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 29, 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.
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Results of Operations and Financial Condition.
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On July 29, 2015, Dyax Corp. issued a press release announcing its
financial results for the quarter ended June 30, 2015. 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 July 29, 2015 reporting Dyax’s
financial results for the quarter ended June 30, 2015.
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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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July 29, 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 July 29, 2015 reporting Dyax’s
financial results for the quarter ended June 30, 2015.
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Exhibit 99.1
Dyax
Corp. Announces Second Quarter 2015 Financial Results
BURLINGTON, Mass.--(BUSINESS WIRE)--July 29, 2015--Dyax Corp. (NASDAQ:
DYAX) today announced financial results for the second quarter ended
June 30, 2015. Dyax will host a webcast and conference call at 5:00 p.m.
(ET) today to review financial results and provide updates on DX-2930,
KALBITOR® (ecallantide) and the Licensing and Funded
Research Portfolio (LFRP). The Company will also provide an introductory
overview of its internal development candidates.
Recent highlights include:
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Receipt of Breakthrough Therapy designation from the U.S. Food and
Drug Administration (FDA) for the investigation of DX-2930 for
hereditary angioedema (HAE);
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Total revenue for the second quarter of 2015 of $26.4 million,
including:
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KALBITOR net sales of $17.8 million and
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Royalty revenue of $4.4 million, as well as
-
Cash, cash equivalents and investments at June 30, 2015 totaled $394.2
million.
2015 Second Quarter Financial Results
Total revenues for the quarter ended June 30, 2015 were $26.4 million,
as compared to $19.6 million for the comparable quarter in 2014. The
second quarter 2015 revenues included $17.8 million of KALBITOR net
sales, as compared to $16.6 million for the same period in 2014, as well
as royalties of approximately $4.4 million based on sales of Eli Lilly
and Company’s CYRAMZA® (ramucirumab). For the six
months ended June 30, 2015, total revenues were $46.8 million, compared
to $33.7 million for the same period in 2014. The six-month 2015
revenues included $33.8 million of KALBITOR net sales, as compared to
$29.1 million in the 2014 period, as well as CYRAMZA royalties of
approximately $7.8 million. The third quarter of 2014 was the first
period in which we recorded royalty revenue.
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 second quarter of 2015 were
$1.4 million, as compared to $975,000 for the same quarter in 2014. For
the six months ended June 30, 2015, cost of product sales were $3.5
million, as compared to $1.8 million for the same period in 2014.
Cost of royalties for the second quarter of 2015 were $2.2 million,
consisting of pass-through fees under an LFRP cross-licensing
arrangement. For the six months ended June 30, 2015, cost of royalties
were $3.9 million.
Research and development expenses at Dyax are primarily related to the
following: 1) the DX-2930 development program, together with other
research programs; 2) KALBITOR medical support and post-marketing
requirements; and 3) pass-through license fees paid by Dyax under the
LFRP. Research and development expenses for the second quarter of 2015
were $14.5 million, as compared to $8.5 million for the same quarter in
2014. For the six months ended June 30, 2015, research and development
expenses were $24.8 million, as compared to $15.3 million for the same
period in 2014. The 2015 increases are primarily related to costs
associated with DX-2930 development.
Selling, general and administrative expenses were $14.2 million for the
second quarter of 2015, as compared to $10.6 million for the same
quarter in 2014. For the six months ended June 30, 2015, selling,
general and administrative costs were $25.2 million, as compared to
$20.1 million for the same period in 2014. The higher selling, general
and administrative costs in 2015 were due to increased charges for
non-cash stock compensation expense, as well as increased sales and
marketing costs supporting KALBITOR commercial efforts.
For the quarter ended June 30, 2015, Dyax reported a net loss of $8.4
million or $0.06 per share attributable to common stockholders, as
compared to a net loss of $3.1 million or $0.02 per share for the same
quarter in 2014. For the six months ended June 30, 2015, Dyax reported a
net loss of $15.7 million or $0.11 per share attributable to common
stockholders, as compared to a net loss of $8.8 million or $0.07 per
share for the same period in 2014.
As of June 30, 2015, Dyax had cash, cash equivalents, and investments
totaling $394.2 million, exclusive of restricted cash.
Financial Guidance
Dyax has reiterated its revenue guidance for 2015. Revenue guidance
includes two components:
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KALBITOR net sales in the range of $60-70 million.
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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.
The Company has revised its operating costs and expenses (cost of
product sales, research and development expenses, and selling, general
and administrative costs) which are expected to be in the range
of $120-125 million, an increase from its previous guidance of $105-110
million. This increase is due to costs associated with the acceleration
of the DX-2930 development program and non-cash stock compensation
charges.
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Webcast and Conference Call
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Date:
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Wednesday, July 29, 2015
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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. The webcast will be archived
on the Dyax website for an indefinite period of time.
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About Dyax
Dyax is a biopharmaceutical company focused on the development and
commercialization of novel biotherapeutics for unmet medical needs. The
Company is developing DX-2930, a fully human monoclonal antibody, for
the prevention of HAE attacks. In March 2015, the Company reported
positive safety, pharmacokinetic, biomarker and proof-of-concept
efficacy results from its Phase 1b clinical trial of DX-2930 in HAE
patients. DX-2930 has received Fast Track and Breakthrough Therapy
designations from the FDA. Additionally, Dyax markets KALBITOR®
(ecallantide) for the treatment of acute attacks of HAE in patients 12
years of age and older.
Both DX-2930 and KALBITOR 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 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 cash flow from KALBITOR and the
LFRP; and financial guidance for projected revenues, KALBITOR net sales
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: 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; Dyax's dependence on the expertise, effort,
priorities and contractual obligations of third parties in the
manufacture, quality control and storage of KALBITOR; Dyax's dependence
on the expertise, effort, priorities and contractual obligations of
licensees and collaborators for development, clinical trials,
manufacturing, sales and distribution of product candidates in the LFRP;
uncertainties as to whether and when new product candidates in the LFRP
will achieve development and regulatory milestones and be commercialized
and generate royalties; 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 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 trademark owned by or licensed to Eli Lilly and Company,
its subsidiaries, or affiliates.
- financial tables follow -
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DYAX CORP. SELECTED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2015
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2014
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2015
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2014
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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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17,760
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$
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16,582
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$
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33,773
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$
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29,089
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Development and license fees
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4,228
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3,003
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5,260
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4,613
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Royalty revenue
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4,385
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-
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7,758
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-
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Total revenues, net
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$
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26,373
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$
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19,585
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$
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46,791
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$
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33,702
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Costs and expenses:
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Cost of product sales
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1,423
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975
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3,519
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1,760
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Cost of royalty revenues
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2,192
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-
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3,879
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-
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Research and development
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14,510
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8,456
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24,752
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15,325
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Selling, general and administrative
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14,153
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10,565
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25,194
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20,054
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Total costs and expenses
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32,278
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19,996
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57,344
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37,139
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Loss from operations
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(5,905
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)
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(411
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)
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(10,553
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)
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(3,437
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)
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Other income (expense):
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Interest and other income
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203
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73
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291
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111
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Interest and other expense
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(2,709
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)
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(2,723
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)
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(5,420
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)
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(5,446
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)
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Total other expense
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(2,506
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)
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(2,650
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)
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(5,129
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)
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(5,335
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)
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Net loss
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$
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(8,411
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)
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$
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(3,061
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)
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$
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(15,682
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)
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$
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(8,772
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)
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Basic and diluted net loss per share
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$
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(0.06
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)
|
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$
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(0.02
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)
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$
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(0.11
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)
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$
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(0.07
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)
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Shares used in computing basic and diluted net loss per share
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144,703,202
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135,873,613
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140,791,906
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130,277,157
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SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION (Unaudited)
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June 30,
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December 31,
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2015
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2014
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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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$
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394,157
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$
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184,652
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Accounts receivable, net
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10,938
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|
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12,221
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Inventory
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11,352
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7,228
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Fixed assets
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5,158
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|
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4,631
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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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5,035
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7,301
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Total assets
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$
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427,740
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$
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217,133
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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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18,207
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|
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$
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18,532
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Deferred revenue
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7,398
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7,574
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Note payable and other long-term debt
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82,111
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|
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82,165
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Other long-term liabilities
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2,863
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|
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|
|
3,059
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|
|
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|
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Total liabilities
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|
|
|
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|
110,579
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|
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111,330
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|
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Common and preferred stock and additional paid-in capital
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|
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|
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878,660
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651,616
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Accumulated deficit and other comprehensive income
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|
|
|
|
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(561,499
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)
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|
|
|
(545,813
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)
|
|
|
|
|
|
|
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Total stockholders' equity
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|
|
|
|
|
317,161
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|
|
|
|
105,803
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|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
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|
|
|
|
$
|
427,740
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|
|
|
$
|
217,133
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|
|
|
|
|
|
|
|
|
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|
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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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