禮來公司 (LLY) 2014 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by.

Welcome to the Q2 2014 earnings call.

(Operator Instructions)

And as a reminder, this conference is being recorded.

I would now like to turn the conference over to our host, Chairman, President and CEO Dr. John Lechleiter.

Please go ahead.

Thank you, and good morning, everyone.

Thanks for joining us today to discuss Eli Lilly and Company's second-quarter 2014 earnings.

As the operator said, I'm John Lechleiter, Lilly's Chairman, President and CEO.

Similar to our last call, this morning we're bringing more of our senior leaders into the room here to participate and to answer your questions, and we hope that this enhances the quality of the information we provide you during these sessions.

Joining me on today's call are Derica Rice, our Chief Financial Officer; Dr. Jan Lundberg, our President of Lilly Research Laboratories; Sue Mahony, President of Lilly Oncology; Enrique Conterno, President of Lilly Diabetes; Dave Ricks, President of Lilly Bio-Medicines; Chito Zulueta, President of Emerging Markets; Jeff Simmons, President of Elanco Animal Health; and Ilissa Rassner, Brad Robling, and Phil Johnson of Lilly's Investor Relations team.

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-K and 10-Q filed with the Securities and Exchange Commission.

The information we provide about our products and our pipeline is for the benefit of the investment community.

It's not intended to be promotional, and is not sufficient for prescribing decisions.

Before we get into our Q2 results in detail, I'd like to offer this context: Even as we feel the full brunt of our patent expiries, we continue to execute our strategy.

Our performance is in line with our expectations, and we're on track to meet the goals we have shared with you for the year.

And the steady advance of our pipeline only strengthens our confidence in our innovation-based strategy.

Cyramza launched to a good reception in the US; empagliflozin has been granted approval in the EU.

Our insulin glargine product has been recommended for approval in Europe, and we presented positive data on a number of late-stage molecules at the recent ASCO and ADA meetings.

We anticipate a number of additional regulatory actions this year, as well as additional regulatory submissions and important Phase III data readouts.

And we continue to manage our expenses rigorously, even as we invest to ensure successful launches and continue to advance our pipeline.

With that, let's turn to the key events since last quarter's call.

Since our last call, we launched Cyramza in the US as a single agent treatment for patients with advanced or metastatic gastric cancer, or gastroesophageal junction adenocarcinoma with disease progression on or after prior chemotherapy.

We're pleased with the uptake we're seeing, with the reports we're receiving from the sales organization, and with feedback from customers on their experience to date.

We've also had a number of positive developments on the regulatory front spanning diabetes and oncology.

The European Commission approved empagliflozin, or Jardiance, indicated in the treatment of type 2 diabetes to improve glycemic control in adults.

As I mentioned on last quarter's call, Lilly and Boehringer Ingelheim anticipate launch of the product in European countries to begin this quarter.

In the US, Boehringer Ingelheim resubmitted the empagliflozin NDA to the FDA.

This was deemed a class I resubmission, which carries a two-month review period.

Consequently, we expect FDA action this quarter.

In Europe, Boehringer Ingelheim submitted the fixed dose combination of empagliflozin and metformin.

Also in Europe, the CHMP issued a positive opinion recommending approval of our new insulin glargine product for the treatment of type 1 and type 2 diabetes.

This product, which is part of the Lilly/Boehringer Ingelheim diabetes alliance, is the first biosimilar insulin recommended for approval in the European Union.

Moving now to oncology: In the US, based on data from the RAINBOW study, we submitted a supplemental BLA for Cyramza as combination therapy in patients with second-line gastric cancer.

This will be a standard review; and therefore, we expect FDA action in the first half of 2015.

In Europe, where our initial submission was based on the REGARD monotherapy study, we've now incorporated the RAINBOW data in our submission dossier, which is currently under review.

And finally, we announced that the FDA granted fast-track status for our BLA for necitumumab as first-line treatment of metastatic squamous non-small cell lung cancer.

We continue to expect FDA submission before the end of this year.

In clinical news, we had a number of detailed data presentations at the annual meetings of the American Society of Clinical Oncology and the American Diabetes Association.

At the ASCO meeting, we presented detailed data from the Phase III REVEL trial studying ramucirumab in second line non-small cell lung cancer.

In this study, Cyramza demonstrated statistically significant improvements across multiple efficacy endpoints, including overall survival, progression-free survival, and overall response rate.

The improvement of overall survival and progression-free survival on the Cyramza plus docetaxel arm was consistent across the majority of subgroups, including non-squamous and squamous histologies.

We remain on track to meet our commitment for regulatory submission in the second half of 2014.

We also presented detailed data from the Phase III SQUIRE trial studying necitumumab in first-line squamous non-small cell lung cancer.

In the Phase III SQUIRE trial, patients with stage IV metastatic squamous non-small cell lung cancer showed a statistically significant improvement in overall survival, progression-free survival, and disease control rate.

As I mentioned earlier, we intend to submit this BLA by year end.

Finally, following our initial disclosure at AACR in April, we presented additional data from the Phase I trial of our CDK 4/6 inhibitor, Abemaciclib.

These data were from two different cohort expansions, one as a single agent in patients with advanced non-small cell lung cancer, and the other in combination with fulvestrant in patients with advanced breast cancer.

Based on these data, as well as the data presented at AACR, we will begin Phase III trials later this year in both advanced breast cancer and advanced lung cancer.

We are pleased with the single agent activity we've seen with Abemaciclib, as well as with the product's safety profile, and believe we could have a best-in-class molecule.

At the ADA meeting, we presented detailed data from three of the Phase III AWARD trials of dulaglutide.

There was significant investor interest in the AWARD-6 trial comparing once weekly dulaglutide, 1.5 milligrams, to once daily liraglutide, 1.8 milligrams.

Results from this study showed that dulaglutide 1.5 milligrams was non-inferior to the highest approved dose of Victoza in the reduction of HbA1c from baseline.

This is the first head-to-head Phase III trial of a GLP-1 to show non-inferiority to liraglutide 1.8 milligrams on this important clinical measure.

Detailed data was also presented for AWARD-2 and AWARD-4, head-to-head trials comparing dulaglutide to insulin glargine with and without mealtime insulin.

Both trials showed that once weekly dulaglutide 1.5 milligrams provided significantly greater reductions in blood glucose for patients with type 2 diabetes.

Additionally, in both studies, hypoglycemia rates were lower for dulaglutide 1.5 milligrams treated patients compared to insulin glargine.

We are very pleased with the results of these three Phase III studies for dulaglutide, as well as with those of the Phase III studies presented at last year's ADA.

If approved, dulaglutide will be the only GLP-1 receptor agonist that is both once weekly and ready to use.

We believe it could provide patients and physicians an important new treatment option for type 2 diabetes.

In the quarter, we also issued two top-line press releases for Phase III trials, one for our basal insulin Peglispro, and the other for Cyramza in second-line hepatocellular cancer.

We announced positive top-line results for three completed Phase III clinical trials in patients with type 2 diabetes for basal insulin Peglispro, which is being studied as a once daily treatment for both type 1 and type 2 diabetes.

The primary efficacy endpoint of non-inferior reduction in HbA1c compared to insulin glargine was met in all three trials.

Having met the primary endpoints, superiority for HbA1c lowering was examined; and in all three trials, basal insulin Peglispro showed a statistically superior reduction in HbA1c compared with insulin glargine.

In addition, in all three clinical trials, patients taking basal insulin Peglispro experienced statistically significant lower rates of nocturnal hypoglycemia, and had comparable to statistically significant less weight gain than those taking insulin glargine.

We remain on track to issue a top-line press release this quarter on our Phase III trials in patients with type 1 diabetes, and to make regulatory filings by the first quarter of next year.

For Cyramza, we announced that the Phase III REACH trial in patients with hepatocellular carcinoma, or liver cancer, did not meet its primary endpoint.

Overall survival favored the Cyramza arm, but was not statistically significant.

Although the REACH study did not meet its primary endpoint, we are encouraged by the efficacy seen in specific subpopulations.

We plan to discuss these results with regulatory authorities to inform future trials.

In business development news, we announced last week an immunotherapy collaboration with UK-based Immunocore Limited to research and potentially develop novel T-cell based cancer therapies.

This collaboration will result in a third-quarter charge of $45 million, or $0.03 per share of EPS after tax, that we've incorporated into our revised guidance for 2014.

Also, we closed the acquisition of Lohmann Animal Health, a privately held German company that is a global leader in poultry vaccines.

This acquisition establishes Elanco as a global poultry leader, and solidifies Elanco's vaccine presence and manufacturing capabilities.

We also entered into an agreement, contingent upon certain closing conditions, to sell the feed additives portion of Lohmann's business to a management-led group.

Finally, along with Sanofi, we announced an agreement to pursue regulatory approval of non-prescription Cialis.

Under the terms of the agreement, Sanofi acquired the exclusive rights to market Cialis OTC, following Sanofi's receipt of all necessary regulatory approvals.

In other news, the English High Court determined that the vitamin dosage regimen patents for Alimta in the UK, France, Italy, and Spain would not be infringed by a generic competitor that has stated an intent to market certain alternative salt forms of pemetrexed in those countries upon expiry of the Alimta compound patents in late 2015.

We strongly disagree with this ruling, and have appealed the ruling to the Court of Appeal.

In the US, based on the US Supreme Court ruling in the Akamai versus Limelight Networks, Teva and APP filed an unopposed motion asking the Court of Appeals to remand the Alimta case back to the District Court to consider the issue of infringement.

No date has been set for a hearing with the District Court.

Note that this does not affect the District Court's decision that our patent is valid.

We remain confident that this patent is both valid and enforceable against generic manufacturers.

A Brazilian labor court ruled against our local subsidiary in a case alleging some employees were exposed to hazardous materials in a manufacturing facility operated by the Company between 1977 and 2003.

We believe the decision is entirely without merit, and we filed an appeal.

Finally, during the second quarter, we executed share repurchases totaling $145 million under our $5-billion share repurchase program.

And now I'll turn the call over to Phil for a discussion of our financial performance for the quarter.

Thanks, John.

First, I'll review our GAAP results, and then discuss a few non-GAAP measures to provide some additional insight into the underlying trends in our Business.

Moving to slide 7, you can see that our Q2 revenue was $4.9 billion, which is 17% lower than Q2 2013.

This decrease in revenue reflects a decline of $1.1 billion in US Cymbalta sales, following the loss of exclusivity in December last year.

In addition, US sales of Evista declined nearly $145 million, following that product's loss of exclusivity in March of this year.

Excluding Cymbalta and Evista in the US, the rest of our worldwide revenue grew 6%, mainly from volume.

Recall that last quarter we stated that our Japan revenue benefited by about $70 million from higher customer purchases in advance of an increase in a local consumption tax.

As expected, this quarter customer purchases in Japan were reduced by a similar amount.

This negative impact on our overall corporate revenue growth was largely offset by a benefit in the US related to an adjustment in the reserves for managed Medicaid rebates and discounts.

Gross margin as a percent of revenue decrease 4.4 percentage points, also driven by the loss of US exclusivity for Cymbalta and Evista.

This quarter, the effect of foreign exchange rates on international inventory sold resulted in a modest addition to cost of sales; while in last year's quarter, it resulted in a modest reduction to cost of sales.

Excluding this FX effect from both 2013 and 2014, gross margin as a percent of revenue declined 3.4 percentage points, from 79.9% in Q2 2013 to 76.5% in Q2 this year.

As in prior calls, we've included a supplementary slide providing our gross margin percent for the last 10 quarters with and without this FX effect.

Non-GAAP measures are shown on slide 8. Total operating expense, defined as the sum of R&D and SG&A, decreased 11%, or nearly $340 million versus Q2 of 2013.

Marketing, selling and administrative expenses were down 11%, while R&D was down 10%.

The reduction in marketing, selling and administrative expenses was due to the reduction in US sales and marketing activities for Cymbalta and Evista, as well as our ongoing cost containment efforts.

The decline in R&D expenses was driven primarily by a reduction in late stage development costs.

Other income and expense was net income of $54 million in Q2 2014, compared to a net income of $12 million in the second quarter of 2013, with this modest change driven by a variety of miscellaneous items.

Our non-GAAP tax rate was 22%, an increase of 1.5 percentage points compared to Q2 last year.

The main reason for this increase in the tax rate is a lapse of the R&D tax credit at the end of last year.

At the bottom line, net income declined 42%, and earnings per share declined 41%.

As in Q1, this decline is significant, but very much in line with our expectations, and places us on track to achieve our full-year guidance.

In slide 9, we provide the same reconciliation of non-GAAP adjusted information for our year-to-date results.

Moving to slide 10, you'll find a reconciliation between reported and non-GAAP EPS.

And additional details about our reported earnings are available in today's earnings press release.

As I mentioned last quarter, nearly all our peers exclude amortization of intangibles from their non-GAAP results, while we include this expense.

For your modeling purposes, please note that we recognized amortization expense of $134 million, representing 2.7% of revenue this quarter.

Now let's look at how price, rate and volume affected our revenue growth.

Given a significant decline in US Cymbalta and Evista sales, I'll provide you with some color on how that affected revenue growth this quarter.

On slide 11, you can see the total revenue decline of 17% in Q2 2014, which is shown in the yellow box on the middle of the page, and that this decline was entirely driven by volume.

Price added about 1% to revenue growth, while the impact of FX was nil.

Excluding US Cymbalta and Evista, the rest of our worldwide revenue grew 6%, with just over half of that growth coming from volume, and the rest from price.

Touching on some of the geographic highlights: For the quarter, US pharma revenue declined 33%, driven by a volume decline of 36%.

Excluding Cymbalta and Evista, the rest of our US pharma revenue increased 13%, comprised of 5% from volume and 8% from price.

The benefit I mentioned earlier from the adjustment for managed Medicaid utilization had a positive effect, adding 2 percentage points of this growth in the form of price.

In Japan, as I mentioned earlier, our Q1 revenue benefited by roughly $70 million, as customers increased purchases in advance of an increase in a consumption tax that went into effect on April 1. As expected, customer purchases in Q2 were reduced by a similar amount, leading to a decline in our Q2 Japan pharma revenue.

Specifically, Japan pharma revenue declined 15% this quarter, driven by a volume decline of 10%.

Adjusting for the timing of customer purchases, our Q2 pharma Japan volume would have increased 5%.

You'll also see that the weaker yen is still reducing our growth rate, but at a much lower rate than in prior quarters.

In emerging markets, we saw good performance growth at 8%, partially offset by a 4% negative impact from foreign exchange.

Volume growth of 7% was driven by Humulin, Forteo, Humalog, Vancocin, and Tradjenta.

Sales in our largest emerging markets country, China, grew 15%.

Finally, Elanco Animal Health posted revenue growth of 11%.

Strong growth in our US Food Animal business, and in both Food and Companion Animal Products O-US, was partially offset by lower US Companion Animal sales.

Also, at the end of April, we closed the acquisition of Lohmann Animal Health.

This added nearly $25 million in revenue, primarily O-US, contributing 4 percentage points to our worldwide Animal Health growth.

Now, let me turn the call over to Derica.

Thanks, Phil.

On slide 12, you'll see the effect of changes in foreign exchange rates on the growth rates for select items of our income statement.

FX had almost no impact on our revenue or operating expenses this quarter.

As Phil mentioned, FX did cause a modest increase in the growth of cost of sales, with a corresponding negative effect on operating income and EPS.

As a result, FX caused our operating income and EPS to decline an additional 2 to 3 percentage points.

Slide 13 shows our pipeline as of July 17.

Changes since our last earnings call are highlighted, with green arrows showing progression, and red arrows showing attrition.

As John discussed earlier, Lilly and Boehringer Ingelheim received European approval for empagliflozin.

In addition, we began Phase II testing of a biologic for diabetes; and we began Phase I testing of two biologics, one for anemia in patients with chronic kidney disease and the other for ulcerative colitis.

And we terminated development of five assets, three in Phase II and two in phase 1.

Next, let me remind you of our key events for 2014, and review our updated 2014 financial guidance.

In the first six and a half months of the year, we are pleased with the progress we have made on the key events we laid out for you at the beginning of the year.

As you can see from the green check marks on slide 14, we've had a productive first half of the year, advancing our pipeline and sharing Phase III data.

While I will not go through each item on the slide, I'll give you a reminder of the potential key events for the remainder of this year, and provide updates along the way.

As John mentioned, later this year we'll begin Phase III trials for Abemaciclib, our CDK 4/6 inhibitor, in both advanced breast cancer and advanced lung cancer.

We no longer expect to move blosozumab, our anti-sclerostin antibody for osteoporosis, into Phase III in 2014.

The formulation we plan to take into Phase III production in -- excuse me, the formulation we plan to take into Phase III produced injection site reactions at a higher rate than desired.

We'll conduct additional work with the formulation used in Phase II before moving forward.

With respect to Phase III data, we expect to report top-line results this year, with detailed data presentations next year for our basal insulin Peglispro studies in patients with type I diabetes, ramucirumab for metastatic colorectal cancer, and three immunology assets: ixekizumab, tabalumab, and baricitinib.

In addition to the submissions we've already completed this year, we continue to expect regulatory submissions this year for: the fixed dose combination of empagliflozin and metformin for type 2 diabetes in the US; necitumumab for first-line squamous non-small cell lung cancer; and ramucirumab for second-line non-small cell lung cancer, as well as for gastric cancer in Japan.

As we previously disclosed, we expect to submit our basal insulin Peglispro for type 1 and type 2 diabetes by the end of the first quarter of 2015, if not earlier.

Also this year, we could have regulatory action on: empagliflozin in the US; dulaglutide in the US and Europe; and our new insulin glargine product in the US; as well as final EC approval following the recent positive CHMP opinion; and ramucirumab in advanced gastric cancer in Europe.

Now, keep in mind that in addition to regulatory approval timing, the launch timing for our new insulin glargine product will be impacted by a number of factors, including patent expirations and ongoing litigation.

In other key events for the remainder of 2014, data package exclusivity for Cymbalta will expire in Europe in the second half of this year, although we do not expect generic duloxetine to enter the European market until 2015.

Now, clearly, we have a lot going on in 2014, and we're looking forward to maintaining the momentum from the first half of this year into the second half.

Now let's turn to our 2014 financial guidance.

Our performance through June places us on track to achieve our full-year financial guidance.

Since our last earnings call, there have been some minor pushes and pulls, but no major changes to our full-year outlook.

As a result, our guidance for nearly all line items, as shown on slide 15, remains unchanged.

We have revised our GAAP EPS guidance to reflect a charge of $45 million pre-tax, or $0.03 per share after tax, related to the immune oncology licensing deal with Immunocore announced last week.

And we slightly revised our outlook for capital expenditures, which has been reduced to $1.2 billion.

On slide 16, we provided a reconciliation between reported and non-GAAP EPS for 2013, and the associated growth rates from these numbers to our 2014 guidance.

Now I'll turn the call back over to John.

Thanks, Derica.

Before the Q&A session, let me briefly sum up.

While our revenues and earnings continue their decline, as we expected, at the same time, the launch of Cyramza, and a number of approvals and impending launches give us great confidence that we're poised for growth in the years ahead.

Our performance is consistent with our expectations, and we're on track to meet our 2014 financial goals.

We recorded growth in the sales of a number of products and key markets, as well as in our Elanco Animal Health business.

The 11% decline in our operating expenses shows our ongoing determination to manage expenses rigorously, so we can get the most from our well-stocked late-stage pipeline.

The steady advance of the pipeline strengthens our confidence in our innovation-based strategy and our commitment to accelerate discoveries to the people who need them.

And now I'll turn the call over to Phil for our Q&A session.

Great.

Thank you, John.

Tawny, we're ready for the first caller, please.

Thank you.

(Operator Instructions)

Tim Anderson, Sanford Bernstein.

Thank you.

Two questions.

The first is, we've seen price competition in diabetes in various ways, starting last year.

And then recently, Glaxo launched their glib 1 at a pretty big list price discount to existing therapies, which you rarely see drug companies do.

This could have an obvious impact on dilaglutide's pricing at launch.

And I'm sure you'll say it's too early to discuss pricing, but I'm hoping you can still address this in general terms.

Because it is a worrisome trend, not just for dula and Lilly, but for other products and other categories for a variety companies.

And then a second question is on Lilly's plans in terms of M&A activity and also tax inversion, you guys in the past have been pretty steadfast about only really considering bolt-on acquisitions.

Is this still the current stance?

Because if so, deals of that size probably would not be big enough to qualify you for inversion.

So how's Lilly thinking about M&A and the potential for inversion?

Great.

Tim, thank you for the questions.

We'll have Enrique Conterno, President, Lilly Diabetes, take the first question on the pricing and the GLP 1 space, and then Derica Rice, the CFO, take your question on M&A.

Enrique?

Well, as we all know, pricing in the US has become extremely competitive when it comes to the diabetes space.

This is driven both by payers and competition.

I think in this particular case, pricing also, in a certain way, reflects the profile of the very specific products.

We are certainly confident in the profile that we bring with dulaglutide and the number of trials that we have conducted.

So we do think that we have a very strong value proposition.

And of course, as we think about diabetes, our stance continues to be the same.

We are a proponent of choice.

We believe choice is important for patients.

And we are seeking, basically, a dual access in the diabetes space, whenever this is possible.

Thanks, Enrique.

Derica?

Tim, as it relates to M&A activity, our stance and strategy has not changed in this space.

We continue to be very interested in looking for those opportunities that can augment our current organic footprint, both commercially, as well as scientifically.

And that really lies in the space that you've seen us play in historically, looking for end licensing deals, and sometimes it's easier to do small M&A transactions to get access to those technologies.

We continue also to be not interested in doing the large-scale M&A.

We just have not seen the long-term benefits from those types of transactions.

As a relates to inversion, if that ever did come about, it would be of secondary benefit, not the primary driver of us taking any type of M&A action.

Great.

Thanks, Derica.

Tawny, next caller, please.

Mark Schoenebaum, ISI Group.

Just if I could ask the pipeline question.

So when I look across your pipeline, you've had some nice success this year, but perhaps maybe nothing truly transformative.

But when I look ahead, I see two things that potentially are really transformative, solanezumab and the CETP inhibitor.

And I was just wondering, I think in the past, you've characterized -- not the recent past, necessarily -- but you've characterized solanezumab as a high-risk pipeline program.

I'd love to know if you still perceive it as such, now that the revised -- now that the new Phase III programs are ongoing.

And I guess, since we can't do a deep dive on earnings call, the same big picture question on CETP.

Do you view that as a high risk moderate risk, or low risk asset?

And maybe you could just remind us on the timelines.

Thanks.

Great.

Mark, thanks for the questions.

We'll have Dave Ricks, President, Lilly Bio-meds answer your questions.

Jan, if you'd like to chime in on anything after Dave, please feel free to.

Dave?

Thanks, Mark, for the question.

We remain excited about both these programs, the CETP inhibitor, evaceptrapib, and solanezumab.

Importantly, we are confident on the timelines we previously communicated as to those data readouts, which are clearly not in this year, but coming up over the next couple years.

And as it relates to CETP inhibitors, and ours specifically, we're confident for several reasons.

One, the LDL inhibition of this asset, we think, is enough by itself to achieve the outcomes we've designed the study to demonstrate.

On top of that, of course, there are other effects, HDL increasing being the most pronounced, as well as other cardiovascular potential impacts.

The testing the CETP hypothesis with a complete inhibitor of CETP, like evaceptrapib, we think is something that's new, and we're doing an accelerated trial.

So we remain excited about that asset.

And should it play out that it has an impact on cardiovascular risk reduction, we think there's ample market opportunity for such a drug.

For solanezumab, I think as we've communicated since the EXPEDITION 1 and 2 studies, we believe in the mild signal we saw in those studies.

We've designed a study now which we think will be the definitive test of solanezumab in mild patients with Alzheimer's.

And we've improved, we believe, the probability of success in that versus EXPEDITION 1 and 2 by importantly screening out patients who did not have amyloid plaque and by powering the study appropriately for this population.

So bottom line, we're bullish on both of these.

Of course, there is technical risk, because both programs did not complete a normal sort of Phase II proof of concept, in the sense that you're demonstrating the outcome before starting a Phase III.

So I'll stop there, and ask Jan if he has any additional --

I think we can also gain some additional confidence from data from competition.

The recent report by Crenezumab at the Alzheimer's meeting in Copenhagen, I think, supports the data that we have with solanezumab.

Because it was reported there that this antibody, which has some similarities to sola in its mechanism of action, also reduced the cognition decline in the mild population of Alzheimer's, which I think is the second now pharmacological agent that actually shows that if you interfere with the amyloid pathway, you can reduce cognition decline in Alzheimer's patients.

Great.

Thank you, Jan.

Tawny, next caller, please.

Jami Rubin, Goldman Sachs

Just a more mundane question.

Derica, your gross margin guidance for the full year is 73%, which assumes a significant deterioration in the second half of the year.

Are you just being conservative with your numbers, or is there something that we should -- that we're not aware of that we should take into consideration for that?

And can you confirm that that would assume a worsening in the second half?

And Dave Ricks, for you, just on PCSK9, I know that is a Phase II asset, and it would seem that the PCSK9 would directly compete with the CETP inhibitor.

What are your plans for this drug?

And I think you are probably fourth in line in bringing a PCSK9 to the marketplace, so if you can elaborate a little bit on where you see that project going.

Thanks.

Thanks for the questions, Jami.

Derica, you want to kick us off?

Sure.

As it relates to our gross margin guidance, let me just walk you through a series of things.

One, typically Q2 is one of our higher gross margin quarters, primarily because one, we do not have the slowdown that usually takes place in our production facilities outside the US, primarily in Europe, due to the summer holiday.

And also, in the fourth quarter, we typically experience the usual maintenance shutdowns.

What we expect, and what you saw in the first half of the year, is that we had very high production volumes running through our manufacturing facilities.

And we anticipate that those production volumes will be lower in the second half, for the reasons I cited earlier.

So the gross margin performance that you're seeing thus far for us is pretty in line with the expectations that we have for the year.

The second thing that I would also highlight is that also what you will see in the last six months of the year is the full absorption and dilutive effect of the Lohmann Animal Health acquisition, which we talked about the $0.05 hit when we announced the deal, for the year, and we also talked about the fact that it would be dilutive to our gross margin, as well.

Great.

Thanks, Derica.

Dave?

Great.

Thanks, Jami, for the question on PCSK9.

I think you're correct that we are behind in this class.

But we think the class has a place in the management of cardiovascular risk.

Obviously, there is assets in front of us that are reading out positive data.

So the probabilities here look good for the class.

I think for us, really, the question is one of differentiation.

Maybe not so different to the question on the GLPs.

We are conducting right now a Phase II experiment to really elucidate a differentiated profile.

And I think that data is going to really key for our decision-making about what to do next, whether that be to proceed full speed ahead, to perhaps share risk with another partner, or perhaps to have someone else take the asset forward and Lilly move on to other opportunities.

So we need to see that proof of concept.

And based on that information, we'll make some decisions in the quarters ahead.

Great.

Thanks, Dave.

Tawny, next caller, please.

John Boris, SunTrust.

Thanks for taking the questions.

First one, for Derica, just one item in your guidance that seemed to change was the CapEx, which seemed to move down on your guidance.

Can you maybe characterize what's going on in the CapEx line, and where that savings is going to be going?

Second question for Jan.

It looked as though there was some pruning of the pipeline through your oncology assets.

Can you maybe help us understand what the next assets are beyond ramu and neci within your strategy that you'll be focusing on within oncology, presenting in Phase II you can point at.

And on the Immunocore deal for novel T-cell based therapies, are there any particular mechanisms that you're targeting along with T-cell area, or looking to optimize with that co discovery and co development strategy?

Thanks.

John, thanks for the questions.

Obviously, I'll have Derica take your first question on capital expenditures.

And maybe Jan and Sue, you'd like to comment on the oncology questions that John had.

Derica?

Sure.

Hello, John.

From a CapEx standpoint, it's really fairly straightforward.

Our manufacturing team and our facilities group have done an excellent job of just driving productivity and being able to bring in projects still on time, but at lower costs.

And so that $100 million change in our outlook for CapEx is really spread across a multitude of projects, capital projects, where you're just eking out increased efficiencies.

Thanks, Derica.

John?

John, with respect to what you term pruning of the pipeline, I think the fact that we had three potential cancer drugs fall out of Phase II is somewhat a factor of just the abundance of cancer opportunities that we have in Phase II.

It reflects the ongoing nature of the business, decision-making related to data that we've gathered, and other priorities that we've reset.

I think going forward, you're going to see Lilly much more focused on the clinical progression of the molecules where we believe we have a competitive lead and that we believe offer the greatest opportunity for Lilly.

We've got -- we're in a great position today of really having an abundance of riches.

And yet we have finite resources.

With an evermore competitive environment, I think it's important that we put clear focus and resources behind those that we believe provide for us the greatest potential and the greatest opportunity for patients at the end of the day.

With respect to the T-cell therapies, I'm going to ask Sue to comment both on your second question about the oncology portfolio, and then specifically on immuno oncology.

But we believe this is, immuno oncology is an important area.

We've said this.

We believe we have assets already in our pipeline that really factor into this disease, to this mechanism, writ large.

And the Immunocore deal was, we think, a great opportunity for us to influence the immune cycle, hopefully for the benefit of cancer treatment in a very specific way.

And again, I'll ask Sue to comment in greater detail.

Sure.

Thanks.

Clearly, with regards to the oncology pipeline, we're looking at the key cancer pathways, including cell cycle inhibition, the tumor micro environment, and immunotherapy.

You're aware of abemaciclib.

Obviously, we're very excited about that molecule.

We've initiated our Phase II study, single agent study.

We're on track to initiate the fulvestrant Phase III study in breast cancer in the next few weeks.

And the additional Phase III studies, both with -- in breast cancer with romatase inhibitors and in lung cancer will be starting in KRAS, lung cancer will be starting toward the end of this year.

So that is one molecule that we're very excited about, and we're moving forward rapidly with that.

In other molecules that we have in our pipeline that we are continuing to progress is our c-Met antibody, which is a bivalent antibody that we believe could have different properties than other agents out there.

And then our TGF beta small molecule inhibitor, or galunisertib, which is in Phase II development, and is actually a molecule that is getting a lot more interest, because it targets a pathway that modulates and functions T regulatory cells.

So that is one agent that we believe that could have, or does have, immune modulating activity.

And we're going to be seeing further combinations with that agent, both with other targeted agents and with other immunotherapy agents.

Two other agents that we've got in clinical development.

as well, that impact the immune system includes CXCR4 peptide antibody, which is in Phase II development.

And that's involved in the trafficking of immune cells in tumors.

And RCSF1R antibody that's in Phase I, and that targets mono sites and macro (Indiscernible) involved in creating an immuno suppressive environment in the tumor.

So we have three assets in clinical development that impact the immune system.

We're also continuing to increase our discovery efforts and capabilities, both internally and through recruitment externally in this area, and we've got a number of targets that we're interested in, in addition to collaborations and partnerships and potential acquisitions that we're looking at.

And Immunocore is the recent one that we've announced.

We're very excited about looking at novel T-cell based cancer therapies.

That deal specifically looks at three targets.

We've identified three targets.

We can't tell you what those targets are now.

But they're ones that we believe that have potential.

And clearly, if we decide to take those into the clinic, we'll be looking at combinations with other immuno oncology assets and other assets within our pipeline for those agents.

So we are very excited by the opportunities that we've got in oncology.

And as John said, it's really a case of making sure that we're prioritizing and putting our focus in the right areas and making sure that we're progressing the molecules that have got the most potential for patients.

Great.

Thank you, Sue.

Tawny, if we could have the next caller, please.

Chris Schott, JPMorgan.

Just had a few here.

So the first one was, as we look at Lilly returning to growth and as cash flow starts to recover, can you just share some of your views on TL products and potential divestitures of non-core assets?

We've seen a number of players in the space at least consider looking at divesting some of those businesses.

Just thoughts from Lilly in terms of, is that something that could be on the table?

Second question, on the CDK program in breast cancer, I think Pfizer announced it's moving forward with a palisick filing based on Phase II data.

If that drug is approved early next year, can you comment a little bit on what that means competitive for Lilly, as you think about your program and the timing of that program relative to Pfizer's launch?

And then finally, I'm not going to try to pronounce the generic name, but your sclerostin inhibitor, just talk about next steps from here and your confidence that this is something you can address.

Just trying to understand what we should be watching for on any update there.

Thanks very much.

Chris, thank you for the questions.

We'll have Derica take the questions on strategies around late stage assets, post patent assets, Sue Mahoney on what the palisick potential approval could mean from a competitive perspective, and then Dave, do you want to take the lead maybe on talking about the sclerostin question?

That would be great.

Derica?

Hello, Chris.

As it relates to our -- I guess this is a little bit of a scale of a further extension of our capital allocation strategy -- we've done a number of deals over the last few years to take advantage and make sure we're maximizing the potential of what's sitting inside not only Lilly's labs, but also Lilly's currently marketed products.

So even if you look at Evista, we did some deals there outside of the US to make sure that we were able to put proper resourcing behind that at a time when we were diverting some of our other resources more towards the pipeline to advance the late stage assets that we saw with future potential.

I think going forward, we'll continue, as you've heard -- even from Dave and from John, as well -- that we have a pretty robust and pretty full clinical stage pipeline today.

And we believe there are potentially more opportunities than we will have the capacity to progress on our own.

So it is possible that going forward you will see us, as we cycle through those, deciding which assets we'll go alone and, as Dave said, which assets we may partner and which assets we may find other ways to monetize the value from.

The good news is that we, at the beginning of this cycle, is we are getting great discovery output from our research labs, and that's what's affording us these opportunities that lie ahead of us.

And we have no intentions of doing anything that will damage that flow of new molecules moving into the clinic, and it gives us the optionality down the road.

Thanks, Derica.

Sue?

With regards to the palbo potential approval, that really doesn't have any significant impact on our plans for Abemaciclib.

Clearly, our focus is on ensuring that we get our Phase III, three Phase III studies up and running as quickly as possible this year, which we are on track to do.

I'm very confident that the team has got a good plan in place to ensure that we get rapid enrollment in these studies.

We are confident in our molecule.

We believe that we could have a best-in-class molecule here, with single agent activity and continuous dosing.

So as I said, our focus really is ensuring that we get these trials up and running as quickly as possible, and I think we're on track to do that.

Great.

Thanks, Sue.

Dave?

Great.

Thanks, Chris.

Maybe just quickly, as well, on the asset mix and looking to change that.

I would say, on the late life cycle in-market assets, I think we're open to that, as well.

But we need to have a transaction that produces value.

So I think when we see those things, we move on them.

I think the Cialis announcement with Sanofi this quarter is an example of that, where we're harvesting late life cycle value from Lilly assets.

On sclerostin antibody, pronounced blosozumab for those on the phone, we had completed a proof of concept study in severe osteoporosis.

We're excited by that data.

We remain excited by that data.

In conducting the transition from a Phase II formulation to a final commercial image, we did have some results that surprised us a bit in making that transition.

We need to do a bit more work on the formulation, so that we have really a competitive, or even differentiated, commercial product image.

We had scheduled -- or had communicated a potential for a start to the Phase II program through the end of 2014.

And today, we're just saying, that's not going to happen in 2014, because of this delay.

As we get more information, we'll come back to the investment community to share firmer timelines.

Great.

Thanks, Dave.

Tawny, next caller, please.

Seamus Fernandez, Leerink.

Just a few quick questions.

First off, maybe for Jan, can you give us your general thoughts on the data that was presented on Roche's crenezumab?

I think we've seen some data that looked somewhat similar.

But can you just maybe compare and contrast what we saw with Lilly's solanezumab versus crenezumab, and how these molecules are fundamentally different?

Second question is for Enrique, on the launch preparation for dulaglutide.

Can you just give us a sense of where we are as we lead into a potential action date from the FDA?

Have we had the facilities -- have they been inspected?

How is inventory building?

And how would you recommend that we assess the dulaglutide launch, given recent product launches and perhaps access?

Although I would think that Lilly might have a bit of a better opportunity, given its ability to leverage the portfolio.

And then just a quick update on the glargine challenge in the US, and if you would consider an at-risk launch following the expiration of the 30-month stay.

And my last question is, if you can remind us, post the Lohmann acquisition and perhaps Novartis, Derica, would you be able to tell us what the overall deal related non-cash charge is that get baked into the P&L on an ongoing basis and your adjusted earnings?

Can you remind us what that number is currently and what it may move to, and then perhaps what prevents Lilly from moving to the industry standard cash EPS?

Thanks a lot.

Okay.

Keep us on track here.

If we miss one of your questions, don't hesitate to let us know.

But I think we'll go ahead and have Jan talk about the data for Roche's crenezumab, obviously, Enrique, the two middle questions on launch prep for dulaglutide and the status of the glargine legal situation here in the US, and then Derica, the last one on the non-cash charges.

So Jan, you want to start, please?

Yes.

First, I would like to make the comment, and since it's not a head-to-head trial, I think it's more comparing than different trials and under different conditions.

But as I said before, the data are generally supportive between solanezumab and crenezumab.

We should remember, though, that the crenezumab is a Phase II trial, which is clearly much smaller than EXPEDITION 1 and 2. And I think for our EXPEDITION 3, it's going to be the most important trial, which is even larger than -- 60% larger than the previous EXPEDITION trials.

And the focus, I think, here, is clear.

It's the mild Alzheimer's patients that could have the best impact from solanezumab; and we are selecting the amyloid positive ones, which is also a key criterion.

Great.

Thank you, Jan.

Enrique?

First, on dulaglutide.

We are, by the way, expecting that the trade name is going to be Trulicity.

We are very much on track.

The action date is for both the US and Europe is this year.

So our launch preparations are very much ongoing.

There's not much more really that I can discuss at this stage, whether it's pricing or inspections and so forth, just to say that at this stage, things are going on track from our perspective.

When it comes to our new insulin glargine product, we're also expecting tentative approvals this year.

And clearly, we do have, in the US, the 30 months stay.

I can't make many comments about the ongoing litigation.

But clearly, we do not believe that we're infringing any of the asserted patents.

So we are hopeful that we can resolve this as soon as we can, hopefully, even before the 30-month stay.

But if that is not the case, we have the conviction in terms of what our position is and that we're not infringing any of those asserted patents.

So we will be planning to launch at that stage.

Enrique, thank you.

Derica?

Hello, Seamus.

For amortization of intangibles that's embedded in our operating results, as you heard from Phil earlier, for the second quarter, about $135 million is what's reflected in our Q2 results.

When we think about Lohmann, if you look at it on a full-year basis, a full 12-month basis, somewhere between $15 million, $20 million.

As it relates to Novartis Animal Health, I'm not able to share that with you until we actually close the deal and we have the final purchase accounting.

So that number is still moving at the moment.

And in terms of any thoughts about moving towards where most of the peers sit of the non-GAAP treatment of amortization, Derica?

Thanks, Phil.

We've obviously gotten some input, both from people such as yourself, Seamus, on the sell side, as well as we've gotten some inquiries from some of our buy side investors, as well.

It is something we're taking under consideration, and actually we'll plan to come back and inform you as to what our actions going forward will be.

Great.

Thanks, Derica.

Tawny, if we can have the next caller, please.

Steve Scala, Cowen.

Thank you.

I have three questions.

First, on dulaglutide.

There' s no question that you have a best-in-class asset.

But what portion of the GLP market would be receptive to a modestly effective but less expensive product from GSK?

And is that portion 10%, or 30%?

Secondly, Lilly has given out some time ago now, a very specific guidance on SG&A and R&D as a percent of sales without specifying a year in which that will be achieved.

Consensus, I believe, has Lilly achieving these targets in 2019.

Can you tell us whether Lilly's internal forecast has you achieving these targets before 2019?

And if you aren't willing to say, would you say whether Lilly plans to achieve these targets this decade?

And then the final question is that it seems that 2015 is setting up to be a phenomenal year, with sales and earnings up very strongly.

Yet consensus covers a wide range.

What early observations would you like to make about 2015?

For instance, please take the opportunity to rein in the high end of those estimates, unless compared your expectations, the high end is just fine.

Thank you.

All right, Steve.

Thank you for the questions.

We'll have Enrique take the dulaglutide question.

Then Derica, you'll have to comment on timing for some of the goals for the SG&A and R&D as a percent of revenue, and then any initial thoughts on 2015.

Enrique?

Steve, thank you for your comments.

I'm going to quote you on dulaglutide as a best-in-class asset.

Very much appreciated.

We certainly believe so.

Look, on your specific question about there are different types of profiles in the GLP 1 class, and some look less efficacious.

I'll be honest, I think the value proposition for those products is very complicated.

We do know that improved glycemic control leads to a reduction in complications.

That is a very strong value proposition.

That's why we seek that.

So it is difficult for me to say what type of share would those products get, but I do not believe it's going to be very much.

Enrique, thank you.

Derica?

Hello, Steve.

As it relates to our margin guidance that we've put out there, Steve, we actually have provided a timeline, at least up until now.

What we've said is that no later than 2019, or by 2019, we will achieve a total operating expense as a percent of sales somewhere in the 48% to 50% range, getting back to the historical levels of profitability that you've seen from Lilly pre-patent expirations.

We still expect to at least meet that timeline.

There clearly will be opportunities to update that outlook as we move forward.

As it relates to 2015, Steve, it's still early.

I'm not in a position to share details on our outlook for 2015.

What we have said, though, is that we do, coming out of 2014, expect to return to growth and to begin our journey towards expanding our margins.

And so that is the kind of performance you should expect to see.

And obviously, in the near future, we'll have an opportunity to give you more specifics around 2015, as we think about our usual timeline for issuing guidance.

And typically, Steve, that guidance is given in that first full week of January.

So probably somewhere around January 7 you should expect to be seeing a day reserved for the 2015 guidance call.

Tawny, if we can have the next caller, please?

Vamil Divan, Credit Suisse.

Thanks so much for taking the questions.

So two that I have.

One on the CGRP antibody, I think that's in pipeline asset people don't talk about too much yet.

Can you talk a little more on your expectations there?

We've obviously seen some set backs previously in that space.

What do you think are the differentiating points for that product, and what would you say are some of the key decision points that you have coming up here?

And then just looking at your slide 14, with the key events, it doesn't look like any other major external data readouts for the rest of this year.

Any chance any of the autoimmune studies that you have ongoing, that we might see some of those at AACR later in the year?

Or if not, should we assume EULAR next year might be a big meeting for you guys with all three of these assets there?

Vamil, thank you for the questions.

We'll have Jan lead off on the CGRP.

Dave, feel free to chime in.

Then I'm going to ask my colleague Ilissa if she wants to comment on some of the data readouts for the back half of the year.

Jan?

Calcitonin gene-related peptide, or CGRP, has been implied as an important mediator in migraines since quite some time.

And it has been shown by small molecules that you can reduce, then, the acute migraine symptoms by giving oral agents.

The problem with those agents were that, yes, they proved the hypothesis that CGRP is an important mediator.

But they were not safe for chronic use, because they had liver toxicity.

That's why I think the antibody, in a way, comes in with an open door where the mechanism has been proven; and antibodies, as we have seen with ours, are generally safer.

So they are more appropriate, also, then for potentially chronic use.

And as you know, we described the positive data from a proof of concept study recently where the effect then in chronic migraine was shown reducing the migraine headache days and also migraine attacks then in so-called episodic migraine.

So what we're doing now with this molecule is to do some more dose ranging and studying and preparations then for Phase III.

And we also recently announced that we will start a study on osteoarthritis also for this agent.

Okay.

Great, Jan.

Thank you.

Dave, any comments?

No.

Okay.

Ilissa?

Thanks, Vamil, for the question.

So while you're correct that we don't have any detailed data readouts listed for our immunology portfolio, we are expecting internal data readouts in the second half of this year, starting with ixekizumab, followed by tabalumab, and then towards the very end of the year, the first trial will read out for baricitinib.

Those trials should have detailed data readouts starting in 2015.

I'll also remind you that we're expecting top line results, as well, for our basal insulin Peglispro in diabetes for the type 1 trials.

And that will be in the third quarter of this year.

And as has been our past practice, Vamil, I think you should expect that the various trials that Ilissa just mentioned would lead to top line press releases providing an updated high level on whether or not the trials have met their endpoint, so what kind of safety profile we've seen and some of our thoughts on next steps for those molecules.

One I might mention that's broader across the portfolio, the REACH trial of ramucirumab in hepatocellular cancer, I think, is quite possible and likely that we would have detailed data presented at a medical meeting before the end of the year that should give us some additional insights into the commentary we've provided around the subgroup data that we found to be quite interesting.

And then also for ramucirumab, there's the colorectal data that would also read out towards the end of this year, possibly early next year, and could have a top line readout, as well.

Okay.

Thank you.

Thanks for the questions.

Tawny, next caller, please.

Colin Bristow, Bank of America Merrill Lynch.

Thanks for taking the questions.

On GLP 1's, we should see Phase II data for Novo's oral GLP 1 in Q2 2015.

I was just wondering if you'd give us your thoughts on this approach and how you view it as a potential competitive threat to the GLP 1 market, as well as the DPP4s and SGLT2s.

On SGLT2 fixed combos, one of you competitors has stated that they view the approval of these as a significant inflection point for the acceleration of cost growth.

I'm just wondering how you're thinking about this opportunity and do you share this view?

And then finally, just on the basal insulin peglispro, I think I heard you say that the US filing was going to be 1Q 2015 or earlier.

What are the factors that could lead to an earlier filing, and how soon could this be?

Thanks a lot.

Great, Colin.

Thank you very much for the questions.

And those are all directed Enrique Conterno.

Enrique?

Thanks.

On oral GLP 1s, we have said that this is an area that is attractive and is an area that we're very much looking at, as well.

One comment, I think your question is probably more appropriate for one of our competitors.

When it comes to the fixed dose combination, if you are referring to the fixed dose combination between a GLP 1 and insulin, we clearly see the combination of a GLP 1 and insulin as important therapy.

We do believe with dulaglutide and our insulin portfolio, we can provide very significant value when it comes to providers and payers.

We do believe that the restriction that is imposed by having a fixed dose combination in this particular case, in a certain way, takes away from the flexibility that endocrinologists want and need, given how insulin is titrated.

They're giving some indications here that I should also comment about the SGLT 2s and DPP4 fixed dose combination.

We do believe this is an important product for us.

Of course, we are developing this with Boehringer Ingelheim.

We have submitted this in the US, and we believe we are significantly ahead of our competition.

Today, about 25% of the SGLT 2 use is on top of a DPP4.

So that gives you a sense of the possibilities for overall class growth and branding growth and the impact that these fixed dose combinations could have.

Finally, you asked about whether we could file earlier than Q1 basal insulin peglispro.

That is a possibility.

But at this stage, I think what we said is we will file by Q1.

Clearly, we are working on getting the readout for our type 1 studies.

And we expect that we are going to be seeing this later this quarter, and we expect a press release together with that.

Great.

Thank you, Enrique.

Next caller, please.

Jeff Holford, Jefferies.

I've got two questions around insulin glargine product.

Firstly, can you give us a bit more color on why you've added the three mil cartridge to your filing, and does this potentially relate to being able to come to the market with a product such as the Opticlick device which [Ipsimed] had previously there to try and get around some of the [solar star] patents.

And then secondly, can you just update us a bit more on your thoughts around timing of European launch and what kind of presentation the product would have, in terms of device or not?

Thank you.

Great, Jeff.

Thank you for the questions.

We'll stay with Enrique.

Sure.

On insulin glargine, we have submitted two separate NDAs.

You're right.

One for pre filled pens and one for insulin -- for cartridges.

Clearly, those are two independent NDAs.

And we have been sued on each one of them.

So that's all I will say, basically, at this stage.

But we will be intending to basically oppose the patent expirations and resolving the ongoing litigation to be able to bring both of those to the market.

Your second question was related to Europe.

Clearly, the patent expiration for Lantis is in 2015.

And we are expecting tentative approval this year.

So we are very much in our preparation, but that's as much as I can comment.

Of course, we take very seriously the patents that are in place, and we will launch after those patents have expired.

Thanks very much.

You're very welcome.

Tawny, next caller, please.

Alex Arfaei, BMO Capital Markets.

Good morning.

Thank you for taking the questions.

A question on ramucirumab for second line metastatic colorectal cancer.

My understanding is that the Phase III trial, those patients could have been treated with Avastin first line.

So how should we think about the process of this trial, given the similar mechanism of action and given the clinical profile we've seen with ramu so far?

Thank you.

Thank you very much, Alex.

Sue Mahony, please.

Yes, Alex, you're right.

This is a second line trial, after Avastin in first line.

Clearly, we'll wait and see what the data shows.

We'll have that data towards the end of this year, and we'll be announcing top line and then we'll be planning to present it at a scientific meeting next year.

So I think it's too early to speculate, at this point.

We'll have to see what the data shows us.

Okay.

Great.

Thank you very much.

And Tawny, next caller, please.

Marc Goodman, UBS.

My first question is how are you thinking about the Biologic psoriasis market?

There's several players there.

So are you thinking about your product being differentiated?

Second, there was a comment earlier on the call about an adjustment in the US for managed Medicaid.

How big was that adjustment?

Can you just explain what happened there?

And then third, just on the insulin products, any major changes in the quarter?

Humalog, Humulin seemed to be bouncing around first quarter, second quarter quite a bit relative to what I would have thought the scripts were doing.

So if you could just give us a sense of what's going on there.

Thanks.

Absolutely happy to, Marc.

Thanks for the questions.

Dave Ricks, we'll have you go ahead and start with the Biologic market, in particularly looking at psoriasis.

Derica, if you'd comment, please, on the managed Medicaid situation.

And then Enrique, for the US insulin sales trends we've been seeing.

Dave?

Yes, thanks, Marc.

As it relates to psoriasis treatment, we've seen a rapid growth of TNF use over the last decade in treating moderate to severe psoriasis.

And then more recently, of course, alternates mechanism with Stellara, which has been met with great success in the market.

We believe Aisle 17s are another step forward in therapy for patients with moderate to severe psoriasis.

And you can see some of the Phase II and Phase III readouts from the three competitors, which are all sort of neck and neck in the very last stages of testing here.

The promise of the class is really to move the standard of what good is from a PASI 75 clearance to really something north of that, PASI 90 or total clearance, which can now be possible for these patients who suffer from this difficult condition.

And we see Aisle17s delivering PASI 100, or complete clearance, substantially above both anto TNFs and Stellara.

So that's the value proposition for the class.

Within the class, of course, we have our own differentiation strategy, which includes, of course, efficacy.

We'll have to see the safety as it bears out.

And then dosing regimens, which are all different between the various players.

We have not disclosed or read out our Phase III program, and that will be coming soon in a top line fashion.

So we'll wait to say any more until when we see those data in a complete form.

But we're bullish on the class.

Excellent.

Great.

Thanks, Dave.

Derica?

Hello, Marc.

As it relates to the US and the managed Medicaid, this is really us, as we got additional receipts in from customers, we were able to true up their accruals and the provisions on our books.

Dollar wise, it's about $60 million which, in effect, was about 2 percentage points of growth in the US.

So just as a reminder, our US overall sales was down about 30%.

If you were to exclude the impact of the Cymbalta and Evista patent expirations, our growth was a positive 13%, which was about 8 percentage point of price, 5 percentage points of volume.

So of that 8 percentage points of price, 2 percentage points of that was the managed Medicaid adjustment.

Excellent.

Thank you, Derica.

Enrique?

Sure.

Marc, you are correct.

When we look at the underlying script growth for our insulin business in the US, Q1 and Q2 are very comparable.

But we do see, in terms of our reported sales, we were at minus 1 for Humalog in Q1 and we were 17% growth for Q2, so a big difference there.

Let's remember that in Q1, we had a significant wholesaler destocking that impacted the growth rate.

In the case of Humalog, that impact was 8 to 9 percentage points in Q1.

So that explains part of the difference.

And in Q2, we just discussed managed Medicaid.

In the case of Humalog, that impact was 4%.

So those where we had, I guess, some very unique impacts to each one of those quarters.

Thank you, Enrique.

Tawny, next caller, please.

Damien Conover, Morningstar.

Great.

Thanks for taking the questions.

Just a follow-up on the insulin franchise.

Just had a question for the pricing power within -- with Humulin.

It looks like a very strong growth in the US with price.

And I wanted to understand that in the context of the Express Scripts negotiations on getting on the formulary there, but still being able to drive some price.

Wondering if that price is coming from customers outside that formulary, or if that formulary still allows for some pricing power?

And then secondly, when you think about the renegotiations with the PBMs, and we're likely to see the formularies in August, wanted to see if anything strategically has changed with the negotiations there after you've had a couple quarters here of a more aggressive negotiation that happened last year?

Thank you.

Excellent, Damien.

Thank you for the questions.

Enrique Conterno.

Sure.

On Humulin, a big part of our human insulin franchise, in the case of Humulin, is that we have a very unique product in Humulin U500, which basically has significant growth and where the pricing pressures are not as high as with the rest of the insulin franchise.

And you basically see some of that reflected in terms of both price and volume.

Your second question related to our ongoing discussions or negotiations with the PBMs and payers.

I won't be able to share much in that front.

Damien, thanks for the questions.

Tawny, next caller, please.

Gregg Gilbert, Deutsche Bank.

Thanks, and good morning.

I wanted to go back briefly to the inversion subject.

And for John and Derica, companies that have done inversions almost always claim that tax efficiency is a secondary sort of effect.

So I'd like to hear how you and the Board's thinking, John, on this subject has evolved over the past year or so.

And sort of a nit picky follow-up.

Derica, you indicated that Lilly isn't considering, or doesn't generally agree with large scale M&A for Lilly.

But would a $20 billion to $30 billion deal, definitionally, be considered large scale M&A?

Thanks.

Great.

Thank you very much for the questions.

Welcome back to the fold.

I wasn't expecting to hear you on the call, but it's great to hear your voice.

Derica, for the inversion and the definition of large scale, please.

Well, to me $20 billion to $30 billion is a pretty large number.

At least from my basic math class in Alabama.

So maybe the rest of the question is moot, then.

(Laughter)

But again, even as we are preparing to go through our series of patent expirations, and there was a lot of speculation of what others thought we needed to do to manage our way through this, this tough period for -- in the history of Lilly.

And clearly, large scale M&A was one of the options that was on the table.

Again, as we looked at all the data, both looking at other transactions by other firms, that historically there is that near-term benefit you can gain; but longer-term, the core to this industry, and we believe the core to our business as Lilly, is your ability to innovate and get new molecules out of your labs that create clinical differentiation.

And so that's what we've chose to focus and expend our energy.

So when we think about business development transactions, ways that we can augment that innovative platform or footprint for us, we're absolutely interested in.

Things that would begin to create a distraction and could begin to hampen or dampen our ability to produce new innovative research and development are things that we're really quite not interested in at the moment.

And for us, it's been a combination of those smaller deals bolting on to our organic strategy.

And I see that being the path going forward.

Gregg, it's John Lechleiter.

It's nice to hear from you.

I think the only other comment I would make is, look, I think that the activity around inversions right now just points to a failure of our US tax code.

And it really keeps American companies, not just pharma industry, but across industries, from being competitive with their overseas counterparts.

It's really, we've been talking about tax reform -- I think the first TV interview I gave when I became CEO in 2008, a big discussion was tax reform.

We need a lower rate.

We need a territorial system.

We don't need Band Aid approaches in between.

It's time for the Congress to step up to the bar and get this thing done.

Thanks, gentlemen.

Thanks, Gregg.

Thanks, John.

Tawny, next caller, please.

Mark Purcell, Barclays.

Thanks for taking my questions.

Staying with diabetes, lots of questions.

But I wondered, for clarification, for the glargine product in Europe, should I expect, from some of the comments you made so far, to see this product launched in Europe in Q2 next year?

And then in terms of the SGLT2/DPP4 combo, actually you're about a year ahead.

So again, given -- heading in towards a Class 1 review, how confident you are of launching that product after the PDUFA early 2015.

Straying away from diabetes and thinking about your margin targets and where you're heading with a very broad pipeline.

Some of these areas you're heading into are fairly crowded.

There could be some serious battles in primary care and cholesterol.

Obviously, there's some entrenched competition, increasing competition in the immunology space.

So how do you consider going alone on some of these assets, outside your query for the moment, versus partnering with players already in the space?

And then lastly, clearly some very rigorous management question on R&D costs, as you mentioned several times on the call.

Should we be more comfortable now towards the lower end of your guidance range for SG&A and R&D cost lines for the full year, or will that phasing effect, such as initiation of new R&D trials which we need to be alerted to, at this point?

Thanks a lot.

Great, Mark.

Thank you for the questions.

We'll have Enrique take the questions on the insulin glargine and the European Union, and then thoughts on the launch timing for SGLT2/DPP4 combo.

And then for the going alone versus partnering, how we think about that given some of the investments required to compete in these marketplaces, Derica, if I'd ask you to maybe make a comment.

Dave, since some of these fall into your business, in particular, if you want to make comments as well, please feel free to.

And then Derica, if you'd comment on the lower end of the guidance ranges we've got for SG&A and R&D, and how people should be thinking about where we're tracking.

Enrique?

So when it comes to glargine in Europe, as I mentioned, we are expecting to launch after the patent expiration in Europe.

I do not believe that I provided an exact date on that.

But clearly, we are undertaking all of the preparations so that we can do that.

When it comes to the SGLT2/DPP 4 combination, the empalina combination, we had shared that we have submitted that.

We shared that early this year, which basically puts us with an action date of early 2015.

Great.

Thank you, Enrique.

Derica?

Mark, I'll start with the guidance, in terms of operating expenses.

I'm not able to guide the investment community to one end or the other of the range.

What I can say is we feel very good about meeting those goals that we established for the year, and we feel very confident that we'll be within the ranges that we provided.

As it relates to, I guess, your earlier question also around -- as we look at our portfolio, the good news is that we believe we've produced an abundance of clinical opportunities in our pipeline.

And some of those are some of our core areas, and some of those are maybe outside or tangental.

Clearly, we'll be able to evaluate each of those molecules and decide which path we choose to pursue, as we consider each one of those.

But the good news is that we have optionality.

And Dave, I don't know if there's anything you'd like to add to that.

Nothing more than we always look, I think, almost for every asset, at options to partner, either to share risk, if it's a clinical stage asset, or as the asset matures, trade value.

Sometimes by accessing reach, sometimes by capability, or there's other unique sort of portfolio fits or portfolio trade options that manifest themselves.

So we're open-minded about all that.

But it has to make sense, in terms of value creation.

And we're not going to talk about those in advance, in this setting.

But I think that's our mindset as it relates to partnering.

Excellent.

Thanks, Dave.

Tawny, next caller, please.

Disregard.

They have disconnected.

Thank you.

Having exhausted the queue, I'll turn it over to John to close our call today.

John.

Okay.

Thanks, Phil.

And I'll be brief.

To all of those on the call, we appreciate your continued interest in Lilly.

Our performance, once again, is in line with our expectations this quarter.

We're on track to meet our 2014 financial goals, and continued progress advancing the pipeline places us on track to return to growth and margin expansion post-2014.

We believe our strategy is the right one for Lilly to create value for patients, for physicians, payers, and of course, our shareholders.

And our ability to execute so far gives us increasing confidence that Lilly is indeed poised for growth.

As always, you can expect we'll keep you apprised of our progress.

Thanks again.

Thank you, ladies and gentlemen,.

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