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8-K - FORM 8-K - NUPATHE INC. | c14340e8vk.htm |
Exhibit 99.1
NuPathe Announces Fourth Quarter and Full Year 2010 Financial Results
and Operational Highlights
and Operational Highlights
CONSHOHOCKEN, PA March 18, 2011 NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical
company focused on the development and commercialization of branded therapeutics for diseases of
the central nervous system, including neurological and psychiatric disorders, today announced
financial results for the quarter and full year ended December 31, 2010 and operational highlights.
NuPathe ended 2010 with strong momentum, including the filing of our New Drug Application (NDA)
for Zelrix for the treatment of acute migraine, said Jane Hollingsworth, chief executive officer
of NuPathe. We expect this momentum to build throughout 2011, with multiple data presentations at
important scientific meetings, a PDUFA date for Zelrix and the commencement of human clinical
trials for NP201 for Parkinsons disease.
Recent Operational Highlights:
| On October 29, NuPathe filed its NDA for Zelrix for the treatment of acute migraine. In January 2011, the NDA was accepted for review by the FDA, prompting additional pre-launch commercialization activities. The Prescription Drug User Fee Act (PDUFA) date for the NDA is August 29, 2011. |
| In October, NuPathe announced positive top-line results from a 12 month open-label trial for Zelrix as well as the development of an in vitro analytical testing method for Zelrix. |
| In October, NuPathe announced the successful completion of two pharmacokinetic trials and a tolerability trial for Zelrix. |
| In October, NuPathe was awarded $650,000 of Qualifying Therapeutic Discovery Project grants under section 48D of the U.S. Internal Revenue Code in connection with the Companys Zelrix, NP201 and NP202 development programs. The award amounts were the maximum granted on a per-program basis. |
| In January, NuPathe announced that William J. Federici, vice president and chief financial officer of West Pharmaceutical Services, Inc., was appointed to the NuPathe Board of Directors and Audit Committee. |
In addition to the steady progression of Zelrix towards commercialization, NuPathe continues to
advance the development of NP201 for the continuous symptomatic treatment of Parkinsons disease
and NP202 for the long-term treatment of schizophrenia
and bipolar disorder. An Investigational New Drug (IND) application remains planned for NP201 in
the first half of 2011.
Fourth Quarter and Full Year 2010 Financial Results
NuPathe reported a net loss of $6.2 million for the fourth quarter of 2010, compared to a net loss
of $3.3 million for the fourth quarter of 2009. Research and development expenses were $5.2 million
in the fourth quarter of 2010, compared to $2.5 million in the fourth quarter of 2009. $1.5
million of the increase resulted from the payment of the NDA filing fee to the FDA. Selling,
general and administrative expenses were $1.6 million in the fourth quarter of 2010, compared to
$0.8 million for the same period in 2009. This increase was primarily due to higher expenses
related to operating as a public company.
For the full year 2010, NuPathe reported a net loss of $24.4 million compared to a net loss of
$15.6 million in 2009.
During the year ended December 31, 2010, NuPathe used $18.4 million of cash for operating
activities and $3.5 million for investing activities, most of which related to the funding of
commercial manufacturing equipment. Also during 2010, NuPathe received $56.9 million from financing
activities, most notably $43.0 million net proceeds from its initial public offering, $10.0 million
from the issuance of convertible notes and $5.0 million of proceeds from the issuance of debt.
NuPathe ended 2010 with $38.9 million in cash and cash equivalents.
Company to Host Conference Call
NuPathe will host a conference call today, March 18, 2011, at 8:30 a.m. EDT to discuss NuPathes
financial results for the quarter and full year ended December 31, 2010 and recent operational
highlights. A question and answer session will follow NuPathes remarks. To participate on the live
call, please dial 877-397-0272 (domestic) or +1-719-325-4838 (international), and provide the
participant passcode 6802591, approximately 10 minutes ahead of the start of the call. A replay of
the call will be available for 90 days within a few hours after the call ends and can be accessed
by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 6802591.
A live audio webcast of the call will be available via the Investor Relations page of the NuPathe
website, www.nupathe.com. Please log on through NuPathes website approximately 10 minutes prior to
the scheduled start time. A replay of the webcast will also be archived on the Companys website
for 90 days following the call.
About Zelrix
Zelrix is an active, single-use, transdermal sumatriptan patch in development for the treatment of
migraine. Zelrix is designed to provide migraine patients fast onset and sustained relief through a
tolerable, non-oral route of administration. Zelrix may provide an attractive treatment option for
many migraine patients because it avoids the need for oral administration and does not depend upon
gastrointestinal absorption. Many migraine patients delay or avoid treatment with oral migraine
medications as a result of underlying nausea and fear of vomiting. In addition, the reduced gastric
motility experienced during migraine may affect the efficacy of oral medications. Zelrix is powered
by SmartRelief, NuPathes proprietary transdermal delivery technology. SmartRelief consists of a
controlled delivery technology that uses a mild electrical current to actively transport medication
through the skin using a process called iontophoresis.
About NuPathe
NuPathe Inc. (www.nupathe.com) is a specialty pharmaceutical company focused on the development and
commercialization of branded therapeutics for diseases of the central nervous system, including
neurological and psychiatric disorders. NuPathes most advanced product candidate, Zelrix, is a
single-use, transdermal sumatriptan patch being developed for the treatment of acute migraine. In
addition to Zelrix, NuPathe has two proprietary product candidates in preclinical development:
NP201 for the continuous symptomatic treatment of Parkinsons disease, and NP202 for the long-term
treatment of schizophrenia and bipolar disorder.
Cautionary Statement About Forward-Looking Information
This press release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby
identified as forward-looking statements for this purpose and include, among others, statements
relating to the timing of an FDA decision on Zelrix, data presentations, the filing of an IND and
commencement of human clinical trials for NP201, the development of NP201 and NP202, and the
potential benefits of, and market for, Zelrix
Forward-looking statements are subject to a number of assumptions, risks and uncertainties that
could cause actual results and events to differ materially from those indicated by the
forward-looking statements contained in this press release including, among others: NuPathes
ability to obtain marketing approval for and commercialize Zelrix; serious adverse events or other
safety risks that could require NuPathe to abandon or delay development of, or preclude or limit
approval of, Zelrix or its other product candidates; varying interpretation of clinical and market
data; and the risks, uncertainties and other factors discussed in NuPathes Annual Report on Form
10-K for the year ended
December 31, 2010 under the caption Risk Factors and elsewhere in such report, which is available
on the Companys website at www.nupathe.com in the Investor Relations SEC Filings section. As
a result, you are cautioned not to place undue reliance on any forward-looking statements.
Additionally, the forward-looking statements contained in this press release are based upon
managements views as of the date of this press release. While NuPathe may update certain
forward-looking statements from time to time, it specifically disclaims any obligation to do so,
whether as a result of new information, future developments or otherwise.
Contact Information:
John Woolford
(443) 213-0506
john.woolford@westwicke.com
(443) 213-0506
john.woolford@westwicke.com
Keith A. Goldan
Vice President, Chief Financial Officer
NuPathe Inc.
(484) 567-0130
Vice President, Chief Financial Officer
NuPathe Inc.
(484) 567-0130
Media Contacts:
Ron Schmid
NuPathe Inc.
(610) 659-3985
NuPathe Inc.
(610) 659-3985
NUPATHE INC.
(A Development-Stage Company)
Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
(A Development-Stage Company)
Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
Period from | ||||||||||||||||||||
January 7, 2005 | ||||||||||||||||||||
Three Months ended December 31, | Years ended December 31, | (inception) through | ||||||||||||||||||
2010 | 2009 | 2010 | 2009 | December 31, 2010 | ||||||||||||||||
Grant revenue |
$ | 650 | $ | | $ | 650 | $ | | $ | 650 | ||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
5,215 | 2,504 | 17,064 | 11,310 | 48,851 | |||||||||||||||
Selling, general and administrative |
1,634 | 757 | 4,772 | 3.142 | 14,599 | |||||||||||||||
6,849 | 3,261 | 21,836 | 14,452 | 68,950 | ||||||||||||||||
Loss from operations |
(6,199 | ) | (3,261 | ) | (21,186 | ) | (14,452 | ) | (68,300 | ) | ||||||||||
Interest income |
23 | 3 | 47 | 30 | 574 | |||||||||||||||
Interest expense |
(179 | ) | (6 | ) | (3,718 | ) | (1,320 | ) | (6,340 | ) | ||||||||||
Loss before tax benefit |
(6,355 | ) | (3,264 | ) | (24,857 | ) | (15,742 | ) | (74,066 | ) | ||||||||||
Income tax benefit |
180 | | 500 | 151 | 651 | |||||||||||||||
Net loss |
(6,175 | ) | (3,264 | ) | (24,357 | ) | (15,591 | ) | (73,415 | ) | ||||||||||
Accretion of redeemable convertible preferred stock |
| (1,033 | ) | (2,533 | ) | (3,617 | ) | |||||||||||||
Net loss available to common stockholders |
$ | (6,175 | ) | $ | (4,297 | ) | $ | (26,890 | ) | $ | (19,208 | ) | ||||||||
Basic and diluted net loss per common share |
($0.42 | ) | ($11.26 | ) | ($4.39 | ) | ($50.31 | ) | ||||||||||||
Weighted average basic and diluted common shares outstanding |
14,548,851 | 381,789 | 6,126,123 | 381,789 | ||||||||||||||||
NUPATHE INC.
(A Development-Stage Company)
Balance Sheet Data
(In thousands)
(Unaudited)
(A Development-Stage Company)
Balance Sheet Data
(In thousands)
(Unaudited)
December 31, | ||||||||
2010 | 2009 | |||||||
Cash and cash equivalents |
$ | 38,918 | $ | 3,927 | ||||
Total assets |
43,753 | 5,009 | ||||||
Total debt |
5,217 | 818 | ||||||
Total stockholders equity (deficit) |
34,265 | (54,474 | ) |
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