Aytu Biopharma Inc (AYTU) 2024 Q2 法說會逐字稿

Welcome to the Aytu Biopharma fiscal 2024 Q2 earnings call. At this time, all participants are in a listen only mode. (Operator Instructions) question and answer session will follow the formal presentation. (Operator Instructions) Please note this conference is being recorded. I will now turn the conference over to your host, [Roger Rice]. You may begin.

歡迎參加 Aytu Biopharma 2024 財年第二季財報電話會議。此時，所有參與者都處於只聽模式。 （操作員說明）問答環節將在正式演示之後進行。（操作員說明）請注意，本次會議正在錄製中。我現在將會議轉交給你們的東道主，[羅傑·賴斯]。你可以開始了。

Good afternoon, everyone, and thank you for joining us for Aytu Biopharma's fiscal 2024 second quarter financial and operational results. Conference call for the period ended December 31, 2023. Joining us on today's call is Aytu CEO, Josh Disbrow; and the Company's Chief Financial Officer, Mark Oki. At the conclusion of today's prepared remarks, we'll open the call for a question and answer session. I'd like to remind everyone that today's call is being recorded. A replay of today's call will be available by using the telephone numbers and conference ID provided in the press release issued earlier today.

大家下午好，感謝您與我們一起了解 Aytu Biopharma 2024 財年第二季的財務與營運表現。截至 2023 年 12 月 31 日的電話會議。Aytu 執行長 Josh Disbrow 參加了今天的電話會議；以及公司財務長 Mark Oki。在今天準備好的演講結束後，我們將開始問答環節。我想提醒大家，今天的通話正在進行錄音。使用今天早些時候發布的新聞稿中提供的電話號碼和會議 ID 可以重播今天的電話會議。

Finally, I'd like to call your attention to the safe harbor disclosure regarding forward-looking information, the conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of A. to biopharma. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay or webcast replay. Actual results may differ materially as a result of risks, uncertainties and other factors, including but not limited to, the factors set forth in the Company's filings with the SEC. A two undertakes no obligation to update or revise any of these forward-looking statements.

最後，我想提請您注意有關前瞻性資訊的安全港披露，今天的電話會議將包含某些前瞻性陳述，包括有關目標、戰略、信念、期望和未來潛在經營業績的陳述A. 生物製藥。儘管管理層認為這些陳述是基於截至目前的估計、假設和預測是合理的，但這些陳述並不能保證未來的表現。時間敏感資訊在任何電話或網路廣播重播或網路廣播重播時可能不再準確。由於風險、不確定性和其他因素（包括但不限於公司向 SEC 提交的文件中列出的因素），實際結果可能會存在重大差異。一二不承擔更新或修改任何這些前瞻性陳述的義務。

With that said, I'd like to turn the event over to Josh Disbrow, Chief Executive Officer of Aytu Biopharma. Josh, please proceed.

話雖如此，我想將這次活動交給 Aytu Biopharma 執行長 Josh Disbrow。喬什，請繼續。

Thank you, Roger, and welcome, everyone. I'm extremely pleased to be speaking with you today following the release of our fiscal 26nd quarter financial results, which culminated in our first quarter of positive operating income in company history. This is clearly quite an achievement and a significant inflection point for a business that incurred more than $100 million consolidated loss from operations in fiscal 22.

謝謝你，羅傑，歡迎大家。我非常高興今天在我們發布第 26 財季財務業績後與大家交談，最終我們實現了公司歷史上第一季的正營業收入。對於一家 22 財年營運綜合虧損超過 1 億美元的企業來說，這顯然是一項相當大的成就，也是一個重要的轉捩點。

Also, another key accomplishment during the quarter was positive. Adjusted EBITDA of $5.1 million, up from $0.7 million last year. Further, this is now our six out of the last seven quarters with positive adjusted EBITDA for our Rx segment. Equally important, our cash balance remained steady at $19.5 million compared to $20 million at the end of the September quarter. All told a very strong quarter. The strategic initiatives we've undertaken to reposition a two as a growing and now operating profitable specialty pharma company focused on commercializing novel prescription therapeutics are clearly working. I'll remind you that this repositioning started in October of 22 when we indefinitely suspended our clinical development programs and continue with the wind-down of our Consumer Health segment, which we announced in mid calendar 23 these two parts of our business were a drain on cash and masks the strength of our Rx segment, which has been growing nicely and has been profitable from a segment perspective, with the Consumer Health segment almost completely wound down, which should be completed around the end of June. The go forward A2 business will be highlighted by our rapidly growing ADHD portfolio which just posted record quarterly revenues of $16.6 million, up 49% compared to Q2 of last year. And our pediatric portfolio focused on poly by floor and tried by floor to complementary prescription fluoride based multivitamins as well as carbon or ER extended release carbon oxygen based antihistamines suspension indicated to treat allergic conditions for patients two years and older on the whole.

此外，本季的另一項關鍵成就是積極的。調整後 EBITDA 為 510 萬美元，高於去年的 70 萬美元。此外，這是我們過去七個季度中的六個季度，我們的 Rx 部門調整後的 EBITDA 為正值。同樣重要的是，我們的現金餘額穩定在 1,950 萬美元，而 9 月季度末的現金餘額為 2,000 萬美元。總而言之，這是一個非常強勁的季度。我們採取的策略性舉措將二號公司重新定位為一家正在成長且目前正在運營的盈利的專業製藥公司，專注於新型處方療法的商業化，這顯然正在發揮作用。我要提醒您的是，這種重新定位始於22 月22 日，當時我們無限期地暫停了我們的臨床開發計劃，並繼續逐步關閉我們的消費者健康部門，我們在23 月中旬宣布，我們業務的這兩個部分正在耗盡現金並掩蓋了我們的Rx 部門的實力，該部門一直增長良好，並且從部門角度來看已經實現盈利，而消費者健康部門幾乎完全結束，該部門應在6月底左右完成。我們快速成長的 ADHD 產品組合將成為未來 A2 業務的亮點，該產品剛剛公佈創紀錄的季度收入 1,660 萬美元，比去年第二季度增長 49%。我們的兒科產品組合主要集中在聚逐層，並逐層嘗試補充處方氟化物複合維生素以及碳或緩釋碳氧抗組織胺懸浮液，整體可治療兩歲及以上患者的過敏性疾病。

Our Rx segment reported Q2 revenue of $18.7 million, up from 18 million last year. Gross profit margin of 78%, up from 72% last year. Rx segment adjusted EBITDA of $5.5 million, up from $3.1 million and Rx segment net income of $0.7 million with continued prescription growth anticipated coupled with further margin improvement driven by our ongoing operational improvements, we believe the future financial profile of a to look strong to expand on the financials in more detail, let me run through a key few points within both our ADHD and pediatric portfolios, starting with ADHD. As I mentioned, our ADHD portfolio experienced a 49% year-over-year increase in net revenue during the second quarter to an A. to record of $16.6 million. Adhd portfolio prescriptions grew an impressive 14.5% over the second quarter of last year. The growth in net revenue and Scripps was driven by strong sales force execution. A significant increase in prescribers of our ADHD brands improve gross to nets due to program and coverage improvements, along with continuing to leverage our innovative A. to Rx Connect platform, which we believe is best in class.

我們的 Rx 部門報告第二季營收為 1,870 萬美元，高於去年的 1,800 萬美元。毛利率為78%，高於去年的72%。Rx 部門調整後的EBITDA 為550 萬美元，高於310 萬美元，Rx 部門淨利潤為70 萬美元，預計處方藥將持續增長，加上我們持續的營運改善推動利潤率進一步改善，我們相信未來的財務狀況將強勁地擴大關於財務方面的更多細節，讓我從過動症開始，介紹一下我們的過動症和兒科投資組合中的幾個關鍵點。正如我所提到的，我們的 ADHD 產品組合第二季的淨收入年增 49%，達到創紀錄的 1,660 萬美元。過動症組合處方較去年第二季增加了 14.5%，令人印象深刻。淨收入和斯克里普斯的成長是由強大的銷售團隊執行力推動的。由於計劃和覆蓋範圍的改進，以及繼續利用我們認為同類最佳的創新 A. to Rx Connect 平台，我們 ADHD 品牌的處方者數量顯著增加，從而提高了淨銷售額。

On the topic of Rx Connect, some of you may have seen an op-ed piece that are recently authored in Medical Economics discussing prescription drug pricing transparency to help address it exposed the opaque pricing system that surrounds U.S. prescription drugs are transparent drug pricing plan works different directly through our 1,000 plus Rx Connect partner pharmacies nationwide to deliver our products at out of pocket costs lower than if our prescriptions were flowed through regular way retail pharmacies. It is taking bold action like companies like ours, along with real commitment to provide patients with access option through programs like Rx Connect is our charge to ensure predictability of out-of-pocket costs for the patients who need our products and through our innovative Rx Connect patient support platform. We are a leading real change. Our team remains committed to ensuring predictable clear out of pocket costs for our novel products.

關於Rx Connect 的主題，你們中的一些人可能已經看過最近在《醫學經濟學》上發表的一篇專欄文章，討論處方藥定價透明度以幫助解決這個問題，暴露了圍繞美國處方藥的不透明定價體系。透明的藥品定價計畫是有效的不同的是，直接透過我們全國 1,000 多家 Rx Connect 合作夥伴藥局交付我們的產品，自付費用低於我們的處方透過常規零售藥局流通的成本。它正在採取像我們這樣的公司一樣的大膽行動，並真正致力於透過Rx Connect 等計劃為患者提供訪問選項，這是我們的責任，以確保需要我們產品的患者和透過我們創新的Rx 的自付費用的可預測性連結患者支援平台。我們正在引領真正的變革。我們的團隊仍然致力於確保我們的新穎產品的可預測的明確自付費用。

In addition to our strong operational execution, the trends we've talked about the fast past few quarters within the ADHD market continue to persist, including the evolving supply disruptions for generic Adderall, IR and ER and various methylphenidate products from several stimulant products being discontinued. All together as of late articles and broadcast news reports air as recently as this week are highlighting the issues which continue to negatively impact patients across the country. Currently, three drug manufacturers are reporting shortages of generic Adderall XR and now five generic manufacturers have discontinued their Adderall XR generics altogether. This is about as of last week as it relates to extended-release methylphenidate as of the end of January eight manufacturers were reporting shortages of ER mental Saturday, while three have discontinued their methylphenidate products. While supply has been constrained, the system is also stress on the demand side of the equation as we continue to see an increase in new ADHD diagnoses of both children and adults with the FDA forecasting get more prescription growth this year as these market wide supply challenges have continued. We've done an exceptional job meeting the demands of patients having maintained supply to meet the growing demand for Xenos and Cotempla. As a reminder, at Xenon as the only approved extended release ODT amphetamine for the treatment of ADHD and is approved is bioequivalent to Adderall XR. So our brand is well positioned to continue to capture additional market share as the extended release and Federman shortage remains ongoing and supply means remains rather very unpredictable. Cotempla is the only approved extended release ODT methylphenidate for the treatment of ADHD and it competes against Concerta and other extended-release methylphenidate, again, several of which are being discontinued. We view the ongoing ADHD supply situation as one that will likely to continue for the foreseeable future in some form or fashion. And with that, a continuing opportunity for more and more patients and prescribers to get experience with both Xenos and Cotempla, it is becoming increasingly apparent that the success we have achieved to capture increased market share is due to two key factors. One, our manufacturing team's focus on meeting increased demand while simultaneously working to transition to our new CMO into our commercial team's strong execution and ability to showcase the benefits of our brand while also fully also effectively leveraging a two Rx Connect. I couldn't be more proud of the tremendous execution of our team to meet the needs of patients that have been so desperately seeking solutions during this time of market turmoil in ADHD, transitioning out of pediatrics, which as a reminder, represents about 11% of our total second quarter Rx segment revenues. Similar to what we discussed last quarter, our pediatric portfolio, net revenues and scripts were impacted primarily by customer ordering timing as a result of payer changes. We've made great progress during the quarter, expanding our customer base, having recently implemented multiple commercial initiatives and have also seen someone slacking of the distribution channel, which has resulted in probably by four shipped units being up significantly for the month of January when looking at it versus December of 23. This is a very good sign. We're excited to see it. There's still work to be done. But based on what we're now seeing, we believe the trend in the pediatric portfolio is in fact, heading in the positive direction. And despite the soft pediatric revenue for the quarter, we're very pleased to see a very healthy Rx segment, adjusted EBITDA of $5.5 million for the quarter.

除了我們強大的營運執行力之外，我們在過去幾個季度討論的ADHD 市場趨勢繼續持續存在，包括仿製藥Adderall、IR 和ER 不斷出現的供應中斷以及來自幾種興奮劑產品的各種哌甲酯產品的停產。本週最近播出的最新文章和廣播新聞報道都強調了繼續對全國患者產生負面影響的問題。目前，三家藥廠報告仿製藥 Adderall XR 短缺，現在五家仿製藥製造商已完全停產其 Adderall XR 仿製藥。這大約是上週的情況，因為它與緩釋哌醋甲酯有關，截至1 月底，八家製造商報告了ER mental Saturday 的短缺，而3 家製造商已經停產了他們的哌醋甲酯產品。雖然供應受到限制，但該系統也對需求方造成壓力，因為我們繼續看到兒童和成人新診斷的 ADHD 數量不斷增加，FDA 預測，由於這些市場範圍內的供應挑戰，今年處方藥將出現更多增長已經繼續。我們在滿足患者需求方面做得非常出色，並保持供應以滿足對 Xenos 和 Cotempla 不斷增長的需求。提醒一下，Xenon 是唯一批准用於治療 ADHD 的緩釋 ODT 安非他明，並且被批准與 Adderall XR 具有生物等效性。因此，我們的品牌處於有利地位，可以繼續佔領更多的市場份額，因為延期發布和費德曼短缺仍然持續，供應方式仍然非常不可預測。Cotempla 是唯一被批准用於治療 ADHD 的緩釋 ODT 哌醋甲酯，它與 Concerta 和其他緩釋哌醋甲酯競爭，其中有幾種已經停產。我們認為目前的過動症供應狀況可能會在可預見的未來以某種形式或方式持續下去。隨之而來的是，越來越多的患者和處方醫生有機會獲得 Xenos 和 Cotempla 的經驗，越來越明顯的是，我們在擴大市場份額方面所取得的成功歸功於兩個關鍵因素。第一，我們的製造團隊專注於滿足不斷增長的需求，同時努力將新的 CMO 轉變為我們的商業團隊強大的執行力和展示我們品牌優勢的能力，同時充分有效地利用兩個 Rx Connect。我對我們團隊的巨大執行力感到無比自豪，他們滿足了在 ADHD 市場動盪時期迫切尋求解決方案的患者的需求，從兒科轉型，提醒一下，兒科約佔 11%我們第二季度Rx 部門總收入的一部分。與我們上季度討論的情況類似，我們的兒科產品組合、淨收入和腳本主要受到付款人變化導致的客戶訂購時間的影響。我們在本季度取得了巨大進展，擴大了我們的客戶群，最近實施了多項商業計劃，並且還看到有人在分銷渠道上放鬆，這導致 1 月份可能有四個出貨量大幅增加與12月23 日相比。這是一個非常好的跡象。我們很高興看到它。還有工作要做。但根據我們現在所看到的情況，我們相信兒科投資組合的趨勢實際上正在朝著正面的方向發展。儘管本季兒科收入疲軟，但我們很高興看到 Rx 部門非常健康，本季調整後 EBITDA 為 550 萬美元。

So to wrap things up, before I turn it over to Mark, it's been our objective to transition a two way from a multipronged operation, which included not only our Rx segment, but also our Consumer Health segment and pipeline development programs, both of which generated negative cash flows to a highly focused pharmaceutical company that can grow and achieve profitability.

因此，總而言之，在我將其交給馬克之前，我們的目標是從多管齊下的營運中實現雙向轉型，其中不僅包括我們的Rx 部門，還包括我們的消費者健康部門和管道開發計劃，這兩個部門為一家高度專注的製藥公司帶來了負現金流，該公司可以發展並實現盈利。

While we have been Rx segment adjusted EBITDA positive for six of the last quarters, six of the last seven quarters witnessed by our trailing three quarter Company-wide adjusted EBITDA of $15 million. The ability to transition this business to operating income is a tremendous accomplishment.

雖然我們在過去的六個季度中 Rx 部門調整後的 EBITDA 為正值，但過去七個季度中的六個季度我們的尾隨三季度全公司調整後的 EBITDA 為 1500 萬美元。能夠將這項業務轉變為營業收入是一項巨大的成就。

Let me turn the core call now over to Mark and then I'll come back to wrap things up before turning it over to questions.

現在讓我將核心電話轉交給馬克，然後我會回來總結事情，然後再將其轉交給問題。

Mark?

標記？

Josh?

喬許？

Thank you, and welcome to everyone joining us on this call. Let's dive in and take a closer look at this quarter's numbers.

謝謝您，並歡迎大家加入我們這次電話會議。讓我們深入了解本季的數據。

Starting with revenue, net revenue for our fiscal 2024 second quarter was $22.9 million, down 13% compared to fiscal 2023 second quarter of $26.3 million and reflects the planned wind-down of the Consumer Health segment.

從營收開始，我們 2024 財年第二季的淨收入為 2,290 萬美元，比 2023 財年第二季的 2,630 萬美元下降 13%，反映了消費者健康部門計畫的縮減。

Looking at the segment contributions, net revenue from prescription for I'm sorry, from Rx product sales in the 2024 second quarter was $18.8 million, up 4% from $18 million in the same quarter a year ago. Within our segments. The ADHD portfolio products notched 49% revenue growth to $16.6 million in the 2024 second quarter against $11.1 million in the quarter a year ago. These robust ADHD portfolio revenue gains reflected the ongoing successful execution of our commercial efforts and market share gains as the ADHD market continues to experience manufacturing and supply chain issues that Josh outlined earlier, our quarterly ADHD written prescriptions were up 14.5% year over year. The second part of the Rx segment is the prescription pediatric portfolio, which again, this quarter reflected declines from the timing related ordering of our prescription multivitamins. Following the payer change feeds experienced a 66% decrease in net revenue to $2.2 million in our 2024 second quarter compared to $6.3 million in 2023. We are confident that we will be able to reinvigorate the multivitamin revenues to more to more normalized levels over the next few quarters since the second quarter's end, we have been seeing some unlocking of this channel and in return and the return of more reasonable channel inventory levels. I want to highlight that even with the impact from this time base multivitamin issue, we continue to post strong results in our Rx segment. In regard to our Consumer Health segment, as I noted, we are winding this winding down this segment, focus our efforts to improve our profitability and cash flows for the 2024 second quarter net revenue from consumer health declined 49% to $4.2 million compared to $8.3 million in the same quarter last year. Our game plan is to sell through all inventory and wrap up Consumer Health operations around June. Overall, as we execute this process, we would expect the segment to generate slightly negative to neutral adjusted EBITDA contribution. Consumer Health contributed a negative adjusted EBITDA of just $280,000 during the second quarter, consolidated gross margin improved to 71% in the second quarter compared to 66% in the quarter years a year ago. The second quarter gross margin was aided by strong ADHD sales growth, enabling improved efficiencies at our Grande Prairie manufacturing facility, coupled with the halving of lower margin sales from our now winding down Consumer Health segments.

從細分市場的貢獻來看，2024 年第二季處方藥 Rx 產品銷售的淨收入為 1,880 萬美元，比去年同期的 1,800 萬美元成長 4%。在我們的細分市場內。ADHD 組合產品的營收在 2024 年第二季成長了 49%，達到 1,660 萬美元，而去年同期為 1,110 萬美元。這些強勁的 ADHD 組合收入成長反映了我們商業努力的持續成功執行和市場份額的成長，因為 ADHD 市場繼續經歷喬許之前概述的製造和供應鏈問題，我們的季度 ADHD 書面處方同比增長 14.5%。Rx 部門的第二部分是處方兒科產品組合，本季再次反映出我們處方複合維生素的時間相關訂購的下降。付款人變更後，2024 年第二季 Feed 的淨收入下降了 66%，降至 220 萬美元，而 2023 年為 630 萬美元。我們相信，自第二季末以來，我們將能夠在未來幾季將多種維生素收入重振至更正常化的水平，我們已經看到該管道的一些解鎖，作為回報，以及更合理的管道庫存的回歸水準。我想強調的是，即使受到這個時間基礎複合維生素問題的影響，我們繼續在處方藥領域取得強勁的業績。關於我們的消費者健康部門，正如我所指出的，我們正在逐步縮減該部門，集中精力提高我們的盈利能力和現金流，2024 年第二季度來自消費者健康的淨收入下降49%，至420萬美元，而同期為8.3 美元去年同期為 100 萬元。我們的計劃是在 6 月左右售完所有庫存並完成消費者健康業務。總體而言，當我們執行此流程時，我們預期該部門將產生小幅負至中性的調整後 EBITDA 貢獻。健康消費品第二季的調整後 EBITDA 為負值，僅 28 萬美元，第二季綜合毛利率從去年同期的 66% 提高至 71%。第二季的毛利率得益於過動症銷售的強勁成長，提高了我們大草原城製造工廠的效率，再加上我們目前正在縮減的消費者健康業務部門的利潤率較低的銷售額減半。

One important note to Josh touched on is that our Rx segment gross margin was 78% during the quarter, up from 72% in last year's second quarter. This is a good metric to understand the go-forward business. Once Consumer Health is completely wound down. As we have commented on in each quarter, our business businesses, gross margin percentage can and do vary due to both seasonal and other factors. I want to remind all listeners that well, we are viewing the second quarter results. We are operating in the third fiscal quarter were most consumers of our products have had their annual insurance deductibles reset starting January first. As such, we expect to experience a greater use of our A. two Rx Connect price protection program, which historically has lowered our gross to net margins. Please remember that this is part of our normal seasonality and that those gross to net adjustments are expected to improve throughout the calendar year.

喬希提到的一個重要事項是，本季我們的 Rx 部門毛利率為 78%，高於去年第二季的 72%。這是了解未來業務的一個很好的指標。一旦消費者健康完全關閉。正如我們在每個季度所評論的那樣，我們的業務、毛利率百分比可能而且確實會因季節性和其他因素而有所不同。我想提醒所有聽眾，我們正在查看第二季的業績。我們在第三財季營運時，我們產品的大多數消費者已從 1 月 1 日開始重置年度保險免賠額。因此，我們預計將更多地利用我們的 A.two Rx Connect 價格保護計劃，該計劃歷來降低了我們的毛利率和淨利潤率。請記住，這是我們正常季節性的一部分，預計全年的總淨調整將有所改善。

Operating expenses, excluding impairment expense, changes in contingent consideration and amortization of intangible assets were $12.5 million in the second quarter of 2024 compared to $20.3 million in the same period a year ago. This represents a decrease of 38% for reflection of our continued focused on reducing costs and winding down the Consumer Health segment.

2024 年第二季的營運費用（不包括減損費用、或有對價變動和無形資產攤提）為 1,250 萬美元，去年同期為 2,030 萬美元。這意味著下降了 38%，反映出我們繼續致力於降低成本和逐步縮減消費者健康業務領域。

Research and development expense was $524,000 in the second quarter of 2024 compared to $1.7 million in the corresponding 2023 quarter, reflecting a normalized base level, highlighting the absence of any substantial drug development expense consistent with our prior announcements. As you saw in our second quarter 2024 press release and heard in Josh's initial comments, we recorded our first quarterly operating profit as a CFO, I'm especially pleased to say the world's operating profit. The primary focus for the swing in profitability were the previously previously noted growth in the ADHD portfolio gross margin improvements along with drops in sales and marketing and general administrative expenses, which produced $2.4 million in operating income against last year's $6.9 million operating loss. While we generated both an operating profit and income before taxes, we recorded $820,000 of income tax expense, resulting in a $220,000 net loss four $0.04 loss per share for the quarter compared to a $6.7 million loss or $2.15 net loss per share for the same quarter last year on top of our pretax earnings, we generated a solid positive adjusted EBITDA this quarter of $5.1 million compared to $727,000 in last year's second quarter. Adjusted EBITDA for the RX segment was $5.5 million. Cash and cash equivalents on December 31st, 2023 were $19.5 million compared to $20 million on September 30th, 2023. We are comfortable with the capital level and believe that our balance sheet provides us with a solid foundation to execute our corporate game plan. As I've noted in prior quarters, we don't give forward guidance. However, we do anticipate that around the end of this fiscal year, we have some we'll have exited our Consumer Health segment as well as continue to hit to move ahead with the outsourcing of our ADHD. productions. These operational changes plus the expected recovery of our pediatric sales should position us for a strong end to our fiscal 2024 and a good start to our fiscal 2025.

2024 年第二季的研發費用為524,000 美元，而2023 年相應季度的研發費用為170 萬美元，反映了正常化的基準水平，突顯出與我們之前宣布的一致，沒有任何實質性的藥物開發費用。正如您在我們的2024 年第二季新聞稿中看到的以及從Josh 的最初評論中聽到的那樣，我們作為首席財務官記錄了我們的第一個季度營業利潤，我特別高興地說是全球營業利潤。獲利能力波動的主要焦點是先前提到的 ADHD 投資組合毛利率的成長以及銷售和行銷以及一般管理費用的下降，這產生了 240 萬美元的營業收入，而去年的營業虧損為 690 萬美元。雖然我們同時產生了營業利潤和稅前收入，但我們記錄了820,000 美元的所得稅費用，導致本季度淨虧損220,000 美元，每股虧損4 美元，而同一季度虧損670 萬美元，即每股淨虧損2.15美元去年，除了稅前收益之外，本季我們還實現了 510 萬美元的穩定正調整 EBITDA，而去年第二季為 727,000 美元。RX 部門調整後的 EBITDA 為 550 萬美元。2023 年 12 月 31 日的現金及現金等價物為 1,950 萬美元，而 2023 年 9 月 30 日為 2,000 萬美元。我們對資本水準感到滿意，並相信我們的資產負債表為我們執行公司遊戲計劃提供了堅實的基礎。正如我在前幾個季度所指出的，我們不提供前瞻性指引。然而，我們確實預計，在本財年末左右，我們將退出我們的消費者健康部門，並繼續努力推動過動症的外包。作品。這些營運變化加上兒科銷售的預期復甦，應該將使我們在 2024 財年有一個強勁的結束，並在 2025 財年有一個良好的開端。

With that, let me turn it back over to Josh.

有了這個，讓我把它轉回給喬希。

Thanks, Mark. So as you might imagine, I'm extremely pleased with the results of the second quarter, highlighted by the Company's first ever quarter of positive operating income and growing adjusted EBITDA. The wind down of the Consumer Health segment has completed combined with the continued growth and operational improvements within our Rx segment. We believe the financial profile of A. two will continue to become increasingly strong with the expectation of positive cash flow generation in the quarters to come, coupled with a strong balance sheet of $19.5 million in cash at the end of December. I couldn't be more excited for the future of the company. I want to sincerely thank the entire team and a team for their hard work and dedication to delivering for patients, clinicians and our stockholders. It has taken a disciplined approach and the whole organization to get to this point and the management team and I are grateful to our A. two colleagues for making such tremendous progress.

謝謝，馬克。正如您可能想像的那樣，我對第二季度的業績非常滿意，尤其是該公司有史以來第一個季度的正營業收入和不斷增長的調整後 EBITDA。隨著我們處方藥部門的持續成長和營運改進，消費者健康部門的逐步結束已經完成。我們相信，A.2 的財務狀況將繼續變得越來越強勁，預計未來幾季將產生正現金流，加上截至 12 月底現金為 1,950 萬美元的強勁資產負債表。我對公司的未來感到無比興奮。我要真誠地感謝整個團隊和整個團隊的辛勤工作和奉獻精神，為患者、臨床醫生和我們的股東提供服務。整個組織採取了嚴格的方法才達到了這一點，我和管理團隊感謝我們的兩位同事取得瞭如此巨大的進步。

Thank you to everyone participating on today's call.

感謝參加今天電話會議的所有人。

We'll now be happy to answer any questions. Operator?

我們現在很樂意回答任何問題。操作員？

(Operator Instructions) Naz Rahman, Maxim Group.

（操作員說明）Naz Rahman，Maxim 集團。

Hi, everyone, and thanks for taking our questions and congratulations on all the progress you've made, especially over the last couple of years. So obviously, as you talked about it, there's a shortage is still ongoing and obviously manufacturers are sort of exiting the space and what gives you confidence that you could on get enough quota for your products, like how are you from conversations with the FDA going? And I guess, do you have a time line of for how much or for what period of time you have inventory for?

大家好，感謝您提出我們的問題，並祝賀您所取得的所有進步，特別是在過去幾年中。很明顯，正如您所說，短缺仍然存在，顯然製造商正在退出這個領域，是什麼讓您有信心為您的產品獲得足夠的配額，例如您與 FDA 的對話進展如何？我想，您是否有一個時間表來說明您的庫存有多少或多長時間？

Yes.

是的。

Thanks knows a good question.

謝謝知道一個好問題。

And obviously, it's and that's an ongoing challenge of every company in the stimulant space is facing I will say the DDAs is becoming increasingly accommodating and open to meetings with us.

顯然，這是興奮劑領域的每家公司都面臨的持續挑戰，我想說 DDA 正變得越來越包容並願意與我們會面。

In fact, at a recent meeting with the FDA or with the DEA rather in a really good dialogue and really good open lines of communication.

事實上，在最近與 FDA 或 DEA 的一次會議上，我們進行了非常好的對話和非常好的開放的溝通管道。

They certainly want to be be helpful.

他們當然想提供協助。

They understand the situation with the shortage. And while that would stand to benefit, not just small manufacturers, but large ones, we're confident that the line of the line of communications are wide open and definitely a high level of interest from the DDA and making sure that they don't put anybody out of stock. They recognize the rise in demand that communicate regularly with the FDA to understand exactly where where they think prescription trends are going.

他們了解短缺的情況。雖然這不僅會讓小型製造商受益，大型製造商也會受益，但我們相信，通訊線路是完全開放的，而且 DDA 肯定會高度感興趣，並確保他們不會這樣做。讓任何人都缺貨。他們認識到需求的增長，因此定期與 FDA 溝通，以準確了解他們認為處方趨勢的發展方向。

And while they have a responsibility to obviously curtail problems like diversion.

雖然他們有責任明顯減少轉移等問題。

They don't want to put anybody in a spot, most notably smaller manufacturers. So we're comfortable with them with the current inventory we frankly could always use more were always in a position to go back and request supplemental and API. and have been doing that as long as frankly, since since the beginning.

他們不想讓任何人陷入困境，尤其是規模較小的製造商。因此，我們對他們目前的庫存感到滿意，坦白說，我們總是可以使用更多庫存，並且總是能夠返回並要求補充和 API。坦白說，從一開始就一直這樣做。

And that goes all the way back to prior to the acquisition of Neos.

這可以追溯到收購 Neos 之前。

And we've got a great team on the ground, great team that is operating diligently. We have we don't have infinite supply, but we're comfortable for the foreseeable future and are comfortable that we can continue to get more API. as as as as we need it.

我們擁有一支出色的團隊，一支勤奮工作的優秀團隊。我們沒有無限的供應，但我們對可預見的未來感到滿意，並且對我們可以繼續獲得更多 API 感到滿意。只要我們需要它。

And what's important about us is we continue to be very nimble. Obviously, we're a small company.

對我們來說重要的是我們繼續保持靈活性。顯然，我們是一家小公司。

We still are operating in the Grand Prairie facility as we transition to the contract manufacturer.

當我們過渡到合約製造商時，我們仍然在大草原城工廠運作。

So we've availed ourselves now to two facilities continue with that transition process while we still make product in Grande Prairie, what I'll say generally speaking is we're we've not stocked out to date and don't have any plans to Got it.

因此，我們現在利用了兩個設施來繼續進行過渡過程，同時我們仍然在大草原城生產產品，一般來說，我們沒有庫存，也沒有任何計劃明白了。

That was very helpful on. So obviously, you're on MyDigi franchise has seen a lot of growth over the last call it, let's call it the calendar quarter and obviously the fiscal on calendar year and the fiscal year two. Could you talk a little bit about how much of that growth or what Nightstar growth is due to, I guess, what percentage growth in prescribers and how much there was a threat in or how much of an increase you saw like on a per prescriber base for writing the scripts, like how much more prescribers writing now versus like last January versus how many more how much more prescribers you have that drove the growth?

這非常有幫助。很明顯，MyDigi 特許經營權比上一個季度（日曆季度）以及顯然的日曆年和第二財年的財務有了很大的增長。您能否談談這種增長有多少，或者夜星的增長是由於什麼造成的，我猜，處方者的增長百分比是多少，以及威脅有多大，或者您看到每個處方者的增長有多少對於編寫腳本，例如現在寫的處方者數量與去年一月相比增加了多少，以及推動增長的處方者數量增加了多少？

Yes.

是的。

Great question now. So the prescription growth is being driven by, as you would expect, a combination of established prescribers and new prescribers. New prescribers actually up are up about 20% year to date when you look at it versus fiscal 23. And so that pretty well mirrors the level of prescribing. And so what that suggests is that the level of prescribing on a per physician basis is it's static, which is good. That's about what you want to see there. They found a place in their practice for dentists and Cotempla. They consistently prescribe it for those types of patients.

現在是個好問題。因此，正如您所期望的那樣，處方藥的增長是由舊處方醫生和新處方醫生共同推動的。與 23 財年相比，今年迄今新開處方的人數實際增加了約 20%。這很好地反映了處方的水平。因此，這表明每個醫生的處方水平是靜態的，這很好。這就是你想在那裡看到的。他們在牙醫和 Cotempla 的診所中找到了一席之地。他們一貫地為這些類型的患者開藥。

And I think we've done clearly a better job of getting out there, given the fact that we still have a very very small share of voice, but the fact that we have increased prescribers by call it 18% to 20% after increasing prescribers by about that same percentage year over year.

我認為我們在走出去方面顯然做得更好，因為我們的話語權仍然非常小，但事實上我們在增加處方人數後增加了 18％ 至 20％ 的處方人數同比增幅大致相同。

The last year or so. And that, as you recall, is coming off of a much higher baseline. So great to see that level of prescriber growth when you've got these products that are somewhat mature, obviously, very, very competitive category with some generic competition and various constraints mostly by virtue of our size, keeping in mind that we essentially work with a small commercial team of, call it 40 or so sales representatives and very encouraging to see that the word is getting out there. And as those prescribers come on board there, there's more or less prescribing at that same consistent level.

去年左右。正如你所記得的，這是一個更高的基準。很高興看到處方者的成長水平，當你擁有這些有些成熟的產品時，顯然，非常非常有競爭力的類別，有一些通用的競爭和各種限制，主要是由於我們的規模，請記住，我們本質上是與一個由 40 名左右銷售代表組成的小型商業團隊，看到這個消息的傳播非常令人鼓舞。當這些處方醫生加入時，或多或少都會有相同的一致水平的處方。

So we're encouraged by that.

所以我們對此感到鼓舞。

Thanks.

謝謝。

And I was sort of on that point, and I know we've talked about and you discussed this ongoing charges, but on have you seen any impact of generic Vyvanse on your products? And also, have you seen any situations where patients if they were able to yet the prior prescriptions or prior stimulus, they switched away from your products? Or do you see a patient just kind of staying on 80s products?

我就在這一點上，我知道我們已經討論過，您也討論了這項持續收費，但您是否看到仿製藥 Vyvanse 對您的產品有任何影響？而且，您是否見過這樣的情況：如果患者能夠接受先前的處方或先前的刺激，他們就會放棄您的產品？或者您看到患者只是停留在 80 年代的產品上？

I'll take the second first more, so more So staying on our products, you're always going to have patients that for whatever reason default back to what they had been on. But we've really held our gains, which has been great to see, we've had patients that have moved over from mixed salts and said, I mean, we are immune to specifically Adderall and to Agennix XR ODT and really like it like the like not just what they feel clinically. And in fact, some patients report that they like it better in some ways, some patients report not necessarily needing a booster dose, which sometimes you'll hear about with with Adderall XR and as much they like the system, they like the program, they like the fact that they can get it predictably, particularly this time of year when deductibles resetting and it can be very, very unpredictable and unexpected in terms of what you might pay at the pharmacy counter. And so equal parts sort of clinical benefits and how they feel and the service and the overall level of predictability that they're getting.

我會更多地採取第二個第一個，所以更多所以繼續使用我們的產品，你總是會有患者出於某種原因默認回到他們之前使用的產品。但我們確實保持了我們的成果，這是很高興看到的，我們有患者已經從混合鹽轉變過來，他們說，我的意思是，我們對特別的Adderall 和Agenix XR ODT 免疫，並且真的很喜歡它不僅僅是他們臨床上的感覺。事實上，一些患者報告說他們在某些方面更喜歡它，一些患者報告不一定需要加強劑量，有時你會聽到 Adderall XR 的說法，他們非常喜歡這個系統，他們喜歡這個程序，他們喜歡這樣的事實：他們可以按預期獲得藥物，尤其是每年的這個時候，免賠額會重置，而且就您在藥房櫃檯可能支付的費用而言，這可能是非常非常不可預測和意外的。因此，臨床益處、他們的感受、服務以及他們獲得的整體可預測性水準都是同等的。

So that's been good to have.

所以這很好。

It's been good to see that level of stickiness again, you're never going to have 100% of your patient stay once they switch to your product. That's just a fact of life of these many these patients have been on Adderall their entire lives or their entire adult lives.

很高興再次看到這種程度的黏性，一旦患者改用您的產品，您將永遠不會 100% 留下來。這就是許多患者一生或整個成年生活都在服用阿得拉的生活事實。

But to see so many sort of come over and stay over. That's been that's been very encouraging. And what I'll say about Vyvanse is it's been a significant issue for patients and prescribers and pharmacies.

但看到這麼多人過來並留下來。這非常令人鼓舞。關於 Vyvanse，我想說的是，這對病人、處方醫生和藥局來說都是一個重大問題。

A significant number of Vyvanse generics were were approved in the low 10s, have significant issues just with some of the manufacturers getting quota so that inhibited their ability to gain any significant share. And you cross you intersect that with the natural issue around PBMs, they're naturally going to contract for a select number of generics that are going to contract with all of those. And so if you have a situation where you've got Vyvanse in supply, you've got a particular distribution center that has it available from manufacture a but manufacture B is the one that has the contract with, say two of the large PBMs.

大量 Vyvanse 仿製藥在 10 左右的時間內獲得批准，但由於某些製造商獲得配額而存在重大問題，從而限制了他們獲得重要份額的能力。你會發現，這與圍繞 PBM 的自然問題相交叉，他們自然會與選定數量的仿製藥簽訂合同，而這些仿製藥將與所有這些仿製藥簽訂合約。因此，如果您有 Vyvanse 供應，那麼您就有一個特定的配送中心，可以從製造商 A 獲得該產品，但製造商 B 是與之簽訂合約的配送中心，例如兩個大型 PBM。

Well, that's going to create a natural issue done that for the product that's physically available.

好吧，這將為實際可用的產品帶來一個自然的問題。

So physical availability does not mean actual availability in this round.

所以本輪物理可用並不代表實際可用。

You have to have payers aligned, which is one of the things that frankly we benefit from because we really take payers out of the picture. Now, obviously, that's not to suggest we don't have coverage.

你必須讓付款人保持一致，坦白說，這是我們受益的事情之一，因為我們確實將付款人排除在外。顯然，這並不是說我們沒有保險。

We do have coverage for our products.

我們確實為我們的產品提供保險。

But even in scenarios where coverage is maybe not if we don't get full reimbursement, our coverage is not optimal. We can still essentially underwrite that prescription. And irrespective of the payer landscape, we can get that prescription filled. So this is all to say Vyvanse has been quite a bit of noise has been quite effective, quite a bit of hassle and sort of disruption as these multiple generics. Again, it's low teen, 13, 14 that are out there. It just creates more of an issue for patients, which in turn creates more of an opportunity for us to sort of smooth that experience out and give patients an opportunity to get something that's easy that's predictable. They don't have to play catch up with the pharmacy figure out which pharmacy has my Vyvanse. And if they have it is at the Vyvanse that my PBM covers and weak again can cut through all that noise. So sort of that, that issue and sort of the fiasco that that has presented itself around Vyvanse has definitely presented a nice opportunity for our brands.

但即使在如果我們沒有獲得全額報銷可能無法承保的情況下，我們的承保也不是最佳的。我們基本上仍然可以承保該處方。無論付款人情況如何，我們都可以按處方配藥。因此，這就是說，Vyvanse 受到了相當多的噪音影響，但也非常有效，但與這些多個仿製藥一樣，也帶來了相當多的麻煩和破壞。再說一次，那裡的人都是低青少年，13 歲、14 歲。它只會給患者帶來更多的問題，反過來又為我們創造了更多的機會來平滑這種體驗，並讓患者有機會獲得簡單、可預測的東西。他們不必追著藥局找出哪個藥局有我的 Vyvanse。如果他們有的話，那就是我的 PBM 覆蓋的 Vyvanse，再次弱化可以消除所有噪音。因此，Vyvanse 周圍出現的這個問題和慘敗無疑為我們的品牌提供了一個很好的機會。

And just on, thanks for the color on just one last question, if I may. So that pediatric business, you often said you gave you some initiatives to reaccelerate growth on. Can you talk a little bit about what those initiatives are and on when we could see the impact of initiatives?

就這樣，如果可以的話，謝謝您對最後一個問題的發言。因此，對於兒科業務，您經常說您給了您一些舉措來重新加速成長。您能否談談這些舉措是什麼以及我們何時可以看到這些舉措的影響？

Yes, happy to.

是的，很高興。

So it's really threefold.

所以它實際上是三重的。

I would say first and foremost is diversification. We had some concentration risk there with some customers.

我想說首先也是最重要的是多元化。我們與一些客戶存在一些集中風險。

And we've now begun in earnest, really diversifying our ordering customers, those most notably some of our pharmacy customers to make sure that we don't run the risk of any one pharmacy having too much of our business.

我們現在已經開始認真地、真正地使我們的訂購客戶多樣化，其中最著名的是我們的一些藥房客戶，以確保我們不會面臨任何一家藥房擁有太多業務的風險。

And we're starting to see some of that come through in that that that large customers now proportionately a smaller part of our business than they were, say a couple of quarters ago. So we're starting to see that equal parts diversification into areas in different geographic areas. So for example, we've begun to move westward. And we've put some virtual reps in place to enable us to access physician customers, pharmacy customers in places outside of the traditional non-Florida areas, which are really in the tri-state area, New York, New Jersey, Connecticut, and then you would add in Pennsylvania. So by getting out into some of the areas out West, California and so forth, while those aren't and I would say, per capita or sort of per per individual state as big as maybe the tri-state area. When you add those together and aggregate all of the potential demand in this non-Ford area. It's a nice opportunity, so are starting to see some nice movement there.

我們開始看到其中的一些情況，因為大客戶現在在我們業務中所佔的比例比幾個季度前要小。因此，我們開始看到不同地理區域的多元化程度相等。例如，我們已經開始向西移動。我們已經安排了一些虛擬代表，使我們能夠接觸到傳統非佛羅裡達地區以外地方的醫生客戶、藥房客戶，這些客戶實際上位於三州地區，紐約州、新澤西州、康涅狄格州和然後你會添加賓夕法尼亞州。因此，透過進入西部、加州等地區的一些地區，而我想說的是，這些地區的人均或每個州的面積可能與三州地區一樣大。當您將這些加在一起並匯總該非福特區域的所有潛在需求時。這是一個很好的機會，所以我們開始看到一些不錯的動作。

As Mark mentioned, and I had as part of my prepared script, we are starting to see some of the unstacking. As we communicated on the last call, it really was a timing issue. Obviously, there's a supply chain. It has to sort of be drained before they need to reorder. We did see some nice reorders here in January or back in January and have seen some improved trajectory. Don't want to comment specifically around what that is because it would potentially create sort of a false sense of exactly where it's going to be not everything is linear.

正如馬克所提到的，作為我準備的腳本的一部分，我們開始看到一些拆解。正如我們在上次通話中溝通的那樣，這確實是一個時間問題。顯然，有供應鏈。在需要重新訂購之前，必須先將其排幹。我們在一月份或一月份確實看到了一些不錯的重新訂購，並且看到了一些改善的軌跡。不想具體評論這是什麼，因為它可能會產生一種錯誤的感覺，並非一切都是線性的。

So what I'll say is we've diversified customers.

所以我要說的是我們的客戶多元化。

We've diversified geographically and we put in some resources to help us very efficiently tap into some new areas and take advantage of some of the positive payer changes that have actually happened in fact there are there are some scenarios where we actually picked up coverage. So sort of one door closes, another couple of doors open up. So and in terms of timing, when I think we might start to see some real impact.

我們已經實現了地域多元化，我們投入了一些資源來幫助我們非常有效地進入一些新領域，並利用一些實際發生的積極的付款人變化，事實上，在某些情況下我們實際上獲得了承保。因此，一扇門關閉，另外幾扇門打開。因此，就時間而言，我認為我們可能會開始看到一些真正的影響。

I'm optimistic that it's in the very near term.

我樂觀地認為這是在不久的將來。

I don't want to suggest that we'll see it this quarter for the March quarter in full, but I think we're starting to see enough signs suggest that the multivitamins are starting to recover, will they get back to where they were? I mean, as I said earlier, there's Well my last call. I think we will wait and see. I think there's an opportunity to get there sort of as we move out. But in the next couple of quarters or so. I think we'll start to see some improvement in that business.

我不想建議我們將在本季度全面看到三月的情況，但我認為我們開始看到足夠的跡象表明多種維生素正在開始恢復，它們會回到原來的狀態嗎？我的意思是，正如我之前所說，這是我的最後一通電話。我想我們拭目以待。我認為當我們搬出去時就有機會到達那裡。但在接下來的幾個季度左右。我認為我們將開始看到該業務有所改善。

And again, I'll highlight the fact that even with this, the pediatric business being sort of at its low point, call it a $2 million quarter.

我要再次強調一個事實，即使如此，兒科業務仍處於低點，稱其為 200 萬美元季度。

The Rx segment posted a $5.5 million EBITDA quarter with positive net income by itself. And as we continue to wind down of the consumer business and as Pediatrix rebounds to whatever degree, that might be excited to see that $5.5 million potentially improve. So we're happy with how the the piece products are starting to show some improvement, but there's still more work to do.

Rx 部門季度 EBITDA 為 550 萬美元，淨利潤為正。隨著我們繼續縮減消費者業務，以及 Pediatrix 反彈至何種程度，我們可能會很高興看到 550 萬美元的潛在成長。因此，我們對單件產品開始顯示出一些改進感到高興，但仍有更多工作要做。

Thanks for taking my questions. And once again, congrats on the quarter Thanks, Noah.

感謝您回答我的問題。再次恭喜本季度，謝謝諾亞。

Appreciate it.

欣賞它。

(Operator Instructions) There are currently no questions in queue. I'd like to turn it back to management for closing remarks.

（操作員說明）目前隊列中沒有問題。我想把它轉回給管理階層做總結發言。

Thank you, John. Again, I just want to reiterate my thanks to the entire team at A. two for all, they've done for their hard work and dedication. We really are delivering for patients and clinicians at an important time, particularly as the ADHD category remains really challenged.

謝謝你，約翰。再次，我想重申對 A.2 整個團隊的感謝，感謝他們的辛勤工作和奉獻精神。我們確實在一個重要的時刻為患者和臨床醫生提供服務，特別是在過動症類別仍然面臨真正的挑戰的情況下。

So my thanks to everybody for putting their best foot forward. We've met demand.

因此，我感謝大家竭盡全力。我們已經滿足了需求。

We've continued to get more physicians and patients introduced to our ADHD brands. And I'm really proud of the progress we're making on the pediatric side of the business as well as we start to see some recovery there. It has indeed taken a significant discipline approach from the ground up and the entire organization to get to this point. But we are grateful to our shareholders, grateful to all of our stakeholders and our our teammates for getting us to this point.

我們不斷向更多的醫生和患者介紹我們的過動症品牌。我對我們在兒科業務方面取得的進展感到非常自豪，我們開始看到那裡的一些復甦。為了達到這一點，它確實從頭開始和整個組織採取了重要的紀律方法。但我們感謝我們的股東、所有利害關係人和我們的隊友讓我們走到了這一步。

So until next time, we're excited about the progress we're making and look forward to sharing more progress on our next call after the after the March quarter closes out. So thanks, everyone, for participating on the call and have a good afternoon and good evening.

因此，直到下一次，我們對所取得的進展感到興奮，並期待在三月季度結束後的下一次電話會議上分享更多進展。感謝大家參與此次電話會議，祝大家下午好、晚上好。

Thank you. This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的會議到此結束，您現在可以掛斷電話了。感謝您的參與。