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 27, 2004
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 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 ¨ 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 April 21, 2004 was 57,561,012 shares.
INDEX
| Page No. | ||||
| PART I. |
FINANCIAL INFORMATION | |||
| Item 1. |
Financial Statements | 3 | ||
| - Condensed Consolidated Balance Sheets, as of March 27, 2004 (unaudited) and December 27, 2003 |
3 | |||
| 4 | ||||
| 5 | ||||
| - Notes to Condensed Consolidated Financial Statements (unaudited) |
6 | |||
| Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations | 14 | ||
| Item 3. |
Quantitative and Qualitative Disclosures About Market Risk | 22 | ||
| Item 4. |
Controls and Procedures | 23 | ||
| PART II. |
OTHER INFORMATION | |||
| Item 1. |
Legal Proceedings | 24 | ||
| Item 2. |
Changes in Securities and Use of Proceeds and Issuer Purchases of Equity Securities | 24 | ||
| Item 3. |
Defaults Upon Senior Securities | 24 | ||
| Item 4. |
Submission of Matters to a Vote of Security Holders | 24 | ||
| Item 5. |
Other Information | 24 | ||
| Item 6. |
Exhibits and Reports on Form 8-K | 24 | ||
| Signatures | 25 | |||
| Certifications | ||||
2
CONDENSED CONSOLIDATED BALANCE SHEETS
| (In thousands, except for share and per share amounts) |
(UNAUDITED) 2004 |
December 27, 2003 |
||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 116,779 | $ | 115,756 | ||||
| Trade accounts receivable, net |
36,904 | 37,062 | ||||||
| Inventories, net |
21,162 | 23,483 | ||||||
| Prepaid expenses and other current assets |
8,854 | 10,284 | ||||||
| Total current assets |
183,699 | 186,585 | ||||||
| Property, plant and equipment, net |
100,874 | 101,831 | ||||||
| Other assets: |
||||||||
| Intangible assets, net |
94,292 | 94,991 | ||||||
| Other, net |
3,740 | 3,894 | ||||||
| Total assets |
$ | 382,605 | $ | 387,301 | ||||
| Liabilities and stockholders equity |
||||||||
| Current liabilities: |
||||||||
| Trade accounts payable |
$ | 14,298 | $ | 10,874 | ||||
| Accrued expenses |
21,803 | 23,956 | ||||||
| Current portion of notes payable, PhosLo acquisition, net |
8,233 | 4,226 | ||||||
| Total current liabilities |
44,334 | 39,056 | ||||||
| Notes payable, PhosLo acquisition, less current portion, net |
15,372 | 23,167 | ||||||
| Other liabilities |
5,536 | 5,762 | ||||||
| Total liabilities |
65,242 | 67,985 | ||||||
| Stockholders equity: |
||||||||
| Convertible preferred stock, par value $.10 per share: 5,000,000 authorized; no shares outstanding |
| | ||||||
| Common stock, par value $.10 per share: 75,000,000 authorized; 58,169,911 and 57,772,302 shares outstanding, respectively |
5,817 | 5,773 | ||||||
| Capital in excess of par value |
300,743 | 297,909 | ||||||
| Treasury stock, 800,315 shares at cost |
(5,240 | ) | (5,240 | ) | ||||
| Retained earnings |
16,035 | 20,874 | ||||||
| Other accumulated comprehensive income |
8 | | ||||||
| Total stockholders equity |
317,363 | 319,316 | ||||||
| Total liabilities and stockholders equity |
$ | 382,605 | $ | 387,301 | ||||
See accompanying notes to consolidated financial statements.
3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| (UNAUDITED) |
||||||||
| For the Three Months Ended |
||||||||
| (In thousands, except per share amounts) |
March 27, 2004 |
March 29, 2003 |
||||||
| Sales |
$ | 46,349 | $ | 51,511 | ||||
| Costs and expenses: |
||||||||
| Costs of products sold |
20,200 | 30,954 | ||||||
| Royalty expense |
3,575 | 3,915 | ||||||
| Gross margin |
22,574 | 16,642 | ||||||
| Selling, general and administrative expense |
12,356 | 10,139 | ||||||
| Research and development expense |
11,429 | 5,794 | ||||||
| Amortization of intangible assets |
2,153 | 88 | ||||||
| Other operating expense, principally freight |
63 | 102 | ||||||
| Operating (loss) income |
(3,427 | ) | 519 | |||||
| Interest income |
336 | 206 | ||||||
| Interest expense |
(1,490 | ) | (1 | ) | ||||
| Other (expense) income, net |
(1 | ) | 9 | |||||
| (Loss) income before provision for income taxes |
(4,582 | ) | 733 | |||||
| Provision for income taxes |
(257 | ) | (184 | ) | ||||
| Net (loss) income |
$ | (4,839 | ) | $ | 549 | |||
| Basic (loss) earnings per share |
$ | (0.08 | ) | $ | 0.01 | |||
| Diluted (loss) earnings per share |
$ | (0.08 | ) | $ | 0.01 | |||
| Basic weighted average shares outstanding |
57,960 | 38,962 | ||||||
| Diluted weighted average shares outstanding |
57,960 | 39,719 | ||||||
See accompanying notes to consolidated financial statements.
4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| (UNAUDITED) |
||||||||
| For the Three Months Ended |
||||||||
| (In thousands) |
March 27, 2004 |
March 29, 2003 |
||||||
| Cash flow from operating activities: |
||||||||
| Net (loss) income |
$ | (4,839 | ) | $ | 549 | |||
| Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities: |
||||||||
| Depreciation and amortization |
4,739 | 2,626 | ||||||
| Provision for doubtful accounts |
144 | 11 | ||||||
| Provision for slow moving or obsolete inventory |
310 | 51 | ||||||
| Write-off of loan origination fees |
539 | | ||||||
| Gain on sale of assets |
(119 | ) | | |||||
| Write-off of obsolete fixed assets |
145 | | ||||||
| Changes in assets and liabilities: |
||||||||
| Decrease in trade accounts receivable |
15 | 6,875 | ||||||
| Decrease (increase) in inventories |
1,966 | (3,789 | ) | |||||
| Decrease (increase) in prepaid expenses and other current assets |
1,042 | (964 | ) | |||||
| Increase in other assets |
(38 | ) | | |||||
| Increase (decrease) in accounts payable and accrued liabilities |
1,022 | (7,644 | ) | |||||
| Total adjustments |
9,765 | (2,834 | ) | |||||
| Net cash provided by (used in) operating activities |
4,926 | (2,285 | ) | |||||
| Cash flow from investing activities: |
||||||||
| Proceeds from sales of assets |
179 | | ||||||
| Capital expenditures |
(1,424 | ) | (562 | ) | ||||
| Expenditures for Manufacturing Rights |
(1,453 | ) | (2,217 | ) | ||||
| Net cash used in investing activities |
(2,698 | ) | (2,779 | ) | ||||
| Cash flow from financing activities: |
||||||||
| Payment of notes payable, PhosLo acquisition |
(4,083 | ) | | |||||
| Proceeds from exercise of employee stock options |
2,878 | 266 | ||||||
| Net cash (used in) provided by financing activities |
(1,205 | ) | 266 | |||||
| Net increase (decrease) in cash and cash equivalents |
1,023 | (4,798 | ) | |||||
| Cash and cash equivalents at beginning of period |
115,756 | 51,737 | ||||||
| Cash and cash equivalents at end of period |
$ | 116,779 | $ | 46,939 | ||||
See accompanying notes to consolidated financial statements.
5
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 OVERVIEW
We apply our knowledge of the human immune system to develop and commercialize products that address serious, unmet medical needs. Our focus is in the areas of infectious, autoimmune and addictive diseases. In addition to five marketed products (PhosLo®, Nabi-HB®, WinRho SDF®, Aloprim and Autoplex® T), we have four products in clinical trials. We expect to file a Marketing Authorization Approval, or MAA, for StaphVAX® in the European Union, or EU, in 2004 based on existing clinical data. For U.S. licensure, we have advanced StaphVAX to confirmatory Phase III clinical trial development and anticipate completing enrollment in this trial in the third quarter of 2004. We anticipate filing a Biologics License Application, or BLA, for StaphVAX by the end of 2005. StaphVAX is designed to prevent the most dangerous and prevalent strains of Staph aureus bacterial infections, which are a major cause of hospital and community-acquired infections, and Staph aureus bacteria are becoming increasingly resistant to antibiotics. Our other products in development are Altastaph, an antibody based product for prevention of Staph aureus infections, Civacir, an antibody based product for preventing hepatitis C re-infection in liver transplant patients and NicVAX, a nicotine vaccine. Altastaph and NicVAX are currently in Phase II clinical trials. Civacir has completed a Phase I/II clinical trial. We have a state-of-the-art fractionation facility for the manufacture of Nabi-HB and our investigational antibody products, Altastaph and Civacir, and for contract manufacturing. We also collect specialty and non-specific antibodies for use in our products and supply pharmaceutical and diagnostic customers our excess production for the subsequent manufacture of their products.
We are headquartered in Boca Raton, Florida and maintain research and development facilities in Rockville, Maryland and have wholly owned foreign subsidiaries located in Ireland for the purpose of facilitating the regulatory approval, sales and marketing of our products in Europe.
The condensed 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 27, 2003.
In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our consolidated financial position as of March 27, 2004 and December 27, 2003, the consolidated results of our operations for the three months ended March 27, 2004 and March 29, 2003 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 full fiscal year.
NOTE 2 ACCOUNTING POLICIES
Accounting estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. 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 2003 consolidated financial statements have been reclassified to conform to the current years presentation.
New accounting pronouncements: In January 2003, the Financial Accounting Standards Board, or FASB, issued Interpretation No. 46, Consolidation of Variable Interest Entities, an interpretation of ARB No. 51, or 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, or VIEs, by the primary beneficiary entity. The primary beneficiary is the entity,
6
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, or 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 us). We have no interests in VIEs and accordingly, the adoption of FIN 46 had no impact on our financial statements.
In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity. SFAS No. 150 establishes standards for how companies classify and measure certain financial instruments with characteristics of both liabilities and equity. It requires companies to classify a financial instrument that is within its scope as a liability, or an asset, in some circumstances. SFAS No. 150 is effective beginning with the second quarter of fiscal 2004. We do not currently have financial instruments with characteristics of both liabilities and equity, and therefore, the adoption of SFAS No. 150 is not expected to have an impact on our financial condition, results of operations or cash flows.
Comprehensive Income (Loss): The Company follows SFAS No. 130, Reporting Comprehensive Income, which computes comprehensive income as the total of net income and all other changes in shareholders equity. For the quarter ended March 27, 2004, comprehensive loss included net loss and the effect of foreign currency translation adjustments. For the quarter ended March 29, 2003, there were no comprehensive income items other than net income.
Stock-Based Compensation: On December 31, 2002, the FASB issued Statement of Financial Accounting Standards, or 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, or 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 March 27, 2004 and March 29, 2003, based on the provisions of SFAS No. 123, as amended by SFAS No. 148:
| For the Three Months Ended |
||||||||
| (In thousands, except per share amounts) |
March 27, 2004 |
March 29, 2003 |
||||||
| Net (loss) income: |
||||||||
| As reported |
$ | (4,839 | ) | $ | 549 | |||
| Add: Stock-based employee compensation expense included in reported net (loss) income, net of tax |
97 | | ||||||
| Deduct: Total stock-based employee compensation expense determined under fair value based method, net of tax |
(1,808 | ) | (823 | ) | ||||
| Pro forma |
$ | (6,550 | ) | $ | (274 | ) | ||
| Basic (loss) earnings per share: |
||||||||
| As reported |
$ | (0.08 | ) | $ | 0.01 | |||
| Add: Stock-based employee compensation expense included in reported net (loss) income, net of tax |
| | ||||||
| Deduct: Total stock-based employee compensation expense determined under fair value based method, net of tax |
(0.03 | ) | (0.02 | ) | ||||