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Operator
Operator
Ladies and gentlemen, thank you for standing by and welcome to Teva's Q4 and full-year 2015 results conference call.
女士們,先生們,感謝你們的支持,歡迎來到 Teva 的第四季度和 2015 年全年業績電話會議。
(Operator Instructions)
(操作員說明)
I must advise this conference is being recorded today on Thursday, February 11, 2016.
我必須告知,本次會議將於 2016 年 2 月 11 日星期四錄製。
I'd now like to turn the conference over to your host for today, Kevin Mannix, Senior Vice President of Investor Relations.
我現在想把會議轉交給今天的主持人,投資者關係高級副總裁凱文曼尼克斯。
Please go ahead.
請繼續。
Kevin Mannix - SVP of IR
Kevin Mannix - SVP of IR
Thank you, Operator.
謝謝你,運營商。
Good morning and good afternoon, everyone.
大家早上好,下午好。
Thank you for joining us today to discuss Teva's fourth-quarter and full-year 2015 financial results.
感謝您今天加入我們討論 Teva 2015 年第四季度和全年的財務業績。
On the call with me today are Erez Vigodman, Teva's Chief Executive Office; Eyal Desheh, Chief Financial Officer; Siggi Olafsson, President and CEO, Global Generic Medicines; Dr. Rob Koremans, President and CEO, Global Specialty Medicines; Dr. Michael Hayden, Head of R&D, Chief Scientific Officer; and Dr. Carlo de Notaristefani, President and CEO of Global Operations.
今天和我通電話的是 Teva 的首席執行官 Erez Vigodman; Eyal Desheh,首席財務官;全球仿製藥公司總裁兼首席執行官 Siggi Olafsson; Global Specialty Medicines 總裁兼首席執行官 Rob Koremans 博士; Michael Hayden 博士,研發主管、首席科學官;以及全球運營總裁兼首席執行官 Carlo de Notaristefani 博士。
We will start the call with presentations from Erez, Siggi and Eyal before opening the call up for questions and answers.
我們將以 Erez、Siggi 和 Eyal 的演講開始電話會議,然後再開始電話會議以進行問答。
A copy of the slides, as well as this morning's earnings release, can be found on our website, www.tevapharm.com, under the Investor Relations section, as well as on the Teva Investor Relations app.
可以在我們的網站 www.tevapharm.com 的“投資者關係”部分以及 Teva 投資者關係應用程序上找到幻燈片的副本以及今天上午的收益發布。
During this call, we will be making forward-looking statements which are predictions, projections or other statements about future events.
在此次電話會議中,我們將做出前瞻性陳述,即對未來事件的預測、預測或其他陳述。
These estimates reflect management's current expectations for Teva's performance.
這些估計反映了管理層目前對 Teva 業績的預期。
Actual results may vary, whether as a result of exchange rate differences, market conditions, or other factors.
實際結果可能會因匯率差異、市場條件或其他因素而有所不同。
In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step up, legal settlements and reserves, impairments, and related tax effects.
此外,非 GAAP 數據不包括已購無形資產的攤銷、與某些監管行動相關的成本、庫存增加、法律結算和準備金、減值以及相關稅收影響。
The non-GAAP data presented by Teva are the results used by Teva's management and Board of Directors to evaluate the operational performance of the Company to compare against the Company's work plans and budgets, and ultimately, to evaluate the performance of management.
Teva 提供的非 GAAP 數據是 Teva 的管理層和董事會用來評估公司運營績效的結果,以與公司的工作計劃和預算進行比較,並最終評估管理層的績效。
Teva provides such non-GAAP data to investors as supplemental data and not in substitution or replacement for GAAP results because management believes such data provides useful information to investors.
Teva 向投資者提供此類非 GAAP 數據作為補充數據,而不是替代或替代 GAAP 結果,因為管理層認為此類數據為投資者提供了有用的信息。
With that, I'll now turn the call over to our CEO, Erez Vigodman.
有了這個,我現在將把電話轉給我們的首席執行官 Erez Vigodman。
Erez?
埃雷茲?
Erez Vigodman - CEO
Erez Vigodman - CEO
Thank you, Kevin.
謝謝你,凱文。
Good morning, good afternoon and thank you for joining us today.
早上好,下午好,感謝您今天加入我們。
2015 was a year of exceptional operational and strategic performance for Teva.
2015 年是 Teva 取得卓越運營和戰略業績的一年。
We delivered in 2015 record operating income, EPS and cash flow, while improving profitability margins across the board.
我們在 2015 年實現了創紀錄的營業收入、每股收益和現金流,同時全面提高了利潤率。
Our financial performance was based on excellent execution in generics, with significant improvement in profitability, strong execution of specialty life-cycle management initiatives, continued transformation of our global operations and network, and strong focus on cash flow generation.
我們的財務業績基於仿製藥的出色執行、盈利能力的顯著提高、專業生命週期管理計劃的有力執行、我們全球運營和網絡的持續轉型以及對現金流生成的高度關注。
Once the Company was put on a solid footing, we have taken the offensive from BD perspective, delivering on all our promises and creating a new Teva.
一旦公司站穩腳跟,我們就會從 BD 的角度採取攻勢,兌現我們所有的承諾並創建一個新的 Teva。
We delivered strong financial results in 2015.
我們在 2015 年取得了強勁的財務業績。
Net revenues, including foreign currencies' effects, went down by 3% to $19.7 billion.
包括外匯影響在內的淨收入下降了 3% 至 197 億美元。
And excluding foreign currency effect, we saw organic growth of 4%.
排除外匯影響,我們看到了 4% 的有機增長。
Operating income grew by 6% year over year and excluding foreign currency effect by 9%.
營業收入同比增長 6%,排除外匯影響增長 9%。
Net income grew by 6% to $4.7 billion, which is translated to EPS of $5.46 without the new shares issued in Q4 2015, to finance the Actavis Generics acquisition and to an EPS of $5.42, including the additional new shares issued.
淨收入增長 6% 至 47 億美元,換算為每股收益 5.46 美元,不計入 2015 年第四季度發行的新股,為 Actavis Generics 收購提供資金,每股收益為 5.42 美元,包括額外發行的新股。
EBITDA grew by 6% to $6.6 billion, cash flow for operations grew by 8% to $5.5 billion, and free cash flow grew by 15% to $4.9 billion.
EBITDA 增長 6% 至 66 億美元,運營現金流增長 8% 至 55 億美元,自由現金流增長 15% 至 49 億美元。
These cash flow numbers include the payment of $970 million in connection with the Modafinil legal settlement earlier this year.
這些現金流量數字包括與今年早些時候莫達非尼法律和解有關的 9.7 億美元付款。
In 2015, we continued the operating profit improvement of our generic business, while maintaining the operating profit of our specialty business, in a year when we face for the first time generic competition to Copaxone and invested in building the future of our specialty franchises.
2015 年,我們繼續提高仿製藥業務的營業利潤,同時保持專藥業務的營業利潤,這一年我們首次面臨仿製藥與 Copaxone 的競爭,並投資建設專藥特許經營權的未來。
We continued to make important progress on managing the right cycle of Copaxone and Treanda.
我們在管理 Copaxone 和 Treanda 的正確循環方面繼續取得重要進展。
On Copaxone, the most recent IMS data suggests that Copaxone 40mg is today the leading medication in the MS market with 25.2% market share versus 20.5% market share of Tecfidera.
關於 Copaxone,最新的 IMS 數據表明,Copaxone 40mg 是當今 MS 市場的領先藥物,市場份額為 25.2%,而 Tecfidera 的市場份額為 20.5%。
The entire Copaxone franchise holds 94.7% of the GA market (Glatopa holds the remaining 5.3%) and 31.6% of the entire MS market.
整個 Copaxone 特許經營權佔據 GA 市場的 94.7%(Glatopa 持有剩餘的 5.3%)和整個 MS 市場的 31.6%。
Copaxone is also the number-one global treatment for MS with 22% TRx share.
Copaxone 也是全球排名第一的 MS 治療藥物,佔 TRx 份額的 22%。
On Treanda, we recently launched Bendeka with our partner Eagle.
在 Treanda 上,我們最近與我們的合作夥伴 Eagle 一起推出了 Bendeka。
We believe healthcare providers will favor the features of Bendeka, including its short-time infusion of 10 minutes versus Treanda.
我們相信醫療保健提供者會喜歡 Bendeka 的特點,包括與 Treanda 相比的 10 分鐘短時間輸液。
Our strong focus on solidifying the foundation of Teva and improving our business fundamentals is manifesting itself in the operational step-up since the beginning of 2014 and the continuous improvement on all relevant financial matters.
我們對鞏固 Teva 的基礎和改善我們的業務基礎的強烈關注體現在自 2014 年初以來的運營升級和所有相關財務事項的持續改進中。
With a series of strategically compelling BD deals, we have transformed Teva in the course of 2015.
通過一系列具有戰略意義的 BD 交易,我們在 2015 年實現了 Teva 的轉型。
With regards to the Labrys acquisition, which was closed already in 2014, we completed in 2015 a very successful Phase II clinical trial and have kicked off the pivotal Phase III study that we believe will demonstrate we have the best-in-class cornerstone drugs for leadership in migraine prevention.
關於已於 2014 年完成的對 Labrys 的收購,我們在 2015 年完成了非常成功的 II 期臨床試驗,並啟動了關鍵的 III 期研究,我們相信這將證明我們擁有同類最佳的基石藥物在預防偏頭痛方面處於領先地位。
We continued with the acquisition of Auspex, an emerging leader in developing innovative medicines for hyperkinetic movement disorders and other rare diseases.
我們繼續收購 Auspex,這是開髮用於多動性運動障礙和其他罕見疾病的創新藥物的新興領導者。
This area was a huge patient unmet need.
這個領域是一個巨大的未滿足的患者需求。
And Auspex has attractive growth to market products to address it.
Auspex 的市場產品有吸引力的增長可以解決這個問題。
For Huntington's disease, we have been granted with an Orphan Drug Designation for SD-809.
對於亨廷頓舞蹈病,我們已獲得 SD-809 的孤兒藥物稱號。
The FDA has also granted breakthrough therapy designation status to SD-809 for the treatment of patients with moderate to severe tardive dyskinesia, the hyperkinetic movement disorder affecting about 500,000 people in the United States.
FDA 還授予 SD-809 突破性治療指定地位,用於治療中度至重度遲發性運動障礙患者,這是一種影響美國約 500,000 人的多動性運動障礙。
Auspex also provides us with a proven technology platform in promising pipeline candidates, like levodopa for Parkinson's, an additional 60 molecules in its patent portfolio.
Auspex 還為我們提供了一個經過驗證的技術平台,用於有前途的候選管道,如用於帕金森症的左旋多巴,其專利組合中還有 60 種分子。
Through our announced acquisition of Actavis Generics, we've established a strong foundation for long-term sustainable growth, anchored by leading generics capabilities in a world-class late-stage pipeline that will accelerate our ability to build an exceptional portfolio folder, both in generics and specialty, as well as the intersection of the two.
通過我們宣布收購 Actavis Generics,我們為長期可持續增長奠定了堅實的基礎,以世界級後期管道中領先的仿製藥能力為基礎,這將加速我們建立卓越組合文件夾的能力,無論是在仿製藥和特殊藥物,以及兩者的交集。
We also delivered on our promise to expand our footprint in key growth markets, with the acquisition of Rimsa in Mexico and the establishment of the JV with Takeda in Japan, one of the fastest-growing generic markets in the world.
我們還兌現了擴大我們在主要增長市場的足蹟的承諾,收購了墨西哥的 Rimsa 並與日本武田建立了合資企業,日本是世界上增長最快的仿製藥市場之一。
Immuneering, Gecko Health, and the partnerships with Microchips, IBM Watson, and Amwell represent innovative technologies in the space between generics and specialty that reinforce our strategy.
Immuneering、Gecko Health 以及與 Microchips、IBM Watson 和 Amwell 的合作代表了仿製藥和專業藥之間領域的創新技術,這些技術加強了我們的戰略。
On the specialty front, we have streamlined our business to areas we have established strength.
在專業方面,我們將業務精簡到我們已經建立實力的領域。
And we are positioned to claim global leadership around anchor products that would be extended over time to additional conditions and indications.
我們有能力在錨定產品方面佔據全球領先地位,這些產品將隨著時間的推移擴展到其他條件和適應症。
In migraine and headache, TEV-48125 is a cornerstone drug for leadership in migraine prevention.
在偏頭痛和頭痛方面,TEV-48125 是引領偏頭痛預防的基石藥物。
Over time, we will develop the core migraine solution platform to additional headache conditions, such as cluster headache.
隨著時間的推移,我們將開發核心偏頭痛解決方案平台以應對叢集性頭痛等其他頭痛病症。
In movement disorders and neurodegeneration SD-809 provides us with attractive close to market products in Huntington's disease, Tardive dyskinesia, Tourette's syndrome.
在運動障礙和神經變性方面,SD-809 為我們提供了在亨廷頓舞蹈病、遲發性運動障礙、圖雷特綜合症方面具有吸引力的接近市場的產品。
The unique technology platform that was developed by Auspex holds great promise across a wide spectrum of movement disorders and other conditions.
Auspex 開發的獨特技術平台在廣泛的運動障礙和其他情況下具有廣闊的前景。
We'll build on our unique patient-centric model, and over time develop and invest in additional novel targets.
我們將建立我們獨特的以患者為中心的模型,並隨著時間的推移開發和投資更多的新目標。
We'll also maintain our position as a leading provider of solutions to MS patients.
我們還將保持我們作為多發性硬化症患者解決方案領先供應商的地位。
In pain, our novel abuse-deterrent technology is generating significant (audio break), including our extended-relief hydrocodone that awaits approval from the FDA.
在痛苦中,我們的新型防濫用技術正在產生重大影響(音頻中斷),包括我們正在等待 FDA 批准的緩釋氫可酮。
During 2016, we plan to submit an application for an immediate-release hydrocodone.
2016 年,我們計劃提交速釋氫可酮申請。
Over time, we will develop and invest in next-generation abuse-deterrent technologies and devices in a quest to become a leader in improving abuse-deterrent and safety of opiates.
隨著時間的推移,我們將開發和投資下一代防濫用技術和設備,以期成為提高阿片類藥物防濫用和安全性的領導者。
In respiratory, we are awaiting approval for Reslizumab.
在呼吸方面,我們正在等待 Reslizumab 的批准。
We are also developing a series of innovative devices and technologies that focus on the most important challenge today in this field, which is improving the adherence and compliance of patients to an integrative approach for the management of chronic asthma and COPD.
我們還開發了一系列創新設備和技術,專注於應對當今該領域最重要的挑戰,即提高患者對慢性哮喘和慢性阻塞性肺病綜合治療方法的依從性和依從性。
We are building a new Teva with a solidified foundation, a significantly enhanced financial profile, a promising specialty pipeline, diversified net revenues and profit streams.
我們正在打造一個擁有堅實基礎、顯著增強的財務狀況、前景廣闊的專業管道、多元化的淨收入和利潤流的新 Teva。
And we are positioned to continue the transformation of our business model.
我們準備好繼續轉變我們的商業模式。
We strongly believe that we are creating here a diversified growth platform, with a balanced portfolio of durable products that offers top-line and bottom line growth prospects and, over time, also multiple expansion opportunities.
我們堅信,我們正在這裡創建一個多元化的增長平台,擁有均衡的耐用產品組合,提供頂線和底線增長前景,並隨著時間的推移提供多種擴張機會。
It's a platform that post the Actavtis generics deal serves approximately 250 million people every day as the world's largest drug cabinet with more than 1,000 molecules.
這是一個發布 Actavtis 仿製藥交易的平台,每天為大約 2.5 億人提供服務,是擁有 1,000 多個分子的世界上最大的藥櫃。
And every one in every five prescriptions in the US, one in every four in the UK, one in every eight in Germany is Teva's.
美國五分之一的處方,英國四分之一的處方,德國八分之一的處方是 Teva 的。
And also, one of the most competitive fully integrated operational platform in the industry that covers full spectrum of products, from volume generics to complex generics, and all the way to specialty medicines and biologics, and with unique capabilities in the space between generics and specialties.
此外,行業內最具競爭力的全集成運營平台之一,涵蓋從批量仿製藥到復雜仿製藥,一直到專科藥物和生物製劑的全系列產品,在仿製藥和專科之間具有獨特的能力.
These efforts will result in a Company well-positioned to ensure we have a strong product development engine in both generics and specialty that can support a sustainable, long-term goal.
這些努力將使公司處於有利地位,以確保我們在仿製藥和專業領域擁有強大的產品開發引擎,以支持可持續的長期目標。
Today we are reaffirming our 2018 target, first presented last year when we announced the proposed Actavis Generics acquisition.
今天,我們重申我們的 2018 年目標,該目標於去年宣布擬議的 Actavis Generics 收購時首次提出。
Using 2015 as the base year, we project a CAGR for top-line growth of 12.5% and 20% CAGR growth in EBITDA, cash flow from operations, and free cash flow.
以 2015 年為基準年,我們預計 EBITDA、運營現金流和自由現金流的複合年增長率為 12.5%,複合年增長率為 20%。
In 2016, our main focus will be on closing and integrating the Actavis Generics business, Rimsa in Mexico, and Takeda JV in Japan and on fully capturing first year synergies.
2016 年,我們的主要重點將是關閉和整合 Actavis Generics 業務、墨西哥的 Rimsa 和日本的 Takeda JV,並充分利用第一年的協同效應。
We expect to provide combined business outlook for the Company during Q2 2016.
我們預計將在 2016 年第二季度為公司提供綜合業務展望。
In 2016, we also expect to continue delivering on the promise of our specialty pipeline with the commercial launches of SD-809 for Huntington's disease; Reslizumab in asthma; Vantrela extended-release hydrocodone, in addition to the launch of the Bendeka recently.
2016 年,我們還希望繼續兌現我們專業管線的承諾,推出用於亨廷頓舞蹈症的 SD-809; Reslizumab 治療哮喘; Vantrela 緩釋氫可酮,以及最近推出的 Bendeka。
We also expect a number of important submissions, including SD-809 for tardive dyskinesia, TV 46763 for pain, QVAR and Respiclick for asthma, and a number of important clinical milestones.
我們還期待一些重要的提交,包括用於遲發性運動障礙的 SD-809、用於疼痛的 TV 46763、用於哮喘的 QVAR 和 Respiclick,以及許多重要的臨床里程碑。
One clinical milestone for 2016 that I would like to provide an update on is Pridopidine.
我想更新的 2016 年的一個臨床里程碑是普利多匹定。
We have indicated to you that during this quarter, we have the pre-specified analysis of the 26-week data from our 52-week PRIDE HD study.
我們已經向您表明,在本季度,我們對來自 52 週 PRIDE HD 研究的 26 週數據進行了預先指定的分析。
At this time, the study's Steering Committee has recommended to continue the study as planned.
目前,該研究的指導委員會已建議按計劃繼續研究。
And in order to maintain the integrity of this ongoing double-blind trial, results of both 26-week and 52-week endpoints will be made available upon study completion in Q3 2016.
為了保持這項正在進行的雙盲試驗的完整性,26 周和 52 週終點的結果將在 2016 年第三季度研究完成後公佈。
Last but not least, we expect to generate $20 billion to $25 billion of free cash flow during the 2016 to 2018 timeframe.
最後但同樣重要的是,我們預計在 2016 年至 2018 年期間將產生 200 億至 250 億美元的自由現金流。
It would allow for rapid deleveraging and the ability to continue pursuing future acquisitions, with focus on growth and entering specialty branded deals in core specialty areas and footprint expansion in key growth markets.
這將允許快速去槓桿化和繼續追求未來收購的能力,重點放在核心專業領域的增長和進入專業品牌交易以及關鍵增長市場的足跡擴張。
With that, I hand it over to Siggi Olafsson to discuss our Global Generic Medicine business.
有了這個,我將它交給 Siggi Olafsson 來討論我們的全球仿製藥業務。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Thank you, Erez.
謝謝你,埃雷茲。
Good morning and good afternoon, everyone.
大家早上好,下午好。
2015 was a very good year for Teva Generics.
2015 年對 Teva Generics 來說是非常好的一年。
Thanks to our strong performance of the base business and good new products launches, we delivered great results in the US and in major markets globally.
由於我們基礎業務的強勁表現和良好的新產品發布,我們在美國和全球主要市場取得了不錯的成績。
We continued improving the operating profit of the generic business, coming from $1.68 billion operating profit in 2013, or 17% of revenue, to $2.68 billion operating profit in 2015, or 28% of revenue.
我們繼續提高仿製藥業務的營業利潤,從 2013 年的 16.8 億美元營業利潤(佔收入的 17%)增加到 2015 年的 26.8 億美元營業利潤,佔收入的 28%。
This is $1 billion improvement in operating profit over 24 months period.
這是 24 個月期間營業利潤增加 10 億美元。
So how did we do this?
那麼我們是怎麼做到的呢?
Not by pricing but by portfolio mix, new products, and efficiency measures.
不是通過定價,而是通過投資組合、新產品和效率措施。
New product launches are very important.
新產品發布非常重要。
We had approximately 450 new product launches in 2015.
2015 年,我們推出了大約 450 款新產品。
This is the key to the growth of generics.
這是仿製藥增長的關鍵。
For 2016, on a full-year pro-forma basis with Actavis Generics, we see over 1,000 new product launches forecasted, growing to approximately 1,500 new launches in 2017.
對於 2016 年,在 Actavis Generics 的全年預估基礎上,我們預計將推出超過 1,000 種新產品,2017 年將增加到約 1,500 種新產品。
Portfolio mix is also important.
投資組合也很重要。
Part of our yearly operating plan is to review our marketed portfolio in addition to the pipeline.
我們年度運營計劃的一部分是審查我們的營銷產品組合以及管道。
Having the largest product offering of any pharma company gives us the opportunity to serve the markets well, but also improve profitability by making the right portfolio decision.
擁有所有製藥公司中最大的產品供應讓我們有機會很好地服務於市場,同時也通過做出正確的投資組合決策來提高盈利能力。
The network optimization and efficiency measurements that have been taken by Carlo and our operation group have delivered approximately half of the profit improvement in generics.
Carlo 和我們的運營團隊採取的網絡優化和效率措施已經實現了大約一半的仿製藥利潤增長。
This is a key strength of Teva, and we will continue improving our operation network and costs.
這是 Teva 的一個關鍵優勢,我們將繼續改善我們的運營網絡和成本。
We have also focused our marketing presence.
我們還專注於我們的營銷存在。
We have terminated business activities in 24 markets, focusing our efforts on larger markets.
我們已經終止了 24 個市場的業務活動,將精力集中在更大的市場上。
And this has improved significantly the efficiency of the overall business.
這顯著提高了整體業務的效率。
And last but not least, we have kept our sales and marketing costs flat.
最後但同樣重要的是,我們保持了銷售和營銷成本不變。
We have invested more in the growth markets.
我們在成長型市場上投入了更多資金。
That's a market we see the opportunity to grow maybe to $700 million to a $1 billion revenue over time and promote mostly branded generics.
這是一個市場,我們看到有機會隨著時間的推移增長到 7 億美元到 10 億美元的收入,並主要推廣品牌仿製藥。
And against that, we have reduced costs in some of the markets in Europe.
與此相反,我們降低了歐洲一些市場的成本。
We are on track of closing the Actavis Generics transaction soon.
我們有望很快完成對 Actavis Generics 的交易。
We have a good collaboration with the regulating agencies.
我們與監管機構有良好的合作。
But as you can imagine, they are doing a very thorough review, which takes a while with the combined pipeline that these two companies have.
但正如您可以想像的那樣,他們正在進行非常徹底的審查,這需要一段時間才能與這兩家公司的聯合管道相結合。
We are continuing down the path towards closing this transaction by the end of this quarter, although closing might slip into April.
我們正在繼續朝著在本季度末完成這筆交易的方向努力,儘管可能會推遲到 4 月。
We remain confident in completing the transaction and haven't had any surprises during the process.
我們對完成交易充滿信心,在此過程中沒有出現任何意外。
The divestiture process is running in parallel.
剝離過程同時進行。
And we are working closely with four to five potential buyers in divesting necessary assets.
我們正在與四到五個潛在買家密切合作,剝離必要的資產。
The plan for the overall integration is in place.
整體整合的計劃已經到位。
The collaboration with Allergan has been outstanding.
與 Allergan 的合作非常出色。
We set up 31 integration teams, co-led by leaders from Actavis Generics and Teva.
我們成立了 31 個整合團隊,由 Actavis Generics 和 Teva 的領導共同領導。
They have prepared detailed plans for day 1, day 30, and day 100; announced leadership teams pending, of course, close of the transaction; and validated synergy targets.
他們為第 1 天、第 30 天和第 100 天制定了詳細的計劃;宣布領導團隊待定,當然,交易結束;並驗證協同目標。
Based on the work we see today, we are very confident in the synergy targets and execution of the transaction.
基於我們今天看到的工作,我們對交易的協同目標和執行非常有信心。
Briefly, on pricing.
簡而言之,關於定價。
As I've previously stated, we and the generic industry overall don't see price inflation of generics as it sometimes is portrayed in the media.
正如我之前所說,我們和整個仿製藥行業都沒有看到媒體有時描述的仿製藥價格上漲。
On the contrary, for 2015, we saw a mid-single-digit price decline for the overall business.
相反,在 2015 年,我們看到整體業務的價格出現了中個位數的下降。
In the US, our largest market, we saw approximately 4% price erosion.
在我們最大的市場美國,我們看到價格下跌了大約 4%。
In Europe, we experienced a little higher price pressure of maybe 5% to 6%.
在歐洲,我們經歷了 5% 到 6% 的更高價格壓力。
And in the growth market, we saw a smaller decline; and in some branded generics markets, even small price increases during 2015.
在成長型市場,我們看到了較小的跌幅;在一些品牌仿製藥市場,2015 年價格甚至出現小幅上漲。
This gives us overall price erosion of approximately 5%.
這使我們的整體價格下降了大約 5%。
Looking forward, the conjunction of price erosion with the mix changes, focus on cost structure, and the new product launches, we continue to drive our business growth, both top line and bottom line.
展望未來,價格侵蝕與組合變化、對成本結構的關注以及新產品的推出相結合,我們將繼續推動我們的業務增長,包括收入和利潤。
We expect to see the same in 2016.
我們希望在 2016 年看到同樣的情況。
Nothing today points to a significant change in the generic pricing environment.
今天沒有任何跡象表明通用定價環境會發生重大變化。
With that, I hand it over to Eyal Desheh to discuss the financial results and guidance.
有了這個,我把它交給 Eyal Desheh 來討論財務結果和指導。
Eyal.
埃亞爾。
Eyal Desheh - CFO
Eyal Desheh - CFO
Thank you, Siggi.
謝謝你,西吉。
Good morning and good afternoon, everyone.
大家早上好,下午好。
I am pleased to share with you the financial review of Q4 2015 end of year.
很高興與大家分享2015年第四季度年末的財務回顧。
This was indeed a transformational year for Teva.
這確實是 Teva 轉型的一年。
I will start with Q4.
我將從第四季度開始。
This was a strong quarter, which closed a very good year.
這是一個強勁的季度,結束了非常好的一年。
Revenues and operating income, net of FX impact, were flat in real terms compared to last year.
扣除外匯影響後的收入和營業收入與去年相比實際持平。
Earnings per share, adjusted to exclude the December 15th equity offering, was $1.32, above the high end of our guidance.
經調整以排除 12 月 15 日的股票發行後的每股收益為 1.32 美元,高於我們指引的上限。
On the same share count basis, earnings per share for the year was $5.46.
在相同的股票數量基礎上,當年每股收益為 5.46 美元。
While foreign exchange had a negative impact of about $260 million on our top line for the quarter, the impact on operating income was much smaller due to our balanced natural hedge.
雖然外匯對我們本季度的收入產生了約 2.6 億美元的負面影響,但由於我們平衡的自然對沖,對營業收入的影響要小得多。
And it was $44 million.
這是4400萬美元。
Our cash flow in Q4, we continued to demonstrate strong cash flow as we have throughout the past two years.
我們在第四季度的現金流,我們繼續表現出過去兩年強勁的現金流。
And this positioned us with improved liquidity ratio ahead of the upcoming closing of the Rimsa and Actavis Generics acquisitions.
這使我們在即將結束對 Rimsa 和 Actavis Generics 的收購之前提高了流動性比率。
Leverage was down to 25%, and debt to EBITDA was down to 1.51 times.
槓桿率降至 25%,債務與 EBITDA 的比率降至 1.51 倍。
When we look at the breakdown of revenues by region, US continues to represent 54% of our total sales.
當我們按地區查看收入明細時,美國繼續占我們總銷售額的 54%。
Generics were 46% of total sales, and Copaxone accounted for 20% of our total sales in Q4.
仿製藥佔第四季度總銷售額的 46%,Copaxone 占我們總銷售額的 20%。
Copaxone represented 40% of our operating profit, down from 47% in Q4 last year.
Copaxone 占我們營業利潤的 40%,低於去年第四季度的 47%。
The share of generic profit was up from 31% to 33% with a 250-basis-point improvement in profitability from Q4 last year.
仿製藥利潤的份額從 31% 上升到 33%,盈利能力比去年第四季度提高了 250 個基點。
And last, the sale of Copaxone were just under $1 billion for the quarter, with stable total TRx level, and an uptrend for the 40-milligram, as you can see on this slide.
最後,本季度 Copaxone 的銷售額略低於 10 億美元,總 TRx 水平穩定,40 毫克呈上升趨勢,如您在這張幻燈片中所見。
So let's look at the year.
那麼讓我們看看這一年。
2015 was indeed a very good year for Teva, with revenues net of the FX impact growing by 4% in real terms; operating income growing 9% in real terms; net income and EPS 6% in nominal value year over year.
2015 年對 Teva 來說確實是非常好的一年,扣除外匯影響後的收入實際增長了 4%;營業收入實際增長 9%;淨收入和每股收益按名義價值同比增長 6%。
Earnings per share, adjusted to exclude December's equity offering were, as mentioned, $5.46.
如前所述,經調整以排除 12 月的股票發行後的每股收益為 5.46 美元。
Our strong results were achieved despite the foreign-exchange headwind.
儘管外匯逆風,我們還是取得了強勁的業績。
This headwind resulted again from the strength of the dollar against most currencies.
這種逆風再次源於美元兌大多數貨幣的強勢。
While the impact on our sales came from most of our major currencies, our operating profits were very well balanced and were mostly influenced by the weakness of the Russian ruble.
雖然我們的銷售額受到大多數主要貨幣的影響,但我們的營業利潤非常平衡,主要受到俄羅斯盧布疲軟的影響。
Looking at EBITDA, this important measurement will continue to drive very strong EBITDA growth, with 7.8% CAGR over the past three years.
從 EBITDA 來看,這一重要指標將繼續推動 EBITDA 強勁增長,過去三年的複合年增長率為 7.8%。
The improved generic business generated 37% of annual operating profit without G&A, while Copaxone's share of this profit was down from 46% to 42%.
改進後的仿製藥業務產生了 37% 的年度營業利潤(不含 G&A),而 Copaxone 在該利潤中的份額從 46% 下降至 42%。
And these two major pieces of our business are coming close in contribution.
我們業務的這兩個主要部分的貢獻正在接近。
So here's the profitability improvement of our generic business, as Siggi already mentioned.
正如 Siggi 已經提到的,這是我們通用業務的盈利能力改善。
In three years, profitability improved over 1,000 basis points, from 17% to over 28% for 2015.
在三年內,盈利能力提高了 1,000 多個基點,從 17% 提高到 2015 年的 28% 以上。
Dividends, our declared dividends for Q4 2015 were $0.34 per share.
股息,我們宣布的 2015 年第四季度股息為每股 0.34 美元。
And now let's move to the Q1 2016 outlook.
現在讓我們來看看 2016 年第一季度的展望。
In 2016, our combined business will change profoundly in all aspects.
2016年,我們合併後的業務將在各個方面發生深刻的變化。
Economically, financially, and also our capital structure is going to change.
在經濟上、財務上以及我們的資本結構都將發生變化。
We will share with you today our outlook for Q1 2016, and will present the new Teva a few weeks following deal closure.
我們今天將與您分享我們對 2016 年第一季度的展望,並將在交易完成幾週後展示新的 Teva。
We expect revenues to continue to be impacted by exchange rates and to be in the range of $4.7 billion to $4.9 billion for the first quarter of 2016.
我們預計收入將繼續受到匯率的影響,2016 年第一季度收入將在 47 億美元至 49 億美元之間。
We further expect EPS for Q1 2016, adjusted to exclude the share added in December 15 equity offering, to be in the range of $1.32 to $1.36.
我們進一步預計 2016 年第一季度的每股收益(調整後不包括 12 月 15 日股票發行中增加的股份)將在 1.32 美元至 1.36 美元之間。
And the fully diluted full share count to be $1.16 to $1.20.
完全稀釋後的全部股份數為 1.16 美元至 1.20 美元。
This is based on share count of 978 shares.
這是基於 978 股的股數。
So I like to thank you all very much for listening to our review this morning.
因此,我非常感謝大家今天早上收聽我們的評論。
And we will now open the call for questions.
我們現在將開始提問。
Operator
Operator
Thank you.
謝謝你。
(Operator Instructions)
(操作員說明)
The first question today comes from the line of Ken Cacciatore from Cowen and Company.
今天的第一個問題來自 Cowen and Company 的 Ken Cacciatore。
Please go ahead.
請繼續。
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
Good morning, everyone.
大家,早安。
Thanks.
謝謝。
Just a question on your discussion within the press release about wanting to focus on integration.
只是關於您在新聞稿中關於希望專注於集成的討論的問題。
Understanding that's clearly a high priority this year of integrating the businesses.
明白這一點顯然是今年整合業務的重中之重。
But wondering with the decline in branded asset values that are available out there, would you be thinking or considering maybe accelerating more business development in that area as you try to continue to diversify away from Copaxone?
但想知道隨著可用品牌資產價值的下降,您是否會考慮或考慮在您嘗試繼續從 Copaxone 轉向多元化時加速該領域的更多業務發展?
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
Yes.
是的。
Hi, Ken, BD focus is shifting now to growth-enhancing specialty deals, and still may be in a very selective (inaudible) with expansion in key growth markets, helping the market over time to assign a higher multiple and higher EPS
嗨,Ken,BD 的重點現在正在轉移到促進增長的專業交易上,並且隨著關鍵增長市場的擴張,仍然可能處於非常有選擇性的(聽不清),隨著時間的推移幫助市場分配更高的倍數和更高的每股收益
Kevin Mannix - SVP of IR
Kevin Mannix - SVP of IR
Any follow-up question?
任何後續問題?
Ken Cacciatore - Analyst
Ken Cacciatore - Analyst
No.
不。
Thank you.
謝謝你。
Kevin Mannix - SVP of IR
Kevin Mannix - SVP of IR
Next question, please.
請下一個問題。
Operator
Operator
David Risinger from Morgan Stanley.
摩根士丹利的大衛瑞辛格。
Please go ahead.
請繼續。
David Risinger - Analyst
David Risinger - Analyst
Yes.
是的。
Thanks very much.
非常感謝。
So I have three questions.
所以我有三個問題。
First, Siggi, could you just talk about why the deal timing might slip into early April?
首先,Siggi,你能談談為什麼交易時間可能會推遲到 4 月初嗎?
Is that simply because certain countries are holding you up, like China, or what is driving that?
這僅僅是因為某些國家阻礙了你,比如中國,還是什麼在推動它?
Second, with respect to the three times a week product, ex-US, there was an encouraging patent win in Europe.
其次,關於每週 3 次的產品(美國除外),在歐洲取得了令人鼓舞的專利勝利。
Could you please talk about that and talk about the durability of that asset ex-US?
您能否談談這個問題並談談該資產(美國除外)的耐用性?
And then, third, consensus seems to expect negative PTAB decisions on the three TW patent challenges late in the summer.
然後,第三,共識似乎預計 PTAB 將在夏末對三項台灣專利挑戰做出否定決定。
Could you talk about that and whether there might be any positive read throughs from the three times a week patent win in Europe?
您能否談談這一點以及每週 3 次在歐洲贏得專利是否有任何積極的解讀?
Thank you very much.
非常感謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
David, let me start on the timing.
大衛,讓我從時間開始。
So timing is simply the size of the pipeline, if you think about the pipeline of the two companies combined, probably over 320 ANDAs.
所以時間就是管道的大小,如果你考慮兩家公司的管道加起來,可能超過 320 個 ANDA。
There's a pretty thorough review that needs to take place between the FTC and the FDA of the pipeline.
FTC 和 FDA 之間需要對該管道進行非常徹底的審查。
I think the review of the commercial overlap is going well, and this is on the US.
我認為對商業重疊的審查進展順利,這是在美國。
In Europe, we are on the clock.
在歐洲,我們正守時。
So we feel that should be -- we should be able to close that in March.
所以我們覺得應該是——我們應該能夠在 3 月份結束它。
And most of the smaller markets are already in-house.
大多數較小的市場已經在內部。
So probably the part which is the most work, which is the US review, is the one that we are focusing on.
所以可能工作量最大的部分,即美國審查,是我們關注的部分。
But there is nothing unexpected coming up.
但是沒有什麼意外的事情發生。
It's just the extent of the work, the extent of the portfolio that we are dealing with that could be the reason it could slip into April.
這只是工作的範圍,我們正在處理的投資組合的範圍可能是它可能滑入 4 月的原因。
But we are still very focused to try to close in this quarter.
但我們仍然非常專注於在本季度結束。
Erez Vigodman - CEO
Erez Vigodman - CEO
So on Copaxone, first, let me just say that with all the patent offices instituted IPRs, on three out of four orange book patents, it is far from an endorsement on the Mylan claims.
因此,關於 Copaxone,首先,我只想說,所有專利局都對四分之三的橙皮書專利制定了知識產權,這遠非對 Mylan 索賠的認可。
We strongly believe that we will prevail at the end of the process.
我們堅信,我們將在進程結束時獲勝。
We strongly believe in the durability of our franchise and our ability to protect it commercially in Italy.
我們堅信我們特許經營權的持久性以及我們在意大利商業上保護它的能力。
But I will just would like to remind basically everyone that even in this scenario, the Copaxone 40-milligram generic financial implication for us are limited, and we shared with the street on the Q3 earning call.
但我只想提醒基本上所有人,即使在這種情況下,40 毫克 Copaxone 通用財務影響對我們來說也是有限的,我們在第三季度財報電話會議上與街頭分享。
It clips $1.2 billion of net revenues and up to $0.65 of EPS post Actavis Generics close in 2017, even if we assume that we face generic competition from generally 2017.
在 Actavis Generics 於 2017 年關閉後,它削減了 12 億美元的淨收入和高達 0.65 美元的每股收益,即使我們假設我們從 2017 年開始普遍面臨仿製藥競爭。
So that's basically captures all the relevant elements.
所以這基本上捕獲了所有相關元素。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Maybe David, on your question to Europe, so that's indeed encouraging.
也許大衛,關於你向歐洲提出的問題,這確實令人鼓舞。
We have a patent that holds till 2030.
我們擁有一項有效期至 2030 年的專利。
Copaxone three times a week, 40 milligrams is actually doing extremely well in Europe.
Copaxone一周三次,40毫克,其實在歐洲做的非常好。
We have it now on the market in 19 countries, and it's really captured the number one spot in new patients, new to brand in countries like Germany, similar like Spain, the Netherlands, Denmark.
我們現在在 19 個國家/地區上市,它確實在新患者中排名第一,在德國、西班牙、荷蘭、丹麥等國家是新品牌。
So we're seeing very good results, and that's really encouraging.
所以我們看到了非常好的結果,這真的很令人鼓舞。
Similar trend as we've seen with the US where also Copaxone 40 is the leading brand, as Erez already said before, and continues to hold strong.
正如我們在美國看到的類似趨勢,Copaxone 40 也是領先品牌,正如 Erez 之前所說,並且繼續保持強勁。
So with Copaxone 40, we really have a good performance on both parts of the ocean, and in some of the other rest of the world markets.
因此,對於 Copaxone 40,我們確實在海洋的兩個部分以及世界其他一些市場上都有良好的表現。
Erez Vigodman - CEO
Erez Vigodman - CEO
Yes.
是的。
And I understand that I was not good enough on the first question that was posed to me, so I just would like to reiterate my answer.
我知道我在第一個問題上做得不夠好,所以我想重申一下我的回答。
I said that our BD focus is shifting now to growth enhancing and specialty deals, and in a very selective fashion also footprint expansion in key growth markets helping the market overtime to assign a higher multiple on a higher EPS.
我說過,我們的 BD 重點現在正在轉向促進增長和專業交易,並且以一種非常有選擇性的方式也在關鍵增長市場進行足跡擴張,幫助市場加班在更高的 EPS 上分配更高的倍數。
Operator
Operator
Your next question comes from the line of Umer Raffat from Evercore.
你的下一個問題來自 Evercore 的 Umer Rafat。
Umer Raffat - Analyst
Umer Raffat - Analyst
Thank you for taking my question.
謝謝你提出我的問題。
I have three if I may.
如果可以的話,我有三個。
First for Erez, have your thoughts on CGRP pricing changed given the slow initial uptick of PCSK9 and they're priced at $15,000?
首先是 Erez,考慮到 PCSK9 的初始上漲緩慢且定價為 15,000 美元,您對 CGRP 定價的看法是否發生了變化?
One.
一。
Secondly, Eyal, question for you more on the long-term tax rate, especially considering there's new branded pipeline that's coming up, and I'm curious where the patents for CGRP are held and what is the tax rate on that patent?
其次,Eyal,關於長期稅率的更多問題,特別是考慮到即將推出的新品牌管道,我很好奇 CGRP 的專利在哪裡持有以及該專利的稅率是多少?
And then finally Michael, if I may, Pridopidine's upcoming phase 2b, if that works, can you file off of that?
最後是邁克爾,如果可以的話,普利多匹定即將進行的第 2b 階段,如果可行的話,你能提出來嗎?
And if there is any updated status on the deuterated pirfenidone from Ausepex.
如果有來自 Ausepex 的氘化吡非尼酮的任何更新狀態。
Thank you.
謝謝你。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Thank you, Umer.
謝謝你,烏默爾。
Let me answer the last question first.
我先回答最後一個問題。
On the Pridopidine, of course, it all depends on the strength of the data that we will see at the end of Q2, early Q3.
當然,關於 Pridopidine,這完全取決於我們將在第二季度末、第三季度初看到的數據強度。
So basically results to be shared in Q3.
所以基本上結果將在第三季度分享。
And we have an agreement with the FDA that if the results are sufficiently strong, covering not only symptomatic therapy, but also change in progression, functional capacity, that we have a reason to go back to the FDA and file associated for that.
我們與 FDA 達成協議,如果結果足夠強大,不僅涵蓋對症治療,還涵蓋進展、功能能力的變化,我們有理由返回 FDA 並為此提交相關文件。
So we will have to wait till the third quarter to really get the full understanding of the implications of that data.
因此,我們將不得不等到第三季度才能真正全面了解該數據的含義。
And then the next question was --
然後下一個問題是——
Erez Vigodman - CEO
Erez Vigodman - CEO
On the CGRP pricing, it's three years away.
在 CGRP 定價方面,還有三年時間。
It's too early to reflect on that.
現在反思還為時過早。
Umer Raffat - Analyst
Umer Raffat - Analyst
Got it.
知道了。
Eyal Desheh - CFO
Eyal Desheh - CFO
Taxes.
稅收。
So long-term tax, tax rate, today we are about 20%, 21%.
所以長期的稅收,稅率,今天我們大概是20%,21%。
We see a decline in long-term tax rate over time, so around 17%.
我們看到長期稅率隨著時間的推移而下降,約為 17%。
Specifically to your question on the CGRP, the IP is not in the US.
具體針對您關於 CGRP 的問題,IP 不在美國。
So it will be taxed at a lower tax rate and will have an impact on our tax rate end of 2018 and beyond.
因此,它將以較低的稅率徵稅,並將對我們 2018 年底及以後的稅率產生影響。
Umer Raffat - Analyst
Umer Raffat - Analyst
Got it.
知道了。
Eyal, just to clarify, the tax rate on the CGRP patent, will that will be left then the tax rate on Copaxone right now, which is about 19% I understand?
Eyal,我想澄清一下,CGRP 專利的稅率,是否會保留到現在 Copaxone 的稅率,據我所知約為 19%?
Eyal Desheh - CFO
Eyal Desheh - CFO
Not the same.
不一樣。
Not the same geography.
不一樣的地域。
But definitely a preferential rate.
但絕對是優惠率。
Umer Raffat - Analyst
Umer Raffat - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Your next question comes from Jami Rubin from Goldman Sachs.
你的下一個問題來自高盛的 Jami Rubin。
Please go ahead.
請繼續。
Your line is open.
你的線路是開放的。
Jami Rubin - Analyst
Jami Rubin - Analyst
Sorry.
對不起。
I was on mute.
我是靜音的。
First question is on Copaxone.
第一個問題是關於 Copaxone 的。
Just wondering if you could comment on what you're seeing -- there is only one generic out there, but what you are seeing in terms of price.
只是想知道您是否可以對您所看到的發表評論——那裡只有一種仿製藥,但您所看到的是價格方面的。
It does seem that you have been able to hold your volumes relatively steady, but revenues did come in a bit lighter than we were expecting.
看起來你們確實能夠保持相對穩定的銷量,但收入確實比我們預期的要少一些。
Are you seeing any changes with respect to price?
你看到價格有什麼變化嗎?
And when you think about 2016, whether or not there is another entrant to the market, do you expect any real changes in terms of the dynamic of price and rebates?
當您想到 2016 年時,無論是否有另一個進入市場的人,您是否預計價格和回扣的動態會發生任何真正的變化?
And then, Erez, for you, I think the question was asked earlier, but on M&A, you have talked about when you start to de-lever next year, you may be in a position to be more aggressive.
然後,埃雷茲,對於你來說,我認為這個問題早先被問過,但在併購方面,你已經談到明年何時開始去槓桿化,你可能會更加積極。
I'm just curious to know what your thoughts are on what's happening with the healthcare tape.
我只是想知道您對醫療膠帶發生的事情有何看法。
Obviously, everything is way down.
顯然,一切都在下降。
Do you think that CEOs of companies have adjusted their expectations and would be willing to accept lower prices, or do you think that time needs to pass before expectations can recalibrate?
您是否認為公司的首席執行官已經調整了他們的預期並願意接受更低的價格,或者您是否認為需要一段時間才能重新調整預期?
And are you in any position to take advantage of that now anyway?
無論如何,您現在是否可以利用它?
Thanks.
謝謝。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Jamie, let me start with the Copaxone.
傑米,讓我從 Copaxone 開始。
Actually, we are not seeing any impact on price at the moment.
實際上,我們目前沒有看到對價格有任何影響。
And what you do see in Europe is, as we transfer to the 43 times a week, which is price per milligram, and has a 10% to 15% lower price depending on the countries, that's something that you see as an impact on the overall sales where we just get 10% to 15% less per patient.
你在歐洲看到的是,當我們每周轉移到 43 次時,這是每毫克的價格,並且根據國家/地區的不同,價格會降低 10% 到 15%,你認為這是對總體銷售額,我們每位患者的收入減少了 10% 到 15%。
In the US, we are not seeing any impact there.
在美國,我們沒有看到任何影響。
What we've seen a bit at the end of last year is more a question of the timing of some of the demand.
我們在去年年底看到的更多是一些需求的時間問題。
The underlying prescriptions and PRX remain very stable and we're confident.
基本處方和 PRX 保持非常穩定,我們有信心。
Information available to us today, which by nature is always a bit limited, but we don't expect to see any generic additional generic in the US market in 2016.
今天我們可用的信息,本質上總是有點有限,但我們預計 2016 年美國市場上不會看到任何仿製藥。
Erez Vigodman - CEO
Erez Vigodman - CEO
And on the question you have posed to me, Jami, we at this stage we are not basically witnessing recalibration of expectations to a large extent at this stage.
關於你向我提出的問題,賈米,我們在這個階段基本上沒有在很大程度上看到期望的重新校準。
And as far as Teva is concerned, number one, we will be more selective in 2016, which basically the -- I think we are very clear that we have -- in 2015, we'll plan to invest not more than $3 billion in a quest to augment further our pipeline in core specialty areas in order to promote long-term organic growth.
就 Teva 而言,第一,我們將在 2016 年更有選擇性,基本上——我認為我們非常清楚我們已經——在 2015 年,我們計劃投資不超過 30 億美元尋求進一步擴大我們在核心專業領域的管道,以促進長期有機增長。
That's what you need to expect from us in the course of 2016.
這就是您在 2016 年對我們的期望。
Over time, as we are able to generate the very strong cash flow from the combined Company, we might then accelerate the pace of potential deals going forward, and then we need to adjust to see it go along our expectations of sales look like.
隨著時間的推移,由於我們能夠從合併後的公司產生非常強勁的現金流,我們可能會加快未來潛在交易的步伐,然後我們需要進行調整以使其符合我們對銷售的預期。
Jami Rubin - Analyst
Jami Rubin - Analyst
Thank you.
謝謝你。
Operator
Operator
Next question comes from Louise Chen from Guggenheim.
下一個問題來自古根海姆的 Louise Chen。
Louise Chen - Analyst
Louise Chen - Analyst
Hi, thanks for taking my questions.
您好,感謝您回答我的問題。
So my first question here is some of your competitors have talked about pricing pressure in the generics business during the quarter.
所以我的第一個問題是你們的一些競爭對手在本季度談到了仿製藥業務的定價壓力。
Curious if you saw that, and if so what might be driving that.
很好奇你是否看到了它,如果是的話,是什麼驅動了它。
And the second thing is as you think about your next larger scale deal, are you more interested in generics, brand deals, and why?
第二件事是,當你考慮下一筆更大規模的交易時,你是否對仿製藥、品牌交易更感興趣,為什麼?
Thanks.
謝謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Louise, let me start on the pricing.
路易絲,讓我開始定價。
As I mentioned in the beginning, we didn't see anything change in fourth quarter.
正如我在開頭提到的,我們在第四季度沒有看到任何變化。
We saw approximately 4% pricing pressure or price decline in the US business over 2015 flat over the year.
我們看到美國業務的定價壓力或價格下降約 4%,與 2015 年持平。
Some of our competitors have seen more pressure.
我們的一些競爭對手看到了更大的壓力。
I think overall, it might have to do with some dosage form differences.
我認為總的來說,這可能與一些劑型差異有關。
But also I think we have been right in adjusting the business.
但我也認為我們在調整業務方面是正確的。
We are running the business for the bottom line.
我們經營業務是為了底線。
As you saw in the slides, we have improved the bottom line.
正如您在幻燈片中看到的那樣,我們改進了底線。
So we might run the business a little differently than our competitors.
因此,我們經營業務的方式可能與競爭對手略有不同。
But overall, we saw mid-single-digit price decline in the US and also on the global level.
但總的來說,我們看到美國和全球範圍內的價格都出現了中個位數的下跌。
Erez Vigodman - CEO
Erez Vigodman - CEO
And on the BD front so again, not to repeat same I used before, I'll just put it another way.
再次在 BD 方面,不再重複我之前使用的內容,我只是換一種方式。
The acquisition of Allergan is transforming Teva, much more than just another generic acquisition for us.
對 Allergan 的收購正在改變 Teva,而不僅僅是我們的另一項通用收購。
It innovates significantly our financial profile.
它極大地改變了我們的財務狀況。
And over time, it will allow for rapid deleveraging and the ability to continue pursuing future acquisitions, but with a focus which is shifting.
隨著時間的推移,它將允許快速去槓桿化和繼續進行未來收購的能力,但重點正在發生變化。
The focus is shifting now on both specialty pharmaceuticals that complement and enhance of core TAs.
現在的重點正在轉移到補充和增強核心 TA 的特殊藥物上。
Strong focus on specialty pharmaceuticals that bolster further the pipeline.
專注於進一步加強產品線的特種藥物。
That augment our core TAs, and in a very selective fashion going forward in expending our footprint and growth market.
這增強了我們的核心 TA,並以一種非常有選擇性的方式繼續擴大我們的足跡和增長市場。
Kevin Mannix - SVP of IR
Kevin Mannix - SVP of IR
Next question please.
請下一個問題。
Operator
Operator
Marc Goodman from UBS.
來自瑞銀的馬克·古德曼。
Marc Goodman - Analyst
Marc Goodman - Analyst
Morning.
早晨。
Siggi, global generics margins at 28%.
Siggi,全球仿製藥利潤率為 28%。
Obviously, we have seen a massive change.
顯然,我們已經看到了巨大的變化。
Can you give us a flavor for, excluding Allergan, how much further there is?
你能給我們介紹一下,除了 Allergan 之外,還有多少?
And then including Allergan, are we talking about moving into the mid 30s.
然後包括 Allergan,我們是否正在談論進入 30 年代中期。
Secondly just on European generics, up 2% constant currency in the quarter, clearly we have turned the corner.
其次,僅就歐洲仿製藥而言,本季度固定匯率上漲 2%,顯然我們已經渡過了難關。
I'm just wondering how should we think about constant-currency growth in Europe going out this year and even the following year?
我只是想知道我們應該如何考慮今年乃至明年歐洲的穩定貨幣增長?
Are we going to see growth of low single-digits?
我們會看到低個位數的增長嗎?
Is that how you think about it?
你是這麼想的嗎?
And then just lastly, a quick question on ProAir and how you're thinking about the switch.
最後,關於 ProAir 的一個快速問題以及您如何考慮轉換。
It doesn't seem like the newer version is ramping up that quickly.
新版本似乎並沒有那麼快升級。
We know that generics are coming at the end of the year.
我們知道仿製藥將在年底問世。
So how are we all thinking about that?
那麼我們是怎麼想的呢?
Thanks.
謝謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Marc, on the overall operating profit of 28%, I think I've said when we set the guidance for the year of 27% midpoint that there could be maybe 100 to 200 basis points more to do if we get that.
馬克,關於 28% 的整體營業利潤,我想我已經說過,當我們為今年設定 27% 的中點指導時,如果我們能做到這一點,可能還有 100 到 200 個基點。
We are closing the year at 28%.
我們今年的收盤價為 28%。
So there might have been a little bit more, but it's only theoretical because we will have a very new and different Company when we close the Actavis transaction.
所以可能會有更多,但這只是理論上的,因為當我們完成 Actavis 交易時,我們將擁有一家非常新的和不同的公司。
So maybe a little bit more, but really I think the big task has been done.
所以可能會多一點,但我真的認為大任務已經完成了。
I think 28% is a really, really good profitability of the business we have in hand today.
我認為 28% 是我們今天手頭業務的非常非常好的盈利能力。
With regards to the European generics, we saw in third quarter and again in fourth quarter we have started to grow on a fixed currency, the top line.
關於歐洲仿製藥,我們在第三季度和第四季度再次看到我們已經開始以固定貨幣增長,即收入。
We obviously, we will not comment on 2016 of the generic business now because the picture will be very different when we combine Teva and the Actavis generics business.
顯然,我們現在不會對 2016 年的仿製藥業務發表評論,因為當我們將 Teva 和 Actavis 仿製藥業務合併時,情況將大不相同。
Because the make-up of the European business in Actavis is very different than in Teva.
因為 Actavis 的歐洲業務構成與 Teva 截然不同。
So let's wait until we give the guidance.
所以讓我們等到我們給出指導。
But overall, we felt in third and fourth quarter we turned the corner and started to see low-single digit growth on the top line but continued growth on the bottom line.
但總的來說,我們覺得在第三和第四季度我們已經轉危為安,開始看到收入的低個位數增長,但利潤繼續增長。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Marc, on the ProAir question, we are now with ProAir at about 4% of the overall ProAir subscription on the RespiClick.
馬克,關於 ProAir 問題,我們現在 ProAir 佔 RespiClick 上 ProAir 總訂閱量的 4% 左右。
It's about 2.5% of the overall SABA market.
它約佔整個 SABA 市場的 2.5%。
If you look at it, 75% of the volume of the RespiClick doesn't come from switches actually; it comes from -- most of it comes from new patients, and about one-third of it comes from switches from other products.
如果你看一下,RespiClick 75% 的音量實際上並不是來自開關;它來自——大部分來自新患者,其中大約三分之一來自其他產品的開關。
And this is also been a launch where we really focused a lot on the new benefits of this device, which is intuitive, which holds a lot of benefits for patients, and that we need to continue to convince not only patients and doctors, who are pretty convinced, but also payers that this is something that is really worth getting up to.
這也是一次發布,我們真的非常關注這個設備的新好處,它很直觀,對患者有很多好處,我們需要繼續說服不僅是患者和醫生,他們是非常確信,但付款人也相信這是真正值得努力的事情。
We now have about 75% of the commercialized covered, which I think is a good step forward.
我們現在覆蓋了大約 75% 的商業化產品,我認為這是向前邁出的一大步。
But we haven't been approaching the market so far with an end to really force a switch.
但到目前為止,我們還沒有以真正強制轉換的方式接近市場。
Maybe a word also on potential generics for ProAir.
也許還可以談談 ProAir 的潛在仿製藥。
First of all, the FDA hasn't registered anything, and this needs to happen.
首先,FDA 還沒有註冊任何東西,這需要發生。
And if it happens, we have an agreement with Perrigo that would allow them from the very end, from December of 2016 on, to come with limited numbers of a generic if they manage to get a registration.
如果發生這種情況,我們與 Perrigo 達成協議,允許他們從 2016 年 12 月的最後一刻開始,如果他們設法獲得註冊,就可以提供數量有限的仿製藥。
So our focus at the moment is really on driving acceptance of the RespiClick, and we're actually very happy with the uptick we're seeing, which is really accelerating at the moment.
因此,我們目前的重點實際上是推動 RespiClick 的接受度,我們實際上對我們看到的上升趨勢感到非常滿意,目前這種上升趨勢確實在加速。
But there is still a bit of work to do there.
但是那裡還有一些工作要做。
Operator
Operator
Your next question comes from the line of Liav Abraham from Citi.
你的下一個問題來自花旗的 Liav Abraham。
Please go ahead.
請繼續。
Liav Abraham - Analyst
Liav Abraham - Analyst
Good morning.
早上好。
First question is on SD-809.
第一個問題是關於 SD-809 的。
Can you comment on the preparations that you are doing ahead of the launch and what you expect that launch to look like as of the second half of this year?
您能否評論一下您在發布前所做的準備工作以及您對今年下半年發布的預期情況?
And then secondly, Michael, I'm interested in any additional comments that you have on your CGRP in the cluster headache indication.
其次,邁克爾,我對您在叢集性頭痛適應症中對 CGRP 的任何其他評論感興趣。
Where do you start on this with FDA?
你從哪裡開始與 FDA 合作?
Can you go straight into Phase III?
能直接進入第三階段嗎?
And when can we anticipate clinical trials to start?
我們什麼時候可以預期開始臨床試驗?
Thanks.
謝謝。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Liav I'll start with the SD-809 preparations for the launch, which we really are in full preparation, as you can imagine.
Liav 我將從 SD-809 的發射準備開始,正如您可以想像的那樣,我們確實在做充分的準備。
For us also understanding Huntington's disease like we understand multiple sclerosis is very important, and we have come to insights that show there is a lot of lessons that we can take from how we have been successful with Copaxone and translate it to Huntington's disease.
對於我們來說,像了解多發性硬化症一樣了解亨廷頓病也非常重要,我們已經得出的見解表明,我們可以從我們如何成功使用 Copaxone 並將其轉化為亨廷頓氏病中吸取很多教訓。
It's obviously a disease with many -- with a much fewer number of patients.
這顯然是一種有很多人的疾病——患者人數要少得多。
Very unsatisfactory current treatments, with only 10% of doctors and patients really getting access to products, so that is far from optimal.
目前的治療方法非常不令人滿意,只有 10% 的醫生和患者真正獲得了產品,因此這遠非最佳。
So we are training our sales reps.
所以我們正在培訓我們的銷售代表。
Our MSLs are out in the market already having scientific discussions, and we're learning as fast and as good as we can.
我們的 MSL 已經上市並進行了科學討論,我們正在盡可能快地學習。
And obviously have also strong discussions with all stakeholders, including payers.
顯然也與包括付款人在內的所有利益相關者進行了深入討論。
Monitoring the market as well.
監控市場也是如此。
You see that there is two generics of tetrabenazine and deutetrabenazine that sells on the market, and we're monitoring that.
你看到市場上銷售丁苯那嗪和 deutetrabenazine 兩種仿製藥,我們正在對此進行監控。
And we see really, really good opportunity.
我們看到了非常非常好的機會。
About 90% of patients really have no therapy at the moment, and that's a vast and huge opportunity.
大約 90% 的患者目前確實沒有治療,這是一個巨大而巨大的機會。
So we are still very -- we remain extremely confident, actually more than ever, that we can launch SD-809 well and as indicated when we acquired Auspex.
所以我們仍然非常 - 我們仍然非常有信心,實際上比以往任何時候都更有信心,我們可以很好地推出 SD-809,正如我們收購 Auspex 時所表明的那樣。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Good morning, Liav.
早上好,利亞夫。
Thank you for the question.
感謝你的提問。
With regard to 48125 on migraine, first just to restate that we have begun the trial for both chronic and episodic.
關於偏頭痛的 48125,首先要重申我們已經開始對慢性和偶發性進行試驗。
This will be in about 145 sites, half in the US and half in Europe.
這將在大約 145 個站點中進行,一半在美國,一半在歐洲。
And already a significant number of sites in the order of around 20 are already open.
並且已經有大約 20 個數量級的大量網站已經開放。
And the study is very much on track.
這項研究進展順利。
Important to note that the study for both chronic and episodic migraine is taking place in the same sites, and we think that will enhance recruitment, and with people already who have participated in the Phase II study.
需要注意的是,針對慢性偏頭痛和發作性偏頭痛的研究是在同一地點進行的,我們認為這將加強招募,並且招募已經參與 II 期研究的人員。
We have committed to starting a trial on cluster headache.
我們已承諾開始對叢集性頭痛進行試驗。
And as you know, known as suicidal headaches, about 600,000 people in the US, 600,000 in Europe.
如您所知,被稱為自殺性頭痛,在美國約有 60 萬人,在歐洲約有 60 萬人。
We do know that 48125, an anti-CGRP, in general, has there been some proof of concept with Lily.
我們確實知道 48125 是一種反 CGRP,一般來說,Lily 有一些概念證明。
We know that this is likely to provide some benefit, and we plan to start the study in the second half of 2016 after discussions with the FDA on the design and the approval of the design for the study.
我們知道這可能會帶來一些好處,我們計劃在與 FDA 討論設計並批准研究設計後,於 2016 年下半年開始研究。
We obviously would hope to go straight into a Phase III study, but this will depend on our discussions with the FDA.
我們顯然希望直接進入 III 期研究,但這將取決於我們與 FDA 的討論。
Liav Abraham - Analyst
Liav Abraham - Analyst
Thanks very much.
非常感謝。
Operator
Operator
The next question comes from Elliot Wilbur from Raymond James.
下一個問題來自 Raymond James 的 Elliot Wilbur。
Please go ahead.
請繼續。
Elliot Wilbur - Analyst
Elliot Wilbur - Analyst
Thank you.
謝謝你。
First, I just wanted to ask a follow-up question of Siggi regarding your earlier comments around profitability of the generic segment.
首先,我只想問 Siggi 的一個後續問題,關於你之前對仿製藥領域盈利能力的評論。
Obviously, experienced a big ramp year over year.
顯然,年復一年地經歷了一個大的增長。
But a lot of that came in the first half and was very product specific, I believe, given certain key launches in the US.
但我相信,其中很多都是在上半年出現的,而且是非常針對特定產品的,因為在美國推出了某些關鍵產品。
The exit rate of 25.5%, just wondering what the defensibility of that level is going forward?
25.5% 的退出率,只是想知道該水平的防禦能力如何?
Do you think that's a floor for the entire book of business pre-Actavis?
您認為這是整個 Actavis 之前的商業書籍的底線嗎?
Just trying to get a sense of whether or not you think we've bottomed.
只是想了解您是否認為我們已經觸底。
And then maybe you could just provide a little bit of color commentary given that level, what the relative rate of profitability is amongst the three revenue buckets, US, Europe, and rest of the world.
然後,也許您可以根據該級別提供一些顏色評論,美國、歐洲和世界其他地區這三個收入類別之間的相對盈利率是多少。
And then a follow-up question.
然後是後續問題。
There has been a lot of time talking about pricing, particularly Copaxone and the generics.
已經有很多時間談論定價,尤其是 Copaxone 和仿製藥。
But maybe you could just comment on pricing trends across your specialty business.
但也許你可以只評論你的專業業務的定價趨勢。
Obviously, seems like payer dynamics become much more difficult in the US market and realization of list price increases becoming increasingly challenging.
顯然,在美國市場,付款人動態似乎變得更加困難,實現標價上漲變得越來越具有挑戰性。
Maybe you could just talk about pricing dynamics within the specialty portfolio, particularly in the US, whether or not you think pricing will still be a positive in 2016 versus 2015.
也許你可以談談專業產品組合中的定價動態,尤其是在美國,無論你是否認為 2016 年的定價與 2015 年相比仍然是積極的。
Thanks.
謝謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
So Elliot, on the profitability, the overall business coming in at 28% versus what we -- for the full year was 25.5% for fourth quarter.
所以 Elliot,就盈利能力而言,整體業務的盈利率為 28%,而我們第四季度全年的盈利率為 25.5%。
I think how you need to think about it is, obviously, when you have an exclusive opportunity, especially in the US, you traditionally have a higher profitability.
我認為你需要考慮的是,很明顯,當你有獨家機會時,尤其是在美國,傳統上你會有更高的盈利能力。
And we saw that in the first two quarters of the year, where we didn't have any exclusive product in third and fourth quarter, there was a lower profitability.
我們看到,在今年前兩個季度,我們在第三和第四季度沒有任何獨家產品,盈利能力較低。
That being said, keep in mind that in the new Teva, in the new combined Teva, with approximately 110 first to files, there will be regular launches of exclusive products that will keep pushing, obviously, the profitability higher.
話雖這麼說,請記住,在新的 Teva 中,在新合併的 Teva 中,大約有 110 個首先提交文件,將定期推出獨家產品,這顯然會繼續推動更高的盈利能力。
Is 25.5% the bottom of the curve?
25.5% 是曲線的底部嗎?
I don't know, on Teva stand alone.
我不知道,在梯瓦獨立。
Really it doesn't matter because we are not -- we are only running Teva stand alone in the first quarter of this year.
真的沒關係,因為我們不是 - 我們只在今年第一季度單獨運營 Teva。
I think that reflects somehow the reality when you don't have any exclusive launch.
我認為這在某種程度上反映了當您沒有任何獨家發佈時的現實。
But keep in mind that from fourth-quarter 2014 to fourth-quarter 2015, there is a 200-basis-point improvement the operating profit.
但請記住,從 2014 年第四季度到 2015 年第四季度,營業利潤提高了 200 個基點。
So there were no exclusive launches in either quarters.
因此,這兩個季度都沒有獨家發布。
So the base business, overall base business improvement from the 12-month period was 200 basis point from fourth quarter to fourth quarter.
因此,從第四季度到第四季度,基礎業務、整體基礎業務在 12 個月期間的改善為 200 個基點。
So I think the overall business is improving.
所以我認為整體業務正在改善。
With regards to the region, just quickly, US has been stable over the year.
關於該地區,很快,美國在過去一年中一直保持穩定。
I mentioned the pricing before.
我之前提到過定價。
There is a lot of competition in the US, there is no question about it.
美國競爭激烈,這是毫無疑問的。
As you well know, there are over 200 generic competitors in the US market and the competition is fierce.
眾所周知,美國市場上有 200 多家仿製藥競爭者,競爭非常激烈。
The opportunity we have is basically the largest pipeline, and I think an extremely good supply chain.
我們擁有的機會基本上是最大的管道,我認為是一個非常好的供應鏈。
Our business in Europe has improved very significantly.
我們在歐洲的業務有了非常顯著的改善。
Over the last two years, been a total turnaround of European business, even more than you see in the overall business.
在過去的兩年裡,歐洲業務實現了全面好轉,甚至比你在整體業務中看到的還要好。
We launched an average around 20 new products in every market we have in Europe going forward.
未來,我們在歐洲的每個市場平均推出約 20 種新產品。
Very stable operation and has been built up very well.
運行非常穩定,並且已經建立得很好。
Probably the fastest growing opportunity net of FX is the growth markets.
外匯增長最快的機會網可能是增長市場。
How we explain growth markets, are markets which we would like to foresee to grow significantly, even to $700 million to $1 billion in revenue.
我們如何解釋增長市場,是我們希望預見到顯著增長的市場,甚至達到 7 億至 10 億美元的收入。
Markets likes Russia, obviously, there is a huge FX impact in Russia.
市場喜歡俄羅斯,顯然,俄羅斯對外匯產生巨大影響。
But the underlying business, the volume, the new launches, and the business we've run in Russia is outstanding.
但我們在俄羅斯經營的基礎業務、數量、新產品和業務都很出色。
I'm very excited about the joint venture.
我對合資企業感到非常興奮。
We will hopefully close that transaction beginning of second quarter.
我們希望在第二季度開始時完成該交易。
We made a very significant acquisition in Mexico with Rimsa, which takes us to a top-tier company with a portfolio of both specialty and generic products.
我們在墨西哥與 Rimsa 進行了一項非常重要的收購,這使我們成為一家擁有專業和非專利產品組合的頂級公司。
So that's where we see the most growth going forward.
所以這就是我們看到未來增長最快的地方。
But I think we have a very unique business model in the Teva generics today and feel that we are running on all cylinders.
但我認為我們今天在 Teva 仿製藥中擁有非常獨特的商業模式,並且感覺我們正在全速運轉。
Erez Vigodman - CEO
Erez Vigodman - CEO
Maybe to just underscore one of the points that were made in there.
也許只是強調其中提出的觀點之一。
The 25.5% operating profit is basically a profit that is naked in terms of new launches, businesses generating.
25.5% 的營業利潤基本上是在新產品發布和業務產生方面赤裸裸的利潤。
You have to just realize that.
你必須意識到這一點。
You compare it to 2013 with launches from businesses that generated 20% -- of 20% operating profits.
您將其與 2013 年的業務進行比較,這些業務產生了 20% - 20% 的營業利潤。
And going forward, that's basically not a customary situation because with 320 ANDAs, 110 of which are FDA first to files, we have a business that will be able to generate on yearly basis exciting launches.
展望未來,這基本上不是慣例情況,因為有 320 個 ANDA,其中 110 個是 FDA 首先提交的文件,我們的業務將能夠每年產生令人興奮的發布。
So the 25.5% that you are witnessing in Q4 2015 is basically an exceptional situation.
所以你在 2015 年第四季度看到的 25.5% 基本上是一個例外情況。
And going forward, that's a business that will be able on top of that, to generate much higher profit that stem from launches that are going to be carried out.
展望未來,這是一項能夠在此基礎上產生更高利潤的業務,這些利潤源於將要進行的發布。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Maybe Elliot also one word on the question of the pricing for the specialty products or the branded products.
也許 Elliot 還要談談特色產品或品牌產品的定價問題。
So clearly there is not only political dispute, but I think well before that started, there were already very clear trends and signs in the market that you have to move away from pricing as a description really to showing the value you bring for your products to patients and payers alike.
很明顯,不僅存在政治爭議,而且我認為早在這開始之前,市場上就已經出現了非常明顯的趨勢和跡象,表明您必須將定價從真正的描述轉變為展示您為產品帶來的價值患者和付款人一樣。
And having differentiated products able to really meet the unmet medical needs and show the value of that is going to be important.
擁有能夠真正滿足未滿足的醫療需求並展示其價值的差異化產品將變得非常重要。
This was in our programs, and we will have to be able to do that in the years to come.
這是我們的計劃,我們必須在未來幾年內做到這一點。
I think in 2016, we planned with fairly moderate price increases, and I would be surprised if many companies have done differently.
我認為在 2016 年,我們計劃以相當適度的價格上漲,如果許多公司採取不同的做法,我會感到驚訝。
The focus has to be on value delivered to patients and payers alike.
重點必須放在為患者和付款人提供的價值上。
That's where we are focusing.
這就是我們關注的地方。
Operator
Operator
Thank you very much.
非常感謝。
Your next question comes Andrew Finkelstein from Susquehanna.
你的下一個問題來自 Susquehanna 的 Andrew Finkelstein。
Please go ahead.
請繼續。
Andrew Finkelstein - Analyst
Andrew Finkelstein - Analyst
Good morning and thanks very much for taking the question.
早上好,非常感謝你提出這個問題。
I was hoping you could talk a bit more about some of the price volume dynamics and how that works in terms of the contracting with the large customers in the US.
我希望你能多談談一些價量動態,以及它在與美國大客戶簽訂合同方面的運作方式。
If you could provide some insight as you approach those relationships this year, both as a stand-alone and with the pending deal.
如果你能在今年處理這些關係時提供一些見解,無論是作為獨立的還是未決的交易。
How does closing the transaction and the launches and the launch calendar you're able to provide to them affect your ability to secure volume and see the moderate overall erosion that you're talking about?
關閉交易和啟動以及您能夠提供給他們的啟動日曆如何影響您確保數量和看到您正在談論的適度整體侵蝕的能力?
And then I had a follow-up on the branded side.
然後我在品牌方面進行了跟進。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Yes.
是的。
So Andrew, I think the overall -- we run the business in ordinary course.
所以安德魯,我認為總體而言 - 我們在普通課程中經營業務。
We are totally independent.
我們是完全獨立的。
There is a still a very fierce competition between Actavis Generics and Teva in the market today, there's no question about that.
今天在市場上Actavis Generics 和Teva 之間的競爭仍然非常激烈,這是毫無疑問的。
We basically launched the product.
我們基本上推出了產品。
We compete on pricing.
我們在價格上競爭。
And you have to keep in mind that especially in the -- in the bigger market, both in the US and Europe, you are really fighting on a molecule by molecule basis.
你必須記住,尤其是在更大的市場中,無論是在美國還是歐洲,你都在逐個分子地戰鬥。
If there is a lowering of the prices, you either have to walk away from the business and that's that.
如果價格下降,你要么不得不離開這家公司,就是這樣。
And that is the fact of the US business, and that doesn't change anything around the combination of the two companies.
這就是美國業務的事實,這不會改變兩家公司合併的任何內容。
I've said it previously, and I think on the last -- on the third-quarter call, what we will offer to the customers as a specialty is basically we will have most launches, the most number of launches in the industry.
我之前已經說過,我認為在最後一次 - 在第三季度的電話會議上,我們將作為專業提供給客戶的基本上是我們將擁有最多的發布,業內最多的發布。
We will pride ourselves of the service level of the high quality of the product.
我們將以高質量產品的服務水平為榮。
But at the end of the day, there is a fierce competition in the market.
但歸根結底,市場競爭激烈。
Over 200 generic companies, and really there is no bundling or anything like that, that can go on in the market.
超過 200 家仿製藥公司,實際上沒有捆綁或類似的東西可以在市場上繼續下去。
So overall, same as without the deal.
總的來說,與沒有交易一樣。
But we see the opportunity going forward based on the huge pipeline that we have.
但我們看到了基於我們擁有的龐大管道的機會。
Andrew Finkelstein - Analyst
Andrew Finkelstein - Analyst
Thanks very much.
非常感謝。
And then on the branded side, you noted the IR hydrocodone product and FDA just announced what they called a sweeping change in its approach to opioid regulation and immediate-release products in particular.
然後在品牌方面,你注意到 IR 氫可酮產品和 FDA 剛剛宣布了他們所謂的對阿片類藥物監管方法的徹底改變,特別是速釋產品。
How do you think about both for your ER and IR abuse-deterrent products, how you're seeing that opportunity?
您如何看待您的 ER 和 IR 濫用威懾產品,您如何看待這個機會?
FDA does seem to be taking more actions to try to discourage the use of opiods in general.
FDA 似乎確實採取了更多行動來試圖阻止一般使用阿片類藥物。
Are they doing -- going to be doing enough to encourage the use of the abuse-deterrent products to help compete against the generic alternatives that are already out there?
他們是否正在做——將做足夠的事情來鼓勵使用防濫用產品來幫助與已經存在的通用替代品競爭?
And how you're thinking about your strategy from maximizing that portfolio opportunity?
您如何通過最大化該投資組合機會來考慮您的策略?
Thanks.
謝謝。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Thank you, Andrew, for that important question.
安德魯,謝謝你提出這個重要問題。
Yes.
是的。
There are a number of opioid NDAs currently under review by the FDA.
FDA 目前正在審查許多阿片類藥物的 NDA。
And certainly the agency has provided additional scrutiny around these applications, and certainly we believe that we're a part of the solution.
當然,該機構已經對這些應用程序進行了額外的審查,當然我們相信我們是解決方案的一部分。
We recognize the really awful and very sad epidemic of opioid abuse in the United States, and we are developing products that really have a chance to both treat people with chronic pain, but also prevent some of the abuse that is likely.
我們認識到阿片類藥物濫用在美國非常可怕和非常可悲,我們正在開發的產品確實有機會治療慢性疼痛患者,但也可以防止一些可能的濫用。
So our abuse-deterrent technology, which is very novel and provides both protection and also can provide pain relief for those patients that need it.
因此,我們的防濫用技術非常新穎,既能提供保護,又能為有需要的患者減輕疼痛。
So we are awaiting our review and approval of [Vantrela], which is ER hydrocodone.
因此,我們正在等待 [Vantrela] 的審查和批准,它是 ER 氫可酮。
We also expect to get the results of immediate-release hydrocodone this year, and to file before the end of the year.
速釋氫可酮也有望在今年出結果,年底前報案。
This product of course, the immediate-release hydrocodone deals with the larger number of patients and people who are suffering from addiction and also from overdose, where 80% of this is due to the immediate-release hydrocodone.
當然,速釋氫可酮這個產品針對的是更多患有成癮和過量服用的患者和人群,其中 80% 是由於速釋氫可酮。
So we are very much aware and working with the agency, working very closely to address all the questions.
因此,我們非常了解該機構並與之合作,密切合作以解決所有問題。
We are looking forward to having approval of this important first product, and then we'll continue to develop products that really have a chance to make a difference in patients' lives.
我們期待著這個重要的第一個產品獲得批准,然後我們將繼續開發真正有機會改變患者生活的產品。
Operator
Operator
Your next question comes from Gregg Gilbert from Deutsche Bank.
你的下一個問題來自德意志銀行的 Gregg Gilbert。
Gregg Gilbert - Analyst
Gregg Gilbert - Analyst
First on your outlook.
首先是你的前景。
When you provide your new outlook in May, do you plan to offer guidance for 2017 and 2018?
當您在 5 月提供新展望時,您是否計劃提供 2017 年和 2018 年的指導?
Maybe more importantly, near term, is all the info you've been getting from Allergan supportive of the previous targets you put out that obviously include their generic business?
也許更重要的是,在短期內,您從 Allergan 獲得的所有信息是否支持您之前提出的目標,這些目標顯然包括他們的通用業務?
Secondly, a question on Treanda.
其次,關於 Treanda 的問題。
I realize there is a legal ruling due in the coming months on the lyophilized generics and that those generics are possibly going to launch if they win.
我意識到未來幾個月將對凍乾仿製藥作出法律裁決,如果獲勝,這些仿製藥可能會上市。
But if you do prevail, what's the best-case timeline for the launch of generic lyophilized products?
但如果你真的獲勝,那麼推出仿製藥凍乾產品的最佳時間表是什麼?
How late would those be?
那要遲到多久?
Thanks.
謝謝。
Erez Vigodman - CEO
Erez Vigodman - CEO
So on guidance, hi Gilbert, on guidance, we are committed to provide guidance for 2016.
所以關於指導,嗨吉爾伯特,關於指導,我們致力於為 2016 年提供指導。
We are considering if now we provide more visibility into 2017 and maybe beyond.
我們正在考慮是否現在提供更多 2017 年甚至更遠的可見性。
But that's too early to comment on that.
但現在對此發表評論還為時過早。
Regarding to a target, we are basically maybe that some of it was spread out already.
關於目標,我們基本上可能已經分散了一些。
But I am reiterating it now.
但我現在重申。
Basically, we are reaffirming all the synergy targets that we announced last year, and basically, we are able to generate all the synergy numbers that were shared with the street.
基本上,我們重申了去年宣布的所有協同目標,基本上,我們能夠生成與街道共享的所有協同數字。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
And on Treanda, we are quite hopeful and positive on the opportunities.
在 Treanda,我們對機會充滿希望和積極。
Generics could come, if the judge so decides, they could come in May.
仿製藥可能會來,如果法官如此決定,他們可能會在 5 月來。
But even if that would happen, we believe that we could, and we've indicated it before, shift about half of the patients, half of the business to support at least a shift to Bendeka, the rapid infusion bendamustine that we have just launched a couple of days ago really.
但即使發生這種情況,我們相信我們可以,並且我們之前已經表明過,轉移大約一半的患者,一半的業務以支持至少轉移到我們剛剛推出的快速輸注苯達莫司汀 Bendeka幾天前真的。
The Treanda life after that, there will be -- Bendeka has a potentially three depending on the FDA, whether they grant it with an orphan drug status and the protection related to that, even seven years life stay.
在那之後的 Treanda 生命,將會有——Bendeka 有可能有 3 年,這取決於 FDA,他們是否授予它孤兒藥物地位和與之相關的保護,甚至七年的生命。
But it's, at the moment, pure speculative.
但目前,這純粹是推測。
So that's something that we need the FDA confirmation on, but we are very positive on that.
所以這是我們需要 FDA 確認的事情,但我們對此非常積極。
And also the patents, per se, on Treanda will go well into the 2020s.
Treanda 的專利本身也將延續到 2020 年代。
But that's something that I need to look up the exact date for the end of the Treanda patent life.
但這是我需要查找 Treanda 專利壽命結束的確切日期的東西。
Operator
Operator
Our next question comes from Irina Koffler from Mizuho.
我們的下一個問題來自瑞穗的 Irina Koffler。
Please go ahead.
請繼續。
Irina Koffler - Analyst
Irina Koffler - Analyst
Thanks for taking the questions.
感謝您提出問題。
Can you help us visualize the layering in of the Takeda business, as well as Rimsa throughout 2016?
您能否幫助我們想像一下整個 2016 年武田(Takeda)業務以及 Rimsa 的分層?
And then the second question is on QVAR.
然後第二個問題是關於 QVAR 的。
It seems a little strong this quarter.
這個季度似乎有點強勢。
Can you maybe describe what happened there.
你能描述一下那裡發生的事情嗎?
Was there any stocking?
有襪子嗎?
Thank you.
謝謝你。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
So maybe if I start on Takeda and Rimsa.
所以也許如果我從 Takeda 和 Rimsa 開始。
We estimate that we will close the Rimsa transaction in first quarter.
我們估計我們將在第一季度完成 Rimsa 交易。
Probably hopefully by the end of this month, beginning of next month.
可能希望在這個月底,下個月初。
That is our goal.
這是我們的目標。
In terms of the Takeda joint venture, the goal has been April 1st.
就武田合資企業而言,目標一直是 4 月 1 日。
It could slip a little bit later in April.
它可能會在四月晚些時候下滑一點。
But the goal is April 1st to close that transaction.
但目標是在 4 月 1 日完成該交易。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
And on QVAR, there has not been extra stocking or anything like that.
在 QVAR 上,沒有額外的庫存或類似的東西。
It is really purely demand-driven.
這真的是純粹的需求驅動。
What you have seen is there has been some release of provisions related to some of the payments we had to do to the public segment in the US, which came in a little bit lower than previously.
你所看到的是,已經發布了一些與我們必須向美國公共部門支付的一些款項相關的規定,這比以前少了一點。
But the underlying business is really performing well and there is a growth of a -- a nice double-digit growth on QVAR as well in the US.
但基礎業務確實表現良好,並且在 QVAR 以及美國都有不錯的兩位數增長。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Can you, going back to Rimsa and Takeda, just explain how much revenue you are expecting to layer in?
回到 Rimsa 和 Takeda,你能解釋一下你期望分層的收入嗎?
Can you provide a little more there?
你能提供更多嗎?
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
No.
不。
So with both companies we will give you a guidance when we close probably close Actavis, what we gave when the Rimsa transaction was announced was a revenue of Rimsa in 2014 was just over $200 million.
因此,對於兩家公司,當我們關閉可能關閉 Actavis 時,我們會給你一個指導,我們在宣布 Rimsa 交易時給出的是 Rimsa 在 2014 年的收入剛剛超過 2 億美元。
So it's not significant.
所以意義不大。
The revenue of the joint venture we have to see.
合資公司的收入我們不得不看。
We are basically finalizing the numbers and we will give that at the guidance time.
我們基本上正在確定數字,我們將在指導時間給出。
That's much more significant.
這要重要得多。
Irina Koffler - Analyst
Irina Koffler - Analyst
Thank you.
謝謝你。
Operator
Operator
Your next question comes from the line of Ronny Gal of Bernstein.
你的下一個問題來自 Bernstein 的 Ronny Gal。
Ronny Gal - Analyst
Ronny Gal - Analyst
Thank you for talking my question.
謝謝你說出我的問題。
The first is on SD-809, as you guys have the discussion, your previous discussion with payers, should we expect that patient will have to fail first on tetrabenazine in order to get the deuterated version, or do you have a fairly good shot at first line?
第一個是關於 SD-809,正如你們討論的那樣,你們之前與付款人的討論,我們是否應該期望患者必須首先在丁苯那嗪上失敗才能獲得氘化版本,或者你們有相當好的機會第一行?
And similarly, are we talking a pricing at roughly the level of the anti -- of the -- of the [$10,000, $15,000 fee] or lower for that for this product?
同樣,我們是否在談論該產品的定價大致相當於 [10,000 美元、15,000 美元的費用] 或更低的水平?
Just to give us a ballpark where to put our first year.
只是為了給我們一個大概的時間來安排我們的第一年。
Should this be a decent quick launch or should we really expect this to be in line with some of the recent branded launches which were a little bit slow out of the gate?
這應該是一個不錯的快速發布,還是我們真的應該期望這與最近推出的一些有點慢的品牌發布一致?
And second, you had a pretty good quarter on the branded respiratory.
其次,你在品牌呼吸系統上有一個很好的季度。
Can you just go over us how you see the new generation of branded products layering in, in terms of timing and potential contributions?
您能否就時間和潛在貢獻向我們介紹一下您如何看待新一代品牌產品的分層?
Just give us a feel for how the tranche looks for the next five years.
讓我們了解一下未來五年的情況。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Ronny, on the SD809, commenting on pricing is something that -- you're aware of the prices of both the original and the branded products in the market -- I'm sorry, of the generics in the market, the two generics.
Ronny,關於 SD809,關於定價的評論是——你知道市場上原裝和品牌產品的價格——對不起,市場上的仿製藥,兩種仿製藥。
We are not going to comment, but they clearly set clear milestones for our prices in going forward.
我們不打算發表評論,但他們清楚地為我們未來的價格設定了明確的里程碑。
So far, the discussions -- in our plans, actually we did expect the patients would have had tried the current tetrabenazine before they move into SD-809.
到目前為止,討論——在我們的計劃中,實際上我們確實希望患者在進入 SD-809 之前已經嘗試過目前的丁苯那嗪。
But in our discussion with payers, we see that if we are able to really commit the right value approach, that might not be the case.
但在我們與付款人的討論中,我們發現,如果我們能夠真正採用正確的價值方法,情況可能並非如此。
In terms it of ramp up, what we see with any new products on the market, not just ours, but we see the penetration of newer products per se is a little bit slower and it's vital to work well up front with payers.
就提升而言,我們看到市場上任何新產品的情況,不僅僅是我們的產品,但我們看到新產品本身的滲透速度有點慢,與付款人預先合作至關重要。
So it will be vital for SD-809 as well.
因此,它對 SD-809 也至關重要。
We do not expect -- we expect it to reach peak number of patients in sales in five years, so that it's going to be a somewhat slower uptick in that sense.
我們不期望 - 我們預計它會在五年內達到銷售患者數量的峰值,因此從這個意義上講,它的增長速度會有所放緩。
In five years, we should be at the 6,000 patients or so we expect in Huntington's disease on SD-809.
五年後,我們應該在 SD-809 上達到我們預期的 6,000 名左右亨廷頓病患者。
Erez Vigodman - CEO
Erez Vigodman - CEO
And maybe just to add an important insight there, today basically the current medications are used by only 10% of the HD patient population.
也許只是為了增加一個重要的見解,今天基本上只有 10% 的 HD 患者使用當前的藥物。
So again it should be [spared] in (inaudible) fashion.
因此,它應該再次以(聽不清)的方式[倖免]。
Only 10% of patients are treated today by tetrabenazine and the generic product.
目前只有 10% 的患者接受丁苯那嗪和仿製藥的治療。
So although we are careful in the mounting business and going forward and the pace of uptake, but it should be stated clearly that we see a vacant space, and we see a big opportunity for us, because 90% of HD patients basically are not treated today.
所以雖然我們在安裝業務和前進以及吸收的速度上都很小心,但是應該明確地說我們看到了一個空位,我們看到了一個很大的機會,因為90%的HD患者基本上沒有得到治療今天。
Are not treated today.
今天不治療。
Why?
為什麼?
Because of the side effects of tetrabenazine.
因為丁苯那嗪的副作用。
And we believe that we are coming here with a solution which is very different and differentiated from the existing therapies.
我們相信,我們帶著一種與現有療法截然不同和不同的解決方案來到這裡。
Michael Hayden - Head of R&D and Chief Scientific Officer
Michael Hayden - Head of R&D and Chief Scientific Officer
Also let me just comment on the respi and then hand it over to Rob just on the actual market size.
另外讓我對 respi 發表評論,然後就實際市場規模將其交給 Rob。
But this is a year of important submissions for our respi portfolio.
但今年是我們 respi 產品組合重要提交的一年。
We expect three submissions this year: FP MDPI and FS MDPI early on in the year and also QVAR BAI for both adults and pediatric asthma in the second half of the year.
我們預計今年將提交三份報告:年初提交 FP MDPI 和 FS MDPI,下半年提交成人和兒童哮喘的 QVAR BAI。
We, of course, are also looking to approvals for Reslizumab IV both in the US in the first quarter and Europe in the third quarter.
當然,我們也期待第一季度在美國和第三季度在歐洲批准 Reslizumab IV。
And FS Spiromax high strength in Europe for asthma and COPD in the third quarter.
FS Spiromax 在第三季度在歐洲用於哮喘和慢性阻塞性肺病的高強度藥物。
So it's going to be a very busy year in respi actually, fruition of a lot of R&D that has been happening over the years, but now products getting to market.
因此,實際上這將是 respi 非常忙碌的一年,多年來進行的大量研發取得了成果,但現在產品進入市場。
Rob.
搶。
Rob Koremans - President and CEO of Global Specialty Medicines
Rob Koremans - President and CEO of Global Specialty Medicines
Yes.
是的。
Thanks, Michael.
謝謝,邁克爾。
So what you're seeing is actually -- Ronny, what you see on the device part with the RespiClick in the US and the DuoResp, same device, different brand name in Europe, we are trying and planning and submitting different combinations, existing product combinations in the same device for us to be able as the only Company actually to offer one in the same device for different interventions with patients so that they can really use one intuitive device.
所以你看到的實際上是 - Ronny,你在美國的 RespiClick 和 DuoResp 的設備部分看到的,相同的設備,歐洲的不同品牌名稱,我們正在嘗試和計劃並提交不同的組合,現有產品同一設備中的組合,使我們能夠作為唯一一家真正在同一設備中為患者提供不同干預措施的公司,這樣他們就可以真正使用一個直觀的設備。
On top of that, with Reslizumab, we are expecting launch in the second quarter of this year, going into the severe high eosinophilic asthma, where -- and that's the patient group that really requires interventions that are badly controlled.
最重要的是,對於 Reslizumab,我們預計將在今年第二季度推出,進入嚴重的高嗜酸粒細胞哮喘,在那裡——這就是真正需要控制不佳的干預措施的患者群體。
And that's also a patient group that we focus on for our further asthma therapies, where we bring our current device further and move into that what we discussed before E-connectivity, so smart feedback around how you actually use your product, and lung function, and giving patients and doctors tools that actually enable them to manage their asthma much better and potentially even prevent asthma attacks.
這也是我們進一步關注哮喘治療的患者群體,我們將當前的設備進一步發展,並進入我們在電子連接之前討論的內容,以便圍繞您實際使用產品的方式和肺功能提供智能反饋,並為患者和醫生提供工具,使他們能夠更好地控制哮喘,甚至有可能預防哮喘發作。
Because they can predict when they happen and seek for help before they happen.
因為他們可以預測它們何時發生並在它們發生之前尋求幫助。
And that's going to be important for a segment of patients, which is probably about 20% or so of the asthma patients that are severe and that currently generate huge costs for payers and have huge medical need.
這對一部分患者來說很重要,這些患者可能佔重症哮喘患者的 20% 左右,目前為付款人帶來巨大成本並有巨大的醫療需求。
That's where we focus more with the devices that are E-connected and smart and will help a solution there.
這就是我們更多地關注電子連接和智能設備的地方,這將有助於解決那裡的問題。
And then for people that are really well treated today, that do not have a severe asthma, and are well controlled or completely controlled, offering generic versions of currently available products is part of our plan.
然後對於今天真正得到很好治療的人,沒有嚴重哮喘,並且控制良好或完全控制的人,提供當前可用產品的通用版本是我們計劃的一部分。
So we have a fully -- we really have a full approach there with -- on severe asthma with Reslizumab first in IV and then later with the sub Q. Well-connected smart devices for the severe patients in asthma, and then for the ones that are better controlled, more cost-effective generic versions.
所以我們有一個完整的——我們真的有一個完整的方法——在重度哮喘上首先在靜脈注射中使用 Reslizumab,然後在 sub Q 中使用。連接良好的智能設備用於嚴重的哮喘患者,然後用於那些更好控制、更具成本效益的通用版本。
We feel that we are really uniquely positioned and quite optimistic about this.
我們覺得我們確實處於獨特的位置並且對此非常樂觀。
Erez Vigodman - CEO
Erez Vigodman - CEO
Ronny, what you are seeing here is the -- basically the fruit from this strong focus.
羅尼,你在這裡看到的是——基本上是這種強烈關注的結果。
We have been exercising on core-TAs.
我們一直在鍛煉核心 TA。
So four TAs with strong focus and we start to this -- basically the outcome that is stemming from that, not just top line but also profitability, I'm talking here about respiratory.
所以四個 TA 非常專注,我們開始這樣做 - 基本上是由此產生的結果,不僅是收入,還有盈利能力,我在這裡談論的是呼吸。
You will continue seeing it going forward.
您將繼續看到它向前發展。
Ronny Gal - Analyst
Ronny Gal - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Your next question comes from Chris Schott from JPMorgan.
你的下一個問題來自摩根大通的 Chris Schott。
Please go ahead.
請繼續。
Chris Schott - Analyst
Chris Schott - Analyst
Thanks very much.
非常感謝。
I think most of mine have been answered.
我想我的大部分問題都得到了回答。
I just had quick one here, which is an update on EpiPen.
我剛剛在這裡有一個快速的,這是 EpiPen 的更新。
Have you guys had a response from the FDA at this point?
你們現在收到 FDA 的回應了嗎?
Is there any other color you can provide in terms of what needs to be done to get an approval here?
關於在這裡獲得批准需要做什麼,您是否可以提供任何其他顏色?
Thanks very much.
非常感謝。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
No.
不。
There couldn't be an investor call without an EpiPen question, Chris.
克里斯,如果沒有 EpiPen 問題,就不可能有投資者電話。
Chris Schott - Analyst
Chris Schott - Analyst
Had to slip one in.
不得不塞進去一個。
Siggi Olafsson - President and CEO of Global Generic Medicines Group
Siggi Olafsson - President and CEO of Global Generic Medicines Group
So overall as I mentioned in third quarter, we had a targeted date in the middle of December.
所以總體而言,正如我在第三季度提到的那樣,我們的目標日期是 12 月中旬。
That date came and went.
那個日期來了又去了。
We have been in contact regularly with the FDA, but they haven't sent us any communication.
我們一直與 FDA 保持定期聯繫,但他們沒有向我們發送任何信息。
So we are waiting, as you are waiting.
所以我們在等待,就像你們在等待一樣。
Still of the opinion that we will get the CRL because we are not at that level of getting approval.
仍然認為我們將獲得 CRL,因為我們還沒有達到獲得批准的那個級別。
We have been -- we speak to the FDA every week about this product.
我們一直——我們每週都與 FDA 討論這個產品。
But at this point in time, we are no closer what will be the content of the complete response letter.
但目前,我們還不清楚完整回复信的內容是什麼。
Chris Schott - Analyst
Chris Schott - Analyst
Thank you.
謝謝你。
Erez Vigodman - CEO
Erez Vigodman - CEO
So I would like to thank everyone for joining us today.
所以我要感謝大家今天加入我們。
We are extremely excited to close the Actavis Generic transaction soon, and we look forward to discussing our future with all of you once we do.
我們非常高興能盡快完成 Actavis Generic 交易,我們期待在完成後與大家討論我們的未來。
Have a great day.
祝你有美好的一天。
Operator
Operator
Thank you very much.
非常感謝。
That does conclude the conference for today.
今天的會議到此結束。
Thank you all for participating and you are now free to disconnect.
感謝大家的參與,您現在可以自由斷開連接了。