Full Press Release Details
NORTH CHICAGO, Ill. , Oct. 25, 2013 /PRNewswire/ --
AbbVie (NYSE: ABBV ) today announced financial results for the third quarter ended Sept. 30, 2013 .
"Our third-quarter performance demonstrates the strength and durability of our product portfolio and the continued execution of our key strategic priorities as an independent biopharmaceutical company," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Our mid- to late-stage pipeline contains a number of potentially significant opportunities, and we look forward to a series of milestones across our pipeline in the coming months."
Third-Quarter Results
Key Events from the Third Quarter
Raising Full-Year 2013 Outlook
AbbVie is raising its diluted earnings-per-share guidance for the full-year 2013 to $3.11 to $3.13 (from $3.07 to $3.13 ) on an adjusted basis, or $2.54 to $2.56 on a GAAP basis. The company's 2013 adjusted diluted earnings-per-share guidance excludes $0.57 per share of intangible asset amortization expense, acquired in-process research and development, and other specified items primarily associated with certain separation-related costs and ongoing restructuring activities.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. In 2013, AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com . Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Conference Call
AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our third-quarter performance. Participating on the call will be Rick Gonzalez , chairman and chief executive officer; Bill Chase, executive vice president and chief financial officer; Laura Schumacher, executive vice president of business development, external affairs and general counsel; Scott Brun , vice president of clinical development; and Larry Peepo , vice president of investor relations. The call will be webcast through AbbVie's Investor Relations Web site at www.abbvieinvestor.com . An archived edition of the call will be available after 11:00 a.m. Central time .
Non-GAAP Financial Results
Financial results for 2013 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company's 2013 financial guidance is also being provided on both a reported and a non-GAAP basis.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2012 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
| AbbVie Inc. Key Product Sales Quarter Ended September 30, 2013 (Unaudited) | ||||||||
| % Change vs. 3Q12 | ||||||||
| Sales (in millions) | International | Total | ||||||
| U.S. | Int'l. | Total | U.S. | Operational | Reported | Operational | Reported | |
| TOTAL SALES | $2,616 | $2,042 | $4,658 | (1.8%) | 11.6% | 10.8% | 3.6% | 3.3% |
| Humira | 1,389 | 1,381 | 2,770 | 22.3 | 16.0 | 16.1 | 19.1 | 19.1 |
| AndroGel | 248 | -- | 248 | (11.1) | n/a | n/a | (11.1) | (11.1) |
| Kaletra | 63 | 174 | 237 | (11.3) | (11.2) | (11.2) | (11.2) | (11.2) |
| Niaspan | 201 | -- | 201 | (13.4) | n/a | n/a | (13.4) | (13.4) |
| Lupron | 141 | 55 | 196 | 6.8 | (1.7) | (3.5) | 4.2 | 3.7 |
| Synthroid | 161 | -- | 161 | 22.9 | n/a | n/a | 22.9 | 22.9 |
| Sevoflurane | 19 | 119 | 138 | (5.0) | 6.1 | 3.5 | 4.4 | 2.2 |
| Creon | 101 | -- | 101 | 9.8 | n/a | n/a | 9.8 | 9.8 |
| Zemplar | 57 | 43 | 100 | 9.6 | 7.7 | 10.3 | 8.8 | 9.9 |
| Synagis | -- | 98 | 98 | n/a | 15.6 | 2.1 | 15.6 | 2.1 |
| Duodopa | -- | 46 | 46 | n/a | 18.9 | 24.3 | 18.9 | 24.3 |
| TriCor/Trilipix | 39 | -- | 39 | (88.3) | n/a | n/a | (88.3) | (88.3) |
| AbbVie Inc. Key Product Sales Nine Months Ended September 30, 2013 (Unaudited) | ||||||||
| % Change vs. 9M12 | ||||||||
| Sales (in millions) | International | Total | ||||||
| U.S. | Int'l. | Total | U.S. | Operational | Reported | Operational | Reported | |
| TOTAL SALES | $7,363 | $6,316 | $13,679 | -- | 10.4% | 8.7% | 4.6% | 3.8% |
| Humira | 3,569 | 4,051 | 7,620 | 20.4 | 13.0 | 11.9 | 16.3 | 15.7 |
| AndroGel | 746 | -- | 746 | (5.2) | n/a | n/a | (5.2) | (5.2) |
| Kaletra | 181 | 553 | 734 | (7.7) | (1.4) | (2.5) | (3.0) | (3.8) |
| Niaspan | 619 | -- | 619 | (2.4) | n/a | n/a | (2.4) | (2.4) |
| Lupron | 410 | 166 | 576 | (1.0) | (4.0) | (5.1) | (1.9) | (2.2) |
| Synagis | -- | 513 | 513 | n/a | 9.9 | 1.4 | 9.9 | 1.4 |
| Synthroid | 433 | -- | 433 | 13.1 | n/a | n/a | 13.1 | 13.1 |
| Sevoflurane | 54 | 358 | 412 | 1.9 | (6.4) | (8.4) | (5.4) | (7.2) |
| Creon | 297 | -- | 297 | 19.8 | n/a | n/a | 19.8 | 19.8 |
| Zemplar | 161 | 127 | 288 | -- | 9.5 | 10.4 | 3.9 | 4.3 |
| TriCor/Trilipix | 274 | -- | 274 | (69.5) | n/a | n/a | (69.5) | (69.5) |
| Duodopa | -- | 129 | 129 | n/a | 16.6 | 19.4 | 16.6 | 19.4 |
| AbbVie Inc. Consolidated Statements of Earnings Quarter and Nine Months Ended September 30, 2013 and 2012 (Unaudited) (In millions, except per share data) | |||||||
| Third Quarter Ended September 30 | Nine Months Ended September 30 | ||||||
| 2013 | 2012 | 2013 | 2012 | ||||
| Net sales | $4,658 | $4,508 | $13,679 | $13,174 | |||
| Cost of products sold | 1,092 | 1,014 | 3,299 | 3,243 | |||
| Selling, general and administrative | 1,261 | 1,085 | 3,904 | 3,578 | |||
| Research and development | 714 | 813 | 2,057 | 2,097 | |||
| Acquired in-process research and development | 220 | -- | 290 | 260 | |||
| Total operating cost and expenses | 3,287 | 2,912 | 9,550 | 9,178 | |||
| Operating earnings | 1,371 | 1,596 | 4,129 | 3,996 | |||
| Interest (income) expense, net | 69 | (1) | 210 | (4) | |||
| Net foreign exchange (gain) loss | 11 | 6 | 40 | 27 | |||
| Other (income) expense, net | 5 | (13) | (14) | (39) | |||
| Earnings before income tax | 1,286 | 1,604 | 3,893 | 4,012 | |||
| Income tax expense | 322 | 19 | 893 | 277 | |||
| Net earnings | $964 | $1,585 | $3,000 | $3,735 | |||
| Diluted earnings per share | $0.60 | $1.01 | $1.86 | $2.37 | |||
| Average diluted shares outstanding | 1,605 | 1,577 | 1,602 | 1,577 |
| AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information Quarter Ended September 30, 2013 (Unaudited) (In millions, except per share data) | |||
| 1. Specified items impacted results as follows: | |||
| 3Q13 | |||
| Earnings | Diluted | ||
| Pre-tax | After-tax | EPS | |
| As reported (GAAP) | $1,286 | $964 | $0.60 |
| Adjusted for specified items: | |||
| Intangible asset amortization | 137 | 98 | 0.06 |
| Separation costs | 51 | 33 | 0.02 |
| Acquired IPR&D | 220 | 220 | 0.13 |
| Restructuring/Other | 14 | 12 | 0.01 |
| As adjusted (non-GAAP) | $1,708 | $1,327 | $0.82 |
| 3Q13 | |||||
| Cost of products sold | SG&A | R&D | Acquired IPR&D | Other (income) expense | |
| As reported (GAAP) | $1,092 | $1,261 | $714 | $220 | $5 |
| Adjusted for specified items: | |||||
| Intangible asset amortization | (137) | -- | -- | -- | -- |
| Separation costs | (4) | (46) | (1) | -- | -- |
| Acquired IPR&D | -- | -- | -- | (220) | -- |
| Restructuring/Other | (7) | -- | (4) | -- | (3) |
| As adjusted (non-GAAP) | $944 | $1,215 | $709 | -- | $2 |
| 3Q13 | |||
| Pre-tax | Income | ||
| income | taxes | Tax rate | |
| As reported (GAAP) | $1,286 | $322 | 25.0% |
| Specified items | 422 | 59 | 14.0% |
| As adjusted (non-GAAP) | $1,708 | $381 | 22.3% |