Insmed Reports Third Quarter 2013 Financial Results
Conference Call Begins Today at 8:30 a.m. Eastern Time
MONMOUTH JUNCTION, NJ--(Marketwired - Nov 5, 2013) - Insmed
Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on
developing an inhaled anti-infective to treat patients battling
serious lung diseases in orphan indications that are often
life-threatening, today reported financial results for the three
and nine months ended September 30, 2013.
Highlights of the third quarter of 2013 and subsequent weeks
include:
- Completed patient enrollment in the Phase 2 clinical trial of
ARIKACE®, or liposomal amikacin for inhalation, for patients with
recalcitrant nontuberculous mycobacteria (NTM) lung disease in the
U.S. and Canada;
- Commenced the Scientific Advice Working Party (SAWP) process
with European Medicines Agency (EMA) for clarity on the path
forward for ARIKACE to treat NTM lung disease in Europe;
- Strengthened the Company's intellectual property position with
the addition of another European patent allowance;
- Completed an underwritten public offering of 6.9 million shares
of common stock, including the underwriters' exercise in full of
their over-allotment option of 900,000 shares, which provided net
proceeds to the Company of approximately $67.0 million.
"During the third quarter we made significant progress advancing
ARIKACE closer to our goal of treating patients with NTM lung
disease. With no approved treatments for this indication,
completion of enrollment in our U.S. and Canadian Phase 2 study is
a significant milestone in bringing ARIKACE to patients with NTM
lung disease who are in great need of an effective treatment
option," stated Will Lewis, President and Chief Executive Officer
of Insmed. "We remain on track to report top-line NTM data and
to initiate a dialogue with the FDA in the first quarter of
2014. In addition we are mapping a path forward for ARIKACE to
treat NTM lung disease in Europe through the SAWP process and
expect to engage in communications with the EMA during the fourth
quarter of 2013."
"We continue work to build Insmed into a world-class
biopharmaceutical company. Importantly, our successful financing in
July with top-tier institutional investors provides us with the
financial resources to advance ARIKACE for NTM lung disease
and Pseudomonas aeruginosa lung infections in cystic
fibrosis (CF) patients to important data readouts and regulatory
filings, and to build our infrastructure to support clinical and
commercial objectives," concluded Mr. Lewis.
Third Quarter Financial Results
For the third quarter of 2013, Insmed reported a net loss of
$17.3 million, or $0.46 per share, compared with a net loss of $9.4
million, or $0.38 per share, for the third quarter of 2012.
Research and development expenses for the third quarter of 2013
increased to $12.1 million from $5.7 million for the third quarter
of 2012, primarily due to higher costs for clinical trial
activities associated with the Company's Phase 3 clinical trial and
two-year open-label extension study in CF patients with
Pseudomonas aeruginosa lung infections in Europe and
Canada, its Phase 2 clinical trial in patients with NTM lung
disease in the U.S. and Canada, and costs related to process
improvements made to manufacturing processes. Also contributing to
the increase were higher internal expenses including compensation
and related expenses due to greater headcount.
General and administrative expenses for the third quarter of
2013 increased to $4.7 million from $3.6 million for the third
quarter of 2012. The increase was primarily due to pre-commercial
market research and related costs.
Balance Sheet Highlights and Cash Guidance
As of September 30, 2013, Insmed had cash, cash equivalents
totaling $128.0 million, compared with $92.9 million as of December
31, 2012. The $35.1 million net increase was due principally to
$67.0 million of net proceeds we received from an underwritten
public offering of our common stock we completed during July
2013. The Company utilized $32.6 million of cash to fund
operations in the first nine months of 2013. As of September 30,
2013, working capital was $109.9 million.
The Company plans to fund further clinical development of
ARIKACE, invest in third-party manufacturing capacity and fund its
efforts to obtain regulatory approvals and prepare for
commercialization. As a result, Insmed estimates that its cash
requirements to fund operations for the fourth quarter of 2013 will
be in the range of $15 million to $17 million. The Company believes
that its cash balance as of September 30, 2013, will be sufficient
to fund its operations through 2014.
Conference Call
Insmed management will host an investment community 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 888-803-5993
(domestic) or 706-634-5454 (international) and referencing
conference ID number 90792237. 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 11, 2013, by dialing
855-859-2056 (domestic) or 404-537-3406 (international) and
referencing conference ID number 90792237. 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
ARIKACE®, or liposomal amikacin for inhalation, for at
least two identified orphan patient populations: cystic fibrosis
patients with Pseudomonas aeruginosa lung infections and
patients with nontuberculous mycobacteria lung disease. 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, 2012 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 |
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Consolidated Balance Sheets |
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(in thousands, except par value, share and per share
data) |
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September 30, 2013 |
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December 31, 2012 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
|
$ |
128,025 |
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$ |
90,782 |
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Certificate of deposit |
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- |
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|
|
2,153 |
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Prepaid expenses and other current assets |
|
|
1,720 |
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|
643 |
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Total current assets |
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|
129,745 |
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|
93,578 |
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In-process research and development |
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|
58,200 |
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58,200 |
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Other assets |
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|
101 |
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|
117 |
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Fixed assets, net |
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|
1,904 |
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|
1,666 |
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Total assets |
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$ |
189,950 |
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$ |
153,561 |
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Liabilities and shareholders' equity |
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Current liabilities: |
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Accounts payable |
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$ |
4,661 |
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$ |
7,060 |
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Accrued expenses |
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|
5,652 |
|
|
|
2,933 |
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|
Accrued compensation |
|
|
1,953 |
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|
|
2,207 |
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|
Accrued lease expense, current |
|
|
303 |
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|
|
295 |
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Deferred rent |
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|
134 |
|
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|
149 |
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Capital lease obligations, current |
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|
64 |
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|
96 |
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Current portion of long term debt |
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|
7,055 |
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|
3,007 |
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Total current liabilities |
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19,822 |
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|
15,747 |
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Accrued lease expense, long-term |
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|
449 |
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|
647 |
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Capital lease obligations, long-term |
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16 |
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|
64 |
|
Debt, long-term |
|
|
12,538 |
|
|
|
16,221 |
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|
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Total liabilities |
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|
32,825 |
|
|
|
32,679 |
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Shareholders' equity: |
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Common stock, $0.01 par value; 500,000,000 authorized
shares, 39,100,899 and 31,488,204 issued and outstanding shares at
September 30, 2013 and December 31, 2012, respectively |
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|
391 |
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|
|
315 |
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Additional paid-in capital |
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532,141 |
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|
455,325 |
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Warrant to purchase common stock |
|
|
- |
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|
790 |
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Accumulated deficit |
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|
(375,407 |
) |
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|
(335,548 |
) |
Total shareholders' equity |
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|
157,125 |
|
|
|
120,882 |
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Total liabilities and shareholders' equity |
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$ |
189,950 |
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|
$ |
153,561 |
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|
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See accompanying notes to consolidated financial
statements |
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INSMED INCORPORATED |
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Consolidated Statements of Comprehensive Loss |
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(in thousands, except per share data) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2013 |
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2012 |
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2013 |
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2012 |
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Other revenue |
|
$ |
- |
|
|
$ |
- |
|
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$ |
11,500 |
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$ |
- |
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Operating expenses: |
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|
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|
|
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|
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Research and development |
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|
12,095 |
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|
|
5,706 |
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|
34,654 |
|
|
|
18,190 |
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General and administrative |
|
|
4,747 |
|
|
|
3,647 |
|
|
|
16,267 |
|
|
|
8,410 |
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|
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Total operating expenses |
|
|
16,842 |
|
|
|
9,353 |
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|
|
50,921 |
|
|
|
26,600 |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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Operating loss |
|
|
(16,842 |
) |
|
|
(9,353 |
) |
|
|
(39,421 |
) |
|
|
(26,600 |
) |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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Investment income |
|
|
40 |
|
|
|
193 |
|
|
|
141 |
|
|
|
901 |
|
Interest expense |
|
|
(525 |
) |
|
|
(222 |
) |
|
|
(1,802 |
) |
|
|
(225 |
) |
Gain on sale of assets, net |
|
|
- |
|
|
|
- |
|
|
|
2 |
|
|
|
5 |
|
|
|
Loss before income taxes |
|
|
(17,327 |
) |
|
|
(9,382 |
) |
|
|
(41,080 |
) |
|
|
(25,919 |
) |
|
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|
|
|
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Provision (benefit) for income taxes |
|
|
- |
|
|
|
- |
|
|
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(1,221 |
) |
|
|
4 |
|
|
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Net loss |
|
$ |
(17,327 |
) |
|
$ |
(9,382 |
) |
|
$ |
(39,859 |
) |
|
$ |
(25,923 |
) |
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|
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Basic and diluted net loss per share |
|
$ |
(0.46 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.19 |
) |
|
$ |
(1.04 |
) |
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|
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Weighted average basic and diluted common shares
outstanding |
|
|
37,389 |
|
|
|
25,013 |
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|
|
33,577 |
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|
|
24,916 |
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|
|
|
|
|
|
|
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|
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|
|
Net loss |
|
$ |
(17,327 |
) |
|
$ |
(9,382 |
) |
|
$ |
(39,859 |
) |
|
$ |
(25,923 |
) |
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Unrealized (loss) gain on short-term investments, net
of taxes |
|
|
- |
|
|
|
199 |
|
|
|
- |
|
|
|
385 |
|
Comprehensive loss |
|
$ |
(17,327 |
) |
|
$ |
(9,183 |
) |
|
$ |
(39,859 |
) |
|
$ |
(25,538 |
) |
|
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|
|
|
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See accompanying notes to consolidated financial
statements |
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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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