Dyax Corp. Announces First Quarter 2013 Financial Results
BURLINGTON, Mass. -- April 25, 2013
Dyax Corp. (NASDAQ: DYAX) today announced financial results for the first
quarter ended March 31, 2013. The Company 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, the broader
angioedema portfolio and the Licensing and Funded Research Program (LFRP).
Highlights of the first quarter 2013 include:
*KALBITOR^® net sales were $8.6 million, an increase over first quarter
2012 sales of $8.0 million and a decline from fourth quarter 2012 sales of
*Investigational New Drug (IND) filing for DX-2930 remains on track for
mid-2013; and the
*LFRP product portfolio includes 13 revenue generating clinical candidates.
A recent announcement from Eli Lilly stated that it has initiated a
rolling Biologic License Application (BLA) for ramucirumab as monotherapy
treatment in second-line gastric cancer.
“The first quarter was challenging for our KALBITOR business, with several
factors affecting our sales,” stated Gustav Christensen, President and Chief
Executive Officer of Dyax. “These included a decrease in the number of new
patients added, a decrease in the number of treatments among existing
hereditary angioedema (HAE) patients and less KALBITOR purchased by our
distributors for the channel. In response, we are refocusing our sales efforts
and KALBITOR service and support programs to identify and better address the
needs of the HAE patients who are best served by having a healthcare
professional treat and monitor their HAE attacks.”
Mr. Christensen added: “Our Licensing and Funded Research portfolio continues
to be an important growth driver for Dyax. With a number of candidates in late
stage development, we expect to see multiple clinical and regulatory
milestones this year.”
2013 First Quarter Financial Results
Total revenues for the first quarter ended March 31, 2013 were $12.0 million,
as compared to $11.5 million for the comparable quarter in 2012. Included in
the 2013 revenues were $8.6 million of KALBITOR net sales, as compared to $8.0
million for 2012.
Quarterly and annual 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
Cost of product sales for KALBITOR for the first quarter of 2013 were
$708,000, as compared to $538,000 for the comparable quarter in 2012. Costs
incurred in manufacturing KALBITOR prior to its approval for sale in the
United States were expensed as research and development costs when incurred
and, accordingly, are not included in cost of product sales during the 2012
quarter. For the 2013 quarter, KALBITOR sales were comprised of a combination
of product manufactured both prior to and following FDA approval. Therefore,
cost of product sales during the 2013 quarter do not reflect the full KALBITOR
Research and development expenses for the first quarter of 2013 were $8.7
million, as compared to $7.9 million for the comparable quarter in 2012.
Research and development expenses primarily relate to the following
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 first quarter of 2013
increased to $11.1 million, as compared to $10.4 million for the comparable
quarter in 2012. The higher selling, general and administrative costs in 2013
were due to $1.1 million of stock compensation expense from the modification
of certain stock options.
For the quarter ended March 31, 2013, Dyax reported a net loss of $11.2
million or $0.11 per share, as compared to a net loss of $11.3 million or
$0.11 per share for the comparable quarter in 2012.
As of March 31, 2013, Dyax had cash, cash equivalents, and investments
totaling $22.1 million, exclusive of restricted cash.
Dyax has implemented a focused commercial strategy to drive its KALBITOR
business. Going forward the Company’s priorities will be to:
*Focus on New Patient Growth: To address new patient growth, Dyax has
focused on the HAE population that is best served by KALBITOR, coupled
with high-touch patient services. This includes patients who benefit from
receiving treatment by a healthcare professional. The Company is
optimizing its service model to best address this HAE patient group.
*Focus on High-Value, Branded Service Programs: Ensure that Dyax’s
first-class service and support programs are concentrated on HAE patient
recruitment and KALBITOR sales. The Dyax commercial team will continue to
focus on patient identification, and patient treatment and retreatment.
*Monitor the Distribution Channel: The Company will work with its
distributors to assess patient demand and monitor the amount of KALBITOR
supply held by distributors to better match supply with expected demand.
Dyax’s revised financial guidance for 2013:
*Top-line total revenue to be in the range of $53-58 million, including
*KALBITOR net sales in the range of $40-44 million.
Based upon its revised guidance, Dyax will not reach cash flow breakeven
during the latter part of 2013. The Company expects to manage operations with
a controlled level of operating cash burn that would approximate $5 million
for the second half of 2013.
Webcast and Conference Call
Date: Thursday, April 25, 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 May 1, 2013 and may
be accessed by dialing 855-859-2056. International callers should dial
404-537-3406. The replay passcode for all callers is 30306762. 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.
For additional information about Dyax, please visit www.dyax.com.
For additional information about KALBITOR, including full prescribing
information and boxed warning on serious hypersensitivity reactions, please
This press release contains forward-looking statements, including statements
regarding the prospects for the LFRP portfolio and our ability to address the
factors reducing KALBITOR sales in the first quarter of 2013, the success of
our commercial strategy, 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
(In thousands, except share and per share data)
Product sales, net $ 8,587 $ 8,010
Development and license $ 3,453 $ 3,479
Total revenues, net $ 12,040 $ 11,489
Costs and expenses:
Cost of product sales 708 538
Research and development 8,671 7,853
Selling, general and 11,124 10,405
Restructuring costs - 1,440
Total costs and expenses 20,503 20,236
Loss from operations (8,463 ) (8,747 )
Other income (expense):
Interest and other income 5 25
Interest and other (2,735 ) (2,560 )
Total other expense (2,730 ) (2,535 )
Net loss $ (11,193 ) $ (11,282 )
Basic and diluted net loss $ (0.11 ) $ (0.11 )
Shares used in computing
basic and diluted net loss 99,644,227 98,798,426
SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
March 31, December 31,
Cash, cash equivalents and short-term $ 22,111 $ 29,046
Accounts receivable, net 7,562 7,507
Inventory 8,958 9,989
Fixed assets 5,284 5,329
Restricted cash 1,100 1,100
Other assets 2,390 2,515
Total assets $ 47,405 $ 55,486
Liabilities and Stockholders' Deficit
Accounts payable and other current liabilities $ 12,030 $ 13,146
Deferred revenue 11,663 11,851
Note payable and other long-term debt 80,385 78,992
Other long-term liabilities 3,148 3,057
Total liabilities 107,226 107,046
Common stock and additional paid-in capital 457,555 454,620
Accumulated deficit and other comprehensive (517,376 ) (506,180 )
Total stockholders' equity (deficit) (59,821 ) (51,560 )
Total liabilities and stockholders' equity $ 47,405 $ 55,486
Jennifer Robinson, 617-250-5741
Associate Director, Investor Relations and Corporate Communications
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