SCOTTSDALE, Ariz., Aug. 7, 2007 (GLOBE NEWSWIRE) -- Medicis (NYSE:MRX) today announced revenue for the three months ended June 30, 2007 of approximately $108.9 million, compared to approximately $85.0 million for the three months ended June 30, 2006, representing a year-over-year increase of approximately 28%. This increase was primarily due to the successful launches of ZIANA(TM) and PERLANE(R) and the continued strength of SOLODYN(R). Net income computed in accordance with U.S. generally accepted accounting principles (GAAP) for the three months ended June 30, 2007 was approximately $15.5 million, or approximately $0.24 per diluted share, compared to GAAP net income of $15.5 million, or $0.25 per diluted share, for the three months ended June 30, 2006.
Non-GAAP earnings per diluted share for the three months ended June 30, 2007, adjusted only for the write-down of the long-lived asset value associated with OMNICEF(R) described below, was approximately $0.28 per diluted share. Comparatively, for the three months ended June 30, 2006, the Company reported non-GAAP earnings per diluted share of $0.24 per diluted share, adjusted only for research and development (R&D) milestones or contract payments. The Company's published guidance for the three months ended June 30, 2007 was approximately $107 million in revenue and approximately $0.25 in non-GAAP earnings per diluted share for the three months ended June 30, 2007. Diluted per share amounts are calculated using the "if-converted" method of accounting.
"We are pleased to announce a solid second quarter," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "We are excited about our strong PERLANE(R) launch and the recent initiation of our highly targeted, direct-to-consumer television ad campaign for the RESTYLANE(R) family of products. Additionally, we are focusing our therapeutic sales and marketing efforts on expanding the market shares for SOLODYN(R) and ZIANA(TM). As we enter the second half of 2007, our focus is on fortifying our research and development pipeline with new products and technologies, and working diligently on the anticipated fourth quarter filing of RELOXIN(R)."
During the quarter ended June 30, 2007, long-lived assets related to OMNICEF(R) were determined to be impaired based on the Company's analysis of the projected future cash flows from continuing sales of the product primarily as a result of pressures in the marketplace from generic competition. As a result of the impairment analysis, the Company recorded a non-cash write-down of approximately $4.1 million ($2.6 million net of tax and $0.04 per fully diluted share) related to these long-lived assets.
Medicis provides non-GAAP financial information which has been adjusted for items such as R&D milestone payments, contract payments, impairment of long-lived assets and litigation reserves. Adjusted balances are referred to as "non-GAAP." Further discussion of the non-GAAP financial information, as well as a reconciliation of the non-GAAP financial results and Medicis' GAAP financial results can be found below.
Acne Products
Medicis recorded revenue of approximately $55.4 million associated with its acne products in the three months ended June 30, 2007, which represents an increase of approximately $18.8 million, or approximately 51%, compared to the three months ended June 30, 2006, and an increase of $9.5 million, or approximately 21%, compared to the three months ended March 31, 2007. This increase is due primarily to increased revenue associated with SOLODYN(R) and ZIANA(TM) in the second quarter of 2007, partially offset by decreases in sales of DYNACIN(R), PLEXION(R) and TRIAZ(R) products due to the focus on the market expansion of the Company's newer products, SOLODYN(R) and ZIANA(TM). Medicis' acne products include primarily DYNACIN(R), PLEXION(R), SOLODYN(R), TRIAZ(R) and ZIANA(TM).
Non-Acne Products
Medicis recorded revenue of approximately $46.2 million associated with its non-acne products in the three months ended June 30, 2007, which represents an increase of approximately $5.8 million, or approximately 14%, compared to the three months ended June 30, 2006, and an increase of $5.5 million, or approximately 14%, compared to the three months ended March 31, 2007. This increase in non-acne is primarily due to the strength of RESTYLANE(R) and launch of PERLANE(R). Medicis' non-acne products include primarily LOPROX(R), PERLANE(R), RESTYLANE(R) and VANOS(TM).
Other Non-Dermatological Products
Medicis recorded revenue of approximately $7.3 million associated with its other non-dermatological products during the three months ended June 30, 2007, which represents a decrease of $0.7 million, or approximately 9%, compared to the three months ended June 30, 2006, and a decrease of $1.3 million, or approximately 15%, compared to the three months ended March 31, 2007. This decrease is primarily due to a decrease in contract revenue. Medicis' other non-dermatological products include primarily AMMONUL(R), BUPHENYL(R) and contract revenue.
Other Income Statement Items
Gross profit margins for the three months ended June 30, 2007 decreased approximately 1.8 percentage points to approximately 87.1%, compared to approximately 88.9% for the three months ended June 30, 2006. The decrease in gross profit margins was primarily attributable to the product mix during the quarter.
GAAP selling, general and administrative (SG&A) expense for the three months ended June 30, 2007 was approximately $59.9 million, or approximately 55.0% of revenue, compared to approximately $51.1 million, or approximately 60.1% of revenue, for the three months ended June 30, 2006. The decrease in SG&A as a percentage of revenue was primarily due to the increase in revenue (approximately 28%) outpacing the increase in SG&A. The increase in SG&A as compared to the same period last year was primarily due to personnel costs associated with the aesthetic sales force expansion and annual salary increases, promotional programs for RESTYLANE(R), promotional spending behind the launches of PERLANE(R) and ZIANA(TM), and costs related to the development and implementation of our new ERP system. Approximately $5.5 million was recorded in SG&A related to FAS 123R share-based compensation expense for the three months ended June 30, 2007 as compared to $6.8 million for the three months ended June 30, 2006, representing a year-over-year decrease of approximately 19.2%.
GAAP R&D expense for the three months ended June 30, 2007 was approximately $7.1 million, or approximately 6.6% of revenue, compared to approximately $43.8 million, or approximately 51.5% of revenue, for the same period last year. For the three months ended June 30, 2006, R&D expense included $38.7 million, or approximately 45.5% of revenue, related to RELOXIN(R). The $38.7 million consisted of $35.1 million associated with the acquisition of the RELOXIN(R) product rights and $3.7 million associated with the development of RELOXIN(R). R&D expense for the three months ended June 30, 2007 consisted of ongoing expenses related to various R&D projects, primarily RELOXIN(R). Approximately $0.1 million was recorded in R&D related to FAS 123R share-based compensation expense for the three months ended June 30, 2007.
Cash Flow
Medicis recorded cash flow of approximately $53.3 million in the three months ended June 30, 2007, which represents an increase of approximately $42.2 million, or approximately 380%, compared to the three months ended June 30, 2006, and an increase of $27.5 million, or approximately 107%, compared to the three months ended March 31, 2007.
2007 Guidance Update
Based upon information available currently to the Company, the Company's financial guidance is as follows:
Calendar 2007
(in millions, except per share amounts)
First Second Third Fourth Calendar
Quarter Quarter Quarter Quarter Year End
(3/31/07) (6/30/07) (9/30/07) (12/31/07) 2007
Actual Actual Estimated Estimated Estimated
------------------------------------------------------
Revenue Objective $95 $109 $120 $130 $454
GAAP diluted
earnings per share
objectives $0.15 $0.24 $0.33 $0.43 $1.15
Write-down of
long-lived asset -- $0.04 -- -- $0.04
----- ----- ----- ------ -----
Non-GAAP diluted
earnings per share
objectives $0.15 $0.28 $0.33 $0.43 $1.19
===== ===== ===== ===== =====
The Company's 2007 non-GAAP diluted earnings per share objective as reported at the beginning of the year was $1.12 per share. Current non-GAAP diluted earnings per share objective is $0.07, or 6%, above the Company's original objective. The earnings per share estimates above include amortization associated with the approximately $29.1 million payment due to Q-Med as a result of the U.S. Food and Drug Administration's ("FDA") approval of PERLANE(R) in May 2007, estimated R&D expenses associated with the RELOXIN(R) project, anticipated promotional spending for RESTYLANE(R), estimated launch costs associated with ZIANA(TM) and PERLANE(R), and the costs associated with the aesthetics sales force expansion.
At the time of this disclosure, Medicis believes these objectives are attainable based upon information currently available to the Company.
"If-Converted" Net Income and Diluted Earnings Per Share
"If-converted" net income and diluted earnings per share amounts are calculated using the "if-converted" method of accounting regardless of whether the outstanding Old Notes and New Notes meet the criteria for conversion and regardless of whether the bondholders actually convert their bonds into shares.
Use of Non-GAAP Financial Information
To the extent that the Company has provided non-GAAP financial information in this press release, it has done so in order to provide meaningful supplemental information regarding its operational performance and to enhance its investors' overall understanding of its core financial performance. Management measures the Company's performance using non-GAAP financial measures such as those that are disclosed in this press release. This information facilitates management's internal comparisons to the Company's historical core operating results, comparisons to competitors' core operating results and is a basis for financial decision making. Management believes that Medicis' investors benefit from seeing the Company's results on the same basis as management, in addition to the GAAP presentation. In our view, the non-GAAP adjustments are informative to investors, allowing them to focus on the ongoing operations and the core results of Medicis' business. Historically, Medicis has reported similar non-GAAP information to its investors and believes that the inclusion of comparative numbers provides consistency in the Company's financial disclosures. This information is not in accordance with, or an alternative for, information prepared using GAAP in the United States. It excludes items, such as special charges for R&D, the impairment of long-lived assets, and litigation reserves that may have a material effect on the Company's net income and diluted net income per common share calculated in accordance with GAAP. The Company excludes such charges and the related tax benefits when analyzing its financial results as the items are distinguishable events and have no impact to the Company's ongoing results of operations. Management believes that by viewing the Company's results of operations excluding these charges, investors are given an indication of the ongoing results of the Company's operations.
About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company's products include the prescription brands RESTYLANE(R) (hyaluronic acid), PERLANE(R) (hyaluronic acid), DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), OMNICEF(R) (cefdinir), PLEXION(R) (sodium sulfacetamide/sulfur), SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream, 0.05%, VANOS(TM) (fluocinonide) Cream, 0.1%, SYNALAR(R) (fluocinolone acetonide), and ZIANA(TM) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL(R) (sodium phenylbutyrate) and AMMONUL(R) (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA(R). For more information about Medicis, please visit the Company's website at www.medicis.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements, including:
* Medicis' future prospects;
* revenue, expense, tax rate and earnings guidance;
* information regarding business development activities and future regulatory approval of the Company's products;
* the successful launches and growth of PERLANE(R), SOLODYN(R) and ZIANA(TM);
* the patentability of certain intellectual property;
* the future expansion of the aesthetics market; and
* expectations relating to the Company's product development pipeline, including the anticipated regulatory filing timeline for RELOXIN(R).
These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. The Company's business is subject to all risk factors outlined in the Company's most recent annual report on Form 10-K for the year ended December 31, 2006, and other documents we file with the Securities and Exchange Commission. At the time of this press release, the Company cannot, among other things, assess the likelihood, timing or forthcoming results of R&D projects, the risks associated with the FDA approval process and risks associated with significant competition within the Company's industry, nor can the Company validate its assumptions of the full impact on its business of the approval of competitive generic versions of the Company's primary brands, and any future competitive product approvals that may affect the Company's brands, including the RESTYLANE(R) franchise. The RESTYLANE(R) franchise currently includes PERLANE(R) and RESTYLANE(R).
Additionally, Medicis may acquire and/or license products or technologies from third parties to enter into new strategic markets. The Company periodically makes up-front, non-refundable payments to third parties for R&D work that has been completed and periodically makes additional non-refundable payments for the achievement of various milestones. There can be no certainty about the periods in which these potential payments could be made, nor if any payments such as these will be made at all. Any estimated future guidance does not include, among other things, the potential payments associated with any such transactions.
There are a number of additional important factors that could cause actual results to differ materially from those projected, including:
* the anticipated size of the markets and demand for Medicis'
products;
* the availability of product supply or changes in the costs of
raw materials;
* the receipt of required regulatory approvals;
* product liability claims;
* the introduction of federal and/or state regulations relating to
the Company's business;
* dependence on sales of key products;
* changes in the treatment practices of physicians that currently
prescribe the Medicis' products;
* the uncertainty of future financial results and fluctuations in
operating results;
* dependence on Medicis' strategy (including the uncertainty of
license payments and/or other payments due from third parties);
* changes in reimbursement policies of health plans and other
health insurers;
* the timing and success of new product development by Medicis or
third parties;
* the inability to secure patent protection from filed patent
applications, inadequate protection of Medicis' intellectual
property or challenges to the validity or enforceability of the
Medicis' proprietary rights;
* the risk of competitive product introductions, including the
introduction of generic and branded competitive products;
* the risks of pending and future litigation or government
investigations; and
* other risks described from time to time in Medicis' filings with
the Securities and Exchange Commission.
Forward-looking statements represent the judgment of Medicis' management as of the date of this release and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.
NOTE: Full prescribing information for any of Medicis' prescription product is available by contacting the Company. OMNICEF(R) is a trademark of Fujisawa Pharmaceutical Co. Ltd. and is used under a license from Abbott Laboratories, Inc. On April 1, 2005, Fujisawa Pharmaceutical Co. Ltd. merged with Yamanouchi Pharmaceutical Co. Ltd., creating Astelles Pharma, Inc. RESTYLANE(R) and PERLANE(R) are trademarks of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other marks (or brands) and names are the property of Medicis or its Affiliates.
Medicis Pharmaceutical Corporation
Summary Statements of Operations
--------------------------------
(in thousands, except per share data)
Three months ended Six months ended
June 30, June 30,
-------------------- --------------------
2007 2006 2007 2006
-------------------- --------------------
Product revenues $ 105,902 $ 80,646 $ 198,273 $ 151,733
Contract revenues 2,962 4,386 5,705 8,456
--------- --------- --------- ---------
Total revenues 108,864 85,032 203,978 160,189
Cost of revenues 14,011 9,419 24,508 21,598
--------- --------- --------- ---------
Gross profit 94,853 75,613 179,470 138,591
Operating expenses:
Selling, general and
administrative 59,894 51,065 122,155 102,288
Impairment of long-lived
assets 4,067 -- 4,067 --
Research and
development 7,148 43,767 15,154 140,985
Depreciation and
amortization 5,878 5,800 11,332 11,656
--------- --------- --------- ---------
Total operating
expenses 76,987 100,632 152,708 254,929
Operating income (loss) 17,866 (25,019) 26,762 (116,338)
Interest income, net 6,683 4,604 13,032 8,967
Income tax expense
(benefit) 9,026 (35,934) 14,983 (34,347)
--------- --------- --------- ---------
Net income (loss) $ 15,523 $ 15,519 $ 24,811 $ (73,024)
========= ========= ========= =========
Basic net income (loss)
per common share $ 0.28 $ 0.28 $ 0.44 $ (1.34)
Diluted net income (loss)
per common share $ 0.24 $ 0.25 $ 0.39 $ (1.34)
Shares used in basic net
income (loss) per common
share 55,936 54,501 55,782 54,429
Shares used in diluted net
income (loss) per common
share 71,318 69,733 71,466 54,429
Cash flow from (used in)
operations $ 53,325 $ 11,075 $ 79,080 $(100,445)
Medicis Pharmaceutical Corporation
Unaudited Reconciliation of Non-GAAP Adjustments
(in thousands, except per share data)
Three months ended Three months ended
June 30, 2007 June 30, 2006
-------------------- --------------------
Dollar EPS Dollar EPS
Value Impact Value Impact
-------- -------- -------- --------
GAAP net income $ 15,523 $ 0.28 $ 15,519 $ 0.28
Interest expense and
associated bond offering
costs (tax-effected) 1,618 (a) 1,675 (a)
-------- --------
GAAP "if-converted" net
income and diluted EPS $ 17,141 $ 0.24 $ 17,194 $ 0.25
Non-GAAP adjustments:
Impairment of long-lived
assets 4,067 0.06 -- --
Special charge for R&D,
including related
professional fees -- -- 39,265 0.56
Income tax effects (1,477) (0.02) (39,650) (0.57)
-------- -------- -------- --------
Non-GAAP "if-converted"
net income and diluted
EPS $ 19,731 $ 0.28 $ 16,809 $ 0.24
======== ======== ======== ========
2007 2006
-------- --------
Shares used in basic net
income per common share 55,936 54,501
Shares used in diluted
net income per common
share 71,318 69,733
(a) In order to determine "if-converted" net income, the tax-
effected net interest on the 2.5% and 1.5% contingent convertible
notes and the associated bond offering costs of $1.6 million and
$1.7 million are added back to GAAP net income for the three
months ended June 30, 2007 and June 30, 2006, respectively.
Medicis Pharmaceutical Corporation
Balance Sheets
June 30, December 31,
2007 2006
---------- ----------
Assets
Cash, cash equivalents & short-term
investments $ 596,515 $ 554,261
Accounts receivable, net -- 36,370
Inventory, net 30,657 27,016
Other current assets 42,106 39,037
---------- ----------
Total current assets 669,278 656,684
Property & equipment, net 9,618 6,576
Intangible assets, net 248,884 232,314
Deferred tax asset 34,356 41,241
Long-term investments 148,395 130,290
Other assets 1,198 2,181
---------- ----------
Total assets $1,111,729 $1,069,286
========== ==========
Liabilities and stockholders' equity
Current liabilities $ 98,565 $ 106,662
Contingent convertible senior notes 2.5%,
due 2032 169,150 169,155
Contingent convertible senior notes 1.5%,
due 2033 283,910 283,910
Other liabilities 543 --
Stockholders' equity 559,561 509,559
---------- ----------
Total liabilities and stockholders' equity $1,111,729 $1,069,286
========== ==========
Working capital $ 570,713 $ 550,022
========== ==========
CONTACT: Medicis
Kara Stancell
(602) 808-3854
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