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Safe 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.
Company Highlights • 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 • 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
Initial 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
R&D Strategy • First-to-Market Opportunities Patents expired No Generic competitors Smaller markets • Technical barriers to entry Complex formulations • Exclusive API sourcing Custom syntheses
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
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
Regulatory 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
Approval Time Line • Industry Average: 14 – 16 months • Able Average: 11 months • Excluding: Phentermines (18 months) delayed by API supplier BAC (22 and 21 months) delayed by API supplier Tramadol patent issues (22 months) • Able Adjusted Average: 8 months
Sales and Marketing • Rapid expansion of customer base • 5 direct sales representatives • Plans to expand salesforce
Manufacturing • Manufacture Tablets, Capsules & Suppositories Licensed for all classes of controlled substances 110,000 square feet in 4 building “campus” • Capital expenditures: 2002 Actual - $6.4 million 2003 Estimated - $4.0 million • Scalable for next 12 months
Operating Income & R&D ($’s in thousands)
2002 Balance Sheet Highlights • Year End: • Cash $ 1.8 million • Net working capital $15.3 million • Deferred tax asset $17.6 million • Long-term debt $ 6.1 million • Stockholders’ equity $34.7 million • Deferred Tax Asset • Capitalized 2002 • NOL’s exceed $50 million, no impairment
Current 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 - $8.30)2.3 million Total “fully-issuable” shares 18.0 million Total fully-diluted shares 17.1 million
Investment Highlights • Rapid expansion of customer base • Growing net sales and operating income • Niche products generate above average margins • Aggressive R&D program and pipeline • Excellent track record with FDA • Highly talented and experienced management team
Income Statements 2002 & 2001($’s in thousands) 20022001 Net sales $52,930 $19,594 Cost of goods sold 27,36212,533 Gross 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% NM Other expenses, net 2,5533,272 Income (loss) before income taxes 8,316 (4,473) Income tax benefit, net 15,130 ------ Net income (loss) before preferred div. $23,446 ($4,473)
Balance Sheets 2002 & 2001($’s in thousands) 20022001 Current assets: Cash & equivalents $1,801 $1,155 Accounts receivable, net 7,874 4,646 Inventory 12,904 4,719 Other current assets 123784 Total current assets 22,70211,304 Property & equipment, net 9,9324,496 Deferred income tax & other assets 18,4941,838 $51,128$17,638 Current liabilities: Notes payable and current portion LTD $890 $587 Accounts payable and accrued exp. 9,7364,568 Total current liabilities 10,626 5,155 Long-term debt, net of current portion 5,810 2,290 Other liabilities -------1,297 Total liabilities 16,4368,742 Total stockholders’ equity 34,6928,896 $51,128$17,638
2002 Financial Analysis ($ in 000’s except per share data) Pro-forma information for one-time items: Q4Year 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 16,72816,322 Pro-forma fully-diluted earnings per share $0.19 $0.63 Reported fully-diluted earnings per share $0.98 $1.44
