x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
SECURITIES EXCHANGE ACT OF 1934 |
¨ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
SECURITIES EXCHANGE ACT OF 1934 |
Washington |
91-1144498 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
Page No. | ||||
PART I |
FINANCIAL INFORMATION |
|||
Item 1. |
Financial Statements (unaudited) |
|||
a) |
3 | |||
b) |
4 | |||
c) |
5 | |||
d) |
6 | |||
Item 2. |
8 | |||
Item 3. |
13 | |||
PART II |
OTHER INFORMATION |
|||
Item 2. |
13 | |||
Item 4. |
13 | |||
Item 6. |
14 | |||
15 |
June 30, 2002 |
December 31, 2001 |
|||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ |
39,090,817 |
|
$ |
36,393,551 |
| ||
Short-term investments |
|
186,690,742 |
|
|
110,683,392 |
| ||
Receivables |
||||||||
Related party |
|
494,456 |
|
|
449,314 |
| ||
Other |
|
5,874,992 |
|
|
3,606,421 |
| ||
Prepaid expenses and other assets |
|
2,907,957 |
|
|
2,291,270 |
| ||
|
|
|
|
|
| |||
Total current assets |
|
235,058,964 |
|
|
153,423,948 |
| ||
Property and equipment, net |
|
50,219,824 |
|
|
49,128,094 |
| ||
Other assets |
|
2,752,847 |
|
|
2,882,522 |
| ||
|
|
|
|
|
| |||
Total assets |
$ |
288,031,635 |
|
$ |
205,434,564 |
| ||
|
|
|
|
|
| |||
LIABILITIES, MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK AND SHAREHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ |
4,152,919 |
|
$ |
4,109,382 |
| ||
Accrued liabilities |
|
3,600,990 |
|
|
3,150,220 |
| ||
Deferred revenue |
|
3,471,521 |
|
|
7,671,521 |
| ||
|
|
|
|
|
| |||
Total current liabilities |
|
11,225,430 |
|
|
14,931,123 |
| ||
Other noncurrent liabilities |
|
2,752,847 |
|
|
2,882,522 |
| ||
Deferred revenue, net of current portion |
|
6,101,222 |
|
|
6,482,416 |
| ||
Commitments and contingencies |
||||||||
Mandatorily redeemable convertible preferred stock |
|
|
|
|
260,540,387 |
| ||
Shareholders equity (deficit) |
||||||||
Common stock, no par value, 150,000,000 shares authorized, 45,771,462 and 12,063,600 issued and outstanding at June 30,
2002 and December 31, 2001, respectively |
|
427,009,987 |
|
|
55,855,870 |
| ||
Non-voting common stock, no par value, 30,000,000 shares authorized, none outstanding |
|
|
|
|
|
| ||
Notes receivable from shareholders |
|
(725,000 |
) |
|
(725,000 |
) | ||
Deferred stock compensation |
|
(21,982,778 |
) |
|
(25,234,712 |
) | ||
Accumulated deficit |
|
(138,054,817 |
) |
|
(111,119,557 |
) | ||
Accumulated other comprehensive income |
|
1,704,744 |
|
|
1,821,515 |
| ||
|
|
|
|
|
| |||
Total shareholders equity (deficit) |
|
267,952,136 |
|
|
(79,401,884 |
) | ||
|
|
|
|
|
| |||
Total liabilities, mandatorily redeemable convertible preferred stock and shareholders equity
(deficit) |
$ |
288,031,635 |
|
$ |
205,434,564 |
| ||
|
|
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2002 |
2001 |
2002 |
2001 |
|||||||||||||
Revenues |
||||||||||||||||
Royalties |
||||||||||||||||
Related party |
$ |
1,077,670 |
|
$ |
665,512 |
|
$ |
2,591,762 |
|
$ |
2,464,846 |
| ||||
Other |
|
800,266 |
|
|
866,664 |
|
|
1,437,021 |
|
|
2,285,536 |
| ||||
Option fee from related party |
|
1,875,000 |
|
|
1,875,000 |
|
|
3,750,000 |
|
|
3,750,000 |
| ||||
License fees and milestone payments |
||||||||||||||||
Related party |
|
|
|
|
|
|
|
750,000 |
|
|
|
| ||||
Other |
|
3,206,647 |
|
|
50,000 |
|
|
4,229,527 |
|
|
50,000 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Total revenues |
|
6,959,583 |
|
|
3,457,176 |
|
|
12,758,310 |
|
|
8,550,382 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Operating expenses |
||||||||||||||||
Research and development (excludes noncash stock-based compensation expense of $1,234,259, $266,673, $2,461,227 and
$353,497, respectively) |
|
16,429,611 |
|
|
11,897,576 |
|
|
30,701,672 |
|
|
22,959,697 |
| ||||
General and administrative (excludes noncash stock-based compensation expense of $585,523, $328,763, $1,164,934 and
$507,266, respectively) |
|
5,739,121 |
|
|
2,444,723 |
|
|
8,939,047 |
|
|
4,832,825 |
| ||||
Noncash stock-based compensation expense |
|
1,819,782 |
|
|
595,436 |
|
|
3,626,161 |
|
|
860,763 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Total operating expenses |
|
23,988,514 |
|
|
14,937,735 |
|
|
43,266,880 |
|
|
28,653,285 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Loss from operations |
|
(17,028,931 |
) |
|
(11,480,559 |
) |
|
(30,508,570 |
) |
|
(20,102,903 |
) | ||||
Interest and other income, net |
|
1,896,480 |
|
|
1,814,008 |
|
|
3,573,310 |
|
|
4,206,661 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Net loss |
|
(15,132,451 |
) |
|
(9,666,551 |
) |
|
(26,935,260 |
) |
|
(15,896,242 |
) | ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Preferred stock dividends and accretion on mandatorily redeemable convertible preferred stock |
|
|
|
|
(5,152,313 |
) |
|
(1,717,865 |
) |
|
(10,304,148 |
) | ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Net loss attributable to common shareholders |
$ |
(15,132,451 |
) |
$ |
(14,818,864 |
) |
$ |
(28,653,125 |
) |
$ |
(26,200,390 |
) | ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Basic and diluted net loss per share |
$ |
(0.33 |
) |
$ |
(1.26 |
) |
$ |
(0.73 |
) |
$ |
(2.22 |
) | ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Weighted-average number of shares used in computing basic and diluted net loss per share |
|
45,750,736 |
|
|
11,792,520 |
|
|
39,325,390 |
|
|
11,792,520 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
||||||||
2002 |
2001 |
|||||||
Cash flows from operating activities |
||||||||
Net loss |
$ |
(26,935,260 |
) |
$ |
(15,896,242 |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities |
||||||||
Depreciation and amortization |
|
2,854,096 |
|
|
2,750,046 |
| ||
Net (gain) loss on disposition of property and equipment |
|
3,613 |
|
|
(1,113 |
) | ||
Noncash stock-based compensation |
|
3,626,161 |
|
|
860,763 |
| ||
Net realized (gain) loss on sale of short-term investments |
|
(136,043 |
) |
|
6,524 |
| ||
Amortization of premium on short-term investments |
|
1,040,851 |
|
|
106,693 |
| ||
Changes in operating assets and liabilities |
||||||||
Receivables |
|
(2,313,713 |
) |
|
610,365 |
| ||
Prepaid expenses and other assets |
|
(1,389,452 |
) |
|
95,970 |
| ||
Accounts payable |
|
43,537 |
|
|
(409,844 |
) | ||
Related party payables |
|
|
|
|
(278,975 |
) | ||
Accrued liabilities |
|
450,770 |
|
|
(924,386 |
) | ||
Deferred revenue |
|
(4,581,194 |
) |
|
(3,750,000 |
) | ||
Other noncurrent liabilities |
|
(129,676 |
) |
|
(260,783 |
) | ||
|
|
|
|
|
| |||
Net cash used in operating activities |
|
(27,466,310 |
) |
|
(17,090,982 |
) | ||
|
|
|
|
|
| |||
Cash flows from investing activities |
||||||||
Purchases of property and equipment |
|
(3,952,439 |
) |
|
(2,746,790 |
) | ||
Purchases of short-term investments |
|
(140,037,519 |
) |
|
(168,686,208 |
) | ||
Proceeds from sale of property and equipment |
|
3,000 |
|
|
37,177 |
| ||
Proceeds from sale and maturity of short-term investments |
|
63,008,588 |
|
|
76,574,544 |
| ||
|
|
|
|
|
| |||
Net cash used in investing activities |
|
(80,978,370 |
) |
|
(94,821,277 |
) | ||
|
|
|
|
|
| |||
Cash flows from financing activities |
||||||||
Net proceeds from issuance of common stock |
|
110,684,449 |
|
|
|
| ||
Proceeds from exercise of stock options |
|
457,497 |
|
|
|
| ||
|
|
|
|
|
| |||
Net cash provided by financing activities |
|
111,141,946 |
|
|
|
| ||
|
|
|
|
|
| |||
Net increase (decrease) in cash and cash equivalents |
|
2,697,266 |
|
|
(111,912,259 |
) | ||
Cash and cash equivalents at beginning of period |
|
36,393,551 |
|
|
172,976,483 |
| ||
|
|
|
|
|
| |||
Cash and cash equivalents at end of period |
$ |
39,090,817 |
|
$ |
61,064,224 |
| ||
|
|
|
|
|
| |||
Supplemental Disclosure of Cash Flow Information |
||||||||
Cash paid for interest |
$ |
4,082 |
|
$ |
1,373 |
| ||
|
|
|
|
|
| |||
Noncash financing activities |
||||||||
Accretion on mandatorily redeemable convertible preferred stock |
$ |
87,719 |
|
$ |
523,271 |
| ||
|
|
|
|
|
| |||
Dividends accrued on mandatorily redeemable convertible preferred stock |
$ |
1,630,146 |
|
$ |
9,780,877 |
| ||
|
|
|
|
|
| |||
Recognition of prepaid offering costs |
$ |
902,441 |
|
$ |
|
| ||
|
|
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2002 |
2001 |
2002 |
2001 |
|||||||||||||
Net loss attributable to common shareholders |
$ |
(15,132,451 |
) |
$ |
(14,818,864 |
) |
$ |
(28,653,125 |
) |
$ |
(26,200,390 |
) | ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Weighted-average shares used in computing basic and diluted net loss per share |
|
45,750,736 |
|
|
11,792,520 |
|
|
39,325,390 |
|
|
11,792,520 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Basic and diluted net loss per share |
$ |
(0.33 |
) |
$ |
(1.26 |
) |
$ |
(0.73 |
) |
$ |
(2.22 |
) | ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Securities not included in net loss per share calculation: |
||||||||||||||||
Mandatorily redeemable convertible preferred stock (as if converted) |
|
|
|
|
23,543,159 |
|
|
|
|
|
23,543,159 |
| ||||
Options to purchase common stock |
|
7,662,334 |
|
|
5,505,901 |
|
|
7,662,334 |
|
|
5,505,901 |
| ||||
Shares subject to repurchase |
|
20,250 |
|
|
|
|
|
20,250 |
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
Total |
|
7,682,584 |
|
|
29,049,060 |
|
|
7,682,584 |
|
|
29,049,060 |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
Amortized Cost |
Gross Unrealized Gain |
Gross Unrealized Loss |
Estimated Fair Value | ||||||||||
Type of security: |
|||||||||||||
Commercial paper and money market |
$ |
12,898,449 |
$ |
230 |
$ |
|
|
$ |
12,898,679 | ||||
Corporate debt securities |
|
64,626,973 |
|
857,239 |
|
(10,982 |
) |
|
65,473,230 | ||||
Asset-backed securities |
|
35,572,786 |
|
239,332 |
|
(15,771 |
) |
|
35,796,347 | ||||
U.S. government and agency securities |
|
64,651,544 |
|
619,315 |
|
|
|
|
65,270,859 | ||||
International debt securities |
|
7,236,244 |
|
16,398 |
|
(1,015 |
) |
|
7,251,627 | ||||
|
|
|
|
|
|
|
|
| |||||
Total |
$ |
184,985,996 |
$ |
1,732,514 |
$ |
(27,768 |
) |
$ |
186,690,742 | ||||
|
|
|
|
|
|
|
|
|
Estimated Fair
Value |
Amortized Cost | |||||
Maturity date: |
||||||
Less than one year |
$ |
25,770,779 |
$ |
25,769,182 | ||
Due in 1-5 years |
|
160,919,963 |
|
159,216,814 | ||
|
|
|
| |||
Total |
$ |
186,690,742 |
$ |
184,985,996 | ||
|
|
|
|
|
the costs involved in filing, prosecuting, enforcing and defending patent claims; |
|
the results of research and development programs; |
|
cash flows under existing and potential future arrangements with licensees, collaborators and other parties; and |
|
the costs associated with the expansion of our facilities. |
|
Our bioinformatics-based discovery strategy is unproven, and we do not know whether we will be able to discover any genes or proteins of commercial value.
|
|
We depend heavily on bioinformatics technology, which may prove to be ineffective in the discovery of therapeutic proteins. |
|
The availability of novel genomic data may decrease in the future, which may adversely affect our ability to discover novel therapeutic proteins.
|
|
We may not be able to develop commercially viable products from the key protein categories on which we focus. |
|
Our patent applications may not result in issued patents, and our competitors may commercialize the discoveries we attempt to patent.
|
|
Third parties may infringe our patents or challenge their validity or enforceability. |
|
We may be subject to patent infringement claims, which could result in substantial costs and liability and prevent us from commercializing our potential
products. |
|
Issued patents may not provide us with any competitive advantage or provide meaningful protection against competitors. |
|
If other parties publish information about the genes or proteins we discover before we apply for patent protection, we may be unable to obtain patent
protection. |
|
The patent field relating to therapeutic protein-based products is subject to a great deal of uncertainty, and if patent laws or the interpretation of patent
laws change, our competitors may be able to develop and commercialize products based on proteins that we discovered. |
|
We expect to incur significant expenses in applying for patent protection and prosecuting our patent applications. |
|
We may be unable to protect our unpatented proprietary technology and information. |
|
We have limited experience with product development activities. |
|
We may experience failures or delays in commencing or completing clinical trials for product candidates. |
|
Clinical trials may fail to demonstrate the safety and effectiveness of our product candidates, which could prevent or significantly delay their regulatory
approval. |
|
We may be unable to satisfy the rigorous government regulations relating to the development and commercialization of our product candidates.
|
|
We may encounter difficulties developing or commercializing our lead product candidate rh Factor XIII. |
|
Our plan to use collaborations to leverage our capabilities may not be successful. |
|
We may not be able to generate any revenue from product candidates developed by collaborators or licensees if they are unable to successfully develop those
candidates. |
|
Because we will depend on third parties to conduct laboratory tests and clinical trials, we may encounter delays in or lose some control over our efforts to
develop product candidates. |
|
We anticipate incurring additional losses and may not achieve profitability. |
|
Our operating results are subject to fluctuations that may cause our stock price to decline. |
|
If we do not obtain substantial additional funding on acceptable terms, we may not be able to continue to grow our business or generate enough revenue to
recover our investment in research and development. |
|
Novo Nordisk has substantial rights to license proteins we discover, which may limit our ability to pursue other collaboration or licensing arrangements or
benefit from our discoveries. |
|
Because we currently do not have the capability to manufacture materials for clinical trials or for commercial sale, we will have to rely on third parties to
manufacture our potential products, and we may be unable to obtain required quantities in a timely manner or on acceptable terms, if at all. |
|
We may not be successful in developing internal manufacturing capabilities or complying with applicable manufacturing regulations.
|
|
Environmental and health and safety laws may result in liabilities, expenses and restrictions on our operations. |
|
Because we currently have no sales or marketing capabilities, we may be unable to successfully commercialize our potential products.
|
|
We may be required to defend lawsuits or pay damages in connection with alleged or actual harm caused by our product candidates.
|
|
Negative public opinion and increased regulatory scrutiny of genetic and clinical research may limit our ability to conduct our business.
|
|
Many of our competitors have substantially greater capabilities and resources than we do and may be able to develop and commercialize products before we do.
|
|
The failure to attract or retain key management or other personnel could decrease our ability to discover, develop and commercialize potential products.
|
|
If the health care system or reimbursement policies change, the prices of our potential products may fall or our potential sales may decline.
|
|
Certain major shareholders have significant control of our management and affairs, which they could exercise against the best interests of other shareholders.
|
|
Provisions in our charter documents could prevent or frustrate any attempts to replace our current management by shareholders. |
|
Our stock price may be volatile. |
(d) Use |
of Proceeds from Registered Securities |
Name |
Votes For |
Votes Withheld | ||
Jonathan S. Leff |
30,611,694 |
3,350 | ||
George B. Rathmann, Ph.D. |
30,611,094 |
3,950 | ||
Lars Rebien Sorensen |
30,464,527 |
150,517 | ||
Bruce L.A. Carter, Ph.D. |
29,787,094 |
827,950 | ||
Edward E. Penhoet, Ph.D. |
30,611,944 |
3,100 | ||
Lori F. Rafield, Ph.D. |
30,611,894 |
3,150 | ||
David I. Hirsh, Ph.D. |
30,611,894 |
3,150 | ||
Kurt Anker Nielsen |
30,611,794 |
3,250 |
Votes For |
27,379,062 | |
Votes Against |
749,534 | |
Abstaining |
8,580 | |
Broker Non-votes |
2,477,868 |
Exhibit Number |
||
3.1 |
Amended and Restated Articles of Incorporation of ZymoGenetics, Inc. | |
99.1 |
Certification of Bruce L.A. Carter Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 | |
99.2 |
Certification of James A. Johnson Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
ZYMOGENETICS, INC. | ||||||||
By: |
/s/ JAMES A. JOHNSON | |||||||
James A. Johnson Senior
Vice President and Chief Financial Officer (Principal Financial Officer and Authorized Officer) |