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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
| [X] |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 27, 2003
OR
| [ ] |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________to____________.
Commission File Number: 000-04829
Nabi Biopharmaceuticals
(Exact name of registrant as specified in its charter)
| Delaware | 59-1212264 | |
| (State or other jurisdiction of | (I.R.S. Employer Identification No.) | |
| incorporation or organization) |
5800 Park of Commerce Boulevard N.W., Boca Raton, FL 33487
(561) 989-5800
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding twelve months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. [X] Yes [ ] No
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). [X] Yes [ ] No
The number of shares outstanding of the registrants common stock, par value $0.10 per share, at October 22, 2003 was 46,659,503 shares.
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Nabi Biopharmaceuticals
INDEX
| Page No. | ||||||
PART I. FINANCIAL INFORMATION |
||||||
Item 1. |
Financial Statements |
3 | ||||
- Consolidated Balance Sheets, as of September 27, 2003 (unaudited) and
December 28, 2002 |
3 | |||||
- Consolidated Statements of Operations for the Three Months and Nine Months
Ended September 27, 2003 and September 28, 2002 (unaudited) |
4 | |||||
- Consolidated Statements of Cash Flows for the Nine Months Ended
September 27, 2003 and September 28, 2002 (unaudited) |
5 | |||||
- Notes to Consolidated Financial Statements (unaudited) |
6 | |||||
Item 2. |
Managements Discussion and Analysis of Financial Condition
and Results of Operations |
15 | ||||
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
26 | ||||
Item 4. |
Controls and Procedures |
26 | ||||
PART II. OTHER INFORMATION |
||||||
Item 1. |
Legal Proceedings |
27 | ||||
Item 2. |
Changes in Securities and Use of Proceeds |
27 | ||||
Item 3. |
Defaults Upon Senior Securities |
28 | ||||
Item 4. |
Submission of Matters to a Vote of Security Holders |
28 | ||||
Item 5. |
Other Information |
28 | ||||
Item 6. |
Exhibits and Reports on Form 8-K |
28 | ||||
Signatures |
29 | |||||
Certifications |
30 | |||||
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Nabi Biopharmaceuticals
CONSOLIDATED BALANCE SHEETS
| (UNAUDITED) | |||||||||||
| September 27, | December 28, | ||||||||||
| (Amounts in Thousands) | 2003 | 2002 | |||||||||
Assets |
|||||||||||
Current assets: |
|||||||||||
Cash and cash equivalents |
$ | 26,248 | $ | 51,737 | |||||||
Trade accounts receivable, net |
35,954 | 36,326 | |||||||||
Inventories, net |
25,819 | 19,388 | |||||||||
Prepaid expenses and other current assets |
5,224 | 5,595 | |||||||||
Total current assets |
93,245 | 113,046 | |||||||||
Property, plant and equipment, net |
100,444 | 104,066 | |||||||||
Other assets: |
|||||||||||
Intangible assets, net |
109,390 | 12,690 | |||||||||
Other, net |
3,948 | 3,014 | |||||||||
Total assets |
$ | 307,027 | $ | 232,816 | |||||||
Liabilities and stockholders equity |
|||||||||||
Current liabilities: |
|||||||||||
Trade accounts payable |
$ | 7,826 | $ | 21,654 | |||||||
Accrued expenses |
23,944 | 16,897 | |||||||||
Notes payable, PhosLo acquisition |
4,014 | | |||||||||
Notes payable |
2,000 | | |||||||||
Total current liabilities |
37,784 | 38,551 | |||||||||
Notes payable, PhosLo acquisition |
23,047 | | |||||||||
Notes payable |
8,000 | | |||||||||
Other liabilities |
7,129 | 5,236 | |||||||||
Total liabilities |
75,960 | 43,787 | |||||||||
Stockholders equity: |
|||||||||||
Convertible preferred stock, par value $.10 per share: 5,000 shares authorized; no shares outstanding |
| | |||||||||
Common stock, par value $.10 per share: 75,000 shares
authorized; 47,239 and 38,947 shares
outstanding, respectively |
4,724 | 3,895 | |||||||||
Capital in excess of par value |
204,134 | 159,568 | |||||||||
Treasury stock, 800 and 386 shares at cost |
(5,240 | ) | (2,140 | ) | |||||||
Retained earnings |
27,449 | 27,706 | |||||||||
Total stockholders equity |
231,067 | 189,029 | |||||||||
Total liabilities and stockholders equity |
$ | 307,027 | $ | 232,816 | |||||||
See accompanying notes to consolidated financial statements
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Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF OPERATIONS
| (UNAUDITED) | ||||||||||||||||||
| For the Three Months | For the Nine Months | |||||||||||||||||
| Ended | Ended | |||||||||||||||||
| September | September | September | September | |||||||||||||||
| (Amounts in Thousands, Except Per Share Data) | 27, 2003 | 28, 2002 | 27, 2003 | 28, 2002 | ||||||||||||||
Sales |
$ | 42,435 | $ | 46,100 | $ | 128,595 | $ | 137,871 | ||||||||||
Costs and expenses: |
||||||||||||||||||
Costs of products sold |
16,101 | 26,352 | 62,781 | 81,649 | ||||||||||||||
Royalty expense |
5,423 | 4,249 | 13,722 | 10,105 | ||||||||||||||
Gross margin |
20,911 | 15,499 | 52,092 | 46,117 | ||||||||||||||
Selling, general and
administrative expense |
9,351 | 8,732 | 32,189 | 28,155 | ||||||||||||||
Research and development expense |
6,454 | 5,597 | 18,183 | 14,939 | ||||||||||||||
Other operating expense,
principally amortization and
freight |
1,588 | 153 | 1,953 | 551 | ||||||||||||||
Operating income (loss) |
3,518 | 1,017 | (233 | ) | 2,472 | |||||||||||||
Interest income |
131 | 192 | 502 | 1,085 | ||||||||||||||
Interest expense |
(506 | ) | (95 | ) | (570 | ) | (2,039 | ) | ||||||||||
Other income (expense), net |
12 | 13 | 30 | (169 | ) | |||||||||||||
Income (loss) before (provision) benefit for income taxes |
3,155 | 1,127 | (271 | ) | 1,349 | |||||||||||||
(Provision) benefit for income taxes |
(962 | ) | (302 | ) | 14 | (364 | ) | |||||||||||
Net income (loss) |
$ | 2,193 | $ | 825 | $ | (257 | ) | $ | 985 | |||||||||
Basic earnings (loss) per share |
$ | 0.05 | $ | 0.02 | $ | (0.01 | ) | $ | 0.03 | |||||||||
Diluted earnings (loss) per share |
$ | 0.05 | $ | 0.02 | $ | (0.01 | ) | $ | 0.02 | |||||||||
Basic weighted average shares outstanding |
45,355 | 38,704 | 41,152 | 38,625 | ||||||||||||||
Diluted weighted average shares outstanding |
46,285 | 39,299 | 41,152 | 39,611 | ||||||||||||||
See accompanying notes to consolidated financial statements
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Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF CASH FLOWS
| (UNAUDITED) | ||||||||||
| For the Nine Months Ended | ||||||||||
| September 27, | September 28, | |||||||||
| (Dollars in Thousands) | 2003 | 2002 | ||||||||
Cash flow from operating activities: |
||||||||||
Net income |
$ | (257 | ) | $ | 985 | |||||
Adjustments to reconcile net income to net cash used in
operating activities: |
||||||||||
Depreciation and amortization |
9,422 | 7,465 | ||||||||
(Recovery) provision for doubtful accounts |
(3 | ) | 391 | |||||||
Provision for slow moving or obsolete inventory |
1,641 | 23 | ||||||||
Write-off of loan origination fees |
| 400 | ||||||||
Non-cash compensation |
689 | 334 | ||||||||
Imputed interest on notes payable |
201 | | ||||||||
Write-off obsolete fixed assets |
23 | 269 | ||||||||
Changes in assets and liabilities: |
||||||||||
Decrease in trade accounts receivable |
375 | 706 | ||||||||
Increase in inventories |
(7,918 | ) | (3,564 | ) | ||||||
Decrease in prepaid expenses and other assets |
372 | 2,382 | ||||||||
Increase in other assets |
(1,027 | ) | (20 | ) | ||||||
Decrease in accounts payable and accrued liabilities |
(5,314 | ) | (10,704 | ) | ||||||
Total adjustments |
(1,539 | ) | (2,318 | ) | ||||||
Net cash used in operating activities |
(1,796 | ) | (1,333 | ) | ||||||
Cash flow from investing activities: |
||||||||||
Capital expenditures |
(4,082 | ) | (4,841 | ) | ||||||
Expenditures for other assets |
(2,019 | ) | (2,760 | ) | ||||||
Acquisition of PhosLo |
(61,255 | ) | | |||||||
Net cash used in investing activities |
(67,356 | ) | (7,601 | ) | ||||||
Cash flow from financing activities: |
||||||||||
Borrowings under debt agreement |
10,000 | | ||||||||
Proceeds from the issuance of common stock |
31,270 | |||||||||
Retirement of convertible subordinated notes |
| (78,500 | ) | |||||||
Purchase of treasury stock |
| (917 | ) | |||||||
Proceeds from exercise of employee stock options |
2,393 | 699 | ||||||||
Net cash provided by (used in) financing activities |
43,663 | (78,718 | ) | |||||||
Net decrease in cash and cash equivalents |
(25,489 | ) | (87,652 | ) | ||||||
Cash and cash equivalents at beginning of period |
51,737 | 131,192 | ||||||||
Cash and cash equivalents at end of period |
$ | 26,248 | $ | 43,540 | ||||||
See accompanying notes to consolidated financial statements
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Nabi Biopharmaceuticals
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 OVERVIEW
Nabi Biopharmaceuticals discovers, develops, manufactures and markets products that power the immune system to help people with serious, unmet medical needs. We have a broad product portfolio and significant research capabilities focused on developing and commercializing novel vaccines and antibody-based therapies that prevent and treat infectious, autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, immune thrombocytopenia purpura (ITP) and nicotine addiction. We have five marketed products, Nabi-HB® [Hepatitis B Immune Globulin (Human)] for the prevention of hepatitis B infections, WinRho SDF® [Rho (D) Immune Globulin Intravenous (Human)] for the treatment of acute, chronic and HIV-related ITP, PhosLo® (calcium acetate) for the control of elevated phosphate levels (hyperphosphatemia) in patients with end-stage kidney (renal) failure, Autoplex® T [Anti-Inhibitor Coagulant Complex, Heat Treated] and Aloprim [(Allopurinol sodium) for injection]. We have a significant clinical trials program including clinical trials of our lead investigational products StaphVAX® (Staphylococcus aureus Polysaccharide Conjugate Vaccine), Altastaph [Staphylococcus aureus Immune Globulin (Human)], Civacir [Hepatitis C Immune Globulin (Human)], and NicVAX (Nicotine Conjugate Vaccine). We have a state-of-the-art fractionation facility for the manufacture of Nabi-HB and our investigational antibody products and for contract manufacturing. We also collect specialty and non-specific antibodies for use in our products as well as to supply pharmaceutical and diagnostic customers for the subsequent manufacture of their products.
The consolidated financial statements include the accounts of Nabi Biopharmaceuticals and its subsidiaries. All significant intercompany accounts and transactions were eliminated during consolidation. These statements should be read in conjunction with the Consolidated Financial Statements and Notes included in our Annual Report on Form 10-K for the year ended December 28, 2002.
In the opinion of management, the unaudited consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary to present fairly our consolidated financial position as of September 27, 2003 and September 28, 2002, the consolidated results of our operations for the three months and nine months ended September 27, 2003 and September 28, 2002 and our cash flows for the nine months then ended. The interim results of operations are not necessarily indicative of the results that may occur for the fiscal year.
NOTE 2 ACCOUNTING POLICIES
Accounting estimates: The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of sales and expenses during the reporting period. Actual results could differ from those estimates.
New accounting pronouncements: In January 2003, the Financial Accounting Standards Board issued Interpretation No. 46, Consolidation of Variable Interest Entities, an interpretation of ARB No. 51 (FIN 46). FIN 46 addresses the consolidation of entities whose equity holders have either (a) not provided sufficient equity at risk to allow the entity to finance its own activities or (b) do not possess certain characteristics of a controlling financial interest. FIN 46 requires the consolidation of these entities, known as variable interest entities (VIEs), by the primary beneficiary of the entity. The primary beneficiary is the entity, if any, that is subject to a majority of the risk of loss from the VIEs activities, entitled to receive a majority of the VIEs residual returns, or both. FIN 46 applies immediately to variable interests in VIEs created or obtained after January 31, 2003. As amended by FASB Staff Position (FSP) No. FIN 46-6, FIN 46 is effective for variable interests in a VIE created before February 1, 2003 at the end of the first interim or annual period ending after December 15, 2003 (the end of fiscal 2003, December 27, 2003, for the Company). We are currently reviewing the potential impact of FIN 46 on our financial statements.
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Basis of presentation: Certain items in the 2002 consolidated financial statements have been reclassified to conform to the current years presentation.
Stock-Based Compensation: On December 31, 2002, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based Compensation Transition and Disclosure. This Statement amends SFAS No. 123, Accounting for Stock-Based Compensation, to provide alternative methods of transition for an entity that voluntarily changes to the fair value based method of accounting for stock-based employee compensation. It also amends the disclosure provisions of that Statement to require prominent disclosure about the effects on reported net income of an entitys accounting policy decisions with respect to stock-based employee compensation. Finally, this Statement amends Accounting Principles Board (APB) Opinion No. 28, Interim Financial Reporting, to require disclosure about those effects in interim financial information. We continue to account for stock-based compensation based on the provisions of APB Opinion No. 25, Accounting for Stock Issued to Employees.
The following table summarizes our results as if we had recorded stock-based compensation expense for the three months ended September 27, 2003 and September 28, 2002 and for the nine months then ended, based on the provisions of SFAS 123, as amended by SFAS 148:
| For the Three Months Ended | |||||||||
| (Dollars in Thousands, except per share amounts) | September 27, 2003 | September 28, 2002 | |||||||
Net income (loss): |
|||||||||
As reported |
$ | 2,193 | $ | 825 | |||||
Compensation expense, net of tax |
(1,982 | ) | (1,586 | ) | |||||
Pro forma |
$ | 211 | $ | (761 | ) | ||||
Basic earnings (loss) per share: |
|||||||||
As reported |
$ | 0.05 | $ | 0.02 | |||||
Compensation expense, net of tax |
(0.04 | ) | (0.04 | ) | |||||
Pro forma |
$ | 0.01 | $ | (0.02 | ) | ||||
Diluted earnings (loss) per share: |
|||||||||
As reported |
$ | 0.05 | $ | 0.02 | |||||
Compensation expense, net of tax |
(0.04 | ) | (0.04 | ) | |||||
Pro forma |
$ | 0.01 | $ | (0.02 | ) | ||||
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| For the Nine Months Ended | |||||||||
| (Dollars in Thousands, except per share amounts) | September 27, 2003 | September 28, 2002 | |||||||
Net (loss) income: |
|||||||||
As reported |
$ | (257 | ) | $ | 985 | ||||
Compensation expense, net of tax |
(6,222 | ) | (3,114 | ) | |||||
Pro forma |
$ | (6,480 | ) | $ | (2,129 | ) | |||
Basic (loss) earnings per share: |
|||||||||
As reported |
$ | (0.01 | ) | $ | 0.03 | ||||
Compensation expense, net of tax |
(0.15 | ) | (0.09 | ) | |||||
Pro forma |
$ | (0.16 | ) | $ | (0.06 | ) | |||
Diluted (loss) earnings per share: |
|||||||||
As reported |
$ | (0.01 | ) | $ | 0.02 | ||||
Compensation expense, net of tax |
(0.15 | ) | (0.08 | ) | |||||
Pro forma |
$ | (0.16 | |||||||