Aytu Biopharma Inc (AYTU) 2026 Q4 法說會逐字稿

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  • Operator

    Operator

  • Greetings. Welcome to the Aytu Biopharma fiscal 2026 full-year and Q4 earnings call. (Operator Instructions) Please note, this conference is being recorded.

    各位好。歡迎參加 Aytu Biopharma 2026 會計年度全年及第四季(Q4)財報電話會議。(接線員指示)請注意,本次會議將被錄音。

  • I will now turn the conference over to your host, Robert Blum, with Lytham Partners. You may begin.

    現在我將把會議交給本次主持人——Lytham Partners 的 Robert Blum。您可以開始了。

  • Robert Blum - Investor Relations

    Robert Blum - Investor Relations

  • All right. Thank you, and good afternoon, everyone. As the operator indicated, during today's call, we will be discussing Aytu Biopharma's fiscal 2026 fourth-quarter and full-year operational and financial results for the period ended June 30, 2026. Joining us on today's call is Aytu's Chief Executive Officer, Josh Disbrow; and Ryan Selhorn, the company's Chief Financial Officer. At the conclusion of today's prepared remarks, we will open the call for a question-and-answer session.

    好的。謝謝,大家午安。如接線員所示,在今天的電話會議中,我們將討論 Aytu Biopharma 截至 2026 年 6 月 30 日期間的 2026 會計年度第四季及全年營運與財務結果。今天與會的有 Aytu 執行長 Josh Disbrow,以及公司財務長 Ryan Selhorn。在我們的事先準備發言結束後,我們將開放問答環節。

  • 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 or by utilizing the link on the company's website under Events and Presentations.

    我想提醒各位,今天的電話會議正在錄音。今日會議的重播可透過今天稍早發布之新聞稿中提供的電話號碼與會議 ID 收聽,或使用公司網站「Events and Presentations」頁面上的連結。

  • Finally, I'd also like to call to your attention the customary 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 Aytu 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.

    最後,我也想請各位注意有關前瞻性資訊的慣例性「安全港」揭露。今天的電話會議將包含若干前瞻性陳述,包括關於 Aytu Biopharma 的目標、策略、信念、預期以及未來潛在營運成果的陳述。儘管管理層基於截至今日的估計、假設與預測認為這些陳述屬合理,但這些陳述並非對未來績效的保證。

  • Time-sensitive information may no longer be accurate at the time of any telephonic 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. Aytu undertakes no obligation to update or revise any of these forward-looking statements except as required by law.

    具時效性的資訊在任何電話或網路重播時點可能已不再準確。實際結果可能因風險、不確定性及其他因素而出現重大差異,包括但不限於公司向美國證券交易委員會(SEC)提交文件中所列之因素。除法律要求外,Aytu 不承擔更新或修訂任何前瞻性陳述之義務。

  • With that said, let me turn the call over to Josh Disbrow, Chief Executive Officer of Aytu Biopharma. Josh, please proceed.

    話不多說,讓我把電話會議交給 Aytu Biopharma 執行長 Josh Disbrow。Josh,請開始。

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Thanks, Robert, and welcome, everyone. I'm very excited about the progress we're making and the opportunity ahead for Aytu. We finished fiscal 2026 with an encouraging fourth quarter as EXXUA continued to build. Our ADHD business performed better than anticipated, and Aytu return to positive adjusted EBITDA.

    謝謝你,Robert,也歡迎各位。我對我們正在取得的進展以及 Aytu 未來的機會感到非常振奮。我們以令人鼓舞的第四季結束 2026 會計年度,因為 EXXUA 持續成長。我們的 ADHD 業務表現優於預期,Aytu 也回到正向的調整後 EBITDA。

  • EXXUA gives us something special to build around. It's the first and only selective serotonin 5-HT1A receptor agonist approved by the FDA for the treatment of major depressive disorder in adults. Its novel mechanism and differentiated tolerability profile address an important need in a category where many patients struggle to find a treatment that works well for them and that they can stay on.

    EXXUA 為我們提供了一個特別的核心來打造成長。它是首個且目前唯一獲 FDA 核准、用於治療成人重度憂鬱症(MDD)的選擇性血清素 5-HT1A 受體致效劑。其新穎的作用機轉與差異化的耐受性特徵,滿足了一項重要需求;在這個領域中,許多患者難以找到既有效、又能長期持續使用的治療。

  • As a reminder, the opportunity is substantial and an estimated 21 million Americans are affected by MDD, and the US prescription MDD market exceeds $22 billion. Even a modest foothold in a market of that size would be meaningful for Aytu. We strongly believe EXXUA has the potential to become an important treatment option and a major growth driver for our company.

    提醒各位,這個機會相當可觀,估計有 2,100 萬名美國人受 MDD 影響,而美國處方用 MDD 市場規模超過 220 億美元。即使只在如此規模的市場中取得適度立足點,對 Aytu 也將具有重大意義。我們堅信 EXXUA 有潛力成為重要的治療選項,並成為公司主要的成長驅動力。

  • It's one thing to have had excitement before a launch occurs. But what makes this especially exciting is that we are now seeing that opportunity begin to take shape in clinical practice. Physicians are gaining experience, patients are continuing treatment and our prescription base is expanding. These early results reinforce our conviction in EXXUA and give us a strong reason to keep building with the same focus on execution and financial discipline.

    在上市前感到興奮是一回事。但更令人振奮的是,我們現在正看到這個機會開始在臨床實務中成形。醫師正在累積使用經驗,患者持續接受治療,而我們的處方基礎也在擴大。這些早期成果強化了我們對 EXXUA 的信心,也讓我們有充分理由以同樣的執行力與財務紀律持續推進。

  • As we have discussed for some time, our approach to EXXUA is methodical. We are building the business with a clear focus on productivity, the return on our commercial investment and preserving cash. As we have communicated, this was never going to be an oversized quote spend at all cost boom or bus type of launch. This quarter gives us meaningful evidence that our approach is working.

    如同我們一段時間以來所討論的,我們對 EXXUA 的策略是循序漸進且有方法的。我們在建立業務時,明確聚焦於生產力、商業投資報酬,以及保留現金。正如我們所傳達的,這從來不是那種不計代價、以超大規模投入的「成敗一搏」式上市。本季為我們提供了重要證據,顯示我們的方法正在奏效。

  • Today, let me spend most of my prepared remarks discussing the EXXUA execution, including what we're seeing in the field and the decisions we are making as the launch develops. I'll also spend a little more time on ADHD because the notable durability of that business certainly deserves attention. Ryan will then cover our financial results and our fiscal 2027 outlook.

    今天,我將把大部分的事先準備發言用於討論 EXXUA 的執行情況,包括我們在第一線看到的狀況,以及隨著上市推進我們所做的決策。我也會多花一些時間談 ADHD,因為該業務顯著的持久性確實值得關注。接著 Ryan 將說明我們的財務結果以及 2027 會計年度展望。

  • EXXUA generated $3.9 million of net revenue in the fourth quarter, up from $2.4 million in the third quarter, bringing its fiscal 2016 contribution to $6.6 million. As a reminder, our formal launch only occurred at the beginning of January and broader field deployment in late February and early March. We remain early in building physician awareness and experience with EXXUA having only just completed our first full quarter of launch.

    EXXUA 在第四季創造 390 萬美元的淨營收,高於第三季的 240 萬美元,使其在 2016 會計年度的貢獻達到 660 萬美元。提醒各位,我們的正式上市僅在 1 月初開始,而更廣泛的第一線部署則在 2 月下旬及 3 月初。在建立醫師對 EXXUA 的認知與使用經驗方面,我們仍處於早期階段,因為我們才剛完成上市後的第一個完整季度。

  • During the June quarter, total prescriptions were 3,323 compared with 1,398 in the March quarter. The monthly progression was 973 prescriptions in April, 1,089 in May and 1,261 in June. As we entered fiscal '27, July increased further to 1,377, August was up at 1,408 prescriptions. Importantly, EXXUA grew from July to August despite the overall MDD market declining. That is meaningful progress as more physicians begin using EXXUA and patients move from initial treatment into refills.

    在 6 月季度,總處方量為 3,323 張,相較於 3 月季度的 1,398 張。按月進展為:4 月 973 張、5 月 1,089 張、6 月 1,261 張。進入 2027 會計年度後,7 月進一步增加至 1,377 張,8 月上升至 1,408 張處方。重要的是,儘管整體 MDD 市場下滑,EXXUA 仍從 7 月成長到 8 月。隨著更多醫師開始使用 EXXUA、患者從初始治療進入續配,這代表了有意義的進展。

  • Line item, I think, is important to understand as we look at the trajectory in the early going is that we have consistently said we would manage this launch methodically, and that includes expecting a high-performing sales organization and holding that sales organization accountable for performance. Where representatives have not been performing at high levels or at the high levels we need, we have made adjustments in real time.

    我認為,當我們觀察早期發展軌跡時,有一點按項目來理解很重要:我們一直強調會以有方法的方式管理這次上市,而其中也包括期待一個高績效的銷售組織,並要求該銷售組織對績效負責。對於未能達到高水準表現、或未達到我們所需高水準的業務代表,我們已即時做出調整。

  • As a result, we have seen ebbs and flows in the number of sales individuals on a month-by-month basis. Importantly, several of those changes occurred during June and July, and our field force reached a low of 32 representatives in July. That was down from 43 reps at the end of March.

    因此,我們看到銷售人員數量在每月之間出現起伏。值得注意的是,其中數項變動發生在 6 月與 7 月期間,而我們的第一線團隊在 7 月降至 32 名代表的低點。這低於 3 月底的 43 名代表。

  • This was intentional as we were demanding high performance across the sales organization. Standards have been set and will be upheld and will remain disciplined with our capital deployment throughout the launch. Those changes temporarily reduced our coverage while we work to fill territories and optimize the profile of our sales specialist position.

    這是刻意為之,因為我們要求整個銷售組織維持高績效。標準已被設定並將被貫徹,我們也將在整個上市過程中對資本配置保持紀律。在我們努力補足區域並優化銷售專員職位的配置特徵之際,這些變動暫時降低了我們的覆蓋範圍。

  • Since that low, we brought the sales force back to approximately 42 representatives, and we continue to fill open positions. We're also adjusting territory coverage based on what we're learning, adding resources where the opportunity to support them and combining sales specialist coverage where that makes better economic sense.

    自那個低點以來,我們已將銷售團隊恢復至約 42 名代表,並持續補足空缺職位。我們也根據學到的經驗調整區域覆蓋,在機會較大的地方增加資源以提供支援,並在更具經濟效益的情況下合併銷售專員的覆蓋。

  • One of the key metrics we're watching is weekly and monthly prescriptions per sales rep, using month-end field force head count as a directional measure. In March, we had 761 prescriptions and 43 sales specials or about 18 prescriptions per sales rep per month. In July, we had 1,377 prescriptions and 32 representatives or approximately 43 prescriptions per rep for the month.

    我們正在追蹤的一項關鍵指標,是每位業務代表每週與每月的處方量,並以月末第一線人力編制作為方向性衡量。在 3 月,我們有 761 張處方與 43 名銷售專員,約為每位業務代表每月 18 張處方。在 7 月,我們有 1,377 張處方與 32 名代表,約為當月每位代表 43 張處方。

  • That's more than a twofold increase in prescriptions per rep with total monthly prescriptions also increasing 81% over that period. We're continuing to be proactive and fine-tuning the team, but we view that as an encouraging measure of the productivity of our commercial effort.

    這相當於每位業務代表的處方量增加逾兩倍,同期每月總處方量也增加了81%。我們持續主動出擊並微調團隊,但我們將其視為衡量我們商業化工作生產力的一項令人鼓舞的指標。

  • To add some additional color on rep performance, which is clearly going to be the key driver of our success with EXXUA, consider some other numbers. If you look at our current active sales specialists, the top 10 are averaging almost 15 prescriptions per week. The top 5 are averaging 18.5 prescriptions per week.

    為了補充一些關於業務代表表現的細節(這顯然將是我們在EXXUA上成功的關鍵驅動因素),請看其他一些數據。若看我們目前活躍的銷售專員,前10名平均每週接近15張處方。前5名平均每週18.5張處方。

  • But importantly, as I share these numbers, I should note that we are not top heavy with respect to the percentage of territories driving the majority of the EXXUA prescriptions. In fact, 24 territories, or approximately 60% of the current sales force, are driving 70% of the EXXUA prescriptions, demonstrating very good breadth across many geographies and across many sales specialists. So that gives us great confidence in knowing that we have a product that is being and can be broadly adopted and broadly sold.

    但重要的是,在我分享這些數字時,我要指出,就推動大多數EXXUA處方的區域占比而言,我們並非由少數頂尖區域所主導。事實上,24個區域(約占目前銷售團隊的60%)推動了70%的EXXUA處方,顯示在多個地理區域以及多位銷售專員之間具有非常好的廣度。因此,這讓我們非常有信心,因為我們知道我們的產品正在、也能夠被廣泛採用並廣泛銷售。

  • To see what EXXUA weekly scripts could be in the relative near term as some of our newer sales specialists we have onboard to come up the curve, consider what a weekly run rate looks like by simply having 45 territories at the weekly script rate of the top 5 or 10 territories. By simply generating 15 prescriptions per rep per week, that gets us to 675 TRxs per week. And at the current selling price, that's already a $26 million annual run rate if you were to simply dollarize TRxs for ease of math.

    為了了解在相對不久的將來,隨著我們新加入的銷售專員逐步上手,EXXUA每週處方量可能達到的水準,請想像一下:只要讓45個區域達到前5或前10名區域的每週處方速度,其每週運行率會是什麼樣子。只要每位代表每週產生15張處方,就可達到每週675張TRx。以目前的銷售價格計算,若為了便於計算將TRx直接換算成金額,這已相當於每年2,600萬美元的年化運行率。

  • Taking that weekly rep average to 20 TRxs per week, which, again, 5 territories are already averaging that, plus or minus. And then you're looking at -- excuse me, 900 TRxs weekly or about a $35 million run rate annually. And then 30 TRxs per rep per week, again, a weekly number achieved by multiple reps already, and that takes the annual run rate to over $50 million, again, by simply dollarizing prescriptions.

    若將每位代表的每週平均提高到20張TRx(同樣地,目前已有5個區域的平均大致達到這個水準,上下略有差異),那麼每週就是——不好意思——900張TRx,或每年約3,500萬美元的年化運行率。再者,若每位代表每週30張TRx(同樣地,這個每週數字已由多位代表達成),則年化運行率可提升至超過5,000萬美元,同樣是透過將處方直接換算成金額得出。

  • So with the refined sales team that will be getting us to 40-plus and more likely closer to 45 territories, you can see why we're excited about a significant lift to script levels in the relative near term. And speaking of near term, and this is happening really before any of the newly hired reps or even up the curve, we're seeing EXXUA take that next leg up.

    因此,透過精煉後的銷售團隊,將使我們達到40多個、且更可能接近45個區域,你就能理解為何我們對相對短期內處方量水準的顯著提升感到振奮。而談到短期,甚至在任何新聘代表尚未完全上手、進入成長曲線之前,我們已看到EXXUA出現下一波上升。

  • For the week ending September 4, just before Labor Day, we generated 394 prescriptions, a significant jump from July and August levels. Again, when the newly onboarded folks get their feet under them, we're excited to see what the script trends look like.

    截至9月4日(勞動節前一週),我們產生了394張處方,較7月與8月的水準大幅跳升。同樣地,當新加入的同仁站穩腳步後,我們很期待看到處方趨勢會呈現什麼樣貌。

  • Growing refill activity is also part of the picture, alongside the work our representatives are doing to develop prescribing relationships. We look at this measure together with total prescriptions, new and repeat prescribers and the economics of the business as we decide where to put the next dollar of investment. This is what we mean by a methodical launch.

    補充處方(續方)活動的成長也是整體圖像的一部分,與我們代表建立開立處方關係的工作相輔相成。我們會將此指標與總處方量、新增與重複開立醫師,以及業務經濟性一併評估,以決定下一筆投資應投向何處。這就是我們所說的有條不紊的上市推進。

  • We are using the data to make staffing and spending decisions, learning from the territories that are performing well and addressing the ones that need improvement. We believe that's how we build a commercial organization that can support EXXUA over time while maintaining the financial discipline we've worked hard to establish.

    我們運用數據來做出人力配置與支出決策,從表現良好的區域學習,並改善需要提升的區域。我們相信,這正是我們在維持辛苦建立的財務紀律之下,打造能長期支持EXXUA的商業組織之道。

  • Perhaps most importantly, the feedback from physicians who are gaining experience with EXXUA remains highly encouraging, and our latest launch to-date update, nearly 1,200 unique prescribers had written EXXUA and nearly 2,500 unique patients have received it. We're seeing repeat prescribing from physicians who are developing a broader base of experience with the product, along with encouraging feedback on patient response and on patient tolerability.

    或許最重要的是,正在累積EXXUA使用經驗的醫師所回饋的意見仍然非常令人鼓舞;而截至目前我們最新的上市進度更新,已有近1,200位不重複開立醫師曾開立EXXUA,且近2,500位不重複病患已接受治療。我們看到醫師在累積更廣泛的產品使用經驗後出現重複開立,同時也收到對病患反應與耐受性的正面回饋。

  • At the same time, many physicians in that prescriber base have only used EXXUA with one or two patients. Of course, we know it takes time for a physician to identify appropriate patients and then assess their experience and then ultimately become comfortable using a new medicine more broadly. That process develops over time.

    同時,在這些開立醫師中,許多人僅在一到兩位病患身上使用過EXXUA。當然,我們知道醫師需要時間來辨識合適病患、評估其使用經驗,並最終更安心地更廣泛使用一種新藥。這個過程會隨時間推進而逐步發展。

  • Our opportunity is to deepen utilization among those early adopters, while continuing to introduce EXXUA to additional prescribers. We remain very encouraged by the response from physicians who are moving beyond their first few patients and continuing to prescribe. And it's precisely those prescribers who have written EXXUA for a handful or more patients that are most impressed with the results. We continue to hear that across the country. And of course, that gives us great confidence in the product.

    我們的機會在於加深這些早期採用者的使用量,同時持續將EXXUA介紹給更多開立醫師。對於那些已不再只用於前幾位病患、並持續開立的醫師所展現的反應,我們仍深受鼓舞。而正是那些已為數位或更多病患開立EXXUA的醫師,對結果最為印象深刻。我們在全國各地持續聽到這樣的回饋。當然,這也讓我們對產品充滿信心。

  • Access also continues to support the launch. Reimbursement approval rates remain encouraging, and we are seeing a growing contribution from Medicaid and Medicare alongside the commercial business. Rx Connect remains an important part of helping patients initiate and continue treatment and helping prescribers and their practices navigate access. Ryan will touch on this a bit, but gross to nets are significantly higher than our initial expectations.

    可近性(Access)也持續支持此次上市。給付核准率仍然令人鼓舞,且我們看到除商業保險業務外,Medicaid與Medicare的貢獻也在增加。Rx Connect仍是協助病患啟動並持續治療、以及協助開立醫師與其診所處理可近性流程的重要一環。Ryan會稍後稍作說明,但總額到淨額(gross-to-net)的幅度顯著高於我們最初的預期。

  • As we move into fiscal '27, we will continue investing in EXXUA sales and marketing and in the medical and scientific education that supports physician understanding of the product. We will continue assessing the results and directing resources toward the activities that are producing the strongest return.

    隨著我們進入2027財政年度,我們將持續投資於EXXUA的銷售與行銷,以及支持醫師理解產品的醫學與科學教育。我們也將持續評估成果,並將資源導向能帶來最強回報的活動。

  • Our fourth-quarter results are an encouraging indication of what this model can deliver. We grew EXXUA revenue, benefited from the continued contribution of our legacy products and generated positive EBITDA at the company level while keeping cash relatively stable. Profitability and cash preservation remains central to how we're managing the launch.

    我們第四季的結果,是此模式可交付成果的一項令人鼓舞的指標。我們提升了EXXUA營收,受惠於既有產品的持續貢獻,並在公司層級實現正向EBITDA,同時使現金水位相對穩定。獲利能力與現金保全仍是我們管理此次上市的核心。

  • Of course, there will continue to be variability in quarterly results as we invest and as the business moves through its normal seasonal patterns. Again, Ryan will walk through that in more detail. Our objective, however, remains to build a durable, profitable EXXUA business on the platform we already have with commercial spending tied to strong ROIs.

    當然,隨著我們持續投資,以及業務依其正常季節性型態運行,季度結果仍會出現波動。同樣地,Ryan會更詳細地說明。然而,我們的目標仍是:在既有平台之上,建立一個具韌性、可獲利的EXXUA業務,並使商業支出與強勁的投資報酬率(ROI)掛鉤。

  • Turning to ADHD. The portfolio performed better than anticipated in the fourth quarter. Net revenue was $10.4 million compared to $9.1 million in the March quarter and $13.1 million in the fourth quarter prior year.

    接著談ADHD。該產品組合在第四季的表現優於預期。淨營收為1,040萬美元,相較於3月季度的910萬美元,以及去年第四季的1,310萬美元。

  • For Adzenys, our brand, and authorized generic together continue to retain approximately 80% of the prescriptions in the market for Adzenys and its generic equivalents. We believe this speaks to the durability of the franchise and the value of the RxConnect model even with substantially less commercial support behind the brand.

    就Adzenys而言,我們的品牌藥與授權學名藥合計仍保有約80%的處方市占,涵蓋Adzenys及其學名藥等同品的市場。我們認為,這反映了該產品線的持久性,以及即使品牌背後的商業支持大幅減少,RxConnect模式仍具價值。

  • We also have our Cotempla authorized generic in the market, and it's gaining prescriptions week over week. As of today, Teva has not yet launched its generic version of Cotempla following the July 1 date permitted under our settlement agreement with Teva, presenting potential upside to our base case assumptions around Cotempla's revenue run rate.

    我們也已將Cotempla的授權學名藥推向市場,且其處方量正逐週增加。截至今日,Teva在我們與Teva的和解協議所允許的7月1日日期之後,仍尚未推出其Cotempla學名藥版本,這使得Cotempla營收運行率在我們基本情境假設之上存在潛在上行空間。

  • As always, ADHD has normal seasonality with the earlier part of our -- the first half of our fiscal year, typically softer due to kids being out of school. The fourth-quarter performance, however, reinforces our confidence in the value this portfolio brings to Aytu. It remains an important source of profit and cash to support our investment in EXXUA.

    一如既往,ADHD業務具有正常季節性,我們——我們財政年度的前半段通常較疲弱,因為孩子們放暑假不在學校。然而,第四季的表現進一步強化了我們對該產品組合為Aytu帶來價值的信心。它仍是支持我們投資EXXUA的重要獲利與現金來源。

  • Rounding out the legacy business, our Pediatric portfolio generated $1.8 million of net revenue in the fourth quarter compared to $0.9 million in the March quarter and $2 million in the prior-year quarter. These are mature products that we continue to service efficiently. And while smaller, Pediatrics does remain a useful and durable contributor to the legacy business and the financial foundation supporting EXXUA.

    為了完善既有業務的版圖,我們的兒科產品組合在第四季創造了180萬美元的淨營收,相較於3月季度的90萬美元,以及去年同期的200萬美元。這些都是成熟產品,我們持續以高效率提供服務。雖然規模較小,兒科業務仍是既有業務中有用且具持久性的貢獻來源,也是支撐EXXUA的財務基礎之一。

  • Overall, we are highly encouraged by the progress in EXXUA and the durability of our legacy business. Our focus remains on execution, profitability and preserving cash.

    整體而言,我們對EXXUA的進展以及既有業務的韌性深受鼓舞。我們的重點仍放在執行力、獲利能力以及保留現金。

  • With that, let me turn the call over to Ryan for financial results and fiscal 2027 outlook. Ryan?

    接下來,我把電話交給Ryan,請他說明財務結果以及2027會計年度展望。Ryan?

  • Ryan Selhorn - Chief Financial Officer, Treasurer, Corporate Secretary

    Ryan Selhorn - Chief Financial Officer, Treasurer, Corporate Secretary

  • Thank you, Josh. Let's jump right into it. I'll primarily cover our fourth-quarter results and then spend a few minutes on our outlook and how we expect fiscal 2027 to unfold. Let's start on the revenue line.

    謝謝你,Josh。我們直接開始。我將主要說明第四季的業績,接著花幾分鐘談談我們的展望,以及我們預期2027會計年度將如何發展。先從營收開始。

  • Net revenue for the fourth quarter of fiscal 2026 was $16.1 million compared to $15.1 million in the prior-year period, an increase of 6%. Revenue also improved from $12.4 million in the third quarter with sequential increases across all three portfolios. For fiscal 2026, net revenue was $57.6 million.

    2026會計年度第四季的淨營收為1,610萬美元,較去年同期的1,510萬美元增加6%。營收也較第三季的1,240萬美元提升,三個產品組合皆呈現季增。2026會計年度全年淨營收為5,760萬美元。

  • Breaking that down, EXXUA contributed $3.9 million in the fourth quarter compared to $2.4 million in the third quarter. We are encouraged by that progression as we build the prescriber base and expand our commercial activity.

    進一步拆解,EXXUA在第四季貢獻390萬美元,相較第三季的240萬美元。隨著我們建立處方醫師基礎並擴大商業活動,我們對這樣的進展感到鼓舞。

  • The recent prescription data Josh discussed showed continued progress with 3,300 scripts written during the fourth quarter. Remember, however, that prescriptions and unit shipments are different measures. During the fourth quarter, we shipped 4,599 units, Revenue reflects product sales into the channel, net of estimated rebates, discounts and other adjustments and will not necessarily move in lockstep with prescriptions in any given period.

    Josh剛才提到的近期處方資料顯示持續進展,第四季共開立3,300張處方。不過請記得,處方數與出貨單位數是不同的衡量指標。第四季我們出貨4,599個單位;營收反映的是銷售至通路的產品銷售額,並扣除估計的回扣、折扣及其他調整,因此在任何特定期間不一定會與處方數同步變動。

  • We continue to see favorable gross to net for EXXUA relative to our initial launch assumptions, payer mix, reimbursement and the level of patient access support all influence these economics. It is still early, and we want to see how those factors develop over a longer period before assuming the current realization rates will hold.

    相較於我們初始上市時的假設,我們持續看到EXXUA的毛額到淨額(gross-to-net)表現較為有利;付款方組合、給付/報銷以及病患可近性支援的程度,皆會影響這些經濟性。目前仍屬早期階段,我們希望在更長期間觀察這些因素的發展,再判斷目前的實現率是否能維持。

  • The ADHD portfolio generated $10.4 million in the fourth-quarter net revenue compared to $13.1 million in the prior-year period and $9.1 million in the third quarter. The sequential improvement benefited primarily from better gross-to-net realization. We continue to view this portfolio as an important source of cash flow with limited promotional spending behind it.

    ADHD產品組合在第四季創造1,040萬美元的淨營收,較去年同期的1,310萬美元下降,但較第三季的910萬美元上升。季增主要受惠於較佳的毛額到淨額實現。我們仍將此產品組合視為重要的現金流來源,且背後的推廣支出有限。

  • The Pediatric portfolio generated $1.8 million in fourth-quarter net revenue compared to $2 million a year ago and $0.9 million in the third quarter. These are mature products and payer mix, returns and ordering patterns can affect the quarterly results. However, they continue to contribute to the cash generation of the legacy business.

    兒科產品組合在第四季創造180萬美元的淨營收,較一年前的200萬美元下降,但較第三季的90萬美元上升。這些是成熟產品,付款方組合、退貨與訂購模式都可能影響季度結果。然而,它們仍持續為既有業務的現金創造做出貢獻。

  • Gross profit was $10.4 million in the fourth quarter with a gross margin of approximately 65% compared to $10.3 million and 68% in the prior-year period. Sequentially, gross margin improved from 61% in the third quarter, which included a $0.7 million inventory write-down. For fiscal 2026, gross profit was $36.8 million or 64%.

    第四季毛利為1,040萬美元,毛利率約65%,相較去年同期為1,030萬美元、毛利率68%。就季比而言,毛利率自第三季的61%改善;第三季包含70萬美元的存貨減記。2026會計年度全年毛利為3,680萬美元,毛利率為64%。

  • EXXUA's underlying economics remain attractive. As we discussed last quarter, the royalty and product cost structure equates to approximately 31% of cost of goods sold or roughly 69% gross contribution margin before certain fixed costs. Our consolidated reported margin also reflects those fixed costs, product mix and inventory adjustments. I'll come back to margin outlook in a moment.

    EXXUA的基本經濟性仍具吸引力。如同我們上季所討論,權利金與產品成本結構約相當於銷貨成本的31%,或在某些固定成本之前約為69%的毛利貢獻率。我們合併報表所揭露的毛利率亦反映了這些固定成本、產品組合以及存貨調整。我稍後會再回到毛利率展望。

  • Turning to operating expenses. Total operating expenses were $11.2 million in the fourth quarter compared to $17.9 million a year ago. The prior-year quarter included a $8.3 million impairment charge. So excluding impairment, restructuring costs and intangible asset amortization from both periods, operating expenses were $10.4 million compared to $8.7 million on an apples-to-apples basis.

    接著談營業費用。第四季總營業費用為1,120萬美元,較一年前的1,790萬美元下降。去年同期包含830萬美元的減損費用。因此,若在兩個期間皆排除減損、重整成本與無形資產攤銷,則營業費用在可比基礎上為1,040萬美元,相較於8,700萬美元。

  • The year-over-year increase primarily reflects EXXUA commercialization costs, partially offset by continued cost discipline elsewhere in the organization. We spent less on certain commercial programs than originally planned during fiscal 2026 and some of that planned activity will shift into fiscal 2027. As Josh mentioned, we want to make sure we have strong ROIs on all investments made. If we don't believe we can get the returns or need to adjust the plan to get it right, we will.

    年增主要反映EXXUA商業化成本,部分被公司其他領域持續的成本紀律所抵銷。在2026會計年度,我們在某些商業計畫上的支出低於原先規劃,其中部分原定活動將延後至2027會計年度。如Josh所提,我們希望確保所有投資都有強勁的投資報酬率(ROI)。若我們認為無法取得預期回報,或需要調整計畫以把事情做對,我們就會這麼做。

  • Interest expense was $0.4 million in the fourth quarter compared to $0.7 million a year ago. For the full year, interest expense declined to $1.9 million from $3.7 million primarily due to the pay down of our fixed payment arrangements. Those arrangements had no remaining balance at June 30.

    第四季利息費用為40萬美元,較一年前的70萬美元下降。全年利息費用由370萬美元降至190萬美元,主要因我們償還了固定付款安排(fixed payment arrangements)。截至6月30日,這些安排已無未償餘額。

  • For the fourth quarter, we reported a net loss of $0.1 million. On a per share basis, the loss rounded to $0.00 per share. This is compared to a net loss of $19.8 million or $2.92 per share in the prior-year period. For fiscal 2026, net loss was $14.3 million.

    第四季我們報告淨損10萬美元。以每股計算,虧損四捨五入為每股0.00美元。相較之下,去年同期淨損為1,980萬美元,或每股2.92美元。2026會計年度全年淨損為1,430萬美元。

  • The fourth quarter included a $1 million noncash derivative warrant liability gain. The prior-year fourth quarter included $18.1 million of combined impairment expense and derivative warrant liability loss. These items have a significant effect on the GAAP comparisons.

    第四季包含100萬美元的非現金衍生性權證負債利益。去年第四季則包含合計1,810萬美元的減損費用與衍生性權證負債損失。這些項目對GAAP比較具有顯著影響。

  • Adjusted EBITDA was a positive $0.5 million for the fourth quarter compared to a positive $2 million a year ago and a negative $2.8 million in the third quarter. For fiscal 2026, adjusted EBITDA was negative $3.7 million. The reconciliation of this non-GAAP measure to net loss is included in today's earnings release.

    第四季調整後EBITDA為正50萬美元,相較一年前為正200萬美元,第三季則為負280萬美元。2026會計年度全年調整後EBITDA為負370萬美元。此非GAAP指標與淨損之調節表已包含在今日的財報新聞稿中。

  • Turning now to the balance sheet. Cash and cash equivalents were $26.3 million at June 30 compared to $26.7 million at March 31 and $31 million at the end of fiscal 2025. While cash was relatively stable during the quarter, we also reduced our revolving credit facility balance to $6.1 million from $10.4 million at March 31. Subsequent to year-end, we repaid the remaining revolver balance.

    接著看資產負債表。截至6月30日,現金及約當現金為2,630萬美元,較3月31日的2,670萬美元略降,亦較2025會計年度期末的3,100萬美元下降。雖然本季現金相對穩定,我們也將循環信用額度(revolving credit facility)餘額由3月31日的1,040萬美元降至610萬美元。在年度結束後,我們已償還剩餘的循環額度餘額。

  • Separately, the carrying value of our term debt, including the current and noncurrent portion, was approximately $11 million at June 30. For fiscal 2026 as a whole, we generated $3.3 million of cash from operating activities compared to using $1.9 million in fiscal 2025, an improvement of $5.2 million.

    另外,我們的定期債務(term debt)帳面價值(含流動與非流動部分)截至6月30日約為1,100萬美元。就2026會計年度全年而言,我們由營運活動產生的現金為330萬美元,相較2025會計年度使用190萬美元,改善520萬美元。

  • Improved receivable collections and inventory turnover were meaningful contributors. We also used $7.9 million in financing activities, primarily to reduce our revolver, term debt and fixed payment arrangements. Accordingly, the year-over-year reduction in cash reflects significant balance sheet deleveraging rather than operating cash burn.

    應收帳款回收改善與存貨周轉提升是重要貢獻因素。我們也在籌資活動中使用790萬美元,主要用於降低循環額度、定期債務以及固定付款安排。因此,現金的年減反映的是資產負債表顯著去槓桿,而非營運現金消耗。

  • Stockholders' equity was $35.3 million at June 30, 2026, compared to $19 million a year earlier. As discussed last quarter, the March warrant amendments reclassified $26.4 million from warrant liabilities to equity. This was a noncash reclassification that reduced our exposure to future earnings volatility associated with those warrants.

    截至2026年6月30日,股東權益為3,530萬美元,較一年前的1,900萬美元增加。如同上季所討論,3月的認股權證修訂將2,640萬美元自認股權證負債重新分類至權益。這是一項非現金的重新分類,降低了我們因該等認股權證而面臨未來盈餘波動的曝險。

  • Before I turn it back over to Josh, I want to walk through the financial framework for fiscal 2027. We are not providing revenue guidance, but we do want to give you a clear view of our planned expenses, margin expectations and the expected progression of profitability and cash flow.

    在我把話題交回給Josh之前,我想先說明2027會計年度的財務架構。我們不提供營收指引,但我們希望讓各位清楚了解我們規劃的費用、毛利率預期,以及獲利能力與現金流的預期進展。

  • Our current plan calls for approximately $49 million to $54 million of operating expenses on a GAAP basis. Excluding noncash expenses, total cash-based operating expenses are expected to be approximately $45 million to $49 million. The largest increase is in sales and marketing, where we expect to invest up to $6 million, now planned for fiscal '27 rather than fiscal '26.

    我們目前的計畫是在GAAP基礎下,營運費用約為4,900萬至5,400萬美元。排除非現金費用後,以現金為基礎的營運費用總額預期約為4,500萬至4,900萬美元。增幅最大的是銷售與行銷,我們預期將投資最多600萬美元,且目前規劃是在27會計年度而非26會計年度投入。

  • This was always part of the plan, but it has been deferred from fiscal '26 to fiscal '27. The increase will support sales force coverage, marketing programs and physician and patient education for EXXUA. We also expect a more modest increase in G&A, including medical affairs and support for the commercial organization.

    這一直都是計畫的一部分,但已從26會計年度延後至27會計年度。這項增加將用於支援銷售團隊覆蓋、行銷方案,以及針對EXXUA的醫師與病患教育。我們也預期一般及行政(G&A)費用將有較溫和的增加,包括醫療事務以及對商業組織的支援。

  • Research and development expense should remain minimal, and we expect the interest expense to continue to decline steadily on a full-year basis. As we mentioned, we will manage spending against the results we are seeing. The budget gives us room to support the opportunity, and the timing and level of investment will depend on the prescription trends, access, commercial performance and available liquidity.

    研發費用應會維持在最低水準,而我們預期利息費用在全年基礎上將持續穩定下降。如同我們提到的,我們將依據所看到的結果來管理支出。預算讓我們有空間支援這項機會,而投資的時點與規模將取決於處方趨勢、給付可近性、商業表現以及可用流動性。

  • We currently expect consolidated gross margin to be lowest in the first part of fiscal 2027 and to improve as the year progresses, driven principally by anticipated product mix as EXXUA continues to scale and the absorption of fixed manufacturing and supply chain costs. Our current expectation is to approach 66% to 67% gross margin in the fourth quarter of fiscal 2027.

    我們目前預期合併毛利率在27會計年度前段將處於最低,並將隨著年度推進而改善,主要受預期產品組合帶動,因EXXUA持續放量,以及固定製造與供應鏈成本的吸收。我們目前的預期是在27會計年度第四季接近66%至67%的毛利率。

  • The timing of the aforementioned investments as well as the normal seasonality are important to understanding the year. We expect lower adjusted EBITDA and operating cash flow in the first half of fiscal 2027 than in the second half. We will be making planned investments in EXXUA sales and marketing ahead of their full contribution, while the ADHD business is typically seasonally softer in the first quarter to half of our fiscal year.

    前述投資的時點以及正常的季節性,對理解全年表現很重要。我們預期27會計年度上半年調整後EBITDA與營運現金流將低於下半年。我們將在EXXUA全面貢獻之前,先行進行規劃中的EXXUA銷售與行銷投資;同時,ADHD業務通常在我們會計年度的第一季至上半年呈現季節性較疲弱。

  • From a cash flow perspective, we also have our annual PDUFA fees that come out in the first half of the year. As we move into the second half, we expect that seasonal pressure to reverse and EXXUA to make a larger contribution as our commercial efforts build. Based on our current plans taken together, we expect the six-month period ending June 30, 2027, to generate positive adjusted EBITDA. We also expect cash flow to improve in the second half although the timing of collections, working capital requirements and payments will continue to affect cash balances.

    從現金流角度來看,我們每年的PDUFA費用也會在上半年支付。進入下半年後,我們預期該季節性壓力將反轉,且隨著商業推動力建立,EXXUA將做出更大的貢獻。綜合我們目前的計畫,我們預期截至2027年6月30日止的六個月期間將產生正向的調整後EBITDA。我們也預期下半年現金流將改善,儘管收款時點、營運資金需求與付款仍將持續影響現金餘額。

  • As always, I'm happy to go over any details during Q&A. With that, Josh, let me turn it back over to you.

    一如既往,我很樂意在問答環節說明任何細節。那麼,Josh,我把話題交回給你。

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Thank you, Ryan. As we look ahead, our conviction in the EXXUA opportunity remains extremely strong. We're seeing physicians gain experience with the product, a growing patient base and improving prescriptions per sales specialist rate we're also taking action where execution needs to improve.

    謝謝你,Ryan。展望未來,我們對EXXUA機會的信心依然非常強。我們看到醫師對產品的使用經驗增加、病患基礎成長,以及每位銷售專員的處方量提升;同時,我們也在需要改善執行的地方採取行動。

  • This is consistent with the approach we've described from the outset. Overall, we're extremely pleased with the progress this quarter and remain excited about the path ahead.

    這與我們從一開始所描述的方法一致。整體而言,我們對本季的進展非常滿意,並對前方的道路持續感到振奮。

  • As always, I want to thank our entire team for their work and everyone participating on today's call. We'll now be happy to answer any questions. Operator?

    一如既往,我要感謝我們整個團隊的努力,以及所有參與今天電話會議的各位。我們現在很樂意回答任何問題。接線員?

  • Operator

    Operator

  • (Operator Instructions) Thomas Flaten, Lake Street Capital.

    (接線員指示) Lake Street Capital的Thomas Flaten。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Just to start off -- well, both of you mentioned that the GTN discount was more favorable than you had expected, and it looks like it's more favorable than our model. Can you talk a little bit about the puts and takes that made that more favorable?

    先從這裡開始——你們兩位都提到GTN折扣比你們預期更有利,看起來也比我們模型更有利。你們能否談談有哪些因素的增減(puts and takes)使其變得更有利?

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • I can take that to start, and then Ryan, feel free to fill in. And thanks, Thomas, for the question.

    我可以先回答,然後Ryan也請隨時補充。也謝謝你,Thomas,提出這個問題。

  • In short, it's just a higher-than-anticipated approval rate, really, across commercial payers. That's a simple answer. We're seeing it consistent. We're seeing it hang on really month to month. It is lower for the titration pack. But frankly, that's come in materially higher than we modeled initially. And the 30 counts and the regular way prescriptions are coming in at a higher approval rate as well. So that's the key piece.

    簡而言之,主要就是整體商業保險支付方的核准率高於預期。這是最簡單的答案。我們看到這個趨勢相當一致。而且幾乎是逐月維持。滴定包(titration pack)的核准率較低。但坦白說,它的表現也顯著高於我們最初建模的水準。而30顆裝以及一般處方的核准率也更高。所以這是關鍵因素。

  • And they are holding on and I think I don't want to suggest have the potential for improvement, but as we build a higher percentage of government business, as you probably know, that's an even higher -- excuse me, an even higher -- yeah, better GTN, I should say. So that's -- and that is representing well north of 20%, 25% of the business.

    而且這些水準維持得住;我不想暗示還有改善空間,但隨著我們建立更高比例的政府端業務,如你所知,那會帶來更高——抱歉,是更高——對,應該說更好的GTN。所以就是這樣——而且目前政府端占比已遠高於20%、25%。

  • If you look at analog products in the category, some have achieved upwards of 35% to 40% of the business coming from Medicare and Medicaid. And so it's a combination of that portion of the business growing and then just overall improvement, overall approval rates better than, again, we had initially modeled than initially anticipated. And this I'll remind you is all with that any commercial contracts, and we have no supplemental Medicaid or Medicare rebates.

    如果你看同類別的類似產品,有些來自Medicare與Medicaid的業務占比可達35%到40%以上。因此,這是該部分業務占比成長與整體核准率提升的綜合作用;整體核准率比我們先前建模、比最初預期都更好。我也提醒各位,這一切是在沒有任何商業合約的情況下達成的,而且我們沒有任何Medicaid或Medicare的補充性回扣。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • And then can you talk a little bit about your utilization of RxConnect for EXXUA? I know it represented a significant chunk of your ADHD portfolio, but maybe some commentary around that would be great.

    另外,你們能否談談EXXUA對RxConnect的使用情況?我知道它在你們的ADHD產品組合中占了相當大的比重,但如果能就此提供一些評論會很棒。

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Yeah. It is -- we look at shipments into RxConnect partner pharmacies and then we look at dispensed claims. I'm most interested in dispensed claims because ultimately, that's where the rubber meets the road, and that's where the patient obviously gets the prescription. It's lower than the current percentage of ADHD, but certainly we would expect it to grow over time.

    可以。我們會看出貨到RxConnect合作藥局的數量,然後也會看已配藥的理賠(dispensed claims)。我最關注的是已配藥理賠,因為最終那才是真正落地的地方,也是病患實際拿到處方的地方。目前它低於ADHD的占比,但我們確實預期會隨時間成長。

  • When you look at sort of dispensed claims for ADHD, that's any given month, upwards of 80% of our total prescriptions are dispensed through an RxConnect partner pharmacy or as part of the program. It's not to that level, but it is growing because we do have quite a few prescriptions coming from white space and from areas where we don't have rep coverage.

    以ADHD的已配藥理賠來看,在任何一個月份,我們總處方量中有高達80%以上是透過RxConnect合作藥局或作為該計畫的一部分完成配藥。EXXUA尚未達到那個水準,但正在成長,因為我們確實有不少處方來自空白市場(white space)以及我們沒有業務代表覆蓋的區域。

  • We do have some, what we call, free-range prescriptions. And we also are going to build a materially higher base of government business. And some of those we don't track at the moment. And while those can and our field at RxConnect partner pharmacies, in many cases, those are just billed out of pharmacy outside of the network.

    我們確實有一些我們所稱的「自由流入」處方(free-range prescriptions)。而且我們也將建立顯著更高的政府端業務基礎。其中有些我們目前無法追蹤。雖然這些處方可以、而且我們的團隊也會在許多情況下導入RxConnect合作藥局,但很多時候它們只是由網路外的藥局開立帳單。

  • And so that's having been said, we would expect over time to continue to drive more and more prescribing to the RxConnect pharmacies, just given the moat that, that represents and what we think can really prove out to be an elongated tail even post loss of exclusivity. But obviously, we've got some time before we get there.

    因此,話說到這裡,隨著時間推移,我們預期會持續推動越來越多的處方流向 RxConnect 藥局,主要是因為這代表著一道護城河,而且我們認為即使在失去獨家權之後,也確實可能證明會形成更長的長尾效應。但顯然,在走到那一步之前,我們還有一些時間。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • And then final one for me, speaking of which, you obviously had a nice sequential uptick on the ADHD portfolio. And I realized that the Cotempla generic didn't come to market.

    然後我最後一個問題,說到這點,你們的 ADHD 產品組合顯然出現了不錯的連續季度回升。而且我也注意到 Cotempla 的學名藥並沒有上市。

  • Can you talk a little bit about how you've been able to not only maintain but then grow sequentially, the ADHD portfolio with limited coverage? Is it just one of those things that happened? Or was there something proactive that you did?

    你能否談談,在給付涵蓋有限的情況下,你們如何不僅維持,還能讓 ADHD 產品組合在季度間持續成長?這只是剛好發生的結果嗎?還是你們有做什麼主動的措施?

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Well, we're always monitoring the base business as it relates to gross-to-net reimbursement rates, pharmacy reimbursement, in particular, and there certainly is real-time adjustments going on to ensure that we're optimizing sort of the payer -- sort of the mix there as it relates to dispensing and filled prescriptions and claims. So that's a piece of it.

    嗯,我們一直在監控基礎業務,特別是與總額到淨額(gross-to-net)報銷率、藥局報銷相關的部分;確實也有即時的調整在進行,以確保我們在配藥、處方填領與理賠方面,能最佳化付款方——也就是付款方組合。所以這是其中一部分。

  • So certainly, there's an element of being proactive. So I would say GTNs had some improvement and some uptick. There was -- and that's -- I mean that's the bulk of it, really. So -- yeah, I would say that has been actively managed and that's something that could be managed with relatively few resources we have, of course, internal resources dedicated to that. And so that's -- it largely has just been optimizing GTNs and ensuring that the pharmacies are sort of in adequate shape with respect to the AG and the brand.

    所以當然,這裡面有主動作為的成分。因此我會說 GTN 有所改善並且有所上升。另外也有——而那——我的意思是,基本上主要就是這些。所以——是的,我會說這一直在被積極管理;而且以我們相對有限的資源來看,這件事其實可以用相對少的資源來管理,當然我們內部也有專門資源投入其中。因此——大體上就是在最佳化 GTN,並確保藥局在授權學名藥(AG)與品牌藥之間的運作狀態都足夠到位。

  • And of course, we're able to seamlessly toggle or they're able to see a toggle between the brand and the AG. And again, I'll remind you that the ANDA has really been slow. The Teva product has kind of hardly scratched 20% when you look at the overall available market of prescriptions. And while prescriptions have come down year on year, that's largely attributable to just the pull promotion that we pulled over a year ago.

    當然,我們也能無縫切換——或者說他們能看到在品牌藥與 AG 之間的切換。另外我再提醒一次,ANDA 的進展其實一直很慢。Teva 的產品在整體可取得的處方市場中,市占幾乎還不到 20%。而雖然處方量年對年有所下降,這主要是因為我們在一年多前撤回了拉動式促銷。

  • Operator

    Operator

  • Naz Rahman, Maxim Group.

    Naz Rahman,Maxim Group。

  • Naz Rahman - Equity Analyst

    Naz Rahman - Equity Analyst

  • Congrats on the progress. Just a couple. So first, in terms of the prior auths, could you provide some color on, I guess, how the prior auths are evolving. And what I mean by that is, are you seeing the prior auths get approved first pass more frequently? Or do you know what percentage of the priorities auths get approved in the first pass and versus how many you're acquiring multiple back and forth? And I have a follow-up after that.

    恭喜進展順利。我有幾個問題。首先,關於事前授權(prior auths),你能否提供一些背景,說明事前授權的情況如何演變?我的意思是,你們是否看到事前授權一次送審就通過的頻率更高?或者你知道有多少比例的事前授權在第一次送審就獲核准,相較之下又有多少需要多次來回補件?我之後還有一個追問。

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Yeah. Thanks for the question. No. In terms of prior auths, it's a still a relatively early stage. And what I'll say is, because of the nature of this patient with multiple failures, we absolutely are having success from a prior authorization perspective. So obviously, we're not doing them. We can't do them on behalf of the customers.

    是的。謝謝你的問題。不。就事前授權而言,目前仍屬相對早期階段。我想說的是,由於這類病患通常有多次治療失敗的背景,從事前授權的角度來看,我們確實取得了成功。所以很明顯地,我們並不是在做這些——我們也不能代表客戶去做。

  • It's the prescribers that ultimately complete the paperwork. But we've made it very simple for them. It's a really straightforward process. Physicians are increasingly utilizing the service. They have to engage with a specific vendor to get signed up and so forth, and they log in and essentially do a very, very simple process.

    最終是由開立處方的醫師完成文件作業。但我們已經把流程做得非常簡單。這是一個非常直接的流程。醫師使用這項服務的比例正在提高。他們需要與特定供應商互動以完成註冊等等,然後登入後基本上就是進行一個非常、非常簡單的流程。

  • And the approval rates for prior authorizations are quite high. If you look at the success we're having with claims that are submitted sort of through the program, it's in the neighborhood of 70%.

    而事前授權的核准率相當高。如果你看透過該計畫提交的理賠成功率,大約在 70% 左右。

  • So it's -- we're having quite a lot of success that's materially higher than most categories, and I think it's because of the ease of use of the program that we've implemented, also the class and the patient type. Again, this is going to be a patient that's often been on multiple medications. So it's been very, very encouraging in the early stages of this.

    所以——我們取得了相當高的成功率,明顯高於多數類別;我認為這是因為我們所導入的計畫易於使用,以及該治療類別與病患類型的特性。再說一次,這通常是已經使用過多種藥物的病患。因此在這個早期階段,結果非常、非常令人鼓舞。

  • Naz Rahman - Equity Analyst

    Naz Rahman - Equity Analyst

  • Got it. That was helpful. And one last question. In terms of coverage and reimbursement, I mean, previously, you talked a lot about the importance of government payers. At this point, when can we expect, I guess, the next large falls of payments in terms of both commercial and government payers? And what would you expect first?

    了解。這很有幫助。最後一個問題。就涵蓋與報銷而言,你們之前談了很多政府付款方的重要性。在目前這個時間點,我們大概何時可以期待下一波較大的付款方覆蓋落地(無論是商業保險或政府付款方)?你們預期會先發生哪一邊?

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Yeah, that's a good question. We don't really think of it as bringing on any sort of one big lever. We think it will sort of organically evolve. Frankly, if these GTN levels just maintained with the coverage we have today without any contracts, that would be a really, really good situation, a really good story.

    是的,這是個好問題。我們不太把它看作是引入某一個很大的單一槓桿。我們認為它會以更自然的方式逐步演進。坦白說,如果這些 GTN 水準在我們今天已有的覆蓋情況下、即使沒有任何合約也能維持,那會是一個非常、非常好的狀況,也會是一個很好的故事。

  • So we continue to really scrutinize the need to contract proactively. In fact, I think we're at the point of not proactively contracting same on both sides, government and commercial. It doesn't do us any good to contract with -- on the government side and pay large supplemental rebates when states in one way shape or form will cover this. They might require prior authorization. But as I just described, those are not exceedingly difficult to get.

    因此我們持續非常審慎地評估是否有必要主動簽約。事實上,我認為我們已經到了不主動簽約的階段——政府端與商業端都是如此。在政府端,當各州無論以何種方式都會涵蓋這個產品時,與其簽約並支付高額補充回扣,對我們並沒有好處。他們可能會要求事前授權。但如我剛才所描述,那並不是特別難取得。

  • And on the commercial side, we're seeing good approval rates without any active contracts in place. Again, understanding the placement of this product is not first line. And so the ability to get claims approved, understanding that this is often for patients that's been on two or three or maybe more medications.

    而在商業端,即使沒有任何現行合約,我們也看到不錯的核准率。同樣地,要理解這個產品的定位並非第一線用藥。因此,在理解這通常是針對已經用過兩到三種、甚至更多藥物的病患的前提下,我們仍能讓理賠獲得核准。

  • So we'll, of course, continue to keep ourselves open to contracting, but we don't think of it as necessarily saying, okay, we're going to have a step function and -- because one of the things that we know is payer contracts don't drive demand. So if you sign an agreement with a large PBM, you don't automatically get a step function in your demand. It still comes down to prescribers sending prescriptions to pharmacies, and that's, of course, driven by us.

    所以我們當然會持續保持對簽約的開放態度,但我們不會把它視為必然會出現某種階梯式跳升——因為我們知道的一件事是,付款方合約並不會帶動需求。也就是說,即使你和一家大型 PBM 簽了協議,你的需求也不會自動出現階梯式成長。最終仍取決於開立處方者把處方送到藥局,而那當然是由我們來驅動的。

  • So what you can do from a payer perspective is you can optimize and tweak sort of GTNs and pricing, but you don't necessarily think of those as just because you have a contract with one of the big three PBMs doesn't mean a physician will automatically prescribe really to the contrary, because we have the RxConnect set up and to some degree, we serve as the backstop, if you will, to guarantee that, that patient never pays more than $50 on a commercial claim. We don't really have a need for -- to go out and shop from the rooftops that we have a contract with a large PBM.

    因此,從付款方角度你能做的是最佳化並微調 GTN 與定價,但你不會認為——僅僅因為你和三大 PBM 之一簽了合約,醫師就會自動開立處方;事實上反而未必如此。因為我們已經建立了 RxConnect,而且在某種程度上,我們作為後盾(backstop),確保該病患在商業保險理賠下自付額不會超過 50 美元。我們並不真的需要——到處大肆宣傳我們和某家大型 PBM 有合約。

  • It doesn't preclude the possibility that we would engage with one, but it has to be on the terms that make sense for us economically. And we're generating enough demand to start to generate some interest and some inbound conversations. But time will tell as to really how valuable conversations turn out to be, and we're really in a good spot based on the GTNs today. And again, don't feel a need to proactively contract on either side of the ledger, commercial or government.

    這並不排除我們會與其中一家合作的可能性,但必須是在對我們經濟效益合理的條件下。而且我們正在產生足夠的需求,開始引起一些興趣,也出現一些主動找上門的對話。但這些對話最終有多大價值,還有待時間驗證;而基於目前的 GTN 水準,我們其實處於很好的位置。同樣地,我們不覺得有必要在帳本的任何一端——商業或政府——主動去簽約。

  • Operator

    Operator

  • (Operator Instructions) Ed Woo, Ascendiant Capital.

    (接線員指示) Ed Woo,Ascendiant Capital。

  • Edward Woo - Analyst

    Edward Woo - Analyst

  • Congratulations on all the progress. My question is on the sales rep. You mentioned that you were at 43 in March, 32 in July, 42 now. Do you have a goal in mind of where you think you want to be maybe in 6 months?

    恭喜你們取得所有進展。我的問題是關於銷售代表。你提到3月是43位、7月是32位、現在是42位。你心中是否有一個目標,認為大概在6個月後希望達到多少?

  • And I know you mentioned that these get up to speed pretty fast. Is it within three months that you feel that they are able to hit or stride?

    我也知道你提到他們上手很快。你覺得是在三個月內就能達到狀態、進入步調嗎?

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Yeah, good question, Ed. Thanks for that. The goal will be dictated, obviously, by cash flow. We said that from the beginning, but certainly materially higher than 42 or 49. I mean, we have a plan that's at least a multiple of that, if not higher in terms of where also we see the footprint getting from a sales specialist perspective, but that will be driven -- the timeline will be driven by profitability and cash flow to enable us to expand in a prudent fashion.

    是的,Ed,問得很好。謝謝。目標顯然會由現金流來決定。我們從一開始就這麼說,但肯定會實質高於42或49。我的意思是,我們有一個計畫,至少是那個數字的數倍,甚至更高,從銷售專員的角度來看,我們也看到覆蓋版圖會擴大;但這將取決於——時間表將由獲利能力與現金流來驅動,使我們能以審慎的方式擴張。

  • And so we don't have a specified goal if it has to be 60 reps by the end of the calendar year and then 120 by the middle of next, although that type of cadence would suggest that we're on a good trajectory and we're generating an adequate level of cash flow to justify that level of investment.

    因此我們沒有設定一個明確目標,例如日曆年年底一定要到60位代表、明年年中到120位;不過那樣的節奏會顯示我們走在良好軌道上,並且產生足夠的現金流,足以合理化那樣的投資水準。

  • And we're being very judicious in how we think about territories. In some cases, we are doubling up in areas. In other cases, we have in keeping a single territory just because it's able to be efficiently managed that way. And ultimately, that's sort of how we think about it.

    而且我們在思考區域配置時非常審慎。有些情況下,我們會在某些區域加派人手、形成重疊覆蓋。其他情況下,我們會維持單一區域,因為那樣能更有效率地管理。最終,我們大致就是這樣來思考。

  • Sorry, I missed the second part of your question.

    抱歉,我漏聽了你問題的第二部分。

  • Edward Woo - Analyst

    Edward Woo - Analyst

  • In terms of how quickly do these sales reps are ramped up (multiple speakers) six months?

    關於這些銷售代表需要多久才能拉升到位(多位講者)六個月?

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Yeah, 6 to 9 months realistically is a good timeframe to really think of somebody as sort of adequately tooled for the job. And if you look at really sort of a breakeven analysis, you would look at something closer to 9 or 12 months.

    是的,實際上6到9個月是一個不錯的時間範圍,才能真正把一個人視為已充分具備勝任工作的工具與能力。如果你看真正的損益兩平分析,你會看更接近9到12個月。

  • But in terms of really identifying, I guess there's a couple of components there, identifying that the person has the requisite skills, drive, demeanor, all the things you need to be successful. That takes less time to ultimately get that rep to turn that into action on the part of the prescribers. So that's something more like six to nine months. And so as we think about a phased approach of getting to that next layer of geographies, we sort of think of it with a six- to nine-month ramp-up period in mind.

    但就辨識而言,我想這裡有幾個面向:確認這個人具備必要的技能、衝勁、態度,以及成功所需的一切。這所需時間較短;而要讓該代表把這些轉化為處方醫師端的實際行動,最終需要更久。所以那更像是6到9個月。因此當我們思考分階段拓展到下一層地理區域時,我們會以6到9個月的拉升期為前提來規劃。

  • So that's what's really encouraging. We had an all-time high prescription -- a weekly prescription level the week ending September 4 of almost 400 prescriptions. I'll remind you, that's still with a something south of 40 reps really active when you think about really that we had a crop that came in a few months ago. They're still just kind of getting their feet under them.

    所以這真的很令人鼓舞。在截至9月4日的那一週,我們的處方量創下歷史新高——每週處方量接近400張。我提醒大家,當你考量到幾個月前才加入的一批人,其實真正活躍的代表還不到40位。他們仍在逐步站穩腳步。

  • So you get another three months down the road, and that crop of rep starts to get turned on and deliver and then another crop that we'll have coming in here in the fall. And so you can really envision that leg up, and that's why I use sort of the numbers I did of if you just got some of those reps up to 10, 15 and certainly, it's realistic to think that they could all be at 20 to 30 a week.

    所以再往後推三個月,那批代表就會開始全面啟動並交出成果,接著秋季我們還會再有一批加入。因此你可以很清楚想像那一段向上的躍升;這也是為什麼我用那些數字來說明:如果你只是讓其中一些代表提升到每週10、15張,而且更現實的是,他們全部都可能達到每週20到30張。

  • It's actually -- that's significantly lower than any of our reps got on Adzenys if you looked at its historical highs. So quite confident that 40 to 45 reps and then expanding to 50 and beyond getting to 20, 30 and then ultimately, 50-plus prescriptions a week, it's pretty exciting to think where that puts us from a revenue trajectory perspective.

    其實——如果你看Adzenys在歷史高點時我們任何代表的表現,那些數字都明顯更高。因此我們相當有信心:40到45位代表,然後擴張到50位以上,達到每週20、30張,並最終到每週50張以上處方;從營收成長軌跡的角度來看,想像那會把我們帶到哪裡,確實令人振奮。

  • Edward Woo - Analyst

    Edward Woo - Analyst

  • And just to clarify, the amount -- I think you mentioned 3,000 prescriptions for the quarter. Does that include refills?

    另外確認一下,那個數量——我想你提到本季3,000張處方。那包含續方嗎?

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • That includes refills. Yeah. That would be starter and that would be initiation. That will be start of titration packs would be sort of the initiation and then we think of refills as once they get transitioned to 30 count, regular sort of stable dose and then a refill beyond that.

    包含續方。是的。那會包含起始用藥,也會包含開始治療。起始會是滴定包(titration packs)的開始,我們把那視為啟始;然後我們把續方視為患者轉換到30顆裝、一般較穩定劑量之後,再往後的續方。

  • And so -- and again, keeping in mind that many of these patients, they just got started over the first month or so. Some patients are titrating more slowly than the label sort of indicates. And so some of these patients are just getting into their first month or so. So we've not yet to see anything resembling some of the compounding effect that we would expect to see as the months move forward.

    因此——再者請記得,許多患者是在第一個月左右才剛開始用藥。有些患者的滴定速度比標籤所示更慢。所以其中一些患者才剛進入他們的第一個月左右。因此我們尚未看到任何類似我們預期會隨著月份推進而出現的那種複利效應。

  • Operator

    Operator

  • We have reached the end of the question-and-answer session. And I will now turn the call over to management for closing remarks.

    問答環節到此結束。我現在把電話交回管理層作結語。

  • Joshua Disbrow - Chief Executive Officer, Director

    Joshua Disbrow - Chief Executive Officer, Director

  • Thank you, John. Again, just to reiterate, we're extremely pleased with the progress this quarter, particularly as it relates to the trajectory we're seeing with EXXUA. We're increasingly encouraged by the number of territories driving meaningful prescriptions and ultimately, the breadth of prescribing we're most excited about the response that we're hearing through physicians due to the feedback they're getting from their patients, patients saying things back to the physicians like it's been life-changing and haven't felt this good in years, and that's just why you do of why we do what we do.

    謝謝你,John。再次重申,我們對本季的進展感到非常滿意,特別是就我們在EXXUA上看到的成長軌跡而言。隨著越來越多的區域帶動具意義的處方量,我們也愈發受到鼓舞;而最令我們興奮的是處方的廣度——我們從醫師端聽到的回饋,來自他們從患者那裡得到的反饋:患者對醫師說,這改變了人生、好多年沒感覺這麼好了;這正是你做——也是我們做我們所做之事的原因。

  • So we continue to have the pedal down, work very hard every single day to ensure that as many prescribers as we can hear about the EXXUA story and ultimately put pen to paper to prescribe what we think is an outstanding treatment and it's proving to be that in the real world. So with that, we're very encouraged.

    因此我們會持續全力以赴,每一天都非常努力,確保盡可能多的處方醫師能聽到EXXUA的故事,並最終落筆開立處方,使用我們認為非常出色、且在真實世界中也證明確實如此的治療。所以總結來說,我們非常受到鼓舞。

  • We are now, of course, into our fiscal '27 and towards the end already of our first quarter. So we look forward to sharing those results with you all in November. Until then, thank you for your interest in Aytu. Thanks for your time and have a good evening.

    當然,我們現在已進入我們的2027會計年度,而且第一季也已接近尾聲。因此我們期待在11月與各位分享那些結果。在那之前,感謝各位對Aytu的關注。謝謝大家的時間,祝各位晚安。

  • Operator

    Operator

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

    今天的電話會議到此結束,您現在可以掛線。感謝您的參與。