Eli Lilly's (LLY) CEO John Lechleiter on Q2 2014 Results - Earnings Call Transcript

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Eli Lilly and Co (LLY) Q2 2014 Results Earnings Conference Call July 24, 2014 9:00 AM ET

Executives

John Lechleiter - Chairman of the Board, President, Chief Executive Officer

Phil Johnson - Vice President, Investor Relations

Derica Rice - Chief Financial Officer, Executive Vice President - Global Services

Enrique Conterno - Senior Vice President and President - Lilly Diabetes

Dave Ricks - Senior Vice President and President, Lilly Bio-Medicines

Jan Lundberg - Executive Vice President - Science and Technology, President - Lilly Research Laboratories

Sue Mahony - Senior Vice President and President - Lilly Oncology

Ilissa Rassner, Director, Investor Relations

Analysts

Tim Anderson - Sanford Bernstein

Mark Schoenebaum - ISI Group

Jamie Rubin - Goldman Sachs

John Boris - SunTrust

Chris Schott - JPMorgan

Seamus Fernandez - Leerink

Steve Scala - Cowen

Vamil Divan - Credit Suisse

Colin Bristow - Bank of America Merrill Lynch

Jeff Holford - Jefferies

Alex Arfaei - BMO Capital Markets

Marc Goodman - UBS

Damien Conover - MorningStar

Gregg Gilbert - Deutsche Bank

Mark Purcell - Barclays

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Q 2014 earnings call. At this time, all participants are in a listen only mode. Later we will conduct a question-and-answer session. (Operator Instructions). 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.

John Lechleiter

Thank you. Good morning, everyone. Thanks for joining us today to discuss Eli Lilly and Company's second quarter 2014 earnings. As the operators said, I am John Lechleiter, Lilly's Chairman, President and CEO.

Similar to our last call, this morning we are 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 three 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 would 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 are 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 U.S. 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 3 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 U.S. 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 are pleased with the uptake we are seeing with the reports we are receiving from the sales organization and with feedback from customers on their experience to-date.

We have also 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 II 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 U.S., 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 I and Type II 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 U.S., 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 have 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 3 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 nonsquamous 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 3 SQUIRE trial studying necitumumab in first-line squamous non-small cell lung cancer. In the Phase 3 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 1 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 3 trials later this year in both advanced breast cancer and advanced lung cancer. We are pleased with the single agent activity we have seen with Abemaciclib as well as with the product 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 3 AWARD trials of dulaglutide. There was significant investor interest in the AWARD-6 trial comparing once-weekly dulaglutide 1.5 mg to once-daily liraglutide 1.8 mg. Results from this study show that dulaglutide 1.5 mg was noninferior to the highest approved dose of Victoza in the reduction of HbA1c from baseline. This is the first head-to-head Phase 3 trial of a GLP-1 to show noninferiority to liraglutide 1.8 mg 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 mg provided significantly greater reductions in blood glucose for patients with Type II diabetes. Additionally, in both studies hypoglycemia rates were lower for dulaglutide 1.5 mg treated patients compared to insulin glargine. We are very pleased with the results of these three Phase 3 studies for dulaglutide, as well as with those of the Phase 3 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 II diabetes.

In the quarter, we also issued two topline press releases for Phase 3 trials, one for our basal insulin peglispro and the other for Cyramza in second line hepatocellular cancer. We announced positive topline results for three completed Phase 3 clinical trials in patients with Type II diabetes for basal insulin peglispro, which is being studied as a once-daily treatment for both Type I and Type II diabetes. The primary efficacy endpoint of noninferior 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 topline press release this quarter on our Phase 3 trial in patients with Type I diabetes and to make regulatory filings by the first quarter of next year.

For Cyramza, we announced that the Phase 3 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 U.K. 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 have incorporated into our revised guidance for 2014.

Also, we close 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 nonprescription 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 U.K., 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 U.S., based on the U.S. 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 will turn the call over to Phil for a discussion of our financial performance for the quarter.

Phil Johnson

Thanks, John. First I will 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 seven, 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 U.S. Cymbalta sales following loss of exclusivity in December last year. In addition, U.S. 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 U.S., 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 U.S. related to an adjustment in the reserves for managed Medicaid rebates and discounts.

Gross margin as a percent of revenue decreased 4.4 percentage points, also driven by the loss of U.S. exclusivity for Cymbalta and Evista. This quarter the effect of foreign exchange rates on international inventory sold resulted in the 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 have 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 eight. 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 U.S. 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 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 the lapse of 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 nine, we provide the same reconciliation of non-GAAP adjusted information for our year-to-date results.

Moving to slide 10, you will find a reconciliation between reported and non-GAAP EPS. 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 the significant decline in U.S. Cymbalta and Evista sales, I will 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 U.S. 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, U.S. Pharma revenue declined 33%, driven by a volume decline of 36%. Excluding Cymbalta and Evista, the rest of our U.S. 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 a two 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 the consumption tax that went into effect on April 1. As expected, customer purchase 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 will 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 of 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 U.S. food animal business and in both food and companion animal products oUS was partially offset by lower U.S. 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 oUS contributing four percentage points to worldwide animal health growth.

Now let me turn the call over to Derica.

Derica Rice

Thanks, Phil. On slide 12, you will 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 the corresponding negative effect on operating income and EPS. As a result, FX caused our operating income and EPS to decline an additional two to three 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 2 testing of a biologic for diabetes and we began Phase 1 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 2 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 6.5 months of the year, we are pleased with the progress we have made on key events we laid out for you at the beginning of the year. As you can see from the green checkmarks on slide 14, we had a productive first half of the year, advancing our pipeline and sharing Phase 3 data. While I will not go through each item on the slide, I will 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 will begin Phase 3 trial for abemaciclib our CDK 4/6 inhibitor in both advanced breast cancer and advanced lung cancer. We no longer expect to move blosozumab, our antisclerostin antibody for osteoporosis into Phase 3 in 2014. The formulation we plan to take into Phase 3 produced injection site reactions at a higher rate than desired. We will conduct additional work with the formulation used in Phase 2 before moving forward.

With respect to Phase 3 data, we expect to report topline 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 have already completed this year, we continue to expect regulatory submissions this year for the fixed dose combination of empagliflozin and metformin for Type II diabetes in the U.S., 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 I and Type II 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 U.S., dulaglutide in the U.S. and Europe and our new insulin glargine product in the U.S. 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 are 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 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 pretax 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 have 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 will turn the call back over to John.

John Lechleiter

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 are poised for growth in the years ahead. Our performance is consistent with our expectations and we are 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 will turn the call over to Phil for our Q&A session.

Phil Johnson

Great. Thank you, John. Toni, we are ready for the first caller, please.

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