2. Obesity May Wipe Out Benefit of
Anti-Smoking Effort, Study Says Obesity and the Economy
From Crisis to Opportunity
Nature and Nachos:
How Fat Happens
Science explains the factors that make
us vulnerable; nutritional labels Nearly 10% of Health
explain the rest Spending Due to Obesity
Ex-military leaders: Young adults 'too fat to fight'
Arena Pharmaceuticals, Inc. 2
3. Today’s Agenda
• Today’s dissatisfied weight management market
– Addressing the needs of patients and physicians
• Clinical overview of lorcaserin
– Phase 3 program and results
– October 22, 2010, PDUFA date
• Lorcaserin’s market opportunity
– Market research
– Building a foundation for launch
– Global patent coverage
• Corporate snapshot
– Pipeline: opportunities beyond lorcaserin
– Financials as of March 31, 2010
– Upcoming milestones
Arena Pharmaceuticals, Inc. 3
4. Forward-Looking Statements
This presentation includes forward-looking statements that involve a number of risks and
uncertainties. Such forward-looking statements include statements about the potential of
lorcaserin and other compounds and programs, including about lorcaserin’s approvability,
regulatory guidance, commercialization opportunities, financing, whether, when and how we and
our collaborators continue to develop compounds, patents, upcoming milestones and news, our
strategy, technologies, future opportunities, potential achievements, goals and expectations, and
other statements that are not historical facts, including statements which may be preceded by the
words “potential,” “believe,” “expect,” “predict,” “continue,” “likely,” “unlikely,” “anticipate,”
“estimate,” “optimistic,” “intend,” “plan,” “project,” “target,” “aim,” “will,” “may” and similar
words. For such statements, we claim the protection of the Private Securities Litigation Reform
Act of 1995. You are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the time they were made. Factors that could cause actual results to differ
materially from the forward-looking statements include, but are not limited to, our ability to
obtain adequate funds; regulatory authorities may not find our clinical or other data sufficient and
may not approve lorcaserin or any of our other drug candidates to be marketed in the United
States or elsewhere; our ability to enter into agreements with pharmaceutical companies to
commercialize lorcaserin or partner other of our compounds or programs; the timing, success and
cost of our clinical, research and development programs; results of clinical trials and other studies
are subject to different interpretations and may not be predictive of future results; our ability to
obtain and defend our patents; and the timing and receipt of payments and fees, if any, from our
collaborators. Additional factors that could cause actual results to differ materially from those
stated or implied by our forward-looking statements are disclosed in our SEC filings. We disclaim
any intent or obligation to update these forward-looking statements, other than as may be
required under applicable law.
Arena Pharmaceuticals, Inc. 4
8. Phentermine Is The Most Prescribed Obesity Drug
Oral Anti–Obesity Drugs TRx Share for Qtr 2, 2008
(54,883) (101,188)
(261,782)
(1,654,282)
Total Rx’s 2,072,135
Note: “Others” primarily consist of amphetamines
Source: Wolters Kluwer Health
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9. Addressing the Needs of Physicians & Patients
• Physicians want new treatments with new mechanistic approaches
– Improved risk/benefit profiles
– Better, longer-term treatment
• Physicians want safe and effective drugs their patients can tolerate
– Safety is of paramount importance
– Treatment duration that enables patients to reduce weight and sustain loss
• Physicians want weight loss to translate into improved health
– Improve quality of life
– Avoid increased risk of depression or anxiety
– Parameters such as blood pressure, cholesterol, triglycerides and heart rate
should move in the right direction
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10. Weight Loss Improves CV Risk Factors
5% - 10% Weight Loss
HbA1c (1)
Blood Pressure (2)
Total Cholesterol (3)
HDL Cholesterol (3)
Triglycerides (4)
T2 Diabetes (5)
Risk of T2 Diabetes (6)
1. R Wing et al. - Arch Intern Med. 1987;147:1749-1753 4. H Ditschunheit et al. - Eur J Clin Nutr. 2002;56:264-270
2. I Mertens, L Van Gaal - Obes Res 2000;8:270-278 5. American Heart Association
Slide Source:www.obesityonline.org
3. G Blackburn - Obes Res 1995;3 (Suppl 2):211S-216S 6. “Diabetes Prevention Program” - N Engl J Med. 2002;346:393-403
Arena Pharmaceuticals, Inc.
12. Lorcaserin for Weight Management
• Novel single agent discovered and developed internally
• Selective drug candidate with the right combination of Phase 3 efficacy,
safety and tolerability to be potential first-line therapy
• First in a new class of serotonin 2C receptor agonists
– Stimulation of 2C receptor strongly associated with feeding behavior and satiety
• Global composition of matter patent coverage of NCE
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13. Completed Pivotal Program: BLOOM & BLOSSOM trials
Lorcaserin: Robust Phase 3 Program
Primary endpoint for all trials: % of patients ≥ 5% weight loss at 52 weeks
Trial BLOOM BLOSSOM BLOOM-DM
Status Complete Complete Fully enrolled
Patients 3,182 4,008 604
Treatment Two years One year One year
duration
Daily dosing 10 mg BID 10 mg QD & BID 10 mg QD & BID
vs. placebo
Echo Screening, 6, 12, 18, Entry, 6, 12 months Entry, 6, 12 months
monitoring 24 months
Echo FDA valvulopathy None None
exclusions
Efficacy Weight loss at 1 yr
Weight loss at 1 yr Weight loss at 1 yr
endpoints Wt loss maintenance in yr 2
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14. BLOOM & BLOSSOM Baseline Demographics
Baseline Demographics
Age 44 years
Gender
Men 16-22%
Women 78-84%
Weight 100 kg
BMI 36
Ethnicity
Caucasian 66-68%
African American 19-20%
Hispanic/Latino 11-13%
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15. Approvable Categorical Weight Loss (MITT)
Lorcaserin 10 mg BID
Placebo
Categorical Weight Loss at Week 52 (MITT-LOCF)
*p < 0.0001
BLOOM BLOSSOM
47.5% 47.2%
50 * *
40
% of Patients
30 22.6% 25.0% 22.6%
20.3% * *
20
7.7% 9.7%
10
0
>5% Weight Loss >10% Weight Loss >5% Weight Loss >10% Weight Loss
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16. Benefit of Long-Term Treatment (Per Protocol)
Lorcaserin 10 mg BID
Placebo
Categorical Weight Loss at Week 52 (Per Protocol)
*p < 0.0001
80
BLOOM BLOSSOM
66.4%
* 63.2%
60 *
% of Patients
36.2%
40 35.1%
32.1% * 34.9%
*
20 13.6% 16.1%
0
>5% Weight Loss >10% Weight Loss >5% Weight Loss >10% Weight Loss
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17. Pivotal Program Efficacy Highlights:
Lorcaserin Patients Completing 1 Year of Treatment
35 lbs Average weight loss for top quartile of BLOSSOM patients
31% Average excess body weight lost by BLOOM patients*
17 lbs Average patient weight loss
>10% Weight loss achieved by over one-third of patients
8% Average patient weight loss
>5% Weight loss achieved by about two-thirds of patients
* Based on normal BMI of 25 kg/m2
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18. Secondary Endpoints Improve:
Combined Pivotal Trial Data
Measurement Improved Measurement Improved
BMI Yes Fasting glucose Yes
Waist Circumference Yes HbA1c Yes
Total Cholesterol Yes Systolic BP Yes
HDL cholesterol Yes Diastolic BP Yes
LDL cholesterol Yes Heart Rate Yes
Triglycerides Yes Quality of Life Yes
MITT-LOCF vs. placebo
Importantly, blood pressure and heart rate decreased
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19. Lorcaserin was Very Well Tolerated
Most Frequent Adverse Events in BLOOM and BLOSSOM
Year One
BLOOM
Lorcaserin Placebo
Headache 18.0% 11.0%
Upper respiratory infection 14.8% 11.9%
Nasopharyngitis 13.4% 12.0%
Dizziness 8.2% 3.8%
Nausea 7.5% 5.4%
Lorcaserin Lorcaserin
BLOSSOM 10 mg BID 10 mg QD
Placebo
Headache 15.6% 15.6% 9.2%
Upper respiratory infection 12.7% 14.6% 12.6%
Nasopharyngitis 12.5% 11.9% 12.0%
Nausea 9.1% 7.6% 5.3%
Dizziness 8.7% 6.2% 3.9%
Headache was the only AE that exceeded placebo by >5%
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20. Pivotal Program Safety And Tolerability
Lorcaserin
Patients started on full dose, without a titration period
2-year data supporting long-term safety profile
Very well tolerated
Low incidence of withdrawals due to AEs
No increased risk of cardiac valvulopathy
Improved quality of life
Rates of depression, anxiety and suicidal ideation similar to placebo
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21. Creating Value in 2010
Lorcaserin NDA accepted for filing
Tentatively scheduled September 16, 2010, Advisory Committee meeting
Assigned October 22, 2010, PDUFA date
Upcoming Lorcaserin Milestones
Peer-reviewed publications
Lorcaserin Advisory Committee meeting
BLOOM-DM Phase 3 results
FDA approval
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23. Potential to Re-Energize Weight Management
If approved, lorcaserin has the potential to serve as
first-line therapy for the majority of overweight* and obese patients
Market research indicates that surveyed physicians expect to:
• Replace currently available agents with lorcaserin as
first-line therapy
• Expand the weight management category to patients
not currently receiving pharmacotherapy
* BMI ≥27 with at least one co-morbidity
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24. Building a Foundation for Launch
Goal: Establish an agreement with a pharmaceutical
company to commercialize lorcaserin
Building a foundation for the anticipated launch:
• Swiss manufacturing facility
• Weight management market research
• Commercial readiness
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25. Global Patent Coverage
Percent of Global Pharmaceutical
Sales Covered by Lorcaserin Patents*
• Composition of matter patent
Pending issued in major jurisdictions,
3.0%
including US, Europe, Japan,
Canada and China
• First expiration is 2023 in most
jurisdictions - does not include
any patent term extensions
Lorcaserin represents a significant
Issued
93.5%
global commercial opportunity
* IMS Health, 2008 sales
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27. Pipeline: Sustaining Innovation
Program / Indication Preclinical Phase 1 Phase 2 Phase 3 NDA
Lorcaserin
Weight Management
APD916
Narcolepsy and Cataplexy
APD791*
Arterial Thrombosis
APD811
Pulmonary Arterial
Hypertension
APD597 Ortho-McNeil-Janssen
Type 2 Diabetes
Cardiovascular
Central Nervous System
Inflammatory Diseases Research Programs
Metabolic Diseases
* Not currently in active development
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28. APD916 for Narcolepsy & Cataplexy
• Market
– Narcolepsy is not rare, but is underrecognized and underdiagnosed(1)
– Narcolepsy affects about one in every 2,000 Americans(1)
• Current treatment
– Treatments are limited and consist of:
− Stimulant drugs to suppress daytime sleepiness
− Antidepressants for cataplexy
• APD916
– Potent and selective inverse agonist of histamine H3 receptor
– Potential to treat narcolepsy and cataplexy by increasing central
histamine activity
• Status
– Entered Phase 1 March 2010
1. National Institutes of Health
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29. Ortho-McNeil-Janssen Collaboration
• Developing orally-active compounds for type 2 diabetes by
targeting GPR119
• Lead compound APD597 in Phase 1
• GPR119 agonists are first-in-class therapeutics targeting a novel
pancreatic beta cell receptor
• Eligible to receive $295M per compound + double-digit royalties
• As of 3/31/10, we have received total payments of $52.5M
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30. Arena Finances
For the Quarter Ended March 31, 2010
(in millions)
Total Revenues $2.5
Expenses:
Cost of manufacturing services 1.9
Research and development 18.3
General and administrative 7.0
Amortization of acquired technology 0.5
Total operating expenses 27.7
Total interest and other expense, net (6.1)
Net loss $(31.3)
Balance Sheet Data as of March 31, 2010:
Cash, cash equivalents and short-term investments $107.6
Total assets $227.3
Total stockholders’ equity $68.7
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31. Creating Value in 2010
Upcoming Milestones
Peer-reviewed publications
APD916 Phase 1 results
Collaboration updates
Lorcaserin Advisory Committee meeting
BLOOM-DM Phase 3 results
FDA approval of lorcaserin
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