Insmed Reports 2013 Fourth Quarter and Full Year Financial Results
MONMOUTH JUNCTION, NJ--(Marketwired - Mar 6, 2014) - Insmed
Incorporated (NASDAQ: INSM) today reported financial results for
the three and twelve months ended December 31, 2013. The Company
will not hold a quarterly conference call to discuss these results
given the proximity to the scheduled announcement in late March of
top-line results from its phase 2 clinical trial with ARIKAYCE® to
treat nontuberculous mycobacteria (NTM) lung infections. The
Company plans to hold a conference call at that time.
Highlights of the fourth quarter of 2013 and subsequent two
months include:
- Reported positive interim data from the two-year, open-label
extension study of ARIKAYCE, or liposomal amikacin for inhalation,
to treat Pseudomonas aeruginosa infections in cystic
fibrosis (CF) patients, which demonstrated long-term safety and
durability of effect at 12 months;
- Entered into a contract manufacturing agreement with Therapure
Biopharma Inc. for the manufacture of ARIKAYCE;
- Received Orphan Medical Product Designation in the European
Union for ARIKAYCE to treat lung infections caused by NTM;
- Secured another European patent allowance, thereby
strengthening the Company's intellectual property position;
- Appointed David W.J. McGirr to its Board of Directors. Mr.
McGirr is the former Chief Financial Officer of Cubist
Pharmaceuticals, Inc.; and
- Appointed Peggy Berry as Vice President of Regulatory
Affairs. Ms. Berry has more than 25 years of experience in
the pharmaceutical industry and began her career at the U.S. Food
and Drug Administration. Ms. Berry has secured ten drug approvals
during her career. She will be reporting to Will Lewis, President
and Chief Executive Officer (CEO).
"2013 was a transformational year, one in which we laid the
foundation to build Insmed into a leading biopharmaceutical company
operating at the intersection of orphan, pulmonary and infectious
diseases," stated Will Lewis, President and CEO of Insmed. "Most
significantly, we advanced the ARIKAYCE clinical programs to treat
NTM lung disease as well as Pseudomonas aeruginosa in CF
patients. We also expanded our leadership team with talented
executives in key regulatory and commercial roles. Our collective
talents are focused on advancing the regulatory strategy and
filings for ARIKAYCE for the treatment of NTM lung infections and
CF patients with Pseudomonas."
"In the near term we plan to report top-line results from our
phase 2 clinical trial of ARIKAYCE to treat NTM lung infections.
Following the release of these data, we expect to have discussions
with regulatory authorities in the U.S. and Europe regarding a path
forward to filing for approval. In the interim, we have initiated a
comprehensive education campaign to raise awareness of NTM and to
increase accurate and early diagnosis," added Mr. Lewis. "It is our
goal to be the leader in this globally uncontested orphan disease
market."
Fourth Quarter Financial Results
For the fourth quarter of 2013, Insmed reported a net loss
attributable to common stockholders of $16.2 million, or $0.41 per
share, compared with a net loss attributable to common stockholders
of $15.5 million, or $0.49 per share, for the fourth quarter of
2012.
Research and development expenses for the fourth quarter of 2013
were $9.6 million as compared to $12.2 million for the fourth
quarter of 2012. Fourth quarter 2013 research development expenses
were primarily comprised of costs for clinical trial activities
associated with the Company's phase 2 trial in patients with NTM
lung disease in the U.S. and Canada and two-year open-label
extension study in CF patients with Pseudomonas aeruginosa
lung infections in Europe and Canada, and costs related to
manufacturing process improvements.
General and administrative expenses for the fourth quarter of
2013 increased to $6.0 million from $3.6 million for the fourth
quarter of 2012. The increase was primarily due to an increase of
$1.0 million of pre-commercial market research and related costs
and a $1.2 million increase in compensation expense (including a
$0.3 million increase in non-cash stock compensation expense).
Full Year Financial Results
For 2013 Insmed posted a net loss attributable to common
stockholders of $56.1 million, or $1.60 per share, compared with a
net loss attributable to common stockholders of $41.4 million, or
$1.56 per share, for 2012. The greater loss is primarily due to an
increase in both research and development expenses and general and
administrative expenses.
Research and development expenses for 2013 increased to $44.3
million from $29.8 million for 2012. The increase was primarily due
to the increased activities related to our phase 3 clinical study
in CF patients and related two-year, open-label safety study in
Europe and Canada, and our phase 2 NTM clinical study in the United
States. We initiated the phase 3 CF study and phase 2 NTM study in
the second quarter of 2012 and initiated the two-year CF extension
study in October 2012.
General and administrative expenses for 2013 increased to $22.2
million from $12.7 million in 2012. The increase was due primarily
to a $5.5 million increase in compensation expense (including an
increase of $3.9 million in non-cash stock-based compensation
expense), a $1.8 million increase in professional fees, including a
$1.4 million increase in legal fees related to the investigation,
accounting and reporting of excess equity awards and $2.9 million
for consulting expenses, mainly for market research and other
related costs. The 2012 results included $2.2 million in severance
expenses related to the departure of several executives and
employees.
Balance Sheet Highlights and Cash Guidance
As of December 31, 2013, Insmed had cash, cash equivalents and
short-term investments of $113.9 million, compared with $92.9
million as of December 31, 2012. The increase was primarily due to
$67.0 million of net proceeds from an underwritten public offering
of common stock completed in July 2013. The Company utilized $46.7
million of cash to fund operations during 2013. Excluding the
one-time $11.5 million cash payment the Company received from
Premacure (now Shire) in May 2013, net cash used in operating
activities for 2013 would have been $58.2 million. As of December
31, 2013, working capital was $99.7 million.
During 2014 the Company plans to continue to fund further
clinical development of ARIKAYCE, invest in third-party
manufacturing capacity, support efforts to obtain regulatory
approvals, and prepare for commercialization. Insmed estimates that
its cash requirements to fund operations for the first quarter of
2014 will be in the range of $15.0 million to $17.0 million. The
Company expects to provide additional 2014 cash guidance when it
releases first quarter 2014 financial results.
About Insmed
Insmed Incorporated is a biopharmaceutical company dedicated to
improving the lives of patients battling serious lung diseases.
Insmed is focused on the development and commercialization of
ARIKAYCE®, or liposomal amikacin for inhalation, for at
least two identified orphan patient populations: patients with
nontuberculous mycobacteria lung disease and cystic fibrosis
patients with Pseudomonas aeruginosa lung infections. .
For more information, visit www.insmed.com.
Forward-looking Statements
This release contains forward-looking statements. Words, and
variations of words, such as "intend," "expect," "will,"
"anticipate," "believe," "continue," "propose" and similar
expressions are intended to identify forward-looking statements.
Investors are cautioned that such statements in this release,
including statements relating to the status, results and timing of
clinical trials and clinical data, the anticipated benefits of
Insmed's products, the anticipated timing of regulatory
submissions, and the ability to obtain required regulatory
approvals, bring products to market and successfully commercialize
products and Insmed's cash needs constitute forward-looking
statements that involve risks and uncertainties that could cause
actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
without limitation, failure or delay of European, Canadian, U.S.
Food and Drug Administration and other regulatory reviews and
approvals, competitive developments affecting the Company's product
candidates, delays in product development or clinical trials or
other studies, patent disputes and other intellectual property
developments relating to the Company's product candidates,
unexpected regulatory actions, delays or requests, the failure of
clinical trials or other studies or results of clinical trials or
other studies that do not meet expectations, the fact that
subsequent analyses of clinical trial or study data may lead to
different (including less favorable) interpretations of trial or
study results or may identify important implications of a trial or
study that are not reflected in Company's prior disclosures, and
the fact that trial or study results or subsequent analyses may be
subject to differing interpretations by regulatory agencies, the
inability to successfully develop the Company's product candidates
or receive necessary regulatory approvals, inability to make
product candidates commercially successful, changes in anticipated
expenses, changes in the Company's financing requirements or
ability raise additional capital, and other risks and challenges
detailed in the Company's filings with the U.S. Securities and
Exchange Commission, including its Annual Report on Form 10-K for
the year ended December 31, 2013 and subsequent filings. Investors
are cautioned not to place undue reliance on any forward-looking
statements that speak only as of the date of this news release. The
Company undertakes no obligation to update these forward-looking
statements to reflect events or circumstances or changes in its
expectations.
-Tables to Follow-
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INSMED INCORPORATED |
|
Consolidated Balance Sheets |
|
(in thousands, except par value, share and per share
data) |
|
|
|
|
|
|
|
|
|
|
December 31, 2013 |
|
|
December 31, 2012 |
|
|
|
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Assets |
|
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Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
113,894 |
|
|
$ |
90,782 |
|
|
Certificate of deposit |
|
|
- |
|
|
|
2,153 |
|
|
Prepaid expenses and other current assets |
|
|
2,269 |
|
|
|
643 |
|
|
|
Total
current assets |
|
|
116,163 |
|
|
|
93,578 |
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
58,200 |
|
|
|
58,200 |
|
Other assets |
|
|
323 |
|
|
|
117 |
|
Fixed assets, net |
|
|
1,812 |
|
|
|
1,666 |
|
|
|
Total
assets |
|
$ |
176,498 |
|
|
$ |
153,561 |
|
|
|
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|
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|
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Liabilities and shareholders' equity |
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Current liabilities: |
|
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|
|
|
|
|
|
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Accounts payable |
|
$ |
5,929 |
|
|
$ |
7,060 |
|
|
Accrued expenses |
|
|
3,905 |
|
|
|
2,933 |
|
|
Accrued compensation |
|
|
2,839 |
|
|
|
2,207 |
|
|
Accrued lease expense, current |
|
|
307 |
|
|
|
295 |
|
|
Deferred rent |
|
|
129 |
|
|
|
149 |
|
|
Capital lease obligations, current |
|
|
64 |
|
|
|
96 |
|
|
Current portion of long term debt |
|
|
3,283 |
|
|
|
3,007 |
|
|
|
Total
current liabilities |
|
|
16,456 |
|
|
|
15,747 |
|
|
|
|
|
|
|
|
|
|
Accrued lease expense, long-term |
|
|
380 |
|
|
|
647 |
|
Capital lease obligations, long-term |
|
|
- |
|
|
|
64 |
|
Debt, long-term |
|
|
16,338 |
|
|
|
16,221 |
|
|
|
Total
liabilities |
|
|
33,174 |
|
|
|
32,679 |
|
|
|
|
|
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|
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Shareholders' equity: |
|
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|
|
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Common stock, $0.01 par value; 500,000,000 authorized
shares, 39,137,679 and 31,488,204 issued and outstanding shares at
December 31, 2013 and December 31, 2012, respectively |
|
|
391 |
|
|
|
315 |
|
|
Additional paid-in capital |
|
|
534,554 |
|
|
|
455,325 |
|
|
Warrant to purchase common stock |
|
|
- |
|
|
|
790 |
|
|
Accumulated deficit |
|
|
(391,621 |
) |
|
|
(335,548 |
) |
Total shareholders' equity |
|
|
143,324 |
|
|
|
120,882 |
|
|
|
Total
liabilities and shareholders' equity |
|
$ |
176,498 |
|
|
$ |
153,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
INSMED INCORPORATED |
|
Consolidated Income Statement |
|
(in thousands, except per share data) |
|
|
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|
|
|
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|
|
|
|
|
|
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|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
11,500 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
9,625 |
|
|
|
12,228 |
|
|
|
44,279 |
|
|
|
29,781 |
|
|
General and administrative |
|
|
5,969 |
|
|
|
3,605 |
|
|
|
22,236 |
|
|
|
12,657 |
|
|
|
Total
operating expenses |
|
|
15,594 |
|
|
|
15,833 |
|
|
|
66,515 |
|
|
|
42,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(15,594 |
) |
|
|
(15,833 |
) |
|
|
(55,015 |
) |
|
|
(42,438 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income |
|
|
25 |
|
|
|
921 |
|
|
|
166 |
|
|
|
1,822 |
|
Interest expense |
|
|
(610 |
) |
|
|
(539 |
) |
|
|
(2,412 |
) |
|
|
(763 |
) |
Other, net |
|
|
(35 |
) |
|
|
- |
|
|
|
(33 |
) |
|
|
5 |
|
|
|
Loss
before income taxes |
|
|
(16,214 |
) |
|
|
(15,451 |
) |
|
|
(57,294 |
) |
|
|
(41,374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for income taxes |
|
|
- |
|
|
|
- |
|
|
|
(1,221 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,214 |
) |
|
$ |
(15,451 |
) |
|
$ |
(56,073 |
) |
|
$ |
(41,374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.41 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.60 |
) |
|
$ |
(1.56 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average basic and diluted common shares
outstanding |
|
|
39,116 |
|
|
|
31,373 |
|
|
|
34,980 |
|
|
|
26,545 |
|
|
|
|
|
|
|
|
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|
|
|
|
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|
|
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Contacts: LHA Anne Marie Fields Senior Vice President
212-838-3777 afields@lhai.com Bruce Voss Managing Director
310-691-7100 bvoss@lhai.com
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