Highest Quarterly Revenues in Company's 20-Year History
SCOTTSDALE, Ariz., Aug. 5, 2009 (GLOBE NEWSWIRE) -- Medicis (NYSE:MRX) today announced record net revenues of approximately $141.2 million for the three months ended June 30, 2009, compared to net revenues of approximately $137.4 million for the three months ended June 30, 2008, representing an increase of approximately 3%. This increase was due primarily to the strength of SOLODYN(R), and the launch of DYSPORT(TM) on June 15, 2009.
Non-generally accepted accounting principles (non-GAAP) earnings per diluted share (defined below) for the three months ended June 30, 2009, was $0.39, compared to non-GAAP earnings per diluted share of $0.44 for the three months ended June 30, 2008.
GAAP net income for the three months ended June 30, 2009, was approximately $15.6 million, compared to GAAP net income of approximately $13.0 million for the three months ended June 30, 2008. GAAP earnings per diluted share for the three months ended June 30, 2009, was $0.25, compared to GAAP earnings per diluted share of $0.21 for the three months ended June 30, 2008.
The Company's achievement of approximately $141.2 million in revenues compares favorably to the Company's previously published guidance of approximately $115-$121 million for the three months ended June 30, 2009. Non-GAAP earnings per diluted share of $0.39 compares favorably to the Company's previously published guidance of approximately $0.08-$0.15 in earnings per diluted share for the three months ended June 30, 2009.
"We are pleased to announce a very solid second quarter," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "This quarter's financial results speak to Medicis' ability to control costs and its desire to achieve our year's original EPS guidance. During 2009, the Company announced three important regulatory successes, including the U.S. Food and Drug Administration's (FDA) approvals of DYSPORT and SOLODYN 65mg and 115mg strengths, and Health Canada's issuance of the Medical Device License (MDL) for the LIPOSONIX(TM)(1) System. Additionally, we announced issuance of two new patents for SOLODYN relating to the 90mg strength. As we move into the second half of 2009, we are intensely focused on creating favorable launches for DYSPORT, LIPOSONIX and our new strengths of SOLODYN. We also anticipate meaningful activity in our research and development program."
Non-GAAP net income for the three months ended June 30, 2009, was approximately $24.9 million, compared to non-GAAP net income of approximately $29.0 million for the three months ended June 30, 2008. Non-GAAP net income for the three months ended June 30, 2009, excludes charges totaling approximately $9.3 million, consisting of a $3.0 million charge (pre-tax) for an upfront research and development (R&D) payment to a Medicis partner, a $2.2 million (pre-tax) net gain on the sale of Medicis Pediatrics to BioMarin Pharmaceutical, Inc. (BioMarin) and income tax charges of $8.5 million (net) related to these transactions. The Company recorded an income tax charge of $9.0 million related to the sale of Medicis Pediatrics to BioMarin based on the gain that was recognized for income tax purposes. Non-GAAP net income for the three months ended June 30, 2008, excluded a $25.0 million (pre-tax) payment to Ipsen upon acceptance by FDA of the Biologics License Application (BLA) for DYSPORT.
Acne Products
Medicis recorded net revenues of approximately $94.2 million from sales of its acne products for the three months ended June 30, 2009, compared to net revenues of approximately $86.4 million for the three months ended June 30, 2008, representing an increase of approximately 9.0%. This increase is due primarily to increased revenues associated with SOLODYN and ZIANA(R) in the second quarter of 2009, and the launch of TRIAZ(R) Foaming Cloths in April 2009. Medicis acne products include primarily PLEXION(R), SOLODYN, TRIAZ and ZIANA.
Non-Acne Products
Medicis recorded net revenues of approximately $37.1 million associated with its non-acne products for the three months ended June 30, 2009, compared to net revenues of approximately $40.5 million for the three months ended June 30, 2008, representing a decrease of approximately 8.4%, and compared to net revenues of approximately $23.5 million for the three months ended March 31, 2009, representing an increase of approximately 58.1%. The year-over-year decrease is a result of the non-acne products category being more sensitive to weaknesses in the U.S. economy offset by the June 15, 2009, launch of DYSPORT. In the second quarter of 2009, the Company began recording revenue on its aesthetic products, including DYSPORT, upon the shipment from its exclusive distributor to physicians. Medicis non-acne products include primarily DYSPORT, LOPROX(R), PERLANE(R), RESTYLANE(R) and VANOS(R).
Other Non-Dermatological Products
Medicis recorded net revenues of approximately $10.0 million associated with its other non-dermatological products for the three months ended June 30, 2009, compared to net revenues of approximately $10.5 million for the three months ended June 30, 2008, representing a decrease of approximately 5.5%. Medicis other non-dermatological products include primarily AMMONUL(R), BUPHENYL(R), LIPOSONIX and contract revenue.
Other Income Statement Items
Gross profit margin for the three months ended June 30, 2009, was in line with the Company's guidance.
Selling, general and administrative (SG&A) expense for the three months ended June 30, 2009, was approximately $71.7 million, or approximately 50.7% of net revenues, compared to approximately $71.9 million, or approximately 52.3% of net revenues, for the three months ended June 30, 2008. The Company continues to implement cost-cutting measures to achieve its 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 June 30, 2009, was approximately $12.1 million, compared to approximately $33.0 million for the three months ended June 30, 2008. R&D expense for the three months ended June 30, 2009, includes a $3.0 million upfront payment to a Medicis partner, and R&D expense for the three months ended June 30, 2008, included the $25.0 million payment to Ipsen upon acceptance by FDA of the BLA for DYSPORT.
2009 Guidance
Based upon information available currently to the Company's management, the Company's financial guidance for the remainder of 2009 is anticipated 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 Estimated Estimated Estimated
--------- --------- --------- --------- ---------
Revenue $100 $141 $147-$154 $168-$179 $556-$574
Non-GAAP
diluted
earnings
per share
objectives $0.09 $0.39 $0.36-$0.42 $0.58-$0.67 $1.42-$1.57
Additional 2009 Guidance Considerations
-- Revenue and non-GAAP diluted earnings per share objectives include
a full year of SOLODYN revenue with no additional generic entry;
-- annual gross profit margins of approximately 89-90% of revenues;
-- annual SG&A expense of approximately 52-54% of revenues;
-- annual R&D expense of approximately 8-10% of revenues;
-- annual depreciation and amortization expense of approximately
$32-$34 million;
-- annual effective tax rate of approximately 39-40%;
-- the non-GAAP diluted earnings per share figures above incorporate
the impact of FAS 123R, totaling approximately $15-$16 million for
the year; and
-- fully diluted weighted average shares outstanding of approximately
63-64 million shares for each of the remaining quarters.
The above guidance could be materially impacted by the following:
-- 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 timing and launches of potential approvals of generic versions
of SOLODYN;
-- the deployment of certain wholesaler inventory reduction strategies
for SOLODYN which continued into 2009 in anticipation of FDA
approval for follow-on forms of SOLODYN;
-- the impact of the U.S.
