Dyax Corp. Announces Third Quarter 2012 Financial Results
BURLINGTON, Mass.--(BUSINESS WIRE)--
Dyax Corp. (NASDAQ: DYAX) today announced financial results for the
third quarter ended September 30, 2012. 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 KALBITOR®
(ecallantide) business and angioedema portfolio, as well as the
Licensing and Funded Research Program (LFRP).
Highlights of the third quarter 2012 include:
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KALBITOR net sales increased to $10.8 million, an 18% increase over
second quarter 2012;
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596 patients have treated with KALBITOR, up 15% from the previous
quarter;
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Operating cash burn in the third quarter was reduced to $5 million; and
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Cash, cash equivalents and investments at September 30, 2012 totaled
approximately $30.4 million.
"The continued growth of KALBITOR sales demonstrates the importance of
this novel therapy to the hereditary angioedema community and the value
of our innovative and comprehensive patient service and support
programs," stated Gustav Christensen, President and Chief Executive
Officer of Dyax. "Further, our experience in the HAE market gives us the
insight with which to build a next generation of products and services
that may allow us to treat and support a broader set of angioedemas. In
addition, the Licensing and Funded Research Program (LFRP) continues to
be a key driver for Dyax due to the LFRP's broad and maturing pipeline
of clinical candidates that potentially address large, high-value
therapeutic markets."
2012 Third Quarter Financial Results
Total revenues for the third quarter ended September 30, 2012 were $13.1
million, as compared to $10.1 million for the comparable quarter in
2011. Included in the 2012 revenues were $10.8 million of KALBITOR net
sales, as compared to $6.6 million for 2011. Total revenues for the nine
months ended September 30, 2012 were $38.6 million compared to $40.2
million for the comparable period in 2011, and included KALBITOR net
sales of $28.0 million and $15.9 million in 2012 and 2011, respectively.
The 2011 nine month revenues included $12.2 million in one-time revenue
under our collaboration with Sigma-Tau.
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 commitments.
Cost of product sales for KALBITOR for the third quarter of 2012 were
$493,000, as compared to $260,000 for the comparable quarter in 2011.
For the nine months ended September 30, 2012, cost of product sales were
$1.4 million, as compared to $781,000 for the comparable period in 2011.
Costs associated with manufacturing KALBITOR drug substance, 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.
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.
Research and development expenses for the third quarter of 2012 were
$6.2 million, as compared to $8.7 million for the comparable quarter in
2011. For the nine months ended September 30, 2012, research and
development expenses were $22.7 million, as compared to $26.2 million
for the same period in 2011. The lower research and development expenses
during the third quarter of 2012 were primarily related to lower
clinical trial costs. In addition, the third quarter and nine months of
2012 reflect an expense decline due to lower personnel costs after the
February 2012 re-alignment around the angioedema and LFRP franchises,
and a reduction in pass-through license fees paid by Dyax licensees
under the LFRP.
Selling, general and administrative expenses for the third quarter of
2012 were $9.1 million, as compared to $8.8 million for the comparable
quarter in 2011. For the nine months ended September 30, 2012, selling,
general and administrative costs were $29.9 million, as compared to
$27.1 million for the same period in 2011. The higher selling, general
and administrative costs in 2012 were primarily due to expanded
infrastructure to support KALBITOR commercial efforts.
For the quarter ended September 30, 2012, Dyax reported a net loss of
$5.2 million or $0.05 per share, as compared to a net loss of $9.7
million or $0.10 per share for the comparable quarter in 2011. For the
nine months ended September 30, 2012, Dyax reported a net loss of $24.4
million or $0.25 per share, as compared to a net loss of $21.1 million
or $0.21 per share for the comparable period in 2011.
As of September 30, 2012, Dyax had cash, cash equivalents, and
investments totaling $30.4 million, exclusive of restricted cash.
Financial Guidance
Dyax has re-affirmed its financial guidance for 2012 and beyond:
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2012 top-line total revenue to be in the range of $50 - 54 million.
This guidance includes KALBITOR sales of $36-40 million, which are
expected to be at the upper end of this range.
-
Cash flow break-even during 2013.
This guidance excludes revenue and cash flow from potential new licenses
or collaborations and any ex-U.S. KALBITOR sales.
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Webcast and Conference Call
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Date:
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Wednesday, October 24, 2012
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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 November 1,
2012 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.
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'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, the Company
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 diagnostic strategy to identify plasma kallikrein
(bradykinin) mediated (PKM) angioedema and a therapeutic candidate,
DX-2930, for the prophylactic treatment of PKM angioedema.
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 includes 11 royalty and/or milestone bearing 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, visit www.KALBITOR.com.
About HAE
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.
Disclaimer
This press release contains forward-looking statements, including
statements regarding the prospects for the LFRP portfolio and increases
in the KALBITOR patient base, treatment rates and sales, prospects for
KALBITOR and DX-2930 to treat a broader range of angioedemas, projected
KALBITOR sales and revenues for 2012, and projected cash flow break-even
in 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; uncertainties 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 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.
- financial tables follow -
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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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Nine Months Ended
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September 30,
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September 30,
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|
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2012
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2011
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2012
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2011
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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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10,814
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$
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6,597
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$
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27,988
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$
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15,888
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Development and license fee revenues
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$
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2,287
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$
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3,535
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$
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10,632
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$
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24,333
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Total revenues, net
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$
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13,101
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$
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10,132
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$
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38,620
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$
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40,221
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|
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|
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|
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Costs and expenses:
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Cost of product sales
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|
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493
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|
|
|
260
|
|
|
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1,447
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|
|
|
781
|
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Research and development expenses
|
|
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6,158
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|
|
|
8,659
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|
|
|
22,664
|
|
|
|
26,238
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Selling, general and administrative expenses
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9,117
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|
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8,790
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29,872
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|
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27,120
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Restructuring costs
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|
-
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|
-
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1,440
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|
-
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|
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|
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Total costs and expenses
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15,768
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17,709
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55,423
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54,139
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Loss from operations
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(2,667
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)
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(7,577
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)
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(16,803
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)
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(13,918
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)
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Other income (expense):
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Interest and other income
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5
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382
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22
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|
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544
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Interest and other expense
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(2,548
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)
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(2,528
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)
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(7,650
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)
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(7,690
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)
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Total other expense
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(2,543
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)
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(2,146
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)
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(7,628
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)
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(7,146
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)
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Net loss
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$
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(5,210
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)
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$
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(9,723
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)
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$
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(24,431
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)
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$
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(21,064
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)
|
|
|
|
|
|
|
|
|
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Basic and diluted net loss per share
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$
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(0.05
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)
|
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$
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(0.10
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)
|
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$
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(0.25
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)
|
|
$
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(0.21
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)
|
|
|
|
|
|
|
|
|
|
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Shares used in computing basic and diluted net loss per share
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99,069,928
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98,748,086
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98,896,984
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98,720,137
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SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
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(Unaudited)
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September 30,
|
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December 31,
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2012
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2011
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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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30,389
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$
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57,504
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Accounts receivable, net
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7,490
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|
|
|
6,092
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|
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Inventory
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|
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10,192
|
|
|
|
7,022
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|
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|
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Fixed asset
|
|
|
|
5,288
|
|
|
|
4,881
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|
|
|
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Restricted cash
|
|
|
|
1,100
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|
|
|
2,366
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|
|
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Other assets
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|
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2,702
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|
|
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5,510
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|
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|
|
|
|
|
|
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Total assets
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$
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57,161
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|
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$
|
83,375
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|
|
|
|
|
|
|
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Liabilities and Stockholders' Equity
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Accounts payable and other current liabilities
|
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|
$
|
11,348
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|
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$
|
17,128
|
|
|
|
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Deferred revenue
|
|
|
|
12,849
|
|
|
|
15,902
|
|
|
|
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Note payable and other long-term debt
|
|
|
|
78,236
|
|
|
|
75,372
|
|
|
|
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Other long-term liabilities
|
|
|
|
3,087
|
|
|
|
2,372
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
105,520
|
|
|
|
110,774
|
|
|
|
|
|
|
|
|
|
|
|
|
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Common stock and additional paid-in capital
|
|
|
|
452,987
|
|
|
|
449,515
|
|
|
|
|
Accumulated deficit and other comprehensive income
|
|
|
|
(501,346
|
)
|
|
|
(476,914
|
)
|
|
|
|
|
|
|
|
|
|
|
|
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Total stockholders' equity (deficit)
|
|
|
|
(48,359
|
)
|
|
|
(27,399
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity (deficit)
|
|
|
$
|
57,161
|
|
|
$
|
83,375
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Dyax Corp.
Jennifer Robinson, 617-250-5741
Associate Director,
Investor Relations and Corporate Communications
jrobinson@dyax.com
Source: Dyax Corp.
News Provided by Acquire Media
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