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Operator
Operator
Good day, and welcome our quarter two fiscal year 2026 Dr Reddy's Laboratories Limited. I'm Aishwarya Sitharam and I'm part of the Dr. Reddy's Investor Relations team. (Operator Instructions) I now hand over the conference to Richa Periwal. Thank you.
大家好,歡迎來到瑞迪博士實驗室有限公司 2026 財年第二季。我是艾西瓦婭·西塔拉姆,我是瑞迪博士實驗室投資者關係團隊的一員。(操作說明)現在我將會議交給 Richa Periwal。謝謝。
Richa Periwal - Investor Relations
Richa Periwal - Investor Relations
Thanks, Aishwarya. Good morning, good evening, and a warm welcome to all. We hope you had a joyful and safe Diwali celebrations with your loved ones. Thank you for joining us for Dr. Reddy's Laboratories Q2 FY26 Earnings Conference Call.
謝謝你,艾西瓦婭。各位早安,晚上好,熱烈歡迎各位。我們希望您與親人度過了一個快樂而安全的排燈節。感謝您參加瑞迪博士實驗室2026財年第二季財報電話會議。
We truly value your time and participation.
我們非常重視您的時間和參與。
Joining us today are members of the leadership team. Mr. Erez Israeli, CEO; Mr. MVN, our CFO; and the Investor Relations team. Earlier today, we released our quarterly financial results.
今天到場的有領導團隊的成員。執行長 Erez Israeli 先生;財務長 MVN 先生;以及投資者關係團隊。今天早些時候,我們發布了季度財務業績。
These are now available on your website for your reference. We will begin today's session with MVN providing an overview of our financial performance for the quarter.
這些資訊現已發佈在您的網站上,供您參考。今天的會議將首先由 MVN 概述我們本季的財務表現。
Following that, Erez will share his insights on key business highlights and our strategic outlook. We will then open the floor for questions. Before we proceed, please note that this call is the proprietary material of Dr. Reddy's Laboratories and may not be rebroadcasted or quoted in any media or public forum without prior written consent from the company. This session is being recorded, and both the audio and the transcript will be made available on our website shortly.
接下來,Erez 將分享他對關鍵業務亮點和我們策略展望的見解。接下來我們將開放提問環節。在繼續之前,請注意,本次通話內容屬於瑞迪博士實驗室的專有資料,未經本公司事先書面同意,不得在任何媒體或公共論壇上轉載或引用。本次會議正在錄音,音訊和文字稿很快就會在我們的網站上發布。
All commentary and analysis during this call are based on our IFRS consolidated financial statements. Please note that certain non-GAAP financial measures may also be discussed. Reconciliations to the corresponding GAAP measures are included in our press release.
本次電話會議中的所有評論和分析均基於我們的國際財務報告準則合併財務報表。請注意,文中也可能會討論某些非GAAP財務指標。與對應GAAP指標的調節表已包含在我們的新聞稿中。
Finally, a reminder that the safe harbor provisions outlined in today's press release apply to all forward-looking statements made during the call.
最後提醒大家,今天新聞稿中概述的安全港條款適用於電話會議期間所做的所有前瞻性陳述。
With that, let me now hand it over to MVN to present the financial highlights for the quarter. Over to you, MVN.
接下來,我將把發言權交給MVN,讓他來介紹本季的財務亮點。接下來就交給你了,MVN。
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
Thank you, Richa, and Aishwarya, good evening, and a warm welcome to all. Thank you for joining us on our Q2 FY26 earnings call. I'm delighted to take you through our financial performance for the quarter. We delivered a steady performance in Q2, achieving near double-digit growth despite lower Lenalidomide renamed sales. The acquired consumer health care business supported the top line momentum.
謝謝Richa和Aishwarya,晚上好,熱烈歡迎各位。感謝您參加我們2026財年第二季財報電話會議。我很高興向大家介紹我們本季的財務表現。第二季度我們取得了穩定的業績,儘管來那度胺(Lenalidomide)更名後的銷售額有所下降,但我們仍實現了接近兩位數的增長。收購的消費者保健業務為營收成長提供了支撐。
EBITDA margin stood at 26.7% for the quarter. All financial figures in this section are translated into US dollars using a convenience translation rate of INR88.78, the exchange rate prevailing as of September 30, 2025.
本季 EBITDA 利潤率為 26.7%。本節的所有財務數據均使用 88.78 印度盧比的便捷匯率轉換為美元,該匯率為 2025 年 9 月 30 日的現行匯率。
Consolidated revenue for the quarter stood at INR8,805 crores which is USD992 million, a growth of 9.8% year over year and 3% on sequential basis. While US generics faced product specific price erosion and lower Lenalidomide sales, overall growth was supported by the integration of consumer health care business and double-digit growth delivery across other markets aided by favorable ForEx. Consolidated gross profit margin for the quarter was 54.7%, a decrease of 492 basis points year over year and 223 basis points sequentially. The decrease in margins during the quarter was due to lower Lenalidomide sales and product-specific price erosion in the US generics.
本季綜合營收為 880.5 億印度盧比,即 9.92 億美元,年增 9.8%,季增 3%。儘管美國仿製藥面臨特定產品價格下跌和來那度胺銷量下降,但整體增長得益於消費者保健業務的整合以及其他市場兩位數的增長,而有利的匯率也為此提供了助力。本季綜合毛利率為 54.7%,年減 492 個基點,季減 223 個基點。本季利潤率下降的原因是來那度胺銷售額下降以及美國仿製藥價格下跌。
Onetime inventory provisions from the discontinuation of the certain pipeline products due to technical challenges in the lower operating leverage in PSAI business. Gross margin was 59.1% for global generics and 18% for PSAI. The SG&A spend for the quarter was INR2,644 crores, which is USD298 million, an increase of 15% on year over year and 3% on a sequential basis.
由於 PSAI 業務營運槓桿較低,技術挑戰導致某些管道產品停產,因此產生一次性庫存準備。全球仿製藥的毛利率為 59.1%,PSAI 的毛利率為 18%。本季銷售、一般及行政費用為 264.4 億印度盧比,即 2.98 億美元,年增 15%,季增 3%。
The year over year increase was primarily driven by focused investments in the acquired NRT consumer healthcare business and in branded generics, which are key to driving sustainable growth. SG&A for the quarter includes a onetime provision of INR70 crores for a VAT liability in one of our subsidiaries and charges related to a discontinued pipeline product. SG&A spend accounted for 30% of revenues during the quarter and was higher by 132 basis points year over year and similar levels on a sequential basis.
年比成長主要得益於對收購的 NRT 消費者保健業務和品牌仿製藥的重點投資,而這些業務是推動永續成長的關鍵。本季銷售、一般及行政費用包括為我們的一家子公司一次性提列的增值稅負債 70 億印度盧比,以及與已停產的管道產品相關的費用。本季銷售、一般及行政費用佔營收的 30%,較上年同期成長 132 個基點,較上季成長幅度相近。
Excluding the one-offs related to VAT provision, SG&A expense as a percentage of revenues was at 29.2% in Q2 FY26. The R&D spend for the quarter was INR620 crores, which is USD70 million, a decline of 15% year over year. And broadly, flat sequentially. The decrease was due to reduced development spend on biosimilars during the quarter as major investments for abatacept have already been completed. We continue to make focused R&D investments in complex generics, APIs and biosimilar pipeline while pursuing strategic collaborations to bring innovative assets that support sustainable long-term growth.
剔除與增值稅準備金相關的一次性支出後,2026 財年第二季銷售、一般及行政費用佔收入的百分比為 29.2%。本季研發支出為 620 億印度盧比,約 7,000 萬美元,較去年同期下降 15%。總體而言,順序是平的。由於阿巴西普的主要投資已經完成,因此本季生物相似藥的研發支出減少,導致支出下降。我們持續對複雜的仿製藥、原料藥和生物相似藥產品線進行重點研發投資,同時尋求策略合作,以引進創新資產,從而支持可持續的長期成長。
The R&D spend was 7% of revenues for the quarter, lower by 203 basis points year over year and 26 basis points on a sequential basis. Other operating income for the quarter was INR267 crores, higher than INR98 crores in the corresponding quarter last year. This was mainly on account of product-related IP settlement income in the United States and onetime reversal of INR88 crores in liabilities related to discontinuation of the pipeline product.
本季研發支出佔營收的 7%,年減 203 個基點,較上季下降 26 個基點。本季其他營業收入為 267 億印度盧比,高於去年同期的 98 億印度盧比。這主要是由於在美國獲得了與產品相關的智慧財產權和解收入,以及因停止生產管道產品而一次性衝回了 88 億印度盧比的負債。
EBITDA for the quarter, inclusive of other income, stood at INR2,351 crores which is USD265 million, an increase of 3% on year over year and a sequential basis. The EBITDA margin stood at 26.7%, lowered by 174 basis points on year over year and flat sequentially. Adjusting for the onetime VAT provision mentioned earlier, the underlying EBITDA margin was at 27.5%. Impairment charge was INR66 crores, including INR54 crores for property, plant and equipment at our Middleburg facility following the discontinuation of the pipeline product, conjugated estrogen. The remaining charge pertains to product related to intangibles impacted by adverse market conditions.
本季 EBITDA(包括其他收入)為 235.1 億印度盧比,即 2.65 億美元,年增 3%,季增 3%。EBITDA利潤率為26.7%,較去年同期下降174個基點,較上季持平。扣除前面提到的一次性增值稅準備金後,基本 EBITDA 利潤率為 27.5%。減損費用為 66 億印度盧比,其中包括因停止生產管道產品結合雌激素而導致的位於米德爾堡工廠的房產、廠房和設備的 54 億印度盧比減值費用。剩餘費用與受不利市場條件影響的無形資產相關產品有關。
The net finance income for the quarter was lower at INR77 crores as compared to INR156 crores for the same quarter last year. The decline in net finance income reflects lower returns from financial investment following the deployment of cash reserves towards acquisition of consumer health care business and other intangible assets in line with our capital allocation strategy.
本季淨財務收入為 77 億印度盧比,低於去年同期的 156 億印度盧比。淨財務收入下降反映了根據我們的資本配置策略,將現金儲備用於收購消費者保健業務和其他無形資產後,金融投資回報降低。
As a result, profit before tax for the quarter stood at INR1,835 crores, that is USD207 million. PBT as a percentage revenues was at 20.8% on an adjusted basis, excluding the onetime VAT provision, the PBT margin was at 21.6%. The effective tax rate for the quarter was at 22.2% compared to 30% in the corresponding period last year. The ETR for Q2 FY26 was lower primarily due to favorable jurisdictional mix for the quarter. The ETR in the corresponding period last year was higher due to reversal of previously recognized deferred tax assets related to land indexation following amendments introduced through the Finance Act 2024 to Income-Tax Act 1961.
因此,該季度稅前利潤為183.5億印度盧比,即2.07億美元。經調整後,不包括一次性增值稅準備金,收入佔比為 20.8%,稅前利潤率為 21.6%。本季實際稅率為 22.2%,而去年同期為 30%。2026 財年第二季 ETR 較低主要是由於該季度司法管轄區組合較為有利。由於 2024 年財政法案對 1961 年所得稅法案進行了修訂,導致先前確認的與土地指數化相關的遞延所得稅資產被沖回,因此去年同期有效稅率較高。
Profit after tax attributable to the equity holders of the parent for the quarter stood at INR1,437 crores, which is USD162 million, a growth of 14% on a year over year, flat on QoQ basis. This is at 16.3% of revenues, Diluted EPS for the quarter is INR17.25. Operating working capital as of September 30, 2025 was INR13,331 crores, which is in USD1.5 billion, an increase of INR3 crores, which is like USD0.4 million over June 30, 2025. CapEx cash outflow for the quarter stood at INR511 crores, which is INR58 million. Free cash flow generated during the quarter was INR1,046 crores, which is USD118 million.
本季歸屬於母公司股東的稅後利潤為 143.7 億印度盧比,即 1.62 億美元,年增 14%,環比持平。這佔收入的 16.3%,本季稀釋後每股收益為 17.25 印度盧比。截至 2025 年 9 月 30 日,營運資金為 1,333.1 億印度盧比,約 15 億美元,比 2025 年 6 月 30 日增加了 3,000 萬印度盧比,約 40 萬美元。本季資本支出現金流出為 511 億印度盧比,即 5,800 萬印度盧比。本季產生的自由現金流為 104.6 億印度盧比,即 1.18 億美元。
As of September 30, we have a net cash surplus of INR2,751 crores which is like USD310 million. Foreign currency cash flow hedges executed through derivative instruments during the period are as follows: USD502 million hedged using combination of forward structured derivative contracts scheduled to mature through December 2026. These contracts are hedged at the rate of INR86.9 per US dollar, RUB4.28 billion hedged at a fixed rate of 1.03 per Russian ruble with maturity falling within next four months.
截至9月30日,我們擁有275.1億印度盧比的淨現金盈餘,約3.1億美元。本期間透過衍生性商品執行的外幣現金流避險情況如下:使用遠期結構化衍生合約組合對沖 5.02 億美元,這些合約將於 2026 年 12 月到期。這些合約以每美元 86.9 印度盧比的匯率進行避險,42.8 億盧布以每盧布 1.03 的固定匯率進行避險,到期日為未來四個月內。
With this, I request Erez to take us through the...
接下來,我請埃雷茲帶我們了解…
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Thank you, MVN. Good day, everyone, and thank you for joining us today. We are pleased to report a consistent performance in Q2 FY26, marked by a double-digit growth and steady profitability.
謝謝你,MVN。大家好,感謝各位今天收看我們的節目。我們很高興地報告,2026 財年第二季業績表現穩定,實現了兩位數成長和穩定的獲利能力。
This performance was driven by contributions across all key markets except for the US generic business. During the quarter, we continued to make a meaningful progress across our strategic priorities namely growing the base, scaling our presence in consumer health care, innovative therapies and biosimilars. We advanced our key pipeline programs, including semaglutide and abatacept.
這一業績得益於除美國仿製藥業務以外的所有主要市場的貢獻。本季度,我們在各項策略重點方面持續取得實質進展,即擴大客戶基礎,擴大我們在消費者保健、創新療法和生物相似藥領域的業務。我們推進了關鍵的研發管線項目,包括索瑪魯肽和阿巴西普。
In addition, we have been driving initiatives to enhance cost efficiencies across our operations while simultaneously pursuing business development activity to support sustainable growth in the coming quarters. Let me now walk you through some of the key highlights of the quarter. Revenue grew by 10% year on year driven by broad-based growth across businesses, benefiting from acquired consumer health care and supported by a favorable ForEx. Growth was partially offset by lower contribution from Lenalidomide and some price erosion in the US in some select products.
此外,我們一直在積極推動各項舉措,以提高營運成本效率,同時開展業務拓展活動,以支持未來幾季的永續成長。現在讓我帶您了解本季的一些主要亮點。受各業務全面成長的推動,營收年增 10%,受益於收購的消費者保健業務,並受到有利的外匯匯率的支持。成長部分被來那度胺貢獻減少以及美國部分特定產品的價格下跌所抵銷。
The EBITDA margin stood at 26.7%. The ROCE for the quarter was around 22%. The cash flow from operation was utilized to our plant expansions and acquisition of strategic brands and securing rights for distribution in defined markets.
EBITDA利潤率為26.7%。本季資本回報率約為 22%。經營活動產生的現金流量用於工廠擴建、收購策略品牌以及取得特定市場的經銷權。
We closed the quarter with net cash surplus of $310 million reinforcing the strength of our balance sheet. We strengthened our innovation-led portfolio to strategic collaboration and launches. We entered the anti-vertigo segment with the acquisition of Stugeron and related brands across 18 markets in APAC and EMEA from Janssen Pharmaceutica.
本季末,我們淨現金盈餘達 3.1 億美元,進一步鞏固了我們資產負債表的穩健性。我們加強了以創新為導向的產品組合,以促進策略合作和產品發布。我們透過從 Janssen Pharmaceutica 收購 Stugeron 及其在亞太和歐洲、中東及非洲 18 個市場的相關品牌,進入了抗眩暈領域。
In India, we strengthened our gastrointestinal portfolio with the launch of two novel drugs Tegoprazan under the brand name of PCAB and Linaclotide under the brand name of Colozo. In partnership with Unitaid, Clinton Health Access Initiative & Wits RHI, we are working to make Lenacapavir, a long-acting HIV prevention tool accessible and affordable in low and middle-income countries. We continue to make progress on our key pipeline products. The subject expert committee, the SEC under Central Drug Standard Control Organization has recommended approval for semaglutide injection in India. We received a positive opinion from European Medicines Agency Committee for medicinal products for human use for denosumab biosimilar candidate.
在印度,我們透過推出兩種新藥加強了我們的胃腸道產品組合,這兩種新藥分別是商品名為 PCAB 的 Tegoprazan 和商品名為 Colozo 的 Linaclotide。我們與 Unitaid、克林頓健康倡議組織和威特沃特斯蘭德大學 RHI 合作,致力於讓長效 HIV 預防藥物 Lenacapavir 在中低收入國家變得可及且價格合理。我們在關鍵在研產品方面持續取得進展。由中央藥品標準控制組織 (CDSCO) 下屬的專家委員會 SEC 建議批准在印度使用司美格魯肽注射。我們收到了歐洲藥品管理局人用藥品委員會對地諾單抗生物相似藥候選物的正面意見。
The US FDA accepted our investigational new drug's IND application for COYA 302, a partner novel drug for the treatment patients with ALS. We also made a steady progress on integrating the acquired nicotine replacement therapy business. We have successfully integrated 2/3 of the business by value, including Canada, Australia and selected key Western European markets. The next phase will include Southern Europe, Israel and Taiwan.
美國FDA已接受我們用於治療ALS患者的新型研究藥物COYA 302的IND申請,COYA 302是我們的合作新藥。我們在整合收購的尼古丁替代療法業務方面也取得了穩步進展。我們已成功整合了價值佔業務三分之二的業務,包括加拿大、澳洲和部分重要的西歐市場。下一階段將包括南歐、以色列和台灣。
On the regulatory front, several inspections were completed across our global facilities. In September 2025, the US FDA conducted a pre-approval inspection on our Bachupally biologics facility and issued a Form 483 with five observations. The agency recently issued a complete response letter in reference to the ongoing resolution of observation pertaining to the biologic license application, the BLA of our rituximab biosimilar candidate. We are actively working to address these observations.
在監管方面,我們對全球各地的設施進行了多次檢查。2025 年 9 月,美國 FDA 對我們位於巴丘帕利的生物製品生產設施進行了上市前檢查,並簽發了 483 表格,提出了五項觀察意見。該機構最近就我們利妥昔單抗生物相似藥候選藥物的生物製品許可申請 (BLA) 的觀察結果的持續解決情況,發布了一封完整的回复函。我們正在積極努力解決這些問題。
The US FDA conclude a GMP inspection at our Mirfield API facility in the UK, resulting in issuing a Form 483 containing seven observations. Additionally, our API site CTO-5 in Miryalaguda, in Telangana as well as our Middleburgh facility in New York were classified as VAI following successful GMP inspection by the US FDA. The GMP and pre-approval inspection PAI conducted by the US
美國 FDA 對我們在英國米爾菲爾德的 API 工廠進行了 GMP 檢查,結果簽發了包含七項觀察結果的 483 表格。此外,我們在特倫甘納邦米里亞拉古達的 API 工廠 CTO-5 以及我們在紐約州米德爾堡的工廠在成功通過美國 FDA 的 GMP 檢查後,被評為 VAI。美國進行的GMP和上市前檢查PAI
FDA in July 2025, at our formulation manufacturing facility, FTO-11 has been formally closed. We have received the EIR establishment inspection report with the inspection outcome categorized as VAI. We continue to be recognized for our industry-leading performance in sustainability.
FDA2025 年 7 月,我們製劑生產設施中的 FTO-11 正式關閉。我們已收到EIR機構檢查報告,檢查結果被歸類為VAI。我們在永續發展方面持續保持行業領先地位,並因此獲得認可。
We retained our MSCI ESG Rating for A for the second consecutive year. Our ESG Risk Rating from Morningstar Sustainalytics improved from 23.6% to 18.4%, representing a lower ESG risk profile. Our waste management practices were recognized with the Diamond Standard for achieving 99.9% of waste diversion from landfills. Further our formulation facilities at Srikakulam FTO-11 became India's first pharmaceutical facility to receive a Leadership in Energy and Environmental Design, Platinum Certification for existing buildings from US Green Building Council.
我們連續第二年保持了MSCI ESG A級評級。來自 Morningstar Sustainalytics 的 ESG 風險評級從 23.6% 提高到 18.4%,顯示 ESG 風險狀況降低。我們的廢棄物管理實踐獲得了鑽石標準認證,實現了 99.9% 的廢棄物從垃圾掩埋場轉移出去。此外,我們在斯里卡庫拉姆 FTO-11 的製劑生產設施成為印度第一家獲得美國綠色建築委員會頒發的現有建築能源與環境設計先鋒獎鉑金認證的製藥企業。
Let me take -- let me take you through the key business highlights for the quarter. Please note that all financial figures mentioned are reported in their respective local currencies. Our North American generic business generated revenues of $373 million for the quarter, a decline of 16% year on year and 7% sequentially. The performance was impacted by price erosion in selected key products, primarily Lenalidomide. During the quarter, we launched seven new products and expect launch momentum to continue in the second half of the fiscal.
讓我帶您了解本季的主要業務亮點。請注意,文中提及的所有財務數據均以其各自的當地貨幣列示。本季度,我們的北美仿製藥業務收入為 3.73 億美元,年減 16%,季減 7%。部分重點產品(主要是來那度胺)的價格下跌影響了業績。本季我們推出了七款新產品,預計下半年將繼續保持這一上市動能。
Our European business reported revenue of $135 million for the quarter, growth of 150% on a year-to-year basis and 3% on quarter on quarter. The year on year performance was primarily driven by contribution from the acquired nicotine replacement therapy portfolio and new product launches, which offset the price erosion pressure -- the pricing pressure. Excluding the NRT, the growth was 6% year on year and quarter on quarter. During the quarter, we launched eight new generic products across European markets, further strengthening our portfolio.
我們的歐洲業務本季營收為 1.35 億美元,年增 150%,季增 3%。年比業績主要得益於收購的尼古丁替代療法產品組合和新產品上市帶來的貢獻,這抵消了價格侵蝕壓力——即定價壓力。剔除NRT後,年增6%,季增6%。本季度,我們在歐洲市場推出了八款新的仿製藥,進一步加強了我們的產品組合。
Our emerging market business delivered revenue of INR1,655 crores in Q2 reflecting a growth of 14% year on year and 18% sequentially. Growth was primarily driven by new product launches across markets and aided by favorable ForEx. During the quarter, we introduced 24 new products across multiple countries, reinforcing our commitment to expanding access and strengthening our market presence. Within this segment, our Russia business delivered a growth of 13% year on year and 18% sequentially in constant currency terms despite prevailing macroeconomic challenges.
我們的新興市場業務在第二季度實現了 165.5 億印度盧比的收入,年增 14%,季增 18%。成長主要由各市場的新產品推出推動,並得益於有利的匯率。本季度,我們在多個國家推出了 24 款新產品,進一步鞏固了我們擴大市場覆蓋範圍和加強市場地位的承諾。在該業務板塊中,儘管面臨宏觀經濟挑戰,我們的俄羅斯業務按固定匯率計算仍實現了同比增長 13% 和環比增長 18%。
Our India business reported revenues of INR1,578 crores in Q2, delivering a double-digit year on year growth of 13% and 7% increase sequentially. This performance was driven by contribution from new product launches, improved pricing and higher volumes. According to IQVIA, we have moved up one place to the 9th position in India pharmaceutical market for the month of September and continued to outpace market growth.
我們的印度業務第二季營收為 157.8 億印度盧比,年成長 13%,季增 7%,實現了兩位數成長。這一業績的提升得益於新產品上市、價格上漲和銷售增加。根據 IQVIA 的數據,我們在 9 月的印度醫藥市場排名上升一位至第 9 位,並持續保持市場成長速度。
With moving annual total MAT growth of 9.4% compared to IPM 7.8% growth. During the quarter, we launched 11 new brands in addition to the acquired Stugeron portfolio, further strengthening our domestic franchise. Our PSAI business reported revenue of $108 million in Q2 FY26, registering growth of 8% year over year and 13% sequentially. During the quarter, we filed 37 Drug Master Files globally. We have further sharpened our R&D focus on programs that offer clear differentiation and strong commercial potential in alignment with our strategic priorities.
與IPM 7.8%的成長率相比,MAT年度總成長率為9.4%。本季度,除了收購的 Stugeron 產品組合外,我們還推出了 11 個新品牌,進一步加強了我們在國內的品牌影響力。我們的 PSAI 業務在 2026 財年第二季營收 1.08 億美元,年增 8%,季增 13%。本季度,我們在全球提交了 37 份藥品主文件。我們進一步加強了研發重點,致力於研發具有明顯差異化優勢和強大商業潛力的項目,以符合我們的策略重點。
We have rationalized few pipeline products that face extended regulatory uncertainty limited market opportunity or increasing competitive intensity.
我們對面臨長期監管不確定性、市場機會有限或競爭日益激烈的少數在研產品進行了合理化調整。
Our focus is anchored around company generic GLP-1 molecules and biosimilar. In addition, we are actively pursuing strategic collaboration and partnership to enhance our innovation ecosystem, accelerate development time lines and expand our capabilities in emerging therapeutic areas. During the quarter, we completed 43 global generic filings. For the quarters ahead, we are focused on robust execution to deliver on our strategic priority, meaning grow our base business, focus on our key pipeline assets like semaglutide and abatacept improving operational efficiency and productivity across the value chain. And we continue to actively explore partnership and value-accretive acquisitions that support our strategic vision and innovation momentum while enhancing our capabilities.
我們的重點是公司通用GLP-1分子和生物相似藥。此外,我們正在積極尋求策略合作與夥伴關係,以增強我們的創新生態系統,加快研發進度,並擴大我們在新興治療領域的能力。本季度,我們完成了 43 項全球仿製藥申報。在接下來的幾個季度裡,我們將專注於穩健執行,以實現我們的戰略重點,即發展我們的基礎業務,專注於我們的關鍵在研資產,如索馬魯肽和阿巴西普,提高整個價值鏈的營運效率和生產力。我們將繼續積極探索合作夥伴關係和增值收購,以支持我們的策略願景和創新勢頭,同時增強我們的能力。
These efforts are aimed to driving sustainable growth and delivering long-term value for our stakeholders. And with that, I will welcome your thoughts and questions as we move into the QA session.
這些努力旨在推動永續成長,並為我們的利害關係人創造長期價值。接下來,我歡迎大家在問答環節提出意見和問題。
Operator
Operator
(Operator Instructions) Neha Manpuria, Bank of America.
(操作員說明)Neha Manpuria,美國銀行。
Neha Manpuria - Analyst
Neha Manpuria - Analyst
Yeah, thanks so much, [Aisha]. Good evening. My first question is on the US business. While I know you talked about product specific erosion and REVLIMID quarter on quarter. One, should we expect any REVLIMID all in the third quarter? And second question on the US
是啊,非常感謝![艾莎]晚安.我的第一個問題是關於美國商業的。我知道您談到了特定產品侵蝕和瑞復美(REVLIMID)的季度環比情況。第一,我們是否應該預期瑞復美(REVLIMID)會在第三季全部上市?第二個問題是關於美國的。
business. You've seen a product discontinuation this year. Last year, we saw NuvaRing being discontinued. You continue to spend a fair bit on R&D. How should we think about the US
商業。今年您已經看到一些產品停產了。去年,我們看到 NuvaRing 停產了。你們在研發方面持續投入大量資金。我們該如何看待美國
product pipeline? Because if I look at Reddy's approval history while we have got a fair bit of approvals, we haven't really got any meaningful large launch approval outside of REVLIMID and probably Vascepa was the last one that I can think about. So I just wanted your thoughts on how we should look at some of these more meaningful launches coming through now that conjugated estrogen has been discontinued. How do you think about the US growth.
產品線?因為如果我看一下瑞迪製藥的審批歷史,雖然我們獲得了相當多的批准,但除了瑞復美(REVLIMID)之外,我們還沒有真正獲得任何有意義的大規模上市批准,而Vascepa可能是我能想到的最後一個。所以我想聽聽你們的看法,既然結合雌激素已經停產,我們應該如何看待現在湧現的一些更有意義的新產品。您如何看待美國經濟成長?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So just, Neha, I think there was some thing with the voice. Just the beginning of your question, I got the rest of it. Since the beginning of the question, I could not hear it sorry about it.
所以,Neha,我覺得你的聲音可能有點問題。我只回答了你問題的開頭部分,剩下的我都明白了。從問題一開始我就沒聽清,對此我感到很抱歉。
Neha Manpuria - Analyst
Neha Manpuria - Analyst
Yes. No problem. I was asking that, is it fair to assume that there would be no REVLIMID limit in the third quarter? Or would we still see some bits of REVLIMID as a part of the settlement in the third quarter?
是的。沒問題。我當時想問的是,是否可以合理假設第三季不會對瑞復美(REVLIMID)實施限制?或者我們還能在第三季的結算協議中看到一些來那度胺的成分?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So we should assume that we will have and -- but less than what was in this quarter. So -- and likely that it's either going to be the last quarter or maybe some tail that will go into Q4. But by and large, Q3 will still have REVLIMID in it. On the R&D question, first, I agree with you. We -- there were certain products that we tried for a while to get an approval.
所以我們應該假設我們會有,但會比本季少。所以——很可能要不是最後一個季度,就是會延續到第四季的尾聲。但總的來說,Q3 仍然會有來那度胺。關於研發問題,首先,我同意你的觀點。我們—我們曾嘗試過一些產品一段時間以獲得批准。
And as we did not get, we kind of pull the trigger on them. We kind of gave ourselves a certain time lines that if we don't we just move on. As we speak, the main products in the United States as related to R&D will be the biosimilars I think the main products in terms of significant growth in the United, which will be abatacept.
由於我們沒有得到他們,我們就對他們採取了行動。我們為自己設定了一些時間期限,如果達不到,我們就繼續前進。就目前而言,我認為美國研發領域的主要產品將是生物相似藥,而就美國市場而言,我認為成長最為顯著的主要產品將是阿巴西普。
On the small molecules, we do have meaningful products that are coming primarily peptides, long-acting peptides. Some of them we missed the first to file, but they are still meaningful. The overall pipeline is about 100 products as we speak, we will tick in the pipeline. And out of that about, I would say, around 20 that will be considered what we call the complex generics. But as we discussed many times in the past, it's hard to predict on this product.
在小分子方面,我們確實有一些有意義的產品,主要來自肽類,長效肽類。有些我們錯過了最早提交的時間,但它們仍然很有意義。目前整個研發管線大約有 100 個產品,我們將逐一進行審核。其中大約有 20 個將被視為我們所謂的複雜仿製藥。但正如我們過去多次討論過的那樣,這款產品很難預測。
So your observation is correct. What we absolutely did is that we're relooking our portfolio, and we are focusing on products that we believe that we have a good chance to be first to market as time will come.
所以你的觀察是正確的。我們所做的,就是重新審視我們的產品組合,並將重點放在我們認為未來很有可能率先推向市場的產品上。
Neha Manpuria - Analyst
Neha Manpuria - Analyst
Understood, Erez. Erez, if I were to just extend this question then to, let's say, a sema filing or abatacept filing. What gives you confidence on getting approvals on those filings? Even in case of abatacept, now that Bachupally, we have got a CRL on rituximab. I'm just wondering if -- I know there's always risk to approval, but how should we think about management's confidence in getting approval for sema in Canada or next year as we think about the abatacept?
明白了,埃雷茲。Erez,如果我把這個問題延伸到,比如說,SEMA備案或Abatacept備案。為什麼對這些申請獲得批准有信心?即使是阿巴西普,現在有了 Bachupally,我們也收到了利妥昔單抗的 CRL。我只是想知道——我知道審批總是有風險的,但是當我們考慮阿巴西普時,我們應該如何看待管理層對明年在加拿大獲得 SEMA 批准的信心?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So on abatacept, let's go with abatacept and I'll go to sema after. On abatacept, we are supposed to submit the BLA, and I'm very confident about it in the end of December of this year -- calendar year, end of end of December 2025, which is exactly the date that we aim to. Here, I have a high level of confidence. It's also important to us because it will open the door for us to launch also the subcu, which is the more important SKU at the beginning of 2028, subject to settlement, of course, of the IP. The confidence comes that we are not doing only with Bachupally, but we increased the chance because we will have also for the United States, CMO that will make it, the product.
所以,關於阿巴西普,我們就先用阿巴西普,之後我再去用賽瑪。根據 abatacept 的規定,我們應該提交 BLA,我對今年 12 月底(日曆年,即 2025 年 12 月底)提交 BLA 非常有信心,這正是我們計劃的目標日期。我對此充滿信心。這對我們來說也很重要,因為它將為我們在 2028 年初推出子產品(更重要的 SKU)打開大門,當然,前提是智慧財產權問題得到解決。我們有信心,因為我們不僅在做 Bachupally,而且我們增加了機會,因為我們還將在美國擁有 CMO,由他來生產該產品。
I'm less concerned about the European approval because Bachupally was already approved by European, but not yet by the US FDA.
我不太擔心歐洲的批准,因為 Bachupally 已經獲得了歐洲的批准,但還沒有獲得美國 FDA 的批准。
And also, in the case of the US, we don't yet know what will happen with the tariff on biologics, while we feel now more comfortable giving all the press that likely there will be no tariff. We need to see when the guidelines will come. But as a balance sheet, we don't know, and we felt the need to have a backup also there. So we will -- if we will not be able to launch from Bachupally we'll be able to launch from the United States. And this will enable us also a potential challenge, if will happen on tariff.
此外,就美國而言,我們還不知道生物製劑的關稅會如何變化,但我們現在更有信心向媒體透露,很可能不會徵收關稅。我們需要看看相關指導方針何時出台。但從資產負債表的角度來看,我們並不清楚,所以我們覺得有必要準備備份。所以,如果我們不能從巴丘帕利發射,我們將從美國發射。如果關稅方面出現問題,這將使我們能夠應對潛在的挑戰。
On the sema, we are expecting the feedback from Health Canada in the next few weeks. It can be any day, but it can be within the next few weeks. And we know if we get that efficiency or not. I'm certain that we will launch all the 12 million pens that I discussed with you last time, obviously, if it will not be in Canada, it will be in other places. So the launch is going to happen.
關於 SEMA,我們預計在未來幾週內會收到加拿大衛生部的回饋。可能是任何一天,但也可能就在未來幾週內。我們知道是否達到了那種效率。我確信我們會推出上次我跟你討論過的1200萬支鋼筆,顯然,即使不在加拿大推出,也會在其他地方推出。所以發射肯定會進行。
The question, of course, if we get a CRL or we'll get something in Canada, obviously, the pricing may be different. But I'm confident that we will sell the product. The question is which market they would come. Can I guarantee that we'll not get the CRL, though I cannot, I wish.
當然,問題是,如果我們拿到 CRL 或在加拿大拿到一些東西,價格顯然會有所不同。但我相信我們一定能賣出這款產品。問題是他們會進入哪個市場。我能保證我們不會收到 CRL 嗎?雖然我不能,但我希望如此。
Neha Manpuria - Analyst
Neha Manpuria - Analyst
Yeah, that's thanks so much.
是啊,太感謝了。
Operator
Operator
Damayanti Kerai, HSBC.
Damayanti Kerai,匯豐銀行。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Hi. Yeah, hi, I hope I'm audible.
你好。嗨,希望我的聲音能被聽到。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes, absolutely. Okay.
是的,絕對的。好的。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Thank you for the opportunity. My first question is again on semaglutide. So Erez, can you remind us the legal status, which was underway in India, litigation with Novo on semaglutide?
謝謝您給我這個機會。我的第一個問題仍然是關於司美格魯肽的。那麼 Erez,你能提醒我們一下,之前在印度進行的關於索馬魯肽的訴訟的法律現狀嗎?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Sure. We are challenging the patents in India. And it's in the -- currently in the high court in Delhi. All the hearings were done, and we are waiting for the decision of the judge. We don't know exactly when she will submit her decisions.
當然。我們正在對印度的專利提出質疑。目前該案正在德里高等法院審理。所有聽證會都已結束,我們正在等待法官的判決。我們尚不清楚她何時會提交決定。
And likely that we ever will not like the decision will appeal. So likely that it will continue after but at this stage, the hearing are done, and we are waiting for the outcome of the decision of the judge.
而且,我們很可能會對這個決定不滿意而提起上訴。因此,此事很可能會繼續下去,但目前聽證會已經結束,我們正在等待法官的裁決結果。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Sure. And just to clarify, this outcome should not be impacting your plans in the ex-India market, right? The markets outside of India?
當然。需要澄清的是,這一結果不應該影響您在印度以外市場的計劃,對嗎?印度以外的市場呢?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Depends what will be the decision of the judge. What we are seeking, we believe that the patent is invalid. And in any case, as we speak today, by the decision that was done in May, we are -- we can produce an export, not to do it in India, but the court in the decision back in May on the -- allowed us to continue to make the product and to export it. In terms of -- in the current state, we can launch in India only at patent expiration, which is right now dated to March '26.
這取決於法官的判決。我們認為,我們所尋求的專利無效。總而言之,正如我們今天所說,根據五月所做的決定,我們可以生產出口產品,雖然不是在印度生產,但法院在五月的裁決中允許我們繼續生產和出口該產品。就目前情況而言,我們只能在專利到期後才能在印度推出產品,而目前的專利到期日是 2026 年 3 月。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Okay. That's clear. My second question is going back to abatacept. So just clarifying earlier discussions. So did you mention you have a CMO in place to manufacture that product in case Bachupally takes some time to get the clearance from the FDA?
好的。這一點很清楚。我的第二個問題是關於阿巴泰克(abatacept)。澄清一下之前的討論。所以你有沒有提到,如果 Bachupally 需要一些時間才能獲得 FDA 的批准,你們已經安排了一家合約生產商來生產該產品?
Or what is the arrangement? Like what kind of risk mitigation strategies are in place?
或者,具體安排是什麼?例如,目前有哪些風險緩解策略?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Sure, correct. So we will have -- I did mention that we will have a CMO in the United States to produce abatacept, in addition to our capacity that is built in Bachupally, India and it's mitigating three risks.
沒錯。因此,我們將——我之前提到過,除了我們在印度巴丘帕利建立的產能外,我們還將在美國設立一家合約生產商來生產阿巴西普,這可以降低三個風險。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Hello.
你好。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes. Can you hear me now?
是的。現在能聽到我說話嗎?
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Yes, I can hear you now.
是的,我現在可以聽到你說話了。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So it's addressing three risks. One is in a case that it will be again, CRL or any regulatory challenges that we will be able to launch from already approved FDA sites in America. Second, if there will be any tariff or any other potential restriction or regulatory burden assets related to make or sell biosimilar in the United States. And number three, to increase capacity. It's allowing us more capacity in the case that we will get nice market share.
所以它解決了三個風險。其中之一是,如果再次出現 CRL 或任何監管挑戰,我們將能夠從美國 FDA 已批准的站點啟動。第二,如果在美國生產或銷售生物類似藥相關的資產會受到任何關稅或其他潛在限製或監管負擔。第三,提高產能。這樣一來,如果我們能獲得可觀的市場份額,我們就能擁有更大的產能。
So we're absolutely going with the CMO option in the United States.
所以我們絕對會在美國採用CMO模式。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Okay. That's helpful. And my last question is for semaglutide, I understand you're working on your in-house fill and finish capacity. So can you share the update on that project?
好的。那很有幫助。我的最後一個問題是關於司美格魯肽的,我了解到你們正在努力提高內部填充和包裝能力。能否分享一下該專案的最新進展?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
It's going on. It will not impact the launches in the next 12 months because by the time that we will have to submit and qualify it, it will be post approval in all the countries. So the -- working with the partner that we have today. This is the famous 12 million units that we discussed in the past. This is still relevant and maybe with some upside.
正在進行中。這不會影響未來 12 個月的上市計劃,因為等到我們需要提交申請並獲得認證時,該產品已在所有國家獲得批准。所以——就是和我們今天的合作夥伴一起工作。這就是我們之前討論過的著名的1200萬台。這仍然具有現實意義,而且可能還有一些積極的方面。
But right now, I think we are about the same range. And this will happen with the current partners, but we will have two cartridge lines in FTO-11. And this will be significantly expanded capacity to many, many more millions. But let's see that we let's say, in that respect, it can go to even up to $50 million, but it's all theoretical at this stage. It will be relevant not for the next 12 months, but for the period after that.
但就目前而言,我認為我們大致處於同一水平。這種情況會與目前的合作夥伴發生,但我們將擁有兩條 FTO-11 墨盒生產線。這將使產能大幅提升,惠及數百萬人。但讓我們看看,比如說,在這方面,它甚至可以達到 5000 萬美元,但這在現階段都只是理論上的。它在未來12個月內可能不適用,但在此之後的一段時間內卻適用。
Damayanti Kerai - Analyst
Damayanti Kerai - Analyst
Sure, that's helpful. I'll get back in the queue. Thank you.
當然,這很有幫助。我重新排隊。謝謝。
Operator
Operator
Dr. Bino Pathiparampil, Elara Capital.
Bino Pathiparampil 博士,Elara Capital。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
Hi, good evening of you. First question on the India market, India business had a strong growth in the quarter. Is there anything in particular that helped you? And was there any impact related to the GST disruption in the quarter?
您好,晚上好。第一個問題是關於印度市場,印度業務在本季實現了強勁成長。有什麼特別對你有幫助的方法嗎?該季度是否受到消費稅(GST)相關幹擾的影響?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes. So we manage well the GST. So the GST was not a significant obstacle for us. We manage that well. It's just execution of our strategy, the way we discussed it for many quarters.
是的。所以我們對消費稅的應對很到位。所以消費稅對我們來說並不是一個重大障礙。我們處理得很好。這只是我們策略的執行,也是我們幾個季度以來討論過的戰略。
We identify the therapeutic areas that we want to focus on. And we made several inorganic moves to buy brands that allow us relevant access. So as well as licensing of innovative products. and just working well and it's likely to continue. We said all along that we believe that innovation will allow us to outpace the market, and we feel very, very comfortable now about that strategy.
我們確定了想要重點關注的治療領域。我們也進行了一些非有機成長,收購了一些能讓我們獲得相關資源的品牌。所以,除了創新產品的授權之外,一切進展順利,而且這種情況很可能會持續下去。我們一直堅信創新將使我們能夠超越市場,現在我們對這項策略感到非常非常有信心。
I think more and more people see that now.
我認為現在越來越多的人都意識到了這一點。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
Understood. You have recently done this acquisition of the Stugeron brand from Janssen. Can you give some idea about what sort of revenues does that business have in its acquired form.
明白了。您最近從 Janssen 收購了 Stugeron 品牌。能否大致介紹一下這家企業被收購後的收入狀況?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So it's 100 plus in terms of size, something like that.
所以它的尺寸超過100,大概就是這樣。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
$100 million?
1億美元?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
No, INR100 Cr, this is in India.
不,是100億印度盧比,這是在印度。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
That is India.
這就是印度。
Richa Periwal - Investor Relations
Richa Periwal - Investor Relations
Bino, India and emerging markets put together.
Bino、印度和新興市場合在一起。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
Is INR100 Cr. And for that, if I'm right, you paid USD15 million.
是 100 億印度盧比。如果我沒記錯的話,你為此支付了 1500 萬美元。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Correct.
正確的。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
Okay. Understood. And any benefit of that in the growth for the quarter is some 20 days of that part of India business?
好的。明白了。而這帶來的季度成長效益僅僅是印度業務那部分20天左右的時間嗎?
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
Not much.
不多。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
No, no, it was very...
不,不,那非常…
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
Insignificant.
微不足道。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes. You can take it as no real impact.
是的。你可以把它看作沒有實際影響。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
Got it. And my last question on the margin outlook beyond REVLIMID. Of course, we keep asking this every quarter. But if you look at current quarter, even with Lenalidomide, if we remove the other income from the EBITDA margin, it is below 23% and with Lenalidomide further coming down in the next quarters, it may fall even further. So do you still fully stick that for full year FY27, you will get back to 25% EBITDA margin?
知道了。我最後一個問題是關於瑞復美(REVLIMID)之後的利潤前景。當然,我們每季都會問這個問題。但如果你看一下當前季度,即使算上來那度胺,如果我們從 EBITDA 利潤率中剔除其他收入,它也低於 23%,而且隨著來那度胺在接下來的幾個季度進一步下降,它可能會進一步下降。所以你仍然完全堅持認為,在2027財年全年,EBITDA利潤率將恢復到25%嗎?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
I'm not sure how did you get to the 23%. I'm aware of 26.7%. But nevermind. Yes, absolutely. Lenalidomide is with higher margin, everybody knows that.
我不太清楚你是怎麼算出23%這個數字的。我知道有 26.7%。不過沒關係。是的,絕對的。來那度胺的利潤率更高,這是眾所周知的。
And naturally, it's impacting and anticipating that we are discussing for four years. We knew exactly when Lena is going to go. And it's happening exactly as we discussed. We are addressing it with a lever that I mentioned, growing the base, contain the cost of BD and focus on these key products. I absolutely believe and I'm maintaining it that in the next two years we will absolutely get back to the growth and to the margins.
當然,我們正在討論四年之久,這無疑會產生影響並引發討論。我們確切地知道莉娜什麼時候會離開。事情的發展正如我們之前所討論的。我們正在利用我提到的槓桿來解決這個問題,即擴大客戶基礎,控制業務拓展成本,並專注於這些關鍵產品。我堅信,而且我始終認為,在未來兩年內,我們一定能夠恢復成長並達到利潤率。
The question is, what will be the journey in this point of time. The more sema we will have, the more growth we'll have, the more BD we'll have, we can actually do it much, much faster. So we are maintaining our commitment for the margins, we are maintaining our commitment for growth. The question is what will be the scenarios between sema, abatacept and BD primarily. And of course, because on the levers that we can control better, we are very confident that this is the base and the cost.
問題是,在此時此刻,我們將走向何方。我們擁有的 SEMA 越多,我們的成長就越多,我們的 BD 就越多,我們實際上可以更快地完成這一切。因此,我們將繼續致力於提高利潤率,並繼續致力於實現成長。問題是,塞瑪、阿巴西普和BD之間主要會有哪些競爭局面。當然,因為我們能夠更好地控制的因素,我們非常有信心這就是基礎和成本。
Bino Pathiparampil - Analyst
Bino Pathiparampil - Analyst
Understood. Thank you. I'll jump back.
明白了。謝謝。我跳回去。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Thank you.
謝謝。
Operator
Operator
Saion Mukherjee, Nomura.
Saion Mukherjee,野村證券。
Saion Mukherjee - Analyst
Saion Mukherjee - Analyst
Yeah, hi. Thanks for taking my question. My first question is on the US-based business. There has been a lot of price erosion over the last three, four years since you have launched REVLIMID how is the base today versus, let's say, before REVLIMID? Is it up, down? If you can give some color so that we get a sense where we should assume the number post-REVLIMID?
嗨,你好。謝謝您回答我的問題。我的第一個問題是關於這家美國公司。自 REVLIMID 上市以來的三、四年間,價格已經大幅下降。現今的市場基礎與 REVLIMID 上市前相比如何?是上升還是下降?如果可以的話,能否提供一些細節信息,以便我們了解在 REVLIMID 之後應該如何估計這個數字?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Sure. So it went down. It went down primarily not so much on volume. There were some products, about I think five that faced competition and price erosion, and that's what took it down. It's not significantly down.
當然。於是,它就倒下了。銷量下降的主因並非銷售本身。大約有五種產品面臨競爭和價格侵蝕,這就是導致它們失敗的原因。下降幅度並不大。
Most of the decline that you see is Lena, Lenalidomide but if you want to compare, it is done.
你看到的大部分下降都是由於來那度胺(Lena)引起的,但如果你想進行比較,那就已經完成了。
Saion Mukherjee - Analyst
Saion Mukherjee - Analyst
And do you see it sort of stabilizing now from the current level? Or do you think there is scope for further price erosion. And if you can just give some color on the pricing dynamics in the US at this point? Anything has changed?
你覺得它現在是否正在從目前的水平趨於穩定?或者您認為價格還有進一步下跌的空間嗎?您能否簡單介紹一下目前美國的定價動態?情況有變化嗎?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
No, no change. I think it's stabilized. And I believe that it stabilized also for a while. We saw the products here and there but yes, I don't foresee additional trends like that in the coming quarters. On the base products.
不,沒有變化。我認為情況已經穩定了。而且我相信它也穩定了一段時間。我們偶爾會看到這類產品,但是,是的,我預期未來幾季不會出現類似的趨勢。以基礎產品為基礎。
The erosion that will be will be on some of the launch products, the products that we launched, those can still face erosion because not all of them, what we call exhausted their potential erosion but it's insignificant as we speak.
部分上市產品,也就是我們推出的產品,可能會受到侵蝕,因為並非所有產品都已達到其潛在侵蝕的程度,但就目前而言,這種侵蝕微不足道。
Saion Mukherjee - Analyst
Saion Mukherjee - Analyst
Okay. My second question is on sema, this $12 million that you mentioned, you feel confident about selling. So if not in Canada, where will this volume be absorbed in your view, which market.
好的。我的第二個問題是關於 SEMA 展會的,你提到的那 1200 萬美元,你對出售它有信心嗎?那麼,如果不是在加拿大,您認為這部分交易量會被哪個市場消化呢?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Sure. So we are going to either directly or to partners going to obtain approval in the next, let's say, 12 to 15 months in 87 countries, most of them are very small. The notable countries besides Canada will be India, Brazil, Turkey. And then we have partners that are selling in several countries of Latin America. So I cannot highlight a particular market and also in Asia.
當然。因此,我們將直接或透過合作夥伴,在未來 12 到 15 個月內,在 87 個國家/地區(其中大多數國家/地區規模很小)獲得批准。除了加拿大之外,值得關注的國家還有印度、巴西和土耳其。此外,我們還有一些合作夥伴在拉丁美洲的多個國家銷售產品。因此,我無法重點介紹某個特定市場,也無法重點介紹亞洲市場。
We have also B2B partners that also preparing their own launches, and we have partners on both the API as well as -- So I believe that the main markets that I mentioned can take, let's say, the lion's share of this quantity. Depends, of course, on the success and how -- and the date that we will actually launch. And the rest will be taken by the B2B parties. Also, the markets that I mentioned are divided to two types of countries.
我們還有一些 B2B 合作夥伴也在準備推出自己的產品,我們在 API 和其他方面都有合作夥伴——所以我相信,我提到的主要市場可以佔據這部分市場的大部分份額。當然,這取決於成功與否以及成功的方式,以及我們實際發布的具體日期。其餘部分將由B2B參與者獲得。此外,我提到的市場又分為兩類國家。
The COPP countries and the non-COPP countries. So it will be a certain sequence in which it will come to play. So far, and the demands that we have, we have already just the orders that we are discussing and gives me confidence that if the approvals will come that we'll be able to sell that, yes.
COPP國家和非COPP國家。所以它會按照一定的順序發揮作用。到目前為止,根據我們目前的需求,我們已經收到了一些訂單,我們正在討論這些訂單,這讓我相信,如果我們獲得批准,我們就能賣出去。
Saion Mukherjee - Analyst
Saion Mukherjee - Analyst
Erez, if I can just add, like this is for 2026. Now what about 2027, how does this 12 million move up in 2027 in your estimate?
Erez,如果我可以補充一點,這就像是為了 2026 年。那麼到 2027 年呢?你估計這 1,200 萬人口到 2027 年會如何成長?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So it can move up even to -- for sure to 15, but it can move up even further than that. It depends on the evolution of the product. and the qualification of FTO-11, which will significantly ramp up the capacity will be towards the second half of 2027. I'm talking about calendar not FY.
所以它甚至可以升至——肯定能升至 15,但還能升得更高。這取決於產品的發展。 FTO-11的認證將在2027年下半年完成,這將大幅提升產能。我指的是日曆年,不是財政年度。
Saion Mukherjee - Analyst
Saion Mukherjee - Analyst
Understood. Yeah. Thank you. I'll join that --
明白了。是的。謝謝。我也同意。--
Operator
Operator
Madhav Marda, Fidelity International.
Madhav Marda,富達國際。
Madhav Marda - Analyst
Madhav Marda - Analyst
Hey, good evening. Thank you so much for your time. I wanted to understand a bit on the -- I think we've delivered double-digit growth in the ex-US markets. Are we confident of maintaining this trajectory over the next one or two years? That's my first question.
嘿,晚上好。非常感謝您抽出時間。我想了解一下——我認為我們在美國以外的市場實現了兩位數的成長。我們是否有信心在未來一兩年內保持這種發展勢頭?這是我的第一個問題。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes, very much so.
是的,的確如此。
Madhav Marda - Analyst
Madhav Marda - Analyst
Okay. And could you highlight any key drivers? Like do we have like new launches lined up, what can help that steady growth? Because India especially 13% was quite a good number, so ahead of market. So just wanted to understand what could drive it.
好的。您能否重點介紹關鍵驅動因素?例如,我們是否有新的產品發布計劃?什麼因素有助於穩定成長?因為印度的增幅尤其可觀,達到了13%,遠超過市場平均。所以,我只是想了解一下是什麼原因導致這種情況發生。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So each one of the markets, we have different drivers. So if you want, I can highlight the markets for you the main markets. In Europe, it's primarily a combination of the NRT business, the leverage of the US portfolio in which the pipeline is coming up and the launch of biosimilar rituximab, denosumab and bevacizumab that we had in the UK. In the case of India, it's obviously the -- it's primarily our inorganic move that we made on innovation and the acquisitions of brands that we did in addition to a normal growth that we had on the legacy pipeline.
因此,每個市場都有不同的驅動因素。如果你需要的話,我可以為你重點介紹主要市場。在歐洲,這主要是 NRT 業務、美國產品組合(其中有即將上市的產品線)的槓桿作用以及我們在英國推出的利妥昔單抗、地諾單抗和貝伐單抗生物相似藥的組合。就印度而言,很明顯,這主要是我們在創新和品牌收購方面採取的非有機成長舉措,此外還有我們在傳統業務方面的正常成長。
So I always mentioned that in India, our legacy pipeline will be like the market and what we are adding value is in the places in which we are bringing products better than the standard of care. This is the strategy and now that we are accumulating enough of those is starting to be shown. It took us, I say, I'm sure we all remember quite a few years to build that. In the emerging markets, it's primarily again leverage of the generic business, especially on injectable and oncology as well as biologics, all of our biologics is going to emerging markets. And in each one of them, we have SLA depends on the market, selective innovation that we also licensed as part of our deal with India.
所以我一直提到,在印度,我們的傳統產品線將與市場類似,而我們創造價值的地方在於,我們能夠提供比現有標準更好的產品。這就是我們的策略,現在我們已經累積了足夠的資源,策略開始顯現效果。我說,我相信大家都記得,我們花了相當長的時間才建成它。在新興市場,主要還是依靠仿製藥業務,尤其是在註射劑、腫瘤藥物以及生物製劑方面,我們所有的生物製劑都將銷往新興市場。在每個專案中,我們都根據市場情況制定了服務等級協議 (SLA),並選擇性地進行了創新,這些創新也是我們與印度達成的協議的一部分。
In the case of Russia, it's primarily our legacy brands as well as some licensing and acquisition that we made in Russia on both the OTC as well as the as the Rx. API is primarily the focus on peptides. And on both -- there is also a lot of demand for the peptides on the API side. I hope I covered the markets for you if I forgot something, please...
就俄羅斯而言,主要包括我們的傳統品牌,以及我們在俄羅斯進行的一些非處方藥和處方藥的授權和收購。API主要專注於勝肽類別。而且,在原料藥方面,勝肽的需求量也很大。希望我涵蓋的市場狀況符合您的要求,如果我遺漏了什麼,請告訴我…
Madhav Marda - Analyst
Madhav Marda - Analyst
Make sense, and my second question is just on abatacept, you said we can submit the BLA by end of calendar year '25. So the Phase III trial, I'm assuming is complete now, and we're expecting sort of an update on that in terms of whether that's completed successfully? Or how should we think about the progress on the trial itself.
明白了,我的第二個問題是關於 Abatacept 的,您說我們可以在 2025 年底之前提交 BLA。所以,我假設 III 期試驗現在已經完成了,我們期待著關於該試驗是否成功完成的最新消息?或者我們應該如何看待審判本身的進展?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
It should be completed very, very soon and so far so good.
應該很快就能完工,目前一切順利。
Madhav Marda - Analyst
Madhav Marda - Analyst
Okay. Okay. Understood. Got it. And if you file on time and so basically, the approval will be in line with the expiry in early calendar year '27. That's how we should think about it.
好的。好的。明白了。知道了。如果你按時提交申請,那麼基本上,審批結果將在 2027 年初到期。我們應該這樣想。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
That's the idea, yes.
沒錯,就是這個意思。
Operator
Operator
Dr. Kunal Dhamesha, Macquarie Capital.
庫納爾·達梅沙博士,麥格理資本。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Yeah. Hi, can you hear me? Yes. Konan, please. Yeah, hi, thanks for taking my question. Just the first one on abatacept. So basically, the first filing that we'll do would be for IB version, right?
是的。你好,你聽得到我說話嗎?是的。請叫小南。你好,謝謝你回答我的問題。只是在abatacept上的第一個。所以基本上,我們首先要提交的是IB版本,對吧?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Correct.
正確的。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
And what kind of the further development, the subcutaneous version would require?
那麼,皮下注射版本需要進行哪些進一步的研發呢?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Can you repeat, sorry?
不好意思,你能再說一次嗎?
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
For the subcutaneous version what further developments...
皮下注射劑型還有哪些後續發展?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
There is another set of tests that allow us to submit the subcu, but it doesn't require additional study.
還有另一組測試可以讓我們提交子樣本,但不需要額外的學習。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Okay. So no Phase III, but some form of characterization, et cetera.
好的。所以沒有 III 期臨床試驗,但會有某種形式的表徵等等。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Correct.
正確的。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
And the first filing that we'll do by December 2025. Would that include Bachupally as a manufacturing source or the CMO as a manufacturing source?
我們將在 2025 年 12 月之前提交第一份文件。這是否包括將 Bachupally 作為生產來源,還是將 CMO 作為生產來源?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Bachupally will start. And the CMO will be a tech transfer from Bachupally.
巴丘帕利將率先上場。首席行銷長將由 Bachupally 的技術轉移而來。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Okay. So then it might -- so Bachupally would be still the keystone for us in a way.
好的。所以,從某種意義上來說,巴丘帕利對我們來說仍然是基石。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes. But in the United States, I absolutely building that we will be able to be, especially for the subcu, the CMO will be enabled as day one launch. The mitigation that we discussed before.
是的。但在美國,我絕對相信我們能夠做到,特別是對於子客戶而言,CMO 將在發布當天就啟用。我們之前討論過的緩解措施。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Sure, yeah --
當然,是的--
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
For the mitigation that we discussed before, yeah.
是的,對於我們之前討論過的緩解措施。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Sure. And the second one on semaglutide Canada. So basically, let's say, over the last -- since we talked in the earlier Q1 earnings call. Your expectation about the market formation has that changed now on the day of patent expiry? Or how should we think about it given that there are more filers whose filings have been accepted by the regulatory authority in Canada?
當然。第二篇是關於司美格魯肽加拿大的。所以基本上,比如說,自從我們在之前的第一季財報電話會議上談到以來。在專利到期日這一天,您對市場形成的預期是否有改變?或者,鑑於加拿大監管機構已經接受了更多申報者的申報文件,我們應該如何看待這個問題?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
No. So nothing changed, at least in my perspective, just to make sure that, that we are expecting in the market to be competitive. There will be multiple players. The question is just the day they will get approval. So it's all about that.
不。所以,至少在我看來,一切都沒有改變,只是為了確保我們在市場上保持競爭力。會有多名玩家參賽。問題只是他們何時能獲得批准。所以一切都與此有關。
That did not change. I believe that the market formation will be as expected. Will -- once there is an approval, there is an application for reimbursement. And according to the rules in Canada of the pricing, that's how the market will play. So nothing changed in the way I think the game will be played is now it's about obtaining approval and obtaining a good outcome from the litigation in India.
這一點沒有改變。我認為市場格局將如預期般形成。威爾——一旦獲得批准,就可以申請報銷。根據加拿大的定價規則,市場就會這樣運作。所以,我認為比賽的走向並沒有改變,現在的關鍵在於獲得批准,並在印度的訴訟中取得好的結果。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Sure. And lastly, on India for sema, when I look at -- we have basically conducted trial for Ozempic and Rybelsus. So does that enable us to launch the weight loss version, which is Wegovy generic as well?
當然。最後,關於印度的 SEMA,當我查看時——我們基本上已經對 Ozempic 和 Rybelsus 進行了試驗。那麼這是否意味著我們可以推出減肥版的Wegovy,它也是Wegovy的通用版本呢?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
For Wegovy we'll have to have an application by itself. We'll have to...
對於 Wegovy,我們需要一個獨立的應用程式。我們必須…
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
It would be a separate application?
這會是一個單獨的應用程式嗎?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
It will be a separate.
這將是單獨的。
Kunal Dhamesha - Analyst
Kunal Dhamesha - Analyst
Okay, perfect. Thank you and all the best.
好的,完美。謝謝,祝一切順利。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Thank you.
謝謝。
Operator
Operator
Tushar Manudhane, Motilal Oswal Financial Services.
Tushar Manudhane,Motilal Oswal 金融服務公司。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Yeah, am I audible? Yes. Thanks for the opportunity. Sir, just on a steady, robust traction of biologics across European markets and Indian market, if you could just highlight how much has been the total biologic sales across different markets on an annualized basis to date.
是的,我的聲音能被聽見嗎?是的。謝謝您給我這個機會。先生,鑑於生物製劑在歐洲市場和印度市場持續強勁的成長勢頭,您能否簡要介紹一下迄今為止不同市場生物製劑的年度總銷售額是多少?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
I'm sorry, It's something and your voices is too low. Just to make sure you asked how our sales evolve in India and Europe, that's what they asked, the question is.
對不起,出了點問題,你們的聲音太小了。為了確保你問的是我們在印度和歐洲的銷售情況如何,他們也問了同樣的問題。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Biologic sales, cumulative biologic sales across different markets.
生物製劑銷售額,不同市場的生物製劑累計銷售額。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
The market or us, I'm sorry -- so we launched in Europe Hopefully, I'm answering it correctly. We launched in the Europe bevacizumab and recently rituximab in multiple countries, and we will increase the numbers of the countries as time goes by. And this is after we got the approval, the recent approval for rituximab for Europe. In India and emerging markets, we were always there. So it is going well.
抱歉,可能是市場的原因——所以我們在歐洲推出了產品。希望我的答案是正確的。我們已在歐洲多個國家推出了貝伐單抗,最近又推出了利妥昔單抗,隨著時間的推移,我們將增加推出的國家數量。這是在我們獲得批准之後,利妥昔單抗最近獲得了歐洲的批准。在印度和新興市場,我們始終都在。一切進展順利。
In the main program that we will launch in Europe will be denosumab and abatacept. This is the main pipeline. The same product, obviously, will be launched in India and emerging markets. But in India, we'll also have pembro as well as nivo. So that's right now the plans in those countries.
我們將在歐洲推出的主要項目將是地諾單抗和阿巴西普。這是主管道。顯然,同樣的產品也將在印度和新興市場推出。但在印度,我們也會銷售 pembro 和 nivo。這就是這些國家目前的計畫。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Got it. And sir, with respect to rituximab, now that we are thinking of having a CMO, will that require let's say, at least the stability data from CMO side and hence maybe more time to sort of get through the regulatory process.
知道了。先生,關於利妥昔單抗,既然我們正在考慮聘請合約生產商,這是否至少需要合約生產商方面提供穩定性數據,因此可能需要更多時間來完成監管流程?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
The CMO that I mentioned is for abatacept, primarily for the subcu and it will require a tech transfer as well as stability. But we believe that we will be able to be ready for the big quantities, which will be in the beginning of calendar '28. So we should be good by then.
我提到的 CMO 是為阿巴西普(abatacept)生產的,主要用於皮下注射,它需要技術轉移以及穩定性。但我們相信,我們將能夠為 2028 年初的大量訂單做好準備。到那時我們應該就沒事了。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Understood. And just lastly, on the PSAI segment, where there has been improvement in the gross margin quarter over quarter, while we are still lower than the historical gross margin but if you can just help understand in terms of the current gross margin and how to think about it over the next one to two years?
明白了。最後,關於PSAI業務板塊,雖然毛利率較上月有所改善,但仍低於歷史毛利率水準。您能否幫助我們理解目前的毛利率,以及未來一到兩年的發展趨勢?
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
So we expect, I think, going forward, PSA gross margin range of 20% to 25%.
因此,我認為,展望未來,PSA 的毛利率將在 20% 到 25% 之間。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Compared to 15% currently, right?
比起目前的15%,對吧?
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
No, this quarter is at 18%. And because I think here, based on the product mix and then I think leverage of the all the overheads and everywhere. I think the range you can expect then going forward, 20%, 25% PSA gross margin.
不,本季是 18%。因為我認為,在這裡,基於產品組合,然後我認為要充分利用所有的間接成本等等。我認為未來預期毛利率範圍為 20% 至 25% PSA。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Got it. And you -- there was an earlier comment of peptide sales within PSA. So if you could quantify how much has that been?
知道了。還有你——之前有人評論過PSA內部的勝肽銷售情況。那麼,如果你能能量化一下這筆費用是多少呢?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
We build a capacity of up to 800 kg. Naturally, we are not even close right now to this level and right now, it's very small, but it will grow as it will come it.
我們生產的產能最高可達 800 公斤。當然,我們現在離這個水平還差得很遠,現在規模還很小,但隨著時間的推移,它會不斷發展壯大。
Tushar Manudhane - Analyst
Tushar Manudhane - Analyst
Got it, sir. Thank you.
明白了,先生。謝謝。
Operator
Operator
Kunal Randeria, Axis Capital.
Kunal Randeria,Axis Capital。
Kunal Randeria - Equity Analyst
Kunal Randeria - Equity Analyst
Hi, good evening. So firstly, I would like to understand how your R&D will take shape given that you're developing a few biosimilars like pembrolizumab and daratumumab and of your R&D budget, how much you would be earmarking for biosimilars and Aurigene. So basically, your non-generic business.
您好,晚上好。首先,我想了解一下,鑑於您正在開發一些生物相似藥,例如帕博利珠單抗和達雷妥尤單抗,您的研發將如何進行?在您的研發預算中,您將撥出多少資金用於生物相似藥和 Aurigene?所以基本上,這就是你的非通用業務。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So just to clarify, daratumumab, we are now developing. It's a product that we license from Helios from a Chinese company. Denosumab was developed by Alvotech, and we have a partnership with them. And so in that respect, the main products that are done internally is still abatacept that we basically finished the clinic of it. As you can see, the R&D is about 7% right now of the sales and likely that it will stay in this range for now.
所以澄清一下,我們現在正在研發 daratumumab。這是我們從中國公司 Helios 獲得授權的產品。地諾單抗由Alvotech公司研發,我們與該公司有合作關係。因此,就這一點而言,內部完成的主要產品仍然是abata,儘管我們基本上已經完成了它的臨床部分。如您所見,研發費用目前約佔銷售額的 7%,短期內可能會保持在這個範圍內。
Kunal Randeria - Equity Analyst
Kunal Randeria - Equity Analyst
Sure, sure. And secondly, again on semaglutide. So do you foresee a situation where the market may not turn out to be as favorable as you think in Canada because besides the number of filers, which are increasing by the day, there are perhaps risks. Let's say, from a compounding pharmacy, which is intending to enter Canada and even the innovator has seen volume pressure in several markets. So there might be a situation where they are aggressive on pricing.
當然,當然。其次,再次談談索瑪魯肽。所以,您是否預見到加拿大市場可能會出現一種情況,即除了申報人數與日俱增之外,可能還存在其他風險,因此市場前景可能不如您想像的那麼有利?假設一家配製藥房打算進入加拿大市場,即使是這家創新藥局也在幾個市場看到了銷售壓力。所以可能會出現他們在定價方面採取激進策略的情況。
So -- is there a risk of the market deterioration?
那麼——市場是否有惡化的風險?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
First of all, I mentioned all along, I think that Canada market will be competitive with multiple players. So I also now in 33 years within pharmaceuticals, I learned not to forecast launch. I always mentioned that it can range from zero to many, many millions of dollars. So -- but yes, the answer is I anticipate that Canada is going to be very, very competitive. I anticipate that Canada will be very, very competitive.
首先,正如我一直提到的,我認為加拿大市場將會競爭激烈,會有多家企業競爭。所以,我在製藥業工作了33年,也學會了不要預測產品上市時間。我一直都說,金額可以從零到數百萬美元不等。所以——是的,我的答案是,我預計加拿大將會非常有競爭力。我預計加拿大將極具競爭力。
As players will get an approval.
玩家將獲得批准。
Kunal Randeria - Equity Analyst
Kunal Randeria - Equity Analyst
Sure, I'm sorry if I can.
當然,如果可以的話,我很抱歉。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
What I anticipate that Canada will be very competitive as players will get an approval.
我預計加拿大將非常有競爭力,因為球員們會獲得批准。
Kunal Randeria - Equity Analyst
Kunal Randeria - Equity Analyst
Right. And if I can, if you don't mind, ask is there -- I mean, any particular price erosion that we can see from the current levels, maybe 80%, 85% kind of price erosion that will eventually settle down to?
正確的。如果可以的話,如果您不介意的話,我想問一下——我的意思是,從目前的水平來看,我們是否可以看到任何特定的價格侵蝕,例如 80%、85% 的價格侵蝕,最終會穩定下來?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
I have no clue. I wish I do.
我完全沒有頭緒。我希望我能做到。
Kunal Randeria - Equity Analyst
Kunal Randeria - Equity Analyst
All right. Thank you.
好的。謝謝。
Operator
Operator
(Operator Instructions) Vivek Agrawal, Citi.
(操作說明)Vivek Agrawal,花旗銀行。
Vivek Agrawal - Analyst
Vivek Agrawal - Analyst
Hello, am I'm audible?
你好,請問我的聲音能被聽見嗎?
Operator
Operator
Yes, loud and clear.
是的,非常清楚。
Vivek Agrawal - Analyst
Vivek Agrawal - Analyst
Yeah, thanks. Thanks for the opportunity. My question is related to NRT and branded markets like India, EM. So the growth was quite decent across the board and really a commendable job. So just want to understand how to look at the investment that you are making behind these markets? Or are these are sustainable investments or, let's say, it can be cut down in future? Thanks.
嗯,謝謝。謝謝您給我這個機會。我的問題與NRT和品牌市場(如印度、新興市場)有關。因此,整體成長相當不錯,這確實是一項值得稱讚的工作。所以,我只是想了解如何看待你在這些市場背後所進行的投資?或者說,這些都是永續投資嗎?或者說,未來可以削減投資?謝謝。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
First of all, I don't think you see the investment in emerging markets. As we speak, we got the market in certain waves. And the markets that we did not get, we are still managed by Haleon, and we are paying them a fee for doing that for us. So naturally, as market is coming to us, the fee for Haleon is going. And therefore, it's -- the margins are going up because we don't need to pay them.
首先,我認為你沒有看到對新興市場的投資。在我們說話的時候,市場正以一定的波浪式波動進行著。而我們未能進入的市場,仍然由 Haleon 公司管理,我們為此向他們支付費用。所以很自然地,隨著市場需求的成長,Haleon 的費用也隨之降低。因此,利潤率上升了,因為我們不需要支付他們費用。
And we are starting to invest in the market that we invest are the only markets that we've got the beginning, meaning UK and Scandinavia. So that's -- so we -- right now, my base is not yet -- it's absolutely not a steady state. We have two more waves to go and before we go. What I can tell that so far, it's exceeding our expectation both on the pace of growth as well as on the margin.
我們開始投資於目前唯一擁有投資機會的市場,即英國和斯堪的納維亞半島。所以,目前我的基地還遠遠沒有達到穩定狀態。我們還有兩波浪潮要湧來,之後就要出發了。就目前來看,無論從成長速度或利潤率來看,它都超出了我們的預期。
In both cases, it's much better than what we presented internally when we approved the project. So it's a kind of a good start, I would call it.
無論哪種情況,都比我們內部批准該專案時提出的方案要好得多。所以,我認為這是一個不錯的開始。
Vivek Agrawal - Analyst
Vivek Agrawal - Analyst
I understand, Erez. And just a related question here. It's on OpEx basically. So on absolute basis, how we should look at the OpEx in FY27. So can it continue to increase, let's say, from '26 level, maybe relatively at a lower pace? Or is there any possibility of absolute decline in OpEx, let's say, in '27 compared to FY26. Thank you.
我明白了,埃雷茲。這裡還有一個相關的問題。基本上就是營運支出。那麼,從絕對意義上講,我們該如何看待 2027 財年的營運支出呢?那麼,它能否繼續成長,比如說,從 2026 年的水平開始,即使增速相對較慢?或者,2027 年的營運支出是否有可能比 2026 財年絕對下降?謝謝。
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
So Vivek, if you look this quarter, we have at 30%. And then if you adjust the one-off, I think we are close to 29.1% at somewhere and then for any modeling, I think we'll be in the zone of like 28% to 30%.
所以維韋克,如果你看一下這個季度,我們達到了 30%。然後,如果你調整一次性因素,我認為我們大概能達到 29.1%,而對於任何建模,我認為我們會在 28% 到 30% 的範圍內。
Vivek Agrawal - Analyst
Vivek Agrawal - Analyst
Thanks, and that's on my side.
謝謝,這方面我沒問題。
Operator
Operator
Dr. Harith Ahamed, Avendus Spark.
哈里斯·艾哈邁德博士,Avendus Spark。
Harith Mohammed - Analyst
Harith Mohammed - Analyst
Hi, thanks for the opportunity. Just on rituximab again. So given this is the second successful PAI and CRL that we've had, are there any specific challenges related to the speciality? I'm asking also because this is a biologics facility and our track record, otherwise on compliance has been quite excellent in recent years.
您好,謝謝您給我這個機會。又開始用利妥昔單抗了。鑑於這是我們第二次成功獲得 PAI 和 CRL,該專業是否有任何特殊挑戰?我這樣問也是因為這是一個生物製品生產設施,近年來我們在合規方面的記錄一直非常出色。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So there is nothing specific per se. We -- it's all obviously, as this is a sterile plant, we have -- we've got queries that are related to the nature of the site. We believe it's addressable. In a case that they will come with another set of questions. What we will do is that we will submit.
所以並沒有什麼特別之處。我們——很明顯,因為這是一處無菌植物,我們——我們有一些與該地點性質相關的疑問。我們認為這個問題是可以解決的。假設他們還會提出另一組問題。我們將提交。
We have an alternate line as a backup, which is FFF two that we feel that FFF two is a fill and finish or for those that are on the line. So we may need to move the product from one line to another in a case that it will not come well on the first one. So it's primarily related to the fact that the first line that we have FFF one is some of the design of it raised those queries and also last time we are addressing it. But if it will not work, we'll have to move to FFM 2. I'm not worried on the not getting approval.
我們有一條備用生產線,即 FFF 二號生產線,我們認為 FFF 二號生產線適合那些正在生產線上的人進行填充和完成。如果產品在第一條生產線上表現不佳,我們可能需要將其從一條生產線轉移到另一條生產線上。所以這主要與我們第一行 FFF 1 的設計引發了這些疑問有關,而且上次我們也在討論這個問題。但如果行不通,我們就得升級到 FFM 2 了。我並不擔心得不到批准。
I'm certain that we get approval. Just to remind all of us, rituximab for us was deliberately chosen in order to start the regulatory process on time to make sure that by the time that abatacept will come, Bachupally will face those kind of stuff. And this is -- it's serving its purpose and hopefully, we can absorb it soon.
我確信我們會獲得批准。提醒大家一下,我們特意選擇利妥昔單抗是為了及時啟動監管程序,以確保在阿巴西普上市之前,巴丘帕利能夠應對這類問題。而這——它正在發揮其作用,希望我們能盡快消化它。
Harith Mohammed - Analyst
Harith Mohammed - Analyst
Okay. A quick one on tocilizumab biosimilar. It's been a while since we got an update on that one. Can you share the status of that program?
好的。簡單介紹一下托珠單抗生物相似藥。我們已經很久沒有收到關於那件事的最新消息了。能否透露一下該專案的進度?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
We don't -- we are not planning to have it as a global product. We will have it only for India.
我們沒有—我們沒有計劃將其作為全球產品推出。我們將只在印度推出。
Harith Mohammed - Analyst
Harith Mohammed - Analyst
Yes. And then one quick follow-up on the previous question. The cost reductions that we have alluded to in the past, 500, 600 basis points of reductions. Are these reflecting to a small extent in the first half numbers? Or should we wait for the coming quarters for this to actually the numbers.
是的。然後,我想就上一個問題再補充一點。我們之前提到的成本削減幅度,是 500 到 600 個基點。這些情況是否在上半年的數據中有所反映?或者我們應該等到接下來的幾季才能看到實際數據。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Yes, I believe so. You can see that despite the fact that Lena is going down. We are maintaining our reasonable numbers. So it's absolutely a reflection of those mitigations. Of course, the full force of it will come as quarters will come.
是的,我也這麼認為。你可以看出,儘管莉娜正在下坡。我們保持了合理的人員數量。所以這絕對反映了這些緩解措施的效果。當然,它的全部威力會在後續行動中顯現。
And we have also shared the numbers. So we believe that with SG&A of around 28% and R&D of around 7%. It comes to the famous 5% to 7% that we set, and there is even opportunity for more if we need to. So we maintain that we will -- we are very, very sensitive to the margins. And naturally, we're discussing it every time, and we will absolutely be really disciplined on those.
我們也公佈了這些數據。因此,我們認為銷售、一般及行政費用佔比約為 28%,研發費用佔 7%。最終達到了我們設定的著名的 5% 到 7% 的目標,如果需要,甚至還有更多的機會。所以我們堅持認為——我們對利潤率非常非常敏感。當然,我們每次都會討論這個問題,而且我們一定會嚴格遵守相關規定。
Harith Mohammed - Analyst
Harith Mohammed - Analyst
Thank you. That's all for me, sir.
謝謝。先生,我的話就這些了。
Neha Manpuria - Analyst
Neha Manpuria - Analyst
Thank you.
謝謝。
Operator
Operator
Gautam, Leo Capital.
高塔姆,利奧資本。
Unidentified Participant
Unidentified Participant
Hi, good evening. My question was on the GLP-1. Do you only plan to do fill and finish or do you also manufacture API drug substances. How much manufacturing capacity do you have? And which markets are we targeting for this?
您好,晚上好。我的問題是關於GLP-1的。你們只打算進行灌裝和包裝,還是也生產原料藥?你們有多少生產能力?我們的目標市場是哪些?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
So we have CTO-6 making the API. I mentioned that the overall potential of all the investments that we put can reach even 800 Kg, but we are very, very far from this output at this stage. We've don't need also. Just that -- but we are preparing it not just for semaglutide, liraglutide, but also for 40-something peptides that we identified and we are going to develop either by ourself or with the partners in the next coming years. So right now, we will have sufficient capacity for the demand that we'll have for the liraglutide semaglutide in the submissions to the relevant authorities of all the peptides that will be of patents, including tirzepatide that will be obviously an R&D project, but it's very important to submit it in relevant markets.
所以我們有 CTO-6 負責開發 API。我曾提到,我們所有投資的總潛力甚至可以達到 800 公斤,但現階段我們距離這個產量還非常非常遠。我們也不需要。就是這樣——但我們不僅在為索瑪魯肽、利拉魯肽做準備,而且還在為我們發現的 40 多種肽做準備,我們將在未來幾年內自行或與合作夥伴一起開發這些肽。所以目前,我們將有足夠的產能來滿足利拉魯肽和索馬魯肽的需求,並向相關機構提交所有已獲專利的肽類藥物的申請,包括替拉帕肽,這顯然是一個研發項目,但將其提交到相關市場非常重要。
And we are also making the product, we are planning to make it in FTO-11 and also with the partners. In general, the approach will be that we will have for every important product in-house capabilities as well as partnership capabilities for all kinds of risk mitigations.
我們也在生產該產品,我們計劃採用 FTO-11 封裝,並與合作夥伴一起生產。總的來說,我們將採取的方法是,對於每款重要產品,我們都將具備內部研發能力以及與合作夥伴攜手應對各種風險的能力。
Unidentified Participant
Unidentified Participant
Okay. So can you just like expand on the fill and finish also what's the capacity we have and the status on that and the markets we are supplying for that?
好的。那麼,您能否詳細介紹灌裝和成品的情況,以及我們的產能、產能現況和我們正在供應的市場?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
I think we discussed it. We have 12 million pens for the semaglutide with the partner. We can -- and we have two lines of cartridge that will be an FTO-11, they can reach even 50 million, but right now it's Theoretical. The cartridge lines are on the way and they will be assembled and will be ready, not for these 12 months, but after.
我想我們討論過這個問題。我們與合作夥伴擁有 1200 萬支用於司美格魯肽的注射筆。我們可以——我們有兩條 FTO-11 型墨盒生產線,它們的產能甚至可以達到 5000 萬,但目前這只是理論上的。墨盒生產線正在運送途中,它們將會組裝完畢並準備就緒,但不是在12個月內,而是之後。
Unidentified Participant
Unidentified Participant
Understood. Thank you.
明白了。謝謝。
Operator
Operator
Sumit Gupta, Centrum Capital.
Sumit Gupta,Centrum Capital。
Sumit Gupta - Analyst
Sumit Gupta - Analyst
Thank you. Good evening. Yes. So just one question on the Indian business. So sir, can you segregate the volume and price growth?
謝謝。晚安.是的。那麼,關於印度商業,我只有一個問題。先生,您能把銷售成長和價格成長分開分析嗎?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
The volume and the price.
成交量和價格。
Mannam Venkatanarasimham - Chief Financial Officer
Mannam Venkatanarasimham - Chief Financial Officer
So Sumit, the price is like in the range of normal 5%, and then the balance growth is like mainly from the new products and volumes.
所以 Sumit,價格漲幅大概在正常的 5% 範圍內,其餘的成長主要來自新產品和銷售。
Sumit Gupta - Analyst
Sumit Gupta - Analyst
Okay. So going forward, like should we expect this to continue? Or can we expect any significant growth in volumes also?
好的。那麼展望未來,我們是否應該預期這種情況會持續下去?或者我們能否期待銷量也有顯著成長?
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
You should expect to continue, we will have new products volume, and the price will be in that range that MVN shared with you.
您應該期待情況會持續,我們將推出新產品,價格將維持在MVN之前與您分享的範圍內。
Saion Mukherjee - Analyst
Saion Mukherjee - Analyst
Understood. Thank you.
明白了。謝謝。
Operator
Operator
We reached the end of the call. I now hand the call over to Richa for the closing comments.
通話結束了。現在我將電話交給Richa,請她做總結發言。
Richa Periwal - Investor Relations
Richa Periwal - Investor Relations
Thank you all for joining us today. We truly appreciate your continued interest in Dr. Reddy's Laboratories and the time you've taken to engage with our Q2 FY26 results. If you have any further questions or need any additional information, please do not hesitate to contact the Investor Relations team. Have a great day.
感謝各位今天蒞臨。我們衷心感謝您一直以來對瑞迪博士實驗室的關注,以及您抽出時間了解我們 2026 財年第二季的業績。如果您有任何其他疑問或需要任何其他信息,請隨時與投資者關係團隊聯繫。祝你有美好的一天。
Stay safe and take care.
注意安全,保重身體。
Erez Israeli - Chief Executive Officer
Erez Israeli - Chief Executive Officer
Thank you.
謝謝。