UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 5, 2014
ACTAVIS plc
(Exact Name of Registrant as Specified in Charter)
Ireland | 000-55075 | 98-1114402 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1 Grand Canal Square, Docklands
Dublin 2, Ireland
(Address of Principal Executive Offices)
(862) 261-7000
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c) |
Item 2.02 Results of Operations and Financial Condition.
On November 5, 2014, Actavis plc (the “Company”) issued a press release reporting the financial results for the three and nine months ended September 30, 2014. A copy of the press release reporting the financial results of the Company is attached to this report as Exhibit 99.1 and incorporated herein by reference.
In its press release, the Company discloses items not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”), or non-GAAP financial measures (as defined in Regulation G promulgated by the U.S. Securities and Exchange Commission) that exclude certain significant charges or credits that are important to an understanding of the Company’s ongoing operations. The Company believes that its inclusion of non-GAAP financial measures provides useful supplementary information to and facilitates analysis by investors in evaluating the Company’s performance and trends. The determination of significant charges or credits may not be comparable to similar measures used by other companies and may vary from period to period. The Company uses both GAAP financial measures and the disclosed non-GAAP financial measures internally to evaluate and manage the Company’s operations and to better understand its business. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
Non-GAAP net income, non-GAAP earnings per share, adjusted EBITDA, adjusted gross margin as a percentage of adjusted net revenues, adjusted SG&A as a percentage of adjusted net revenues, and adjusted R&D expense are supplemental measures of our performance that are not required by, or presented in accordance with, GAAP. We define non-GAAP net income as consolidated net (loss) / income for such period adjusted for the following net of tax: (i) amortization expenses, (ii) asset impairment charges and losses / (gains) and expenses associated with the sale of assets, (iii) business restructuring charges associated with Actavis’s Global Supply Chain and Operational Excellence Initiatives or other restructurings of a similar nature, (iv) costs and charges associated with the acquisition of businesses and assets including, but not limited to, milestone payments, integration charges, other charges associated with the revaluation of assets or liabilities and charges associated with the revaluation of acquisition related contingent liabilities that are based in whole or in part on future estimated cash flows (v) litigation charges and settlements and (vi) other unusual charges or expenses. We define adjusted EBITDA as an amount equal to consolidated net (loss) / income for such period adjusted for the following (i) interest expense, (ii) interest income, (iii) provision for income taxes, (iv) depreciation and amortization expenses, (v) losses attributable to non-controlling interest, (vi) stock-based compensation expense, (vii) asset impairment charges and losses / (gains) and expenses associated with the sale of assets, (viii) business restructuring charges associated with Actavis’s Global Supply Chain and Operational Excellence Initiatives or other restructurings of a similar nature, (ix) costs and charges associated with the acquisition of businesses and assets including, but not limited to, milestone payments, integration charges, other charges associated with the revaluation of assets or liabilities and charges associated with the revaluation of acquisition related contingent liabilities that are based in whole or in part on future estimated cash flows (x) litigation charges and settlements and (xi) other unusual charges or expenses.
The information in this report (including the exhibits) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
d. Exhibits:
99.1 | Press Release of Actavis plc entitled “Actavis Net Revenue Increases 83% to $3.7 Billion in Third Quarter 2014; Non-GAAP EPS Increases 53% to $3.19” dated November 5, 2014. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: November 5, 2014 | ACTAVIS plc | |
By: | /s/ R. Todd Joyce | |
R. Todd Joyce | ||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
Description | |
|
||
99.1 | Press Release of Actavis plc entitled “Actavis Net Revenue Increases 83% to $3.7 Billion in Third Quarter 2014; Non-GAAP EPS Increases 53% to $3.19” dated November 5, 2014. |
Actavis Net Revenue Increases 83% to $3.7 Billion in Third Quarter 2014; Non-GAAP EPS Increases 53% to $3.19
DUBLIN, Nov. 5, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today reported net revenue increased 83 percent to $3.7 billion for the third quarter ended September 30, 2014, compared to $2.0 billion in the third quarter 2013. On a non-GAAP basis, diluted earnings per share for the third quarter 2014 increased to $3.19, compared to $2.09 per diluted share in the third quarter 2013. GAAP loss per diluted share for the third quarter 2014 was $3.95, compared to GAAP earnings per share of $0.49 in the prior year period.
Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO
For the third quarter 2014, adjusted EBITDA increased 158 percent to $1.3 billion, compared to $489 million for the third quarter 2013. Cash flow from operations for the third quarter of 2014 was $522 million and cash and marketable securities were $340 million as of September 30, 2014.
"Our 53 percent year-over-year growth in non-GAAP EPS reflects the strong contributions of our new brand pharmaceutical portfolios, resulting from the acquisitions of Warner Chilcott and Forest, as well as the continued strong performance of our U.S. Generics and International businesses and the Anda Distribution business," said Brent Saunders, CEO and President. "During the quarter, our North American Brands business was driven by strong sales from key products including our Namenda® products, Bystolic®, Linzess®, Lo Loestrin® Fe, Estrace® Cream, Daliresp® and Tudorza™. During the quarter we completed the harmonization of our U.S. brand sales and marketing functions, and we now have a fully operational sales team in place to support our seven core therapeutic categories across all prescriber audiences. Within our North American Generics business, we capitalized on continued strength across the business. We also saw strong commercial performance in key international markets, particularly the UK and Russia.
"Our commitment to invest in organic growth through development-focused R&D resulted in a number of milestones during the quarter, including the acceptance for filing of New Drug Applications for eluxadoline, ceftazidime-avibactam and Liletta™ by the U.S. Food and Drug Administration (FDA). Our investment in generic R&D is reflected in 228 Abbreviated New Drug Applications (ANDAs) pending at the FDA; the initiation of patent challenges for generic forms of Ampyra®, Butrans® and Neupro®; and more than 570 marketing authorizations approved outside the United States," Saunders added.
"Additionally, we continue to execute on smart, targeted business development opportunities. Shortly after the close of the quarter we announced our planned acquisition of Durata Therapeutics, including Durata's novel antibiotic Dalvance™, as well as our exclusive option to acquire Rhythm Health, Inc., which is developing relamorelin, a peptide ghrelin agonist, for the treatment of diabetic gastroparesis and other GI functional disorders. These transactions complement our existing product franchises and position the Company for continued long-term growth.
"When I outlined our roadmap for accelerated growth last quarter, we committed to driving balanced performance across brands and generics, retaining our commitment to invest in organic growth and accelerating integration and synergy capture. We can report substantial progress across the board."
Third Quarter 2014 Business Segment Results
Third quarter 2014 results for Actavis plc include the contribution from the Forest acquisition, which closed on July 1, 2014. Actavis presents its operating results in three revenue-producing segments: North American Brands, North American Generics and International (which includes generic, branded generic, brands outside of North America and over-the-counter pharmaceutical products) and Anda Distribution. Prior year comparable results have been included. Refer to the attached reconciliation tables for adjustments to GAAP earnings.
North America Brands Segment Information | ||||||||||
| ||||||||||
|
|
|
| Three Months Ended |
| Nine Months Ended | ||||
|
|
|
| September 30, |
| September 30, | ||||
|
|
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
Product sales | $ 1,608.3 |
| $ 136.9 |
| $ 2,754.6 |
| $ 379.0 | |||
Other revenue | 11.0 |
| 16.1 |
| 45.9 |
| 48.4 | |||
Net revenues | 1,619.3 |
| 153.0 |
| 2,800.5 |
| 427.4 | |||
Operating expenses: |
|
|
|
|
|
|
| |||
Cost of sales(1) | 706.3 |
| 41.4 |
| 1,055.6 |
| 105.6 | |||
Selling and marketing | 503.3 |
| 46.1 |
| 694.9 |
| 136.6 | |||
General and administrative | 377.0 |
| 32.8 |
| 529.8 |
| 78.9 | |||
Segment contribution | $ 32.7 |
| $ 32.7 |
| $ 520.2 |
| $ 106.3 | |||
Segment margin | 2.0% |
| 21.4% |
| 18.6% |
| 24.9% | |||
|
|
|
|
|
|
|
|
|
|
|
Adjusted gross profit (2) | $ 1,367.4 |
| $ 116.8 |
| $ 2,402.8 |
| $ 327.3 | |||
Adjusted gross margin as a percentage of adjusted net revenues (2) | 84.4% |
| 76.1% |
| 85.8% |
| 76.5% | |||
|
|
|
|
|
|
|
|
|
|
|
Adjusted SG&A percentage of adjusted net revenues (3) | 29.7% |
| 37.9% |
| 27.0% |
| 40.3% | |||
|
|
|
|
|
|
|
|
|
|
|
(1)Cost of sales excludes amortization and impairment of acquired intangibles. | ||||||||||
(2)Refer to Table 7 included in this release for the reconciliation of net revenues and cost of sales to adjusted gross profit and adjusted gross margin as a percentage of adjusted net revenues. | ||||||||||
(3)Refer to Table 8 included in this release for the reconciliation of net revenues and SG&A to adjusted SG&A as a percentage of adjusted net revenues. |
North American Brands revenue increased to $1.6 billion for the third quarter 2014, driven by the acquisitions of Warner Chilcott and Forest, which includes strong sales of key promoted products including our Namenda® products, Bystolic®, Linzess®, Lo Loestrin® Fe, Estrace® Cream, Daliresp™ and Tudorza®. Additional product revenue detail is presented in table 2 at the end of this press release.
The Company continues to enhance manufacturing efficiencies related to its once-daily dosing of Namenda XR®, and is now producing product at capacities sufficient to support transitioning all Namenda IR twice daily tablet patients to its Namenda XR® once-daily product. Assuming a favorable ruling from the court later in November denying the injunction sought by the New York State Attorney General, the Company will discontinue the general sale and distribution of Namenda® IR immediate-release tablets in January 2015. After that date, the Company has determined that it will make Namenda IR® immediate release tablets available for prescribing to patients upon an indication of medical need as determined by their physician. The immediate release product will be made available through Foundation Care, a full service specialty mail-order pharmacy serving patients nationwide.
"Our previous survey of 250 physicians treating Alzheimer's patients and 250 caregivers found once-daily administration was important in their decision to use Namenda XR® when compared to Namenda® IR tablets," said Saunders. "However, in that survey a small number of doctors suggested that for select groups of patients, perhaps less than 3 percent, the continued utilization of the twice-a-day tablet dosing of Namenda® might be necessary for treatment. We listened to these physicians and have tailored the Foundation Care program to permit physicians to exercise their medical judgment to prescribe Namenda® IR to this specific patient population."
Adjusted gross margin as a percentage of adjusted net revenues within North American Brands increased to 84.4 percent in the third quarter of 2014 from 76.1 percent in the third quarter of 2013, primarily as a result of the acquisitions of Warner Chilcott and Forest.
Selling, General & Administrative (SG&A) expenses within North American Brands increased to $880.3 million in the third quarter of 2014 compared to $78.9 million in the third quarter of 2013, driven primarily by the acquisitions of Warner Chilcott and Forest.
On a non-GAAP basis, adjusted SG&A as a percent of adjusted net revenue for the North American Brands segment was 29.7 percent, down from 37.9 percent in the third quarter of 2013.
North America Generics and International Segment Information |
|
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended | ||||
|
|
|
| September 30, |
| September 30, | ||||
|
|
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
Product sales | $ 1,613.2 |
| $ 1,528.0 |
| $ 4,872.6 |
| $ 4,578.6 | |||
Other revenue | 27.4 |
| 24.9 |
| 91.9 |
| 78.4 | |||
Net revenues | 1,640.6 |
| 1,552.9 |
| 4,964.5 |
| 4,657.0 | |||
Operating expenses: |
|
|
|
|
|
|
| |||
Cost of sales(1) | 811.9 |
| 774.6 |
| 2,346.4 |
| 2,414.0 | |||
Selling and marketing | 175.1 |
| 153.8 |
| 503.9 |
| 483.5 | |||
General and administrative | 181.2 |
| 190.7 |
| 557.7 |
| 540.9 | |||
Segment contribution | $ 472.4 |
| $ 433.8 |
| $ 1,556.5 |
| $ 1,218.6 | |||
Segment margin | 28.8% |
| 27.9% |
| 31.4% |
| 26.2% | |||
|
|
|
|
|
|
|
|
|
|
|
Adjusted gross profit (2) | $ 891.1 |
| $ 799.9 |
| $ 2,693.6 |
| $ 2,397.4 | |||
Adjusted gross margin as a percentage of adjusted net revenues (2) | 55.3% |
| 51.5% |
| 56.2% |
| 51.4% | |||
|
|
|
|
|
|
|
|
|
|
|
Adjusted SG&A percentage of adjusted net revenues (3) | 20.3% |
| 19.2% |
| 20.1% |
| 19.8% | |||
|
|
|
|
|
|
|
|
|
|
|
(1)Cost of sales excludes amortization and impairment of acquired intangibles. | ||||||||||
(2)Refer to Table 7 included in this release for the reconciliation of net revenues and cost of sales to adjusted gross profit and adjusted gross margin as a percentage of adjusted net revenues. | ||||||||||
(3)Refer to Table 8 included in this release for the reconciliation of net revenues and SG&A to adjusted SG&A as a percentage of adjusted net revenues. |
North American Generics revenue was $979.9 million for the third quarter 2014, driven by strong base business performance partially offset by additional generic competition of certain key products including our generic version of Lidoderm® and our authorized generic version of Concerta®. North American Generics revenue consists of non-branded pharmaceutical revenue in the United States, Latin America and Canada.
International revenue increased 15 percent to $660.7 million for the third quarter 2014 as a result of the acquisitions of Warner Chilcott and Forest and strong growth in key markets including the UK and Russia/CIS. International revenue consists of all brand, branded generic, generic and over-the-counter pharmaceutical revenue derived outside North America.
Adjusted gross margin as a percentage of adjusted net revenues within North American Generics and International increased to 55.3 percent in the third quarter of 2014 from 51.5 percent in the third quarter of 2013, primarily as a result of strong base business performance and additional products added to our international markets as a result of the acquisition of Warner Chilcott in the fourth quarter of 2013 and the acquisition of Forest in the third quarter of 2014.
Selling, General & Administrative (SG&A) expenses within North American Generics and International increased three percent to $356.3 million in the third quarter of 2014 compared to $344.5 million in the third quarter of 2013. On a non-GAAP basis, adjusted SG&A as a percent of adjusted net revenue for our North American Generics and International segment was 20.3 percent.
Anda Distribution Segment Information | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended |
| ||||
|
|
|
| September 30, |
| September 30, |
| ||||
|
|
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues | $ 423.2 |
| $ 307.1 |
| $ 1,240.4 |
| $ 813.9 |
| |||
Operating expenses: |
|
|
|
|
|
|
|
| |||
Cost of sales | 364.8 |
| 267.2 |
| 1,070.5 |
| 700.5 |
| |||
Selling and marketing | 28.8 |
| 23.7 |
| 83.0 |
| 66.3 |
| |||
General and administrative | 9.1 |
| 8.6 |
| 25.7 |
| 23.9 |
| |||
Segment contribution | $ 20.5 |
| $ 7.6 |
| $ 61.2 |
| $ 23.2 |
| |||
Segment margin | 4.8% |
| 2.5% |
| 4.9% |
| 2.9% |
| |||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit | $ 58.4 |
| $ 39.9 |
| $ 169.9 |
| $ 113.4 |
| |||
Gross margin | 13.8% |
| 13.0% |
| 13.7% |
| 13.9% |
| |||
SG&A as a percentage of net revenues | 9.0% |
| 10.5% |
| 8.8% |
| 11.1% |
|
Anda Distribution segment net revenues for the third quarter 2014 increased 38 percent to $423.2 million, compared to $307.1 million in the third quarter 2013, as a result of volume increases for products within the Anda portfolio and new launches. Anda Distribution segment revenues consist only of sales of third-party products and exclude sales of Actavis' brand and generic products.
Anda Distribution segment gross margin was 13.8 percent in the third quarter of 2014 compared to 13.0 percent in the prior year period.
SG&A expenses within Anda Distribution increased to $37.9 million in the third quarter of 2014 compared to $32.3 million in the third quarter of 2013. SG&A as a percent of revenue for our Anda Distribution segment was 9.0 percent.
Other Operating Expenses
In the third quarter 2014, consolidated SG&A expenses were $1.27 billion, compared to $456 million in the third quarter 2013, primarily as a result of the Warner Chilcott and Forest Laboratories acquisitions.
R&D expense increased to $391.8 million in the third quarter of 2014 compared to $163.7 million in the third quarter of 2013, driven by the acquisitions of Warner Chilcott and Forest. Within R&D, $115.3 million was invested in generic development, $248.0 million was invested in brand development and $28.5 million was invested in biosimilar development during the quarter.
Amortization expense for the third quarter 2014 was $874 million, compared to $146 million in the third quarter of 2013, primarily due to amortization expense associated with the Warner Chilcott and Forest acquisitions.
Integration and Pipeline Update
Actavis also made significant progress in the integration of the legacy Actavis and legacy Forest organizations and R&D activities during the quarter. The Company has now completed the restructuring of the U.S. sales and marketing organization, made initial decisions regarding the rationalization of certain brand R&D projects and announced the planned closure of Forest's Earth City, Missouri facilities and consolidation of facilities in the New York and New Jersey area. Rationalization of the North American Brands pipeline is focused on identifying candidates in development where maximization of return on R&D investment is better served through the reallocation of resources to other ongoing projects. The Company intends to provide a complete review of its brand R&D investment strategy, development rationale and pipeline update in early 2015.
Updated Second Half and Full Year 2014 Financial Outlook
Actavis' estimates include the Forest business. Estimates are based on actual results for the first nine months of 2014 and management's current belief about prescription trends, pricing levels, inventory levels and the anticipated timing of future product launches and events.
Actavis estimates the following for the second half and full year 2014:
Second Half 2014
Full Year 2014
In keeping with standard practice, the Company expects to provide an updated full year 2015 financial outlook early next year.
Webcast and Conference Call Details
Actavis plc will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss third quarter 2014 results. The dial-in number to access the call is US/Canada (877) 251-7980, International (706) 643-1573. The Conference ID is 8164798. To access the live webcast, go to Actavis' Investor Relations Web site at http://ir.actavis.com.
A replay of the conference call will also be available beginning approximately two hours after the call's conclusion and will remain available through 12:00 midnight Eastern Time on November 19, 2014. The replay may be accessed by dialing (855) 859-2056 and entering Conference ID# 8164798. From international locations, the replay may be accessed by dialing (404) 537-3406 and entering the same Conference ID#. To access the webcast replay, go to Actavis' Investor Relations Web site at http://ir.actavis.com.
About Actavis
About Actavis plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.
Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.
For more information, visit Actavis' website at www.actavis.com.
Actavis Cautionary Statement Regarding Forward-Looking Statements
Statements contained in this communication that refer to Actavis' estimated or anticipated future results, including estimated synergies, or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such forward-looking statements include, but are not limited to, statements about the benefits of the Forest acquisition, including future financial and operating results, Actavis' plans, objectives, expectations and intentions. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the inherent uncertainty associated with financial projections; restructuring and integration in connection with the Forest acquisition and other announced acquisitions, including the ability to recognize the anticipated synergies and benefits of the Forest acquisition and other announced acquisitions; the anticipated size of the markets and continued demand for Actavis' products; the impact of competitive products and pricing; access to available financing on a timely basis and on reasonable terms; the risks of fluctuations in foreign currency exchange rates; the risks and uncertainties normally incident to the pharmaceutical industry, including product liability claims and the availability of product liability insurance on reasonable terms; outcomes in material litigation involving Actavis, including without limitation the decision, expected later this year, on a preliminary injunction motion brought before the U.S. District Court in the Southern District of New York, seeking to prevent Actavis from executing its strategy to withdraw Namenda IR tablets from distribution; the difficulty of predicting the timing or outcome of pending or future litigation or government investigations; periodic dependence on a small number of products for a material source of net revenue or income; variability of trade buying patterns; changes in generally accepted accounting principles; risks that the carrying values of assets may be negatively impacted by future events and circumstances; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; market acceptance of and continued demand for Actavis' products; costs and efforts to defend or enforce intellectual property rights; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Actavis' facilities, products and/or businesses; changes in the laws and regulations affecting, among other things, pricing and reimbursement of pharmaceutical products; changes in tax laws or interpretations that could increase Actavis' consolidated tax liabilities; the loss of key senior management or scientific staff; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Annual Report on form 10-K for the year ended December 31, 2013, Current Report on Form 8-K filed on May 20, 2014 and from time to time in Actavis' other investor communications, in Warner Chilcott Limited's Registration Statement on Form S-4 effective as of October 16, 2014, in Forest Laboratories, Inc.'s Annual Report on Form 10-K for the year ended March 31, 2014 and in Furiex Pharmaceuticals, Inc.'s Annual Report on Form 10-K for the year ended December 31, 2013 and such companies' other filings with the Securities and Exchange Commission. Except as expressly required by law, Actavis disclaims any intent or obligation to update or revise these forward-looking statements.
The following table presents Actavis plc's results of operations for the three and nine months ended September 30, 2014 and 2013:
|
|
|
|
|
|
|
|
|
| Table 1 |
ACTAVIS PLC | ||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(Unaudited; in millions, except per share amounts) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended | ||||
|
|
|
| September 30, |
| September 30, | ||||
|
|
|
|
|
|
| ||||
|
|
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
| $ 3,683.1 |
| $ 2,013.0 |
| $ 9,005.4 |
| $ 5,898.3 | ||
|
|
|
|
|
|
|
|
|
| |
Operating expenses: |
|
|
|
|
|
|
|
| ||
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
| 1,883.0 |
| 1,083.2 |
| 4,472.5 |
| 3,220.1 | ||
Research and development |
| 391.8 |
| 163.7 |
| 721.3 |
| 432.1 | ||
Selling, general and administrative |
| 1,274.5 |
| 455.7 |
| 2,395.0 |
| 1,330.1 | ||
Goodwill impairment |
| - |
| - |
| - |
| 647.5 | ||
In-process research and development impairments |
| 305.0 |
| - |
| 321.3 |
| 4.4 | ||
Amortization |
| 873.6 |
| 146.3 |
| 1,720.7 |
| 454.3 | ||
Asset sales, impairments and contingent consideration adjustment, net |
| 7.3 |
| 13.6 |
| 12.7 |
| 165.0 | ||
Total operating expenses |
| 4,735.2 |
| 1,862.5 |
| 9,643.5 |
| 6,253.5 | ||
Operating (loss) / income |
| (1,052.1) |
| 150.5 |
| (638.1) |
| (355.2) | ||
|
|
|
|
|
|
|
|
|
|
|
Non-operating income (expense): |
|
|
|
|
|
|
|
| ||
Interest income |
| 1.6 |
| 1.4 |
| 3.8 |
| 3.4 | ||
Interest expense |
| (132.1) |
| (52.9) |
| (284.0) |
| (162.1) | ||
Other income (expense), net |
| 31.9 |
| (2.1) |
| 1.1 |
| 22.3 | ||
Total other income (expense), net |
| (98.6) |
| (53.6) |
| (279.1) |
| (136.4) | ||
(Loss) / income before income taxes and noncontrolling interest |
| (1,150.7) |
| 96.9 |
| (917.2) |
| (491.6) | ||
(Benefit) / provision for income taxes |
| (107.9) |
| 31.4 |
| (19.9) |
| 111.0 | ||
Net (loss) / income |
| (1,042.8) |
| 65.5 |
| (897.3) |
| (602.6) | ||
Loss / (income) attributable to noncontrolling interest |
| - |
| 0.1 |
| (0.3) |
| 0.6 | ||
Net (loss) / income attributable to ordinary shareholders |
|
|
| $ (1,042.8) |
| $ 65.6 |
| $ (897.6) |
| $ (602.0) |
|
|
|
|
|
|
|
|
|
|
|
(Loss) / earnings per share attributable to ordinary shareholders: |
|
|
|
|
|
|
|
| ||
Basic |
| $ (3.95) |
| $ 0.50 |
| $ (4.39) |
| $ (4.57) | ||
Diluted |
| $ (3.95) |
| $ 0.49 |
| $ (4.39) |
| $ (4.57) | ||
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
| ||
Basic |
| 264.3 |
| 132.5 |
| 204.4 |
| 131.7 | ||
Diluted |
| 264.3 |
| 134.4 |
| 204.4 |
| 131.7 |
The following table details product revenue for significant products within the North American Brands segment for the three and nine months ending September 30, 2014.
|
|
|
|
|
|
|
| Table 2 |
ACTAVIS PLC | ||||||||
NORTH AMERICA BRANDS SEGMENT REVENUE | ||||||||
(Unaudited; in millions) | ||||||||
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended | ||||
|
| September 30 |
| September 30 | ||||
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
North American Brands |
|
|
|
|
|
|
|
|
CNS |
|
|
|
|
|
|
|
|
Namenda franchise |
| $ 427.6 |
| $ - |
| $ 427.6 |
| $ - |
Viibyrd® / Fetzima® |
| 66.4 |
| - |
| 66.4 |
| - |
Saphris ® |
| 36.8 |
| - |
| 36.8 |
| - |
Other CNS |
| 23.8 |
| - |
| 23.8 |
| - |
Total CNS |
| 554.6 |
| - |
| 554.6 |
| - |
Gastroenterology |
|
|
|
|
|
|
|
|
Delzicol®/Asacol® HD |
| 141.2 |
| - |
| 418.4 |
| - |
Linzess®/Costella ™ |
| 80.0 |
| - |
| 80.0 |
| - |
Carafate ® / Sulcrate ® |
| 42.3 |
| - |
| 42.3 |
| - |
Canasa ® / Salofalk ® |
| 34.8 |
| - |
| 34.8 |
| - |
Zenpep ®, Ultrase ® & Viokace ® |
| 34.1 |
| - |
| 34.1 |
| - |
Other Gastroenterology |
| 8.5 |
| - |
| 8.5 |
| - |
Total Gastroenterology |
| 340.9 |
| - |
| 618.1 |
| - |
Women's Health |
|
|
|
|
|
|
|
|
Lo Loestrin® Fe |
| 71.6 |
| - |
| 202.0 |
| - |
Estrace® Cream |
| 66.7 |
| - |
| 177.9 |
| - |
Minastrin® 24 Fe |
| 54.0 |
| - |
| 158.4 |
| - |
Other Women's Health |
| 49.2 |
| 26.9 |
| 146.5 |
| 68.2 |
Total Women's Health |
| 241.5 |
| 26.9 |
| 684.8 |
| 68.2 |
Cardiovascular & Respiratory |
|
|
|
|
|
|
|
|
Bystolic® |
| 138.6 |
| - |
| 138.6 |
| - |
Daliresp ® |
| 30.0 |
| - |
| 30.0 |
| - |
Tudorza ® |
| 28.4 |
| - |
| 28.4 |
| - |
Total Cardiovascular & Respiratory |
| 197.0 |
| - |
| 197.0 |
| - |
Urology |
| 73.5 |
| 60.1 |
| 213.3 |
| 172.6 |
Anti-Infectives |
| 20.2 |
| - |
| 20.2 |
| - |
Dermatology/Established Brands |
| 191.6 |
| 66.0 |
| 512.5 |
| 186.6 |
Total North American Brands |
| $ 1,619.3 |
| $ 153.0 |
| $ 2,800.5 |
| $ 427.4 |
The following table presents Actavis plc's Condensed Consolidated Balance Sheets as of September 30, 2014 and December 31, 2013.
|
|
|
|
|
| Table 3 |
ACTAVIS PLC | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(Unaudited; in millions) | ||||||
|
|
|
| September 30, |
| December 31, |
|
|
|
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
| ||
| Cash and cash equivalents |
| $ 339.4 |
| $ 329.0 | |
| Marketable securities |
| 1.0 |
| 2.5 | |
| Accounts receivable, net |
| 2,229.3 |
| 1,404.9 | |
| Inventories, net |
| 2,627.3 |
| 1,786.3 | |
| Other current assets |
| 930.6 |
| 641.0 | |
| Assets held for sale |
| 124.7 |
| 271.0 | |
| Property, plant and equipment, net |
| 1,704.3 |
| 1,616.8 | |
| Investments and other assets |
| 376.8 |
| 242.3 | |
| Product rights and other intangibles, net |
| 19,957.3 |
| 8,234.5 | |
| Goodwill |
| 25,176.7 |
| 8,197.6 | |
|
| Total assets |
| $ 53,467.4 |
| $ 22,725.9 |
|
|
|
|
|
|
|
Liabilities & Equity |
|
|
|
| ||
| Current liabilities |
| $ 4,481.3 |
| $ 3,048.3 | |
| Liabilities held for sale |
| - |
| 246.6 | |
| Long-term debt and capital leases |
| 15,093.8 |
| 8,517.4 | |
| Deferred income taxes and other liabilities |
| 4,747.3 |
| 1,376.5 | |
| Total equity |
| 29,145.0 |
| 9,537.1 | |
|
| Total liabilities and equity |
| $ 53,467.4 |
| $ 22,725.9 |
The following table presents Actavis plc's Condensed Consolidated Statements of Cash Flows for the three and nine months ended September 30, 2014 and 2013.
|
|
|
|
|
|
|
|
|
|
|
|
| Table 4 |
ACTAVIS PLC | |||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||
(Unaudited; In millions) | |||||||||||||
|
|
|
|
|
|
| Three Months Ended September 30, |
| Nine Months Ended September 30, | ||||
|
|
|
|
|
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
Cash Flows From Operating Activities: |
|
|
|
|
|
|
| ||||||
Net (loss) income |
|
|
|
| $ (1,042.8) |
| $ 65.5 |
| $ (897.3) |
| $ (602.6) | ||
Reconciliation to net cash provided by operating activities: |
|
|
|
|
|
|
| ||||||
Depreciation |
|
|
|
| 64.6 |
| 50.1 |
| 169.7 |
| 147.7 | ||
Amortization |
|
|
|
| 873.6 |
| 146.3 |
| 1,720.7 |
| 454.3 | ||
Provision for inventory reserve |
| 34.9 |
| 21.0 |
| 110.2 |
| 50.5 | |||||
Share-based compensation |
| 228.2 |
| 49.5 |
| 259.4 |
| 75.8 | |||||
Deferred income tax benefit |
| (261.0) |
| (32.5) |
| (412.5) |
| (170.0) | |||||
(Earnings) on equity method investments | (0.5) |
| (1.6) |
| (2.3) |
| (3.3) | ||||||
Goodwill impairment |
|
|
| - |
| - |
| - |
| 647.5 | |||
In-process research and development impairments | 305.0 |
| - |
| 321.3 |
| 4.4 | ||||||
Loss / (gain) on sale of securities and asset sales and impairments, net | 6.8 |
| 23.0 |
| 34.2 |
| 24.1 | ||||||
Amortization of inventory step up | 493.3 |
| - |
| 703.3 |
| 93.5 | ||||||
Amortization of deferred financing costs | 8.0 |
| 1.9 |
| 34.4 |
| 5.7 | ||||||
Increase / (decrease) in allowance for doubtful accounts | 7.3 |
| 0.5 |
| 10.3 |
| (0.5) | ||||||
Accretion of contingent payment consideration | 5.1 |
| 5.1 |
| 13.6 |
| 6.5 | ||||||
Contingent consideration fair value adjustment | (1.4) |
| 5.9 |
| (37.8) |
| 156.2 | ||||||
Non-cash impact of debt extingushemnt | (91.7) |
| - |
| (91.7) |
| - | ||||||
Excess tax benefit from stock-based compensation | - |
| (55.0) |
| (22.7) |
| (69.2) | ||||||
Other, net |
|
|
|
| (15.9) |
| 1.1 |
| (27.1) |
| 2.3 | ||
Changes in assets and liabilities (net of effects of acquisitions): |
|
|
|
|
|
|
| ||||||
| Decrease / (increase) in accounts receivable, net | (202.7) |
| 17.4 |
| (365.6) |
| (28.7) | |||||
| Decrease / (increase) in inventories | (112.3) |
| (51.5) |
| (266.7) |
| (266.5) | |||||
| Decrease / (increase) in prepaid expenses and other current assets | 38.8 |
| 40.8 |
| 69.3 |
| 62.0 | |||||
| Increase / (decrease) in accounts payable and accrued expenses | 239.3 |
| 38.0 |
| 292.3 |
| 19.5 | |||||
| Increase / (decrease) in deferred revenue | (2.6) |
| 0.9 |
| (11.2) |
| 23.7 | |||||
| Increase / (decrease) in income and other taxes payable | (39.5) |
| (52.1) |
| (140.9) |
| (71.9) | |||||
| Increase / (decrease) in other assets and liabilities | (12.2) |
| (3.5) |
| (31.5) |
| 0.8 | |||||
| Total adjustments | 1,565.1 |
| 205.3 |
| 2,328.7 |
| 1,164.4 | |||||
| Net cash provided by operating activities | 522.3 |
| 270.8 |
| 1,431.4 |
| 561.8 | |||||
Cash Flows From Investing Activities: |
|
|
|
|
|
|
| ||||||
Additions to property, plant and equipment | (93.3) |
| (43.6) |
| (174.1) |
| (117.4) | ||||||
Additions to product rights and other intangibles | (0.1) |
| (2.6) |
| (0.1) |
| (5.0) | ||||||
Proceeds from the sale of assets |
| 433.2 |
| 13.1 |
| 451.2 |
| 25.0 | |||||
Proceeds from sales of property, plant and equipment | 7.8 |
| - |
| 12.0 |
| 5.9 | ||||||
Net proceeds from marketable securities | 1.5 |
| - |
| 1.5 |
| - | ||||||
Acquisition of business, net of cash acquired | (4,803.4) |
| - |
| (4,922.6) |
| (194.6) | ||||||
| Net cash (used in) investing activities | (4,454.3) |
| (33.1) |
| (4,632.1) |
| (286.1) | |||||
Cash Flows From Financing Activities: |
|
|
|
|
|
|
| ||||||
Proceeds from borrowings on the revolving credit facility | - |
| - |
| 80.0 |
| 125.0 | ||||||
Proceeds from borrowings of long-term indebtedness | 4,400.0 |
| - |
| 8,076.2 |
| - | ||||||
Debt issuance costs |
|
|
|
| (6.3) |
| (0.5) |
| (58.2) |
| (0.5) | ||
Payments on debt, including capital lease obligations | (4,407.7) |
| (43.9) |
| (4,875.5) |
| (260.6) | ||||||
Proceeds from stock plans |
|
|
| 35.2 |
| 38.5 |
| 43.3 |
| 44.0 | |||
Payments of contingent consideration | (4.8) |
| (0.9) |
| (12.6) |
| (3.1) | ||||||
Repurchase of ordinary shares |
| (40.3) |
| (142.9) |
| (99.7) |
| (165.4) | |||||
Acquisition of noncontrolling interest | - |
| - |
| - |
| (10.4) | ||||||
Excess tax benefit from stock-based compensation | - |
| 55.0 |
| 22.7 |
| 69.2 | ||||||
| Net cash (used in) / provided by financing activities | (23.9) |
| (94.7) |
| 3,176.2 |
| (201.8) | |||||
Effect of currency exchange rate changes on cash and cash equivalents | 1.7 |
| (1.9) |
| (2.1) |
| (24.9) | ||||||
Movement in cash held for sale |
| - |
| - |
| 37.0 |
| - | |||||
| Net (decrease) / increase in cash and cash equivalents | (3,954.2) |
| 141.1 |
| 10.4 |
| 49.0 | |||||
Cash and cash equivalents at beginning of period | 4,293.6 |
| 226.9 |
| 329.0 |
| 319.0 | ||||||
Cash and cash equivalents at end of period | $ 339.4 |
| $ 368.0 |
| $ 339.4 |
| $ 368.0 |
The following table presents a reconciliation of reported net (loss) / income and diluted earnings per share to non-GAAP net income and diluted earnings per share for the three and nine months ended September 30, 2014 and 2013:
|
|
|
|
|
|
|
| Table 5 |
ACTAVIS PLC | ||||||||
RECONCILIATION TABLE | ||||||||
(Unaudited; in millions except per share amounts) | ||||||||
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended | ||||
|
| September 30, |
| September 30, | ||||
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP to non-GAAP net income calculation |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
| Reported GAAP net (loss) / income attributable to
| $ (1,042.8) |
| $ 65.6 |
| $ (897.6) |
| $ (602.0) |
| Adjusted for: |
|
|
|
|
|
|
|
| Amortization | 873.6 |
| 146.3 |
| 1,720.7 |
| 454.3 |
| Global supply chain initiative(1) | 8.3 |
| 18.5 |
| 38.6 |
| 50.5 |
| Acquisition and licensing charges (2) | 907.1 |
| 83.1 |
| 1,217.1 |
| 380.3 |
| Accretion on contingent liabilities | 5.1 |
| 5.1 |
| 13.5 |
| 6.5 |
| Impairment/asset sales and related costs | 303.5 |
| 13.6 |
| 326.1 |
| 666.6 |
| Non-recurring losses (gains) | 85.9 |
| 7.9 |
| 84.5 |
| (1.9) |
| Legal settlements | (10.0) |
| 15.0 |
| (8.5) |
| 45.8 |
| Income taxes on items above | (277.7) |
| (73.7) |
| (432.3) |
| (182.5) |
| Non-GAAP net income attributable to
| $ 853.0 |
| $ 281.4 |
| $ 2,062.1 |
| $ 817.6 |
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
| Diluted (loss) earnings per share - GAAP | $ (3.95) |
| $ 0.49 |
| $ (4.39) |
| $ (4.57) |
|
|
|
|
|
|
|
|
|
| Diluted earnings per share - Non-GAAP | $ 3.19 |
| $ 2.09 |
| $ 9.98 |
| $ 6.12 |
|
|
|
|
|
|
|
|
|
| Basic weighted average common shares outstanding | 264.3 |
| 132.5 |
| 204.4 |
| 131.7 |
| Effect of dilutive securities: |
|
|
|
|
|
|
|
| Dilutive share-based compensation arrangements | 3.1 |
| 1.9 |
| 2.2 |
| 2.0 |
| Diluted weighted average common shares outstanding | 267.4 |
| 134.4 |
| 206.6 |
| 133.7 |
|
|
|
|
|
|
|
|
|
| ||||||||
(1) | Includes accelerated depreciation charges. | |||||||
|
|
|
|
|
|
|
|
|
(2) | Includes stock-based compensation due to the Warner Chilcott, Furiex and Forest acquisitions. |
The following table presents a reconciliation of reported net income / (loss) for the three and nine months ended September 30, 2014 and 2013 to adjusted EBITDA:
|
|
|
|
|
|
|
|
| Table 6 |
ACTAVIS PLC | |||||||||
ADJUSTED EBITDA, RECONCILIATION TABLE | |||||||||
(Unaudited; in millions) | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Nine Months Ended | ||||
|
|
| September 30, |
| September 30, | ||||
|
|
| 2014 |
| 2013 |
| 2014 |
| 2013 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) / income attributable to ordinary shareholders |
| $ (1,042.8) |
| $ 65.6 |
| $ (897.6) |
| $ (602.0) | |
Plus: |
|
|
|
|
|
|
|
|
|
Interest expense |
| 132.1 |
| 52.9 |
| 284.0 |
| 162.1 | |
Interest income |
| (1.6) |
| (1.4) |
| (3.8) |
| (3.4) | |
Provision for income taxes |
| (107.9) |
| 31.4 |
| (19.9) |
| 111.0 | |
Depreciation (includes accelerated depreciation) |
| 64.6 |
| 50.1 |
| 169.7 |
| 147.7 | |
Amortization |
| 873.6 |
| 146.3 |
| 1,720.7 |
| 454.3 | |
EBITDA |
| (82.0) |
| 344.9 |
| 1,253.1 |
| 269.7 | |
Adjusted for: |
|
|
|
|
|
|
|
| |
Global supply chain initiative |
| 8.3 |
| 8.3 |
| 24.8 |
| 22.7 | |
Acquisition and licensing and other charges |
| 705.9 |
| 44.9 |
| 1,014.2 |
| 342.1 | |
Impairment/asset sales and related costs |
| 303.5 |
| 13.6 |
| 326.1 |
| 666.6 | |
Non-recurring losses (gains) |
| 85.9 |
| 7.9 |
| 84.5 |
| (1.9) | |
Legal settlements |
| (10.0) |
| 15.0 |
| (8.5) |
| 45.8 | |
Accretion on contingent liabilities |
| 5.1 |
| 5.1 |
| 13.5 |
| 6.5 | |
Share-based compensation |
| 244.8 |
| 49.5 |
| 276.0 |
| 75.8 | |
Adjusted EBITDA |
| $ 1,261.5 |
| $ 489.2 |
| $ 2,983.7 |
| $ 1,427.3 |
The following table presents a reconciliation of reported net revenues and cost of sales by segment for the three and nine months ended September 30, 2014 and 2013 to adjusted net revenues, adjusted cost of sales, adjusted gross profit and adjusted gross margin as a percentage of adjusted net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Table 7 |
|
|
ACTAVIS PLC | |||||||||||||||||
ADJUSTED GROSS MARGIN AS A PERCENTAGE OF ADJUSTED NET REVENUES | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Three Months Ended | ||||||||||||
|
|
| September 30, 2014 |
| September 30, 2013 | ||||||||||||
(Unaudited; $ in millions) |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net revenues |
| $ 1,619.3 |
| $ 1,640.6 |
| $ 423.2 |
| $ 3,683.1 |
| $ 153.0 |
| $ 1,552.9 |
| $ 307.1 |
| $ 2,013.0 | |
Adjustments to net revenue ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Purchase accounting adjustments |
| - |
| 4.8 |
| - |
| 4.8 |
| 0.4 |
| 0.3 |
| - |
| 0.7 |
| Operating results of assets held for sale / sold |
| - |
| (34.3) |
| - |
| (34.3) |
| - |
| - |
| - |
| - |
| Manufacturing and supply contract termination payment |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
Adjusted net revenues |
| $ 1,619.3 |
| $ 1,611.1 |
| $ 423.2 |
| $ 3,653.6 |
| $ 153.4 |
| $ 1,553.2 |
| $ 307.1 |
| $ 2,013.7 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales (1): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Cost of Sales |
| $ 706.3 |
| $ 811.9 |
| $ 364.8 |
| $ 1,883.0 |
| $ 41.4 |
| $ 774.6 |
| $ 267.2 |
| $ 1,083.2 | |
Adjustments to cost of sales ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Integration and restructuring |
| (9.6) |
| 0.3 |
| - |
| (9.3) |
| - |
| (2.5) |
| - |
| (2.5) |
| Contingent consideration fair value and accretion adjustment |
| (1.1) |
| 0.2 |
| - |
| (0.9) |
| (4.8) |
| (1.4) |
| - |
| (6.2) |
| Operating results of assets held for sale / sold |
| - |
| (28.0) |
| - |
| (28.0) |
| - |
| - |
| - |
| - |
| Operational Excellence Initiative |
| - |
| (8.3) |
| - |
| (8.3) |
| - |
| (17.4) |
| - |
| (17.4) |
| Acquisition accounting fair market value adjustment to stock-based compensation |
| (5.9) |
| - |
| - |
| (5.9) |
| - |
| - |
| - |
| - |
| Purchase accounting adjustments |
| (437.8) |
| (56.1) |
| - |
| (493.9) |
| - |
| - |
| - |
| - |
Adjusted cost of sales |
| $ 251.9 |
| $ 720.0 |
| $ 364.8 |
| $ 1,336.7 |
| $ 36.6 |
| $ 753.3 |
| $ 267.2 |
| $ 1,057.1 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted gross profit |
| 1,367.4 |
| 891.1 |
| 58.4 |
| 2,316.9 |
| 116.8 |
| 799.9 |
| 39.9 |
| 956.6 | |
Adjusted gross margin as a percentage of adjusted net revenues |
| 84.4% |
| 55.3% |
| 13.8% |
| 63.4% |
| 76.1% |
| 51.5% |
| 13.0% |
| 47.5% | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)Cost of sales excludes amortization and impairment of acquired intangibles. | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Nine Months Ended |
| Nine Months Ended | ||||||||||||
|
|
| September 30, 2014 |
| September 30, 2013 | ||||||||||||
(Unaudited; $ in millions) |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net revenues |
| $ 2,800.5 |
| $ 4,964.5 |
| $ 1,240.4 |
| $ 9,005.4 |
| $ 427.4 |
| $ 4,657.0 |
| $ 813.9 |
| $ 5,898.3 | |
Adjustments to net revenue ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Purchase accounting adjustments |
| - |
| 10.3 |
| - |
| 10.3 |
| 0.4 |
| 5.9 |
| - |
| 6.3 |
| Operating results of assets held for sale / sold |
| - |
| (183.8) |
| - |
| (183.8) |
| - |
| - |
| - |
| - |
| Manufacturing and supply contract termination payment |
| - |
| - |
| - |
| - |
| - |
| 5.0 |
| - |
| 5.0 |
Adjusted net revenues |
| $ 2,800.5 |
| $ 4,791.0 |
| $ 1,240.4 |
| $ 8,831.9 |
| $ 427.8 |
| $ 4,667.9 |
| $ 813.9 |
| $ 5,909.6 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales (1): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Cost of Sales |
| $ 1,055.6 |
| $ 2,346.4 |
| $ 1,070.5 |
| $ 4,472.5 |
| $ 105.6 |
| $ 2,414.0 |
| $ 700.5 |
| $ 3,220.1 | |
Adjustments to cost of sales ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Integration and restructuring |
| (14.0) |
| 0.3 |
| - |
| (13.7) |
| - |
| (3.8) |
| - |
| (3.8) |
| Contingent consideration fair value and accretion adjustment |
| (2.1) |
| (6.0) |
| - |
| (8.1) |
| (5.1) |
| (1.4) |
| - |
| (6.5) |
| Operating results of assets held for sale / sold |
| - |
| (144.6) |
| - |
| (144.6) |
| - |
| - |
| - |
| - |
| Operational Excellence Initiative |
| - |
| (30.7) |
| - |
| (30.7) |
| - |
| (44.8) |
| - |
| (44.8) |
| Acquisition accounting fair market value adjustment to stock-based compensation |
| (5.9) |
| - |
| - |
| (5.9) |
|
|
|
|
|
|
|
|
| Purchase accounting adjustments |
| (635.9) |
| (68.0) |
| - |
| (703.9) |
| - |
| (93.5) |
| - |
| (93.5) |
Adjusted cost of sales |
| $ 397.7 |
| $ 2,097.4 |
| $ 1,070.5 |
| $ 3,565.6 |
| $ 100.5 |
| $ 2,270.5 |
| $ 700.5 |
| $ 3,071.5 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted gross profit |
| 2,402.8 |
| 2,693.6 |
| 169.9 |
| 5,266.3 |
| 327.3 |
| 2,397.4 |
| 113.4 |
| 2,838.1 | |
Adjusted gross margin as a percentage of adjusted net revenues |
| 85.8% |
| 56.2% |
| 13.7% |
| 59.6% |
| 76.5% |
| 51.4% |
| 13.9% |
| 48.0% | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)Cost of sales excludes amortization and impairment of acquired intangibles. |
The following table presents a reconciliation of reported net revenues and SG&A expenses by segment for the three and nine months ended September 30, 2014 and 2013 to adjusted net revenues, adjusted SG&A expenses, adjusted SG&A as a percentage of adjusted net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Table 8 |
|
|
ACTAVIS PLC | |||||||||||||||||
ADJUSTED SG&A AS A PERCENTAGE OF ADJUSTED NET REVENUES | |||||||||||||||||
| |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Three Months Ended | ||||||||||||
|
|
| September 30, 2014 |
| September 30, 2013 | ||||||||||||
(Unaudited; $ in millions) |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net revenues |
| $ 1,619.3 |
| $ 1,640.6 |
| $ 423.2 |
| $ 3,683.1 |
| $ 153.0 |
| $ 1,552.9 |
| $ 307.1 |
| $ 2,013.0 | |
Adjustments to net revenue ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Purchase accounting adjustments |
| - |
| 4.8 |
| - |
| 4.8 |
| 0.4 |
| 0.3 |
| - |
| 0.7 |
| Operating results of assets held for sale / sold |
| - |
| (34.3) |
| - |
| (34.3) |
| - |
| - |
| - |
| - |
| Manufacturing and supply contract termination payment |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
Adjusted net revenues |
| $ 1,619.3 |
| $ 1,611.1 |
| $ 423.2 |
| $ 3,653.6 |
| $ 153.4 |
| $ 1,553.2 |
| $ 307.1 |
| $ 2,013.7 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SG&A: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
SG&A |
| $ 880.3 |
| $ 356.3 |
| $ 37.9 |
| $ 1,274.5 |
| $ 78.9 |
| $ 344.5 |
| $ 32.3 |
| $ 455.7 | |
Adjustments to SG&A ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Legal matters |
| 9.7 |
| 0.3 |
| - |
| 10.0 |
| - |
| (15.0) |
| - |
| (15.0) |
| Acquisition, integration & restructuring expenses |
| (110.9) |
| (5.2) |
| - |
| (116.1) |
| - |
| (10.2) |
| - |
| (10.2) |
| Pending acquisition related costs |
| (31.3) |
| (12.8) |
| - |
| (44.1) |
| (20.7) |
| (20.6) |
| - |
| (41.3) |
| U.S. Branded Pharma fee |
| (105.0) |
| (10.8) |
| - |
| (115.8) |
| - |
| - |
| - |
| - |
| Other |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| Global supply chain initiative accelerated depreciation and severance costs |
| - |
| - |
| - |
| - |
| - |
| (0.2) |
| - |
| (0.2) |
| Contract termination payments |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| Operating results for assets held for sale / sold |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| Acquisition accounting fair market value adjustment to stock-based compensation |
| (161.7) |
| - |
| - |
| (161.7) |
| - |
| - |
| - |
| - |
| Costs associated with holding assets out for sale |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
| - |
Adjusted SG&A |
| $ 481.1 |
| $ 327.8 |
| $ 37.9 |
| $ 846.8 |
| $ 58.2 |
| $ 298.5 |
| $ 32.3 |
| $ 389.0 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted SG&A as a percentage of adjusted net revenues |
| 29.7% |
| 20.3% |
| 9.0% |
| 23.2% |
| 37.9% |
| 19.2% |
| 10.5% |
| 19.3% | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Nine Months Ended |
| Nine Months Ended | ||||||||||||
|
|
| September 30, 2014 |
| September 30, 2013 | ||||||||||||
(Unaudited; $ in millions) |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total |
| North American Brands |
| North American Generics and International |
| Anda Distribution |
| Total | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net revenues |
| $ 2,800.5 |
| $ 4,964.5 |
| $ 1,240.4 |
| $ 9,005.4 |
| $ 427.4 |
| $ 4,657.0 |
| $ 813.9 |
| $ 5,898.3 | |
Adjustments to net revenue ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Purchase accounting adjustments |
| - |
| 10.3 |
| - |
| 10.3 |
| 0.4 |
| 5.9 |
| - |
| 6.3 |
| Operating results of assets held for sale / sold |
| - |
| (183.8) |
| - |
| (183.8) |
| - |
| - |
| - |
| - |
| Manufacturing and supply contract termination payment |
| - |
| - |
| - |
| - |
| - |
| 5.0 |
| - |
| 5.0 |
Adjusted net revenues |
| $ 2,800.5 |
| $ 4,791.0 |
| $ 1,240.4 |
| $ 8,831.9 |
| $ 427.8 |
| $ 4,667.9 |
| $ 813.9 |
| $ 5,909.6 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SG&A: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
SG&A |
| $ 1,224.7 |
| $ 1,061.6 |
| $ 108.7 |
| $ 2,395.0 |
| $ 215.5 |
| $ 1,024.4 |
| $ 90.2 |
| $ 1,330.1 | |
Adjustments to SG&A ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Legal matters |
| 7.5 |
| 1.0 |
| - |
| 8.5 |
| - |
| (45.8) |
| - |
| (45.8) |
| Acquisition, integration & restructuring expenses |
| (130.7) |
| (32.1) |
| - |
| (162.8) |
| (22.6) |
| (30.3) |
| - |
| (52.9) |
| Acquisition related expenses |
| (68.2) |
| (12.8) |
| - |
| (81.0) |
| (20.7) |
| (20.6) |
| - |
| (41.3) |
| U.S. Branded Pharma fee |
| (105.0) |
| (10.8) |
| - |
| (115.8) |
| - |
| - |
| - |
| - |
| Other |
| - |
| 1.4 |
| - |
| 1.4 |
| - |
| - |
| - |
| - |
| Global supply chain initiative accelerated depreciation and severance costs |
| - |
| (6.4) |
| - |
| (6.4) |
| - |
| (2.8) |
| - |
| (2.8) |
| Contract termination payments |
| (10.0) |
| - |
| - |
| (10.0) |
| - |
| - |
| - |
| - |
| Operating results for assets held for sale / sold |
| - |
| (33.5) |
| - |
| (33.5) |
| - |
| - |
| - |
| - |
| Acquisition accounting fair market value adjustment to stock-based compensation |
| (161.7) |
| - |
| - |
| (161.7) |
| - |
| - |
| - |
| - |
| Costs associated with holding assets out for sale |
| - |
| (5.7) |
| - |
| (5.7) |
| - |
| - |
| - |
| - |
Adjusted SG&A |
| $ 756.6 |
| $ 962.7 |
| $ 108.7 |
| $ 1,828.0 |
| $ 172.2 |
| $ 924.9 |
| $ 90.2 |
| $ 1,187.3 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted SG&A as a percentage of adjusted net revenues |
| 27.0% |
| 20.1% |
| 8.8% |
| 20.7% |
| 40.3% |
| 19.8% |
| 11.1% |
| 20.1% |
The following table presents a reconciliation of expected GAAP Research & Development expense to adjusted Research & Development expense for the three and nine months ended September 30, 2014:
ACTAVIS PLC | |||||||||||||||
ADJUSTED R&D EXPENSE | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Table 9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended September 30, 2014 |
| Nine Months Ended September 30, 2014 | ||||||||||||
(Unaudited; $ in millions) | Generic Development |
| Brand Development |
| Biosimilar Development |
| Total |
| Generic Development |
| Brand Development |
| Biosimilar Development |
| Total |
Research and Development expense | $ 115.3 |
| $ 248.0 |
| $ 28.5 |
| $ 391.8 |
| $ 353.5 |
| $ 290.6 |
| $ 77.2 |
| $ 721.3 |
Adjustments to research and development ((remove from) / add to) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustments | - |
| 1.3 |
| - |
| 1.3 |
| - |
| 19.3 |
| - |
| 19.3 |
Write-off of contingent consideration | - |
| - |
| - |
| - |
| - |
| 24.7 |
| - |
| 24.7 |
Integration and restructuring expenses | - |
| - |
| - |
| - |
| (0.3) |
| - |
| - |
| (0.3) |
Accretion expense | - |
| (4.2) |
| - |
| (4.2) |
| - |
| (11.4) |
| - |
| (11.4) |
Operating results for assets held for sale | - |
| - |
| - |
| - |
| (2.7) |
| - |
| - |
| (2.7) |
Brand related milestone payments | - |
| (17.1) |
| - |
| (17.1) |
| - |
| (17.1) |
| - |
| (17.1) |
Accelerated depreciation and product transfer costs | - |
| - |
| - |
| - |
| (1.5) |
| - |
| - |
| (1.5) |
Acquisition, integration & restructuring expenses | (0.9) |
| (18.2) |
| - |
| (19.1) |
| (1.7) |
| (18.2) |
| - |
| (19.9) |
Acquisition accounting fair market value adjustment to stock-based compensation | - |
| (46.1) |
| - |
| (46.1) |
| - |
| (46.1) |
| - |
| (46.1) |
Acquisition related settlements | - |
| - |
| - |
| - |
| - |
| (0.3) |
| - |
| (0.3) |
Adjusted research and development expense | $ 114.4 |
| $ 163.7 |
| $ 28.5 |
| $ 306.6 |
| $ 347.3 |
| $ 241.5 |
| $ 77.2 |
| $ 666.0 |
The following table presents a reconciliation of expected adjusted earnings per share with expected GAAP earnings per share for the six months ending December 31, 2014:
|
|
|
|
|
| Table 10 |
|
|
|
|
|
|
|
|
|
| Six Months Ending December 31, 2014 |
| ||
(Unaudited; $ in millions) |
| Low |
| High |
| |
|
|
|
|
|
|
|
GAAP to non-GAAP net income calculation |
|
|
|
|
| |
|
|
|
|
|
|
|
| Expected GAAP net (loss) attributable to
|
| (1,249.5) |
| (1,222.7) |
|
| Adjusted for: |
|
|
|
|
|
| Amortization |
| 1,747.1 |
| 1,747.1 |
|
| Global supply chain initiative(1) |
| 13.3 |
| 13.3 |
|
| Acquisition and licensing charges (2) |
| 1,329.1 |
| 1,329.1 |
|
| Accretion on contingent liabilities |
| 10.2 |
| 10.2 |
|
| Impairment/asset sales and related costs |
| 303.5 |
| 303.5 |
|
| Non-recurring losses (gains) |
| 85.9 |
| 85.9 |
|
| Legal settlements |
| (10.0) |
| (10.0) |
|
| Income taxes on items above |
| (459.5) |
| (459.5) |
|
| Non-GAAP net income attributable to
|
| 1,770.1 |
| 1,796.9 |
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
|
|
|
| |
|
|
|
|
|
|
|
| Diluted earnings (loss) per share - GAAP |
| $ (4.72) |
| $ (4.62) |
|
|
|
|
|
|
|
|
| Diluted earnings per share - Non-GAAP |
| $ 6.60 |
| $ 6.70 |
|
|
|
|
|
|
|
|
| Basic weighted average ordinary shares outstanding |
| 264.8 |
| 264.8 |
|
| Effect of dilutive securities: |
|
|
|
|
|
| Dilutive share-based compensation arrangements |
| 3.4 |
| 3.4 |
|
| Diluted weighted average ordinary shares outstanding |
| 268.2 |
| 268.2 |
|
|
|
|
|
|
|
|
(1) | Includes accelerated depreciation charges. | |||||
|
|
|
|
|
|
|
(2) | Includes stock-based compensation. |
The following table presents a reconciliation of expected adjusted earnings per share with expected GAAP earnings per share for the twelve months ending December 31, 2014:
|
|
|
|
|
| Table 11 |
|
|
|
|
|
|
|
|
|
|
|
| Twelve Months Ending December 31, 2014 |
|
| ||
(Unaudited; $ in millions) |
| Low |
| High |
|
| |
|
|
|
|
|
|
|
|
GAAP to non-GAAP net income calculation |
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| Expected GAAP net (loss) attributable to
|
| (1,091.0) |
| (1,068.9) |
|
|
| Adjusted for: |
|
|
|
|
|
|
| Amortization |
| 2,594.2 |
| 2,594.2 |
|
|
| Global supply chain initiative(1) |
| 43.6 |
| 43.6 |
|
|
| Acquisition and licensing charges (2) |
| 1,639.1 |
| 1,639.1 |
|
|
| Accretion on contingent liabilities |
| 18.6 |
| 18.6 |
|
|
| Impairment/asset sales and related costs |
| 326.1 |
| 326.1 |
|
|
| Non-recurring losses (gains) |
| 84.5 |
| 84.5 |
|
|
| Legal settlements |
| (8.5) |
| (8.5) |
|
|
| Income taxes on items above |
| (614.1) |
| (614.1) |
|
|
| Non-GAAP net income attributable to
|
| 2,992.5 |
| 3,014.6 |
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| Diluted earnings (loss) per share - GAAP |
| (4.96) |
| (4.86) |
|
|
|
|
|
|
|
|
|
|
| Diluted earnings per share - Non-GAAP |
| 13.51 |
| 13.61 |
|
|
|
|
|
|
|
|
|
|
| Basic weighted average common shares outstanding |
| 219.9 |
| 219.9 |
|
|
| Effect of dilutive securities: |
|
|
|
|
|
|
| Dilutive share-based compensation arrangements |
| 1.6 |
| 1.6 |
|
|
| Diluted weighted average common shares outstanding |
| 221.5 |
| 221.5 |
|
|
|
|
|
|
|
|
|
|
(1) | Includes accelerated depreciation charges. | ||||||
|
|
|
|
|
|
|
|
(2) | Includes stock-based compensation. |
The following table presents a reconciliation of expected GAAP Research & Development expense to adjusted Research & Development expense for the six months ending December 31, 2014:
| Table 12 |
|
|
(Unaudited; $ in millions) | Six Months Ended December 31, 2014 |
Research and Development | 734.2 |
Adjustments to research and development ((remove from) / add to) |
|
Contingent consideration fair value adjustments | 1.3 |
Accretion expense | (8.4) |
Brand related milestone payments | (17.1) |
Acquisition, integration & restructuring expenses | (19.8) |
Acquisition accounting fair market value adjustment to stock-based
| (46.1) |
Adjusted research and development | 644.1 |
The following table presents a reconciliation of expected GAAP SG&A expense to adjusted SG&A expense for the six months ending December 31, 2014:
|
| Table 13 |
|
|
|
(Unaudited; $ in millions) | Six Months Ended December 31, 2014 | |
Selling, general and administrative ("SG&A") | 2,288.8 | |
Adjustments to SG&A ((remove from) / add to) |
| |
| Legal matters | 10.0 |
| Acquisition, integration & restructuring expenses | (162.9) |
| Pending acquisition related costs | (44.1) |
| US Branded Pharma fee | (115.8) |
| Acquisition accounting fair market value adjustment to stock-based compensation | (283.4) |
Adjusted SG&A | 1,692.6 |
Non-GAAP adjustments
A complete reconciliation from GAAP financials to non-GAAP financials for the third quarter and first nine months of 2014 will be available on the Actavis Investor Relations website (ir.actavis.com) under the "Financial Information" and "Quarterly Results" subheadings.
CONTACTS: | Investors: |
| Lisa DeFrancesco |
| (862) 261-7152 |
|
|
| Media: |
| Charlie Mayr |
| (862) 261-8030 |
|
|
| David Belian |
| (862) 261-8141 |