證券交易委員會提交的最新 10-K 表年度報告以及隨後的 10-Q 表季度報告的風險因素部分。錯誤的結果可能與此處預測的結果有重大差異，無論是由於新資訊、未來事件或其他原因，我們不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務。

This conference call contains time-sensitive information and is accurate only as of today. Additionally, here, I will refer to non-GAAP financial metrics, specifically adjusted EBITDA and our adjusted earnings as well as core results for just core gross margin, core net income and core diluted net income per share for a reconciliation of any non-GAAP measures with the most directly comparable GAAP measures is included in the company's earnings release and letter to stockholders, both of which are available on the website.

本次電話會議包含時效性訊息，僅截至今日準確。此外，在這裡，我將參考非公認會計原則財務指標，特別調整後的EBITDA 和我們調整後的收益，以及核心毛利率、核心淨利潤和核心攤薄每股淨利潤的核心業績，以對任何非公認會計原則的調節與最直接可比較的公認會計原則衡量標準包含在公司的收益報告和致股東的信中，兩者均可在網站上取得。

By now, you should have received a copy of the earnings press release. Do you have not received a copy, please go to the Investor Relations page at the Company's website, www.harrow.com. Joining me on today's call are Harrow's Chief Executive Officer, Mark L. Baum; and Arrow's Chief Financial Officer, Andrew Boll. With that, I'll turn the call over to Mark to go over some prepared remarks prior to the question and answer session.

到目前為止，您應該已經收到了收益新聞稿的副本。如果您還沒有收到副本，請造訪公司網站 www.harrow.com 的投資者關係頁面。參加今天電話會議的還有哈羅公學執行長馬克·L·鮑姆 (Mark L. Baum)；以及 Arrow 財務長安德魯波爾 (Andrew Boll)。這樣，我會將電話轉給馬克，讓他在問答環節之前回顧一些準備好的發言。

Thanks, Jamie, and thanks to everyone for joining us on today's call. I wanted to first address the change in cadence for earnings release and conference calls. We believed it was in the best interest of our analysts and investors to extend the amount of time between when we issued our earnings release and hosted our calls, we hoped this would allow more time to digest the results and read through our corporate presentation and my letter to stockholders prior to the call, we hope you have found this timing change helpful.

謝謝傑米，也謝謝大家參加今天的電話會議。我想先解決收益發布和電話會議節奏的變化。我們認為，延長我們發布收益報告和主持電話會議之間的時間符合我們的分析師和投資者的最佳利益，我們希望這將讓我們有更多的時間來消化結果並閱讀我們的公司演示和我的報告。在電話會議之前致股東的一封信，我們希望您發現這一時間變更更有幫助。

So if you're on this call, I assume you'll review these materials, and I'll use this time to augment your understanding through some high-level commentary. 2023, which is now more than 75 days in the rearview mirror was a transformative year for Harrow was a transformation that was four years in the making, all of which I pointed out in my letter to stockholders when I quoted what I said about four years ago in 2020 when we were hatching our plan to become a leading North American ophthalmic pharmaceutical business here or a few of the 2023 fruits of that plan.

因此，如果您參加這次電話會議，我假設您會查看這些材料，並且我將利用這段時間透過一些高級評論來增強您的理解。 2023 年，距離現在已經超過75 天，對哈羅來說是變革的一年，這是一場醞釀四年的變革，我在給股東的信中引用了我所說的四年的內容時指出在所有這些2020 年之前，當時我們正在醞釀了成為北美領先的眼科製藥企業的計劃或該計劃 2023 年的一些成果。

Number one, we achieved record revenues with 2023 revenues increasing 47% over 2022 revenues, two adjusted EBITDA more than doubled in 2023 from 2022. Three, the addition of numerous high utility ophthalmic pharmaceutical products to our portfolio before beginning to generate cash flow from our big three products.

第一，我們實現了創紀錄的收入，2023 年的收入比 2022 年的收入增長了 47%，第二，2023 年調整後的 EBITDA 比 2022 年增長了一倍多。第三，在開始從我們的三大產品產生現金流之前，在我們的產品組合中添加大量高效用眼科藥品。

I hear so Viva and triathlons, which made up our most significant short term and long term financial drivers. And finally, delivering $8.7 million in cash from operating activities in the fourth quarter of last year and delivering our second consecutive year of positive cash flow from operations.

我聽說 Viva 和鐵人三項是我們最重要的短期和長期財務驅動力。最後，去年第四季的營運活動產生了 870 萬美元的現金，並連續第二年實現正營運現金流。

You see we strengthened our balance sheet last year, especially our cash position ending the year with $83 million in cash and cash equivalents, and this includes our position in pharmaceuticals. We expect our cash pile to continue to grow over the coming years.

你看，我們去年加強了我們的資產負債表，特別是我們的現金頭寸在年底達到了 8300 萬美元的現金和現金等價物，其中包括我們在藥品領域的頭寸。我們預計未來幾年我們的現金儲備將繼續成長。

Equally important, we fortified our talent base, adding new members to the Harrow family professionals with experience commercial relationships and fresh perspectives to further enhance our transformation. I have highlighted the names of a few of these folks in both the letter to stockholders and the new hero corporate deck. Our stockholders have been asking us for more granularity around our quarterly results.

同樣重要的是，我們加強了人才基礎，為哈羅家族專業人士增添了新成員，他們擁有豐富的商業關係和新鮮的視角，以進一步促進我們的轉型。我在致股東的信和新英雄公司的幻燈片中都強調了其中一些人的名字。我們的股東一直要求我們提供更詳細的季度業績。

They want to know why we're so bullish on our company and the growth trajectory we see in front of us this cycle. I've tried to provide more granularity this detailed information highlights among other things, the amazing success we've had with our by launch. Based on our success to date, I am convinced that Veeva has the potential to dominate the large US chronic dry eye disease market as the leading cyclosporin and anti-inflammatory product.

他們想知道為什麼我們如此看好我們的公司以及我們在這個週期中看到的成長軌跡。我試圖提供更詳細的信息，這些詳細信息突出顯示了我們的發布所取得的驚人成功。基於我們迄今為止的成功，我相信 Veeva 有潛力作為領先的環孢菌素和抗發炎產品主導美國大型慢性乾眼症市場。

The V. by adoption curve driven by our small but mighty sales force speaks volumes as a positive feedback about Veeva from actual patients on social media, I would encourage you to think about the size of the cyclosporin market alone in the United States has about 8 million units last year. Without question, cyclosporin is the number one, most trusted active ingredient for U.S. dry eye disease patients.

由我們小而強大的銷售團隊推動的 V. 採用曲線很能說明問題，因為社交媒體上的實際患者對 Veeva 的積極反饋，我鼓勵您考慮僅在美國環孢菌素市場的規模就有大約 8去年萬台。毫無疑問，環孢菌素是美國乾眼症患者排名第一、最值得信賴的活性成分。

Eye care professionals, trust, cyclosporin payers, trust, cyclosporin patients, trust cyclosporin. You see the V by tree is rolling with all of our key performance metrics moving in the right direction. In fact, ICEO. of Silarx, our specialty pharmacy partner recently told me that Veeva has been one of if not the most successful launches he has seen mark by word, Veeva will significantly benefit millions of U.S. dry eye disease patients and generate substantial value for Harrow stockholders over a very long period.

眼保健專業人員，信任，環孢素付款人，信任，環孢素患者，信任環孢素。您會看到 V 樹正在滾動，我們所有的關鍵績效指標都在朝著正確的方向發展。事實上，ICEO。我們的專業藥局合作夥伴Silarx 最近告訴我，Veeva 即使不是他所見過的最成功的產品之一，也是最成功的產品之一，Veeva 將極大地造福數百萬美國乾眼症患者，並為Harrow股東創造可觀的價值長時間。

I'll also discuss our progress in manufacturing triathlons, including a production batch, which is set for next month. This is a PPQ batch and to the extent that we're successful meeting, all the parameters would become a commercial batch. I talk about the number of units we expect to have available for sale when triathlons is eventually reintroduced into the market we also lay out the expected addressable market in terms of unit volume and our new pricing, which combined make clear why we believe Trius and should be a multi nine figure revenue product.

我還將討論我們在鐵人三項製造方面的進展，包括定於下個月進行的批量生產。這是一個 PPQ 批次，只要我們成功滿足要求，所有參數都將成為商業批次。我談到了當鐵人三項最終重新引入市場時，我們預計可出售的單位數量，我們還從單位數量和新定價方面列出了預期的潛在市場，這兩者結合起來清楚地表明了為什麼我們相信Trius 並且應該是一個多九位數收入的產品。

And hopefully soon I hit on the continued uptake of by Hazel since its May 2023 launch and news about the recent publication by CMS of the IESOASP. or average selling price in thus positioned ASP. file. This is something that we had previously requested from CMS and it was not acted upon until soon after we met with them on January 9 of this year.

希望我很快就能了解 Hazel 自 2023 年 5 月推出以來的持續使用情況以及有關 CMS 最近發布 IESOASP 的消息。或由此定位的 ASP 中的平均銷售價格。文件。這是我們先前向 CMS 提出的要求，直到今年 1 月 9 日我們與他們會面後不久才採取行動。

I'll also talk about the return of infamous Rx to its previous growth trajectory, fulfilling our performance promise that I made in our last stockholders' letter. I also included quotes from actual users of our products. You see in recent conversations with fellow stockholders.

我還將談論臭名昭著的 Rx 恢復到之前的成長軌跡，履行我在上一封股東信中所做的業績承諾。我還引用了我們產品的實際用戶的言論。你可以在最近與其他股東的對話中看到。

I have noted the reliance on opinions of so-called key opinion leaders, KOLs who Paul my further investigation. It actually not used our products. I thought it was important for you to hear from ophthalmologists and optometrists who with 100% certainty have actually used our products.

我注意到了對所謂關鍵意見領袖、KOL 意見的依賴，他們保佑我進行進一步的調查。它實際上沒有使用我們的產品。我認為對您來說，聽取眼科醫生和驗光師的意見很重要，他們 100% 確定實際上使用過我們的產品。

I also want to mention that it's never been a better time to be a hero stockholder. I say this because of the amazing progress we made in 2023. And because of what is right in front of us, right in front of our eyes, a clear pathway to achieving our goals including significant revenue and profitability growth, ultimately making us a leading strategic North American ophthalmic pharmaceutical company, fine as both a hero stockholder and a senior executive at this company.

我還想提一下，現在是成為英雄股東的最佳時機。我這樣說是因為我們在 2023 年取得了驚人的進步。因為就在我們眼前，就在我們眼前，有一條實現我們目標的明確途徑，包括顯著的收入和盈利增長，最終使我們成為北美領先的戰略性眼科製藥公司，成為英雄股東以及該公司的一名高階管理人員。

I continue to be perfectly fine eating my own cooking. I have never sold a share of Harrow stock, and I do not plan to do so. In fact, recently I purchased Taro shares fact 3 times in the past 12 months precisely because I believe in Harold's long term value and because the shares have been available at an attractive price, we are now happy to answer your questions. I will pause to have our operator poll for questions.

我繼續吃自己做的飯，感覺很好。我從未出售過哈羅的股票，也不打算這樣做。事實上，最近我在過去 12 個月內 3 次購買了 Taro 股票，正是因為我相信 Harold 的長期價值，而且這些股票的價格很有吸引力，我們現在很樂意回答您的問題。我將暫停讓我們的接線員詢問問題。

(Operator Instructions) Mayank Mamtani, B. Riley Securities.

（操作員指示）Mayank Mamtani，B. Riley 證券。

With bonding theme. Thanks for taking our questions and appreciate the granularity provided to what 4Q results and the forward looking outlook. Maybe just on the 2024 guide and also the longer term on '27 number that you put out, are you able to give some breakdown on the incremental contribution that was in there between you three drivers that either drives in them.

具有粘合主題。感謝您提出我們的問題，並感謝我們提供的第四季度結果和前瞻性展望的詳細資訊。也許僅在 2024 年指南以及您發布的 27 號的長期數據中，您是否能夠對三位車手之間的增量貢獻進行一些細分。

We let me why. And also, relatedly notice you didn't give EBITDA guidance of forward-looking. It could help to understand how you're thinking of spend in 2024? And then I have a couple of quick follow-ups.

我們讓我知道為什麼。另外，請注意，您沒有給予前瞻性的 EBITDA 指導。這有助於了解您如何看待 2024 年的支出？然後我進行了一些快速跟進。

Thank you, Mike. Yes. So look, where we are standing behind the better than $180 million in revenue guidance that we put out for 2024. We don't guide by product. And the one comment that I'll make is what I think is 800 pound animal in the room. And that is what we put out today in our Form 8-K filing and the confirmation from CMS that in fact, he so we'll be paid for separately in the physician's office setting is without question the most positive consequential event.

謝謝你，麥克。是的。看看我們為 2024 年制定的超過 1.8 億美元的收入指引。我們不按產品進行指導。我要發表的一個評論是我認為房間裡有 800 磅重的動物。這就是我們今天在 8-K 表格文件中提出的內容，以及 CMS 的確認，事實上，他讓我們在醫生辦公室環境中單獨支付費用，這無疑是最積極的後果事件。

I think that has happened to our company since founded it with Andrew back in 2011. So this is a very big event. It certainly supports our confidence in our guidance, which is a number of greater than $180 million. And but once again, we're not going to guide by product, but we're very excited about what we put out today in the Form 8-K.

我認為自 2011 年與 Andrew 共同創立我們公司以來，這種情況就發生在我們身上。所以這是一個非常大的事件。這無疑支持了我們對超過 1.8 億美元的指導的信心。但再次強調，我們不會按產品進行指導，但我們對今天在 8-K 表格中發布的內容感到非常興奮。

It's something that happened yesterday afternoon about 2 o'clock Central it kind of hit us with a very, very positive surprise, but it certainly gives us far greater confidence in our guidance. In terms of our spend in 2024, Andrew do you want to kind of talk about our approach with some of the spend in the fourth quarter, maybe 2023? And how we're thinking about 2024, especially in light of what we put out in the 8-K this morning.

這是昨天下午 2 點左右發生的事情，這給我們帶來了非常非常積極的驚喜，但它確實讓我們對我們的指導更有信心。就我們 2024 年的支出而言，安德魯，您是否想談談我們對第四季度（也許是 2023 年）的一些支出的方法？以及我們如何看待 2024 年，特別是考慮到我們今天早上在 8-K 比賽中發布的內容。

Yes, I think smart mine think thanks for the question. And you can kind of see some of the expense infrastructure changing in the Q4 numbers, November, we decided to make a shift in our Our plans are we buying this launch on this resulted in a much heavier spend on the sales and marketing efforts in the initial plan for it. And in the K you can kind of read, year over year we added about 100 new employees, some of which the vast majority of those were coming from or came in during the fourth quarter and were really tied to the V by launch on the commercial side from.

是的，我認為聰明的我認為謝謝你的問題。您可以看到第四季度數據中的一些費用基礎設施發生了變化，11 月，我們決定改變我們的計劃，我們購買此產品的推出導致了在銷售和營銷工作上的支出大幅增加。對此的初步計劃。在 K 中，你可以讀到，我們逐年增加了大約 100 名新員工，其中絕大多數來自第四季度或在第四季度加入，並且透過廣告發布真正與 V 聯繫在一起。側從。

And so a lot of that expense is going to obviously continue into 2024. One of the reasons we're not giving specific EBITDA guidance is as revenues grow. We will invest in the the operating expense will invest in the sales and marketing efforts to further revenue growth. And that said, we have a leverage ratio number that we want to we want to get to, which is being having a leverage ratio less than five times.

因此，大部分支出顯然將持續到 2024 年。我們不提供具體 EBITDA 指導的原因之一是隨著收入的增長。我們將投資於營運費用，將投資於銷售和行銷工作，以進一步實現收入成長。也就是說，我們有一個我們想要達到的槓桿率數字，就是槓桿率低於五倍。

And so we're focused on that. But at the same time, we're going to be focused on growing revenues and accelerating revenue growth from these product areas. But we see an opportunity to invest further on the sales marketing side, like Mark said, he's a great example where we're now we've got this great outcome with CMS. It's time to invest more heavily on the sales and marketing efforts there and really kind of put the fruits of now trying to grow revenues.

所以我們專注於此。但同時，我們將專注於增加收入並加速這些產品領域的收入成長。但我們看到了在銷售行銷方面進一步投資的機會，就像 Mark 所說，他是一個很好的例子，我們現在已經透過 CMS 取得了巨大的成果。現在是時候加大對銷售和行銷工作的投資，並真正投入現在努力增加收入的成果了。

Yes, I'll add one further comment to that. And we said this in our Form 10-K, which we filed the you obviously know, and this is kind of hits on one of the points Andrew made related to Oaktree, who is our senior lender, and you probably know that they can receive warrants if our leverage ratio it exceeds 5 times in 2024. And I think both Andrew and I have a far greater confidence, but as a result of the Form 8-K that was filed this morning, we sincerely doubt that our friends at Oaktree will be receiving any warrants under our agreement with them.

是的，我將對此添加進一步的評論。我們在10-K 表格中說了這一點，我們提交了您顯然知道的內容，這對安德魯提出的與橡樹資本相關的觀點之一有所打擊，橡樹資本是我們的高級貸款人，您可能知道他們可以獲得如果我們的槓桿率在 2024 年超過 5 倍，就有保證。我認為安德魯和我都有更大的信心，但根據今天早上提交的 8-K 表格，我們真誠地懷疑橡樹資本的朋友是否會根據我們與他們達成的協議收到任何認股權證。

Yes, that's very helpful color. Thank you. And on the cyber-attack issued in February of good. Could you just clarify if that is unique to hydro and also what visibility you have on a utility by either and yet maintain a clear debate and expectation for that segment to expand, including I think you make some reference to the bilateral IVD procedures.

是的，這是非常有用的顏色。謝謝。並於二月發布了關於網路攻擊的良好報告。您能否澄清一下這是否是水力發電所獨有的，以及您對公用事業公司的可見度，但仍對該部分的擴大保持明確的辯論和期望，包括我認為您提到了雙邊 IVD 程序。

Is that sort of organic demand you're getting from these right now and especially those of you know they're using more I am more worried and injections unbilled days that you can have separate billing for them to do units versus one year or so. And maybe one final question. I wouldn't be right.

您現在從這些產品中得到的有機需求是嗎？特別是那些知道他們使用更多的產品的人，我更擔心的是，注射未計費的天數，您可以為他們的單位與一年左右的時間單獨計費。也許還有最後一個問題。我不會是對的。

What was the first part, Mike, I missed it?

第一部分是什麼，麥克，我錯過了？

The cyber attack issue, whether that is unique to hydro or that's a broader pharma wide issue of processing claims right now.

網路攻擊問題，無論是水電公司獨有的問題，還是目前處理索賠的更廣泛的製藥行業問題。

Sure. Yes. So the issue of Change Healthcare is affected numerous companies, including us that sell not only Part D as in David products, but also Part B as in Bravo product. So the system is still sort of being unplugged and the change healthcare issue has affected payments to our customers from the government and this has affected our sales temporarily in the first quarter, but we are seeing evidence that the systems beginning to be unclog.

當然。是的。因此，Change Healthcare 的問題影響了許多公司，包括我們，它們不僅銷售 David 產品中的 D 部分，還銷售 Bravo 產品中的 B 部分。因此，該系統仍然有點被拔掉，醫療保健問題的變化影響了政府向我們的客戶支付的費用，這暫時影響了我們第一季的銷售，但我們看到有證據表明系統開始暢通。

We expect recovery in full normalization in the second quarter but this is an issue the cyber attack that has affected us, but it has affected many, many companies who are selling to the pharma market in terms of retina, the the reason why we went to CMS and I talked about this in our last letter to stockholders is because there was uptake in the retina market.

我們預計第二季將完全正常化，但這是一個影響我們的網路攻擊問題，它影響了許多向製藥市場銷售視網膜產品的公司，這就是我們去的原因CMS 和我在上一封致股東的信中談到了這一點，因為視網膜市場有所成長。

The retina market is in the form of the intravitreal injection market specifically is a very large market, exceeding 10 million unit opportunities per year. We saw uptake in that market. We were seeing reimbursement happen in that market around the country, but the market is unique in that it is highly concentrated.

視網膜市場以玻璃體內注射市場的形式出現，具體來說是一個非常大的市場，每年超過 1000 萬單位的機會。我們看到了該市場的成長。我們看到全國各地的市場都有報銷，但該市場的獨特之處在於高度集中。

There are very large groups of potential buyers for these these products. And so in the face of those sorts of opportunities in front of us. We thought it was prudent to confirm with CMS that in fact, our J code, which is a product-specific permanent J code, would in fact, be separately reimbursable in the physician's office setting.

這些產品有大量的潛在買家。因此，面對我們面前的這些機會。我們認為謹慎的做法是與 CMS 確認，事實上，我們的 J 代碼（產品特定的永久 J 代碼）實際上可以在醫生辦公室環境中單獨報銷。

And so as we promised in the last letter to stockholders, we requested a meeting with CMS. We had that meeting on January ninth, and we have been waiting patiently to hear from them. As we said in the call, the prepared remarks, we were added to the ASP. file the physicians ASP. file recently, but we did not know whether or not that confirmed separate payment in the physician's office.

因此，正如我們在上一封致股東的信中所承諾的那樣，我們要求與 CMS 舉行會議。我們在 1 月 9 日舉行了那次會議，我們一直在耐心等待他們的消息。正如我們在電話中所說的，準備好的評論，我們已被添加到 ASP 中。向醫生提交 ASP。最近提交了文件，但我們不知道這是否確認了醫生辦公室的單獨付款。

And that happened just yesterday afternoon, which as I said, is a very important event for the Company. Our expectation now is that we will be able to, with this news open up of the market for intravitreal injections that can benefit from the unique it attributes to buy his own and that that is going to start here very, very soon and that it will significantly change.

這件事發生在昨天下午，正如我所說，這對公司來說是非常重要的事件。我們現在的期望是，隨著玻璃體內注射市場開放的消息，我們將能夠從獨特的玻璃體內注射屬性中受益，購買自己的注射劑，這將很快從這裡開始，它將很快開始。顯著改變。

I think the trajectory or I hear So and also, I think for our Company, but he does a fantastic product for that application. It's also obviously used in numerous other ophthalmic interventions, and it's a very, very exciting opportunity for us and thank you.

我認為軌跡或我聽到所以，而且，我認為對於我們公司來說，但他為該應用程式提供了出色的產品。它顯然也用於許多其他眼科幹預措施，這對我們來說是一個非常非常令人興奮的機會，謝​​謝。

And lastly, on the why you put out some good launch metrics that you say it could take up to 18 months for ramp up. So just curious what dynamics in play I have to follow to get visibility and what peak sales could be on that. I'll hop back into queue. Thanks for taking my questions.

最後，關於為什麼您提出了一些良好的發布指標，您說可能需要長達 18 個月的時間才能提升。因此，我只是好奇我必須遵循哪些動態才能獲得可見性，以及其銷售高峰可能是多少。我會跳回隊列。感謝您回答我的問題。

Thank you, Mike. First of all, with respect to ZY., I want to mention a person because V by the team, the commercial effort is being led by a woman named Maria Lloyd, and she is extraordinary and the effort that she has put into this project is just amazing. So I'm really grateful to everything that she has done. He's very experienced.

謝謝你，麥克。首先，關於ZY.，我想提一個人，因為V團隊的商業工作是由一位名叫Maria Lloyd的女性領導的，她非常出色，她為這個項目付出的努力是太棒了。所以我真的很感謝她所做的一切。他非常有經驗。

She was involved in the launch of Restasis knows the dry eye market extremely well. And she's brought a lot of wonderful people into our organization that are working on her team, but as you saw in our recent corporate presentation, all of the numbers, all of the metrics with respect to the Veeva launch are up into the right, which is fantastic.

她參與了 Restasis 的推出，她對乾眼市場非常了解。她為我們的組織帶來了很多優秀的人才，他們在她的團隊中工作，但正如您在我們最近的公司演示中看到的那樣，與Veeva 發布相關的所有數字、所有指標都在正確的位置，這太棒了。

But importantly, the product is performing extremely well in the market. And I referenced the social media information that's out there and publicly available. And so we have very high hopes for that product as I've said for several years, we've studied the dry eye market. We know it very well. We've compounded 0.1% cyclosporin with our infamous Rx business now for over five years.

但重要的是，該產品在市場上表現非常出色。我參考了現有的、公開的社群媒體資訊。因此，正如我多年來所說的那樣，我們對該產品抱有很高的期望，我們已經研究了乾眼市場。我們非常了解這一點。我們將 0.1% 環孢菌素與我們臭名昭著的 Rx 業務混合已有五年多了。

And what Veeva presents to the market is really a complete shift in the cyclosporin market, which is 8 million units strong last year in the U.S. market. So we think we have a product that can dominate the category. And in terms of what what the opportunity is, there's so many patients that have failed other cyclosporin products, whether it's the 0.05% branded version of cyclosporin or its generic version or even the 0.09% cyclosporin product that is branded and available.

Veeva 向市場呈現的確實是環孢素市場的徹底轉變，去年美國市場的環孢素市場銷售高達 800 萬份。所以我們認為我們有一個可以主導該類別的產品。就機會而言，有許多患者對其他環孢菌素產品失敗，無論是 0.05% 品牌環孢菌素或其仿製藥，甚至是品牌和可用的 0.09% 環孢菌素產品。

The tolerability profile of those products is very different from the tolerability profile of VSI. And so there are a lot of people that have failed those products and those are candidates to benefit from device and in terms of what the size of the market can be, this is a product that gives me far greater confidence that the number that I wrote about a couple of letters to stockholders ago, which was a $1 billion in revenue in the aggregate for our product portfolio that that can actually be met.

這些產品的耐受性概況與 VSI 的耐受性概況非常不同。因此，有很多人未能通過這些產品，而這些產品是從設備中受益的候選者，就市場規模而言，這款產品給了我比我寫的數字更大的信心大約是之前寫給股東的幾封信，我們的產品組合的總收入實際上可以達到10 億美元。

I mean that is a that is a real target for us now and the uptake in refi, certainly this Form 8-K that was filed this morning. This puts us in the zone of where we wanted to be I talked about our revenue getting to $1 billion or more with our product portfolio of certain things went our way. Well, the the things that we announced today that certainly qualifies as something going our way. So we're really excited about that and what Maria and her amazing team are doing with Veeva.

我的意思是，這是我們現在的真正目標，也是 refi 的採用，當然也是今天早上提交的 8-K 表格。這讓我們進入了我們想要達到的目標，我談到我們的收入達到 10 億美元或更多，而我們的某些產品組合進展順利。好吧，我們今天宣布的事情肯定符合我們的期望。因此，我們對此以及 Maria 和她出色的團隊與 Veeva 所做的事情感到非常興奮。

Aaron Wukmir, Lake Street Capital Markets.

Aaron Wukmir，湖街資本市場。

Hey, good morning, guys. This is Aaron on the line for Brooks. Appreciate all the color so far, I guess related to trial it has there been anymore on setbacks. I mean, I know you had a few comments in the US in the prepared remarks, but I guess if you could just provide a bit more color on sort of the inventory timing and how you're thinking about that and maybe just your confidence there to get that four before year end would be helpful, sir. Thank you.

嘿，早上好，夥計們。我是亞倫，正在接聽布魯克斯的電話。欣賞到目前為止所有的顏色，我想與嘗試有關，它已經不再有挫折了。我的意思是，我知道您在準備好的發言中對美國發表了一些評論，但我想您是否可以就庫存時間安排以及您對此的看法以及您的信心提供更多信息先生，在年底之前獲得四個會很有幫助。謝謝。

So look, as I said in the letter to stockholders, Triapine was not really being made for more than five years by our manufacturing partner and the people and the processes that are involved in making that product were kind of dormant and because they weren't practicing that knowledge wasn't being produced. And we knew that it was going to be a challenge of reintroducing the product into the market in terms of manufacturing it. But what I can tell you is that the progress that we've made in the last six months in particular is given that everyone in our organization, a very high degree of confidence that we're going to have success meeting all of the required parameters to make trade-offs.

所以，正如我在致股東的信中所說，我們的製造合作夥伴已經五年多沒有真正生產特里亞平了，而且參與生產該產品的人員和流程都處於休眠狀態，因為它們沒有實踐知識並沒有被產生。我們知道，在製造方面將產品重新引入市場將是一個挑戰。但我可以告訴你的是，我們在過去六個月中取得的進展尤其是因為我們組織中的每個人都非常有信心，我們將成功滿足所有必需的參數來做出權衡。

And here very soon, there were people on our organization by the way that were somewhat doubtful. But what I can tell you is at this point because of the progress that we've made, there is no one in our organization, whether they're an employee or a consultant who does not have a high degree of confidence that we're going to have presence made successfully.

很快，我們組織中就有人對此表示懷疑。但我可以告訴你的是，在這一點上，由於我們所取得的進展，我們組織中沒有人，無論是員工還是顧問，對我們的發展沒有高度的信心。將成功出席。

And very soon, we have a batch being produced a PPQ batch, which is effectively a commercial batch that meets the production parameters, the performance specifications that's going to happen, as I said, in the middle of it middle of April. So we'll produce two more batches if that first one is successful and then within a period of a couple of months, we should be able to be back on track.

很快，我們就會生產一批 PPQ 批次，這實際上是一個商業批次，滿足生產參數和性能規格，正如我所說，將在 4 月中旬實現。因此，如果第一批成功，我們將再生產兩批，然後在幾個月內，我們應該能夠回到正軌。

There's quite a bit more information, as I said, in the letter to stockholders and also in our corporate presentation about presence. But it is a very high utility product. It's an unusual product with an unusual label and of the physician community. I can tell you is very interested in seeing it back in the market and we think it's going to happen very soon.

正如我所說，在致股東的信中以及我們關於存在的公司演示中，還有更多資訊。但它是一種非常實用的產品。這是一種不尋常的產品，具有不尋常的標籤，屬於醫生群體。我可以告訴您，您非常有興趣看到它重新回到市場上，我們認為這很快就會發生。

We I can't predict whether it's going to happen I know by June or or by August. What I can tell you is that we're getting very strong help from our our manufacturing partner and our manufacturing partner, as you can see on the box for the product is a very sophisticated organization. And we, as I said, have a high degree of confidence. We'll have Travis back here very, very soon.

我無法預測這是否會在六月或八月之前發生。我可以告訴您的是，我們從我們的製造合作夥伴和我們的製造合作夥伴那裡得到了非常強大的幫助，正如您在產品包裝盒上看到的那樣，這是一個非常複雜的組織。正如我所說，我們擁有高度的信心。我們很快就會讓崔維斯回到這裡。

Great. That's super helpful commentary.

偉大的。這是超級有用的評論。

Thanks.

謝謝。

(Operator Instructions) Jeffrey Cohen, Ladenburg Thalmann.

（操作說明）Jeffrey Cohen、Ladenburg Thalmann。

Good morning. Thanks for taking our questions. I should hold true for Mark and Andrew, firstly, could you talk about perhaps the anticipated cadence on the top line for the year? Should we expect something somewhat linearly increasing as we did last year? And then secondly, on could you touch upon anticipated margins for the year inclusive of trend?

早安.感謝您回答我們的問題。我對馬克和安德魯的看法應該是正確的，首先，您能談談今年營收的預期節奏嗎？我們是否應該期待像去年那樣線性成長？其次，您能否談談今年的預期利潤率（包括趨勢）？

Yes, Andrew, do you want to tackle that? I think we're going to keep our numbers where we are, which is an over $180 million. And I think with that said, the news of this morning our margins should the increase, not decrease. But Andrew, do you want to add anything?

是的，安德魯，你想解決這個問題嗎？我認為我們將保持現有的數字，超過 1.8 億美元。我認為話雖如此，今天早上的消息我們的利潤率應該會增加，而不是減少。但是安德魯，你想補充什麼嗎？

Yes, Jeff, just to reiterate what Mark said from a revenue perspective, we're sticking with what we say, which is more than $180 million this year, and we feel like it strongly intact. And then on EBITDA margins or operating margins, the approach is going to be kind of dependent upon revenue opportunity. And so we're going to kind of temper and for revenue growth with EBITDA expectations.

是的，傑夫，只是從收入角度重申馬克所說的話，我們堅持我們所說的，今年的收入超過 1.8 億美元，我們感覺它完好無損。然後，就 EBITDA 利潤率或營業利潤率而言，該方法將在一定程度上取決於收入機會。因此，我們將根據 EBITDA 預期調整收入成長。

I mentioned the leverage ratios, and we want to be sure we're coming in under four times levered at the end of the year. Some But outside of that will continue if we see opportunities to invest in that revenue growth plan for the out years, especially I'm thinking about Veeva, can you give us a Easel and traffic to an extent we'll do it and so that the actual margin percent may be different depending on the revenue number for the year. But certainly we'll keep the leverage ratio in mind as we make investments and and plan for the future.

我提到了槓桿率，我們希望確保到年底我們的槓桿率低於四倍。一些 但除此之外，如果我們看到未來幾年有機會投資該收入增長計劃，特別是我正在考慮 Veeva，您能否給我們一個畫架和流量，我們會這樣做，以便實際利潤率可能會有所不同，取決於當年的收入數字。但在我們進行投資和規劃未來時，我們肯定會牢記槓桿率。

Okay, got it. And lastly, first, could you talk about pricing at all if you take any pricing in '23 years or any anticipated pricing for '24? And any commentary would be appreciated. Thank you.

好，知道了。最後，首先，如果你考慮 23 年的任何定價或 24 年的任何預期定價，你能談談定價嗎？任何評論將不勝感激。謝謝。

Andrew, you want to touch on that? I'll just say to start in that to be clear, our philosophy on on pricing of any product is focused on access and affordability. The that is the cornerstone of our company and there are products that we have raised prices on. There are also other products in our portfolio.

安德魯，你想談談這個嗎？我首先要明確的是，我們對任何產品定價的概念都集中在可及性和可負擔性。這是我們公司的基石，我們已經提高了一些產品的價格。我們的產品組合中還有其他產品。

We've actually lowered prices on and made and even more accessible. But before we do anything, just philosophically, we always make sure that we have a patient assistance program in place that is aggressive, whether it's a branded product or a compounded product to ensure access and affordability to anyone who can benefit from our product. Andrew, do want to add anything on pricing?

實際上，我們已經降低了價格，並使之變得更加容易獲得。但在我們做任何事情之前，從哲學上講，我們始終確保我們有一個積極的患者援助計劃，無論是品牌產品還是複合產品，以確保任何可以從我們的產品中受益的人都能獲得併負擔得起。安德魯，想在定價方面添加一些內容嗎？

Yes, Jeff, just some more specifically in the corporate deck, we have some some wholesale acquisition cost pricing for some of the products tracings from being the most notable one where lack pricing for that product is going to be $944 at the time we relaunched the product into the market. And to Mark's point Black is list price. There's a gross to net element to that.

是的，傑夫，只是在公司層面上更具體一些，我們有一些產品的批發採購成本定價，其中一些產品是最引人注目的，在我們重新推出產品時，該產品的定價將為944 美元。產品投入市場。對馬克來說，黑色就是標價。這其中有一個總的和淨的因素。

And you see that in the accounting and the footnotes, we talked a lot about the growth in our accounting and which factors in the patient assistance programs the co-pay assistance programs, making sure we're living up to our mission change access and affordability for the patient. And so ultimately, we're going to price the products to make sure we have steady supply of the products we can make money, selling the products and getting them to the patients. But we're also keeping in mind that patient home and the actual [settlement].

您會看到，在會計和腳註中，我們談論了很多關於會計增長的內容，以及患者援助計劃、共同支付援助計劃中的哪些因素，以確保我們履行我們的使命，改變訪問和負擔能力為了病人。因此，最終，我們將對產品進行定價，以確保我們有穩定的產品供應，我們可以賺錢，銷售產品並將其提供給患者。但我們也牢記患者之家和實際情況[沉降]。

Yeah, a great example of that related to trade essence is related to transition to the price of trade. Essence had not see any adjustment for 16 years since the product actually hit the market. And so one of the challenges is with a product that's on the FDA's drug shortage list that's not being made that has not been priced competitively.

是的，與貿易本質相關的一個很好的例子就是與貿易價格的轉變有關。自從產品實際上市以來，Essence已經16年沒有出現任何調整。因此，挑戰之一是 FDA 藥品短缺清單上的產品尚未生產且定價不具競爭力。

There's just not a profit incentive to actually make the product available and therefore, it ends up on the drug shortage list year after year after year. And so we thought about pricing for triathlons which is, as Andrew said, [944] unit. We looked at the other preservative free. It came so on product that's in the market. It's not competitive with our product, but it is a preservative free triamcinolone product, and it's priced at more than $1,800 per unit. And so we're almost half of that price.

只是沒有利潤激勵來實際提供該產品，因此，它最終年復一年地出現在藥品短缺名單上。因此，我們考慮了鐵人三項的定價，正如安德魯所說，[944] 單位。我們看了另一種不含防腐劑的。市場上的產品就是這樣。它與我們的產品沒有競爭力，但它是一種不含防腐劑的曲安奈德產品，每單位售價超過 1,800 美元。所以我們的價格幾乎是這個價格的一半。

So we're always going to the lower end price and trying to be more accessible and more affordable on their other intravitreal steroid products that are certainly over $1,400, $1,500 per unit. And so we remain significantly lower than them, but we did adjust the price to create enough profit incentive for us to invest in the product and make sure that we have a steady supply of the product to provide to the market, which is considerable.

因此，我們總是追求較低的最終價格，並努力讓他們的其他玻璃體內類固醇產品更容易獲得、更實惠，每單位肯定超過 1,400 美元、1,500 美元。所以我們仍然明顯低於他們，但我們確實調整了價格，為我們投資產品創造足夠的利潤激勵，並確保我們有穩定的產品供應給市場，這是相當可觀的。

Carsten, I think it does for us. Thanks again for the comprehensive commentary and Rudolf Fischer.

卡斯滕，我認為這對我們有用。再次感謝魯道夫·費雪的全面評論。

Thank you, Jeff.

謝謝你，傑夫。

This concludes our question and answer session. I would like to turn the conference back over to Mark L. Baum for any closing remarks.

我們的問答環節到此結束。我想將會議轉回馬克·L·鮑姆 (Mark L. Baum) 發表閉幕詞。

Thank you, Drew. And I guess I kind of want to apologize to those of you who are waiting for the issuance of our fourth quarter and year end earnings and letter to stockholders less yesterday, which we intended to publish immediately after the market closed. But as I said earlier, very fortunately, yes, fortunately, after drafting all of our documents and preparing our press release and getting everything ready to go, the most positively.

謝謝你，德魯。我想我想向那些正在等待我們發布第四季度和年終收益以及致股東信的人道歉，而不是昨天，我們打算在市場收盤後立即發布這些信。但正如我之前所說，非常幸運，是的，幸運的是，在起草了我們所有的文件、準備了我們的新聞稿並做好了一切準備之後，這是最積極的。

Consequential thing that has happened to our company actually happened on I mentioned the news that we received from CMS yesterday. I was just going to make a huge, though, which is our low viscosity patented topical anesthetic gel, which is doing fantastic things in clinics and surgery centers across the country.

我們公司發生的重大事件實際上發生在我提到昨天我們從 CMS 收到的消息。不過，我只是打算製作一個巨大的，這是我們的低黏度專利局部麻醉凝膠，它在全國各地的診所和手術中心發揮著出色的作用。

It's going to make it separately payable separately reimbursable in the physician's office and it opens up a very large market for IESO., and it allows Medicare beneficiaries to experience the unique benefits of the product. So as we calm down from that excitement and we decided to not delay our filings. We made those filings and then ultimately put out a separate Form 8-K before the market opened revealing this wonderful new development.

它將使其在醫生辦公室單獨支付、單獨報銷，這為IESO開闢了一個非常大的市場，並且讓醫療保險受益人體驗到該產品的獨特好處。因此，當我們從興奮中平靜下來時，我們決定不推遲我們的申請。我們提交了這些文件，並最終在市場開市前發布了一份單獨的 8-K 表格，揭示了這一精彩的新發展。

So once again, we apologize for being slightly tardy yesterday and publishing everything I heard from some of our stockholders, but we hope you appreciate that this was an example of no news being very good news. Indeed, yesterday was special for every member of the aero family, and it was an answer to some of our players actually on past letters to stockholders.

因此，我們再次為昨天稍微遲到並發布我從一些股東那裡聽到的所有內容而道歉，但我們希望您能理解這是一個沒有消息就是好消息的例子。事實上，昨天對於航空家族的每一位成員來說都是特別的，這實際上是對我們一些球員在過去致股東信中的答复。

As I mentioned earlier, I have opined about aggregate revenue potential. It said that our product portfolio can achieve $1 billion in annual revenue, if as I said some things go. Our way from yesterday's news was an example of a thing that went our way. It's a beautiful thing for many reasons because we're seeing amazing stories, practical stories of how I hear those positively changing anesthesia protocols around the country for ophthalmic procedures, Stephen, reducing patient exposure to dangerous opioids.

正如我之前提到的，我對總收入潛力發表了看法。它說，如果像我說的那樣，我們的產品組合可以實現 10 億美元的年收入。昨天的新聞就是我們所經歷的事情的一個例子。出於多種原因，這是一件美麗的事情，因為我們看到了令人驚嘆的故事，我如何聽到全國各地眼科手術麻醉方案發生積極變化的實際故事，斯蒂芬，減少患者接觸危險的阿片類藥物。

Our team feels very good about what we believe is going to happen to a he though and therefore Harrow. So they close this communication from what has been a world win a couple of days. I want to acknowledge and thank all members of our hero family, our loyal employees, their families, support our employees and our stockholders for their patience and steadfast support.

我們的團隊對我們相信將發生在他身上以及哈羅公學上的事情感到非常滿意。因此，他們在幾天前贏得了世界冠軍後就結束了這種溝通。我要感謝我們英雄家族的所有成員、我們忠誠的員工、他們的家人、支持我們的員工和股東的耐心和堅定支持。

Your belief in our mission has been a cornerstone of our progress. And together, we're going to build a company that we can be proud of never been truer than today that the very best is not only yet to come for Hero, but it is soon to come. Thanks to everyone for attending today's call and for your interest in Harrow, you have any investor-related questions, please email Jamie Webb at J Web -- JWEBB at Harrow, inc.com.

您對我們使命的信念是我們進步的基石。我們將共同打造一家讓我們感到自豪的公司，這一點比今天更加真實：對於 Hero 來說，最好的時刻不僅尚未到來，而且即將到來。感謝大家參加今天的電話會議以及對哈羅的興趣，如果您有任何與投資者相關的問題，請發送電子郵件至 J Web 的 Jamie Webb -- JWEBB at Harrow, inc.com。

This will conclude our call.

我們的通話到此結束。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。