Ladies and gentlemen, thank you for standing by. Welcome to the Q3 2017 Earnings Conference Call. At this time, telephone lines are in a listen only mode. Later, there will be an opportunity for questions and answers with instructions given at that time. And as a reminder, today's conference call is being recorded.
I would now like to turn the conference call over to your first speaker, Dave Ricks. Please go ahead.
Good morning. Thank you for joining us for Eli Lilly and Company's Q3 2017 earnings call. I'm Dave Ricks, Lilly's Chairman and CEO.
Joining me
on the call today are Derica Rice, our Chief Financial Officer Josh Smiley, currently our Treasurer and the CFO elect Doctor. Jan Lundberg, President of Lilly Research Laboratories Enrique Canterno, President of Lilly Diabetes and Lilly USA Doctor. Suma Hone, President of Lilly Oncology Christy Shaw, President of Lilly Biomedicines and Jeff Simmons, President of Elanco Animal Health. We're also joined by Christina Wright, Chris Ogden and Phil Johnson of the IR team. This will be the last earnings call for 2 senior executives that have been instrumental in our company's success.
At the end of the year, Maria Crowe, President of Manufacturing Operations and Derica Rice, our CFO will retire. Maria has helped Lilly earn the trust of patients we serve by making medicines with the highest levels of quality and safety. Derica played a key role in leading Lilly through the challenging period of patent expirations we called years YZ and emerging as a much stronger company. Both have built strong organizations that will carry on their work. So beginning here, please join me in a round of applause to thank both of them for their contributions to our company.
During this conference call, we anticipate making projections and forward looking statements based on our current expectations. Our actual results could differ materially due to a number of factors, including those listed on Slide 3 and those outlined in our latest forms 10 ks and 10 Q filed with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and it's not sufficient for prescribing decisions. In Q3, we generated worldwide revenue growth of 9%, driven by volume growth in our human pharmaceutical business, once again led by our newest products.
I'd also highlight the outstanding performance of our diabetes products, which in total grew 39% this quarter. We also continue to expand our margins, including the effect of foreign exchange excluding the effects of foreign exchange on international inventory sold, gross margin as a percent of revenue increased by over 70 basis points. And total operating expenses as a percent of revenue declined by over 310 basis points to 50.8%. Our pipeline progress continued. Highlights include the FDA approved and we launched Verzenio, the U.
S. Trade name for abemaciclib for advanced breast cancer based on the MONARCH-1 and MONARCH-two trials. We submitted the BLA for galkanezumab for migraine prevention and we initiated the Phase III program for our ultra rapid insulin. In terms of capital deployment, we entered into a global immuno oncology collaboration with CureVac AG, focused on the development and commercialization of up to 5 cancer vaccine products based on CureVac's RNA active technology. And we returned over $500,000,000 to our shareholders through our dividend.
In other news, we received an important ruling upholding our Alimta method of use patent in the U. S. IPR proceeding. If upheld through all remaining challenges, Alimta would maintain U. S.
Exclusivity until May of 2022. Our performance Slides 56 contain more details on these events as well as other key events since our July earnings call. I'd highlight that we've submitted abemaciclib for advanced breast cancer in Europe and Japan, and the U. S. FDA granted a priority review designation for the abemaciclib MONARCH III NDA.
Along with Incyte, we announced that the NDA for baricitinib in RA will be resubmitted before the end of January 2018. After further discussions with the FDA, we've also submitted the sNDA to include the KEYNOTE 021 gs data in the OLYMPTA label. We announced a series of actions to accelerate our efforts to focus our resources on developing new medicines and improve our cost structure. And earlier this morning, we announced that we are reviewing strategic alternatives for our Elanco Animal Health business, including an IPO, a merger, sale or retaining the business. Moving to our financial results, Slide 7 summarizes our presentation of GAAP results and non GAAP measures, while Slide 8 provides a summary of our GAAP results.
I'll focus my comments on our non GAAP adjusted measures to provide insight into the underlying trends in our business. So please refer to today's earnings press release for the detailed description of the year on year changes in our Q3 GAAP results. Looking at the non GAAP measures on Slide 9, you can see the revenue increase of 9% that I mentioned earlier. Gross margin as a percent of revenue decreased to 75.1%. This decrease was primarily driven by the effect of foreign exchange rate on international inventories sold and negative product mix, partially offset by manufacturing efficiencies.
Excluding the effect of FX on international inventory sold, gross margin as a percent of revenue increased by over 70 basis points. Total operating expenses increased 3% with marketing, selling administrative expenses decreasing 1% and R and D expenses increasing 7%. As mentioned earlier, as a percent of revenue, OpEx declined by over 3 10 basis points. The decrease in marketing, selling and administrative expenses was driven by lower spending on late lifecycle products, partially offset by higher spending on our new products. The increase in R and D expenses was driven by a milestone payment related to the base inhibitor we're developing in collaboration with AstraZeneca and to a lesser extent, higher late stage clinical development costs.
Other income and expense was an expense of $14,000,000 this quarter compared to income of $27,000,000 in last year's quarter. Our tax rate was 18.9%, a decrease of 3 10 basis points compared to the same quarter last year, primarily driven by a net discrete tax benefit this quarter of approximately $30,000,000 At the bottom line, net income and earnings per share both increased 19%. We achieved the significant earnings growth by delivering high single digit volume based revenue growth, while significantly reducing our OpEx ratio, creating positive leverage. Slide 10 details the same non GAAP measures for September year to date, while Slide 11 provides a reconciliation between reported and non GAAP EPS. You'll find additional details on these adjustments on Slide 24 and Slide 25.
Moving to Slide 12, let's take a look at the effect of price, rate and volume on revenue growth. Effective foreign exchange was minimal this quarter. Excluding the slight headwind from FX, our worldwide revenue growth on a performance basis was 9% and was driven by volume, a much lesser extent by price. It's worth noting that in our human pharma business, each major geographies drove volume growth again this quarter. By geography, you'll notice that U.
S. Pharma revenue increased 10%, primarily driven by volume. Trulicity, Basaglar and Talt were the main drivers of this growth, with recent loss of exclusivity leading to large volume declines for both Strattera and Effion. It's also worth noting that last year's Q3 included $145,000,000 benefit from a Cymbalta returns reserve reversal. Excluding this from the base period, our U.
S. Product growth was 17%. Moving to Europe, pharma revenue grew 7%, excluding FX, driven almost entirely by volume despite headwinds on Alimta due to generic erosion in certain countries as well as competitive and pricing pressures. Excluding Alemta, the rest of our European pharma revenue grew 13% on a performance basis. This was led by Trulicity.
In Japan, despite a large negative impact from the entry of generic ZYPREXTA last June, pharma revenue increased 13%, excluding FX. Excluding Vyprexa, the rest of our Japan pharma revenue grew 17% in performance terms this quarter, led by Cyramza, Cymbalta and Trulicity. Our pharma revenue in the rest of the world increased 9% on a performance basis this quarter, led by Humalog and Trulicity. Turning to Animal Health, excluding the impact of FX, worldwide revenue increased 4% driven by volume. Food animal product revenue declined by 7%, while companion animal product revenue increased 34%.
On a performance basis, excluding the BI U. S. Vaccines acquisition and adjusting for last year's purchasing patterns, our Animal Health revenue decreased 10% with food animal product revenue down 7% and companion animal product revenue down 17%. The food animal decline was driven primarily by market access pressure as well as by competitive pressure in U. S.
Cattle, while the companion animal decline was due to competitive pressures affecting Trifexis, our flea, heartworm and intestinal parasite product. Slide 13 outlines the same information for our September year to date results. Now let's look at the drivers of our worldwide volume growth on Slide 14. In total, our new products comprised of Trulicity, Vazalore, Taltz, Jardiance, Lartruvo, Ceramza, Olumiant and Fortraza were the engine of our worldwide volume growth. You can see that these products drove 13.7 percentage points of volume growth quarter over the same quarter last year.
While the loss of exclusivity for Cymbalta, Proterra, Effient, Axuron, DYPREXTA and Avista provided a drag of 610 basis points. Slide 15 provides a view of our new product uptake. In total, these brands generated over $1,200,000,000 in revenue this quarter and now represent nearly 22% of our total worldwide revenue, up from just 18% last quarter. Moving to Slide 16, as I mentioned earlier, changes in foreign exchange rates had essentially no effect on our Q3 2017 revenue growth. Similarly, FX had no meaningful impact on our operating expense growth.
FX did, however, have a large effect on growth in cost of sales and consequently in operating income and EPS. For example, growth in non GAAP EPS was 19%, including the effect of foreign exchange and 30% in constant currency terms. This is consistent with the 28% growth we've seen year to date. Now I'll turn the call over to Derica for review of our overall corporate pipeline, progress on potential key events and an update on our 2017 financial guidance.
Thanks, Dave. Slide 17 shows select NMEs as of October 17. Movement since our last earnings calls include the U. S. Approval of vimeciclib for advanced breast cancer, the U.
S. Submission of dalconizumab for migraine prevention, the initiation of Phase 3 for our ultra rapid acting insulin, the addition of a Phase 1 immunology asset from our recent collaboration with Nektar Therapeutics and termination of development of 2 Phase 1 assets. Our select Nylex pipeline shown on Slide 18 reflects the 3 and 4.5 milligram dulaglutide study and the negative outcome of the abemaciclib lung cancer study JUNIPER. Turning to Slide 19, you can see the considerable progress we've made on the key events we projected for 2017. Dave and I have already mentioned many of the key events that occurred since our last earnings call.
So I'll simply comment on just one change. Following the positive data presented at EADV, we now expect to begin the Phase 3 program for baricitinib in atopic dermatitis before the end of this year. Turning to our 2017 financial guidance on Slide 20, you will see that we've raised and narrowed the range for revenue to $22,400,000,000 to $22,700,000,000 primarily due to the uptake trends we're seeing for our new pharmaceutical products and to a lesser extent to a stronger euro. We've also narrowed the range for full year R and D expense to a range of $5,100,000,000 to $5,200,000,000 We've decreased our GAAP and non GAAP tax rate to reflect the tax effect of this quarter's business development and restructuring charges, as well as the discrete tax benefit mentioned earlier. For EPS, we've raised our non GAAP EPS range by 0 point 0 $5 to $4.15 to $4.25 per share and we've reduced our GAAP EPS range to $1.73 to $1.83 per share.
Before we go to the Q and A session, let me briefly sum up. We've delivered another strong quarter in Q3. Led by our new products, worldwide revenue grew 9%. By making disciplined investments in our business, we leverage our top line growth into 19% non GAAP EPS growth or 30% growth when excluding FX. We continue to have strong momentum behind our innovation based strategy.
Since our last earnings call, we received U. S. Approval for and launched Verzenio. We submitted Galconizumab for migraine prevention here in the U. S.
We started Phase 3 for our next generation Mill Time Insulin and we bolstered our pipeline with the CureVac deal. We also announced actions to focus our resources on developing new medicines and to improve the company's cost structure, as well as the review of strategic alternatives for our Elanco Animal Health business. Going forward, our management team will remain focused on launching new products with excellence, reloading our late stage pipeline, driving increased productivity to expand our operating margins and investing in our core drivers of our business, talent, scientific capabilities and technology platforms to ensure our future growth prospects. This concludes our prepared remarks. Now I'll turn the call over to Phil to moderate the Q and A session.
Phil?
Thank you, Derica. We would like to take questions from as many callers as possible. So we do ask that you limit your questions to 2 or one 2 part question. Now, Alan, if you can go ahead and provide the instructions for the Q and A session, we're ready for the first caller.
Absolutely. First question will come from the line of Tim Anderson with Bernstein. Go ahead please. One moment.
Thank you. On Trulicity, an important growth driver, you guys called it out, a major future growth driver. I'm wondering if you can just give us your thoughts on the curve of that product as you go into 2018 as you are facing new branded competition from Novo's weekly product, you've had some compelling head to head data. I'm wondering how you think that might impact your product. And equally importantly, they have their oral GLP-one, we have several Phase 3 readouts coming in 2018.
And I'm wondering if you can give us your opinion of the viability of that program. It seems that if they had a good clinical profile that could be problematic for injectable GLP-1s or do you think the clinical profile of that product will in fact be problematic? And then on Humalog, no biosimilar yet approved. You guys have I think a patent that you could potentially assert and leverage into a delay or maybe a settlement with Sanofi? Can you give us any update there?
Great. Tim, thank you for the question. So Enrique, we'll go to you for the questions on Trulicity heading into 2018 with new branded competition coming and thoughts on the oral GLP-one space. And then we do have our General Counsel, Mike Harrington with us. So Mike, if you'd like to give the update on litigation with Sanofi.
Enrique? Well, thank you for the question. And indeed Trulicity is having a terrific year. It's a unique time when it comes to innovation in diabetes. And let me try to maybe frame some comments and provide some color as we think about Trulicity going forward.
I will not provide an outlook for the product, but some things to think about. The biggest opportunity for Trulicity is when we think about this class is that and when we look at injectables, GLP-1s as a class still represent less than 30% of the basal insulin prescriptions. We see significant benefit when it comes to the GLP-one class. So the opportunity for growth is very significant. Trulicity has an enviable position in this market, by the benefit that it basically offers when it comes to the real world efficacy of the product.
Of course, the ones weekly dosing and we have a single dose spend that is ready to use and does not require basically managing or seeing the needle, which is so important for a patient that is transitioning in many cases from an oral medicine. Now clearly we do have competition, yes. But I think what we have to keep in mind too is that the competition is also going to help fuel the overall growth of the class. The class has very healthy growth and we expect that that's going to be a continued catalyst for Trulicity as we think about the growth of the class and the type of position that we have in the market. Our trends continue to be very solid for the product.
Clearly, when it comes to CEMA, we'd like to see all of their data when it comes to sustained 7, but we feel good about the position that we basically have when we look at both the combination of our efficacy and the safety profile that our product offers. You asked about oral GLP-1s that is an area of interest to us. We do see that in the innovation space as important, but we need to wait for all of their data to basically come out before I can make more comments. And then I believe that Mike is going to comment on Chemoloc.
Thanks Tim for your question. The deadline under the Hatch Waxman Act for Lilly to challenge Sanofi has expired and we have not filed suit to challenge their follow on biosimilar. As you know, Tim, the Hatch Waxman Act notice remaining Orange Book listed patent that we have that is The only remaining Orange Book listed patent that we have that is relevant to this discussion protects our QuickPen delivery device. And we have thoroughly analyzed both the Sanofi device and our own device. Lilly's QuickPen is an innovative device that offers a number of advantages for patients, but for purposes of analyzing the patents, it's a fundamentally different device than the Sanofi pen that they intend to use with their follow on Lispro.
We always vigorously defend our intellectual property and we'll continue to do so aggressively, but we don't engage in litigation to enforce patents unless there is a factual and legal basis to do so. And here, we didn't have a factual and legal basis to support litigation.
Great. Mike, thank you for the update. Alan, if we can go to the next caller, please.
Sure. That will be from Dave Risinger with Morgan Stanley. Go ahead, please. Mr. Reisinger, your line is open.
Sorry. My apologies. I had it on mute. So thanks very much for taking my questions. My first question is with respect to
the Animal Health
business. So you've announced that you're exploring strategic alternatives. Could you just provide a little bit more color on the timing, why now? I know that this is something you've contemplated for years, but the business' organic growth hasn't been inspiring recently. And so it'd be helpful for you to just provide a little bit more color about why now and how you see the businesses organic growth prospects going forward?
And then second, with respect to Forteo, I believe there may potentially be generic entry in the U. S. And Europe in 2019, but it would be helpful to get your perspective on how investors should think about the generic threat to Forteo in 2019. Thank you.
Hey, Dave. Thank you for the questions. So Dave Ricks, if we can have you answer the question on the alternatives are being explored and timing for the length of the health review. And then Christy, if you want to comment on the outlook for Forteo post generic entry.
Great. Thanks, Dave. Rather than touch on the short term operational things, we may get other calls on that. And it is true, we've had some challenges in the business this year. We don't look at the question of how we should position Elanco in the short term.
We think of it as the long term and we've been as you point out asked this question for a long time. It's a natural one to ask. What I think where we think we are now, why now is over the last many years we've grown this business rather substantially through acquisition, but also through our own organic actions. And we now have a global business that's highly competitive. It's a top tier animal health business amongst the top 5 globally and we participate in all the relevant segments of animal health.
Most recently, combining BI's vaccine business in North America coupled with Novartis, and it's taken some work to fully operationalize and get those companies pulled together in a way that we think this company is poised to compete effectively and really grow aggressively ahead. And so now is a good time, having completed those acquisitions and scaled the business to reflect on the best posture for Elanco Animal Health. And as we said today, we're exploring options. We expect to be able to get back to investors by mid-twenty 18 with the results of our analysis and the full range of options are in scope, keeping the business, IPO or spin or perhaps some other combination that we might determine is the best way to maximize the value to Lilly shareholders. So we'll follow-up with you as that process progresses, but we think this is a good time to step back and look at this question.
Thanks, Dave. Christy?
Yes. On the Forteo question, we continue to be very pleased with the performance of Forteo and the data continues to support how strong it is in the fracture prevention and treatment. And so as we look at Forteo in the future, we do have the same estimate as you do, which is the expiration of the patent being in 2019 and that's across U. S, Major Europe and Japan. Obviously, it is difficult to make Forteo, it's not easy.
So that will really be the question mark. But our estimates are that 2019 is when we'll lose that intellectual property protection.
Great. Thank you, Christy. Alan, if we can go to Thanks, Howard. Welcome. Alan, next caller please.
Sir, that will come from the line of Andrew Baum with Citi. Go ahead, please.
Thanks for the question. I'm surprised that you haven't used your balance sheet for more than $1,000,000
Andrew? It's very low volume and it's cutting it out, is it?
Is there
any better?
Terrific. So I was saying I'm surprised that I haven't seen Lilly use their balance sheet for any more substantial business development within oncology given the reshaping of the business. Could you just maybe share a little bit of color? Is that a question of the bid ask spread? Is it available assets?
Is it clinical data needs to be turned over? What is potentially delaying that? And second, the relative performance of Taltz versus your competitor Cosentyx, especially in the last quarter would seem to disfavor Lilly. Could you outline what are the end market dynamics that are driving this as a disproportionate marketing and how you're thinking about adjusting going forwards?
Great. Andrew, thank you for the questions. Derica, if you'll address the question on using our balance sheet for business development in oncology and any impediments we're seeing to actioning that? And then Christy to comment on dynamics with Taltz and Cosentyx in that market.
Derek? Sure. Hi, Andrew. Good morning. We have no apprehension or reservations about using our business, our balance sheet to pursue our therapeutic goals, whether it's in oncology or across our other therapeutic segments in which we compete.
And we do continuously look at the market place for external asset opportunities that we'd like to pursue. Most recently, you've seen just this year 3 deals in the area of oncology. Now all of those are early stage deals and that's by design, that's the area that we've chosen to focus on. If we can find late stage assets like we did with Colucid at the beginning of this year, we'll pursue that as well. In regards to market prices, oncology is still very expensive real estate.
And one of the things we have to make sure that we do in protecting our shareholders is
that we do good diligence
on those opportunities we look at. And sometimes it is tough finding value and some of the assets at the market prices at which they're being touted. So that's something we've been cognizant of and that's why we've chosen to go look to go earlier rather than later if we can.
Great. Thanks, Derica. Christi?
Yes. Andrew, so on Taltz, we continue to be very pleased with the performance of Taltz, especially as we see patients with clear skin. And as you look at the dermatology office, defining our competitors really is not the IL-seventeen versus the IL-seventeen. What you see is really the TNFs under really not reaching that clear status. And the more we have new agents like the IL-17s and the newer agents that are coming out, the more that we'll see the expectations of both physicians and patients increase.
A couple of those details for you on what you're seeing in the numbers. If you look at the data, there's a couple of things. One is Cosentyx has added free goods to their NBRx data. So IMS tells us there's a lot of volatility in that data and it will take weeks for that to or maybe even months for that to actually level out. So what we're looking at is actually the net sales.
And if you look at net sales in the U. S. In the dermatology office, we are performing the same as Cosentyx was at the same period of time, which is pretty remarkable for a second entry into the market. And usually if you got 80%, that would be great, but for us to be able to do that. So we continue to feel very good about it.
The other thing to note is we do see seasonality in the summertime. So as you look at it specifically in the dermatology office with psoriasis, that's where you'll see the seasonality. You don't see that with psoriatic arthritis or ankylosing spondylitis. So that is another thing that's kind of clouding the numbers as you see the seasonality more affect our numbers because we're rolling the derm office right now. And then as you look into the future, we're very excited to hear from the FDA by the end of the year, which as we continue to see the breadth and depth of prescribers continue to increase, We see our early adopters increasing their number of prescriptions.
We see more physicians trying Taltz with the psoriatic arthritis launch and our entry into the rheumatology office in December January, given FDA approval, we should see another step level increase in Taltz. So we're very confident and continue to believe in the Taltz performance.
Great. Thank you, Christy. Alan, if we can go to the next caller, please.
That will be from Jamie Rubin with Goldman Sachs. Go ahead, please.
Thank you. Just a couple of follow-up questions. First on Dalenenko, can you remind us, Dave, what the operating margin is on that business? I seem to recall that's a lower margin business than your base business, but your overall operating margins at around 22% or so are well below the industry average. So if you contemplate spinning that business or selling that business, can you talk sort of generally about what impact you would see that having on your overall margins?
And then secondly, just given the opportunity to take advantage of the risk of the PE arbitrage given where Zoetis is trading, what do you think you will do with those proceeds? And
just if
I can ask a question about the cost cutting announcement that you made a couple of months ago, the 3,500 positions that you are reducing, that has generated some debate among investors regarding your confidence and your ability to hit your sort of mid single digit top line growth projection over the intermediate term. Can you shed a little bit of light on the reasons for the additional cost cutting program. I know that should lead to an improvement in operating margins. But should we think of this as an insurance policy against the top line growth opportunity? Or is this or should we look at this as above and beyond what the company expects to perform going forward?
Thanks very much.
Jamie, thank you for the question. If I can, I'm going to reorder our answers just to sort of get the flow going here. So Dave, if you wouldn't mind handling the head reduction question, the last one Jamie had first.
You're going
to provide any comments on Elanco margins then? Jeff, feel free to complement that answer if you'd like and a little bit to Derica for the question around use of proceeds, if we are having transactions yielding proceeds in the future. Dave?
Sure. Yes, thanks, Jamie. Use the Dow Elanco name, that's harkening back to the old days. It's just Elanco now. But I appreciate the questions.
Let me on the cost cutting, so we announced this in early September. This has no relation to our belief about the revenue line, just to be clear. What we're looking at is looking beyond our what we've long held out this 2018 target of 15% operating expense as a percent of sales. And we've said for some time qualitatively that, that was a stepping stone on the way to a more productive higher operating margin company. These actions put us further down that road.
That's how I would think of them, both to become more competitive with our operating margins, but also to free up cash flow and operating expense capacity to invest in R and D. We see a number of late stage projects that have read out positively more than we expected. They're now launching, but we need to invest behind those with important new indications and other uses like Verzenio in adjuvant setting like Olumiant and atopic dermatitis like we spoke about today. So that's what it's for. It's about our quest to become even stronger for the future, nothing to do with our conviction on the 5% revenue growth, which I remind investors we did 9% again this quarter.
So we continue to trend above that CAGR we committed to. And although we know 2018 will be facing some more generic events, we're very confident on the 5% by 2020. So with that, let me turn it over to Jeff on the Elanco operating margin story. We can compare that to Lilly afterward and Derek can comment on the balance sheet.
Yes. So Jamie, just on our margin, as we've shared pretty openly with as we've come through the integrations of Novartis as well as Lohman and now BI, we've been hovering around 20% for the past 2 years. We feel good about our not only this assessment, but our strategy going forward on our margin expansion opportunities as we've been pretty open about. And we've got a pretty aggressive agenda. We announced 2 events this quarter that are part of that agenda that is well underway.
And the first was our consolidation of our large Wood Iowa manufacturing facility into our Fort Dodge, the BI acquisition facility, as well as we're seeking options for our BST. The 2 big drivers that give us this current state is no question some
of the forces in the lower sales and
the other is product mix. And we are working aggressively not only to drive these margins closer, as we've said, to the 30% over time. That will not happen here in the short term, but over time, that will happen by both the margin expansion productivity agenda as well as the innovation that drives our product mix change.
Thanks, Jeff. Derica?
Jamie, in regards to potential proceeds, we haven't gotten that far in our thinking. Right now, what we're really focused on is what's the best path forward in terms of maximizing the value of the Animal Health asset on behalf of the Lilly shareholders. And as Dave highlighted, we'll look at that full array of options before us. That having been said, even back to the earlier question that Andrew asked, we have the balance sheet capacity today to pursue the types of opportunities that we're interested in. So, while we're contemplating, these strategic alternatives for Elanco, it is not inhibiting us or preventing us from moving forward with our current organic and inorganic strategy in terms of assets we want to pursue.
So we're still moving full speed ahead. And as Dave highlighted earlier, back to your 5%, over the last 3 years, and recall when we gave the guidance in 2015, we've averaged in terms of top line growth somewhere between 7% to 9% in each year. And this year, as Dave said, we're tracking towards 9% growth. So we're very confident that we can beat that minimum threshold of 5% for the decade, which take us out through 2020, and we think we're actually well on track to achieve that.
Thanks, Derica. Jamie, thanks for the questions. Alan, if we can go to the next caller, please.
Yes, sir. That will come from the line of Umer Raffat with Evercore. Please go ahead.
Hi, guys. Thank you so much for taking my question. I wanted to focus on a couple of things. 1, on baricitinib perhaps. Just curious what your confidence is on the 4 milligram dose in particular?
And then secondly, just touching up again on lithpro. A, can you confirm and I heard the prior comments, but can you confirm that there is no settlement at present between you and Sanofi on the LIFFRO launch? And then also how do you think about LIFFRO launch? And in theory, how should or shouldn't it be different than VASAKLAR versus Lantus? Thank you.
Great. Umer, thank you for the question. I assume with the 4 milligram, you're referring to the ongoing review at the FDA for our rheumatoid arthritis application. Is that correct?
Correct.
Okay. So Christy, we'll go to you for the question on the baricitinib 4 milligram. Mike Harrington, if you'd like to comment on whether or not there's any kind of settlement with Sanofi? And then Enrique for the dynamics that people might think about for the launch of Lifespro whenever that occurs here in the future. Christy?
So I think it's important as we discuss the 4 milligrams of baricitinib to see, well, how is it doing where we are commercializing the 4 milligrams. As we look at Europe, for example, but but as you look at the 5 months in which it's been available, it has exceeded every rheumatoid arthritis launch in history, including HUMIRA. So as we look at that uptake in the 4 milligrams is the majority of the use, And we see what the patients are seeing and coming back to their offices where they are debilitated. They've tried other agents and they've gone on baricitinib and really things like in Japan, they're now able to drive where they haven't been able to before. It's really life changing.
So as we look at the U. S. And our discussions with FDA and the ongoing conversations we continue to have, the 4 milligrams is imperative for these patients to get the benefit and the efficacy that they need to be able to go about their daily lives. So it is still our strategy that we believe in the 4 milligrams. We're seeing it play out in the real world.
And we look forward to having the resubmission and it will it is on track to happen before the end of January as we had mentioned in the past. And then after that, we'll have a 6 month clock in which we'll get a read, but we're very optimistic. Thanks, Christy. Mike?
And, Yuma, I can confirm there is no settlement agreement in place between Lilly and Sanofi related to their follow on Lispro.
Thanks Mike.
Enrique? So there are a few things to consider when we basically compare and contrast that basal insulin situation visavismiltoninsulin. And when we enter of course with Basaglar and all of the learnings that we got there and then hopefully we can apply those learnings in reverse in a certain way. So first the basal insulin class is was significantly more open at the time that basagular entered. So we had a number of different basal medicines in formularies and that's relative to the mealtime insulin space where most formularies are really under exclusive status and that leads to lower prices.
So the situation today and the economics for the payers today are such that it was easier to create viable economics for the payer in the basal insulin space relative to where we are in the multi insulin space. 2 is that in the case of Humalog, we have a full range of formulations, not just Humalog, but Humalog mixtures. We have a concentrated, multaminesulin Humalog U200. And we recently even just launched the Humalog QuickPen Junior, which basically is the first half unit prefilled pen in the market. So we're excited about that offering and we do believe that offering places gives us some strength when it comes to a follow on Lispro just coming into the market.
Of course, it's additional competition and we have to see when will they launch. It is likely that they had to resubmit of course to get final approval And we are that's probably a question from a timing perspective for Sanofi.
Great.
Thank you, Enrique. Alan, if we can go to the next caller.
That will be Tony Butler with Guggenheim Securities. Go ahead, please.
Yes. Good morning. Enrique, back to Trulicity, if I may. To what degree is the growth due to switches from Victoza versus that from orals straight to Trulicity? Part B of this is does or would diabetic retinopathy actually cloud the class assuming that's part of the warning of semaglutide in the label?
And then the second question is really around abemaciclib in non small cell lung cancer. One trial did not show OS and I'm curious your confidence on the other trials specifically in non small cell lung cancer. Thanks very much.
Great. Tony, thank you for the questions. So Enrique, first two for you on the source of Trulicity growth as well as if the diabetic retinopathy that was seen in one of the Novo studies might impact the overall class. And then, Sue, over to you for a discussion on other trials that are ongoing for venocycline in non small cell lung cancer. Enrique?
Very good. When it comes to the source of Trulicity growth, I think it's important to highlight that our strategy from the very beginning was not to focus on current GLP-one users. So most of our strategy has been on additional adoption by specialists and then really the breadth in primary care. I believe the strategy has been highly successful. So these sorts of our business by a very significant amount.
I don't have the actual figures with me, but it's minimal whatever we get in terms of switching from other GOP-1s. We like for that to continue given the opportunity when it comes to patients on oral medicines that could benefit from better control. When it comes to retinopathy, the data for Trulicity, I think is very clear and we do not have a signal when it comes to retinopathy. We have to see how a potential warning or how the labeling of retinopathy for stemaglutide will basically read out. But clearly, we see significant advantages of GLP-1s in general and we are counting on significant growth of this
Thanks Thanks, Enrique. Sue?
Yes, sure. Toni, with regards to the Juniper study, which was abemacitin KRAS mutation positive advanced lung cancer, we did not see an overall survival advantage. As you mentioned, we did see though in single agent activity and progression free survival and overall response rate. And this is the first study that there's been prospectively looking at elotinib in KRAS mutation positive breast cancer. And without giving you full data, we did use historical control and had assumed based on control about 6.5 month overall survival.
With elotinib, we saw higher than that. What we are continuing to progress though, other studies in lung cancer and we continue to be confident in those, particularly around rational combinations. We do believe particularly with regard to KRAS mutation positive lung cancer, which is really hard to treat that rational combinations will be important. And we've got a number of those ongoing in including IO combination with a vemaciclib in combination with PI3K mTOR. And also we've got a Phase 2 squamous to lung study ongoing.
In addition to that, we're looking at other tumors as well. So our lifecycle plan continues to look at progressing abemacitlib to ZENIO now in breast cancer, but also in other tumor types.
Great. Thanks very much.
Yes, you're very welcome. Alan, if we can go to the next caller.
That will be Mark Goodman with UBS. Go ahead.
Yes, morning. If we look in the Phase 2 pipeline there, there's 8 products. I think many of us know the base, but several of the others are not as well known. Can you just talk about some of the products and where we should be focused and what kind of data we should be expecting and where is excitement there? And then just secondly on Basaglar, it had a very strong uptick relative to the script trends.
I was just wondering if there was any stocking or anything unusual in inventory change there? Thanks.
Great, Mark. Thanks for the questions. So Jan, if you'd like to take the lead on the Phase 2 pipeline question. Others feel free to augment that answer if you'd like. And then Enrique, anything unusual in the quarter on the Basaglar numbers, if you can comment on that.
John?
Okay. So let me start in immunology with mirikizumab, our IL-twenty three p19 antibody, which is tested in psoriasis as well as the 2 IBD indications, ulcerative colitis and Crohn's. And we are expecting data late early next year, the first half or particularly psoriasis will come first. In immunology, we also have the oral BTK inhibitor, the Bruton Tyrosine kinase, which we are testing in RA with also data coming next year. And we are interested clearly because it's another potential oral agent in the immunology space.
For diabetes, we have 2 agents. The first one is GIP GLP-one. It's the dual agonist then of 2 different mechanisms to lower body weight and also having potentially a better glucose control. We are particularly interested in this agent since in preclinical models, it had actually better efficacy than any other GLP-one agent studied, including semaglutide. The Dacra is another variant of in protein like molecules with the amylin and also the caliphonin stimulating receptor agent.
And the reason here is to have not only body weight lowering, but also potential an insulin sensitization activity. And clearly, these two agents are somewhat in parallel for readouts. And we also have a high dose dulaglutide coming about the same time. And then I think we will make a choice about what is the next potential Phase III then in the insulin space. The base inhibitor we also have in Phase II is a very potent oral agent that has potentially less peripheral issues in relation then to the targeting Phase 2.
And we are actually running this also as a kind of a backup to LANABASISTAT, as you know, which is in Phase 3. And we're also considering potential combinations of these base inhibitor with N3PG. Since in preclinical models, that has been shown to have an extraordinary clearance of not only plaques, but also diffused amyloid. Perhaps Sue can talk about the oncology space.
Sure. Well, prexassertive, we have in Phase 2 in ovarian cancer. We are specifically looking at developing this medicine and looking at biomarkers. So firstly, looking at ovarian cancer and then we will progress hopefully with a biomarker driven registration study, should the Phase 2 data warrant that. Mirastinib, we are developing actually this medicine in biliary tract cancer.
We have a study for both fyramza and amarastinib in biliary tract cancer depending on the data on the Phase 2 on that, we will progress 1 or either, potentially both, but probably 1 or either of those medicines in that indication. And PI3K mTOR inhibitor, we're really developing that as a combination therapy. And we have, as I mentioned earlier, a combination of PI3K mTOR with abemaciclib.
Great. Thank you. Enrique, on Basaglar?
Sure. So we are very pleased with the performance of Basaglar and the continued adoption of Basaglar as a key basal insulin. When we look at the quarter, I think there's nothing on the stocking side, but there was $12,000,000 worth of a benefit related to changes in rebates and of the estimates of rebates and discounts for prior periods.
Great. Thank you, Enrique. Alan, if we can go to the next caller, please.
Yes, sir. That will be Seamus Fernandez with Leerink Partners. Go ahead, please.
Thanks for the question. So just a couple here. You guys have obviously evaluated the Elanco potential spend for quite some time. Did want to talk a little bit and just kind of get your sense of in the current market, we've seen companies make these types of announcements and then it takes a longer period of time to actually execute on the spin and then the results in disappointment. Just trying to get a sense of your commitment to offering a definitive conclusion as of the middle of 2018 as you stated in your press release.
And if we could, just to get a sense, I think the spin is fairly obvious. But historically most companies have talked about the synergies between the business. Dave, I was just hoping you could talk about if you see those synergies in the business any longer given the evolution of Lilly's business? And then my second question, we did see a few additional VTEs announced for a competitor JAK inhibitor in an ACR abstract. Wanted to know if there has been any change in the frequency or rate of VTE that you've seen in any of your clinical data or if it's still consistent as part of the resubmission, if it's consistent with the rates that we've seen in the past, which I believe you've stated are consistent with the historical rates of VTE for patients with RA?
Thanks.
Seamus, thank you for the question. So Dave, we'll go to you for the first couple of questions on we'll be able to provide definitive answer by mid-twenty 18 on the strategy for Elanco going forward and your view on synergies with that business and then over to Christy to talk about the rates we're seeing of VTE in our program with baricitinib.
Yes. Hi, Seamus. Thanks for the questions. Of course, we came out today and said mid-eighteen because that's what we believe we're going to hit. So that's our best estimate of being able to get back to investors and we think that's ample time to evaluate the questions before us as we look at the options to maximize the value of this asset over the long term.
So that's our focus, and I wouldn't wobble from that certainly today in day 1. And I think this is a business that has been it does have some synergies with the core of Lilly, but primarily is operating outside of the core business of Lilly. There is some back office synergies we gain. And of course, we've talked through time about the R and D synergies. Although, as we've looked into that, I think they are currently rather modest.
One reason for that is the platforms used across animal health are different. We have a large vaccine portfolio that doesn't synergize with pharma R and D today. We have a feed additives business that has really no synergy connecting to Lilly. On the companion side, therapeutics, that has some potential. But as we've looked at this, I think there's no reason to believe we couldn't maintain some of those synergies contractually if we had a different structure.
So we are looking at all of this and mid year next year is our deadline.
Great.
Thanks, Dave. Christi?
Sure. In regards to thromboembolic events with baricitinib, we continue to monitor the real world evidence where we've launched commercially, as well as accumulating data, for our resubmission. As you know, the last time we submitted was January of 2015. So we have much more data to resubmit. And everything that we've seen, we've seen nothing in our atopic dermatitis studies and everything is consistent as we've said before with normal background rates in the rheumatoid arthritis patient population.
So no new news to report there.
Great. Thank you, Christy. Alan, next caller please.
That will be the line of Chris Schott with JPMorgan. Go ahead please.
Great. Thanks very much. Just a couple of questions here. Maybe first on Jardiance Dynamics, you're obviously seeing very healthy share gains. We're thinking about overall category growth.
Are you happy with the trends we're seeing there? And what do you think it's going to take to further expand usage of the class overall? My second question was a broader diabetes question. I know each segment is different, but just as we've gotten maybe further into contracting season, etcetera, just any preliminary comments about 2018, either pricing or access to the portfolio, anything we should just be keeping in mind as we think out to next year? And then my final question was on Elanco.
As we think about strategic options, do you believe further consolidation among the large animal health players is possible from an antitrust perspective as we think about the various kind of options that you're considering with this strategic review? Thank you.
Chris, thank you for the questions. Enrique, the first couple for you on Jardiance particular class growth potential catalysts for that going forward. And then the diabetes 2018 access picture to the extent that you can comment. And Dave, if you can talk through the question on the Elanco consolidation in the animal health industry question. Enrique?
So
Jardiance has pretty quickly become the new standard when it comes to initiating patients on an SGLT2 therapy. Our share now in when it comes to new to brand prescriptions is now north of 50%. And the overall trends when it comes to volume and share I think are very strong. Of course, when we look at the class, we do see some dynamics to the overall related to the overall leader of the class. But as we think about long term the long term opportunity for this product, we need to focus much more on Jardiance than on the class and the trend that basically Jardiance can continue to have.
Clearly, the opportunity is enormous. Let's keep in mind that there are 160,000,000 prescriptions written for oral medicines in the United States. And SGLT2s have only 10,000,000 of those. And we are basically looking at a product that has an indication to reduce the risk of cardiovascular death for people with type 2 diabetes and establish cardiovascular disease, which we believe is about 30% or so of the people with diabetes. So the opportunity is enormous and we are thinking of that opportunity with that lens in mind.
When it comes to 2018 and as we think about pricing and access, I think the clearly the different pharmaceutical benefit managers have already announced their formularies. But we do see a continuation of the trends when it comes to pricing pressures in diabetes. There was one notable exception in that we saw that we were surprised and that was the exclusion of Jardiance from the CVS Health formulary. We of course are very disappointed with this decision and we don't believe this is in the best interest of patients given the profile of Jardiance from a safety perspective and the label when it comes to cardiovascular and the fact that the competitor has a black box related to amputation. So we'll make our case with the physicians and with the patients.
Thank you.
Thanks, Enrique. Dave? Yes. So an Elanco is a combination still possible in the sector. Obviously, Animal Health has had a lot of combinations.
We've been a part of that. But to answer the question, really, you have to look at the facts of the combination you might be looking at. So I guess, yes, it's possible, but we need to look at the product mix that would be resulting in any combination and then determine the antitrust risk. We do think that's an avenue, but we'd have to look at the facts in each geography. Thanks, Dave.
We can go to the next caller, please.
That will be John Borris with SunTrust. Go ahead, please.
Thanks for taking the questions. First question just has to do with abemaciclib listening to the Novartis call this morning. It certainly seems as though the launch of Kisqali is certainly underwhelmed Novartis. What have you learned from the Pfizer and both the Novartis launches relative to the profile of abemaciclib as we track this product going forward here that gives you confidence that it will have some relatively robust uptake? And then second question just has to do with pricing in particular.
Questions we get all the time are the difference between gross to net and the FDA's approval of so many innovative agents in therapeutic categories that over time is going to lead to an increase in the gross to net differential as discounting and rebating plays a much greater role. Dave, how do you think about the business, especially your most profitable affiliate, the U. S, in managing that going forward to add some comfort to investors who take a long term view and invest for the long term. And then on the patient front, obviously a lot of discounts and rebates certainly aren't passed on to customers as their deductibles and their co pays are going up. What's a potential solution?
Is there one out there to potentially ensure that a greater amount of that discount rebate gets back into the customer's pocket so they can afford the new innovative medicines that you have here going forward? Thanks.
Great. Thank you for the So Sue, we'll go to you for things we've learned from the Ibrance and the Kaskali launch as we think about launching Rezenio. And then Dave, the questions on managing the U. S. Market, particularly the dynamics will be brought by more branded agents being approved and causing competition as well as, what solutions there might be to help with the patient side of the equation where a lot of the cost increases have been occurring.
Sue?
Yes, John. Thanks for the Clearly, it's early days. We've only been a few weeks out in the market with Vazenio. But we are very pleased with what we're hearing so far and our progress to date. We can't give you any quantitative data because of timing.
But from a qualitative perspective, we are seeing our milestones on access being achieved. We got the channel access ahead of plan just literally days after approval. We've seen hospitals and pharmacists stocking the product and actually patients being started. What we're trying to do is to ensure that access is as easy as possible for patients and also that the first experience that patients and physicians have with Pzenio is good. What we are hearing is that the differentiating factors for Pzenio are resonating.
The single agent activity is a differentiator for Vazenio. Also the fact that we can continuously dose, we've been very proactive from a side effect and safety profile. People are very appreciative of that and are telling us that the diarrhea is manageable. We're providing low perimide and support around that and people are very appreciative of that and saying it's manageable. What we are hearing from physicians is that they see Kisqali more like Palbo and that we have some differentiating features that they think are important and clinically relevant.
So I'm very interested in giving you an update as we get further down the launch of Vazenio in the U. S. Just on that, we've also submitted to Europe and Japan based on the MONARCH II and the MONARCH III data. The single agent activity data will also be included in that package. And we have just recently announced that we've also got priority review for the MONARCH 3.
So that's the in combination with AI, which means that the FDA is looking at an 8 month review versus a 12 month. And that's as a reminder, based on the interim data from the MONARCH 3. So we hope to have final data on that either the end of this year or next year.
Thank you, Sue. Dave?
Yes. So thanks, John, for your question. If I have it correctly, what you're saying is, as we think about the whole sector through time across all therapeutic areas, how do we what underlying trends do we see that would affect the innovative pharma business and how does that affect our thinking about growth. I mean, I don't think we've ever been more bullish about the underlying science and the therapeutic areas we operate in, And that's good news for the pricing dynamics too. So just to put that together, where we see very competitive pricing dynamics are in relatively older categories with less differentiation and in more primary care versus specialty care.
And the second one is really because primary care doctors are much more time pressured and working through and building a system in your office to deal with the various formulary for a broader set of products and specialists is a challenge for primary care doctors. Specialists have set that up and worked through it. So the anecdote for this long term, which affects our strategy, I can't speak to the broader sector, but we see where the investment is flowing, I think it's consistent, is to continue to focus on creating more and more differentiated assets at launch, bigger effect sizes, more difference versus standard of care. I think you see example in our recent launches with Trulicity with going to a weekly from a daily or Taltz by getting 40% complete clearance versus what TNFs can do, which is somewhere in the mid teens. That's the kind of medicines we need to be working on going forward, those that make a profound change versus the standard of care.
And then investing through the life cycle, so that you don't find yourself less differentiated as competitors continue to launch. Those are two dynamics that affect our thinking about the business. Coupled with specialty care, which is an underlying global trend that both the there's more innovative opportunities in areas like immunology and oncology relative to others' areas of scientific inquiry, and that happens to correlate highly with where reimbursement can happen a little more easily because the hurdles that are produced by the payer system, basically patients and providers are more willing to work through them for more serious disease. I'm not saying that's a great answer for humanity long term. I think we need to find a way to pay for and fund innovation in conditions like diabetes and cardiovascular disease, which are still some of the largest killers in the world.
But that's just, I think, where both innovation is flowing and where R and D dollars have. That affects our strategy and our thinking to continue to stay ahead of what will be a price effect due to competition. The ultimate antidote is differentiation. In terms of patient, you're asking a very important question. We've seen in the U.
S. The structural problem for many years of the pharmacy benefit having about 20% copay by patients out of pocket versus about 4% or 5% for services like hospital services. That really hasn't changed. What has changed is the number of patients who are exposed to very high deductibles. So there's both a cash flow issue during the year as well as just overall out of pocket increases, particularly for brand name drugs.
Generic prices remain relatively low, penetration relatively high. We think an immediate step that should be taken in all sectors, all segments is to pass through rebates to patients. This provides an immediate point of sale discount. I will share with you that that is something commercial payers are now offering in the 2018 cycle. We ourselves as an employer are evaluating that.
We think that's a great step to ease out of pocket burden. We've advocated aggressively with CMS that, that should be a policy at Part D, particularly for a donut hole. That's one solution to help seniors pay for their medications. And then I think long term, we need to ask, I think, a broader question, which we can get at through value pricing mechanisms potentially, which is to really ask, are medicines a better way to deliver health care than other parts of the health care system? And if so, why do we ask patients to pay more for And I think that's a debate, a national debate we need to continue to engage in.
Again, I think we're making great strides scientifically, but the system isn't well equipped to help patients have affordable access to these inventions.
Great. Thanks, Dave. Alan, if we can go to the next caller, please.
Yes, sir. That will be Greg Gilbert with Deutsche Bank. Go ahead, please.
Thanks. Back to Animal Health. Jeff, perhaps you can comment with some more granularity on some of the revenue pressures you're seeing and are they Elanco issues or industry issues? And where's your atopic dermatitis pipeline given the success of Apoquel and Cytoplank? Interested to know when you could show up in that market?
And then for Enrique, higher level question beyond the sort of tit for tat on individual diabetes compounds. In the past when we've met, you've suggested that there could be more of a push to partner with technology companies to enhance your overall diabetes franchise and solutions based approach. So what can you say about that strategy at this point? Thanks.
Greg, thank you for the question. So Jeff, commentary on the revenue pressures, what's Elanco versus industry in terms of dynamics and a little bit the pipeline outlook for getting into the atopic dermatitis, the companion animal space. And then Enrique, question over to you on our strategy for working with devices and device companies going forward. Jeff?
Yes, Greg, real quick like on Animal Health. I think I would just come back on Elanco just kind of to anchor back. We again grew 4% excluding FX. We did see strong growth in global poultry
and
I think that overall sector is growing well. We grew 17% and then of course the U. S. Compatible vaccine. The pressures really remain and I'll kind of separate them.
1 is all around market access, which is driven by the clean food kind of movement with antibiotics and productivity products. I think this is an industry issue depending on the product mix. And then I think competitive pressures that are coming from a combination again in food animal, that's a mix of economics of the industry as well as some generic pressures. So we saw that in U. S.
Cattle both with beef and dairy. The companimal parasiticide space, let me just highlight, as Dave mentioned, Trifexis was an issue where we lost some share. No question, I think everyone is seeing increased spending. Innovation is getting rewarded, so the new entrants have gained share. We still feel very good about companials and the parasiticide space in general, given the size of our portfolio, existing portfolio and our heartworm platform as well as our pipeline.
The market itself is still growing on the companimal side and parasiticides. And then I think lastly is just the channel opportunities that are coming there. So again, I think you've got some industry dynamics with cattle, beef and dairy. You've got some generic pressures a little bit there where there's lacking innovation on the food animal side. But overall, again, we see sectors like poultry, aqua and even companimals growing in the vaccine space.
I think relative to atopic dermatitis, we're actively exploring several mechanisms here related to symptom treatment as well as interruption of disease process for the canine atopic dermatitis area. We're leveraging Lilly's experience here, no question and we'll continue to advance some novel product concepts, both large molecule and small molecule are being studied here. So it's an active platform in our pipeline and we're focused on this.
Great. Thanks, Jeff. Enrique?
So we are in fact excited about the opportunity brought by the convergence of both pharmaceuticals and technology to be able to create differentiated solutions and to be able to improve outcomes. And I think for an area like diabetes, we think that this could be pretty revolutionary. So that's something that we have a high interest on. I'm not prepared to share too much more than that, but just to say that we are actively working on it. Great.
Thanks, Enrique. Alan, if we can go to the next caller.
Yes, sir. That will be Steve Scala from Macquarie. Please go ahead.
Thank you very much. On baricitinib, I have a follow-up to Seamus' question. So you stated that DVTs are in line with the expected background rate. Would you confirm that there has been no new imbalances even if they still remain within the expected background rate. And then on the Q2 call, Doctor.
Mahoney said that KEYNOTE-one hundred and eighty nine top line release was not expected till late this year or early next. That was a surprising statement at the time given the September primary completion, but it has turned out to be correct. So I'm wondering if Doctor. Mahoney has any additional updates on the KEYNOTE-one hundred and eighty nine timing. Thank you.
Great. Steve,
thank you for the questions. Christy, a question on DBTs, any new imbalances? And then, Sue, any update on the KEYNOTE-one hundred and eighty nine readout timing. Christy?
Yes. I can confirm there are no new imbalances in regards to DVTs. Great.
And Sue?
And Steve, mine will be a quick answer to I don't have any update. I think you need to go to Moe for any update on 189.
Okay, great. Thank you. Alan, if we can go to the next caller.
That will be Vamil Divan from Credit Suisse. Go ahead.
Hi, great. Thanks for taking the question. So one, I just want to ask a question about the guidance, the more mid term guidance. And you mentioned the 5% plus sales CAGR. And as we look at the models, I think our numbers and also consensus in general is a little bit less than that.
So as you review the models, are there certain products that you'd highlight where you think the extra sort of $400,000,000 or so in revenues may come by 2020 to get to that 5% number? And are there any expectations for business development that's built into that number? And then related to that, when do you think you may be comfortable giving us more guidance on 2020 in terms of OpEx or margins or maybe EPS growth or something along those lines? Thanks.
Great, Vamil. Thank you for the questions. Josh, we're going to road test you here. So if you'd like to comment a little bit, are there any BD transactions or placeholders built into that mid term guidance and any kind of qualitative comments you can give around where the street may be missing something and to our confidence in those numbers? And then we might give more details on 2020 or further out years in terms of mid term guidance.
Sure. Thanks. First on the business development piece, we don't have future business development sales built into our projections around the 5%. As you know, we're very active in looking at external innovation and opportunities. So if we see those, those would obviously help or add to our projections.
I think as it relates to the 5% goal itself, as Derica mentioned, we're very confident given the performance. Again, this period was from 2015 to 2020 and we look at how we performed since 2015 and where we are today, we think we've got really strong momentum to get us to the 5% CAGR through 2020. I think when we look at the models, we don't provide product level guidance. But I think our collective confidence is based on the strength of the new product portfolio. As we mentioned, we they contributed 14 points of growth this quarter.
And you look across that portfolio of opportunities, Trulicity, Jardiance, Basaglar, Olumiant, Taltz, abemaciclib, etcetera. We think and with the pain portfolio coming, we see that portfolio continuing to grow and continuing to drive growth. So I think it's probably the collective performance of the new products that give us the confidence that we're well on our way toward that 5% target. I think as it relates to the OpEx guidance, we will provide 2018 guidance in December on our call and you can expect us to provide some updates on how we see the remainder of the decade performing there. I think as Dave mentioned in an earlier answer, as it relates to our margins and guidance, we've used 2018 just as a mile marker along the way toward being a more productive and expanded margin company and we'll look to provide some more color on that in our 2018 call this December.
Great. Josh, thank you very much. Alan, next caller?
Yes, sir. That will be from the line of Geoff Meacham with Barclays. Go ahead.
Good morning, guys. Thanks for the question. Just a couple of quick ones. On baricitinib, on the back of the recent data in atopic dermatitis, maybe just help us with the size and scope of the Phase 3 program that you're starting later this year and what you guys see as a biggest product differentiator? And on the RA side for Berry, should we expect any formal updates at medical meetings coming up just on the broader safety question?
And then last one on Olymta. I know overall demand trends have in fact been negatively impacted by, but what are you guys seeing with respect to first line lung trends just of late? Thank you.
Great. Jeff, thanks for the question. So Christy, the first two to you, sort of
the size and scope of
the Phase 3 program and potential areas for differentiation, Any updates to the RA safety database coming at medical meetings? And then Sue, over to you for the trends in first line non small cell non squamous non small cell lung cancer for Alemta. Kristie?
So on the atopic dermatitis front, I think just to clarify, we've got a lot of questions on our Phase 2 data, which I think is relevant for the question on what our Phase 3 study design looks like. So in our Phase 2 data readout, we were very pleased with the results. Unlike our competitors, one of the things that we looked at is, how what is the depth of efficacy that we could achieve. And what I mean by that is we actually took, the very, resistant patient to corticosteroids. So we took patients for 4 weeks, they were on the moderate dose of topical steroids and those patients that responded were actually taken out of pre randomization.
So only those patients that were not responding to topical steroids were actually randomized to Phase 3. And so you had, 1st of all, resistant patients to steroids, but second of all, you had patients that had less severe less disease severity. So the EASI scores at baseline were around 20 where you see our competitors who did the opposite used washout period of 4 weeks where patients will have an increased disease activity. Their EASI scores actually started at 3032. So that being able to show the results that we did in that patient population really gives us a lot of confidence as we move to the Phase 3 studies.
And we will study Phase 3 similar to what our competitors did, now that we know the depth of the efficacy. So as we look at monotherapy, we look at various doses of the 1, 2 and 4 milligrams. We'll be looking at different dosing, lower and higher. We are very confident that we'll have a robust study with robust results.
And in terms of any updates from the RA program, safety updates coming at medical meetings, are there any my understanding was that basically they have some repeats of things that were done earlier this year, but not necessarily new data?
Correct. So we have a press release that will be coming out soon. We have 33 different scientific releases on both baricitinib and Taltz at ACR. And baricitinib will be new analysis that we've seen in safety, but no new surprises in a negative way. And we look forward to showing you those and links to those will be within the press release.
Great. Thanks, Christy. Sue?
Yes. Jeff, with regards to Alimtra, as you mentioned, we have been challenged by IO uptake in the frontline setting over the past few months, and we've been seeing a sort of steady decline. We are pleased to see that we have seen a flattening in the frontline share. We now have a 26% share of market in frontline. We've also seen an increase in the 2nd line share as IOs move to frontline.
And interestingly, as we're looking at the new brand, we're seeing an increase in the uptake of Alimta with KEYTRUDA from Mike Stearning.
Thank you for the update, Sue. Alan, next caller please.
It will be Richard Perkis with Piper Jaffray. Go ahead please.
I have two questions for Enrique. Two quick ones. What proportion of patients initiating GLP-one therapy in the U. S. Now have some evidence of diabetic retinopathy?
And then on average in the U. S, how frequently are type 2 diabetic patients' retinas visualized?
Enrique, I won't try to repeat. I think you heard those clearly, so we'll go to you for
the second part. So the first one was
the percent initiating GLP-1s that have evidence of retinopathy. And then the second one is the percent of patients, diabetics in the U. S. That are actually being scanned currently to look for epilepsy.
Yes. So, excellent questions. Unfortunately, on the last question, not enough. There's really a nominal number of patients with diabetes that actually do get screening. When we look at patients with diabetes, I don't have the specific numbers for GLP-1s, but when we look generally for patients with diabetes, there are about 30% of patients with diabetes have some degree of retinopathy.
If you were to look at the more serious retinopathy, which is vision threatening, we are looking probably a number of 3% to 5%.
Great. Thank you, Enrique. Alan, next caller please.
Yes, sir. That will be from the line of Jeff Halford with Jefferies. Go ahead please.
Hi. Thanks very much for taking the question.
I just want to dig
a bit more into the Jack and Barry safety. So can you just help us understand a bit better, what the additional data and exposure data that you have will achieve do you think in light of the questions, the FDA have around your original submission? Because I think as you referred to before, there was a cluster of events there and just how additional exposure data potentially changes that? Secondly, can you just tell us exactly what is the background rate data that you refer to in terms of what you think should be there in this population? Obviously, some of these clinical trial populations have different levels of cardiovascular risk.
And I don't know if you really talked to whether your view was that some of the trials you had a particularly high or relatively low cardiovascular risk? And then is there anything that you're doing differently in your Phase 3 atopic dermatitis trial in terms of crossover, length of exposure, just other things to help address this question a bit more robustly going forward? Thank you.
All right. Christy, all those are for you. So the additional safety data, what we think it's going to achieve, what is that background rate that we're referring to in this population? What population is that? And then if there's anything we're doing with atopic dermatitis studies in Phase 3 that could help to shed light on this particular safety issue as well.
So in terms of what the additional data will help us with, let me start with the background rates actually, if that's okay. Background rates in the rheumatoid arthritis patient population already are 0.3 to 0.8 per 100 patient years. So in the general rheumatoid arthritis patients, if they weren't on baricitinib, that would be the incidence that they report. And so when I say that our background rates are similar to that, our specific background rate during the development programs was 0.46 per 100 patient years. And so what I also say now, since we've submitted in the real world evidence in atopic dermatitis and all of the data that we've accumulated, that background rate is still within, the general rate of the the rheumatoid arthritis development program or the background rate of the rheumatoid arthritis patient.
So that's what I hopefully that clarifies that our background rate is similar to what you'd see without using baricitinib in this patient population. The additional data, I think, as we discussed with FDA, you have your clinical trial program, we submitted in January 2015. Since then, typically when the FDA looks at approving a drug, they say, is it safe and is it effective? What is that balance? And now that we have real world evidence, when they look at that, they're trying to protect patients.
Now that we have patients actually in the real world on baricitinib, why that is important is they can actually see in the real world when you're using baricitinib, how does it really play out. And now that we've had over 5,000 patients with physicians using it in clinical practice, the way that someone normally would not in a controlled environment, we believe that that gives even more confidence that, our background rates matching rheumatoid arthritis in clinical trials as well as now in the new world, in the real world evidence is consistent. And then as we look at atopic dermatitis, I think the thing that this confirms is if you look at the patient population of patients who actually had a thromboembolic event, each one of those patients had high risk for those before they had a thromboembolic event. So in the atopic dermatitis trials, we see a much younger patient population, which is part of the reason we probably don't see any in the through the Phase II trials we've seen so far and why we wouldn't anticipate seeing that many or a difference as we move forward with the Phase III trials.
Great. Thank you, Christy. It's very helpful. Thank you.
You're very welcome. Have time for one more question, Alan.
That will be from the line of Alex Arfaei from BMO Capital Markets.
Good morning, folks. Thank you for taking the questions. Two questions, please, on a clarification. First, why did you discontinue the N3P G antibody in Alzheimer's? If I recall correctly, at your Alzheimer's R and D date, this was highlighted, particularly given that it is similar to aducanumab.
What's incrementally new there that led to the discontinuation? 2nd on Elanco, unless I'm mistaken, it's not growing organically excluding the BI vaccine acquisitions. So does it have enough of a pipeline on R and D productivity to sustain growth in line with the market? And then finally to clarify on Hemalog, did I hear you correctly that there are no legal barriers from your side preventing Sanofi from launching their biosimilars? Thank you.
Thank you for the questions, Alex. So Jan, if you'll answer the question on the discontinuation of the M3PG asset in the pipeline. Maybe Jeff and or Dave, you want to comment on sort of what are the growth drivers going forward in pipeline prospects for Elanco? And then Mike, if you want to clarify on the Humalog legal situation.
Yes. If we start with the plaque specific antibody M3TG, as you can see on the pipeline chart, we actually had 2 molecules for that target. And the front runner molecule is still then inside the pipeline as active. And the follow on molecule did not meet the clinical criteria that we wanted. So hence, we stopped it.
Just to be clear, we took a 2 to get 1 strategy in Phase I here. So
I would read on
the down selection plan all along.
And then Jeff on the strength of the animal health pipeline.
Yes, Alex, good question. Yes, we feel very good about our pipeline. Also I think we launched a series of products last year and into this year that we're going to see growth on and then we're we'll talk more as we get near the end of the year in our guidance call and going into next year about additional launches. So it's not just a pipeline, but I think existing launches that are occurring now and ones that are right on top of us. And then I think the last thing is we're shifting our mix into these faster growing markets.
So as I mentioned, the food animal vaccines, nutritional health, compan animals and aqua, as our mix gets higher in those spaces, that will also drive more additional organic growth.
Maybe if I could just add to that. Just to be clear, we're not growing organically this year. The growth is the BI addition and companion, and we described the food animal pressures. I think we're not evaluating this business through the lens of 20 17 performance. We're looking at the last 10 years and we've built a globally competitive animal health company with a nice pipeline with good opportunities to improve margins and grow at pace and in some segments above industry pace.
And as we look forward and do this analysis, we'll be looking again at those long term trends in Animal Health. And because we're broadly positioned across many of these segments and we do have innovation coming, we do expect forward trends to reflect those assumptions as we do the analysis. So this year we've washed out some challenges. We've had some performance challenges. BI has helped us in terms of the stated growth rate.
But we're looking at this decision making through a much broader lens of time. Great.
Thank you. Mike? Alex, you're correct. We have no legal basis to preclude Sanofi from entering the market. And Enrique described earlier, we
will compete with them in the marketplace. Thank you, Mike. That concludes the Q and A session. So Dave, if you'd like to wrap up the call, please.
Yes, I would. Again, I want to recognize and thank both Maria Crow, who's been with us today and through many years, as well as Erica Rice, last earnings call with us as CFO for a great performance through your careers and many contributions to our company. So thank you again. We appreciate all of your participation on today's earnings call and your interest in our company. Through the last through the 1st 9 months of 2017, we generated solid revenue growth driven by volume of our new pharmaceutical products and we continue to improve margins, leading to even faster income growth.
We believe Lilly remains a compelling investment given the strength of our product portfolio, our top and bottom line growth prospects over the balance of the decade. Please follow-up with the IR team if we've not answered any questions on the call or you have follow-up questions. That concludes the call today. Have a great day.
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