Eli Lilly and Company

Transcription

1 Eli Lilly and Company Strategic Diabetes Alliance with Boehringer Ingelheim January 11 th, 2011

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 such factors as 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. For additional information about the factors that affect the company's business, please see the company's latest Form 10-Q and Form 10-K filed with the Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements. 2

3 Deal Overview Global co-development and co-commercialization Boehringer Ingelheim (BI) assets: Linagliptin, a novel DPP-4 inhibitor under regulatory review in the U.S., EU and Japan BI 10773, an SGLT-2 inhibitor in Phase 3 Lilly assets: LY , a novel basal analog insulin to enter Phase 3 in 2011 LY , a new insulin glargine product to enter Phase 3 in 2011 Upon successful completion of Phase 2 development, if BI opts-in, an anti-tgf beta antibody, which recently began Phase 2 3

4 Deal Rationale These assets are worth more managed together as a portfolio, drawing upon the complementary capabilities of Lilly and BI Combined drug development and medical expertise enhances development of all compounds in clinical development Allows the companies to build, and efficiently utilize, a larger commercial infrastructure Creates an innovative, balanced portfolio Companies could offer patients and physicians treatment options spanning from early disease onset to later complications Provides Lilly greater access to large oral diabetes market in two attractive classes, DPP-4 and SGLT-2 inhibitors Potentially contributes two launches in Years YZ of products with long revenue streams Linagliptin, could launch in 2011 and has IP into mid-2020s BI 10773, could launch in 2014 and has IP into late-2020s 4

5 Summary of Key Deal Terms Up-front payment of 300 million from Lilly to BI BI eligible for total of 625 million in success-based regulatory milestone payments Lilly eligible for total of $650 million in success-based regulatory milestone payments on its basal analog insulins If BI opts-in to anti-tgf beta antibody, Lilly eligible for up to $525 million in opt-in and success-based regulatory milestone payments Lilly and BI to share equally in: On-going and future development expenses Commercialization expenses Gross margin Each innovator company eligible for performance payments tied to sales of products it originally developed 5

6 Linagliptin Overview Highly potent and highly selective DPP-4 inhibitor 5 mg once-daily dose; IC50=1nM >10,000x more selective for DPP-4 than for DPP-8 and DPP-9 Approximately 5% excreted via the kidneys; mainly excreted unchanged via the enterohepatic system Submitted in the U.S., EU and Japan for use in adult patients with type 2 diabetes as: Monotherapy Add-on to metformin, sulfonylurea, thiazolidinediones or metformin/sulfonylurea 6

7 Linagliptin Phase 3 Clinical Trials Status Trial # Duration # Patients Description Completed week 389 vs placebo in combination with pioglitazone week 503 vs placebo week 702 vs placebo in combination with metformin week 1,058 vs placebo in combination with metformin+sulfonylurea /26 week 561 vs placebo and vs voglibose (Japanese patients) week 245 vs placebo in combination with sulfonylurea /52 week 227 vs placebo in patients for whom metformin is inappropriate Fully Enrolled week 1,560 vs glimepiride both in combination with metformin /130 week 1,130 vs placebo in combination with basal insulin week 2,124 open label extension of /52 week 130 vs placebo in patients with chronic severe renal impairment Enrolling week 290 vs placebo in combination with metformin+pioglitazone week 240 vs placebo in elderly patients /52 week 240 vs placebo and glimepiride in patients with moderate to severe renal impairment week 285 vs placebo in combination with metformin week 440 vs placebo (Chinese patients) years 6,000 CV safety study vs glimepiride in high-risk patients week 260 vs placebo (Black/African-American patients) week 512 vs metformin (safety study) Note: Information from clinicaltrials.gov as of January 9,

8 Linagliptin Efficacy Summary Placebo-corrected, adjusted mean change from baseline HbA1c mean change from baseline (%) Linagliptin Linagliptin + pioglitazone vs. placebo (week 12) vs. voglibose (week 26) Initial comb + TZD Monotherapy Add-on to metformin Add-on to Met+SU Japanese study Add-on to SU Metformin ineligible patients 8

9 Linagliptin Safety Summary Cardiovascular event risk: Prospective, pre-defined meta-analysis of CV events from eight Phase 3 studies in over 5,000 type 2 diabetes patients showed linagliptin was not associated with an increase in CV risk CV safety trial initiated in 2010 Tolerability In completed clinical trials, adverse events and serious adverse events observed at comparable rates for linagliptin and placebo Pooled analysis of 12 placebo-controlled trials showed incidence of hypoglycemia with linagliptin was low and similar to placebo, unless linagliptin was administered on a background of sulfonylurea A commonly reported adverse event with linagliptin treatment was nasopharyngitis (5.9%) vs placebo (5.1%) 9

10 Linagliptin Development Program Regulatory submissions completed in the U.S., Europe and Japan in the second half of 2010 Future regulatory submissions: Fixed-dose combination with metformin o U.S. and EU in 2011; Japan in 2014 Fixed-dose combination with pioglitazone o tbd 10

11 BI Overview Potent and selective SGLT-2 inhibitor BI is potent (3.1 nm) and selective (~2700x vs. SGLT-1) SGLT-2 acts as a conduit for re-absorption of glucose Inhibition of SGLT-2 reduces the amount of glucose in the bloodstream Mechanism of action is insulin-independent Mechanistically possible for this class of drugs to reduce glucose levels without weight gain and with a low risk of hypoglycemia Phase 3 clinical testing began in mid-2010 Phase 3 clinical program evaluates BI at 10 mg and 25 mg doses In total, the Phase 3 program will enroll approximately 10,000 patients, including a cardiovascular safety trial 11

12 BI Phase 3 Clinical Trials Status/Phase Trial # Duration # Patients Description Enrolling week 468 vs placebo in combination with pioglitazone or with pioglitazone + metformin week 920 vs placebo and sitagliptin week 1,390 vs placebo in combination with metformin or with metformin + sulfonylurea years 4,000 CV safety study in T2DM patients with high cardiovascular risk week 1,400 vs glimepiride both in combination with metformin /52 week 682 vs placebo in patients with renal impairment Note: Information from clinicaltrials.gov as of January 9,

13 BI Efficacy Summary Phase 2b Study presented at EASD 2010 Objectives: Evaluated safety, tolerability, PK and PD of BI vs. placebo and vs. metformin in T2D after 12 weeks Population: T2D patients (one or no pretreatment, washed out) Dose groups: 10, 25, 50 mg q.d., placebo, metformin Patients randomized 408, ~80 per treatment group BI PBO 5mg 10mg 25mg PBO Metformin HbA1c (%) * -0.48* -0.63* * HbA1c vs PBO (%) -0.52* -0.57* -0.72* -0.82* FPG (mg/dl) * -28.9* -31.1* * BW (kg) * -2.33* -2.03* * p<0.001 vs PBO 13

14 BI Efficacy Summary Phase 1c Phase 1c presented at ADA week clinical study Study in 80 patients with type 2 diabetes Objective: Assessed safety, tolerability and PK/PD Doses: 10 mg, 25 mg, and 100 mg once daily Results showed: Peak plasma concentrations at ~1.5 hours after dosing Mean terminal half life at steady-state ranged from 13 to 17 hours Increase in urinary glucose excretion Glucose excreted in the urine was similar for all BI treatment arms Increased urinary glucose excretion resulted in proportional reductions in FPG and MDG levels 14

15 BI Safety Summary In the Phase 2b study (disclosed at EASD 2010) Reported adverse events were comparable among treatment groups Most frequently reported AEs (BI groups): o frequent urination, thirst, and nasopharyngitis. Urinary tract infection frequency was low (1.2%) and comparable to placebo (1.2%) and metformin (1.3%) Incidence of genital infections was low: mycosis (0.8%) and pruritis (1.2%) with BI versus none with metformin or placebo Rates of hypoglycemia were similar between groups 15

16 BI Development Program Depending upon patient enrollment, regulatory submissions targeted: BI o U.S. and Europe by 2013 o Japan tbd BI fixed-dose combinations with metformin and with linagliptin: o tbd 16

17 Basal Analog Insulin LY Glucodynamic Response Data generated to date have shown: Flat steady-state profile 3.0 Long half-life and duration of action Glucose Infusion Rate (mg/min/kg) Time (hr) Insulin Glargine LY Modeled From Phase 1 Data Low within patient variability Acceptable safety profile; as expected, most common reported adverse event was hypoglycemia Development status: Two Phase 2 trials initiated early 2010; results expected Q Phase 3 slated to begin H Potential regulatory submissions in

18 Basal Analog Insulin LY Lilly s new insulin glargine product Compound will be extensively studied to generate a robust data package Well positioned to compete effectively in this space, given Lilly s: knowledge of the diabetes market manufacturing know-how and infrastructure deep understanding of patient/physician needs capabilities/experience with insulin delivery devices Registration studies slated to begin in 2011 with a goal of regulatory submissions in

19 Anti-TGF beta Antibody Monoclonal antibody that selectively inhibits TGF-beta 1 isoform, a cytokine shown in pre-clinical experiments to contribute to renal fibrosis Properties of molecule support development as onceweekly subcutaneous injection Phase 2 began in late 2010 BI may opt-in upon successful completion of Phase 2 19

20 Financial Impact Economic perspective deal is value enhancing Accounting perspective: Near-term dilution due to up-front payment, launch expenses for linagliptin and Phase 3 development costs for BI 10773, partially offset by funding from BI for development of our basal insulins Greatest amount of dilution in 2011 due largely to up-front payment; total EPS impact estimated at $0.45-$0.50 per share Assuming successful launch of linagliption, progressively and significantly less dilution in 2012 and 2013, no dilution to slight accretion in 2014 and more significant accretion in 2015 and beyond 20

21 Summary Deal creates one of the most robust diabetes pipelines in the industry Provides Lilly enhanced access to large and growing oral diabetes market in two exciting product classes Supports increased reach of commercial organization Provides two potential product launches in Years YZ 21

22 22