IMAGE SOURCE: THE MOTLEY FOOL.
Pfizer Inc. (NYSE:PFE)
Q3 2017 Earnings Conference Call
Oct. 31, 2017, 8:00 a.m. EDT
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day, everyone, and welcome to Pfizer's Third-Quarter 2017 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chuck Triano, Senior Vice President of Investor Relations. Please go ahead, sir.
Charles E. Triano -- Senior Vice President of Investor Relations
Good morning, and thank you for joining us today to review Pfizer's Third-Quarter 2017 performance. I'm joined today by our Chairman and CEO, Ian Read; Frank D'Amelio, our CFO; Mikael Dolston, President of Worldwide Research and Development; Albert Bourla, Group President of Pfizer Innovative Health; John Young, Group President of Pfizer Essential Health; and Doug Lankler, our General Counsel. The slides that will be presented on this call can be viewed on our website, Pfizer.com/investors.
Before we start, I'd like to remind you that our discussions during this conference call will include forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Additional information regarding these factors is discussed under the Disclosure Notice section in the Earnings Release we issued this morning, as well as in Pfizer's 2016 annual report on Form 10K, including in Part I, Item 1(a) and that is filed with the SEC, and available at SEC.gov, and at our website at Pfizer.com.
Forward-looking statements during this conference call speak only as of the original date of this call, and we undertake no obligation to update or revise any of those statements. Discussions during the call will also include certain financial measures that were not prepared in accordance with U.S. Generally Accepted Accounting Principles. Reconciliation of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in Pfizer's current report on Form 8K dated today, October 31st, 2017. You may obtain a copy of the Form 8K on our website at Pfizer.com/investors. Any non-GAAP measures presented are not, and should not be viewed as substitutes for financial measures required by U.S. GAAP. They have no standardized meaning prescribed by U.S. GAAP and may not be comparable to the calculations of similar measures at other companies.
We will now make prepared remarks and then we will move to a question and answer session. With that, I now turn the call over to Ian Read. Ian?
Ian C. Read -- Chairman and Chief Executive Officer
Thank you, Chuck, and good morning everyone.
During my remarks today, I will briefly talk about the progress and opportunities within each of our businesses. Our recent announcement regarding our consumer healthcare business and some of the promising assets in our pipeline which, we believe, have the potential to become a foundation for our future growth prospects.
Starting with the quarter, we again reported solid operational revenue growth. If you exclude the impact of the Hospira Infusion Systems divestiture and the unfavorable impact of foreign exchange, revenues for the quarter increased 4% operationally, compared to the prior-year quarter. We also raised the mid-point of our adjusted diluted EPS guidance for the year.
I'll begin with a few words regarding the performance of each of our businesses starting with Pfizer's Innovative Health. This business had another strong quarter, growing its top line 11% operationally. This increase was driven by continued growth of key brands including IBRANCE and Eliquis globally, and XANDI, Lyrica, XELJANZ, and Chantix in the U.S. IBRANCE had another strong quarter with revenues up 59% on an operational basis compared with the same quarter last year. We remain confident in its continued growth potential, and leadership despite there now being two other approved CDK 4/6 Inhibitors. IBRANCE share is now nearly 50% for first-time new patient starts in advanced breast cancer. Prescription volume continues to grow. As of the end of September, IBRANCE has been prescribed by more than 11,000 physicians to 70,000 patients in the U.S., and more than 18,000 patients in the E.U., and received regulatory approval in more than 70 countries including Japan.
With XTANDI, we continue to see growth in prescription volume. Although XTANDIs revenue growth is not yet tracking in line with prescription growth due to patient assistance free-drug program utilization as a portion of total demand, we are pleased to report that we have now recorded sequential revenue growth for two consecutive quarters. I would also note, that the patient assistance program proportion of total demand was comparable with that seen in the first and second quarters. We continue to expect that the program utilization will normalize as we move into next year. Of note, the number of urologists actively prescribing XTANDI, again, reached an all-time high this quarter. These increases remain one of the key factors supporting XTANDIs continued growth.
In June, we announced the readout of the XTANDI Phase III Prosper Trial in non-metastatic castration-resistant prostate cancer has been accelerated by two years. We are pleased the trial met its primary endpoint of improved metastatic pre-survival. We have said previously we see these positive results as key value drivers that support our acquisition thesis for motivation. We are working with our partner, Istelist on worldwide submission plans based on the Prosper Data to seek expansion of the label to non-metastatic CRPC.
We continue to hit all-time highs in terms of new rheumatology prescriptions for XELJANZ. We received a record 9.8% sample weekly new prescription share for the month of September for our current indications of rheumatoid arthritis. With the weekly high reaching 10% so far in October, XELJANZ continues to be the fastest growing, advanced RA therapy. We see the potential for two additional and meaningful growth opportunities for XELJANZ with our two pending regulatory submissions for other conditions. The psoriatic arthritis XELJANZ received an overwhelmingly positive vote in favor of approval at the FDA Advisory Committee Meeting in August. We anticipate a final decision by the FDA before the end of the year. XELJANZ has also been accepted for review by the FDA for ulcerative colitis, with a due for a date in March. We've completed filings for both pending indications in multiple other countries.
For Eucrisa, we see steady progress. Approximately 83,000 patients started treatment with Eucrisa by the end of the third quarter. More than 23,000 prescribers have provided Eucrisa to patients across a dermatological, pediatric and primary care communities. More than 60% of those prescribers are repeat prescribers. Prescription volume and share velocity continue to strengthen through the third quarter, supported by the successful launch of our DTC Campaign.
Turning now to Pfizer Essential Health, while revenues for the quarter declined, we, once again, saw strong operational growth both in emerging markets and our bio-similars portfolio. We also continue to see the value of bio-similars in expanding patient access to important, high quality, low-cost treatment options. Our bio-similars business continues to grow with global revenue increasing 67% operationally in the quarter. In September, we presented two positive Phase III Readouts for our first oncology bio-similar Trastuzumab, which is a proposed bio-similar to Herceptin. The Readouts were presented at the European Society for Medical Oncology 2017 Congress. Both the FDA And the EMA have accepted our filings for this potential therapy.
As of the end of September, Inflectra in the U.S. has grown, albeit slowly, to a 4.9% share of the overall U.S. Infliximab market by volume. We continue to have 100% Medicare coverage, as well as strong coverage in Medicaid. In situations where the insurer and provider are the same, such as the V.A., we have seen rapid uptake of Inflectra, with a share in these situations reaching 54%, up from 20% in quarter two. That said, Inflectra penetration in the U.S. continues to be slower than expected due to the exclusionary contracting of Remicaid by J&J, contracting that we believe violates the Anti-Trust laws.
As you know, we recently filed suit in the U.S. District Court against J&J. We did this to help ensure the true value bio-similars can be unlocked for the benefit of patients, providers in our nation's healthcare system. We're actually working on a range of strategies to help Inflecta accessibility to more patients and to also lay the groundwork for a smoother, more rapid uptake of all future bio-similars in the U.S. marketplace. Additionally, just yesterday, along with our partner, Celtrion, we presented new data switching patients with Crohns Disease to Inflectra from Remicaid leads to a comparable efficacy safety and tolerability to treatment with Remicade. That's adding to the totality of evidence supporting the switch to Inflectra.
In our Essential Health portfolio, we have been experiencing supply shortages with some products. The shortages are primarily for products from Legacy Hospira Portfolio and are largely driven by capacity constraints and technical issues. When we acquired Hospira, we originally thought it would take one to two years to integrate the manufacturing plants and resolve the majority of the supply chain issues. We have a robust action plan in place, and we believe will make substantial progress in 2018 toward reducing the sterile injectable shortages. As we look ahead, in addition to continuing to expect revenue growth from our patient Patsur from our Patent Protected Portfolio; we are very encouraged by the convergence of two positive trends. First, the decline in the number and the revenue impact of L.O.E.s stating our business, and further strengthening of our R&D pipeline and it's potential to drive incremental revenue.
We expect the full year, year-over-year impact of L.O.E.s to continue to be significantly lower than our recent past. We are forecasting the impact to be approximately 2 billion in each of the next three years. About 1 billion in 2021 and then 500 million or less from 2022 through 2025. At the same time, we expect a steady flow of new products to begin to emerge from our pipeline. Here are a few of our most recent advances. The development plan for Tergaflosen for Type II Diabetes remains on track, and we expect a decision from the FDA in December.
In oncology, our POP Inhibitor Talazoparib, topline results from the Phase III BRCA trail will readout at the end of the year. The end BRCA trial is exploring Talazoparib versus standard of care, chemotherapy, in germline BRCA positive metastatic breast cancer.
In partnership with Merck, KGA, we expect data on Vivencio, our PDL I inhibitor, in combination with our 411BB Agent later this year. The study is looking at patients who had not been previously treated with an immune checkpoint inhibitor. These data could be ready for potential presentation during 2018. We also anticipate data from our triplet combination with Vivencia, our 41BB agent and our Ox40 monoclonal antibody in late 2018. This study is recruiting on track.
Also by the end of the year, we plan to submit an application with the FDA for Lolathanib, our next generation ALC inhibitor for the treatment of ALC positive metastatic, non-small cell lung cancer. On October 16th we presented full results of the Lolathanib Phase II data that will form the basis of our discussions with the agency.
In information immunology, we recently presented positive Phase II data for our once-daily oral JAK I inhibitor in atopic dermatitis. We are planning to move this compound into Phase III studies shortly.
The vaccines, we've started Phase II trials for our next-gen 20 val in pneumococcal vaccine, and have received fast track designation for it from the FDA. These pipeline advances represent just a few of the assets that we expect to form the foundation for offsetting our remaining L.O.E.s. We believe the combination of our strengthening pipeline and the anticipated continuing easing of L.O.E. impact has a potential to support a nice inflection for our future revenue growth rates.
I'll close my remarks with a few comments regarding our consumer health business. Earlier this month we announced that we were reviewing strategic options for this business. This could include everything from a full or partial separation of the business to ultimately deciding to retain the business. We are taking this action as part of our regular ongoing reviews of our portfolio, pipeline, and business strategy. Although there was a strong connection between our consumer healthcare business and elements of our core by our pharmaceutical portfolio, it is also distinct enough from our core business that there is a potential for its value to be fully realized outside the company. We anticipate there will be broad interest from potential inquirers and we expect to make a decision in 2018.
In summary, we continue to execute on our strategy. The fundamentals of our business are strong, and we have several key brands that we believe are positioned for continued growth. The unfavorable of L.O.E.s remains lower than in previous years, and we expect it to drop off even further in the coming years. And our innovative core is as strong and vibrant as it's ever been, which is positioning well in the areas of greatest patient need and where science is evolving.
Now I'll turn it over to Frank who will go into greater detail in the results for the quarter.
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
Thanks, Ian. Good day everyone.
As always, the charts I'm reviewing today are included in our webcast.
Moving on to the financials; third-quarter 2017 revenues were approximately 13.2 billion, and reflect the year-over-year operational growth of 178 million. Third-quarter in 2017 revenues were also slightly offset by the unfavorable impact the foreign exchange of 54 million. If you exclude both the revenues of our Hospira Infusion Systems, or HIS, in both periods, as well as the negative impact of the foreign exchange, third-quarter 2017 revenues will increase $458 million or 4%. Our Innovative Health Business recorded 11% operational revenue growth in the third-quarter 2017, driven by IBRANCE and Eloquis globally. The addition, Extandia revenues in the U.S. from the Medivation acquisition in September of 2016, and Lyrica, and XELJANZ both primarily in the U.S. All of this was partially offset by lower revenues for Embrel in most developed Europe markets due to continued bio-similar competition and Viagra in the U.S. because of wholesale or destocking prior to anticipated generic competition beginning in December of 2017.
Revenues for our Essential Health Business decreased 11% operationally, of which 5% was attributable to the divestiture of the HIS business in February of this year. The remainder of the decline was due to a 22% operational decline from Peri-L.O.E. products including Pristiq in the U.S. which lost marketing exclusivity in March of 2017, and Lyrica and Vivend in developed Europe markets. As well as a 12% operational decline in the Sterile Injectibles Portfolio primarily due to Legacy Hospira Product shortages in the U.S., all of which were partially offset by operational growth of 67% from biosimilars.
In emerging markets, however, Pfizer's overall Essential Health Revenues grew 7% operationally, primarily due to 6% growth from the Legacy Established Products Portfolio, and 14% growth from the Sterile Injectibles Portfolio.
Third-quarter reported diluted EPS was $0.47 compared with $0.22 in the year-ago quarter primarily due to the non-recurrence of a remeasurement loss on HIS in the year-ago quarter, higher gross margins, and lower restructuring implementation costs, all of which were partially offset by higher purchase accounting adjustments. Adjusted diluted EPS for the third-quarter was $0.67 versus $0.61 in the year-ago quarter. The increase was primarily due to higher revenues, adjusted gross margin, and adjusted other income as well as fewer shares outstanding, partially offset by product losses of exclusivity, product supply, and a higher effective income tax rate.
I want to point out that diluted weighted average shares outstanding declined by 109 million shares versus the year-ago quarter due to our share repurchase program reflecting the impact of our $5 billion accelerated share repurchase agreement executed in February and completed in May of 2017. As I previously mentioned, foreign exchange negatively impacted third-quarter 2017 revenues by approximately 54 million and positively impacted adjusted the cost of sales, adjusted S&A expenses, and the adjusted R&D expenses in the aggregate by $16 million. As a result, foreign exchange unfavorably impacted third quarter 2017 adjusted diluted EPS by $0.01 versus the year-ago quarter.
As you can see on the chart, we narrowed the ranges for certain components of 2017 financial guidance. We narrowed our revenue guidance range, and we now expect 2017 revenues to be in the range of 52.4 billion to 53.1 billion. This range continues to absorb an anticipated 2.3 billion negative impact due to continuing product losses of exclusivity, 1.2 billion due to the divestiture of HIS and an anticipated $100 million negative impact due to adverse changes in foreign exchange rates versus 2016 rates. Also, supply challenges primarily related to Legacy Hospira Products have had a negative impact on projected 2017 revenues of several hundred million dollars. Consequently, we lowered the mid-point of our 2017 revenue guidance range. That said, we expect these challenges to moderate in full year 2018.
I want to point out that if we exclude the impact of foreign exchange and the sale of HIS, the mid-point of our updated revenue guidance would represent a 2% increase from fiscal years 2016 revenue levels. Concerning adjusted diluted EPS, we increased the mid-point of our guidance range by $0.03, and we now expect 2017 adjusted diluted EPS to be in the range of 2.58 to 2.62. The mid-point of our updated 2017 adjusted diluted EPS guidance range, which is 2.60 versus our 2016 actual adjusted diluted EPS of 2.40 implies a growth rate of approximately 8% year-over-year. It's important to note that this guidance range includes the anticipated negative impacts of approximately $0.03 due to the sale of Hospira Infusion Systems; $0.01 for the foreign exchange compared to 2016; and $0.01 resulting from our May 2017 agreement with Sangamo to develop and commercialize gene therapy programs for Hemophilia A. Excluding these, the mid-point of our diluted EPS would have been 2.65 which represents a 10% increase versus 2016 actual results; which is significant given the 2.3 billion of topline headwinds we are facing due to the product losses of exclusivity that I just mentioned.
I wanna take a moment to comment on the impact of the hurricanes that took place toward the end of the third quarter. First and foremost, we have nearly 2,000 Pfizer colleagues who live and work in Puerto Rico, their safety and well-being is our priority. I'm pleased to say that we have confirmed the safety of all colleagues in Puerto Rico and we are now providing direct assistance to them. Pfizer also has three manufacturing sites in Puerto Rico. While these sites sustained some damage, we have made significant progress in repairing our facilities in anticipation of ramping up to full operations over the coming months. As a result of dual-source supply options and sufficient pre-hurricane inventory levels, our assessment at this point is that any revenue impact is expected to be insignificant. We will continue to monitor the situation closely and make any updates to our outlook if warranted.
Moving on to key takeaways. We continued to deliver strong financial performance in the third quarter of 2017 excluding HIS revenues and the impact of foreign exchange from both periods; revenues increased 4% operationally year-over-year driven by the strong growth from IBRANCE, Eloquis, XELJANZ, Chantix and the contribution of newly acquired products including Xtandi. We narrowed certain 2017 financial guidance ranges including raising the mid-point of our 2017 adjusted diluted EPS guidance range by $0.03 to 2.60 from 2.57. We accomplished several key product and pipeline milestones, and we returned 10.8 billion to shareholders year-to-date 2017 through dividends and share repurchases which includes a 5 billion accelerated share repurchase agreement executed in February. Finally, we remain committed to delivering attractive shareholder returns in 2017 and beyond.
Now it'll turn it back to Chuck.
Charles E. Triano -- Senior Vice President of Investor Relations
Thank you, Frank and Ian. Operator, can we please poll for questions?
...
Questions and Answers:
Operator
Ladies and gentlemen, if you would like to ask a question, please press star then the number one on your telephone keypads.
Your first question comes from Umer Raffat from Evercore.
Umer Raffat -- Evercore ISI -- Analyst
Hi guys. Thank you so much for taking my question.
Perhaps, first, Ian one for you, if there were to be no tax reform, is your bias at that point to look for an ex-U.S. company or not? And I wanna tie my second question back to the first one as well which is when we get these updates on Evalumab, plus 41BB, and OX40 combinations from your ongoing medley trial, how does that inform whether or not you'll look externally for a large IO acquisition? Thank you so much.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you for the questions. On the tax reform issue, if there's no tax reform, we will continue to look at acquisitions based on the value creation for shareholders as we've always done. I don't really wanna speculate on that. On the IO development, obviously the IO is an interesting category, it has a lot of arability right now in the performance of different products. We remain focused on improving our business in IO, and we'll have to wait to see what the readout of those trails as to what it tells and what direction we wanna take.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Ian. Next question, please.
Operator
Your next question comes from Chris Schott from JP Morgan.
Chris Schott -- JP Morgan -- Analyst
Great. Thanks very much.
Just two questions here, maybe the first was just elaborating a little bit on IBRANCE trends in the U.S. I think you talked about 50% penetration right now. My question is where do you see penetration peaking over time and what do you think it's gonna take to get that additional penetration in the market? My second question was on repatriation, and tax reform. I think you've talked in the past of about 160 billion of foreign earnings at Pfizer and that repatriation of these earnings still allowed the company to bring back significant future earning to the U.S. at a very low tax rate. To the extent that we get repatriation, should we think of that as just fundamentally altering your approach to either leverage or capital deployment? I guess the other way of looking at it, should we think about a step up in Pfizer's annual capital deployment, if this were to occur, whether that's large deals, small deals, or repo? Or is this just gonna be business as usual as it relates to business installment? Thank you.
Ian C. Read -- Chairman and Chief Executive Officer
Albert, you wanna deal with IBRANCE?
Albert Bourla -- President Vaccines, Oncology, Consumer Healthcare
Yes. Thank you.
First of all, let me say that we are very pleased with the results of IBRANCE, we had 59% growth globally versus the same quarter of last year. IBRANCE last year was already a $2 billion product, so this is significant growth. Moving forward, the growth for IBRANCE will come, in the U.S., from expanded usage with already prescribing physicians, but also from expanding the CDK market, as you well alluded. The penetration of CDK right now is 50%, but if you see the new patients, it is 57%, the historical was always 50%. I think the introduction of new CDK competitors in the market, and more importantly, the publication of more data is enhancing the confidence of physicians in the class and will benefit overall the class. I don't see any reason why this will not go very high because it is the standard of care anyway.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you. Frank, do you wanna discuss the repatriation alternatives?
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
So, Chris, all the numbers you cited, the 160 billion is a number I've cited previously. Remember, that's accumulated profit and earnings, that's not cash. You basically said that in your question. You really had two questions; one was, does it alter our approach in capital allocation? From my perspective, the answer is, no. Our priorities for capital allocation don't change they are dividends, share buy-backs, investing in the business, and M&A, those will continue to be our capital allocation priorities going forward.
Then your second question was, would that alter our approach to business development? My answer is no. From my perspective our approach doesn't change, it's we're agnostic to size, and hopefully, our actions over the past, or in the past have demonstrated that. Our compass on deals has been, is, and will remain shareholder value.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Frank and Albert. Next question, please, operator.
Operator
Your next question comes from Andrew Baum, from Citi.
Andrew Baum -- Citi -- Analyst
Thank you.
A couple of questions. Firstly, the on Talazoparib, given the recent Astra deal and we anticipate that heavy investments in the program, can you just outline where you intend to go and how quickly with your DNA damage reparation both therapy selected patient was in combination with events and your quarter portfolio? Second, while I know shareholder value, will guide your direction, should I think Pfizer has no interest in asset swaps with enthusiastic potential buyers to your business such as GSK, and the events of a trade sale most likely use will be cash to fund business values?
Ian C. Read -- Chairman and Chief Executive Officer
Albert. Sorry. Mike, would you like to take the Talo question?
Mikael Dolsten -- President-Worldwide Research and Development
Yeah. Thank you for your interest in Talazoparib. We regard it as a very potent PARP inhibitor. It's dosed at 1mg. and it has tumor activity that has been very efficacious in pre-clinical models and our clinical studies. We look forward to the near readout of our Phase III and BRCA trial that's Talazoparib versus standard of care in BRCA post-hemostatic breast cancer. We also are looking at Avelumab, plus Talazoparib, plus some tumor indications which may allow us to take benefit of the increased impact of Talazoparib to make tumors immunogenic, which Avelumab will benefit the patient. We are starting those studies, and look forward to expanding them rapidly. We see, also, opportunity with Talazoparib in other combinations such as XTANDI in prostate cancer. Indeed, it's an important growing asset for us.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you, Mikael.
On the question of the consumer business, we have some time in looking and seeking strategic deals for our consumer business whereby we would have perhaps [inaudible] [00:30:00]involving asset swaps. I think this process we've undertaken, the strategic review, may shake loose more alternatives in that aspect. Regarding the proceeds, it's really premature to speculate given the fact it may not be; we may spin the division as a separate company depending on how we create maximum value. We have to wait to see exactly how we recover the full value of this business.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Ian and Mikael. Next question, please, operator.
Operator
Thank you, and we'll go next to Greg Gilbert from Deutsche Bank.
Greg Gilbert -- Deutsche Bank -- Analyst
Thanks.
Sticking with the theme of big deals. Since you're asked about your willingness and interested in doing big deals so often, I was hoping you would offer your historical view on whether very large deals in the industry and for Pfizer, in particular, have value enhancing? Secondly, John, can you go into some more detail about what's causing the shortages? Is this a systemwide issue, is it tied to FDA issues, or just demand outstripping supply? When do you expect a close-out letter from McPherson? Thanks.
Ian C. Read -- Chairman and Chief Executive Officer
Okay, Frank. Retrospective on big deals, please.
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
Yes. I guess the big deal would be Wyeth, in terms of what we've done. I think the retrospective on that is it's been very value enhancing. If you look at our portfolio today, much of it has come from the Wyeth acquisition. When we announced that deal, we announced 4 billion in synergies; we clearly exceeded that. If you look at the value we got for the nutrition business that came from Wyeth if you look at the value, we got in Zoetis much of which came from the Wyeth acquisition. If you look at the consumer business that we currently have. Quite frankly, if you look at the Wyeth business retrospectively significant value creation from that acquisition.
Ian C. Read -- Chairman and Chief Executive Officer
I think, in general, I would say, that the big deals prior to that have also been value creation deals. As we've always said we're agnostic to size, we have a core competency in business development and integrating companies, and we'll continue to use that competence.
John, you wanna comment on...?
John B. Young -- President-Global Established Pharma Business
Yeah. Thanks for the question, Greg.
In the Essential Health Portfolio, as Frank mentioned in his comments, we have been experiencing some supply shortages for some of our products. The shortages are primarily for products from the Legacy Hospira Portfolio, and they're driven by, I guess, a blend of what we term capacity constraints and technical issues. I think as Frank also mentioned, when we acquired Hospira, we originally thought that it would take one to two years to integrate their manufacturing plants and resolve the majority of the supply chain issues that we were aware of. What I would say is we have a robust action plan in place, and we believe that we'll make substantial progress in 2018 toward reducing the sterile injectable shortages.
In regard to McPherson, I think all I would say is that we've submitted a corrective and preventative action plan to the FDA, and we've been diligently working to address the items outlined in the warning letter. We provide regular updates to the FDA on the status of that action plan and will continue to do so.
Charles E. Triano -- Senior Vice President of Investor Relations
Thank you. Next question, please, operator.
Operator
Your next question comes from David Marris from Wells Fargo.
David Marris -- Wells Fargo -- Analyst
Good morning.
On bio-similars in the J&J suit, maybe if you could just address on, how pervasive do you think these types of anti-competitive contracts are? What do you think the timeline on resolution and potential outcomes could be? Do you think this largely explains the major difference in the uptake in Europe and other outside the U.S. markets on bio-similars versus the U.S., or do you think there's another dynamic going on? Thank you.
Ian C. Read -- Chairman and Chief Executive Officer
Doug, would you like to answer that?
Doug M. Lankler -- President-Executive Vice President & General Council
Sure.
Taking the last part of the question first, we do think so. We think in, what we're calling, the closed market area we're seeing uptake that we think supports our claim that J&Js anti-competitive practices concerning Remicade have denied U.S. patients and the broader healthcare system the benefits of robust price competition and therapeutic options in the biologics marketplace. Our concern that J&J has threatened to withhold significant rebates to insurers for both current and future patients, and also engaged in, what we think are inappropriate and inaccurate marketing claims. For example, suggesting that patients need to fail first on Remicade before using Inflectra seem to be unique to J&J, but obviously, we believe it's a violation of the Anti-Trust Laws.
Ian C. Read -- Chairman and Chief Executive Officer
John, do you wanna add something?
John B. Young -- President-Global Established Pharma Business
Yeah. I would just add, David, as Ian mentioned in his comments, Inflectra is actually performed well in closed-systems in the United States. Those are the systems which prioritize healthcare cost savings over short-term rebating. As of quarter three, we've reached a 54% share in those closed systems. I think, in our perspective is, that the performance in those closed systems demonstrates that where payors, providers, and patients have access to Inflectra, Inflectra can offer significant value. The closed systems, obviously, only represent a relatively small portion of the market around about 5% in total Infliximab volume. As Doug has commented, due to J&Js exclusionary contracting, lower pricing Inflectra has largely not received commercial access, a parity to Remicade and remains disadvantaged. Overall, I think that performance in the closed systems really represent the value that Inflectra can deliver to healthcare providers and to patients.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, John and Doug. Can we move to our question, please?
Operator
Your next question comes from Jamie Reuben from Goldman Sachs.
Jamie Reuben -- Goldman Sachs -- Analyst
Thank you. I just have a couple.
First for you, Ian. Has Pfizer had discussions with other companies regarding alternative drug distribution models or potential new entrants into the drug distribution business. Obviously, I'm referring to the havoc is wreaked upon that industry because of the threat from Amazon. Just would love your thoughts on that. Just taking a five-year view, do you see new entrants entering the drug distribution industry, PDM, or drug retail pharmacy industry? Just wondering what your thoughts are on that?
Then, just if I can move to the essential health business, that business continues to be a real drag on your overall performance, you cited specific reasons this quarter. At the time of the Hospira deal, I think you had projected that business would eventually flatten out because of growth in emerging markets, opportunities from the sterile injectable business, as well as biosimilars. But that doesn't seem to be panning out, is this business salvageable? Can it ever stop declining and then back start growing or is this just an anchor you're gonna have to deal with? Thanks very much.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you, Jamie. On the potential changes in distribution, all I would say is that any system of distribution that can cut costs and get a wide availability of products to patients is something that the whole industry would be interested in. Vis a vis, a distribution system going back into PDMS and adjudication, I think that's somewhat more of a difficult strategic proposal as it then enters in the whole issue of the world of insurers and PDMs, and siding on differential access, that's a whole different skill set. Regarding the Essential Health Business, I'll ask John to make his comments on that.
John B. Young -- President-Global Established Pharma Business
Yes. Thanks for your question Jamie.
Let me just reiterate what we've said in the past, which is we've always said that in the medium-term, we believe we can return the essential health business to low to mid-single growth. We didn't specifically put a timeline on that, but we framed that as being a three to four-year period. The reason that we believe that it was gonna take time was because of the headwind of L.O.E.s. Frank commented on that during his comments. Whilst for the corporation, the impact is moderating in 2017. We still have some headwinds, predominantly in the essential health business. In quarter three, just to quantify that, the total L.O.E. impact on the business in the quarter was around about $339 million due to just a range of products that have gone off patent or are experiencing generic competition. Pristiq, Lyrica, Relpax, Nitrostat, so on. The thing about those time-line events, however, is that by definition they will moderate. So that basic aspiration to return this business to be low to mid-single digit grower is something that we still retain. Just to break out the performance in the quarter for you Jamie while Pfizer Essential Health declined by 11% if you actually exclude the impact of the infusion systems business divestiture, and the impact of L.O.E.s, the business was actually flat in the quarter. I think while we are still on that path to recovery, I think we remain committed to, and actually very positive by the aspirations return this business to the growth profile that we've outlined in previous quarters.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, John. Next question, please?
Operator
Your next question comes from Seamus Mendes from Lyric.
Seamus Menendez -- Lyric -- Analyst
Thanks for the questions.
First question, Ian, and Frank. Can you guys comment on the structure that you think would really optimize the value for the consumer business? You guys have sold businesses in the past, but also, I think the Zoetis split was a great example of success. You've also done some creative combinations. I'm just trying to get a better sense of where you think the most value has really been added for shareholders in the context of those different decision points with Consumer. The second question really is, when we think about the opportunity in the IO space, would you guys please comment on clinical trials that could read out next year that you're most excited to see the results of? Thanks
Ian C. Read -- Chairman and Chief Executive Officer
Okay, I'll ask Frank to answer, give you our thoughts on the structure that would most likely optimize value, and then I'll ask Albert to talk about IO studies. Sorry, I'll ask Mikael how the IO studies are reading out.
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
So, Seamus, on structure, let me just start with obviously, we have a baseline view in terms of what we think that consumer business is worth based on. Obviously, our projections on future cash flows discounted back to their present value. In terms of structure, it's really what maximizes value. If you look at what we've done in the past, in terms of some of our larger divestments, we sold the Capsigel business, we sold the nutrition business, and then we split, to your point, the Zoetis business. When we were doing the Zoetis transaction, we were receiving incoming calls, had offers, but quite frankly, but didn't think those offers exceeded the value that we could get from a split. We went ahead, and we proceeded with a split. My short answer is, we will pursue the structure that best maximizes the value to our shareholders. Hopefully, our actions in the past have demonstrated that that's what we've done.
Ian C. Read -- Chairman and Chief Executive Officer
Mikael?
Mikael Dolsten -- President-Worldwide Research and Development
Thank you for your interest in our IO Portfolio. We actually have, together with our partner Merck AJ, a well-running IO Portfolio. We have 30 studies including nine in new pivotal indications and more than 6,300 patients enrolled. In the near-term readout from now toward '19, we have actually eight pivotal readouts starting quite soon with Gastrique Third Line, followed by, in '18, Lyme Second Line, Ovarian Second Line. As you come toward the end of '18 and into '19, real interesting studies in earlier lines such as kidney cancer, Pumba Bivencio and Leighton, Bivencio and Gastrique first line maintenance, in lung first line, bladder first line, ovarian first, chemo, Meyer, all in '19. In addition to those eight pivotal studies that can be registration enabling for us, we have a number of non-pivotal that can guide us to accelerate the programs. That includes late this year, and early next year IO combos with 41BB, followed by Bivencio with Oxford, which have here to date on Bivencio with Roletany and with also late next year, our triple combo will be part of this.
I would also like to say that we have beyond the checkpoint inhibitor, a very interesting vaccine opportunity where we have our prostate vaccines that will be followed by another vaccine going to human studies in the quite near future; that contains multiple vaccine components, plus PD1 lockade, plus CITALOR lockade, really interesting concept. Finally, beyond the IO you probably are aware that we have a very rich and vibrant oncology portfolio where we recently announced in our targeted portfolio positive data for extending Prosper. We have, in preparation for registration, plans around Dacomitinib, Loriatanib. We have soon readout of Telesepariab, and we have positive data on Glestigib which may make us engage in, also, ulcerative study. It's a very rich and quality pipeline where obviously, IO and Bivencios is an important piece. Thank you.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Mikael. We'll move to our next question, please?
Operator
Thank you, and we'll go next to Vamil Divan from Credit Suisse.
Vamil Divan -- Credit Suisse -- Analyst
Great. Thanks so much for taking my questions.
First, I just wanted to see if you could get a little more color on the impact of price in the U.S. on the quarter for the Innovative Health business as a whole, or at least some of the key products like IBRANCE, Lyrica, Eliquis, XELJANZ? And then my second question is also touching on Eliquis. Just curious there what your thoughts are? Have you seen positive data from Xarelto from the Compass study? They have some additional data coming from their lifecycle management program over the next few years. Do you see that data, in any way, impacting Eliquis' growth? Just curious, just looking back now, there's a very limited lifecycle management program around Eliquis, and I think it deserves some priding for such a large product? Is there anything that you and Bristol are doing in terms of trying to come up with new indications or somehow extend out that product beyond what it is right now? Thanks so much.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you. Frank, impact, price, and then Albert can discuss Eliquis.
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
Globally, all in. Total company price for the quarter was zero. In the U.S. it was +3%, that's for the quarter. If you go to year-to-date, so the nine-months cumulatively, same numbers. All in, enterprisewide, the total company globally, zero. In the U.S. +3%.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you. Eliquis, Albert.
Albert Bourla -- President Vaccines, Oncology, Consumer Healthcare
First of all, let me say that Eliquis had a phenomenal performance again this quarter, 43% professional growth for the quarter. The U.S. significant growth of 39% professional growth. It is the number one drug prescribed by specialists and primary care physicians.
To your question on data resemble, based on the direction that I'm going to say we'll see the potential impact of [inaudible] upon Eliquis business will be limited. First of call in the protocol exclusion of net and VAF base. The Rivaroxaban only arm did not meet efficacy imparts. The bleeding rates for both Rivaroxaban in the trial and the different dose on the Rivaroxaban, NBIF post. That being said, I want to emphasize that we cannot make comparisons to other studies, but we feel very confident on the growth projections that we have right now with Eliquis.
Charles E. Triano -- Senior Vice President of Investor Relations
Thank you. Next question, please, operator?
Operator
Thank you, and we'll go next to David Risinger from Morgan Stanley.
David Risinger -- Morgan Stanley -- Analyst
Thanks very much. I have two questions, first, could you please update us on the recent IPR developments on your pneumococcal vaccine patents through 2026, and the potential implications for Merck's 15 Valent vaccine or other potential pneumococcal vaccine competitors? And then second, could you just frame for us where IBRANCE X.U.S. rollout stands and whether you ultimately expect X.U.S. IBRANCE sales to eclipse the dollar revenue opportunity in the U.S. Thank you.
Ian C. Read -- Chairman and Chief Executive Officer
Doug, please. The IPO in the party review process.
Doug M. Lankler -- President-Executive Vice President & General Council
Sure. Thanks for the question, David.
We were very pleased to see the October 20th denial of Merck's inter parties review filings on two of our U.S. patents covering compositions of pneumococcal vaccines. These patents stand as valid and will not expire until 2026. We believe these patents, and others in our portfolio may present freedom to operate issues for Merck or anybody else trying to develop a pneumococcal vaccine. As Ian mentioned at the outset of the call, we have started Phase II trials for our next generation 20 Valent Pneumococcal Vaccine and have received fast track designation from the FDA.
Ian C. Read -- Chairman and Chief Executive Officer
Albert on IBRANCE.
Albert Bourla -- President Vaccines, Oncology, Consumer Healthcare
Yes, X.U.S. IBRANCE is performing very well, and we are very pleased. Let me focus on Europe right now. It is the best performing area because we also have the upcoming launch of Zapat, but it's not started yet. The early E.U. launch indicators show rapid IBRANCE adoption in the first line. This also strong adoption of IBRANCE in patients who were already treated with [inaudible] therapy. Also, in patients in later lines of therapy. We are having positive discussions with reimbursement bodies right now. Pricing and reimbursement process are ongoing across Europe in accordance with national procedures and timelines. We have already secured investment in several countries. We are in the middle of multiple negotiations, so I wouldn't like to speak more about that.
Our international sales were this quarter, $165 million. This is up 30% versus the previous quarter sequential of the second quarter. In Europe, particularly, the growth was even greater, 35% up versus the previous quarter. We see this trend continue as we are launching in other jurisdictions and as we are getting price reimbursement in Europe. As we are going, of course, to places like Japan.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you, Albert.
Charles E. Triano -- Senior Vice President of Investor Relations
Next question, please, operator?
Operator
Thank you, and we'll go next to Tim Anderson from Bernstein.
Timothy Anderson -- Bernstein -- Analyst
Thank you.
A couple of questions. On the lawsuit with J&J on Inflectra. If you don't win, do you think that would have broad negative ramifications to other future U.S. filed similar launches? And it would foretell a different future uptake profile in the U.S. My guess is that you'll answer that, yes, otherwise you wouldn't be suing unless you're suing for some other reason. The second question is going back to a question I've frequently asked in the past, your commitment to Evalimab, the reason for my question is pretty obvious, in the past, you've said you're committed. Some investors I've talked to claim that over the last couple of months management has said you'd be willing to upgrade your Anti-PD under the right circumstances. I'm wondering if you'd like to either confirm or deny that or maybe at a minimum just add some current color to the question.
Ian C. Read -- Chairman and Chief Executive Officer
Under the lawsuit, Tim, I think the lawsuit was taken because we strongly believe that the actions of J&J are not acceptable under the Anti-Trust litigation. More importantly, I think, the solution to this will come from a societal view on that bio-similars are there to provide access to patients once the patent has expired, and that enough is enough. You shouldn't be using contracting mechanisms to extend your exclusivity when society expects to get access to products once the patent is expired. We believe there will be quite rigorous debates within society, within CMS, how does the governmental systems accrue the benefits of biosimilars? So, we see it as both a legal strategy and a strategy of altering the policymakers that Europe is, obviously, benefiting from bio-similars, so why isn't the U.S.? Given that the law was passed to bio-similars readily available.
On Evalimab, we remain committed to our programs with our partner. Regarding any rumors you may or may not have heard, I really can't speculate on them. I've actually, I think, addressed a couple of questions from you on calls about our partnership with Merck, and I don't really think it would be helpful to add any more comments.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Ian. Next question, please?
Operator
Your next question comes from John Boris from Sun Trust.
John Boris -- Sun Trust -- Analyst
Thanks for taking the questions, and congrats on the quarter.
The first question for Frank, I know you haven't outlined 2018 guidance, but can you maybe walk us through qualitatively some of the headwinds and tailwinds are that you're expecting for 18 that might impact or shape our models? Second question, on the Established Health Business, on some of the smaller companies we've seen multi-source competition being accelerated by A&DA approvals on injectables. Are you seeing an increased number of ANDAs being approved across injectable and is that having an impact on pricing? The third question on IBRANCE, in Europe, in particular, in markets where you have to negotiate pricing, are you recording any deferred revenues for revenue recognition purposes that might show up in 4Q or 2018? That should do it for the questions. Thanks.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you, John, On IBRANCE the answer is no. We continue to sell IBRANCE under our traditional model of selling and booking sales when you make them. On the Essential Business, perhaps John could make some comments?
John B. Young -- President-Global Established Pharma Business
Yeah. So, John, I think the FDA has been very clear about the perspective that they have that they believe that competition is the most important factor in being able to reduce healthcare costs. That's actually a position that Pfizer has long supported, we believe in a competitive marketplace, and we also believe that the availability of timely approval of generic alternatives is as critical to patient access in the long-term sustainability of the healthcare system.
We manufacture and commercialize a number of products, and the FDA published an off-patent pharmaceutical product with limited or no competition to date. We do anticipate that certain products on that list that we currently commercialize could face competition from additional manufacturers over the next several years. All that said, we also are currently exploring opportunities to bring to market certain other products on the list, which Pfizer could have the manufacturing capability and capacity to produce reliably. The FDA has been very clear about their perspective in this space; it's a competitive market space and one that we expect to remain so.
Ian C. Read -- Chairman and Chief Executive Officer
I would add that the requirements from the FDA and the European Union on manufacturing sterile injectables continue to increase and ensures that any competitor that needs to have robust, good manufacturing practices, which is also positive for patients.
Frank on with models.
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
So, John, we'll give detailed guidance for 2018 on our next earnings call as we always do when we close out the fiscal year. We'll close out '17, and then we'll provide guidance on '18. In terms of, you mentioned headwinds and tailwinds, the way I'll do this, I think, is maybe the rhythm of the revenue. We'll have L.O.E.s next year, our current estimate on L.O.E.s is about $2 billion, that'll be a headwind. In terms of tailwinds, we continue to expect new products like IBRANCE, Eliquis, and XELJANZ to perform very nicely. Our recently acquired products like XTANDI and Eucrisa, we expect to perform very nicely in emerging markets. If you look at emerging markets for the quarter up 11%, year-to-date up 9%. We continue to expect those areas of the business to perform well. Bio-similars, this quarter up 67% on a quarter-over-quarter basis. Lots of areas where we expect to see continued growth going forward, we'll give details on guidance on the next call.
Charles E. Triano -- Senior Vice President of Investor Relations
Thank you, Frank. We'll take your next question, please?
Operator
Thank you, and we'll go next to Richard Perkins from Piper Jaffray.
Richard Perkins -- Piper Jaffray -- Analyst
Thanks. I have two quick questions.
Firstly, on XELJANZ, how much interest are you getting from rheumatologists and gastroenterologists on the prospects of its approval in psoriatic arthritis and ulcerative colitis? Also, I noticed you JAK I, you presented data in atopic dermatitis, can you just give us some color on how it compares to other JAK inhibitors in that space? Thanks very much.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you, Richard. Of course, on XELJANZ, we don't do any remarketing activities on indications that have been approved. But, in discussions with experts who advise us, we think it is a competitive profile in both of those conditions. On the JAK I will ask Mikael to add some commentary.
Mikael Dolsten -- President-Worldwide Research and Development
Thank you for your interest in JAK I. We shared data recently at the EADB Conference in Europe. Obviously, there has been another JAK I, that together define the JAK I class performance in atopic dermatitis. On the efficacy side, we shared that it was a very impressive number of patients reached cleared, or almost cleared skin lesions, about 45% in that range. What is very interesting with this class, is that it has a rapid onset of action. Within a few weeks you see improvement, and between week four and six, you have reached a very significant part of the maximal effect. Atopic dermatitis patients suffer, particularly, from pruritis itch. I think this is really unique in the JAK I clause and was evident in our study that already, two days, I repeat two days, of the initiation of therapy you could see itch relief, and then within two weeks, it has reached real impactful effect and plateaued at 64%. Got very substantial itch relief. To the best of my knowledge, there hasn't been any reported drug or recently approved drug that has had such favorable rapid onset which is critical for these patients. Thank you for your interest.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Mikael. Next question, please?
Operator
Your next question comes from Steve Scala from COWEN.
Steve Scala -- COWEN -- Analyst
Thank you. I have a few questions.
I think the sale of Pfizer Consumer to J&J a decade ago was viewed as at a great price but in retrospect a strategic mistake for Pfizer. Would you agree with that characterization? And why is it different now? Second, regarding XTANDI in the Prosper trial, the release says Pfizer will discuss the results with health authorities. Given the positive study, what is there to discuss as opposed to just filing outright? Lastly, I appreciate that it is completely in line with background rate, but there are about 40 DVTs, or PEs reported in XELJANZ studies. Has Pfizer looked at whether these patients were also on Celebrex or other COX-II inhibitors? If you have, what did it show? Thank you very much.
Ian C. Read -- Chairman and Chief Executive Officer
Steve, thank you.
I'm not sure that your general characterization of the J&J deal is accurate, but that's something that's in the past. We make decisions on the future dispositions based on the facts we see today and the opportunities we see today. We believe it is well worth exploring the strategic alternatives for that business. Vis a vis, Prosper..., Yeah, would you please?
Mikael Dolsten -- President-Worldwide Research and Development
Steve, I want to be clear, we were delighted with the Prosper because of the Brine Reports but came two years earlier than anticipated. We are looking forward to disclosing detailed results at an upcoming major medical congress. Given the nature of the daypack and the importance of the claim, we have resourced very well the teams preparing the dossier, and we expect to file soon.
Concerning XELJANZ, first of all, as you know, it's been performing excellently. It's been prescribed to more than 100,000 patients worldwide, and we had an advisory committee recently for expansion into psoriatic arthritis and got an overwhelmingly positive vote the efficacy and safety profile. Concerning specifically thromboembolic events we have, of course, carefully looked at XELJANZ both in clinical studies comparing XELJANZ to control group, as well as in registers and how it's performed in the market. We do not see any difference between XELJANZ treated, or other treatment of rheumatoid arthritis patients. We are aware that there have been some competitors reports of some of their compounds in this phase, but we do not see any issues with XELJANZ at all in all our different analysis where the clinical registers on the use of the drug in the market. We are very pleased with the profile of XELJANZ as it stands.
Charles E. Triano -- Senior Vice President of Investor Relations
Thank you, Mikael. Next question, please?
Operator
Your next question comes from Alex Arfaei from BMO.
Alex Arfaei -- BMO Capital Markets -- Analyst
Good morning, folks. Thank you for taking the questions.
I have three, if I may. First, following up on XELJANZ X.U.S., could you please comment on how we should think about the uptake there relative to the strong growth that we're seeing in the U.S. Second, on Eucrisa, I think it's fair to say that the launch is slower than expected. Is the outlook for that product still peak sales of 2 billion even with the JAK I's emerging as competition? Third, on Hospira Sterile Injectables, I think Frank you said supply challenges lead to sales being several hundred million lower. If that reflects demand is it fair to say that most of that should come back in 2018 as you addressed those shortages? Thank you.
Ian C. Read -- Chairman and Chief Executive Officer
Albert, could you address the XELJANZ X.U.S. and the Eucrisa performance.
Albert Bourla -- President Vaccines, Oncology, Consumer Healthcare
Let me start X.U.S. with Europe. We are very pleased with the performance in Europe. The XELJANZ can be given as monotherapy in case of intolerance to methotrexate, or when treatment with methotrexate is inappropriate. So far, we have launched in nine markets, and those include U.K., Netherlands, Sweden, but we do not have pricing negotiations completed with the rest. We think that the uptake in XELJANZ is based on our initial interactions with physicians will be very strong in Europe.
Now, let me go back to Eucrisa. First of all, let me start, yes, we think that will be a 2 billion plus product. We are very excited with the progress. In the third-quarter, we almost doubled the number of patients versus the previous quarter, the second-quarter. As Ian said, we have 83,000, and the product has been prescribed by more than 20,000 physicians. The majority of them, 60% of them are repeaters. We have 90% of commercial lives that have removed the NDC block which is very, very good. They're now covering Eucrisa. However, at this moment, only approximately 50% of the commercial lives have unrestricted access or require one electronic stamp, some require more. They're working very hard to revisit those.
Also, I need to emphasize that the net sales, they saw significant sampling and couponing which was introduced to launch and drive success. The free-trial voucher has now expired; however, we have a standard co-pay that continues to be supporting patient's affordability.
Ian C. Read -- Chairman and Chief Executive Officer
I think the JAK I marketplace is different from the topical Eucrisa marketplace, and they're, appropriately, medically segmented giving opportunities for both products.
Albert Bourla -- President Vaccines, Oncology, Consumer Healthcare
Very different, and very different profile. With Eucrisa having a benign profile in terms of safety and can be given to kids as young as two-years-old.
Ian C. Read -- Chairman and Chief Executive Officer
Thank you. Frank, please.
Frank A. D'Amelio -- Chief Financial Officer and EVP Business Operations
Alex, John mentioned that the Hospira remediation efforts in the Legacy Hospira Manufacturing Facilities are taking a little bit longer to remediate than we thought. However, we believe that the end of 2018 will substantially complete those. As a result, we expect that several hundred million in 2017 to moderate in 2018, which means we'll be lower in 2018 than 2017.
Charles E. Triano -- Senior Vice President of Investor Relations
Thanks, Frank. Next question, please?
Operator
Your next question comes from Mark Goodman from UBS.
Mark Goodman -- UBS -- Analyst
Yes, Mikael, I was hoping you could give us some highlights on some of the key products in the pipeline that have moved into clinical studies, maybe into Phase II and stuff. I saw there was a Nash drug that moved in there. Maybe you can talk about that a little bit and then also provide us an update on Tenusinab, when are we gonna see the first pivotal study?
Ian C. Read -- Chairman and Chief Executive Officer
Good questions, Mark. Mikael?
Mikael Dolsten -- President-Worldwide Research and Development
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