Enrollment objective achieved in phase 3 CONVERT
study
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 September
30, 2016 and provided a business update.
Business Update
- Achieved enrollment objective in global phase 3 study
of ARIKAYCE™. Today the company announced that it has
achieved its patient enrollment objective in the phase 3 study of
ARIKAYCE (liposomal amikacin for inhalation). The study, which is
known as CONVERT or INS-212, is evaluating ARIKAYCE in treatment
refractory nontuberculous mycobacteria (NTM) lung disease caused by
Mycobacterium avium complex (MAC). The primary efficacy endpoint is
the proportion of subjects who achieve culture conversion at Month
6 in the ARIKAYCE plus multi-drug regimen arm compared to the
multi-drug regimen without ARIKAYCE arm.
- Published phase 2 study of ARIKAYCE. In
October 2016, the American Journal of Respiratory and Critical Care
Medicine published the company’s phase 2 study of ARIKAYCE in NTM
lung disease. The manuscript, which is entitled “Randomized Trial
of Liposomal Amikacin for Inhalation in Nontuberculous
Mycobacterial Lung Disease” by Olivier et al. is accessible online
at http://www.atsjournals.org/.
- Presented new analyses of phase 2 study of ARIKAYCE at
CHEST. A poster describing the stability and consistency
of effect with ARIKAYCE treatment in the phase 2 study was recently
presented at the CHEST annual meeting.
- Presented new NTM disease burden data at ISPOR European
Congress. Three posters describing the burden of NTM lung
disease were recently presented at the International Society for
Pharmacoeconomic and Outcomes Research (ISPOR) Annual European
Congress.
- Secured global exclusive rights to novel oral inhibitor
of dipeptidyl peptidase I.In October, the company acquired
the global exclusive rights to INS1007 (formerly known as AZD7986)
from AstraZeneca. INS1007 is a small molecule, reversible inhibitor
of dipeptidyl peptidase I (DPP1), an enzyme responsible for
activating neutrophil serine proteases (NSPs) in neutrophils when
they are formed in the bone marrow. In chronic inflammatory lung
diseases, neutrophils accumulate in the airways and result in
excessive active NSPs that cause lung destruction and inflammation.
The company expects to begin a phase 2 dose-ranging study of
INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in 2017.
Non-CF bronchiectasis is a rare, progressive, neutrophil-driven
pulmonary disorder with no approved therapies.
- Presented phase 1 study of INS1009 at ERS
2016. In September, results from a phase 1 study of
INS1009 were presented at the European Respiratory Society
International Congress. The study was a randomized, double-blind,
placebo-controlled single ascending dose study of INS1009 to
determine its safety, tolerability, and pharmacokinetics in healthy
volunteers. The pharmacokinetic characteristics supported once- or
twice-daily whereas existing inhaled therapies are dosed four to
nine times per day. The adverse event profile was consistent with
other inhaled prostanoids. INS1009 is the company’s
inhaled treprostinil prodrug, which may offer therapeutic
potential in rare pulmonary disorders.
- Appointed chief commercial officer. The
company enhanced its senior leadership team with the appointment of
Roger Adsett as chief commercial officer. Prior to joining Insmed,
Mr. Adsett was senior vice president, head of the gastrointestinal
and internal medicine business unit at Shire plc. In that capacity
he oversaw Shire's global commercial P&L across six specialty
and two rare disease brands. Before joining Shire, Mr. Adsett
worked at AstraZeneca for 11 years. Mr. Adsett will be charged with
overseeing the development and execution of Insmed's global
commercial strategy.
“Recent months have been marked by strong progress across all
aspects of our business,” said Will Lewis, president and chief
executive officer of Insmed. “We are pleased to report that the
enrollment phase of the CONVERT study is now complete, which
positions us for top-line data next year. There is a significant
need for new treatments for patients with refractory NTM lung
disease and we look forward to advancing the development of
ARIKAYCE. With respect to our earlier-stage pipeline, we are
encouraged by the high-level of inbound physician interest in our
clinical program for INS1007 in non-CF bronchiectasis. Physicians
are eagerly awaiting new treatment options for this debilitating
disorder and we believe INS1007 has the potential to achieve
disease modification by impeding tissue destruction, inflammation,
and mucus hypersecretion through the inhibition of DPP1.”
Third Quarter Financial Results
For the third quarter of 2016, Insmed posted a net loss of $37.8
million, or $0.61 per share, compared with a net loss of $31.0
million, or $0.50 per share, for the third quarter of 2015.
Research and development expenses were $23.4 million for the
third quarter of 2016, compared with $19.2 million for the third
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, as well as an increase in headcount and related
expenses. These increases were partially offset by a decrease in
manufacturing expenses primarily due to the completion of the
build-out of additional production capacity at a contract
manufacturer in 2015.
General and administrative expenses for the third quarter of
2016 were $13.7 million, compared with $11.0 million for the third
quarter of 2015. The increase was primarily related to
pre-commercial activities, namely the buildout of the company’s
infrastructure and NTM disease awareness activities.
Balance Sheet Highlights and Cash Guidance
As of September 30, 2016, Insmed had cash and cash equivalents
of $201 million. Excluding depreciation and stock-based
compensation expense, the company’s cash operating expenses for the
nine months ended September 30, 2016 were $91 million. Insmed ended
the third quarter of 2016 with $35 million in debt and $183 million
of working capital.
On September 30, 2016, Insmed closed a $55 million debt
agreement with Hercules Capital, Inc. The transaction refinanced
the company’s existing debt of $25 million and added a total of $30
million of new debt, $20 million of which was funded in early
October in connection with the upfront payment for the global
exclusive rights to INS1007.
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
second half of 2016 to be in the range of $62 to $72 million.
Conference Call
Insmed will host a conference call beginning today at 8:30 AM
Eastern Time. Shareholders and other interested parties may
participate in the conference call by dialing (877) 698-3991
(domestic) or (817) 522-1636 (international) and referencing
conference ID number 4675771. The call will also be webcast live on
the internet on the company’s website at www.insmed.com.
A replay of the conference call will be accessible approximately
two hours after its completion through November 17, 2016 by dialing
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
referencing conference ID number 4675771. A webcast of the call
will also be archived for 90 days under the Investor Relations
section of the company’s website at www.insmed.com.
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). Insmed’s
earlier-stage clinical pipeline includes INS1007, a novel oral
inhibitor of dipeptidyl peptidase I with therapeutic potential in
non-cystic fibrosis bronchiectasis, and INS1009, an
inhaled prodrug formulation of treprostinil that may offer a
differentiated product profile for rare pulmonary disorders. 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 successfully develop INS1007 (formerly known as AZD7986)
for the treatment of non-CF bronchiectasis; the ability to complete
development of, receive, and maintain regulatory approval for, and
successfully commercialize ARIKAYCE, INS1007, and INS1009; the
number of patients enrolled and the timing of patient enrollment in
the company’s global phase 3 clinical study of ARIKAYCE; estimates
of expenses and future revenues and profitability; status, timing,
and the results of preclinical studies and clinical trials and
preclinical and clinical data described herein; the sufficiency of
preclinical and clinical data in obtaining regulatory approval for
the company’s product candidates; the timing of responses to
information and data requests from the US Food and Drug
Administration, the European Medicines Agency, and other regulatory
authorities; expectation as to the timing of regulatory review and
approval; estimates regarding capital requirements, including
milestone payments and royalty obligations due to AstraZeneca, and
the needs for additional financing, the ability to repay our
existing indebtedness, estimates of the size of the potential
markets for product candidates; selection and licensing of product
candidates; the 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; the 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 impact
of any litigation the company is a party to, including, without
limitation, the class action lawsuit filed against the company; 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 Statements of Net
Loss |
(in thousands, except per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
23,433 |
|
|
|
19,221 |
|
|
|
67,851 |
|
|
|
54,631 |
|
General and administrative |
|
13,716 |
|
|
|
11,024 |
|
|
|
38,498 |
|
|
|
30,272 |
|
Total operating expenses |
|
37,149 |
|
|
|
30,245 |
|
|
|
106,349 |
|
|
|
84,903 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(37,149 |
) |
|
|
(30,245 |
) |
|
|
(106,349 |
) |
|
|
(84,903 |
) |
|
|
|
|
|
|
|
|
Investment income |
|
138 |
|
|
|
75 |
|
|
|
472 |
|
|
|
166 |
|
Interest expense |
|
(769 |
) |
|
|
(725 |
) |
|
|
(2,015 |
) |
|
|
(2,165 |
) |
Other income (expense),
net |
|
45 |
|
|
|
(67 |
) |
|
|
92 |
|
|
|
(36 |
) |
Loss before income taxes |
|
(37,735 |
) |
|
|
(30,962 |
) |
|
|
(107,800 |
) |
|
|
(86,938 |
) |
|
|
|
|
|
|
|
|
Provision for income
taxes |
|
25 |
|
|
|
- |
|
|
|
71 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(37,760 |
) |
|
$ |
(30,962 |
) |
|
$ |
(107,871 |
) |
|
$ |
(86,938 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.61 |
) |
|
$ |
(0.50 |
) |
|
$ |
(1.74 |
) |
|
$ |
(1.51 |
) |
|
|
|
|
|
|
|
|
Weighted average basic
and diluted common shares outstanding |
|
61,878 |
|
|
|
61,774 |
|
|
|
61,871 |
|
|
|
57,565 |
|
|
INSMED INCORPORATED |
|
Consolidated Balance Sheets |
|
(in thousands, except par value and share
data) |
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
|
September 30, 2016 |
|
December 31, 2015 |
|
|
|
(Unaudited) |
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
200,518 |
|
|
$ |
282,876 |
|
|
Prepaid expenses and other current
assets |
|
|
5,778 |
|
|
|
5,242 |
|
|
Total current assets |
|
|
206,296 |
|
|
|
288,118 |
|
|
|
|
|
|
|
|
In-process research and
development |
|
|
58,200 |
|
|
|
58,200 |
|
|
Fixed assets, net |
|
|
10,274 |
|
|
|
8,092 |
|
|
Other assets |
|
|
1,874 |
|
|
|
2,146 |
|
|
Total assets |
|
$ |
276,644 |
|
|
$ |
356,556 |
|
|
|
|
|
|
|
|
Liabilities and
shareholders' equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
8,283 |
|
|
$ |
7,468 |
|
|
Accrued expenses |
|
|
14,528 |
|
|
|
10,995 |
|
|
Other current liabilities |
|
|
647 |
|
|
|
683 |
|
|
Current portion of long-term
debt |
|
|
- |
|
|
|
3,113 |
|
|
Total current liabilities |
|
|
23,458 |
|
|
|
22,259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt, long-term |
|
|
34,681 |
|
|
|
22,027 |
|
|
Other long-term
liabilities |
|
|
676 |
|
|
|
572 |
|
|
Total liabilities |
|
|
58,815 |
|
|
|
44,858 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity: |
|
|
|
|
|
Common stock, $0.01 par value;
500,000,000 |
|
|
|
|
|
authorized shares, 61,877,905 and
61,813,995 issued and outstanding shares at September 30, 2016 and
December 31, 2015, respectively |
|
|
619 |
|
|
|
618 |
|
|
Additional paid-in capital |
|
|
914,049 |
|
|
|
900,043 |
|
|
Accumulated deficit |
|
|
(696,834 |
) |
|
|
(588,963 |
) |
|
Accumulated other comprehensive
loss |
|
|
(5 |
) |
|
|
- |
|
|
Total shareholders'
equity |
|
|
217,829 |
|
|
|
311,698 |
|
|
Total liabilities and shareholders'
equity |
|
$ |
276,644 |
|
|
$ |
356,556 |
|
|
|
|
|
|
|
Insmed Incorporated:
Susan Mesco
Head of Investor Relations
908-947-4326
Insmed (NASDAQ:INSM)
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