使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good day, and welcome to the Harrow fourth-quarter 2025 earnings conference call. (Operator Instructions) Please note that this call may be recorded.
大家好,歡迎參加 Harrow 2025 年第四季財報電話會議。(操作員說明)請注意,本次通話可能會被錄音。
I would now like to turn the call over to Mike Biega, Vice President, Investor Relations and Communications, please go ahead.
現在我將把電話交給投資者關係和傳播副總裁邁克·比加,請開始吧。
Michael Biega - Vice President - Investor Relations and Communications
Michael Biega - Vice President - Investor Relations and Communications
Good morning, and welcome to Harrow's fourth-quarter and full year 2025 earnings conference call. My name is Mike Biega, Vice President of Investor Relations and Communications, and I'm excited to be introducing today's call.
早安,歡迎參加 Harrow 2025 年第四季及全年財報電話會議。我是投資者關係與傳播副總裁麥克·比加,很高興能為大家介紹今天的電話會議。
The company's remarks may include forward-looking statements within the meaning of federal securities laws. 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 technologies and FDA approval of certain drug candidates in a timely manner or at all.
該公司的言論可能包含聯邦證券法意義上的前瞻性陳述。前瞻性聲明受多種風險和不確定性的影響,其中許多風險和不確定性超出了 Harrow 的控制範圍,包括其不時在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,例如與公司能否及時或根本無法將其獲得 FDA 批准的產品、複合配方和技術商業化相關的風險和不確定性。
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 filed with the Securities and Exchange Commission.
有關這些風險和不確定性的清單和說明,請參閱公司向美國證券交易委員會提交的最新年度報告(10-K 表格)中的「風險因素」部分。
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.
哈羅的實際結果可能與預期結果有重大差異。Harrow公司聲明,無論因新資訊、未來事件或其他原因,均無意願或義務更新或修改任何財務預測或前瞻性聲明。
This conference call contains time-sensitive information and is accurate only as of today.
本次電話會議包含有時效性的信息,僅截至今日有效。
Joining me on today's call are Mark Baum, Chief Executive Officer; Andrew Boll, President and Chief Financial Officer; Patrick Sullivan, Chief Commercial Officer; and Amir Shojaei, Chief Scientific Officer.
今天與我一起參加電話會議的有:首席執行官 Mark Baum;總裁兼首席財務官 Andrew Boll;首席商務官 Patrick Sullivan;以及首席科學官 Amir Shojaei。
With that, I would like to turn the call over to Mark. Mark?
接下來,我想把電話交給馬克。標記?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Good morning, and thank you for joining us.
早安,感謝各位的參與。
Over the past five years, Harrow has undergone a fundamental transformation. Harrow now owns one of the largest portfolios of prescription ophthalmic products in the United States market, and we have been the most prolific acquirer of ophthalmic pharmaceutical products in the US market, having completed more than a half a dozen transactions, integrating over 15 branded products into our scalable commercial platform that reaches every populated county within the United States and touches with impact nearly every key ophthalmic disease segment.
過去五年,哈羅發生了根本性的變化。Harrow 目前擁有美國市場上最大的眼科處方產品組合之一,我們一直是美國市場上最活躍的眼科藥品收購者,已完成六項以上的交易,將 15 多個品牌產品整合到我們可擴展的商業平台中,該平台覆蓋美國所有有人居住的縣,並對幾乎所有關鍵眼科疾病領域都產生了影響。
As you'll note in my letter to stockholders, I am proud of the fact that during the last five years, hundreds of members of the Harrow family, including my incredible leadership team, drove real economic accomplishment and stockholder value creation, which resulted in a more than 700% appreciation in the Harrow stock price during this period.
正如您將在我給股東的信中看到的那樣,我感到自豪的是,在過去的五年裡,包括我傑出的領導團隊在內的數百名哈羅家族成員,推動了真正的經濟成就和股東價值創造,這使得哈羅的股價在此期間上漲了 700% 以上。
As a founder and a large Harrow shareholder, I am proud of our track record and the returns we are providing to stockholders who have had the patience to let this team do its thing. But this team isn't done. And frankly, we've only just begun.
身為創辦人和 Harrow 的大股東,我為我們所取得的成就以及我們為股東帶來的回報感到自豪,感謝股東們一直以來的耐心,讓這個團隊得以發展壯大。但這支隊伍還沒有完成使命。坦白說,我們才剛開始。
I can't guarantee where our stock price will be five years from now. However, I can say with nearly absolute certainty that Harrow will be a larger and more powerful enterprise, positively impacting the lives of millions of Americans. I resolutely believe that then we will be selling more of every one of our key products like VEVYE, IHEEZO and TRIESENCE. But I predict we will also sell many more units of other products that many stockholders haven't thought too much about.
我無法保證五年後我們的股價會是多少。然而,我可以幾乎絕對肯定地說,哈羅將會發展成為一家規模更大、實力更強的企業,對數百萬美國人的生活產生正面影響。我堅信,到那時,我們所有主要產品(如 VEVYE、IHEEZO 和 TRIESENCE)的銷售都會有所增長。但我預測,我們還會銷售更多其他產品,而許多股東並沒有太多考慮這些產品。
I also predict that we will complete compelling new acquisitions of products and/or businesses structured to appropriately balance risk and potential reward. And finally, I can say confidently that one or two product candidates from our recent Melt Pharmaceuticals acquisition, specifically what we are now calling G-MELT and YOCHIL will be approved for marketing and that if they are coded and reimbursed in the way that we expect, they will make massive improvements to the standard of care in ocular surgery and more generally, in the lives of so many Americans in need of an alternative to IV and opioid-based medications for sedation and anxiety.
我還預測,我們將完成對產品和/或業務的引人注目的新收購,這些收購的結構將適當地平衡風險和潛在回報。最後,我可以自信地說,我們最近收購的 Melt Pharmaceuticals 公司中的一到兩種候選產品,特別是我們現在稱之為 G-MELT 和 YOCHIL 的產品,將會獲得上市批准。如果它們的編碼和報銷方式符合我們的預期,它們將極大地改善眼科手術的護理標準,更廣泛地說,也將改善許多需要替代靜脈注射和阿片類藥物進行鎮靜和抗焦慮治療的美國人的生活。
It's a very large market. And of course, these assets, as I reflected in my letter to stockholders, should in due course, become our largest revenue products. My bet is that if we do all of that and maybe even a little bit more, patient stockholders should be handsomely rewarded. I invite you to join me for the ride because our best days are absolutely ahead of us.
這是一個非常大的市場。當然,正如我在給股東的信中所述,這些資產在適當的時候應該會成為我們最大的收入來源。我敢打賭,如果我們做到這一切,甚至做得更多,那麼耐心等待的股東將會獲得豐厚的回報。我邀請你與我一同踏上這段旅程,因為我們最美好的日子絕對還在後頭。
Now let me provide a bit of color on our business as things stand today. We are entering the final phase of our current five-year plan, and we are doing so with momentum. The portfolio we've assembled, the pipeline we've advanced and the commercial infrastructure we've built were designed for scale. This is not a single product company or a single product story, we are meaningfully diversified and our commercial platform is built for durability, operating leverage and sustained growth.
現在讓我來簡單介紹一下我們公司目前的營運狀況。我們正進入目前五年計畫的最後階段,而且我們正以強勁的勢頭推進這一階段。我們建造的產品組合、我們推進的專案線以及我們建立的商業基礎設施都是為了規模化而設計的。這不是一家單一產品公司或單一產品故事,我們實現了實質的多元化,我們的商業平台旨在實現持久性、營運槓桿和持續成長。
Today, Harrow operates as one Harrow, one strategy, one commercial engine, one unified organization. We have constructed a diversified ophthalmic franchise focused on expanding patient access, improving affordability and delivering strong clinical outcomes.
如今,哈羅集團以一個統一的策略、一個商業引擎、一個統一的組織形式運作。我們已建立起多元化的眼科特許經營體系,致力於擴大患者就醫管道、提高醫療可負擔性並提供良好的臨床療效。
In the fourth quarter of 2025, we saw clear validation of that strategy. For the first time, all of our core growth drivers accelerated simultaneously. That alignment reinforces our confidence and supports our goal of exceeding $250 million in quarterly revenue by the end of 2027.
2025年第四季度,我們看到了該策略的明確驗證。我們所有核心成長動力首次同時加速成長。這種一致性增強了我們的信心,並支持我們實現到 2027 年底季度收入超過 2.5 億美元的目標。
Financially, 2025 was a strong year. We delivered great top-line growth and demonstrated operating leverage, underscoring the earnings power embedded in our model as revenue scales.
從財務角度來看,2025 年是表現強勁的一年。我們實現了強勁的營收成長,並展現了營運槓桿效應,凸顯了隨著營收規模擴大,我們模式中蘊含的獲利能力。
Let me briefly highlight some of the key drivers. VEVYE is positioned for revenue acceleration and increasing new prescription velocity. Expanded payer coverage is now in effect, so we are doubling the VEVYE sales force to ensure that we fully capture the opportunity to build a product with peak sales potential of multiples of last year's numbers. More sales professionals will equal more prescriptions, and this should correlate to increasing profitable revenue growth.
讓我簡要介紹其中一些關鍵驅動因素。VEVYE 已做好加速營收成長和提高新處方開立速度的準備。擴大支付方覆蓋範圍現已生效,因此我們將 VEVYE 銷售團隊規模擴大一倍,以確保我們充分抓住機會,打造一款銷售潛力達到去年數倍的產品。銷售人員越多,處方量就越多,這應該會與獲利收入的成長呈正相關。
Our data backs this up. With covered patients averaging approximately nine refills annually, effectively a full year of therapy, this reinforces the durability of the demand for VEVYE. As access continues to expand and commercial intensity increases, we expect total prescription growth to continue this year and for many years to come as VEVYE finally becomes a nine-figure revenue product this year.
我們的數據也證實了這一點。參保患者平均每年大約需要續藥九次,相當於一整年的治療時間,這進一步鞏固了 VEVYE 需求的持久性。隨著市場准入範圍不斷擴大和商業化程度不斷提高,我們預計今年以及未來很多年,隨著 VEVYE 今年最終成為一款年收入達九位數的產品,處方總量將繼續增長。
IHEEZO delivered a record quarter, driven by real traction in a growing number of retina specialists' offices. We have broadened our addressable market by focusing on in-office procedures, effectively increasing our procedure volume TAM by more than 2.5 million units annually. We're also expecting IHEEZO price improvements to begin in the second half of this year as we release a new retina-focused packaging format.
IHEEZO 實現了創紀錄的季度業績,這得益於越來越多的視網膜專科醫生診所的實際業務成長。我們專注於診室內手術,擴大了目標市場,有效地將手術量 TAM 每年增加了 250 萬單位以上。我們也預計,隨著我們推出新的視網膜專用包裝形式,IHEEZO 的價格改善將於今年下半年開始。
At around the same time, we expect retina-specific data readouts from studies underway to show from a patient's perspective, the difference between IHEEZO and legacy anesthesia modalities. This is only going to help us, we believe. We got to see what the data says. These 2026 activities should further enhance financial performance and with multiple growth levers now in place, IHEEZO represents a durable and critical part of our long-term strategy.
大約在同一時間,我們預計正在進行的研究中視網膜特異性數據讀數將從患者的角度顯示 IHEEZO 與傳統麻醉方式之間的差異。我們相信,這只會對我們有幫助。我們得看看數據是怎麼說的。這些 2026 年的活動應該會進一步提升財務業績,並且隨著多種成長槓桿的到位,IHEEZO 代表著我們長期策略中持久而關鍵的一部分。
TRIESENCE generated its strongest quarter since relaunch, reflecting accelerating adoption in the very large ocular inflammation market. Based on what I am seeing this quarter with new account trials starting in numerous potentially very large accounts and growing confidence in market access, I have asked our talent team to at least double the dedicated TRIESENCE sales force to deepen penetration in what remains a very large market.
TRIESENCE 自重新上市以來取得了最強勁的季度業績,反映出其在龐大的眼部發炎市場中的應用正在加速成長。根據我本季所看到的,許多潛在的大客戶開始進行新帳戶試用,並且對市場准入越來越有信心,我已經要求我們的人才團隊至少將 TRIESENCE 的專職銷售人員增加一倍,以加深在這個仍然非常大的市場中的滲透。
Momentum here is early, but it looks meaningful. And because of the origin of the revenue, it is likely highly sustainable. It's not easy to get a product like TRIESENCE added to a surgical treatment protocol. But once you do, and I have seen this happen many times over the years, if the product delivers exceptional outcomes as TRIESENCE appears to be doing, then surgeons are often reticent to change. This is what I mean by the sustainability of the TRIESENCE's momentum.
雖然目前勢頭尚處於早期階段,但看起來很有意義。而且由於收入來源的原因,這種模式很可能具有很強的可持續性。將 TRIESENCE 這類產品添加到外科治療方案中並不容易。但一旦你這樣做了(多年來我見過很多次這種情況),如果該產品像 TRIESENCE 一樣帶來卓越的效果,那麼外科醫生往往不願改變。這就是我所謂的TRIESENCE發展動能的可持續性。
On a related topic, for years, I've spoken about tracking the migration of elite sales representatives. This is nearly a surefire leading indicator of future success. You see sales reps go where they can win, where they can make money and provide for themselves and their families. Well, the word is getting out, the TRIESENCE is on the move. These elite reps from around the country are hearing about our commitment to this product, and they know they will also be selling the G-MELT too, if they can make it on to our team.
關於一個相關的主題,多年來,我一直在談論追蹤精英銷售代表的流動情況。這幾乎可以肯定是未來成功的可靠先行指標。你會看到銷售代表總是去那些能贏錢、能賺錢養活自己和家人的地方。消息已經傳開了,TRIESENCE 正在行動。來自全國各地的這些精英銷售代表都聽說了我們對這款產品的承諾,他們也知道,如果他們能加入我們的團隊,他們也將銷售 G-MELT。
A lot of folks want to get in on the G-MELT, believe me. So we are seeing a mushrooming inbound interest from some of the most prolific ocular surgery pharmaceutical representatives who want to take these coveted surgical physicians at Harrow on the TRIESENCE's team. This is really good news.
相信我,很多人都想參與 G-MELT 計畫。因此,我們看到一些最活躍的眼科手術醫藥代表對 TRIESENCE 團隊表現出濃厚的興趣,他們希望將哈羅醫院這些備受追捧的外科醫生招入麾下。這真是個好消息。
Now on to our rare specialty and compounded products. Behind the scenes, believe it or not, we've been planning a few positive surprises for our stockholders from the part of our portfolio they would probably least expect. Yes, our rare specialty and compounded products. This portfolio is now under new sales leadership, and it will benefit from new resources we are providing to finally bring out the value we expect from this exciting and unique group of products.
接下來介紹我們的稀有特種產品和複合產品。信不信由你,我們在幕後一直在策劃一些驚喜,希望能為股東們帶來一些意想不到的好處,這些驚喜可能來自我們投資組合中最出人意料的部分。是的,我們稀有的特種產品和複合產品。該產品組合目前由新的銷售領導團隊負責,我們將提供新的資源,使其最終能夠充分發揮這組令人興奮且獨特的產品的價值,從而為該產品組合帶來益處。
As I discussed more in my letter to stockholders, there are three products from within this portfolio that our team has been quietly doing great work on. One product is awaiting a coding decision from CMS, which we expect in April. There are no guarantees. But if this comes through next month, it will open up a very nice, attractive market for this product.
正如我在給股東的信中詳細討論的那樣,我們團隊一直在默默地為該產品組合中的三款產品進行出色的研發工作。其中一款產品正在等待 CMS 的編碼決定,我們預計在 4 月做出決定。沒有任何保證。但如果下個月這件事得到批准,將會為這款產品開闢一個非常好的、極具吸引力的市場。
Regarding another product in this portfolio, we have a key study underway that we expect to read out later this year. Our entire team is super excited about this opportunity. This is a big one. And based on what we know about this product, we expect the study to be able to highlight the opportunity that we have uncovered. And once the data is announced, it should fuel opening up, as I said, a very sizable and compelling market for this product.
關於該產品組合中的另一款產品,我們正在進行一項關鍵研究,預計今年稍後公佈結果。我們整個團隊都對這個機會感到無比興奮。這是件大事。根據我們對該產品的了解,我們預計這項研究將能夠突出我們發現的機會。一旦數據公佈,正如我所說,這將推動該產品打開一個非常龐大且極具吸引力的市場。
In fact, we are also simultaneously working out supply chain issues to ensure that if things work out the way we expect, that we'll be able to supply the market adequately given the historically lower volumes that this product has required. And there is a third product that we expect to be revived from this portfolio to also fill yet another nice but happens to be a smaller market opportunity, but a good one, nevertheless.
事實上,我們也在同時解決供應鏈問題,以確保如果一切按預期發展,鑑於該產品歷來所需的銷售量較低,我們能夠充分滿足市場需求。我們預計該產品組合中的第三款產品也將重新面世,以填補另一個雖小但不錯的市場機會。
The bottom line is that I believe our stockholders may be positively surprised throughout the year and into next year as our plans for this portfolio are revealed.
總之,我相信隨著我們針對該投資組合的計劃逐步揭曉,我們的股東們在今年乃至明年都可能會感到驚喜。
A few final points. In 2026, we will also launch two important products, BYQLOVI and BYOOVIZ, further expanding our retina and specialty footprint and leveraging our commercial platform. Beyond commercialization, our pipeline continues to advance, and Amir will shortly speak about the great work he and his team are doing.
最後還有幾點要說明。2026 年,我們還將推出兩款重要產品 BYQLOVI 和 BYOOVIZ,進一步擴大我們在視網膜和專業領域的市場份額,並充分利用我們的商業平台。除了商業化之外,我們的研發管線也在不斷推進,Amir 很快就會談到他和他的團隊正在做的出色工作。
In summary, Harrow is a diversified ophthalmic platform with multiple accelerating growth drivers and increasing operating leverage we have demonstrated the ability to build, integrate and grow and generate a heck of a great return for our patient stockholders as our five-year track record demonstrates. But as I said at the outset, I really believe that we are still in the early innings of our growth and stockholder value creation story.
總而言之,Harrow 是一個多元化的眼科平台,擁有多個加速成長的驅動因素和不斷提高的營運槓桿,我們已經證明了我們有能力建構、整合和發展,並為我們的患者股東創造巨大的回報,正如我們五年來的業績記錄所證明的那樣。但正如我一開始所說,我真的相信我們仍處於成長和股東價值創造故事的早期階段。
With that said, I will turn it over to Andrew. Andrew?
說完這些,我就把麥克風交給安德魯了。安德魯?
Andrew Boll - President, Chief Financial Officer, Company Secretary
Andrew Boll - President, Chief Financial Officer, Company Secretary
Good morning, everyone. I'll begin with our fourth-quarter and full year 2025 financial results.
各位早安。我將首先介紹我們2025年第四季和全年的財務表現。
For the fourth quarter of 2025, consolidated revenues were $89.1 million, representing 33% year-over-year growth. For the full year, revenue was $272 million, up 36% versus 2024. Growth reflected continued strength across our brand portfolio and expanding commercial execution, particularly in the second half of the year.
2025 年第四季,合併收入為 8,910 萬美元,年增 33%。全年營收為 2.72 億美元,比 2024 年成長 36%。成長反映了我們品牌組合的持續強勁勢頭和不斷擴大的商業執行力,尤其是在下半年。
Adjusted EBITDA was $24.2 million in Q4 and $61.9 million for the full year, reflecting 54% year-over-year growth. This margin expansion demonstrates the operating leverage in our model as revenue scales faster than costs even as we continue investing in commercialization and R&D.
第四季調整後 EBITDA 為 2,420 萬美元,全年為 6,190 萬美元,年增 54%。這一利潤率的擴張反映了我們模式的經營槓桿效應,即使我們繼續投資於商業化和研發,收入的成長速度也超過了成本的成長速度。
In addition, during 2025, we generated just under $44 million of cash from operations, which helped us end the year with $72.9 million in cash and cash equivalents. Overall, 2025 was a year of strong execution, improving profitability and disciplined capital allocation.
此外,在 2025 年,我們從經營活動中產生了近 4,400 萬美元的現金,這幫助我們以 7,290 萬美元的現金及現金等價物結束了這一年。整體而言,2025 年是執行力強勁、獲利能力不斷提高、資本配置嚴謹的一年。
Moving on to our core growth drivers. Starting with VEVYE, fourth-quarter revenues were $25.9 million, up 14% sequentially, bringing full year revenue to $88.7 million, a 216% increase over 2024. Growth reflects expanding demand. IHEEZO generated $35.9 million in Q4 and $81.3 million for the full year, representing 64% quarter-over-quarter growth and 65% year-over-year growth. Performance was driven by increasing penetration across new and existing accounts, particularly in retina.
接下來談談我們的核心成長驅動因素。以 VEVYE 為例,第四季營收為 2,590 萬美元,季增 14%,全年營收達 8,870 萬美元,比 2024 年成長 216%。成長反映了需求的擴大。IHEEZO 第四季營收為 3,590 萬美元,全年營收為 8,130 萬美元,季增 64%,較去年同期成長 65%。業績成長主要得益於新舊客戶的滲透率不斷提高,尤其是在視網膜領域。
Based on the momentum we are seeing with TRIESENCE and other modest investments we intend to make in this franchise, we are disclosing this revenue separately for the first time. TRIESENCE fourth-quarter revenue was $5.1 million, a 36% increase from the third quarter, totaling $9.9 million for the year, a 193% increase from 2024. The growth was primarily driven by accelerating adoption of TRIESENCE in ocular inflammation.
基於 TRIESENCE 的發展勢頭以及我們計劃對該特許經營權進行的其他適度投資,我們首次單獨披露這部分收入。TRIESENCE 第四季營收 510 萬美元,比第三季成長 36%,全年營收總計 990 萬美元,比 2024 年成長 193%。成長的主要驅動力是 TRIESENCE 在眼部發炎治療領域得到加速應用。
Our rare specialty and compounding portfolio generated $22.2 million in Q4 and $92.3 million for the full year. The temporary compounding inventory constraint discussed last quarter is expected to be resolved in the coming weeks, and we expect inventory levels to normalize near the end of the first quarter. We do not anticipate a recurrence of this issue.
我們的稀有特種藥品和複利產品組合在第四季度創造了 2,220 萬美元的收入,全年創造了 9,230 萬美元的收入。上季討論的暫時性庫存積壓問題預計將在未來幾週內解決,我們預計庫存水準將在第一季末恢復正常。我們預計此類問題不會再發生。
For 2026, we are approaching guidance with greater transparency and structure and are committed to providing greater insight into the seasonality of our business and how we expect performance to build throughout the year.
對於 2026 年,我們將以更透明和結構化的方式提供指導,並致力於更深入地了解我們業務的季節性以及我們預期全年業績將如何成長。
We expect full year 2026 revenue between $350 million and $365 million. For modeling purposes, we currently expect first half revenue in the range of $133 million to $153 million and the second half revenue in the range of $203 million to $226 million, reflecting the expected phasing of demand, channel dynamics and launch timing across the year.
我們預計 2026 年全年營收將在 3.5 億美元至 3.65 億美元之間。出於建模目的,我們目前預計上半年營收在 1.33 億美元至 1.53 億美元之間,下半年營收在 2.03 億美元至 2.26 億美元之間,反映了全年預期的需求階段、通路動態和上市時間。
Adjusted EBITDA is expected to be between $80 million to $100 million for the full year, with the majority of the EBITDA generated in the second half of 2026.
預計全年調整後 EBITDA 將在 8,000 萬美元至 1 億美元之間,其中大部分 EBITDA 將在 2026 年下半年產生。
As in prior years, the second half is expected to be stronger with that weighting being more pronounced in 2026. Historically, quarterly revenue patterns have been consistent, though 2026 will be slightly more second half weighted. Like the past two years, the first quarter is expected to be our lowest revenue quarter, primarily due to stocking activity from the fourth quarter and insurance resets and a higher concentration of high deductible plans.
與往年一樣,預計下半年表現會更強勁,2026 年這種趨勢會更加明顯。從歷史數據來看,季度營收模式一直比較穩定,不過 2026 年下半年的營收比例會略高一些。與過去兩年一樣,預計第一季將是我們收入最低的季度,主要原因是第四季度的庫存活動、保險重置以及高免賠額計劃的集中度較高。
We estimated fourth-quarter demand for IHEEZO resulted in approximately 1.5 quarters of incremental inventory being built across the channel. That inventory is expected to be drawn down largely during Q1. As a result, although we are seeing demand grow for IHEEZO similar to the first quarter of 2025, because we are drawing down on Q4 2025 inventory within the channel, we do not anticipate meaningful IHEEZO revenue in the first quarter.
我們估計,第四季度對 IHEEZO 的需求導致整個通路增加了約 1.5 個季度的庫存。預計該庫存將在第一季大幅減少。因此,儘管我們看到對 IHEEZO 的需求成長與 2025 年第一季類似,但由於我們正在消耗通路內 2025 年第四季的庫存,我們預計第一季 IHEEZO 的營收不會有顯著成長。
VEVYE entered the year with expanded coverage effective January 1. While we expect improved access will increasingly drive prescription growth throughout the year, the first quarter typically reflects an increased mix of high-deductible plans, which creates near-term pressure for VEVYE and our branded portfolio. The financial impact of the coverage will start to be more pronounced as the year progresses and once our expanded sales force is fully deployed.
VEVYE 於 1 月 1 日起擴大了保險覆蓋範圍。雖然我們預計全年處方藥供應的改善將逐步推動處方藥供應的成長,但第一季通常反映出高免賠額計劃的比例增加,這將給 VEVYE 和我們的品牌產品組合帶來短期壓力。隨著時間推移以及我們擴大的銷售團隊全面部署,這項保險的財務影響將開始變得更加明顯。
We typically operate with a disciplined, methodical approach to spend, and we have done that for a reason to protect profitability, drive ROI and preserve strong cash flow. This year, however, we see a clear opportunity to maintain that discipline while increasing the pace and level of investment to expand our revenue base for years to come.
我們通常以嚴謹、有條不紊的方式進行支出,這樣做是為了保護獲利能力、提高投資回報率並保持強勁的現金流。然而,今年我們看到了一個明顯的機遇,可以在保持這種紀律的同時,加快投資步伐並加大投資力度,從而在未來幾年擴大我們的收入基礎。
As a result, we expect SG&A to increase to approximately $185 million to $205 million in the year as we expand our sales force across our major products and categories, including VEVYE and TRIESENCE, and prepare to support the launches of BYOOVIZ and BYQLOVI. We plan to add roughly 100 new sales roles in the first half of the year, and we'll pair that with increased promotional and marketing investment to drive awareness, adoption and sustained growth in the back half of the year and into 2027.
因此,隨著我們在主要產品和類別(包括 VEVYE 和 TRIESENCE)中擴大銷售隊伍,並準備好支援 BYOOVIZ 和 BYQLOVI 的上市,我們預計本年度的銷售、一般及行政費用將增加到約 1.85 億美元至 2.05 億美元。我們計劃在今年上半年新增約 100 個銷售職位,並加大促銷和行銷投入,以推動下半年及 2027 年的認知度、採用率和持續成長。
Importantly, even as we invest, we will continue to manage expenses with a careful eye toward profitability and cash flow, holding ourselves accountable to returns and managing the spend accordingly. We also expect R&D expenses to increase this year to approximately $30 million to $35 million as we complete studies required for the Melt product candidates, NDA submissions and as we invest in post-market studies that Amir will discuss later, efforts we believe can support near- and long-term growth across key products.
重要的是,即使在我們進行投資的同時,我們也會繼續密切關注盈利能力和現金流,謹慎管理支出,對回報負責,並據此管理支出。我們也預計,隨著我們完成 Melt 產品候選藥物所需的研究、NDA 提交以及對上市後研究的投資(Amir 稍後將討論這些研究),今年的研發費用將增加到約 3000 萬美元至 3500 萬美元。我們相信,這些努力可以支持關鍵產品的近期和長期成長。
Looking to the second quarter, we expect IHEEZO will lose pass-through status effective April 1, impacting the ASC market. Approximately 30% of 2025 units were generated in the ASC setting. We've been preparing for this transition through our retina pivot in 2024 and the recently announced in-office expansion strategy, which, as Mark said, added about 2.5 million annual procedures to our TAM. The continued growth in retina and the in-office utilization is expected to offset and ultimately exceed the ASC impact.
展望第二季度,我們預計 IHEEZO 將於 4 月 1 日起失去轉嫁地位,這將對 ASC 市場產生影響。2025 個單位中約有 30% 是在 ASC 環境中產生的。我們一直在為這一轉變做準備,包括 2024 年的視網膜轉型和最近宣布的診所擴張策略。正如 Mark 所說,該策略每年為我們的總目標市場 (TAM) 增加約 250 萬例手術。視網膜疾病的持續增長和診室內的治療利用率預計將抵消並最終超過門診手術中心的影響。
We also plan to launch BYQLOVI in Q2, which will support incremental growth in our specialty portfolio.
我們還計劃在第二季推出 BYQLOVI,這將有助於我們特種產品組合的逐步成長。
Now looking at the third quarter. We typically experience some late summer softness due to both doctors, staff and patients going on vacations. The third quarter will include the first full quarter of BYOOVIZ revenue contribution, which should provide incremental growth. We are anticipating that IHEEZO will also catch some of the additional tailwinds as a complementary product to BYOOVIZ.
現在來看第三季。由於醫生、員工和患者都會去度假,我們通常會在夏末經歷一段產品銷售下滑期。第三季將包括 BYOOVIZ 第一個完整的季度收入貢獻,這將帶來增量成長。我們預計 IHEEZO 作為 BYOOVIZ 的補充產品,也將獲得一些額外的發展動力。
In addition, beginning in the third quarter, we expect to start to see the impact of our expanded and fully deployed VEVYE and TRIESENCE sales force, driving growth for both products. Also starting in the third quarter, we are expecting a pricing improvement for IHEEZO to go into effect. When you combine that with the continued retina growth and the in-office expansion, we expect IHEEZO will have a strong second half of 2026 and position us very well for 2027.
此外,從第三季開始,我們預計將開始看到我們擴大並全面部署的 VEVYE 和 TRIESENCE 銷售團隊的影響,從而推動這兩個產品的成長。此外,我們預計從第三季開始,IHEEZO 的價格將有所改善。結合視網膜的持續成長和診室內的擴張,我們預計 IHEEZO 在 2026 年下半年將取得強勁成長,並為 2027 年奠定良好的基礎。
The fourth quarter should remain our strongest quarter, driven by demand patterns, stocking activity and patients reaching out-of-pocket maximums.
第四季仍將是我們表現最強勁的季度,這主要得益於需求模式、庫存活動以及患者自付費用達到上限等因素。
Finally, as Mark discussed in his letter, as we intentionally transition compounded volume to FDA-approved branded alternatives, shifting revenue into our specialty portfolio, we expect compounded revenue to be approximately $60 million to $65 million for the full year, with Q1 the softest quarter as we exit the final stages of the inventory shortage.
最後,正如馬克在信中討論的那樣,隨著我們有意將複合製劑的收入過渡到 FDA 批准的品牌替代品,並將收入轉移到我們的特藥產品組合中,我們預計全年復合製劑的收入約為 6000 萬美元至 6500 萬美元,其中第一季度是最疲軟的季度,因為我們正在走出庫存短缺的最後階段。
In summary, we expect a softer first half as we work through channel inventory, absorb the ASC transition and navigate seasonal deductible dynamics. In the second half, we expect meaningful acceleration driven by a fully deployed VEVYE and TRIESENCE sales force, contributions from BYOOVIZ and BYQLOVI, improved IHEEZO pricing, expanding retina and in-office adoption and incremental contribution from specialty products.
總而言之,我們預計上半年業績將較為疲軟,因為我們需要消化通路庫存、消化 ASC 過渡期的影響以及應對季節性免賠額的變化。下半年,我們預計在 VEVYE 和 TRIESENCE 銷售團隊全面部署、BYOOVIZ 和 BYQLOVI 的貢獻、IHEEZO 定價的改進、視網膜和診室內應用的擴大以及專業產品的增量貢獻的推動下,業績將出現顯著增長。
Now I'll turn the call over to Pat Sullivan.
現在我將把電話交給派特·沙利文。
Patrick Sullivan - Chief Commercial Officer
Patrick Sullivan - Chief Commercial Officer
Thank you, Andrew. Starting with VEVYE, we exited 2025 with strong fourth-quarter momentum at a clear inflection point as expanded coverage went live. Despite limited coverage throughout 2025, we delivered a 115% increase in prescribers writing VEVYE, underscoring strong underlying demand for the product, but there is so much more opportunity for VEVYE growth in the large and growing US dry eye category. With broader coverage now in place for our sales force expansion underway, we expect prescriber growth to continue.
謝謝你,安德魯。從 VEVYE 開始,我們在 2025 年第四季取得了強勁的成長勢頭,這是一個明顯的轉折點,因為擴大的覆蓋範圍已經上線。儘管 2025 年的覆蓋範圍有限,但我們開立 VEVYE 處方的醫生數量增加了 115%,這凸顯了該產品強勁的潛在需求,但 VEVYE 在美國這個龐大且不斷增長的乾眼症市場中還有更大的增長機會。隨著我們銷售團隊擴張計劃的推進,覆蓋範圍也更加廣泛,我們預計處方醫生數量將繼續增長。
Consistent with the data shared in 2024, covered patients average approximately nine refills in 2025, effectively a full year of therapy. That level of persistence underscores VEVYE's differentiated clinical profile, rapid onset, sustained efficacy and comfortable on-eye experience without the stinging and burning commonly associated with other treatments.
與 2024 年公佈的數據一致,參保患者在 2025 年平均需要續約約 9 次,相當於一整年的治療。這種持久性凸顯了 VEVYE 的差異化臨床特性、快速起效、持續療效以及舒適的眼部體驗,而不會像其他治療方法那樣產生刺痛和灼熱感。
The bottom line, though, is that we do not believe that any product in the category has this level of refill persistence. Since coverage expansion began, we have seen acceleration in new prescription trends despite navigating a challenging period with insurance benefits resetting and high deductible plans, and we expect continued improvement as the year progresses.
但總而言之,我們認為該類別中沒有任何一款產品具有這種等級的替換裝持久性。自從健保覆蓋範圍擴大以來,儘管面臨保險福利重置和高免賠額計劃帶來的挑戰,我們仍看到新處方趨勢加速增長,我們預計隨著時間的推移,這一趨勢將繼續改善。
To fully capitalize on this opportunity, we remain on track to double the VEVYE sales force by Memorial Day, expanding our VEVYE presence among eye care professionals to drive higher prescription volume through 2026. Turning to IHEEZO. This product materially outperformed our expectations in 2025 with an impressive 56% growth in unit demand year over year.
為了充分利用這一機遇,我們仍按計劃在陣亡將士紀念日之前將 VEVYE 銷售團隊規模擴大一倍,擴大 VEVYE 在眼科護理專業人員中的影響力,以推動 VEVYE 在 2026 年之前實現更高的處方量。轉向 IHEEZO。該產品在 2025 年的表現遠超我們的預期,單位需求量年增了 56%,增幅令人矚目。
Growth was driven by our expansion in the new retina practices and deeper utilization within existing accounts. Ordering accounts increased 49% year over year and retina specialists represented approximately 70% of fourth quarter unit volume, underscoring where adoption and clinical traction are strongest.
成長主要得益於我們在視網膜新領域的拓展以及現有客戶的更深入利用。訂購帳戶年增 49%,視網膜專科醫生佔第四季度單位銷量的約 70%,凸顯了該產品在臨床應用和推廣方面最強勁的領域。
Importantly, we believe we are still in the early innings of penetration with significant untapped market opportunity ahead as we continue to expand utilization and drive broader adoption. Looking ahead, in the second half of 2026, we expect a net price improvement, which we expect will further enhance the product's revenue and overall financial profile. Importantly, this comes as we prepare to launch BYOOVIZ in mid-2026, further accelerating IHEEZO's expansion into new retina accounts while deepening penetration within our existing customer base.
重要的是,我們相信我們仍處於市場滲透的早期階段,隨著我們不斷擴大利用率和推動更廣泛的採用,未來將有巨大的未開發市場機會。展望未來,我們預計在 2026 年下半年,淨價格將有所改善,我們預計這將進一步提高該產品的收入和整體財務狀況。重要的是,我們正準備在 2026 年年中推出 BYOOVIZ,這將進一步加速 IHEEZO 向新的視網膜帳戶擴張,同時加深我們在現有客戶群中的滲透。
We are also expanding IHEEZO into the office-based setting to broaden utilization beyond retina. This initiative targets more than 2.5 million anesthesia relevant procedures that already benefit from established reimbursement pathways, reducing access friction. Earlier engagement has been encouraging, supported by a dedicated commercial effort and our existing relationship in the office-based channel.
我們也將 IHEEZO 的應用範圍擴展到辦公室環境,以擴大其在視網膜以外的用途。這項措施的目標是超過 250 萬例與麻醉相關的手術,這些手術已經受益於既定的報銷途徑,從而減少了就醫障礙。早期的合作令人鼓舞,這得益於我們投入的專項商業努力以及我們在辦公室管道中已有的關係。
Turning to TRIESENCE. We delivered a record quarter, driven by accelerating momentum in ocular inflammation and continued strength in retina. Despite formally launching in market on October 1, we saw a good portion of the Q4 unit volume come from ocular surgery accounts, and we expect this large market will drive the majority of new volume going forward. Nearly half of the fourth quarter ordering accounts were new and helped drive quarter-over-quarter growth in unit volume.
轉向TRIESENCE。在眼部發炎領域發展勢頭加快和視網膜領域持續強勁的推動下,我們實現了創紀錄的季度業績。儘管該產品於 10 月 1 日正式上市,但我們發現第四季度銷售的大部分來自眼科手術客戶,我們預計這個龐大的市場將在未來推動大部分新銷售。第四季近一半的訂單客戶都是新客戶,這有助於推動季度環比銷售成長。
To extend this trajectory, we are in the process of doubling the dedicated TRIESENCE sales force. Based on current trends, we see substantial runway for continued growth in 2026 and beyond.
為了延續這一發展勢頭,我們正在將 TRIESENCE 的專職銷售團隊規模擴大一倍。根據目前的趨勢,我們認為2026年及以後仍有龐大的成長空間。
Finally, our rare specialty and compounded portfolio performance rebounded in the fourth quarter as new commercial leadership took hold and execution improved. While we are encouraged by that momentum, I believe there is substantial room to grow this portfolio of everyday workhorse products from current share levels. We are implementing several revenue-generating initiatives tied to these assets, which we expect to detail later this year.
最後,隨著新的商業領導層上任和執行力的提高,我們的稀有特種產品和複合投資組合業績在第四季度出現反彈。雖然我們對目前的成長動能感到鼓舞,但我認為,從目前的市佔率水準來看,這一系列日常實用產品還有很大的成長空間。我們正在實施與這些資產相關的幾項創收計劃,預計今年稍後公佈詳情。
In parallel, as Mark discussed in his letter, we are focused on converting compounded utilization into FDA-approved branded products through the launch of PharmaPack Max and PharmaPack Prime, further strengthening the long-term revenue profile of this segment. In closing, each of our core growth drivers accelerated in the fourth quarter, and we entered 2026 with clear commercial momentum.
同時,正如馬克在信中所討論的那樣,我們正致力於透過推出 PharmaPack Max 和 PharmaPack Prime,將複合製劑轉化為 FDA 批准的品牌產品,從而進一步加強該領域的長期收入前景。總之,我們的每個核心成長動力在第四季度都得到了加速,我們帶著清晰的商業勢頭進入了 2026 年。
We are scaling the organization to support the trajectory, doubling the sales forces behind VEVYE and TRIESENCE, expanding IHEEZO into the office-based setting and preparing for important launches this year. With strengthened infrastructure, expanding access and a diversified ophthalmic portfolio, we believe we are well positioned to drive sustained growth and delivering increased value to patients and shareholders.
為了支持這一發展軌跡,我們正在擴大組織規模,將 VEVYE 和 TRIESENCE 的銷售團隊規模擴大一倍,將 IHEEZO 擴展到辦公室環境,並為今年的重要產品發布做準備。憑藉更完善的基礎設施、更廣泛的市場覆蓋率和多元化的眼科產品組合,我們相信我們已做好充分準備,推動持續成長,並為患者和股東創造更多價值。
With that, I'll turn it over to Amir.
接下來,我將把麥克風交給阿米爾。
Amir Shojaei - Chief Scientific Officer
Amir Shojaei - Chief Scientific Officer
Thanks, Pat. I'd like to turn to our pipeline, which we believe represents a compelling long-term value driver for Harrow. The next phase of growth is highly focused and capital efficient. We're advancing clinically relevant programs aligned with clear unmet needs in ophthalmology and tightly integrated with our commercial infrastructure and regulatory expertise. While there are several programs on this slide and more that you don't know about yet, I'm only going to focus today on G-MELT, formerly known as MELT-300 and the ongoing IHEEZO studies.
謝謝你,帕特。我想談談我們的管道項目,我們相信它代表了哈羅公司極具吸引力的長期價值驅動因素。下一階段的成長將高度聚焦且注重資本效率。我們正在推動與眼科領域明確未滿足需求相符的臨床相關項目,並將這些項目與我們的商業基礎設施和監管專業知識緊密結合。雖然這張投影片上展示了幾個項目,還有更多你還不知道的項目,但我今天只專注於 G-MELT(以前稱為 MELT-300)和正在進行的 IHEEZO 研究。
G-MELT exemplifies our strategy. It is a fully opioid-free and IV-sparing procedural sedation candidate that has the potential to redefine that standard of care, and I believe has the potential to become our largest product. Today, procedural sedation often requires IV access and uses opioid-based regimens, introducing complexity, staffing burden, monitoring requirements and longer recovery times.
G-MELT 正是我們策略的典範。它是一種完全不含鴉片類藥物且無需靜脈注射的鎮靜劑,有望重新定義該護理標準,我相信它有潛力成為我們最大的產品。如今,手術鎮靜通常需要靜脈注射,並使用鴉片類藥物方案,這增加了複雜性、人員配備負擔、監測要求和更長的恢復時間。
G-MELT has the potential to simplify that model. From a development perspective, we initiated the remaining pharmacokinetic work earlier this year and are advancing CMC activities with our CDMO partner. We remain on track for an NDA submission in early 2027, while continuing to evaluate opportunities to accelerate timelines. We view G-MELT as platform-level upside, a differentiated sedation solution with the potential to broadly improve procedural efficiency and create meaningful long-term value in the ophthalmic market and eventually beyond.
G-MELT 有潛力簡化該模型。從研發角度來看,我們在今年稍早啟動了剩餘的藥物動力學工作,並正在與我們的 CDMO 合作夥伴進行 CMC 活動。我們仍按計劃在 2027 年初提交 NDA,同時繼續評估加快進度的機會。我們認為 G-MELT 具有平台層面的優勢,它是一種差異化的鎮靜解決方案,有可能廣泛提高手術效率,並在眼科市場甚至更廣泛的領域創造有意義的長期價值。
Pipeline value also comes from expanding the evidence base for marketed products, including IHEEZO. I'm amazed that our team has been so successful with IHEEZO and retina given its supporting data within cataract surgery. I know from my experience developing back-of-the eye products, that retina professionals who are the primary users of IHEEZO want to see specific data based on procedures they need IHEEZO for, namely intravitreal injections. Therefore, we are investing in clinical data generation to support adoption, strength and differentiation and reinforce long-term positioning with both clinicians and payers.
研發管線的價值也來自於擴大已上市產品(包括 IHEEZO)的證據基礎。考慮到 IHEEZO 在白內障手術中的支持數據,我很驚訝我們的團隊在 IHEEZO 和視網膜治療方面取得瞭如此大的成功。根據我開發眼部後部產品的經驗,我知道 IHEEZO 的主要用戶——視網膜專業人士——希望看到基於他們需要使用 IHEEZO 的手術(即玻璃體內注射)的具體數據。因此,我們正在投資臨床數據生成,以支持產品採用、增強實力和實現差異化,並加強與臨床醫生和支付方的長期合作關係。
While this slide highlights IHEEZO, similar work is underway across the portfolio. High-quality evidence builds clinical confidence, drives utilization and supports sustained reinvestment in the franchise.
雖然這張投影片重點介紹了 IHEEZO,但類似的工作正在整個投資組合中進行。高品質的證據能夠增強臨床信心,促進資源利用,並支持對該領域進行持續的再投資。
For IHEEZO, we are sponsoring multiple complementary studies in intravitreal injection procedures. The first and most near-term data is an investigator-initiated randomized trial led by Dr. Sabin Dang comparing IHEEZO to standard anesthetic approaches evaluating pain and ocular symptoms with data expected at ASRS this year in July. You could see the code he provided us with on the bottom left of the slide.
對於 IHEEZO,我們正在贊助多項玻璃體內注射手術的互補研究。第一個也是近期最直接的數據是由 Sabin Dang 博士領導的一項研究者發起的隨機試驗,該試驗將 IHEEZO 與標準麻醉方法進行比較,評估疼痛和眼部症狀,預計數據將於今年 7 月在 ASRS 上公佈。你可以在幻燈片的左下角看到他提供的代碼。
As for our own Harrow-sponsored IHEEZO study, my team has put together a Phase 4 multicenter randomized trial assessing patient-reported pain and safety across approximately 240 patients. We initiated the study in the first quarter of 2026 under the IND and expect to have data available by the end of 2026. Together, these studies are designed to generate clinically meaningful practice-relevant evidence that supports further and more broad-based adoption, reinforcing IHEEZO as a durable long-term growth driver.
至於我們自己由哈羅贊助的 IHEEZO 研究,我的團隊已經制定了 4 期多中心隨機試驗,評估約 240 名患者報告的疼痛和安全性。我們在 2026 年第一季根據 IND 啟動了這項研究,預計到 2026 年底將有數據可用。這些研究旨在共同產生具有臨床意義的實踐相關證據,以支持進一步和更廣泛的採用,從而鞏固 IHEEZO 作為持久的長期成長驅動力的地位。
In summary, Harrow's pipeline is focused, efficient and impactful. It complements our commercial momentum, expands our addressable markets and creates multiple pathways for long-term value creation. We are building not just individual products, but a sustainable innovation engine that positions Harrow for continued growth.
總而言之,哈羅的人才培育計畫目標明確、有效率且卓有成效。它與我們的商業發展勢頭相輔相成,擴大了我們的目標市場,並為長期價值創造創造了多種途徑。我們打造的不僅僅是單一產品,而是一個可持續的創新引擎,這將使 Harrow 能夠持續發展。
With that, I'll turn it over for questions.
接下來,我將把發言權交給提問者。
Operator
Operator
(Operator Instructions) Chase Knickerbocker, Craig-Hallum.
(操作說明)Chase Knickerbocker,Craig-Hallum。
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
I appreciate the candid thoughts in the shareholder letter. So Mark, you kind of mentioned in the letter that you expect kind of continued commercial growth and commercial mix improvement for VEVYE kind of through the year. What have you seen so far from a commercial mix perspective in Q1?
我讚賞股東信中坦誠的觀點。馬克,你在信中提到,你預計 VEVYE 在今年將持續實現商業成長和商業組合改善。從商業組合的角度來看,您在第一季看到了哪些情況?
And then can you walk us through what your ASP assumptions or direction of ASP for VEVYE is in the 2026 guide kind of versus volume?
那麼,您能否詳細介紹一下您在 2026 年指南中對 VEVYE 的平均售價 (ASP) 假設或方向,以及 ASP 與銷售的關係?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes. So regarding ASP, I think the only -- I'll answer the second question first. On ASP and net pricing, the only comment that we've made and that we intend to make is regarding the buoyancy and the slight uptick in ASP, which I had forecasted probably a quarter or two late. But nevertheless, as I said in the letter to stockholders, we saw that direction of travel and we eventually got there.
是的。關於ASP,我認為唯一的問題是──我先回答第二個問題。關於平均售價和淨價,我們唯一發表的評論,也是我們打算發表的評論,是關於平均售價的上漲勢頭和小幅上漲,而我對此的預測可能晚了一兩個季度。但是,正如我在給股東的信中所說,我們看到了這個發展方向,最終我們也實現了這個目標。
So with a more sustainable and buoyant net pricing for VEVYE, that, coupled with some of the things that we're seeing on the commercial side with this new coverage, we have initiated this program to more than double the VEVYE sales force.
因此,VEVYE 的淨定價更加可持續和穩定,再加上我們在商業方面看到的一些新覆蓋範圍帶來的影響,我們啟動了這項計劃,旨在將 VEVYE 的銷售隊伍擴大一倍以上。
In terms of the build and what we're seeing on the ground today for VEVYE, as I said also in the letter to stockholders, even in the fourth quarter, we started to see a little bit of momentum build. I think I've said in the past, that CVS had actually sent out letters to thousands and thousands of eye care professionals around the United States, alerting them to the new positioning, the preferred positioning for VEVYE on their formulary. And that alone, I think, began the positive momentum that we're also seeing a little bit in the first quarter.
就 VEVYE 的發展現狀和我們目前在實際工作中看到的,正如我在給股東的信中所說,即使在第四季度,我們也開始看到一些發展勢頭。我想我以前說過,CVS 實際上已經向全美成千上萬的眼科護理專業人員發出信函,告知他們 VEVYE 在其處方集中的新定位,即首選定位。我認為,光是這一點就開啟了我們在第一季也看到的正面動能。
What I can say regarding the first quarter is that typically, it's a weaker period. And we're quite surprised with the new prescription volumes that we're seeing today relative to what we thought we would see, which is to say that the new prescription volumes are meaningfully better than what we thought we would be receiving at this point in the year. So we expect that to build throughout the year.
關於第一季度,我可以說的是,通常來說,這是一個相對疲軟的時期。我們對目前的新處方量感到非常驚訝,與我們預期的相比,新處方量明顯好於我們今年這個時候的預期。因此我們預計這種情況會在今年持續成長。
As I said in my prepared remarks, we have data that demonstrates very clearly that more reps in the field for this particular product, given the persistence of the product and the market interest in the product yields more prescriptions. And for us, building those new prescriptions ultimately leads to more and more total prescriptions and more revenue. So we're very much bent towards building volume in VEVYE, and that's how we're set up for this year, and that's what you should expect.
正如我在準備好的演講稿中所說,我們有數據非常清楚地表明,鑑於該產品的持久性和市場對該產品的興趣,增加該產品的銷售代表人數可以帶來更多的處方。對我們來說,開出這些新處方最終會帶來越來越多的處方和更多的收入。所以,我們非常注重在 VEVYE 提高產量,這就是我們今年的計劃,也是你們應該期待的。
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
Helpful, Mark. And just for my second question, another multiparter sorry, but just on the TRIESENCE Phase 3 cataract announced this morning. Obviously, a large potential volume opportunity. Just a couple of questions to help us understand the magnitude. So what percentage of the cataract market do you think is kind of the sweet spot for TRIESENCE as it relates to kind of the value prop versus the multi-drop regimens that are pretty pervasive today? How should investors kind of think about the TAM expansion from this label expansion kind of within cataract for TRIESENCE?
謝謝你的幫助,馬克。我的第二個問題,抱歉,又是多部分的問題,但只是關於今天早上宣布的 TRIESENCE 三期白內障治療。顯然,這是一個巨大的潛在交易量機會。這裡有幾個問題,幫助我們了解事情的嚴重性。那麼,您認為 TRIESENCE 在白內障市場中佔據多大比例的份額比較合適,因為它具有價值主張,而目前市面上普遍使用多滴眼液療法?投資人該如何看待 TRIESENCE 品牌擴張帶來的 TAM 擴張?
And then second, I think investors often have kind of question on duration of opportunity with pass-through products in the ASC. Can you just remind us or discuss the unique aspects of TRIESENCE that may allow for longer-term payment outside the bundle or how you plan to approach pricing there?
其次,我認為投資者經常對 ASC 中的轉嫁產品的投資機會持續時間有疑問。您能否提醒我們或討論一下 TRIESENCE 的獨特之處,例如允許在套餐之外進行更長期的付款,或者您打算如何進行定價?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Sure. Once again, I'll take the second question -- the second part first. In terms of reimbursement for the product, TRIESENCE is a very unique label in that it is both used in the office setting of care, and it's also used in the hospital and outpatient department setting of care. And as a result of that, and I don't want to go into the nuances of reimbursement policy, but we believe that TRIESENCE will not be limited by a TPT or a temporary pass-through period.
當然。我再次回答第二個問題──先回答第二部分。就產品報銷而言,TRIESENCE 是一個非常獨特的標籤,因為它既可用於診間護理環境,也可用於醫院和門診部護理環境。因此,我不想深入探討報銷政策的細微差別,但我們相信 TRIESENCE 不會受到 TPT 或臨時過渡期的限制。
And regarding the first part of the question, in terms of what the TAM expansion might be for this study that Amir just received clearance on, I believe, yesterday. I go back to, I think, another comment that I made in my prepared remarks, and that is that our vision for cataract surgery is that in the future, patients in the United States should have an IV-free, opioid-free and even an eye drop-free procedure.
至於問題的第一部分,關於 Amir 昨天剛獲得批准的這項研究的 TAM 擴展範圍,我認為是這樣的。我想,我還要回到我在準備好的演講稿中提到的另一個觀點,那就是我們對白內障手術的願景是,未來美國的患者應該能夠接受無需靜脈注射、無需阿片類藥物,甚至無需滴眼液的手術。
That is what I would want my mother to have. That's what I would want anyone that I love to have, not to have to put eye drops in their eye multiple times per day, multiple different eye drop bottles that's assuming you're using an FDA-approved product, of course. And so that should be the ideal, and that's what we're working towards.
我希望我母親能擁有那樣的幸福。我希望我愛的人都能擁有這樣的生活:不必每天多次滴眼藥水,也不必使用多種不同的眼藥水——當然,前提是你使用的是獲得 FDA 批准的產品。所以,這應該是理想狀態,也是我們努力的方向。
That's what the G-MELT is about, and that's what this expansion with TRIESENCE is about. It's about putting power in the hands of the surgeon to deliver the anti-inflammatory into the eye so that the patient doesn't need to administer these post-surgical eye drops. What's interesting is anecdotally, what we've seen is that for patients who are using this on label, which is a subsegment of the cataract surgery population, it's those patients who really can't administer eye drops, who have other comorbidities.
這就是 G-MELT 的意義所在,也是 TRIESENCE 擴充包的意義所在。其目的是賦予外科醫生權力,讓他們能夠將消炎藥注入眼內,這樣患者就不需要在術後使用眼藥水了。有趣的是,根據我們的觀察,對於那些按說明書使用這種藥物的患者(這是白內障手術人群中的一個子群體),那些確實無法自行滴眼藥水或患有其他合併症的患者。
What we decided to do because those patients are having such exceptional results is to invest in expanding the label so that all cataract surgery patients have access to this therapy. And what's terrific is, as I said, we've got reimbursement. We have an exceptional clinical outcome. And with this amazing study that Amir and his team are going to execute, we're going to have a very broad-based label that will finally give cataract surgeons access to an easy to administer, highly efficacious post-cataract surgery anti-inflammatory that they themselves can inject.
由於這些患者的治療效果非常顯著,我們決定加強投入,擴大適應症範圍,讓所有白內障手術患者都能獲得這種療法。正如我所說,最棒的是,我們可以獲得報銷。我們取得了卓越的臨床療效。憑藉 Amir 和他的團隊即將開展的這項了不起的研究,我們將獲得一個非常廣泛的標籤,最終使白內障外科醫生能夠獲得一種易於給藥、高效的白內障術後抗炎藥,他們可以自己注射這種藥物。
And here's the best thing for consumers, for patients. It has the lowest out-of-pocket of any injectable steroid at around $37 per unit. So it's affordable, it's accessible, it's highly efficacious, and we're going to invest for a very small amount of money in a study that will significantly expand the number of patients who will have access to it.
這對消費者和患者來說是最好的。在所有註射類固醇藥物中,它的自付費用最低,每單位約為 37 美元。所以它價格實惠、容易取得、療效顯著,我們將投入少量資金進行一項研究,這將大大增加能夠獲得該藥物的患者人數。
And in the United States, by the time this data reads out, that should be about 5 million procedures annually. So it's a very large market opportunity. And as I've said for a couple of years, TRIESENCE is a slow grower. We've got a lot to prove there for sure, but this is a product that in the next couple of years is going to be a meaningful value driver for our stockholders.
而到這些數據公佈之時,美國每年的手術量應該約為 500 萬例。所以這是一個非常大的市場機會。正如我過去幾年一直強調的那樣,TRIESENCE 的發展速度很慢。我們當然還有很多需要證明的地方,但這款產品在未來幾年內將成為我們股東的重要價值驅動因素。
Operator
Operator
Timur Ivannikov, Cantor Fitzgerald.
蒂穆爾·伊万尼科夫,康托爾·菲茨杰拉德。
Timur Ivannikov - Analyst
Timur Ivannikov - Analyst
This is Timur Ivannikov on for Steve Seedhouse. So first, on IHEEZO, I think you mentioned price improvements in the second half of 2026. Could you clarify, is that a price improvement from Q2 '26 or from Q4 '25? And do you expect Q2 '26 ASP to be significantly lower?
這裡是蒂穆爾·伊万尼科夫,替史蒂夫·西德豪斯為您報道。首先,關於 IHEEZO,我想您提到 2026 年下半年價格會有所改善。請問,這個價格是比 2026 年第二季有所改善,還是比 2025 年第四季有所改善?你預計2026年第二季的平均售價會大幅下降嗎?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Andrew, do you want to take that?
安德魯,你想拿嗎?
Andrew Boll - President, Chief Financial Officer, Company Secretary
Andrew Boll - President, Chief Financial Officer, Company Secretary
Yes. So and just to try to make sure I answer the question correctly, we expect by the time we get to Q3 of 2026, pricing for IHEEZO will be better than what it was in 2025 and in the first part of 2026.
是的。為了確保我正確回答這個問題,我們預計到 2026 年第三季度,IHEEZO 的定價將比 2025 年和 2026 年上半年的定價更好。
Timur Ivannikov - Analyst
Timur Ivannikov - Analyst
And then second question is on the TRIESENCE cataract trial design. I just wanted to understand the trial a little better. I think you mentioned the trial design versus placebo. Could you talk about the use of droplets -- anti-inflammatory eye droplets in both groups? I mean, are you allowed to dose the droplets in the treatment arm and the control arm?
第二個問題是關於 TRIESENCE 白內障試驗的設計。我只是想對審判過程有更深入的了解。我想你有提到試驗設計與安慰劑的比較。您能否談談兩組患者使用抗發炎眼藥水的情況?我的意思是,治療組和對照組的滴劑劑量可以自行設定嗎?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Amir, can you handle that one?
阿米爾,你能應付得了嗎?
Amir Shojaei - Chief Scientific Officer
Amir Shojaei - Chief Scientific Officer
Yes. I think the protocol design is pretty clear. We're going to have a control arm, which will not get TRIESENCE. And then -- but we do have rescue criteria already built in, and those rescue criteria would allow drops again, per protocol.
是的。我認為協議設計非常清晰。我們將設立一個對照組,該組不會接受 TRIESENCE。但是我們已經制定了救援標準,根據協議,這些救援標準將允許再次墜落。
Operator
Operator
Mayank Mamtani, B. Riley Securities.
Mayank Mamtani,B. Riley Securities。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
I appreciate the helpful go-forward guidance framework. So on VEVYE NRx improving and the commercial mix also improving, Mark, are you able to share with us any end of year or second half loaded kind of market share targets that you may have, so we can understand the growth in the market. Obviously, multiple companies investing here on the penetration side, but also want to understand how you're thinking about share gains in both the cash pay and also obviously, the commercial mix markets?
我非常感謝這份有益的後續指導框架。鑑於 VEVYE NRx 的改善以及商業組合的改善,Mark,您能否與我們分享您預計的年底或下半年的市場份額目標,以便我們了解市場的成長?顯然,許多公司都在投資市場滲透,但我們也想了解您是如何看待現金支付市場以及商業組合市場中市佔率成長的?
And then I have a follow-up on IHEEZO.
接下來,我還要跟進 IHEEZO 的狀況。
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Sure. Yes. So we have three goals for VEVYE. First of all, I just want to say that the dry eye market in the US is as Pat said, a very large market. We believe it still continues to be underpenetrated, and we continue to see data that demonstrates that there are large segments of the dry eye patient population that are receiving products on a monthly basis that burn and sting cause pain, sneeze.
當然。是的。所以,我們為 VEVYE 設定了三個目標。首先,我想說的是,正如 Pat 所說,美國的乾眼症市場是一個非常大的市場。我們認為它仍然滲透率不足,而且我們不斷看到數據表明,很大一部分乾眼症患者每月都在使用會引起灼熱感和刺痛感、導致疼痛和打噴嚏的產品。
I mean, the list of these effects are too long. And so when we see that patients are getting access to these nonoptimal therapies for whatever reason, whether it's coverage or they're just not aware of VEVYE, we see that as opportunity to convert those patients to a therapy that doesn't burn and sting and that has all of the positive benefits that VEVYE offers, including now these enhanced coverage metrics.
我的意思是,這些影響的清單太長了。因此,當我們看到患者由於各種原因(無論是醫保覆蓋範圍還是他們根本不了解 VEVYE)而獲得這些非最佳療法時,我們認為這是一個機會,可以將這些患者轉化為一種不會灼燒和刺痛,並且具有 VEVYE 所提供的所有積極益處的療法,包括現在這些增強的醫保覆蓋指標。
But in terms of what our goals are, to be clear, the first goal is we believe VEVYE will be the number one cyclosporine in the US market. Cyclosporine is the most trusted active ingredient in the dry eye market, and we aim to be the number one cyclosporine.
但就我們的目標而言,需要明確的是,第一個目標是我們相信 VEVYE 將成為美國市場上排名第一的環孢素。環孢素是乾眼症市場上最值得信賴的活性成分,我們的目標是成為環孢素領域的佼佼者。
Second to that, we believe we can capture the anti-inflammatory market. So any product that actually has an active ingredient and that would be an anti-inflammatory, and we believe all forms of dry eye disease, we don't care which one you choose, have an inflammatory component to them. And so we aim to be secondarily the number one anti-inflammatory.
其次,我們相信我們能夠佔領抗發炎藥市場。所以任何含有活性成分且具有抗發炎作用的產品,我們認為所有形式的乾眼症,無論你選擇哪一種,都具有發炎成分。因此,我們的目標之一是成為排名第一的抗發炎藥物。
And then eventually, and it's not going to happen overnight. We think we have the opportunity with this particular product to be the number one most prescribed dry eye product.
然後最終會實現,但這不會一蹴可幾。我們認為這款產品有機會成為處方量排名第一的乾眼症產品。
Now for the last couple of years, our competition has had a sales organization that even the most inferior products in the market have had much larger sales organizations than we've had. And we are now, as I said, more than doubling our sales force. I think we're more than halfway there. So I'm actually surprised that the talent team is doing a great job. And there's just a lot of people that want to join this Maria's team and sell VEVYE.
近幾年來,我們的競爭對手的銷售組織規模越來越大,即使是市場上最糟糕的產品,其銷售組織也比我們大得多。正如我所說,我們現在正在將銷售團隊規模擴大一倍以上。我認為我們已經完成了一半以上。所以,我其實很驚訝人才團隊做得這麼出色。很多人都想加入瑪莉亞的團隊,銷售 VEVYE 產品。
But in terms of specific market share percentages, we're not giving those goals. I think to be the number one cyclosporine in the market, we probably need to have just north of 20% market share. So that gives you a sense of what we think is achievable.
但就具體的市佔率百分比而言,我們並沒有設定這些目標。我認為,要成為市場上排名第一的環孢素,我們可能需要佔據略高於 20% 的市場。這樣您就能對我們認為可以實現的目標有所了解。
And by the way, in many markets, we are already there. The problem is, is that we touched historically so few markets with a sales organization of just under 50 people that even if you have better than 20% market share in the Greater Cincinnati area, which happens to be the case, there are many other markets where you just simply don't have that level of market share.
順便說一句,在很多市場,我們做到了。問題在於,由於我們歷史上涉足的市場非常有限,銷售團隊也只有不到 50 人,因此即使你在大辛辛那提地區擁有超過 20% 的市場份額(事實也的確如此),但在其他許多市場,你根本無法達到這樣的市場份額水平。
So with this enhanced sales force, now numbering close to about 100, we'll touch more markets. We will increase our market share, I believe, and we'll get closer and closer to that goal of being the number one cyclosporine.
因此,憑藉這支人數接近 100 人的擴充銷售隊伍,我們將開拓更多市場。我相信,我們將提高市場份額,並越來越接近成為環孢素第一品牌的目標。
Pat, do you want to add to that at all?
派特,你還有什麼要補充的嗎?
Patrick Sullivan - Chief Commercial Officer
Patrick Sullivan - Chief Commercial Officer
Thanks, Mark. I think one of the things we're most optimistic about, as we stated in our earnings is the increase in writing that we see -- we saw 115% growth in our writing. And I think, as Mark mentioned, the feedback that we received from our eye care professionals and from their patients is extremely positive around the fact that VEVYE uniquely manages inflammation, how rapid it works and at the same time, is the unique tolerability profile.
謝謝你,馬克。正如我們在收益報告中所述,我們最樂觀的事情之一是寫作量的增長——我們的寫作量增加了 115%。正如馬克所提到的那樣,我們從眼科護理專業人員及其患者那裡收到的反饋非常積極,他們認為 VEVYE 能夠獨特地控制炎症,起效迅速,同時還具有獨特的耐受性。
We are extremely encouraged in our next phase of expansion to cover a much larger portion of the market and increase VEVYE's presence to really grow this product to be the number one cyclosporine. So Mayank, we're well on our way to building our next phase of growth for VEVYE.
我們對下一階段的擴張充滿信心,希望能夠涵蓋更大的市場份額,並提高 VEVYE 的市場份額,真正將該產品發展成為排名第一的環孢素。所以 Mayank,我們正朝著 VEVYE 的下一個成長階段穩步前進。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
And then on IHEEZO, obviously, a lot going on here, ASC pass-through status expiration, but also price per unit improvement that you mentioned. And there's also some data generation activity you noted at ASRS conference middle of the year. I was just curious to contextualize its contribution to the guidance.
然後,關於 IHEEZO,顯然有很多事情正在發生,ASC 轉嫁狀態到期,但也有你提到的單位價格改善。此外,您在年中的 ASRS 會議上也提到了一些資料產生活動。我只是好奇它對指導意見的貢獻的具體情況。
Are you also thinking like VEVYE, this is a nine-digit revenue contributor for this year? Or is it more a reasonable target for next year?
您是否也像 VEVYE 一樣認為,這將為今年帶來九位數的收入貢獻?或者,明年設定一個更合理的目標是否更適合?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes. I don't want to comment on the revenues for that product. I think the only product we've given guidance on specifically is VEVYE, which is clearly on the road to nine figures. What I will tell you is this, just as a reminder, in 2024, we had absolutely zero retina presence. We didn't have a retina sales force. We didn't have any products in that market. And only a couple of years ago, did we hire that sales organization.
是的。我不想對該產品的收入發表評論。我認為我們唯一給出具體指導的產品是 VEVYE,它顯然正在朝著九位數銷售額邁進。我還要提醒你們一點,2024 年,我們在視網膜上的存在感完全是零。我們沒有專門負責視網膜銷售的團隊。我們在那個市場上沒有任何產品。就在幾年前,我們才組了那個銷售團隊。
So in really August of 2024, we began what we call the retina pivot, where we were able to attract great people from much larger companies that had tremendous backgrounds in retina, and we built this organization. I remember going to ASRS in Stockholm, nobody knew who Harrow was. They had -- we had no presence in that market. And it's a very tight community, the retina community.
因此,在 2024 年 8 月,我們開始了所謂的視網膜轉型,我們能夠從規模更大的公司吸引到在視網膜領域擁有豐富經驗的優秀人才,並組建了這個組織。我記得去斯德哥爾摩參加ASRS的時候,沒人知道Harrow是誰。他們有——而我們當時在這個市場上沒有任何影響力。視網膜領域是一個非常緊密的群體。
And what I can tell you is over the last 1.5 years, two years or so, I think if you go to retina professionals now and ask them if they know who Harrow is, they really know who Harrow is. I have to say another thing about IHEEZO specifically because it is amazing what Ali and her team have done, taking a product where the clinical studies supporting the NDA were in cataract surgery, and they have been able to adapt that data to the intravitreal injection market now with more than 70% of the unit volume for IHEEZO in the retina market.
我可以告訴你的是,在過去的1.5到2年左右的時間裡,如果你現在去問視網膜專家是否知道哈羅是誰,他們肯定都知道哈羅是誰。關於 IHEEZO,我還要特別提一下,因為 Ali 和她的團隊所取得的成就令人驚嘆。他們將支持 NDA 的臨床研究應用於白內障手術,並成功地將這些數據應用於玻璃體內注射市場,現在 IHEEZO 在視網膜市場的銷售量佔比超過 70%。
What's really exciting is what Amir talked about with the Dang study. What Ali has wanted for well over a year, we've had numerous conversations is specific data related to the performance of IHEEZO in the intravitreal injection procedure. And we had all this anecdotal information, doctors would tell us how it performed. Some doctors had other benefits that they experienced from the product, including efficiency in their workflow.
真正令人興奮的是 Amir 談到的 Dang 研究。一年多來,阿里一直想要的,也是我們多次討論過的,是關於 IHEEZO 在玻璃體內注射手術中的表現的具體數據。我們掌握了很多軼事信息,醫生們會告訴我們它的表現如何。有些醫生從產品中還獲得了其他益處,包括提高了工作流程效率。
But what I think you're going to see in the middle of the year, finally, for Ali and her team is a data set that will demonstrate the real difference between IHEEZO and these legacy modes of providing these patients with anesthesia for these intravitreal injections. And I have to tell you, if you're a patient getting these injections, the anesthesia and pain control really matters. And we think we have a product, at least anecdotally, we've received tremendous information from accounts that use this product about its performance.
但我認為,到今年年中,阿里和她的團隊最終會得到一個數據集,該數據集將證明 IHEEZO 與這些傳統的為患者提供玻璃體內注射麻醉的方式之間的真正區別。我必須告訴你,如果你是接受這些注射的病人,麻醉和疼痛控制真的很重要。我們認為我們的產品不錯,至少從一些用戶的回饋來看,我們已經收到了很多關於該產品性能的資訊。
And in the middle of the year at ASRS, and he got a late breaker, by the way. I mean, it's not easy to get these, but he is going to present this data. And I think that is going to fuel significant demand in the retina market for this product.
而且,在 ASRS 年中,他還獲得了一個遲來的突破機會。我的意思是,要取得這些數據並不容易,但他會公佈這些數據。我認為這將極大地刺激視網膜市場對該產品的需求。
So in terms of how we -- how IHEEZO fits into our overall guide this year and certainly in 2027, depending on how this data comes out, this is an opportunity, I think, to significantly improve the unit volume demand for IHEEZO.
所以,就我們而言,IHEEZO 如何融入我們今年的整體指導方針,以及當然在 2027 年,這取決於這些數據的出爐情況,我認為這是一個大幅提高 IHEEZO 單位銷售需求的機會。
And then as Andrew said that, coupled with this new packaging format that's specifically for retina and a meaningfully improved price, I think that by the end of next year, you're going to hopefully be surprised at what we think we can generate from this particular product.
正如 Andrew 所說,再加上這種專為視網膜設計的新包裝形式以及大幅改善的價格,我認為到明年年底,你們或許會對我們認為這款產品能夠帶來的收益感到驚訝。
Mayank Mamtani - Analyst
Mayank Mamtani - Analyst
And lastly, very quickly, the OpEx expansion that you have -- you're seeing your R&D was higher in fourth quarter. Is it sort of a first half loaded kind of dynamic? And is there a steady-state OpEx spend, Andrew, you're trying to get at some point this year?
最後,簡單來說,關於營運支出擴張—您可以看到,第四季度的研發投入更高了。這是一種前半程節奏很快的動態嗎?安德魯,你今年有沒有計劃實現穩定的營運支出目標?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Thank you, Mike. Andrew, do you want to tackle the OpEx?
謝謝你,麥克。安德魯,你想負責營運支出嗎?
Andrew Boll - President, Chief Financial Officer, Company Secretary
Andrew Boll - President, Chief Financial Officer, Company Secretary
Yes, absolutely. Thanks, Mayank. And I want to be sure to note, in Q4 in the P&L, there's an $8.5 million charge for acquired in-process R&D, which was associated with the Melt acquisition, was our upfront costs and some of the transaction costs associated with the deal. But none of that acquisition cost was capitalized. It all ran through the P&L and ran through R&D according to GAAP rules.
是的,絕對的。謝謝,Mayank。我還要特別指出,在第四季度的損益表中,有一筆 850 萬美元的費用,用於支付收購過程中的研發項目,這與收購 Melt 有關,是我們的前期成本以及與該交易相關的一些交易成本。但這些收購成本均未資本化。所有費用都計入損益表,並依照公認會計準則計入研發費用。
And we also didn't back it out or add it back in, I should say, to the EBITDA number for 2024. But kind of looking forward the adjusted EBITDA -- looking forward at the OpEx spend, and Mayank, I'm going to kind of break it into two parts. You've got the SG&A side, which we're adding that sales -- those sales heads right now, we've been adding them aggressively in Q1. We'll continue to add them in Q2.
而且,我們應該說,我們也沒有將其從 2024 年的 EBITDA 資料中剔除或重新加回。但展望調整後的 EBITDA——展望營運支出,Mayank,我打算把它分成兩部分。你們還有銷售、一般及行政費用方面,我們正在增加銷售人員——目前,我們在第一季一直在積極增加這些銷售主管。我們將在第二季度繼續增加它們。
And then we've also been preparing. So we're preparing from a marketing and promotion standpoint, which is also increasing that spend. And we're kind of trying to get ahead of a lot of that as well so that when these people get hired and trained, they're hitting the ground running with VEVYE and TRIESENCE for that matter.
我們一直在做準備。因此,我們正在從行銷和推廣的角度進行準備,這也意味著支出將會增加。我們也正努力提前做好很多準備,以便當這些人被雇用和培訓後,他們能夠立即上手 VEVYE 和 TRIESENCE 的工作。
From an R&D perspective, a lot of that cost, as you know, is going to be trial dependent. We sort of have a base here of R&D spend year over year. But as we put out this announcement this morning regarding the TRIESENCE's IND being accepted and that study picking up. Those costs will kind of show up in the middle part of the year, so Q2, Q3.
從研發的角度來看,如你所知,很多成本都取決於試驗結果。我們這裡有一個每年研發支出的基準線。但正如我們今天早上發布的公告所述,TRIESENCE 的 IND 申請已被接受,並且該研究正在推進中。這些成本會在年中顯現出來,也就是第二季和第三季。
So we'll have a little bit of a ramp in the middle part of the year and then it should come down a little bit on the R&D side in Q4 as you sort of wrap up those studies along with some of the melt studies.
所以,我們會在年中稍微增加一些投入,然後在第四季度研發方面會稍微減少一些投入,因為我們會完成一些研究以及一些熔化研究。
Operator
Operator
Lachlan Hanbury-Brown, William Blair.
拉特蘭·漢伯里-布朗,威廉·布萊爾。
Lachlan Hanbury-Brown - Analyst
Lachlan Hanbury-Brown - Analyst
I guess, first, I would appreciate maybe a little more color on how you're thinking about the IHEEZO dynamics in 2026. So you said you think the in-office procedure expansion beyond retina can offset the ASC loss. Is that sort of specifically talking about Q2? Or is that more of a longer term you think looking a year or so out, it will more than offset that.
首先,我想請您更詳細地談談您對 2026 年 IHEEZO 的發展動態有何看法。所以你說你認為診室內的手術範圍擴大到視網膜以外可以彌補 ASC 的損失。這是特指Q2嗎?或者,你認為從長遠來看,例如展望未來一年左右,這將足以彌補這一點。
So I guess, should we expect maybe a drop in Q2 in unit demand?
所以我想,我們是否應該預期第二季單位需求可能會下降?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes. I don't want to be specific about demand in any particular quarter other than to say that in Q4, Q1, Q2, Q3, I think I've said this, we expect demand to continue to increase. So demand continues to increase. That's separate from revenue recognition, but demand for the product does continue to increase.
是的。我不想具體說明某個季度的需求情況,只想說,在第四季、第一季、第二季、第三季度,我想我已經說過,我們預期需求將持續成長。因此,需求持續成長。這與收入確認是分開的,但對該產品的需求確實在持續增長。
In terms of when we're likely to see the offset from the loss of the ASC units, when I looked at the ASC units specifically, the number of units that we're losing relative to the overall opportunity that we're adding when we add these in-office opportunities with this 2.5 million unit increase to our TAM, it's such a small level of success, and we have a discrete team going into the same customers that are using it in the ASC that don't know that they can use it also in their clinics.
至於我們何時才能彌補 ASC 單元損失的影響,當我具體查看 ASC 單元時,考慮到我們失去的單元數量相對於我們通過增加診所內機會(這為我們的總目標市場增加了 250 萬個單元)而獲得的整體機會而言,這只是很小的成功。而且我們還有一個專門的團隊去拜訪那些在 ASC 中使用該技術的客戶,他們並不知道也可以在自己的診所中使用該技術。
Remember, every one of the doctors that's using it in the ASC is a surgeon, but they also only spend a day or two a week in the surgery operating room -- the surgical operating room. The rest of the week, they spend in their office doing procedures. And so it's a simple idea.
請記住,在 ASC 中使用它的每一位醫生都是外科醫生,但他們每周也只在手術室——外科手術室——待上一兩天。一週剩下的時間,他們都在辦公室處理各種事務。所以,這是一個很簡單的想法。
We're going to the same customers that are using the product satisfactorily in the ASC, and we're saying, hey, you're doing more procedures in your office than you're doing in the surgical suite. And it's not for every procedure, but for those procedures where this could be impactful, we're going to the same customers and trying to convert their in-office business. And it's such a small number of units, as I said, that we don't have to really be that successful to fully offset the entirety of what we're losing when we lose the temporary pass-through code.
我們去找那些在門診手術中心 (ASC) 中對產品使用情況感到滿意的客戶,然後告訴他們,嘿,你們在辦公室裡做的手術比在手術室裡做的手術還多。雖然這不適用於所有手術,但對於那些可能產生影響的手術,我們正在聯繫相同的客戶,並試圖將他們的門診業務轉化為線上手術。正如我所說,這個數量非常少,所以我們不需要取得很大的成功就能完全彌補失去臨時過路代碼所造成的全部損失。
So is that going to happen in the first quarter or the second quarter? No. I doubt it. It should happen throughout the year. And as I said, it's such a small number of units relative to what the overall opportunity is that we can fail and fail and fail again and still end up eating up all of those lost units from the ASC.
那麼這件事會在第一季發生還是第二季發生呢?不。我對此表示懷疑。這種情況應該全年都會發生。正如我所說,相對於整體機會而言,這個數量非常少,即使我們一次又一次地失敗,最終仍然可以彌補 ASC 損失的所有單位。
Lachlan Hanbury-Brown - Analyst
Lachlan Hanbury-Brown - Analyst
That's good color. I guess second question is just on VEVYE and the new coverage, just wondering what you're seeing in terms of the patients that are sort of getting scripts filled under that coverage. Are they new-to-brand patients? Or is there a sizable chunk of them who were previously paying cash pay or maybe you previously managed to get coverage for them who are now just converting to be sort of covered more easily?
顏色真好看。我想第二個問題是關於 VEVYE 和新的保險範圍,只是想知道您在使用這項保險範圍獲得處方藥的患者方面看到了什麼情況。他們是第一次使用該品牌的患者嗎?或者,其中有相當一部分人以前是現金支付的,或者你以前設法為他們爭取到了保險,現在只是為了更容易獲得保險而轉換保險方式?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes. I can't say specifically with numbers, what percentage or what number of patients are converting. What I can sort of echo what we've said in the past and that in 2025, there were a lot of patients who we received prescriptions for, but -- legal prescriptions, but who were denied access to the product for one reason or another, who chose not to get their prescription filled. And so we're going out to those patients.
是的。我無法用具體數字說明轉換率是多少,或是有多少患者轉換了。我可以重申我們過去說過的話,那就是到 2025 年,會有很多病人拿到處方,但這些處方是合法的,卻因為這樣那樣的原因被拒絕獲得藥品,他們選擇不去配藥。所以我們要去探望這些病人。
Now those patients still have legal prescriptions, and we can contact them and make them aware of the existence of coverage and try to capture as many of those as possible. At the same time, there are patients who are paying cash, as you said, so these consignment patients who do have coverage now, but formerly did not, and we can go to them. We know exactly who those folks are as well and convert them.
現在這些患者仍然持有合法處方,我們可以聯繫他們,讓他們了解保險覆蓋範圍,並盡可能爭取他們的投保。同時,正如你所說,也有一些病人是自費的,所以這些寄售病人現在有醫保了,但以前沒有,我們可以去拜訪他們。我們也清楚知道這些人是誰,並且能夠轉化他們。
This is a sizable number of people. And you're talking about well north of 30 million new covered lives where you have the best access for VEVYE now. So we have to see how things play out. I think based on what we're seeing in the first quarter, we thought we would not be where we are. We're in a better place than where we thought we would be in terms of new prescriptions.
這是一個相當多的人數。而且,您現在所說的新增投保人數遠遠超過 3,000 萬,而 VEVYE 正好能為這些人提供最佳的投保途徑。所以,我們得看看事情會如何發展。我認為,根據我們第一季所看到的情況來看,我們沒想到會取得現在這樣的成績。就新處方而言,我們現在的處境比我們預想的要好。
The new-to-brand side of things, I think, is going to come once we get these new bodies out, these new sales reps, you'll have more and more of that new-to-brand. And I can say -- and I don't want to steal Pat's thunder, but Pat, do you want to actually talk about the whole new-to-brand because I know that's really been a focus of yours?
我認為,一旦我們推出這些新員工、這些新的銷售代表,就會出現越來越多的新客戶。我可以說——我不想搶帕特的風頭,但是帕特,你真的想談談整個新品牌嗎?因為我知道這真的是你關注的重點?
Patrick Sullivan - Chief Commercial Officer
Patrick Sullivan - Chief Commercial Officer
Yes. Thanks, Mark. And I think the core to our next phase of growth for VEVYE is really around driving new growth for VEVYE. We know better as possible when it comes to managing dry eye disease, as Mark mentioned. And our main focus going forward is ultimately to win the new-to-brand patients, and I think that's going to be a heavy focus for us.
是的。謝謝你,馬克。我認為 VEVYE 下一階段成長的核心在於推動 VEVYE 實現新的成長。正如馬克所提到的那樣,我們在治療乾眼症方面應該盡可能地了解更多。我們未來的主要重點最終是贏得新品牌患者,我認為這將是我們工作的首要任務。
And obviously, beginning of this year in our conversion from CVS, we are really in our expansion and leading up to our expansion, heavily focused on the right patient and working with our physicians and our communication approach to make sure that we are targeting these patients because what we do know is those that are having -- either coming in that are having dry disease symptoms or having unresolved or persistent symptoms on other subdoptimal treatments, VEVYE is the perfect treatment for that.
顯然,今年年初我們從 CVS 轉型,我們正處於擴張階段,並且在擴張之前,我們非常注重尋找合適的患者,並與我們的醫生和溝通方式合作,以確保我們能夠鎖定這些患者,因為我們知道,對於那些患有乾性疾病症狀或在其他次優治療中症狀未得到解決或持續存在的患者來說,VEVYE 是完美的治療方法。
Our goal moving forward is to make sure that we have the right presence with our customers and ultimately target the right patients going forward. So Mark, to your point, new-to-brand for us is a huge focus and will really start to come to life for us as we go to our next phase of expansion.
我們未來的目標是確保與客戶建立正確的聯繫,並最終鎖定合適的患者群體。所以馬克,你說得對,對我們來說,新品牌是一個重要的關注點,隨著我們進入下一個擴張階段,它將真正開始煥發生機。
Operator
Operator
Tom Shrader, BTIG.
湯姆·施拉德,BTIG。
Thomas Shrader - Equity Analyst
Thomas Shrader - Equity Analyst
On the VEVYE sales force, after your increase, where does that put you relative to competitors like MIEBO? Would you be on an equal playing field?
在 VEVYE 銷售團隊中,你的職位有所提升,與 MIEBO 等競爭對手相比,你的職位處於什麼位置?你們之間會有公平的競爭環境嗎?
And then just a remedial question on the Melt franchise. Are you still wedded to two products? It seems like the first product is the bigger product. It's the combination. Does your compounding business inform you that there really is a need for two products?
然後是一個關於 Melt 系列遊戲的補習題。你仍然只鍾情於這兩款產品嗎?看起來第一款產品是更大的一款產品。是兩者結合的結果。您的配藥業務是否顯示確實需要兩種產品?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes. So I'll take the first question. In terms of the VEVYE sales force, I actually -- we don't know exactly how many reps these competitors have out in the field. We've heard that one of our competitors that has a pretty sizable market share has upwards of 300 people. So we're going to have around 100 ourselves, but what I can tell you is that our reps are so powerful that one Harrow rep with VEVYE is equal to four of theirs, I'm kidding.
是的。那我先回答第一個問題。就 VEVYE 的銷售團隊而言,實際上——我們並不確切知道這些競爭對手有多少銷售代表在外奔波。我們聽說,我們的一家市佔率相當大的競爭對手擁有超過 300 名員工。所以我們自己大概會有 100 人左右,但我可以告訴你的是,我們的代表非常強大,一個 Harrow 代表 VEVYE 就相當於他們四個代表,我開玩笑的。
But we really do have a terrific sales organization that's well trained and they have an outstanding product to sell. This is the second phase of our expansion. So this -- we had the initial hiring for this product. This is the second phase, taking us up to around 100 territories or so. There very likely could be a slight increase in the number of territories as we see this investment pay off.
但我們確實擁有一支非常優秀的銷售團隊,他們訓練有素,而且他們還有一款非常出色的產品要銷售。這是我們擴張的第二階段。所以,我們最初是為這款產品招募的。這是第二階段,將涵蓋大約 100 個地區。隨著這項投資取得成效,領土數量很可能會略有增加。
And so -- but we're excited to have this sales force double -- more than doubling here in the near term. And I'm also pleased with the quality of people we've been able to attract and those that we've continued to retain who are on Maria's team.
所以——但我們很高興看到這支銷售隊伍在短期內翻一番——甚至不止翻一番。我對我們能夠吸引到的人才品質以及我們一直留住的、在瑪麗亞團隊中的人才品質也感到滿意。
In terms of Melt and the need for both products, the MKO Melt, which is a compounded formulation that we've sold for a number of years, is -- has really informed the entirety of the development program. One of the nice things about the G-MELT when it is approved, is that we're going to discontinue the compounded version of the product, and we'll hopefully convert all of that business into an FDA-approved and hopefully reimbursable product.
就 Melt 和兩種產品的需求而言,MKO Melt 是一種我們已經銷售多年的複合配方,它確實為整個開發計劃提供了指導。G-MELT 獲得批准後的好處之一是,我們將停止生產該產品的複方版本,並希望將所有業務轉化為 FDA 批准且有望獲得報銷的產品。
It is very hard, as I've said, over the years, to sell compounded medications. They're not FDA approved. They don't have a label, particularly in anesthesia and sedation where an anesthesia professional is going to think twice or three times about whether or not they're going to use a compounded formulation.
正如我多年來一直強調的那樣,銷售複方藥物非常困難。它們未經美國食品藥物管理局(FDA)批准。它們沒有標籤,尤其是在麻醉和鎮靜方面,麻醉專業人員會重複考慮是否要使用複方製劑。
So when we have an on-label FDA-approved product that is also hopefully reimbursed, this should significantly expand the market opportunity for the G-MELT in cataract surgery, but also for other procedures where a sublingual non-opioid sedation choice can prevail.
因此,當我們有了一個獲得 FDA 批准的標籤產品,並且有望獲得報銷時,這將大大擴大 G-MELT 在白內障手術中的市場機會,以及其他可以採用舌下非阿片類鎮靜劑的手術的市場機會。
In terms of why we need also the 210 program, the 210 program addresses a different market segment. And believe it or not, in terms of the total number of units of opportunity for it, based on the expected label, and we still need to discuss that with the FDA and come to a resolution around what ultimately a label might look like for what is now called YOCHIL, that product in terms of unit demand is bigger in unit volume demand, we believe, than even the G-MELT.
至於為什麼我們還需要 210 計劃,210 計劃針對的是不同的市場區隔。信不信由你,就其總單位機會數量而言,根據預期的標籤,我們仍然需要與 FDA 討論並就目前稱為 YOCHIL 的產品的最終標籤可能是什麼樣子達成一致,我們相信,該產品的單位需求量甚至比 G-MELT 還要大。
The G-MELT will be used certainly in cataract surgery, which is what we're studying it for. We also believe it will be used as the compounded product is used in ENT for endoscopy. It's used in dermatology, plastics, dental, widely used in dental. It's used to deal with claustrophobia in MRI tubes. And so that's the experience that we have with the MKO Melt, the compounded version.
G-MELT肯定會用於白內障手術,這也是我們研究它的目的。我們也認為它將被用作耳鼻喉科內視鏡檢查中使用的複方製劑。它用於皮膚科、整形外科、牙科,尤其在牙科領域應用廣泛。它用於治療核磁共振檢查室中的幽閉恐懼症。這就是我們使用 MKO Melt(複合版)的體驗。
And our expectation is that the G-MELT when it's approved, eventually will be used in markets outside of ophthalmology, which happen to be even bigger markets than the ophthalmic market. But the answer is yes, we need two products.
我們預計,G-MELT 獲得批准後,最終將應用於眼科以外的市場,而這些市場恰好比眼科市場更大。但答案是肯定的,我們需要兩種產品。
They serve different markets. One is specifically related to anxiety. And it will also, as I said, be available, and I said this, I think, in the letter to stockholders in three different -- ultimately be available in a number of different strengths.
它們服務於不同的市場。其中一項與焦慮症有關。而且,正如我所說,它最終將以三種不同的濃度提供——我認為我在給股東的信中也說過這一點。
Thomas Shrader - Equity Analyst
Thomas Shrader - Equity Analyst
If I can sneak in one follow-up. The new TRIESENCE, I mean, it seems like it's a much easier product to make and use. Do you think you might expand that outside the eye where that steroid is used? Or is this entirely a formulation for the eye?
如果我能偷偷補充一點的話。全新的TRIESENCE產品,我的意思是,看起來製作和使用起來都容易得多。你認為可以將這種類固醇的使用範圍擴大到眼睛以外嗎?或者這完全是一種眼部配方?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
It's purely for the eye. We started our company in 2014. Our first sale was with triamcinolone acetonide for injection. And this is a product category, an active ingredient we know really, really well. Our compounded formulation, once again, the enthusiasm for TRIESENCE for us comes from our experience having sold Tri-Moxi in well over 1 million cataract surgeries.
純粹是為了觀賞。我們公司成立於2014年。我們的第一筆銷售是注射用曲安奈德。而這正是我們非常了解的產品類別和活性成分。我們再次強調,我們對 TRIESENCE 的熱情源於我們銷售 Tri-Moxi 的經驗,該產品已用於超過 100 萬例白內障手術。
So it's a market we know well. It's just -- this product is just going to be for the eye, but we have real high hopes that we can once again create this protocol, which is IV-free, opioid-free and even eye drop-free eventually for cataract surgery patients, which is really where the market needs to go.
所以,這是我們非常熟悉的市場。這款產品目前僅用於眼部,但我們非常希望能夠再次製定出這種無需靜脈注射、無需阿片類藥物,甚至最終無需眼藥水的治療方案,用於白內障手術患者,而這正是市場需要發展的方向。
Operator
Operator
Thomas Flaten, Lake Street Capital Markets.
托馬斯·弗拉頓(Thomas Flaten),湖街資本市場。
Thomas Flaten - Analyst
Thomas Flaten - Analyst
Following up on VEVYE, with respect to the sales force expansion, can you talk a little bit about -- and I think you alluded to this, Mark, that it's a lot of new territory, but new territory versus territory splitting because of overload.
關於 VEVYE 的銷售團隊擴張,可以稍微談談嗎?我想你之前也提到過這一點,Mark,那就是有很多新的領域,但是新領域和由於業務過載而進行的區域分割之間有什麼區別呢?
And then how you see the dynamics between the ophthalmology and optometry community playing into that growth expectation?
那麼,您認為眼科和驗光界之間的動態關係將如何影響這種成長預期?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
I'll take the second one first, and then I'll flip the first to Pat. But in terms of the sales force -- actually, pardon me. I think the right -- your second -- sales force expansion and what else, Thomas?
我先拿第二個,然後把第一個給帕特。但就銷售團隊而言——實際上,請原諒我這麼說。我認為正確的做法──你的第二個建議──是擴大銷售團隊,還有什麼呢,湯瑪斯?
Thomas Flaten - Analyst
Thomas Flaten - Analyst
The ophthalmology versus optometry.
眼科學與驗光學。
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes, I'll answer. Yes. So ophthalmology and optometry, believe it or not, the optometric market is a critical market. I would say that I would be slightly biased towards the optometric market. I think now optometrists are writing as many or probably more prescriptions for dry eye medications than ophthalmologists. That's what the data that I'm seeing shows.
好的,我會回答。是的。所以,不管你信不信,眼科和驗光,驗光市場是一個至關重要的市場。我認為我對驗光市場略有偏愛。我認為現在驗光師開出的乾眼症藥物處方數量可能與眼科醫生一樣多,甚至更多。我看到的數據也證實了這一點。
But Pat, do you want to talk about the sales force expansion specifically?
帕特,你想具體談談銷售團隊擴張的問題嗎?
Patrick Sullivan - Chief Commercial Officer
Patrick Sullivan - Chief Commercial Officer
Yes. Thanks, Mark. And I think when we think about the expansion, I mean, this is a real great opportunity for us to look at the great progress that VEVYE has done for dry eye disease patients to date. And I think one of the first things we do is look at this, to your point, you were talking about like basically business interruption versus business continuity.
是的。謝謝你,馬克。我認為,當我們考慮擴張時,這確實是一個絕佳的機會,讓我們能夠回顧 VEVYE 迄今為止在乾眼症患者方面的巨大進步。我認為我們首先要做的事情之一就是看看這一點,正如你剛才所說,你剛才談到的基本上是業務中斷與業務連續性。
It sounded like your question was around -- I think we're taking a very methodical approach to make sure that we are, one, relooking at making sure that this approach going forward. It is sales force expansion, but it is about VEVYE's brand presence and promotional efficiency in front of our customers going forward.
聽起來你的問題是關於——我認為我們正在採取非常系統化的方法,以確保我們首先重新審視並確保這種方法能夠繼續下去。雖然這是銷售團隊的擴張,但更重要的是 VEVYE 品牌在未來客戶面前的影響力和推廣效率。
This is a very, very active category that is large, growing and active. And for us, like to the prior question by one of your colleagues around playing in that dynamic part of the market where that new to brand is, it's going to take not only having our current territories be very efficient, but also our expansions. We are being very, very thoughtful in how we're, one, putting our footprint together.
這是一個非常非常活躍的類別,規模龐大,發展迅速。對我們來說,就像你們一位同事之前提出的問題一樣,關於如何在充滿活力的市場中扮演新品牌的角色,這不僅需要我們現有的市場區域非常高效,還需要我們的擴張。我們正在非常、非常認真地考慮如何,首先,如何留下我們的足跡。
But I think the key takeaway here is VEVYE is poised for significant growth going forward, but it will be about how we want to put a new VEVYE presence in front of our customers that one is really about differentiation, new to brand and having the right presence that is commensurate with being a number one -- goal of being the number one cyclosporine and number one dry disease treatment.
但我認為關鍵在於,VEVYE 已做好充分準備,未來將實現顯著增長,但關鍵在於我們如何向客戶展現全新的 VEVYE 形象,這真正關乎差異化、品牌創新以及與成為行業第一相稱的形象——我們的目標是成為環孢素類藥物和乾性疾病治療領域的領導者。
So to your question, very thoughtful on how we'll drive that business to maintain our aims and our growth going forward.
所以對於您的問題,我們非常認真地考慮瞭如何推動業務發展,以保持我們的目標並實現未來的成長。
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Got it. And John, just as a practical matter, look, we need to get salespeople in these offices. They need to see their VEVYE reps more frequently. And that's what this is about. We know where the high-value targets are. We know who's prescribing dry eye disease.
知道了。約翰,從實際角度來說,我們需要在這些辦公室裡配備銷售人員。他們需要更頻繁地與 VEVYE 的代表見面。這就是問題的關鍵。我們知道高價值目標在哪裡。我們知道是誰在開出導致乾眼症的處方。
We know who is looking for dry eye disease. And this expansion is going to allow more Harrow VEVYE reps to get in those offices far more frequently. And our data demonstrates very clearly that when we do that, we end up with more prescriptions for VEVYE. And I think you're going to see that throughout the year.
我們知道哪些人正在尋找乾眼症的診斷資訊。此次擴張將使更多 Harrow VEVYE 的代表能夠更頻繁地進入這些辦公室。我們的數據非常清楚地表明,當我們這樣做時,最終會獲得更多 VEVYE 處方。我認為你今年會持續看到這種情況。
Thomas Flaten - Analyst
Thomas Flaten - Analyst
And Mark, to follow up on the last commentary around Melt being used or MKO being used a lot outside of ophthalmology indications. What can we expect with respect to dealmaking to get Melt appropriately exploited in those opportunities that are outside ophthalmology?
馬克,我想就上次關於 Melt 或 MKO 在眼科適應症之外被廣泛使用的評論做個補充。在眼科以外的交易機會中,我們可以期待哪些交易能讓 Melt 得到適當的利用?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Well, right now, we are completely focused on two things. One is Amir and his team building this data set. I've put a bounty on him getting that NDA and sooner than he even thinks he's able to get it in. And I'm hopeful that we can hopefully -- we can beat some of these time lines that we've laid out. So it's all about getting the NDA in and getting the data in front of the FDA so that we can hopefully get this approved and then ultimately get it coded for reimbursement.
目前,我們完全專注於兩件事。其中一位是 Amir 和他的團隊,他們正在建立這個資料集。我懸賞要他盡快拿到那份保密協議,比他預想的還要快。我希望我們能夠——我們能夠超越我們所製定的一些時間表。所以,關鍵在於提交新藥申請,並將數據提交給FDA,以便我們能夠獲得批准,並最終使其獲得報銷資格。
The second thing is that the market, even in ophthalmology, you're talking about 5 million use cases minimally per year. And that's just really cataract surgery. If you tack on glaucoma surgeries and other relevant procedures, you can add another couple of million procedures. So for a reimbursed nonopioid, non-IV sedation medicant, the opportunity in ophthalmology is very large. It's billions of dollars per year where our competition is IVs and opioids.
第二點是,即使在眼科領域,每年至少有 500 萬個使用案例。這就是白內障手術。如果把青光眼手術和其他相關手術也算上,手術量可能還要增加數百萬例。因此,對於一種可報銷的非鴉片類、非靜脈注射鎮靜藥物來說,眼科領域的機會非常大。我們每年的競爭對手是靜脈注射藥物和鴉片類藥物,而這個市場的規模高達數十億美元。
I mean, the data -- there was a Duke study, there was a Mayo study, the data is clear. Patients today are getting dosed with fentanyl for sedation during cataract surgery in particular. And so we aim to change that. We've got to build our commercial strategy for the G-MELT, and that is underway. So that's the second component.
我的意思是,數據——有杜克大學的研究,有梅奧診所的研究,數據很清楚。如今,尤其是在白內障手術中,患者會接受芬太尼鎮靜劑治療。因此,我們的目標是改變這種狀況。我們必須為 G-MELT 制定商業策略,目前這項工作正在進行中。這是第二個組成部分。
Other than that, outside of the US market in ophthalmology and getting the studies completed and filing the NDA, if something happens where there's a partnership that is revealed or an opportunity like that, that's revealed, we'll certainly pursue it. But we have such a big revenue opportunity with the G-MELT in ophthalmology that we need to really stay focused on that, and that's what we're going to do.
除此之外,除了美國眼科市場之外,在完成研究並提交新藥申請之後,如果出現合作機會或其他類似機會,我們一定會積極爭取。但是,G-MELT 在眼科領域有著巨大的收入機會,所以我們需要真正專注於此,而這正是我們將要做的。
Operator
Operator
Jeffrey Cohen, Ladenburg Thalmann & Company.
Jeffrey Cohen,Ladenburg Thalmann & Company。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
I guess two from our end. Firstly, Mark or Andrew, could you comment any on margins and/or tariffs and ratifications throughout 2026 or any net changes that you're seeing now from '25?
我猜我們這邊有兩個。首先,Mark 或 Andrew,你們能否就 2026 年的利潤率和/或關稅以及批准情況發表一些評論,或者你們目前看到的與 2025 年相比的任何淨變化?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Andrew, do you want to tackle tariffs, margins?
安德魯,你想談談關稅和利潤率嗎?
Andrew Boll - President, Chief Financial Officer, Company Secretary
Andrew Boll - President, Chief Financial Officer, Company Secretary
Yes. Jeff, from what -- yes, on the tariff side, we're not expecting much impact. I think the analysis we did last year was almost in a worst-case scenario when we kind of relooked at things and we're doing that on a continual basis. The analysis we did last year is still holding strong and actually, we're in better shape than we would have been last year in that worst-case scenario around Liberation Day.
是的。傑夫,從什麼方面來看——是的,就關稅方面而言,我們預計不會有太大影響。我認為我們去年所做的分析幾乎是在最糟糕的情況下進行的,當時我們重新審視了各種情況,而且我們也一直在進行這樣的分析。我們去年所做的分析仍然有效,事實上,在解放日前後最糟糕的情況下,我們現在的處境比去年好得多。
So not -- to answer your question more directly, we should -- we're not expecting to see any impact on margins as it relates to tariffs this year.
所以——更直接地回答你的問題——我們預計今年關稅不會對利潤率產生任何影響。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Got it. And then secondly, any commentary on your midyear expected launch on BYOOVIZ as far as preparations and commercial organization and how that might look like midyear?
知道了。其次,對於您預計年中在 BYOOVIZ 上推出的產品,您能否就準備工作、商業組織以及年中可能的情況發表一些看法?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Andrew, do you want to touch on that at all. Anything you want to add there? We're -- I think we're ready to go. We're -- I think we start realizing revenue. And the team has got a very unique strategy. Andrew, do you want to touch on that or Pat?
安德魯,你想談談這件事嗎?你還有什麼要補充的嗎?我想我們已經準備好了。我認為我們開始獲利了。而且這支隊伍有著非常獨特的策略。安德魯,你想談談這個話題嗎?還是帕特?
Andrew Boll - President, Chief Financial Officer, Company Secretary
Andrew Boll - President, Chief Financial Officer, Company Secretary
Yes, I can touch on a little bit and then hand it over to Pat. The -- Jeff, we're really leveraging the existing retina team with that launch. There's some incremental costs that will go into that. We'll have some variable costs as we get the hub up to help support the product. But we're just -- we're really excited to get that thing going. We've got a great partner in Samsung as well. That's helping us as we prep.
是的,我可以簡單介紹一下,然後交給帕特。傑夫,我們這次發表會確實充分利用了現有的視網膜團隊。這會產生一些額外的成本。為了建造支援產品的中心,我們將產生一些可變成本。但我們真的——我們非常興奮能把這件事啟動起來。我們在三星也擁有一個非常棒的合作夥伴。這對我們的準備工作很有幫助。
This is a very dynamic market. We're going to be getting in with BYOOVIZ right away in the middle of this year, which is the Lucentis reference biosimilar. And then you may have recently seen that Samsung announced they entered into a settlement with the innovator drug for Eylea. And so we'll be able to get into the market a little earlier than we expected with that product as well at the beginning of next year, which will be in January.
這是一個充滿活力的市場。今年年中,我們將立即與 BYOOVIZ 合作,它是 Lucentis 的參考生物相似藥。然後,您可能最近已經看到,三星宣布他們與 Eylea 的創新藥生產商達成了和解協議。因此,我們能夠在明年年初,也就是一月份,比預期更早將產品推向市場。
But from a spend perspective, like I said, we'll leverage most of the existing sales force. There will be some small incremental costs there and maybe some variable costs related to the hub activity for the products, but should be highly, highly accretive to earnings and new revenues. Pat, do you want to add anything?
但從支出角度來看,正如我所說,我們將充分利用現有的大部分銷售人員。雖然會產生一些小的增量成本,也可能會產生一些與產品樞紐活動相關的變動成本,但這應該會對收益和新收入產生非常大的增值作用。派特,你還有什麼要補充的嗎?
Patrick Sullivan - Chief Commercial Officer
Patrick Sullivan - Chief Commercial Officer
Thanks, Andrew. I think the one thing to add is, as Mark mentioned, we're really excited to get this going. Thinking about back to Mark's comments about the team that we have here, a very deep set of heritage in the retina space.
謝謝你,安德魯。我想補充一點,正如馬克提到的那樣,我們非常興奮能啟動這個計畫。回想起馬克對我們團隊的評價,他們在視網膜領域有著非常深厚的歷史底蘊。
So I think to me, we will capitalize on that very quickly. I think in addition, when you think about our current portfolio, we made significant strides in growing our retina business, and this is going to help us significantly with our presence and growing the value of that franchise. And we are actively right now preparing the market and targeting our business to take off here in the middle of this year. So we're super excited about BYOOVIZ going forward.
所以我認為,我們會很快利用這一點。此外,我認為,考慮到我們目前的投資組合,我們在發展視網膜業務方面取得了顯著進展,這將極大地幫助我們擴大市場份額並提升該業務的價值。我們目前正積極籌備市場,並計劃在今年年中在這裡開展業務,爭取起飛。所以我們對 BYOOVIZ 的未來發展感到非常興奮。
Operator
Operator
Yi Chen, H.C. Wainwright.
易晨,H.C. Wainwright。
Yi Chen - Analyst
Yi Chen - Analyst
Could you comment on your marketing strategy for the biosimilar, whether they will have a dedicated sales force and how you are going to present your biosimilar as a differentiated product from other biosimilar competitors?
您能否談談貴公司針對生物相似藥的行銷策略,例如是否會設立專門的銷售團隊,以及將如何把貴公司的生物相似藥與其他生物類似藥競爭對手區分開來?
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Yes. Thanks for the question. As I think Andrew referenced and as Pat discussed, and I think as you know, it is a highly dynamic market. It is competitive. And we have a unique place in the market with our Lucentis reference biosimilar. And at this point, I really don't want to reveal specifically how we're going to attain the market share that we expect to drive towards.
是的。謝謝你的提問。正如安德魯所提到的,也正如帕特討論過的,而且我想你也知道,這是一個瞬息萬變的市場。競爭很激烈。我們的 Lucentis 參考生物相似藥在市場上佔據了獨特的地位。目前,我真的不想具體透露我們將如何實現我們預期達到的市佔率目標。
What I have said in the past is that based on our cost in getting into the deal, the level of success that we need to achieve to make this highly profitable is quite low. We're not playing to get 30% market share with BYOOVIZ. We're playing to get a handful of percentage points of market share in this market, which is the largest market in ophthalmology by revenue.
我過去曾說過,根據我們達成這筆交易的成本,我們需要取得的成功程度要達到很高的利潤水平是相當低的。我們參與 BYOOVIZ 的目的不是為了獲得 30% 的市佔率。我們的目標是在這個眼科收入最高的市場中,爭取幾個百分點的市佔率。
And so our expectations are quite modest, and we believe that the strategy that we're going to employ with the team that we have, which, as Pat said, has a tremendous background and relationships and this market is going to be successful in helping us get to our goals. But we don't have -- we're trying to get about a handful of percentage points of market share, which is what we've said historically.
因此,我們的預期相當保守,我們相信,正如帕特所說,我們擁有一支背景和人脈都非常豐富的團隊,而這個市場將幫助我們成功實現目標。但我們還沒有——我們正努力爭取幾個百分點的市場份額,這和我們過去的說法一樣。
Andrew Boll - President, Chief Financial Officer, Company Secretary
Andrew Boll - President, Chief Financial Officer, Company Secretary
I can add a little bit too. The one big advantage we have compared to everyone else in this market is we have other products that we're selling these doctors. And so it allows us to provide a really comprehensive offering. You can talk about the patient experience with our anesthetic. No one else has that anesthetic in the biosimilars.
我也可以補充一點。我們相對於市場上其他公司的一個巨大優勢是,我們還有其他產品也在向這些醫生銷售。因此,這使我們能夠提供真正全面的產品和服務。您可以談談患者對我們麻醉劑的體驗。其他生物相似藥中都沒有這種麻醉劑。
And so it's more than just the biosimilar products that we're going to be selling. It's the comprehensive package of products where we totally support the practice and focus in on the patient experience.
因此,我們銷售的不僅是生物相似藥產品。這是一套全面的產品方案,我們全力支持診所運營,並專注於提升患者體驗。
Operator
Operator
I'm showing no further questions. I'd like to turn the call back over to Mark Baum, CEO, for closing remarks.
我不再提問。我謹將電話轉回給執行長馬克·鮑姆,請他作總結發言。
Mark Baum - Chairman of the Board, Chief Executive Officer
Mark Baum - Chairman of the Board, Chief Executive Officer
Well, first, and this is not in my script, I have to say that this call is the longest call I think we've ever had. It was -- reminds me of our recent state of the union. It set a record. And so we're going to definitely work next time to try and make this call a little bit more efficient.
首先,雖然這不在我的稿子裡,但我必須說,這通電話可能是我們有史以來最長的一次通話了。這讓我想起了我們最近的國情咨文。它創造了一項紀錄。所以下次我們一定會努力讓這通通話更有效率。
So we apologize for the time that this call took, but I think it was worthwhile. And hopefully, anyone who is listening feels a lot more knowledgeable about where this company is and where we're going over the coming quarters and years.
因此,我們對這通通話花費的時間表示歉意,但我認為這是值得的。希望所有收聽的人都能對公司現狀以及未來幾季和幾年的發展方向有更深入的了解。
Across the portfolio, we're seeing tangible momentum, improved access, expanding adoption and growing commercial execution. We've got a great new commercial leadership team, multiple products are scaling meaningfully, key franchises are gaining depth and we're seeing early signs of inflection where we've been patient and disciplined.
在整個產品組合中,我們看到了切實的進展,市場准入得到改善,採用率不斷提高,商業執行力也不斷增強。我們擁有一支優秀的新商業領導團隊,多款產品正在大幅擴大規模,重點特許經營業務正在不斷深化,在我們保持耐心和自律的領域,我們已經看到了轉折點的早期跡象。
And the result is that you own a business with increasing revenue concentration that is in durable high-value assets and that we have multiple pathways with other products for continued growth. I want to thank you for your continued confidence in Harrow. We're building something durable and lasting and valuable, and we believe the most exciting part of our story is still ahead.
結果是,您擁有一家收入日益集中於耐用高價值資產的企業,我們還有其他產品可以實現持續成長的多條途徑。感謝您一直以來對哈羅的信任。我們正在打造經久耐用、價值非凡的產品,我們相信,我們故事中最令人興奮的部分還在後頭。
This will conclude our call. Thank you.
通話到此結束。謝謝。
Operator
Operator
Thank you for your participation. You may now disconnect. Everyone, have a great day.
感謝您的參與。您現在可以斷開連線了。祝大家今天過得愉快。