Harrow Inc (HROW) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to Harrow's Q4 2022 Earnings Conference Call. My name is MJ, 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.

下午好，歡迎來到哈羅 2022 年第四季度收益電話會議。我的名字是 MJ，我將是您今天電話的接線員。 （操作員說明）提醒一下，正在錄製此會議。我現在想把電話轉給 Harrow 的傳播和投資者關係總監 Jamie Webb。

Thank you, operator. Good afternoon, and welcome to Harrow's Fourth Quarter and Year-end 2022 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 Harrow'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 its FDA-approved products and compounded formulations and technology and FDA approval of certain drug candidates in a timely manner or at all.

謝謝你，運營商。下午好，歡迎來到哈羅 2022 年第四季度和年終收益電話會議。在我們今天開始之前，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哈羅的控制範圍，包括不時在其提交給美國證券交易委員會的文件中描述的風險和不確定性，例如與公司將其商業化的能力相關的風險和不確定性FDA 批准的產品和復合配方和技術，以及 FDA 及時或根本不批准某些候選藥物。

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. Harrow's results may differ materially from those projected. Harrow 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列表和描述，請參閱公司最近向美國證券交易委員會提交的 10-K 表格年度報告和隨後的 10-Q 表格季度報告的風險因素部分。 Harrow 的結果可能與預期的結果大相徑庭。 Harrow 不承擔更新或修改任何財務預測或前瞻性陳述的任何意圖或義務，無論是因為新信息、未來事件還是其他原因。

This conference call contains time-sensitive information and is accurate only as of today. Additionally, Harrow referred to non-GAAP financial metrics, specifically adjusted EBITDA and/or adjusted earnings as well as core results such as core gross margin, core net income and core diluted net income per share. 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.

此電話會議包含時間敏感的信息，並且僅在今天準確。此外，Harrow 還提到了非 GAAP 財務指標，特別是調整後的 EBITDA 和/或調整後的收益，以及核心毛利率、核心淨收入和核心稀釋每股淨收入等核心業績。任何非 GAAP 指標與最直接可比的 GAAP 指標的對賬包含在公司的收益發布和致股東的信中，兩者都可以在網站上找到。

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

到目前為止，您應該已經收到一份收益新聞稿。如果您沒有收到副本，請訪問公司網站 www.harrow.com 的投資者關係頁面。和我一起參加今天電話會議的還有哈羅 (Harrow) 的首席執行官馬克·鮑姆 (Mark L. Baum)；和哈羅的首席財務官 Andrew Boll。有了這個，我想把電話轉給馬克，讓他在問答環節之前複習一些準備好的評論。

Thanks, Jamie, and thanks to everyone for joining us on today's call. Our fourth quarter 2022 earnings release, corporate presentation and letter to stockholders have all been posted to the Investor Relations section of our website. I want to encourage you to review these documents for a better understanding of the company's results. In particular, consider reviewing our stockholder letters, which I believe will help you track where we've been and where we're heading as we execute our strategy to become a leading U.S. ophthalmic pharmaceutical company.

謝謝杰米，也感謝大家參加今天的電話會議。我們的 2022 年第四季度收益發布、公司介紹和致股東的信都已發佈到我們網站的投資者關係部分。我想鼓勵您查看這些文件，以便更好地了解公司的業績。特別是，考慮查看我們的股東信，我相信這將幫助您了解我們在執行成為美國領先的眼科製藥公司的戰略時所取得的成就和前進的方向。

Many of you know that I'm a follower and admirer of the great American businessmen, capitalists and philosophers, Warren Buffett and Charlie Munger. Our stockholder letters are inspired by Mr. Buffett's similar annual letters for Berkshire Hathaway. This latest stockholder letter stands out because it describes a bit of the history of our company, which is important to know as we enter our third 5-years planning cycle. And for those stockholders who want to know more about our tortuous history, there is an entire section of our Investor Relations section of our website dedicated to this subject.

你們中的許多人都知道，我是偉大的美國商人、資本家和哲學家沃倫巴菲特和查理芒格的追隨者和崇拜者。我們的股東信件的靈感來自巴菲特先生給伯克希爾哈撒韋公司的類似年度信件。這封最新的股東信之所以引人注目，是因為它描述了我們公司的一些歷史，在我們進入第三個 5 年規劃週期時了解這一點很重要。對於那些想更多地了解我們曲折歷史的股東，我們網站的投資者關係部分有一整節專門討論這個主題。

When I read it, I remind myself of the challenges we have had breaking gravity, if you will, building our business from scratch. In any case, given the recent banking debacle, it has never been more important to really know what you own, and I hope these stockholder letters provide greater transparency to you as fellow owners of Harrow.

當我讀到它時，我提醒自己我們在打破重力方面所面臨的挑戰，如果你願意的話，從頭開始建立我們的業務。無論如何，考慮到最近的銀行業崩潰，真正了解你擁有什麼變得前所未有的重要，我希望這些股東信件能為哈羅的其他所有者提供更大的透明度。

On this call, I want to make a few comments about the Harrow business, and we'll jump right into our Q&A. As a result of the diligence, tenacity and creativity of the Harrow family, as I promised in prior stockholder letters, 2022 was a transformational year in a positive sense, and 2023 is continuing that momentum. Here are a few examples of what I mean. This January, we completed our fab five transaction, and we're currently working to transfer all the new drug applications connected to those products as quickly as possible, which will allow Harrow to begin the process of reviving marketing and sales detailing for ILEVRO, NEVANAC, VIGAMOX, MAXIDEX and TRIESENCE, products which in the aggregate in recent years, provided north of $200 million in revenue for their former owner.

在這次電話會議上，我想就 Harrow 的業務發表一些評論，我們將直接進入問答環節。由於哈羅家族的勤奮、堅韌和創造力，正如我在之前的股東信中承諾的那樣，2022 年是積極意義上的轉型年，而 2023 年將延續這一勢頭。以下是我的意思的幾個例子。今年 1 月，我們完成了我們的 fab five 交易，我們目前正在努力盡快轉移與這些產品相關的所有新藥申請，這將使 Harrow 能夠開始恢復 ILEVRO、NEVANAC 的營銷和銷售細節的過程、VIGAMOX、MAXIDEX 和 TRIESENCE，這些產品近年來總計為其前所有者提供了超過 2 億美元的收入。

In February, we received a permanent J-code for IHEEZO. And just weeks ago, we received Temporary Pass-through Reimbursement status, making IHEEZO the only topical ocular anesthetic in the U.S. eligible for reimbursement. Combined with the excellent success we've had with our market access strategy to date, these codes should greatly enhance our launch of IHEEZO this May as they will allow increased patient access in every traditional site of ophthalmic care, including the eye care professional's office, the ambulatory surgery center and the hospital and outpatient departments.

2 月，我們收到了 IHEEZO 的永久 J 代碼。就在幾週前，我們獲得了臨時通過報銷資格，使 IHEEZO 成為美國唯一有資格獲得報銷的局部眼部麻醉藥。結合我們迄今為止在市場准入戰略方面取得的巨大成功，這些代碼將極大地促進我們今年 5 月推出的 IHEEZO，因為它們將允許更多的患者進入每個傳統的眼科護理場所，包括眼科護理專業人員的辦公室，門診手術中心以及醫院和門診部。

I want to add that we are not stopping our momentum. In fact, we're currently working on several M&A transactions that are in various phases of closure, including some which are at an advanced stage. We believe closing any 1 of these deals could add rocket fuel, if you will, to our growth trajectory for this year and for many years to come. And while I can't guarantee that any of these transactions will be consummated, I think our recent record for executing complementary M&A transactions speaks for itself. Feel free to review our Q4 numbers, which are available in both our press release and our stockholder letter.

我想補充一點，我們不會停止我們的勢頭。事實上，我們目前正在處理幾筆處於不同關閉階段的併購交易，包括一些處於後期階段的交易。我們相信，如果您願意，完成這些交易中的任何一項都可以為我們今年和未來許多年的增長軌跡添加火箭燃料。雖然我不能保證這些交易中的任何一項都會完成，但我認為我們最近執行補充併購交易的記錄不言自明。請隨時查看我們的第四季度數據，這些數據在我們的新聞稿和股東信中均有提供。

But beginning with the fab five acquisition closing and subsequent market access wins for IHEEZO, and while our core ImprimisRx business is improving and we expect it will only continue to grow, as stockholders, you need to know that the Harrow of Q4 2022 has a different business and financial prospect than the Harrow of Q1 2023. With that said, we are all hands on deck for the launch of IHEEZO in the coming weeks. And as we get deeper into this year, we expect continued momentum as we see the fab five NDAs transfer, we begin to execute our strategy with VIGAMOX, TRIESENCE comes back into stock and hopefully, we're able to close some of these acquisitions.

但是，從 IHEEZO 完成五家晶圓廠收購和隨後贏得市場准入開始，雖然我們的核心 ImprimisRx 業務正在改善，我們預計它只會繼續增長，但作為股東，你需要知道 2022 年第四季度的 Harrow 有一個不同的業務和財務前景比 2023 年第一季度的 Harrow 還要好。話雖如此，我們都準備好在未來幾週推出 IHEEZO。隨著我們今年的深入，我們預計隨著五個 NDA 的轉讓，我們將繼續保持增長勢頭，我們開始執行我們與 VIGAMOX 的戰略，TRIESENCE 重新上市，希望我們能夠完成其中的一些收購。

The bottom line for us is that by leveraging the resources and infrastructure that we've put into place, 2023 should be a breakout year, and I believe that we have positioned Harrow to be the largest pure-play ophthalmic pharmaceutical company in the United States, uniquely providing both branded pharmaceutical products and high-quality compounded pharmaceutical products that meet the needs of our more than 11,000 institutional customers and the millions of Americans they serve. We are now happy to take your questions. I will pause to have our operator poll for questions. Operator?

我們的底線是，通過利用我們已經投入的資源和基礎設施，2023 年應該是突破性的一年，我相信我們已經將 Harrow 定位為美國最大的純眼科製藥公司，獨特地提供品牌醫藥產品和高質量的複合醫藥產品，以滿足我們超過 11,000 名機構客戶和他們所服務的數百萬美國人的需求。我們現在很樂意回答您的問題。我會停下來讓我們的接線員投票提問。操作員？

(Operator Instructions)

（操作員說明）

Today's first question comes from Brooks O'Neil with Lake Street Capital Markets.

今天的第一個問題來自 Lake Street Capital Markets 的 Brooks O'Neil。

Obviously, you have a lot on the plate and there's a lot to ask about so I'll try to keep it as focused as I can. I'm hoping, Mark, you might just talk a little bit about your initial -- how the fab five have impacted the company in the first month or 2 of ownership, the steps you're taking, and how you expect that to unfold as the year goes along?

顯然，你有很多事情要做，而且有很多問題要問，所以我會盡量集中註意力。我希望，馬克，你可以談談你最初的想法——五巨頭在所有權的第一個月或第二個月對公司產生了怎樣的影響，你正在採取的步驟，以及你希望如何展開隨著時間的流逝？

Sure. And thanks for the question, Brooks. We closed the transaction. The way the deal works, until we've had the NDA transfer to us, we are not permitted to engage in marketing activities as well as sales detailing activities. So in effect, the level of revenue, the level of profits from these products is relatively consistent with what we've seen before we actually close the transaction. With that said, we do believe in the coming months, we are going to see these NDAs transfer. And I believe the last NDA to transfer will likely be VIGAMOX. We're expecting that sometime in the middle of the summer.

當然。謝謝你的問題，布魯克斯。我們關閉了交易。按照交易的方式，在我們將 NDA 轉讓給我們之前，我們不得從事營銷活動和銷售細節活動。因此，實際上，這些產品的收入水平、利潤水平與我們實際完成交易之前所看到的情況相對一致。話雖如此，我們確實相信在接下來的幾個月裡，我們將看到這些 NDA 的轉移。我相信最後一個轉讓的 NDA 很可能是 VIGAMOX。我們期待在夏季中期的某個時候。

But what I can tell you is that as soon as those NDA transfers take place, that does give us the green light to begin our marketing efforts. It gives us the green light to begin the sales detailing that the former owner had engaged in many years past. Those are the types of activities that led to the types of revenue numbers that I mentioned. We believe that the market need for these products is largely the same today as it was back then when these products were doing $200-plus million in revenue.

但我可以告訴你的是，一旦這些 NDA 轉讓發生，這確實為我們開始營銷工作開了綠燈。它為我們開綠燈，可以開始出售前所有者在過去多年從事的詳細銷售工作。這些是導致我提到的收入數字類型的活動類型。我們相信，今天這些產品的市場需求與當時這些產品的收入超過 200 萬美元時基本相同。

And we are very excited to release our commercial organization in this effort. We think we'll be very successful. Time will tell, but this effort is going to begin in the summer in full steam. But in terms of its impact over the last few months, we really have not seen anything inconsistent with the revenue levels that existed prior to our ownership.

我們非常高興能夠在這項工作中發布我們的商業組織。我們認為我們會非常成功。時間會證明一切，但這項努力將在夏季全面展開。但就其在過去幾個月的影響而言，我們確實沒有看到任何與我們擁有之前存在的收入水平不一致的情況。

Okay, great. So let me just switch over to IHEEZO. I know we're all excited to see that happen. And I think you guys know that I'm not a traditional pharmaceutical analyst, so I'm going to ask you a basic question that hopefully will be helpful to me as well as investors on the call. But talk just a little bit about what it means for IHEEZO, for the company, for doctors, for payers to have the transitional pass-through approval and to have the permanent J-code for that drug.

好的，太好了。所以讓我切換到 IHEEZO。我知道我們都很高興看到這種情況發生。我想你們知道我不是傳統的醫藥分析師，所以我要問你們一個基本問題，希望對我和電話會議的投資者有所幫助。但是，請談談這對 IHEEZO、公司、醫生、付款人獲得過渡性通過批准並擁有該藥物的永久 J 代碼意味著什麼。

Sure. And to be clear, transitional pass-through is a policy that Congress put into place that really facilitates innovation. In the cataract surgery, for example, in the ASC environment, the fees are capitated. And so on a capitated fee environment, there are not the incentives to pharmaceutical companies -- or for pharmaceutical companies to innovate. And so the policy really allows for innovators who come up with a novel product like IHEEZO to get it into the market, and depending on the pricing of the product, to receive payment outside of the capitated fee, outside of the bundled payment.

當然。需要明確的是，過渡性傳遞是國會制定的一項真正促進創新的政策。在白內障手術中，例如在 ASC 環境中，費用是按人頭計算的。在按人頭付費的環境中，沒有激勵製藥公司——或製藥公司進行創新的動力。因此，該政策確實允許創新者想出像 IHEEZO 這樣的新產品，將其推向市場，並根據產品的定價，在捆綁支付之外的人頭費之外收取費用。

And so that is what pass-through is. It allows doctors to try these new innovative products like IHEEZO. And so we did, in fact, receive an exemption from that capitated fee, and so it can be built outside of the bundled fee beginning on April 1. We're really excited about that. As I've said in prior calls, we make drug at Harrow for about 1 out of every 5 cataract surgeries. And so when you think about what that means in terms of numbers, there's 5 million or so cataract surgeries, it's about 1 million procedures a year. And so we're of the belief that our customers, many of them will be excited to try an FDA-approved product as opposed to the compounded products that we've historically sold.

這就是傳遞。它允許醫生嘗試這些新的創新產品，如 IHEEZO。因此，事實上，我們確實獲得了該按人頭收費的豁免，因此從 4 月 1 日開始，它可以在捆綁費用之外構建。我們對此感到非常興奮。正如我在之前的電話中所說，我們在哈羅為大約每 5 次白內障手術中的 1 次生產藥物。因此，當您考慮這在數字方面意味著什麼時，大約有 500 萬次白內障手術，即每年大約 100 萬次手術。因此，我們相信我們的客戶，他們中的許多人會很高興嘗試 FDA 批准的產品，而不是我們過去銷售的複合產品。

They'll also be excited about the opportunity to be -- have reimbursement for the topical anesthetic as opposed to having to pay for it out of their capitated fee, which is what happens when an ASC has to purchase a compounded product. Now with respect to the office environment and the permanent J-code that was issued because the ASC -- in the ASC environment, that is a temporary pass-through period. That is a 3-year period. And there are about 5 million or so procedures, as I said, that we could impact during that period.

他們也會很高興有機會獲得局部麻醉劑的報銷，而不是從他們的人頭費中支付，這是當 ASC 必須購買複合產品時發生的情況。現在關於辦公室環境和因為 ASC 而發布的永久 J 代碼——在 ASC 環境中，這是一個臨時的傳遞期。那是一個3年的時間。正如我所說，在此期間我們可能會影響大約 500 萬個程序。

But in the office environment, the J-code itself is permanent. And what that allows is for physicians to use the product in that environment and to use the J-code for payment. And there is no limitation in terms of the number of years, unlike that of the ASC environment. Now with respect to the temporary nature of the pass-through code, to be clear, we do intend to demonstrate that we may be able to extend that pass-through payment period as some other products in that environment have been extended such as OMIDRIA and DEXTENZA, but we'll have to see how that goes.

但在辦公環境中，J代碼本身是永久性的。這允許醫生在該環境中使用該產品並使用 J 代碼進行支付。並且與 ASC 環境不同，在年數方面沒有限制。現在關於傳遞代碼的臨時性質，需要明確的是，我們確實打算證明我們可以延長傳遞付款期限，因為該環境中的其他一些產品已經延長，例如 OMIDRIA 和DEXTENZA，但我們必須看看情況如何。

Right now, we're very excited about the 3-year temporary pass-through period as well as the permanent J-code, in particular, to potentially impact the intravitreal injection market, which is about twice the size of the cataract surgery market in terms of unit volumes.

現在，我們對 3 年的臨時傳遞期以及永久性 J 代碼感到非常興奮，特別是可能影響玻璃體內註射市場，該市場的規模約為美國白內障手術市場的兩倍單位體積方面。

Great. I'm just going to ask 2 more. I'm sure there are other people who want to ask questions. So I'll ask 1 that may be more appropriate for Andrew, but I think I noticed that G&A expenses were up somewhat this quarter and R&D expenses were down. Can you guys just talk a little bit about the dynamics there and what we should expect going forward?

偉大的。我只想再問2個。我敢肯定還有其他人想問問題。所以我會問 1 可能更適合安德魯，但我想我注意到本季度 G&A 費用有所上升，而研發費用有所下降。你們能談談那裡的動態以及我們對未來的期望嗎？

Andrew, do you want to take that?

安德魯，你想接受嗎？

Yes. Brooks, good to hear from you. Thanks for the question. Appreciate you always asking me a question. Mark talks a lot. I never get to say much. But anyways, to your question specifically on G&A, or SG&A, the expenses were up for the year, which is sort of the trend throughout 2022. We had expenses increase in our SG&A as we prepared for the IHEEZO launch and even as we prepared to kind of bring in these fab five products.

是的。布魯克斯，很高興收到你的來信。謝謝你的問題。感謝你總是問我問題。馬克話很多。我永遠不會說太多。但是無論如何，對於您特別針對 G&A 或 SG&A 的問題，今年的費用有所增加，這在某種程度上是整個 2022 年的趨勢。我們的 SG&A 費用在我們為 IHEEZO 發布做準備時增加了，甚至在我們準備帶上這五種很棒的產品。

But actually, we started to see that settle out a little bit in Q4, so looking at Q3 of 2022, the SG&A expense was slightly down for the quarter, which is great. And you kind of see that in our guidance with the -- a lot of that new revenue falling to the adjusted EBITDA line.

但實際上，我們開始看到第四季度有所解決，所以看看 2022 年第三季度，該季度的 SG&A 費用略有下降，這很好。你可以在我們的指導中看到——很多新收入都落入了調整後的 EBITDA 線。

In regards to R&D year-over-year, the big difference there is last year, we had a $3.1 million charge related to a milestone payment for IHEEZO. And that milestone payment, because it was prior to IHEEZO being approved, we had to run it through R&D as required in process R&D to have the big difference there.

關於研發同比，去年有很大的不同，我們有 310 萬美元的費用與 IHEEZO 的里程碑付款有關。而那個里程碑付款，因為它是在 IHEEZO 獲得批准之前，我們必須按照流程研發的要求通過研發來運行它，以便在那裡有很大的不同。

Cool, great. And then the last 1 for me. I'm just curious, as you guys think about the company and the business, you have a lot on your plate, some truly huge opportunities with IHEEZO and the fab five and even some of the other formulations that you've introduced. So talk to us about why you feel compelled to pursue additional acquisitions. And maybe give us some sense of your confidence that you can put more on the plate and not have crumbs fall off.

很酷，很棒。然後是我的最後一個。我只是好奇，當你們考慮公司和業務時，你們有很多事情要做，IHEEZO 和 fab five 的一些真正巨大的機會，甚至你們介紹的其他一些配方。因此，請與我們談談為什麼您覺得有必要進行額外的收購。也許讓我們感受到您的信心，即您可以在盤子上放更多東西，而且麵包屑不會掉落。

That's a great question, Brooks. And I think my answer is I really need you -- well, first of all, I really need to close the transactions. It's 1 thing to engage and negotiating them and papering them up, but it's another thing to getting them closed. So once again, I don't want to get over our skis. I wouldn't have mentioned it if I didn't think that we would get at least one of these deals over the line and there are several. But let me get one of them done, any one of them, and I think the answer will be evident that these are highly strategic transactions. These are not simply purchases of products. These are not, in some way, similar to the purchase of the Novartis, the first Novartis deal that we did as an example. These are highly strategic deals and there are reasons why we want to engage in these transactions. But let me not get too far afield. Let's just get them completed and then we'll have this conversation. I think that when our stockholders see one of these deals announced, they'll be quite pleased. But let's get 1 done.

這是一個很好的問題，布魯克斯。我想我的回答是我真的需要你——好吧，首先，我真的需要完成交易。與他們進行接觸和談判並把他們寫下來是一回事，但讓他們關閉是另一回事。所以再一次，我不想忘記我們的滑雪板。如果我不認為我們至少會在線獲得這些交易中的一項並且有幾項，我就不會提到它。但讓我完成其中一項，其中任何一項，我認為答案將是顯而易見的，這些都是高度戰略性的交易。這些不僅僅是購買產品。在某種程度上，這些與收購 Novartis 並不相似，這是我們作為示例所做的第一筆 Novartis 交易。這些都是高度戰略性的交易，我們有理由參與這些交易。但是讓我不要離得太遠。讓我們先完成它們，然後再進行對話。我認為當我們的股東看到其中一項交易宣佈時，他們會非常高興。但是讓我們完成1。

The next question comes from Sahil Kazmi with B. Riley Securities.

下一個問題來自 B. Riley Securities 的 Sahil Kazmi。

Congrats on a really-- truly transformative 2022 and looking forward to similar progress in '23 and appreciate you taking our questions. So a couple from us here. Maybe we can start with just at a high level, as you've reaffirmed your revenue guidance of $135 million to $143 million, can you talk about how you expect that to be different across the first half and the second half of the year as the NDAs get transferred, the IHEEZO launch comes through?

祝賀 2022 年真正實現變革，並期待在 23 年取得類似進展，感謝您提出我們的問題。我們這裡有一對夫婦。也許我們可以從高水平開始，因為您已經重申了 1.35 億美元至 1.43 億美元的收入指導，您能否談談您對上半年和下半年的預期會有何不同，因為NDA 被轉移，IHEEZO 發布通過了嗎？

Yes. So the -- in terms of the guidance, candidly, I think when Andrew built his model, we really have not put a whole lot into '23 on a relative basis for IHEEZO. What we really, I think, modeled out essentially is some growth in our ImprimisRx business as well as revenues from the first Novartis transaction and the closing of the second Novartis transaction. And I don't believe we really included that much TRIESENCE in there either. And so we have a very modest amount from IHEEZO.

是的。所以——就指導而言，坦率地說，我認為當安德魯建立他的模型時，我們真的沒有在 IHEEZO 的相對基礎上投入很多到 23 年。我認為，我們真正模擬出來的本質上是我們 ImprimisRx 業務的一些增長，以及來自第一筆諾華交易和第二筆諾華交易的收入。我也不相信我們真的在其中包含了那麼多 TRIESENCE。因此，我們從 IHEEZO 獲得了非常少量的資金。

What we didn't want to do because this is a launch, this is a new product, and we can't guarantee that there will be massive instantaneous uptake of this product. We do think we're going to be very successful in due course, but we would expect the first half to be certainly more biased towards our legacy products and revenues from the fab five transaction. And I think as we get into the second half of the year, as the launch of IHEEZO really takes a footing, that's when I would expect to see potentially us hopefully getting to where we want to be and possibly even beyond.

我們不想做的事情是因為這是一次發布，這是一種新產品，我們無法保證該產品會立即被大量接受。我們確實認為我們會在適當的時候取得非常成功，但我們預計上半年肯定會更偏向於我們的遺留產品和來自 fab 5 交易的收入。而且我認為，隨著我們進入下半年，隨著 IHEEZO 的推出真正站穩腳跟，那時候我希望看到我們有希望達到我們想要達到的目標，甚至可能超越。

Great. That's really helpful. And then maybe staying on IHEEZO with some of the reimbursement hurdles sort of getting through with the J-code and pass-through status. Can you talk about how you're thinking about the pricing strategy there or when you may plan to disclose that to the street?

偉大的。這真的很有幫助。然後可能會在 IHEEZO 上遇到一些報銷障礙，比如通過 J 代碼和傳遞狀態。你能談談你是如何考慮那裡的定價策略的，或者你打算什麼時候向公眾披露這一點？

Sure. So the price is actually publicly available through Red Book, if you have certain subscriptions, but the price per unit is public and it is $544 per unit.

當然。所以價格實際上是通過紅皮書公開的，如果你有一定的訂閱，但每單位的價格是公開的，每單位 544 美元。

Excellent. And then just the last question as you kind of think about the subsidiaries here, both Melt and Surface, it was really helpful to see an update from Surface discussing their dry eye program. But to the extent you have visibility, do you know when we can expect to see some of the Phase II data from Surface? And kind of what are the next steps in the potential monetization of Melt after their pivotal data?

出色的。然後是最後一個問題，當你想到這裡的子公司時，包括 Melt 和 Surface，看到 Surface 的更新討論他們的干眼症計劃真的很有幫助。但就您的可見性而言，您知道我們什麼時候可以看到 Surface 的一些 II 期數據嗎？在他們的關鍵數據之後，Melt 潛在貨幣化的下一步是什麼？

Sure. So at the recent AECOS meeting in Aspen, Kamran Hosseini gave a nice talk about the Phase II chronic dry eye disease data for his drug candidate. I believe there is some publicly available video or audio related to that, and what I'll try to do is gather that and make it available to you. But he has spoken about his Phase II data. I know they're in discussions with strategics. The data was extraordinary, and they continue to work towards a Phase III program for that asset as well as the other programs that they have.

當然。因此，在最近在阿斯彭舉行的 AECOS 會議上，Kamran Hosseini 就他的候選藥物的 II 期慢性乾眼病數據發表了精彩的演講。我相信有一些與此相關的公開視頻或音頻，我將嘗試收集並提供給您。但他談到了他的第二階段數據。我知道他們正在與戰略部門進行討論。數據非同尋常，他們繼續致力於該資產的 III 期計劃以及他們擁有的其他計劃。

In terms of Melt Pharmaceuticals, which we own 46% of, as well as a senior piece of debt and a 5% royalty on their MELT-300 program, they did report, once again, amazing data, Phase II data. And it was really pivotal data in terms of efficacy for this program. And they had really excellent sedation data. They were able to demonstrate that their MK, their midazolam-ketamine combination product, from a sedation perspective, worked statistically significantly better than the midazolam alone, which is tough to do. Midazolam is a very good sedation drug, that they were able to show stat sig on their MELT-300 program using the Zydis delivery technology.

就我們擁有 46% 股份的 Melt Pharmaceuticals 以及一筆高級債務和 5% 的 MELT-300 計劃特許權使用費而言，他們確實再次報告了驚人的數據，即 II 期數據。就該計劃的功效而言，這確實是關鍵數據。他們有非常好的鎮靜數據。他們能夠證明，從鎮靜的角度來看，他們的 MK，即他們的咪達唑侖-氯胺酮組合產品，在統計上比單獨使用咪達唑侖的效果要好得多，而這很難做到。咪達唑侖是一種非常好的鎮靜藥物，他們能夠使用 Zydis 遞送技術在他們的 MELT-300 程序中顯示統計信號。

They have a meeting with FDA in the middle of May, and it is an end of Phase II meeting to confirm what will be required in a Phase III program. And in the past, the FDA has indicated that the Phase III program would be against placebo, so active versus placebo, which is a very attractive prospect for Melt Pharmaceuticals. It's a fairly derisked study. And so the company is going to FDA to confirm what would be required. The FDA could change its mind. The FDA may confirm what they had previously said about what would be required. We'll have to see. That will happen in mid-May.

他們在 5 月中旬與 FDA 舉行了會議，在 II 期會議結束時確認 III 期計劃的要求。並且在過去，FDA 已經表示 III 期計劃將針對安慰劑，因此與安慰劑相比，這對 Melt Pharmaceuticals 來說是一個非常有吸引力的前景。這是一項相當冒險的研究。因此該公司將向 FDA 確認需要什麼。 FDA 可能會改變主意。 FDA 可能會確認他們之前所說的要求。我們得拭目以待。這將在五月中旬發生。

And then once that occurs, we would expect the company to work towards capitalizing itself so that it can complete that program and ultimately get that product out to market. We sell at Harrow, through our ImprimisRx business, a compounded lozenge. We call it the MKO Melt. It is the compounded product that really inspired us to create Melt Pharmaceuticals in the first place. And so once again, the idea is that if there's an FDA-approved version of this product available, we would certainly prefer to sell the FDA-approved product, make that available to the significant customer base that already purchases the compounded or a compounded version. And so that's really the idea there.

然後一旦發生這種情況，我們希望公司努力實現自身資本化，以便完成該計劃並最終將該產品推向市場。我們在哈羅通過我們的 ImprimisRx 業務銷售複合錠劑。我們稱之為 MKO 熔體。正是這種複合產品真正激發了我們最初創建 Melt Pharmaceuticals 的靈感。因此，再一次，我們的想法是，如果有該產品的 FDA 批准版本可用，我們當然更願意銷售 FDA 批准的產品，將其提供給已經購買複合版本或複合版本的重要客戶群.這就是真正的想法。

But unlike some other products, the MELT-300 product, if it's approved, would not only be impactful in ophthalmology, it could be used in other areas outside of ophthalmology, dermatology, plastics, women's health, ER medicine, colonoscopies, potentially, there are many, many uses for this, we believe, as a novel IV-free and opioid-free sedation product.

但與其他一些產品不同的是，如果 MELT-300 產品獲得批准，它不僅會對眼科產生影響，它還可以用於眼科、皮膚科、塑料、女性健康、急診醫學、結腸鏡檢查以外的其他領域，有可能我們相信，作為一種新型的無靜脈注射和無阿片類藥物的鎮靜產品，它有很多很多用途。

Excellent. Really helpful overview. And once again, congrats on a really successful 2022 and look forward to following the story later this year.

出色的。真正有用的概述。再次祝賀 2022 年取得真正的成功，並期待在今年晚些時候繼續講述這個故事。

(Operator Instructions) Seeing no further questions in the queue, I would like to turn the call back to Mark Baum for closing remarks.

（操作員說明）看到隊列中沒有其他問題，我想將電話轉回給 Mark Baum 以作結束語。

Thank you. And as I also said in my letter to stockholders, the phenomenal effort of the Harrow family led to the achievement of even more than I had dared hoped for. Our achievements to date, including the fact that Harrow is in the best financial and operational shape of its history would not have been possible without the tenacity and hard work of our team, nor would it be possible without the financial support of our stockholders, all of you, many of whom have been with us through thick and thin, good and bad days.

謝謝。正如我在致股東的信中所說，哈羅家族的非凡努力帶來了比我敢於希望的還要多的成就。我們迄今為止取得的成就，包括哈羅處於其歷史上最佳財務和運營狀態的事實，如果沒有我們團隊的堅韌和辛勤工作，也是不可能的，如果沒有我們股東的財務支持，所有這些都是不可能的你們中的許多人與我們一起度過了風雨兼程、風雨兼程的日子。

I look forward to rewarding those stockholders for their patience and their trust and for helping us to deliver on our mission to make great pharmaceutical products that are accessible, affordable, and to stay focused on the unmet needs of the eye care professionals and their patients that we serve. Thanks to everyone for attending today's call and for your interest in Harrow. If you have any investor-related questions, please e-mail Jamie Webb at jwebb, W-E-B-B@harrowinc.com. This will conclude our call.

我期待著回報這些股東的耐心和信任，並幫助我們實現我們的使命，即生產易於獲得、價格合理的優質醫藥產品，並繼續專注於眼科保健專業人員及其患者未滿足的需求我們服務。感謝大家參加今天的電話會議以及對哈羅的關注。如果您有任何與投資者相關的問題，請發送電子郵件至 jwebb 的 Jamie Webb，W-E-B-B@harrowinc.com。這將結束我們的通話。

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。您現在可以斷開連接。