Nov. 4, 2009 (GlobeNewswire) --
SCOTTSDALE, Ariz., Nov. 4, 2009 (GLOBE NEWSWIRE) -- Medicis (NYSE:MRX) today announced revenues of approximately $151.8 million for the three months ended September 30, 2009, compared to revenues of approximately $115.4 million for the three months ended September 30, 2008, representing an increase of approximately 31.5%. This increase was due primarily to the strength of SOLODYN(R) and the launch of DYSPORT(TM) during the quarter.
Non-generally accepted accounting principles (non-GAAP) net income per diluted share (defined below) for the three months ended September 30, 2009, was $0.50, compared to non-GAAP net income per diluted share of $0.26 for the three months ended September 30, 2008, representing an increase of approximately 91.8%.
The Company's achievement of approximately $151.8 million in revenues is consistent with the Company's previously published guidance of approximately $147-$154 million for the three months ended September 30, 2009. Non-GAAP net income per diluted share of $0.50 compares favorably to the Company's previously published guidance of approximately $0.36-$0.42 in net income per diluted share for the three months ended September 30, 2009. As a result of the third quarter financial results, the Company has raised its revenue and EPS guidance for the calendar year (see "2009 Guidance" below).
"We are pleased to announce another record quarter fueled by the strength of SOLODYN," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "We are encouraged by the positive physician and patient response to DYSPORT. As we look to year's end, we are focused on our research and development efforts, having achieved our goal of three product approvals in 2009."
Non-GAAP net income for the three months ended September 30, 2009, was approximately $32.1 million, compared to non-GAAP net income of approximately $16.1 million for the three months ended September 30, 2008, representing an increase of approximately 99.1%. Non-GAAP net income for the three months ended September 30, 2009, excludes charges totaling approximately $11.0 million (net), consisting of a $17.0 million charge (pre-tax) for upfront and milestone research and development (R&D) payments to Medicis partners and an income tax benefit of approximately $6.0 million related to these transactions.
GAAP net income for the three months ended September 30, 2009, was approximately $21.1 million, compared to GAAP net loss of approximately ($14.7) million for the three months ended September 30, 2008. GAAP net income per diluted share for the three months ended September 30, 2009, was $0.33, compared to GAAP net loss per diluted share of ($0.26) for the three months ended September 30, 2008.
Acne Products
Medicis recorded revenues of approximately $106.8 million from sales of its acne products for the three months ended September 30, 2009, compared to revenues of approximately $66.3 million for the three months ended September 30, 2008, representing an increase of approximately 61.1%. This increase is due primarily to increased sales of SOLODYN and TRIAZ(R) in the quarter. Medicis acne products include primarily PLEXION(R), SOLODYN, TRIAZ and ZIANA(R).
Non-Acne Products
Medicis recorded revenues of approximately $35.5 million associated with its non-acne products for the three months ended September 30, 2009, compared to revenues of approximately $34.1 million for the three months ended September 30, 2008, representing an increase of approximately 4.2%. This increase is due primarily to increased sales of RESTYLANE(R) and the launch of DYSPORT in the quarter, offset by a decrease in LOPROX(R) sales. Medicis non-acne products include primarily DYSPORT, LOPROX, PERLANE(R), RESTYLANE and VANOS(R).
Other Non-Dermatological Products
Medicis recorded revenues of approximately $9.5 million associated with its other non-dermatological products for the three months ended September 30, 2009, compared to revenues of approximately $15.1 million for the three months ended September 30, 2008, representing a decrease of approximately 36.9%. This decrease is due primarily to a decrease in contract revenue. Medicis other non-dermatological products include primarily AMMONUL(R), BUPHENYL(R), LIPOSONIX(R)(1) and contract revenue.
Other Income Statement Items
Gross profit margin for the three months ended September 30, 2009, increased approximately 0.5 percentage points to approximately 91.1%, compared to approximately 90.6% for the three months ended September 30, 2008. This increase was due primarily to increased sales of the higher-margin product SOLODYN.
Selling, general and administrative (SG&A) expense for the three months ended September 30, 2009, was approximately $71.9 million, or approximately 47.4% of revenues, compared to approximately $71.6 million, or approximately 62.0% of revenues, for the three months ended September 30, 2008. The Company continues to manage cost structure in non-strategic areas to achieve profitability objectives. This flat year-over-year cost structure, which includes three product launches, is evidence of the success to date of these efforts.
R&D expense for the three months ended September 30, 2009, was approximately $27.4 million, compared to approximately $37.6 million, inclusive of a $30.5 million acquired in-process R&D charge associated with the acquisition of LipoSonix, for the three months ended September 30, 2008. This represents a decrease of approximately 27.2%. R&D expense for the three months ended September 30, 2009, includes upfront and milestone payments to Medicis partners of $17.0 million.
2009 Guidance
Based upon information currently available, the Company's financial guidance for the remainder of 2009 is as follows:
Calendar 2009
(in millions, except per share amounts)
First Second Third Fourth Calendar
Quarter Quarter Quarter Quarter Year End
(3/31/09) (6/30/09) (9/30/09) (12/31/09) 2009
Actual Actual Actual Estimated Estimated
-------------------------------------------------------
Revenue $100 $141 $152 $168-$174 $561-$567
Non-GAAP
diluted net
income per
share
objectives $0.09 $0.39 $0.50 $0.58-$0.62 $1.56-$1.60
Additional 2009 Guidance Considerations
-- The Company is anticipating a significant increase in R&D and SG&A
spending in the fourth quarter of 2009 as compared to the third
quarter of 2009. The sequential increase in R&D expense is
primarily related to costs associated with the U.S. clinical
trials for LIPOSONIX. The sequential increase in SG&A expense is
primarily attributable to promotional costs associated with the
launch of DYSPORT in the U.S.
-- Revenue and non-GAAP diluted net income per share objectives
include a full year of SOLODYN revenue with no additional generic
entry;
-- annual gross profit margins of approximately 90-91% of revenues;
-- annual SG&A expense of approximately 51-53% of revenues;
-- annual R&D expense of approximately 7-9% of revenues;
-- annual depreciation and amortization expense of approximately $30
million;
-- annual effective tax rate of approximately 37-38%;
-- the non-GAAP diluted net income per share figures above
incorporate the impact of share-based compensation expense,
totaling approximately $18-$20 million for the year; and
-- fully diluted weighted average shares outstanding of
approximately 62-64 million shares for the year.
The above guidance could be materially impacted by the following:
-- the timing of potential approvals of generic versions of SOLODYN,
as well as potential commercial launches of such products;
-- the timing of additional SOLODYN patent allowances, if any;
-- uncertainty relating to the Company's continued ability to
utilize the SOLODYN Patient Access Card in the current manner,
which may affect the average selling price;
-- the impact of the U.S. economy on the Company's aesthetic and
therapeutic franchises;
-- the financial impact of changes in accounting or governmental
pronouncements; and
-- potential special charges associated with business development
transactions and R&D milestones, contract payments or impairment
charges on the Company's assets.
Diluted Net Income Per Share
Diluted net income per share amounts are calculated using the "if-converted" method of accounting regardless of whether the Company's outstanding convertible bonds meet the criteria for conversion and regardless of whether the bondholders actually convert their bonds into shares.
Use of Non-GAAP Financial Information
The Company has disclosed non-GAAP financial information in this press release to provide meaningful supplemental information regarding its operational performance and to enhance its investors' overall understanding of its core financial performance.