Insmed Reports Fourth Quarter 2015 Financial Results
10 Mars 2016 - 1:46AM
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on the unmet needs of patients with rare diseases,
today reported financial results for the fourth quarter and year
ended December 31, 2015.
Business Update
- Global Phase 3 ARIKAYCE™ study
advancing. Patient enrollment continues in the company’s
global phase 3 study of ARIKAYCE (liposomal amikacin for inhalation
or LAI) in nontuberculous mycobacteria (NTM) lung disease caused by
Mycobacterium avium complex (MAC) (CONVERT™ or INS-212 study). The
CONVERT study is taking place in 16 countries and more than 115
sites. The company continues to expect to achieve its enrollment
objective in the second half of 2016.
- EMA regulatory review of ARIKAYCE progressing.
The company submitted its responses to the European Medicine
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) 120-day questions in December 2015 and expects to receive
the CHMP’s 180-day list of outstanding issues (LOI) in the first
quarter of 2016. Insmed anticipates responding to the LOI and
participating in an oral hearing with the CHMP in the second
quarter of 2016 to address the LOI on the company’s marketing
authorization application (MAA) for ARIKAYCE. The company continues
to expect the CHMP to render an opinion on its MAA around the
middle of 2016.
- Phase 1 clinical study of INS1009 underway.
Insmed is conducting a phase 1 study of INS1009 in healthy
subjects. INS1009 is the company’s nebulized treprostinil prodrug.
The company believes INS1009 may offer a differentiated product
profile with therapeutic potential in rare pulmonary disorders such
as pulmonary arterial hypertension (PAH), idiopathic pulmonary
fibrosis (IPF), sarcoidosis, and severe refractory asthma.
- INS1009 patent issued. The U.S. patent and
trademark office issued U.S. patent no. 9,255,064 (the ’064 patent)
on February 9, 2016. The ‘064 patent, entitled “Prostacyclin
compounds, compositions and methods of use thereof” is the first
patent to issue with claims reciting INS1009. Other treprostinil
prodrugs are also claimed and described in the patent.
Methods of using treprostinil prodrugs, including INS1009, are
described in the patent. The ‘064 patent provides exclusivity for
INS1009 until October 24, 2034.
“Last year, Insmed made important progress advancing our
clinical and regulatory activities and establishing the foundation
of our commercial infrastructure for ARIKAYCE in Europe,” said Will
Lewis, president and chief executive officer of Insmed. “We
enhanced our global team and managed our resources, ending the year
with $283 million in cash. In 2016, our priorities include
completing patient enrollment in the phase 3 CONVERT study,
advancing the European regulatory review of ARIKAYCE, and reporting
new data from our internal research programs.”
Fourth Quarter Financial Results
For the fourth quarter of 2015, Insmed posted a net loss of
$31.2 million, or $0.51 per share, compared with a net loss of
$17.6 million, or $0.36 per share, for the fourth quarter of
2014.
Research and development expenses were $19.6 million for the
fourth quarter of 2015, compared with $14.8 million for the fourth
quarter of 2014. The increase was primarily due to the company’s
global phase 3 CONVERT study of ARIKAYCE in NTM lung disease.
General and administrative expenses for the fourth quarter of
2015 were $12.9 million, compared with $8.3 million for the fourth
quarter of 2014. The increase was primarily related to
pre-commercial activities in Europe and personnel-related expenses,
including non-cash stock-based compensation expense.
Balance Sheet Highlights and Cash Guidance
As of December 31, 2015, Insmed had cash and cash equivalents of
$283 million. The company is investing in the following activities
in 2016: (i) clinical development of ARIKAYCE, (ii) regulatory and
pre-commercial initiatives for ARIKAYCE, and (iii) preclinical and
clinical activities for its earlier-stage pipeline. As a result,
Insmed expects its cash-based operating expenses for the first half
of 2016 will be in the range of $58 to $68 million.
About Insmed
Insmed Incorporated is a global biopharmaceutical company
focused on the unmet needs of patients with rare diseases. The
company is advancing a global phase 3 clinical study of ARIKAYCE™
(liposomal amikacin for inhalation) in nontuberculous mycobacteria
(NTM) lung disease, a rare and often chronic infection that is
capable of causing irreversible lung damage and can be fatal. There
are currently no products indicated for the treatment of NTM lung
disease in the United States or European Union (EU). In the EU, the
company has filed a marketing authorization application seeking
approval of ARIKAYCE for use in patients with NTM lung disease.
Insmed’s earlier-stage clinical pipeline includes INS1009, a
nebulized prodrug formulation of treprostinil that the company
believes may offer a differentiated product profile with
therapeutic potential in rare pulmonary disorders such as pulmonary
arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF)
sarcoidosis, and severe refractory asthma. To complement its
internal research, Insmed actively seeks in-licensing opportunities
for a broad range of rare diseases. For more information,
visit www.insmed.com.
“Insmed” and “ARIKAYCE” are the company's trademarks. All other
trademarks, trade names or service marks appearing in this press
release are the property of their respective owners.
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 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, market
conditions, failure or delay of European, 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 the 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, the inability to make
product candidates commercially successful, changes in anticipated
expenses, changes in the company’s financing requirements or
ability to 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, 2015. 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.
Financial Statements to Follow
|
Insmed Incorporated |
Consolidated Balance Sheets |
(in thousands, except par value and share
data) |
|
|
|
|
|
|
|
As of |
|
As of |
|
|
December 31,
2015 |
|
December 31, 2014 |
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
282,876 |
|
|
$ |
159,226 |
|
Prepaid
expenses and other current assets |
|
|
5,242 |
|
|
|
5,488 |
|
Total current assets |
|
|
288,118 |
|
|
|
164,714 |
|
|
|
|
|
|
In-process research and
development |
|
|
58,200 |
|
|
|
58,200 |
|
Fixed assets, net |
|
|
8,092 |
|
|
|
7,534 |
|
Other assets |
|
|
2,146 |
|
|
|
416 |
|
Total
assets |
|
$ |
356,556 |
|
|
$ |
230,864 |
|
|
|
|
|
|
Liabilities and
shareholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
7,468 |
|
|
$ |
9,249 |
|
Accrued
expenses |
|
|
10,995 |
|
|
|
9,638 |
|
Other
current liabilities |
|
|
683 |
|
|
|
743 |
|
Current
portion of long-term debt |
|
|
3,113 |
|
|
|
-- |
|
Total current
liabilities |
|
|
22,259 |
|
|
|
19,630 |
|
|
|
|
|
|
Other long-term
liabilities |
|
|
572 |
|
|
|
141 |
|
Debt, long-term |
|
|
22,027 |
|
|
|
24,856 |
|
Total
liabilities |
|
|
44,858 |
|
|
|
44,627 |
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
Common
stock, $0.01 par value; 500,000,000 authorized shares,
61,813,995 and 49,806,131 issued and outstanding shares at December
31, 2015 and December 31, 2014, respectively |
|
|
618 |
|
|
|
498 |
|
Additional
paid-in capital |
|
|
900,043 |
|
|
|
656,519 |
|
Accumulated
deficit |
|
|
(588,963 |
) |
|
|
(470,780 |
) |
Total shareholders'
equity |
|
|
311,698 |
|
|
|
186,237 |
|
Total
liabilities and shareholders' equity |
|
$ |
356,556 |
|
|
$ |
230,864 |
|
|
|
|
|
|
|
|
|
|
|
Insmed Incorporated |
Consolidated Statements of Comprehensive
Loss |
(in thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
Three Months Ended December
31, |
|
Years Ended December
31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
19,646 |
|
|
|
14,799 |
|
|
|
74,277 |
|
|
|
56,292 |
|
General and
administrative |
|
12,944 |
|
|
|
8,267 |
|
|
|
43,216 |
|
|
|
31,073 |
|
Total
operating expenses |
|
32,590 |
|
|
|
23,066 |
|
|
|
117,493 |
|
|
|
87,365 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(32,590 |
) |
|
|
(23,066 |
) |
|
|
(117,493 |
) |
|
|
(87,365 |
) |
|
|
|
|
|
|
|
|
Investment income |
|
95 |
|
|
|
17 |
|
|
|
261 |
|
|
|
58 |
|
Interest expense |
|
(724 |
) |
|
|
(620 |
) |
|
|
(2,889 |
) |
|
|
(2,415 |
) |
Other income /
(expense), net |
|
3 |
|
|
|
(11 |
) |
|
|
(33 |
) |
|
|
141 |
|
Loss
before income taxes |
|
(33,216 |
) |
|
|
(23,680 |
) |
|
|
(120,154 |
) |
|
|
(89,581 |
) |
|
|
|
|
|
|
|
|
Benefit from income
taxes |
|
(1,971 |
) |
|
|
(6,033 |
) |
|
|
(1,971 |
) |
|
|
(10,422 |
) |
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
$ |
(31,245 |
) |
|
$ |
(17,647 |
) |
|
$ |
(118,183 |
) |
|
$ |
(79,159 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.51 |
) |
|
$ |
(0.36 |
) |
|
$ |
(2.02 |
) |
|
$ |
(1.84 |
) |
|
|
|
|
|
|
|
|
Weighted average basic
and diluted common shares outstanding |
|
61,805 |
|
|
|
49,662 |
|
|
|
58,633 |
|
|
|
43,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insmed Incorporated:
Susan Mesco
Head of Investor Relations
908-947-4326
Insmed (NASDAQ:INSM)
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