EXHIBIT 99.1
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News Release
Fresenius Kabi Pharmaceuticals Holding, Inc.
Releases Third Quarter Results
SCHAUMBURG, Ill.—Nov. 4, 2008 – Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ: APCVZ) (“FKP Holdings”) the newly formed holding company that acquired APP Pharmaceuticals, Inc. (“APP”) on September 10, 2008, today released financial results for the third quarter and for the nine months ended September 30, 2008. These results include APP’s results for the portion of the third quarter and the nine-month period prior to the closing of the acquisition and FKP Holdings’ results from July 2, 2008 through September 30, 2008, which also includes the results of operations of APP post acquisition.
Third quarter revenues were $198 million, a 29 percent increase over APP’s revenue of $153 million for the same period in 2007. Revenues for the nine-month period ended September 30, 2008 were $544 million, a 20 percent increase over APP’s revenue of $453 million for the same period in 2007.
For the third quarter, net loss was $242 million, as compared to a net loss of $8 million for APP in the third quarter of 2007, after inclusion of a net loss from discontinued operations of $22 million in 2007. Net loss for the nine-month period ended September 30, 2008 was $209 million compared to APP’s net income of $26 million for the same period in 2007, after inclusion of a net loss from discontinued operations of $25 million during 2007. Excluding acquisition and separation related charges net income for the quarter was $21 million and $56 million for the nine-month period ended September 30, 2008.
For the third quarter and for the nine months ending September 30, 2008, Adjusted EBITDA, as defined in the indenture governing the Contingent Value Rights (CVRs) of FKP Holdings, was $87 million and $217 million, respectively.
Revenue guidance for 2008 has been modified to be between $765 million and $785 million and Adjusted EBITDA guidance for 2008 has been modified to be between $315 million and $325 million. Guidance previously provided by APP was revenue between $800 million and $820 million and Adjusted EBITDA between $325 million and $350 million. The components of Adjusted EBITDA are reflected in APP’s 2nd quarter earnings release filed on July 31, 2008 and changes in guidance primarily related to Adjusted EBITDA result from changes in the revenue guidance noted above.
On a going forward basis, the financial results for FKP Holdings will not be reported in an earnings release and will be reported in FKP Holdings’ filings with the Securities and Exchange Commission.
Use of Non-GAAP Financial Measures
Amounts reported on a combined basis (i.e., including both the successor and predecessor periods) above and in the accompanying tables are non-GAAP measures and should not be considered in isolation of, or as a substitute for, the discrete information prepared and presented for the predecessor and successor periods in accordance with GAAP. Similarly, Adjusted EBITDA is a defined term in the indenture governing the Contingent Value Rights (CVRs), however it is not a recognized term under GAAP and should not be considered in isolation of, or as a substitute for, the information prepared and presented in accordance with GAAP. Because not all companies calculate Adjusted EBITDA identically, FKP Holdings’ definition of adjusted EBITDA may not be comparable to similarly titled measures of other companies. The attached financial pages provide a reconciliation of net income to Adjusted EBITDA.
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About Fresenius SE
Fresenius SE is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2007, group sales were approximately EUR 11.4 billion. On June 30, 2008 the Fresenius Group had 117,453 employees worldwide. For more information visit the company’s website at www.fresenius.com.
About Fresenius Kabi Pharmaceuticals Holding, Inc.
Fresenius Kabi Pharmaceuticals Holdings, a wholly owned subsidiary of Fresenius SE, acquired the Schaumburg, Illinois-based APP Pharmaceuticals on September 10, 2008. Under the terms of the agreement, Fresenius acquired the outstanding common stock of APP for $23.00 in cash per share plus a Contingent Value Right that could deliver up to an additional $6.00 per CVR in cash, pending achievement of certain financial targets (payable in Q2 2011).
About APP Pharmaceuticals
APP is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations.
Forward-Looking Statement
The statements contained in this news release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding financial guidance for 2008. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the continued market acceptance and demand of new and existing products; the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing of the company’s products; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in Fresenius Kabi Pharmaceuticals Holding’s prospectus dated August 20, 2008 and other documents it has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of this release. Fresenius Kabi Pharmaceuticals Holding assumes no obligations to update any forward-looking statements contained in this news release as the result of new information or future events or developments.
CONTACT: Investor and Media Inquiries:
Christine Cassiano
Hill & Knowlton
(310) 633-9495
Fresenius SE
Investor Inquiries:
Fresenius SE Birgit Grund, Senior Vice President
++49 6172 608 2485
On September 10, 2008, APP Pharmaceuticals, Inc. (“APP”) closed an Agreement and Plan of Merger entered into on July 6, 2008, with Fresenius SE and certain of its direct and indirect subsidiaries pursuant to which APP became a wholly-owned operating subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (“FKP Holdings or the Company”), which is a wholly owned subsidiary of Fresenius SE. For accounting purposes the Company has separated its historical financial results for the Predecessor Company (APP) for all periods prior to September 10, 2008, the effective date of the merger, and the Successor Company (FKP Holdings) for all periods after July 2, 2008, which include the results of APP from September 10, 2008. The separate presentation is required as there was a change in accounting basis, which occurred when purchase accounting was applied to the acquisition of the Predecessor. Purchase accounting requires that the historical carrying value of assets acquired and liabilities assumed be adjusted to fair
FRESENIUS KABI PHARMACEUTICALS HOLDING, INC.
CONSOLIDATED RESULTS OF OPERATIONS
(Unaudited, in thousands)
| | | | | | | | | | | | | | | | | | | | | | | |
| | Three months Ending September 30, 2008 | | | July 2 through September 30, 2008 | | | July 1 through September 9 2008 | | | Three months Ending September 30, 2007 | | | Change Favorable (Unfavorable) (Unfavorable) | |
| | | | | | $ | | | % | |
| | Combined | | | (Successor) | | | (Predecessor) | | | (Predecessor) | | | | | | | |
Revenues | | | | | | | | | | | | | | | | | | | | | | | |
Critical care | | $ | 129,614 | | | $ | 29,606 | | | $ | 100,008 | | | $ | 91,584 | | | $ | 38,030 | | | 42 | % |
Anti-infective | | | 53,815 | | | | 13,792 | | | | 40,023 | | | | 43,032 | | | | 10,783 | | | 25 | % |
Oncology | | | 11,463 | | | | 4,294 | | | | 7,169 | | | | 14,073 | | | | (2,610 | ) | | -19 | % |
Contract manufacturing and other | | | 2,988 | | | | 388 | | | | 2,600 | | | | 4,490 | | | | (1,502 | ) | | -33 | % |
| | | | | | | | | | | | | | | | | | | | | | | |
Total revenue | | | 197,880 | | | | 48,080 | | | | 149,800 | | | | 153,179 | | | | 44,701 | | | 29 | % |
Cost of sales | | | 90,642 | | | | 22,190 | | | | 68,452 | | | | 85,055 | | | | 5,587 | | | 7 | % |
Amortization of inventory step-up | | | 12,588 | | | | 12,588 | | | | — | | | | — | | | | 12,588 | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Gross profit | | | 94,650 | | | | 13,302 | | | | 81,348 | | | | 68,124 | | | | 26,526 | | | 39 | % |
| | | | | | | | | | | | | | | | | | | | | | | |
Percent to total revenue | | | 47.8 | % | | | 27.7 | % | | | 54.3 | % | | | 44.5 | % | | | | | | | |
Research and development | | | 11,036 | | | | 2,066 | | | | 8,970 | | | | 11,351 | | | | (315 | ) | | -3 | % |
Selling, general and administrative | | | 23,813 | | | | 5,508 | | | | 18,305 | | | | 22,061 | | | | 1,752 | | | 8 | % |
Amortization of in-process R&D | | | 252,000 | | | | 252,000 | | | | — | | | | — | | | | 252,000 | | | — | |
Amortization of merger related intangibles | | | 5,960 | | | | 3,389 | | | | 2,571 | | | | 3,856 | | | | 2,104 | | | 55 | % |
Separation costs | | | 235 | | | | — | | | | 235 | | | | 352 | | | | (117 | ) | | -33 | % |
Merger related costs | | | 44,799 | | | | 1,188 | | | | 43,611 | | | | — | | | | 44,799 | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Total operating expenses | | | 337,843 | | | | 264,151 | | | | 73,692 | | | | 37,620 | | | | 300,223 | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Percent to total revenue | | | 170.7 | % | | | 549.4 | % | | | 49.2 | % | | | 24.6 | % | | | | | | | |
(Loss) income from operations | | | (243,193 | ) | | | (250,849 | ) | | | 7,656 | | | | 30,504 | | | | (273,697 | ) | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Percent to total revenue | | | -122.9 | % | | | -521.7 | % | | | 5.1 | % | | | 19.9 | % | | | | | | | |
Interest income and other | | | 215 | | | | (16 | ) | | | 231 | | | | 886 | | | | (671 | ) | | -76 | % |
Gain on contingent value right | | | 52,241 | | | | 52,241 | | | | — | | | | — | | | | 52,241 | | | | |
Interest expense | | | (42,363 | ) | | | (27,866 | ) | | | (14,497 | ) | | | (3,831 | ) | | | (38,532 | ) | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
(Loss) income from continuing operations before income taxes | | | (233,100 | ) | | | (226,490 | ) | | | (6,610 | ) | | | 27,559 | | | | (260,659 | ) | | — | |
Income tax (benefit) expense | | | 8,761 | | | | (8,135 | ) | | | 16,896 | | | | 13,449 | | | | (4,688 | ) | | -35 | % |
| | | | | | | | | | | | | | | | | | | | | | | |
Net (loss) income from continuing operations | | $ | (241,861 | ) | | $ | (218,355 | ) | | $ | (23,506 | ) | | $ | 14,110 | | | $ | (255,971 | ) | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Net loss from discontinued operations, net of taxes | | | — | | | | — | | | | — | | | | (22,495 | ) | | | 22,495 | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Net (loss) income | | $ | (241,861 | ) | | $ | (218,355 | ) | | $ | (23,506 | ) | | $ | (8,385 | ) | | $ | (233,476 | ) | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Selected ratios as a percentage of total net revenues: | | | | | | | | | | | | | | | | | | | | | | | |
Research and development | | | 5.6 | % | | | 4.3 | % | | | 6.0 | % | | | 7.4 | % | | | | | | | |
Selling, general and administrative | | | 12.0 | % | | | 11.5 | % | | | 12.2 | % | | | 14.4 | % | | | | | | | |
On September 10, 2008, APP Pharmaceuticals, Inc. (“APP”) closed an Agreement and Plan of Merger entered into on July 6, 2008, with Fresenius SE and certain of its direct and indirect subsidiaries pursuant to which APP became a wholly-owned operating subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (“FKP Holdings or the Company”), which is a wholly owned subsidiary of Fresenius SE. For accounting purposes the Company has separated its historical financial results for the Predecessor Company (APP) for all periods prior to September 10, 2008, the effective date of the merger, and the Successor Company (FKP Holdings) for all periods after July 2, 2008, which include the results of APP from September 10, 2008. The separate presentation is required as there was a change in accounting basis, which occurred when purchase accounting was applied to the acquisition of the Predecessor. Purchase accounting requires that the historical carrying value of assets acquired and liabilities assumed be adjusted to fair
FRESENIUS KABI PHARMACEUTICALS HOLDING, INC.
CONSOLIDATED RESULTS OF OPERATIONS
(Unaudited, in thousands)
| | | | | | | | | | | | | | | | | | | | | | | | |
| | Nine months Ending September 30, 2008 | | | July 2 through September 30, 2008 | | | January 1 through September 9 2008 | | | Nine months Ending September 30, 2007 | | | Change Favorable (Unfavorable) (Unfavorable) | |
| | | | | | $ | | | % | |
| | Combined | | | (Successor) | | | (Predecessor) | | | (Predecessor) | | | | | | | |
Revenues | | | | | | | | | | | | | | | | | | | | | | | | |
Critical care | | $ | 334,328 | | | $ | 29,606 | | | $ | 304,722 | | | $ | 265,858 | | | $ | 68,470 | | | | 26 | % |
Anti-infective | | | 156,071 | | | | 13,792 | | | | 142,279 | | | | 133,561 | | | | 22,510 | | | | 17 | % |
Oncology | | | 44,210 | | | | 4,294 | | | | 39,916 | | | | 39,927 | | | | 4,283 | | | | 11 | % |
Contract manufacturing and other | | | 9,268 | | | | 388 | | | | 8,880 | | | | 13,428 | | | | (4,160 | ) | | | -31 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total revenue | | | 543,877 | | | | 48,080 | | | | 495,797 | | | | 452,774 | | | | 91,103 | | | | 20 | % |
Cost of sales | | | 269,827 | | | | 22,190 | | | | 247,637 | | | | 239,063 | | | | 30,764 | | | | 13 | % |
Amortization of inventory step-up | | | 12,588 | | | | 12,588 | | | | — | | | | — | | | | 12,588 | | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Gross profit | | | 261,462 | | | | 13,302 | | | | 248,160 | | | | 213,711 | | | | 47,751 | | | | 22 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
Percent to total revenue | | | 48.1 | % | | | 27.7 | % | | | 50.1 | % | | | 47.2 | % | | | | | | | | |
Research and development | | | 37,199 | | | | 2,066 | | | | 35,133 | | | | 33,994 | | | | 3,205 | | | | 9 | % |
Selling, general and administrative | | | 69,013 | | | | 5,508 | | | | 63,505 | | | | 66,800 | | | | 2,213 | | | | 3 | % |
Amortization of in-process R&D | | | 252,000 | | | | 252,000 | | | | — | | | | — | | | | 252,000 | | | | — | |
Amortization of merger related intangibles | | | 13,672 | | | | 3,389 | | | | 10,283 | | | | 11,568 | | | | 2,104 | | | | 18 | % |
Separation costs | | | 2,239 | | | | — | | | | 2,239 | | | | 1,056 | | | | 1,183 | | | | 112 | % |
Merger related costs | | | 44,799 | | | | 1,188 | | | | 43,611 | | | | — | | | | 44,799 | | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Total operating expenses | | | 418,922 | | | | 264,151 | | | | 154,771 | | | | 113,418 | | | | 305,504 | | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Percent to total revenue | | | 77.0 | % | | | 549.4 | % | | | 31.2 | % | | | 25.0 | % | | | | | | | | |
(Loss) income from operations | | | (157,460 | ) | | | (250,849 | ) | | | 93,389 | | | | 100,293 | | | | (257,753 | ) | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Percent to total revenue | | | -29.0 | % | | | -521.7 | % | | | 18.8 | % | | | 22.2 | % | | | | | | | | |
Interest income and other | | | 1,577 | | | | (16 | ) | | | 1,593 | | | | 1,816 | | | | (239 | ) | | | -13 | % |
Gain on contingent value right | | | 52,241 | | | | 52,241 | | | | — | | | | — | | | | 52,241 | | | | — | |
Interest expense | | | (72,990 | ) | | | (27,866 | ) | | | (45,124 | ) | | | (12,747 | ) | | | (60,243 | ) | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
(Loss) income from continuing operations before income taxes | | | (176,632 | ) | | | (226,490 | ) | | | 49,858 | | | | 89,362 | | | | (265,994 | ) | | | — | |
Income tax (benefit) expense from continuing | | | | | | | | | | | | | | | | | | | | | | | | |
operations | | | 32,180 | | | | (8,135 | ) | | | 40,315 | | | | 38,843 | | | | (6,663 | ) | | | -17 | % |
| | | | | | | | | | | | | | | | | | | | | | | | |
Net income from continuing operations | | $ | (208,812 | ) | | $ | (218,355 | ) | | $ | 9,543 | | | $ | 50,519 | | | $ | (259,331 | ) | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Net loss from discontinued operations, net of taxes | | | — | | | | — | | | | — | | | | (24,693 | ) | | | 24,693 | | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Net (loss) income | | $ | (208,812 | ) | | $ | (218,355 | ) | | $ | 9,543 | | | $ | 25,826 | | | $ | (234,638 | ) | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | |
Selected ratios as a percentage of total net revenues: | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development | | | 6.8 | % | | | 4.3 | % | | | 7.1 | % | | | 7.5 | % | | | | | | | | |
Selling, general and administrative | | | 12.7 | % | | | 11.5 | % | | | 12.8 | % | | | 14.8 | % | | | | | | | | |
FRESENIUS KABI PHARMACEUTICALS HOLDING, INC.
Reconciliation of Net Income to Adjusted EBITDA per the CVR Agreement
Three and Nine Months Ended September 30, 2008
(unaudited, in thousands)
The CVR (Contingent Value Rights) agreement defines Adjusted EBITDA, including both the predecessor and successor periods as: net income, excluding the impact of depreciation and amortization, interest expense net of interest income, income tax expense, non-cash stock-based compensation expense, separation related costs, pre-launch costs associated with Puerto Rico manufacturing facility, other taxes, technology transfer costs, the gain or loss on the sale of fixed assets and gains or losses on our contingent value rights and other items and limitations as defined in the CVR Indenture. The amount payable on June 30, 2011 will be determined based on the Adjusted EBITDA of the Company and its predecessor over the three year period ended December 31, 2010. However, Adjusted EBITDA is not a recognized term under GAAP and should not be considered in isolation of, or as a substitute for, the information prepared and presented in accordance with GAAP. Because not all companies calculate Adjusted EBITDA identically, the definition of Adjusted EBITDA may not be comparable to similarly titled measures of other companies. Adjusted EBITDA for the three and nine months ended September 30, 2008 is as follows:
| | | | | | | | |
| | Three months | | | Nine months | |
Net loss | | $ | (241,861 | ) | | $ | (208,812 | ) |
Depreciation | | | 4,875 | | | | 14,132 | |
Amortization | | | 273,329 | | | | 289,333 | |
Interest expense, net of interest income | | | 42,003 | | | | 71,881 | |
Provision for income taxes | | | 8,761 | | | | 32,180 | |
| | | | | | | | |
EBITDA | | | 87,107 | | | | 198,714 | |
| | |
Stock-based compensation expense | | | 1,237 | | | | 5,750 | |
Puerto Rico pre-launch costs, net of depreciation | | | 5,144 | | | | 16,500 | |
(Gain) on CVR | | | (52,241 | ) | | | (52,241 | ) |
Separation, merger and other non-recurring costs | | | 44,799 | | | | 46,408 | |
Other taxes | | | 486 | | | | 908 | |
Other non-cash charges | | | 165 | | | | 495 | |
Technology transfer | | | 14 | | | | 119 | |
Loss on sale of fixed assets | | | 27 | | | | 73 | |
| | | | | | | | |
Adjusted EBITDA | | $ | 86,738 | | | $ | 216,726 | |
| | | | | | | | |
FRESENIUS KABI PHARMACEUTICALS HOLDING, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
| | | | | | | |
| | Successor September 30, 2008 | | Predecessor December 31, 2007 | |
| | (in thousands) | |
Assets | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 2,994 | | $ | 31,788 | |
Accounts receivable, net | | | 78,637 | | | 85,209 | |
Inventories | | | 220,408 | | | 149,191 | |
Prepaid expenses and other current assets | | | 13,354 | | | 13,531 | |
Current receivables from related parties | | | — | | | 6,996 | |
Income taxes receivable | | | 23,734 | | | — | |
Deferred income taxes | | | 11,479 | | | 17,109 | |
| | | | | | | |
Total current assets | | | 350,606 | | | 303,824 | |
Property, plant and equipment, net | | | 143,970 | | | 132,528 | |
Intangible assets, net | | | 606,611 | | | 463,154 | |
Goodwill | | | 3,731,172 | | | 160,239 | |
Deferred financing costs and other non-current assets, net | | | 114,989 | | | 17,842 | |
| | | | | | | |
Total assets | | $ | 4,947,348 | | $ | 1,077,587 | |
| | | | | | | |
| | |
Liabilities and stockholders' equity (deficit) | | | | | | | |
Current liabilities: | | | | | | | |
Accounts payable | | $ | 37,791 | | $ | 36,502 | |
Accrued liabilities | | | 43,260 | | | 45,595 | |
Current payables from related parties | | | 9,580 | | | — | |
Short term portion of debt | | | 17,231 | | | 5,000 | |
| | | | | | | |
Total current liabilities | | | 107,862 | | | 87,097 | |
| | | | | | | |
Long-term debt | | | 980,269 | | | 995,000 | |
Deferred income taxes, non-current | | | 145,401 | | | 71,011 | |
Payable to parent company | | | 2,922,601 | | | — | |
Other non-current liabilities | | | 109,563 | | | 4,250 | |
| | | | | | | |
Total liabilities | | | 4,265,696 | | | 1,157,358 | |
| | | | | | | |
| | |
Stockholders' equity (deficit) | | | 681,652 | | | (79,771 | ) |
| | | | | | | |
Total liabilities and stockholders' equity | | $ | 4,947,348 | | $ | 1,077,587 | |
| | | | | | | |