-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, F8dXKET5koAmU47Uyyoqfjiv3zxA3VHS/F6Z+ZrkfSTlS5jIKAQMG3ee+9in2UQK Ow+Lnn1Kyhb42aRNPjzO0g== 0001104659-05-034272.txt : 20050727 0001104659-05-034272.hdr.sgml : 20050727 20050727084723 ACCESSION NUMBER: 0001104659-05-034272 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050727 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050727 DATE AS OF CHANGE: 20050727 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DYAX CORP CENTRAL INDEX KEY: 0000907562 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 043053198 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24537 FILM NUMBER: 05975587 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 MAIL ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 STREET 2: 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: BIOTAGE INC DATE OF NAME CHANGE: 19951117 8-K 1 a05-13577_18k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

 

WASHINGTON, D.C.  20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): July 27, 2005

 

DYAX CORP.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-24537

 

04-3053198

(State or Other Jurisdiction of
Incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

300 Technology Square

Cambridge, MA  02139

(Address of Principal Executive Offices)  (Zip Code)

 

(617) 225-2500

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o                  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 2.02.                                        Results of Operations and Financial Condition.

 

On July 27, 2005, Dyax Corp. issued a press release announcing its financial results for the quarter ended June 30, 2005.  Pursuant to Item 2.02, a copy of the press release is hereby furnished to the Commission as Exhibit 99.1 to this report and is incorporated by reference herein.

 

Item 9.01.                                        Financial Statements and Exhibits.

 

(c)                                  Exhibits.

 

99.1                        Press release of Dyax Corp. dated July 27, 2005 reporting Dyax’s financial results for the quarter ended June 30, 2005.

 

2



 

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 hereunto duly authorized.

 

 

DYAX CORP.

 

 

 

 

Dated:   July 27, 2005

  By:

/s/ Stephen S. Galliker

 

 

 

Stephen S. Galliker

 

 

Executive Vice President, Finance

 

 

and Administration, and Chief

 

 

Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit

 

 

No.

 

Description

 

 

 

99.1

 

Press release of Dyax Corp. dated July 27, 2005 reporting Dyax’s financial results for the quarter ended June 30, 2005.

 

4


 

EX-99.1 2 a05-13577_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Contact:

Stephen S. Galliker

Executive Vice President Finance and Administration, CFO

Dyax Corp.

(617) 250-5733

ssg@dyax.com

 

Dyax Corp. Announces Second Quarter Financial Results

 

CAMBRIDGE, MA, July 27, 2005Dyax Corp. (Nasdaq: DYAX) today announced financial results for the second quarter ended June 30, 2005.  The Company will host a webcast and conference call at 10 am (ET) this morning to report these financial results and corporate progress for the quarter, and to provide an update on the Company’s lead DX-88 program in hereditary angioedema (HAE).

 

Financial Results:

 

For the quarter ended June 30, 2005, the Company reported a net loss of $7.9 million or $0.23 per share, as compared to a net loss of $8.2 million or $0.26 per share for the comparable quarter in 2004.  For the six months ended June 30, 2005, the Company reported a net loss of $16.4 million or $0.50 per share, as compared to a net loss of $15.6 million or $0.50 per share for the comparable six month period in 2004.

 

Revenues for the quarter ended June 30, 2005 increased by 64% to $6.7 million as compared to $4.1 million for the same period in 2004.  Revenues for the six month period ended June 30, 2005 increased by 6.4% to $10.4 million as compared to $9.8 million in the comparable six month period in 2004.  The revenue increase for the quarter was primarily due to the recognition of a fully paid $1.5 million patent license option fee, a $1.1 million increase in reimbursable manufacturing expenses arising from our DX-890 product collaboration with Debiopharm S.A., and a $441,000 increase in other licensing activities.  Revenue associated with our collaboration with Debiopharm may vary substantially from quarter to quarter due to the timing of production activities.  These increases were partially offset by a $443,000 decrease in funded research revenue under existing and continuing relationships.

 

Research and development expenses for the quarter ended June 30, 2005 increased $4.6 million to $14.1 million as compared to $9.5 million for the same period in 2004.  For the six month period

 



 

ended June 30, 2005, research and development expenses increased $4.8 million to $24.6 million as compared to $19.8 million for the same period in 2004.  The increase in research and development expense for the quarter was primarily due to an increase of $3.7 million in manufacturing expenses and clinical and preclinical trial costs related to the development of DX-88 for HAE, as well as a $1.1 million increase of manufacturing expenses arising from our DX-890 product collaboration with Debiopharm S.A..

 

The development of DX-88 for HAE is jointly managed and funded by Dyax and Genzyme Corporation under our Dyax-Genzyme LLC joint venture (“the LLC”).  The expenses incurred by Dyax on the DX-88 program for HAE are included in overall research and development expenses, and are then reimbursed by the LLC.   In turn, Dyax and Genzyme each fund one half of the LLC’s total expenses.  For the quarter ended June 30, 2005, $6.1 million of the Company’s research and development expense was reimbursed by the joint venture, and Dyax recognized a loss of $3.4 million, representing its portion of the LLC’s net loss.

 

As of June 30, 2005, Dyax had approximately $65.9 million in net cash (cash, cash equivalents, and short term investments, exclusive of restricted cash), an increase of $8.8 million from December 31, 2004.  This increase reflects net proceeds of approximately $23.5 million from the Company’s registered direct offering of common stock that occurred in May 2005.

 

Henry E. Blair, Chairman, President and CEO of Dyax stated, “We continued to make progress during the second quarter, particularly in the development of DX-88 for the treatment of hereditary angioedema.  New data from two important trials reaffirm our strategy of initiating our pivotal Phase III trial using subcutaneously administered DX-88.  We are pleased to advance the most conveniently administered product for HAE patients and physicians and we remain resolute in our commitment, together with Genzyme, to bring DX-88 to market as the drug of choice.  Our timelines are unchanged; we look forward to initiating our pivotal study before year end and to commencing our BLA filing in 2006, with approval expected in the U.S. in 2007, followed by approval in the E.U.”

 

Mr. Blair continued, “Several of our collaborators’ clinical programs are also moving forward.  During the quarter, Amgen advanced a Dyax-discovered peptide into late stage clinical trials.  Clinical programs also advanced at ImClone Systems and Epix Pharmaceuticals using antibodies and peptides, respectively, from Dyax’s libraries.  Our Discovery Research team continues to make excellent strides in building Dyax’s pipeline.  At the Drug Discovery Technology Conference in Boston in August, we will be presenting animal data on one of our new leads.  Overall I’m extremely pleased with the Company’s achievements during the quarter.”

 



 

2005 Guidance:

 

Regarding Dyax’s guidance for the remainder of this year, Stephen S. Galliker, Executive Vice President, Finance and Administration and Chief Financial Officer for Dyax remarked, “The proceeds received from our May financing strengthened our balance sheet.  We expect that existing cash, cash equivalents and short-term investments plus anticipated cash flow from product development revenues and collaborations will be sufficient to continue to support our current operating plans into 2007.  We remain on track with our guidance for net cash consumption of approximately $30 million for the year.”

 

Webcast and Conference Call

 

Dyax Corp. will host a webcast and conference call, including an open question and answer session to discuss second quarter 2005 financial results and company progress.

 

Date:

 

Wednesday, July 27, 2005

Time:

 

10:00 a.m. ET

Telephone Access:

 

Domestic callers, dial 866-831-6243

 

 

International callers, dial 617-213-8855

 

 

Passcode I.D. 68930942

Online Access:

 

Go to the Investor Relations section of the Dyax website (www.dyax.com) and follow instructions for live webcast.  Participants may register in advance.

 

A replay of the conference call will be available through August 27, 2005 and can be accessed by dialing 888-286-8010.  International callers should dial 617-801-6888.  The replay passcode I.D. for all callers is 25927667.  The webcast will be archived on the Dyax website for an indefinite period of time.

 

About Dyax

 

Dyax Corp. is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on cancer and inflammatory indications.  Dyax utilizes its proprietary phage display drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.

 

DX-88 and DX-890 are recombinant small proteins that are currently in clinical trials for their therapeutic potential in three separate indications.  In its joint venture with Genzyme Corporation, Dyax has successfully completed two Phase II trials of DX-88 for the treatment of hereditary angioedema (HAE).  A third Phase II trial is ongoing, and a pivotal Phase III trial is planned.

 



 

Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during heart surgery (CABG procedures) and is in partnering discussions for further development of DX-88 in this indication.  For DX-890, Debiopharm S.A., has completed two Phase IIa trials and is now conducting a Phase IIb trial of DX-890 for the treatment of cystic fibrosis (CF).  Both compounds have orphan drug designation in the US and EU, and DX-88 also has Fast Track designation in the US for the treatment of HAE.

 

DX-88 and DX-890 were identified using Dyax’s patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets.  Dyax leverages its technology broadly with over 75 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.

 

Dyax Disclaimer

 

This press release contains forward-looking statements regarding Dyax Corp., including statements regarding its revenues, results of operations, cash resources, antibody discovery technology, clinical trials of DX-88, and collaborations.  Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections for Dyax and the industry and markets in which Dyax competes.  The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict.  Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements because of uncertainties associated with various activities and aspects of Dyax’s business, including the timing and results of clinical trials, regulatory review of Dyax’s products and related trials for approval, Dyax’s efforts to develop and commercialize novel products, its dependence on collaborators for development, clinical trials, manufacturing, sales and distribution of products developed by or licensed to collaborators, its changing requirements and costs associated with planned research and development activities, intense competition, the uncertainty of patent and intellectual property protection, Dyax’s dependence on key management and key suppliers, the impact of future alliances or transactions involving Dyax or others, and other risk factors described or referred to in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission.  Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release.  These statements speak only as of the date of this release, and Dyax undertakes no obligation to update or revise these statements, except as may be required by law.

 

Dyax and the Dyax logo are the registered trademarks of Dyax Corp.

 

-   financial tables follow -

 



 

DYAX CORP.

SELECTED CONSOLIDATED STATEMENT OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

(In thousands, except share and per share data)

 

Product development and license fee revenues

 

$

6,693

 

$

4,074

 

$

10,400

 

$

9,771

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

14,064

 

9,499

 

24,626

 

19,831

 

less: Research and development expenses reimbursed by joint venture

 

(6,054

)

(2,299

)

(10,082

)

(3,809

)

Equity loss in joint venture

 

3,357

 

1,334

 

5,551

 

2,216

 

General and administrative

 

3,393

 

3,686

 

6,830

 

6,961

 

Total operating expenses

 

14,760

 

12,220

 

26,925

 

25,199

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(8,067

)

(8,146

)

(16,525

)

(15,428

)

Other income (expense), net

 

142

 

(30

)

153

 

(183

)

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(7,925

)

$

(8,176

)

$

(16,372

)

$

(15,611

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.23

)

$

(0.26

)

$

(0.50

)

$

(0.50

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per share

 

34,167,525

 

31,192,426

 

32,881,639

 

30,916,949

 

 

SELECTED CONSOLIDATED BALANCE SHEET INFORMATION

(Unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2005

 

2004

 

 

 

(In thousands)

 

Cash and cash equivalents

 

$

9,129

 

$

6,978

 

Short-term investments

 

56,815

 

50,163

 

Restricted cash

 

4,493

 

4,642

 

Working capital

 

55,781

 

46,832

 

Total assets

 

90,039

 

82,760

 

Stockholders’ equity

 

55,308

 

47,831

 

 

# # #

 


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