Raptor Pharmaceutical Corp. Announces Third Quarter Fiscal 2012 Financial Results

Raptor Pharmaceutical Corp. 

11.07.2012 23:45
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NOVATO, Calif., 2012-07-11 23:45 CEST (GLOBE NEWSWIRE) --
Raptor Pharmaceutical Corp. ('Raptor' or the 'Company') (Nasdaq:RPTP), today
provided an update on the Company's business and announced financial results
for the third quarter ended May 31, 2012. 

Operational Highlights

  -- In June 2012, the U.S. Food and Drug Administration ('FDA') accepted for
     filing the Company's New Drug Application ('NDA') for its investigational
     drug candidate, Cysteamine Bitartrate Delayed-Release Capsules ('RP103'),
     for the potential treatment of nephropathic cystinosis. The FDA has
     assigned a user fee review goal date of January 30, 2013. In March 2012,
     Raptor announced that the European Medicines Agency ('EMA') had validated
     its Marketing Authorization Application ('MAA') for RP103 and that the MAA
     is under review by the EMA. The Company expects a decision from the EMA in
     the first half of calendar 2013.
  -- In June 2012, Raptor completed enrollment of its Phase 2/3 clinical trial
     of RP103 for the potential treatment of Huntington's Disease. The
     96-patient clinical trial, funded by the French government, is being
     conducted under a collaboration agreement with The Centre Hospitalier
     Universitaire d'Angers, at 8 active clinical sites throughout France.
     Following 18 months of blinded treatment, interim results of this clinical
     trial are expected to be announced in the first half of calendar 2014.
  -- In June 2012, the first patient was dosed in the Company's Phase 2b
     clinical trial evaluating the safety and potential efficacy of RP103 in
     pediatric patients as a potential treatment of non-alcoholic
     steatohepatitis ('NASH'), an advanced form of non-alcoholic fatty liver
     disease ('NAFLD'). Raptor is conducting this trial within a cooperative
     research and development agreement ('CRADA') with the National Institute of
     Diabetes and Digestive and Kidney Diseases ('NIDDK'), part of the National
     Institutes of Health. The trial is expected to enroll a total of 160
     pediatric patients at 10 U.S. centers in the NIDDK-sponsored NASH Clinical
     Research Network.
  -- In May 2012, Raptor acquired exclusive rights to intellectual property from
     McGill University in Montreal, Canada that covers the use of cysteamine and
     related compounds in the potential treatment of malaria in combination with
     artemisinin, the current standard of care.
  -- In June 2012, Raptor acquired exclusive rights to intellectual property
     related to cysteamine and related compounds in the potential treatment of
     Parkinson's Disease from Universite Laval, Quebec, Canada.

'This past quarter has been a pivotal and productive time for us,' said
Christopher M. Starr, Ph.D., Raptor's Chief Executive Officer. 'While we have
remained focused on building our commercial infrastructure both in the U.S. and
the E.U. in anticipation of approval and launch of RP103 for the potential
treatment of nephropathic cystinosis, we continued to work towards maximizing
the value of our proprietary enteric-coated formulation of cysteamine through
the advancement of our clinical trials in Huntington's Disease and NASH and
through expansion of our IP portfolio.' 

Third Quarter 2012 Financial Results

Raptor believes that its cash, cash equivalents and short term investments as
of May 31, 2012 of approximately $43.1 million will be sufficient to meet its
operating requirements and obligations through the first quarter of calendar
2013. 

Raptor's net loss for the three and nine months ended May 31, 2012 was
approximately $3.0 million and $28.4 million, or $0.06 and $0.60 per share,
respectively. Net loss for the three and nine months ended May 31, 2011 was
approximately $20.3 million and $33.4 million, or $0.62 and $1.06 per share,
respectively. 

Research and development expenses increased $2.1 million, or 54%, from
approximately $3.9 million during the three months ended May 31, 2011, to
approximately $6.0 million during the three months ended May 31, 2012. The
increase in research and development expenses for the three months ended May
31, 2012 was primarily due to an increase in RP103 manufacturing expenses to
support ramp-up for the potential commercial launch of the cystinosis
indication and the NASH Phase 2b clinical trial, which began in June 2012, and
milestone payments paid to the University of California, San Diego ('UCSD') for
Raptor's IND filing for NASH and MAA filing for cystinosis. Research and
development expenses increased $4.7 million, or 46%, from approximately $10.3
million during the nine months ended May 31, 2011, to approximately $15.0
million during the nine months ended May 31, 2012. The increase in research and
development expenses for the nine months ended May 31, 2012 was primarily due
to an increase in RP103 manufacturing as described above, the absence of tax
rebates that were received in the prior year and an increase in headcount and
related salaries and benefits. 

General and administrative expenses increased $2.4 million, or 141%, from
approximately $1.7 million during the three months ended May 31, 2011, to
approximately $4.1 million during the three months ended May 31, 2012. The
increase in general and administrative expenses for the three months ended May
31, 2012 was primarily due to increased stock option expense for employees and
the Board, the additional headcount in Finance and Commercial Operations, and
consulting services for marketing and reimbursement studies and tax strategy
both in the U.S. and the E.U. in preparation for the potential launch of RP103
for nephropathic cystinosis. General and administrative expenses increased $4.3
million, or 95%, from approximately $4.6 million during the nine months ended
May 31, 2011, to approximately $8.9 million during the nine months ended May
31, 2012. The increase in general and administrative expenses was due to the
same increases described above for the three months ended May 31, 2012. 

About Cysteamine and RP103

RP103, Raptor's proprietary delayed release oral medication, is currently being
investigated in several indications.  RP103 is an enteric coated, microbead
formulation of cysteamine bitartrate. 

In December 2007, Raptor obtained an exclusive, worldwide license from UCSD for
the development of RP103 for the potential treatment of nephropathic
cystinosis, plus RP103 and other forms of cysteamine for the potential
treatment of NASH, currently in a Phase 2b clinical trial in the U.S., and
Huntington's Disease currently in a Phase 2/3 clinical trial in France.  In
March 2012, Raptor filed for marketing approval of RP103 for the potential
treatment of nephropathic cystinosis in the U.S. and E.U. The FDA has accepted
for filing Raptor's NDA for RP103 for the potential treatment of nephropathic
cystinosis and assigned a user fee review goal date of January 30, 2013. 
Raptor's E.U. marketing application of RP103 for the potential treatment of
nephropathic cystinosis is under review by the EMA and Raptor expects a
decision in the first half of calendar 2013. In 2010, the Company acquired an
exclusive worldwide license to intellectual property covering the use of
transglutaminase inhibitors, a class of molecules chemically similar to
cysteamine, in the potential treatment of Huntington's Disease and other
neurological disorders from the Weizmann Institute of Science in Israel and
Niigata University in Japan. Raptor has been granted orphan product designation
for RP103 for the potential treatment for nephropathic cystinosis by the FDA
and EMA and for RP103 for the potential treatment of Huntington's Disease by
the FDA. 

About Raptor Pharmaceutical Corp.

Raptor Pharmaceutical Corp. (Nasdaq:RPTP) ('Raptor') seeks to research,
produce, and deliver medicines that improve life for patients with severe, rare
disorders. Raptor currently has product candidates in clinical development to
potentially treat nephropathic cystinosis, Non-alcoholic Steatohepatitis
('NASH'), Huntington's Disease ('HD'), aldehyde dehydrogenase deficiency
('ALDH2'), and thrombotic disorder. 

Raptor's preclinical programs are based upon bioengineered novel drug
candidates and drug-targeting platforms derived from the human
receptor-associated protein and related proteins that are designed to target
cancer and infectious diseases. 

For additional information, please visit www.raptorpharma.com.

The Raptor Pharmaceutical Corp. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7180 

                           FORWARD LOOKING STATEMENTS

This document contains forward-looking statements as that term is defined in
the Private Securities Litigation Reform Act of 1995. These statements relate
to future events or our future results of operation or future financial
performance, including, but not limited to the following statements: that the
FDA will decide on Raptor's NDA by the user fee goal date of January 30, 2013;
that the EMA will make a decision on Raptor's MAA in the first half of calendar
2013; that the NIDDK will be able to complete the Phase 2b clinical trial in
NASH, that the trial will enroll 160 pediatric patients at 10 U.S. centers  and
that results will be announced by the first half of calendar 2014; that The
Centre Hospitalier Universitaire d'Angers will be able to complete the Phase
2/3 clinical trial in Huntington's Disease and that results will be announced
by the first half of calendar 2014; that Raptor will be able to build its
commercial infrastructure in the U.S. and the E.U.; that Raptor will receive
drug approval for RP103 for nephropathic cystinosis; that Raptor will be able
to successfully launch RP103 for nephropathic cystinosis, if approved; that
Raptor will maximize the value of its proprietary enteric-coated formulation of
cysteamine through further expansion of its IP portfolio; that Raptor's cash,
cash equivalents and short term investments as of May 31, 2012 of approximately
$43.1 million will be sufficient to meet its operating requirements and
obligations through the first quarter of calendar 2013; and that Raptor will be
able to successfully develop RP103 or any of its other product candidates.
These statements are only predictions and involve known and unknown risks,
uncertainties and other factors, which may cause the Company's actual results
to be materially different from these forward-looking statements. Factors which
may significantly change or prevent the Company's forward looking statements
from fruition include: that Raptor may be unsuccessful in developing any
products or acquiring products; that Raptor's technology may not be validated
as it progresses further and its methods may not be accepted by the scientific
community; that Raptor is unable to retain or attract key employees whose
knowledge is essential to the development of its products; that unforeseen
scientific difficulties develop with the Company's process; that Raptor's
patents are not sufficient to protect essential aspects of its technology; that
competitors may invent better technology; that Raptor's products may not work
as well as hoped or worse, that the Company's products may harm recipients; and
that Raptor may not be able to raise sufficient funds for development or
working capital. As well, Raptor's products may never develop into useful
products and even if they do, they may not be approved for sale to the public.
Raptor cautions readers not to place undue reliance on any such forward-looking
statements, which speak only as of the date they were made. Certain of these
risks, uncertainties, and other factors are described in greater detail in the
Company's filings from time to time with the Securities and Exchange Commission
(the 'SEC'), which Raptor strongly urges you to read and consider, including:
Raptor's annual report on Form 10-K, as amended by Form10-K/A, filed with the
SEC on November 11, 2011 and December 19, 2011, respectively; and Raptor's
quarterly report on Form 10-Q filed with the SEC on July 10, 2012; all of which
are available free of charge on the SEC's web site at http://www.sec.gov.
Subsequent written and oral forward-looking statements attributable to Raptor
or to persons acting on its behalf are expressly qualified in their entirety by
the cautionary statements set forth in Raptor's reports filed with the SEC.
Raptor expressly disclaims any intent or obligation to update any
forward-looking statements. 


         For more information, please contact:
         
         Trout Group (investors)
         Lauren Glaser
         (646) 378-2972
         lglaser@troutgroup.com
         
         EVC Group (media)
         Janine McCargo
         (646) 688-0425
         jmccargo@evcgroup.com
News Source: NASDAQ OMX



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Language:     English
Company:      Raptor Pharmaceutical Corp.
              
               
              United States
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ISIN:         US75382F1066
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