The news release, Insmed (Nasdaq: INSM) Announces First Quarter
2008 Financial Results, issued earlier today by Insmed Inc., was
incorrectly transmitted by PR Newswire. Complete, corrected release
follows: RICHMOND, Va., May 8 /PRNewswire-FirstCall/ -- Insmed Inc.
(NASDAQ:INSM), a developer of follow-on biologics (FOB) and
biopharmaceuticals, today reported results for the first quarter
ended March 31, 2008. Recent Company Highlights -- Follow-on
Biologics Program -- Received regulatory approval from the United
Kingdom's Medicines and Healthcare products Regulatory Agency to
initiate a clinical trial for Insmed's most advanced FOB candidate,
INS-19 (Granulocyte Colony Stimulating Factor or G-CSF), a FOB of
the FDA-approved product Neupogen(R), which had U.S. sales of
approximately $0.9 billion in 2007; -- Received and completed
questionnaire from the Chairman and Ranking Member of the U.S.
House of Representatives' Subcommittee on Health on the possible
development of legislation to establish a FOB regulatory pathway
and; -- Participated in two FOB-focused events: the Center for
Business Intelligence's "Evaluate the Legislative, Economic and
Scientific Implications of the Industry Debate on: Biosimilars and
Follow-On Biologics", and the American Enterprise Institute
Follow-On Biologics Program. -- IPLEX(TM) -- All sites have been
initiated, received Investigational Review Board approvals and are
actively recruiting trial participants in the Phase 2 clinical
trial for IPLEX(TM) in Myotonic Muscular Dystrophy ("MMD"). The
trial presently has 50% of the required 60 patients enrolled and:
-- Received $2.3 million in cost recovery revenue in the first
quarter related to the expanded access program ("EAP") for
IPLEX(TM) in Italy to treat patients with Amyotrophic Lateral
Sclerosis ("ALS"), also known as Lou Gehrig's Disease. The EAP
currently includes 20 physicians and approximately 90 subjects have
enrolled. "We continue to be pleased with the progress achieved in
both our FOB and IPLEX(TM) programs," said Geoff Allan, President
and CEO of Insmed. "We are aggressively pursuing a partner for our
FOB program and continue to advance the development of IPLEX(TM) in
MMD and ALS." Revenues for the first quarter ended March 31, 2008
were $2.3 million, up from $1.7 million for the corresponding
period in 2007. The increase was primarily attributable to a $1.6
million improvement in cost recovery from our EAP to treat patients
with ALS in Italy. This was partially offset by the revenues lost
from our withdrawal of IPLEX(TM) in the short stature market
pursuant to the terms of our March 2007 Settlement Agreement with
Genentech Inc. and Tercica Inc., and the absence of license income
from our agreement with Napo Pharmaceuticals Inc., ("Napo") from
which we received a milestone payment in the first quarter of 2007.
The net loss for the first quarter of 2008 was $4.9 million or
$0.04 per share, compared with a net loss of $10.3 million or $0.10
per share in the first quarter of 2007. This $5.4 million
improvement was primarily attributable to the $0.6 million increase
in revenues noted above and a $4.9 million reduction in total
expenses. The $4.9 million total reduction in expenses was due to a
$3.9 million decline in selling, general and administrative
expenses ("SG&A Expenses"), a $0.9 million decrease in research
and development expenses ("R&D Expenses"), and the elimination
of $576,000 cost of goods sold, which was partially offset by a
$392,000 non-cash loss on investments. The reduction in SG&A
Expenses was due primarily to the elimination of litigation
expenses following the March 2007 settlement and the removal of
commercial expenses associated with our business restructuring
plan. The elimination of the cost of goods sold resulted from our
withdrawal of IPLEX(TM) from the short stature market. The lower
R&D Expenses reflected the reduced operating costs at our
manufacturing facility located in Boulder, Colorado as we
streamlined the facility to support our clinical activities
following the withdrawal of IPLEX(TM) from the commercial short
stature market. The realized loss on investments arises from the
write-down of our investment in Napo. This investment, which was
funded by a milestone payment from Napo, was recorded as part of
our agreement with Napo in 2007. Interest income in the first
quarter of 2008 at $279,000 was slightly below the $301,000 earned
in the same period of 2007 and was primarily due to the lower
interest rate environment. Interest expense increased to $354,000
in the most recent period from $151,000 during the corresponding
period of 2007. The reduction was due to an increase in the debt
discount amortization resulting from the quarterly payment of our
2005 convertible notes, which began in March 2008. As of March 31,
2008, we had total cash, cash equivalents and short-term
investments on hand of $12.0 million, compared to $16.5 million on
hand as of December 31, 2007. The $4.5 million decrease in cash,
cash equivalents and short-term investments primarily reflects the
use of $3.9 million for operating activities and a $553,000
principal repayment of our 2005 convertible notes, which began on
March 1, 2008. Conference Call To participate in today's 8:30 AM ET
live conference call, please dial 888-680-0879 (U.S. callers) or
617-213-4856 (international callers), and provide passcode
36651483. A live webcast of the call will also be available at:
http://phx.corporate-ir.net/playerlink.zhtml?c=122332&s=wm&e=1833642.
Please allow extra time prior to the webcast to register, download
and install any necessary audio software. The webcast will be
archived for 30 days, and a telephone replay of the call will be
available for seven days beginning today at 10:30 AM ET at
888-286-8010 (U.S. callers) or 617-801-6888 (international
callers), using passcode 13315852. About Insmed Insmed Inc. is a
biopharmaceutical company with unique protein process development
and manufacturing experience and a proprietary protein platform
aimed at niche markets with unmet medical needs. For more
information, please visit http://www.insmed.com/. Forward-Looking
Statements This release contains forward-looking statements which
are made pursuant to provisions of Section 21E of the Securities
Exchange Act of 1934. Investors are cautioned that such statements
in this release, including statements relating to planned clinical
study design, regulatory and business strategies, plans and
objectives of management and growth opportunities for existing or
proposed products, constitute forward-looking statements which
involve risks and uncertainties that could cause actual results to
differ materially from those anticipated by the forward-looking
statements. The risks and uncertainties include, without
limitation, risks that product candidates may fail in the clinic or
may not be successfully marketed or manufactured, we may lack
financial resources to complete development of product candidates,
the FDA may interpret the results of studies differently than us,
competing products may be more successful, demand for new
pharmaceutical products may decrease, the biopharmaceutical
industry may experience negative market trends, our entrance into
the follow on biologics market may be unsuccessful, our common
stock could be delisted from the Nasdaq Capital Market and other
risks and challenges detailed in our filings with the U.S.
Securities and Exchange Commission, including our Annual Report on
Form 10-K for the year ended December 31, 2007. Readers are
cautioned not to place undue reliance on any forward-looking
statements which speak only as of the date of this release. We
undertake no obligation to publicly release the results of any
revisions to these forward-looking statements that may be made to
reflect events or circumstances that occur after the date of this
release or to reflect the occurrence of unanticipated events.
Investor Relations Contact: Brian Ritchie - FD 212-850-5683
Corporate Communications Contact: John Procter - Gibraltar
Associates 202-879-5808 INSMED INCORPORATED Consolidated Balance
Sheets (in thousands, except share and per share data) (unaudited)
March 31, December 31, 2008 2007 Assets Current assets: Cash, cash
equivalents and short-term investments $12,030 $16,479 Accounts
receivable, net 327 250 Prepaid expenses 110 244 Total current
assets 12,467 16,973 Long-term assets: Restricted cash - long term
2,095 2,095 Investments 108 258 Deferred financing costs, net 142
170 Property and equipment, net - 4 Total long-term assets 2,345
2,527 Total assets $14,812 $19,500 Liabilities and stockholders'
equity Current liabilities: Accounts payable $804 $904 Accrued
project costs & other 515 503 Payroll liabilities 799 631
Interest payable 20 23 Deferred rent 115 115 Deferred income 271
245 Convertible debt 2,211 2,211 Debt discount (865) (950) Net
convertible debt 1,346 1,261 Total current liabilities 3,870 3,682
Long-term liabilities: Convertible debt 2,211 2,764 Debt discount
(476) (651) Net long-term convertible debt 1,735 2,113 Asset
retirement obligation 2,217 2,217 Total liabilities 7,822 8,012
Stockholders' equity: Common stock; $.01 par value; authorized
shares 500,000,000; issued and outstanding shares, 121,904,312
1,219 1,219 Additional paid-in capital 341,403 341,270 Accumulated
deficit (335,632) (330,759) Accumulated other comprehensive loss:
Unrealized loss on investment - (242) Net stockholders' equity
6,990 11,488 Total liabilities and stockholders' equity $14,812
$19,500 INSMED INCORPORATED Consolidated Statements of Operations
(in thousands, except per share data - unaudited) Three Months
Ended March 31, 2008 2007 Sales, net $ - $423 Royalties 25 35
License income - 500 Other expanded access program income 2,292 702
Total revenues 2,317 1,660 Operating expenses: Cost of goods sold -
576 Research and development 5,241 6,105 Selling, general and
administrative 1,482 5,382 Realized loss on investments 392 - Total
expenses 7,115 12,063 Operating loss (4,798) (10,403) Interest
income 279 301 Interest expense (354) (151) Net loss $(4,873)
$(10,253) Basic and diluted net loss per share $(0.04) $(0.10)
Shares used in computing basic and diluted net loss per share
121,904 101,328 INSMED INCORPORATED Consolidated Statements of Cash
Flows (in thousands - unaudited) Three Months Ended March 31, 2008
2007 Operating activities Net loss $(4,873) $(10,253) Adjustments
to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 292 82 Stock based compensation
expense 133 56 Stock options issued for services - 8 Realized loss
on investments 392 - Changes in operating assets and liabilities:
Accounts receivable (77) 130 Inventory - 576 Other assets 134 52
Accounts payable (100) (2,936) Accrued project costs 12 (547)
Payroll liabilities 168 812 Deferred income 26 - Asset retirement
obligation - 147 Interest payable (3) - Net cash used in operating
activities (3,896) (11,873) Investing activities Decreases
(increases) of short-term investments 5,601 12,044 Purchases of
investments - (500) Net cash provided by investing activities 5,601
11,544 Financing activities Repayment of convertible notes (553) -
Cash restricted to restricted letters of credit - 297 Net cash
(used in) provided by financing activities (553) 297 Increase
(decrease) in cash and cash equivalents 1,152 (32) Cash and cash
equivalents at beginning of period 3,554 2,121 Cash and cash
equivalents at end of period $4,706 $2,089 Supplemental information
Cash paid for interest $68 $71 The table below details the "Cash
and cash equivalents" from the statement of cash flows to "Cash,
cash equivalents and short-term investments" shown on the balance
sheet. March 31, 2008 Cash and Cash Equivalents 4,706 Short-Term
Investments 7,324 Total Cash and Cash Equivalents and Short-Term
Investments 12,030 DATASOURCE: Insmed Inc. CONTACT: Investor
Relations Contact, Brian Ritchie of FD, +1-212-850-5683, ;
Corporate Communications Contact, John Procter of Gibraltar
Associates, +1-202-879-5808, Web site: http://www.insmed.com/
Copyright
Insmed (NASDAQ:INSM)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Insmed (NASDAQ:INSM)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024