Rockwell Medical Inc (RMTI) 2025 Q1 法說會逐字稿

Good morning and welcome to Rockwell Medical's first-quarter 2025 results conference call and webcast. Please note that this event is being recorded. At this time, I would like to turn the conference call over to Heather Hunter, Senior Vice President, Chief Corporate Affairs Officer at Rockwell Medical. Heather, please go ahead.

早安，歡迎參加 Rockwell Medical 2025 年第一季業績電話會議和網路廣播。請注意，此事件正在被記錄。現在，我想將電話會議交給 Rockwell Medical 資深副總裁兼首席企業事務官 Heather Hunter。希瑟，請繼續。

Good morning and thank you for joining us for this update on Rockwell Medical.

早安，感謝您收看 Rockwell Medical 的最新動態。

Joining me on today's conference call are Dr. Mark Strobeck, Rockwell Medical's President and Chief Executive Officer; and Jesse Neri, Rockwell Medical's Chief Financial Officer.

參加今天電話會議的還有 Rockwell Medical 總裁兼執行長 Mark Strobeck 博士；以及 Rockwell Medical 財務長 Jesse Neri。

Before we begin, I would like to remind you that this conference call will contain forward-looking statements about Rockwell Medical within the meaning of the federal securities laws including, but not limited to, the types of statements identified as forward-looking in our annual report on Form 10-K and our subsequent periodic reports filed with the SEC. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions and expectations only as of today. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our periodic reports filed with the SEC.

在我們開始之前，我想提醒您，本次電話會議將包含聯邦證券法所定義的有關 Rockwell Medical 的前瞻性陳述，包括但不限於我們向美國證券交易委員會提交的 10-K 表年度報告和後續定期報告中確定為前瞻性的陳述類型。這些聲明受風險和不確定性的影響，可能導致實際結果有所不同。請注意，這些前瞻性陳述僅反映我們截至今天的觀點和預期。除法律要求外，我們明確否認有任何義務根據新資訊或未來事件更新或修改這些前瞻性聲明。我們向美國證券交易委員會提交的定期報告中更詳細地討論了可能導致實際結果與此類前瞻性陳述中表達或暗示的結果有重大差異的因素。

Rockwell Medical's quarterly report on Form 10-Q for the three months ended March 31, 2025, was filed prior to this call and provides a full analysis of the company's business strategy as well as our first-quarter 2025 results. The reconciliation of non-GAAP measures we discussed in today's call can also be found in today's press release. Our Form 10-Q and other reports filed with the SEC, along with today's press release, our updated investor presentation, and a replay of today's conference call and webcast can be found on Rockwell Medical's website under the Investors section.

Rockwell Medical 截至 2025 年 3 月 31 日的三個月的 10-Q 表季度報告已於本次電話會議之前提交，其中提供了公司業務戰略以及 2025 年第一季度業績的全面分析。我們在今天的電話會議上討論的非公認會計準則指標的對帳也可以在今天的新聞稿中找到。我們的 10-Q 表格和向美國證券交易委員會提交的其他報告，以及今天的新聞稿、我們更新的投資者介紹以及今天的電話會議和網絡廣播的重播，都可以在 Rockwell Medical 網站的“投資者”部分找到。

Now I would like to turn the call over to Rockwell Medical's President and CEO, Dr. Mark Strobeck.

現在我想把電話轉給 Rockwell Medical 總裁兼執行長 Mark Strobeck 博士。

Thank you, Heather. Good morning and thank you for joining us today for Rockwell Medical's first-quarter 2025 earnings conference call and webcast.

謝謝你，希瑟。早安，感謝您今天參加 Rockwell Medical 2025 年第一季財報電話會議和網路廣播。

As we discussed back in March, the first quarter was going to be a transition period for Rockwell. During the first quarter, we continued to diversify our customer base with some of the leading regional, national, and global hemodialysis providers and health systems. We remain a preferred provider as a result of our continued reliability, high-quality products, and customer-centric approach, and have signed a number of new contracts during this period.

正如我們在三月所討論的那樣，第一季將是羅克韋爾的過渡期。在第一季度，我們繼續透過一些領先的區域、國家和全球血液透析提供者和醫療系統來擴大我們的客戶群。由於我們持續的可靠性、高品質的產品和以客戶為中心的理念，我們仍然是首選供應商，並且在此期間簽署了許多新合約。

Our business in the first quarter performed according to plan, with revenue and gross profit in line with our expectations for the year. In addition, we continue to consolidate and further automate our manufacturing operations to reduce expenses and sustain our gross margin, which was also within our guidance range for the year.

我們第一季的業務表現符合計劃，收入和毛利符合我們全年的預期。此外，我們繼續整合和進一步自動化我們的製造業務，以降低開支並維持我們的毛利率，這也在我們今年的指導範圍內。

As for our largest customer, we continue to work with them to find ways to support their business going forward. Although we have not entered into a new agreement, we are still in active discussions with them about terms for potential contract extension.

對於我們最大的客戶，我們將繼續與他們合作，尋找支持其未來業務發展的方法。雖然我們尚未達成新的協議，但我們仍在與他們積極討論潛在的續約條款。

One area that we are closely monitoring is the recent cyber attack that occurred in our industry. As you may know, last month, our largest customer announced a company-wide ransomware incident impacting certain elements of its network. We were notified by our customer of this cyber attack and immediately disconnected all systems that were connected to their organization to prevent any potential impact of our own IT infrastructure. We are actively monitoring our network and have not experienced any direct implications to or impact on our systems to-date.

我們正在密切關注的一個領域是最近發生在我們行業內的網路攻擊。您可能知道，上個月，我們最大的客戶宣布了一起全公司範圍的勒索軟體事件，影響了其網路的某些元素。我們從客戶那裡獲悉了這次網路攻擊，並立即斷開了與其組織連接的所有系統，以防止對我們自己的 IT 基礎設施造成任何潛在影響。我們正在積極監控我們的網絡，迄今為止我們的系統尚未受到任何直接影響或衝擊。

Another area that we are closely monitoring is tariffs. Rockwell Medical's hemodialysis concentrates are manufactured right here in America and have been since the company was founded nearly 30 years ago. Approximately 90% of our revenue comes from dialysis providers within the United States. 10% is generated ex-U.S., of which, only one country is directly impacted by the recent U.S. tariff actions. This equates to a negligible amount of our total annualized revenue. Because we manufacture our products in the United States, we can manage our own supply chain and nimbly respond to real-world demand. While we do source a few supplies from outside the United States, we do not anticipate tariffs to impact our costs on those supplies.

我們密切關注的另一個領域是關稅。Rockwell Medical 的血液透析濃縮液自公司成立近 30 年以來就一直在美國生產。我們約有 90% 的收入來自美國境內的透析服務提供者。 10%來自美國以外，其中只有一個國家直接受到美國近期關稅行動的影響。這相當於我們年度總收入的一小部分。由於我們的產品在美國生產，我們可以管理自己的供應鏈並靈活地回應現實世界的需求。雖然我們確實從美國以外採購一些物資，但我們預期關稅不會影響這些物資的成本。

In the first quarter, we added a single-use bicarbonate cartridge technology to our portfolio of hemodialysis concentrates products. The addition of this bicarb cartridge to our portfolio represents an exciting opportunity for us to diversify our offering and address one of the fastest-growing segments within the dialysis products market. We officially launched this new product in February and are starting to see some traction with our customers.

在第一季度，我們在血液透析濃縮液產品組合中增加了一次性碳酸氫鹽筒技術。將這種碳酸氫鈉濾芯添加到我們的產品組合中，為我們提供了一個令人興奮的機會，可以實現產品多樣化，並滿足透析產品市場中成長最快的細分市場之一的需求。我們在二月正式推出了這款新產品，並開始受到客戶的青睞。

We continue to be very active in pursuing business development opportunities. We are seeking transactions that can further strengthen our position in the renal market and will provide access to new markets either through product acquisitions or international expansion. These opportunities are intended to be revenue-generating, immediately accretive to our business. We are engaged in due diligence on a number of opportunities and are looking for just the right one that meets our growth targets and objectives. We hope to have more to say on this in the coming quarters.

我們將繼續積極尋求業務發展機會。我們正在尋求能夠進一步加強我們在腎臟市場地位的交易，並透過產品收購或國際擴張進入新市場。這些機會旨在創造收入，並立即增加我們的業務。我們對許多機會進行了盡職調查，並正在尋找符合我們成長目標和目的的正確機會。我們希望在接下來的幾個季度中對此有更多了解。

Rockwell remains a leading supplier that has the scalability to manufacture and deliver to the more than 12,000 individual purchasing facilities, including outpatient dialysis clinics and hospitals in the U.S., along with select international markets.

羅克韋爾仍然是一家領先的供應商，具有可擴展性，可以製造並向超過 12,000 個獨立採購機構（包括美國的門診透析診所和醫院）以及精選的國際市場交付產品。

We are reiterating our projected guidance for 2025 with net sales between $65 million and $70 million, gross margin between 16% and 18%, and adjusted EBITDA between a negative $500,000 and a positive $500,000.

我們重申對 2025 年的預計，淨銷售額在 6,500 萬美元至 7,000 萬美元之間，毛利率在 16% 至 18% 之間，調整後的 EBITDA 在負 50 萬美元至正 50 萬美元之間。

Now I will turn the call over to Jesse to review our first-quarter 2025 financial results in further detail. Jesse?

現在，我將把電話交給傑西，讓他更詳細地回顧我們 2025 年第一季的財務表現。傑西？

Thank you, Mark. Good morning, everyone. I will now review our first quarter 2025 financial results in greater detail. Net sales for the first quarter were $18.9 million, representing a 17% decrease over net sales of $22.7 million for the same period in 2024. The decrease in net sales was driven by our largest customer transitioning to another supplier. This customer agreed to a one-time non-refundable payment of $900,000 to ensure continuity of supply for products purchased during the first quarter.

謝謝你，馬克。大家早安。我現在將更詳細地回顧我們 2025 年第一季的財務表現。第一季淨銷售額為 1,890 萬美元，較 2024 年同期的淨銷售額 2,270 萬美元下降 17%。淨銷售額的下降是由於我們最大的客戶轉向了另一家供應商。該客戶同意一次性支付 90 萬美元不可退還款項，以確保第一季購買的產品的供應連續性。

Gross profit for Q1 2025 was $3 million, which was in line with gross profit for the same period in 2024. Gross margin for Q1 2025 was 16%, representing an increase from 14% for the same period in 2024. Net loss for Q1 2025 was $1.5 million, which represents an improvement over a net loss of $1.7 million for the same period in 2024. Adjusted EBITDA for Q1 2025 was a negative $400,000.

2025 年第一季的毛利為 300 萬美元，與 2024 年同期的毛利持平。2025 年第一季的毛利率為 16%，高於 2024 年同期的 14%。2025 年第一季淨虧損為 150 萬美元，較 2024 年同期的 170 萬美元淨虧損有所改善。2025 年第一季調整後的 EBITDA 為負 40 萬美元。

Seasonal items associated with payroll tax and other public company-related expenses historically incurred in Q1 drove our adjusted EBITDA to be slightly negative. Cash, cash equivalents, and investments available for sale at March 31, 2025, was $17.3 million, compared to $21.6 million at December 31, 2025. The decrease was driven by timing of payments and collections and seasonal items historically incurred in the first quarter.

與工資稅和其他上市公司相關費用相關的季節性項目通常發生於第一季度，導致我們的調整後 EBITDA 略為負值。截至 2025 年 3 月 31 日的現金、現金等價物及可供出售投資為 1,730 萬美元，而 2025 年 12 月 31 日為 2,160 萬美元。下降的原因是付款和收款的時間以及第一季歷史上發生的季節性項目。

Now I'll turn the call back over to Mark.

現在我將把電話轉回給馬克。

Thank you, Jesse. Operator, please open the phone lines for any questions.

謝謝你，傑西。接線員，如有任何疑問，請打開電話線路。

(Operator Instructions)

（操作員指示）

Ram Selvaraju, H.C. Wainwright.

拉姆·塞爾瓦拉朱（H.C.）溫賴特。

Hi. Thanks so much for taking my questions and congrats on the performance not so far in the quarter in line with your previously reported guidance. I was wondering if you could firstly give us some sense on the following two aspects. First and foremost, with regard to the negotiations that are ongoing with your largest historical customer, kind of give us a sense of some scenarios that could ultimately arise from those negotiations. In other words, would there be a scaled down contractual commitment by this customer? Could the customer still elect to diversify away from Rockwell entirely? Or would there conceivably be a situation in which the customer continued to order from Rockwell at levels comparable to those seen in the past? And then secondly, if you could give us a sense of any kind of directionality with regard to top line revenue cadence for the remainder of 2025? And if you have visibility at this point as to which of the remaining three quarters of the year are likely to be the weakest with respect to revenue? Thank you.

你好。非常感謝您回答我的問題，並祝賀您本季迄今的業績符合您先前報告的指導。我想知道您是否可以先就以下兩個方面向我們介紹一下。首先，關於您正在與您最大的歷史客戶進行的談判，請讓我們了解這些談判最終可能出現的一些情況。換句話說，該客戶的合約承諾是否會縮減？客戶是否仍會選擇完全放棄羅克韋爾？或者是否可能出現這樣的情況：客戶繼續向羅克韋爾訂購與過去相當的量？其次，您能否向我們介紹一下 2025 年剩餘時間內營收節奏的任何方向性？現在您是否可以預見，今年剩餘三個季度中哪個季度的收入可能會最弱？謝謝。

Thank you, Ram. Let me address the first of your questions. So the discussions that we have ongoing right now with our largest customer are to continue to maintain some level of service to them for the future going forward. It will likely be at a much smaller scale than we have done previously. But I think from the way that we're looking at it is we have a good relationship with them, we're a strong supplier of their organization, and so we're looking to put in place a longer term arrangement that will maintain some supply as well as provide them some supply for their -- they have safety stock that they have that we would be looking to replenish. So that's the extent of the relationship that we're currently negotiating with them.

謝謝你，拉姆。讓我來回答你的第一個問題。因此，我們目前正在與最大的客戶進行的討論是為了在未來繼續為他們保持一定程度的服務。它的規模可能比我們以前做的要小得多。但我認為，從我們的角度來看，我們與他們有著良好的關係，我們是他們組織的強大供應商，因此，我們希望建立一個長期協議，以維持一些供應，並為他們提供一些供應 - 他們擁有我們希望補充的安全庫存。這就是我們目前與他們談判的關係程度。

As it relates to revenue going forward, I think it's tough to predict that in the sense of we're in the process right now of finding additional customers, bringing on new customers. And some of those are going to be incredibly meaningful. So we're really not in a position today to be able to provide that level of guidance. I think it's safe to say, we feel really confident in the guidance that we've provided and feel good that there is a strong possibility that we will be able to improve that. Jesse, I don't know if you have anything further to say.

至於未來的收入，我認為很難預測，因為我們現在正處於尋找更多客戶、吸引新客戶的過程中。其中一些將會非常有意義。所以我們今天確實無法提供這種程度的指導。我認為可以肯定地說，我們對所提供的指導非常有信心，並且相信我們很有可能能夠改進這一點。傑西，我不知道你還有什麼要說的。

Mark, I think that's right. I mean, the way things are looking right now, I would say, Q2 is probably going to be the low point for the year and then build from there. But to Mark's point, it's still a little bit early to say.

馬克，我認為這是對的。我的意思是，從目前的情況來看，我想說，第二季可能是今年的低谷，然後從那裡開始回升。但就馬克的觀點而言，現在說還太早。

Okay. And then if you could comment on any emergent dynamics or anything in respect to the at-home dialysis market and the specific product offerings that you've brought (technical difficulty)? Thank you.

好的。然後，如果您可以評論任何新興動態或任何有關家庭透析市場以及您帶來的特定產品供應的情況（技術難度）？謝謝。

The at-home market, I would say, is continuing to progress as we've expected. From our vantage point today, it will certainly be a part of the path to delivering treatment. It's not a large part today, but it's certainly one that continues to grow. Our product offering that we've put together for the at-home market is now beginning to start to -- we're starting to increase sales of that product. And we suspect that there will be more coming through the remainder of the year. The nice part for us about that product offering, not only as it significantly improves, our patient is able to administer the dialysis treatment at home by using product types that are much more manageable for the patient, but it's also a much higher margin product for us. And so we're looking to see that begin to grow here in the second half of the year.

我想說，家居市場正在按照我們的預期繼續發展。從我們今天的角度來看，它肯定會成為提供治療途徑的一部分。如今，它所佔份額還不算大，但肯定會繼續成長。我們為家庭市場提供的產品現在開始——我們開始增加該產品的銷售量。我們預計今年剩餘時間將有更多此類事件發生。對我們來說，該產品的優點在於，它不僅顯著改善了我們的患者，使他們能夠使用更易於患者管理的產品類型在家中進行透析治療，而且對我們來說，它也是一種利潤率更高的產品。因此，我們期待看到這一趨勢在今年下半年開始成長。

Great. Thank you very much.

偉大的。非常感謝。

Jeremy Pearlman, Maxim Group.

傑里米·珀爾曼（Jeremy Pearlman），馬克西姆集團（Maxim Group）。

Good morning. Thank you for taking my questions. First, maybe if you could expand any more information on your international market expansion on the West Coast? Where you see the opportunities there and how is that progressing?

早安.感謝您回答我的問題。首先，您能否提供一些有關您在西海岸拓展國際市場的資訊？您認為那裡有哪些機會？進展如何？

We continue to expand our business, what we call sort of internationally. But it's primarily in Latin America. That's a big opportunity for us and one that we continue to see an opportunity for us to provide products to those emerging dialysis centers. And a lot of our growth continues to be within that region. Again, it's advantageous for us. We aren't responsible for the distribution of those products. That's taken on by the customer. And so that turns out to be a good piece of business for us.

我們繼續擴大我們的業務，也就是我們所說的國際業務。但它主要在拉丁美洲。這對我們來說是一個巨大的機會，我們繼續看到為這些新興透析中心提供產品的機會。我們的大部分成長仍然發生在該地區。再一次，這對我們有利。我們不負責這些產品的分銷。這是由客戶承擔的。所以這對我們來說是一筆好生意。

As far as expansion into the western portion of the United States, we still believe that that's a good opportunity. We still believe that based on our data, that is largely being supported by one manufacturer. And so we think there's an opportunity there. We're still trying to determine what's the sort of the best approach for us to take to enter into that West Coast market. We've developed now critical mass as it relates to customers out in the West. So with that in hand, it likely makes more sense for us to contemplate establishing a facility out in the West. But we haven't made any final determinations yet on how to best do that. But it's certainly an area that we think is a ripe opportunity for us to expand.

至於向美國西部擴張，我們仍然認為這是一個很好的機會。我們仍然相信，根據我們的數據，這在很大程度上得到了一家製造商的支持。因此我們認為那裡有機會。我們仍在努力確定進入西海岸市場的最佳方法。我們現在已經發展出與西方客戶相關的臨界規模。因此，考慮到這一點，我們考慮在西方建立一個工廠可能更有意義。但我們尚未就如何最好地實現這一目標做出最終決定。但我們確實認為這是一個值得我們擴展的成熟領域。

Understood. And then maybe if you could just help us, I know the loss of the largest customer was a little bit of a setback and you're trying to mitigate that by taking on new customers, how much of that revenue do you think you could take on? Are there enough in the small independent dialysis providers that you'd be able to pick up and to cover most of that expense, the the lost revenue? How are you looking at that?

明白了。那麼也許您能幫助我們，我知道失去最大的客戶對我們來說是一個小小的挫折，而您正試圖透過接納新客戶來緩解這種影響，您認為您能承擔多少收入？小型獨立透析提供者是否有足夠的收入來彌補大部分費用和損失的收入？您對此有何看法？

We think there is. And it's in the areas likely that you've just discussed. And I would add to that, within our own existing footprint today, there's still a significant number of customers that exist that don't currently purchase Rockwell products that could. So our commercial efforts are focused, A, to expand our customer base within our existing footprint; B, to expand our customer base internationally within Latin America primarily; and then third will be to continue to further penetrate into the West. We believe that there's an opportunity there that is large enough that would allow us to replace a significant portion of the revenue that we lost.

我們認為有。它可能就在您剛才討論過的領域。我想補充一點，在我們現有的業務範圍內，仍然有相當多的客戶目前沒有購買羅克韋爾的產品。因此，我們的商業努力集中於：A、在現有業務範圍內擴大客戶群； B、主要在拉丁美洲擴大我們的國際客戶群；第三是繼續進一步向西方滲透。我們相信，那裡存在著足夠大的機會，可以讓我們彌補很大一部分的損失收入。

Okay. Understood. And then just last question, I just want to make sure, I think I heard this as part of an answer to another question, the revenue guidance that you're reaffirming today, that's as your customer base stands now? And then if any other customers you may sign on as the year goes on, that could just be potential upside? Or are there any customers that you assume or you're able to get baked into that guidance?

好的。明白了。然後是最後一個問題，我只是想確認一下，我認為我聽到的這個是作為對另一個問題的回答的一部分，即您今天重申的收入指導，是基於您目前的客戶群嗎？那麼，如果隨著時間的推移，您可能會簽約其他客戶，這可能只是潛在的上升空間嗎？或者您是否假設有任何客戶或您是否能夠將其納入該指導？

No. So this is based on our current customer base today. And so any new customer would add to that. So there would be potential upside there.

不。這是基於我們目前的客戶群。因此任何新客戶都會對此進行補充。因此，那裡存在潛在的上升空間。

Okay. Great. Thank you for taking my questions. Have a nice day.

好的。偉大的。感謝您回答我的問題。祝你今天過得愉快。

There are no further questions. This concludes today's conference call and webcast. You may now disconnect.

沒有其他問題了。今天的電話會議和網路廣播到此結束。您現在可以斷開連線。