The acquisition of the global branded prescription pharmaceuticals business ("PGP") of P&G on October 30, 2009 (the "PGP Acquisition") significantly impacted the Company's financial position and results of operations in the quarter ended September 30, 2010, compared to the prior year quarter. The Company reported GAAP net income of $57.5 million, or $0.23 per diluted share, in the quarter ended September 30, 2010, compared with GAAP net income of $424.2 million, or $1.69 per diluted share, in the prior year quarter. The quarter ended September 30, 2009 included a gain of $380.1 million, net of tax (or $1.51 per diluted share), related to the termination of the Company's exclusive product licensing rights from LEO Pharma A/S ("LEO") in the United States to TACLONEX, TACLONEX SCALP, DOVONEX and all dermatology products in LEO's development pipeline, as well as the sale to LEO of related assets, in return for $1,000.0 million in cash (the "LEO Transaction"). Cash net income ("CNI") for the quarter ended September 30, 2010 was $219.4 million, or $0.86 per diluted share, compared to $483.3 million in the prior year quarter. Excluding the gain of $380.1 million relating to the LEO Transaction, adjusted CNI increased by $116.2 million in the third quarter of 2010 compared to the prior year quarter.
References in this press release to "cash net income" or "CNI" mean our net income adjusted for the after-tax effects of two non-cash items: amortization (including impairments, if any) of intangible assets and amortization (including write-offs, if any) of deferred loan costs related to our debt. Reconciliations from our reported results in accordance with US GAAP to CNI, adjusted CNI and adjusted earnings before interest, taxes, depreciation and amortization ("EBITDA") for all periods are presented in the tables at the end of this press release.
Recent Events
Special Dividend Transaction
On September 8, 2010, the Company paid a special cash dividend of $8.50 per share, or $2,144.3 million in the aggregate, to the holders of its ordinary shares. In order to fund the special cash dividend and pay related fees and expenses, on August 20, 2010, the Company incurred $1,500.0 million aggregate principal amount of new term loan indebtedness in connection with an amendment to its new senior secured credit facilities and issued $750.0 million aggregate principal amount of 7.75% senior notes due 2018 (the "Initial 7.75% Notes"). The increase in the Company's indebtedness negatively impacted the Company's interest expense during the quarter ended September 30, 2010.
ENABLEX Acquisition
On September 23, 2010, the Company and Novartis Pharmaceuticals Corporation ("Novartis"), entered into a definitive asset purchase agreement pursuant to which the Company agreed to acquire the U.S. rights to Novartis' ENABLEX product for an upfront payment of $400.0 million in cash at closing, plus future milestone payments of up to $20.0 million in the aggregate based on 2011 and 2012 net sales of ENABLEX (the "ENABLEX Acquisition"). On October 18, 2010, concurrent with the closing of the ENABLEX Acquisition, the Company and Novartis terminated their existing co-promotion agreement and the Company assumed full control of sales and marketing of ENABLEX for the U.S. market. On September 29, 2010, the Company issued an additional $500.0 million aggregate principal amount of 7.75% senior notes due 2018 (the "Additional 7.75% Notes" and together with the Initial 7.75% Notes, the "7.75% Notes"), at a premium, in order to fund the $400.0 million upfront payment in connection with the ENABLEX Acquisition and for general corporate purposes.
Product approvals
On October 8, 2010, the U.S. Food and Drug Administration ("FDA") approved the Company's next generation ACTONEL product for the treatment of postmenopausal osteoporosis in the United States. This product will be marketed as ATELVIA delayed-release tablets. On October 21, 2010, the FDA approved the Company's new oral contraceptive product for the prevention of pregnancy in the United States. This product will be marketed as LO LOESTRIN FE. The Company expects to begin commercial shipments of these products during the fourth quarter of 2010 and commence its marketing efforts in the first quarter of 2011.
Revenue
Revenue in the quarter ended September 30, 2010 was $703.2 million, an increase of $450.4 million, or 178.2%, over the prior year quarter. Sales related-deductions have increased sequentially during the nine months ended September 30, 2010. The increase was due primarily to higher utilization in our loyalty card programs and, to a lesser extent, higher utilization in our commercial and government rebate programs. In addition to transactions such as the PGP Acquisition and the LEO Transaction, period over period changes in the net sales of our products are a function of a number of factors including changes in: market demand, gross selling prices, sales-related deductions from gross sales to arrive at net sales and the levels of pipeline inventories of our products held by our direct and indirect customers. We use IMS Health, Inc. estimates of filled prescriptions for our products as a proxy for market demand in the U.S.
Net sales of our oral contraceptive products increased $14.3 million, or 17.3%, in the quarter ended September 30, 2010, compared with the prior year quarter. LOESTRIN 24 FE generated net sales of $84.5 million in the quarter ended September 30, 2010, an increase of 30.8%, compared with $64.6 million in the prior year quarter. The increase in LOESTRIN 24 FE net sales was primarily due to an increase in filled prescriptions of 64.4% and higher average selling prices, offset in part by the contraction of pipeline inventories relative to the prior year quarter and the impact of higher sales-related deductions, including the increased utilization of customer loyalty cards.
Revenues of ACTONEL were $267.6 million in the quarter ended September 30, 2010. ACTONEL revenues in North America totaled $153.8 million in the quarter ended September 30, 2010, including $135.5 million in the United States. Filled prescriptions of ACTONEL in the U.S. decreased 24.8% in the quarter ended September 30, 2010 compared to the prior year quarter. In the United States, ACTONEL continues to face market share declines due to the impact of managed care initiatives encouraging the use of generic versions of other products. In addition, generic competition in Canada began to negatively impact our net sales of ACTONEL in the first quarter of 2010 and we expect generic competition in Western Europe to negatively impact our net sales of ACTONEL beginning in the fourth quarter of 2010.
Net sales of our dermatology products decreased $62.5 million in the quarter ended September 30, 2010 relative to the prior year quarter, primarily as a result of the termination of the Company's distribution agreement with LEO. From the closing of the LEO Transaction on September 23, 2009 until LEO assumed responsibility for its own distribution services on June 30, 2010, the Company recorded net sales (and cost of sales at nominal distributor margins) for all TACLONEX and DOVONEX products sold in the United States pursuant to the distribution agreement executed in connection with the LEO Transaction. The Company did not record any net sales of DOVONEX or TACLONEX in the quarter ended September 30, 2010. Net sales of DORYX decreased $9.7 million, or 20.1%, to $38.5 million in the quarter ended September 30, 2010, compared to $48.2 million in the prior year quarter. The decrease in DORYX net sales was primarily due to an increase in sales-related deductions and a contraction of pipeline inventories relative to the prior year quarter, offset in part by higher average selling prices and a 3.5% increase in filled prescriptions. The increase in sales-related deductions compared to the prior year quarter was primarily due to the increased usage of our customer loyalty card for DORYX 150 mg.
Net sales of ASACOL in the quarter ended September 30, 2010 were $180.8 million. ASACOL net sales in North America totaled $167.0 million in the quarter ended September 30, 2010, including $161.1 million in the United States. Filled prescriptions of ASACOL in the U.S. decreased 5.1% in the quarter ended September 30, 2010 compared to the prior year quarter.
Revenues related to ENABLEX in the quarter ended September 30, 2010 were $23.1 million. As a result of the ENABLEX Acquisition, the Company will continue to receive a contractual percentage of Novartis' sales of ENABLEX through October 18, 2010, which will be included in "other revenue" on a net basis. Beginning on October 19, 2010, the Company assumed responsibility for the commercial shipment of all ENABLEX product in the U.S. and will record all product sales and related expenses on a gross basis.
Cost of Sales (excluding Amortization of Intangible Assets)
Cost of sales increased $37.3 million, or 84.1%, in the quarter ended September 30, 2010 compared with the prior year quarter, primarily due to a 165.9% increase in product net sales. Our gross margin, as a percentage of total revenue, increased to 88.4% in the quarter ended September 30, 2010 as compared to 82.4% in the prior year quarter, primarily due to a favorable mix of products sold as compared to the prior year quarter.
Selling, General and Administrative ("SG&A") Expenses
SG&A expenses for the quarter ended September 30, 2010 were $251.4 million, an increase of $192.3 million, or 325.3%, from $59.1 million in the prior year quarter. A&P expenses increased $20.0 million, or 262.3%, in the quarter ended September 30, 2010 as compared with the prior year quarter, primarily due to advertising and other promotional spending attributable to the acquired PGP products. Selling and distribution expenses increased $112.2 million, or 565.7%, in the quarter ended September 30, 2010 as compared to the prior year quarter. The increase was primarily due to co-promotion expenses of $65.5 million under the Actonel Collaboration Agreement between the Company and Sanofi-Aventis U.S. LLC and increased sales-related headcount and expenses resulting from the PGP Acquisition. G&A expenses increased $60.1 million, or 189.9%, in the quarter ended September 30, 2010, as compared with the prior year quarter. The increase was due in large part to increases in infrastructure costs, compensation expenses and professional and consulting fees primarily relating to the integration of PGP. Included in G&A expenses in the quarter ended September 30, 2010 were consulting and other professional fees relating to the PGP integration of $2.3 million, expenses payable to P&G under the Transition Services Agreement of $7.4 million, and severance costs of $1.0 million.
Research and Development ("R&D")
Our investment in R&D for the quarter ended September 30, 2010 was $33.3 million, an increase of $21.7 million, or 186.1%, compared with $11.6 million in the prior year quarter. The quarter ended September 30, 2010 included payments of $6.4 million primarily consisting of a $5.0 million payment to TaiGen Biotechnology Co. Ltd, resulting from the amendment of a license agreement with respect to a nemonoxacin product under development as well as a $1.0 million milestone payment to Paratek Pharmaceuticals, Inc., paid upon the achievement of a developmental milestone under our agreement to develop a treatment for acne and rosacea. Excluding these payments, R&D expenses increased $15.3 million compared to the prior year quarter. The increase in R&D expenses in the quarter ended September 30, 2010 relative to the prior year quarter was primarily due to the addition of R&D projects from PGP, higher costs associated with an increase in personnel and facilities and costs incurred relating to ongoing product development efforts.
Amortization of Intangible Assets
Amortization of intangible assets in the quarters ended September 30, 2010 and 2009 was $162.6 million and $57.0 million, respectively. The increase in amortization expense in the quarter ended September 30, 2010 compared to the prior year quarter was due primarily to the amortization of intellectual property assets acquired in the PGP Acquisition which accounted for $125.5 million of the amortization expense in the third quarter of 2010. We expect amortization expense to be significantly higher in 2010, relative to 2009, as a result of the PGP Acquisition, as well as the FDA's approval of ATELVIA and the ENABLEX Acquisition in the fourth quarter of 2010.
Net Interest Expense
Net interest expense for the quarter ended September 30, 2010 was $60.8 million, an increase of $36.8 million, or 153.6%, from $24.0 million in the prior year quarter. Included in net interest expense in the quarter ended September 30, 2009 was $6.6 million relating to the write-off of deferred loan costs associated with the repayment of $479.8 million of indebtedness under our prior senior secured credit facilities. Excluding the write-off of deferred loan costs, interest expense increased $43.4 million in the quarter ended September 30, 2010, as compared to the prior year quarter primarily due to a significant increase in our total outstanding indebtedness which was incurred to fund, among other things, the PGP Acquisition, the special cash dividend, the ENABLEX Acquisition and to pay related costs and expenses. The Company did not make any optional prepayments of debt during the quarter ended September 30, 2010.
Net Income and Cash Net Income
For the quarter ended September 30, 2010, we reported net income of $57.5 million, or $0.23 per diluted share, and CNI of $219.4 million, or $0.86 per diluted share. Earnings per share figures are based on 254.0 million diluted ordinary shares outstanding. In calculating CNI, we add back the after-tax impact of the amortization (including impairments, if any) of intangible assets and the amortization (including write-offs, if any) of deferred loan costs. These items are tax-effected at the estimated marginal rates attributable to them. In the quarter ended September 30, 2010, the marginal tax rate associated with the amortization of intangible assets was 4.9% and the marginal tax rate for amortization (including write-offs) of deferred loan costs was 8.7%.
Liquidity, Balance Sheet and Cash Flows
As of September 30, 2010, our cash and cash equivalents totaled $1,071.0 million and our total debt outstanding was $5,222.4 million, which consisted of $3,962.4 million of borrowings under our new senior secured credit facilities, $1,250.0 million aggregate principal amount of 7.75% Notes, and $10.0 million of unamortized premium related to the 7.75% Notes. We generated $250.2 million of cash from operating activities in the quarter ended September 30, 2010, compared with $111.1 million of cash from operating activities in the prior year quarter, an increase of $139.1 million.
2010 Financial Guidance Update
Based on our year-to-date results and current outlook for the remainder of 2010, we are raising our estimate of adjusted CNI per share by $0.10 from a range of $3.25 to $3.35 to a range of $3.35 to $3.45. The increase is the result of lower than previously expected SG&A expenses primarily as a result of better than anticipated progress in the P&G integration and the timing of R&D expenses, which more than offset declines in adjusted total revenue. The Company is reducing its estimate of adjusted total revenue from a range of $2,900.0 million to $2,950.0 million to a range of $2,800.0 million to $2,850.0 million based on current revenue trends, including higher than previously estimated sales-related deductions.
For the complete list of changes to the Company's full year 2010 guidance, please refer to the table on the last page of this press release.
Investor Conference Call
The Company is hosting a conference call open to all interested parties, on Monday, November 8, 2010 beginning at 8:00 AM EST. The number to call within the United States and Canada is (877) 354-4056. Participants outside the United States and Canada should call (678) 809-1043. A replay of the conference call will be available for two weeks following the call and can be accessed by dialing (800) 642-1687 from within the United States and Canada or (706) 645-9291 from outside the United States and Canada. The passcode for the replay ID number is 21329663.
The Company
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the North American and Western European pharmaceuticals markets. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-F
Forward Looking Statements
This press release contains forward-looking statements, including statements concerning our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," "intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial indebtedness, including increases in the LIBOR rates on our variable-rate indebtedness above the applicable floor amounts; competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products); our ability to protect our intellectual property; a delay in qualifying any of our manufacturing facilities that produce our products or production or regulatory problems with either third party manufacturers or API suppliers upon whom we may rely for some of our products or our own manufacturing facilities; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains; the loss of key senior management or scientific staff; adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject; government regulation, including domestic and foreign health care reform, affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; changes in tax laws or interpretations that could increase our consolidated tax liabilities, such as the recently enacted excise tax legislation in Puerto Rico; our ability to realize the anticipated opportunities from the PGP Acquisition; the other risks identified in our periodic filings including our Annual Report on Form 10-K for the year ended December 31, 2009, and from time-to-time in our other investor communications.
We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.
Reconciliations to GAAP Net Income
CNI
To supplement its condensed consolidated financial statements presented in accordance with US GAAP, the Company provides a summary to show the computation of CNI and Adjusted CNI. CNI is defined as the Company's GAAP net income adjusted for the after-tax effects of two non-cash items: amortization (including impairments, if any) of intangible assets and amortization (including write-offs, if any) of deferred loan costs related to the Company's debt. Adjusted CNI represents CNI as further adjusted to exclude one-time impacts from the LEO Transaction, the PGP Acquisition and the income from the reversal of a contingent liability relating to the termination of a contract. The Company believes that the presentation of CNI and Adjusted CNI provides useful information to both management and investors concerning the approximate impact of the above items. The Company also believes that considering the effect of these items allows management and investors to better compare the Company's financial performance from period-to-period, and to better compare the Company's financial performance with that of its competitors. The presentation of this additional information is not meant to be considered in isolation of, or as a substitute for, results prepared in accordance with US GAAP.
Adjusted EBITDA
To supplement its condensed consolidated financial statements presented in accordance with US GAAP, the Company provides a summary to show the computation of adjusted EBITDA taking into account certain charges that were taken during the quarters ended September 30, 2010 and 2009. The computation of adjusted EBITDA is based on the definition of EBITDA contained in the Company's senior secured credit facilities.
WARNER CHILCOTT PUBLIC LIMITED COMPANY | |||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||
(In thousands of U.S. dollars, except per share amounts) | |||||
(Unaudited) | |||||
Quarter Ended | Nine Months Ended | ||||
Sept-30-10 | Sept-30-09 | Sept-30-10 | Sept-30-09 | ||
REVENUE: | |||||
Product net sales | $ 659,650 | $ 248,061 | $ 2,132,843 | $ 732,650 | |
Other revenue | 43,542 | 4,734 | |||
