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, 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
July 29, 2014, Dyax Corp. issued a press release announcing its
financial results for the quarter ended June 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 July 29, 2014 reporting Dyax’s
financial results for the quarter ended June 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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July 29, 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 July 29, 2014 reporting Dyax’s
financial results for the quarter ended June 30, 2014.
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Exhibit 99.1
Dyax
Corp. Announces Second Quarter 2014 Financial Results
BURLINGTON, Mass.--(BUSINESS WIRE)--July 29, 2014--Dyax Corp. (NASDAQ:
DYAX) today announced financial results for the second quarter ended
June 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 – the hereditary angioedema (HAE) business, including
KALBITOR® (ecallantide), DX-2930, and the Licensing and
Funded Research Portfolio (LFRP).
Highlights for the second quarter 2014 included:
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Commenced dosing in the Phase 1b study of DX-2930 in HAE patients;
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Dyax licensee, Eli Lilly and Company (Lilly), began marketing CYRAMZA™
(ramucirumab) as a single agent treatment for patients with advanced
gastric cancer after prior chemotherapy;
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KALBITOR® net sales were $16.6 million, an increase
over the second quarter 2013 net sales which were $8.6 million;
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KALBITOR patient demand units (units sold by distributors to hospitals
or patients) increased by approximately 40% over the second quarter
2013; and
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Cash, cash equivalents and investments at June 30, 2014 totaled $187.7
million.
"We achieved a number of milestones in the second quarter, including
continued growth in the KALBITOR business,” said Gustav Christensen,
President and Chief Executive Officer of Dyax. “We also commenced dosing
in the Phase 1b study of DX-2930, our drug candidate for the prevention
of HAE attacks. We expect to report data from this study in early 2015.”
Mr. Christensen concluded, “Our licensee, Lilly, also launched CYRAMZA,
the first approved product from our LFRP. Dyax is eligible to receive a
net royalty of 2.5% on the first ten years of commercial sales. We
continue to execute on our goals and Dyax remains well-positioned for
future growth thanks to the diversity of our businesses.”
2014 Second Quarter Financial Results
Total revenues for the quarter ended June 30, 2014 were $19.6 million,
as compared to $11.3 million for the comparable quarter in 2013.
Included in 2014 revenues were $16.6 million of KALBITOR net sales, as
compared to $8.6 million for the same period in 2013. For the six months
ended June 30, 2014, total revenues were $33.7 million, compared to
$23.4 million for the same period in 2013. The six-month 2014 revenues
included $29.1 million of KALBITOR net sales, as compared to $17.2
million in the 2013 period.
Dyax expects quarterly and annual revenues to continue to fluctuate due
to the timing and amount of distributor demand and future milestone
payments, the clinical activities of collaborators and licensees, the
timing and completion of contractual commitments and the level of
KALBITOR utilization, which continues to vary significantly,
particularly in patients who experience and treat frequent HAE attacks.
Cost of product sales for KALBITOR for the second quarter of 2014 were
$975,000, as compared to $563,000 for the same quarter in 2013. For the
six months ended June 30, 2014, cost of product sales were $1.8 million,
as compared to $1.3 million for the same period in 2013. For the 2013
periods, KALBITOR sales were comprised of a combination of product
manufactured both prior to and following FDA approval. Accordingly, cost
of product sales during the 2013 periods do not reflect the full
KALBITOR manufacturing cost.
Research and development expenses for the second quarter of 2014 were
$8.5 million, as compared to $6.5 million for the same quarter in 2013.
For the six months ended June 30, 2014, research and development
expenses were $15.3 million, as compared to $15.1 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 $10.6 million for the
second quarter of 2014, as compared to $10.2 million for the same
quarter in 2013. For the six months ended June 30, 2014, selling,
general and administrative costs were $20.1 million, as compared to
$21.3 million for the same period in 2013. The higher selling, general
and administrative costs in the six months ended June 30, 2013 were
primarily due to $1.1 million of non-cash stock option expense from the
modification of certain stock options.
For the quarter ended June 30, 2014, Dyax reported a net loss of $3.1
million or $0.02 per share attributable to common stockholders, as
compared to a net loss of $8.4 million or $0.08 per share for the same
quarter in 2013. For the six months ended June 30, 2014, Dyax reported a
net loss of $8.8 million or $0.07 per share attributable to common
stockholders, as compared to a net loss of $19.6 million or $0.19 per
share for the same period in 2013.
As of June 30, 2014, Dyax had cash, cash equivalents, and investments
totaling $187.7 million, exclusive of restricted cash.
Financial Guidance
Dyax has revised its financial guidance for 2014:
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Top-line total revenue expected to be in the range of $61-66 million,
including KALBITOR net sales of $51–56 million.
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Revised guidance reflects the expectations that quarterly and
annual KALBITOR net sales will fluctuate due to the level of
KALBITOR utilization for individual patients. Utilization
continues to vary significantly based on fluctuations in the
number of HAE attacks and the consistency with which patients
treat their HAE attacks with KALBITOR.
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Total top-line revenue guidance excludes royalties from CYRAMZA
for which revenue is expected to be recognized, commencing with
the third quarter of 2014.
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Operating costs and expenses (cost of product sales, research and
development expenses, and selling, general and administrative costs)
are now expected to be in the range of $80-82 million.
Webcast and Conference Call
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Date:
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Tuesday, July 29, 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 (www.dyax.com)
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 August 25,
2014 and may be accessed by dialing 855-859-2056. International
callers should dial 404-537-3406. The replay passcode for all
callers is 65668940. 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®
for the treatment of acute attacks of hereditary angioedema (HAE) in
patients 12 years of age and older. Dyax is currently developing
DX-2930, a fully human monoclonal antibody inhibitor of plasma
kallikrein, as a subcutaneous injection for the prevention of HAE
attacks.
Both KALBITOR and DX-2930 were identified using Dyax's patented 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 Licensing and Funded Research Portfolio (LFRP). The
Company is eligible to receive future milestones and/or royalties
dependent upon the development and commercialization of these
candidates. In April 2014, Dyax’s licensee Eli Lilly received FDA
approval for CYRAMZA™ (ramucirumab) as a single-agent treatment for
patients with advanced gastric cancer after prior chemotherapy, making
this the first approved 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 timing and amount of royalties from CYRAMZA,
the prospects for product candidates in the LFRP, the prospects for
continued clinical development of DX-2930, and guidance for total
revenue, KALBITOR net sales and operating costs and expenses for 2014.
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.
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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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Six Months Ended
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June 30,
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June 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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16,582
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$
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8,568
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$
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29,089
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$
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17,155
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Development and license fees
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$
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3,003
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$
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2,768
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$
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4,613
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$
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6,221
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Total revenues, net
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$
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19,585
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$
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11,336
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$
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33,702
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$
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23,376
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Costs and expenses:
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Cost of product sales
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975
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563
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1,760
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1,271
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Research and development
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8,456
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6,450
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15,325
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15,121
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Selling, general and administrative
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10,565
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10,173
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20,054
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21,297
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Total costs and expenses
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19,996
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17,186
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37,139
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37,689
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Loss from operations
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(411
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)
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(5,850
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)
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(3,437
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)
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(14,313
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)
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Other income (expense):
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Interest and other income
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73
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4
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111
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9
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Interest and other expense
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(2,723
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)
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(2,586
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)
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(5,446
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)
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(5,321
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)
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Total other expense
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(2,650
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)
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(2,582
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)
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(5,335
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)
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(5,312
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)
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Net loss
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$
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(3,061
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)
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$
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(8,432
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)
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$
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(8,772
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)
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$
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(19,625
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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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(0.08
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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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(0.19
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)
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Shares used in computing basic and diluted net loss per share
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135,873,613
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104,977,247
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130,277,157
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102,325,469
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SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
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(Unaudited)
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June 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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187,699
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$
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111,381
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Accounts receivable, net
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5,243
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6,506
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Inventory
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7,815
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8,362
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Fixed assets
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4,677
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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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2,090
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1,898
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Total assets
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$
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208,624
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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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13,298
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$
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14,822
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Deferred revenue
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7,338
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8,021
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Note payable and other long-term debt
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82,051
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81,979
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Other long-term liabilities
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2,983
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|
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3,063
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Total liabilities
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105,670
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107,885
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Common and preferred stock and additional paid-in capital
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|
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645,596
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|
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560,282
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Accumulated deficit and other comprehensive income
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|
|
|
(542,642
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)
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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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102,954
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|
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26,322
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|
|
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|
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Total liabilities and stockholders' equity
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|
|
$
|
208,624
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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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