UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

ý

 

Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the period ended March 31, 2003

 

 

Or

 

o

 

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the transition period from            to             .

 

Commission File No. 000-24537

 

DYAX CORP.

(Exact Name of Registrant as Specified in its Charter)

 

DELAWARE

 

04-3053198

(State of Incorporation)

 

(I.R.S. Employer Identification Number)

 

300 TECHNOLOGY SQUARE, CAMBRIDGE, MA 02139

(Address of Principal Executive Offices)

 

(617) 225-2500

(Registrant’s Telephone Number, including Area Code)

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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

 

ý

 

NO

 

o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

 

YES

 

o

 

NO

 

ý

 

Number of shares outstanding of Dyax Corp.’s Common Stock, par value $0.01, as of May 1, 2003: 24,475,658.

 

 



 

DYAX CORP.

 

TABLE OF CONTENTS

 

PART I

 

FINANCIAL INFORMATION

 

 

 

Item 1

-

Financial Statements

 

 

 

 

 

 

Consolidated Balance Sheets (Unaudited) as of March 31, 2003 and December 31, 2002

 

 

 

 

 

Consolidated Statements of Operations and Comprehensive Loss (Unaudited) For the three months ended March 31, 2003 and 2002

 

 

 

 

 

Consolidated Statements of Cash Flows (Unaudited) For the three months ended March 31, 2003 and 2002

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

 

 

Item 2

-

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

 

Item 3

-

Quantitative and Qualitative Disclosures About Market Risk

 

 

 

Item 4

-

Controls and Procedures.

 

 

 

 

PART II

-

OTHER INFORMATION

 

 

 

 

Item 2

-

Use of Proceeds from Registered Securities

 

 

 

 

Item 6

-

Exhibits and Reports on Form 8-K

 

 

 

 

Signature

 

 

 

 

Certifications

 

 

 

Exhibit Index

 

 

2



 

PART I - FINANCIAL INFORMATION

 

Item 1 - Financial Statements

 

DYAX CORP.

 

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

 

 

 

March 31,
2003

 

December 31,
2002

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

30,996,000

 

$

28,199,000

 

Accounts receivable, net of allowances for doubtful accounts of $249,000 and $256,000 at March 31, 2003 and December 31, 2002, respectively

 

6,173,000

 

6,829,000

 

Inventories

 

3,211,000

 

3,389,000

 

Current portion of notes receivable, employees

 

1,278,000

 

1,353,000

 

Other current assets

 

2,214,000

 

2,018,000

 

 

 

 

 

 

 

Total current assets

 

43,872,000

 

41,788,000

 

Fixed assets, net of accumulated depreciation of $8,262,000 and $7,150,000 at March 31, 2003 and December 31, 2002, respectively

 

21,765,000

 

22,455,000

 

Notes receivable, employees

 

 

20,000

 

Goodwill, net

 

111,000

 

111,000

 

Other intangibles, net

 

3,546,000

 

3,638,000

 

Restricted cash

 

5,920,000

 

5,635,000

 

Other assets

 

263,000

 

259,000

 

 

 

 

 

 

 

Total assets

 

$

75,477,000

 

$

73,906,000

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

12,896,000

 

$

12,979,000

 

Current portion of deferred revenue

 

7,151,000

 

7,565,000

 

Current portion of long-term obligations

 

3,820,000

 

3,552,000

 

 

 

 

 

 

 

Total current liabilities

 

23,867,000

 

24,096,000

 

Deferred revenue

 

223,000

 

233,000

 

Long-term obligations

 

17,506,000

 

17,946,000

 

Other long-term liabilities

 

946,000

 

788,000

 

 

 

 

 

 

 

Total liabilities

 

42,542,000

 

43,063,000

 

 

 

 

 

 

 

Commitments and Contingencies (Notes 11,12 and 13)

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock, $0.01 par value; 50,000,000 shares authorized at March 31, 2003 and December 31, 2002; 24,473,046 and 19,705,040 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively

 

245,000

 

197,000

 

Additional paid-in capital

 

149,884,000

 

141,637,000

 

Accumulated deficit

 

(117,206,000

)

(110,827,000

)

Deferred compensation

 

(492,000

)

(668,000

)

Accumulated other comprehensive income

 

504,000

 

504,000

 

 

 

 

 

 

 

Total stockholders’ equity

 

32,935,000

 

30,843,000

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

75,477,000

 

$

73,906,000

 

 

THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THE UNAUDITED
CONSOLIDATED FINANCIAL STATEMENTS.

 

3



 

DYAX CORP.

 

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

 

 

 

Three Months Ended
March 31,

 

 

 

2003

 

2002

 

Revenues:

 

 

 

 

 

Separations product revenues

 

$

5,419,000

 

$

4,982,000

 

Biopharmaceutical product development and license fee revenues

 

3,856,000

 

3,904,000

 

Total revenues

 

9,275,000

 

8,886,000

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

Cost of products sold

 

2,445,000

 

2,172,000

 

 

 

 

 

 

 

Research and development:

 

 

 

 

 

Research and development

 

7,422,000

 

7,467,000

 

Other non-cash compensation

 

46,000

 

123,000

 

 

 

 

 

 

 

Selling, general and administrative:

 

 

 

 

 

Selling, general and administrative

 

5,325,000

 

5,995,000

 

Other non-cash compensation

 

94,000

 

156,000

 

 

 

 

 

 

 

Total costs and expenses

 

15,332,000

 

15,913,000

 

 

 

 

 

 

 

Loss from operations

 

(6,057,000

)

(7,027,000

)

 

 

 

 

 

 

Other (expense) income:

 

 

 

 

 

Interest income

 

102,000

 

173,000

 

Interest expense

 

(424,000

)

(210,000

)

Total other (expense) income

 

(322,000

)

(37,000

)

 

 

 

 

 

 

Net loss

 

(6,379,000

)

(7,064,000

)

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

Foreign currency translation adjustments

 

 

(149,000

)

Comprehensive loss

 

$

(6,379,000

)

$

(7,213,000

)

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.31

)

$

(0.36

)

Shares used in computing basic and diluted net loss per share

 

20,378,534

 

19,560,357

 

 

THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THE UNAUDITED
CONSOLIDATED FINANCIAL STATEMENTS.

 

4



 

DYAX CORP.

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

 

 

Three Months Ended
March 31,

 

 

 

2003

 

2002

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(6,379,000

)

$

(7,064,000

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization of fixed assets

 

1,063,000

 

579,000

 

Amortization of other intangibles

 

144,000

 

5,000

 

Provision for doubtful accounts

 

(7,000

)

 

Loss on the disposal of fixed assets

 

43,000

 

 

Compensation expenses associated with stock options

 

140,000

 

279,000

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

656,000

 

124,000

 

Inventories

 

174,000

 

(372,000

)

Other assets

 

(197,000

)

93,000

 

Accounts payable and accrued expenses

 

(99,000

)

1,461,000

 

Deferred revenue

 

(423,000

)

334,000

 

Other long-term liabilities

 

145,000

  

 

 

 

 

 

 

 

Net cash used in operating activities

 

(4,740,000

)

(4,561,000

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Increase in capitalized software development costs

 

(52,000

)

 

Purchase of fixed assets

 

(306,000

)

(5,308,000

)

Notes receivable, employees

 

95,000

 

20,000

 

 

 

 

 

 

 

Net cash used in investing activities

 

(263,000

)

(5,288,000

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from the issuance of common stock under employee stock purchase plan and exercise of stock options

 

71,000

 

427,000

 

Net proceeds from registered directed offering

 

8,261,000

 

 

Proceeds from landlord for leasehold improvements

 

 

2,352,000

 

Proceeds from long-term obligations

 

703,000

 

1,212,000

 

Repayment of long-term obligations

 

(980,000

)

(562,000

)

Increase in restricted cash

 

(270,000

)

 

 

 

 

 

 

 

Net cash provided by financing activities

 

7,785,000

 

3,429,000

 

Effect of foreign currency translation on cash balances

 

15,000

 

(339,000

) 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

2,797,000

 

(6,759,000

)

Cash and cash equivalents at beginning of the period

 

28,199,000

 

51,034,000

 

 

 

 

 

 

 

Cash and cash equivalents at end of the period

 

$

30,996,000

 

$

44,275,000

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

Interest paid

 

$

455,000

 

$

210,000

 

Income taxes paid

 

$

 

$

 

Supplemental disclosure of non cash investing and financing activities:

 

 

 

 

 

Acquisition of property and equipment under long-term obligations

 

$

58,000

 

$

1,121,000

 

 

THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THE CONSOLIDATED FINANCIAL

STATEMENTS.

 

5



 

DYAX CORP.

 

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

1.             NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

Dyax Corp. (Dyax or the Company) is a biopharmaceutical company principally focused on the discovery, development and commercialization of therapeutics for oncology and inflammatory conditions. The Company has two product candidates in clinical trials, DX-88 and DX-890, and has collaborative agreements for the development of both of these product candidates. The Company is currently conducting a phase II 48-patient double-blind placebo-controlled trial of DX-88 for the treatment of patients with hereditary angioedema in the United States of America (U.S.) with the intent to add international sites. During the quarter ended March 31, 2003, the Company completed a phase II nine-patient open-label European study in hereditary and acquired angioedema and was granted orphan drug designation for the angioedema indication in both the U.S. and in Europe. The Company is also conducting a phase I/II study of DX-88 in cardiopulmonary bypass in the U.S. The Company’s collaborator for DX-890 has completed a phase IIa trial in adult patients with cystic fibrosis and has initiated a second phase IIa trial in children with cystic fibrosis.

 

The Company uses its proprietary, patented technology, known as phage display, to identify human monoclonal antibodies, small proteins and peptides as potential therapeutics for the treatment of various conditions and diseases.  The Company is using phage display technology to build a broad portfolio of product candidates that it plans to develop and commercialize on its own or with others.  On behalf of collaborators, the Company also uses phage display technology to identify compounds that can be used in therapeutics, diagnostic imaging, the development of research reagents, and in purifying and manufacturing biopharmaceuticals.  The Company is further leveraging its phage display technology through collaborations and licenses that are structured to generate revenues through research funding, license fees, technical and clinical milestone payments, and royalties.

 

The Company, through its Biotage subsidiary, develops, manufactures and sells chromatography separations systems and products and is a leading supplier of chromatography separations systems that use disposable cartridges to separate and purify pharmaceuticals being produced for research or clinical development.

 

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with FDA and other governmental regulations and approval requirements.

 

The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information and with the instructions to Form 10-Q. The consolidated financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated. Certain amounts from prior years have been reclassified in the accompanying unaudited consolidated financial statements in order to be consistent with current year classifications.

 

6



 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect (i) the reported amounts of assets and liabilities, (ii) disclosure of contingent assets and liabilities at the dates of the financial statements and (iii) the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.  The results of operations for the three months ended March 31, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003.

 

It is management’s opinion that the accompanying unaudited interim consolidated financial statements reflect all adjustments (which are normal and recurring) necessary for a fair presentation of the results for the interim periods. The financial statements should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002.

 

2.             PRODUCT WARRANTY

 

The Company provides separations product customers with a twelve-month warranty for performance in all material respects in accordance with its standard published specifications on its chromatography separations systems from the date of shipment. Estimated warranty obligations based on prior claim history, are included in the results of operations as cost of products sold and are evaluated and provided for at the time of sale.

 

Accrued warranty cost activity during the three months ended March 31, 2003 consists of the following:

 

 

 

 

 

 

 

 

 

Balance at December 31, 2002

 

$

316,000

 

Accruals of warranties issued during the period

 

60,000

 

Settlements made during the period

 

(60,000

)

 

 

 

 

Balance at March 31, 2003

 

$

316,000

 

 

3.             STOCKHOLDERS’ EQUITY

 

Stock Options:  The Company’s 1995 Equity Incentive Plan is an equity plan under which equity awards, including awards of restricted stock and incentive and nonqualified stock options to purchase shares of common stock, may be granted to employees and consultants of the Company by action of the Compensation Committee of the Board of Directors. The Company accounts for the plan using the intrinsic value method prescribed under the recognition and measurement principles of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees”, and related Interpretations. No stock-based employee compensation cost is reflected in net income, as all options granted under those plans had an exercise price equal to the market value of the underlying common stock on the date of grant. The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition provisions of Financial Accounting Standards Board (FASB) Statement No. 123, “Accounting for Stock-Based Compensation”, to stock-based employee compensation.

 

7



 

 

 

Three Months Ended March 31,

 

 

 

2003

 

2002

 

 

 

 

 

 

 

Net loss as reported

 

$

(6,379,000

)

$

(7,064,000

)

Less: Total stock-based employee compensation expense determined under fair value based method for all awards

 

(2,124,000

)

(2,010,000

)

Pro forma net loss

 

$

(8,503,000

)

$

(9,074,000

)

 

 

 

 

 

 

Non-cash stock-based employee compensation included in net loss as reported

 

$

140,000

 

$

279,000

 

Basic and diluted net loss per share as reported

 

$

(.31

)

$

(.36

)

Pro forma basic and diluted net loss per share

 

$

(.42

)

$

(.46

)

 

The fair value of each stock option granted is estimated on the grant date using the minimum value method with the following weighted average assumptions:

 

 

 

Three Months Ended March 31,

 

 

 

2003

 

2002

 

 

 

 

 

 

 

Expected option term

 

6.0

 

6.0

 

Risk-free interest rate

 

3.34

%

4.88

%

Expected dividend yield

 

None

 

None

 

Volatility factor

 

160

%

108

%

 

4.             INVENTORY

 

Inventories consist of the following:

 

 

 

March 31,
2003

 

December 31,
2002

 

 

 

 

 

 

 

Raw materials

 

$

2,578,000

 

$

2,410,000

 

Work in process

 

224,000

 

355,000

 

Finished products

 

409,000

 

624,000

 

 

 

$

3,211,000

 

$

3,389,000

 

 

8



 

5.             ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expenses consist of the following:

 

 

 

March 31,
2003

 

December 31,
2002

 

 

 

 

 

 

 

Accounts payable

 

$

5,007,000

 

$

3,429,000

 

Accrued employee compensation and related taxes

 

2,116,000

 

2,928,000

 

Accrued external research and development and contract manufacturing

 

2,553,000

 

2,398,000

 

Licensed patent technology payable

 

1,500,000

 

2,000,000

 

Other accrued liabilities

 

1,720,000

 

2,224,000

 

 

 

$

12,896,000

 

$

12,979,000

 

 

6.             NET LOSS PER SHARE

 

Net loss per share is computed under Statement of Financial Accounting Standards (SFAS) No. 128, “Earnings Per Share”.  Basic net loss per share is computed using the weighted average number of shares of common stock outstanding.  Diluted net loss per share does not differ from basic net loss per share since potential common shares from the exercise of stock options are antidilutive for all periods presented and, therefore, are excluded from the calculation of diluted net loss per share.  Stock options totaling 4,193,390 and 3,498,670 were outstanding at March 31, 2003 and 2002, respectively.

 

7.             COMPREHENSIVE LOSS

 

Accumulated other comprehensive income (loss) is calculated as follows:

 

 

 

Three Months Ended
March 31,

 

 

 

2003

 

2002

 

Accumulated other comprehensive income (loss):

 

 

 

 

 

Foreign currency translation adjustment:

 

 

 

 

 

Balance at beginning of period

 

$

504,000

 

$

94,000

 

Change during period

 

 

(149,000

)

Balance at end of period

 

$

504,000

 

$

(55,000

)

 

8.             BUSINESS SEGMENTS

 

The Company discloses business segments under SFAS No. 131, “Disclosures about Segments of an Enterprise and Related Information”.  Segment data does not include allocations of corporate administrative costs to each operating segment.  The Company evaluates the performance of its segments and allocates resources to them based on losses before corporate administrative costs, interest and taxes.

 

9



 

The Company has two reportable segments: (i) Separations and (ii) Biopharmaceutical.  The Separations segment, which is conducted through our wholly owned subsidiary, Biotage, Inc., develops, manufactures and sells chromatography separations systems.  The Biopharmaceutical segment is principally focused on the discovery, development and commercialization of therapeutic products.  It also licenses its proprietary technology to third parties and licenses affinity ligands developed using the Company’s phage display technology to third parties for separations and other applications.

 

The Company’s reportable segments are strategic business units that offer different products and services.  They are managed separately because each business requires different technologies and marketing strategies.

 

The following table presents certain segment financial information and the reconciliation of segment loss from operations to consolidated totals.

 

 

 

Separations

 

Biopharmaceutical

 

Total

 

THREE MONTHS ENDED MARCH 31, 2003

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues from external customers and collaborators

 

$

5,419,000

 

$

3,856,000

 

$

9,275,000

 

Segment loss from operations

 

$

(516,000

)

$

(3,951,000

)

$

(4,467,000

)

Segment assets

 

$

21,743,000

 

$

17,101,000

 

$

38,844,000

 

 

 

 

 

 

 

 

 

THREE MONTHS ENDED MARCH 31, 2002

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues from external customers and collaborators

 

$

4,982,000

 

$

3,904,000

 

$

8,886,000

 

Segment loss from operations

 

$

(358,000

)

$

(4,636,000

)

$

(4,994,000

)

Segment assets

 

$

16,946,000

 

$

8,011,000

 

$

24,957,000

 

 

 

 

 

Three Months Ended
March 31,

 

 

 

2003

 

2002

 

RECONCILIATIONS:

 

 

 

 

 

Loss from operations:

 

 

 

 

 

Loss from operations from reportable segments

 

$

(4,467,000

)

$

(4,994,000

)

Unallocated amounts:

 

 

 

 

 

Corporate expenses

 

(1,590,000

)

(2,033,000

)

Other (expense) income, net

 

(322,000

)

(37,000

 )

Consolidated net loss

 

$

(6,379,000

)

$

(7,064,000

)

 

10



 

9.             GOODWILL AND OTHER INTANGIBLE ASSETS

 

In June 2001, FASB issued SFAS No. 142, “Goodwill and Other Intangible Assets”. SFAS 142 requires that ratable amortization of goodwill be replaced with periodic tests of the goodwill’s impairment and that intangible assets other than goodwill be amortized over their useful lives.  The provisions of SFAS 142 are effective for fiscal years beginning after December 15, 2001.  Pursuant to SFAS 142, the Company ceased amortizing goodwill on January 1, 2002 and completed a test for goodwill impairment during July 2002.  No impairment charge was required.  Intangible assets other than goodwill continue to be amortized on a straight-line basis over their remaining estimated useful lives. Capitalized license rights are amortized using a systematic method over their useful lives.  Useful lives are based on management’s estimate of the period that the capitalized license will generate revenues directly or indirectly, currently seven years.  Capitalized software development costs are amortized over the estimated useful lives of the related software products, currently three to five years.  Patents are amortized over a period of fifteen years.  The covenant not to compete is amortized over a period of five years.  The remaining goodwill balance of $111,000 as of March 31, 2003 has been allocated to the Company’s Separations business segment.

 

Goodwill and other intangible assets consist of the following:

 

 

 

March 31,
2003

 

December 31,
2002

 

 

 

Weighted
-Average
Life-
Years

 

Gross
Carrying
Amount

 

Accumulated
Amortization

 

Weighted
-Average
Life-
Years

 

Gross
Carrying
Amount

 

Accumulated
Amortization

 

Licensed patent technology

 

7

 

$

3,500,000

 

$

208,000

 

7

 

$

3,500,000

 

$

83,000

 

Goodwill

 

 

2,452,000

 

2,341,000

 

 

2,452,000

 

2,341,000

 

Capitalized software development costs

 

5

 

334,000

 

99,000

 

5

 

282,000

 

85,000

 

Patent

 

15

 

100,000

 

85,000

 

15

 

100,000

 

83,000

 

Covenant not to compete

 

5

 

75,000

 

71,000

 

5

 

75,000

 

68,000

 

 

 

 

 

$

6,461,000

 

$

2,804,000

 

 

 

$

6,409,000

 

$

2,660,000

 

 

Estimated five year future amortization expense for other intangible assets as of December 31, 2002 are as follows:

 

2003

 

$

574,000

 

2004

 

568,000

 

2005

 

550,000

 

2006

 

518,000

 

2007

 

511,000

 

 

11



 

10.           COMMITMENTS AND CONTINGENCIES

 

On March 28, 2003, the Company’s Biotage subsidiary entered into a master capital lease for the purchase of qualified fixed assets. During the three months ended March 31, 2003, Biotage sold to and leased back from the lender a total of $143,000 of laboratory equipment. Interest pursuant to this capital lease is 9.90%. Principal and interest payments are payable monthly over 36 months. No gain or loss was recorded as part of this transaction. The Company was required to provide cash collateral in the amount of $500,000, of which $162,000 is included in restricted cash on the Company’s balance sheet. As of March 31, 2003, there was $139,000 in obligations under capital lease arrangements outstanding under the loan, which is included in long-term obligations on the Company’s balance sheet.

 

In connection with the construction of Biotage’s facility in Charlottesville, Virginia, Biotage executed a loan agreement for approximately $4.3 million from a commercial bank.  Construction was completed during the forth quarter of 2002.  The note will be converted to a term loan in August 2003 and will be repaid over 20 years with interest at a rate fixed for five-year periods based on the five-year U.S. Treasury note rate in effect plus 1.58%.  Interest is fixed at 5.83% for the first five years and will be adjusted once every five years thereafter, but may be adjusted earlier if Biotage fails to maintain an average non-interest bearing compensating balance of $750,000 at the lending bank, which is included in cash and cash equivalents on the Company’s balance sheet.  As of March 31, 2003, there was $4.3 million outstanding under the loan, which is included in long-term obligations on the Company’s balance sheet.

 

On August 29, 2002, the Company’s Biotage subsidiary signed a $400,000 promissory note with a commercial bank to fund the purchase of furniture and fixtures.  The note is payable ratably over 60 months, beginning October 1, 2002, and carries an interest rate of 7.0%.  Under the terms of the note, Biotage has assigned $400,000 to the bank as collateral, which is included in restricted cash on the Company’s balance sheet.  As of March 31, 2003, there was $366,000 outstanding under the loan, which is included in long-term obligations on the Company’s balance sheet.

 

On May 31, 2002, the Company and Genzyme Corporation amended and restated their collaboration agreement for the development of DX-88 (the Amended Collaboration Agreement).  The Company and Genzyme also executed a senior secured promissory note and security agreement under which Genzyme agreed to loan the Company up to $7.0 million and the Company pledged a percentage interest in its wholly owned subsidiary, Biotage.  The security agreement provides for the Company to pledge a higher percentage interest in Biotage should the Company, under the Amended Collaboration Agreement, fail to meet certain financial covenants.  The financial covenants state that the Company must maintain at least $20.0 million in cash or cash equivalents based on the Company’s quarterly consolidated financial statements and that the Company maintains at least one continued listing standard for the Nasdaq National Market.

 

As of October 18, 2002, the Company had received the $7.0 million under this Genzyme note.  The note bears interest at the prime rate (4.25% at March 31, 2003) plus 2%.  Interest is payable quarterly.  The principal and all unpaid interest will be due on the maturity date of May 31, 2005.  The Company may extend the maturity date to May 31, 2007 if the Amended Collaboration Agreement is in effect, no default or event of default exists and the Company satisfies the financial covenants as of the initial maturity date.  As of March 31, 2003, there was $7.0 million outstanding under the loan, which is included in long-term obligations on the Company’s balance sheet.

 

12



 

During 2001, Dyax S.A., the Company’s research subsidiary located in Belgium, signed a capital lease for the purchase of qualified fixed assets. During the year ended December 31, 2002, Dyax S.A. sold to and leased back from the lender a total of $1.7 million of laboratory and office equipment. Interest pursuant to this capital lease ranges between 4.55% and 5.60%. Principal and interest are payable quarterly over 60 months.  No gain or loss was recorded as part of these transactions. Dyax S.A. was required to provide cash collateral in the amount of $539,000, which is included in restricted cash on the Company’s balance sheet. As of March 31, 2003, there was $1.4 million in obligations under capital lease arrangements outstanding under the loan, which is included in long-term obligations on the Company’s balance sheet.

 

During 2001, the Company signed a capital lease and debt agreement for the purchase of qualified fixed assets and leasehold improvements.  Interest pursuant to this agreement ranges between 10.01% and 10.33%.  Principal and interest are payable ratably over 36 or 42 months. Capital lease obligations are collateralized by the assets under lease.  Other debt obligations are collateralized by a stand-by letter of credit for the amount financed.  If at the end of any fiscal quarter the Company’s unrestricted cash is less than the greater of $25.0 million or the Company’s annualized cash needs, the Company must provide an irrevocable letter of credit in the amount equal to the amount of debt financed, which was $1.8 million at March 31, 2003.  Annualized cash needs are determined by multiplying cash used in operations for the most recently ended quarter by four.  The lender has no obligation to fund any further amounts.  During the three months ended March 31, 2003 and the year ended December 31, 2002, the Company sold to and leased back from the lender $170,000 and $2.0 million, respectively, of leasehold improvements, laboratory, production and office equipment.  No gain or loss was recorded as part of these transactions. As of March 31, 2003, there was $3.0 million outstanding related to capital leases and $1.8 million outstanding related to the leasehold improvements debt agreement, totaling $4.8 million outstanding under the loan, which is included in long-term obligations on the Company’s balance sheet.

 

During 1997, the Company signed a capital lease agreement for the purchase of qualified fixed assets from a lender for a total of $2.9 million of laboratory and office equipment.  Interest pursuant to this agreement ranges between 10.42% and 14.02%.  Principal and interest are payable ratably over 60 months. The capital lease obligations are collateralized by the assets under the lease. As of March 31, 2003, there was $877,000 outstanding under the agreement, which is included in long-term obligations on the Company’s balance sheet.

 

The Company also has a capital lease for equipment in The Netherlands, the former site of its European research facility. In 2000, the Company sold to the lessor and leased back $297,000 of laboratory equipment under this facility. Interest pursuant to this agreement is at 5.60%. Principal and interest is payable monthly over 60 months.  No gain or loss was recorded as part of this transaction.  As of March 31, 2003, there was $134,000 outstanding under the capital lease, which is included in long-term obligations on the Company’s balance sheet.

 

In June 2001, the Company entered into an agreement to initially lease approximately 67,000 square feet of laboratory and office space in Cambridge, Massachusetts.  The lease commenced in the first quarter of 2002 and has an initial term of ten years, expiring February 2012.  The Company was required to provide a cash-collateralized letter of credit in the amount of $4.3 million, which may be reduced after the fifth year of the lease term.  The cash collateral is included in restricted cash on the Company’s balance sheet.  Under the terms of the agreement, the landlord loaned the Company approximately $2.4 million during 2002 to be used towards the cost of leasehold improvements, the outstanding balance of $2.3 million is included in long-term obligations on the Company’s balance sheet as of March 31, 2003.  The loan bears interest at a rate of 12.00% and is payable in 107 remaining equal monthly installments through February 2012.  Under the terms of the lease agreement, the Company is obligated to lease an additional 24,122 square feet of space on November 1, 2007 and has the option to extend the entire lease for two additional five-year terms.

 

13



 

The Company had operating leases covering 25,000 square feet of manufacturing, office and storage space in Charlottesville, Virginia.  The leases for the Charlottesville facility expired during January 2003. The Company leases approximately 4,000 square feet of office space in the United Kingdom under an operating lease that permits the Company to renew after each five-year period over a twenty five year period; however, should the Company elect not to renew at the end of a five year period, there is a termination fee equal to one year’s rent. The Company maintains approximately 1,500 square feet of office space in Japan under an operating lease, which expires in January 2005. The Company maintains approximately 10,000 square feet of laboratory and office space in Belgium under an operating lease, which expires in December 2004.  The Belgium lease has three additional one-year term extension options. Additionally, the Company has operating leases for automobiles and equipment expiring in July 2003 through November 2005.

 

Rent expense for the three months ended March 31, 2003 and 2002 was approximately $903,000 and $997,000, respectively.  Rent expense for the three months ended March 31, 2003 and 2002 was net of sublease payments of $346,000 and $0, respectively.

 

11.           COLLABORATIVE AGREEMENT

 

On May 31, 2002, the Company and Genzyme Corporation amended their collaboration agreement for the development and commercialization of DX-88.  Under the Amended Collaboration Agreement, the Company had an option until March 31, 2003 to purchase Genzyme’s interest in the application of DX-88 for the prevention of blood loss and other systemic inflammatory responses in cardiopulmonary bypass and other surgery. The Company exercised its option to purchase Genzyme’s interest in the cardiopulmonary bypass and other surgery indication in the first quarter of 2003, which requires the Company to pay $1.0 million to Genzyme in the second quarter of 2003. Upon exercise, the security agreement provided that Genzyme release its security interest in the portion of the DX-88 program relating to the cardiopulmonary bypass and other surgery indication and that the Company pledge a percentage of its interest in its wholly owned subsidiary, Biotage, as additional collateral for the Genzyme loan (see note 11).

 

On January 6, 2003, the Company and Cambridge Antibody Technology Limited (CAT) amended a licensing agreement between the parties dated December 31, 1997. Under the expanded terms of the amended agreement, CAT granted the Company worldwide licenses for research and certain other purposes for all CAT antibody phage display patents (the “CAT patents”). The Company also received options for licenses to develop therapeutic and diagnostic antibody products under the CAT patents. CAT will receive milestone and royalty payments in connection with antibody products advanced into clinical trials by the Company, its collaborators or its customers. CAT will have the option to co-fund and co-develop antibodies developed by the Company and to share the Company’s revenues from certain other applications of antibody phage display technology.  Additionally, CAT is no longer required to pay the Company royalties related to the Company’s Ladner patents on antibody products developed by CAT, except in relationship to Humira™. CAT has options to buy the Company out of any future royalties it may owe on Humira™ under a predetermined schedule. The Companies are currently in dispute regarding these potential royalty payments.

 

12.           LITIGATION

 

George Pieczenik and I.C. Technologies America, Inc. sued the Company in 1999 for patent infringement of three United States patents. The complaint was initially filed against the Company in New York, dismissed for lack of jurisdiction and then refiled in the United States District Court in Massachusetts. On February 25, 2003, the District Court granted summary judgment of noninfringement in the Company’s favor with respect to the three asserted patents.  On March 5, 2003, the plaintiff filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit.

 

14



 

Item 2 -  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The discussion in this item and elsewhere in this report contains forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements.  These risks and uncertainties include those described under “Important Factors That May Affect Future Operations and Results” below.

 

OVERVIEW

 

We are a biopharmaceutical company principally focused on the discovery, development and commercialization of therapeutics for oncology and inflammatory conditions. We have two product candidates in clinical trials, DX-88 and DX-890, and have collaborative agreements for the development of both of these product candidates. We are currently conducting a phase II 48-patient double-blind placebo-controlled trial of DX-88 for the treatment of patients with hereditary angioedema in the United States of America (U.S.) with the intent to add international sites. During the quarter ended March 31, 2003, we completed a phase II nine-patient open-label European study in hereditary and acquired angioedema and were granted orphan drug designation for the angioedema indication in both the U.S. and in Europe. We are also conducting a phase I/II study of DX-88 in cardiopulmonary bypass in the U.S. Our collaborator for DX-890 has completed a phase IIa trial in adult patients with cystic fibrosis and has initiated a second phase IIa trial in children with cystic fibrosis.

 

We use our proprietary, patented technology, known as phage display, to identify human monoclonal antibodies, small proteins and peptides as potential therapeutics for the treatment of various conditions and diseases. We are using phage display technology to build a broad portfolio of product candidates that we plan to develop and commercialize either ourselves or with others. On behalf of collaborators, we also use phage display technology to identify compounds that can be used in therapeutics, diagnostic imaging, the development of research reagents, and in purifying and manufacturing biopharmaceuticals. We are further leveraging our phage display technology through collaborations and licenses that are structured to generate revenues through research funding, license fees, technical and clinical milestone payments, and royalties.

 

We also develop, manufacture and sell chromatography separations systems and products through our Biotage subsidiary. We are a leading developer, manufacturer and supplier of chromatography separations systems that use disposable cartridges to separate and purify pharmaceuticals being produced for research and clinical development.

 

15



 

RESULTS OF OPERATIONS

 

THREE MONTHS ENDED MARCH 31, 2003 AND 2002

 

Total revenues for the three month period ended March 31, 2003 (the 2003 Quarter) were $9.3 million, compared with $8.9 million for the three month period ended March 31, 2002 (the 2002 Quarter), an increase of $389,000 or 4%. Separations product revenues and Biopharmaceutical product development and license fee revenues accounted for 58% and 42%, respectively, of our total revenues in the 2003 Quarter, as compared with 56% and 44% in the 2002 Quarter. Separations product sales increased to $5.4 million in the 2003 Quarter from $5.0 million in the 2002 Quarter, an increase of $437,000 million or 9%. The increase in separations product sales was primarily due to increased sales of our discovery consumables as well as increased sales of Kiloprep systems.

 

Biopharmaceutical product development and license fee revenues were $3.9 million in both the 2003 Quarter and the 2002 Quarter. In the 2003 Quarter, we had higher revenues in our funded research and collaboration efforts in the areas of therapeutics, affinity separations and research reagents. This increase was offset by lower revenue from our DX-890 product collaboration with Debiopharm S.A. in the form of reimbursement of our costs of drug manufacture, which on a quarter to quarter basis may vary substantially due to the timing of production activities.

 

Cost of products sold for the 2003 Quarter was $2.4 million compared to $2.2 million for the 2002 Quarter, an increase of $273,000 or 13%.  The gross margin on product revenues for the 2003 Quarter was 55% compared to 56% for the 2002 Quarter, primarily reflecting a product mix of more lower margin Kiloprep systems and production cartridge sales during the 2003 Quarter as compared to the product mix for the 2002 Quarter.

 

Research and development expenses for the 2003 Quarter were $7.5 million, compared with $7.6 million for the 2002 Quarter, a decrease of $122,000 or 2%.  The decrease resulted primarily from lower compound manufacturing expenditures for collaborative arrangements, reduced employee costs and lower non-cash compensation charges. These decreases were partly offset by a $1.0 million charge to acquire additional rights to our DX-88 compound in the cardiopulmonary bypass and other surgery indication from Genzyme, which will be paid in the second quarter of 2003, and costs related to product line development by our Biotage subsidiary.

 

Selling, general and administrative expenses decreased to $5.4 million for the 2003 Quarter compared to $6.2 million for the 2002 Quarter, a decrease of $732,000 or 12%. The decrease was primarily due to lower costs in outside patent and other legal counsel, lower employee costs, and benefits received from subletting a portion of our Cambridge, MA facility and the occupancy of our Charlottesville, VA facility. These decreases were partly offset by higher depreciation expense, insurance expense and marketing costs at our Biotage subsidiary.

 

Other expense/income was a net expense of $322,000 for the 2003 Quarter compared to net expense of $37,000 for the 2002 Quarter.  Interest income decreased due to lower average cash and cash equivalent balances and lower interest rates.  Interest expense increased due to additional long-term debt obligations.

 

Our net loss for the 2003 Quarter was $6.4 million compared to $7.1 million for the 2002 Quarter.

 

16



 

LIQUIDITY AND CAPITAL RESOURCES

 

Through March 31, 2003, we have funded our operations principally through the sale of equity securities, which have provided aggregate net cash proceeds since inception of approximately $140.7 million, including net proceeds of $62.4 million from our August 2000 initial public offering and net proceeds of $8.3 million from our March 2003 registered directed offering.  We have also generated funds from separations product sales, biopharmaceutical product development revenues, biopharmaceutical license fees, interest income, long-term debt obligations and other sources.  As of March 31, 2003, we had cash and cash equivalents of approximately $31.0 million, an increase of approximately $2.8 million from December 31, 2002.  We primarily invest excess cash in U.S. Treasury obligations and certificates of deposit.

 

Our operating activities used cash of $4.7 million and $4.6 million for the 2003 and 2002 Quarters, respectively. The use of cash in both quarters resulted primarily from losses from operations and changes in our working capital accounts, net of depreciation, amortization, provision for doubtful accounts, loss on disposal of fixed assets and non-cash compensation expense.

 

Our investing activities used cash of $263,000 and $5.3 million for the 2003 and 2002 Quarters, respectively.  Our investing activities consisted primarily of purchases of fixed assets. Our reduced investment level during the 2003 Quarter compared to the 2002 Quarter reflects the 2002 completion of our facilities expansion projects.

 

Our financing activities provided cash of $7.8 million for the 2003 Quarter and $3.4 million of cash during the 2002 Quarter.  Our financing activities for the 2003 Quarter consisted primarily of the $8.3 million net proceeds from the registered directed offering, proceeds from long-term obligations, the exercise of stock options and the sale of common stock under our employee stock purchase plan.  These proceeds were partly offset by repayments of long-term obligations and an increase in restricted cash to secure our long-term obligations.  Our financing activities for the 2002 Quarter consisted primarily of proceeds from our Cambridge landlord for leasehold improvements, borrowings under long-term obligations, the exercise of stock options and the sale of common stock under our employee stock purchase plan.  These proceeds were partly offset by repayments of long-term obligations.

 

We have financed fixed asset purchases through capital leases and debt. Capital lease obligations are collateralized by the assets under the leases. Certain debt obligations are collateralized by a stand-by letter of credit for the amount financed.  If at the end of any quarter our unrestricted cash is less than the greater of $25.0 million or annualized cash needs, we must provide to the lender an irrevocable letter of credit in an amount equal to the amount financed by that lender, which was $1.8 million at March 31, 2003.  Annualized cash needs are determined by multiplying cash used in operations for the most recently ended quarter by four. We anticipate we will be required to provide this letter of credit during the 3rd quarter of 2003.

 

OUTLOOK

 

For the year ended December 31, 2003, we anticipate total revenues will increase by approximately 20% to 30%. Separations product revenues should continue to grow due to our continued strength in the chromatography separations systems market, particularly our cartridge chromatography and Horizon instrumentation product lines. We also expect Biopharmaceutical product development and license revenues to grow based on our expectations regarding additional collaboration opportunities available to us in the therapeutic antibody area, the continued progress in clinical development, and expanded arrangements relating to our DX-88 and DX-890 product candidates.

 

17



 

Statements about our expectations of the period of time through which financial resources will be adequate to support our operations are forward-looking statements that involve risks and uncertainties. Actual results could vary as a result of a number of factors. We believe that existing cash and cash equivalents plus anticipated cash flow from product revenues and collaborations will be sufficient to support our current operating plans into 2004. If our existing resources and cash flows from product sales and collaborations are insufficient to satisfy our liquidity requirements, we may need to sell additional equity, debt securities or otherwise further leverage assets. The sale of any equity or debt securities may result in additional dilution to our stockholders, and we cannot be certain that additional financing will be available in amounts or on terms acceptable to us, if at all. If we are unable to obtain any required additional financing, we may be required to reduce the scope of our planned research, development and commercialization activities, which could harm our financial condition and operating results.

 

CRITICAL ACCOUNTING POLICIES

 

In our Form 10-K for the year ended December 31, 2002, our most critical accounting policies and estimates upon which our financial status depends upon were identified as those relating to inventories, allowance for doubtful accounts, valuation of long-lived and intangible assets, revenue recognition and litigation claims. We reviewed our policies and determined that those policies remain our most critical accounting policies for the quarter ended March 31, 2003. We did not make any changes in those policies during the three months ended March 31, 2003.

 

IMPORTANT FACTORS THAT MAY AFFECT FUTURE OPERATIONS AND RESULTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking statements appear principally in the section entitled “Management’s Discussion and Analysis of Financial Conditions and Results of Operations.” Forward-looking statements may appear in other sections of this report as well. Generally, the forward-looking statements in this report use words like “expect,” “believe,” “continue,” “anticipate,” “estimate,” “may,” “will,” “could,” “opportunity,” “future,” “project,” and similar expressions.

 

The forward-looking statements include statements about our:

 

                                           results of operations;

 

                                           research and development programs;

 

                                           clinical trials; and

 

                                           collaborations.

 

Statements that are not historical facts are based on our current expectations, beliefs, assumptions, estimates, forecasts and projections for our business and the industry and markets in which we compete. The forward-looking statements contained in this report are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. We caution investors not to place undue reliance on the forward-looking statements contained in this report. These statements speak only as of the date of this report, and we do not undertake any obligation to update or revise them, except as required by law.

 

18



 

The following factors, among others, create risks and uncertainties that could affect our future or other performance:

 

                  our history of operating losses and our expectation that we will incur significant additional operating losses;

 

                  any inability to raise the capital that we will need to sustain our operations;

 

                  any inability to successfully and expeditiously complete the rigorous clinical trials and regulatory approvals processes that any biopharmaceutical or diagnostic product candidates that we develop must undergo, which could substantially delay or prevent their development or marketing;

 

                  our dependence on third parties to manufacture biopharmaceuticals, which may adversely affect our ability to commercialize any biopharmaceuticals we may develop;

 

                  our lack of experience in conducting clinical trials, regulatory processes, and conducting sales and marketing activities, any or all of which may adversely impact our ability to commercialize any biopharmaceuticals we may develop;

 

                  our dependence on the expertise, effort, priorities and contractual obligations of our collaborators, any changes in our collaborators’ business direction or priorities or defaults in their obligations may have an adverse impact on our research revenues and ultimately our license revenues and expenses;

 

                  any failure by us or our collaborators to gain market acceptance of our biopharmaceuticals;

 

                  competition and technological change that may make our potential products and technologies less attractive or obsolete;

 

                  any inability to obtain and maintain intellectual property protection for our products and technologies;

 

                  time consuming and expensive proceedings to obtain, enforce or defend patents and to defend against charges of infringement that may result in unfavorable outcomes and could limit our patent rights and our activities;

 

                  significant fluctuations in our revenues and operating results, which have occurred in the past and which we expect to continue to fluctuate in the future;

 

                  any loss or inability to hire and retain qualified personnel;

 

                  difficulties in managing our growth;

 

                  our dependence on one supplier for a key component in our separations products;

 

                  our handling, storage or disposal of hazardous materials used and generated in our business may be time-consuming and expensive;

 

                  our exposure to product liability;

 

19



 

                  risks associated with international sales and operations and collaborations;

 

                  failure to acquire technology and integrate complementary businesses;

 

                  our common stock may continue to have a volatile public trading price and low trading volume; and

 

                  anti-takeover provisions in our governing documents and under Delaware law and our shareholder rights plan that may make an acquisition of us more difficult.

 

As a result of the foregoing and other factors, we may experience material fluctuations in our future operating results, which could materially affect our business, financial position, and stock price. These risks and uncertainties are discussed in more detail in Exhibit 99.1 entitled, “Important Factors Affecting Future Operations and Results” filed with our Annual Report on Form 10-K for the year ended December 31, 2002.

 

Item 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our exposure to market risk consists primarily of our cash and cash equivalents. We place our investments in high-quality financial instruments, primarily U.S. Treasury funds and certificates of deposit, which we believe are subject to limited credit risk. We currently do not hedge interest rate exposure. As of March 31, 2003, we had cash and cash equivalents of $31.0 million consisting of cash and highly liquid, short-term investments. Our short-term investments will decline by an immaterial amount if market interest rates increase, and therefore, our exposure to interest rate changes is immaterial. Declines of interest rates over time will, however, reduce our interest income from our short-term investments.

 

As of March 31, 2003, we had $21.3 million outstanding under long-term obligations.  Interest rates on $10.0 million of these obligations are fixed and therefore are not subject to interest rate fluctuations.  Interest rates on the remaining $11.3 million are variable as follows:  i) Interest on the $7.0 million Genzyme note is variable based on the prime interest rate and is therefore subject to interest rate fluctuations.  A 1% increase in the prime rate will result in an additional $70,000 in annual interest expense.  ii) Interest on Biotage’s $4.3 million Charlottesville facility loan is fixed over the next five years and therefore would not be subject to interest rate fluctuations over that period.

 

Most of our transactions are conducted in U.S. dollars. We have collaboration and technology license agreements, product sales, sales office subsidiaries and a research subsidiary located outside the United States. Transactions under certain of these agreements and by our subsidiaries are conducted in local foreign currencies.  If exchange rates undergo a change of up to 10%, we do not believe that it would have a material impact on our results of operations or cash flows.

 

20



 

Item 4 - CONTROLS AND PROCEDURES

 

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we have evaluated the effectiveness of the design and operation of our disclosure controls and procedures within 90 days of the filing date of this quarterly report.  Based on their evaluation, our principal executive officer and principal financial officer concluded that these controls and procedures are effective in timely alerting them to material information required to be disclosed by us in the reports that we file with the SEC.  There were no significant changes in our internal controls or in other factors that could significantly affect our internal controls subsequent to the date of their evaluation.

 

PART II - OTHER INFORMATION

 

Item 2 - Use of Proceeds from Registered Securities

 

On August 18, 2000, we sold 4,600,000 shares of common stock (including 600,000 shares pursuant to the exercise by the underwriters of their over allotment option) at a price of $15.00 per share in our initial public offering and received proceeds of approximately $62.4 million, net of underwriter commissions.  From August 18, 2000 through March 31, 2003, we used approximately $44.0 million to fund operating activities and $17.0 million for the purchase of fixed assets.

 

21



 

Item 6 - Exhibits and Reports on Form 8-K

 

(a)   - Exhibits

 

EXHIBIT NO.

 

DESCRIPTION

 

 

 

3.1

 

Restated Certificate of Incorporation of the Company.  Filed as Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2000 and incorporated herein by reference.

 

 

 

3.2

 

Amended and Restated By-laws of the Company. Filed as Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2000 and incorporated herein by reference.

 

 

 

3.3

 

Certificate of Designations Designating the Series A Junior Participating Preferred Stock of the Company. Filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 000-24537) and incorporated herein by reference.

 

 

 

3.4

 

Certificate of Correction to the Restated Certificate of Incorporation of the Company. Filed as Exhibit 3.4 to the Company’s Amendment No. 1 to the Annual Report on Form 10-K/A (File No. 000-24537) and incorporated herein by reference.

 

 

 

10.1

 

Amended Agreement between Cambridge Antibody Technology Limited and Dyax Corp. dated January 6, 2003. Filed herewith.

 

 

 

99.1

 

Certification pursuant to 18 U.S.C. Section 1350. Filed herewith.


                                                                 This Exhibit has been filed separately with the Commission pursuant to an application for confidential treatment.  The confidential portions of this Exhibit have been omitted and are marked by an asterisk.

 

(b)   - Reports on Form 8-K

 

i.                  We filed a Current Report on Form 8-K on February 19, 2003, regarding our issuance of a press release announcing our financial results for the fourth quarter and year ended December 31, 2002.

 

ii.               We filed a Current Report on Form 8-K on March 18, 2003, in order to furnish certain exhibits for incorporation by reference into our Registration Statement on Form S-3 that was previously filed with Securities and Exchange Commission (File No. 333-86904).  This Registration Statement was declared effective by the Commission on May 3, 2002. In connection with our sale of 4,721,625 shares of common stock, we filed (i) a Placement Agent Agreement dated March 13, 2003 between Dyax and Pacific Growth Equities, Inc., (ii) a Form of Common Stock Purchase Agreement between Dyax and each of the purchasers named in Schedule I thereto, and (iii) an opinion from Palmer & Dodge LLP relating to the sale and issuance of shares of Dyax common stock sold in the offering.

 

22



 

DYAX CORP.

 

SIGNATURE

 

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.

 

 

DYAX CORP.

 

 

Date:    May 7, 2003

 

 

/s/  Stephen S. Galliker

 

Executive Vice President, Finance
and Administration, and Chief Financial Officer

 

23



 

Certification Pursuant to §240.13a-14 or §240.15d-14 of the Securities Exchange Act of 1934

 

I, Henry E. Blair, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Dyax Corp.;

 

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

 

a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

b) evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

 

c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

6. The registrant’s other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

 

Date:     May 7, 2003

/s/ Henry E. Blair

 

Chief Executive Officer

 

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Certification Pursuant to §240.13a-14 or §240.15d-14 of the Securities Exchange Act of 1934

 

I, Stephen S. Galliker, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Dyax Corp.;

 

2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

 

a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

b) evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

 

c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

6. The registrant’s other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

 

Date:     May 7, 2003

/s/ Stephen S. Galliker

 

Chief Financial Officer

 

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DYAX CORP.

 

EXHIBIT INDEX

 

EXHIBIT NO.

 

DESCRIPTION

 

 

 

3.1

 

Restated Certificate of Incorporation of the Company.  Filed as Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2000 and incorporated herein by reference.

 

 

 

3.2

 

Amended and Restated By-laws of the Company. Filed as Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q (File No. 000-24537) for the quarter ended September 30, 2000 and incorporated herein by reference.

 

 

 

3.3

 

Certificate of Designations Designating the Series A Junior Participating Preferred Stock of the Company. Filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 000-24537) and incorporated herein by reference.

 

 

 

3.4

 

Certificate of Correction to the Restated Certificate of Incorporation of the Company. Filed as Exhibit 3.4 to the Company’s Amendment No. 1 to the Annual Report on Form 10-K/A (File No. 000-24537) and incorporated herein by reference.

 

 

 

10.1

 

Amended Agreement between Cambridge Antibody Technology Limited and Dyax Corp. dated January 6, 2003. Filed herewith.

 

 

 

99.1

 

Certification pursuant to 18 U.S.C. Section 1350. Filed herewith.


                                                                  This Exhibit has been filed separately with the Commission pursuant to an application for confidential treatment.  The confidential portions of this Exhibit have been omitted and are marked by an asterisk.

 

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