-----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, LKPUwMS+ZK4Zo/3pdSJoQnImM1n2T/74N71/cP6m9NJW893QQSl14HVRavli+094 xPXwTC8P2cF4m/v0OE+bsA== 0001104659-06-048843.txt : 20060726 0001104659-06-048843.hdr.sgml : 20060726 20060726083708 ACCESSION NUMBER: 0001104659-06-048843 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060726 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060726 DATE AS OF CHANGE: 20060726 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: 06980395 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 a06-16748_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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 26, 2006

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 26, 2006, Dyax Corp. issued a press release announcing its financial results for the quarter ended June 30, 2006.  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.

(d)  Exhibits.

99.1      Press release of Dyax Corp. dated July 26, 2006 reporting Dyax’s financial results for the quarter ended June 30, 2006.

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 26, 2006

By:

/s/ Ivana Magovcevic-Liebisch

 

 

Ivana Magovcevic-Liebisch

 

 

Executive Vice President, Corporate Communications and General Counsel

 




 

EXHIBIT INDEX

Exhibit

 

 

No.

 

Description

99.1

 

Press release of Dyax Corp. dated July 26, 2006 reporting Dyax’s financial results for the quarter ended June 30, 2006.

 



EX-99.1 2 a06-16748_1ex99d1.htm EX-99

Exhibit 99.1

Contacts:

Ivana Magovčević-Liebisch
General Counsel and Executive Vice President,
Corporate Communications
(617) 250-5759
imagovcevic@dyax.com

Nicole P. Jones
Associate Director, Investor Relations and
Corporate Communications
(617) 250-5744
njones@dyax.com

Dyax Corp. Announces Second Quarter Financial Results

CAMBRIDGE, MA, July 26, 2006 — Dyax Corp. (Nasdaq: DYAX) today announced financial results for the second quarter ended June 30, 2006.  Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.

Financial Results:

For the quarter ended June 30, 2006, the Company reported a net loss of $8.7 million or $0.20 per share, as compared to a net loss of $7.9 million or $0.23 per share for the comparable quarter in 2005.  For the six months ended June 30, 2006, Dyax reported a net loss of $18.7 million or $0.45 per share, as compared to a net loss of $16.4 million or $0.50 per share for the comparable six month period in 2005.  On January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Accounting for Stock-Based Compensation”.  For the three and six months ended June 30, 2006, it recorded expenses for stock-based compensation of $516,000 and $1.0 million included in research and development and general and administrative expenses, respectively, in our Selected Consolidated Statements of Operations.

Revenues for the second quarter ended June 30, 2006 decreased to $3.4 million as compared to $6.7 million for the comparable quarter in 2005.  Revenues for the six months ended June 30, 2006 decreased to $6.1 million as compared to $10.4 million in the comparable six month period in 2005.  These decreases were primarily due to decreases in revenues associated with DX-890 product manufacturing for the collaboration with Debiopharm in 2006, the recognition of a fully paid patent license option fee during the six months ended June 30, 2005, and a decrease in funded research revenue under our existing and continuing relationships in 2006.  These decreases were partially




 

offset by the recognition in the 2006 periods of a milestone payment received from Debiopharm in December 2005.  The receipt and recognition of clinical milestone payments received from our collaborators and licensees may vary substantially from period-to-period due to the timing of their clinical activities and the applicable period for amortization of the payments.

Research and development expenses for the quarter decreased to $10.5 million as compared to $14.1 million for the comparable period in 2005.  For the sixth months ended June 30, 2006, research and development expenses decreased to $21.1 million as compared to $24.6 million for the comparable period in 2005.  The decrease in research and development expenses for the quarter was primarily a result of decreased manufacturing costs due to the timing of these activities associated with the development of DX-88 for HAE and decreased manufacturing costs associated with the restructuring of the DX-890 product collaboration with Debiopharm.

Under our amended agreement with Debiopharm, signed in December 2005, we are no longer responsible for manufacturing DX-890 for Debiopharm.  During 2006, we were reimbursed for the completion of the technology transfer to Debiopharm and our other DX-890 activities, which were completed in June 2006.  Going forward, we will not have any further revenue or expense associated with DX-890 product manufacturing for Debiopharm.

As of June 30, 2006, Dyax had a total of $63.0 million in cash, cash equivalents, and short-term investments, exclusive of restricted cash, a net increase of $12.3 million from December 31, 2005.  This increase resulted primarily from the $30.1 million in net cash proceeds from our underwritten common stock offering in March 2006, less our operating cash requirements for the six month period.  The main reason for raising these funds was to allow us to proceed with a Phase IIb trial in on-pump CABG surgery as well as move forward our other potential clinical leads.

Corporate Progress:

Henry E. Blair, Chairman and Chief Executive Officer of Dyax, remarked, “During the second quarter, we continued to make advancements in the Phase III (EDEMA3) placebo-controlled trial for our lead indication, DX-88 for HAE.  To date, we have treated approximately two-thirds of the 62 required patients.  The EDEMA3 trial remains on schedule for completion in the second half of 2006.”

With respect to the regulatory pathway for DX-88 in HAE, Mr. Blair explained, “Discussions with the FDA are still ongoing and a meeting has been scheduled for late summer, which should enable




 

us to clarify the requirements for the remaining clinical program as well as the overall plan for the BLA submission.  We will give further guidance with regard to a design of a study and new timelines for the program as soon as practical after the meeting.”

Mr. Blair continued, “Preparations for the Phase IIb 150-patient, placebo-controlled trial for DX-88 for on-pump CABG surgery are well underway.  We are finalizing the protocol and have scheduled an early Fall principal investigator meeting.  We anticipate opening sites by the end of the year.  In addition, our Discovery Research team continued to make progress with the fully human monoclonal antibody DX-2240, which offers a unique mechanism for inhibiting tumor growth and has displayed promising in vivo results when combined with other cancer therapies such as Avastin®.  We had a successful pre-IND meeting for DX-2240 and remain on track to initiate a clinical trial in 2007.”

2006 Guidance:

Regarding Dyax’s financial outlook for the year 2006, Stephen S. Galliker, Executive Vice President of Finance & Administration and Chief Financial Officer of 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 2008.  We do not anticipate our net cash consumption for the year to change and expect to use approximately $40 million in cash to support operations in 2006.”

Webcast and Conference Call

Dyax Corp. will host a webcast and conference call, including an open question and answer session to discuss second quarter 2006 financial results and company progress.

Date:

Wednesday, July 26, 2006

 

 

Time:

10:00 a.m. ET

 

 

Telephone Access:

Domestic callers, dial 866-362-4666

 

International callers, dial 617-597-5313

 

Passcode 32709501

 

 

Online Access:

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

 

A replay of the conference call will be available through August 26, 2006 and may be accessed by dialing 888-286-8010.  International callers should dial 617-801-6888.  The replay passcode for all callers is 38597336.  The webcast will be archived on the Dyax website for an indefinite period of time.




 

About Dyax

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

Dyax’s lead product candidate is DX-88, a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications.  In its joint venture with Genzyme Corporation, Dyax has successfully completed three Phase II trials of DX-88 for the treatment of hereditary angioedema (HAE).  A Phase III trial is ongoing.  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 planning a Phase IIb trial for further development of DX-88 in this indication.  DX-88 has orphan drug designation in the U.S. and E.U. for the treatment of angioedema.

Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets.  Dyax leverages this 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, please visit www.dyax.com.

Disclaimer

This press release contains forward-looking statements regarding Dyax Corp., including statements regarding its future cash resources, projected use of cash, antibody discovery technology, clinical trials of DX-88 and plans for clinical development of other compounds, and ongoing and future collaborations and licenses.  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 risks and uncertainties associated with:  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.  EDEMA3 is a service mark of Dyax Corp.

— financial tables follow —

# # #




 

DYAX CORP.
SELECTED CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

Product development and license fee revenues

 

$

3,424

 

$

6,693

 

$

6,098

 

$

10,400

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development(1)

 

10,503

 

14,064

 

21,095

 

24,626

 

less: Research and development expenses reimbursed by joint venture

 

(4,326

)

(6,054

)

(8,233

)

(10,082

)

Equity loss in joint venture

 

2,751

 

3,357

 

5,196

 

5,551

 

General and administrative(2)

 

3,666

 

3,393

 

7,520

 

6,830

 

Total operating expenses

 

12,594

 

14,760

 

25,578

 

26,925

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(9,170

)

(8,067

)

(19,480

)

(16,525

)

Other income (expense), net

 

512

 

142

 

825

 

153

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,658

)

$

(7,925

)

$

(18,655

)

$

(16,372

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.20

)

$

(0.23

)

$

(0.45

)

$

(0.50

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per share

 

43,578,939

 

34,167,525

 

41,354,940

 

32,881,639

 


(1)             Includes $286 and $572 of stock-based compensation expense for the three and six months ended June 30, 2006, respectively

(2)             Includes $230 and $449 of stock-based compensation expense for the three and six months ended June 30, 2006, respectively

SELECTED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2006

 

2005

 

 

 

(In thousands)

 

Cash and cash equivalents

 

$

14,071

 

$

8,640

 

Short-term investments

 

48,939

 

42,024

 

Restricted cash

 

4,377

 

4,408

 

Working capital

 

46,121

 

41,756

 

Total assets

 

85,750

 

75,917

 

Stockholders' equity

 

53,679

 

40,938

 

 



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