Alimera Sciences Inc (ALIM) 2024 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Alimera Sciences first-quarter and 2024 financial results and corporate update conference call. (Operator Instructions) Participants on this call are advised that the audio of this conference call is being broadcast live over the Internet, and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through August 14, 2024.

女士們先生們，謝謝你們的支持。早安，歡迎參加 Alimera Sciences 第一季和 2024 年財務表現和公司更新電話會議。（操作員說明）本次電話會議的參與者請注意，本次電話會議的音訊正在透過網路進行現場直播，並且也被錄製用於回放。電話會議的網路直播重播將在電話會議結束後約一小時提供，直至 2024 年 8 月 14 日。

I would now like to turn the call over to Scott Gordon of CORE IR, the company's Investor Relations firm. Please go ahead sir.

我現在想將電話轉給該公司投資者關係公司 CORE IR 的 Scott Gordon。請先生繼續。

Thank you, operator. Good morning and thank you for participating in today's conference call. Joining me from Alimera's leadership team are Rick Eiswirth, President and Chief Executive Officer; and Elliot Maltz, Chief Financial Officer; Todd Wood, President US Operations; and Philip Ashman, President of International Operations.

謝謝你，接線生。早安，感謝您參加今天的電話會議。與我一起加入 Alimera 領導團隊的是總裁兼執行長 Rick Eiswirth；馬爾茨 (Elliot Maltz)，財務長；托德‧伍德 (Todd Wood)，美國營運總裁；以及國際營運總裁 Philip Ashman。

During this call management will be making forward-looking statements, including statements that address Alimera's expectations for future performance or operational results, future financial position, outlook and guidance and timeline for achieving positive cash flow. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

在本次電話會議期間，管理層將做出前瞻性聲明，包括涉及 Alimera 對未來業績或運營業績的預期、未來財務狀況、前景和指導以及實現正現金流的時間表的聲明。前瞻性陳述涉及風險和其他因素，可能導致實際結果與這些陳述有重大差異。

For more information about these risks, please refer to the risk factors described in Alimera's most recently filed periodic reports on Form 10-Q, or Form 8-K filed with the SEC today, and the Form 10-K filed with the SEC from year ended December 31, 2023, as well as Alimera's press release that accompanies this call, particularly the cautionary statements they're in.

有關這些風險的更多信息，請參閱 Alimera 最近向 SEC 提交的表格 10-Q 或表格 8-K 定期報告中描述的風險因素，以及自去年以來向 SEC 提交的表格 10-K截至2023 年12 月31 日，以及Alimera 隨本次電話會議發布的新聞稿，特別是其中的警告聲明。

Today’s conference call will include references to adjusted EBITDA, which is a non-GAAP financial measure. Please see the explanatory language and reconciliation table located in Alimera's earnings press release that accompanies this call. The content of this call contains time-sensitive information that is accurate only as of today, May 14, 2024. Except as required by law, Alimera disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

今天的電話會議將提及調整後的 EBITDA，這是非 GAAP 財務指標。請參閱本次電話會議隨附的 Alimera 收益新聞稿中的解釋性語言和調節表。本次通話的內容包含時效性訊息，僅截至今天（2024 年 5 月 14 日）準確。除法律要求外，Alimera 不承擔任何公開更新或修改任何資訊以反映本次電話會議後發生的事件或情況的義務。

It is now my pleasure to turn the call over to Rick Eiswirth. Rick, please go ahead.

現在我很高興將電話轉給 Rick Eiswirth。瑞克，請繼續。

Thank you, Scott, and good morning to everyone on the call. We experienced a very good first quarter aligning with our internal expectations. As we continue to see the benefits of integrating YUTIQ in our US portfolio, we're also seeing excellent growth in both our international distributor markets, as well as some of our key direct markets in Europe.

謝謝你，斯科特，祝所有參加電話會議的人早安。我們的第一季表現非常好，符合我們的內部預期。隨著我們不斷看到將 YUTIQ 整合到我們的美國產品組合中的好處，我們也看到我們的國際經銷商市場以及歐洲的一些主要直接市場的出色成長。

In Q1, our consolidated global net revenue increased 70% over Q1 2023 to $23 million, driven primarily by the acquisition of YUTIQ and growth in global end-user demand, 23% on a pro forma basis. You may note that this revenue is below that for Q4 2023, but this seasonal decline is anticipated each year as patient deductibles are reset and physicians resubmit their benefit verifications lowering the utilization of higher priced products like YUTIQ and ILUVIEN.

第一季度，我們的綜合全球淨收入比 2023 年第一季成長 70%，達到 2,300 萬美元，這主要是由於收購 YUTIQ 和全球最終用戶需求成長（預計成長 23%）推動的。您可能會注意到，這筆收入低於2023 年第四季的收入，但預計每年都會出現季節性下降，因為患者免賠額被重置，醫生重新提交福利驗證，從而降低了YUTIQ 和ILUVIEN 等價格較高的產品的利用率。

As we communicated last quarter, we are now generating positive adjusted EBITDA on a quarterly basis, achieving $1.8 million in Q1 2024 versus an EBITDA loss of $2.4 million in Q1 ‘23. We reiterate our confidence in achieving $105 million in revenue and at least 20% adjusted EBITDA margins this year. As I mentioned before, we do expect our revenue to fluctuate quarter to quarter due to the seasonality of our business. Adjusted EBITDA will also fluctuate quarter to quarter due to this seasonality as spending is more consistent on a quarter-to-quarter basis.

正如我們上季度所傳達的那樣，我們現在按季度產生正調整 EBITDA，在 2024 年第一季實現 180 萬美元，而 2023 年第一季的 EBITDA 虧損為 240 萬美元。我們重申，我們有信心今年實現 1.05 億美元的收入和至少 20% 的調整後 EBITDA 利潤率。正如我之前提到的，由於我們業務的季節性，我們確實預計我們的收入會出現季度波動。由於這種季節性，調整後的 EBITDA 也將按季度波動，因為每季的支出更加一致。

In our US segment, net revenue in Q1 2024 increased 92% to $14.6 million versus $7.6 million in Q1 2023, primarily again due to the acquisition of YUTIQ. US end-user demand for our products was up 96% in Q1 versus the prior year when including the addition of YUTIQ and 2% on a pro forma basis. We believe that the growth of a ILUVIEN and YUTIQ in Q1 softened from integrating a combined two-product sales call. We restructured the call plan to prioritize targets across current users and that's all targets and enhance the level of effort against each product. We are seeing improvement as we've seen sequential growth in monthly end-user demand for our products on an aggregate basis every month since December of last year.

在我們的美國部門，2024 年第一季的淨收入成長了 92%，達到 1,460 萬美元，而 2023 年第一季為 760 萬美元，這主要還是由於收購了 YUTIQ。第一季美國最終用戶對我們產品的需求比去年同期成長了 96%（其中包括 YUTIQ 的添加），預計成長了 2%。我們認為，ILUVIEN 和 YUTIQ 在第一季的成長因整合兩種產品的銷售電話而有所放緩。我們重組了通話計劃，以優先考慮當前用戶的目標，這就是所有目標，並提高了每個產品的工作水平。我們看到了改善，因為我們看到自去年 12 月以來每個月最終用戶對我們產品的需求總體上都在連續增長。

Further, our US sales team has been selling both YUTIQ and ILUVIEN for three quarters now, and we're starting to see the value of cross selling the two products to accounts in this quarter, as the percentage of accounts using both products have slightly increased from 26% to 28%. In order to accelerate the growth of our products, we're tightening our messaging decisions for both ILUVIEN and YUTIQ.

此外，我們的美國銷售團隊已經銷售 YUTIQ 和 ILUVIEN 三個季度了，我們開始看到本季向客戶交叉銷售這兩種產品的價值，因為使用這兩種產品的客戶百分比略有增加從26% 增至28%。為了加速我們產品的成長，我們正在收緊 ILUVIEN 和 YUTIQ 的訊息傳遞決策。

For ILUVIEN and DME, we are refining the value proposition, linking the severity of disease to retinal thickness variability as this concept is catching on with retina specialists and being utilized by our competition. If the swelling in the retina is allowed to recur as acute treatments were off, it can lead to permanent retinal damage and vision loss over time. The sooner the retina can return to a healthy level and the more consistently can stay there, the better opportunity to improve and save vision.

對於 ILUVIEN 和 DME，我們正在完善價值主張，將疾病的嚴重程度與視網膜厚度變異性聯繫起來，因為這個概念正在受到視網膜專家的歡迎，並被我們的競爭對手所利用。如果急性治療停止後，視網膜腫脹再次出現，隨著時間的推移，可能會導致永久性視網膜損傷和視力喪失。視網膜越早恢復到健康水平並且能夠更持續地保持在健康水平，改善和挽救視力的機會就越大。

For YUTIQ, our sales team now have the three year data from the YUTIQ PIVOTAL 001 study that illustrates the benefit of long-term control for chronic non-infectious uveitis affecting the posterior segment of the eye. It shows that the median time to the first recurrence of uveitis is over 1,000 days for the YUTIQ patient, while it's less than 100 days for the same patient, a substantial benefit.

對於 YUTIQ，我們的銷售團隊現在擁有 YUTIQ PIVOTAL 001 研究的三年數據，該數據說明了長期控制影響眼後段的慢性非感染性葡萄膜炎的益處。結果表明，YUTIQ 患者到葡萄膜炎首次復發的中位數時間超過 1,000 天，而同一患者則不到 100 天，這是一個巨大的優點。

Turning to our international business. We are pleased with our continued momentum to begin the year. In Q1 2024, international net revenue grew 42% to $8.5 million, driven by a 53% increase in end user demand. We continue to see growing utilization in the UK, Portugal, Ireland, Spain and France.

轉向我們的國際業務。我們對今年伊始的持續動能感到高興。2024 年第一季度，在最終用戶需求成長 53% 的推動下，國際淨收入成長 42% 至 850 萬美元。我們繼續看到英國、葡萄牙、愛爾蘭、西班牙和法國的利用率不斷增長。

In March, the UK National Institute for Health and Care Excellence, or NICE, issued final guidance stating that the fluocinolone intravitreal implant is recommended for treating visual impairment caused by chronic diabetic macular edema irrespective of lens sight. What this means for us is that now faking patients or those that have a natural lens now have access to ILUVIEN. NICE reimbursement to-date has been limited to only pseudophakic patients or those that had undergone cataract surgery. This is a significant expansion of our potential user base among the chronic diabetic macular edema or DME patient population.

今年三月，英國國家健康與護理卓越研究所（NICE）發布了最終指南，指出氟輕鬆玻璃體內植入物被推薦用於治療慢性糖尿病性黃斑水腫引起的視力障礙，無論晶狀體視力如何。這對我們來說意味著現在假患者或那些擁有天然水晶體的患者現在可以使用 ILUVIEN。迄今為止，NICE 報銷僅限於人工水晶體眼患者或接受白內障手術的患者。這顯著擴大了我們在慢性糖尿病黃斑水腫或 DME 患者群體中的潛在用戶群。

According to the UK Macular Society, safety patients represent up to 75% of the broader DME population in the United Kingdom. We expect the availability of this wider reimbursement to positively impact utilization in the UK in the second half of 2024. NICE guidance can also impact reimbursement in other countries such as Spain and Italy. We believe that this NICE decision if adopted in other markets will broaden our potential patient base in these countries as well.

根據英國黃斑部協會的數據，安全病患佔英國 DME 族群的 75%。我們預計這種更廣泛的報銷將對 2024 年下半年英國的利用率產生正面影響。NICE 指南也會影響西班牙和義大利等其他國家的報銷。我們相信，這個好的決定如果在其他市場採用，也將擴大我們在這些國家的潛在患者基礎。

I would now like to highlight the continued progress and key milestones we achieved this quarter in our clinical trials. We reached the enrollment target for the Phase 4 open-label synchronicity study in January that we inherited from EyePoint just a few months after our acquisition of YUTIQ. This study, which will read out in the second half of next year, will provide retina specialists with a broader sense of the utility of our fluocinolone acetonide implant across a variety of patients with chronic non-infectious uveitis affecting the posterior segment of the eye, also known as NIUPS. This potentially -- this will potentially benefit both YUTIQ in the United States and ILUVIEN in Europe and the Middle East.

我現在想強調我們本季在臨床試驗中取得的持續進展和關鍵里程碑。我們在 1 月達到了 4 期開放標籤同步性研究的入組目標，該研究是在收購 YUTIQ 幾個月後從 EyePoint 繼承的。這項研究將於明年下半年公佈，它將讓視網膜專家更廣泛地了解我們的氟輕鬆植入物在患有影響眼後段的慢性非感染性葡萄膜炎的各種患者中的效用，也稱為NIUPS。這可能會讓美國的 YUTIQ 以及歐洲和中東的 ILUVIEN 受益。

Additionally, we have three abstracts highlighting our YUTIQ CALM registry study presented last week at two meetings. The Association for Research and Vision and Ophthalmology, also known as ARVO, and the retinal World Congress, all demonstrating that real-world safety and efficacy outcomes are consistent with the pivotal clinical trial outcomes.

此外，我們還提供了三份摘要，重點介紹了上週在兩次會議上提出的 YUTIQ CALM 註冊研究。研究與視覺與眼科協會（也稱為 ARVO）和視網膜世界大會均證明，現實世界的安全性和有效性結果與關鍵臨床試驗結果一致。

Separately, we were pleased to announce that the first patient has been randomized in the DRCR retina networks protocol AL. The study is titled, the randomized clinical trial, evaluating intravitreal forisumab injections for fluocinolone acetonide intravitreal implants versus observation for the prevention of visual acuity loss due to radiation retinopathy. This study will assess the development of macular edema and associated long-term visual acute effects of consistent and continuous release corticosteroids or repeated injections of anti-VEGF initiated near the time of radiation therapy compared to observation, developing patients at risk for radiation retinopathy.

另外，我們很高興地宣布，第一位患者已隨機分配到 DRCR 視網膜網路協議 AL 中。研究的標題是隨機臨床試驗，評估玻璃體內福瑞單抗注射液玻璃體內植入物與觀察預防放射性視網膜病變引起的視力喪失的效果。本研究將評估黃斑水腫的發展以及與觀察相比，持續持續釋放皮質類固醇或在放射治療附近開始重複注射抗 VEGF 藥物的相關長期視覺急性影響，從而評估處於放射性視網膜病變風險的患者。

The study plans to include 600 patients with primary choroidal melanoma seeing in treatment with plaque brachiotherapy. Over 40% of radiation retinopathy patients have been shown to experience the devastating vision loss associated with radiation retinopathy within three years of treatment. And currently, there are no FDA approved pharmacotherapies for radiation retinopathy.

研究計畫納入 600 名接受斑塊近距離放射治療的原發性脈絡膜黑色素瘤患者。超過 40% 的放射性視網膜病變患者在治療三年內出現了與放射性視網膜病變相關的毀滅性視力喪失。目前，FDA 還沒有批准治療放射性視網膜病變的藥物療法。

And with that update, I'll now turn the call over to Elliot to review our first-quarter financial results in greater detail.

隨著這一更新，我現在將把電話轉給埃利奧特，以更詳細地審查我們第一季的財務業績。

Thanks, Rick, and hello, everyone. We completed quarter one as we anticipated, delivering results expected from the Street.

謝謝瑞克，大家好。我們按照預期完成了第一季度，實現了華爾街預期的結果。

Consolidated net revenue in Q1 2024 was up 70% to approximately $23 million, compared to $13.5 million in Q1 2023. Consistent with the seasonal business pattern we see in the first quarter of the calendar year, revenue was down versus the fourth quarter of 2023 as patients' insurance plans change and practices resubmit benefits verifications.

2024 年第一季的合併淨收入成長 70%，達到約 2,300 萬美元，而 2023 年第一季為 1,350 萬美元。與我們在日曆年第一季看到的季節性業務模式一致，隨著病患保險計畫的變化以及實踐重新提交福利驗證，收入較 2023 年第四季有所下降。

Looking at our operational segments, US net revenue increased 92% to approximately $14.6 million in Q1 2024 compared to $7.6 million in Q1 2023, driven primarily by the acquisition of YUTIQ. End-user demand in the US for our fluocinolone implant was 1,968 units in Q1 2024, a 2% increase compared to Q1 2023 on a pro forma basis. International net revenue increased 42% to approximately $8.5 million in Q1 2024, compared to approximately $6 million in Q1 ‘23. The increase was driven primarily by end-user demand growth of 23% in our direct markets and a 72% increase in stocking shipments to our international distributors. Total end-user demand in our International segment was up 53% to 2,050 units, compared to Q1 2023, due to strong growth in our direct markets and solid performance from our distributors in France and Spain.

從我們的營運部門來看，2024 年第一季美國淨收入成長了 92%，達到約 1,460 萬美元，而 2023 年第一季為 760 萬美元，這主要是因為收購 YUTIQ。2024 年第一季度，美國最終用戶對氟輕鬆植入物的需求為 1,968 單位，按預計計算，與 2023 年第一季相比成長 2%。2024 年第一季度，國際淨收入成長 42%，達到約 850 萬美元，而 2023 年第一季約為 600 萬美元。這一增長主要是由於我們直接市場的最終用戶需求增長了 23%，以及我們的國際分銷商的庫存出貨量增長了 72%。與 2023 年第一季相比，我們國際業務的最終用戶總需求成長了 53%，達到 2,050 台，這得益於我們直接市場的強勁成長以及法國和西班牙經銷商的穩健表現。

Now, looking at the rest of our P&L. Total operating expenses in the first quarter of 2024 were approximately $22 million, compared to approximately $14.8 million in Q1 of ‘23. The increase was primarily attributable to $3.3 million of additional sales and marketing expenses driven by the expansion of our commercial infrastructure to support selling two products in the US, as well as $2.4 million in additional amortization expense attributable to the YUTIQ acquisition in May of 2023, as well as a $1.3 million increase in general and administrative expenses relating to $700,000 of personnel costs and $0.5 million of stock-based compensation expense.

現在，看看我們其餘的損益表。2024 年第一季的總營運支出約為 2,200 萬美元，而 2023 年第一季的總營運支出約為 1,480 萬美元。這一增長主要歸因於我們的商業基礎設施擴張以支持在美國銷售兩種產品，從而帶來了330 萬美元的額外銷售和營銷費用，以及2023 年5 月收購YUTIQ 帶來的240 萬美元的額外攤銷費用 此外，與 70 萬美元的人事費用和 50 萬美元的股票薪酬費用相關的一般和行政費用增加了 130 萬美元。

Net loss was approximately $6.3 million in Q1 2024, compared to approximately $5 million in Q1 2023. We generated positive adjusted EBITDA again this quarter as planned. Q1 2024, we generated approximately $1.8 million of adjusted EBITDA, compared to an adjusted EBITDA loss of approximately $2.4 million in Q1 of ‘23. On our last call, we noted that our target adjusted EBITDA margin is 20% for the full year. We remain confident in this guidance, but we anticipate adjusted EBITDA margins will fluctuate quarter to quarter since expenses remain relatively consistent, but revenues fluctuate due to seasonality.

2024 年第一季的淨虧損約為 630 萬美元，而 2023 年第一季的淨虧損約為 500 萬美元。本季我們再次按計劃實現了正向調整 EBITDA。2024 年第一季度，我們產生了約 180 萬美元的調整後 EBITDA，而 2023 年第一季調整後 EBITDA 損失約為 240 萬美元。在上次電話會議中，我們指出全年調整後 EBITDA 利潤率的目標是 20%。我們對此指引仍然充滿信心，但我們預計調整後的 EBITDA 利潤率將按季度波動，因為費用保持相對穩定，但收入因季節性而波動。

As of March 31, 2024, we had cash and cash equivalents of approximately $14.3 million, compared to $12.1 million at the end of 2023. This quarter, we increased our term loan agreement with our lender SLR Capital Partners by $5 million. This provides us with more operating flexibility and be phrased the impact of some upcoming contractual obligations, such as the $7.5 million consideration owing to EyePoint in 2024, resulting from the acquisition of YUTIQ last year, of which $1.9 million was paid in March. Additionally, during Q1 2024, we triggered $1.1 million of revenue-based milestone fees under our term loan and exit fee agreements with SLR, and we expect to trigger the remaining $1.3 million over the rest of 2024.

截至 2024 年 3 月 31 日，我們的現金和現金等價物約為 1,430 萬美元，而 2023 年底為 1,210 萬美元。本季度，我們與貸方 SLR Capital Partners 的定期貸款協議增加了 500 萬美元。這為我們提供了更大的營運彈性，並體現了一些即將到來的合約義務的影響，例如去年收購YUTIQ 後，2024 年應付EyePoint 的750 萬美元對價，其中190 萬美元是在3 月支付的。此外，在 2024 年第一季度，我們根據與 SLR 的定期貸款和退出費協議觸發了 110 萬美元的基於收入的里程碑費用，我們預計將在 2024 年剩餘時間內觸發剩餘的 130 萬美元。

Now, I'll turn it back over to Rick to give his closing comments.

現在，我將把它轉回給里克，讓他發表結束語。

Thank you, Elliot. As we said, we are pleased with our start to 2024, which was consistent with our internal expectations and previous guidance. However, it remains a significant opportunity to grow the utilization of ILUVIEN and YUTIQ in 2024 and beyond. We believe that our success in growing utilization of ILUVIEN in both DME and uveitis in our international markets is a leading indicator for what we can accomplish with our fluocinolone acetonide franchise in the United States.

謝謝你，艾利奧特。正如我們所說，我們對 2024 年的開局感到滿意，這符合我們的內部預期和先前的指導。然而，在 2024 年及以後，這仍然是提高 ILUVIEN 和 YUTIQ 使用率的重要機會。我們相信，我們在國際市場上不斷增加 ILUVIEN 在 DME 和葡萄膜炎治療中的使用率是我們在美國氟輕鬆特許經營權所能取得的成就的領先指標。

We believe our restructured call plans in US, which prioritize current users and high-decile targets will enhance the level of effort against each product and promote the cross-selling opportunity. As I commented earlier, we believe we are seeing early signs of success with sequential monthly demand growth since December and an uptick in the percentage of accounts utilizing both products.

我們相信，我們在美國重組後的通話計劃優先考慮當前用戶和高十分位目標，這將提高每種產品的工作水平並促進交叉銷售機會。正如我之前評論的那樣，我們相信我們已經看到了成功的早期跡象，自 12 月以來每月需求連續增長，並且使用這兩種產品的帳戶比例有所上升。

We believe that the numerous studies we have conducted around the world with ILUVIEN are a good indicator that the NEW DAY study will report a successful outcome and support the use of ILUVIEN earlier in the treatment paradigm for DME. And we believe the synchronicity study will highlight increased utility of YUTIQ in the general retina specialist population. We remain confident in our ability to deliver more than $105 million in revenue this year and greater than 20% EBITDA margins.

我們相信，我們在世界各地以 ILUVIEN 進行的大量研究是一個很好的指標，表明 NEW DAY 研究將報告成功的結果，並支持 ILUVIEN 在 DME 治療範例中的早期使用。我們相信同步性研究將凸顯 YUTIQ 在一般視網膜專家族群中的實用性的增加。我們仍然對今年實現超過 1.05 億美元的收入和超過 20% 的 EBITDA 利潤率充滿信心。

Thank you very much. That concludes our prepared remarks, and I'll now turn the call over to the operator for questions.

非常感謝。我們準備好的發言就到此結束，現在我將把電話轉給接線員詢問問題。

(Operator Instructions) Chase Knickerbocker, Craig-Hallum.

（操作員說明）Chase Knickerbocker，Craig-Hallum。

Good morning, guys. Thanks for taking the questions. Maybe just first for me, more of a qualitative one. Just as you're engaged -- as your sales force -- combined sales force are going out looking to harvest the synergies of both indications, are you finding that a lot of physicians still that might have -- might be using your product in DME? For example, we're not aware of the indication for uveitis. Or maybe, just getting a sense of how warm the water is as far as those synergies still go, and how much more upside there is to drive awareness.

早安，夥計們。感謝您提出問題。也許對我來說只是第一個，更多的是定性的。正如您所參與的那樣——作為您的銷售團隊——聯合銷售團隊正在尋找兩種適應症的協同效應，您是否發現許多醫生仍然可能在 DME 中使用您的產品？例如，我們不知道葡萄膜炎的適應症。或者，也許只是了解一下，就這些協同作用而言，水有多溫暖，以及還有多少好處可以提高人們的意識。

Yeah, sure. I think it's a combination of a lot of things, Chase. And I'll ask Todd to comment on this a little bit more, but I think it is an awareness issue, making sure doctors know that we have both assets now to some extent where they're using one product. It is a challenge that the team has been trying to figure out how to streamline the conversation about DME and uveitis to be able to talk about both in the same short window they get in the clinic, because there are quite a few products that are competing for clinic time with our team on the road now. And so, you're getting less time in the clinic and talking to the doctor and is trying to squeeze both of those in the same conversation.

是的，當然。我認為這是很多因素的結合，蔡斯。我會請托德對此進行更多評論，但我認為這是一個意識問題，確保醫生知道我們現在在某種程度上擁有這兩種資產，而他們正在使用一種產品。團隊一直在努力找出如何簡化有關 DME 和葡萄膜炎的對話，以便能夠在診所的同一個短窗口內討論這兩者，這是一個挑戰，因為有相當多的產品在競爭現在我們的團隊正在路上進行臨床治療。因此，你在診所與醫生交談的時間越來越少，並且試圖將兩者擠在同一次談話中。

But Todd, do you want to talk a little bit more about how you've been trying to refine that messaging?

但是托德，你想多談談你是如何努力改進這種訊息傳遞的嗎？

Yeah. Yeah, certainly. Thanks, Chase. Thanks for the question. And to add on to what Rick mentioned, sometimes for classic uveitis and DME. There are different providers in different patients because sometimes it just gets referred on to a uveitis specialists. And what we are currently engaging on is an education campaign because there's many disease states that are of chronic inflammation that are uveitic. And so, we're educating providers on the fact that they are probably seeing a lot of uveitis even though it's not classic uveitis, it's tied to another disease. So that's currently what we're implementing right now to create that crossover.

是的。是的，當然。謝謝，蔡斯。謝謝你的提問。補充一下 Rick 提到的內容，有時是針對經典葡萄膜炎和 DME。不同的患者有不同的提供者，因為有時它只是被轉介給葡萄膜炎專家。我們目前正在進行的是一項教育活動，因為有許多疾病狀態都是葡萄膜炎的慢性發炎。因此，我們正在教育提供者這樣一個事實：他們可能會看到很多葡萄膜炎，即使這不是典型的葡萄膜炎，而是與另一種疾病有關。這就是我們目前正在實施的方法來創建這種交叉。

Got it. And then, staying on the same line of taking a different tack. Taking a look at the ASP data, it looks like there's never been any rebating done here on either product line. Have you given any thought to potentially initiating any rebating strategy to help drive those initial conversations forward, and maybe drive some extra demand early in the combination of these indications in the US?

知道了。然後，保持同一條路線，採取不同的策略。從 ASP 數據來看，這兩個產品線似乎都沒有進行任何折扣。您是否考慮過可能啟動任何回扣策略，以幫助推動這些初步對話的進展，並可能在美國結合這些跡象儘早推動一些額外的需求？

Yeah, Chase, it's a timely question. We actually have been looking at that. We call it -- we refer to it as a non-clinical value program. But we have implemented as of April 1, a non-clinical value program in the US, where we are providing value back to the physician practices that are using ILUVIEN or YUTIQ more consistently. And frankly, there's a separate program for ILUVIEN and YUTIQ. And then, there's a little bit more value provided back for those practices that are using both products more consistently. So we implemented that on April 1. It's slowly been rolled out, but we do expect that we'll have some small impact in Q2 and have an impact -- greater impact as we move throughout the year.

是的，蔡斯，這是一個及時的問題。我們實際上一直在關注這一點。我們稱之為——我們稱之為非臨床價值計劃。但我們已於 4 月 1 日在美國實施了一項非臨床價值計劃，為更一致地使用 ILUVIEN 或 YUTIQ 的醫生實踐提供價值。坦白說，ILUVIEN 和 YUTIQ 有一個單獨的程式。然後，為那些更一致地使用這兩種產品的實踐提供更多的價值。所以我們在 4 月 1 日實施了該計劃。它正在慢慢推出，但我們確實預計我們將在第二季產生一些小的影響，並隨著我們全年的進展而產生更大的影響。

Are you seeing any impact on initial conversations from that non-clinical value that you're willing to add to your potential new customers as well? And then, just lastly on the model side. Sales and marketing spend, would you expect that to be flat from here? Or was there any non-recurring or non-cash items in the quarter? Sorry, if I missed it.

您是否認為您也願意為潛在新客戶添加的非臨床價值對初始對話產生任何影響？最後是模型方面。您預計銷售和行銷支出將持平嗎？或本季是否有任何非經常性或非現金項目？抱歉，如果我錯過了。

Yeah. Well, I'll ask Todd to comment on some of the early feedback we've gotten from the -- it's what we're referring to as the Amplify program on the non-clinical value. And then, maybe Elliot can address the comment on the financials.

是的。好吧，我將請托德對我們從非臨床價值的放大計劃中獲得的一些早期反饋發表評論。然後，也許埃利奧特可以談談對財務狀況的評論。

Yeah. The initial feedback has been very well. It's greatly accepted. Obviously, the marketplace has been anticipating something like this for some time. And as we've launched it, they've -- we've just got a tremendous amount of positive feedback. Now, it's just a matter to see what type of impact that is as we look at their purchasing patterns throughout the end of this quarter.

是的。最初的反饋非常好。是大受接受的。顯然，市場對這種情況的預期已經有一段時間了。當我們推出它時，我們收到了大量的正面回饋。現在，只要我們觀察他們整個季度末的購買模式，就可以看出這是什麼類型的影響。

Yeah. And with regard to just total expense in the sales and marketing line, I think this quarter was maybe a bit higher than what we anticipate on a go-forward basis. We did have some one-time costs that were incurred during the first quarter of ‘24, which should normalize as we move through the rest of the year. Not a very material number, but maybe in the 5% to 10% range that we're talking about in terms of one-time cost at our P&L this quarter in sales and marketing.

是的。就銷售和行銷線的總費用而言，我認為本季可能比我們未來的預期要高一些。我們確實有一些一次性成本是在 2024 年第一季產生的，隨著今年剩餘時間的推移，這些成本應該會正常化。這不是一個非常重要的數字，但可能在我們本季銷售和行銷損益表的一次性成本方面討論的 5% 到 10% 範圍內。

Got it. Thanks for the questions, guys.

知道了。謝謝你們的提問，夥伴們。

Yi Chen, H.C. Wainwright & Company.

陳毅, H.C.溫賴特公司。

Hi, thank you for taking my question. With respect to the protocol AL trial, does Alimera need to financially support your study?

你好，謝謝你回答我的問題。關於 AL 試驗方案，Alimera 是否需要為您的研究提供經濟支持？

I am sorry, I didn't quite understand that. Yi, can you repeat the question?

抱歉，我不太明白。易，你能重複這個問題嗎？

The protocol AL, the DRCR retinal network study with ILUVIEN or faricimab injections, does Alimera need to financially fund this study?

AL 方案，使用 ILUVIEN 或 Faricimab 注射進行的 DRCR 視網膜網絡研究，Alimera 是否需要為這項研究提供經濟資助？

Yes. Well, we are making contributions of about $1.25 million over the period of four or five years and it's pretty straight lined over the course of the year. So it's about $0.25 million a year.

是的。嗯，我們在四、五年內捐款約 125 萬美元，而且全年捐款金額相當直線。所以每年大約是 25 萬美元。

Okay, okay. And could you give us some color on how many radiation retinopathy patients out there could -- that potentially benefit further.

好吧，好吧。您能否告訴我們有多少放射性視網膜病變患者可以—這可能會進一步受益。

It's a pretty small population. I mean, it would be considered an orphan disease indication, probably less than 10,000 patients a year. But at the same time, there's nothing out there approved to treat it at this time.

這是一個相當小的人口。我的意思是，這將被視為孤兒疾病適應症，每年可能有不到 10,000 名患者。但同時，目前還沒有任何藥物被批准可以治療它。

Okay. Okay. And regarding the UK NICE recommendation for chronic DME patients with natural lens having access to ILUVIEN, how much more -- I mean, how large is the impact on the top line revenue from the UK do you expect to see?

好的。好的。關於英國 NICE 對患有天然水晶體的慢性 DME 患者使用 ILUVIEN 的建議，還有多少 - 我的意思是，您預計會對英國的營收產生多大的影響？

Yeah. Yi, it's hard to give specific guidance around that. The phakic population is probably about 25% of the DME population. However, it's probably a little bit greater in the more chronic patients that it will be utilized -- where it would be utilized specifically in the UK. But certainly, overtime, we think this can more than double the market for available patients in the UK.

是的。易，很難就此給出具體指引。有晶狀體眼族群可能約佔 DME 族群的 25%。然而，它在慢性病患者中的使用可能會更大一些——特別是在英國。但當然，隨著時間的推移，我們認為這可以使英國可用患者的市場增加一倍以上。

How quickly it will be adopted in these patients? It's a little bit unclear. We'll probably be able to tell you a little bit more after we get a quarter or two of experience with it. But we do know that in some of the hospitals, patients are already being identified where they've got -- still have a phakic lens and they're being on identified for utilization of ILUVIEN. So it's starting to pick up, but probably won't be able to give much guidance until we get another quarter or two out.

它將多快在這些患者中被採用？有點不清楚。在我們獲得一兩個季度的經驗後，我們可能會告訴您更多。但我們確實知道，在一些醫院，已經對患者進行了鑑定——他們仍然擁有有晶狀體晶狀體，並且他們正在接受 ILUVIEN 的使用鑑定。因此，它開始回升，但在我們再過一兩個季度之前，可能無法提供太多指導。

Got it. Got it. And the 4,028 units for the quarter, that is the user demand, including US and ex-US territories. Is that correct?

知道了。知道了。本季的 4,028 台，即使用者需求，包括美國和美國以外的地區。這是正確的嗎？

Yes, that is correct. That's correct.

是的，這是正確的。這是正確的。

Okay, got it, got it. Thank you.

好的，明白了，明白了。謝謝。

Naz Rahman, Maxim Group.

納茲·拉赫曼，馬克西姆集團。

Hi, everyone. Thanks for taking our questions, and congrats on the progress. Just a couple. I want to expand on the UK management reimbursement question a little bit. Could you comment on how the reimbursement is in the UK, or how it differs from other international territories? And what the implication that also needs for your margins? How could we better reimbursement in the UK to translate the potential margin improvement, if any, later down the line?

大家好。感謝您提出我們的問題，並祝賀我們的進展。只是一對。我想稍微擴充一下英國管理報銷問題。您能否評論一下英國的報銷情況，或者它與其他國際地區有何不同？這對您的利潤率有何影響？我們如何在英國更好地進行報銷，以轉化未來潛在的利潤率改善（如果有的話）？

So the reimbursement change doesn't -- Naz, the reimbursement change doesn't really have an impact on the margin because it's still going to be reimbursed at the same price. But Philip, maybe you could give us a little bit of commentary on where we have phakic restrictions and don't across Europe.

因此，報銷變化不會——納茲，報銷變化實際上不會對利潤產生影響，因為它仍然會以相同的價格報銷。但是菲利普，也許你可以給我們一些評論，說明我們在歐洲哪些地方有晶狀體眼限制，而沒有。

Yes. So the UK is one of the countries that adopted this pseudophakic limitation. The other countries include Italy, and Spain as well. And unfortunately, in Europe, the way things work, all of these reimbursement authorities speak to one another. So even in countries that don't have the limitation, there's a dampening impact which -- it will be interesting to see how it translates across Europe.

是的。所以英國是採用這種人工水晶體限制的國家之一。其他國家還包括義大利和西班牙。不幸的是，在歐洲，按照事情的運作方式，所有這些報銷機構都會互相交流。因此，即使在沒有限制的國家，也會產生抑制性影響——看看它如何在整個歐洲轉化將會很有趣。

But clearly, the UK guidance is now in place and implemented. We launched it in on -- at the end of April. So we're watching carefully to see how it progresses there, and we're working with our partners in Spain and Italy already to look at plans for how we can help them challenge the limitation in those countries, too. But hopefully, that helps. And just to echo what Rick said, because it's an important point, there has been no change in price at all with this. So in the sense of the United Kingdom, what we expect is more volume with the requisite impact of that volume coming through in the overall revenue.

但顯然，英國的指導方針現已到位並實施。我們在四月底推出了它。因此，我們正在仔細觀察那裡的進展情況，並且我們已經與西班牙和義大利的合作夥伴合作，研究如何幫助他們挑戰這些國家的限制的計劃。但希望這會有所幫助。只是為了回應里克所說的，因為這是一個重要的觀點，所以價格根本沒有變化。因此，就英國而言，我們期望的是更多的銷量，以及該銷量對總收入的必要影響。

Got it. That was helpful. Our next question is on the pipeline or indication expansion. You mentioned on the call, could you expand a little more about what you're thinking? And also, have you seen any potential off-label use of either YUTIQ or ILUVIEN for RVO or potentially other indications?

知道了。這很有幫助。我們的下一個問題是關於管道或適應症的擴展。您在電話中提到，可以詳細說明一下您的想法嗎？另外，您是否看過 YUTIQ 或 ILUVIEN 可能用於 RVO 或其他潛在適應症的標籤外用途？

Yeah. So I think from a pipeline perspective, we've been holding some advisory boards and looking at potential opportunities to expand the indications for ILUVIEN as we've discussed. I think that probably the leading candidate beyond potentially something in radiation retinopathy could arise out of the DRCR study, would be vein occlusion.

是的。因此，我認為從管道的角度來看，我們一直在召開一些顧問委員會，並尋找潛在的機會來擴大 ILUVIEN 的適應症，正如我們所討論的那樣。我認為 DRCR 研究中可能出現的除了放射性視網膜病變之外的主要候選藥物可能是靜脈阻塞。

We hear from physicians a lot that there's a need for a chronic long-term low-dose steroid in RVO. We do know that there are physicians that have utilized it on a compassionate use basis or have found patients that have signs of uveitis and DME with their RVO and treated those patients as well and have come back to us with cases where it works. But we are trying to work with the advisory board to try to refine what exactly that available patient population would look like and what a trial structure would look like, and that's something that we hope to flush out between now and the end of the year where we could potentially redirect some of the spending from Synchronicity and NEW DAY as that bleeds down.

我們經常從醫生那裡聽到，RVO 需要長期使用低劑量類固醇。我們確實知道，有些醫生在同情使用的基礎上使用了它，或者發現了 RVO 有葡萄膜炎和 DME 跡象的患者，並對這些患者進行了治療，並帶著它有效的病例回到我們這裡。但我們正在努力與諮詢委員會合作，試圖完善現有患者群體的具體情況以及試驗結構，這是我們希望從現在到今年年底之間解決的問題隨著這些支出的減少，我們可能會重新調整同步性和新一天的部分支出。

Got it. And then, my last question is on the comp study for YUTIQ. Could you provide some color on when we might see some data from that study or what conversion data might be presented at?

知道了。然後，我的最後一個問題是關於 YUTIQ 的比較研究。您能否提供一些信息，說明我們何時會看到該研究的一些數據，或者可能會呈現哪些轉化數據？

Yeah. So that's study was a registry study, and it's slowly producing publications by the participants in that study. As we mentioned, there were two -- there were three presentations both at ARVO and at the World -- Retinal World Congress over the past couple of weeks. And as those papers are published, we'll be able to share this publicly. But those papers haven't been shared yet, they were just presentations of the meetings. But in general, what you're seeing there is that the registry studies are showing that the safety and efficacy is very, very consistent with what you saw -- what we saw in the pivotal studies for uveitis.

是的。所以這項研究是一項登記研究，而該研究的參與者正在慢慢發表出版物。正如我們所提到的，過去幾週在 ARVO 和世界視網膜世界大會上做了兩場、三場演講。當這些論文發表時，我們將能夠公開分享。但這些論文還沒有被分享，它們只是會議的示範。但總的來說，您所看到的是，登記研究表明其安全性和有效性與您所看到的非常非常一致——我們在葡萄膜炎的關鍵研究中看到的。

And I'd just like to remind you that the reason you see that, you see it across DME as well is because ILUVIEN and YUTIQ are, for the most part, they're self-compliant. Once they're injected in the eye, they deliver a very consistent low dose of fluocinolone acetonide every day for three years, and you're not reliant on capacity at a doctor's office, patient getting back to the office for consistent therapy. And it's why you don't see the same results in a real-world setting with the anti-VEGFs and the other acute therapies because they're not injected at the same frequency they are in the clinical studies.

我想提醒您的是，您在 DME 中看到這一點的原因是因為 ILUVIEN 和 YUTIQ 在很大程度上是自我相容的。一旦將它們注射到眼睛中，三年內每天都會提供非常一致的低劑量氟輕鬆，並且您不依賴醫生辦公室的能力，患者會返回辦公室進行一致的治療。這就是為什麼您在現實世界中使用抗 VEGF 和其他急性療法看不到相同的結果，因為它們的注射頻率與臨床研究中的頻率不同。

Got it. Thank you for taking our questions.

知道了。感謝您接受我們的提問。

Absolutely. Thank you, Naz.

絕對地。謝謝你，納茲。

James Molloy, Alliance Global Partners.

詹姆斯·莫洛伊，聯盟全球合作夥伴。

Hey, good morning guys. Thank you for taking my questions. I had a question on margins in the quarter. How do you -- would you guys be able to decouple the sales and marketing from sales? I see that -- thinking of the $23 million in the first quarter here, I know it's seasonality from the fourth quarter, but it looks similar to the '23, you guys posted in the third quarter last year with better gross margins and better EBITDA margins.

嘿，早上好，夥計們。感謝您回答我的問題。我對本季的利潤率有疑問。你們如何能夠將銷售和行銷與銷售脫鉤？我看到了——想想第一季的 2300 萬美元，我知道這是第四季度的季節性，但它看起來與 23 年相似，你們去年第三季發布的毛利率和 EBITDA 都更好邊距。

Is there a way to get the margins going in the first quarter? Or do you expect to see that going to improve through the year? Or what happens in the first quarter that crushes the margins well besides the seasonability?

有沒有辦法提高第一季的利潤率？或者您預計今年情況會有所改善嗎？或者除了季節性因素之外，第一季還發生了什麼導致利潤率大幅下降的情況？

Yeah. So I mean, there were some fixed costs that keep our business fairly consistent. That's the majority of our P&L structure. But there are some one-off items, some relating to integration of new hub services and transitioning from having two hubs supporting each product to having a single hub in the US. There were some non-recurring expenses in the first quarter that are tied to internal meetings to align the sales force on the cross-sell opportunity and to train reps on selling both products.

是的。所以我的意思是，有一些固定成本可以讓我們的業務保持相當穩定。這是我們損益表結構的大部分。但有一些一次性項目，其中一些與新中心服務的整合以及從支援每種產品的兩個中心過渡到在美國擁有一個中心有關。第一季有一些非經常性費用與內部會議相關，目的是協調銷售人員的交叉銷售機會，並培訓代表銷售兩種產品。

We have some that came from EyePoint last year that needed more training and attention, focusing on DME and vice versa for the legacy Alimera employees as they've taken on the uveitis indication and their selling opportunity. We believe that the majority of those costs are now done. And on a go-forward basis, our P&L should reflect really the fixed cost structure we have with fewer of those one-off items that can weigh down the P&L for an individual quarter. So as we move through the rest of the year, we expect our costs to remain fairly stable. And on a full-year basis, get us to that 20% EBITDA margin that we indicated in our guidance.

去年，我們有一些來自 EyePoint 的員工需要更多的培訓和關注，專注於 DME，反之亦然，對於 Alimera 的老員工來說，因為他們已經接受了葡萄膜炎適應症和銷售機會。我們相信大部分成本現已完成。從長遠來看，我們的損益表應該真正反映我們的固定成本結構，減少那些可能影響單一季度損益表的一次性項目。因此，隨著今年剩餘時間的推移，我們預計成本將保持相當穩定。在全年基礎上，讓我們達到我們在指導中指出的 20% EBITDA 利潤率。

One point, Jim -- the last -- Jim, the last piece of operational integration was completed as of April 1, where we and EyePoint provided benefit investigation hotlines where we run benefits for the physicians' offices to make sure the insurance coverage was there and they understood co-pays, et cetera. We were running two systems in parallel until April 1, which means we were incurring more costs and that integration was complete as of April 1. So that's another issue you see.

一點，吉姆——最後一點——吉姆，最後一項運營整合已於 4 月 1 日完成，我們和 EyePoint 提供了福利調查熱線，我們為醫生辦公室提供福利，以確保保險覆蓋範圍他們了解共同支付等等。直到 4 月 1 日之前，我們一直在並行運行兩個系統，這意味著我們會產生更多成本，並且整合已於 4 月 1 日完成。這是你看到的另一個問題。

And that goes into sales and marketing expense in the quarter?

這會計入本季的銷售和行銷費用嗎？

Yes.

是的。

Thank you. Then, what's the -- can you guys break out the US ILUVIEN versus YUTIQ in the quarter?

謝謝。那麼，你們能在本季打破美國 ILUVIEN 與 YUTIQ 的對決嗎？

We're not doing that. Going -- we talked about that a couple of quarters ago. We're going to talk about the fluocinolone acetonide franchise going forward because it's on a consolidated basis, just like it is in Europe going forward.

我們不會那樣做。去——我們幾個季度前就討論過這個問題。我們將討論未來的氟輕鬆丙酮特許經營權，因為它是在一個綜合的基礎上，就像歐洲未來的情況一樣。

Okay. Great. Understood. Then, maybe, last question. How many reps you guys have currently in the field? And can you talk a little bit about any anecdotal stories in the field on the new messaging and how that's been received?

好的。偉大的。明白了。然後，也許是最後一個問題。你們目前在該領域有多少代表？您能否談談該領域有關新訊息傳遞的任何軼事以及人們如何接受這些訊息？

Sure. Right now, we've got 35 territories in the US, but I'll ask Todd to comment on feedback on the messaging. Todd, if you want to do that?

當然。目前，我們在美國有 35 個地區，但我會請托德對訊息回饋發表評論。托德，你想這麼做嗎？

Yeah, sure. The messaging has been received quite well. And where this has been derived from is you look at some of the growth that we're experiencing internationally. Philip and his team have been out in front with this messaging a little bit before the US. And so, we've really bolstered our efforts around it with the new call plan that Rick mentioned a little bit earlier.

是的，當然。該消息得到了很好的接收。這是從我們在國際上經歷的一些增長中得出的。菲利普和他的團隊比美國更早傳達了這個訊息。因此，我們確實透過里克之前提到的新通話計劃加強了圍繞它的努力。

And when you look at the advocacy use, our key proponents of the product, they're aware of fluctuating retina thickness. They take that into account with their treatment paradigm, and they recognize that fluctuating thickness can lead to impaired vision. And then, also on top of that, early intervention is better to prevent impaired vision. So that's how the advocates of ILUVIEN are using the product today. So we're trying to expand that to a broader base and get more people on board with that since there is initial momentum from the advocacy groups.

當您查看宣傳使用時，我們產品的主要支持者，他們意識到視網膜厚度的波動。他們在治療模式中考慮到了這一點，並認識到厚度波動會導致視力受損。除此之外，早期介入可以更好地預防視力受損。這就是 ILUVIEN 的倡導者如今使用該產品的方式。因此，我們正在努力將其擴大到更廣泛的基礎，並讓更多的人參與其中，因為倡導團體已經產生了初步動力。

Great. Thank you for taking the questions.

偉大的。感謝您提出問題。

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

我們的問答環節到此結束。我想將會議轉回給里克·艾斯沃斯 (Rick Eiswirth) 發表閉幕詞。

Great. Thank you. And I'd like to thank everyone for participating on today's call and your continued interest in Alimera. We do look forward to sharing our ongoing progress when we report our second-quarter results in August. Thank you all, and have a good day.

偉大的。謝謝。我要感謝大家參加今天的電話會議以及對 Alimera 的持續關注。我們確實期待在八月報告第二季度業績時分享我們的持續進展。謝謝大家，祝你有美好的一天。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。