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:
- Completed dosing of the third cohort
(300mg) in the Phase 1b study of DX-2930 in October;
- Receipt of royalty revenue based on
sales of CYRAMZA® (ramucirumab), the first approved therapeutic
product from the LFRP;
- KALBITOR® net sales were $20.3 million,
a 22% increase over the second quarter 2014 net sales which were
$16.6 million; and
- 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.
Webcast and Conference Call
Date:
Tuesday, October 28, 2014
Time:
5:00 p.m. ET
Telephone Access:
Domestic callers, dial
877-674-2415; reference the Dyax conference call
International callers, dial
708-290-1364
No passcode required.
Online Access:
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.
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 -
DYAX CORP. SELECTED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30, 2014
2013 2014
2013 (In thousands, except share and per share
data) Revenues: Product sales, net $ 20,274 $ 10,772 $ 49,363 $
27,927 Development and license fees 1,035 2,919 5,648 9,140 Royalty
revenue 684 - 684 - Total revenues, net
$ 21,993 $ 13,691 $ 55,695 $ 37,067
Costs and expenses: Cost of product sales 1,393 720 3,153
1,991 Cost of royalty revenues 342 - 342 - Research and development
8,268 8,105 23,593 23,226 Selling, general and administrative
10,132 8,507 30,186 29,804 Total costs
and expenses 20,135 17,332
57,274 55,021 Income (loss) from
operations 1,858 (3,641 ) (1,579 ) (17,954 ) Other income
(expense): Interest and other income 81 199 192 206 Interest and
other expense (2,755 ) (2,746 ) (8,201 )
(8,065 ) Total other expense (2,674 ) (2,547 ) (8,009 )
(7,859 ) Net loss $ (816 ) $ (6,188 ) $ (9,588 ) $ (25,813 )
Basic and diluted net loss per share $ (0.01 ) $ (0.06 ) $
(0.07 ) $ (0.25 ) Shares used in computing basic and
diluted net loss per share 136,282,842
109,731,276 132,301,051 104,821,199
SELECTED CONSOLIDATED CONDENSED BALANCE SHEET
INFORMATION (Unaudited) September
30, December 31, 2014
2013 (In thousands)
Assets
Cash, cash equivalents and investments $ 187,877 $ 111,381
Accounts receivable, net 6,096 6,506 Inventory 7,329 8,362 Fixed
assets 4,709 4,960 Restricted cash 1,100 1,100 Other assets 4,725
1,898 Total assets $ 211,836 $ 134,207
Liabilities and
Stockholders' Equity
Accounts payable and other current liabilities $ 14,556 $
14,822 Deferred revenue 7,110 8,021 Note payable and other
long-term debt 82,003 81,979 Other long-term liabilities 3,045
3,063 Total liabilities 106,714
107,885 Common and preferred stock and additional
paid-in capital 648,547 560,282 Accumulated deficit and other
comprehensive income (543,425 ) (533,960 ) Total
stockholders' equity 105,122 26,322
Total liabilities and stockholders' equity $ 211,836
$ 134,207
Dyax Corp.Jennifer Robinson, 617-250-5741Director, Investor
Relationsand Corporate Communicationsjrobinson@dyax.com
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