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): October 28, 2014
DYAX
CORP.
(Exact
Name of Registrant as Specified in Charter)
Delaware
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000-24537
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04-3053198
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(State or Other Jurisdiction of
Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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55 Network Drive Burlington, MA 01803
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(Address
of Principal Executive Offices) (Zip Code)
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(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:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 2.02.
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Results of Operations and Financial Condition.
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On
October 28, 2014, Dyax Corp. issued a press release announcing its
financial results for the quarter ended September 30, 2014. 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.
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Financial Statements and Exhibits.
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(d)
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Exhibits.
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99.1
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Press release of Dyax Corp. dated October 28, 2014 reporting
Dyax’s financial results for the quarter ended September 30, 2014.
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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.
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DYAX CORP.
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Dated:
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October 28, 2014
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By:
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/s/ Gustav Christensen
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Gustav Christensen
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Chief Executive Officer and President
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EXHIBIT INDEX
Exhibit No.
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Description
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99.1
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Press release of Dyax Corp. dated October 28, 2014 reporting
Dyax’s financial results for the quarter ended September 30, 2014.
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Exhibit 99.1
Dyax
Corp. Announces Third Quarter 2014 Financial Results
BURLINGTON, Mass.--(BUSINESS WIRE)--October 28, 2014--Dyax Corp.
(NASDAQ: DYAX) today announced financial results for the third quarter
ended September 30, 2014. Dyax will host a webcast and conference call
at 5:00 p.m. (ET) today to review financial results and provide updates
regarding its key value drivers –including the KALBITOR®
(ecallantide) business, DX-2930 and the Licensing and Funded Research
Portfolio (LFRP).
Highlights for the third quarter 2014 included:
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Completed dosing of the third cohort (300mg) in the Phase 1b study of
DX-2930 in October;
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Receipt of royalty revenue based on sales of CYRAMZA®
(ramucirumab), the first approved therapeutic product from the LFRP;
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KALBITOR® net sales were $20.3 million, a 22% increase
over the second quarter 2014 net sales which were $16.6 million; and
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Cash, cash equivalents and investments at September 30, 2014 totaled
$187.9 million.
"We have made tremendous progress this year and continue to build on the
positive momentum in our key areas,” said Gustav Christensen, President
and Chief Executive Officer of Dyax. “The KALBITOR business is
performing above our expectations and the DX-2930 program is progressing
through the clinic with Phase 1b results scheduled to report early next
year. Additionally, the LFRP is now generating royalty revenue as the
pipeline continues to mature and produce positive clinical developments.”
2014 Third Quarter Financial Results
Total revenues for the quarter ended September 30, 2014 were $22.0
million, as compared to $13.7 million for the comparable quarter in
2013. Included in 2014 revenues were $20.3 million of KALBITOR net
sales, as compared to $10.8 million for the same period in 2013. The
2014 third quarter revenues also included the initial royalties of
approximately $700,000 based on sales of CYRAMZA, the first approved
therapeutic product from the LFRP. For the nine months ended September
30, 2014, total revenues were $55.7 million, compared to $37.1 million
for the same period in 2013. The nine-month 2014 revenues included $49.4
million of KALBITOR net sales, as compared to $27.9 million in the 2013
period.
Dyax expects quarterly and annual revenues to fluctuate. For KALBITOR,
revenue fluctuations are primarily due to variability in the rate at
which patients utilize KALBITOR to treat attacks (particularly among
patients who experience and treat frequent attacks), as well as the
timing and amount of distributor demand. For the LFRP, revenue
fluctuations may be caused by the irregularity of future milestone
payments, the clinical activities of our licensees, and the timing and
completion of contractual commitments.
Cost of product sales for KALBITOR for the third quarter of 2014 were
$1.4 million, as compared to $720,000 for the same quarter in 2013. For
the nine months ended September 30, 2014, cost of product sales were
$3.2 million, as compared to $2.0 million for the same period in 2013.
Cost of royalties for the third quarter of 2014 was approximately
$300,000, consisting of pass-through fees under an LFRP cross-licensing
arrangement.
Research and development expenses for the third quarter of 2014 were
$8.3 million, as compared to $8.1 million for the same quarter in 2013.
For the nine months ended September 30, 2014, research and development
expenses were $23.6 million, as compared to $23.2 million for the same
period in 2013. Research and development expenses primarily relate to
the following Dyax initiatives: 1) development costs associated with
DX-2930, together with other research programs; 2) KALBITOR medical
support and post-marketing requirements; and 3) pass-through license
fees paid by Dyax licensees under the LFRP.
Selling, general and administrative expenses were $10.1 million for the
third quarter of 2014, as compared to $8.5 million for the same quarter
in 2013. For the nine months ended September 30, 2014, selling, general
and administrative costs were $30.2 million, as compared to $29.8
million for the same period in 2013.
For the quarter ended September 30, 2014, Dyax reported a net loss of
$816,000 or $0.01 per share attributable to common stockholders, as
compared to a net loss of $6.2 million or $0.06 per share for the same
quarter in 2013. For the nine months ended September 30, 2014, Dyax
reported a net loss of $9.6 million or $0.07 per share attributable to
common stockholders, as compared to a net loss of $25.8 million or $0.25
per share for the same period in 2013.
As of September 30, 2014, Dyax had cash, cash equivalents, and
investments totaling $187.9 million, exclusive of restricted cash.
Financial Guidance
With the performance of KALBITOR net sales during the first nine months
of 2014, the Company expects to surpass its previous 2014 top-line total
revenue guidance of $67 million. The Company intends to provide
financial guidance for 2015 in conjunction with its release of fourth
quarter and full year 2014 financial results.
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Webcast and Conference Call
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Date:
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Tuesday, October 28, 2014
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Time:
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5:00 p.m. ET
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Telephone Access:
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Domestic callers, dial 877-674-2415; reference the Dyax
conference call
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International callers, dial 708-290-1364
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No passcode required.
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Online Access:
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Go to the Investor Relations section of the Dyax website (http://investor.dyax.com/events.cfm)
and follow instructions for accessing the live webcast.
Participants may register in advance.
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A replay of the conference call will be available through November 24,
2014 and may be accessed by dialing 855-859-2056. International
callers should dial 404-537-3406. The replay passcode for all
callers is 13955843. The webcast will be archived on the Dyax
website for an indefinite period of time.
About Dyax
Dyax is a fully integrated biopharmaceutical company focused on the
discovery, development and commercialization of novel biotherapeutics
for unmet medical needs. The Company currently markets KALBITOR®
(ecallantide) for the treatment of acute attacks of hereditary
angioedema (HAE) in patients 12 years of age and older. Dyax is also
developing DX-2930, a fully human monoclonal antibody, for the potential
prophylactic treatment of HAE.
Both KALBITOR and DX-2930 were identified using Dyax's proprietary phage
display technology. Dyax has broadly licensed this technology and has a
portfolio of product candidates being developed by its licensees, which
it refers to as the LFRP. The Company is eligible to receive future
milestones and/or royalties dependent upon the development and
commercialization of these candidates. In 2014, Dyax’s licensee Eli
Lilly and Company began marketing their FDA approved product, CYRAMZA®
(ramucirumab), as a single-agent treatment for patients with advanced
gastric cancer after prior chemotherapy, making this the first
royalty-bearing therapeutic product from Dyax’s LFRP.
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full prescribing
information, please visit www.KALBITOR.com.
Disclaimer
This press release contains forward-looking statements, including
statements regarding the prospects for product candidates in the LFRP,
the prospects for and timing of the clinical development of DX-2930 and
financial guidance for 2014 revenue. Statements that are not historical
facts are based on Dyax’s current expectations, beliefs, assumptions,
estimates, forecasts and projections about the industry and markets in
which Dyax and its licensees compete. 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
involved in any future projections, as well as uncertainties associated
with various activities and aspects of Dyax’s business, including risks
and uncertainties associated with the following: competition from new
and existing treatments for HAE; uncertainty regarding KALBITOR’s market
share; uncertainty regarding treatment rates for patients on KALBITOR
and distributor channel inventory levels; uncertainty regarding the
clinical development and prospects for regulatory approval of DX-2930;
Dyax’s dependence on licensees and collaborators for development,
clinical trials, manufacturing, sales and distribution of product
candidates in the LFRP; uncertainties as to whether one or more product
candidates in the LFRP will achieve development and regulatory
milestones and be commercialized and generate royalties; uncertainties
regarding Lilly’s ability to successfully market CYRAMZA for the
treatment of advanced gastric cancer; Dyax’s dependence on the
expertise, effort, priorities and contractual obligations of third
parties in the manufacture of KALBITOR and DX-2930; uncertainties
regarding the development and any resulting marketing, sales and
distribution of KALBITOR outside of the United States; changing
requirements and costs associated with Dyax's planned research and
development activities; 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 Item 1A,
“Risk Factors” in Dyax’s most recent Annual Report on Form 10-K as
updated by its Quarterly Reports on Form 10-Q 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 obligations to update or revise
these statements, except as may be required by law.
Dyax, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.
CYRAMZA® is a registered trademark of Eli Lilly and
Company.
- financial tables follow -
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DYAX CORP.
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SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2014
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2013
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2014
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2013
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(In thousands, except share and per share data)
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Revenues:
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Product sales, net
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$
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20,274
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$
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10,772
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$
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49,363
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$
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27,927
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Development and license fees
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1,035
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2,919
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5,648
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9,140
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Royalty revenue
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684
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-
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684
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-
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Total revenues, net
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$
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21,993
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$
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13,691
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$
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55,695
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$
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37,067
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Costs and expenses:
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Cost of product sales
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1,393
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720
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3,153
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1,991
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Cost of royalty revenues
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342
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-
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342
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-
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Research and development
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8,268
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8,105
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23,593
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23,226
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Selling, general and administrative
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10,132
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8,507
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30,186
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29,804
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Total costs and expenses
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20,135
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17,332
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57,274
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55,021
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Income (loss) from operations
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1,858
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(3,641
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)
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(1,579
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)
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(17,954
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)
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Other income (expense):
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Interest and other income
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81
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199
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192
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206
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Interest and other expense
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(2,755
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)
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(2,746
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(8,201
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)
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(8,065
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Total other expense
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(2,674
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(2,547
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)
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(8,009
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(7,859
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)
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Net loss
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$
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(816
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$
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(6,188
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$
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(9,588
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$
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(25,813
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)
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Basic and diluted net loss per share
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$
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(0.01
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)
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$
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(0.06
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)
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$
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(0.07
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)
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$
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(0.25
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)
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Shares used in computing basic and diluted net loss per share
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136,282,842
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109,731,276
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132,301,051
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104,821,199
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SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
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(Unaudited)
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September 30,
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December 31,
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2014
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2013
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(In thousands)
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Assets
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Cash, cash equivalents and investments
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$
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187,877
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$
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111,381
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Accounts receivable, net
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6,096
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6,506
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Inventory
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7,329
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8,362
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Fixed assets
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4,709
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4,960
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Restricted cash
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1,100
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1,100
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Other assets
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4,725
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1,898
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Total assets
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$
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211,836
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$
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134,207
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Liabilities and Stockholders' Equity
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Accounts payable and other current liabilities
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$
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14,556
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$
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14,822
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Deferred revenue
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7,110
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8,021
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Note payable and other long-term debt
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82,003
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81,979
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Other long-term liabilities
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3,045
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3,063
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Total liabilities
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106,714
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107,885
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Common and preferred stock and additional paid-in capital
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648,547
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560,282
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Accumulated deficit and other comprehensive income
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(543,425
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)
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(533,960
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)
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Total stockholders' equity
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105,122
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26,322
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Total liabilities and stockholders' equity
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$
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211,836
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$
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134,207
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CONTACT:
Dyax Corp.
Jennifer Robinson, 617-250-5741
Director,
Investor Relations
and Corporate Communications
jrobinson@dyax.com
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