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): February 24, 2015
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. Results of
Operations and Financial Condition.
On February 24, 2015, Dyax Corp. issued a press release announcing its
financial results for the fourth quarter and year ended December 31,
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. Financial
Statements and Exhibits.
(d) Exhibits.
99.1 Press release of Dyax Corp. dated February 24, 2015
reporting Dyax’s financial results for the fourth quarter and year ended
December 31, 2014.
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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February 24, 2015
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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 February 24, 2015 reporting
Dyax’s financial results for the fourth quarter and year ended
December 31, 2014.
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Exhibit 99.1
Dyax
Corp. Announces Fourth Quarter and Full Year 2014 Financial Results
BURLINGTON, Mass.--(BUSINESS WIRE)--February 24, 2015--Dyax Corp.
(NASDAQ: DYAX) today announced financial results for the fourth quarter
and year ended December 31, 2014. Dyax will host a webcast and
conference call at 8:30 a.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).
Recent highlights include:
-
Completion of dosing in the expanded Phase 1b study of DX-2930 in
hereditary angioedema (HAE) patients;
-
KALBITOR net sales were $18.9 million for the fourth quarter of 2014
and $68.3 million for the full year;
-
Commencement in 2014 of royalty revenue based on sales of Eli Lilly
and Company’s CYRAMZA® (ramucirumab), the first
approved therapeutic product from the LFRP; and
-
Cash, cash equivalents and investments at December 31, 2014 totaled
$184.7 million.
“In 2014, Dyax made significant progress across all our business areas,”
said Gustav Christensen, President and Chief Executive Officer of Dyax.
“We completed dosing in the Phase 1b study of DX-2930 in HAE patients
and expect to report results in April. We saw growth in KALBITOR sales
in 2014 along with continued profitability in the KALBITOR business. We
also began receiving royalty revenues from the first marketed LFRP
product, Lilly’s CYRAMZA®. As we look ahead, we
are planning to initiate the Phase 2 trial of DX-2930 in the second half
of 2015, and we are expecting a number of other milestone events from
the LFRP.”
2014 Fourth Quarter and Full Year Financial Results
Total revenues for the fourth quarter ended December 31, 2014 were $26.0
million, as compared to $16.9 million for the comparable quarter in
2013. These include KALBITOR net sales of $18.9 million and $12.6
million for the fourth quarter of 2014 and 2013, respectively. Fourth
quarter 2014 KALBITOR net sales represent primarily patient demand units
(units sold by distributors to hospitals or patients), as well as
approximately $1.1 million of sales into the distributor channel. The
2014 fourth quarter revenues also included royalties of approximately
$3.1 million based on sales of CYRAMZA, the first approved therapeutic
product from the LFRP.
Total revenues for the twelve months ended December 31, 2014 were $81.7
million, including $68.3 million of KALBITOR net sales, as compared to
$53.9 million for the comparable period in 2013, which included $40.5
million of KALBITOR net sales. The 2014 revenues also included royalties
of approximately $3.8 million based on the initial sales of CYRAMZA.
Dyax expects quarterly and annual revenues to fluctuate. For KALBITOR,
revenue fluctuations are primarily due to variability in the rate at
which individual 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 timing of any 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 fourth quarter of 2014
were $1.6 million, as compared to $700,000 for the same quarter in 2013.
For the twelve months ended December 31, 2014, cost of product sales
were $4.7 million, as compared to $2.7 million for the same period in
2013. Cost of royalties for the three and twelve months ended December
31, 2014 were $1.5 million and $1.9 million, respectively, consisting of
pass-through fees under an LFRP cross-licensing arrangement.
Research and development expenses at Dyax are primarily related to the
following research and development initiatives: 1) development costs
associated with DX-2930, a fully human monoclonal antibody inhibitor of
plasma kallikrein, 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. Research and
development expenses for the fourth quarter of 2014 were $12.3 million,
as compared to $6.5 million for the comparable quarter in 2013. The 2014
increase is primarily related to costs associated with DX-2930
development, as well as pass-through license fees paid by Dyax licensees
under the LFRP. For the twelve months ended December 31, 2014, research
and development expenses were $35.9 million, as compared to $29.7
million for the same period in 2013.
Selling, general and administrative expenses were $10.2 million for the
fourth quarter of 2014, as compared to $8.9 million for the comparable
quarter in 2013. For the twelve months ended December 31, 2014, selling,
general and administrative costs were $40.4 million, as compared to
$38.7 million for the same period in 2013.
For the quarter ended December 31, 2014, Dyax reported a net loss of
$2.3 million, or $0.02 per share attributable to common stockholders, as
compared to a net loss of $2.0 million, or $0.02 per share, for the
comparable quarter in 2013. For the twelve months ended December 31,
2014, Dyax reported a net loss of $11.9 million, or $0.09 per share
attributable to common stockholders, as compared to a net loss of $27.8
million, or $0.26 per share, for the comparable period in 2013.
As of December 31, 2014, Dyax had cash, cash equivalents, and
investments totaling $184.7 million, exclusive of restricted cash.
Financial Guidance for 2015
-
Revenue guidance includes two components:
-
KALBITOR net sales in the range of $60-70 million, reflecting the
Company’s expectation that quarterly and annual KALBITOR net sales
will fluctuate due to continued volatility in the level of
KALBITOR utilization for individual patients. This volatility in
utilization rates is due to fluctuations in the number of HAE
attacks experienced by patients and the consistency with which
patients treat their HAE attacks with KALBITOR.
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Development and license fees in the range of $7-9 million. These
fees exclude all potential royalties which would be earned from
licensees’ sales of LFRP product.
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Operating costs and expenses (cost of product sales, research and
development expenses, and selling, general and administrative costs)
to be in the range of $105-110 million.
Webcast and Conference Call
Date:
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Tuesday, February 24, 2015
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Time:
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8:30 a.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 March 23, 2015
and may be accessed by dialing (855) 859-2056. International
callers should dial (404) 537-3406. The replay passcode for all
callers is 72013650. 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
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 under its
Licensing and Funded Research Portfolio (LFRP). The current portfolio
includes one FDA approved product, Eli Lilly and Company’s CYRAMZA®
(ramucirumab), for which Dyax receives royalties, and multiple product
candidates in various stages of clinical development for which the
Company is eligible to receive future milestones and/or royalties.
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
and the likelihood that we will become eligible to receive additional
milestone and royalty payments under the LFRP; the prospects for and
timing of the clinical development of DX-2930, including the expected
timing of results in the Phase 1b study and initiation of the Phase 2
study; and financial guidance for projected KALBITOR net sales,
development and license fees and operating costs and expenses for 2015.
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 the
timing and outcome of the clinical trial regulatory approval process;
uncertainty regarding treatment rates for patients on KALBITOR and
distributor channel inventory levels; 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 of new product candidates in the LFRP will be
commercialized and generate royalties; Dyax’s dependence on the
expertise, effort, priorities and contractual obligations of third
parties in the manufacture of KALBITOR worldwide and in 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 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.
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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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Twelve Months Ended
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December 31,
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December 31,
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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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18,909
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$
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12,599
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$
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68,272
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$
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40,526
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Development and license fees
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4,021
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4,260
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9,669
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$
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13,400
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Royalty revenue
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3,098
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-
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3,782
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-
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Total revenues, net
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$
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26,028
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$
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16,859
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$
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81,723
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$
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53,926
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Costs and expenses:
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Cost of product sales
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1,553
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697
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4,706
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2,688
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Cost of royalty revenues
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1,549
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-
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1,891
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-
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Research and development
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12,349
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6,469
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35,942
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29,695
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Selling, general and administrative
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10,233
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8,938
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40,419
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38,742
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Total costs and expenses
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25,684
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16,104
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82,958
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71,125
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Income (loss) from operations
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344
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755
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(1,235
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)
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(17,199
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)
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Other income (expense):
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Interest and other income
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82
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8
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274
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214
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Interest and other expense
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(2,716
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)
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(2,727
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)
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(10,917
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)
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(10,792
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)
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Total other expense
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(2,634
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)
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(2,719
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)
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(10,643
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)
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(10,578
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)
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Net loss
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$
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(2,290
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)
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$
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(1,964
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)
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$
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(11,878
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)
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$
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(27,777
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)
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Basic and diluted net loss per share
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$
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(0.02
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)
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|
|
$
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(0.02
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)
|
|
|
|
$
|
(0.09
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)
|
|
|
|
$
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(0.26
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)
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|
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|
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|
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Shares used in computing basic and diluted net loss per share
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136,533,907
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119,573,601
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133,367,963
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|
|
|
|
|
108,539,613
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SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
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(Unaudited)
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|
December 31,
|
|
|
|
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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$
|
184,652
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|
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|
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$
|
111,381
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Accounts receivable, net
|
|
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|
12,221
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|
|
|
|
|
6,506
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Inventory
|
|
|
|
7,228
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|
|
|
|
|
8,362
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Fixed assets
|
|
|
|
4,631
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|
|
|
|
|
4,960
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Restricted cash
|
|
|
|
1,100
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|
|
|
|
|
1,100
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Other assets
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|
|
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7,301
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|
|
|
|
|
1,898
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|
|
|
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|
|
|
Total assets
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|
$
|
217,133
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|
|
|
$
|
134,207
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|
|
|
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|
|
|
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Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and other current liabilities
|
|
|
$
|
18,532
|
|
|
|
|
$
|
14,822
|
|
Deferred revenue
|
|
|
|
7,575
|
|
|
|
|
|
8,021
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|
Note payable and other long-term debt
|
|
|
|
82,165
|
|
|
|
|
|
81,979
|
|
Other long-term liabilities
|
|
|
|
3,058
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|
|
|
|
|
3,063
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|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
111,330
|
|
|
|
|
|
107,885
|
|
|
|
|
|
|
|
|
|
Common and preferred stock and additional paid-in capital
|
|
|
|
651,616
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|
|
|
|
|
560,282
|
|
Accumulated deficit and other comprehensive income
|
|
|
|
(545,813
|
)
|
|
|
|
|
(533,960
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)
|
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
|
105,803
|
|
|
|
|
|
26,322
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
|
|
$
|
217,133
|
|
|
|
|
$
|
134,207
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CONTACT:
Dyax Corp.
Mary Jenkins, 617-250-5543
Senior
Specialist, Investor Relations
and Corporate Communications
mjenkins@dyax.com
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