使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning and welcome to the Bausch Health 1Q '19 Earnings Conference Call. (Operator Instructions)
早上好,歡迎參加 Bausch Health 19 年第一季財報電話會議。(操作員說明)
Please note this event is being recorded.
請注意此事件正在被記錄。
I now would like to turn the call over to your host today, Arthur Shannon, SVP, Head of Investor Relations & Global Communications. Please go ahead, sir.
我現在想將電話轉給今天的東道主,高級副總裁兼投資者關係和全球傳播主管阿瑟·香農 (Arthur Shannon)。請繼續,先生。
Arthur J. Shannon - Senior VP and Head of IR & Communications
Arthur J. Shannon - Senior VP and Head of IR & Communications
Thank you, Keith, appreciate it.
謝謝你,基思,很感激。
Good morning, everyone, and welcome to our first quarter 2019 financial results conference call. Participating on today's call are Chairman and Chief Executive Officer, Joe Papa; and Chief Financial Officer, Paul Herendeen.
大家早安,歡迎參加我們的 2019 年第一季財務業績電話會議。出席今天電話會議的有董事長兼執行長 Joe Papa;財務長 Paul Herendeen。
In addition to this live webcast, a copy of today's slide presentation and a replay of this conference call will be available on our website under the Investor Relations section.
除了本次網路直播之外,今天的幻燈片簡報的副本和本次電話會議的重播也將在我們網站的投資者關係部分提供。
Before we begin, we'd like to remind you that our presentation today contains forward-looking information. We would ask that you take a moment to read the forward-looking statement legend at the beginning of the presentation as it contains important information.
在開始之前,我們想提醒您,我們今天的演示包含前瞻性資訊。我們要求您花點時間閱讀簡報開頭的前瞻性聲明圖例,因為它包含重要資訊。
This presentation contains non-GAAP financial measures. For more information about these measures, please refer to Slide 2 of the presentation. Non-GAAP reconciliations can be found in the appendix to the presentation posted on our website.
本簡報包含非公認會計準則財務指標。有關這些措施的更多信息,請參閱簡報的幻燈片 2。非 GAAP 調整表可在我們網站上發布的簡報的附錄中找到。
Finally, the financial guidance in this presentation is effective as of today only. It is our policy to generally not update guidance until the following quarter and to not update or affirm guidance other than through broadly disseminated public disclosure.
最後,本簡報中的財務指引僅從今天起生效。我們的政策是,通常在下個季度之前不會更新指導意見,並且除非透過廣泛傳播的公開披露,否則不會更新或確認指導意見。
With that, it's my pleasure to turn the call over to Joe.
至此,我很高興將電話轉給喬。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Thank you, Art, and thank you, everyone, for joining us today. I'll begin with the first quarter highlights before turning the call over to Paul Herendeen, our CFO, to review the financial results in detail and update our 2019 guidance. We'll then review the segment highlights before opening the line for questions.
謝謝你,阿特,也謝謝大家今天加入我們。我將從第一季的亮點開始,然後將電話轉給我們的財務長 Paul Herendeen,詳細審查財務業績並更新我們的 2019 年指引。然後,我們將在開始提問之前回顧該部分的要點。
Beginning with Slide 4. Bausch Health is off to a strong start in 2019 as we pivot to offense. The 21,000 employees of Bausch Health companies are fully engaged and truly motivated to turn around Bausch Health, and the quarterly results are excellent.
從幻燈片 4 開始。Bausch Health 公司的 21,000 名員工完全投入並真正積極地扭轉 Bausch Health 的局面,季度業績非常出色。
First, organic growth of 5% in the first quarter was the highest quarter of total company organic growth since the third quarter of 2015. Our top 10 products grew organically by 11% in the aggregate compared to the first quarter of 2018. We generated $413 million of cash from operations, and we continue to manage debt and allocate capital strategically, reducing debt by more than $100 million using cash on hand while also completing the Synergy acquisition during the first quarter.
首先,第一季有機成長5%,是自2015年第三季以來公司整體有機成長最高的季度。與 2018 年第一季相比,我們的十大產品整體有機成長了 11%。我們從營運中產生了 4.13 億美元的現金,我們繼續策略性地管理債務和分配資本,利用手頭現金減少了超過 1 億美元的債務,同時在第一季完成了對 Synergy 的收購。
We also increased R&D investment by approximately 30% in the first quarter versus last year.
第一季我們也比去年增加了約 30% 的研發投入。
Importantly, as you can see from the list on the right, our new product launches and strategic acquisitions are helping to round out our product portfolio in dermatology, ophthalmology and GI. A few highlights to note. We completed the acquisition of TRULANCE, which is a great addition to the Salix franchise, and also acquired dolcanatide, an investigational treatment for ulcerative colitis and opioid-induced constipation. BRYHALI has experienced rapid uptake by dermatologists in the first 4 months since launch. And in April, DUOBRII was approved by the FDA, and we're planning to launch it next month.
重要的是,正如您從右側清單中看到的那樣,我們的新產品發布和策略性收購正在幫助完善我們在皮膚科、眼科和胃腸道領域的產品組合。需要注意的幾個要點。我們完成了對 TRULANCE 的收購,這是對 Salix 特許經營權的重要補充,還收購了多卡那肽,一種治療潰瘍性結腸炎和阿片類藥物引起的便秘的研究性治療藥物。自推出後的前 4 個月內,BRYHALI 就得到了皮膚科醫生的快速認可。今年 4 月,DUOBRII 獲得 FDA 批准,我們計劃在下個月推出。
Finally, we also completed a number of strategic transactions that have the potential to expand our portfolio including the acquisition of an investigational eye drop for itchy eyes associated with allergies and a license agreement with UCLA to develop and commercialize a novel compound for the treatment of NASH and an exclusive license agreement with Mitsubishi Tanabe to develop and commercialize a late-stage investigational treatment for inflammatory bowel disease.
最後,我們也完成了許多有潛力擴大我們的產品組合的策略交易,包括收購一種用於治療與過敏相關的眼睛發癢的研究性滴眼劑,以及與加州大學洛杉磯分校簽訂的許可協議,以開發和商業化一種用於治療NASH 的新型化合物並與三菱田邊簽訂獨家許可協議,開發炎症性腸道疾病的後期研究治療並將其商業化。
So as you can see, overall, 2019 is off to a great start. We are launching new products, we are meeting our operational goals, and we are well positioned to pivot to offense in 2019.
正如您所看到的,總體而言,2019 年是一個好的開始。我們正在推出新產品,我們正在實現我們的營運目標,並且我們已準備好在 2019 年轉向進攻。
On Slide 5, we present a snapshot of key Q1 financial highlights for our 4 segments. In the first quarter, approximately 77% of our revenue was generated by the Bausch + Lomb/International segment and the Salix segment, which grew organically by 7% on a combined basis. B + L/International grew organically by 8% compared to the prior quarter driven by the demand. Salix grew by 5% organically driven by XIFAXAN, which started the year with a great quarter of 11% growth. Excellent results from our 2 largest segments.
在投影片 5 中,我們展示了 4 個細分市場第一季主要財務亮點的快照。第一季度,我們約 77% 的收入來自 Bausch + Lomb/International 部門和 Salix 部門,這兩個部門合併後有機成長了 7%。在需求的推動下,B + L/International 與上一季相比有機成長了 8%。在 XIFAXAN 的推動下,Salix 成長了 5%,該公司年初的季度成長率高達 11%。我們兩個最大的細分市場取得了出色的業績。
On Slide 6, we laid out the attributes that make Bausch Health a unique health care solution. First, durable revenue flow. Our 2 largest segments generate approximately 77% of our revenue and are growing organically at 7% in Q1 '19. Second, we have a diverse business by product, geography and revenue type. Only one product accounts for more than 10% of our revenue. We operate in more than 100 countries, so we truly have a global footprint, and we have the opportunity to leverage that global footprint by launching our products in international markets around the world. Next, a majority of the business is insulated from U.S. branded prescription pricing. As the chart shows, nearly 60% of our revenue is generated from products that are not exposed to U.S. brand prescription pricing and not subject to LOE -- significant LOEs. Finally, a critical mass of people consume our products. Every day, approximately 150 million people around the world would use a Bausch Health product.
在投影片 6 中,我們列出了使 Bausch Health 成為獨特的醫療保健解決方案的屬性。首先,持久的收入流。我們最大的兩個細分市場約占我們收入的 77%,並且在 19 年第一季以 7% 的有機成長率成長。其次,我們的業務在產品、地理和收入類型方面具有多元化。只有一種產品占我們收入的10%以上。我們的業務遍及 100 多個國家,因此我們確實擁有全球足跡,並且我們有機會透過在世界各地的國際市場推出我們的產品來利用全球足跡。其次,大部分業務不受美國品牌處方藥定價的影響。如圖所示,我們近 60% 的收入來自不受美國品牌處方定價影響且不受 LOE(重要 LOE)約束的產品。最後,有一定數量的人消費我們的產品。每天,全球約有 1.5 億人使用 Bausch Health 產品。
With that, I'll turn it over to Paul.
有了這個,我會把它交給保羅。
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
Thank you, Joe, and good morning. I'm going to cover our Q1 financial results mainly by focusing on Slide 7 and walking down the top level P&L for the total company.
謝謝你,喬,早安。我將主要透過投影片 7 和整個公司的頂層損益表來介紹我們第一季的財務表現。
Based on the hard work of our colleagues across Bausch Health, we put a really good quarter on the board. We reported revenue growth of $21 million or plus 1% despite a $59 million currency headwind, an $80 million growth track from LOE assets and $18 million of divestiture discontinued revenues contained in the prior year quarter.
基於 Bausch Health 同事的辛勤工作,我們在董事會上取得了非常好的成績。儘管面臨 5900 萬美元的貨幣逆風、LOE 資產的 8000 萬美元的增長軌道以及上一季包含的 1800 萬美元的剝離中斷收入,但我們報告的收入增長了 2100 萬美元或超過 1%。
Over the period from 2016 to 2018, we dealt with a revenue growth track, aggregating roughly $1.3 billion from a basket of products that lost exclusivity in that relatively short window. And we also absorbed the loss of roughly $870 million of revenue associated with divested assets. So to start 2019 with 1% reported revenue growth for the quarter feels pretty good to us.
在 2016 年至 2018 年期間,我們經歷了一條收入成長軌道,在一籃子產品中,在相對較短的時間內失去了獨家經營權,總計獲得了約 13 億美元的收入。我們也吸收了與資產剝離相關的約 8.7 億美元收入損失。因此,2019 年伊始,該季度報告的營收成長 1%,這對我們來說感覺非常好。
Adjusting for the FX, excluding the $6 million positive impact from the acquisition of Synergy and the impact of discontinued and divested assets, we posted organic revenue growth of 5% in the quarter. A tip of the hat to our various business unit leaders. Our growth was a function of solid, fundamental execution, meaning driven by increased volumes for the total company, up 2%. Our promotional efforts combined with roughly 300 basis points of improvements in realized net pricing enabled us to deliver the 5% organic growth. Joe said it, but I'm going to say too because it feels good. The 5% organic growth for the company is the highest organic growth we posted since Q3 of 2015.
調整匯率後,排除收購 Synergy 帶來的 600 萬美元正面影響以及停產和剝離資產的影響,我們公佈本季有機收入將成長 5%。向我們各個業務部門的領導致敬。我們的成長得益於堅實、基本的執行力,這意味著整個公司的銷售量成長了 2%。我們的促銷努力加上已實現淨定價約 300 個基點的改進,使我們能夠實現 5% 的有機成長。喬這麼說,但我也會這麼說,因為感覺很好。該公司 5% 的有機成長是我們自 2015 年第三季以來的最高有機成長。
The B + L/International segment representing 55% of our total revenue saw organic growth of 8% with all 5 subsegments posting growth versus Q1 of 2018. Increased volume accounted for 7% of the organic growth in our largest segment. That's good stuff. Global Vision Care was up 9%.
B + L/國際部門占我們總營收的 55%,有機成長了 8%,所有 5 個子部門均較 2018 年第一季成長。銷量成長占我們最大細分市場有機成長的 7%。那是好東西。Global Vision Care 上漲 9%。
We continue to be on a roll in Vision Care. In the U.S., which currently accounts for roughly 30% of our Global Vision Care business, we're up a gaudy 17%. And in international markets, we posted a solid 6% increase. The Biotrue ONEday family of daily disposables was the main driver, both in the U.S. and internationally. In the U.S., the ramp of Biotrue ONEday toric was the biggest contributor of Biotrue SVS, and our ULTRA silicone hydrogel lens contributed to growth in the U.S. as well. Internationally, the growth was driven by the Biotrue ONEday family and our daily silicon hydrogel lenses, including both ULTRA and daily disposable AQUALOX lenses.
我們在視力保健領域繼續前進。在美國,目前約占我們全球視力保健業務的 30%,我們的增幅高達 17%。在國際市場,我們實現了 6% 的穩健成長。Biotrue ONEday 系列日用一次性用品是美國和國際市場的主要動力。在美國,Biotrue ONEday toric 的成長是 Biotrue SVS 的最大貢獻者,我們的 ULTRA 矽水凝膠鏡片也為美國的成長做出了貢獻。在國際上,這一增長是由 Biotrue ONEday 系列和我們的日用矽水凝膠鏡片(包括 ULTRA 和日拋 AQUUALOX 鏡片)推動的。
Growth was strongest in the Asia Pac region, but we saw growth from many markets. The Head of the International B + L, Tom Appio, and the Head of our International Vision Care group, Yang Yang, continue to deliver solid results. Our Head of U.S. B + L Joe Gordon took over a somewhat stagnant U.S. Vision Care business in early 2017, and he together with this lieutenant John Ferris and many others in the U.S. Vision Care team have delivered an impressive string of quarterly growth.
亞太地區的成長最為強勁,但我們也看到了許多市場的成長。國際 B+L 負責人 Tom Appio 和國際視力照護團隊負責人 Yang Yang 繼續取得紮實的成果。我們的美國B+L 主管Joe Gordon 於2017 年初接管了有些停滯的美國視力保健業務,他與中尉約翰·費里斯(John Ferris) 以及美國視力保健團隊的許多其他人一起實現了令人印象深刻的季度增長。
Global Surgical was up 4% organically. International Surgical accounts for about 70% of the revenue in this subsegment and delivered 7% organic growth mainly on strength in interior and posterior disposables, including for our Stellaris and Stellaris Elite systems. Geographically, growth was seen across all international markets -- almost all, excuse me. Our Head of International Surgical, Luc Bonnefoy, has provided terrific leadership of this group as evidenced by the growth delivered quarter after quarter.
Global Surgical 有機成長 4%。International Surgical 約佔該細分市場收入的 70%,並實現了 7% 的有機成長,主要得益於內部和後部一次性用品的實力,包括我們的 Stellaris 和 Stellaris Elite 系統。從地理上看,所有國際市場都出現了成長——對不起,幾乎所有市場。我們的國際外科主管 Luc Bonnefoy 對團隊提供了出色的領導,季度復一季度的成長證明了這一點。
Global Consumer revenue was up 6% organically with roughly half of that revenue coming from LUMIFY that we launched in the U.S. in May last year. Global sales of our eye vitamins, particularly PreserVision, continue to grow in response to continued promotional inputs. Note that the global shift to daily contact lenses was and will be a headwind for our Solutions business within Global Consumer.
全球消費者收入有機成長了 6%,其中約一半收入來自我們去年 5 月在美國推出的 LUMIFY。由於持續的促銷投入,我們的眼睛維生素(尤其是 PreserVision)的全球銷售持續成長。請注意,全球向日常隱形眼鏡的轉變曾經並將成為我們全球消費者解決方案業務的阻力。
Global Ophtho Rx was up 16% organically, about the same in the U.S. as in the international markets. VYZULTA was a growth driver for us, accounting for about 1/3 of the segment growth, mainly on increased volume. Internationally, we had strong performance across a number of geographies, especially in China, the U.K. and Germany. International Rx was up 9% organically. This segment has had its challenges as we worked to put in place the right team to sort through a number of legacy issues, including channel inventory levels and supply chain disruptions. I mentioned in February that it looked like we might have turned the corner with this business. After 8% organic growth in Q4 of '18 versus Q4 of '17 and 9% in Q1 of '19 versus Q1 2018, it feels like we're pointed in the right direction. We had especially strong contributions in the quarter from Canada, Russia, Amoun in Egypt and Eastern Europe.
全球 Ophtho Rx 有機成長 16%,美國市場與國際市場大致相同。VYZULTA 是我們的成長動力,約佔該細分市場成長的 1/3,主要是銷量的增加。在國際上,我們在多個地區都表現強勁,尤其是在中國、英國和德國。International Rx 有機成長 9%。這個細分市場面臨挑戰,因為我們努力組建合適的團隊來解決許多遺留問題,包括通路庫存水準和供應鏈中斷。我在二月提到過,看起來我們可能已經扭轉了這項業務的困境。與 17 年第四季相比,18 年第四季有機成長 8%,與 2018 年第一季相比,19 年第一季有機成長 9%,感覺我們已經指明了正確的方向。本季度,加拿大、俄羅斯、埃及阿蒙和東歐的貢獻尤其強勁。
Before I move on to Salix, important safety tip with respect to the International Rx business. Q1 of 2018 and Q4 of 2017 represented favorable comps for this business unit. We expect the growth of International Rx business to moderate over the remainder of 2019. Over time, we'd expect this segment to be a relatively consistent mid-single-digit grower on a constant currency basis.
在我繼續講 Salix 之前,先講一下有關國際處方藥業務的重要安全提示。2018 年第一季及 2017 年第四季該業務部門的業績表現良好。我們預計國際處方藥業務的成長將在 2019 年剩餘時間內放緩。隨著時間的推移,我們預計該細分市場在貨幣不變的基礎上將保持相對穩定的中個位數成長。
Turning to Salix. Salix revenue was up 5% organically. The story here was the continued momentum of XIFAXAN, up 11%. XIFAXAN TRx, a good proxy for units, were up 8% compared with Q1 of 2018. The growth of XIFAXAN plus contributions from RELISTOR and GLUMETZA helped Salix overcome the $26 million growth drag from a loss of exclusivity on UCERIS. The entire Salix team led by Mark McKenna, Josh Coyle and Nicola Kayel continues to perform at a high level.
轉向柳樹。Salix 收入有機成長 5%。這裡的故事是 XIFAXAN 的持續勢頭,上漲了 11%。XIFAXAN TRx 是單位的良好代表,與 2018 年第一季相比上漲了 8%。XIFAXAN 的成長加上 RELISTOR 和 GLUMETZA 的貢獻幫助 Salix 克服了因失去 UCERIS 獨家經營權而造成的 2,600 萬美元的成長拖累。由 Mark McKenna、Josh Coyle 和 Nicola Kayel 領導的整個 Salix 團隊繼續保持高水準。
The Ortho Dermatologics segment was down 1% organically. The medical derm business was down 10% on a 29% volume decline offset in part by continued improvements in our realized net selling prices. We have made purposeful changes to our co-pay assistance programs in this business to improve gross to nets and to reduce nonprofitable volumes. Nearly offsetting the decline in medical derm was a 34% organic growth of Solta. The rollout of Thermage FLX has progressed very well, in fact ahead of expectations, particularly in the Asia Pac region. I'm going to recognize again the leader of Solta, Tom Hart. He has done a remarkable job with this business.
Ortho Dermatologics 部門有機下降 1%。醫學皮膚業務下降 10%,銷售量下降 29%,部分被我們實現的淨銷售價格的持續改善所抵消。我們對該業務的自付費用援助計劃進行了有針對性的改變,以提高淨收入並減少非營利業務量。Solta 34% 的有機成長幾乎抵消了醫用皮膚的下降。Thermage FLX 的推出進展非常順利,事實上超出了預期,特別是在亞太地區。我將再次認出索爾塔的領袖湯姆·哈特。他在這項業務上做得非常出色。
The diversified segment was down 4% organically. The neuro business was down 11% due to the continued decline of the LOE assets, and that decline was offset in part by another good quarter from our generics business, which was up 16%. That performance was aided by sales of authorized generics of our brands that loss exclusivity and by the continued ability of our generics team working closely with our supply chain folks to capitalize on shortages of products in the market. For the avoidance of doubt, long term you should not expect our GRx business to be a grower. Instead, think of it as a means for us to capture and preserve some of the economics of our brands that lose exclusivity and as a way to leverage our manufacturing capabilities to periodically capitalize on market opportunities.
多元化業務有機下降 4%。由於 LOE 資產的持續下降,神經業務下降了 11%,而這一下降被我們的仿製藥業務的另一個良好季度所部分抵消,該業務增長了 16%。這一業績得益於我們品牌失去排他性的授權仿製藥的銷售,以及我們仿製藥團隊與供應鏈人員密切合作以利用市場產品短缺的持續能力。為避免疑義,從長遠來看,您不應期望我們的 GRx 業務會成為成長型企業。相反,我們可以將其視為一種手段,以獲取和保留失去排他性的品牌的一些經濟性,並作為利用我們的製造能力定期利用市場機會的一種方式。
I want to spend a minute on our gross profit margin as this is where you can see evidence of the work that we started back in 2016 to improve the efficiency of our supply chain. We've now wrapped that initiative into what we call our CORE program, Cost Optimization and Revenue Enhancement. In Q1 of 2019, we saw a 210 basis point improvement in our gross margin compared with Q1 of 2018. Part of that favorability is mix for sure, but a meaningful part of the improvement flows from the work that Dennis Asharin, our Head of Global Manufacturing, and his team are doing to reduce costs, including by eliminating noneconomic SKUs. We expect to continue to improve our gross margins in 2020 and beyond.
我想花一點時間介紹一下我們的毛利率,因為在這裡您可以看到我們自 2016 年開始為提高供應鏈效率而開展的工作的證據。現在,我們已將該計劃納入我們所謂的核心計劃:成本優化和收入增強。2019 年第一季度,我們的毛利率較 2018 年第一季提高了 210 個基點。這種好感的一部分肯定是混合的,但改進的一個有意義的部分來自我們的全球製造主管 Dennis Asharin 和他的團隊正在做的降低成本的工作,包括消除非經濟的 SKU。我們預計 2020 年及以後的毛利率將持續提高。
Within operating costs, total company adjusted selling, advertising and promotional expenses were up 6% on a constant currency basis. This reflects our allocation of additional promotional resources in certain of our businesses where we believe we can drive sustained growth, particularly the Global B + L Vision Care and Consumer businesses and in Salix.
在營運成本中,公司調整後的銷售、廣告和促銷費用總額以固定匯率計算增加了 6%。這反映出我們在某些業務中分配了額外的促銷資源,我們相信這些業務可以推動持續成長,特別是全球 B + L 視力照護和消費者業務以及 Salix。
Total company adjusted G&A expense was 15% favorable, down on a constant currency basis. A meaningful component of this improvement is from the reduction of outside legal costs associated with cases that we settled or disposed of. Our General Counsel, Christina Ackermann, and her team have done a wonderful job of systematically dispatching legacy cases and, in doing so, reducing our fees for outside legal counsel.
公司調整後的一般管理費用總額為 15%,以固定匯率計算下降。這項改進的一個有意義的組成部分是與我們和解或處置的案件相關的外部法律成本的減少。我們的總法律顧問克里斯蒂娜·阿克曼(Christina Ackermann)和她的團隊在系統地處理遺留案件方面做得非常出色,並以此減少了我們外部法律顧問的費用。
R&D was up 29% on a constant currency basis. Normally, with an expense, you'd call that unfavorable. But I'm going to say that this is a good thing. We've been working to ensure that the projects that make up our development pipeline deserve to be there and that the allocation of our investment between businesses is aligned with our view of opportunities for value creation. Sounds straightforward, but it took us a bit of time to ensure that we are investing our R&D dollars productively.
以固定匯率計算,研發成長 29%。通常情況下,如果有費用,你會認為這是不利的。但我要說這是一件好事。我們一直在努力確保構成我們開發管道的項目值得存在,並且我們在企業之間的投資分配符合我們對價值創造機會的看法。聽起來很簡單,但我們花了一些時間來確保我們有效地投入研發資金。
The net result of the things I've just talked about was that our reported adjusted EBITA for Q1 was up 6% versus Q1 of 2018. This is the only time in my remarks I'll mention EBITA. Main drivers were: the 1% reported growth of revenue, the 210 basis point improvement in gross margins and the reduction of G&A expenses offset in part by the increased investment in R&D and increased advertising and promotional expenses to support brands in launch phase.
我剛才談到的最終結果是,我們報告的第一季調整後 EBITA 比 2018 年第一季成長了 6%。這是我在演講中唯一一次提到 EBITA。主要驅動因素包括:報告收入成長 1%、毛利率提高 210 個基點以及一般管理費用減少,但在一定程度上被研發投資增加以及為支持品牌推出階段而增加的廣告和促銷費用所抵消。
Adjusted EBITDA was up 2%, that's 400 basis points less than adjusted EBITA due to transactional FX gains of $27 million in Q1 of 2018.
由於 2018 年第一季交易性外匯收益為 2,700 萬美元,調整後 EBITDA 成長了 2%,比調整後 EBITA 低 400 個基點。
Looking at adjusted net income, reported ANI was up 15% on a 2% increase in adjusted EBITDA due to a decrease in interest expense of $10 million compared with the prior year quarter and a lower effective tax rate on adjusted earnings in Q1 of 2019 versus Q1 of 2018.
從調整後淨利潤來看,報告的ANI 增長了15%,調整後EBITDA 增長了2%,原因是利息支出比上年同期減少了1000 萬美元,而且2019 年第一季調整後收益的有效稅率低於去年同期2018 年第一季。
All right. I've covered many of the highlights of the 4 segments, so I'm not going to step through slides 8, 9, 10 and 11 but will point out that the improvements in gross profit margin were seen across all 4 segments.
好的。我已經介紹了這 4 個細分市場的許多亮點,因此我不會逐步介紹幻燈片 8、9、10 和 11,但我會指出,所有 4 個細分市場的毛利率均有所改善。
On Slide 12, the balance sheet summary, you'll see that by March 31, 2019, the principal amount of our outstanding debt declined by $158 million from the year-end 2018 as we used available cash to retire debt. We finished the quarter with $784 million of cash on hand.
在投影片12(資產負債表摘要)中,您會看到,截至2019 年3 月31 日,我們的未償債務本金比2018 年底減少了1.58 億美元,因為我們使用了可用現金來償還債務。本季結束時,我們手頭現金為 7.84 億美元。
On to Slide 13 and the cash flow summary. Cash generated from operations was $413 million for the quarter, in line with our expectations. This amount was reduced a bit by an increase in our investment in inventories during the quarter, including API and finished goods, as we gear up and ramp up to support products in launch phase. When thinking about the quarterly phasing of our cash from operations, recall that we stated that our interest expense was paid out disproportionately in Q2 and Q4. Approximately 1/3 of our interest expense settles in each of Q2 and Q4 and 1/6 in Q1 and Q3. So bear that mind when you're thinking about the quarterly phasing of cash generated from operations. You'll also see that roughly $190 million of cash that we paid to acquire certain assets of Synergy.
前往投影片 13 和現金流量摘要。本季營運產生的現金為 4.13 億美元,符合我們的預期。由於我們在本季度增加了庫存投資(包括 API 和製成品),因此這一金額有所減少,因為我們正在準備好以支援推出階段的產品。在考慮我們的營運現金的季度分階段時,請回想一下,我們表示我們的利息支出在第二季和第四季支付得不成比例。我們大約 1/3 的利息支出在第二季和第四季結算,1/6 在第一季和第三季結算。因此,當您考慮營運產生的現金的季度階段時,請記住這一點。您還會看到我們為收購 Synergy 的某些資產支付了約 1.9 億美元的現金。
On to our updated guidance for the full year 2019 on Slide 14. We increased the ranges for both revenue and adjusted EBITDA guidance by $50 million. Other changes to our guidance include a reduction in our expected effective tax rate on adjusted earnings from roughly 10% to roughly 8%. The main driver of this was a discrete, meaning nonrecurring type, item from a favorable tax ruling in the quarter. The mix of pretax earnings by jurisdiction was also favorable. An important point, our effective tax rate on adjusted earnings is very sensitive to the mix of pretax earnings by tax jurisdiction, and our tax rate, especially in quarterly periods, can be vagarious. While we are presently guiding to an effective tax rate on adjusted pretax earnings of roughly 8% for the full year 2019 due -- that's due mainly to the discrete items, for modeling purposes I'd stick with circa 10% for 2020 and beyond.
關於我們在投影片 14 上更新的 2019 年全年指南。我們將收入範圍和調整後 EBITDA 指導值提高了 5000 萬美元。我們的指導方針的其他變化包括將調整後收益的預期有效稅率從大約 10% 降低到大約 8%。其主要驅動因素是本季有利稅收裁決中的離散(即非經常性)項目。按管轄區劃分的稅前收益組合也很有利。重要的一點是,我們調整後收益的有效稅率對稅收管轄區的稅前收益組合非常敏感,而且我們的稅率,特別是在季度期間,可能會變化無常。雖然我們目前指導 2019 年全年調整後稅前收益的有效稅率約為 8%,這主要是由於離散項目,但出於建模目的,我會堅持 2020 年及以後的稅率約為 10%。
Our guidance for depreciation and stock-based comp change slightly, and we increased our guidance for contingent consideration, milestones and license agreements by $10 million. To the extent that we license rights to development assets in the future, this is where those upfront payments would show up.
我們對折舊和基於股票的補償的指導略有變化,並且我們將或有對價、里程碑和許可協議的指導增加了 1000 萬美元。如果我們將來獲得開發資產的權利許可,那麼這些預付款就會出現在其中。
Finally, we held our guidance range for gross margin at 71% to 72% despite the 73.4% gross margin we posted in Q1. This tells you that we expect lesser gross margins over the balance of the year. But it's safe to assume that at this time, it's more likely that our margin will be in the upper part of that range.
最後,儘管我們第一季的毛利率為 73.4%,但我們仍將毛利率指引範圍維持在 71% 至 72%。這告訴您,我們預計今年剩餘時間的毛利率會較低。但可以肯定的是,目前我們的利潤率更有可能處於該範圍的上部。
Let's move on to the guidance bridge on Slide 15. First, as of today, changes in FX rates from the date of our prior guidance in February reduced our full year expectations for revenue by $30 million and for adjusted EBITDA by $5 million. Second, the changes in assumptions around LOE assets netted to 0 and had no impact on our full year revenue or adjusted EBITDA guidance. Third, we've added the impact of TRULANCE into our full year guidance. We recorded $6 million of revenue for TRULANCE in Q1, and a good portion of those sales were to rebuild the channel as pipeline inventories were quite low at the time we acquired the Synergy assets.
讓我們繼續討論幻燈片 15 上的引導橋。首先,截至今天,自我們 2 月之前的指導之日起,外匯匯率的變化使我們的全年收入預期減少了 3000 萬美元,調整後 EBITDA 減少了 500 萬美元。其次,圍繞 LOE 資產的假設變化淨值為零,對我們的全年收入或調整後的 EBITDA 指引沒有影響。第三,我們將 TRULANCE 的影響納入了全年指導。我們在第一季為 TRULANCE 帶來了 600 萬美元的收入,其中很大一部分銷售額用於重建管道,因為我們收購 Synergy 資產時管道庫存相當低。
For the full year, including the $6 million realized in Q1, we're expecting revenue of $55 million and no operating profit in 2019. We're essentially relaunching this brand and are committed to investing the promotional resources needed to establish momentum for TRULANCE. For a branded pharma product, TRULANCE currently has a relatively high cost of goods sold, roughly 30% of net revenue. That's something we expect to improve upon in the future but not in 2019. So with the promotional resources that we're committing, we are not expecting TRULANCE to be a contributor to profit in 2019, so we feel that the brand will be a meaningful contributor to reported revenue and profit in 2020 and beyond. We will exclude the results for TRULANCE from organic growth for the next year.
對於全年而言,包括第一季實現的 600 萬美元,我們預計 2019 年收入為 5,500 萬美元,並且沒有營業利潤。我們實際上正在重新推出這個品牌,並致力於投入必要的促銷資源來為 TRULANCE 建立動力。對品牌醫藥產品而言,TRULANCE 目前的銷售成本相對較高,約佔淨收入的 30%。我們預計未來會改進這一點,但 2019 年不會。因此,根據我們承諾的促銷資源,我們預計 TRULANCE 不會為 2019 年的利潤做出貢獻,因此我們認為該品牌將為 2020 年及以後報告的收入和利潤做出有意義的貢獻。我們將把 TRULANCE 的業績排除在明年的有機成長之外。
Finally, our base business. Our base business accounted for $25 million of the increased revenue guidance and -- the increase in the revenue guidance range and $55 million of the increase to the adjusted EBITDA guidance range. The $55 million improvement in adjusted EBITDA from the base business is comprised of 3 pieces: the gross profit on the incremental $25 million of revenue; higher gross margins across the total business, albeit still within the guidance range for gross margin; and third, slightly lower than -- slightly lower expected SG&A costs.
最後是我們的基礎業務。我們的基礎業務佔收入指導範圍增加的 2500 萬美元,收入指導範圍的增加和調整後 EBITDA 指導範圍增加的 5500 萬美元。基礎業務調整後 EBITDA 的 5,500 萬美元改善由三個部分組成:增量 2,500 萬美元收入的毛利;整個業務的毛利率較高,但仍處於毛利率指引範圍內;第三,略低於預期的 SG&A 成本。
That's it for me, Joe. Back to you.
我就是這樣,喬。回到你身邊。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Thank you, Paul. Let's go through some of the highlights in our B + L/International segment on Slide 16. First, this segment delivered its 10th consecutive quarter of organic quarter, up 8%, and quarter 1 '19 was the highest quarter of growth for the Bausch + Lomb/International segment since the Bausch + Lomb acquisition in 2013. Importantly, this growth was driven by increased unit volume across all reporting segments of the business. In the aggregate, the top 10 prior to Bausch + Lomb/International grew organically by 8% compared to the prior year quarter. In Global Consumer, our eye vitamins Ocuvite and PreserVision, LUMIFY are the key growth drivers. Finally, e-commerce has become an increasingly important channel for the products in our Global Consumer business as the Amazon data demonstrates with 89% growth compared to the first quarter 2018.
謝謝你,保羅。讓我們回顧一下幻燈片 16 上的 B + L/國際部分的一些亮點。首先,該部門連續第 10 季有機成長,成長 8%,2019 年第 1 季是博士倫/國際部門自 2013 年收購博士倫以來成長最高的季度。重要的是,這一增長是由所有報告業務部門的單位銷售增加所推動的。總體而言,博士倫/國際之前的前 10 名企業與去年同期相比有機成長了 8%。在全球消費者中,我們的眼部維生素 Ocuvite 和 PreserVision、LUMIFY 是主要的成長動力。最後,電子商務已成為我們全球消費品業務中越來越重要的產品管道,亞馬遜數據顯示,與 2018 年第一季相比,電子商務成長了 89%。
Turning to Slide 17, LUMIFY, which generated $10 million in revenue in the quarter is exceeding expectations. Approximately 9 months on the market, LUMIFY is the #1 product in the Redness Reliever category with approximately 28% market share, which is reflected in the chart on the right. LUMIFY is also the #1 physician recommended product in the Redness Reliever category. And we're getting great feedback from consumers. A recent home use study with over 300 participants found that 95% were satisfied with LUMIFY.
轉向幻燈片 17,LUMIFY 在本季創造了 1000 萬美元的收入,超出了預期。LUMIFY 上市約 9 個月,是紅血絲緩解劑類別中排名第一的產品,佔據約 28% 的市場份額,如右圖所示。LUMIFY 也是紅血絲緩解劑類別中排名第一的醫生推薦產品。我們從消費者那裡得到了很好的回饋。最近一項針對 300 多名參與者的家庭使用研究發現,95% 的參與者對 LUMIFY 感到滿意。
Turning now to Vision Care on Slide 18. We reported 6% organic revenue growth in the international business driven primarily by China and Japan and 17% organic revenue growth in the U.S. driven by market share gains outpacing competitors.
現在轉向幻燈片 18 上的視力保健。我們報告稱,國際業務的有機收入增長了 6%,主要由中國和日本推動,美國的有機收入增長了 17%,因為市場份額增長超過了競爭對手。
Moving to the Global Ophtho Rx on the right. Our market access team is doing a great job. Less than a month after launching in the U.S., Lotemax SM already has greater than 40% commercial and Medicare Part D coverage. VYZULTA TRx weekly scripts grew by approximately 20% quarter-over-quarter as we show in the chart. And in terms of adherence, we have found that patients who start on VYZULTA are 34% more likely to stay on it than other branded agents.
前往右側的 Global Ophtho Rx。我們的市場准入團隊做得很好。在美國推出後不到一個月,Lotemax SM 的商業和醫療保險 D 部分覆蓋率已超過 40%。如圖表所示,VYZULTA TRx 每週腳本環比增長約 20%。在依從性方面,我們發現開始使用 VYZULTA 的患者比其他品牌藥物繼續使用該藥物的可能性高出 34%。
On to Slide 19 for a Salix update. Organic revenue growth of 5% during the first quarter was primarily driven by XIFAXAN, and this was the eighth consecutive quarter of our organic revenue growth. In addition to our internal development activities, we're expanding our GI business through acquisition and licensing deals. We completed the purchase of certain assets from Synergy Pharmaceuticals, which provided a marketed product, TRULANCE, and a development candidate. We entered into a license agreement with UCLA to develop and commercialize a novel compound for the treatment of NASH, and we have an exclusive license agreement to develop and commercialize a late-stage investigational treatment for inflammatory bowel disease.
請參閱投影片 19 以了解 Salix 更新。第一季 5% 的有機收入成長主要由 XIFAXAN 推動,這是我們有機收入連續第八個季度成長。除了我們的內部開發活動外,我們還透過收購和授權交易擴大我們的地理標示業務。我們完成了對 Synergy Pharmaceuticals 某些資產的收購,該公司提供了已上市產品 TRULANCE 和開發候選產品。我們與加州大學洛杉磯分校簽訂了一項許可協議,以開發和商業化一種用於治療NASH 的新型化合物,並且我們還擁有一項獨家許可協議,以開發和商業化炎症性腸道疾病的後期研究治療方法。
Moving to XIFAXAN, which grew 11% in the first quarter, it was fueled by IBS-D prescriptions, which were up 18%. This is an important metric when you look at the graph on the right, which shows that 90% of the IBS-D market is still being treated with older antispasmodic or antidiarrheal products. In other words, 90% of the market and opportunities still remain, which means there is still significant growth opportunity for XIFAXAN in IBS-D. We're seeing that in the IBS-D script growth.
XIFAXAN 第一季成長 11%,IBS-D 處方藥成長了 18%,推動了該成長。當您查看右圖時,這是一個重要的指標,該圖顯示 90% 的 IBS-D 市場仍在使用較舊的解痙或止瀉產品進行治療。換句話說,90%的市場和機會仍然存在,這意味著XIFAXAN在IBS-D領域仍然存在顯著的成長機會。我們在 IBS-D 腳本的成長中看到了這一點。
Finally, RELISTOR revenues grew by approximately 30% in the quarter versus a year ago.
最後,RELISTOR 本季營收與去年同期相比成長了約 30%。
Move over to Slide 20. As we mentioned earlier, we acquired TRULANCE from Synergy Pharmaceuticals during the first quarter. TRULANCE is a treatment for chronic idiopathic constipation and irritable bowel syndrome with constipation with a number of competitive advantages, including more patient-friendly dosing and the lowest incidents of adverse reaction in the category. Salix now has an opportunity to establish the best-in-class IBS product portfolio on the market with the potential for leading products in both categories, XIFAXAN for IBS-D and TRULANCE for IBS-C.
移至投影片 20。正如我們之前提到的,我們在第一季從 Synergy Pharmaceuticals 收購了 TRULANCE。TRULANCE 是一種治療慢性特發性便秘和伴隨便秘的腸躁症的藥物,具有許多競爭優勢,包括更適合患者的劑量以及該類別中不良反應發生率最低。Salix 現在有機會建立市場上一流的 IBS 產品組合,並具有在兩個類別中領先產品的潛力:用於 IBS-D 的 XIFAXAN 和用於 IBS-C 的 TRULANCE。
We've also done an excellent job in increasing commercial coverage. In the first 30 days since the acquisition of TRULANCE, we have achieved the following. We added approximately 2.4 million covered lives across 5 regional plans. We increased the TRULANCE reach and frequency, the calls to high-volume prescribers by more than 30%. And in the last 4 weeks' data, TRx is about -- are up about 2.3% versus the previous 4 weeks. With this in mind, we expect to generate approximately $55 million in TRULANCE revenue in 2019 and invest in the sales force, advertising and promotion and R&D.
我們在增加商業覆蓋範圍方面也做得非常出色。在收購 TRULANCE 後的前 30 天,我們取得了以下成果。我們在 5 個區域計畫中增加了約 240 萬人的受保生命。我們將 TRULANCE 的覆蓋範圍和頻率以及對大批量處方者的呼叫增加了 30% 以上。在過去 4 週的數據中,TRx 與前 4 週相比上漲了約 2.3%。考慮到這一點,我們預計 2019 年 TRULANCE 收入約為 5,500 萬美元,並投資於銷售團隊、廣告和促銷以及研發。
To sum it up, our GI portfolio is well positioned for growth, and we believe TRULANCE has significant potential.
總而言之,我們的 GI 投資組合處於良好的成長態勢,我們相信 TRULANCE 具有巨大的潛力。
Moving on to Slide 20, Ortho Dermatologics. Let's start with some product highlights. First, SILIQ generated $5 million of U.S. sales in the first quarter, and TRx scripts grew by more than 500% versus Q1 2018, albeit 2018 was early in the launch. ALTRENO, which is the first formulation of tretinoin in a lotion for the treatment of acne, had a great quarter with TRx scripts growing by more than 3x in the first quarter versus the fourth quarter. In addition, we launched a new cash pay prescription model which is available through Dermatology.com. It offers improved and predictable fulfillment options for patients and prescribers. The initial feedback from health care providers is quite positive.
前往投影片 20,皮膚科矯形科。讓我們從一些產品亮點開始。首先,SILIQ 第一季在美國的銷售額達到 500 萬美元,TRx 腳本與 2018 年第一季相比成長了 500% 以上,儘管 2018 年還處於發布初期。ALTRENO 是第一個用於治療痤瘡的乳液中的維A酸配方,該季度表現出色,TRx 腳本在第一季度比第四季度增長了 3 倍多。此外,我們還推出了新的現金支付處方模式,可透過 Dermatology.com 購買。它為患者和處方者提供了改進且可預測的履行選項。醫療保健提供者的初步回饋非常積極。
With organic revenue growth of 34% Global Solta, our medical aesthetics business, delivered another strong quarter. Growth was driven by strong demand of Thermage FLX following the launch in Asia Pacific.
我們的醫學美容業務 Global Solta 的有機收入成長了 34%,再次實現強勁的季度業績。熱瑪吉 FLX 在亞太地區推出後的強勁需求推動了成長。
Finally, I want to provide an early read on BRYHALI, which has experienced rapid uptake by dermatologists in the first 4 months since launch. The fact that we have been successful in changing prescriber trends in a highly genericized market is very encouraging and speaks to the strength of the product attributes and our team in launching innovative, new products that improve people's lives. And in terms of market access, starting in June, BRYHALI will have approximately 50% commercial coverage, which accounts for about -- approximately 90 million covered lives in the United States.
最後,我想提供有關 BRYHALI 的早期解讀,自推出以來的前 4 個月內,皮膚科醫生迅速接受了該產品。事實上,我們在高度通用化的市場中成功改變了處方者的趨勢,這一事實非常令人鼓舞,這證明了我們的產品屬性和我們的團隊在推出改善人們生活的創新新產品方面的實力。在市場准入方面,從 6 月開始,BRYHALI 將擁有約 50% 的商業覆蓋率,覆蓋美國約 9,000 萬人。
On to Slide 22. DUOBRII is now approved after a brief delay, and we're planning for launch next month. We believe DUOBRII is well positioned within the large and growing plaque psoriasis market and has the potential to change how psoriasis is treated due to a number of differentiating features. First, it's a unique combination, the first and only topical lotion combining halobetasol and tazarotene in one formulation. Second, DUOBRII provides an opportunity for a longer duration of use, safety was established in a long-term study of up to 24 weeks of continuous use and up to 52 weeks of as needed use. Also, DUOBRII has the potential to delay some patients from switching to more expensive biologic treatments, which could result in substantial health care savings.
轉到投影片 22。DUOBRII 經過短暫的延遲後現已獲得批准,我們計劃在下個月推出。我們相信 DUOBRII 在龐大且不斷增長的斑塊型乾癬市場中處於有利地位,並且由於具有許多差異化特徵,有可能改變銀屑病的治療方式。首先,它是一種獨特的組合,也是第一個也是唯一一個將鹵倍他索和他扎羅汀結合在一個配方中的外用乳液。其次,DUOBRII 提供了更長時間使用的機會,安全性是在長達 24 週的連續使用和長達 52 週的按需使用的長期研究中確定的。此外,DUOBRII 有可能延遲一些患者轉向更昂貴的生物治療,這可能會帶來大量的醫療費用節省。
Next is patient preference. More than 85% of psoriasis patients on therapy use a topical medication.
接下來是患者的偏好。超過 85% 的牛皮癬患者在接受治療時使用外用藥物。
Finally, expected coverage. We are laser focused on getting early access to commercial coverage, and we are using the team's success with BRYHALI in setting aggressive goals. We expect to launch with approximately 30% of covered lives and expect that number will grow to around 75% of covered lives 12 months post launch.
最後是預期的覆蓋範圍。我們專注於儘早獲得商業報道,並利用團隊在 BRYHALI 方面的成功來設定積極的目標。我們預計推出後將涵蓋約 30% 的生命,並預計在發布後 12 個月內該數字將增至約 75% 的覆蓋生命。
To sum it up. We believe DUOBRII has the potential to become a preferred treatment for adult plaque psoriasis patients based on efficacy, safety and affordability relative to other treatments.
把它們加起來。我們相信,基於相對於其他治療方法的療效、安全性和可負擔性,DUOBRII 有潛力成為成人斑塊型乾癬患者的首選治療方法。
On to Slide 23. I'm happy to report that all of the Significant Seven products have now been approved and 6 of the 7 have already been launched. Anticipated revenue growth is shown in the blue bar from approximately $75 million of revenue in 2017 to approximately $300 million in 2019. In the first quarter of 2019, the Significant Seven products revenue increased by more than 125% versus the prior year quarter. We've also provided highlights in charts so you can see the progress each product is making in its respective market.
轉到投影片 23。我很高興地向您報告,所有重要的七項產品現已獲得批准,而這 7 項產品中的 6 項已經推出。藍色長條顯示預期收入成長,從 2017 年的約 7500 萬美元收入增長到 2019 年的約 3 億美元。2019年第一季度,七大產品營收較上年同期成長超過125%。我們還在圖表中提供了重點內容,以便您可以看到每種產品在各自市場中的進展。
Slide 24 lays out our expectations for 2019. In summary, 2019 is off to a great start. Our new product launches, promising pipeline and focus on Project CORE have positioned the company to pivot to offense in 2019, and strong operational execution is leading us to raise our full year 2019 revenue and adjusted EBITDA guidance.
投影片 24 列出了我們對 2019 年的期望。總而言之,2019 年是一個好的開始。我們的新產品發布、前景廣闊的產品線以及對 CORE 項目的關注使公司在 2019 年轉向進攻,而強大的運營執行力使我們提高了 2019 年全年收入並調整了 EBITDA 指導。
To review our expectations, we expect revenue to grow in 2019 versus 2018 at or above the midpoint of our guidance range and at current FX rates. Second, we expect to generate approximately $1.5 billion to $1.6 billion of cash from operations, and we plan to use more than $1 billion of that cash to reduce debt and/or fund bolt-on acquisitions. R&D investment is expected to increase by about 10% in 2019. Revenue generated by our Significant Seven products is expected to approximately double in 2019. Project CORE is expected to deliver more than $75 million of operating profit in 2019. And finally, we continue to expect a 3-year CAGR from the midpoint of our 2019 guidance of 4% to 6% revenue growth and 5% to 8% adjusted EBITDA growth over the period from 2019 to '22 on a constant currency basis and excluding TRULANCE.
為了回顧我們的預期,我們預計 2019 年營收成長將較 2018 年達到或高於我們指導範圍的中點和當前匯率。其次,我們預計將從營運中產生約 15 億至 16 億美元的現金,並且我們計劃使用其中超過 10 億美元的現金來減少債務和/或為補強收購提供資金。預計2019年研發投入將成長10%左右。我們的七大產品產生的收入預計在 2019 年將增加一倍左右。CORE 計畫預計 2019 年將實現超過 7,500 萬美元的營業利潤。最後,我們繼續預期 2019 年至 22 年期間以固定匯率計算的 3 年複合年增長率為 4% 至 6% 的收入增長和 5% 至 8% 的調整後 EBITDA 增長,不包括特魯蘭斯。
With that operator, let's open up the line for questions.
透過該接線員,我們可以開通提問線路。
Operator
Operator
(Operator Instructions) And the first question comes from Chris Schott with JPMorgan.
(操作員說明)第一個問題來自摩根大通的 Chris Schott。
Christopher Thomas Schott - Senior Analyst
Christopher Thomas Schott - Senior Analyst
Congrats on the performance. I just had 2 questions really centered around gross margin. I guess first of all, a little bit more color in terms of what drove the gross margin strength this quarter and why we should be thinking about this kind of step down to that 71% to 72% range for the full year? And the second question on gross margins as well is you mentioned you believe you can increase gross margins in 2020 and beyond. Just some more color in terms of the magnitude of gross margin improvement we can think about. And is this a business that over time could get to kind of like 7 -- mid-70s gross margins? Or are we talking about more modest improvement than that?
恭喜你的表現。我只有兩個關於毛利率的問題。我想首先,關於推動本季毛利率走強的因素以及為什麼我們應該考慮全年下降到 71% 至 72% 的範圍,請多加一些色彩?關於毛利率的第二個問題是,您提到您相信您可以在 2020 年及以後提高毛利率。我們可以考慮一下毛利率改善的幅度。隨著時間的推移,這項業務的毛利率是否會達到 7 至 70 年代中期的水平?或者我們正在談論比這更溫和的改進?
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
Yes. It's Paul. I'll take those questions. I mean much like I mentioned, the variability of our effective -- global effective tax rate, a lot of this has to do with mix, but I called out specifically that there was a fair amount of improvement that was associated with our Project CORE that involves eliminating SKUs that are -- kind of fall below the line. In terms of profitability, you know that over the period, the last couple of years now, we've made a real effort and made a lot of progress in reducing our investment in -- overall investment in our inventories, which leads to lesser write-off, which leads to lesser scrap and such. And we just saw a very large impact of that flowing through in Q1 of this year. The reason why I called out that we expected to be lower over the balance of the year is we expected to be lower because we have a lot better visibility into what we expect our mix to be over the balance of 2019, and we didn't want people to get out ahead themselves with respect to the assumption on gross margin profit in the full year 2019. You've -- you and I have known each other a long time, a lot of folks on the -- online. Anytime you look at a 90-day period comparing it back to another 90-day period, it's helpful, but the longer the period you look at, the better. And at this stage, we're guiding to 71% to 72%. And as I said in my remarks, probably in the top part of that because we got off to a very strong start.
是的。是保羅。我會回答這些問題。我的意思很像我提到的,我們有效的全球有效稅率的可變性,這在很大程度上與混合有關,但我特別指出,與我們的核心項目相關的有相當多的改進涉及消除那些低於該線的SKU。就盈利能力而言,您知道,在過去的幾年裡,我們在減少庫存投資方面做出了真正的努力並取得了很大進展,這導致了寫入量的減少-off,這會減少廢品等。我們剛剛看到今年第一季產生的巨大影響。我之所以指出我們預計今年剩餘時間的業績會較低,是因為我們對 2019 年剩餘時間的組合預期有更好的了解,而我們並沒有希望人們對2019 年全年毛利率的假設有所了解。你和我已經認識很久了,在網路上認識了很多人。每當您查看 90 天的時間段並將其與另一個 90 天的時間段進行比較時,這都會很有幫助,但您查看的時間段越長越好。現階段,我們的目標是 71% 到 72%。正如我在演講中所說,可能在上面部分,因為我們有了一個非常強勁的開始。
Your question about can this continue on to -- into 2020 and beyond and where is the ceiling, there are certainly opportunities for us to continue improvement. I think that we backed -- well, it's been a while now. We back -- a while back said we could probably get a couple 100 basis points of improvement in our gross margin related to improvements in efficiency over a period of time. As I say, a wise man once said that you can forecast on the amount and the time but not both. We will continue to go through that process. It is a never-ending process. Dennis Asharin and his team are on this. Joe, myself and a handful of others meet on this once a month. So we think we can continue to get improvement from improvements in efficiency.
你的問題是,這種情況能否持續到 2020 年及以後,上限在哪裡,我們當然有機會繼續改進。我認為我們支持——嗯,已經有一段時間了。不久前我們說過,與一段時間內效率的提高有關,我們的毛利率可能會提高 100 個基點。正如我所說,一位智者曾經說過,你可以預測數量和時間,但不能同時預測兩者。我們將繼續經歷這個過程。這是一個永無止境的過程。丹尼斯·阿沙林和他的團隊正在研究這個問題。喬、我自己和其他一些人每月會面一次。所以我們認為我們可以繼續從效率的提高中得到改進。
Last, safety tip on -- FX plays a role here. It plays a role. That's not what drove us this quarter versus the prior year quarter, but it plays a role. We are a global company. We manufacture in a number of different currencies where the inputs are denominated in those currencies and then we sell elsewhere based on local currency. So there is an impact with respect to how this gets recognized through our P&L regarding FX. But important points are we are making progress, we expect to continue to make progress. And don't get out ahead of yourself based on Q1. It was fortunate, and I think we'll be in the upper end of that range for 2019.
最後,安全提示——外匯在這裡發揮作用。它發揮作用。與去年同期相比,這並不是推動我們本季發展的因素,但它確實發揮了作用。我們是一家全球性公司。我們以多種不同的貨幣進行生產,其中投入品以這些貨幣計價,然後我們根據當地貨幣在其他地方銷售。因此,這對於如何透過我們的外匯損益表進行確認會產生影響。但重要的是我們正在取得進展,我們期望繼續取得進展。並且不要根據第一個問題而超出自己的預期。很幸運,我認為 2019 年我們將處於該範圍的上限。
Operator
Operator
The next question comes from Greg Gilbert with SunTrust.
下一個問題來自 SunTrust 的 Greg Gilbert。
Gregory B. Gilbert - Analyst
Gregory B. Gilbert - Analyst
First, Paul, on that FX comment, can you just factor -- or let us know what you're factoring in for the revenue guidance impact due to FX this year? That's a housekeeping question. The strategic question I have for you guys is about the Bausch division. There's pretty striking difference between your company's valuation and that for other eye care comps. And obviously, there are a lot of variables that affect fact that. But my question is are you willing to consider a separation of the B + L segment if evaluation disconnect persists over time? And if you are willing to consider, can you walk us through the mechanics and the time that would be involved so that we can envision something potentially tangible beyond just your willingness to consider it?
首先,保羅,關於外匯評論,您能否考慮一下——或者讓我們知道您在考慮今年外匯對收入指導的影響時考慮了什麼?這是一個家政問題。我向你們提出的策略問題是關於鮑什部門的。貴公司的估值與其他眼保健公司的估值之間存在顯著差異。顯然,有很多變數會影響這一事實。但我的問題是,如果評估脫節隨著時間的推移持續存在,您是否願意考慮分離 B + L 部分?如果您願意考慮,您能否向我們介紹其中的機制和所涉及的時間,以便我們可以設想一些潛在的有形的東西,而不僅僅是您願意考慮的?
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
It's Paul. I'll start with the easy one. The FX change that we saw from when we originally provided guidance in February was $30 million. You see it's on the bridge on Slide 15 of our deck. That number has been a little volatile over the course of the last, I'll call it, week to 10 days. It moves around quite a bit, and so we try to run it as of the last available day, and it was -- it's minus $30 million as we're sitting here now. I hope that answers the question. Joe, you want to start off on the Alcon question?
是保羅。我將從簡單的開始。與我們最初在 2 月提供指導時相比,我們看到的匯率變化為 3000 萬美元。您可以看到它位於我們甲板第 15 張幻燈片的橋上。在過去的一周到十天內,這個數字有點不穩定。它的變動相當大,因此我們嘗試在最後一天運行它,而我們現在坐在這裡的金額是負 3000 萬美元。我希望這能回答這個問題。喬,你想從愛爾康問題開始嗎?
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Sure. I think on the Alcon question, I think since Paul and I joined, Greg, that we've always been looking to -- seeking to maximize shareholder value for our shareholders. We think that the Alcon business and the IPO shines a bright light on the value. They're trading at 20x plus EBITDA. And obviously, Bausch + Lomb, our eye care business represents our largest business segment. So we do think it shines a bright light on this. As to what happens for specifically in our business, I think what we're focused on right now is being laser focused on just increasing the value of this business. And as you saw with the quarter, significant growth -- our highest growth for this business since the acquisition in 2013. And I think our goal always is going to be over the long term to maximize shareholder value, but I'm not really going to get into any specifics on any other options other than to say we are today laser focused on just driving the value of this business over the near term and long term in terms of our total Bausch Health business but specifically our Bausch + Lomb franchise.
當然。我認為關於愛爾康的問題,我認為自從保羅和我加入以來,格雷格,我們一直在尋求——尋求為我們的股東實現股東價值最大化。我們認為愛爾康業務和首次公開募股為價值帶來了光明。他們的交易價格是 20 倍加 EBITDA。顯然,博士倫我們的眼部護理業務代表了我們最大的業務部門。所以我們確實認為它在這方面發出了明亮的光芒。至於我們業務中具體發生的情況,我認為我們現在的重點是專注於增加這項業務的價值。正如您在本季看到的那樣,顯著成長——這是自 2013 年收購以來我們該業務的最高成長。我認為,從長遠來看,我們的目標始終是實現股東價值最大化,但我並不打算詳細討論任何其他選擇,只是說我們今天專注於推動股東價值就我們整個Bausch Health 業務而言,特別是我們的Bausch + Lomb 特許經營權而言,這項業務是短期和長期的。
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
If I might Joe, I want to follow on, on that because there are a lot of questions out there now that there's some information on Alcon and trying to compare that to our B + L/International segment. And I'd encourage you to do it. As Joe said, is that there does appear to be a -- somewhat of a valuation disconnect between the way people think about our business versus the way they think about Alcon. There are reasons for that, and that's -- as they say, the -- this is why there are markets. People value things in a different way.
如果可以的話,喬,我想繼續說下去,因為現在有很多問題,因為有一些關於愛爾康的信息,並試圖將其與我們的 B + L/國際部分進行比較。我鼓勵你這樣做。正如喬所說,人們對我們業務的看法與對愛爾康的看法之間似乎確實存在某種程度的估值脫節。這是有原因的,正如他們所說,這就是市場存在的原因。人們以不同的方式評價事物。
But I'd just point out, we -- our segment presentation -- and you look at our -- in the quarter, for example, our adjusted -- I'm going to go EBITA. I said I wouldn't say EBITA again, but I'm going to. EBITA, there -- as a percentage of revenue was circa 27% in the quarter. Compare that to -- I believe that the last full year that Alcon reported, I think it was something like 17%. Now those numbers are not 100% comparable because they necessarily have corporate allocations and things that you have to have in place to be as -- to be a stand-alone company. And what I would suggest as a financial analyst myself, I look at our business and I say the -- there's probably $20 million in the -- if we're looking at the quarter now, there's probably 20 -- low $20 million-type G&As that ought to be allocated to this business if we're standalone beyond what we see in our quarterly results for the segment is probably $50 million of our unallocated -- well, total R&D.
但我想指出的是,我們——我們的分部演示——你看看我們的——在本季度,例如,我們調整後的——我將轉向息稅折舊攤銷前利潤(EBITA)。我說過我不會再說 EBITA,但我還是會說。該季度的 EBITA 佔營收的百分比約為 27%。相比之下——我相信愛爾康報告的最後一整年,我認為這一比例約為 17%。現在這些數字並不是100%具有可比性,因為它們必然有公司配置以及成為一家獨立公司所必須具備的東西。作為一名金融分析師,我自己的建議是,我審視我們的業務,我說——如果我們現在看這個季度,可能有 20 家——低 2000 萬美元類型的企業如果我們是獨立的,超出了我們在該部門季度業績中看到的範圍,那麼應該分配給該業務的一般管理費用可能是我們未分配的總研發費用中的5000 萬美元。
So total R&D would be more like the $18 million that you see plus another $50 million. And if you'd put those 2 things in place, looks like we have an EBITA margin in our business of about $20 million. I think we called it out on the call earlier today, our business is growing nicely now that we've put a very solid team in place, and we think that the results for this segment may be a little bit underappreciated this is a very, very good business.
因此,研發總額更像是您看到的 1800 萬美元加上另外 5000 萬美元。如果你把這兩件事都落實到位,看起來我們的業務 EBITA 利潤率約為 2000 萬美元。我想我們今天早些時候在電話會議上就指出了這一點,我們的業務發展得很好,因為我們已經組建了一支非常堅實的團隊,我們認為這一部分的結果可能有點被低估了,這是一個非常、生意很好。
Last thing, I might as well continue on because we get the question a lot, is people say, well, gee, what about that international Rx revenue that flows in there. I will tell you that the net margin -- so when you can get down to EBITA, the percentage of revenue for that business is very similar to the balance of that B + L/International segment results. And the second part about it is I would say that the durability duration of that -- those revenue streams, if we continue as we have so far to invest behind them in terms of R&D, has very similar economic characteristics to the balance of that business. So we like this segment. We like it a lot. And it's good for us that there's a viable comp out there that people can look at and say, well, how do -- how does this stake up relative to another competitor. So thanks for the question.
最後一件事,我不妨繼續說下去,因為我們收到了很多問題,人們說,好吧,天啊,流入那裡的國際治療收入怎麼樣。我會告訴你淨利潤——所以當你可以算出 EBITA 時,該業務的收入百分比與 B + L/國際部門結果的餘額非常相似。關於它的第二部分是,我想說的是,這些收入流的持久性,如果我們繼續像迄今為止在研發方面投資的那樣,與該業務的平衡具有非常相似的經濟特徵。所以我們喜歡這個片段。我們非常喜歡它。這對我們來說是件好事,因為人們可以看到一個可行的補償,然後說,嗯,這個補償相對於其他競爭對手來說如何。謝謝你的提問。
Operator
Operator
(Operator Instructions) And the next question comes from Umer Raffat with Evercore.
(操作員說明)下一個問題來自 Evercore 的 Umer Raffat。
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Joe, just to clarify something you said earlier and then I get to my question, are you saying no to the idea of split? Or is it something you're not ready to address just yet? And my question was back to your comment on volume-based growth, I guess one thing that I'm trying to reconcile is in the Bausch division, the gross margin's up 250 bps year-over-year. So there's an implication there, the pricing component to that, and yet you said it's all volume-based growth. So I'm just trying to reconcile the 2, especially also because a lot of growth came in the Ophtho Rx segment.
喬,只是為了澄清你之前所說的一些事情,然後我開始回答我的問題,你是否反對分裂的想法?或者您還沒有準備好解決這個問題?我的問題回到了您對基於銷量的增長的評論,我想我試圖協調的一件事是 Bausch 部門的毛利率同比增長了 250 個基點。因此,這其中有一個含義,即定價部分,但你說這都是基於數量的增長。所以我只是想協調這兩者,特別是因為 Ophtho Rx 細分市場出現了很大的成長。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Okay. So on the first part of your question, I was -- I'm not trying to suggest anything specific answer other than that we are committed to maximizing shareholder value over the long term, and we will take a look at whatever we can do to deal with that question. On the specific question of Bausch + Lomb, our total growth in Bausch + Lomb was 8%, of which 7% was volume and 1% was price. So I -- my commentary is clearly, the majority of the growth in our Bausch + Lomb franchise is driven by the volume at 7% of the total 8%. Does that answer your question?
好的。因此,關於你問題的第一部分,我並不是想提出任何具體的答案,只是我們致力於長期實現股東價值最大化,我們將考慮我們能做些什麼來實現這一目標。關於博士倫的具體問題,我們博士倫的總成長是8%,其中7%是數量,1%是價格。因此,我的評論很明確,博士倫特許經營權的大部分增長是由銷量推動的,佔總銷量的 7%(佔總銷量的 8%)。這是否回答你的問題?
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Umer Raffat - Senior MD & Senior Analyst of Equity Research
Well...
出色地...
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
Yes. It's Paul, Umer. I'll -- let me come on because that -- this business is -- that segment is comprised of the 5 different subsegments. And yes, when you look at [Clens], when you look at Ophtho Rx, it was up 16% and roughly the same internationally and within the U.S. Yes, we did get some price in the U.S., but that's -- the scale of that relative to the entire segment, it doesn't dwarf it. Joe is exactly right, and the way I articulated in my prepared remarks, it's 7% volume, 1% price across that segment.
是的。是保羅,烏默。我會——讓我繼續,因為——這個業務——這個細分市場由 5 個不同的子細分市場組成。是的,當你看[Clens] 時,當你看Ophtho Rx 時,它上漲了16%,在國際上和美國國內大致相同。規模相對於整個細分市場,它並沒有相形見絀。喬是完全正確的,正如我在準備好的發言中所闡述的那樣,該細分市場的銷量佔 7%,價格佔 1%。
Operator
Operator
Next question comes from Louise Chen with Cantor.
下一個問題來自 Louise Chen 和 Cantor。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
Congratulations on the quarter. So first question I have was do you have any update on your cash pay model on the derm business. And how that's progressed relative to your expectations? Any numbers you can put behind it would be great. And then my second question here is on MT-1303. The kind of trials it would take to get this drug approved, where you are with those? And then how does your mechanism of action compare to ILs and JAKs? Because there's a lot in development for INI.
恭喜本季。所以我的第一個問題是,您對皮膚業務的現金支付模式有任何更新嗎?相對於您的期望,進展如何?如果你能在後面加上任何數字那就太好了。我的第二個問題是關於 MT-1303 的。要使這種藥物獲得批准需要什麼樣的試驗,您目前的進展如何?那麼您的作用機轉與 IL 和 JAK 相比如何?因為 INI 還需要大量開發。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Okay. We're going to try to get each one of those. I'm going to start on the cash pay derm model. First, I'm not going to share any specific quantitative numbers other than what I would absolutely refer everyone to is go to Dermatology.com and you'll see exactly what we're doing. We think that the -- what's the problem? The problem out there today in dermatology is that there's uncertainty over prior authorizations. There are expensive co-pays for patients. There's variable generic formulations. And what we think we can do with our cash pay model is in one place ensure that patients get a predictable product, they get a predictable price point and they get predictable access. And we -- if you look at it, you'll see a product like ALTRENO, our newest product, is priced at $115. And versus what some of the co-pays are for generic formulations of tretinoin, we think we're very well priced, and we've got a very great opportunity. The initial feedback from the physicians -- dermatologists has been exceptional. We really like what we're doing there in terms of getting a very predictable response, but I think it's probably little bit early to go into any specific numbers. But I would refer everybody to go to Dermatology.com.
好的。我們將盡力獲得其中的每一項。我將從現金支付皮膚模型開始。首先,我不會分享任何具體的定量數字,除了我絕對建議大家訪問 Dermatology.com,您會確切地看到我們正在做的事情。我們認為──問題是什麼?如今皮膚科的問題是先前的授權存在不確定性。患者需要支付昂貴的自付費用。有多種通用配方。我們認為,我們可以利用現金支付模式做的是,在一個地方確保患者獲得可預測的產品、可預測的價格點以及可預測的存取權限。如果你看一下,你會發現像 ALTRENO 這樣的產品,我們的最新產品,售價為 115 美元。與維他命A酸通用製劑的一些共同支付費用相比,我們認為我們的價格非常合理,而且我們有一個非常好的機會。醫生、皮膚科醫生的初步回饋非常好。我們真的很喜歡我們在那裡所做的事情,因為我們得到了非常可預測的回應,但我認為現在討論任何具體數字可能還為時過早。但我建議大家造訪 Dermatology.com。
On the second part of your question, on the Mitsubishi Tanabe product, we are very early on that, but we do have a plan in place to look at what this opportunity is. We are making sure that as we look at the profile with this product, we do think there's an opportunity and a very -- inflammatory bowel disease is a very big opportunity there. We're looking at Crohn's, ulcerative colitis as 2 opportunities there. There was some initial data already in this category, but one that we think there is a chance here specifically in ulcerative colitis, as an example, that we think there may be -- the S1P-class products will give a good response based on at least the data we've seen. And specifically, our product has a unique long half-life, and we believe it could provide a differentiated dosing opportunity, especially in the maintenance and the remission setting. So look for us to have more comments on that as we bring forward that development program. Did I get all of your questions? Thank you.
關於你問題的第二部分,關於三菱田邊產品,我們很早就開始這樣做,但我們確實有一個計劃來看看這個機會是什麼。我們確保,當我們查看該產品的概況時,我們確實認為存在機會,而且發炎性腸道疾病是一個非常大的機會。我們將克隆氏症和潰瘍性結腸炎視為其中的兩個機會。這一類別中已經有一些初步數據,但我們認為特別是在潰瘍性結腸炎方面有機會,例如,我們認為可能存在——S1P 級產品將根據以下方面給出良好的反應:至少我們看到的數據。具體來說,我們的產品具有獨特的長半衰期,我們相信它可以提供差異化的給藥機會,特別是在維持和緩解環境中。因此,在我們提出該開發計劃時,請期待我們對此提出更多評論。我收到你所有的問題了嗎?謝謝。
Operator
Operator
It comes from David Amsellem with Piper Jaffray.
它來自 David Amsellem 和 Piper Jaffray。
David A. Amsellem - MD and Senior Research Analyst
David A. Amsellem - MD and Senior Research Analyst
So just on TRULANCE, Joe, you've said in the past that you're looking for, I guess, parity with Linzess in terms of payer access. So can you talk about where you are now and where you expect to be later this year, and then how we should think about the gross-to-net on that product? And then secondly, just thinking about overall strategy in acquisitions, are you looking at adding an EBITDA-generating asset or assets? And to the extent that you are, is that something where you would consider issuing equity or using the acquisition of a cash-generating asset to issue equity and potentially accelerate your deleveraging somewhat? Help us understand your thought process there.
喬,就 TRULANCE 而言,您過去曾說過,我想您正在尋求在付款人訪問方面與 Linzess 平起平坐。那麼您能談談您現在的情況以及您預計今年稍後的情況嗎?其次,考慮一下收購的整體策略,您是否正在考慮增加一項或多項產生 EBITDA 的資產?就您而言,您是否會考慮發行股票或透過收購現金產生資產來發行股票,並可能在一定程度上加速去槓桿化?幫助我們了解您的思考過程。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Sure. On the first question on payer access, we actually -- we like the position we're in. We think the most important thing to do is what we did in the first quarter already, is driving additional regional plan to enroll additional players -- I'm sorry, additional patients into the marketplace by working with these regional plans. As I mentioned on the call, we've already in the first 30 days added 2.4 million lives. But the real thing that we're doing right now on the access is to make sure that we have a good pull-through model on the access. That's one of the things that we're looking for in terms of driving the -- not only the access but just making sure that we pull through that program as we talk to physicians. The important way we're going to do that is improve reach and frequency. And as I mentioned on the call, that's already happening just really in the first 30 days in terms of driving the reach/frequency.
當然。關於付款人訪問的第一個問題,我們實際上 - 我們喜歡我們所處的位置。我們認為最重要的事情是我們在第一季所做的事情,即推動額外的區域計劃來招募更多的參與者——對不起,通過與這些區域計劃合作,更多的患者進入了市場。正如我在電話中提到的,我們在前 30 天內就已經增加了 240 萬人的生命。但我們現在在訪問方面所做的真正事情是確保我們在訪問方面有一個良好的拉通模型。這是我們在推動方面所尋求的事情之一——不僅是訪問,而且只是確保我們在與醫生交談時完成該計劃。我們要做的重要方法是提高覆蓋範圍和頻率。正如我在電話中提到的,在推動覆蓋率/頻率方面,這種情況在前 30 天內就已經發生了。
On the M&A side, I think we've had a lot of conversations on M&A and use of equity. I don't think we can rule -- ever rule out anything, but I think right now, we are focused on driving the EBITDA of our company to help us delever this business, and we think that's the best way to overall delever, drive EBITDA, and that's what we're going to focused at doing. We think TRULANCE is a good example where we are going to do exactly that. We acquired it for the $190 million approximately. We will now develop that product, grow it significantly from where it is today. And I think it's just a classic textbook case of how we think in the long term it will add to the value of the Salix business and, more importantly, to help us delever.
在併購方面,我認為我們已經就併購和股權使用進行了許多對話。我不認為我們可以排除任何事情,但我認為現在,我們專注於提高公司的 EBITDA,以幫助我們去槓桿化這項業務,我們認為這是整體去槓桿化的最佳方式,推動EBITDA,這就是我們要重點做的事情。我們認為 TRULANCE 是一個很好的例子,我們正是這樣做的。我們以大約 1.9 億美元的價格收購了它。我們現在將開發該產品,並在目前的基礎上大幅成長。我認為這只是一個經典的教科書案例,說明我們從長遠來看它將如何增加 Salix 業務的價值,更重要的是,幫助我們去槓桿化。
Operator
Operator
And that comes from David Risinger with Morgan Stanley.
這是來自摩根士丹利的大衛‧瑞辛格(David Risinger)。
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
David Reed Risinger - MD in Equity Research and United States Pharmaceuticals Analyst
Sorry about that. I am in transit. I have 2 questions. First, could you talk about the outlook for the Lotemax franchise? Obviously, you have a compelling line extension that was recently approved, but you also face partial generic competition. It'd be great to get your perspective on the revenue outlook for that franchise. And then second, if you could remind us about your free cash flow expectations for 2019.
對於那個很抱歉。我正在過境。我有 2 個問題。首先,您能談談 Lotemax 特許經營的前景嗎?顯然,您有一個最近獲得批准的引人注目的產品線延伸,但您也面臨部分仿製藥競爭。如果您能了解您對該系列的收入前景的看法,那就太好了。其次,您能否提醒我們您對 2019 年自由現金流的預期。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Okay. First, on the Lotemax SM. We're delighted with what's happening already with the teams out there promoting the product. Within 30-plus days of the approval, we already have, as I mentioned on the call, plus 40% commercial coverage plus 40% Part D coverage, which is quite extraordinary, but the market access team and the business team led by Joe Gordon have done a really remarkable thing of trying to work with existing payers to make sure that we had access for the product and that physicians understood the benefits of this product for patients. As it would relate to the specifics of the Lotemax generic, loteprednol generic, we have not seen that launch yet. It is a little bit earlier than we expected to be clear, but yet -- to our knowledge, it has -- I've not seen it in the marketplace yet. Should it come to the market, we will have our own authorized generic. But as of this time, we have not yet seen it in the marketplace. So I think that's the Lotemax portion of the question. Paul, do you want to take the cash flow?
好的。首先,關於 Lotemax SM。我們對推廣該產品的團隊已經發生的事情感到高興。在批准後的30 多天內,正如我在電話中提到的,我們已經有了40% 的商業覆蓋率和40% D 部分的覆蓋率,這非常了不起,但喬·戈登領導的市場准入團隊和業務團隊我們做了一件非常了不起的事情,嘗試與現有的付款人合作,以確保我們能夠使用該產品,並且醫生了解該產品對患者的好處。由於它與 Lotemax 仿製藥、loteprednol 仿製藥的具體細節相關,因此我們尚未看到該產品的上市。這比我們預期的要早一點,但據我們所知,我還沒有在市場上看到它。如果它進入市場,我們將擁有自己的授權仿製藥。但截至目前,我們還沒有在市場上看到它。所以我認為這就是問題的 Lotemax 部分。保羅,你想拿走現金流嗎?
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
Yes, sure. And David, we're -- we started, I guess it was -- must have been last quarter with providing a range of expectations for the cash from -- cash generated from operations. That's a GAAP number, so it's after everything. And we guided to our expectations for the year of about $1.5 billion to $1.6 billion. We also include within our guidance the kind of cash items that would degrade that -- not degrade, would be deducted from that number to arrive at a free cash flow number, and that -- those numbers, it's based from the CapEx plus contingent consideration, milestones and license agreements, restructuring and other that aggregate about $385 million based on our guidance today. So we have $1.5 billion to $1.6 billion minus that number. I point out that we did already also -- if you're thinking about free cash flow available for other things, we did deploy that $190 million of cash to the Synergy -- the acquisition of the assets of Synergy earlier this year, something we -- I would -- one of my favorite phrase, I'd do that 100 out of 100 times.
是的,當然。大衛,我們——我猜是——我們從上個季度開始就對營運產生的現金提供了一系列預期。這是一個 GAAP 數字,所以它是最重要的。我們對今年的預期約為 15 億至 16 億美元。我們還在我們的指導中納入了會降低的現金項目,而不是降低,將從該數字中扣除以獲得自由現金流量,而這些數字是基於資本支出加上或有考慮因素根據我們今天的指導,里程碑和許可協議、重組和其他總計約3.85 億美元。所以減去這個數字我們就有 15 億到 16 億美元。我指出,我們也已經這樣做了——如果你考慮可用於其他事情的自由現金流,我們確實將這 1.9 億美元現金部署到 Synergy——今年早些時候收購了 Synergy 的資產,這是我們- - 我會-- 我最喜歡的一句話之一,我會這樣做100 次中的100 次。
Operator
Operator
It comes from Gary Nachman with BMO.
它來自 BMO 的 Gary Nachman。
Gary Jay Nachman - Analyst
Gary Jay Nachman - Analyst
First, as you launched DUOBRII, how do you anticipate reimbursement and uptake will be relative to some of your other recent derm launches? Will you add any new reps to just reallocate the detailing efforts of the current derm team? And then, Paul, how much flexibility do you have with expenses? It seems like you're scaling back SG&A a little bit relative to your initial expectations.
首先,當您推出 DUOBRII 時,與您最近推出的其他一些皮膚護理產品相比,您預計報銷和使用情況如何?您會添加任何新的代表來重新分配當前皮膚團隊的細節工作嗎?然後,保羅,你在開支方面有多大的彈性?相對於您最初的預期,您似乎稍微縮減了銷售、管理費用 (SG&A)。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Sure. So let me start with DUOBRII. We are very excited about, we think, the opportunity for DUOBRII. We think actually, it has an opportunity to really change the treatment paradigm because of the ability to use a high-potency corticosteroid plus a retinoid. Together, it get -- there is a synergistic effect that's actually even better than if you use the 2 and apply them separately to the same skin. So we know we've got a very unique formulation that has some very unique qualifications, and we're really excited about what that means for patients in terms of improving the lives of patients because as I said in the comments, we know 85% of patients would prefer or use a topical dermatologic. So that's we're -- why we think it's a great situation.
當然。讓我從 DUOBRII 開始。我們認為 DUOBRII 的機會讓我們感到非常興奮。我們認為實際上,由於能夠使用高效皮質類固醇加類維生素A,它有機會真正改變治療模式。總之,它會產生協同效應,實際上比使用兩種藥物並將它們單獨塗抹在同一皮膚上更好。因此,我們知道我們有一個非常獨特的配方,具有一些非常獨特的資格,我們對這對改善患者生活意味著什麼感到非常興奮,因為正如我在評論中所說,我們知道 85%的患者更喜歡或使用局部皮膚科藥物。這就是我們認為這是一個很好的情況的原因。
Specifically, as I've mentioned in the call, I want to give you the specific numbers, we said that we will launch soon in -- next month at 30% of covered lives, and we expect that number to grow to about 75% of covered lives 1 year into the launch. On the question of adding reps, this is a thing that -- we already added reps in 2018, so we are well positioned for psoriasis. And we believe that there -- the actual incremental cost of selling is going to be minimal for the launch of DUOBRII. We think we've already got that underhand -- under way. Paul, you want to take the SG&A portion?
具體來說,正如我在電話中提到的,我想給你們具體的數字,我們說我們將很快在下個月推出,覆蓋率達到 30%,我們預計這個數字將增長到 75% 左右推出一年後的受保生命。關於增加代表的問題,我們已經在 2018 年增加了代表,所以我們已經為牛皮癬做好了準備。我們相信,對於 DUOBRII 的推出,實際增加的銷售成本將是最小的。我們認為我們已經在暗中進行了。Paul,你想承接 SG&A 部分嗎?
Paul S. Herendeen - Executive VP & CFO
Paul S. Herendeen - Executive VP & CFO
Yes, sure. I -- and Gary, I hope I didn't give the impression we're scaling back or cutting back or doing anything. It's just a reflection of we guided to -- the beginning of the year in February, we said $2.45 billion for a total of just SG&A expense. We did not change that guidance. But sitting here at the end of Q1, we feel like for the balance of the year, we may be -- we maybe will be a little on the lower side of that versus the upper side of that. A lot of that is, yes, as the year plays out, it's a -- and with the passage of time, you get better clarity as to where you're spending, what you're spending, et cetera, and just we feel a little bit better about being perhaps a shade below that and a shade above that. We're not cutting back.
是的,當然。我和加里,我希望我沒有給人留下我們正在縮減或削減或做任何事情的印象。這只是我們指導的反映 - 年初 2 月份,我們說 SG&A 支出總額為 24.5 億美元。我們沒有改變該指導方針。但在第一季末,我們感覺今年剩下的時間裡,我們可能會處於較低的水平,而不是較高的水平。其中很多是,是的,隨著時間的推移,隨著時間的推移,你會更清楚地知道你在哪里花錢,你在花什麼等等,而我們只是覺得稍微低於該值和高於該值會更好一些。我們不會削減開支。
Operator
Operator
Again, it comes from David Steinberg with Jefferies.
同樣,它來自大衛·斯坦伯格和杰弗里斯。
David Michael Steinberg - Equity Analyst
David Michael Steinberg - Equity Analyst
In terms of legal challenges, the companies have a lot of cases either dismissed or settled at favorable terms over the last couple years. I was just curious. As you look at your portfolio of challenges ahead, which are ones that are most concerning to you that are riskiest? What sort of exposure might you have? And is there some sort of time line you can give us in terms of resolution? And then back to TRULANCE, you've offered some pretty healthy first year guidance. Just curious if you would offer anything in terms of peak sales potential. And do you see TRULANCE as a product that's going to grow the market or will be more taking share from Amitiza and Linzess? And then finally, in terms of marketing tactics, Synergy had some very memorable television ads, but the product didn't do that well. Are you also going to do some DTC for TRULANCE?
在法律挑戰方面,過去幾年,這些公司有許多案件被駁回或以有利條件和解。我只是好奇而已。當您審視未來的挑戰組合時,哪些是您最關心且風險最大的挑戰?您可能會受到什麼樣的曝光?您可以給我們解決方案的時間表嗎?然後回到 TRULANCE,您提供了一些非常健康的第一年指導。只是好奇您是否會提供有關峰值銷售潛力的任何資訊。您認為 TRULANCE 是一款能夠擴大市場的產品,還是會更多地從 Amitiza 和 Linzess 手中奪取份額?最後,在行銷策略方面,Synergy 有一些非常令人難忘的電視廣告,但產品表現不佳。你也打算為 TRULANCE 做一些 DTC 嗎?
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Okay. So I'm going to try to get all those. On the question, first, on the legal challenges, first of all, Christina Ackermann and the legal team have just done an outstanding job in terms of resolving this litigation. If you think about some of the questions in front of us going back a couple of years ago, just since the first quarter of 2018 to-date, they resolved 80 individual cases, either resolve themselves, et cetera. And just even -- of that 80, there is actually 10 that were done just in the first quarter of 2019. So great work there. Obviously, one of the most important cases that came -- or got resolved was an arbitration with Johnson & Johnson and ourselves on the question of Shower-to-Shower. Christina and the team have just done an outstanding job of resolving that.
好的。所以我會盡力獲得所有這些。關於這個問題,第一,關於法律挑戰,首先,克里斯蒂娜·阿克曼和法律團隊剛剛在解決這起訴訟方面做得非常出色。如果你回想一下我們面前的一些問題,可以追溯到幾年前,從 2018 年第一季至今,他們解決了 80 個個案,或者自行解決,等等。甚至,在這 80 項中,實際上有 10 項是在 2019 年第一季完成的。那裡的工作非常出色。顯然,發生或解決的最重要的案件之一是與強生公司和我們就淋浴間問題進行的仲裁。克里斯蒂娜和團隊剛剛出色地解決了這個問題。
On the question -- the second question was peak sales potential. I'm not going to give any specific peak sales number, but we clearly think we can move from that 4% market share we have today that we illustrated in the graph to significantly multiples of that in terms of what's going to happen. And we do expect to grow the market. We don't view this as being something that we will simply be taking share. We do believe the market will grow as we have new therapies for treating IBS-C. Especially. We think that there's an opportunity for growth.
關於這個問題——第二個問題是峰值銷售潛力。我不會給出任何具體的峰值銷售數字,但我們顯然認為,就即將發生的情況而言,我們可以從圖表中所示的今天 4% 的市場份額轉向數倍的增長。我們確實希望擴大市場。我們不認為這是我們簡單分享的事情。我們相信,隨著我們擁有治療 IBS-C 的新療法,市場將會成長。尤其。我們認為存在成長機會。
On the final question of the direct-to-consumer, right now we are engaged in -- primarily in winning the battle in the doctor's office. We want to be able to talk about why we have a product that has some significant dosing benefits for patients and that you can dose that with or without food. It's a once-a-day product versus one of the products being a twice-a-day product. And importantly, it's got one of the best adverse side effect reaction -- adverse reactions, side effect profiles in these products. So we believe we can focus there, focus with physicians in the near term. And then the question of whether or not we do anything beyond that in terms of direct-to-consumers, I think, we'll just wait and see what happens there. But right now we're focused primarily on winning the battle in the physician office.
關於直接面向消費者的最後一個問題,我們現在主要致力於贏得醫生辦公室的戰鬥。我們希望能夠談論為什麼我們的產品對患者有一些顯著的劑量益處,並且您可以在與食物一起或不與食物一起服用時服用該產品。這是一種每天一次的產品,而其中一種產品是每天兩次的產品。重要的是,它具有最佳的不良副作用反應之一——這些產品的不良反應、副作用概況。因此,我們相信我們可以在短期內重點關注這一點,並專注於醫生。然後,我認為,我們是否會在直接面向消費者方面做更多的事情,我們只會等待,看看那裡會發生什麼。但現在我們主要關注的是贏得醫生辦公室的戰鬥。
Operator
Operator
And that comes from Irina Koffler with Mizuho.
這來自瑞穗的伊琳娜‧科夫勒 (Irina Koffler)。
Irina Rivkind Koffler - MD of Americas Research & Senior Analyst
Irina Rivkind Koffler - MD of Americas Research & Senior Analyst
I just wanted to touch base on the $300 million guidance for the Significant Seven. I know that DUOBRII has been pushed back to June launch. So maybe you can comment on which products are doing stronger than expected to get you to that number and how confident are you in that number.
我只是想談談對「重要七人」的 3 億美元指引。我知道 DUOBRII 已被推遲到六月發布。因此,也許您可以評論哪些產品的表現比預期更好,可以幫助您達到該數字,以及您對該數字的信心有多大。
Joseph C. Papa - CEO & Chairman of the Board
Joseph C. Papa - CEO & Chairman of the Board
Sure. Well, first of all, we are focused on all of the Significant Seven. You're absolutely right, we did raise guidance for the year despite the fact that we did have a short delay, if I could use the word short delay. But I will say that clearly, the -- with DUOBRII, the clear opportunity we see are very strong performance in our LUMIFY products, we see strong performance in RELISTOR as being the keys to what we are doing already this year. But notwithstanding that, we are excited about all the 7 products. Having them all approved was that -- this is something we put forward in 2017. And now to have them all approved and soon to launch, the DUOBRII with a label that we think is unsurpassed, there's no product out there with a label like DUOBRII for the treatment of psoriasis, that is a high-potency corticosteroid, we think that's very important for patients. We're really excited about that over the long term. So that really is where I would say the Significant Seven are going for us. We're excited. We look forward to it.
當然。嗯,首先,我們關注所有重要的七個。你說得完全正確,我們確實提高了今年的指導,儘管我們確實有短暫的延遲(如果我可以使用“短暫延遲”這個詞)。但我要明確地說,對於 DUOBRII,我們看到的明顯機會是我們的 LUMIFY 產品的強勁表現,我們認為 RELISTOR 的強勁表現是我們今年已經開展的工作的關鍵。但儘管如此,我們對這 7 款產品都感到興奮。讓它們全部獲得批准就是──這是我們在 2017 年提出的。現在,所有這些都獲得批准並很快推出,DUOBRII 的標籤我們認為是無與倫比的,沒有任何產品帶有像 DUOBRII 這樣的標籤,用於治療牛皮癬,這是一種高效皮質類固醇,我們認為這是對於患者來說非常重要。從長遠來看,我們對此感到非常興奮。所以這確實是我想說的「重要七人」為我們服務的地方。我們很興奮。我們期待它。
With that, let me wrap up the call. We look forward to seeing many of you at the conferences over the next 6 weeks. Thank you, everyone. Have a great day. Thank you for joining us.
就這樣,讓我結束這通通話。我們期待在未來 6 週的會議上見到你們中的許多人。謝謝大家。祝你有美好的一天。感謝您加入我們。
Operator
Operator
Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.
謝謝。會議現已結束。感謝您參加今天的演講。現在您可以斷開線路。