NuPathe Announces First Quarter 2013 Financial Results and Operational
CONSHOHOCKEN, PA -- (Marketwired) -- 05/14/13 -- NuPathe Inc.
(NASDAQ: PATH) today announced financial results for the quarter
ended March 31, 2013, as well as recent operational highlights.
"Approval of ZECUITY was a significant milestone for NuPathe as a
company and offers a new treatment option for migraine patients,
especially the millions of patients who suffer from migraine-related
nausea in addition to their headache pain," said Armando Anido, chief
executive officer of NuPathe. "We remain focused on securing
commercial partners and preparing for the launch of ZECUITY, which
remains on track for the fourth quarter of 2013."
Quarterly and Recent Highlights
-- In January, the U.S. Food & Drug Administration (FDA) approved
ZECUITY(R) (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 into April 2029.
-- In February, the automatic conversion of our Series A Preferred Stock
was triggered, resulting in the conversion of 100% of the outstanding
Series A Preferred Stock into common stock, as well as the termination
of the "full ratchet" anti-dilution feature of the warrants we issued
in connection with the Series A Preferred Stock in October 2012.
-- In April and May, the United States Patent and Trademark Office
(USPTO) issued notices of allowance for U.S. Patent applications
12/074,101 and 11/784,526, respectively. Both patent applications are
entitled "Implants for the Treatment of Dopamine Associated States."
Once issued, the patents will provide protection for NP201, NuPathe's
erm biodegradable ropinirole implant for the treatment of
Parkinson's disease, into July 2028 and October 2027, respectively.
First Quarter 2013 Financial Results
NuPathe reported a net loss of
$17.7 million, or $0.68 per diluted share, for the first quarter of
2013, compared with a net loss applicable to common shareholders of
$6.3 million, or $0.43 per diluted share, for the first quarter of
2012. The 2013 first quarter period included a $12.2 million non-cash
charge, or $0.47 per diluted share, for the change in fair value of
the warrants that were issued in October 2012. Total operating
expenses for the first quarter of 2013 were $5.0 million, compared to
$5.8 million in the first quarter of 2012.
Research and development expenses were $2.0 million in the first
quarter of 2013, compared with $3.5 million in the first quarter of
2012. The decrease was largely attributable to higher expenses in the
2012 period for clinical and manufacturing related activities as the
Company prepared for the Zecuity NDA resubmission, as well as reduced
compensation expenses in the 2013 period due to fewer headcount.
Selling, general and administrative expenses were $3.0 million in the
first quarter of 2013, compared with $2.4 million for the same period
in 2012. The 2013 period increase was primarily attributable to a
$1.1 million increase in non-cash stock compensation expense,
partially offset by lower headcount and reduced commercial operations
Net cash used in operating activities for the three months ended
March 31, 2013 was $3.9 million, primarily the result of spending for
normal operating activities and continued development of ZECUITY.
During this period NuPathe also used $0.5 million of cash in
investing activities and $0.1 million in financing activities.
As of March 31, 2013, NuPathe had $18.0 million in cash and cash
equivalents and working capital of $14.2 million, compared with $22.6
million in cash and cash equivalents and working capital of $19.8
million as of December 31, 2012. 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. To meet its
capital needs, the Company intends to raise additional capital
through corporate collaborations, partnerships or other strategic
transactions, debt or equity financings or other funding
opportunities. 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.
As of May 10, 2013, NuPathe had 31,072,196 common shares outstanding.
Company to Host Conference Call
NuPathe will host a conference call
today, May 14, 2013, at 8:30 a.m. EDT to discuss the Company's
financial results for the quarter ended March 31, 2013, and recent
operational highlights. A question and answer session will follow
NuPathe's remarks. To participate on the live call, please dial
888-539-3696 (domestic) or +1-719-457-1035 (international), and
provide the participant passcode 1787292, 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 1787292.
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.
ZECUITY(R) (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
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
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)
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(R) (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. NuPathe 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
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 issuance of patents for U.S. patent applications
12/074,101 and 11/784,526; the scope and duration of product
exclusivity and protection expected to be afforded by the referenced
patents; the sufficiency of the Company's cash and cash equivalents
to fund operations 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,
2012 under the caption "Risk Factors" and elsewhere in such report,
which is 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.
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).
2. Lipton, R. et al.
Classification of primary headaches. Neurology. 2004:63:427-435.
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/.
6. Lipton, R. et al. "Frequency a
nd 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.
(A Development-Stage Company)
Statements of Operations
(In thousands, except share and per share amounts)
Three Months Ended March 31,
Research and development $ 1,990 $ 3,454
Selling, general and administrative 2,984 2,387
Loss from operations (4,974) (5,841)
Interest income 5 10
Interest expense (251) (453)
Change in fair value of warrants (12,162) -
Net loss (17,382) (6,284)
Series A Preferred Stock dividends (314) -
Net loss applicable to common stockholders $ (17,696) $ (6,284)
Basic and diluted net loss per common share $ (0.68) $ (0.43)
Weighted average basic and diluted common
shares outstanding 25,883,876 14,732,582
(A Development-Stage Company)
Balance Sheet Data
March 31, 2013 December 31, 2012
Cash and cash equivalents $ 18,026 $ 22,570
Working capital 14,184 19,847
Total assets 27,006 30,607
Long-term debt 7,352 8,102
Total stockholders' equity 15,390 3,013
Keith A. Goldan
Vice President, Chief Financial Officer
Sage Strategic Marketing
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