-----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, QOLuD8XrF5Zp0tYcKCs+spxBEAzs8MjBe6fG3bQvOpP0mN2NNEs/XG4uvst+N9yu qtByuiZIE4h2XdW8vDgX6w== 0001104659-05-018317.txt : 20050427 0001104659-05-018317.hdr.sgml : 20050427 20050427090317 ACCESSION NUMBER: 0001104659-05-018317 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050427 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050427 DATE AS OF CHANGE: 20050427 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: 05774679 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 a05-7408_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): April 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 April 27, 2005, Dyax Corp. issued a press release announcing its financial results for the quarter ended March 31, 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 April 27, 2005 reporting Dyax’s financial results for the quarter ended March 31, 2005, furnished pursuant to Item 2.02.

 

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:    April 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 April 27, 2005 reporting Dyax’s financial results for the quarter ended March 31, 2005.

 

4


EX-99.1 2 a05-7408_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 First Quarter Financial Results

 

CAMBRIDGE, MA, April 27, 2005Dyax Corp. (Nasdaq: DYAX) today announced financial results for the first quarter ended March 31, 2005.   The Company will host a webcast and conference call at 10 am (ET) this morning to report 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 March 31, 2005, the Company reported a net loss of $8.4 million or $0.27 per share, as compared to a net loss of $7.4 million or $0.24 per share for the comparable quarter of 2004.

 

Revenues for first quarter ended March 31, 2005 decreased 35% to $3.7 million as compared to $5.7 million for the same period in 2004.  The decrease in revenue during the 2005 period is primarily due to a $2.4 million decrease in revenue arising from the Company’s DX-890 product collaboration with Debiopharm S.A. Revenue associated with this collaboration may vary substantially from quarter to quarter due to the timing of production activities.  The decrease was partially offset by an increase of $351,000 in licensing revenue.  The increase in licensing revenue was primarily due to milestones achieved under existing licenses.

 

Research and development expenses for the first quarter ended March 31, 2005 increased $230,000 to $10.6 million as compared to $10.3 million for the same period in 2004.  Although total research and development expenses did not change significantly there were significant changes in two of our largest programs in the reported quarters.  There was a $2.4 million increase in expenses for the development of DX-88 for the treatment of hereditary angioedema (HAE) in the 2005 quarter.  This

 



 

increase is mainly attributable to increases in manufacturing, preclinical and clinical trial costs, and increases in personnel costs.  This increase was partially offset by a $1.9 million decrease in manufacturing costs associated with the Company’s DX-890 product collaboration with Debiopharm S.A.  Expenses associated with this collaboration may vary substantially from quarter to quarter due to the timing of production activities.

 

The development of DX-88 for HAE is jointly managed and funded by Dyax and Genzyme Corporation under our Dyax-Genzyme LLC joint venture.  Increases in research and development expenses reimbursed by joint venture and our equity loss in joint venture are directly related to the increases in expenses for the development of DX-88 for HAE.

 

As of March 31, 2005, Dyax had $49.5 million in cash, cash equivalents, and short term investments, exclusive of restricted cash (net cash), a decrease of $7.7 million from December 31, 2004.

 

Henry E. Blair, Chairman, President and CEO of Dyax remarked, “I’m pleased to report that important progress was made in the first quarter in all areas – therapeutic development, revenue generating collaborations, and new drug discovery.  Not only have our own clinical programs advanced, but our collaborators’ have as well.  EPIX Pharmaceuticals, for example, has advanced a product from a peptide that Dyax discovered into Phase II development. In addition, ImClone Systems has advanced the second of two antibodies from Dyax libraries into Phase I trials.  I’m pleased to see our collaborators’ successes, which reflect the quality of Dyax’s proprietary technology, state-of-the-art libraries and capabilities.  In fact, the advantages of Dyax’s proprietary approach to antibody discovery were highlighted in the March issue of Nature Biotechnology.”

 

With respect to the Company’s DX-88 program in hereditary angioedema, Mr. Blair commented, “Our January announcement of interim results from our ongoing open label, Phase II trial highlighted advances we have made in our lead program for the clinical development of DX-88 in hereditary angioedema.  The results of this EDEMA2 trial demonstrated that DX-88 can retain its clinical benefit in multiple dosing for separate HAE attacks, and also helped to identify an optimal flat dose of DX-88 to be used in trials moving forward. Further positive DX-88 data was presented in March at the AAAAI conference, where an analysis of life-threatening laryngeal attacks of HAE treated with DX-88 across multiple trials was presented that showed high response rates to DX-88.”

 

Mr. Blair continued, “In the HAE program, we are very excited about the advances in the development of an easily administered subcutaneous method for administration of DX-88. We have commenced a safety and pharmacokinetics trial of subcutaneous DX-88 in healthy volunteers and expect to complete this study during the first half of the year. We now plan to initiate a pivotal Phase III trial for DX-88 in HAE this year, in which barring any unexpected developments, we will

 



 

dose DX-88 subcutaneously.  Our current plan is to complete this pivotal trial and, assuming successful results, submit a BLA in 2006 for approval in the US and Europe during 2007. We expect this strategy to substantially reduce the time required to bring to market a product that enables convenient self-administration.  Patient feedback to this approach during a recent meeting of the US HAE Association was strongly supportive. At this meeting, attended by Dyax and Genzyme and all potential competitors, it became even more evident that DX-88 is the clear frontrunner in HAE.  The Dyax-Genzyme team remains firmly committed to bringing the best product to market first.”

 

2005 Guidance:

 

Regarding Dyax’s guidance for the year 2005, Stephen S. Galliker, Executive Vice President Finance & Administration and Chief Financial Officer for Dyax commented, “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 2006. We reiterate our expectation for net cash consumption of approximately $30 million for the year 2005.  We expect cash contributions during 2005 from our ongoing operations to be approximately equivalent to those during 2004, and we remain diligent in our careful management of cash requirements.”

 

Webcast and Conference Call

 

Dyax Corp. will host a webcast and conference call, including an open question and answer session to discuss first quarter 2005 financial results and company progress. Also during this call, Henry E. Blair, Chairman, President and CEO of Dyax, will provide an update on the Company’s lead DX-88 program in hereditary angioedema (HAE).

 

Date:

 

Wednesday, April 27, 2005

Time:

 

10:00 a.m. ET

Telephone Access:

 

Domestic callers, dial 800-659-2037

 

 

International callers, dial 617-614-2713

 

 

Passcode I.D. 82421651

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 May 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 73089783.

 



 

About Dyax

 

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

 

DX-88 and DX-890 are recombinant small proteins that are currently in clinical development 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 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 on-pump open heart surgery (CABG procedures) and is in partnering discussions with respect to Phase II development.  For DX-890, Debiopharm SA, 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 is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium.  For online information about Dyax Corp., please visit www.dyax.com.

 

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 uncertainty associated with various factors, including the timing and results of clinical trials, the uncertainty of regulatory approval for Dyax’s products and related trials, Dyax’s ability to develop and commercialize 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 development activities, intense competition, the uncertainty of patent and intellectual property protection, Dyax’s dependence on key management and key suppliers, the uncertainty of regulatory approvals for our products, 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
March 31,

 

 

 

2005

 

2004

 

 

 

(In thousands, except per share data)

 

 

 

 

 

 

 

Product development and license fee revenues

 

$

3,707

 

$

5,697

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Research and development

 

10,562

 

10,332

 

less: Research and development expenses reimbursed by joint venture

 

(4,028

)

(1,510

)

Equity loss in joint venture

 

2,194

 

882

 

General and administrative

 

3,437

 

3,275

 

Total operating expenses

 

12,165

 

12,979

 

 

 

 

 

 

 

Loss from operations

 

(8,458

)

(7,282

)

Other income (expense), net

 

11

 

(153

)

 

 

 

 

 

 

Net Loss

 

$

(8,447

)

$

(7,435

)

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.27

)

$

(0.24

)

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per share

 

31,581,465

 

30,641,476

 

 

SELECTED CONSOLIDATED BALANCE SHEET INFORMATION

(Unaudited)

 

 

 

March 31,
2005

 

December 31,
2004

 

 

 

(In thousands)

 

Cash and cash equivalents

 

$

23,076

 

$

6,978

 

Short term investments

 

26,405

 

50,163

 

Restricted cash

 

4,626

 

4,642

 

Working capital

 

38,181

 

46,832

 

Total assets

 

76,067

 

82,760

 

Stockholders’ equity

 

39,619

 

47,831

 

 

# # #

 


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