Full Press Release Details
NORTH CHICAGO, Ill. , April 28, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV ) announced financial results for the first quarter ended March 31, 2016 .
"AbbVie delivered strong first-quarter results, including significant revenue and EPS growth, and margin expansion," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "In addition to our strong financial performance, we also continue to advance several strategic priorities, including the addition of two highly compelling late-stage pipeline assets through the Stemcentrx acquisition and BI collaboration. We also secured two important approvals with the expansion of the IMBRUVICA label into first-line CLL and the recent approval of Venclexta. We expect 2016 to be a year of top-tier financial performance for AbbVie and we're off to an exceptional start."
First-Quarter Results
Key Events from the First Quarter
Full-Year 2016 Outlook
AbbVie is updating its diluted earnings-per-share guidance to include the impact of the Stemcentrx acquisition, which is expected to be $0.20 dilutive in 2016. As a result, AbbVie now expects diluted earnings-per-share of $4.62 to $4.82 on an adjusted basis for the full-year 2016, representing 10 percent growth versus 2015 at the midpoint. The company's 2016 adjusted diluted earnings-per-share guidance excludes $0.75 per share of intangible asset amortization expense, the impact of the Venezuelan currency devaluation, and other specified items. Including these items, AbbVie's diluted earnings-per-share guidance is $3.87 to $4.07 on a GAAP basis.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. 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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 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 first-quarter performance. 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 2015 and 2016 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 2016 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," of AbbVie's 2015 Annual Report on Form 10-K, 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 Revenues | ||||||||
| Quarter Ended March 31, 2016 | ||||||||
| (Unaudited) | ||||||||
| % Change vs. 1Q15 | ||||||||
| Net Revenues (in millions) | International | Total | ||||||
| U.S. | Int'l. | Total | U.S. | Operational | Reported | Operational | Reported | |
| TOTAL NET REVENUES | $3,494 | $2,464 | $5,958 | 31.9% | 11.9% | 3.1% | 22.4% | 18.2% |
| Humira | 2,195 | 1,382 | 3,577 | 31.9 | 4.6 | (4.6) | 19.2 | 14.9 |
| Imbruvica | 325 | 56 a | 381 | n/m | n/m | n/m | n/m | n/m |
| Viekira | 125 | 289 | 414 | (9.3) | n/m | n/m | 86.9 | 79.2 |
| Lupron | 151 | 39 | 190 | 1.1 | 3.5 | (7.5) | 1.6 | (0.8) |
| Synagis | -- | 319 | 319 | n/a | 2.1 | (4.6) | 2.1 | (4.6) |
| Synthroid | 182 | -- | 182 | (2.4) | n/a | n/a | (2.4) | (2.4) |
| Creon | 150 | -- | 150 | 18.2 | n/a | n/a | 18.2 | 18.2 |
| AndroGel | 156 | -- | 156 | 1.9 | n/a | n/a | 1.9 | 1.9 |
| Kaletra | 33 | 100 | 133 | (19.7) | (18.7) | (27.9) | (19.0) | (26.1) |
| Sevoflurane | 17 | 94 | 111 | (1.4) | (6.1) | (13.5) | (5.5) | (11.8) |
| Duodopa | 7 | 61 | 68 | n/m | 23.6 | 16.6 | 36.7 | 29.8 |
| Note: "Operational" growth reflects the percentage change over the prior year excluding the impact of exchange rate fluctuations. |
| n/a = not applicable |
| n/m = not meaningful |
| a Reflects profit sharing for Imbruvica international revenues. |
| AbbVie Inc. | ||||
| Consolidated Statements of Earnings | ||||
| Quarter Ended March 31, 2016 and 2015 | ||||
| (Unaudited) (In millions, except per share data) | ||||
| First Quarter Ended March 31 | ||||
| 2016 | 2015 | |||
| Net revenues | $5,958 | $5,040 | ||
| Cost of products sold | 1,369 | 942 | ||
| Selling, general and administrative | 1,355 | 1,473 | ||
| Research and development | 946 | 811 | ||
| Acquired in-process research and development | 10 | 127 | ||
| Total operating cost and expenses | 3,680 | 3,353 | ||
| Operating earnings | 2,278 | 1,687 | ||
| Interest expense, net | 200 | 126 | ||
| Net foreign exchange loss | 302 | 164 | ||
| Other expense, net | - | 1 | ||
| Earnings before income tax expense | 1,776 | 1,396 | ||
| Income tax expense | 422 | 374 | ||
| Net earnings | $1,354 | $1,022 | ||
| Diluted earnings per share | $0.83 | $0.63 | ||
| Diluted earnings per share, excluding specified items a | $1.15 | $0.94 | ||
| Weighted-average diluted shares outstanding | 1,625 | 1,608 |
| AbbVie Inc. | ||||
| Reconciliation of GAAP Reported to Non-GAAP Adjusted Information | ||||
| Quarter Ended March 31, 2016 | ||||
| (Unaudited) (In millions, except per share data) | ||||
| 1. | Specified items impacted results as follows: | |||
| 1Q16 | ||||
| Earnings | Diluted | |||
| Pre-tax | After-tax | EPS | ||
| As reported (GAAP) | $1,776 | $1,354 | $0.83 | |
| Adjusted for specified items: | ||||
| Intangible asset amortization | 165 | 133 | 0.08 | |
| Pharmacyclics acquisition related costs | 57 | 35 | 0.02 | |
| Foreign exchange loss | 298 | 298 | 0.18 | |
| Other | 67 | 54 | 0.04 | |
| As adjusted (non-GAAP) | $2,363 | $1,874 | $1.15 |
| Intangible asset amortization reflects costs recognized as a result of licensing and acquisition activities. Pharmacyclics acquisition related costs reflect the amortization of the acquisition date fair value step-up for inventory as well as integration and other costs related to the acquisition of Pharmacyclics. The foreign exchange loss relates to a devaluation of AbbVie's net monetary assets denominated in the Venezuelan bolivar. Other is primarily associated with the impairment of an intangible asset and a milestone payment for a previously announced collaboration. | |
| 2. | The impact of the specified items by line item was as follows: |
| 1Q16 | ||||||
| Cost of products sold | SG&A | R&D | Acquired IPR&D | Net foreign exchange loss | ||
| As reported (GAAP) | $1,369 | $1,355 | $946 | $10 | $302 | |
| Adjusted for specified items: | ||||||
| Intangible asset amortization | (165) | -- | -- | -- | -- | |
| Pharmacyclics acquisition related costs | (45) | (4) | (8) | -- | -- | |
| Venezuela devaluation loss | -- | -- | -- | -- | (298) | |
| Other | (44) | (4) | (9) | (10) | -- | |
| As adjusted (non-GAAP) | $1,115 | $1,347 | 929 | -- | 4 |
| 1Q16 | ||||
| Pre-tax | Income | |||
| income | taxes | Tax rate | ||
| As reported (GAAP) | $1,776 | $422 | 23.7% | |
| Specified items | 587 | 67 | 11.4% | |
| As adjusted (non-GAAP) | $2,363 | $489 | 20.7% |
| AbbVie Inc. | ||||
| Reconciliation of GAAP Reported to Non-GAAP Adjusted Information | ||||
| Quarter Ended March 31, 2015 | ||||
| (Unaudited) (In millions, except per share data) | ||||
| 1. | Specified items impacted results as follows: | |||
| 1Q15 | ||||
| Earnings | Diluted | |||
| Pre-tax | After-tax | EPS | ||
| As reported (GAAP) | $1,396 | $1,022 | $0.63 | |
| Adjusted for specified items: | ||||
| Intangible asset amortization | 68 | 52 | 0.03 | |
| Separation costs | 104 | 89 | 0.05 | |
| Acquired IPR&D | 127 | 127 | 0.08 | |
| Shire termination | 170 | 170 | 0.11 | |
| Other | 95 | 63 | 0.04 | |
| As adjusted (non-GAAP) | $1,960 | $1,523 | $0.94 |
| Intangible asset amortization reflects costs recognized as a result of licensing and acquisition activities. Separation costs are expenses related to the separation of AbbVie from Abbott. Acquired IPR&D primarily reflects the C 2 N collaboration. Shire termination reflects the completed liquidation of remaining foreign currency positions related to the terminated Shire transaction. Other is primarily associated with restructuring activities and interest expense for the Pharmacyclics acquisition. | |
| 2. | The impact of the specified items by line item was as follows: |
| 1Q15 | ||||||
| Cost of products sold | SG&A | Acquired IPR&D | Interest expense, net | Net foreign exchange loss/(gain) | ||
| As reported (GAAP) | $942 | $1,473 | $127 | $126 | $164 | |
| Adjusted for specified items: | ||||||
| Intangible asset amortization | (68) | -- | -- | -- | -- | |
| Separation costs | (3) | (101) | -- | -- | -- | |
| Acquired IPR&D | -- | -- | (127) | -- | -- | |
| Shire termination | -- | -- | -- | -- | (170) | |
| Other | (9) | (27) | -- | (59) | -- | |
| As adjusted (non-GAAP) | $862 | $1,345 | -- | $67 | ($6) |
| 1Q15 | ||||
| Pre-tax | Income | |||
| income | taxes | Tax rate | ||
| As reported (GAAP) | $1,396 | $374 | 26.8% | |
| Specified items | 564 | 63 | 11.2% | |
| As adjusted (non-GAAP) | $1,960 | $437 | 22.3% |