ANI Pharmaceuticals, Inc. (ANIP) 2026 Q2 法說會逐字稿

Good day, everyone, and welcome to today's Annie Pharmaceuticals, Inc. Second Quarter 2026 Earnings Results Call. Please note this call is being recorded.

各位好，歡迎參加今天 Annie Pharmaceuticals, Inc. 2026 年第二季財報結果電話會議。請注意，本次電話會議將被錄音。

(Operator Instructios) It is now my pleasure to turn the conference over to Irina Koffler. Please go ahead.

(接線員指示) 現在我很榮幸將會議交給 Irina Koffler。請開始。

Thank you, Daniel. Welcome to ANI Pharmaceuticals second quarter 2026 earnings results call. This is Irina Koffler, Investor Relations for ANI. With me on today's call are Nikhil Alwani, President and Chief Executive Officer, Stephen Carey, Senior Vice President and Chief Financial Officer, and Chris Mutts, Senior Vice President and Head of ANI. Rare disease business. Earlier this morning on August 7, 2026, we released our results for the second quarter 2026 via a press release that is available on our website. This call is also available via webcast and is accompanied by a slide deck that can be accessed by going to the events section of the investors page of our website. Before we begin, I would like to remind you that we will be making forward-looking statements and discussing certain non-GAAP measures. Forward-looking statements are subject to substantial risks and uncertainties, speak only to the call's original date, and we take no obligation to update or revise any of the statements. During this call, we will also refer to certain non-GAAP financial measures to describe our performance and have provided a reconciliation to the most directly comparable GAAP financial measures within the materials that accompany this call. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com.

謝謝你，Daniel。歡迎參加 ANI Pharmaceuticals 2026 年第二季財報結果電話會議。我是 Irina Koffler，ANI 的投資人關係負責人。今天與我一同出席的有：總裁兼執行長 Nikhil Alwani、資深副總裁兼財務長 Stephen Carey，以及資深副總裁暨 ANI 罕見疾病事業部主管 Chris Mutts。罕見疾病業務。今天稍早（2026 年 8 月 7 日），我們已透過新聞稿發布 2026 年第二季業績，並可於我們的網站查閱。本次電話會議亦提供網路直播，並附有簡報資料，可至我們網站投資人頁面的「活動」區域存取。在開始之前，我想提醒各位，我們將發表前瞻性陳述並討論若干非 GAAP 指標。前瞻性陳述存在重大風險與不確定性，僅反映本次電話會議原始日期之情況，我們不承擔更新或修訂任何陳述之義務。在本次電話會議中，我們也將引用若干非 GAAP 財務衡量指標來說明我們的表現，並已在隨本次電話會議提供的資料中，提供與最直接可比的 GAAP 財務衡量指標之調節表。存檔的網路直播將在我們的網站 anipharmaceuticals.com 上提供 30 天。

And with that, I'll turn the call over to Nikhil Lalwani.

接下來，我將把電話會議交給 Nikhil Lalwani。

Thank you, Irina. Good morning, everyone, and thank you for joining us for A&I's second quarter 2026 earnings call. Starting on slide 5, our entire organization demonstrated outstanding focus during the second quarter as we continued to transform A&I into a leading rare disease company. We reported record second quarter 2026 revenues of $266 million for the overall business, record cartrophin revenues of $117.1 million, and record adjusted EBITDA of $71.6 million. In the second quarter, we grew total net revenues 26% year-over-year, driven by persistent execution across our rare disease and generics businesses with incremental contribution from the Harmony intellectual property out-licensing deal we announced last quarter. We also grew adjusted EBITDA 32% year-over-year to an all-time high and above our prior expectations. Furthermore, we achieved all of this while executing the single largest rare disease sales force expansion in our history, where we increased our sales force by 50% to approximately 180 reps. Our strategic plan is on track and we are well positioned to drive meaningful growth in 2026 and beyond.

謝謝你，Irina。各位早安，感謝各位參加 A&I 2026 年第二季財報電話會議。從第 5 頁投影片開始，我們整個組織在第二季展現了卓越的專注力，持續推動 A&I 轉型為領先的罕見疾病公司。我們公布整體業務 2026 年第二季創紀錄的營收 2.66 億美元、Cortrophin 創紀錄的營收 1.171 億美元，以及創紀錄的調整後 EBITDA 7,160 萬美元。第二季我們的總淨營收年增 26%，主要受惠於罕見疾病與學名藥業務的持續執行力，以及我們在上一季宣布的 Harmony 智慧財產權對外授權交易所帶來的增量貢獻。我們的調整後 EBITDA 亦年增 32%，創下歷史新高，並高於先前預期。此外，我們在達成上述成果的同時，也完成了公司史上最大規模的罕見疾病銷售團隊擴編，將銷售人力增加 50%，至約 180 名業務代表。我們的策略計畫進展順利，並已做好準備在 2026 年及其後推動具意義的成長。

Turning to slide 6.

接著看第 6 頁投影片。

Our first area of focus in our transformation into a rare disease company is delivering organic growth for our Q durable branded rare disease medicines, Cortrophin Gel and Illuvian. We delivered $117.1 million in Cortrophin. Gel net revenues for the second quarter, up 43% year-over-year and 56% over quarter one 2026, consistent with the expectations we outlined during our last quarterly call. Second quarter revenues from our existing specialties of rheumatology, nephrology, neurology, ophthalmology and pulmonology was healthy, and we are seeing significant momentum in demand in the third quarter with July representing the highest month for new cases initiated. We expect our existing specialty sales force to continue its strong trajectory in the second-half of 2026.

我們轉型為罕見疾病公司的第一個重點，是推動我們兩項具持久性的品牌罕見疾病藥物 Cortrophin Gel 與 Illuvian 的內生成長。第二季 CortrophinGel 淨營收達 1.171 億美元，年增 43%，較 2026 年第一季成長 56%，符合我們在上一季電話會議中所提出的預期。第二季來自既有專科領域（風濕免疫科、腎臟科、神經科、眼科與胸腔科）的營收表現健康；我們也在第三季看到需求顯著加速，其中 7 月為新啟動病例數最高的月份。我們預期既有專科銷售團隊在 2026 年下半年將延續強勁成長軌跡。

We completed our gout-focused organization expansion, and the team was fully operational at the end of June, as expected. We are pleased that we have seen strong demand driven by the high unmet need for patients who are most severely impacted by acute gouty arthritis flares and who need an additional treatment option. Our leading indicators are very positive, such as total new cases initiated per sales rep, and a number of prescribers with multiple new cases. We believe we are at the start of a sizable inflection for this business and look forward to updating you on our progress. Taking a step back, our conviction in the growth and durability of Clotrophin gel have only increased over time since our 2022 launch. Clotrophin has grown at a compounded annual growth rate of 103% to $348 million in sales in 2025, and we're just getting started. We believe Clotrophin will serve as the key building block catalyzing our transformation into a rare disease company. Now that we are midway through the year, we are modestly revising our Clotrophin gel revenue guidance to $520 million to $540 million, primarily to account for results in the first half of 2026.

我們已完成以痛風為重點的組織擴編，團隊如預期於 6 月底全面投入運作。我們很高興看到需求強勁，主要由於急性痛風性關節炎發作、受影響最嚴重且需要額外治療選項的患者存在高度未被滿足的需求。我們的領先指標非常正向，例如每位業務代表所啟動的新病例總數，以及具有多個新病例的開立處方醫師數量。我們相信這項業務正處於顯著拐點的起點，並期待向各位更新我們的進展。回過頭來看，自 2022 年上市以來，我們對 Clotrophin gel 成長性與持久性的信心只隨時間而增加。Clotrophin 以 103% 的複合年成長率成長，2025 年銷售額達 3.48 億美元，而我們才剛開始。我們相信 Clotrophin 將成為推動我們轉型為罕見疾病公司的關鍵基石。現在我們已進入年度中段，我們將 Clotrophin gel 營收指引小幅調整為 5.20 億至 5.40 億美元，主要是為了反映 2026 年上半年的實際結果。

Our expectations for the back half remained largely intact with what we had expected at the start of the year. Importantly, this still represents 50% to 55% growth for Kotrophin compared to 2025 and the addition of the gout expansion creates a strong new growth trajectory for Kotrophin. We believe we are well-positioned to achieve our revised 2026 guidance based on the continued momentum in existing specialties as evidenced by the highest new case in July and the strong demand generation from the gout expansion. For Alluvian, we delivered $18.7 million of revenue in the second quarter. We announced the top-line results from the Phase 4 open-label synchronicity trial. In NIUPS and plan to unveil detailed results and additional analysis at a medical conference in the fourth quarter of 2026.

我們對下半年的預期大致維持與年初所預期一致。重要的是，這仍代表 Kotrophin 相較 2025 年將成長 50% 至 55%，而痛風擴編也為 Kotrophin 帶來強勁的新成長軌跡。基於既有專科持續的動能（7 月新病例數創新高）以及痛風擴編帶來的強勁需求創造，我們相信有充分條件達成修訂後的 2026 年指引。至於 Alluvian，我們第二季營收為 1,870 萬美元。我們已公布第 4 期開放標籤 synchronicity 試驗的主要結果。在 NIUPS，並計畫於 2026 年第四季的醫學會議上揭露更詳細的結果與額外分析。

These results are particularly relevant for retina specialists who see a large population of uveitis patients. Uveitis remains a category in which steroids are the standard of care and where we see an opportunity to build an increasing share of voice over time. Over the long-term, we continue to believe the addressable patient populations in DME and NIUPS represent at least 10x the number of patients treated with Eluvian today, a significant and durable opportunity for value creation.

這些結果對視網膜專科醫師尤其重要，因為他們會接觸到大量葡萄膜炎患者。葡萄膜炎仍屬於以類固醇為標準治療的領域，我們看見有機會隨時間推進逐步提升我們的聲量占比。長期而言，我們仍相信 DME 與 NIUPS 的可觸及患者族群至少是目前使用 Eluvian 治療患者數的 10 倍，這是一個重大且具持久性的價值創造機會。

Turning to slide 7, our strategic priority, our second strategic priority is continued execution in generics. To date, we have launched 12 generics in 2026 and are on track to launch at least 15 in the full year. We also continue to hold our position as the number two player in overall CGT filings. Driven by our superior R&D capabilities and operational execution, we delivered another strong quarter with generics revenue of $99.1 million, up 10% year-over-year. As a reminder, A&I is uniquely positioned to capitalize on opportunities in the evolving tariff landscape that may arise, with approximately 95% of our revenues coming from finished goods manufactured in the US. Bringing high-quality generics and rare disease products made in the US to our patients plays an important role in our success.

接著看第 7 頁投影片，我們的策略重點——第二個策略重點——是持續在學名藥業務上落實執行。截至目前，我們在 2026 年已推出 12 項學名藥，並正按計畫在全年至少推出 15 項。我們也持續維持在整體 CGT 申報量方面的第二大業者地位。憑藉我們更優異的研發能力與營運執行力，我們再度交出強勁的一季：學名藥營收 9,910 萬美元，年增 10%。提醒各位，A&I 具備獨特優勢，可把握可能在不斷演變的關稅環境中出現的機會，因為我們約 95% 的營收來自於在美國製造的成品。將在美國製造的高品質學名藥與罕見疾病產品提供給患者，對我們的成功扮演重要角色。

Third, we remain focused on executing a disciplined capital allocation strategy. We are investing in organic growth that have expanded our Cortrophin commercial footprint in acute cardioarthritis flares. We continue to deploy a high single-digit percentage of generics revenue into generics R&D programs. We are also evaluating attractive inorganic growth opportunities to expand the scope and scale of our rare disease business.

第三，我們仍專注於執行嚴謹的資本配置策略。我們正投資於有機成長，已擴大 Cortrophin 在急性痛風性關節炎發作（flare）方面的商業覆蓋。我們持續將學名藥營收中高個位數百分比投入學名藥研發（R&D）計畫。我們也在評估具吸引力的非有機成長機會，以擴大我們罕見疾病業務的範疇與規模。

Turning to Slide 8.

接著看第 8 張投影片。

Our strong second quarter performance demonstrates the steadfast execution of our strategic priorities as we deploy the cash created by generics and brands in our virtuous cycle towards our transformation to becoming a leading rare disease company. We are confident in delivering 50% to 55% Cortrophin revenue growth in 2026 and are pleased that our gout expansion is off to a strong start.

我們第二季的強勁表現，展現了我們在策略優先事項上的堅定執行；我們將學名藥與品牌藥在良性循環中所創造的現金加以運用，推動公司轉型，成為領先的罕見疾病公司。我們有信心在 2026 年實現 Cortrophin 營收成長 50% 至 55%，也很高興看到我們的痛風擴張計畫有一個強勁的開端。

Taken together, these initiatives are expected to create operational leverage in 2027 and beyond as we maximize the Cortrophin growth opportunity. In 2026, we expect to deliver $1.1 billion in revenue. Representing 26% growth over 2025 at the midpoint of our guidance range with rare disease as the primary driver of that growth. We also expect to expand the bottom line with adjusted EBITDA forecasted to grow 27% year-over-year to $285 million to $300 million.

綜合而言，這些措施預期將在 2027 年及之後帶來營運槓桿效益，因為我們將把握 Cortrophin 的成長機會並加以最大化。在 2026 年，我們預期可實現 11 億美元營收。以我們指引區間中點計算，較 2025 年成長 26%，而罕見疾病將是該成長的主要驅動力。我們也預期將擴大獲利表現，調整後 EBITDA 預估將年增 27%，達 2.85 億至 3.00 億美元。

Our balance sheet is healthy with the capacity to support future potential business development opportunities to expand the scope and scale of our rare disease business. I'll now turn the call to Chris to discuss our rare disease business and provide color from the ongoing launch in acute cardioarthritis squares. Chris.

我們的資產負債表健全，具備支持未來潛在業務發展機會的能力，以擴大我們罕見疾病業務的範疇與規模。接下來我把電話交給 Chris，請他討論我們的罕見疾病業務，並就急性痛風性關節炎發作的持續上市推進提供更多說明。Chris。

Thank you, Nikhil, and good morning, everyone.

謝謝你，Nikhil，各位早安。

In the second quarter, Cortrophin grew 43% year over year to $117.1 million, in line with our expectations. This growth originated primarily from our existing specialties, such as nephrology, neurology, ophthalmology, pulmonology, and rheumatology, which represent the base Cortrophin business before the recent gout expansion. Momentum in our existing specialties has continued into the third quarter with a record number of new cases initiated in July. We also continue to realize meaningful revenue synergies in ophthalmology, with second quarter Cortrophin volumes in ophthalmology, again doubling over the same period a year ago.

第二季，Cortrophin 年增 43% 至 1.171 億美元，符合我們的預期。這項成長主要來自我們既有的專科領域，例如腎臟科、神經科、眼科、胸腔／肺科以及風濕免疫科；在近期痛風擴張之前，這些領域構成 Cortrophin 的基礎業務。我們既有專科的動能延續至第三季，7 月啟動的新病例數創下紀錄。我們也持續在眼科實現顯著的營收協同效益；第二季眼科的 Cortrophin 用量再次較去年同期倍增。

Moving now to slide 11.

接著看第 11 張投影片。

The overall ACTH market is quite healthy and expected to grow nearly 30% in 2026 to reach over $1.3 billion in sales, with Cortrophin expected to grow 50% to 55% year-over-year in 2026.This market expansion is driven by growth in key underpenetrated specialties that have significant upside potential. There are a large number of prescribers and patients who are naive to the ACTH category across all therapeutic areas. ANI is steadily reaching this segment, including as part of our gout expansion now reaching podiatrists and primary care physicians. Approximately half of Cortrophin gel prescribers in our core specialties are naive to ACTH.

整體 ACTH 市場相當健康，預期 2026 年將成長近 30%，銷售額超過 13 億美元；同時，Cortrophin 預期在 2026 年將年增 50% 至 55%。此市場擴張由關鍵且滲透率偏低的專科領域成長所帶動，具有顯著的上行潛力。在所有治療領域中，仍有大量開立處方的醫師與患者對 ACTH 類別尚不熟悉（naive）。ANI 正穩步觸及這一族群，包括透過我們的痛風擴張計畫，現已觸及足病科醫師與基層照護醫師。在我們核心專科中，約有一半的 Cortrophin gel 處方醫師對 ACTH 仍屬不熟悉（naive）。

Here on slide 12, we return to the size of the overall opportunity for Cortrophin gel. Across indications, we estimate there are almost a million addressable patients, and yet, to date, ACTH therapies are vastly underpenetrated. With ANI's demonstrated ability to educate healthcare providers to help identify new patients who are appropriate candidates for Cortrophin treatment, we have confidence that there is significant runway for continued strong multi-year Cortrophin growth and market expansion.

在第 12 張投影片，我們回到 Cortrophin gel 整體機會的規模。跨各適應症，我們估計可觸及的患者接近 100 萬人，但截至目前，ACTH 治療的市場滲透率仍然非常低。憑藉 ANI 已證實能夠教育醫療照護提供者，協助辨識適合接受 Cortrophin 治療的新患者，我們有信心 Cortrophin 在未來多年仍有顯著的成長跑道，並可推動市場持續擴張。

Turning to slide 13. We have made our largest commercial expansion in the first half of 2026, increasing our sales headcount by 50% to approximately 180 sales representatives, based on what we view as a transformational multi-year growth opportunity for our business in the podiatry and primary care settings.

接著看第 13 張投影片。我們在 2026 年上半年完成了最大規模的商業擴張，將銷售人力增加 50%，至約 180 名業務代表；這是基於我們認為在足病科與基層照護場景中，存在可帶動公司多年轉型式成長的機會。

Our team was fully onboarded and trained by the end of June and have been out in the field engaging with their new prescribers. Gout is a condition with significant patient burden, and our market research, as well as our early experience, shows us that people view the disease as disruptive, anxiety-provoking, and frustrating.

我們的團隊已於 6 月底前完成全面到職與訓練，並已在第一線與其新的處方醫師互動。痛風是一種對患者負擔沉重的疾病；我們的市場研究以及早期經驗顯示，人們普遍認為該疾病會干擾生活、引發焦慮並令人挫折。

Pain from acute gouty arthritis flares has been described by some as unbearable and can come on quickly and unexpectedly, especially in the middle of the night or the early morning. We believe podiatrists and primary care physicians are actively managing a much larger volume of acute cardioarthritis flares than specialists, and most often earlier in the patient journey, either due to referral gaps or access limitations.

急性痛風性關節炎發作所造成的疼痛，有些人形容為難以忍受，且可能快速且出乎意料地出現，尤其是在半夜或清晨。我們相信，相較於專科醫師，足病科醫師與基層照護醫師正在積極處理更大量的急性痛風性關節炎發作病例，而且通常在患者旅程更早期介入，原因可能包括轉診缺口或就醫可近性限制。

Our sales representatives are educating podiatrists and primary care providers about Cortrophin gel and the identification of appropriate patients. We're focused on the most severe patients who have experienced multiple flares a year who have previously been treated with injectable medicines like steroids or pain-relieving medications.

我們的業務代表正向足病科醫師與基層照護提供者介紹 Cortrophin gel，並協助辨識合適的患者。我們聚焦於最嚴重的患者族群：一年內經歷多次發作，且過去曾使用類固醇等注射藥物或止痛藥物治療的患者。

These patients may benefit from an additional treatment option. Our patient support team is helping patients request and access clotrophin gel to treat the current flare and to have drug readily available for when the next flare hits.

這些患者可能會受益於額外的治療選項。我們的患者支持團隊正協助患者申請並取得 Cortrophin gel，用於治療當次發作，並讓藥物可隨時備用，以便下一次發作時能立即使用。

Turning to slide 14.

接著看第 14 張投影片。

We feel confident about the opportunity in the podiatry and primary care settings because of the insights and results generated by both the pilots conducted in 10 territories, as well as the strong momentum we are seeing today from the gout expansion. While it is early days, we are pleased to see encouraging trends in our leading indicators. To date, we have been generating very strong demand with meaningful breadth and depth of prescribing.

我們對足病科與基層照護場景的機會充滿信心，原因在於：我們在 10 個區域進行的試點所產生的洞見與成果，以及目前從痛風擴張計畫所看到的強勁動能。雖然仍在早期階段，我們很高興看到在領先指標上出現令人鼓舞的趨勢。截至目前，我們已創造非常強勁的需求，且處方覆蓋的廣度與深度都相當可觀。

Over 95% of our new sales representatives have generated multiple. New cases and momentum in demand persists with record new cases achieved by the team week over week. We've seen traction with both primary care and podiatry offices with initial and repeat prescribing. Over a third of our prescribers have initiated two or more patient cases. Our patient support team has been successful in helping these patients get access to therapy. ANI's entire organization is dedicated to making this new commercial expansion successful. We're excited that this weekend our marketing, medical, and sales teams will be engaging with customers at the American Pediatric Medical Association Scientific Meeting, or APMA, being held in Nashville, and we intend to be increasingly visible to this key prescriber audience going forward. I wanted to thank the entire Cortrophin team for their superior focus and execution. Our new gout expansion is off to a very encouraging start, and we look forward to their contribution in the second-half of 2026 and beyond.

超過 95% 的新進業務代表已產生多筆處方。新病例與需求動能持續，團隊每週的新病例數屢創新高。我們在基層照護與足病科診所皆看到進展，包含首次與重複開立處方。超過三分之一的處方醫師已啟動兩個或以上的患者病例。我們的患者支持團隊也成功協助這些患者取得治療可近性。ANI 全體組織都致力於讓這次新的商業擴張取得成功。我們很期待本週末，我們的行銷、醫學與銷售團隊將在於納許維爾舉行的美國足病醫學協會科學年會（APMA）與客戶互動；未來我們也將在這個關鍵處方族群面前提高能見度。我想感謝整個 Cortrophin 團隊的高度專注與卓越執行力。我們新的痛風擴張計畫有一個非常令人振奮的開始，我們也期待其在 2026 年下半年及往後帶來的貢獻。

On slide 15, turning to our retina franchise, we continue to make progress to support a return to growth for Alluvian. We recently reported top-line results from the Synchronicity Phase IV open-label trial and non-infectious uveitis of the posterior segment. And plan to present the detailed results and additional analyses at a medical meeting in fourth quarter 2026. These data will support increased engagement with retina specialists who treat NIUPS as we continue sharing insights and new findings from the synchronicity study. The second quarter reflects strong execution across our team as we continue to accelerate into a leading rare disease company. With that, I will now turn the call over to Steve to detail our financials.

在第15頁投影片，轉到我們的視網膜產品線，我們持續取得進展，以支持 Alluvian 重回成長軌道。我們近期公布了 Synchronicity 第四期開放標籤試驗在後段非感染性葡萄膜炎（NIUPS）方面的主要（top-line）結果。並計畫於 2026 年第四季在一場醫學會議上發表詳細結果與額外分析。這些數據將支持我們加強與治療 NIUPS 的視網膜專科醫師之互動，並持續分享 Synchronicity 研究的洞見與新發現。第二季反映出我們團隊在各方面的強勁執行力，持續加速邁向領先的罕見疾病公司。接下來，我將把電話會議交給 Steve，請他說明我們的財務表現。

Thanks, Chris, and good morning to everyone on the call. Now I'll review our second quarter results and 2026 guidance in more detail. Starting with slide 17, A&I total net revenues were $266 million in the second quarter, up 26% over the prior year period. Revenues from Cortrophin gel in the second quarter were $117.1 million, up 43% from the prior year period, driven by increased volume and performing in line with our expectations. Alluvia net revenues were $18.7 million in the second quarter, down 16% from the prior year, primarily based on timing of international shipments. We remain on track to meet our full-year guidance for this product.

謝謝你，Chris，也向所有參與電話會議的各位道早安。接下來我將更詳細地回顧我們第二季的業績與 2026 年指引。從第17頁投影片開始，A&I 第二季總淨營收為 2.66 億美元，較去年同期成長 26%。第二季 Cortrophin gel 營收為 1.171 億美元，較去年同期成長 43%，主要由銷量增加所帶動，表現符合我們的預期。Alluvia 第二季淨營收為 1,870 萬美元，較去年同期下降 16%，主要是受國際出貨時點影響。我們仍按計畫達成該產品的全年指引。

In January, we entered into a licensing transaction with Harmony Biosciences. We recognized $17.7 million of associated revenues in the second quarter, consisting of $9.7 million of royalty income on sales of Wakeix. And $8 million of revenue based upon work completed in the quarter toward the achievement of certain development milestones. We expect to recognize the remaining $2 million from the development milestone in the third quarter of 2026. Revenues for generics in the second quarter were $99.1 million, an increase of 10% over the prior year, driven by continued strength in the partner generic launch that commenced in the third quarter of 2025, contribution from new product launches and commercial and operational outperformance.

今年 1 月，我們與 Harmony Biosciences 達成一項授權交易。我們在第二季認列了 1,770 萬美元的相關收入，其中包括 Wakeix 銷售所帶來的 970 萬美元權利金收入。以及 800 萬美元收入，係基於本季為達成特定開發里程碑所完成的工作而認列。我們預期將於 2026 年第三季認列該開發里程碑剩餘的 200 萬美元。第二季學名藥營收為 9,910 萬美元，較去年同期成長 10%，主要受惠於自 2025 年第三季開始的合作夥伴學名藥上市持續強勁、新產品上市貢獻，以及商業與營運表現優於預期。

Turning to slide 18, non-GAAP cost of sales increased 34% to $99.6 million in the second quarter of 2026 compared to the prior year period. Non-GAAP gross margin in the second quarter was 62.6%, a decrease of approximately 230 basis points from the prior year driven by product mix. Non-GAAP research and development expenses decreased 11% to $14.1 million in the second quarter, primarily due to phasing of generic R&D spend. Non-GAAP selling, general and administrative expenses increased 20% to $80.7 million in the second quarter. Driven by our GAAP expansion for Cortrophin, as well as an overall increase in activities to support the ongoing growth of our business, adjusted non-GAAP diluted earnings per share was $2.21 for the second quarter, compared to $1.80 per share in the prior year period.

轉到第18頁投影片，2026 年第二季非 GAAP 銷貨成本較去年同期增加 34% 至 9,960 萬美元。第二季非 GAAP 毛利率為 62.6%，較去年同期下降約 230 個基點，主要由產品組合所致。第二季非 GAAP 研發費用下降 11% 至 1,410 萬美元，主要因學名藥研發支出的時程配置所致。第二季非 GAAP 銷售、一般及行政費用增加 20% 至 8,070 萬美元。在 Cortrophin 的 GAAP 擴張，以及整體為支持業務持續成長而增加活動的帶動下，第二季調整後非 GAAP 稀釋每股盈餘為 2.21 美元，較去年同期的每股 1.80 美元增加。

Adjusted non-GAAP EBITDA for the second quarter was $71.6 million, up 32% compared to the prior year period. We ended the second quarter with $360.2 million in unrestricted cash, up $74.6 million as compared to the December 31, 2025 balance sheet. Cash flow from operations was $56.7 million in the second quarter and $115 million on a year-to-date basis. As of June 30, 2026, we had $620.9 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. At the end of the second quarter, our gross leverage was 2.4 times and our net leverage was one time, our trailing 12-month adjusted non-GAAP EBITDA of $259.6 million. Turning to slide 19, we are reaffirming our 2026 financial guidance for total net revenue, adjusted non-GAAP EBITDA and adjusted non-GAAP EPS. Which reflects significant top and bottom line growth, and modestly revising our guidance for Cortrophin gel. Our guidance outlined on slide 19 is as follows. We expect 2026 total company net revenue of $1.08 billion to $1.14 billion, representing 26% year-over-year growth. From a quarterly cadence perspective, we expect the third quarter total company revenues to be modestly higher as compared to second quarter and accelerating sequential growth in the fourth quarter.

第二季調整後非 GAAP EBITDA 為 7,160 萬美元，較去年同期成長 32%。第二季結束時，我們持有不受限制現金 3.602 億美元，較 2025 年 12 月 31 日資產負債表增加 7,460 萬美元。第二季營運活動現金流為 5,670 萬美元，年初至今為 1.15 億美元。截至 2026 年 6 月 30 日，我們未償還債務本金為 6.209 億美元，包含我們的高級可轉換公司債與定期貸款。第二季末，我們的總槓桿倍數為 2.4 倍，淨槓桿倍數為 1.0 倍，係以過去 12 個月調整後非 GAAP EBITDA 2.596 億美元計算。轉到第19頁投影片，我們重申 2026 年總淨營收、調整後非 GAAP EBITDA 與調整後非 GAAP EPS 的財務指引。該指引反映顯著的營收與獲利成長，同時對 Cortrophin gel 指引做小幅修訂。第19頁投影片所列指引如下。我們預期 2026 年全公司淨營收為 10.8 億至 11.4 億美元，代表年增 26%。就季度節奏而言，我們預期第三季全公司營收將較第二季小幅提高，並在第四季加速呈現連續成長。

We are revising our guidance for Cortrophin Gel net revenue to $520 million to $540 million, primarily to account for results in the first half of the year. Our expectations for the back half of the year remain largely intact. From a quarterly cadence perspective, we expect third quarter Cotrophin revenues to be in the range of $143 million to $153 million. With further sequential gains in the fourth quarter driven by continued performance of our existing specialties team in addition to the full deployment of our gout expansion sales force. We are reaffirming our Alluvian net revenue guidance of $78 million to $83 million, which reflects stronger Alluvian revenue in the back half of the year compared to the first half.

我們將 Cortrophin Gel 淨營收指引修訂為 5.20 億至 5.40 億美元，主要是為反映上半年業績結果。我們對下半年表現的預期大致維持不變。就季度節奏而言，我們預期第三季 Cotrophin 營收將落在 1.43 億至 1.53 億美元區間。第四季在既有專科團隊持續表現，以及痛風擴張銷售團隊全面部署的帶動下，預期將進一步呈現連續增長。我們重申 Alluvian 淨營收指引為 7,800 萬至 8,300 萬美元，該指引反映 Alluvian 在下半年營收將較上半年更強。

This guidance assumes no meaningful contribution from third-party patient assistance foundations in line with our prior expectations. We expect adjusted non-GAAP EBITDA of $285 million to $300 million. From a quarterly cadence perspective, we expect third quarter non-GAAP EBITDA to be down sequentially, however higher than the first quarter of 2026 non-GAAP EBITDA.

此指引假設第三方病患協助基金不會有任何具實質意義的貢獻，與我們先前的預期一致。我們預期調整後非 GAAP EBITDA 為 2.85 億至 3.00 億美元。就季度節奏而言，我們預期第三季非 GAAP EBITDA 將較第二季呈現連續下滑，但仍高於 2026 年第一季的非 GAAP EBITDA。

This will be driven by two factors. First, we expect to recognize the final $2 million Harmony development milestone in the third quarter as compared to the $8 million recognized in the second quarter. And secondly, the third quarter will be the first fully loaded quarter of the gout expansion and associated operating expense. We continue to expect fourth quarter EBITDA to be the highest of the year as we begin to achieve leverage on the gout expansion with increasing Cortrophin gel revenues. We continue to expect adjusted non-GAAP earnings per share between $9.19 and $9.69. We continue to expect adjusted gross margin to be between 59.9% and 60.9% in 2026. We continue to anticipate 21.5 million and between 21.5 million and 21.8 million shares outstanding for the purpose of calculating full-year non-GAAP diluted EPS and a full-year U.S. GAAP effective tax rate of approximately 26% to 28%. With that, I'll turn the call back to Nikhil.

這將由兩項因素所驅動。第一，我們預期第三季將認列 Harmony 開發里程碑最後的 200 萬美元，相較於第二季認列的 800 萬美元。第二，第三季將是痛風擴張計畫及其相關營運費用首次完整反映的一季。隨著 Cortrophin gel 營收增加、我們開始在痛風擴張上取得規模效益，我們仍預期第四季 EBITDA 將為全年最高。我們仍預期調整後非 GAAP 每股盈餘介於 9.19 至 9.69 美元之間。我們仍預期 2026 年調整後毛利率介於 59.9% 至 60.9%。就計算全年非 GAAP 稀釋 EPS 而言，我們仍預期流通在外股數約為 2,150 萬股，區間為 2,150 萬至 2,180 萬股，且全年美國 GAAP 有效稅率約為 26% 至 28%。接下來，我把電話會議交回給 Nikhil。

Turning to Slide 21. In closing, we are making meaningful progress against our strategic priorities to accelerate our transformation into a leading rare disease company to continue executing in generics and to deploy capital in a disciplined manner. We are very encouraged by the initial demand that our Cortrophin sales force expansion in Grout is driving and the momentum of our existing specialties.

接著看第 21 張投影片。總結來說，我們在策略優先事項上取得了實質進展，正加速轉型為領先的罕見疾病公司，同時持續在學名藥業務上執行，並以嚴謹自律的方式部署資本。我們對 Cortrophin 在痛風（gout）領域擴編銷售團隊所帶動的初期需求，以及既有專科領域的動能，感到非常振奮。

Overall, we expect to deliver over $1 billion in revenue in 2026, with rare disease approaching 60% of total revenues. We are confident in achieving our 2026 financial guidance, which reflects significant top and bottom-line growth.

整體而言，我們預期在 2026 年實現超過 10 億美元的營收，其中罕見疾病業務將接近總營收的 60%。我們有信心達成 2026 年的財務指引，該指引反映營收端與獲利端皆有顯著成長。

Operator, please open the line for questions.

接線員，請開放提問。

(Event Instructions) Vamil Divan with Guggenheim Partners. Your line is open.

(活動說明) Guggenheim Partners 的 Vamil Divan。您的線路已開通。

Great. Thanks for taking my questions. So just focusing on Cortroprin here. Can you give a little bit more detail in terms of what you've been thinking so far in terms of the gout uptake? I appreciate the comments you made. I'm just sort of thinking about the way. Structure the guidance here, you're going to get about $143,000, $153,000 in the third quarter. It's a pretty meaningful step up from there into the fourth quarter. So just try to see what you've seen so far in gout and kind of the confidence it gives you to see the further uptake through the course of the year. And then sort of tied to that also, obviously a lot of potential patients, sub cortrophin going to hit across the current indications as you showed on the one slide here. Can you maybe just give us a sense of how penetrated you think some of these. Current indications are. Again, just trying to get a sense in terms of obviously, there's a big runaway out of you, but trying to get a sense of how far you penetrated them to get a sense of what maybe is left to penetrate them.

很好。謝謝讓我提問。我想先聚焦在 Cortroprin。能否再多提供一些細節，說明你們目前對痛風（gout）採用/滲透（uptake）的觀察與想法？我很感謝你剛才的評論。我只是從另一個角度在想：就你們這裡的指引結構來看，第三季大約會落在 143,000 到 153,000。而第四季相較之下會有相當明顯的跳升。所以我想了解你們目前在痛風端看到的情況，以及這些觀察如何讓你們對今年後續的進一步採用更有信心。另外也連帶想問，顯然潛在病患很多，Cortrophin 也會如你們在那張投影片所示，橫跨目前的適應症。你們能否大概分享一下，你們認為其中一些現有適應症的滲透率大概到什麼程度？同樣地，我想理解的是：很明顯你們還有很長的成長跑道，但想知道目前已滲透到什麼程度，以便判斷還剩下多少空間可繼續滲透。

Good morning, Vamil, and thank you for your questions. I think your first question is on the gout expansion. As we said, the leading indicators from the gout expansion are very positive, right? What we're seeing is the so first of all, our gout focus organization expansion was fully operational by the end of June as expected. And then the leading indicators of demand that we've pointed out are. Which we're pleased with is the breadth and the depth of the prescribing, right? So over 95% of the reps generated multiple new patient cases, over a third of the prescribers have initiated two or more cases, and we also saw balanced demand between primary care and podiatrists. We also see continued. Success and growth in the territories that were the 10 pilot territories that we had, which based on whose success we actually thought about the Gout expansion, right? So I think all of those very pleased with the progress and the leading indicators of demand that we've pointed out for the Gout expansion. Now, when it comes to guidance, Steve pointed out that our Q3 guidance for Cortrofin is 143 to 153. And then your question was around the step up from there.

早安，Vamil，謝謝你的提問。我想你的第一個問題是關於痛風擴張。如同我們所說，痛風擴張的領先指標非常正面，對吧？我們看到的是：首先，我們以痛風為重點的組織擴編如預期在 6 月底前已全面到位並開始運作。接著，我們所指出的需求領先指標是：我們很滿意的是處方開立的廣度與深度，對吧？超過 95% 的業務代表帶來多個新病患案例，超過三分之一的處方醫師已啟動兩個或以上案例，而且我們也看到基層醫療（primary care）與足病醫師（podiatrists）之間的需求相當均衡。我們也持續看到先前 10 個試點區域的成功與成長；正是基於那些成功，我們才進一步推動痛風擴張，對吧？因此，我認為我們對進展以及痛風擴張所呈現的需求領先指標都非常滿意。至於指引方面，Steve 提到我們第三季 Cortrofin 的指引為 143 到 153。而你的問題是關於之後的跳升。

So when you think about the Gout expansion, right, we've executed our largest rare disease Salesforce expansion and we've increased our reps by 50%, this expansion from 120 to 180 reps, right? So that's a meaningful expansion. That expansion was operational by the end of June. I already spoke about the. The leading indicators of demand. So we expect Q3 to keep building on this momentum and therefore Q4 will have significantly higher impact from the gout expansion. In parallel, our existing specialties, which were the primary drivers of growth for the 56% quarter-on-quarter growth in 2Q and have continued the momentum in 3Q with the highest number of new cases initiated in July, that also has continued momentum. And then, lastly, that Q4 also benefits from the typical channel and insurance. Dynamics acting as tailwinds.

當你思考痛風擴張時，對吧，我們已完成我們最大規模的罕見疾病銷售團隊擴編，業務代表人數增加了 50%，也就是從 120 人擴至 180 人，對吧？這是一個相當有意義的擴編。該擴編在 6 月底前已開始運作。我剛才也談到需求的領先指標。因此，我們預期第三季會在此動能上持續累積，而第四季將會更明顯地反映痛風擴張帶來的影響。同時，我們既有的專科領域——這些是第二季季增 56% 成長的主要驅動因素——在第三季也延續動能，7 月啟動的新案例數創下最高。最後，第四季也會受惠於典型的通路與保險動態所帶來的順風。

So finally, as a reference point, in 2025 to where we did a sales force expansion, revenue contribution from H2 was 61% of the total. And then just again, as the reference point, the expansion in 2026 is 3x the expansion in 2025 in terms of number of reps and was completed in the second quarter versus the first quarter in 2025. And then lastly, your question was on penetration across the addressable market. It's very low, very low. And so there is a huge opportunity, and we continue to believe in the strong multi-year growth opportunity for clotrophin and are investing in multiple ways to capture that opportunity and to, most importantly, be true to our purpose of serving patients, improving lives.

最後，作為參考點，2025 年我們也做過一次銷售團隊擴編，下半年（H2）的營收貢獻占全年總額的 61%。再補充一個參考點：2026 年的擴編在業務代表人數上是 2025 年的 3 倍，且是在第二季完成，而 2025 年是在第一季完成。最後，你的問題是關於在可觸及市場（addressable market）中的滲透率。非常低，非常低。因此機會非常大；我們仍然相信 Cortrophin 具有強勁的多年期成長機會，並正以多種方式投資以掌握這個機會，最重要的是，忠於我們服務病患、改善生活的使命。

Thank you.

謝謝。

Glen Santangelo with Barclays.

Barclays 的 Glen Santangelo。

Yeah, thanks for taking my question. Hey, Nikhil, at the beginning of the year, you called out all these prior authorization reverification issues that would impact 1Q. But then on May 8, when you reported 1Q, you said that this was kind of behind the company. This quarter, you're talking about the early progress of your sales force expansion, the early success in gout. But yet you come in light and you're sort of trimming the guide for the year. And so I'm just want to try to get your sense for how the months have progressed and how, the insurance reverification issues have progressed. And is that playing a role here in the second quarter? Because, what we find a little perplexing is the disconnect between the IQVIA data and what you're reporting. And so I'm kind of curious if we have a situation where scripts are getting written, but not approved, any sort of. Details around sort of how the first half played out from 1Q to 2Q would be helpful.

好的，謝謝讓我提問。嗨，Nikhil，今年年初你提到先前授權（prior authorization）重新驗證（reverification）的一些問題會影響第一季。但在 5 月 8 日你們公布第一季時，你說這件事大致已經過去了。這一季你們談到銷售團隊擴編的早期進展、痛風領域的早期成功。但你們的表現卻低於預期，且你們也略微下修全年指引。所以我想了解你們對各月份進展的看法，以及保險重新驗證問題的進展情況。這是否在第二季仍扮演某種角色？因為我們覺得有點困惑的是 IQVIA 數據與你們所報告的結果之間似乎存在落差。因此我想知道是否出現處方已開立、但未獲核准的情況，或任何類似的。若能提供一些細節，說明上半年從第一季到第二季的發展，會很有幫助。

Thanks. Good morning, Glen, and thank you for your question. So first is on the insurance reverification, which drove impacted the performance in the first quarter. That issue is behind us, and there is no impact from insurance reverifications in the Q2 number. And then to level set here, we did make our guidance range for the quarter achieving the 56% and 43% year-over-year growth in Q2 and are proud of the progress we made.

謝謝。早安，Glen，謝謝你的提問。首先談保險重新驗證，這確實影響了第一季的表現。這個問題已經過去了，第二季的數字不再受到保險重新驗證的影響。另外先校準一下：我們確實達成了本季的指引區間，第二季年增分別為 56% 與 43%，我們也為所取得的進展感到自豪。

And there are a diverse range of inputs that drives our guidance, right, such as number of cases initiated, the indication mix, patient pull-through, payer type and other such factors. And then in terms of momentum, right, going into Q2 and. Obviously, we're sharing Q3 data too. The growth in Q2 came primarily from existing specialties, and the momentum has continued into the third quarter from existing specialties itself. We have the highest number of months of new patient cases initiated in July. As expected and as previously discussed, given the timing of operationalizing our gout expansion, it did not have a meaningful impact on Q2 reported revenues. But we continue to expect measurable revenues in the third quarter and robust growth in the fourth quarter, and we're giving metrics on the indicators of demand, right, that I already laid out. And so our expectation for Q3 and Q4 hinges on both the continued momentum in the existing security.

而且有各式各樣的輸入因素會驅動我們的指引，對吧，例如啟動的病例數、適應症組合、病患後續延續（pull-through）、付款方類型以及其他此類因素。然後就動能而言，對吧，進入第二季以及。顯然，我們也在分享第三季的數據。第二季的成長主要來自既有專科，而這股動能也在第三季持續，且同樣來自既有專科本身。我們在七月創下新病患病例啟動月份數的最高紀錄。如預期且如先前所討論，鑑於我們痛風擴張計畫落地執行（operationalizing）的時點，它對第二季所報告的營收並未產生實質影響。但我們仍預期第三季將出現可衡量的營收，第四季將有強勁成長；我們也提供我先前已列出的需求指標相關衡量數據。因此，我們對第三季與第四季的預期，取決於既有業務的持續動能。

Talked about, as well as the very positive early feedback from the GROUT launch, where we have over 95% of our team has generated multiple new cases and over a third of our prescribers have initiated two or more cases. And we continue to have success going to. To prescribers who are naive to ACTH, right? We have over the history of us commercializing cortrophin, over half of our prescribers were naive to ACTH and began using ACTH to serve patients.

如同先前談到的，以及GROUT上市（launch）非常正面的早期回饋：我們的團隊中有超過95%已產生多個新病例，且超過三分之一的處方醫師已啟動兩個或以上的病例。而且我們持續在推進方面取得成功。也就是接觸那些對ACTH尚不熟悉（naive）的處方醫師，對吧？在我們商業化Cortrophin的歷程中，超過一半的處方醫師原本對ACTH並不熟悉，但後來開始使用ACTH來服務病患。

With the linkage to IQVIA. And the question around that, while the IQVIA data has historically provided directional insights on revenues, we also know that there is a lot of volatility in the data and it has over or understated quarterly revenues in the past. That's really all we have to say about the IQVIA data. But we understand that and to be helpful to investors, we have been providing to investors many of our key internal metrics such as next quarter's revenue guidance or various demand metrics from July in the 1st month of the current quarter. Thank you, Glenn.

關於與IQVIA的連結。以及圍繞該點的問題：雖然IQVIA數據在歷史上確實能提供營收的方向性洞見，但我們也知道該數據波動很大，過去曾對單季營收出現高估或低估。這就是我們對IQVIA數據要說的全部。但我們理解這點，並且為了對投資人有所幫助，我們一直向投資人提供許多關鍵的內部指標，例如下一季的營收指引，或是本季第一個月（七月）的各項需求指標。謝謝你，Glenn。

Dennis Ding Jefferies.

Dennis Ding，Jefferies。

Hey, good morning. Thanks for taking our questions. We had two on the quarter opening guidance. So number one, what factors didn't play out to your expectations that has driven the guidance revision? Because you guys landed within your Q1 and Q2 soft guidance, but then lower 2026 by about $30 million. So I'm just curious, did early Q3 demand. Not meet your expectations or maybe you're seeing incremental headwinds on access as we've seen a couple of other spec pharma companies flag additional step edits and things even though they're in other therapeutic areas, so that's question number one. And then question number two is that your guidance also assumes a pretty big step-up in Q4. But if I look at last year, that that was actually the slowest sequential step-up that Cortrophin had. So I'm just wondering what gives you the confidence that Q4 would play out as expected, appreciating that the gout expansion is happening and is accelerating?

嗨，早安。謝謝回答我們的問題。我們有兩個關於本季期初指引的問題。第一，哪些因素沒有如你們預期發展，因而導致指引下修？因為你們第一季與第二季都落在你們較溫和（soft）的指引區間內，但卻把2026年下調了約3,000萬美元。所以我想了解的是，是否第三季初期需求。未達你們預期？或者你們是否看到在可近性（access）方面出現額外逆風——我們看到其他幾家專科製藥公司也提到新增的逐步編輯（step edits）等情況，雖然是在其他治療領域——這是第一個問題。第二個問題是，你們的指引也假設第四季會有相當大的季增跳升。但如果我看去年，第四季其實是Cortrophin最慢的連續季增跳升。所以我想知道，你們憑什麼有信心第四季會如預期發展？我理解痛風擴張正在進行且正在加速。

Good morning and thank you for your questions, Dennis. So our revised guidance principally accounts for the actual performance in the first half and largely maintains our expectations for both the existing specialties and the gout expansion in the back half. We expect to deliver 50% to 55% year-over-year growth, right, for Cortrophin to $520 million to $540 million in Cortrophin revenue. For the full year. And importantly, Clotrophin has a strong multi-year growth opportunity driven by the large, significantly underpenetrated almost 1 million patients that we estimate as our addressable market. And we continue to see momentum across both our existing specialties and from the gal expansion. You asked about Q3. Metrics, in existing specialties, highest number of new cases initiated in July. In the gout expansion, 95% of the reps, an expansion that was operational at the end of June, 95% of reps fully operational at the end of June, 95% of reps have initiated two or more cases. A third of our prescribers have written.

早安，Dennis，謝謝你的提問。我們修訂後的指引主要反映上半年實際表現，同時在下半年大致維持我們對既有專科與痛風擴張的預期。我們預期Cortrophin將實現50%到55%的年增率，對吧，也就是Cortrophin營收達5.20億至5.40億美元。以全年計。而且重要的是，Clotrophin具備強勁的多年成長機會，動能來自我們估計可觸及市場中規模龐大、且滲透率仍顯著偏低的近100萬名病患。我們持續看到既有專科與痛風擴張兩方面的動能。你問到第三季。在既有專科方面，七月的新病例啟動數創下最高。在痛風擴張方面，該擴張於六月底完成落地運作，六月底時有95%的業務代表已完全到位運作，而其中95%的業務代表已啟動兩個或以上的病例。我們有三分之一的處方醫師已經開立。

Two or more cases. So we are seeing very strong demand generation and very positive demand generation, which is on track or ahead on metrics that we have, right? Week on week, we're continuing to see that momentum. We do not see any additional headwinds in the back half of the year and our, very importantly, our expectations for the back half of the year are largely intact with what we had originally anticipated at the start of the year, right? And so the revised guidance is simply taking into account. The actual results from the first half. And then you asked about the question on the step-up in Q4. I think the big difference with last year is we have an expansion that's 3x the previous year's expansion that's fully operational at the end of June. So these reps will have been out three months in Q3, but then you'll have a full quarter and most reps will be out between three to five months when you get to the fourth quarter. So you'll see a much. Bigger impact from the gout expansion in the fourth quarter. Thank you, Dennis.

兩個或以上的病例。因此我們看到非常強勁的需求創造與非常正面的需求生成，這些都符合我們掌握的指標，甚至在某些指標上超前，對吧？我們每週都持續看到這股動能。我們沒有看到下半年有任何額外逆風；而且非常重要的是，我們對下半年的預期大致維持在年初原先所預期的水準，對吧？因此，修訂後的指引只是把。上半年的實際結果納入考量。然後你問到第四季跳升的問題。我認為與去年最大的差異在於：我們這次的擴張規模是去年的3倍，並且在六月底已完全到位運作。因此這些業務代表在第三季將外出推進三個月，而到了第四季，你將會有完整一季的貢獻，且多數業務代表屆時外出推進時間將介於三到五個月。所以你會看到更。大的痛風擴張影響在第四季反映出來。謝謝你，Dennis。

Okay, got it. And if I can have a quick follow-up. So on the dedicated gout expansion, can you comment on how many flares have been treated so far? Because based on some of your comments, I mean, you guys had 65 dedicated gout reps. You said 95% of them had multiple new cases. So if you conservatively assume two cases each, maybe that's 125 patients or flares from the end of June.

好的，了解。如果我可以再快速追問一下。關於專責的痛風擴張，你能否評論一下到目前為止治療了多少次急性發作（flares）？因為根據你們的一些說法，我的意思是，你們有65位專責痛風的業務代表。你說其中95%都有多個新病例。所以如果保守假設每人兩個病例，那可能就是從六月底起約125位病患或125次發作。

To the end of July. So that's about a month, and that's going to ramp up through the year. Do you think those are fair assumptions?

到七月底。所以大約是一個月，而這會在今年內逐步加速提升。你覺得這些假設合理嗎？

Yeah. Thank you, Dennis, for your question. Look, we're trying to give as many internal metrics to be helpful to investors, but we are not at this point sharing flares per rep or number of cases per rep, et cetera, because as I said, there are many factors that drive our guidance. And so I'll keep it at that. Thank you, Dennis.

是的。Dennis，謝謝你的問題。你看，我們試著提供盡可能多的內部指標來協助投資人，但目前我們不會分享每位業務代表的發作數（flares per rep）或每位業務代表的病例數等，因為如我所說，有許多因素會驅動我們的指引。所以我就先說到這裡。謝謝你，Dennis。

Thanks.

謝謝。

David Amsellem with Piper Sandler.

Piper Sandler 的 David Amsellem。

Thanks. So just a couple for me. First, just wanted to clarify, Nikhil, are cases the same as prescriptions written? And if they're not, can you talk about how many of those cases that you refer to a percentage of those cases are actually becoming active prescriptions? That's number one. Number two, as you think about.

謝謝。我這邊就幾個問題。首先想確認一下，Nikhil，你們說的「病例（cases）」是否等同於開立的處方（prescriptions written）？如果不等同，能否談談你們提到的那些病例中，有多少比例實際轉化為正在使用的有效處方？這是第一點。第二點，當你們在思考……

The ramp in the back half of the year, how long does it take on average to get a script filled from when it was written? Are you seeing any significant lags there that could be or have been problematic just beyond the authorization issues that you cited earlier this year? And then lastly, operating leverage with the expansion in place, how are you thinking about operating leverage beyond this year? Do you think you're going to need further sales force expansion to support the gout indication or other indications? Just generally speaking, if you can talk about that as well, that would be helpful. Thank you.

今年下半年放量的情況時，從處方開立到實際完成配藥（script filled）平均需要多久？除了你們今年稍早提到的授權問題之外，你們是否看到任何顯著的延遲，可能造成或已經造成問題？最後，隨著擴編到位，對於今年以後的營運槓桿你們怎麼看？你們認為為了支持痛風適應症或其他適應症，還需要進一步擴充銷售團隊嗎？如果可以也請大致談談，會很有幫助。謝謝。

Good morning and thank you, David. So when we say new cases initiated, we mean prescriptions, we mean the same thing as enrollments, enrollment forms. So when we say, number highest number of new cases initiated for existing specialties in the month of July, then that means the highest number of enrollment forms or prescriptions that were written in July. And the same thing when we talked about, from the gout expansion, the leading indicators of demand, there are a third of our prescribers have written more than two prescriptions, meaning intent to treat more than two enrollment forms and initiated new cases initiated. So new cases initiated is the terminology we use. So that's one. The second on time to.

早安，謝謝你，David。我們所說的「新啟動病例（new cases initiated）」指的就是處方，也等同於註冊（enrollments）、註冊表單（enrollment forms）。所以當我們說 7 月在既有專科領域的新啟動病例數創下單月新高，意思就是 7 月開立的註冊表單或處方數量最高。同樣地，當我們談到痛風擴展帶來的需求領先指標時，我們有三分之一的處方醫師已開立超過兩張處方，代表其治療意圖超過兩份註冊表單，並啟動新病例。因此「新啟動病例」是我們使用的術語。這是第一點。第二點，關於時間到……

From the time of the enrollment or the new case initiation to fulfillment, that time varies. It varies on a number of different factors. It can be in a matter of a couple of days to, a couple weeks, and it depends on the payer type, the patient, the physician's office. I think it's a number of different factors that drives it. I think importantly. We're five of our launch, right? And we have consistently, across the five years, kept improving this process to support prescribers and prescriber offices and patients who are appropriate for ACTH and clotrophin therapy to get the medication that they need in time. There is no lag or any new headwind that we're facing on that front. We continue to work with the prescriber's office in the appropriate fashion to ensure that these enrollments end up with patients on therapy. And then the last question was on third question was on operating leverage. Absolutely, David. The investment that we've made in this year by expanding our rare disease sales force by about 50% from 120 reps to 180 reps will see impact in the back half, but we'll see the full-year impact on operating leverage in 2027. And so you can expect higher sales in 2027 and operating leverage from the investment made this year.

從註冊或新病例啟動到完成供藥（fulfillment）的時間會有所不同。它取決於多種因素。可能只需要幾天，也可能需要幾週，取決於付款方類型、病患情況、以及醫師診所端。我認為是多種因素共同驅動。我認為重要的是，我們已經上市五年了，對吧？而且在這五年中，我們持續改善流程，以支持處方醫師、診所端以及適合接受 ACTH 與 Cortrophin 治療的病患，能及時取得所需藥物。在這方面我們沒有看到任何延遲或新的逆風。我們會持續以適當方式與處方醫師診所合作，確保這些註冊最終能讓病患開始用藥治療。最後一題是關於營運槓桿。當然，David。我們今年將罕見疾病銷售團隊擴編約 50%，從 120 位業務代表增加到 180 位，這項投資的效果會在下半年開始顯現，但營運槓桿的全年效果會在 2027 年完整反映。因此你可以預期 2027 年銷售更高，並且能看到今年投資所帶來的營運槓桿。

Thank you, David.

謝謝你，David。

Ekaterina Nezkova with JPMorgan.

JPMorgan 的 Ekaterina Nezkova。

Thanks so much. So first, I just want to go back to the patient reverification issue. What percent of the volumes that you lost in Q1 were you eventually able to recover in Q2 versus how much of that volume was permanently lost? And similar kind of line of questioning, but should we expect a similar issue as we kind of think about 27? And then the next topic I wanted to talk about is just also clotrophin gel trends that you're seeing in terms of vials per patient, just any big shifts in terms of, the number of vials you're kind of seeing each patient use. Thanks.

非常感謝。首先我想回到病患重新驗證（reverification）問題。你們在第一季流失的量中，有多少比例在第二季最終得以追回？又有多少是永久流失？類似的問題，但當我們思考 27 年時，是否也應預期會出現類似狀況？接著我想談的下一個主題，是你們觀察到的 Cortrophin gel 趨勢：就每位病患使用的藥瓶數（vials per patient）而言，是否有任何重大變化，例如每位病患使用的藥瓶數量是否出現明顯移動。謝謝。

Got it. Good morning, and thank you, Ekaterina, for your questions.

了解。早安，也謝謝你，Ekaterina，提出問題。

First question is on, I'll take your second question first, which is on the vials or the usage per patient. The usage per patient varies across indications and prescribers. So we are not seeing any significant shift. The mix of indications, right? We have is there are some indications for which there's a higher usage per patient and there are some indications where there's a lower number of lower usage per patient, whatever the prescriber feels is appropriate for the patient. So we're not seeing, any specific change in by any indication, right, of the usage per patient. And then going back to your re-verification question, look, we. We worked through the reverification issues. And again, just to remind investors, there was a large bolus of patients that needed to be reverified, that patients who were on therapy on December 31, 2025 and needed to be reverified in 2026 early as part of their insurance process. And because of the large bolus as well as weather-related issues, it took a bit more time.

第一個問題，我先回答你的第二個問題，也就是每位病患的藥瓶數或使用量。每位病患的使用量會因適應症與處方醫師而異。因此我們沒有看到任何顯著變化。就適應症組合而言，對吧？我們確實有一些適應症每位病患使用量較高，也有一些適應症每位病患使用量較低，端看處方醫師認為對病患最合適的方式。所以我們沒有看到任何特定適應症在每位病患使用量上出現明確變化。再回到你關於重新驗證的問題，坦白說，我們……我們已經處理並解決重新驗證的問題。再次提醒投資人，當時有一大批需要重新驗證的病患，也就是在 2025 年 12 月 31 日仍在治療中的病患，依其保險流程在 2026 年初需要重新驗證。由於這一大批量，再加上天候相關因素，整體花了更長時間。

Now, we were able to convert many or most of those patients through the re-verification process, right? And there was some shifting of that in the timing of that that happened. Did we lose some patients? Yes, but that's also patient pull through. This is also consistent with what has happened in the previous year. So there is not an additional impact that we're seeing from that. So thank you, Katrina. Thanks.

目前我們已經讓許多或大多數病患完成重新驗證流程並成功轉換，對吧？而且其中也出現了一些時點上的遞延與移轉。我們是否流失了一些病患？是的，但那也屬於病患續用/轉化（patient pull through）的一部分。這也與過去一年發生的情況一致。因此我們沒有看到額外的影響。謝謝你，Katrina。謝謝。

Gary Nachman with Canaccord Genuity.

Canaccord Genuity 的 Gary Nachman。

Thanks and good morning. A few more on Cortrophin for me. So what portion of Cortrophin volume was from gouty arthritis flares in 2Q versus 1Q?

謝謝，早安。我還有幾個關於 Cortrophin 的問題。第二季（2Q）Cortrophin 的用量中，有多少比例來自痛風性關節炎急性發作（gouty arthritis flares），相較於第一季（1Q）？

If you could quantify that, it would be helpful. And maybe where do you see that going by the end of the year? And then just following up on the last usage question, within GADI flares, is the revenue per patient a bit lower? So assuming you need a lot more of those patients on a relative basis, I'm curious if that's a dynamic to consider with the revenue as the mix is going to shift going forward. And then any anticipated pressure in gross to nets at all that might be impacting the revenue based on the dynamics that you're seeing in the space, including with your competitor? And then I have one follow-up.

如果你們能量化會很有幫助。另外，到今年年底你們預期這個比例會走到哪裡？再追問剛才關於使用量的問題，在 GADI 急性發作中，每位病患的收入（revenue per patient）是否會稍低一些？因此如果相對而言需要更多這類病患，我想了解這是否是未來組合變動下、需要納入收入考量的動態因素。另外，基於你們在市場上看到的動態（包括競爭對手的情況），毛額到淨額（gross-to-nets）是否有任何預期壓力，可能影響收入？最後我還有一個追問。

Got it. So thank you for your good morning and thank you for your questions, Gary. I think your first question on. What was the contribution of gout? So I'll speak to existing specialties where you remember that even we have spoken about gout being about 18% of our sales as we were reporting in the past, right? So that's what that gout was giving from existing specialty, rheumatology, nephrology, and from the pilot territories. That's the last sort of number that we've shared. In Q2 from the gout expansion where we've had this expanded sales force that goes into primary care and podiatry, we had limited impact in the second quarter in revenues, right? And this was as expected. We obviously will expect to see a ramp in Q3 and then a much bigger ramp in Q4 on sales from that. So gout as a percentage of sales across existing specialty and from the gout expansion will increase from that 18%. But.

了解。所以謝謝你的早安問候，也謝謝你的提問，Gary。我想你第一個問題是關於。痛風的貢獻是多少？我先談既有專科；你會記得我們過去在對外報告時提到，痛風約占我們銷售額的18%，對吧？所以那就是既有專科（風濕科、腎臟科）以及試點區域所帶來的痛風貢獻。那是我們最後一次分享的數字。在第二季，來自痛風擴張（我們擴編的銷售團隊進入基層醫療與足病科）的營收影響有限，對吧？而這也符合預期。我們顯然預期第三季會開始爬坡，第四季則會有更大幅度的爬坡，帶動相關銷售。因此，痛風在既有專科與痛風擴張合計的銷售占比，將會從18%往上提高。但是。

As I said, there's 750,000 patients in the other specialties, right, which we believe is the under-penetrated and that are significantly under-penetrated, right? So this is ex-gout. So a million patients including gout, but 750,000 patients ex-gout, and there is a significant growth opportunity there. So that will keep growing, right, and we'll keep investing to capture that growth in the non-gout areas too. At this point, we're not projecting what's the gout mix of the business going to be going forward. Your second question was on the gout number of vials per patient. Yes, the gout number of vials per patient is lower or number of PFS per patient or MLs per patient is lower, but then there's a lot more gout patients. And even when you think of the prescribers that we go to. The number of patients that each prescriber are seeing, our experience has been through the 10 territories where we did the pilots, as well as in the expansion in the first few weeks of the expansion, that the number of patients that are suffering from acute guardioarthritis flares and who the prescribers believe are appropriate to consider for a new treatment option, such as Clotrophin.

如我所說，其他專科有75萬名患者，對吧？我們認為那部分的滲透率偏低，而且是顯著低滲透，對吧？所以這是不含痛風（ex-gout）。包含痛風合計約100萬名患者，但不含痛風約75萬名患者，而那裡有顯著的成長機會。所以那部分會持續成長，對吧？我們也會持續投資，以在非痛風領域同樣抓住這個成長。目前我們不會去預測未來痛風在整體業務中的占比會是多少。你第二個問題是關於痛風患者每位使用的藥瓶數。是的，痛風患者每位使用的藥瓶數較低，或每位使用的預充式注射器（PFS）數較低，或每位使用的毫升數較低，但痛風患者的人數要多得多。而且即使你去想我們拜訪的開立處方醫師。每位處方醫師所看到的患者數，我們在做試點的10個區域，以及擴張初期的前幾週的經驗顯示，罹患急性痛風性關節炎發作、且處方醫師認為適合考慮新的治療選項（例如 Clotrophin）的患者數。

Is a larger number, right, just on a per office basis. So we'll see more patients and there'll be less usage per patient. So we think of it that way. And then the third question on the gross to net, there is no, nothing to highlight here. We obviously try to strike a balance with, as you refer to our competitor between sharing information that is competitively sensitive with. Information that is helpful to investors. So nothing new to share at this time.

是更大的，對吧？就每家診所而言。所以我們會看到更多患者，但每位患者的使用量會更少。所以我們是這樣看待的。第三個問題關於毛額到淨額（gross-to-net），這裡沒有、沒有什麼需要特別強調的。我們當然會努力在你提到的競爭對手之間取得平衡：一方面是分享具有競爭敏感性的資訊，另一方面是。對投資人有幫助的資訊。所以目前沒有新的內容可以分享。

Just a follow-up on David's operating leverage question. So just how aggressive are you at this point looking to expand the rare disease business through M&A and what kind of assets are you looking for? So I guess how important is it to further leverage. The increased sales force, I guess, particularly in podiatry and primary care, is that going to be a focus or do you not want to mess with that because you need to focus on the cortrophin growth? So just, your latest thoughts on the importance of M&A at this point in rare disease. Thanks. Yeah.

追問一下 David 關於營運槓桿的問題。所以你們目前在透過併購（M&A）擴張罕見疾病業務方面有多積極？你們在找什麼樣的資產？所以我想問的是，進一步槓桿化。擴編後的銷售團隊，尤其是在足病科與基層醫療，這會是重點嗎？還是你們不想干擾那部分，因為需要專注在 cortrophin 的成長？所以就是，你們目前對於在罕見疾病領域進行併購的重要性有什麼最新看法。謝謝。嗯。

So disciplined capital allocation is a critical.

嚴謹的資本配置是關鍵。

Our path of our success story and plans going forward and executing M&A to expand the scope and scale of our rare disease business is a top priority from a capital allocation perspective. And where do we plan to invest or where we've been evaluating opportunities? Very much two sets of opportunities. So commercial or neuro commercial assets that are. Synergistic either with our call points, right? And we have the benefit with Clotrophin having multiple call points. So synergistic with the call points from a sales force perspective or leveraging the rest of our infrastructure, right, which is the market access, medical affairs, patient support, a lot of the which is also a critical part in the rare disease space. So those are the two sets of sort of core capabilities that we want to add assets that are synergistic with that.

這是我們成功故事的路徑，以及未來計畫的一部分；從資本配置角度來看，透過執行併購來擴大我們罕見疾病業務的範疇與規模，是最優先事項之一。那我們計畫投資在哪裡，或我們一直在評估哪些機會？大致上是兩類機會。也就是商業化資產或神經領域的商業化資產，這些資產。在我們的拜訪對象（call points）上具有協同效益，對吧？而 Clotrophin 的優勢在於它有多個拜訪對象。因此，無論是從銷售團隊角度與這些拜訪對象形成協同，或是槓桿化我們其餘的基礎設施，對吧？包括市場准入（market access）、醫療事務（medical affairs）、病患支持；其中許多在罕見疾病領域也是非常關鍵的一環。所以這兩類算是我們的核心能力，我們希望新增的資產能與之形成協同。

Thank you, Gary.

謝謝你，Gary。

Thomas Smith Leering Partners.

Thomas Smith，Leering Partners。

Hey, guys. Good morning. Thanks for the updates and for taking our questions.

嗨，各位。早安。謝謝你們的最新進展，也謝謝你們回答我們的問題。

Also, too, on the Cortrophin count launch, if I may, are there any differences you're seeing in payer mix between these podiatrists and primary care settings versus the base business specialties? And can you just elaborate a little bit on how you're engaging with these new specialties to help them navigate the reimbursement process? Separately. You also called out success and growth coming from these 10 initial pilot categories, excuse me, territories. Just wondering if you could elaborate and maybe quantify how much of the demand in the quarter came from those territories and how broadly do you expect the experience within those pilot centers to play out now that you have the Salesforce expansion fully in place? Thanks so much.

另外，關於 Cortrophin 的痛風適應症上市推廣（count launch），如果可以的話，你們是否看到足病科與基層醫療場景的付款方組合（payer mix），相較於既有業務的專科，有任何差異？以及你們能否再多說一點，你們如何與這些新專科互動，協助他們掌握報銷流程？另外。你們也提到成功與成長來自這10個最初的試點類別，抱歉，是試點區域。想請問你們能否進一步說明，並且或許量化一下本季需求有多少來自那些區域？以及在你們已全面完成 Salesforce 擴編之後，你們預期這些試點中心的經驗會在多大範圍內複製與展開？非常感謝。

Yeah, great. Thank you for your question. I think that to your question on supporting the podiatrist or engaging with the podiatrist and PCP offices, we've taken we're in year five of Cortrophin and we've engaged with new prescribers along the way, right? Over half of our prescribers are new and we're naive to ACTH. And then we obviously have the learnings from the pilots that we did in the middle of last year. For podiatry and PCP. So we've taken all those learnings as we have engaged with the podiatrists and PCP offices, and we have found that on both fronts, both in terms of the engagement and the discussions with the podiatrists and PCPs, as well as in the support that's needed for them.

好的，很好。謝謝你的提問。我想針對你關於支持足病科醫師、或與足病科與基層醫療（PCP）診所互動的問題，我們已經——Cortrophin 進入第5年，我們一路以來都在與新的處方醫師互動，對吧？我們的處方醫師有一半以上是新的，且對 ACTH 並不熟悉。而且我們也明顯有從去年年中所做的試點中獲得的學習。針對足病科與 PCP。因此，當我們與足病科醫師與 PCP 診所互動時，我們把這些學習都納入做法中；我們也發現，在兩個面向上——不論是與足病科醫師與 PCP 的互動與討論，或是他們所需要的支持——都是如此。

Our experiences in the gout expansion to date has been pretty consistent. And then to your and so we were continuing to build on that, right? So very positive and very consistent. I think the second question on contribution from the pilot territories, I mean, remember, there were 10 territories roughly. And then as we've gone into the expansion, we've had about 64 reps, right? And 95% of them are seeing have initiated two or more cases. The impact is beyond the demand generation is beyond the 10-pilot territory. The momentum is across the entire team. So thank you for your questions, Tom.

我們迄今在痛風擴張方面的經驗一直相當一致。然後回到你的問題，我們也持續在此基礎上推進，對吧？所以非常正面且非常一致。我想第二個問題是關於試點區域的貢獻；請記得，當時大約有10個區域。而隨著我們進入擴張階段，我們大約有64位業務代表，對吧？其中95%的人已經看到、並已啟動兩個或以上的個案。其影響不僅僅是需求創造，也不僅限於那10個試點區域。這股動能遍及整個團隊。所以謝謝你的提問，Tom。

Brandon Folkes with HC Wainwright.

HC Wainwright 的 Brandon Folkes。

Hi, thanks for taking my questions. Staying on the Cortrophin guidance, can you just elaborate on the growth of Cortrophin outside of gout, especially those specialties which use a higher number of vials per script? Is Cortrophin use declining in any of those specialties? Secondly, you reiterated Cortrophin guidance in May on a flag in the first half of the year as a driver of the changing guidance.

嗨，謝謝讓我提問。延續 Cortrophin 指引的話題，你能否進一步說明 Cortrophin 在痛風以外的成長情況，特別是那些每張處方會使用較多瓶數的專科？Cortrophin 在這些專科中是否有任何使用量下滑？第二，你在5月重申 Cortrophin 指引，並提到上半年出現一個「旗標」作為指引變動的驅動因素。

So can you just elaborate if those drivers of the guidance change arose in May and June of this year? And if so, are they resolved? If it is just timing on the sales force expansion, why don't we see that bump in 3Q? And then just lastly, outside of the gas sales force expansion, what are the other drivers of the 4Q quadrope and revenue inflection?

所以你能否說明，這些導致指引變動的驅動因素是否是在今年5月與6月出現的？如果是，現在是否已解決？如果只是銷售團隊擴編的時點問題，為什麼我們在第三季看不到那個增幅？最後，除了痛風銷售團隊擴編之外，第四季 Cortrophin 與營收出現拐點的其他驅動因素是什麼？

Good morning, Brandon, and thank you for your questions. So the first question is on the existing specialties. Look, we see strong multi-year growth potential across the existing specialties. And as I mentioned, there's 750,000 addressable patient population outside of the Gallup. Specialty, right? So across the key existing specialties, there are 750,000 patients and we're just, they're significantly under penetrated and there continues to be robust momentum across these existing specialties. The Q2 to Q1 growth of 56% quarter on quarter and the 43% year over year growth was, essentially achieved by the existing specialties.

早安，Brandon，謝謝你的提問。第一個問題是關於既有專科。你看，我們在既有專科領域看到強勁的多年成長潛力。而且如我提到的，在痛風之外有75萬名可觸及的病患族群。也就是在痛風專科之外，對吧？因此，在主要既有專科中有75萬名病患，而我們的滲透率仍明顯偏低，這些既有專科也持續展現強勁動能。第二季相較第一季的季增56%，以及年增43%，基本上都是由既有專科所達成。

And then are you seeing, you asked, is there a slowdown? We are not seeing a slowdown across specialties.

至於你問到是否有放緩，我們沒有看到各專科出現放緩。

In fact, I think one of the things we highlighted is there's a doubling of the ophthalmology volumes year over year. So to give you an example, obviously we're trying to find a balance between sharing information that is helpful with information that is competitively sensitive. So we give that as an example. But as far as 3Q goes, the momentum is strong, right? We gave multiple metrics for July, and especially for existing specialties, we said that there's the highest number of new patient cases initiated in July, right? And obviously, new patient cases initiated translates to new patient starts, translates to volumes dispensed. Yeah, so thank you for your questions, Brandon.

事實上，我想我們強調的一點是，眼科的用量年對年翻倍。所以舉例來說，顯然我們正嘗試在分享有助益的資訊與具競爭敏感性的資訊之間取得平衡。因此我們以此作為例子。但就第三季而言，動能依然強勁，對吧？我們提供了7月的多項指標，尤其針對既有專科，我們說7月啟動的新病患個案數達到最高，對吧？而且很明顯，新病患個案啟動會轉化為新病患開始用藥，進而轉化為實際發藥量。好的，謝謝你的提問，Brandon。

Thank you. I'm showing no further questions at this time. This concludes today's conference call.

謝謝。我目前顯示沒有其他問題。今天的電話會議到此結束。

Thank you for participating. You may now disconnect.

感謝各位參與。您現在可以斷線。