Dyax Corp. (NASDAQ: DYAX) today announced financial results for
the second quarter ended June 30, 2015. Dyax will host a webcast
and conference call at 5:00 p.m. (ET) today to review financial
results and provide updates on DX-2930, KALBITOR® (ecallantide) and
the Licensing and Funded Research Portfolio (LFRP). The Company
will also provide an introductory overview of its internal
development candidates.
Recent highlights include:
- Receipt of Breakthrough Therapy
designation from the U.S. Food and Drug Administration (FDA) for
the investigation of DX-2930 for hereditary angioedema (HAE);
- Total revenue for the second quarter of
2015 of $26.4 million, including:
- KALBITOR net sales of $17.8 million
and
- Royalty revenue of $4.4 million, as
well as
- Cash, cash equivalents and investments
at June 30, 2015 totaled $394.2 million.
2015 Second Quarter Financial
Results
Total revenues for the quarter ended June 30, 2015 were $26.4
million, as compared to $19.6 million for the comparable quarter in
2014. The second quarter 2015 revenues included $17.8 million of
KALBITOR net sales, as compared to $16.6 million for the same
period in 2014, as well as royalties of approximately $4.4 million
based on sales of Eli Lilly and Company’s CYRAMZA® (ramucirumab).
For the six months ended June 30, 2015, total revenues were $46.8
million, compared to $33.7 million for the same period in 2014. The
six-month 2015 revenues included $33.8 million of KALBITOR net
sales, as compared to $29.1 million in the 2014 period, as well as
CYRAMZA royalties of approximately $7.8 million. The third quarter
of 2014 was the first period in which we recorded royalty
revenue.
Dyax expects quarterly and annual revenues to fluctuate. For
KALBITOR, revenue fluctuations are primarily due to variability in
the rate at which individual 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
timing of any 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 second quarter of
2015 were $1.4 million, as compared to $975,000 for the same
quarter in 2014. For the six months ended June 30, 2015, cost of
product sales were $3.5 million, as compared to $1.8 million for
the same period in 2014.
Cost of royalties for the second quarter of 2015 were $2.2
million, consisting of pass-through fees under an LFRP
cross-licensing arrangement. For the six months ended June 30,
2015, cost of royalties were $3.9 million.
Research and development expenses at Dyax are primarily related
to the following: 1) the DX-2930 development program, together
with other research programs; 2) KALBITOR medical support and
post-marketing requirements; and 3) pass-through license fees
paid by Dyax under the LFRP. Research and development expenses for
the second quarter of 2015 were $14.5 million, as compared to $8.5
million for the same quarter in 2014. For the six months ended June
30, 2015, research and development expenses were $24.8 million, as
compared to $15.3 million for the same period in 2014. The 2015
increases are primarily related to costs associated with DX-2930
development.
Selling, general and administrative expenses were $14.2 million
for the second quarter of 2015, as compared to $10.6 million for
the same quarter in 2014. For the six months ended June 30, 2015,
selling, general and administrative costs were $25.2 million, as
compared to $20.1 million for the same period in 2014. The higher
selling, general and administrative costs in 2015 were due to
increased charges for non-cash stock compensation expense, as well
as increased sales and marketing costs supporting KALBITOR
commercial efforts.
For the quarter ended June 30, 2015, Dyax reported a net loss of
$8.4 million or $0.06 per share attributable to common
stockholders, as compared to a net loss of $3.1 million or $0.02
per share for the same quarter in 2014. For the six months ended
June 30, 2015, Dyax reported a net loss of $15.7 million or $0.11
per share attributable to common stockholders, as compared to a net
loss of $8.8 million or $0.07 per share for the same period in
2014.
As of June 30, 2015, Dyax had cash, cash equivalents, and
investments totaling $394.2 million, exclusive of restricted
cash.
Financial Guidance
Dyax has reiterated its revenue guidance for 2015. Revenue
guidance includes two components:
- KALBITOR net sales in the range
of $60-70 million.
- Development and license fees in the
range of $7-9 million. These fees exclude all potential
royalties which would be earned from licensees' sales of LFRP
product.
The Company has revised its operating costs and expenses (cost
of product sales, research and development expenses, and selling,
general and administrative costs) which are expected to be in the
range of $120-125 million, an increase from its previous
guidance of $105-110 million. This increase is due to costs
associated with the acceleration of the DX-2930 development program
and non-cash stock compensation charges.
Webcast and Conference Call
Date:
Wednesday, July 29, 2015
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. The webcast will be archived on the Dyax
website for an indefinite period of time.
About Dyax
Dyax is a biopharmaceutical company focused on the development
and commercialization of novel biotherapeutics for unmet medical
needs. The Company is developing DX-2930, a fully human monoclonal
antibody, for the prevention of HAE attacks. In March 2015, the
Company reported positive safety, pharmacokinetic, biomarker and
proof-of-concept efficacy results from its Phase 1b clinical trial
of DX-2930 in HAE patients. DX-2930 has received Fast Track and
Breakthrough Therapy designations from the FDA. Additionally, Dyax
markets KALBITOR® (ecallantide) for the treatment of acute attacks
of HAE in patients 12 years of age and older.
Both DX-2930 and KALBITOR were identified using Dyax's
proprietary phage display technology. Dyax has broadly licensed
this technology under its Licensing and Funded Research Portfolio
(LFRP). The current portfolio includes one FDA approved product,
Eli Lilly and Company’s CYRAMZA (ramucirumab), for which Dyax
receives royalties, and multiple product candidates in various
stages of clinical development for which the Company is eligible to
receive future milestones and royalties.
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 cash flow from
KALBITOR and the LFRP; and financial guidance for projected
revenues, KALBITOR net sales and operating costs and expenses for
2015. 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: 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;
Dyax's dependence on the expertise, effort, priorities and
contractual obligations of third parties in the manufacture,
quality control and storage of KALBITOR; Dyax's dependence on the
expertise, effort, priorities and contractual obligations of
licensees and collaborators for development, clinical trials,
manufacturing, sales and distribution of product candidates in the
LFRP; uncertainties as to whether and when new product candidates
in the LFRP will achieve development and regulatory milestones and
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 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.
CYRAMZA is a trademark owned by or licensed to Eli Lilly and
Company, its subsidiaries, or affiliates.
- financial tables follow -
DYAX
CORP.SELECTED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited) Three Months Ended
Six Months Ended June 30, June 30,
2015 2014 2015
2014 (In thousands, except share and
per share data) Revenues: Product sales, net $ 17,760 $ 16,582
$ 33,773 $ 29,089 Development and license fees 4,228 3,003 5,260
4,613 Royalty revenue 4,385 - 7,758 -
Total revenues, net $ 26,373 $ 19,585 $ 46,791
$ 33,702 Costs and expenses: Cost of product sales
1,423 975 3,519 1,760 Cost of royalty revenues 2,192 - 3,879 -
Research and development 14,510 8,456 24,752 15,325 Selling,
general and administrative 14,153 10,565 25,194 20,054
Total costs and expenses 32,278
19,996 57,344 37,139
Loss from operations (5,905 ) (411 ) (10,553 ) (3,437 )
Other income (expense): Interest and other income 203 73 291
111 Interest and other expense (2,709 ) (2,723 )
(5,420 ) (5,446 ) Total other expense (2,506 ) (2,650
) (5,129 ) (5,335 ) Net loss $ (8,411 ) $ (3,061 ) $ (15,682
) $ (8,772 ) Basic and diluted net loss per share $ (0.06 )
$ (0.02 ) $ (0.11 ) $ (0.07 ) Shares used in
computing basic and diluted net loss per share 144,703,202
135,873,613 140,791,906
130,277,157
SELECTED CONSOLIDATED CONDENSED BALANCE
SHEET INFORMATION(Unaudited)
June 30,
December 31,
2015
2014
(In thousands)
Assets
Cash, cash equivalents and investments $ 394,157 $ 184,652
Accounts receivable, net 10,938 12,221 Inventory 11,352 7,228 Fixed
assets 5,158 4,631 Restricted cash 1,100 1,100 Other assets 5,035
7,301 Total assets $ 427,740 $ 217,133
Liabilities and
Stockholders' Equity
Accounts payable and other current liabilities $ 18,207 $
18,532 Deferred revenue 7,398 7,574 Note payable and other
long-term debt 82,111 82,165 Other long-term liabilities 2,863
3,059 Total liabilities 110,579
111,330 Common and preferred stock and additional
paid-in capital 878,660 651,616 Accumulated deficit and other
comprehensive income (561,499 ) (545,813 ) Total
stockholders' equity 317,161 105,803
Total liabilities and stockholders' equity $ 427,740
$ 217,133
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version on businesswire.com: http://www.businesswire.com/news/home/20150729006630/en/
Dyax Corp.Jennifer Robinson, 617-250-5741Director, Investor
Relationsand Corporate Communicationsjrobinson@dyax.com
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