Horizon Pharma Announces Preliminary Fourth Quarter and Full Year 2012 Revenues, Full U.S. Commercial Launch of RAYOS(R) (Pre...
February 11 2013 - 7:30AM
Marketwired
Horizon Pharma, Inc. (NASDAQ: HZNP) today announced preliminary
(unaudited) revenues for the fourth quarter and fiscal year ended
December 31, 2012.
- Full year 2012 preliminary gross and net revenues were $23.0
million and $19.6 million, respectively.
- DUEXIS® full year 2012 preliminary gross
and net revenues were $13.2 million and $11.0 million,
respectively.
- Fourth quarter preliminary gross and net revenues were $8.2
million and $6.7 million, respectively.
- DUEXIS fourth quarter preliminary gross and net revenues were
$7.1 million and $6.0 million, respectively.
- New prescriptions for DUEXIS increased 57% in the fourth
quarter of 2012 to 31,130 versus 19,874 in the third quarter of
2012. New prescriptions for DUEXIS were 10,754 in December
2012.
- Total prescriptions for DUEXIS increased 56% in the fourth
quarter of 2012 to 39,060 versus 25,054 in the third quarter of
2012. Total prescriptions for DUEXIS were 13,969 in December
2012.
- The Company had cash and cash equivalents of $104.1 million at
December 31, 2012.
During the fourth quarter, the Company changed from recognizing
revenue upon product being dispensed through patient prescriptions
to recognizing revenue when product is sold into the wholesale and
pharmacy channel. Based on approximately one year of minimal
product return quantities and an enhanced ability and historical
experience upon which to monitor DUEXIS inventory levels in the
distribution channel and to assess the relative risk of potential
product returns, the Company believes it now has the ability to
reliably estimate returns and has begun recognizing revenue on the
sale of DUEXIS at the point of sale to the wholesaler. This change
in timing of revenue recognition resulted in a preliminary one-time
increase to DUEXIS revenue of $1.8 million gross and $1.4 million
net and is reflected in the fourth quarter and full year results
presented.
Full RAYOS Commercial Launch Underway
Horizon also announced today it has initiated the full commercial
launch of RAYOS® (prednisone) delayed-release tablets to
rheumatologists and high-value primary care physicians through its
full 150-person sales force. As previously announced, Horizon's
commercial effort for RAYOS will focus on rheumatology indications,
including rheumatoid arthritis (RA) and polymyalgia rheumatica
(PMR), which collectively comprise approximately three million
patients in the U.S. The Company's sales representatives will
promote RAYOS to approximately 3,500 rheumatologists in the U.S.,
who write over ninety-five percent of rheumatologist RA and PMR
prescriptions.
In addition, the Company announced the approval of LODOTRA in
South Korea in January, which triggered a milestone payment from
its partner MundiPharma. The South Korean approval marks the 20th
country in which LODOTRA is approved outside of the United
States.
"Preliminary results were promising in the fourth quarter, with
total fourth quarter DUEXIS prescriptions growing 56% versus the
third quarter of 2012," said Timothy P. Walbert, chairman,
president and chief executive officer, Horizon Pharma. "In
addition, feedback from the initial launch of RAYOS has been
positive as we saw over 100 rheumatologists prescribe RAYOS during
our targeted launch in December last year. This gives us confidence
moving forward as we have now implemented the full commercial
launch of RAYOS through our 150-person sales force."
About DUEXIS DUEXIS®, a proprietary
single-tablet combination of the NSAID ibuprofen and the histamine
H2-receptor antagonist famotidine, is indicated for the relief of
signs and symptoms of rheumatoid arthritis and osteoarthritis and
to decrease the risk of developing upper gastrointestinal ulcers,
which in the clinical trials was defined as a gastric and/or
duodenal ulcer, in patients who are taking ibuprofen for those
indications. The clinical trials primarily enrolled patients less
than 65 years of age without a prior history of gastrointestinal
ulcer. Controlled trials do not extend beyond 6 months. For more
information, please visit www.DUEXIS.com.
About RAYOS RAYOS®, known as LODOTRA®
outside the U.S., is a proprietary delayed-release formulation of
low-dose prednisone. The pharmacokinetic profile of RAYOS is
different with an approximately four-hour lag time from that of
immediate-release prednisone formulations. In clinical trials
studying use of RAYOS in RA, patients were administered RAYOS at 10
p.m. with food. The delayed-release profile of RAYOS helps to
achieve therapeutic prednisone blood levels at a time point when
cytokine levels start rising during the middle of the night. While
the pharmacokinetic profile of RAYOS differs in terms of lag time
from immediate-release prednisone, its absorption, distribution and
elimination processes are comparable. For more information, please
visit www.RAYOSrx.com.
About Horizon Pharma Horizon Pharma, Inc.
is a specialty pharmaceutical company that has developed and is
commercializing DUEXIS and RAYOS/LODOTRA, both of which target
unmet therapeutic needs in arthritis, pain and inflammatory
diseases. The Company's strategy is to develop, acquire, in-license
and/or co-promote additional innovative medicines where it can
execute a targeted commercial approach in specific therapeutic
areas while taking advantage of its commercial strengths and the
infrastructure the Company has put in place. For more information,
please visit www.horizonpharma.com.
Forward Looking Statements This press
release contains forward-looking statements, including statements
regarding Horizon's on-going commercial launches of DUEXIS and
RAYOS, commercialization plans for DUEXIS and RAYOS and the timing
for implementing those plans and confidence regarding 2013
operating results. These forward-looking statements are based on
management's expectations and assumptions as of the date of this
press release, and actual results may differ materially from those
in these forward-looking statements as a result of various factors,
including, but not limited to, risks regarding the company's
ability to commercialize products successfully, potential delays or
changes in strategy for the commercial launch of DUEXIS and RAYOS,
whether physicians will prescribe and patients will use DUEXIS and
RAYOS and competition in the market for the Company's products. For
a further description of these and other risks facing Horizon,
please see the risk factors described in Horizon's filings with the
United States Securities and Exchange Commission, including those
factors discussed under the caption "Risk Factors" in those
filings. Forward-looking statements speak only as of the date of
this press release. Horizon undertakes no obligation to update or
revise these statements, except as may be required by law.
The financial information set forth in this press release
reflect Horizon's preliminary estimates, which are subject to
completion of Horizon's fourth quarter and year-end review and
audit process. Horizon's actual fourth quarter and full year 2012
financial and operating results could differ materially from the
preliminary estimates set forth in this press release.
Contacts Robert J. De Vaere Executive Vice President and
Chief Financial Officer Email Contact Investors Kathy Galante Burns
McClellan, Inc. 212-213-0006 Email Contact
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