Dyax Corp. Announces Fourth Quarter and Full Year 2012 Financial Results
BURLINGTON, Mass. -- February 13, 2013
Dyax Corp. (NASDAQ: DYAX) today announced financial results for the fourth
quarter and year ended December 31, 2012. Dyax will host a webcast and
conference call at 5:00 p.m. (ET) today to review financial results and
updates regarding its key value drivers - the KALBITOR^® (ecallantide)
business and angioedema portfolio, as well as the Licensing and Funded
Research Program (LFRP).
Highlights of 2012 include:
*KALBITOR^® fourth quarter 2012 net sales increased to $11.8 million, a
9.3% increase over the third quarter;
*KALBITOR net sales increased 74% to $39.8 million for the year,
contributing to total revenues of $54.7 million for 2012;
*LFRP portfolio now includes 13 royalty and/or milestone eligible clinical
candidates, of which three are in Phase 3 and four are in Phase 2 clinical
*Cash, cash equivalents and investments at December 31, 2012 totaled $29
“2012 was another strong year for the KALBITOR business with sales reaching
$39.8 million,” stated Gustav Christensen, President and Chief Executive
Officer of Dyax. “It was also an important year for our Licensing and Funded
Research Program (LFRP), which demonstrated its potential for value creation
following the release of positive Phase 3 data from one of our collaborator’s
drug candidates. In the year ahead, the robust LFRP pipeline will continue to
mature, with multiple data read-outs expected throughout 2013.”
Mr. Christensen added: “Dyax is translating its years of know-how and
expertise, both in the angioedema field and antibody discovery, to advance its
strategy for creating meaningful value for our shareholders. We look forward
to a productive 2013.”
2012 Fourth Quarter and Full Year Financial Results
Total revenues for the fourth quarter ended December 31, 2012 were $16.0
million, as compared to $8.5 million for the comparable quarter in 2011.
Fourth quarter 2012 revenues included $11.8 million of KALBITOR net sales, as
compared to $7.0 million for 2011.
Revenues for the year ended December 31, 2012 were $54.7 million, as compared
to $48.7 million in 2011. Included in the 2012 revenues were $39.8 million of
KALBITOR net sales, as compared to $22.9 million for 2011. The 2011 revenues
also included $10.5 million of development and license fee revenue associated
with the expansion of our ex-U.S collaborations for ecallantide.
Quarterly and annual development and license fee revenues are expected to
continue to fluctuate due to the timing and amount of future milestone
payments, the clinical activities of collaborators and licensees, and the
timing and completion of contractual commitments.
Cost of product sales for KALBITOR for the fourth quarter of 2012 were
$705,000, as compared to $442,000 for the comparable quarter in 2011. For the
year ended December 31, 2012, cost of product sales were $2.2 million as
compared to $1.2 million for the comparable period in 2011. Costs associated
with manufacturing KALBITOR drug substance for these sales, which were
incurred prior to KALBITOR's approval in the United States, were expensed as
research and development costs and, accordingly, are not included in the cost
of product sales during the 2012 and 2011 periods reported.
Research and development expenses for the fourth quarter of 2012 were $7.4
million, as compared to $8.4 million for the comparable quarter in 2011. For
the year ended December 31, 2012, research and development expenses decreased
to $30.0 million, as compared to $34.7 million for the comparable period in
The 2012 fourth quarter and year reflect reduced expenses due to lower
clinical trial and personnel costs, as well as a reduction in pass-through
license fees paid by Dyax licensees under the LFRP.
Research and development expenses primarily relate to the following Dyax
research and development initiatives: 1) KALBITOR medical support and
post-marketing requirements; 2) development of a single-injection formulation
of KALBITOR; 3) development costs associated with DX-2930, a fully human
monoclonal antibody inhibitor of plasma kallikrein; and 4) pass-through
license fees paid by Dyax licensees under the LFRP.
Selling, general and administrative expenses for the fourth quarter of 2012
decreased to $10.0 million, as compared to $10.6 million for the comparable
quarter in 2011. For the year ended December 31, 2012, selling, general and
administrative costs increased to $39.9 million, as compared to $37.7 million
for the comparable period in 2011. The higher selling, general and
administrative costs for the year 2012 were primarily due to expanded
infrastructure to support KALBITOR commercial efforts.
For the quarter ended December 31, 2012, Dyax reported a net loss of $4.8
million or $0.05 per share, as compared to a net loss of $13.5 million or
$0.14 per share for the comparable quarter in 2011. For the year ended
December 31, 2012, the net loss was $29.3 million or $0.30 per share, as
compared to $34.6 million or $0.35 per share for the comparable period in
As of December 31, 2012, Dyax had cash, cash equivalents, and investments
totaling $29.0 million, exclusive of restricted cash.
Dyax’s financial guidance for 2013:
*2013 top-line total revenue to be in the range of $65-70 million, and
*Includes KALBITOR net sales in the range of $52-56 million.
*Cash flow breakeven during the latter part of 2013.
*When Dyax reaches cash flow breakeven, it will continue disciplined
management of operations around the breakeven point. The Company does
not expect this to result in positive earnings in 2014. Dyax will
invest in plasma kallikrein focused development, either alone or,
where appropriate, through partnerships.
Webcast and Conference Call
Date: Wednesday, February 13, 2013
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.
Go to the Investor Relations section of the
Online Access: Dyax website (www.dyax.com) and follow
instructions for accessing the live webcast.
Participants may register in advance.
A replay of the conference call will be available through February 20, 2013
and may be accessed by dialing 855-859-2056. International callers should
dial 404-537-3406. The replay passcode for all callers is 34848675. The
webcast will be archived on the Dyax website for an indefinite period of time.
Dyax is a fully integrated biopharmaceutical company focused on the discovery,
development and commercialization of novel biotherapeutics for unmet medical
needs. The Company’s key value drivers are the KALBITOR^® (ecallantide)
business and the angioedema portfolio, as well as the Licensing and Funded
Research Program (LFRP).
Dyax developed KALBITOR on its own and, since February 2010, has been selling
it in the United States for the treatment of acute attacks of hereditary
angioedema (HAE) in patients 16 years of age and older. Outside the United
States, the Company has established partnerships to obtain regulatory approval
for and commercialization of KALBITOR in certain markets and is evaluating
opportunities in others.
The Company is currently developing products to expand its angioedema
portfolio, including a suite of diagnostic assays to identify
plasma-kallikrein-(bradykinin)-mediated (PKM) angioedemas and a therapeutic
candidate, DX-2930, for the prophylactic treatment of HAE and PKM angioedemas.
KALBITOR and DX-2930 were identified using Dyax’s patented phage display
technology, which rapidly selects compounds that bind with high affinity and
specificity to therapeutic targets. Dyax leverages this technology broadly
through the LFRP. This program has provided the Company a portfolio of product
candidates being developed by its licensees, which currently includes13
royalty and/or milestone eligible product candidates in various stages of
clinical development, including three in Phase 3 trials.
Dyax is headquartered in Burlington, Massachusetts. For additional information
about Dyax, please visit www.dyax.com.
About KALBITOR (ecallantide)
KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute
attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
KALBITOR, which was discovered and developed by Dyax, is the first
subcutaneous treatment available in the U.S. for treating acute HAE attacks.
Important KALBITOR Safety Information
Anaphylaxis has been reported after administration of KALBITOR. Because of the
risk of anaphylaxis, KALBITOR should only be administered by a healthcare
professional with appropriate medical support to manage anaphylaxis and
hereditary angioedema. Healthcare professionals should be aware of the
similarity of symptoms between hypersensitivity reactions and hereditary
angioedema and patients should be monitored closely. KALBITOR should not be
administered to patients with known clinical hypersensitivity to KALBITOR.
For more information about KALBITOR, including full prescribing information,
Hereditary angioedema (HAE) is a rare acute inflammatory condition
characterized by episodes of severe, often painful swelling affecting the
extremities, gastrointestinal tract, genitalia, and larynx. HAE is caused by
low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally
occurring molecule that inhibits plasma kallikrein, a key mediator of
inflammation, and other serine proteases in the blood. HAE is estimated to
affect 1 in 10,000 to 1 in 50,000 individuals. Learn more at www.HAEHope.com.
This press release contains forward-looking statements, including statements
regarding the prospects for the LFRP portfolio and increases in KALBITOR
sales, prospects for KALBITOR and DX-2930 to treat a broader range of
angioedemas, and projected KALBITOR sales and revenues for 2013. 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 whether KALBITOR will gain broad market acceptance;
uncertainty regarding treatment rates for patients on KALBITOR; 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; Dyax’s dependence on licensees and collaborators for
development, clinical trials, manufacturing, sales and distribution of LFRP
and other licensed products; the uncertainty of negotiations with potential
partners and collaborators; uncertainties as to whether one or more of Dyax’s
licensees’ new product candidates will 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 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.
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Twelve Months Ended
December 31, December 31,
2012 2011 2012 2011
(In thousands, except share and per share data)
Product sales, $ 11,795 $ 6,996 $ 39,783 $ 22,884
and license $ 4,235 $ 1,520 $ 14,867 $ 25,853
Total $ 16,030 $ 8,516 $ 54,650 $ 48,737
Cost of 705 442 2,152 1,223
development 7,364 8,438 30,028 34,676
general and 10,043 10,620 39,915 37,740
Restructuring - - 1,440 -
Total costs 18,112 19,500 73,535 73,639
Loss from (2,082 ) (10,984 ) (18,885 ) (24,902 )
Interest and 92 28 111 554
Interest and (2,844 ) (2,579 ) (10,491 ) (10,251 )
Total other (2,752 ) (2,551 ) (10,380 ) (9,697 )
Net loss $ (4,834 ) $ (13,535 ) $ (29,265 ) $ (34,599 )
diluted net $ (0.05 ) $ (0.14 ) $ (0.30 ) $ (0.35 )
loss per share
Shares used in
basic and 99,271,225 98,764,384 98,991,056 98,731,289
loss per share
SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
December 31, December 31,
Cash, cash equivalents and short-term $ 29,046 $ 57,504
Accounts receivable, net 7,507 6,092
Inventory 9,989 7,022
Fixed assets 5,329 4,881
Restricted cash 1,100 2,366
Other assets 2,515 5,510
Total assets $ 55,486 $ 83,375
Liabilities and Stockholders' Equity
Accounts payable and other current $ 13,146 $ 17,128
Deferred revenue 11,851 15,902
Note payable and other long-term debt 78,992 75,372
Other long-term liabilities 3,057 2,372
Total liabilities 107,046 110,774
Common stock and additional paid-in 454,620 449,515
Accumulated deficit and other (506,180 ) (476,914 )
Total stockholders' equity (deficit) (51,560 ) (27,399 )
Total liabilities and stockholders' equity $ 55,486 $ 83,375
Jennifer Robinson, 617-250-5741
Associate Director, Investor Relations and Corporate Communications
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