UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
| [X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2003
OR
| [ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________________ to__________________
Commission file number 0-18443
MEDICIS PHARMACEUTICAL CORPORATION
| Delaware | 52-1574808 | |
|
|
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| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
8125 North Hayden Road
Scottsdale, Arizona 85258-2463
(602) 808-8800
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES [X] NO [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2) YES [X] NO [ ]
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
| Class | Outstanding at November 7, 2003 | |||
| Class A Common Stock $.014 Par Value | 27,045,299 | |||
| Class B Common Stock $.014 Par Value | 379,016 | |||
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MEDICIS PHARMACEUTICAL CORPORATION
Table of Contents
| Page | ||||||
| PART I. | FINANCIAL INFORMATION | |||||
| Item 1 | Financial Statements | |||||
Condensed Consolidated Balance Sheets as of
September 30, 2003 and June 30, 2003
|
3 | |||||
Condensed Consolidated Statements of Income
for the Three Months Ended September 30, 2003 and 2002
|
5 | |||||
Condensed Consolidated Statements of Cash Flows for the
Three Months Ended September 30, 2003 and 2002
|
6 | |||||
Notes to the Condensed Consolidated Financial Statements
|
7 | |||||
| Item 2 | Managements Discussion and Analysis of Financial Condition
and Results of Operations
|
15 | ||||
| Item 4 | Controls and Procedures | 21 | ||||
| PART II. | OTHER INFORMATION | |||||
| Item 1 | Legal Proceedings | 21 | ||||
| Item 6 | Exhibits and Reports on Form 8-K | 22 | ||||
| SIGNATURES | 23 | |||||
2
Part I. Financial Information
Item 1. Financial Statements
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
| September 30, 2003 | June 30, 2003 | |||||||||||
| (unaudited) | ||||||||||||
Assets |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ | 49,318 | $ | 44,346 | ||||||||
Restricted cash and short-term investments |
53,923 | 53,837 | ||||||||||
Short-term investments |
481,390 | 454,480 | ||||||||||
Accounts receivable, net |
41,805 | 51,661 | ||||||||||
Inventories, net |
20,785 | 14,005 | ||||||||||
Deferred tax assets, net |
11,215 | 10,450 | ||||||||||
Other current assets |
20,869 | 16,849 | ||||||||||
Total current assets |
679,305 | 645,628 | ||||||||||
Property and equipment, net |
3,903 | 3,094 | ||||||||||
Intangible assets: |
||||||||||||
Intangible assets related to product line
acquisitions and business combinations |
249,727 | 245,989 | ||||||||||
Other intangible assets |
13,659 | 13,099 | ||||||||||
| 263,386 | 259,088 | |||||||||||
Less: accumulated amortization |
43,365 | 40,254 | ||||||||||
Net intangible assets |
220,021 | 218,834 | ||||||||||
Goodwill |
59,413 | 59,435 | ||||||||||
Deferred tax assets, net |
4,076 | | ||||||||||
Deferred financing costs, net |
8,887 | 9,991 | ||||||||||
Other non-current assets |
| 8 | ||||||||||
| $ | 975,605 | $ | 936,990 | |||||||||
See accompanying notes to condensed consolidated financial statements.
3
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
| September 30, 2003 | June 30, 2003 | ||||||||||
| (unaudited) | |||||||||||
Liabilities |
|||||||||||
Current liabilities: |
|||||||||||
Accounts payable |
$ | 24,587 | $ | 18,568 | |||||||
Short-term contract obligation |
18,041 | 18,306 | |||||||||
Income taxes payable |
| 481 | |||||||||
Other current liabilities |
42,036 | 31,492 | |||||||||
Total current liabilities |
84,664 | 68,847 | |||||||||
Long-term liabilities: |
|||||||||||
Contingent convertible senior notes |
453,073 | 400,000 | |||||||||
Deferred tax liability, net |
| 7,022 | |||||||||
Stockholders Equity |
|||||||||||
Preferred stock, $0.01 par value; shares
authorized: 5,000,000; no shares issued |
| | |||||||||
Class A common stock, $0.014 par value;
shares authorized: 50,000,000; issued and
outstanding: 31,395,187 and 31,254,841 at
September 30, 2003 and at June 30, 2003,
respectively |
440 | 438 | |||||||||
Class B common stock, $0.014 par value; shares
authorized: 1,000,000; issued and
outstanding: 379,016 and 379,016 at
September 30, 2003 and
at June 30, 2003, respectively |
5 | 5 | |||||||||
Additional paid-in capital |
451,740 | 446,096 | |||||||||
Accumulated other comprehensive income |
1,905 | 2,400 | |||||||||
Deferred compensation |
(1,598 | ) | (1,727 | ) | |||||||
Accumulated earnings |
176,284 | 204,817 | |||||||||
Less: Treasury stock, 4,340,734 shares at cost
at September 30, 2003 and at June 30, 2003 |
(190,908 | ) | (190,908 | ) | |||||||
Total stockholders equity |
437,868 | 461,121 | |||||||||
| $ | 975,605 | $ | 936,990 | ||||||||
See accompanying notes to condensed consolidated financial statements.
4
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share data)
| Three Months Ended | ||||||||||
| September 30, 2003 | September 30, 2002 | |||||||||
Net revenues |
$ | 63,295 | $ | 58,745 | ||||||
Operating costs and expenses: |
||||||||||
Cost of product revenue |
10,181 | 9,158 | ||||||||
Selling, general and administrative |
30,011 | 21,605 | ||||||||
Research and development |
3,539 | 7,876 | ||||||||
Depreciation and amortization |
3,426 | 2,006 | ||||||||
Loss on early extinguishment of debt |
58,660 | | ||||||||
Operating costs and expenses |
105,817 | 40,645 | ||||||||
Operating (loss) income |
(42,522 | ) | 18,100 | |||||||
Interest income |
2,596 | 3,310 | ||||||||
Interest expense |
(2,874 | ) | (3,134 | ) | ||||||
(Loss) income before income tax benefit
(expense) |
(42,800 | ) | 18,276 | |||||||
Income tax benefit (expense) |
15,636 | (6,397 | ) | |||||||
Net (loss) income |
$ | (27,164 | ) | $ | 11,879 | |||||
Basic net (loss) income per common share |
$ | (1.00 | ) | $ | 0.43 | |||||
Diluted net (loss) income per common share |
$ | (1.00 | ) | $ | 0.42 | |||||
Cash dividend declared per common share |
$ | 0.05 | $ | | ||||||
Shares used in computing basic net (loss)
income per common share |
27,298 | 27,483 | ||||||||
Shares used in computing diluted net (loss)
income per common share |
27,298 | 28,336 | ||||||||
See accompanying notes to condensed consolidated financial statements.
5
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
| Three Months Ended | ||||||||||
| September 30, 2003 | September 30, 2002 | |||||||||
Operating Activities: |
||||||||||
Net (loss) income |
$ | (27,164 | ) | $ | 11,879 | |||||
Adjustments to reconcile net (loss) income to
net cash provided by operating activities: |
||||||||||
Depreciation and amortization |
3,998 | 2,737 | ||||||||
Gain on sale of available-for-sale investments |
(117 | ) | (191 | ) | ||||||
Amortization of deferred compensation |
129 | 129 | ||||||||
Deferred income tax (benefit) expense |
(11,864 | ) | 1,037 | |||||||
Provision for doubtful accounts and returns |
| 750 | ||||||||
Accretion of premium on investments |
1,573 | 965 | ||||||||
Loss on early extinguishment of debt |
58,660 | | ||||||||
Changes in operating assets and liabilities: |
||||||||||
Accounts receivable |
9,856 | 4,543 | ||||||||
Inventories |
(6,780 | ) | 711 | |||||||
Other current assets |
(4,020 | ) | (1,863 | ) | ||||||
Accounts payable |
6,019 | 7,318 | ||||||||
Income taxes payable |
(481 | ) | 5,059 | |||||||
Tax benefit of stock option exercises |
1,349 | 870 | ||||||||
Other current liabilities |
2,593 | 747 | ||||||||
Net cash provided by operating activities |
33,751 | 34,691 | ||||||||
Investing Activities: |
||||||||||
Purchase of property and equipment |
(1,123 | ) | (178 | ) | ||||||
Payment of direct merger costs |
(299 | ) | (464 | ) | ||||||
Payments for purchase of product rights |
(797 | ) | (10,358 | ) | ||||||
Purchase of available-for-sale investments |
(165,480 | ) | (271,778 | ) | ||||||
Increase in restricted cash |
(86 | ) | | |||||||
Sale of available-for-sale investments |
96,129 | 231,861 | ||||||||
Maturity of available-for-sale investments |
40,375 | 12,305 | ||||||||
Change in other assets |
8 | 8 | ||||||||
Net cash used in investing activities |
(31,273 | ) | (38,604 | ) | ||||||
Financing Activities: |
||||||||||
Payment of deferred financing costs |
(557 | ) | (81 | ) | ||||||
Payment of dividends |
(1,362 | ) | | |||||||
Purchase of treasury stock |
| (14,730 | ) | |||||||
Proceeds from the exercise of stock options |
4,298 | 3,218 | ||||||||
Net cash provided by (used in) financing activities |
2,379 | (11,593 | ) | |||||||
Effect of foreign currency exchange rate
on cash and cash equivalents |
115 | (48 | ) | |||||||
Net increase (decrease) in cash and cash equivalents |
4,972 | (15,554 | ) | |||||||
Cash and cash equivalents at beginning of period |
44,346 | 96,517 | ||||||||
Cash and cash equivalents at end of period |
$ | 49,318 | $ | 80,963 | ||||||
See accompanying notes to condensed consolidated financial statements.
6
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2003
(unaudited)
1. ORGANIZATION AND BASIS OF PRESENTATION
Medicis Pharmaceutical Corporation and its wholly owned subsidiaries (Medicis or the Company) is a leading specialty pharmaceutical company focusing primarily on developing and marketing drugs in the United States for the treatment of dermatological, pediatric and podiatric conditions and the marketing of dermal aesthetic products in Canada. The Company offers a broad range of drugs addressing various conditions including acne, fungal infections, asthma, rosacea, hyperpigmentation, photoaging, psoriasis, eczema, skin and skin-structure infections, seborrheic dermatitis and cosmesis (improvement in the texture and appearance of skin). In March 2003, Medicis expanded into the dermal aesthetic market through its acquisition of the exclusive U.S. and Canadian rights to market, distribute and commercialize the dermal restorative product lines known as RESTYLANE®, PERLANE and RESTYLANE Fine Lines from Q-Med AB, a Swedish biotechnology/medical device company and its affiliates, collectively Q-Med. The RESTYLANE®, PERLANE and RESTYLANE Fine Lines products are currently sold in numerous countries by Q-Med, but are not yet approved for use in the U.S. Medicis offers RESTYLANE®, PERLANE and RESTYLANE Fine Lines in Canada for treating fine lines and wrinkles, shaping facial contours, correcting deep facial folds and enhancing the appearance and fullness of lips. In addition to the Companys expansion into the dermal aesthetic market, Medicis expanded into the pediatric market in November 2001 through its merger with Ascent Pediatrics, Inc. (Ascent). Ascent markets products to U.S.-based pediatricians, including an oral treatment for children with asthma and other inflammatory respiratory conditions. Since the merger, the Ascent sales force has introduced three of the Companys core dermatological brands to high prescribing pediatricians.
The accompanying interim consolidated condensed financial statements of Medicis have been prepared in conformity with generally accepted accounting principles, consistent in all material respects with those applied in the Companys Annual Report on Form 10-K for the fiscal year ended June 30, 2003 (fiscal 2003). The financial information is unaudited but reflects all adjustments, consisting only of normal recurring accruals, which are, in the opinion of the Companys management, necessary to a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The information included in this Form 10-Q should be read in conjunction with the Companys Annual Report on Form 10-K for the fiscal year ended June 30, 2003. Certain prior period amounts have been reclassified to conform with current period presentation.
2. STOCK-BASED COMPENSATION
At September 30, 2003, the Company had five stock-based employee compensation plans. The Company accounts for those plans under the recognition and measurement principles of Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees and related Interpretations. Other than restricted stock as discussed in Note 12, no stock-based employee compensation cost is reflected in net income, as all options granted under those plans had an exercise price equal to the market value of the underlying common stock on the date of grant.
7
The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition provisions of Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (SFAS No. 123), to stock-based employee compensation (amounts in thousands, except per share amounts):
| THREE MONTHS ENDED | ||||||||
| SEPTEMBER 30, | ||||||||
| 2003 | 2002 | |||||||
Net (loss) income, as reported |
$ | (27,164 | ) | $ | 11,879 | |||
Deduct: Total stock-based employee
compensation expense determined under
fair value based method for all awards,
net of related tax effects |
4,352 | 4,175 | ||||||
Pro-forma net (loss) income |
$ | (31,516 | ) | $ | 7,704 | |||
(Loss) earnings per share: |
||||||||
Basic as reported |
$ | (1.00 | ) | $ | 0.43 | |||
Basic pro forma |
$ | (1.15 | ) | $ | 0.28 | |||
Diluted as reported |
$ | (1.00 | ) | $ | 0.42 | |||
Diluted pro forma |
$ | (1.15 | ) | $ | 0.27 | |||
As required, the pro forma disclosures above include options granted since April 1, 1996. Consequently, the effect of applying SFAS No. 123 for providing pro forma disclosures may not be representative of the effects on reported net income for future years until all options outstanding are included in the pro forma disclosures. For purposes of pro forma disclosures, the estimated fair value of stock-based compensation plans and other options is amortized to expense primarily over the vesting period.
3. RESEARCH AND DEVELOPMENT COSTS AND ACCOUNTING FOR STRATEGIC COLLABORATIONS
All research and development costs, including payments related to products under development, and research consulting agreements, are expensed as incurred. The Company makes up-front, non-refundable payments to third parties for new technologies and for research and development work that has been completed. These up-front payments may be expensed at the time of payment depending on the nature of the payment made.
The Companys policy on accounting for costs of strategic collaborations determines the timing of the recognition of certain development costs. In addition, this policy determines whether the cost is classified as development expense or capitalized as an asset. Management is required to form judgments with respect to the commercial status of such products in determining whether development costs meet the criteria for immediate expense or capitalization.
On September 26, 2002, Medicis entered into an exclusive license and development agreement with Dow Pharmaceutical, Inc. (Dow) for the development and commercialization of a patented dermatologic product. Under terms of the agreement, Medicis made an initial payment of $5.4 million to Dow and in accordance with the agreement between the parties, is required to make potential additional payments upon the certification that certain development milestones have occurred. The initial $5.4 million was recorded as a charge to research and development expense during the quarter ended September 30, 2002.
On September 4, 2002, the Company purchased the Abbreviated New Drug Application (ANDA) for a pediatric prescription product from a third-party pharmaceutical company for $9.0 million. Under terms of the agreement, the Company may be required to make future contingent payments based on the achievement of certain milestones. The contingent payments, if the milestones are achieved, would be
8
payable at the six-, 12-, and 18-month anniversaries of the closing of the agreement. During the quarter ended September 30, 2003, the second milestone was achieved and $3.5 million became payable to the third-party pharmaceutical company. The Company accounted for the initial payment and the subsequent contingent payments as an acquisition of an intangible asset and commenced amortizing the asset over 15 years beginning in the second quarter of fiscal 2003.
4. AQUISITION OF DERMAL AESTHETIC ENHANCEMENT PRODUCTS FROM THE Q-MED GROUP
On March 10, 2003, Medicis acquired all outstanding shares of HA North American Sales AB from Q-Med, a Swedish biotechnology/medical device company. HA North American Sales AB holds a license for the exclusive U.S. and Canadian rights to market, distribute and commercialize the dermal restorative product lines known as RESTYLANE®, PERLANE and RESTYLANE Fine Lines. The RESTYLANE®, PERLANE and RESTYLANE Fine Lines products are currently being sold in numerous countries by Q-Med, but are not yet approved for use in the United States. The products are approved for use in Canada, and Medicis is currently selling these products in Canada. Under terms of the agreements, a wholly owned subsidiary of Medicis acquired all outstanding shares of HA North American Sales AB for total consideration of approximately $160.0 million, payable upon the successful completion of certain milestones or events. Medicis paid $58.2 million upon closing of the transaction, and will pay approximately $53.3 million upon U.S. Food and Drug Administration (FDA) approval of RESTYLANE®, approximately $19.4 million upon certain cumulative commercial milestones being achieved and approximately $29.1 million upon FDA approval of PERLANE. As of September 30, 2003, the Company incurred approximately $3.9 million of costs related to the due diligence and execution of the transaction, consisting of approximately $3.7 million of professional services and approximately $0.2 million of other costs. Payments and costs related to this acquisition are capitalized as an intangible asset and are amortized over 15 years beginning in March 2003.
In countries where they are currently marketed, RESTYLANE®, PERLANE and RESTYLANE Fine Lines are injectable, transparent, non-animal stabilized hyaluronic acid gels, which require no patient sensitivity tests in advance of product administration. These transparent, injectable products have varying gel particle sizes which provide physicians in countries where the products are approved with flexibility in treating fine lines and wrinkles, shaping facial contours, correcting deep facial folds and enhancing the appearance and fullness of lips.
In countries where the products are currently marketed, pre-packaged, glass syringes provide physicians with various options to treat nasolabial folds, glabellar lines, periorbital lines, perioral lines, vermillion borders, lips, chins, cheeks, smile lines, worry lines and oral commissures. In the U.S., the FDA regulates these products as medical devices. A pre-market approval application for RESTYLANE® was filed with the FDA in June 2002 and is currently under review. On September 10, 2003, the Company was informed by Q-Med of the FDAs verbal notification that the FDAs General and Plastic Surgery Devices Advisory Panel will review the pre-market approval application for RESTYLANE® at a meeting scheduled for November 21, 2003. We anticipate that requirements for filing applications for PERLANE and RESTYLANE Fine Lines will be discussed with the FDA following the approval of RESTYLANE®.
5. MERGER OF ASCENT PEDIATRICS, INC.
As part of its merger with Ascent completed in November 2001, the Company may be required to make contingent purchase price payments for each of the first five years following closing based upon reaching certain sales threshold milestones on the Ascent products for each twelve month period ended November 15, 2006. From time to time the Company assesses the probability and likelihood of payment in the coming respective November period based on current sales trends. There can be no assurance that such payment will ultimately be made nor is the accrual of a liability an indication of current sales levels. As of September 30, 2003, the second-year threshold had been deemed to be probable, and approximately $10.3 million was recorded as additional goodwill and as a short-term contract obligation. A total of approximately $18.0 million is included in short-term contract obligation in the Companys condensed consolidated balance sheets as of September 30, 2003, representing the first two years contingent
9
payments. Pursuant to the merger agreement, payment of the contingent portion of the purchase price will be withheld pending the final outcome of the litigation discussed in Note 16.
6. SEGMENT AND PRODUCT INFORMATION
The Company operates in one significant business segment: Pharmaceuticals. The Companys current pharmaceutical franchises are divided between the Dermatological and Non-Dermatological fields. The Dermatological field represents products for the treatment of Acne and Acne-related dermatological conditions and Non-acne dermatological conditions. The Non-Dermatological field represents products for the treatment of Asthma and Urea Cycle Disorder. The Acne and Acne-related dermatological product lines include DYNACIN®, PLEXION® and TRIAZ®. The Non-acne dermatological product lines include ESOTERICA®, LIDEX®, LOPROX®, LUSTRA®, OMNICEF®, RESTYLANE® and SYNALAR® . The Non-Dermatological product lines include BUPHENYL® and ORAPRED®.
The Companys pharmaceutical products, with the exception of BUPHENYL®, are promoted to dermatologists, podiatrists or pediatricians. Such products are often prescribed by physicians outside these three specialties; including family practitioners, general practitioners, primary-care physicians, plastic surgeons and OB/GYNs, as well as hospitals, government agencies and others. All products, with the exception of BUPHENYL®, are sold primarily to wholesalers and retail chain drug stores. BUPHENYL® is primarily sold directly to hospitals and pharmacies.
The percentage of net revenues for each of the product categories is as follows:
| THREE MONTHS ENDED | |||||||||
| SEPTEMBER 30, | |||||||||
| 2003 | 2002 | ||||||||
Acne and acne-related dermatological products |
35 | % | 37 | % | |||||
Non-acne dermatological products |
46 | 55 | |||||||
Non-dermatological products |
19 | 8 | |||||||
Total net revenues |
100 | % | 100 | % | |||||
7. RESTRICTED CASH AND SHORT-TERM INVESTMENTS
In connection with the acquisition of dermal aesthetic enhancement products from Q-Med (see Note 4), the Company was required to establish an escrow account related to the $53.3 million the Company will pay to Q-Med upon FDA approval of the RESTYLANE® product. The Company initially funded the restricted cash account through transfers of existing short-term investments into the escrow account. The balance in the escrow account as of September 30, 2003 was approximately $53.9 million. Interest income earned on this account accrues to the benefit of the Company.
8. INVENTORIES
The Company utilizes third parties to manufacture and package inventories held for sale, takes title to certain raw materials and components once received at the manufacturers facilities, and warehouses finished goods at third-party warehouse facilities until packaged for final distribution and sale. Inventories consist of salable products held at the Companys third-party warehouses, as well as raw materials and components at the manufacturers facilities, and are valued at the lower of cost or market using the first-in, first-out method. The Company provides valuation reserves for estimated obsolescence or unmarketable inventory in an amount equal to the difference between the cost of inventory and the estimated market value based upon assumptions about future demand and market conditions.
10
Inventories at September 30, 2003 and June 30, 2003, are as follows (amounts in thousands):
| September 30, 2003 | June 30, 2003 | ||||||||
Raw materials |
$ | 7,746 | < | ||||||