Insmed Incorporated (Nasdaq:INSM) today reported financial
results for the three and six months ended June 30, 2014.
Highlights of the second quarter of 2014 and recent weeks
include:
- Announced plans to file a Market
Authorization Application (MAA) with the European Medicines Agency
(EMA) for ARIKAYCE™, or liposomal amikacin for inhalation, for the
treatment of two orphan lung diseases: nontuberculous mycobacterial
(NTM) lung infections in treatment refractory patients and
Pseudomonas aeruginosa lung infections in patients with cystic
fibrosis (CF);
- Announced plans to initiate two global
Phase 3 clinical trials of ARIKAYCE in NTM; one for the broad NTM
patient population and one confirmatory study for treatment
refractory patients with NTM lung infections;
- Received Breakthrough Therapy
Designation from the U.S. Food and Drug Administration (FDA) for
ARIKAYCE to treat NTM lung infections; and
- Appointed David R. Brennan, former
Chief Executive Officer of AstraZeneca plc, to the Insmed Board of
Directors.
“With the recent regulatory clarity, we are moving forward with
preparation for commercialization in Europe while simultaneously
advancing our two global NTM studies,” said Will Lewis, President
and Chief Executive Officer of Insmed. “Given these positive
developments, we are pleased with the progress we are making toward
our goal of bringing this potentially front line therapy to the
benefit of the thousands of NTM and CF patients.”
Second Quarter Financial Results
For the second quarter of 2014, Insmed posted a net loss of
$23.2 million, or ($0.59) per share, compared with a net loss of
$8.9 million, or ($0.28) per share, for the second quarter of 2013.
The increase in net loss was primarily due to $11.5 million in
Other revenue received during the 2013 quarter related to a
one-time payment for the sale of the Company’s right to receive
future royalties under its license agreement with Premacure (now
Shire plc), as well as to higher expenses in the 2014 quarter.
Research and development expense in the 2014 second quarter
increased to $14.9 million from $12.2 million in the second quarter
of 2013. The increase in research and development expense was
primarily due to the build-out of additional third-party
manufacturing capacity and higher compensation and
personnel-related expenses. These increases were partially offset
by a decrease in external clinical expenses, which was primarily
related to the completion of the Company’s Phase 3 pivotal study in
CF patients in 2013.
General and administrative expense for the second quarter of
2014 was $7.9 million compared with $7.5 million in the second
quarter of 2013. The increase in general and administrative expense
primarily resulted from an increase in pre-commercial activities
and higher personnel costs due to an increase in headcount. These
increases were largely offset by a $1.4 million decrease in
non-cash stock compensation expense in the second quarter of 2014,
compared with the prior year’s second quarter.
Balance Sheet Highlights and Cash Guidance
As of June 30, 2014, Insmed had cash and cash equivalents of
$82.7 million and working capital of $64.9 million. Excluding
depreciation and non-cash stock compensation expense, the Company’s
cash operating expenses for the three months ended June 30, 2014
was $19.7 million and includes expenditures of $2.1 million related
to the build out of additional and redundant third party
manufacturing capacity.
During the second half of 2014, the Company plans to continue to
fund further clinical development of ARIKAYCE, increase its
investment in third-party manufacturing capacity, support efforts
to obtain regulatory approvals and prepare for ARIKAYCE
commercialization. As a result, Insmed estimates that its cash
operating expenses for the second half of 2014 will be in the range
of $42 million to $47 million, which includes additional
expenditures of $6 million to $8 million for third-party
manufacturing capacity. In addition, in the second half of 2014 the
Company expects to invest $2.5 million to $3.5 million in new
capital expenditures and pay current liabilities of $2.5 million
related to the Company’s new office and laboratory facilities in
Bridgewater, N.J. The Company expects current cash balances will be
sufficient to fund operations into 2015.
Senior Leadership Team Update
Matthew Pauls, Chief Commercial Officer (CCO), will be leaving
Insmed in August 2014 to become the Chief Executive Officer of a
biopharmaceutical company based in Sweden and the U.S. Insmed plans
to initiate a search to identify a new CCO.
Lilia Arviza, PhD, recently joined Insmed in the newly created
role of Vice President of Global Medical Affairs. Dr. Arviza is
responsible for medical education, medical communication and
oversight of grants, investigator initiated studies and the medical
science liaison personnel. Dr. Arviza has more than 15 years of
medical affairs experience at companies focused on orphan diseases
and broader therapeutic indications.
Gina Eagle, MD, was recently promoted to Vice President of
Clinical Development. Dr. Eagle is responsible for designing and
overseeing the clinical trials and development of the Company’s
product candidates. Dr. Eagle spent 6 years practicing medicine and
has more than 9 years of experience in clinical development in the
pharmaceutical industry.
Kevin McDermott was recently promoted to Vice President of
Global Market Access. Mr. McDermott is responsible for developing
pricing strategies, creating a strong pharmacoeconomic foundation,
and securing market access worldwide. Mr. McDermott has more
than 14 years of senior leadership in market access.
“We welcome Lilia and look forward to sharing her passion and
expertise in medical affairs. We also congratulate Gina and Kevin
on their recent promotions,” stated Mr. Lewis. “In addition, we
wish Matt continued success in his new role as CEO, and we
appreciate his contributions to Insmed over the last year.”
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 (NTM) lung infections and cystic fibrosis (CF)
patients with Pseudomonas aeruginosa lung infections. For more
information, please visit http://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 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, , 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, 2013 and its subsequent
quarterly reports on Form 10-Q. 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.
INSMED INCORPORATEDConsolidated
Balance Sheets(in thousands, except par value, share and per
share data)
As of As of June 30, 2014 December 31, 2013
Assets (unaudited) Current assets: Cash and cash equivalents
$ 82,697 $ 113,894 Prepaid expenses and other current assets
4,015 2,269
Total current assets
86,712 116,163 In-process research and development 58,200
58,200 Fixed assets, net 4,778 1,812 Other assets 420
323 Total assets $ 150,110 $ 176,498
Liabilities and shareholders' equity Current
liabilities: Accounts payable $ 11,407 $ 5,929 Accrued expenses
4,546 3,905 Accrued compensation 2,071 2,839 Accrued lease expense,
current 314 307 Deferred rent 167 129 Capital lease obligations,
current 32 64 Current portion of long term debt 3,281
3,283 Total current liabilities 21,818 16,456
Accrued lease expense, long-term 250 380 Debt, long-term
16,494 16,338 Total liabilities 38,562
33,174 Shareholders' equity:
Common stock, $0.01 par value; 500,000,000 authorized shares,
39,276,389 and 39,137,679 issued and
outstanding shares at
June 30, 2014 and December 31, 2013,
respectively.
393 391 Additional paid-in capital 540,298 534,554 Accumulated
deficit (429,143 ) (391,621 ) Total shareholders'
equity 111,548 143,324 Total
liabilities and shareholders' equity $ 150,110 $ 176,498
INSMED
INCORPORATED Consolidated Statements of Comprehensive Loss
(Unaudited) (in thousands, except per share data)
Three months ended June 30, Six months ended June 30,
2014 2013 2014 2013
Other revenue $ - $ 11,500 $ - $ 11,500
Operating expenses: Research and development 14,942
12,225 26,293 22,559 General and administrative 7,874
7,544 14,602 11,520 Total
operating expenses 22,816 19,769
40,895 34,079 Operating loss (22,816 )
(8,269 ) (40,895 ) (22,579 ) Investment income 12 50 29 101
Interest expense (595 ) (635 ) (1,201 ) (1,277 ) Other income, net
175 - 156 2
Loss before income taxes (23,224 ) (8,854 ) (41,911 ) (23,753 )
Benefit from income taxes - -
(4,389 ) (1,221 ) Net loss and comprehensive
loss $ (23,224 ) $ (8,854 ) $ (37,522 ) $ (22,532 )
Basic and diluted net loss per share $ (0.59 ) $ (0.28 ) $ (0.96 )
$ (0.71 )
Weighted average basic and diluted common
shares outstanding
39,273 31,754 39,256
31,654
LHAAnne Marie Fields, 212-838-3777Senior Vice
Presidentafields@lhai.comorBruce Voss, 310-691-7100Managing
Directorbvoss@lhai.com
Insmed (NASDAQ:INSM)
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