Conference Call Begins Today at 8:30 a.m.
Eastern Time
Insmed Incorporated (Nasdaq:INSM) today reported financial
results for the three and nine months ended September 30, 2014.
Highlights of the third quarter of 2014 include:
- Reported its U.S. regulatory strategy
to initiate one global phase 3 confirmatory study of ARIKAYCE™, or
liposomal amikacin for inhalation, for patients with nontuberculous
mycobacterial (NTM) lung infections who failed prior standard of
care treatment;
- Announced plans to file a Market
Authorization Application (MAA) by year-end 2014 with the European
Medicines Agency (EMA) for ARIKAYCE for the treatment of two orphan
lung diseases: NTM lung infections and Pseudomonas aeruginosa lung
infections in patients with cystic fibrosis (CF);
- Strengthened the Company’s balance
sheet with an underwritten public offering, which provided net
proceeds of approximately $108.0 million; and
- Introduced INS-1009 (inhaled
treprostinil), the Company’s novel inhalation formulation of a
proven prostacyclin for the treatment of pulmonary arterial
hypertension (PAH), with the presentation of several pre-clinical
studies at the European Respiratory Society meeting.
“We are pleased with the recent regulatory clarity for our NTM
program in both Europe and the U.S. We continue to advance our
regulatory filing and our preparations for commercialization in
Europe, while simultaneously moving forward with our global phase 3
study in NTM patients who failed prior standard-of-care treatment.
We expect to initiate this global NTM study in early 2015 and to
complete enrollment within one year. We anticipate having
preliminary top-line clinical results in mid-2016. We were also
pleased to introduce INS-1009 for the novel treatment of PAH, as it
expands our pipeline and underscores our commitment to new
treatments for orphan lung diseases,” said Will Lewis, President
and Chief Executive Officer of Insmed.
Third Quarter Financial Results
For the third quarter of 2014, Insmed posted a net loss of $24.0
million, or ($0.54) per share, compared with a net loss of $17.3
million, or ($0.46) per share, for the third quarter of 2013. The
increase in net loss was primarily due to increases in personnel
costs, manufacturing expenses and pre-commercial activities.
Research and development expense for the third quarter of 2014
increased to $15.2 million from $12.1 million in the third quarter
of 2013. The increase in research and development expense was
primarily due to higher compensation and personnel-related expenses
and the build-out of additional third-party manufacturing
capacity.
General and administrative expense for the third quarter of 2014
was $8.2 million compared with $4.7 million in the third quarter of
2013. The increase in general and administrative expense primarily
resulted from greater personnel costs due to an increase in
headcount and an increase in pre-commercial activities.
Balance Sheet Highlights and Cash Guidance
As of September 30, 2014, Insmed had cash and cash equivalents
of $167.3 million and working capital of $149.6 million, both of
which reflect an underwritten public offering in August, which
generated $108.0 million of net proceeds to the Company. Excluding
depreciation and non-cash stock compensation expense, the Company’s
cash operating expenses for the three months ended September 30,
2014 was $19.7 million. In addition, during the third quarter of
2014 the Company paid $2.9 million for capital expenditures
primarily related to the build out of its office and laboratory
facilities in Bridgewater, New Jersey.
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 fourth
quarter of 2014 will be in the range of $22 million to $26 million.
In addition, the Company expects to pay approximately $2 million
related to the completion of the build out of its office and
laboratory facilities in New Jersey. The Company expects current
cash balances will be sufficient to fund operations into 2016.
Conference Call
Insmed management will host a conference call to discuss these
results and answer questions today beginning at 8:30 a.m. Eastern
time. Shareholders and other interested parties may participate in
the call by dialing 855-803-5993 (domestic) or 706-634-5454
(international) and referencing conference ID number 22672003. The
call will also be broadcast live on the Company's website at
www.insmed.com.
A replay of the conference call will be accessible two hours
after its completion through November 12, 2014, by dialing
855-859-2056 (domestic) or 404-537-3406 (international) and
referencing conference ID number 22672003. The call will also be
archived for 90 days on the Company's website at
www.insmed.com.
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 INCORPORATED Consolidated Balance
Sheets (in thousands, except par value, share and per share
data) As of September
30, 2014 As of December 31, 2013 (Unaudited)
Assets Current
assets: Cash and cash equivalents $ 167,311 $ 113,894 Prepaid
expenses and other current assets 3,532 2,269
Total current assets 170,843 116,163 In-process
research and development 58,200 58,200 Fixed assets, net 5,982
1,812 Other assets 418 323 Total assets
$ 235,443 $ 176,498
Liabilities and
shareholders' equity Current liabilities: Accounts payable $
8,867 $ 5,929 Accrued expenses 3,547 3,905 Accrued compensation
3,032 2,839 Accrued lease expense, current 317 307 Deferred rent
321 129 Capital lease obligations, current 16 64 Current portion of
long term debt 5,178 3,283 Total
current liabilities 21,278 16,456 Accrued lease expense,
long-term 185 380 Debt, long-term 14,713
16,338 Total liabilities 36,176 33,174
Shareholders' equity:
Common stock, $0.01 par value; 500,000,000
authorizedshares, 49,605,544 and 39,137,679 issued andoutstanding
shares at September 30, 2014 andDecember 31, 2013, respectively
496 391 Additional paid-in capital 651,904 534,554 Accumulated
deficit (453,133 ) (391,621 ) Total shareholders'
equity 199,267 143,324 Total
liabilities and shareholders' equity $ 235,443 $ 176,498
INSMED INCORPORATED Consolidated
Statements of Comprehensive Loss (Unaudited) (in thousands,
except per share data)
Three Months endedSeptember 30,
Nine Months endedSeptember 30,
2014 2013 2014 2013 Other revenue $ - $ - $ -
$ 11,500 Operating expenses: Research and development
15,200 12,095 41,493 34,654 General and administrative 8,204
4,747 22,806 16,267
Total operating expenses 23,404 16,842
64,299 50,921 Operating
loss (23,404 ) (16,842 ) (64,299 ) (39,421 ) Investment
income 12 40 41 141 Interest expense (594 ) (525 ) (1,795 ) (1,802
) Other (expense) / income, net (4 ) -
152 2 Loss before income taxes (23,990 )
(17,327 ) (65,901 ) (41,080 ) Benefit from income taxes
- - (4,389 ) (1,221 )
Net loss and comprehensive loss $ (23,990 ) $ (17,327 ) $
(61,512 ) $ (39,859 ) Basic and diluted net loss per
share $ (0.54 ) $ (0.46 ) $ (1.50 ) $ (1.19 )
Weighted average basic and dilutedcommon
shares outstanding
44,082 37,389 40,882
33,577
Investor Relations:LHAAnne Marie Fields,
212-838-3777Senior Vice Presidentafields@lhai.comorBruce Voss,
310-691-7100Managing Directorbvoss@lhai.com
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