Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company
focused on the development and commercialization of drug candidates
for the treatment of metabolic diseases and endocrine disorders
with unmet medical needs, today announced results for the three and
six month periods ended June 30, 2006. -0- *T 1st Half 1st Half
$000's (except EPS) Q2 2006 Q2 2005 2006 2005
---------------------------------------------------------------------
Total Revenues 210 28 263 85 Net loss (8,911)(8,524) (22,339)
(14,288) Earnings per share (0.09) (0.19) (0.25) (0.32)
---------------------------------------------------------------------
*T Discussion of Revenue and Expense Items Revenues for the three
months ended June 30, 2006 were $210,000 as compared with $28,000
in the corresponding period of 2005. The $210,000 revenue figure
for the second quarter of 2006 was made up of $172,000 in sales to
patients in our named patient program, $8,000 in sales to
commercial patients and $30,000 in royalties. Commercial sales of
our FDA approved drug IPLEX(TM), commenced on May 25, 2006 with the
first month's supply being provided free to many of the children in
order for them to begin treatment immediately rather than wait for
IPLEX(TM) to be approved by the individuals' payer plan. The
$28,000 of revenue for the second quarter of 2005 reflects only
royalties as receipts from our named patient program for the second
quarter of 2005, totalling $27,000, were classed as a reduction in
expense, as we were reporting results on a research and development
basis at the time. Cost of goods sold for the second quarter of
2006 was $23,000. The cost of goods sold for the current quarter
was favorably impacted by the consumption of intermediates and raw
materials which were manufactured and expensed in prior quarters
when all costs were classed as research and development expense.
The net loss for the second quarter ended June 30, 2006 was $8.9
million or $0.09 per share, as compared to a net loss of $8.5
million or $0.19 per share for the corresponding quarter of 2005.
The $0.4 million increase in the net loss for the second quarter of
2006 as compared to the second quarter of 2005 was due mainly to a
$3.5 million increase in selling, general and administration
(SG&A) expense, which was partially offset by a combination of
a $1.7 million decrease in interest expense, a $1.0 million
reduction in research and development expense and a $0.3 million
increase in interest income. The rise in SG&A expenses for the
three months ended June 30, 2006 is mainly due to the hiring and
ramping up of our commercial team and associated marketing expenses
for our commercial launch of IPLEX(TM), and the recording of patent
litigation expenses in the SG&A category as we commenced
commercial operations in the second quarter of 2006. Prior to the
second quarter of 2006 the patent litigation expenses were recorded
in research and development. The decrease in interest expense is
due to a $1.8 million reduction in non-cash amortization associated
with the convertible debt discount on the 2005 notes, which was
partially offset by a $0.1 million reduction in actual cash
interest payments on the 2005 notes. The decrease in research and
development expenses for the three months ended June 30, 2006, as
compared to the corresponding period of 2005, was mainly due to the
capitalization of inventory and construction in progress at the our
production facility in Boulder, Colorado and the recording of the
patent litigation expenses in SG&A. The increase in interest
income for the quarter resulted from the higher level of cash on
hand for investment as a result of the completion of our public
offering in March of 2006. Revenues reported for the six months
ended June 30, 2006 were $263,000 as compared to $85,000 reported
for the same period in 2005. The $263,000 of revenues reported for
the half year were made up of $172,000 in sales to patients in our
named patient program, $8,000 in sales to commercial patients
reported and $83,000 from royalties. The $85,000 of revenue for the
first half of 2005 reflects only royalties, as receipts from our
named patient program for the first half of 2005, totalling
$134,000, were classified at the time as a reduction in expense.
Cost of goods sold for the six months ended June 30, 2006 were
$23,000, the same as reported for the second quarter of 2006. The
net loss for the six months ended June 30, 2006 was $22.3 million,
or $0.25 per share, compared to the net loss of $14.3 million, or
$0.32 per share, reported for the corresponding period in 2005. The
$8.1 million increase in the net loss for the first half of 2006 as
compared to the first half of 2005 was due primarily to a $6.0
million increase in SG&A expense, a $1.9 million increase in
research and development expense and a $0.9 million rise in
interest expense, partially offset by a $0.6 million increase in
interest income. The rise in SG&A expenses is primarily due to
the build-up of our commercial team and associated marketing
expenses in connection with the launch of IPLEX(TM), together with
the recording in SG&A of patent litigation expenses, which were
higher than corresponding quarters. The higher research and
development expenses were mainly due to higher product and process
development expenses at our manufacturing facility in Boulder,
Colorado, as we added personnel and continued scale up and process
improvements in support of current and future IPLEX(TM) production.
These increases were partially offset by the recording of patent
litigation expenses in SGA and the capitalization of inventory and
construction in progress. The higher interest expense results from
a $1.1 million increase in non-cash amortization of the March 2005
convertible debt discount, offset by a $0.2 million reduction in
actual cash interest payments, as the conversion of the March 2005
notes and warrants, which were exercised during the first quarter
of 2006, resulted in an acceleration of the debt discount and a
reduction in interest paid. The increase in interest income for the
quarter resulted from the higher level of cash on hand for
investment. As of June 30, 2006, we had total cash and cash
equivalents of $48.4 million which represents an increase of $29.6
million from December 31, 2005. This net increase is due to the
$52.1 million in net cash provided by financing activities during
the first half of the year, which was partially offset by the $19.5
million in net cash used during the half in support of our business
operations and $3.0 million of construction in progress at our
manufacturing facility. The $52.1 million of cash from financing
activities was generated from a combination of $42.8 million in net
proceeds from the sale of common stock in March 2006, $8.8 million
from the exercise of certain outstanding warrants and $0.4 million
from a reduction in a restricted letter of credit and employee
option exercises. Conference Call We will host a conference call on
Tuesday, August 8; at 4:30 p.m. Eastern Time to discuss the
financial results for the first quarter of 2006 and provide a
business update. Interested investors can listen to the call over
the internet from Insmed's investor relations website at
www.insmed.com or by dialling (800) 361-0912 (domestic) or (913)
981-5559 (international). A telephonic replay of the call will be
available for one week at 888-203-1112 (domestic) or (719) 457-0820
(international), passcode: 1703416. A web replay of the call will
be available through our corporate website, in the investor
relations segment, beginning at 6:00 p.m. About IPLEX(TM) IPLEX(TM)
is approved in the United States as the only once daily treatment
for children with short stature associated with severe primary
IGF-I deficiency (Primary IGFD). IPLEX(TM), a complex of
recombinant human IGF-I and its binding protein IGFBP-3
(rhIGF-I/rhIGFBP-3), is the only FDA-approved IGF-I replacement
therapy that also replaces deficient IGFBP-3 in these patients. The
drug, which was launched in the second quarter of 2006, is also
being investigated for various other indications with unmet medical
needs, including severe insulin resistance, myotonic muscular
dystrophy and HIV Associated Adipose Redistribution Syndrome
(HARS). For more information about IPLEX(TM) please go to
www.go-IPLEX.com. About Insmed Incorporated Insmed is a
biopharmaceutical company focused on the development and
commercialization of drug candidates for the treatment of metabolic
diseases and endocrine disorders with unmet medical needs. For more
information, please visit www.insmed.com. Our leading product,
IPLEX(TM) was approved as an orphan drug by the United States Food
and Drug Administration in December 2005 for the treatment of
growth failure in children with severe primary IGF-I deficiency
(Primary IGFD) or with growth hormone (GH) gene deletion who have
developed neutralizing antibodies to GH. Statements included within
this press release, which are not historical in nature, may
constitute forward-looking statements for purposes of the safe
harbor provided by the Private Securities Litigation Reform Act of
1995. Forward-looking statements in this press release include, but
are not limited to, statements regarding financial position,
results of operations, cash flows, financing plans, business
strategies, capital and other expenditures, competitive positions,
commercial acceptance of IPLEX(TM), growth opportunities for
approved or proposed products, plans and objectives of management.
Such forward-looking statements are subject to numerous risks and
uncertainties, including risks that we may not successfully launch
IPLEX(TM), our product candidates may fail in clinical trials or
may not be successfully marketed, we may lack financial resources
to complete development of product candidates, we may be unable to
raise additional financing necessary to continue current
operations, we may not be able to sufficiently expand the
manufacturing capacity of our leased manufacturing facility in
Boulder, Colorado, and utilize that facility to manufacture our
approved product, IPLEX(TM), and other product candidates,
competing products may be more successful, we may have a negative
outcome of our current litigation with third parties regarding our
patent rights, demand for new pharmaceutical products may decrease
and the biopharmaceutical industry may experience negative market
trends. As a result of these and other risks and uncertainties,
actual results may differ materially from those described in this
press release. For further information with respect to factors that
could cause actual results to differ from expectations, reference
is made to reports filed by the Company with the Securities and
Exchange Commission under the Securities Exchange Act of 1934, as
amended. The forward-looking statements made in this release are
made only as of the date hereof and Insmed disclaims any intention
or responsibility for updating predictions or financial guidance
contained in this release. -0- *T INSMED INCORPORATED Condensed
Consolidated Balance Sheets (in thousands, except share and per
share data) June 30, Dec. 31, 2006 2005 ---------- --------- Assets
Current assets: Cash and cash equivalents $48,356 $18,835
Restricted cash 285 285 Accounts receivable 105 - Inventories 1,797
- Other current assets 190 83 ----------- --------- Total current
assets 50,733 19,120 Long-term assets: Restricted cash - long term
2,830 3,118 Deferred financing costs, net 262 532 Property and
equipment, net 3,029 17 ------------------------ Total long-term
assets 6,121 3,667 ------------------------ Total assets $56,854
$22,829 =========== ========= Liabilities and stockholders' equity
Current liabilities: Accounts payable $2,884 $968 Accrued project
costs & other 1,353 1,990 Payroll liabilities 1,690 1,574
Interest payable 28 52 Restructuring reserve 121 286 -----------
--------- Total current liabilities 6,076 4,870 Long-term
liabilities: Convertible debt 6,013 11,438 Debt discount (2,466)
(5,001) ----------- --------- Net convertible debt 3,547 6,437
Asset retirement obligation 1,330 1,034 ------------------------
Total liabilities 10,953 12,341 ----------- --------- Stockholders'
equity: Common stock; $.01 par value; authorized shares
500,000,000; issued and outstanding shares, 100,228,903 in 2006 and
66,525,792 in 2005 1,002 665 Additional paid-in capital 321,895
264,522 Accumulated deficit (276,996) (254,658) -----------
--------- Net stockholders' equity 45,901 10,529 -----------
--------- Total liabilities and stockholders' equity $56,854
$22,870 =========== ========= INSMED INCORPORATED Condensed
Consolidated Statements of Operations (in thousands, except per
share data - unaudited) Three Months Ended Six Months Ended June 30
June 30 ----------------- ------------------- 2006 2005 2006 2005
-------- -------- --------- --------- Sales $ 180 $ - $ 180 $ -
Royalties 30 28 83 85 -------- -------- --------- --------- Total
revenues 210 28 263 85 Operating expenses: Cost of goods sold 23 -
23 - Research and development 4,348 5,339 11,522 9,626 Selling,
general and administrative 5,163 1,640 8,963 2,933 --------
-------- --------- --------- Total costs and expenses 9,534 6,979
20,508 12,559 -------- -------- --------- --------- Operating loss
(9,324) (6,951) (20,245) (12,474) Interest income 577 252 889 316
Interest expense (164) (1,825) (2,983) (2,130) -------- --------
--------- --------- Net loss $(8,911) $(8,524) $(22,339) $(14,288)
======== ======== ========= ========= Basic and diluted net loss
per share $ (0.09) $ (0.19) $ (0.25) $ (0.32) ======== ========
========= ========= Shares used in computing basic and diluted net
loss per share 100,152 44,998 90,125 44,992 ========== ========
========= ========= INSMED INCORPORATED Condensed Consolidated
Statements of Cash Flows (in thousands - unaudited) Six Months
Ended June 30 2006 2005 -------- -------- Operating activities Net
loss $(22,339) $(14,288) Adjustments to reconcile net loss to net
cash used in operating activities: Depreciation and amortization
2,809 1,573 Non-cash stock acceleration 14 Stock based compensation
expense 481 - Stock options issued for services 40 - Changes in
operating assets and liabilities: Accounts receivable (105)
Inventory (1,797) Other assets (107) (16) Accounts payable 1,916
(690) Accrued project costs (636) (586) Payroll liabilities 116
(149) Restructuring reserve (165) (158) Asset retirement obligation
296 296 Interest payable (24) 315 -------- -------- Net cash used
in operating activities (19,515) (13,689) -------- --------
Investing activities Purchase of Property, Plant and Equipment
(3,016) - -------- -------- Net cash used in investing activities
(3,016) - -------- -------- Financing activities Proceeds from
issuance of convertible debt with detachable stock warrants -
35,000 Proceeds from issuance of common stock 165 Public offering -
issuance of 23 million shares 43,240 - Issuance costs (421) -
Warrants converted into shares 8,810 - Other 135 -------- ---------
Total proceeds from issuance of common stock 51,764 165 Costs
incurred in conjunction with issuance of debt - (2,428) Cash
restricted to restricted letters of credit 288 185 --------
-------- Net cash provided by financing activities 52,052 32,922
-------- -------- Increase in cash and cash equivalents 29,521
19,233 Cash and cash equivalents at beginning of period 18,835
9,222 -------- -------- Cash and cash equivalents at end of period
$ 48,356 $ 28,455 ======== ======== Supplemental information Cash
paid for interest $ 165 $ 411 *T
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