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发帖数: 2883 | 1 【 以下文字转载自 JQCLUB 俱乐部 】
发信人: winnie91107 (爱的承诺), 信区: JQCLUB
标 题: ISIS
发信站: BBS 未名空间站 (Fri Aug 5 13:32:08 2011, 美东)
Isis Reports Financial Results and Highlights for Second Quarter 2011
21 hours 30 minutes ago - PR Newswire via Comtex
PR Newswire
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today announced its financial
results for the quarter ended June 30, 2011. The Company finished the second
quarter of 2011 with a pro forma net operating loss (NOL) of $11.6 million
and $24.9 million for the three and six months ended June 30, 2011,
respectively, compared to a pro forma NOL of $15.5 million and $17.1 million
for the same periods in 2010. The Company finished the second quarter of
2011 with more than $395 million in cash. Isis remains on track to meet its
2011 guidance of an NOL in the low $40 million range and a year-end cash
balance of more than $350 million.
"We were pleased to announce last week that Genzyme submitted the mipomersen
marketing application to the European Medicines Agency and remains on track
to submit the US application for marketing approval later this year.
Pending regulatory approval, mipomersen will be marketed under the brand
name Kynamro(TM). The Kynamro European regulatory submission is a
significant achievement and brings this potentially life-changing drug
closer to patients who are at great risk of dying from their cardiovascular
disease. We continue to work closely with Genzyme to complete all the steps
necessary for a successful approval and launch planned in 2012," said B.
Lynne Parshall, COO and CFO of Isis. "We believe the initial commercial
opportunities for Kynamro are significant and could provide us with the
opportunity to earn significant commercial revenue."
Upcoming Key Milestones
File for marketing approval for Kynamro(TM) (mipomersen) in the United
States in the fourth quarter of 2011 for patients with homozygous Familial
Hypercholesterolemia (FH).
Initiate Phase 2 studies on ISIS-CRPRx in patients with Rheumatoid Arthritis
and Multiple Myeloma.
Financial Results
On a GAAP basis, Isis reported a loss from operations of $14.1 million and $
30.2 million for the three and six months ended June 30, 2011, respectively,
compared to $18.7 million and $23.6 million for the same periods in 2010.
All pro forma amounts referred to in this press release exclude non-cash
stock compensation. Please refer to the reconciliation of pro forma and GAAP
measures, which is provided later in this release.
Revenue
Revenue for the three and six months ended June 30, 2011 was $24.8 million
and $46.0 million, respectively, compared to $23.5 million and $53.4 million
for the same periods in 2010. Isis' revenue fluctuates based on the nature
and timing of payments under agreements with the Company's partners,
including license fees, milestone-related payments and other payments. For
example, in the first half of 2011 Isis recognized as revenue a $5 million
milestone payment Isis earned from GlaxoSmithKline (GSK) for the initiation
of a Phase 1 study for ISIS-TTRRx. However, revenue in the first half of
2011 included less revenue from Bristol-Myers Squibb and Alnylam
Pharmaceuticals compared to the first half of 2010, primarily because
amortization of upfront fees from these collaborations ended in 2010,
although Isis continues to receive research support from Bristol-Myers
Squibb. In the second quarter of 2010, Isis earned $1.9 million from Regulus
related to its strategic alliance with Sanofi, which also contributed to
lower revenue in the first half of 2011.
Operating Expenses
On a pro forma basis, operating expenses for the three and six months ended
June 30, 2011 were $36.4 million and $70.9 million, respectively, compared
to $39.0 million and $70.5 million for the same periods in 2010. Isis'
operating expenses in the first half of 2011 reflected higher costs
associated with Isis' maturing pipeline of drugs offset by lower costs
associated with the completion of the mipomersen Phase 3 program that
supports the initial regulatory filings. Although Isis' operating expenses
were essentially flat compared to 2010, as drugs move forward to more
advanced stages of development, including into larger, longer clinical
studies, the costs of development will increase. On a GAAP basis, Isis'
operating expenses for the three and six months ended June 30, 2011 were $38
.9 million and $76.1 million, respectively, compared to $42.2 million and $
77.0 million for the same periods in 2010.
Net Loss
Isis reported a net loss of $17.9 million and $37.9 million for the three
and six months ended June 30, 2011, respectively, compared to $25.2 million
and $34.8 million for the same periods in 2010. Basic and diluted net loss
per share for the three and six months ended June 30, 2011 was $0.18 per
share and $0.38 per share, respectively, compared to $0.25 per share and $0.
35 per share for the same periods in 2010. Isis' net loss for the second
quarter of 2011 decreased compared to the same period in 2010 primarily due
to a decrease in Isis' operating expenses and its share of Regulus' net loss
, which reflects additional revenue Regulus earned from its alliance with
Sanofi. In the first half of 2011 Isis' net loss increased compared to the
same period in 2010 primarily due to a decrease in Isis' revenue offset in
part by a decrease in Isis' share of Regulus' net loss as described above.
Balance Sheet
As of June 30, 2011, Isis had cash, cash equivalents and short-term
investments of $395.2 million compared to $472.4 million at December 31,
2010 and had working capital of $318.7 million at June 30, 2011 compared to
$377.2 million at December 31, 2010. The decrease in cash and working
capital primarily relates to cash used to fund Isis' operations.
Isis' leases on its primary research and development facilities expire at
the end of 2011. Rather than invest in costly renovations to its existing
facilities, the Company chose to consolidate the majority of its operations
in a new leased facility that Biomed Realty Trust, Inc. (BMR) constructed.
To make the Company's move, scheduled for August 2011, as efficient as
possible, Isis requested access to the new facility prior to the completion
of construction. To gain early access, Isis agreed to modify its lease to
accept additional responsibility. As a result, accounting rules required
Isis to record the cost of the facility as a fixed asset with a
corresponding liability. Beginning in the third quarter, Isis will
depreciate the building over its economic life and Isis' rent payments,
which begin on January 1, 2012, will decrease the liability over the term of
the lease.
Business Highlights
"The most significant events for Isis this year are the submission of
regulatory filings for Kynamro in both Europe and the United States. With
the European submission, we are one step closer to commercialization.
Together with Genzyme, we have put together a comprehensive package for
these filings that includes data from more than 700 mipomersen-treated
patients, including a significant number of patients with long-term drug
exposure. In all clinical studies conducted, including four Phase 3 studies,
we observed an efficacy and safety profile for mipomersen that we believe
supports our initial market opportunities. With longer-term dosing, LDL-C
reductions are sustained with a safety profile that is consistent with our
Phase 3 experience," continued Ms. Parshall. "In addition, together with
Genzyme, we are making progress toward initiating additional studies to
provide additional patient exposure to support future regulatory filings."
"Already 2011 has been a very successful year, but we have many more events
to look forward to as we continue to make significant progress in our
pipeline. We anticipate reporting Phase 1 data on several drugs that could
provide early evidence of clinical activity supporting disease opportunities
that represent very large commercial opportunities. We will also continue
to add drugs to our pipeline this year. In short, we are maturing the
pipeline as we move important drugs toward the market and expanding our
pipeline with the addition of novel drugs in new disease areas. All of these
activities are setting the stage for what we hope will be a very exciting
2012," concluded Ms. Parshall.
Corporate and Drug Development Highlights
Genzyme submitted a marketing application for mipomersen in Europe for
patients with homozygous FH and severe heterozygous FH.
Genzyme announced the brand name, Kynamro, that mipomersen will be marketed
under if the necessary approvals are granted.
Data from two Phase 3 studies of mipomersen was presented at the 79th
European Atherosclerosis Society Congress. The data highlight the potential
of mipomersen in lowering Lp(a) and potentially reducing the necessity for
lipid-apheresis.
Isis initiated Phase 1 studies on ISIS-PTP1BRx and ISIS-TTRRx, the first
drug selected as part of its collaboration with GSK. Upon Phase 1 initiation
, Isis earned a $5 million milestone payment from GSK.
Isis and GSK expanded their collaboration by initiating a sixth program to
discover and develop drugs to treat rare and infectious diseases and Isis
received a $3 million payment from GSK.
The Isis and GSK collaboration was awarded the Breakthrough Alliance Award
of 2011 as the breakthrough deal of 2010.
Conference Call
At 4:30 p.m. Eastern Time today, August 4, Isis will conduct a live webcast
conference call to discuss the earnings release and related activities.
Interested parties my listen to the call by dialing 866-543-6407 and refer
to passcode "ISIS 2011", or access the webcast at www.isispharm.com. A
webcast replay will be available for a limited time at the same address.
About Isis Pharmaceuticals, Inc.
Isis is exploiting its leadership position in antisense technology to
discover and develop novel drugs for its product pipeline and for its
partners. Isis' broad pipeline consists of 24 drugs to treat a wide variety
of diseases with an emphasis on cardiovascular, metabolic and severe and
rare/neurodegenerative diseases, and cancer. Isis' partner, Genzyme, plans
to commercialize Isis' lead product, mipomersen, following regulatory
approval, which is expected in 2012. Isis' patents provide strong and
extensive protection for its drugs and technology. Additional information
about Isis is available at www.isispharm.com.
Forward-Looking Statements
This press release includes forward-looking statements regarding Isis
Pharmaceuticals' financial position and outlook, Isis' business, the planned
commercialization of mipomersen, and the therapeutic and commercial
potential of Isis' technologies and products in development, including the
business of Regulus, Isis' jointly owned subsidiary. Any statement
describing Isis' goals, expectations, financial or other projections,
intentions or beliefs is a forward-looking statement and should be
considered an at-risk statement. Such statements are subject to certain
risks and uncertainties, particularly those inherent in the process of
discovering, developing and commercializing drugs that are safe and
effective for use as human therapeutics, and in the endeavor of building a
business around such drugs. Isis' forward-looking statements also involve
assumptions that, if they never materialize or prove correct, could cause
its results to differ materially from those expressed or implied by such
forward-looking statements. Although Isis' forward-looking statements
reflect the good faith judgment of its management, these statements are
based only on facts and factors currently known by Isis. As a result, you
are cautioned not to rely on these forward-looking statements. These and
other risks concerning Isis' programs are described in additional detail in
Isis' annual report on Form 10-K for the year ended December 31, 2010 and
its most recent quarterly report on Form 10-Q, which are on file with the
SEC. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis," "
Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its
subsidiaries, including Regulus Therapeutics Inc., its jointly owned
subsidiary.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc.
Regulus Therapeutics is a trademark of Regulus Therapeutics Inc. Kynamro(TM
) is a trademark of Genzyme Corporation.
ISIS PHARMACEUTICALS, INC.
SELECTED FINANCIAL INFORMATION
Condensed Consolidated Statements of Operations
(In Thousands, Except Per Share Data)
Three
months ended, Six months ended,
June 30,
June 30,
2011
2010 2011 2010
--------- ---------
Revenue: (unaudited)
(unaudited)
Research and development revenue under collaborative agreements $24,305
$21,143 $44,319 $49,699
Licensing and royalty revenue 518
2,360 1,651 3,730
---------
--------- --------- ---------
Total revenue 24,823
23,503 45,970 53,429
---------
--------- --------- ---------
Expenses:
Research and development 36,009
39,124 70,254 71,111
General and administrative 2,874
3,051 5,884 5,869
---------
--------- --------- ---------
Total operating expenses 38,883
42,175 76,138 76,980
---------
--------- --------- ---------
Loss from operations (14,060)
(18,672) (30,168) (23,551)
Other income (expense):
Equity in net loss of Regulus Therapeutics Inc. (1,033)
(3,942) (1,889) (5,428)
Investment income 616
859 1,321 1,814
Interest expense (3,437)
(3,261) (6,851) (6,498)
Gain (loss) on investments, net 34
(136) (285) (1,146)
---------
--------- --------- ---------
Loss before income tax expense (17,880)
(25,152) (37,872) (34,809)
Income tax expense (9)
(2) (11) (2)
---------
--------- --------- ---------
Net loss $(17,889)
$(25,154) $(37,883) $(34,811)
Basic and diluted net loss per share $(0.18 )
$(0.25) $(0.38 ) $(0.35)
---------
--------- --------- ---------
Shares used in computing basic and diluted net loss per share 99,602
99,091 99,586 99,052
Isis Pharmaceuticals, Inc.
Reconciliation of GAAP to Pro Forma Basis:
Condensed Consolidated Operating Expenses and Loss From Operations
(In Thousands)
Three months ended,
Six months ended,
June 30,
June 30,
2011 2010
2011 2010
--------- --------
- --------- ---------
(unaudited)
(unaudited)
As reported operating expenses according to GAAP $38,883 $42,175
$76,138 $76,980
Excluding compensation expense related to stock options (2,500) (3,132)
(5,232) (6,488)
Pro forma operating expenses $36,383 $39,043
$70,906 $70,492
As reported loss from operations according to GAAP $(14,060) $(18,672
) $(30,168) $(23,551)
Excluding compensation expense related to stock options (2,500) (3,132)
(5,232) (6,488)
Pro forma loss from operations $(11,560) $(15,540
) $(24,936) $(17,063)
Reconciliation of GAAP to Pro Forma Basis
As illustrated in the Selected Financial Information in this press release,
pro forma operating expenses and pro forma loss from operations were
adjusted from GAAP to exclude compensation expense related to stock options,
which are non-cash. Isis has regularly reported non-GAAP measures for
operating expenses and loss from operations as pro forma results. These
measures are provided as supplementary information and are not a substitute
for financial measures calculated in accordance with GAAP. Isis reports
these pro forma results to better enable financial statement users to assess
and compare its historical performance and project its future operating
results and cash flows. Further, the presentation of Isis' pro forma results
is consistent with how Isis' management internally evaluates the
performance of its operations.
Isis Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(In Thousands)
June 30, December 31,
2011 2010
----------- ------------
(unaudited)
Assets:
Cash, cash equivalents and short-term investments $395,184 $472,353
Other current assets 15,536 10,784
Property, plant and equipment, net 88,010 35,703
Other assets 30,842 31,637
----------- ------------
Total assets $529,572 $550,477
Liabilities and stockholders' equity:
Other current liabilities $23,261 $31,388
Current portion of deferred contract revenue 68,719 74,502
2 5/8% convertible subordinated notes 137,073 132,895
Long-term obligations, less current portion 64,187 15,867
Investment in Regulus Therapeutics Inc. 2,759 870
Long-term deferred contract revenue 21,356 50,413
Stockholders' equity 212,217 244,542
------------
Total liabilities and stockholders' equity $529,572 $550,477
SOURCE Isis Pharmaceuticals, Inc. |
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