IRVINE, Calif., Feb. 23 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals,
Inc. (Nasdaq: ISTA) a specialty pharmaceutical company focused on the
commercialization and development of unique and uniquely improved products for
serious conditions of the eye, today reported financial results for the fourth
quarter and year ended December 31, 2005.
ISTA reported net revenue for the fourth quarter and year ended December
31, 2005 of $3.7 million and $10.7 million, respectively. Net product sales
for the fourth quarter and year ended December 31, 2005 were $3.6 million and
$10.4 million, respectively. Net product sales for the fourth quarter 2005
included Xibrom(TM) net sales of $1.5 million, Istalol(R) net sales of
$1.4 million and Vitrase(R) net sales of $0.7 million.
The net loss for the fourth quarter and year ended December 31, 2005 was
$10.7 million (or $0.41 per share) and $38.5 million (or $1.51 per share),
respectively, compared with a net loss of $9.7 million (or $0.50 per share)
and $40.4 million (or $2.22 per share) for the same periods in 2004. At
December 31, 2005, ISTA had cash and cash equivalents of $38.6 million.
"2005 was a busy and productive year for us. We finished 2005 with
$10.7 million in annual sales, the majority of which occurred in the second
half of the year after we expanded our sales force to over 70 representatives.
During the fourth quarter, we experienced an acceleration in prescription
activity and orders that has positioned us well for revenue growth in 2006.
In addition, we added a strong steroid product to our pipeline and initiated
and completed enrollment in two clinical studies for two other products in our
pipeline," said Vicente Anido, Jr. President and Chief Executive Officer of
ISTA. "Finally, we strengthened our balance sheet by raising additional
capital early in 2005 and adding a credit facility, so that we ended the year
in a strong cash position."
Revenue for the quarter and year ended December 31, 2005 was $3.7 million
and $10.7 million, respectively, as compared to ($95,000) and $1.9 million,
respectively for the same periods in 2004. The increase in revenue for the
2005 periods resulted from increased sales of Istalol(R) and the launch of the
Company's second and third products, Vitrase(R) (for use as a spreading agent)
and Xibrom(TM) (for the treatment of ocular inflammation and pain following
cataract surgery), respectively during 2005. Because of increasing demand for
its products during the fourth quarter and year ended 2005, ISTA decreased its
sales return allowance by $0.2 million and $0.5 million, respectively and had
a corresponding increase in net product sales during the fourth quarter and
year ended 2005. As of December 31, 2005, ISTA maintained a reserve of
$0.8 million recorded as a sales return allowance. ISTA recognizes product
sales upon shipment to the customer and records and adjusts reserves based
upon estimated and actual returns.
Product gross margin for the fourth quarter and year ended December 31,
2005 was $2.4 million (or 66% of net product sales) and $6.8 million (or 66%
of net product sales), respectively, as compared to no product gross margin
and $192,000 (or 12% of net product sales), respectively, for the same periods
in 2004. The increase in gross product margin for the 2005 periods is
primarily due to changes in the Company's product mix resulting from launching
two new products in 2005 and the reversal of a portion of the ISTA's sales
return allowance which increased net product sales and gross margin during the
fourth quarter and year ended 2005 by $0.2 million and $0.5 million,
respectively, or 5% of net product sales during both the fourth quarter and
year ended 2005.
Research and development expenses for the fourth quarter and year ended
December 31, 2005 were $5.0 million and $16.6 million, respectively, as
compared to $3.5 million and $15.6 million during the same periods of 2004.
The increase in research and development expenses for 2005 was primarily the
result of an increase in clinical development costs, which include clinical
investigator fees, study monitoring costs and data management costs, due to
the commencement and completion during the second half of 2005 of the fixed
combination product tobramycin 0.3% and prednisolone acetate 1.0% Phase III
study and the ecabet sodium Phase IIb study.
Selling, general and administrative expenses for the fourth quarter and
year ended December 31, 2005 were $8.7 million and $30.6 million,
respectively, as compared to $5.4 million and $25.8 million for the same
periods in 2004. The increase in the 2005 periods primarily resulted from
higher sales and marketing expenses associated with the commercial launch of
Vitrase (for use as a spreading agent) and Xibrom during 2005 and increased
administrative costs related to expanding the Company's operations and other
general corporate expenses, such as facility and personnel costs. In
addition, during the fourth quarter of 2005, ISTA experienced higher marketing
expenses due to participation in key industry meetings. During 2004, ISTA
recorded a one-time expense of $10.0 million in connection with the Company's
reacquisition from Allergan, Inc. of all rights to market and sell Vitrase(R)
for all uses in the United States and other specified markets.
2005-6 Corporate Highlights:
* Increased net product sales in 2005 in excess of 500% compared to the
prior year
* Completed transition to a commercial business by hiring its own sales
force and completing the launch of its second and third products
* Successfully completed a public offering of its common stock for
proceeds of $56.2 million, before offering expenses and underwriting
discounts, and secured a credit facility to finance working capital
needs in 2006
* Added two new products to its R&D pipeline, Tobra/Pred and a strong
steroid
Xibrom(TM)
* Received FDA approval for Xibrom for inflammation following cataract
surgery - March 2005
* Launched Xibrom - June 2005
* Received FDA approval for Xibrom expanded indication to treat pain
following cataract surgery - January 2006
* Grew Xibrom total prescriptions by 65% fourth quarter over third
quarter 2005
Istalol(R)
* Grew Istalol total prescriptions by 26% fourth quarter over third
quarter 2005
Vitrase(R)
* Launched Vitrase for use as a spreading agent - January 2005
* Obtained reimbursement codes from the Center for Medicare and Medicaid
Services
Fixed Combination Product - Tobramycin 0.3% and prednisolone acetate 1.0%
* Filed an Investigational New Drug (IND) application for a fixed
combination product - April 2005
* Completed enrollment of the fixed combination product Phase III study
by the end of 2005 and announced positive results during the first
quarter of 2006
Ecabet Sodium
* Filed an IND for ecabet sodium for the treatment of dry eye Phase IIb -
March 2005
* Completed enrollment of ecabet sodium Phase IIb study by the end of
2005
* Announced positive Phase IIb results during the first quarter of 2006
ISTA will host a conference call with a simultaneous webcast today,
February 23, 2006 at 10:30 AM Eastern Time, to discuss its fourth quarter and
full year 2005 results. To access the live conference call, U.S. and Canadian
participants may dial 800-291-5365; international participants may dial
617-614-3922. The access code for the live call is 59935540. To access the
24-hour audio replay, U.S. and Canadian participants may dial 888-286-8010;
international participants may dial 617-801-6888. The access code for the call
is 81379873. This conference call will also be webcast live and archived on
ISTA's website for 30 days at http://www.istavision.com.
About ISTA
ISTA is a specialty pharmaceutical company focused on the development and
commercialization of unique and uniquely improved ophthalmic products. ISTA's
products and product candidates seek to address serious diseases and
conditions of the eye such as dry eye, vitreous hemorrhage, diabetic
retinopathy, hyphema, glaucoma, ocular pain and inflammation. Building on this
pipeline, ISTA's goal is to continue its growth as a specialty pharmaceutical
company by acquiring complementary products, either already marketed or in
late-stage development. For additional information regarding ISTA, please
visit ISTA Pharmaceuticals' Website at http://www.istavision.com.
Any statements contained in this press release that refer to future events
or other non-historical matters are forward-looking statements. ISTA
disclaims, except as expressly required by law, any intent or obligation to
update any forward-looking statements. Such statements are based on ISTA's
expectations as of the date of this press release and are subject to risks and
uncertainties that could cause actual results to differ materially. Important
factors that could cause actual results to differ from current expectations
include, among others, such risks and uncertainties as detailed from time to
time in ISTA's public filings with the U.S. Securities and Exchange
Commission, including but not limited to ISTA's Annual Report on Form 10-K for
the year ended December 31, 2004 and its Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005.
ISTA Pharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
(unaudited) (unaudited)
2005 2004 2005 2004
Revenue:
Product Sales, net $3,613 $(165) $10,382 $1,619
License Fees 70 70 278 278
Total Revenue 3,683 (95) 10,660 1,897
Cost of products sold 1,231 788 3,542 1,427
Gross profit margin 2,452 (883) 7,118 470
Operating expenses:
Research and
development 4,907 3,492 16,611 15,583
Selling, general
and administrative 8,662 5,380 30,599 25,841
Total operating
expenses 13,569 8,872 47,210 41,424
Loss from operations (11,117) (9,755) (40,092) (40,954)
Interest income/
(expense), net 382 97 1,612 530
Net loss $(10,735) $(9,658) $(38,480) $(40,424)
Net loss per common
share, basic and
diluted $(0.41) $(0.50) $(1.51) $(2.22)
Shares used in computing
net loss per common
share, basic and
diluted 25,887 19,322 25,490 18,190
ISTA Pharmaceuticals, Inc.
Summary of Consolidated Balance Sheets Data
(in thousands)
(unaudited)
December 31, December 31,
2005 2004
Cash and short-term investments $38,626 $27,748
Working capital 32,990 18,872
Total assets 45,339 30,373
Total stockholders' equity 30,335 15,318
SOURCE ISTA Pharmaceuticals, Inc.
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Related links:
http://www.istavision.com
CONTACT:
Vince Anido, +1-949-788-5311,
vanido@istavision.com, or Lauren Silvernail, +1-949-788-5302,
lsilvernail@istavision.com, both of ISTA Pharmaceuticals, Inc.;
or Media - Justin Jackson, jjackson@burnsmc.com, or Investors -
Lisa Burns, or Laura Siino, lsiino@burnsmc.com, all of Burns
McClellan, +1-212-213-0006
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