Raptor Pharmaceutical Corp. Reports First Quarter Fiscal Year 2013 Financial Results
1/9/2013 4:00 PM EST
Raptor Pharmaceutical Corp.
Press release
Raptor Pharmaceutical Corp. Reports First Quarter Fiscal Year 2013 Financial
Results
NOVATO, Calif., 2013-01-09 22:00 CET (GLOBE NEWSWIRE) -- Raptor Pharmaceutical
Corp. ("Raptor" or the "Company") (Nasdaq:RPTP), today reported financial
results for its first fiscal quarter ended November 30, 2012.
Financial Results and Other Recent Highlights
-- Net loss for the fiscal first quarter ended November 30, 2012 was
approximately $13.4 million or $0.26 per share, compared to approximately
$11.4 million or $0.25 per share for the same period of the prior fiscal
year.
-- Cash, cash equivalents and short-term investments ("Cash") as of November
30, 2012 were approximately $35.5 million.
-- As previously announced, on December 20, 2012, the Company signed a $50
million loan agreement with HealthCare Royalty Partners and received
approximately $23.4 million, net of fees and commissions, from the first
tranche.
-- Management estimates that the Company's Cash as of December 31, 2012 of
approximately $58 million (including the first tranche of cash received
from the loan agreement) will fund the Company into the fourth quarter of
calendar 2013.
-- As previously announced, on December 21, 2012, the Company received a
notice from the U.S. Food and Drug Administration ("FDA") in which the FDA
required additional time to complete its review of Raptor's New Drug
Application ("NDA") for RP103 for the potential treatment of nephropathic
cystinosis and extended the initial Prescription Drug User Fee Act
("PDUFA") goal date from January 30, 2013 to April 30, 2013. No new studies
were requested by the FDA.
"We have made great progress in advancing the development of RP103 and ensuring
financial stability for the potential U.S. commercial launch of RP103," said
Christopher M. Starr, Ph.D., Raptor's Chief Executive Officer. "In November in
a poster session at Kidney Week, we presented positive long-term data from
extended use of RP103 in patients with nephropathic cystinosis. In addition, in
December we secured a $50 million loan facility which enables us to execute our
pre-launch initiatives and to build our commercial infrastructure in
anticipation of a potential FDA approval of RP103 for the treatment of
cystinosis."
Financial Results for First Fiscal Quarter Ended November 30, 2012
Research and development expenses in the first quarter of fiscal 2013 were
approximately $6.8 million, an increase of approximately $1.8 million or 35%,
over expenses of approximately $5.0 million in the same period of the prior
fiscal year. The increase was primarily due to an increase in RP103
manufacturing expenses to support the ramp-up for the commercial launch of
RP103 for the treatment of nephropathic cystinosis, if approved. The increase
was also due to: Raptor's share of the costs to conduct the NIDDK-sponsored
NASH Phase 2b clinical trial of RP103; the addition of staff to support Medical
Affairs, Regulatory and Clinical Operations; and the increased costs for
preclinical development programs.
General and administrative expenses in the first quarter of fiscal 2013 were
approximately $6.4 million, an increase of approximately $4.1 million or 172%,
over approximately $2.3 million in the same period of the prior fiscal year.
The increase was primarily due to pre-commercial expenses related to
preparation for the launch of RP103 for the treatment of nephropathic
cystinosis, if approved, and for the addition of staff for Commercial
Operations (to support pre-commercial and future commercial activities),
Finance and Human Resources. General and administrative expenses also increased
for non-cash stock option compensation expense and legal expenses, and due to a
decrease in general and administrative expenses allocated to research and
development due to a change in allocation methodology.
Cash as of November 30, 2012, included approximately $5.9 million received
under an At-The-Market financing agreement along with approximately $1.0
million received from warrant exercises during the first fiscal quarter of
2013.
Recent Events
On December 20, 2012, the Company signed a $50 million loan agreement with
HealthCare Royalty Partners. The Company received approximately $23.4 million,
net of fees and commissions, in the first tranche. The Company will receive an
additional $25 million before expenses upon receiving FDA approval of RP103 as
a therapy for nephropathic cystinosis. The loan bears interest at an annual
fixed rate of 10.75% and a variable royalty rate, tiered down, based on a
percentage of future product net sales. The loan is interest-only for the first
two years.
On December 21, 2012, the Company received a notice from the FDA in which the
FDA required additional time to complete its review of Raptor's NDA for RP103
for the potential treatment of nephropathic cystinosis and extended the initial
PDUFA goal date from January 30, 2013 to April 30, 2013.
In December 2012, Raptor changed its year end from August 31 to December 31.
Therefore the Company will file a transitional Annual Report, on or before
March 18, 2013, on Form 10-KT for the short period from September 1, 2012 to
December 31, 2012. Thereafter, the Company will file quarterly reports on Form
10-Q for each calendar quarter.
About Raptor Pharmaceutical Corp.
Raptor seeks to research, develop, and provide access to medicines that improve
life for patients with severe and rare disorders. Raptor currently has product
candidates in clinical development designed to potentially treat nephropathic
cystinosis, non-alcoholic steatohepatitis, Huntington's Disease, and aldehyde
dehydrogenase deficiency.
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
Raptor will be able to launch RP103 for the potential treatment of nephropathic
cystinosis; that Raptor will be able to draw on the second $25 million tranche
under the loan agreement with HealthCare Royalty Partners; and that Raptor will
receive regulatory approval from the FDA of RP103 for the potential treatment
of nephropathic cystinosis by April 30, 2013, or at all. 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, filed with the SEC on November 14, 2012,
and Raptor's quarterly report on Form 10-Q filed with the SEC on January 9,
2013, all 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.
Raptor Pharmaceutical Corp.
(A Development Stage Company)
Condensed Consolidated Balance Sheets
(In thousands, except per share data, or unless otherwise specified)
November August
30, 31,
2012 2012
(unaudite (1)
d)
---------------------
ASSETS
Current assets:
Cash and cash equivalents $ 13,426 $ 23,580
Restricted cash 163 169
Short-term investments 22,056 15,307
Prepaid expenses and other 2,688 3,111
---------------------
Total current assets 38,333 42,167
Intangible assets, net 2,168 2,205
Goodwill 3,275 3,275
Fixed assets, net 397 403
Deposits 26 105
Deferred offering costs 116 134
Debt issuance costs 161 --
---------------------
Total assets $ 44,476 $ 48,289
=====================
LIABILITIES AND STOCKHOLDERS' EQUITY
Liabilities
Current liabilities:
Accounts payable $ 1,846 $ 1,601
Accrued liabilities 2,972 2,652
Common stock warrant liability 16,238 17,266
Deferred rent 8 14
Capital lease liability - current 8 8
---------------------
Total current liabilities 21,072 21,541
Capital lease liability - long-term 11 13
---------------------
Total liabilities 21,083 21,554
---------------------
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value per share, 15,000 shares -- --
authorized, zero shares issued and outstanding
Common stock, $0.001 par value per share, 150,000 shares 52 51
authorized 52,098 and 50,568 shares issued and
outstanding as at November 30, 2012 and August 31, 2012,
respectively
Additional paid-in capital 153,454 143,380
Accumulated other comprehensive loss (68) (50)
Deficit accumulated during development stage (130,045) (116,646)
---------------------
Total stockholders' equity 23,393 26,735
---------------------
Total liabilities and stockholders' equity $ 44,476 $ 48,289
=====================
(1) Derived from the Company's audited consolidated financial statements as of
August 31, 2012.
Raptor Pharmaceutical Corp.
(A Development Stage Company)
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
(In thousands, except per share data, or unless otherwise specified)
For the
period
from
September 8,
For the three months 2005
ended
November 30 (inception)
to
------------------------
November 30,
2012 2011 2012
-------------------------------------
Revenues: $ -- $ -- $ --
-------------------------------------
Operating expenses:
General and administrative 6,365 2,336 37,941
Research and development 6,785 5,016 67,466
-------------------------------------
Total operating expenses 13,150 7,352 105,407
-------------------------------------
Loss from operations (13,150) (7,352) (105,407)
Interest income 119 64 832
Interest expense 0 (1) (119)
Foreign currency transaction gain 60 59 234
Realized gain on short-term investments 0 0 214
Unrealized loss on short-term investments (64) (35) (66)
Adjustment to fair value of common stock (364) (4,168) (25,733)
warrants
-------------------------------------
Net loss (13,399) (11,433) (130,045)
Other comprehensive loss
Foreign currency translation adjustment (18) (8) (68)
-------------------------------------
Comprehensive loss $ (13,417) $ (11,441) $ (130,113)
=====================================
Net loss per share:
Basic and diluted $ (0.26) $ (0.25)
========================
Weighted-average shares outstanding used
to compute:
Basic and diluted 51,557 45,623
========================
CONTACT: Georgia Erbez
Chief Financial Officer
Raptor Pharmaceutical Corp.
(415) 382-1111 x204