Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on the unmet needs of patients with rare diseases,
today reported financial results for the quarter ended March 31,
2016.
Business Update
- Global Phase 3 CONVERT study
advancing. Patient enrollment continues to proceed on
track 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 at more than 130 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 remains on track with previous guidance, having
submitted its responses to the European Medicine Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) 180-day list
of outstanding issues related to the company’s Marketing
Authorization Application (MAA) for ARIKAYCE. Insmed expects to
participate in an oral explanation meeting in the second quarter of
2016 and the CHMP to render an opinion on its MAA around the middle
of 2016.
- Data accepted for presentation at ATS 2016.
Three ARIKAYCE-related abstracts and one treprostinil prodrug
abstract have been accepted for presentation at the American
Thoracic Society (ATS) 2016 International Conference taking place
May 13-18 in San Francisco. The ATS presentations include (i)
one-year follow-up data from the phase 2 112 study, (ii) lung
distribution and retention data from a scintigraphy study in
patients with NTM lung disease, (iii) a preclinical study of
ARIKAYCE, and (iv) a preclinical study of a variety of treprostinil
prodrugs.
- Phase 1 clinical study of INS1009 submitted for
presentation. Insmed has completed a phase 1 study of
INS1009 and submitted the results for presentation at a future
medical meeting. This first-in-human study of INS1009 was designed
to determine the maximum-tolerated dose of a single dose of INS1009
and to characterize the pharmacokinetic profile of free
treprostinil and INS1009 in healthy volunteers. INS1009 is one of
the company’s nebulized treprostinil prodrugs, which 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.
- Canadian patent strengthens global patent
portfolio. The Canadian Intellectual Property Office
issued patent no. 2,838,111, which covers pharmaceutical
formulations that include mixtures of liposomal quinolone
antibiotics, together with free, unencapsulated quinolone
antibiotics, such as ciprofloxacin. The patent also covers the use
of such formulations for the treatment of various pulmonary
disorders, for example, in bronchiectasis patients. The Canadian
patent complements ARIKAYCE’s global intellectual property estate.
Counterpart patent applications to this Canadian patent are pending
in other countries.
“2016 is off to a solid start with all of our clinical,
regulatory, and commercial-readiness activities remaining on track
with our previously stated timelines,” said Will Lewis, president
and chief executive officer of Insmed. “Our top corporate priority
is our global phase 3 CONVERT study and we look forward to
achieving our patient enrollment objective later this year. In
parallel with our clinical activities, our team is advancing the
regulatory process for ARIKAYCE in Europe. For INS1009, we
completed the phase 1 study and submitted the results for
presentation at an international respiratory congress in the third
quarter. Lastly, our talented team of scientists remain focused on
advancing a number of preclinical programs and identifying our next
candidates for clinical development.”
First Quarter Financial Results
For the first quarter of 2016, Insmed posted a net loss of $33.5
million, or $0.54 per share, compared with a net loss of $27.4
million, or $0.55 per share, for the first quarter of 2015.
Research and development expenses were $20.5 million for the
first quarter of 2016, compared with $17.2 million for the first
quarter of 2015. The increase was primarily due to the advancement
of the company’s global phase 3 CONVERT study of ARIKAYCE in NTM
lung disease.
General and administrative expenses for the first quarter of
2016 were $12.5 million, compared with $9.5 million for the first
quarter of 2015. The increase was primarily related to
pre-commercial activities in Europe, namely the buildout of the
company’s infrastructure and NTM disease awareness activities, as
well as an increase in headcount and related expenses.
Balance Sheet Highlights and Cash Guidance
As of March 31, 2016, Insmed had cash and cash equivalents of
$253 million. Excluding depreciation and stock-based compensation
expense, the company’s cash operating expenses for the quarter
ended March 31, 2016 were $28 million. Insmed ended the first
quarter of 2016 with $25 million in debt and working capital of
$233 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. Insmed
continues to expect its cash-based operating expenses for the first
half of 2016 to 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 press release contains forward looking statements.
“Forward-looking statements,” as that term is defined in the
Private Securities Litigation Reform Act of 1995, are statements
that are not historical facts and involve a number of risks and
uncertainties. Words herein such as “may,” “will,” “should,”
“could,” “would,” “expects,” “plans,” “anticipates,” “believes,”
“estimates,” “projects,” “predicts,” “intends,” “potential,”
“continues,” and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
identify forward-looking statements.
Forward-looking statements are based upon the company’s current
expectations and beliefs, and involve known and unknown risks,
uncertainties and other factors, which may cause actual results,
performance and achievements and the timing of certain events to
differ materially from the results, performance, achievements or
timing discussed, projected, anticipated or indicated in any
forward-looking statements. Such factors include, among others, the
factors discussed in Item 1A “Risk Factors” in the company’s Annual
Report on Form 10-K for the year ended December 31, 2015 and
subsequent quarterly reports on Form 10-Q, and the following: the
ability to complete development of, receive regulatory approval
for, and successfully commercialize ARIKAYCE, or liposomal amikacin
for inhalation (LAI), and INS1009, nebulized treprostinil prodrug;
estimates of expenses and future revenues and profitability; plans
to develop and market new products and the timing of these
development programs; status, timing, and the results of
preclinical studies and clinical trials and preclinical and
clinical data described herein; the timing of responses to
information and data requests from the US Food and Drug
Administration, the European Medicines Agency, and other regulatory
authorities; clinical development of product candidates; ability to
obtain and maintain regulatory approval for product candidates;
expectation as to the timing of regulatory review and approval;
estimates regarding our capital requirements and the needs for
additional financing; estimates of the size of the potential
markets for product candidates; selection and licensing of product
candidates; ability to attract third parties with acceptable
development, regulatory and commercialization expertise; the
benefits to be derived from corporate license agreements and other
third party efforts, including those relating to the development
and commercialization of product candidates; the degree of
protection afforded to the company by its intellectual property
portfolio; the safety and efficacy of product candidates; sources
of revenues and anticipated revenues, including contributions from
license agreements and other third party efforts for the
development and commercialization of products; ability to create an
effective direct sales and marketing infrastructure for products
the company elects to market and sell directly; the rate and degree
of market acceptance of product candidates; the timing, scope and
rate of reimbursement for product candidates; the success of other
competing therapies that may become available; and the availability
of adequate supply and manufacturing capacity and quality for
product candidates.
The company cautions readers not to place undue reliance on any
such forward-looking statements, which speak only as of the date
they are made. Insmed disclaims any obligation, except as
specifically required by law and the rules of the Securities and
Exchange Commission, to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
Financial Statements to Follow
Insmed Incorporated |
Consolidated Balance Sheets |
(in thousands, except par value and share
data) |
|
|
|
|
|
|
|
As of |
|
As of |
|
|
March 31, 2016 |
|
December 31,
2015 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
252,872 |
|
|
$ |
282,876 |
|
Prepaid expenses and other current
assets |
|
|
5,618 |
|
|
|
5,242 |
|
Total current assets |
|
|
258,490 |
|
|
|
288,118 |
|
|
|
|
|
|
In-process research and
development |
|
|
58,200 |
|
|
|
58,200 |
|
Fixed assets, net |
|
|
8,899 |
|
|
|
8,092 |
|
Other assets |
|
|
2,117 |
|
|
|
2,146 |
|
Total assets |
|
$ |
327,706 |
|
|
$ |
356,556 |
|
|
|
|
|
|
Liabilities and
shareholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
8,688 |
|
|
$ |
7,468 |
|
Accrued expenses |
|
|
10,495 |
|
|
|
10,995 |
|
Other current liabilities |
|
|
686 |
|
|
|
683 |
|
Current portion of long-term
debt |
|
|
5,674 |
|
|
|
3,113 |
|
Total current
liabilities |
|
|
25,543 |
|
|
|
22,259 |
|
|
|
|
|
|
Debt, long-term |
|
|
19,114 |
|
|
|
22,027 |
|
Other long-term
liabilities |
|
|
586 |
|
|
|
572 |
|
Total liabilities |
|
|
45,243 |
|
|
|
44,858 |
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
Common stock, $0.01 par value;
500,000,000 |
|
|
|
|
|
|
|
|
authorized shares, 61,872,863 and
61,813,995 |
|
|
|
|
|
|
|
|
issued and outstanding shares at
March 31, 2016 |
|
|
|
|
|
|
|
|
and December 31, 2015,
respectively |
|
|
619 |
|
|
|
618 |
|
Additional paid-in capital |
|
|
904,342 |
|
|
|
900,043 |
|
Accumulated deficit |
|
|
(622,495 |
) |
|
|
(588,963 |
) |
Accumulated other comprehensive
loss |
|
|
(3 |
) |
|
|
-- |
|
Total shareholders'
equity |
|
|
282,463 |
|
|
|
311,698 |
|
Total liabilities and shareholders'
equity |
|
$ |
327,706 |
|
|
$ |
356,556 |
|
Insmed Incorporated |
Consolidated Statements of Net
Loss |
(in thousands, except per share
data) |
|
|
|
|
|
(Unaudited) |
|
Three Months Ended March
31, |
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
Revenues |
$ |
-- |
|
|
$ |
-- |
|
|
|
|
|
Operating
expenses: |
|
|
|
Research and development |
|
20,547 |
|
|
|
17,164 |
|
General and administrative |
|
12,520 |
|
|
|
9,542 |
|
Total operating expenses |
|
33,067 |
|
|
|
26,706 |
|
|
|
|
|
Operating loss |
|
(33,067 |
) |
|
|
(26,706 |
) |
|
|
|
|
Investment income |
|
170 |
|
|
|
23 |
|
Interest expense |
|
(622 |
) |
|
|
(722 |
) |
Other income, net |
|
15 |
|
|
|
36 |
|
Loss before income taxes |
|
(33,504 |
) |
|
|
(27,369 |
) |
|
|
|
|
Provision for income
taxes |
|
28 |
|
|
|
-- |
|
|
|
|
|
Net loss |
$ |
(33,532 |
) |
|
$ |
(27,369 |
) |
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.54 |
) |
|
$ |
(0.55 |
) |
|
|
|
|
Weighted average basic
and diluted common shares outstanding |
|
61,858 |
|
|
|
49,957 |
|
Insmed Incorporated:
Susan Mesco
Head of Investor Relations
908-947-4326
Insmed (NASDAQ:INSM)
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