Eli Lilly and Company Investment Community Meeting

Transcription

1 Eli Lilly and Company Investment Community Meeting October 3, :30 a.m. 12:30 p.m.

2 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. The company's results may be affected by factors including, but not limited to, the risks and uncertainties in pharmaceutical research and development; competitive developments; regulatory actions; litigation and investigations; business development transactions; economic conditions; and changes in laws and regulations, including health care reform. For additional information about the factors that affect the company's business, please see the company's latest Forms 10-K and 10-Q filed with the Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements. 2

3 Lilly Diabetes Enrique A. Conterno Executive Vice President and President, Lilly Diabetes Report to the Investment Community Eli Lilly and Company October 3,

4 Diabetes Global Epidemic If current trends continue, 1 in 3 U.S. adults will develop diabetes in their lifetime by Centers for Disease Control, August

5 Diabetes Market Opportunities $65B GLPs Orals Insulin $6B $27B Potential Future Lilly Diabetes Portfolio $3B $14B $36B Dulaglutide* Trajenta Empagliflozin* Humalog $19B 2012 Market Actual* 2018 Market Estimates* *IMS Health Disease Insights (scaled to WW and indexed for Net Effective Pricing), September 2013 $31B Humulin Basal Insulin Peglispro* New Insulin Glargine Product* * Molecules not approved 5

6 Competitive Landscape in the U.S. Oral DPP-4 Tradjenta Januvia Omarigliptin Onglyza SGLT-2 Empagliflozin Ertugliflozin Forxiga Invokana GLP-1 Dulaglutide Victoza Semaglutide Byetta / Bydureon Lyxumia Albiglutide Insulins Human Humulin Novolin Insuman Basal Analog New Insulin Glargine Product Levemir Lantus Rapid Analog Humalog NovoLog Apidra Novel Basal Basal Insulin Peglispro Tresiba/ Ryzodeg New Lantus U300 Source: Various pharmaceutical manufacturer websites; Decision Resources Market Analyzer; Monitor Deloitte research; Deutsche Bank Pipeline Report Molecules in italics not approved 6

7 Lilly Diabetes Uniquely positioned We have an attractive base business anchored by Lilly s insulin franchise and Trajenta with partner Boehringer Ingelheim. We have the potential to expand our diabetes portfolio with as many as four new medicines in next three years, each of which has opportunity to compete effectively. This comprehensive portfolio and its potential for combinations and solutions offers a unique opportunity to meet the needs of patients. 7

8 Lilly Diabetes Key Events in 2013 Building momentum Phase 3 data external disclosure / internal readouts: Initial trials of dulaglutide for type 2 diabetes Initial trials of empagliflozin for type 2 diabetes 1 Initial trials of basal insulin peglispro for type 1 and type 2 diabetes Trials of new insulin glargine product for type 1 and type 2 diabetes 1 Regulatory submissions: Dulaglutide for type 2 diabetes Empagliflozin for type 2 diabetes 1 New insulin glargine product for type 1 and type 2 diabetes 1 Insulin lispro U-200 denotes that an event has occurred 1 in collaboration with Boehringer Ingelheim 8

9 Lilly Diabetes Key Events in 2013 Building momentum Phase 3 data external disclosure / internal readouts: Initial trials of dulaglutide for type 2 diabetes Initial trials of empagliflozin for type 2 diabetes 1 Initial trials of basal insulin peglispro for type 1 and type 2 diabetes Trials of new insulin glargine product for type 1 and type 2 diabetes 1 Regulatory submissions: Dulaglutide for type 2 diabetes Empagliflozin for type 2 diabetes 1 New insulin glargine product for type 1 and type 2 diabetes 1 Insulin lispro U-200 denotes that an event has occurred 1 in collaboration with Boehringer Ingelheim 9

10 Humalog Global performance Humalog Unit Evolution (MMUs) Q Unit Growth CAGR = 7% Humalog Growth Mealtime Analog Mkt Growth US 4% 4% ACE 5% 5% Japan 0% -1% EMBU 28% 26% Source: IMS MIDAS database. All data is Humalog units. 3 month moving average. Humalog brand includes Humalog, Humalog Mix25 and Humalog Mix50 as well as Liprolog and Liprolog Mix. Note: This is an estimate derived from the use of information under license from IMS Health information service. 10

11 Humalog and Humulin Focused on innovation and the customer experience We will compete with incremental innovation that helps provide a better experience for patients Small vials Savvio * Humulin U-500 Lispro U-200 ** We will continue to look for additional opportunities to differentiate Savvio * Savvio is not approved in the U.S. ** The safety and efficacy of the agent under investigation has not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. 11

12 Tradjenta U.S. share of market 30% NBRx, NRx, TRx SOM DPP-4 Franchises including FDCs 60% NBRx SOM ENDOs Monotherapy excluding FDCs 25% 50% 20% 40% 33% 7% 15% 30% 10% 20% 5% 10% 0% 0% 12-Jun 12-Jul 12-Aug 12-Sep 12-Oct 12-Nov 12-Dec 13-Jan 13-Feb 13-Mar 13-Apr 13-May 13-Jun Onglyza NBRx Tradjenta NBRx Tradjenta NRx Tradjenta TRx Tradjenta Januvia Onglyza Source: IMS National Prescription Audit 12

13 Trazenta Japan Market and market share evolution USD billions DPP-4 Revenue and DOTs CAGR = 86% 12 months ending June DOT thousands Trazenta Market Share of DPP-4 Revenue 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% Oct 2012 Nov Dec Jan 2013 Feb Mar Apr May June Revenue Source: IMS Monthly Midas DOTs Increased momentum after approval of Trazenta as an add-on to other diabetes therapies Source: IMS Japan Pharmaceutical Market 13

14 Lilly Diabetes Late-Stage Pipeline The following assets are part of the Lilly-Boehringer Ingelheim collaboration: Trajenta, Empagliflozin, New Insulin Glargine Product. *The safety and efficacy of the agents under investigation has not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated. 14

15 Lilly Diabetes Late-Stage Pipeline Broad portfolio offers additional options ORALS MARKETED INSULINS The following assets are part of the Lilly-Boehringer Ingelheim collaboration: Trajenta, Empagliflozin, Jentadeuto, Empa+Lina, Empa+Met IR, Empa+Met XR, and Lina+Met XR. *The safety and efficacy of the agents under investigation has not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated. 15

16 Empagliflozin Clinical Profile Trial Comparator Reduction from Baseline in HbA1c* Reduction in Body Weight Reduction in Systolic BP Phase 3 studies met primary objectives EMPA-REG MONO (monotherapy) EMPA-REG MET (add-on to met) EMPA-REG METSU (add-on to met + SU) EMPA-REG BASAL (add-on to basal insulin) EMPA-REG RENAL (renal study) EMPA-REG PIO (add-on to pioglitazone + met) Data presented at ADA 2013 Placebo Placebo Placebo Placebo 10mg only Placebo mild/moderate RI Placebo = statistically significant reduction achieved *primary endpoint RI = renal impairment Safety profile: Increased incidence of genital infections Overall similar incidences of UTIs with empa and placebo. Increased incidence in women vs. placebo. LDL and HDL cholesterol increased Incidence of hypoglycemia similar to placebo, except in combination with SU where increased incidence compared to placebo was observed Submitted in U.S., EU, and other geographies 16

17 Dulaglutide Clinical Profile Trial AWARD-1 (combination with met + pio) AWARD-2 (combination with met + SU) AWARD-3 (monotherapy) AWARD-4 (combination with Insulin lispro) AWARD-5 (combination with met) Change in HbA1c Comparator 0.75mg 1.5mg Exenatide BID Superior Superior Glargine Non-inferior Superior Metformin Superior Superior Glargine Superior Superior Sitagliptin Superior Superior Phase 3 studies met primary objectives 58% - 78% of patients on 1.5mg achieved ADA goal of HbA1c < 7% (AWARD-1, 3, 5) * Safety profile: Most common adverse events in AWARD-1 through 5 were GI related In AWARD-1, 3, and 5, nausea was mostly mild to moderate, transient, and typically occurred in the first few weeks of therapy * Ongoing studies: AWARD-6 (H2H vs liraglutide 1.8mg) AWARD-7 (H2H vs glargine in patients with CKD) AWARD-8 (add-on to SU) *Detailed data have not been disclosed for AWARD-2 and AWARD-4 17

18 Dulaglutide Device Once weekly administration Can be taken any time of the day Does not need to be timed to meals Ready-to-use solution formulation No need to reconstitute or re-suspend prior to administering Small, 29 gauge needle already attached (no need for separate needle Rx) Single-use pen is specifically designed to help the injection experience Pre-installed needle is hidden from view Patient does not handle needle (attaching or detaching) Delivery process is fully automatic so patient does not need to pierce their own skin: Device inserts needle into skin, delivers dulaglutide, and retracts the needle to original hidden location 18

19 Basal Insulins Long history and expertise in insulins Infrastructure, commercial footprint, relationships, device expertise, and manufacturing capacity already in place Manufacturing technical agenda is underway Creates significant manufacturing flexibility Creates the capacity to support twice the insulin demand we have today with our current manufacturing footprint Increases our insulin gross margin percent by several percentage points 19

20 Lilly s New Insulin Glargine Product Requires substantial capabilities and expertise in diabetes therapies Compound extensively studied; all completed trials met primary and secondary endpoints Submitted in Europe under the EMA s biosimilar pathway and on track to submit in the U.S. this year Data disclosures planned in

21 Basal Insulins Unmet needs Despite 90 years of insulin use and advances in therapy for patients with diabetes, treatment remains associated with notable limitations. Unmet Needs Improved glycemic control Reduction in hypoglycemia Further simplicity Weight neutrality Reduction in mealtime insulin The Lancet 21

22 Basal Insulin Peglispro Phase 2 Results Comparable or greater improvements in glycemic control (A1c) Significantly lower rates of nocturnal hypoglycemia Associated with weight loss Reduction in use of mealtime insulin Higher overall rate of hypoglycemia in T1 patients Elevated ALT/AST levels (mean values within normal reference range) Modest increase in triglycerides and LDL cholesterol and decrease in HDL cholesterol in T1 patients with significant differences compared with insulin glargine No significant changes in any lipid parameter from baseline in T2 patients; however, significant increases in triglycerides compared to insulin glargine Phase 3 Program IMAGINE1-5 trials are fully enrolled and ongoing Initial trials will have internal data readouts in 2013 If Phase 3 studies are successful, we could submit to regulatory authorities as early as

23 Lilly Diabetes Key Events in 2014 Building momentum Potential Phase 3 data external disclosure / internal readouts: AWARD-2, AWARD-4, and AWARD-6 of dulaglutide for type 2 diabetes Remaining ongoing trials of basal insulin peglispro for type 1 and type 2 diabetes Trials of Lilly s new insulin glargine product for type 1 and type 2 diabetes 1 Potential regulatory submissions: Basal insulin peglispro for type 1 and type 2 diabetes Empagliflozin + linagliptin fixed dose combination 1 Empagliflozin + metformin fixed dose combination 1 Potential regulatory actions: Empagliflozin for type 2 diabetes 1 Lilly s new insulin glargine product for type 1 and type 2 diabetes 1 Dulaglutide for type 2 diabetes 1 in collaboration with Boehringer Ingelheim 23

24 Lilly Diabetes Positioned for growth Contribute to driving Lilly s return to growth post-2014 Successfully launch a broad portfolio that is competitive in the marketplace Continue solid performance of marketed products insulins and Trajenta 24