able laboratories, inc

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ABLE LABORATORIES, INC.

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ABLE LABORATORIES, INC. Safe Harbor Statement. - PowerPoint PPT Presentation

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Page 1: ABLE  LABORATORIES,  INC

ABLE LABORATORIES, INC.

Page 2: ABLE  LABORATORIES,  INC

Safe Harbor StatementSafe Harbor Statement

Except for historical facts, the statements in this presentation, as well as oral statements or other written statements made or to be made by Able Laboratories, Inc., are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. For example, statements about the Company’s anticipated growth and future operations, the current or expected market size for its products, the success of current or future product offerings, the research and development efforts and the Company’s ability to file for and obtain U.S. Food and Drug Administration (FDA) approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company’s current predictions of future events. The statements are inherently uncertain, and actual results could differ materially from the statements made herein. There is no assurance that the Company will achieve the sales levels that will make its operations profitable or that FDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks, and uncertainties, please refer to the Company’s filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10–K and its latest Quarterly Report on Form 10-Q. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments.

Page 3: ABLE  LABORATORIES,  INC

Company Highlights

2002: Net sales - $52.9 MM vs. $19.6 MM 2001 Operating income - $10.9 MM vs. ($1.2 MM) 2001

Received 26 FDA approvals since March 2001

Robust pipeline with 15 ANDAs under review by the FDA

Generic drug manufacturer with tablet, capsule, suppository and sustained release formulation capabilities

33 products / over 40 strengths

110,000 square feet of facilities

Over 300 employees

Page 4: ABLE  LABORATORIES,  INC

Initial R&D StrategyInitial R&D Strategy

Focus on:

Products with $10 - $100 million of sales

Significant growth trends in price

Products with limited competition

Technical Barriers to Entry

Page 5: ABLE  LABORATORIES,  INC

R&D StrategyR&D Strategy

First-to-Market

Exclusive API sourcingTechnical barriers to entry

Page 6: ABLE  LABORATORIES,  INC

R&D StrategyR&D Strategy

First-to-Market OpportunitiesPatents expiredNo Generic competitorsSmaller markets

Technical barriers to entry Complex formulations

Exclusive API sourcingCustom syntheses

Page 7: ABLE  LABORATORIES,  INC

R & D Pipeline

15 ANDAs pending

23 Active projects in development

17 Products (5 pending & 12 in development) which could be first-to-market

Fiscal 2003 estimated R&D budget substantially higher than 2002 actual $6.9 million

Page 8: ABLE  LABORATORIES,  INC

Market Analysis

Market for current products $ 3.5 billion

Market for pending approvals $ 0.6 billion(10 Products - 15 ANDAs)

Market for products under development $ 2.9 billion(23 Products - 25 ANDAs)

First-to-Market (17 Prod. – 21 ANDAs): $300 million

5 Products pending approvals $ 80 million

12 Products in R&D $220 million

Page 9: ABLE  LABORATORIES,  INC

Regulatory StatusRegulatory Status

2002 Highlights:

2 cGMP and 3 pre-approval inspections with no Form 483 observations received

10 ANDA approvals received

Consent Decree dissolved February 2002

Page 10: ABLE  LABORATORIES,  INC

Approval Time LineApproval Time Line

Industry Average: 14 – 16 months

Able Average: 11 months

Excluding: Phentermines (18 months) delayed by API supplierBAC (22 and 21 months) delayed by API

supplier Tramadol patent issues (22 months)

Able Adjusted Average: 8 months

Page 11: ABLE  LABORATORIES,  INC

Sales and Marketing

Rapid expansion of customer base

5 direct sales representatives

Plans to expand salesforce

Page 12: ABLE  LABORATORIES,  INC

ManufacturingManufacturing

Manufacture Tablets, Capsules & SuppositoriesLicensed for all classes of controlled

substances 110,000 square feet in 4 building “campus”

Capital expenditures:2002 Actual - $6.4 million

2003 Estimated - $4.0 million

Scalable for next 12 months

Page 13: ABLE  LABORATORIES,  INC

3,531

5,071

7,066

9,304

12,500

15,02516,101

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

2nd Qtr '01 3rd Qtr '01 4th Qtr '01 1st Qtr '02 2nd Qtr '02 3rd Qtr '02 4th Qtr '02

Net Sales ($’s in thousands)

Page 14: ABLE  LABORATORIES,  INC

570527

816

1,020

1,708

2,215

2,002

0

500

1,000

1,500

2,000

2,500

2nd Qtr '01 3rd Qtr '01 4th Qtr '01 1st Qtr '02 2nd Qtr '02 3rd Qtr '02 4th Qtr '02

R&D Expenditures ($’s in thousands)

Page 15: ABLE  LABORATORIES,  INC

(980)

194

548

1,724

2,421

3,377 3,347

(1,000)

(500)

0

500

1,000

1,500

2,000

2,500

3,000

3,500

2nd Qtr '01 3rd Qtr '01 4th Qtr '01 1st Qtr '02 2nd Qtr '02 3rd Qtr '02 4th Qtr '02

Operating Income ($’s in thousands)

Page 16: ABLE  LABORATORIES,  INC

(980)

570

194

527 548816

1,724

1,020

2,421

1,708

3,377

2,215

3,347

2,002

(1,300)

(800)

(300)

200

700

1,200

1,700

2,200

2,700

3,200

3,700

2nd Qtr '01 3rd Qtr '01 4th Qtr '01 1st Qtr '02 2nd Qtr '02 3rd Qtr '02 4th Qtr '02

Operating income

R&D

Operating Income & R&D($’s in thousands)

Page 17: ABLE  LABORATORIES,  INC

2002 Balance Sheet Highlights2002 Balance Sheet Highlights

Year End:Cash $ 1.8 millionNet working capital $15.3 millionDeferred tax asset $17.6 millionLong-term debt $ 6.1 millionStockholders’ equity $34.7 million

Deferred Tax AssetCapitalized 2002NOL’s exceed $50 million, no impairment

Page 18: ABLE  LABORATORIES,  INC

Current CapitalizationCurrent Capitalization

Common stock outstanding 12.9 million

Series Q Preferred Stock

($4.9 Million Face Value) 2.8 million

Employee options

(Price Range $3.75 - $8.30) 2.3 million

Total “fully-issuable” shares 18.0 million

Total fully-diluted shares 17.1 million

Page 19: ABLE  LABORATORIES,  INC

Investment HighlightsInvestment Highlights

Rapid expansion of customer base

Growing net sales and operating income

Niche products generate above average margins

Aggressive R&D program and pipeline

Excellent track record with FDA

Highly talented and experienced management team

Page 20: ABLE  LABORATORIES,  INC

Thank YouThank You

Page 21: ABLE  LABORATORIES,  INC

Income Statements 2002 & 2001Income Statements 2002 & 2001($’s in thousands)($’s in thousands)

2002 2001Net sales $52,930 $19,594Cost of goods sold 27,362 12,533Gross profit 25,568 7,061 Gross margin 48.3% 36.0%

SG&A expenses 7,754 5,909 % of net sales 14.7% 30.2%Research & development expenses 6,945 2,352 % of net sales 13.1% 12.0%

Operating income 10,869 (1,201) % of net sales 20.5% NMOther expenses, net 2,553 3,272

Income (loss) before income taxes 8,316 (4,473)Income tax benefit, net 15,130 ------

Net income (loss) before preferred div. $23,446 ($4,473)

Page 22: ABLE  LABORATORIES,  INC

Balance Sheets 2002 & 2001Balance Sheets 2002 & 2001($’s in thousands)($’s in thousands)

2002 2001Current assets: Cash & equivalents $1,801 $1,155Accounts receivable, net 7,874 4,646Inventory 12,904 4,719Other current assets 123 784

Total current assets 22,702 11,304Property & equipment, net 9,932 4,496Deferred income tax & other assets 18,494 1,838

$51,128 $17,638Current liabilities:Notes payable and current portion LTD $890 $587Accounts payable and accrued exp. 9,736 4,568

Total current liabilities 10,626 5,155Long-term debt, net of current portion 5,810 2,290Other liabilities ------- 1,297

Total liabilities 16,436 8,742Total stockholders’ equity 34,692 8,896

$51,128 $17,638

Page 23: ABLE  LABORATORIES,  INC

2002 Financial Analysis 2002 Financial Analysis ($ in 000’s except per share data)($ in 000’s except per share data)

Pro-forma information for one-time items:

Q4 Year

Net income before preferred dividend $16,388 $23,446

Add: Asset write-off $1,993 $1,993

Less: NOL tax benefit ($15,130) ($15,130)

Adjusted net income for fully-diluted comp. $3,251 $10,309

Fully-diluted average shares outstanding 16,728 16,322

Pro-forma fully-diluted earnings per share $0.19 $0.63

Reported fully-diluted earnings per share $0.98 $1.44

Page 24: ABLE  LABORATORIES,  INC

PersonnelPersonnel

2001 2002 March 2003

Production 63 135 145

Quality 56 100 93

R & D 11 18 21

Sales & Admin. 16 32 34

Total 146 285 305

Page 25: ABLE  LABORATORIES,  INC

Generic Name Brand Name Sales (Brand/

Generic) MM Indication(s) Major Generic Competitiors

Acetaminophen & Codeine Tylenol w/ Cod #3 & #4 200 Mild relief of severe painTeva, Barr, Purepac, Mallinckrodt, Ranbaxy, Watson

Butalbital /APAP/ Caffeine Fioricet 103 Headache Westward, Qualitest, Inwood, Watson

Butalbital /APAP/ Caffeine Esgic Plus 16 Headache Forest, Novartis

Carisoprodol Soma 322 Muscle Relaxant Schein, Watson, Qualitest

Clorazepate Dipotassium Tranxene 134 Anxiety Mylan, Watson, Taro

Diphenoxylate w/atr Lomotil 43 Anti-diarrhea Mylan, IVAX

Hydrocodone w/APAP Family Vicodin Family 948 Pain Watson, Mallinkrodt, Qualitest

Hydrocortisone Acetate Anusol HC 14 Hemorrhoids Paddock, G & W,

Indomethacin ER Indocin SR 50 Rheumatoid Arthritis Eon

Lithium Carbonate IR Eskalith 33 Bi-polar Disorder Roxane

Methocarbamol Robaxin 65 Musculoskeletal Pain Geneva, Watson, Westward

ProductsProducts

Page 26: ABLE  LABORATORIES,  INC

Products, continuedProducts, continued

Generic Name Brand Name Sales (Brand/

Generic) MM Indication(s) Major Generic Competitiors

Methylphenidate SR Ritalin SR 180 Attention disorder Medeva, Schein, Geneva

Nitroglycerin Nitrostat 32 Anti-angina Ethex

Phenazopyridine Phyridium 28 Urinary Tract Amide, Vintage

Phentermine Adipex P 86 Obesity Purepac, Amide

Phentermine Beads 38 Obesity Eon

Phentermine Caps Fastin 29 Obesity Eon, Purepac, Amide

Prochlorperazine Compazine 19 Nausea G&W Paddock

Promethazine Phenergan 7 Nausea, Vomiting, other G&W

Propoxyphene Napsylate Darvocet 539 Pain Mylan, IVAX, Teva, Purepac

Tramadol Ultram 550 Pain Partnered with IVAX

TOTAL 3.5 Billion