Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact: Investors:
Glenn Sblendorio
Chief Financial Officer
T: 212-824-3100
F212-824-3240
E-mail: glenn.sblendorio@eyetech.com
www.eyetech.com
Eyetech Pharmaceuticals, Inc.
Reports Second Quarter 2004 Financial Results
- Eyetech files new drug application for Macugen(TM)(pegaptanib sodium
injection) and accelerates pre-launch activities -
New York, NY - July 23, 2004 - Eyetech Pharmaceuticals, Inc. (Nasdaq: EYET), a
biopharmaceutical company that specializes in the development and
commercialization of novel therapeutics to treat diseases of the eye, today
reported its consolidated financial results for the three months ended June 30,
2004.
Second Quarter 2004 Financial Highlights
- ----------------------------------------
o Collaboration revenues of $12.5 million for the second quarter 2004
compared to $11.2 million for the same period in 2003. Collaboration
revenues for the half-year period ended June 30, 2004 were $24.3
million compared to $18.5 million for the same period in 2003.
o Operating loss of $31.9 million for the second quarter 2004 compared
to an operating loss of $10.1 million for the same period in 2003. For
the half-year period ended June 30, 2004, the operating loss was $47.5
million compared to $16.0 for the same period in 2003. The increased
operating loss reflects milestone payments, acceleration of pre-launch
activities for Macugen for the treatment of the wet form of
age-related macular degeneration (AMD) and completion of a secondary
offering on behalf of stockholders.
Second quarter results do not include a milestone payment from our
partner, Pfizer Inc., which is payable to us upon acceptance for
review by the Food and Drug Administration (FDA) of our complete new
drug application (NDA) filing for Macugen.
o Research and development expenses for the second quarter were $33.9
million in 2004 compared to $19.7 million for the same period in 2003.
The principal reason for this increase was $9.2 million of milestone
payments to Gilead Sciences, Inc., Nektar Therapeutics and Isis
Pharmaceuticals, Inc. related to the completed submission of our NDA
for Macugen and an initial payment to Archemix Corp. in connection
with our research and development collaboration. In addition, as a
result of the early submission of our NDA filing for Macugen, we
incurred approximately $4.4 million of development expenses in
connection with our acceleration of pre-launch activities for Macugen,
specifically for pre-approval inspection readiness and raw material
purchases.
o Sales and marketing expenses for the second quarter were $6.2 million
in 2004 compared to $0.7 million in the same period in 2003. This
increase is primarily due to the accelerated hiring of a sales force.
o General and administrative expenses for the second quarter were $4.3
million in 2004 compared to $0.8 million in the same period in 2003.
This increase is primarily due to $1.0 million of costs incurred in
connection with our secondary offering, $1.5 million for the write
down of our lease on our former corporate offices in New York and
increased administrative and facility costs.
o Net loss attributable to common stockholders for the second quarter
was $31.0 million in 2004 compared to $11.3 million for the same
period in 2003. Basic and diluted net loss per common share in the
second quarter was $0.77 in 2004, compared to $2.88 for the same
period in 2003. Pro forma basic and diluted loss per common share in
the second quarter was $0.77 in 2004, compared to $0.40 for the same
period in 2003. Net loss attributable to common stockholders for the
half-year period ended June 30, was $46.8 million in 2004 compared to
$19.0 million for the same period in 2003. Basic and diluted net loss
per common share for the half-year period ended June 30, was $1.38 in
2004,
compared to $4.94 for the same period in 2003. Pro forma basic and
diluted loss per common share for the half-year period ended June 30,
was $1.23 in 2004, compared to $0.69 for the same period in 2003. The
pro forma basic and diluted loss per common share gives effect to the
automatic conversion of our outstanding convertible preferred stock
into shares of common stock upon completion of our initial public
offering in February 2004.
o $253.2 million in cash, cash equivalents and marketable securities at
June 30, 2004.
Commenting on Eyetech's achievements during the first half of 2004, Chief
Executive Officer and co-founder, David R. Guyer, M.D. stated, "We continue to
meet our objectives by completing, ahead of schedule, the filing of our NDA for
the use of Macugen in the treatment of wet AMD. We look forward to our meeting
with the public advisory committee of the FDA on August 27, 2004 and are working
to bring Macugen to patients in 2005."
Second Quarter 2004 Operations Highlights
- -----------------------------------------
o Completed the filing of our NDA with the FDA for Macugen in the second
quarter of 2004.
o The FDA announced the meeting of a public advisory committee of the
FDA to discuss our NDA for the use of Macugen (pegaptanib sodium
injection) for the treatment of wet AMD (21-756, pegaptanib sodium
injection (proposed trade name, Macugen)) to be held on August 27,
2004.
o Released data from a Phase 2 study of Macugen which showed positive
visual and anatomical outcomes in the treatment of diabetic macular
edema (DME). Diabetic retinopathy is the leading cause of blindness in
people less than 50 years of age in developed countries. DME is the
leading cause of vision loss in diabetic retinopathy.
o Completed a secondary public offering of 4,439,000 shares of common
stock in the second quarter 2004. All of the shares were sold by
selling stockholders at $38.50 per
share. Eyetech did not issue any primary shares in, or receive any
proceeds from, the offering.
o Completed the recruitment of 43 regional sales representatives and 5
regional sales managers in anticipation of our planned launch of
Macugen.
o Appointed two new independent board members, Phillip M. Satow, former
pharmaceutical executive from Forest Laboratories, Inc. and Pfizer
Inc., and Michael J. Regan, former Vice Chairman and the Chief
Administrative Officer of KPMG LLP.
Conference Call and Webcast Information
- ---------------------------------------
Eyetech's senior management will host a conference call on Monday, July 26, 2004
beginning at 8:30 a.m., New York time, to discuss the results and provide a
company update. Live audio of the conference call will be available to
investors, members of the news media and the general public by dialing
888-275-0218 (in the United States) or 706-679-7756 (internationally). A
playback of the call will be available through August 9, 2004 by dialing
800-642-1687, passcode 8692831 (in the United States), or 706-645-9291, passcode
8692831 (internationally). To access the call by live webcast, please log on to
the Investor Relations section of our website at www.eyetech.com. An archived
version of the webcast will be available at the same location through
August 26, 2004.
In the event that any non-GAAP financial measure is discussed on the conference
call that is not described in this release, related complementary information
will be made available on the Investor Relations page of Eyetech's website at
www.eyetech.com as soon as practical after the conclusion of the conference
call.
About Eyetech
- -------------
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in
the development and commercialization of novel therapeutics to treat diseases of
the eye. Eyetech's initial focus is on diseases affecting the back of the eye.
The company's most advanced product
candidate is Macugen (pegaptanib sodium injection), which Eyetech is developing
with Pfizer Inc. for the prevention and treatment of diseases of the eye and
related conditions. Eyetech and Pfizer filed an NDA for the use of Macugen in
the treatment of the wet form of age-related macular degeneration in the second
quarter of 2004. Eyetech's lead clinical trials include two Phase 2/3 pivotal
clinical trials for the use of Macugen in the treatment of the wet form of
age-related macular degeneration, a Phase 2 clinical trial for the use of
Macugen for the treatment of diabetic macular edema and a Phase 2 clinical trial
for the use of Macugen in the treatment of retinal vein occlusion.
Safe Harbor Statement
- ---------------------
This press release contains forward-looking statements that involve substantial
risks and uncertainties. All statements, other than statements of historical
facts, included in this press release regarding our strategy, future operations,
future financial position, future revenues, projected costs, prospects, plans
and objectives of management are forward-looking statements. We may not actually
achieve the plans, intentions or expectations disclosed in our forward-looking
statements and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking statements we make.
Various important factors could cause actual results or events to differ
materially from the forward-looking statements that we make, including risks
related to: our heavy dependence on the success of Macugen, which is still under
development; our dependence on our strategic collaboration with Pfizer;
obtaining regulatory approval to market Macugen and any other products that we
may develop in the future; our dependence on third parties to manufacture
Macugen; obtaining, maintaining and protecting the intellectual property
incorporated into our product candidates; and our ability to obtain additional
funding to support our business activities. These and other risks are described
in greater detail in the "Risk Factors" section of our most recent prospectus
filed under Rule 424(b)(4) with the SEC. Our forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers, dispositions,
joint ventures or investments we may make. We do not assume any obligation to
update any forward-looking statements.
EYETECH PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(All amounts in thousands, except per share amounts)
(Unaudited)
QUARTER ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
----------------------- -----------------------
2003 2004 2003 2004
-------- -------- -------- --------
Collaboration revenue $ 11,199 $ 12,550 $ 18,508 $ 24,262
Costs and expenses:
Research and development 19,721 33,914 31,338 55,844
Sales and marketing 743 6,178 1,311 9,977
General and administrative 342 4,320 1,445 5,962
-------- -------- -------- --------
Total costs and expenses 20,807 44,411 34,095 71,784
Operating loss (9,608) (31,861) (15,587) (47,521)
Interest income, net 536 839 1,093 1,488
-------- -------- -------- --------
Net loss (9,072) (31,022) (14,494) (46,033)
Preferred stock accretion (2,259) -- (4,518) (816)
-------- -------- --------
Net loss attributable to common
stockholders $(11,331) $(31,022) $(19,012) $(46,849)
======== ======== ======== ========
Basic and diluted net loss per
common share $ (2.88) $ (0.77) $ (4.94) $ (1.38)
Weighted average common
shares outstanding 3,932 40,839 3,847 33,960
Pro forma basic and diluted
net loss per common share $ (0.40) $ (0.77) $ (0.69) $ (1.23)
Pro forma weighted average
common shares outstanding 28,073 40,839 27,471 38,123
Each outstanding share of preferred stock of the Company automatically converted
into one share of common stock upon completion of the Company's initial public
offering. Accordingly, pro forma basic and diluted net loss per common share has
been calculated assuming the preferred stock was converted as of the original
date of issuance of the preferred stock. Pro forma common shares outstanding for
the six-months ending June 30, 2004 of 38,123 is based on the conversion of
4,163 shares of our convertible preferred stock on a weighted average basis as
of June 30, 2004.
EYETECH PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
DECEMBER 31, 2003 JUNE 30, 2004
----------------- -------------
Cash and cash equivalents $ 25,014 $ 79,780
Marketable securities 106,360 173,405
Other current assets 3,863 5,568
Net fixed assets and other assets 14,243 15,501
--------------- ---------------
Total assets $ 149,480 $ 274,253
=============== ===============
Current liabilities $ 20,098 $ 29,220
Long-term liabilities 186,971 3,396
Deferred revenue, less current portion 65,417 64,689
Stockholders' equity (123,006) 176,949
--------------- ---------------
Total liabilities and stockholders' equity $ 149,480 $ 274,253
=============== ===============