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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10Q
x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended June 30, 2002
¨ 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 0-23272
NPS PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
Delaware |
|
870439579 |
(State or other jurisdiction of
incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
420 Chipeta Way, Salt Lake City, Utah |
|
84108-1256 |
(Address of principal executive offices) |
|
(Zip Code) |
(801) 583-4939
(Registrants telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
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 12 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 at least the past
90 days. YES x NO ¨
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
Class
|
|
Outstanding at July 19, 2002
|
Common Stock $.001 par value |
|
30,423,017* |
* Includes 402,598 shares of exchangeable stock which are
exchangeable at any time into common stock on a one-for-one basis. Holders of shares of exchangeable stock are entitled to dividends and other rights economically equivalent to those of the common stock, and, through a voting trust, holders are
entitled to vote at all meetings of stockholders of the Registrant, also on a one-for-one basis.
|
PART I |
|
FINANCIAL INFORMATION |
|
Page No.
|
|
Item 1. |
|
Condensed Consolidated Financial Statements. |
|
|
|
|
|
|
|
3 |
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4 |
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5 |
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7 |
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Item 2. |
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10 |
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Item 3. |
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15 |
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PART II |
|
OTHER INFORMATION |
|
|
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Item 4. |
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16 |
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Item 5. |
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17 |
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Item 6. |
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17 |
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18 |
2
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
(a Development Stage Enterprise)
(in thousands)
(unaudited)
|
|
June 30, 2002
|
|
|
December 31, 2001
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
48,378 |
|
|
$ |
39,142 |
|
Marketable investment securities |
|
|
127,370 |
|
|
|
168,376 |
|
Accounts receivable |
|
|
2,306 |
|
|
|
8,609 |
|
Other current assets |
|
|
2,944 |
|
|
|
3,228 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
180,998 |
|
|
|
219,355 |
|
Plant and equipment: |
|
|
|
|
|
|
|
|
Land |
|
|
428 |
|
|
|
409 |
|
Building |
|
|
1,166 |
|
|
|
1,097 |
|
Equipment |
|
|
9,327 |
|
|
|
8,892 |
|
Leasehold improvements |
|
|
3,020 |
|
|
|
2,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
13,941 |
|
|
|
13,386 |
|
Less accumulated depreciation and amortization |
|
|
9,362 |
|
|
|
8,518 |
|
|
|
|
|
|
|
|
|
|
Net plant and equipment |
|
|
4,579 |
|
|
|
4,868 |
|
Goodwill, net of accumulated amortization |
|
|
7,165 |
|
|
|
6,838 |
|
Purchased intangible assets, net of accumulated amortization |
|
|
3,417 |
|
|
|
3,913 |
|
Other assets |
|
|
2 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
196,161 |
|
|
$ |
234,976 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current installments of obligations under capital leases |
|
$ |
2 |
|
|
$ |
4 |
|
Accounts payable |
|
|
9,862 |
|
|
|
10,737 |
|
Accrued expenses |
|
|
4,514 |
|
|
|
2,060 |
|
Accrued severance |
|
|
6 |
|
|
|
240 |
|
Deferred revenue |
|
|
162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
14,546 |
|
|
|
13,041 |
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
30 |
|
|
|
30 |
|
Additional paid-in capital |
|
|
385,409 |
|
|
|
382,681 |
|
Deferred compensation |
|
|
(13 |
) |
|
|
(34 |
) |
Accumulated other comprehensive income |
|
|
341 |
|
|
|
261 |
|
Deficit accumulated during development stage |
|
|
(204,152 |
) |
|
|
(161,003 |
) |
|
|
|
|
|
|
|
|
|
Net stockholders equity |
|
|
181,615 |
|
|
|
221,935 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
196,161 |
|
|
$ |
234,976 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
3
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
(In thousands, except per share data)
(Unaudited)
|
|
Three Months Ended June
30,
|
|
|
Six Months Ended June
30,
|
|
|
October 22, 1986, (inception) through June 30, 2002
|
|
|
|
2002
|
|
|
2001
|
|
|
2002
|
|
|
2001
|
|
|
Revenues from research and license agreements |
|
$ |
1,094 |
|
|
$ |
491 |
|
|
$ |
1,881 |
|
|
$ |
982 |
|
|
$ |
75,400 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,239 |
|
|
|
16,930 |
|
|
|
41,343 |
|
|
|
24,197 |
|
|
|
220,889 |
|
General and administrative |
|
|
3,577 |
|
|
|
2,797 |
|
|
|
7,159 |
|
|
|
6,476 |
|
|
|
66,310 |
|
Amortization of goodwill and acquired intangibles |
|
|
332 |
|
|
|
858 |
|
|
|
657 |
|
|
|
1,724 |
|
|
|
7,629 |
|
In-process research and development acquired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
24,148 |
|
|
|
20,585 |
|
|
|
49,159 |
|
|
|
32,397 |
|
|
|
312,588 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(23,054 |
) |
|
|
(20,094 |
) |
|
|
(47,278 |
) |
|
|
(31,415 |
) |
|
|
(237,188 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,817 |
|
|
|
3,173 |
|
|
|
3,833 |
|
|
|
6,978 |
|
|
|
32,385 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5 |
) |
|
|
(806 |
) |
Gain (loss) on sale of marketable investment securities |
|
|
(39 |
) |
|
|
371 |
|
|
|
96 |
|
|
|
824 |
|
|
|
1,936 |
|
Gain (loss) on disposition of equipment, leasehold improvements and leases |
|
|
13 |
|
|
|
|
|
|
|
13 |
|
|
|
11 |
|
|
|
(1,174 |
) |
Foreign currency transaction gain |
|
|
74 |
|
|
|
18 |
|
|
|
56 |
|
|
|
21 |
|
|
|
244 |
|
Other |
|
|
54 |
|
|
|
365 |
|
|
|
141 |
|
|
|
1,351 |
|
|
|
2,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income |
|
|
1,919 |
|
|
|
3,927 |
|
|
|
4,139 |
|
|
|
9,180 |
|
|
|
34,864 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before tax expense |
|
|
(21,135 |
) |
|
|
(16,167 |
) |
|
|
(43,139 |
) |
|
|
(22,235 |
) |
|
|
(202,324 |
) |
Income tax expense |
|
|
10 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
1,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before cumulative effect of change in accounting principle |
|
|
(21,145 |
) |
|
|
(16,167 |
) |
|
|
(43,149 |
) |
|
|
(22,235 |
) |
|
|
(203,652 |
) |
Cumulative effect on prior years (to December 31, 1999) of changing to a different revenue recognition
method |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(500 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(21,145 |
) |
|
$ |
(16,167 |
) |
|
$ |
(43,149 |
) |
|
$ |
(22,235 |
) |
|
$ |
(204,152 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common and common equivalent share: |
|
$ |
(0.70 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.42 |
) |
|
$ |
(0.75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common and common-equivalent shares outstandingbasic and diluted |
|
|
30,364 |
|
|
|
29,846 |
|
|
|
30,288 |
|
|
|
29,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
4
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
(a Development Stage Enterprise)
(in thousands)
(unaudited)
|
|
Six Months Ended June 30,
|
|
|
October 22, 1986 (inception) through June 30, 2002
|
|
|
|
2002
|
|
|
2001
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(43,149 |
) |
|
$ |
(22,235 |
) |
|
$ |
(204,152 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,449 |
|
|
|
2,522 |
|
|
|
18,653 |
|
Loss (gain) on disposition of equipment, leasehold improvements and leases |
|
|
(13 |
) |
|
|
(11 |
) |
|
|
1,173 |
|
Realized gain on sale of marketable investment securities |
|
|
(96 |
) |
|
|
(824 |
) |
|
|
(1,936 |
) |
Issuance of common and preferred stock in lieu of cash for services |
|
|
588 |
|
|
|
386 |
|
|
|
2,266 |
|
Compensation expense on stock options |
|
|
65 |
|
|
|
1,780 |
|
|
|
4,580 |
|
Write off of in-process research and development |
|
|
|
|
|
|
|
|
|
|
17,760 |
|
Decrease (increase) in operating assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
6,401 |
|
|
|
(580 |
) |
|
|
(1,938 |
) |
Other current assets and other assets |
|
|
90 |
|
|
|
(2,271 |
) |
|
|
(2,064 |
) |
Increase (decrease) in operating liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and accrued severance |
|
|
745 |
|
|
|
2,966 |
|
|
|
11,654 |
|
Deferred revenue |
|
|
163 |
|
|
|
|
|
|
|
(323 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(33,757 |
) |
|
|
(18,267 |
) |
|
|
(154,327 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net sale (purchase) of marketable investment securities |
|
|
40,771 |
|
|
|
(61,011 |
) |
|
|
(113,224 |
) |
Acquisition of equipment and leasehold improvements |
|
|
(399 |
) |
|
|
(1,130 |
) |
|
|
(12,282 |
) |
Proceeds from sale of equipment |
|
|
13 |
|
|
|
9 |
|
|
|
1,299 |
|
Cash paid for acquisition, net of cash received |
|
|
|
|
|
|
|
|
|
|
(676 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activites |
|
|
40,385 |
|
|
|
(62,132 |
) |
|
|
(124,883 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from note payable to bank |
|
|
|
|
|
|
|
|
|
|
124 |
|
Proceeds from issuance of preferred stock |
|
|
|
|
|
|
|
|
|
|
17,581 |
|
Proceeds from issuance of common stock |
|
|
2,310 |
|
|
|
1,190 |
|
|
|
313,990 |
|
Proceeds from long-term debt |
|
|
|
|
|
|
|
|
|
|
1,166 |
|
Principal payments on note payable to bank |
|
|
|
|
|
|
|
|
|
|
(124 |
) |
Principal payments under capital lease obligations |
|
|
(2 |
) |
|
|
(342 |
) |
|
|
(2,159 |
) |
Principal payments on long-term debt |
|
|
|
|
|
|
|
|
|
|
(2,854 |
) |
Repurchase of preferred stock |
|
|
|
|
|
|
|
|
|
|
(300 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
2,308 |
|
|
|
848 |
|
|
|
327,424 |
|
Effect of exchange rate changes on cash |
|
|
300 |
|
|
|
158 |
|
|
|
164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
9,236 |
|
|
|
(79,393 |
) |
|
|
48,378 |
|
Cash and cash equivalents at beginning of period |
|
|
39,142 |
|
|
|
131,083 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
48,378 |
|
|
$ |
51,690 |
|
|
$ |
48,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
5
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
(a Development Stage Enterprise)
Condensed Consolidated Statements of
Cash Flows
(in thousands)
(unaudited)
|
|
Six Months Ended June 30,
|
|
October 22, 1986 (inception) through June 30, 2002
|
|
|
2002
|
|
|
2001
|
|
Supplemental Disclosure of Cash Flow Information: |
|
|
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
|
|
|
$ |
|
|
$ |
806 |
Cash paid for taxes |
|
|
10 |
|
|
|
|
|
|
1,328 |
|
Supplemental Schedule of Noncash Investing and Financing Activities: |
|
|
|
|
|
|
|
|
|
|
Acquisition of equipment through incurrence of capital lease obligations |
|
|
|
|
|
|
|
|
|
1,478 |
Acquisition of leasehold improvements through incurrence of debt |
|
|
|
|
|
|
|
|
|
197 |
Issuance of stock for stock subscription receivable |
|
|
21 |
|
|
|
455 |
|
|
4,021 |
Unrealized gain (loss) on marketable investment securities |
|
|
(330 |
) |
|
|
221 |
|
|
1,700 |
See accompanying notes to condensed consolidated financial statements.
6
NPS PHARMACEUTICALS
(Unaudited)
(1) Basis of Presentation
The
accompanying unaudited condensed consolidated financial statements included herein have been prepared by NPS Pharmaceuticals, Inc. (NPS) pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). The condensed
consolidated financial statements include the financial statements of NPS and its subsidiaries, collectively referred to as the Company. Investments in a limited liability partnership and in non-public corporations in which the Company has the
ability to exercise significant influence, but not control, are accounted for by the equity method. The Company carries all other investments in non-public corporations at cost. In managements opinion, the interim financial data presented
includes all adjustments (consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated. All monetary amounts are reported in U.S. dollars unless specified otherwise.
Certain information required by generally accepted accounting principles has been condensed or omitted pursuant to rules and regulations of the SEC. Operating results for the three and six months ended June 20, 2002, are not necessarily indicative
of the results that may be expected for any future period or the year ending December 31, 2002.
This report
should be read in conjunction with the Companys audited consolidated financial statements and the notes thereto for the year ended December 31, 2001, included in the Companys Annual Report on Form 10-K filed with the SEC.
The preparation of the condensed consolidated financial statements 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 condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from these estimates.
(2) Loss Per Common Share
Basic loss per common share is the amount of loss for the period available to each common and exchangeable share outstanding during the
reporting period. Diluted loss per common share is the amount of loss for the period available to each common and exchangeable share outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of
common shares for all dilutive potential common shares outstanding during the period.
Potential common shares of
approximately 3.2 million and 2.8 million during the three and six months ended June 30, 2002 and 2001, respectively, that could potentially dilute basic earnings per share in the future were not included in the computation of diluted loss per share
because to do so would have been anti-dilutive for the periods presented.
(3) Operating Segment
The Company is engaged in the discovery, development, and commercialization of pharmaceutical products and in its current state of development, considers its operations to
be a single reportable segment. Financial results of this reportable segment are presented in the accompanying condensed consolidated financial statements. The Companys only non-United States revenues relate to the Companys Canadian
subsidiary and represent 87 percent and 58 percent of the Companys total revenues for the three months ended June 30, 2002 and 2001, respectively, and represent 84 percent and 59 percent of the Companys total revenues for the six months
ended June 30, 2002 and 2001, respectively.
7
(4) Comprehensive Loss
The components of the Companys comprehensive loss are as follows, in thousands:
|
|
Three months ended June 30, 2002
|
|
|
Three months ended June 30, 2001
|
|
|
Six months ended June 30, 2002
|
|
|
Six months ended June 30, 2001
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross unrealized gain (loss) on marketable investment securities |
|
$ |
1,290 |
|
|
$ |
(176 |
) |
|
$ |
(234 |
) |
|
$ |
1,045 |
|
Reclassification for realized loss(gain) on marketable investment securities |
|
|
39 |
|
|
|
(371 |
) |
|
|
(96 |
) |
|
|
(824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain (loss) on marketable investment securities |
|
|
1,329 |
|
|
|
(547 |
) |
|
|
(330 |
) |
|
|
221 |
|
Foreign currency translation gain (loss) |
|
|
323 |
|
|
|
997 |
|
|
|
410 |
|
|
|
(104 |
) |
Net loss |
|
|
(21,145 |
) |
|
|
(16,167 |
) |
|
|
(43,149 |
) |
|
|
(22,235 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(19,493 |
) |
|
$ |
(15,771 |
) |
|
$ |
(43,069 |
) |
|
$ |
(22,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5) Plan of Termination
As of December 31, 2001, the Company had a balance of approximately $240,000 for accrued severance for salaries and benefits payable to
former employees under formal plans of termination. Approximately $234,000 was paid in severance benefits during the first six months of 2002.
(6) Goodwill and Identifiable Intangible Assets
In July 2001, the
Financial Accounting Standards Board (FASB), issued Statement on Financial Accounting Standard (SFAS) No. 141, Business Combinations, and SFAS No. 142, Goodwill and Other Intangible Assets. SFAS No. 141 prohibits the use of the
pooling-of-interests method of accounting and requires that the purchase method of accounting be used for all business combinations initiated after June 30, 2001 and is applicable to all purchase method business combinations completed after June 30,
2001. SFAS No. 141 also specifies that intangible assets acquired in a purchase method business combination must meet certain criteria to be recognized and reported apart from goodwill, noting that any purchase price allocable to an assembled
workforce may not be accounted for separately. SFAS No. 142 requires that goodwill and intangible assets with indefinite useful lives no longer be amortized effective January 1, 2002; rather, these assets must be tested for impairment at least
annually in accordance with the provisions of SFAS No. 142. SFAS No. 142 also requires that intangible assets with definite useful lives be amortized over their respective estimated useful lives to their estimated residual values, and reviewed for
impairment in accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets.
Beginning January 1, 2002, the Company adopted the provisions of SFAS No. 142. The Company completed its impairment review of goodwill during the first quarter of 2002 and determined that no impairment charge was required upon
adoption.
Goodwill. The cost of acquired companies in excess of the
fair value of the net assets and purchased intangible assets at acquisition date is recorded as goodwill. As of June 30, 2002, the Company had goodwill, net, of $6.8 million from the acquisition of Allelix Biopharmaceuticals Inc. (Allelix) in
December 1999. Through December 31, 2001, goodwill was amortized over a period of six years on a straight-line basis. The following table sets forth reported net loss and basic and diluted net loss per share,
8
as adjusted, to exclude amortization of goodwill and the assembled workforce component of purchased intangibles, which would not have been
recorded under SFAS No. 142:
|
|
Three months ended June 30, 2001
|
|
|
Six months ended June 30, 2001
|
|
|
|
(in thousands, except per share data) |
|
Net loss, as reported |
|
$ |
(16,167 |
) |
|
$ |
(22,235 |
) |
Amortization expense of goodwill and assembled workforce |
|
|
521 |
|
|
|
1,045 |
|
|
|
|
|
|
|
|
|
|
Net loss, as adjusted |
|
$ |
(15,646 |
) |
|
$ |
(21,190 |
) |
Basic and diluted net loss per share, as reported |
|
|
(0.54 |
) |
|
|
(0.75 |
) |
Amortization expense of goodwill and assembled workforce per basic and diluted share |
|
|
.02 |
|
|
|
.04 |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share, as adjusted |
|
$ |
(0.52 |
) |
|
$ |
(0.71 |
) |
|
|
Year ended December 31,
|
|
|
|
2001
|
|
|
2000
|
|
|
1999
|
|
|
|
(in thousands, except per share data) |
|
Net loss, as reported |
|
$ |
(49,968 |
) |
|
$ |
(32,112 |
) |
|
$ |
(35,654 |
) |
Amortization expense of goodwill and assembled workforce |
|
|
2,074 |
|
|
|
2,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, as adjusted |
|
$ |
(47,894 |
) |
|
$ |
(29,948 |
) |
|
$ |
(35,654 |
) |
Basic and diluted net loss per share, as reported |
|
|
(1.67 |
) |
|
|
(1.34 |
) |
|
|
(2.77 |
) |
Amortization expense of goodwill and assembled workforce per basic and diluted share |
|
|
.07 |
|
|
|
.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share, as adjusted |
|
$ |
(1.60 |
) |
|
$ |
(1.25 |
) |
|
$ |
(2.77 |
) |
Purchased Intangible
Assets. Purchased intangible assets consist of patents acquired in our December 1999 acquisition of Allelix and are amortized over a period of five years on a straight-line basis. The following table sets forth the
gross carrying amount, accumulated amortization and net carrying amount of purchased intangible assets:
|
|
As of June 30, 2002
|
|
|
As of December 31, 2001
|
|
|
|
(in thousands) |
|
Gross carrying amount |
|
$ |
6,834 |
|
|
$ |
6,522 |
|
Accumulated amortization |
|
|
(3,417 |
) |
|
|
(2,609 |
) |
Net carrying amount |
|
$ |
3,417 |
|
|
$ |
3,913 |
|
Amortization expense associated with purchased intangible assets
was $332,000 and $337,000 for the three months ended June 30, 2002 and 2001 respectively, and $657,000 and $675,000 for the six months ended June 30, 2002 and 2001, respectively. Estimated amortization expense for existing purchased intangible
assets is expected to be $1.3 million for each of the fiscal years ending December 31, 2002 through December 31, 2004.
(7) Recent Accounting Pronouncements
In June 2001, the FASB issued
SFAS No. 143, Accounting for Asset Retirement Obligations, which addresses financial accounting and reporting for obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs. The standard
applies to legal obligations associated with the retirement of long-lived assets that result from the acquisition, construction, development and/or normal use of the asset.
The Company is required and plans to adopt the provisions of SFAS No. 143 for the quarter ending March 31, 2003. To accomplish this, the Company must identify legal
obligations for asset retirement obligations, if any, and determine the fair value of these obligations on the date of adoption.
9
Because of the effort necessary to comply with the adoption of SFAS No. 143, it is not practicable for management to estimate the impact of
adopting this Statement as of the date of this report on Form 10-Q.
In August 2001, the FASB issued SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets, which supersedes both SFAS No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of and the accounting and reporting
provisions of APB Opinion No. 30, Reporting the Results of OperationsReporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions, for the disposal of a
segment of a business. SFAS No. 144 retains the fundamental provisions in SFAS No. 121 for recognizing and measuring impairment losses on long-lived assets held for use and long-lived assets to be disposed of by sale, while also resolving
significant implementation issues associated with SFAS No. 121. SFAS No. 144 retains the basic provisions of APB Opinion No. 30 on how to present discontinued operations in the income statement but broadens that presentation to include a component
of an entity rather than a segment of a business.
On January 1, 2002, the Company adopted the provisions of SFAS
No. 144. The adoption of SFAS No. 144 for long-lived assets held for use did not have a material impact on the condensed consolidated financial statements.
(8) Legal Proceedings
The Company is not involved in any
legal actions. From time to time, such actions may arise in the normal course of business.
The Managements Discussion and Analysis of Financial Condition and Results of Operations section contains forward-looking statements pertaining generally to preclinical testing and clinical trials of potential products, the
expected continuation of our collaborative agreements, the receipt of research payments thereunder, the future achievement of various milestones in product development and the receipt of payments related thereto, the potential receipt of royalty
payments, the period of time that our existing capital resources will meet our funding requirements, and our financial results and operations. Our actual results could differ materially from those anticipated in these forward-looking statements as a
result of various factors, including those set forth below.
Overview
Our objective is to build a profitable biopharmaceutical company by discovering, developing and commercializing small molecule drugs and recombinant proteins. Our product
candidates are primarily for the treatment of bone and mineral disorders, gastrointestinal disorders and central nervous system disorders. We have three product candidates in active clinical development and several preclinical product candidates. We
have incurred cumulative losses from inception through June 30, 2002 of approximately $204.2 million, net of cumulative revenues from research and license agreements of approximately $75.4 million. We expect to continue to incur significant
operating losses over at least the next several years as we continue our current and anticipated development projects, particularly our clinical trial programs for PREOS, our proprietary drug candidate for the treatment of osteoporosis, (human parathyroid hormone, formerly known as ALX1-11) and ALX-0600, our
proprietary drug candidate for the treatment of gastrointestinal disorders, as we maintain our contractual commitment to fund research activities in our metabotropic glutamate receptor program, and as we develop internal marketing and sales
capabilities and manufacturing relationships.
10
Results of Operations
Revenues. Substantially all our revenues have come from license fees, research and development support or milestone payments from our
licensees and collaborators. These revenues fluctuate from quarter to quarter. Our revenues were $1.1 million for the quarter ended June 30, 2002, compared to $491,000 for the quarter ended June 30, 2001. Revenues for the six months ended June 30,
2002 were $1.9 million compared to $982,000 for the six months in the prior year. The increases in revenues for the three and six months ended June 30, 2002 as compared to the same periods in 2001 are primarily related to amounts earned under our
research funding agreement with the Government of Canada pursuant to the Technology Partnership Canada program. See Liquidity and Capital Resources below for further discussion of payments that we may earn in the future under these
agreements.
Research and Development. Our research and development
expenses arise primarily from compensation and other related costs of our personnel who are dedicated to research and development activities and from the fees paid and costs reimbursed to outside professionals to conduct research, clinical studies
and trials, and to manufacture drug compounds and related supplies prior to FDA approval. Our research and development expenses increased to $20.2 million for the quarter ended June 30, 2002, from $16.9 million for the comparable period of 2001, and
to $41.3 million for the six months ended June 30, 2002 from $24.2 million in the comparable period in 2001. The increase in research and development expenses for the three and six months ended June 30, 2002 was due primarily to the costs of
conducting our clinical trials for PREOS, including the costs of our pivotal Phase III trial for which enrollment was completed in March 2002, increased activities in the development of ALX-0600 and costs to arrange for manufacturing and to
manufacture clinical supplies of PREOS and ALX-0600.
General and
Administrative. Our general and administrative expenses consist primarily of the costs of our management and administrative staff, business insurance, taxes, professional fees and market research and promotion
activities for our product candidates. Our general and administrative expenses increased to $3.6 million for the quarter ended June 30, 2002 from $2.8 million for the quarter ended June 30, 2001. Additionally, general and administrative expenses
increased to $7.2 million for the six months ended June 30, 2002 from $6.5 million for the same period in the prior year. The increases in general and administrative expenses for the three and six months ended June 30, 2002 as compared to the same
periods in the prior year are due primarily to increased marketing activities associated with PREOS and the hiring of additional marketing personnel.
Amortization of Goodwill and Purchased Intangibles. Goodwill and purchased intangibles originated with our December 1999 acquisition of Allelix Biopharmaceuticals,
Inc. (Allelix). The remaining intangible assets, net of accumulated amortization, at June 30, 2002 total approximately $10.6 million. Amortization of goodwill and acquired intangibles decreased from $858,000 to $332,000 for the three months ended
June 30, 2002 as compared to the same period in the prior year and from $1.7 million to $657,000 for the six months ended June 30, 2002 as compared to the same period in the prior year. The decrease is the result of our adoption of the provisions of
SFAS No. 142, Goodwill and Other Intangible Assets, on January 1, 2002. SFAS No. 142 eliminated the amortization of goodwill. During the three and six months ended June 30, 2001, we recorded amortization expense of $521,000 and $1.1 million,
respectively, or $0.02 and $0.04, respectively, per basic and diluted share, that would not have been recorded under SFAS No. 142.
In-Process Research and Development Acquired. We recorded an expense of $17.8 million in 1999 for in-process research and development that we acquired as part of our purchase of Allelix.
The acquired in-process research and development consisted of five drug development programs, of which PREOS, for osteoporosis, and ALX-0600, for gastrointestinal disorders, accounted for 83 percent of the total value.
11
Since the date of the acquisition, we revised our plans for the next series of
clinical trials for PREOS and ALX-0600. We started a pivotal Phase III clinical trial with PREOS. We have also completed a pilot Phase II clinical trial with ALX-0600 in a small number of patients with short bowel syndrome. Since the date of
acquisition and through June 30, 2002, we have incurred development costs of approximately $83.8 million for PREOS and $10.7 million for ALX-0600. Total development costs and time-to-completion for each of these product candidates will depend on the
costs we incur to conduct current clinical trials and to perform any additional work we find necessary to obtain FDA approval.
We believe the assumptions we used in the valuation of the in-process research and development we acquired from Allelix were reasonable at the time of the acquisition. However, we have modified our development plans as new data have
become available regarding each product candidate. Accordingly, actual results may vary from the projected results in the valuation.
Total Other Income, Net. Our total other income, net, decreased from $3.9 million to $1.9 million for the three months ended June 30, 2002, as compared with the same period in the prior
year and from $9.2 million to $4.1 million for the six months ended June 30, 2002 as compared with the same period in the prior year. The decreases for the three and six months ended June 30, 2002 are mainly the result of decreased interest income
of $1.4 million and $3.1 million, respectively, and a decreased gain on sale of marketable investment securities of $410,000 and $728,000, respectively, both resulting from lower interest rates and decreased cash, cash equivalent, and marketable
investment security balances. Balances of cash, cash equivalent, and marketable investment securities decreased as a result of the need to fund current operations and will continue to decrease as we operate our business. Additionally, during the six
months ended June 30, 2001, we recognized income of $964,000 from an equity method investment. A similar income amount was not recorded during the six months ended June 30, 2002.
Future Outlook. We estimate that revenues in the third quarter of 2002 will be approximately $750,000 from existing research and
development funding and license agreements. We expect that research and development expenses in the third quarter of 2002 will be between $24.0 and $26.0 million and general and administrative expenses will be between $3.5 and $4.0 million. The
projected increase in research and development expenses over actual expenses of $20.2 million for the second quarter of 2002 is primarily due to the anticipated signing of a long-term manufacturing agreement for the commercial production of bulk
drug product for PREOS in the third quarter of 2002. We expect amortization of purchased intangibles to be approximately $340,000 and other income, net, to be between $1.5 and $1.9 million.
Liquidity and Capital Resources
We have
financed operations since inception primarily through payments received under collaborative research and license agreements and the private and public issuance and sale of equity securities. As of June 30, 2002, we had recognized $75.4 million of
cumulative revenues from payments for research support, license fees and milestone payments and $331.3 million from the sale of equity securities for cash. Our principal sources of liquidity are cash, cash equivalents, and marketable investment
securities, which totaled $175.7 million at June 30, 2002. The primary objectives for our marketable investment security portfolio are liquidity and safety of principal. Investments are made to achieve the highest rate of return to us, consistent
with these two objectives. Our investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer.
We could receive future milestone payments of up to $92.5 million in the aggregate if each of our current licensees
accomplishes the specified research and/or development milestones provided in the respective agreements. In addition, all of the agreements require the licensees to make royalty payments to us if they sell products covered by the terms of our
license agreements. However, we do not control the subject matter, timing or resources applied by our licensees to their development programs. Thus,
12
potential receipt of milestone and royalty payments from these licensees is largely beyond our control. Some of the late-stage development
milestone payments from AstraZeneca will not be due if we elect a co-promotion option under which we may commercialize products. Further, each of these agreements may be terminated before its scheduled expiration date by the respective licensee
either for any reason or under certain conditions.
Prior to the time that we acquired Allelix in December 1999,
Allelix had entered into a research funding agreement with the Government of Canada pursuant to the Technology Partnership Canada program. Under this agreement, Canada is obligated to reimburse us for up to 30 percent of eligible research and
development costs we incur for our ALX-0600 product candidate through December 2002 up to a maximum of Cdn. $8.4 million. As of June 30, 2002, we had invoiced Canada for a total of Cdn. $7.5 million for reimbursement. The agreement provides Canada
with a 10 percent royalty on revenues we receive from the sale or license of ALX-0600. Our royalty obligation terminates on December 31, 2008 if we have paid at least Cdn. $23.9 million. If we have not paid that amount by that date, our royalty
obligation continues until the earlier of the date we have paid Cdn. $23.9 million, or December 31, 2017. The agreement imposes a number of obligations on us to conduct certain development activities within Canada and use Canadian-based companies to
provide certain services in connection with the development of ALX 0600. We have used and currently use non-Canadian-based companies for some of these services. For example, we arranged for a non-Canadian contract manufacturer to manufacture bulk
supplies of ALX-0600 for our Phase II clinical trials. We notified the Canadian government of our arrangements and received their authorization to proceed. Violations of the terms of the agreement can result in a forfeiture of the technology to
Canada, but we are in ongoing discussions with them, and do not expect that our actions will result in actions by Canada to obtain rights to the program.
We have entered into sponsored research, license, and purchase agreements that obligate us to make research support and milestone payments to academic or commercial research institutions and
individuals. As of June 30, 2002, we have a total commitment of up to $4.2 million for future research support and milestone payments. Further, depending on the commercial success of certain of our products, we may be required to pay license fees or
royalties. We expect to enter into additional sponsored research and license agreements in the future.
Under our
agreement with AstraZeneca, we are required to co-direct the research and pay for an equal share of the research costs, including personnel and capital, through at least September 2003 and, under certain circumstances, through March 2006.
Additionally, as of June 30, 2002, we have a non-cancelable commitment for future manufacturing of PREOS of approximately $19.7 million. We expect to enter into additional collaborative research agreements and manufacturing agreements in the future,
which may require up-front payments and long-term commitments of cash.
We expect that our existing capital
resources including interest earned thereon, will be sufficient to allow us to maintain our current and planned operations through at least 2003. However, our actual needs will depend on numerous factors, especially with regard to the clinical trial
programs and pre-launch market development and production costs for PREOS and ALX-0600. If we advance current proprietary programs; if we in-license or otherwise acquire other technologies, product candidates or companies; or if current clinical
trials are accelerated, delayed, modified or terminated for any reason, we may need to make substantial additional expenditures or we may need to substantially reduce planned expenditures. Our clinical trials may be accelerated, delayed, modified or
terminated for several reasons including the risk that our product candidates will demonstrate safety concerns, the risk that regulatory authorities may not approve our product candidates for further development or may require additional or expanded
clinical trials to be performed, and the risk that our manufacturers may not be able to supply sufficient quantities of our drug candidates to support our clinical trials, which could lead to a disruption or cessation of the clinical trials. We do
not have on hand sufficient supplies of our product candidates to meet our clinical trial requirements and we are dependent on outside manufacturers to provide these supplies on a timely basis. We have sufficient clinical supplies of PREOS to meet
our clinical needs into
13
the first quarter of 2003. If any of the events that pose these risks comes to fruition, we may have to substantially curtail, modify, terminate
or postpone current and planned clinical trials, our business may be materially harmed, our stock price may be adversely affected, and our ability to raise additional capital may be impaired.
We need to raise substantial additional funds to support our long-term research, product development, and commercialization programs. The Company regularly considers
various fundraising alternatives, including, for example, partnering of existing programs, monitoring of potential revenue streams, debt or equity financing and merger and acquisition alternatives. No decision has been made as of this date on the
future use of any one or more of the various alternatives available to us. To provide for financial flexibility and increased liquidity, we filed a shelf registration statement in January 2002. Under the shelf registration statement, we may offer up
to $250.0 million of debt securities, common stock, preferred stock, depository shares, and/or warrants, with terms to be determined by market conditions. We may also seek additional funding through strategic alliances, collaborations, or license
agreements and other financing mechanisms. There can be no assurance that additional financing will be available on acceptable terms, if at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one
or more of our research and development programs, or to obtain funds through arrangements with licensees or others that may require us to relinquish rights to certain of our technologies or product candidates that we may otherwise seek to develop or
commercialize on our own.
Critical Accounting Policies
Our critical accounting policies are as follows:
|
|
|
revenue recognition; and |
|
|
|
valuation of long-lived and intangible assets and goodwill. |
Revenue Recognition. We earn our revenue from research and development support payments, license fees and milestone payments. As
described below, significant management judgment and estimates must be made and used in connection with the revenue recognized in any accounting period. Material differences may result in the amount and timing of our revenue for any period if our
management made different judgments or utilized different estimates.
We apply the provisions of Staff Accounting
Bulletin No. 101, Revenue Recognition (SAB No. 101), to all of our revenue transactions. We recognize revenue from our research and development support agreements as related research and development costs are incurred and from milestone
payments as agreed upon events representing the achievement of substantive steps in the development process are achieved and where the amount of the milestone payment, approximates the value of achieving the milestone. We recognize nonrefundable
license fees over the period we have continuing involvement. Cash received in advance of the performance of the related research and development support and for nonrefundable license fees when we have continuing involvement is recorded as deferred
revenue and recognized as income over the period of our continuing involvement. Where questions arise about contract interpretation, contract performance, or possible breach, we continue to recognize revenue unless we determine that such
circumstances are material and/or that payment is not probable.
Valuation of Long-lived and Intangible
Assets and Goodwill. We assess the impairment of identifiable intangibles, long-lived assets and related goodwill whenever events or changes in circumstances indicate that the carrying value may not be recoverable.
Factors we consider important which could trigger an impairment review include the following:
|
|
|
significant underperformance relative to expected historical or projected future operating results; |
|
|
|
significant changes in the manner of our use of the acquired assets or the strategy for our |
14
|
|
|
significant negative industry or economic trends; |
|
|
|
significant decline in our stock price for a sustained period; and |
|
|
|
our market capitalization relative to net book value. |
When we determine that the carrying value of intangibles, long-lived assets, and related goodwill and enterprise level goodwill may not be recoverable based upon the existence of one or more of the
above indicators of impairment, we measure any impairment based on a projected discounted cash flow method using a discount rate determined by our management to be commensurate with the risk inherent in our current business model. To date, we have
not determined the existence of any indication of impairment sufficient to require us to adjust our historical measure of value of such assets. Our balance sheet reflects net intangible assets, long-lived assets, and goodwill of $15.2 million as of
June 30, 2002.
In 2002, SFAS No. 142, Goodwill and Other Intangible Assets, became effective and as a
result, we have ceased amortizing goodwill. In lieu of amortization, we performed an initial impairment review of our goodwill in 2002 and we will perform an annual impairment review thereafter. As of January 1, 2002, we had unamortized goodwill in
the amount of $6.8 million and unamortized identifiable intangible assets in the amount of $3.9 million, all of which were subject to the transition provisions of SFAS No. 142. During the three and six months ended June 30, 2001, we recorded
amortization expense of $521,000 and $1.1 million, respectively, or $0.02 and $0.04, respectively, per basic and diluted share, that would not have been recorded under SFAS No. 142. The assembled workforce component of identifiable intangible assets
was fully amortized as of December 31, 2001. We did not record an impairment charge upon completion of the initial impairment review in the first quarter of 2002.
Caution on Forward-Looking Statements
Our business is
subject to significant risks which could cause actual results to differ materially from those anticipated in forward-looking statements made in this section. Such risks include but are not limited to, the risks inherent in our research and
development activities, including the successful continuation of our strategic collaborations, the successful completion of clinical trials, the lengthy, expensive and uncertain process of seeking regulatory approvals, uncertainties associated both
with the potential infringement of patents and other intellectual property rights of third parties, and with obtaining and enforcing our own patents and patent rights, uncertainties regarding government reforms and of product pricing and
reimbursement levels, technological change and competition, manufacturing uncertainties and dependence on third parties. Even if our product candidates appear promising at an early state of development, they may not reach the market for numerous
reasons. Such reasons include the possibilities that the product will be ineffective or unsafe during clinical trials, will fail to receive necessary regulatory approvals, will be difficult to manufacture on a large scale, will be uneconomical to
market or will be precluded from commercialization by propriety rights of third parties. For more information about the risks we face, see Risk Factors included in Part I of our Form 10-K filed with the SEC.
Interest Rate
Risk. Our primary objectives in managing our investment portfolio are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. The securities we hold in our investment portfolio are
subject to interest rate risk. At any time, sharp changes in interest rates can affect the fair value of the investment portfolio and its interest earnings. After a review of our marketable investment securities, we believe that in the event of a
hypothetical 10 percent increase in interest rates, the resulting decrease in fair market value of our marketable investment securities would be insignificant to the financial statements. Currently, we do not hedge these interest rate exposures. We
have established policies and procedures to manage exposure to fluctuations in interest rates. We place our investments with high quality issuers and limit the amount of credit exposure to any one issuer and do not use derivative financial
instruments in our investment portfolio. We maintain an investment
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portfolio of various issuers, types and maturities, which consist mainly of highly liquid, investment-grade securities and money market funds.
These securities are classified as available-for-sale and, consequently, are recorded on the balance sheet at fair value with unrealized gains or losses reported as accumulated other comprehensive income as a separate component in stockholders
equity.
Foreign Currency Risk. Some of our research and
development operations are in Canada. As a result, our financial results could be affected by factors such as a change in the foreign currency exchange rate between the U.S. dollar and the Canadian dollar, or by weak economic conditions in Canada.
When the U.S. dollar strengthens against the Canadian dollar, the cost of expenses in Canada decreases. When the U.S. dollar weakens against the Canadian dollar, the cost of expenses in Canada increases. The monetary assets and liabilities in our
foreign subsidiary which are impacted by the foreign currency fluctuations are cash, marketable investment securities, accounts receivable, accounts payable, and certain accrued liabilities. A hypothetical 10% increase or decrease in the exchange
rate between the U.S. dollar and the Canadian dollar from the June 30, 2002 rate would cause the fair value of such monetary assets and liabilities in Canada to change by an insignificant amount. We are not currently engaged in any foreign currency
hedging activities.
PART II OTHER INFORMATION
The
Companys Annual Meeting of Stockholders was held on May 23, 2002. The stockholders approved all proposals by the vote specified below:
Proposal One: |
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To elect ten (10) directors as set forth in the Proxy Statement. |
Nominees
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For
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Withheld
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Santo J. Costa |
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19,340,191 |
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2,621,142 |
John R. Evans |
|
19,278,359 |
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2,680,974 |
James G. Groninger |
|
19,271,091 |
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2,690,242 |
Hunter Jackson |
|
14,267,799 |
|
7,693,534 |
Joseph Klein, III |
|
19,270,391 |
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2,690,942 |
Donald E. Kuhla |
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19,270,591 |
|
2,690,742 |
Thomas N. Parks |
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19,279,359 |
|
2,681,974 |
Edward Rygiel |
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19,276,359 |
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2,684,974 |
Calvin Stiller |
|
19,349,359 |
|
2,611,974 |
Peter G. Tombros |
|
19,349,691 |
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2,611,642 |
Proposal Two: |
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To consider and act upon a proposal to increase by 2,000,000 shares the aggregate number of common stock for which options may be granted under two of the
Companys equity incentive plans as follows: (a) an additional 1,900,000 shares under the 1998 Stock Option Plan; and (b) an additional 100,000 shares under the 1994 Non-Employee Directors Stock Option Plan: For: 10,504,523; Against:
7,238,335; Abstain: 106,444. |
Proposal Three: |
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To ratify the appointment of KPMG LLP as independent auditors for the Company for the 2002 fiscal year: For: 21,544,027; Against: 413,878; Abstain: 2,448.
|
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On May 15, 2002, we announced that we had sufficient clinical
supplies of PREOS to meet the needs of our current clinical trials into the third quarter of 2002. As of July 23, 2002, we have on hand sufficient inventory of clinical supplies of PREOS to meet the needs of all of our current clinical trials into
the first quarter of 2003. After an extensive review of the process used to prepare finished drug we have implemented changes in that process which have resulted in the production of clinical supplies of PREOS that meet our release specifications.
Based on the results of production modifications made to date, we expect to continue to be able to produce sufficient and timely clinical supplies of PREOS to enable us to meet the needs of our current clinical trials through completion.
Statements made in this Item 5 relating to meeting the needs of our clinical trials into the first quarter of
2003 and our ability to produce sufficient and timely clinical supplies of PREOS are forward-looking statements. Such statements involve risks and uncertainties, which may cause actual results to differ materially from those in the forward-looking
statement. There can be no assurances that future production runs will result in the production of clinical supplies of PREOS that will meet our release specifications for use in our current clinical trials nor that we can avoid new, unforeseen
problems in the production process. Failure to timely produce adequate clinical supplies of PREOS would likely result in disruption or termination of the clinical development of PREOS. Disruption or termination of our current clinical trials would
materially harm our business, our stock price would likely be adversely affected, and our ability to raise additional capital impaired.
On December 31, 2001, the Board of Directors approved an amendment to our shareholders rights plan, which extended the expiration date of the plan to December 31, 2011 and increased the definition of the Purchase Price
to $300.00. We intend to seek approval of the amendment from stockholders of the Company at the 2003 Annual Meeting of Stockholders.
(b) Reports on Form 8-K.
On April 12, 2002, the Company filed a report on Form 8-K with the SEC disclosing the adoption by certain
officers and directors of plans to sell shares of Company common stock under SEC Rule 10b5-1.
On June 13, 2002,
the Company filed a report on Form 8-K with the SEC regarding a press release dated June 11, 2002, a conference call held on June 12, 2002, and a webcast presentation held on June 13, 2002, all of which provided additional information regarding the
manufacture of clinical supplies of PREOS, its proprietary drug candidate for the treatment of osteoporosis.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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NPS PHARMACEUTICALS, INC. |
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Date: July 23, 2002 |
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By: |
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/s/ HUNTER JACKSON
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Hunter Jackson, President and Chief Executive Officer |
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Date: July 23, 2002 |
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By: |
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MORGAN R. BROWN
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Morgan R. Brown, Chief Accounting Officer |
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