UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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 March 29, 2003 | ||
| OR | ||
| o |
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 incorporation or organization) |
(I.R.S. Employer Identification No.) |
5800 Park of Commerce Boulevard N.W., Boca Raton, FL 33487
(Address of principal executive offices, including zip code)
(561) 989-5800
(Registrants telephone number, including area code)
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 o No
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). x Yes o No
The number of shares outstanding of registrants common stock, par value $0.10 per share, at April 24, 2003 was 39,101,017 shares.
Nabi Biopharmaceuticals
INDEX
| Page No. | |||||||||||||
PART I |
FINANCIAL INFORMATION | ||||||||||||
Item 1 |
Financial Statements | 3 | |||||||||||
| | Consolidated Balance Sheets, as of March 29, 2003 (unaudited) and | ||||||||||||
| December 28, 2002 | 3 | ||||||||||||
| | Consolidated Statements of Operations for the Three Months Ended | ||||||||||||
| March 29, 2003 and March 30, 2002 (unaudited) | 4 | ||||||||||||
| | Consolidated Statements of Cash Flows for the Three Months Ended | ||||||||||||
| March 29, 2003 and March 30, 2002 (unaudited) | 5 | ||||||||||||
| | Notes to Consolidated Financial Statements (unaudited) | 6 | |||||||||||
Item 2 |
Management's Discussion and Analysis of Financial Condition | ||||||||||||
| and Results of Operations | 11 | ||||||||||||
Item 3 |
Quantitative and Qualitative Disclosures About Market Risk | 15 | |||||||||||
Item 4 |
Controls and Procedures | 16 | |||||||||||
PART II |
OTHER INFORMATION | ||||||||||||
Item 1 |
Legal Proceedings | 17 | |||||||||||
Item 2 |
Changes in Securities and Use of Proceeds | 17 | |||||||||||
Item 3 |
Defaults Upon Senior Securities | 17 | |||||||||||
Item 4 |
Submission of Matters to a Vote of Security Holders | 17 | |||||||||||
Item 5 |
Other Information | 17 | |||||||||||
Item 6 |
Exhibits and Reports on Form 8-K | 17 | |||||||||||
| Signatures | 18 | ||||||||||||
| Certifications | 19 | ||||||||||||
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Nabi Biopharmaceuticals
CONSOLIDATED BALANCE SHEETS
| (UNAUDITED) | ||||||||||
| (Amounts in Thousands, Except Per Share Data) | March 29, 2003 | December 28, 2002 | ||||||||
Assets |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ | 46,939 | $ | 51,737 | ||||||
Trade accounts receivable, net |
29,440 | 36,326 | ||||||||
Inventories, net |
23,126 | 19,388 | ||||||||
Prepaid expenses and other current assets |
6,560 | 5,595 | ||||||||
Total current assets |
106,065 | 113,046 | ||||||||
Property, plant and equipment, net |
101,730 | 103,706 | ||||||||
Other assets: |
||||||||||
Intangible assets, net |
15,178 | 13,050 | ||||||||
Other, net |
3,014 | 3,014 | ||||||||
Total assets |
$ | 225,987 | $ | 232,816 | ||||||
Liabilities and stockholders equity |
||||||||||
Current liabilities: |
||||||||||
Trade accounts payable |
$ | 15,022 | $ | 21,654 | ||||||
Accrued expenses |
15,909 | 16,897 | ||||||||
Total current liabilities |
30,931 | 38,551 | ||||||||
Other liabilities |
5,212 | 5,236 | ||||||||
Total liabilities |
36,143 | 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; 39,095 and 38,947 shares issued and
outstanding, respectively |
3,910 | 3,895 | ||||||||
Capital in excess of par value |
160,017 | 159,568 | ||||||||
Treasury stock, 424 and 386 shares at cost |
(2,338 | ) | (2,140 | ) | ||||||
Retained earnings |
28,255 | 27,706 | ||||||||
Total stockholders equity |
189,844 | 189,029 | ||||||||
Total liabilities and stockholders equity |
$ | 225,987 | $ | 232,816 | ||||||
See accompanying notes to consolidated financial statements
3
Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF OPERATIONS
| (UNAUDITED) | |||||||||
| For the Three Months Ended | |||||||||
| (Amounts in Thousands, Except Per Share Data) | March 29, 2003 | March 30, 2002 | |||||||
Sales |
$ | 51,511 | $ | 40,969 | |||||
Costs and expenses: |
|||||||||
Costs of products sold |
30,954 | 25,288 | |||||||
Royalty expense |
3,915 | 1,559 | |||||||
Gross margin |
16,642 | 14,122 | |||||||
Selling, general and administrative expense |
10,139 | 9,183 | |||||||
Research and development expense |
5,794 | 4,412 | |||||||
Other operating expenses, principally amortization and freight |
190 | 198 | |||||||
Operating income |
519 | 329 | |||||||
Interest income |
206 | 647 | |||||||
Interest expense |
(1 | ) | (1,867 | ) | |||||
Other income, net |
9 | 10 | |||||||
Income (loss) before (provision) benefit for income taxes |
733 | (881 | ) | ||||||
(Provision) benefit for income taxes |
(184 | ) | 220 | ||||||
Net income (loss) |
$ | 549 | $ | (661 | ) | ||||
Basic earnings (loss) per share: |
$ | 0.01 | $ | (0.02 | ) | ||||
Diluted earnings (loss) per share: |
$ | 0.01 | $ | (0.02 | ) | ||||
Basic weighted average shares outstanding |
38,962 | 38,523 | |||||||
Diluted weighted average shares outstanding |
39,719 | 38,523 | |||||||
See accompanying notes to consolidated financial statements
4
Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF CASH FLOWS
| (UNAUDITED) | ||||||||||
| For the Three Months Ended | ||||||||||
| (Dollars in Thousands) | March 29, 2003 | March 30, 2002 | ||||||||
Cash flow from operating activities: |
||||||||||
Net income (loss) |
$ | 549 | $ | (661 | ) | |||||
Adjustments to reconcile net income (loss) to net cash used
by operating activities: |
||||||||||
Depreciation and amortization |
2,626 | 2,577 | ||||||||
Provision for doubtful accounts |
11 | 4 | ||||||||
Provision for slow moving or obsolete inventory |
51 | (135 | ) | |||||||
Write-off of loan origination fees |
| 400 | ||||||||
Other |
| 13 | ||||||||
Changes in assets and liabilities: |
||||||||||
Decrease in trade accounts receivable |
6,875 | 9,165 | ||||||||
Increase in inventories |
(3,789 | ) | (2,268 | ) | ||||||
(Increase) decrease in prepaid expenses and other assets |
(964 | ) | 1,920 | |||||||
Increase in other assets |
| (20 | ) | |||||||
Decrease in accounts payable and accrued liabilities |
(7,644 | ) | (14,125 | ) | ||||||
Total adjustments |
(2,834 | ) | (2,469 | ) | ||||||
Net cash used by operating activities |
(2,285 | ) | (3,130 | ) | ||||||
Cash flow from investing activities: |
||||||||||
Capital expenditures |
(562 | ) | (1,206 | ) | ||||||
Expenditures for intangible asset |
(2,217 | ) | (326 | ) | ||||||
Net cash used by investing activities |
(2,779 | ) | (1,532 | ) | ||||||
Cash flow from financing activities: |
||||||||||
Purchase of treasury stock |
| (917 | ) | |||||||
Proceeds from exercise of employee stock options |
266 | 504 | ||||||||
Net cash provided (used) by financing activities |
266 | (413 | ) | |||||||
Net decrease in cash and cash equivalents |
(4,798 | ) | (5,075 | ) | ||||||
Cash and cash equivalents at beginning of period |
51,737 | 131,192 | ||||||||
Cash and cash equivalents at end of period |
$ | 46,939 | $ | 126,117 | ||||||
See accompanying notes to consolidated financial statements
5
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 biopharmaceutical products that prevent and treat infectious, autoimmune and addictive diseases, such as hepatitis B, hepatitis C and Staphylococcus aureus infections, immune thrombocytopenia purpura (ITP) and nicotine addiction. We have four 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, 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 March 29, 2003, the consolidated results of our operations for the three months ended March 29, 2003 and March 30, 2002 and our cash flows for the three 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.
Basis of presentation: Certain items in the March 30, 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 APB Opinion No. 28, Interim Financial Reporting, to require disclosure about those effects in interim financial information. We intend to continue to account for stock-based
6
compensation based on the provisions of APB Opinion No. 25.
The following table summarizes our results as if we had recorded stock-based compensation expense for the three months ended March 29, 2003 and March 30, 2002, based on the provisions of SFAS 123, as amended by SFAS 148:
| For the Three Months Ended | |||||||||
| (Dollars in Thousands, except per share amounts) | March 29, 2003 | March 30, 2002 | |||||||
Net income (loss): |
|||||||||
As reported |
$ | 549 | $ | (661 | ) | ||||
Compensation expense, net of tax |
(823 | ) | (807 | ) | |||||
Pro forma |
$ | (274 | ) | $ | (1,468 | ) | |||
Basic earnings (loss) per share: |
|||||||||
As reported |
$ | 0.01 | $ | (0.02 | ) | ||||
Compensation expense, net of tax |
(0.02 | ) | (0.02 | ) | |||||
Pro forma |
$ | (0.01 | ) | $ | (0.04 | ) | |||
Diluted earnings (loss) per share: |
|||||||||
As reported |
$ | 0.01 | $ | (0.02 | ) | ||||
Compensation expense, net of tax |
(0.02 | ) | (0.02 | ) | |||||
Pro forma |
$ | (0.01 | ) | $ | (0.04 | ) | |||
NOTE 3 INVENTORIES
The components of inventories, stated at the lower of cost or market with cost determined on the first-in first-out (FIFO) method, are as follows:
| (Dollars in Thousands) | March 29, 2003 | December 28, 2002 | |||||||
Finished goods |
$ | 13,920 | $ | 12,142 | |||||
Work in process |
8,289 | 6,235 | |||||||
Raw materials |
917 | 1,011 | |||||||
Total |
$ | 23,126 | $ | 19,388 | |||||
NOTE 4 EARNINGS PER SHARE
Basic earnings per share is computed by dividing our net income by the weighted average number of shares outstanding during the period.
When the effects are not anti-dilutive, diluted earnings per share is computed by dividing our net income by the weighted average number of shares outstanding and the impact of all dilutive potential common shares, primarily stock options. The dilutive impact of stock options is determined by applying the treasury stock method.
7
The following table reconciles net income (loss) and shares for the basic and diluted earnings (loss) per share computations:
| For the Three Months Ended | |||||||||||||||||||||||||
| (Amounts in Thousands, Except Per Share Amounts) | March 29, 2003 | March 30, 2002 | |||||||||||||||||||||||
| Net | Per Share | Net | Per Share | ||||||||||||||||||||||
| Income | Shares | Amount | Loss | Shares | Amount | ||||||||||||||||||||
Basic earnings (loss) per share |
$ | 549 | 38,962 | $ | 0.01 | $ | (661 | ) | 38,523 | $ | (0.02 | ) | |||||||||||||
Effect of dilutive securities: |
|||||||||||||||||||||||||
Stock options and other dilutive securities |
| 757 | | | | | |||||||||||||||||||
Diluted earnings (loss) per share |
$ | 549 | 39,719 | $ | 0.01 | $ | (661 | ) | 38,523 | $ | (0.02 | ) | |||||||||||||
NOTE 5 OPERATING SEGMENT INFORMATION
The following table presents information related to our two operating business segments:
| For the Three Months Ended | ||||||||||
| (Dollars in Thousands) | March 29, 2003 | March 30, 2002 | ||||||||
Sales: |
||||||||||
Biopharmaceutical products |
$ | 22,660 | $ | 15,309 | ||||||
Antibody products |
28,851 | 25,660 | ||||||||
Total |
$ | 51,511 | $ | 40,969 | ||||||
Gross Margin: |
||||||||||
Biopharmaceutical products |
$ | 15,467 | $ | 11,062 | ||||||
Antibody products |
1,175 | 3,060 | ||||||||
Total |
$ | 16,642 | $ | 14,122 | ||||||
Operating income (loss): |
||||||||||
Biopharmaceutical products |
||||||||||