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NuPathe Announces Fourth Quarter and Full Year 2012 Financial Results and Operational Highlights

NuPathe Announces Fourth Quarter and Full Year 2012 Financial Results and 
Operational Highlights 
CONSHOHOCKEN, PA -- (Marketwire) -- 03/26/13 --  NuPathe Inc.
(NASDAQ: PATH) today announced financial results for the quarter and
full year ended December 31, 2012, as well as recent operational
highlights. 
"Our efforts in 2012 culminated in a major milestone for NuPathe with
FDA's approval of ZECUITY, the first and only prescription migraine
patch, in January," said Armando Anido, chief executive officer of
NuPathe. "We remain focused on securing commercial partners and
preparing for the launch of ZECUITY, which is expected in the fourth
quarter of this year." 
Quarterly and Recent Highlights 


 
--  On January 17, 2013, the U.S. Food & Drug Administration (FDA)
    approved ZECUITY(TM) (sumatriptan iontophoretic transdermal system)
    for the acute treatment of migraine with or without aura in adults.
    ZECUITY is a single-use, battery-powered patch that actively delivers
    sumatriptan, the most prescribed migraine medication, through the
    skin. As the first and only prescription migraine patch, we believe
    ZECUITY will be an attractive treatment option for millions of
    migraine patients, especially those who experience migraine-related
    nausea (MRN) with their attacks.
--  In connection with the approval of ZECUITY, four of NuPathe's patents
    were listed in the FDA's Orange Book. Based on these patents, NuPathe
    expects product exclusivity for ZECUITY through April 21, 2029.
--  In November, NuPathe entered into an $8.5 million term loan with
    Hercules Technology Growth Capital. Approximately $8.0 million of the
    loan proceeds were used to pay off the company's previous term loan
    facility and the remainder is available for general working capital
    purposes.
--  In October, NuPathe completed the sale of $28 million of securities
    resulting in approximately $26.3 million of net proceeds. The
    securities were sold as units, each consisting of a fractional share
    of newly designated Series A preferred stock and a warrant to purchase
    one share of the Company's common stock. The purchase price per unit
    was $2.00. All shares of the Series A Preferred Stock have converted
    into shares of common stock, an
d as of March 26, 2013, there were
    29,071,164 common shares outstanding.

  
Fourth Quarter and Full Year 2012 Financial Results
 NuPathe reported a
net loss applicable to common shareholders of $19.1 million for the
fourth quarter of 2012, compared with a net loss applicable to common
shareholders of $5.6 million for the fourth quarter of 2011. For the
full year 2012, NuPathe reported a net loss of $37.8 million,
compared with a net loss of $23.2 million for the full year 2011.
Both the fourth quarter and full year 2012 periods include a $13.25
million non-cash charge for a deemed dividend related to the
preferred stock that we issued in October 2012. Excluding this
non-cash charge, the net loss for the fourth quarter and full year
2012 would have been $5.9 million and $24.5 million, respectively. 
Research and development expenses were $1.1 million in the fourth
quarter of 2012, compared with $3.2 million in the fourth quarter of
2011. The fourth quarter 2012 decrease was largely attributable to
reduced spending on clinical and manufacturing related expenses for
ZECUITY. The 2011 period included higher expenses in these areas for
efforts related to the resubmission of the ZECUITY NDA. Selling,
general and administrative expenses were $2.6 million in the fourth
quarter of 2012, compared with $1.9 million for the same period in
2011. The 2012 period increase was primarily attributable to higher 
non-cash stock compensation expense. For the full year 2012, research
and development expenses and selling, general and administrative
expenses were $10.1 million and $10.9 million, respectively, compared
to full year 2011 research and development expenses and selling,
general and administrative expenses of $12.4 million and $9.4
million, respectively. 
Net cash used in operating activities for the twelve months ended
December 31, 2012, was $20.6 million, primarily the result of
spending for normal operating activities and development and
regulatory expenses for the preparation of the resubmission of the
ZECUITY NDA. During this period NuPathe also used $0.5 million of
cash in investing activities, while financing activities provided
$20.6 million in cash, primarily related to the equity offering
completed in October and the term loan completed in November,
partially offset by early repayment of the company's previous term
loan facility.  
As of December 31, 2012, NuPathe had $22.6 million in cash and cash
equivalents and working capital of $19.8 million, compared with $23.1
million in cash and cash equivalents and working capital of $11.0
million as of December 31, 2011. Management estimates that the
Company's existing cash and cash equivalents will be sufficient to
fund operations and debt service obligations into the fourth quarter
of 2013. The additional capital that the Company will require to
launch ZECUITY and to fund operations and debt service obligations
beyond that point will depend largely upon the timing, scope, terms
and structure of a commercial partnership for ZECUITY. However, there
is no assurance that the Company will be able to secure a commercial
partner on acceptable terms, and additionally no assurance that
additional required capital will be available when needed or on
acceptable terms. 
Company to Host Conference Call
 NuPathe will host a conference call
today, March 26, 2013, at 8:30 a.m. EDT to discuss the Company's
financial results for the quarter and year ended December 31, 2012,
and recent operational highlights. A question and answer session will
follow NuPathe's remarks. To participate on the live call, please
dial 888-510-1786 (domestic) or +1-719-325-2452 (international), and
provide the participant passcode 4967850, 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 4967850. 
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 NuPathe's website approximately 10 minutes prior to the
scheduled start time. A replay of the webcast will also be archived
on the Company
's website for 90 days following the call. 
About ZECUITY 
 ZECUITY(TM) (sumatriptan iontophoretic transdermal
system) is indicated for the acute treatment of migraine with or
without aura in adults. ZECUITY is a single-use, battery-powered
patch applied to the upper arm or thigh during a migraine. Following
application and with a press of a button, ZECUITY initiates
transdermal delivery (through the skin), bypassing the
gastrointestinal tract. Throughout the four-hour dosing period, the
microprocessor within ZECUITY continuously monitors skin resistance
and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of
sumatriptan, the most prescribed migraine medication in the U.S.,
with minimal patient-to-patient variability.  
Important Safety Information 
 Patients should not take ZECUITY if
they have heart disease, a history of heart disease or stroke,
peripheral vascular disease (narrowing of blood vessels to your legs,
arms, stomach or kidney), transient ischemic attack (TIA) or problems
with blood circulation, uncontrolled blood pressure, migraines that
cause temporary paralysis on one side of the body or basilar
migraine, Wolff-Parkinson-White syndrome or other disturbances of
heart rhythm. Very rarely, certain people, even some without heart
disease, have had serious heart-related problems after taking
triptans like ZECUITY.  
Patients should not use ZECUITY if they have taken other migraine
medications such as ergotamine medications or other triptans in the
last 24 hours or if they have taken monoamine oxidase-A (MAO-A)
inhibitors within the last 2 weeks. 
Patients should not use ZECUITY during magnetic resonance imaging
(MRI). 
Patients should not use ZECUITY if they have an allergy to
sumatriptan or components of ZECUITY or if they have had allergic
contact dermatitis (ACD) following use of ZECUITY. If patients
develop ACD, they should talk to their healthcare provider before
using sumatriptan in another form. 
ZECUITY, like other triptans, may be associated with a potentially
life-threatening condition called serotonin syndrome, mainly when
used together with certain types of antidepressants including
serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine
reuptake inhibitors (SNRIs).  
Patients should tell their healthcare provider before using ZECUITY
if they have heart disease or a family history of heart disease,
stroke, high cholesterol or diabetes; have gone through menopause;
are a smoker; have had epilepsy or seizures or if they are pregnant,
nursing or thinking about becoming pregnant.  
The most common side effects of ZECUITY are application site pain,
tingling, itching, warmth and discomfort. Most patients experience
some skin redness after removing ZECUITY. This redness typically goes
away in 24 hours.  
Please see full Prescribing Information for ZECUITY. 
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088. 
Patients and healthcare providers interested in more information on
ZECUITY should visit www.zecuity.com. 
About Migraine and Migraine-Related Nausea (MRN)
 Migraine is a
debilitating neurological disease afflicting a large underserved
patient population. Migraine is characterized by headache pain
accompanied by associated neurological and GI symptoms including
nausea, vomiting, photophobia, and phonophobia.(1,2) In the U.S., 31
million adults, with approximately three times as many women as
men,(3) suffer from migraine.(3,4,5) Of the 16 million migraine
patients who are diagnosed and treated, approximately eight million
experience migraine-related nausea (MRN) in at least half of their
migraine attacks.(6) These frequent-MRN patients report significantly
more migraine symptom burden and experience significantly more
interference with work, social and family life.(6) Many migraine
patients who experience MRN delay or avoid taking orally administered
medications due to nausea or vomiting.(7) 
About NuPathe
 NuPathe Inc. is a specialty pharmaceutical company
focused on innovative neuroscience solutions for diseases of the
central nervous system including neurological and psychiatric
disorders. NuPathe's lead product, ZECUITY (sumatriptan iontophoretic
transdermal system), has been approved by the FDA for the acute
treatment of migraine with or without aura in adults. ZECUITY is
expected to be available by prescription in the fourth quarter of
2013. In addition to ZECUITY, NuPathe has two proprietary product
candidates based on its LAD(TM), or Long-Acting Delivery,
biodegradable implant technology that allows delivery of therapeutic
levels of medication over a period of months with a single dose.
NP201, for the continuous symptomatic treatment of Parkinson's
disease, utilizes a leading FDA-approved dopamine agonist,
ropinirole, and is designed to provide up to two months of continuous
delivery. NP202, for the long-term treatment of schizophrenia and
bipolar disorder, is designed to address the long-standing problem of
patient noncompliance by providing three months of continuous
delivery of risperidone, an atypical antipsychotic. NuPa
the is
actively seeking partnerships to maximize the commercial potential
for ZECUITY and its other product candidates in the U.S. and
territories throughout the world. 
For more information about NuPathe, please visit our website at
www.nupathe.com. You can also follow us on StockTwits
(stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare
(slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com). 
Cautionary Note Regarding Forward-Looking Statements 
 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 potential benefits of, and
commercial opportunity for, ZECUITY and NuPathe's other product
candidates; partnering plans for ZECUITY and NuPathe's other product
candidates; the timing of the expected launch and availability of
ZECUITY; the scope and duration of product exclusivity expected to be
afforded by the referenced patents; the sufficiency of the Company's
cash and cash equivalents to fund operation and debt service
obligations into the fourth quarter of 2013; and other statements
relating to NuPathe's plans, objectives, expectations and beliefs
regarding its future operations, performance, financial condition and
other future events. Forward-looking statements are based upon
management's current expectations and beliefs and are subject to a
number of risks, uncertainties, assumptions and other factors that
could cause actual results and events to differ materially from those
indicated herein including, among others: NuPathe's ability to obtain
sufficient capital to launch ZECUITY and continue as a going concern;
NuPathe's ability to obtain commercial partners for ZECUITY and its
other product candidates; risks and uncertainties relating to
intellectual property; NuPathe's reliance on third parties to
manufacture ZECUITY; NuPathe's ability to establish and effectively
manage its supply chain; NuPathe's ability to establish effective
marketing and sales capabilities; market acceptance among physicians
and patients and the availability of adequate reimbursement from
third party payors for ZECUITY; and the risks, uncertainties and
other factors discussed in NuPathe's Annual Report on Form 10-K for
the year ended December 31, 2011 and Quarterly Report on Form 10-Q
for the quarter ended September 30, 2012 under the caption "Risk
Factors" and elsewhere in such reports, which are available on
NuPathe's website at www.nupathe.com in the "Investor Relations --
SEC Filings" section. 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. You are cautioned not
to place undue reliance on any forward-looking statements. 
References 
(1) ICHD-II. Cephalagia 2004; 24 (Suppl 1). 
 (2) Lipton, R. et al.
Classification of primary headaches. Neurology. 2004:63:427-435.  
(3) Lipton, R. et al. Prevalence and Burden of Migraine in the United
States: Data From the American Migraine Study II. Headache,
July/August 2001: p. 646. 
 (4) US Census Data. 1999, accessed at
http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13; and 2010,
accessed at http://www.census.gov/2010census/data/. 
 (5) NuPathe
Analysis. 
 (6) Lipton, R. et al. "Frequency and Burden of
Headache-Related Nausea: Results from the American Migraine
Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103.
Funded by a research grant from NuPathe Inc. 
 (7) Silberstein, S.
Migraine symptoms: results of a survey of self-reported migraineurs.
Headache 1995;35:387-396.  


 
                                                                            
                                NUPATHE INC.                                
                       (A Development-Stage Company)                        
                          Statements of Operations                          
             (In thousands, except share and per share amounts)             
                                (Unaudited)                                 
                                                                            
                                                                            
                                                                            
                                                                            
                            Three Months Ended                              
                               December 31,        Years Ended December 31, 
                         ------------------------  ------------------------ 
                             2012         2011         2012         2011    
                         -----------  -----------  -----------  ----------- 
Operating expenses:                                                         
  Research and                                                              
   development           $     1,116  $     3,202  $    10,149  $    12,407 
  Selling, general and                           
                           
   administrative              2,552        1,907       10,884        9,416 
                         -----------  -----------  -----------  ----------- 
                               3,668        5,109       21,033       21,823 
                         -----------  -----------  -----------  ----------- 
    Loss from operations      (3,668)      (5,109)     (21,033)     (21,823)
Interest income                    6           13           23           72 
Interest expense                (286)        (508)      (1,579)      (1,483)
Change in fair value of                                                     
 warrants                     (1,287)           -       (1,287)           - 
Loss on debt                                                                
 extinguishment                 (799)           -         (799)           - 
                         -----------  -----------  -----------  ----------- 
    Loss before tax                                                         
     benefit                  (6,034)      (5,604)     (24,675)     (23,234)
                         -----------  -----------  -----------  ----------- 
Income tax benefit               141           47          141           47 
                         -----------  -----------  -----------  ----------- 
    Net loss                  (5,893)      (5,557)     (24,534)     (23,187)
                                                                            
Deemed dividend              (13,250)           -      (13,250)           - 
                         -----------  -----------  -----------  ----------- 
Net loss applicable to                                                      
 common stockholders     $   (19,143) $    (5,557) $   (37,784) $   (23,187)
                         ===========  ===========  ===========  =========== 
Basic and diluted net                                                       
 loss per common share   $     (1.15) $     (0.38) $     (2.48) $     (1.58)
                         ===========  ===========  ===========  =========== 
                                                                            
Weighted average basic                                                      
 and diluted common                                                         
 shares outstanding       16,608,248   14,732,582   15,210,047   14,630,125 
                         ===========  ===========  ===========  =========== 
                                                                            
                                                                            
                                                                            
                                                                            
                                NUPATHE INC.                                
                        (A Development-Stage Company)                       
                             Balance Sheet Data                             
                               (In thousands)                               
                                 (Unaudited)                                
                                                                            
                                         December 31, 2012 December 31, 2011
                                         ----------------- -----------------
                                                                            
Cash and cash equivalents                $          22,570 $          23,059
Working capital (deficit)                           19,847            10,995
Total assets                                        30,607            30,849
Long-term debt                                       8,102             5,481
Total stockholders' equity                           3,013            12,971

  
Contact Information:  
INVESTOR CONTACTS
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com 
Keith A. Goldan
Vice President
Chief Financial Officer
NuPathe Inc.
(484) 567-0130 
MEDIA CONTACTS:
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com 
 
 
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