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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 PERIOD ENDED JUNE 30, 2002
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: 0-31265
TELIK, INC.
(EXACT NAME
OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE
|
|
93-0987903
|
(STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) |
|
(I.R.S. EMPLOYER IDENTIFICATION NO.) |
750 GATEWAY BOULEVARD, SOUTH SAN FRANCISCO, CA 94080
(ADDRESS, INCLUDING ZIP CODE, OF PRINCIPAL EXECUTIVE OFFICES)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (650) 244-9303
SECURITIES REGISTERED
PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK $0.01 PAR VALUE
(TITLE OF CLASS)
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 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: Common Stock $0.01 par value
|
|
Outstanding at July 31, 2002:
|
|
|
27,863,924 shares |
INDEX
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PAGE
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PART I. FINANCIAL INFORMATION |
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Item 1: |
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Financial Statements (Unaudited) |
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3 |
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4 |
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5 |
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6 |
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Item 2: |
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8 |
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Item 3: |
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17 |
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PART II. OTHER INFORMATION |
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Item 1: |
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18 |
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Item 2: |
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18 |
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Item 3: |
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18 |
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Item 4: |
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19 |
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Item 5: |
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19 |
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Item 6: |
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19 |
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20 |
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
TELIK, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and per share data)
|
|
June 30, 2002
|
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December 31, 2001
|
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|
|
(Unaudited) |
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(Note 1) |
|
Assets |
|
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,720 |
|
|
$ |
39,508 |
|
Short-term investments |
|
|
18,898 |
|
|
|
13,722 |
|
Prepaid expenses and other current assets |
|
|
930 |
|
|
|
991 |
|
|
|
|
|
|
|
|
|
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Total current assets |
|
|
41,548 |
|
|
|
54,221 |
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Property and equipment, net |
|
|
1,556 |
|
|
|
1,096 |
|
Long-term investments |
|
|
1,557 |
|
|
|
1,944 |
|
Other assets |
|
|
63 |
|
|
|
54 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
44,724 |
|
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$ |
57,315 |
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Liabilities and stockholders equity |
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Current liabilities: |
|
|
|
|
|
|
|
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Accounts payable |
|
$ |
3,150 |
|
|
$ |
3,338 |
|
Accrued clinical trials |
|
|
824 |
|
|
|
881 |
|
Accrued compensation |
|
|
705 |
|
|
|
636 |
|
Other accrued liabilities |
|
|
1,312 |
|
|
|
460 |
|
Current portion of capital lease obligations |
|
|
5 |
|
|
|
|
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Deferred revenue |
|
|
917 |
|
|
|
662 |
|
|
|
|
|
|
|
|
|
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Total current liabilities |
|
|
6,913 |
|
|
|
5,977 |
|
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Non-current portion of capital lease obligations |
|
|
29 |
|
|
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Commitments |
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Stockholders equity: |
|
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Preferred stock, $0.01 par value, 5,000,000 shares authorized, none issued and outstanding |
|
|
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Common stock, $0.01 par value, 100,000,000 shares authorized, 27,859,799 and 27,765,484 issued and outstanding at June
30, 2002 and December 31, 2001, respectively |
|
|
279 |
|
|
|
278 |
|
Additional paid-in capital |
|
|
135,268 |
|
|
|
134,812 |
|
Deferred stock compensation |
|
|
(890 |
) |
|
|
(1,173 |
) |
Note receivable from employee |
|
|
(48 |
) |
|
|
(105 |
) |
Accumulated other comprehensive income |
|
|
4 |
|
|
|
33 |
|
Accumulated deficit |
|
|
(96,831 |
) |
|
|
(82,507 |
) |
|
|
|
|
|
|
|
|
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Total stockholders equity |
|
|
37,782 |
|
|
|
51,338 |
|
|
|
|
|
|
|
|
|
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Total liabilities and stockholders equity |
|
$ |
44,724 |
|
|
$ |
57,315 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes
3
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2002
|
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|
2001
|
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|
2002
|
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|
2001
|
|
Contract revenue from collaborations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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With related parties |
|
$ |
348 |
|
|
$ |
397 |
|
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$ |
745 |
|
|
$ |
794 |
|
Other |
|
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|
|
|
|
|
|
|
|
|
|
|
67 |
|
Other revenues |
|
|
17 |
|
|
|
8 |
|
|
|
42 |
|
|
|
33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total revenues |
|
|
365 |
|
|
|
405 |
|
|
|
787 |
|
|
|
894 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
8,282 |
|
|
|
4,257 |
|
|
|
13,046 |
|
|
|
7,760 |
|
General and administrative |
|
|
1,367 |
|
|
|
1,026 |
|
|
|
2,542 |
|
|
|
2,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total costs and expenses |
|
|
9,649 |
|
|
|
5,283 |
|
|
|
15,588 |
|
|
|
9,917 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Loss from operations |
|
|
(9,284 |
) |
|
|
(4,878 |
) |
|
|
(14,801 |
) |
|
|
(9,023 |
) |
Interest income, net |
|
|
205 |
|
|
|
516 |
|
|
|
477 |
|
|
|
1,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Net loss |
|
$ |
(9,079 |
) |
|
$ |
(4,362 |
) |
|
$ |
(14,324 |
) |
|
$ |
(7,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing net loss per common share, basic and diluted |
|
|
27,808 |
|
|
|
22,767 |
|
|
|
27,766 |
|
|
|
22,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
4
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands, unaudited)
|
|
Six Months Ended June 30,
|
|
|
|
2002
|
|
|
2001
|
|
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(14,324 |
) |
|
$ |
(7,878 |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
|
|
Depreciation |
|
|
260 |
|
|
|
233 |
|
Amortization of deferred stock compensation |
|
|
268 |
|
|
|
360 |
|
Stock options granted to non-employees |
|
|
74 |
|
|
|
|
|
Forgiveness of notes receivable from related parties |
|
|
28 |
|
|
|
|
|
Amortization of discount (premium) on investments |
|
|
(48 |
) |
|
|
109 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
24 |
|
|
|
323 |
|
Accounts payable |
|
|
(188 |
) |
|
|
600 |
|
Accrued clinical trials |
|
|
(57 |
) |
|
|
(296 |
) |
Accrued compensation |
|
|
69 |
|
|
|
35 |
|
Other accrued liabilities |
|
|
852 |
|
|
|
(201 |
) |
Deferred revenue |
|
|
255 |
|
|
|
1,389 |
|
Long-term liabilities |
|
|
|
|
|
|
(14 |
) |
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(12,787 |
) |
|
|
(5,340 |
) |
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Sales and maturities of investments |
|
|
43,900 |
|
|
|
64,845 |
|
Purchases of investments |
|
|
(48,670 |
) |
|
|
(63,710 |
) |
Purchases of property and equipment |
|
|
(683 |
) |
|
|
(274 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
(5,453 |
) |
|
|
861 |
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
Principal payments under capital lease obligations |
|
|
(3 |
) |
|
|
(2 |
) |
Net proceeds from issuance of common stock |
|
|
398 |
|
|
|
582 |
|
Payment of promissory note from employee |
|
|
57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
452 |
|
|
|
580 |
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(17,788 |
) |
|
|
(3,899 |
) |
Cash and cash equivalents at beginning of period |
|
|
39,508 |
|
|
|
11,959 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
21,720 |
|
|
$ |
8,060 |
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
4 |
|
|
$ |
2 |
|
|
|
|
|
|
|
|
|
|
Equipment acquired under capital leases |
|
$ |
37 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
5
Notes to Condensed Financial Statements
(Unaudited)
1. |
|
Basis of presentation and summary of significant accounting policies |
We have prepared the accompanying financial statements in accordance with generally accepted accounting principles for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. We believe
all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month and six-month periods ended June 30, 2002 are not necessarily indicative of the
results that may be expected for the year ending December 31, 2002 or any other period. The balance sheet at December 31, 2001 has been derived from the audited financial statements at that date. You should read these financial statements and notes
in conjunction with our audited financial statements for the year ended December 31, 2001, which are included in our Annual Report on Form 10-K.
Revenue recognition
Contract revenue consists of revenue from research and development
collaboration agreements. Our research and development collaboration agreements provide for periodic payments in support of our research activities. We recognize contract revenue from these agreements as earned based upon the performance
requirements of the agreements and we recognize payments of up-front technology access and license fees ratably over the period of the related research program. Payments received, which are related to future performance, are deferred and recognized
as revenue when earned over future performance periods.
We have received United States government grants, which
support research efforts in defined projects. We recognize revenue from such government grants as costs relating to the grants are incurred.
2. |
|
Comprehensive income (loss) |
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in unrealized gains (losses) on investments.
Comprehensive income (loss) for the three-month and six-month periods ended June 30, 2002 and 2001 are as follows (in thousands):
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2002
|
|
|
2001
|
|
|
2002
|
|
|
2001
|
|
Net loss |
|
$ |
(9,079 |
) |
|
$ |
(4,362 |
) |
|
$ |
(14,324 |
) |
|
$ |
(7,878 |
) |
Change in unrealized gain/(loss) on investments |
|
|
4 |
|
|
|
5 |
|
|
|
(29 |
) |
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(9,075 |
) |
|
$ |
(4,357 |
) |
|
$ |
(14,353 |
) |
|
$ |
(7,789 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. |
|
Basic and diluted net loss per share |
We have computed net loss per common share according to the Financial Accounting Standards Board Statement No. 128, Earnings Per Share, which requires disclosure of basic and diluted
earnings per share. Basic earnings per share excludes any dilutive effects of options, shares subject to repurchase, warrants and convertible securities. Diluted earnings per share includes the impact of potentially dilutive securities. A
reconciliation of shares used in the calculation is as follows:
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2002
|
|
|
2001
|
|
|
2002
|
|
|
2001
|
|
Net loss |
|
$ |
(9,079 |
) |
|
$ |
(4,362 |
) |
|
$ |
(14,324 |
) |
|
$ |
(7,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares of common stock outstanding |
|
|
27,847 |
|
|
|
22,863 |
|
|
|
27,819 |
|
|
|
22,804 |
|
Less: weighted average common shares subject to repurchase |
|
|
(39 |
) |
|
|
(96 |
) |
|
|
(53 |
) |
|
|
(96 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing net loss per common share, basic and diluted |
|
|
27,808 |
|
|
|
22,767 |
|
|
|
27,766 |
|
|
|
22,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6
TELIK, INC.
Notes to
Condensed Financial Statements(Continued)
(Unaudited)
4. |
|
Cash, cash equivalents and investments |
The following is a summary of cash, cash equivalents and investments (in thousands):
|
|
Amortized Cost
|
|
Gross Unrealized Gains/ (Losses)
|
|
|
Estimated Fair Value
|
June 30, 2002 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
Cash and money market funds |
|
$ |
5,343 |
|
$ |
|
|
|
$ |
5,343 |
Commercial paper |
|
|
14,670 |
|
|
(2 |
) |
|
|
14,668 |
Corporate notes |
|
|
1,710 |
|
|
(1 |
) |
|
|
1,709 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
21,723 |
|
$ |
(3 |
) |
|
$ |
21,720 |
|
|
|
|
|
|
|
|
|
|
|
Short term investments: |
|
|
|
|
|
|
|
|
|
|
U.S. Government notes |
|
$ |
2,000 |
|
$ |
1 |
|
|
$ |
2,001 |
Corporate notes |
|
|
16,897 |
|
|
|
|
|
|
16,897 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
18,897 |
|
$ |
1 |
|
|
$ |
18,898 |
|
|
|
|
|
|
|
|
|
|
|
Long term investments: |
|
|
|
|
|
|
|
|
|
|
U.S. Government notes |
|
$ |
1,551 |
|
$ |
6 |
|
|
$ |
1,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,551 |
|
$ |
6 |
|
|
$ |
1,557 |
|
|
|
|
|
|
|
|
|
|
|
December 31, 2001 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
Cash and money market funds |
|
$ |
39,508 |
|
$ |
|
|
|
$ |
39,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
39,508 |
|
$ |
|
|
|
$ |
39,508 |
|
|
|
|
|
|
|
|
|
|
|
Short term investments: |
|
|
|
|
|
|
|
|
|
|
U.S. Government notes |
|
$ |
6,976 |
|
$ |
16 |
|
|
$ |
6,992 |
Corporate notes |
|
|
6,730 |
|
|
|
|
|
|
6,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
13,706 |
|
$ |
16 |
|
|
$ |
13,722 |
|
|
|
|
|
|
|
|
|
|
|
Long term investments: |
|
|
|
|
|
|
|
|
|
|
Corporate notes |
|
$ |
1,927 |
|
$ |
17 |
|
|
$ |
1,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,927 |
|
$ |
17 |
|
|
$ |
1,944 |
|
|
|
|
|
|
|
|
|
|
|
5. |
|
Registration statement on Form S-3 |
In May 2002, we filed a registration statement on Form S-3 to offer and sell, from time to time, equity and debt securities in one or more offerings up to a total dollar amount of $100 million. Under
this registration statement, $100 million remains available for future offerings and we have no current commitments to offer and sell any securities that may be offered and sold pursuant to this registration statement.
In July 2002, we entered into a lease for a research and office facility of approximately 92,000 square feet located at 3165 Porter Drive in Palo Alto, California. The term of the lease is 11.5 years, commencing in
January 2003 and terminating in May 2014. Under the terms of this lease, we may finance up to $5.0 million in leasehold improvements made to the facility. We anticipate this facility will replace our current research and office facilities in
South San Francisco, California. Our total financial commitment for the full term of the Palo Alto lease is approximately $39.1 million.
7
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Special Note Regarding Statements of Expected Future Performance
This Quarterly Report on Form 10-Q contains statements indicating expectations about future performance and other forward-looking statements that involve risks and uncertainties. We usually use words
such as may, will, should, expect, plan, anticipate, believe, estimate, predict, future, intend,
potential, or continue or the negative of these terms or similar expressions to identify forward-looking statements. These statements appear throughout the Form 10-Q and are statements regarding our current intent, belief, or
expectation, primarily with respect to our operations and related industry developments. Examples of these statements include, but are not limited to, statements regarding the following: the extent to which our issued and pending patents may protect
our products and technology, our ability to identify new product candidates using TRAP technology (our proprietary Target-Related Affinity Profiling technology, which is discussed below), the potential of such product candidates to lead to the
development of safer or more effective therapies, our ability to develop the technology derived from our collaborations, our anticipated timing for filing an IND (Investigational New Drug application) with the Food and Drug Administration (FDA) or
for the initiation or completion of phase 1, phase 2 or phase 3 testing for any of our product candidates, our future operating expenses, our future losses, our future expenditures for research and development and our use of proceeds from the
initial and follow-on public offerings. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q. Our actual results could differ materially from those anticipated
in these forward-looking statements for many reasons, including the risks faced by us and described in the section of this Item 2 titled Additional Factors That May Affect Future Results, and elsewhere in this Quarterly Report on Form
10-Q.
The following discussion and analysis should be read in conjunction with the unaudited financial statements
and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with the financial statements and notes thereto and Managements Discussion and Analysis of Financial Condition and Results of Operations contained in our
Annual Report on Form 10-K for the year ended December 31, 2001.
Overview
We are engaged in the discovery, development and commercialization of small molecule therapeutics. We have incurred net losses since
inception and expect to incur substantial and increasing losses for the next several years as we expand our research and development activities and move our product candidates into later stages of development. The process of carrying out the
development of our own unpartnered products to later stages of development and our research programs for our corporate partners may require significant additional research and development expenditures including preclinical testing and clinical
trials, as well as for obtaining regulatory approval. To date, we have funded our operations primarily through the sale of equity securities and through non-equity payments from collaborative partners.
We received funding in the form of equity investments totaling $27.6 million in the year ended December 31, 2001 from our follow-on public
offering completed in October 2001. We received funding in the form of equity investments totaling $42.5 million in the year ended December 31, 2000. This funding included net proceeds of $35.6 million from our initial public offering in
August 2000 and net proceeds of $7.0 million from our issuance of Series K convertible preferred stock in March 2000. We received funding in the form of equity investments from our collaborative partner Sanwa, in an aggregate amount of $11.0
million during the years of 1996 through 1998.
Since 1996, we have received $14.6 million in non-equity payments
from collaborators, including $10.8 million from Sanwa. Our most recent non-equity payment from a collaborator was $1.0 million, for research funding, received from Sanwa in March 2002.
At June 30, 2002 our accumulated deficit was $96.8 million.
8
Critical accounting policies
We believe the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our financial statements.
Revenue recognition
Since Teliks inception, most of our revenues have been generated from license and research agreements with collaborators. We recognize cost reimbursement revenue
under these collaborative agreements as the related research and development costs are incurred. We recognize milestone fees upon completion of specified milestones according to contract terms. Deferred revenue represents the portion of research
payments received that has not been earned.
We also have several royalty and licensing agreements with other
pharmaceutical, biotechnology and genomics companies. Under these agreements, we may receive fees for collaborative research efforts, royalties on future sales of products, or some combination of these items. We recognize nonrefundable signing or
license fees that are not dependent on future performance under these agreements as revenue when received or over the term of the arrangement if we have continuing performance obligations.
Research and development expenses
Our research and development expenses include salaries and benefits costs, fees for contractors and consultants, and an allocation of administrative and corporate costs. Research and development expenses consist of costs incurred for
discovery research, screening and identification of drug candidates, preclinical studies, drug and product development, manufacturing, and clinical activities. All such costs are charged to research and development expenses as incurred. Costs of
materials and other supplies are charged to research and development expense upon receipt.
Use of estimates
In preparing our financial statements to conform with accounting principles generally accepted in the United
States, we make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. These estimates include useful lives for fixed assets for depreciation calculations and assumptions for valuing stock
option grants. Actual results may differ from these estimates.
Results of operations
Three-month periods ended June 30, 2002 and 2001
Revenues
Revenues were $0.4
million in both of the three-month periods ended June 30, 2002 and 2001. Revenues resulted from our collaborative agreements with Sanwa and funded research related to a grant received from the National Institutes of Health.
We expect near-term future revenue to fluctuate depending upon our ability to enter into new collaborative research agreements and the
amounts of payments relating to such agreements.
Research and development expenses
Research and development expenses for the three-month periods ended June 30, 2002 and 2001 were $8.3 million and
$4.3 million, respectively. Our research and development activities consist primarily of discovery research, screening and identification of drug candidates, preclinical studies, drug and product development, manufacturing, and clinical
activities. We group these activities into two major categories: research and preclinical and clinical development. Research and preclinical costs primarily represent our new drug discovery efforts and preclinical work for
our selected clinical candidates. Costs associated with clinical development represent the advancement of our existing product candidates through clinical trials.
9
We estimate the costs associated with these activities approximate the following
(in thousands):
|
|
Three Months Ended June 30,
|
|
|
2002
|
|
2001
|
Research and preclinical |
|
$ |
2,699 |
|
$ |
2,409 |
Clinical development |
|
|
5,583 |
|
|
1,848 |
|
|
|
|
|
|
|
Total research and development |
|
$ |
8,282 |
|
$ |
4,257 |
|
|
|
|
|
|
|
We utilize many of our resources across multiple research projects
that are ongoing at any one time. Significant portions of our research and development costs are not directly allocated to individual projects. Therefore, we do not maintain actual cost incurred information on a project-by-project basis.
The increase in research and development expense in the three-month period ended June 30, 2002 compared to the
same period in 2001 was principally due to clinical development costs associated with TLK286 including phase 2 clinical trials, manufacturing, and product development costs. In addition, we initiated a phase 1-2a clinical trial of TLK199 in April
2002. We expect research and development expenditures to continue to increase in future periods as a result of increased manufacturing and other clinical development costs primarily relating to our TLK286 and TLK199 product candidates. The timing
and the amount of this anticipated increase in expense will depend upon the outcome of our ongoing clinical trials, regulatory requirements, advancement of our preclinical programs and manufacturing product supply costs.
General and administrative expenses
General and administrative expenses for the three-month periods ended June 30, 2002 and 2001 were $1.4 million and $1.0 million, respectively. This increase was due primarily to staffing costs for
additional administrative personnel and activities related to the growth of the company. We expect future general and administrative expenses will increase to support expanded business activities.
Net interest income
Net interest income was $0.2 million and $0.5 million for the three-month periods ended June 30, 2002 and 2001, respectively, and resulted primarily from earnings on investments. This decrease in net interest income in 2002
was principally due to lower average interest rates outstanding in 2002.
Six-month periods ended June 30,
2002 and 2001
Revenues
Revenues for the six-month periods ended June 30, 2002 and 2001 were $0.8 million and $0.9 million, respectively. Revenues resulted from our collaborative agreements with
Sanwa and Sankyo and funded research related to grants received from the National Institutes of Health.
We expect
near-term future revenue to fluctuate depending upon our ability to enter into new collaborative research agreements and the amounts of payments relating to such agreements.
Research and development expenses
Research and development expenses for the six-month periods ended June 30, 2002 and 2001 were $13.0 million and $7.8 million, respectively. Our research and development activities consist primarily of discovery research,
screening and identification of drug candidates, preclinical studies, drug and product development, manufacturing, and clinical activities. We group these activities into two major categories: research and preclinical and clinical
development. Research and preclinical costs primarily represent our new drug discovery efforts and preclinical work for our selected clinical candidates. Costs associated with clinical development represent the advancement of our existing
product candidates through clinical trials.
We estimate the costs associated with these activities approximate
the following (in thousands):
|
|
Six Months Ended June 30,
|
|
|
2002
|
|
2001
|
Research and preclinical |
|
$ |
5,354 |
|
$ |
4,492 |
Clinical development |
|
|
7,692 |
|
|
3,268 |
|
|
|
|
|
|
|
Total research and development |
|
$ |
13,046 |
|
$ |
7,760 |
|
|
|
|
|
|
|
The increase in research and development expense in the six-month
period ended June 30, 2002 compared to the same period in 2001 was principally due to clinical development costs associated with TLK286 including phase 2 clinical trials, manufacturing, and product development costs. In addition, we initiated a
phase 1-2a clinical trial of TLK199 in April 2002.
10
General and administrative expenses
General and administrative expenses for the six-month periods ended June 30, 2002 and 2001 were $2.5 million and $2.2 million,
respectively. This increase was due primarily to staffing costs for additional administrative personnel and activities related to the growth of the company.
Net interest income
Net interest income was $0.5 million
and $1.1 million for the six-month periods ended June 30, 2002 and 2001, respectively, and resulted primarily from earnings on investments. This decrease in net interest income in 2002 was principally due to lower average interest rates outstanding
in 2002.
Liquidity and Capital Resources
We have financed our operations from inception primarily through the private placement of equity securities, our initial public offering, our follow-on public offering, revenue from collaborative
agreements, interest earned on investments and equipment lease line financings. Through June 30, 2002, we have raised $128.1 million from the sale of equity securities, including $11.0 million from collaborators, and we have received $14.6 million
in non-equity payments from collaborators.
In the six-month period ended June 30, 2002, our operating activities
resulted in net cash outflows of $12.8 million, resulting primarily from our operating loss of $14.3 million. Investing activities consumed cash of $5.5 million, primarily due to the net effect of purchases and sales of short-term securities.
Purchases of property and equipment were $0.7 million principally for new laboratory equipment. Financing activities provided cash of $0.5 million, principally from exercises of stock options and purchases of stock through our employee stock
purchase plan.
We believe our existing cash resources, plus anticipated proceeds from corporate collaborations,
will be sufficient to satisfy our anticipated cash requirements for at least an additional 15 months. Our periodic estimates of anticipated cash requirements will vary depending upon our current forecast of future operating expenses. Changes in our
research and development plans or other changes affecting our operating expenses may affect actual future consumption of existing cash resources. In any event, we will need to raise substantial additional capital to fund our operations in the
future. We expect to finance our future cash needs through the sale of equity securities, strategic collaborations, equipment financing and possibly debt financing. In May 2002, we filed a registration statement on Form S-3 to offer and sell, from
time to time, equity and debt securities in one or more offerings up to a total dollar amount of $100 million. Under this registration statement, $100 million remains available for future offerings and we have no current commitments to offer
and sell any securities that may be offered and sold pursuant to this registration statement.
In July 2002 we
entered into a lease for a research and office facility of approximately 92,000 square feet located at 3165 Porter Drive in Palo Alto, California. The term of the lease is 11.5 years, commencing in January 2003 and terminating in
May 2014. Under the terms of this lease we may finance up to $5.0 million in leasehold improvements made to the facility.
Our future contractual obligations, including the Palo Alto facility lease, are as follows (in thousands):
|
|
Payments Due by Period
|
|
|
|
|
For years ending December 31,
|
Contractual Obligations
|
|
Total
|
|
2002
|
|
2003
|
|
2004
|
|
2005-2006
|
|
After 2006
|
Capital Lease Obligations |
|
$ |
74 |
|
$ |
26 |
|
$ |
14 |
|
$ |
11 |
|
$ |
23 |
|
$ |
|
Operating Leases |
|
|
40,368 |
|
|
722 |
|
|
3,067 |
|
|
3,145 |
|
|
6,475 |
|
|
26,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Contractual Cash Obligations |
|
$ |
40,442 |
|
$ |
748 |
|
$ |
3,081 |
|
$ |
3,156 |
|
$ |
6,498 |
|
$ |
26,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our future capital uses and requirements will depend on numerous
factors, including the following:
|
|
|
the progress and success of preclinical studies and clinical trials of our product candidates; |
|
|
|
the progress and number of research programs in development; |
|
|
|
the costs and timing of obtaining regulatory approvals; |
|
|
|
our ability to establish, and the scope of, new collaborations; |
|
|
|
our ability to meet the milestones identified in our collaborative agreements which trigger payments; and |
|
|
|
the costs and timing of obtaining, enforcing and defending our patent and intellectual property rights. |
11
ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS
Our business is subject to various risks, including those described below. You should carefully consider these risk factors as each of
these risks could adversely affect our business, operating results and financial condition.
We have a history of net losses,
which we expect to continue for at least several years. We will never be profitable unless we develop, and obtain regulatory approval and market acceptance of, our product candidates.
Due to the significant research and development expenditures required to develop our TRAP technology and identify new product candidates, and the lack of any products to
generate revenue, we have not been profitable and have generated operating losses since we were incorporated in 1988. As of June 30, 2002, we had an accumulated deficit of $96.8 million. We expect to incur losses for at least the next several years
and expect that these losses will actually increase as we expand our research and development activities and incur significant clinical testing costs. To date, we have derived substantially all of our revenues, which have not been significant, from
project initiation fees and research reimbursement paid pursuant to existing collaborative agreements with third parties and achievement of milestones under current collaborations. We expect that this trend will continue until we develop, and obtain
regulatory approval and market acceptance of, our product candidates. We cannot assure you when, if ever, we will receive product revenue, if any, sufficient to become profitable.
All of our product candidates are in research and development. If clinical trials of TLK286 and TLK199 are delayed or unsuccessful or if we are unable to complete the preclinical development of our
diabetes or other preclinical product candidates, our business may be adversely affected.
Preclinical testing
and clinical trials are long, expensive and uncertain processes. It may take us or our collaborators several years to complete this testing, and failure can occur at any stage of the process. Success in preclinical testing and early clinical trials
does not ensure that later clinical trials will be successful. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after promising results in
earlier trials.
Any clinical trial may fail to produce results satisfactory to the FDA. Preclinical and clinical
data can be interpreted in different ways, which could delay, limit or prevent regulatory approval. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be repeated or a program to be
terminated. We typically rely on third-party clinical investigators to conduct our clinical trials and, as a result, we may face additional delays outside our control.
We do not know whether planned clinical trials will begin on time or whether any of our ongoing clinical trials will be completed on schedule, or at all. We do not know
whether any clinical trials will result in marketable products. Typically, there is a high rate of attrition for product candidates in preclinical and clinical trials.
Only one of our product candidates, TLK286, has completed the stage of human testing designed to determine safety, known as phase 1 clinical trials and, to date, we have
only limited data on safety and efficacy in humans, with respect to this product candidate. We initiated phase 2 clinical trials of TLK286 in colorectal, ovarian and non-small cell lung cancers in the first half of 2001 and in breast cancer in the
first quarter of 2002. In April 2002, we initiated a phase 1-2a clinical trial for TLK199. Finally, we recently selected TLK19781, one of a family of orally active small molecule insulin receptor activators that we are developing for potential
treatment of diabetes, for advancement into IND-stage development. Our success depends, in part, on our ability to complete preclinical development of our diabetes or other preclinical product candidates, and take them through early clinical trials.
We do not anticipate that any of our products will reach the market for at least several years.
We believe that our ability to
compete depends, in part, on our ability to use our proprietary TRAP technology to discover, develop and commercialize new pharmaceutical products. We may not be competitive if we are unable to utilize our TRAP technology or if the technology proves
ineffective.
TRAP, our proprietary drug discovery technology, is a relatively new drug discovery method that
uses a protein panel of approximately 20 proteins selected for their distinct patterns of interacting with small molecules. This panel may lack essential types of interactions that we have not yet identified, which may result in our inability to
identify active compounds that have the potential to be developed into commercially viable drugs.
If we are
unable to continue to identify new product candidates using TRAP technology, we may not be able to maintain our product pipeline and develop commercially viable drugs.
12
If we are unable to raise adequate funds in the future, we will not be able to continue to fund our
operations, research programs, preclinical testing and clinical trials to develop our products.
The process
of carrying out the development of our own unpartnered products to later stages of development and developing other research programs to the stage that they may be partnered will require significant additional expenditures, including the expenses
associated with preclinical testing, clinical trials and obtaining regulatory approval. As a result, we will require additional financing to fund our operations. We do not know whether additional financing will be available when needed, or that, if
available, we will obtain financing on terms favorable to our stockholders. We have expended substantial amounts of cash to date and expect capital outlays and operating expenditures to increase over the next several years as we expand our research
and development activities.
If our competitors develop and market products that are more effective than ours, or obtain marketing
approval before we do, our commercial opportunity will be reduced or eliminated.
The biotechnology and
pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. Some of the drugs that we are attempting to develop, for example TLK199, will have to compete with existing therapies. In addition, a
number of companies are pursuing the development of pharmaceuticals that target the same diseases and conditions that we are targeting. We face competition from pharmaceutical and biotechnology companies in the United States and abroad. Our
competitors may develop new screening technologies and may utilize discovery techniques or partner with collaborators in order to develop products more rapidly or successfully than we, or our collaborators, are able to do. Many of our competitors,
particularly large pharmaceutical companies, have substantially greater financial, technical and human resources than we do. In addition, academic institutions, government agencies and other public and private organizations conducting research may
seek patent protection with respect to potentially competing products or technologies and may establish exclusive collaborative or licensing relationships with our competitors.
Our competitors may succeed in developing technologies and drugs that are more effective or less costly than any which are being developed by us or which would render our
technology and potential drugs obsolete and noncompetitive. In addition, our competitors may succeed in obtaining FDA or other regulatory approvals for product candidates more rapidly than we, or our collaborators. We cannot assure you that drugs
resulting from our research and development efforts, or from our joint efforts with our existing or future collaborative partners, will be able to compete successfully with our competitors existing products or products under development or
that they will obtain regulatory approval in the United States or elsewhere.
If we do not obtain regulatory approval to market
products in the United States and foreign countries, we or our collaborators will not be permitted to commercialize our product candidates.
Even if we are able to achieve success in our preclinical testing, we, or our collaborators, must provide the FDA and foreign regulatory authorities with clinical data that demonstrate the safety and
efficacy of our products in humans before they can be approved for commercial sale. Failure to obtain regulatory approval will prevent commercialization of our products.
The pharmaceutical industry is subject to stringent regulation by a wide range of authorities. We cannot predict whether regulatory clearance will be obtained for any
product that we are developing or hope to develop. A pharmaceutical product cannot be marketed in the United States until it has completed rigorous preclinical testing and clinical trials and an extensive regulatory clearance process implemented by
the FDA. Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the product and requires the expenditure of substantial resources. Of particular significance are the requirements
covering research and development, testing, manufacturing, quality control, labeling and promotion of drugs for human use.
Before commencing clinical trials in humans, we, or our collaborators, must submit and receive approval from the FDA of an IND application. We must comply with FDA Good Laboratory Practices regulations in our preclinical
studies. Clinical trials are subject to oversight by institutional review boards and the FDA and:
|
|
|
must be conducted in conformance with the FDAs IND regulations; |
|
|
|
must meet requirements for informed consent; |
|
|
|
must meet requirements for Good Clinical Practices; |
|
|
|
may require large numbers of participants; and |
|
|
|
may be suspended by us, our collaborators or the FDA at any time if it is believed that the subjects participating in these trials are being exposed to
unacceptable health risks or if the FDA finds deficiencies in the IND application or the conduct of these trials. |
13
Before receiving FDA clearance to market a product, we or our collaborators must
demonstrate that the product is safe and effective in the patient population that will be treated. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be repeated, a program to be
terminated and could delay approval. We typically rely on third party clinical investigators to conduct our clinical trials and other third party organizations to perform data collection and analysis and, as a result, we may face additional delaying
factors outside our control. In addition, delays or rejections may be encountered based upon additional government regulation from future legislation or administrative action or changes in FDA policy or interpretation during the period of product
development, clinical trials and FDA regulatory review. Failure to comply with applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension
of production or injunction, as well as other regulatory action. We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approval.
If regulatory clearance of a product is granted, this clearance will be limited to those disease states and conditions for which the product is demonstrated through
clinical trials to be safe and efficacious. We cannot ensure that any compound developed by us, alone or with others, will prove to be safe and efficacious in clinical trials and will meet all of the applicable regulatory requirements needed to
receive marketing clearance.
Outside the United States, the ability to market a product is contingent upon
receiving a marketing authorization from the appropriate regulatory authorities. This foreign regulatory approval process typically includes all of the risks associated with FDA clearance described above and may include additional risks.
As our product programs advance, we will need to hire additional scientific and management personnel. Our research and development
efforts will be seriously jeopardized if we are unable to attract and retain key personnel.
Our success
depends on the continued contributions of our principal management and scientific personnel and on our ability to develop and maintain important relationships with leading academic institutions, scientists and companies in the face of intense
competition for such personnel. In particular, our research programs depend on our ability to attract and retain highly skilled chemists and other scientists. As we progress to advanced phase 2 and 3 clinical trials, we will also need to expand our
clinical development personnel. We do not have employment contracts with our key employees. If we lose the services of Dr. Michael Wick or any of our other key personnel, our research and development efforts could be seriously and adversely
affected. There is currently a shortage of skilled executives and employees with technical expertise in the biotechnology industry, and this shortage is likely to continue. As a result, competition among numerous companies, academic and other
research institutions for skilled personnel and experienced scientists is intense and turnover rates are high. In recent years, the cost of living in the San Francisco Bay Area has increased significantly, which we expect will adversely affect our
ability to compete for qualified personnel and will increase costs. Because of this competitive environment, we may encounter increasing difficulty in attracting qualified personnel as our operations expand and the demand for these professionals
increases, and this difficulty could significantly impede the achievement of our research and development objectives.
If physicians
and patients do not accept our products, our ability to generate product revenue in the future will be adversely affected.
Our product candidates may not gain market acceptance among physicians, patients and the medical community. We believe that market acceptance will depend on our ability to provide acceptable evidence of safety, efficacy, convenience
and ease of administration and cost effectiveness. In addition, we believe market acceptance depends on the effectiveness of our marketing strategy and the pricing of our products. Physicians may elect not to recommend our products even if we meet
the above criteria. If any of our product candidates fails to achieve market acceptance, we may not be able to successfully market and sell the product, which would limit our ability to generate revenue and adversely affect our operations.
If we, or our licensees and licensors, cannot obtain and defend our respective intellectual property rights, or if our products or
technologies are found to infringe patents of third parties, we could become involved in lengthy and costly legal proceedings that could adversely affect our business.
Our success will depend in a large part on our own, our licensees and our licensors ability to obtain and defend patents for each partys respective
technologies and the compounds and other products, if any, resulting from the application of these technologies. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual
questions. Accordingly, we cannot predict the breadth of claims allowed in our or other companies patents.
Our success will also depend, in part, on our ability to operate without infringing the intellectual property rights of others. We cannot assure you that our activities will not infringe patents owned by others. If our products or
technologies are found to infringe patents issued to third parties, the manufacture, use and sale of our products could be enjoined, and we could be required to pay substantial damages. In addition, we may be required to obtain licenses to patents
or other proprietary rights of third parties. No assurance can be given that any licenses required under any such patents or proprietary rights would be made available on terms acceptable to us, if at all. Failure to obtain such licenses could
negatively affect our business.
14
The degree of future protection for our proprietary rights is uncertain and we
cannot assure you that:
|
|
|
we were the first to make the inventions covered by each of our pending patent applications; |
|
|
|
we were the first to file patent applications for these inventions; |
|
|
|
others will not independently develop similar or alternative technologies or duplicate any of our technologies; |
|
|
|
any of our pending patent applications will result in issued patents; |
|
|
|
any patents issued to us or our collaborators will provide a basis for commercially viable products, will provide us with any competitive advantages or will not
be challenged by third parties; |
|
|
|
any of our issued patents will be valid or enforceable; |
|
|
|
we will develop additional proprietary technologies that are patentable; or |
|
|
|
the patents of others will not have an adverse effect on our ability to do business. |
In addition, we could incur substantial costs and use of our key employees time and efforts in litigation if we are required to defend against patent suits
brought by third parties or if we initiate these suits, and we cannot predict whether we would be able to prevail in any such suit.
Others may have filed and in the future may file patent applications covering small molecules or therapeutic products that are similar to ours. We cannot assure you that any patent application filed by someone else will not
have priority over patent applications filed by us. Any legal action against us or our collaborators claiming damages and seeking to enjoin commercial activities relating to the affected products and processes could, in addition to subjecting us to
potential liability for damages, require us or our collaborators to obtain a license to continue to manufacture or market the affected products and processes. We cannot predict whether we, or our collaborators, would prevail in any of these actions
or that any license required under any of these patents would be made available on commercially acceptable terms, if at all. We believe that there may be significant litigation in the industry regarding patent and other intellectual property rights.
If we become involved in litigation, it could consume a substantial portion of our managerial and financial resources and we may not be successful in any such litigation.
In addition, some of our patents and intellectual property rights are owned jointly by us and our collaborators. We cannot assure you that these joint owners will not use
these patents and other intellectual property in ways that may negatively affect our business. We will not be able to prevent such use.
We also rely on trade secrets to protect technology, including our TRAP technology, where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we require
employees, academic collaborators and consultants to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary information in the event of any unauthorized use or disclosure or the lawful
development by others of such information. If the identity of specific proteins or other elements of our technology become known, our competitive advantage in drug discovery could be reduced.
We will be dependent upon collaborative arrangements to complete the development and commercialization of some of our product candidates. These collaborative arrangements may place the
development of our product candidates outside of our control, may require us to relinquish important rights or may otherwise not be on terms favorable to us.
We expect to enter into collaborative arrangements with third parties for clinical trials, manufacturing, regulatory approvals or commercialization of some of our products, particularly outside North
America, or in disease areas requiring larger and longer clinical trials, such as diabetes. Dependence on collaborative arrangements will subject us to a number of risks. We may not be able to control the amount and timing of resources our
collaborative partners may devote to the product candidates. Our collaborative partners may experience financial difficulties. Should a collaborative partner fail to develop or commercialize a compound or product to which it has rights from us, we
may not receive any future milestone payments and will not receive any royalties associated with this compound or product. Business combinations or significant changes in a collaborative partners business strategy may also adversely affect a
partners willingness or ability to complete its obligations under the arrangement. Failure to enter into additional collaborative agreements on favorable terms could have a material adverse effect on our business, financial condition and
results of operations.
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Some of our collaborations are for early-stage programs and allow partners
significant discretion in electing whether to pursue any of the planned activities. We do not anticipate significant revenues to result from these relationships until the collaborator has advanced products into clinical trials, which will not occur
for several years, if at all. Such arrangements are subject to numerous risks, including the right of the collaboration partner to control the timing of the research and development efforts, and discretion to advance lead candidates to clinical
trials and commercialization of the product. In addition, a collaborative partner could independently move forward with a competing lead candidate developed either independently or in collaboration with others, including our competitors.
If we are unable to contract with third parties to manufacture our products in sufficient quantities and at an acceptable cost, we
may be unable to meet demand for our products and lose potential revenue.
We do not currently operate
manufacturing facilities for clinical or commercial production of our products under development. We expect to continue to rely on third parties for the manufacture of our product. We currently lack the resources or capability to manufacture any of
our products on a clinical or commercial scale. As a result, we will be dependent on corporate partners, licensees or other third parties for the manufacturing of clinical and commercial scale quantities of our products. Our products may be in
competition with other products for access to these facilities. For this and other reasons, our collaborators or third parties may not be able to manufacture these products in a cost effective or timely manner. If not performed in a timely manner,
the clinical trial development of our product candidates or their submission for regulatory approval could be delayed, and our ability to deliver products on a timely basis could be impaired or precluded. We are currently dependent upon two sources
of supply for clinical quantities of TLK286 and a sole source of supply for clinical quantities of TLK199. If our suppliers fail to perform, our clinical trials or commercialization of TLK286 and TLK199 would be delayed. We may not be able to enter
into any necessary third-party manufacturing arrangements on acceptable terms, if at all. Our current dependence upon others for the manufacture of our products may adversely affect our future profit margins and our ability to commercialize products
on a timely and competitive basis.
If we are unable to create sales, marketing and distribution capabilities or enter into agreements
with third parties to perform these functions, we will not be able to commercialize products.
We currently
have no sales, marketing or distribution capabilities. In order to commercialize any products, we must internally develop sales, marketing and distribution capabilities, or establish collaborations or other arrangements with third parties to perform
these services. We intend to market some products directly in North America and rely on relationships with one or more pharmaceutical companies with established distribution systems and direct sales forces to market other products and address other
markets. We may not be able to establish in-house sales and distribution capabilities or relationships with third parties. To the extent that we enter into co-promotion or other licensing arrangements, our product revenues are likely to be lower
than if we directly marketed and sold our products, and any revenues we receive will depend upon the efforts of third parties, whose efforts may not be successful.
If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
The testing and marketing of medical products entail an inherent risk of product liability. If we cannot successfully defend ourselves
against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products. If we are unable to obtain sufficient product liability insurance at an acceptable cost, potential product liability
claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with corporate collaborators.
If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages.
Our research and development activities involve the controlled use of potentially harmful biological materials, hazardous materials, chemicals and various radioactive compounds, and are subject to federal, state and local laws and
regulations governing the use, storage, handling and disposal of these materials and specified waste products. We cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling or disposal of these
materials. In the event of contamination or injury, we could be held liable for damages that result, and any liability could exceed our resources.
We have implemented anti-takeover provisions which could discourage or prevent a takeover, even if an acquisition would be beneficial to our stockholders.
Provisions of our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to
acquire us, even if doing so would be beneficial to our stockholders. These provisions include:
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establishing a classified Board of Directors requiring that members of the Board be elected in different years lengthening the time needed to elect a new
majority of the Board; |
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authorizing the issuance of blank check preferred stock that could be issued by our Board of Directors to increase the number of outstanding shares
or change the balance of voting control and thwart a takeover attempt; |
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prohibiting cumulative voting in the election of directors, which would otherwise allow for less than a majority of stockholders to elect director candidates;
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limiting the ability of stockholders to call special meetings of the stockholders; |
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prohibiting stockholder action by written consent and requiring all stockholder actions to be taken at a meeting of our stockholders; and
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establishing advance notice requirements for nominations for election to the Board of Directors and for proposing matters that can be acted upon by stockholders
at stockholder meetings. |
In addition, in November 2001, we adopted a stockholder rights plan
that may discourage delay or prevent a merger that a stockholder may consider favorable.
Substantial future sales of our common stock
by us or by our existing stockholders could cause our stock price to fall.
Additional equity financings or
other share issuances by us, including shares issued in connection with strategic alliances, could adversely affect the market price of our common stock. Sales by existing stockholders of a large number of shares of our common stock in the public
market or the perception that additional sales could occur could cause the market price of our common stock to drop.
Our stock price
may be volatile, and you may not be able to resell your shares at or above your purchase price.
The market
prices for securities of biotechnology companies in general have been highly volatile, with recent significant price and volume fluctuations, and may continue to be highly volatile in the future. You may not be able to sell your shares quickly or at
the market price if trading in our stock is not active or the volume is low. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock:
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announcements of technological innovations or new commercial products by our competitors or us; |
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developments concerning proprietary rights, including patents; |
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developments concerning our collaborations; |
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publicity regarding actual or potential medical results relating to products under development by our competitors or us; |
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regulatory developments in the United States and foreign countries; |
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economic and other external factors or other disaster or crisis; or |
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period-to-period fluctuations in financial results. |
ITEM 3.
Quantitative and Qualitative Disclosures About Market Risk
The following discussion
about our market risk exposure involves forward-looking statements. We are exposed to market risk related mainly to changes in interest rates. We do not invest in derivative financial instruments.
The fair value of our investments in marketable securities at June 30, 2002 was $20.5 million, with a weighted-average maturity of 83 days
and a weighted-average interest rate of 2.15%. Our investment policy is to manage our marketable securities portfolio to preserve principal and liquidity while maximizing the return on the investment portfolio. Our marketable securities portfolio is
invested in corporate debt securities with an average maturity of under one year and a minimum investment grade rating of A to minimize credit risk. Although changes in interest rates may affect the fair value of the marketable securities portfolio
and cause unrealized gains or losses, such gains or losses would not be realized unless the investments were sold prior to maturity.
We have operated primarily in the United States and all funding activities with our collaborators to date have been made in U.S. dollars. Accordingly, we do not have any exposure to foreign currency rate fluctuations.
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PART II. OTHER INFORMATION
ITEM 1.
Legal Proceedings
We are not currently involved in any legal proceedings.
ITEM 2.
Changes in Securities and Use of Proceeds
On August 11, 2000, a registration statement
on Form S-1 (No. 333-33868) was declared effective by the Securities and Exchange Commission, pursuant to which 5,750,000 shares of our common stock were offered and sold by us at a price of $7.00 per share, generating gross offering proceeds of
$40.3 million. The managing underwriters were Lehman Brothers Inc., Chase Securities Inc., Legg Mason Wood Walker, Inc., UBS Warburg LLC and Fidelity Capital Markets, a division of National Financial Services Corporation. In connection with the
offering, we incurred approximately $2.8 million in underwriting discounts and commissions, and approximately $1.9 million in other related expenses. The net proceeds from the offering, after deducting the foregoing expenses, were approximately
$35.6 million.
From the time of receipt through June 30, 2002, we have applied the net proceeds from the offering
as follows:
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Estimations, in $000s
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Purchases and installation of machinery and equipment |
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$ |
1,118 |
Repayment of indebtedness |
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13 |
Working capital used in operations |
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21,513 |
Net proceeds to be applied in future periods |
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12,956 |
We plan to use the balance of the net proceeds of our initial
public offering for clinical trials, preclinical studies and general corporate purposes, including working capital and product development. We may use a portion of the net proceeds to acquire or invest in products and technologies that are
complementary to our own, although no acquisitions are planned or being negotiated as of the date of this filing, and we have not allocated any portion of the net proceeds for any specific acquisition. None of the net proceeds of the initial public
offering were paid directly or indirectly to any director, officer, general partner of Telik or their associates, persons owning 10% or more of any class of equity securities of Telik, or an affiliate of Telik. We expect that our use of proceeds
from the offering will conform to the intended use of proceeds as described in our initial public offering prospectus dated August 11, 2000.
ITEM 3.
Defaults Upon Senior Securities
Not applicable.
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ITEM 4.
Submission of Matters To a Vote of Security Holders
We held our Annual Meeting of
Stockholders on May 14, 2002. The results of the voting were as follows:
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To approve the election of one director, Edward W. Cantrall, Ph.D., to hold office until the 2005 Annual Meeting of Stockholders.
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FOR: 24,931,128 AGAINST: ABSTAIN: 371,654
BROKER NON-VOTES:
To approve the election of one director,
Steven R. Goldring, M.D., to hold office until the 2005 Annual Meeting of Stockholders.
FOR: 24,931,861 AGAINST: ABSTAIN: 370,921
BROKER NON-VOTES:
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2. |
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To ratify the selection of Ernst & Young LLP as independent auditors of Telik for its fiscal year ending December 31, 2002. |
FOR: 24,648,515 AGAINST: 649,647 ABSTAIN: 4,620
BROKER NON-VOTES:
ITEM 5.
Other Information
Not applicable.
ITEM 6.
Exhibits and Reports on Form 8-K
99.1 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
No reports were filed on Form 8-K for the quarterly period ended June 30, 2002.
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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.
TELIK, INC. |
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Dated August 13, 2002 |
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By: |
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/s/ CYNTHIA M. BUTITTA
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Cynthia M. Butitta Chief Operating Officer and Chief Financial Officer (Duly Authorized Officer and Principal Financial
Officer) |
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