ABBVIE REPORTS FULL-YEAR 2015 AND FOURTH-QUARTER FINANCIAL RESULTS

ABBVIE REPORTS FULL-YEAR 2015 AND FOURTH-QUARTER FINANCIAL RESULTS

- REPORTS FULL-YEAR ADJUSTED EPS OF $4.29, UP 29.2 PERCENT; GAAP EPS OF $3.13

- DELIVERS FULL-YEAR ADJUSTED NET REVENUES OF $22.819 BILLION, UP 22.1 PERCENT ON AN OPERATIONAL BASIS; GAAP NET REVENUES OF $22.859 BILLION, UP 14.5 PERCENT

- EXPANDED ADJUSTED OPERATING MARGIN TO 42.3 PERCENT IN 2015, UP 610 BASIS POINTS; ADJUSTED GROSS MARGIN OF 82.9 PERCENT, UP 280 BASIS POINTS

- REPORTS FOURTH-QUARTER ADJUSTED EPS OF $1.13, UP 27 PERCENT; GAAP EPS OF $0.92

- REPORTS FOURTH-QUARTER ADJUSTED NET REVENUES OF $6.360 BILLION, UP 24.4 PERCENT ON AN OPERATIONAL BASIS; GAAP NET REVENUES OF $6.40 BILLION, UP 17.4 PERCENT

- REVENUE GROWTH IN THE QUARTER REFLECTS 16.0 PERCENT GLOBAL OPERATIONAL SALES GROWTH FROM HUMIRA; REPORTED GLOBAL HUMIRA SALES INCREASED 10.5 PERCENT

- FOURTH-QUARTER GLOBAL IMBRUVICA NET REVENUE WAS $343 MILLION; FOURTH-QUARTER GLOBAL VIEKIRA SALES WERE $554 MILLION

- CONFIRMS 2016 ADJUSTED EPS GUIDANCE RANGE OF $4.90 TO $5.10, REFLECTING STRONG DOUBLE-DIGIT GROWTH VERSUS 2015

Jan 29, 2016

NORTH CHICAGO, Ill.Jan. 29, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced financial results for the fourth quarter and full year ended Dec. 31, 2015.

"AbbVie delivered strong performance in 2015, exceeding original sales, margin expansion, and earnings projections for the year," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We achieved significant growth in 2015, and expect to continue building on that momentum in 2016 with another year of strong performance."

Fourth-Quarter Results

  • Worldwide adjusted net revenues were $6.360 billion in the fourth-quarter, up 18.4 percent. On an operational basis, adjusted net revenues increased 24.4 percent, excluding a 6.0 percent unfavorable impact from foreign exchange rate fluctuations.
  • Global HUMIRA sales increased 16.0 percent on an operational basis, excluding the impact of foreign exchange. Exceptional U.S. HUMIRA growth of 20.7 percent was driven by continued momentum across all three major market categories - rheumatology, dermatology and gastroenterology. International HUMIRA sales growth was also strong in the fourth quarter, up 9.7 percent on an operational basis. Reported international HUMIRA sales growth in the quarter was reduced by 13.1 percent due to unfavorable foreign exchange.
  • Fourth-quarter global IMBRUVICA net revenue was $343 million, with U.S. sales of $295 million and international profit sharing of $48 million for the quarter.
  • Total company revenue growth was also driven by $554 million in global VIEKIRA sales in the quarter, as well as strong operational growth from Duodopa, Creon and Lupron.
  • Adjusted gross margin ratio in the fourth quarter was 80.5 percent, excluding intangible asset amortization and other specified items. On a GAAP basis, the gross margin ratio was 77.0 percent.
  • Adjusted selling, general and administrative (SG&A) expense was 23.9 percent of net revenues in the fourth quarter. On a GAAP basis, SG&A was 27.1 percent of net revenues.
  • Adjusted research and development (R&D) expense was 15.9 percent of net revenues in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline. On a GAAP basis, R&D was 16.8 percent of net revenues.
  • Adjusted operating margin in the fourth quarter was 40.1 percent, compared to 35.8 percent in fourth-quarter 2014. On a GAAP basis, the operating margin was 33.0 percent.
  • Net interest expense was $199 million. The adjusted tax rate in the quarter was 21.6 percent and 21.1 percent on a GAAP basis.
  • Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.13 in the fourth quarter, up 27 percent. Diluted earnings per share were $0.92 on a GAAP basis.

Key Events from the Fourth Quarter

  • AbbVie submitted a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) to the U.S. Food and Drug Administration (FDA) for use in treatment-naïve chronic lymphocytic leukemia (CLL) patients, based on results from the Phase 3 RESONATE™-2 study. These data, published in The New England Journal of Medicine (NEJM), found that IMBRUVICA significantly decreased the risk of progression or death (progression-free survival, PFS) and significantly decreased the risk of death (overall survival, OS) versus chlorambucil in treatment-naïve patients 65 years and older with CLL.
  • AbbVie submitted a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for venetoclax in patients with relapsed/refractory (R/R) CLL in patients with chromosome 17p deletion to the FDA and European Medicines Agency (EMA), respectively. Priority review status was granted by the FDA and validation provided by the EMA for these submissions based on results from a Phase 2, open-label trial that found treatment with venetoclax demonstrated a 79.4 percent overall response rate (ORR) as monotherapy treatment, including patients that achieved complete remission.
  • AbbVie has now received three FDA Breakthrough Therapy Designations for venetoclax. The first designation was received early last year for the treatment of patients with R/R CLL with chromosome 17p deletion. The second designation for venetoclax was received earlier this month for combination therapy with rituximab for patients with R/R CLL, including those with chromosome 17p deletion. A third designation was received this week for venetoclax in combination with hypomethylating agents (HMAs) in patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy).
  • AbbVie submitted a sNDA to the FDA for labeling considerations based on safety and efficacy results from the Phase 3 HELIOS trial of IMBRUVICA in patients with R/R CLL. The trial found that treatment with IMBRUVICA plus bendamustine and rituximab, versus placebo plus rituximab, significantly reduced the risk of disease progression or death by 80 percent and significantly improved ORR compared to placebo plus rituximab in previously-treated CLL/SLL patients.
  • The FDA accepted AbbVie's sNDA and granted priority review for VIEKIRA PAK without ribavirin in patients with genotype 1b (GT1b) chronic hepatitis C virus infection (HCV) and compensated cirrhosis (Child-Pugh A). The application was supported by data from the TURQUOISE-III study, which showed 100 percent sustained virologic response at 12 weeks post-treatment (SVR12) in this patient population.
  • AbbVie announced that the FDA accepted its NDA for a once-daily, fixed-dosed formulation of VIEKIRA PAK to treat GT1 HCV. The proposed dosing for the fixed-dose formulation is three oral tablets, taken once daily with a meal, with or without ribavirin. AbbVie anticipates regulatory action on the new formulation in 2016.
  • At the American Society of Hematology's Annual Meeting (ASH) in December 2015, AbbVie presented new results from a Phase 2, open-label study of venetoclax in treatment-naïve patients 65 years and older with AML who were not eligible for intensive-induction chemotherapy. These data found that combination treatment with venetoclax and hypomethylating agents resulted in complete response rates of approximately 71 percent, which is roughly double the response rate that would be expected with current standard of care treatment. AbbVie plans to initiate registration studies of venetoclax for this indication in 2016.
  • AbbVie's IMBRUVICA partner Janssen presented results from the Phase 3 RAY study which demonstrated treatment with IMBRUVICA significantly prolonged PFS and improved ORR in patients with R/R mantle-cell lymphoma (MCL), compared with temsirolimus. Specifically, IMBRUVICA was found to reduce the risk of disease progression or death by 57 percent with a median follow-up of 20 months. These data were also published online in The Lancet.
  • AbbVie announced that data from a Phase 2 study evaluating IMBRUVICA therapy in treatment-naïve patients with follicular lymphoma (FL) demonstrated that a combination of IMBRUVICA and rituximab was well-tolerated and associated with ORR of 82 percent.
  • AbbVie presented data from its next-generation HCV regimen (ABT-493 and ABT-530) being evaluated as a pan-genotypic, once-daily treatment option for patients with HCV at the 2015 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Results demonstrated 12 weeks of treatment resulted in 97-100 percent SVR12 in GT1 non-cirrhotic HCV, 96-100 percent in genotype (GT2) and 83-94 percent in genotype 3 (GT3) patients. Additionally, data from the SURVEYOR-I study were also presented at the meeting and showed that non-cirrhotic GT1 HCV patients who received shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved SVR12 rates of 97 percent. The company initiated Phase 3 studies in the fourth quarter of 2015.
  • At the American College of Rheumatology (ACR) Annual Meeting, AbbVie presented the full 12-week, Phase 2b safety data for ABT-494, an investigational oral JAK-1 inhibitor, from the BALANCE-I study (efficacy data was previously top-lined). This study evaluated a broad dose range to understand the boundaries of JAK-1 selectivity and the efficacy of ABT-494 versus placebo in previously treated patients with rheumatoid arthritis (RA) with persistent and active disease. The study met its primary endpoint, achieving an ACR20 response after 12 weeks of treatment using an LOCF approach, and ACR20 for all dose levels. The BALANCE I and II results support the company's decision to move ABT-494 into Phase 3 studies with a once-daily dose. The Phase 3 program was initiated in late 2015 and a Phase 2 trial of ABT-494 is ongoing for the treatment of Crohn's disease.
  • The FDA approved Empliciti (elotuzumab) for the treatment of multiple myeloma (MM) as a combination therapy in patients who have received one to three prior therapies. Empliciti was co-developed by AbbVie and Bristol-Myers Squibb (BMS) and will be marketed by BMS. This approval was based on data from a Phase 3 study which demonstrated that patients treated with Empliciti plus standard of care therapy achieved a 30 percent reduction in the risk of disease progression or death compared to standard of care alone. This is the first FDA approval for an immune-stimulatory antibody for MM in this indication.

Confirming Full-Year 2016 Outlook

AbbVie is confirming its diluted earnings-per-share guidance of $4.90 to $5.10 on an adjusted basis for the full-year 2016, representing strong double-digit growth versus 2015 and positioning AbbVie to be among the industry leaders for growth again in 2016. The company's 2016 adjusted diluted earnings-per-share guidance excludes $0.45 per share of intangible asset amortization expense and other specified items.  Including these items, AbbVie's diluted earnings-per-share guidance is $4.45 to $4.65 on a GAAP basis.

About AbbVie

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 fourth-quarter performance. The call will be webcast through AbbVie's Investor Relations Web site atwww.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 2014 and 2015 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, and 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 2014 Annual Report on Form 10-K and in item 1A, "Risk Factors" of Part II of AbbVie's second quarter 2015 Quarterly Report on Form 10-Q, which have 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.


 

View News Release Full Screen

AbbVie Inc.

Key Product Revenues

Quarter Ended Dec. 31, 2015

(Unaudited)

     

% Change vs. 4Q14

 

Net Revenues (in millions)

 

International

Total

 

U.S.

Int'l.

Total

U.S.

Operational

Reported

Operational

Reported

ADJUSTED NET REVENUES a

$3,811 a

$2,549

$6,360 a

23.6% a

25.4%

11.4%

24.4% a

18.4% a

Humira

2,332

1,385

3,717

20.7

9.7

(3.4)

16.0

10.5

Imbruvica

295

48b

343

n/m

n/m

n/m

n/m

n/m

Viekira

197

357

554

n/m

n/m

n/m

n/m

n/m

Creon

185

--

185

22.8

n/a

n/a

22.8

22.8

Synagis

--

266

266

n/a

(1.2)

(10.7)

(1.2)

(10.7)

Lupron

189

46

235

17.9

7.7

(1.9)

15.6

13.4

Synthroid

194

--

194

3.7

n/a

n/a

3.7

3.7

Kaletra

40

145

185

(21.8)

5.9

(4.6)

(1.0)

(8.9)

AndroGel

194

--

194

(15.7)

n/a

n/a

(15.7)

(15.7)

Sevoflurane

22

86

108

1.6

(0.5)

(13.2)

(0.1)

(10.5)

Duodopa

6

56

62

n/m

14.5

(0.2)

24.4

9.7

 

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 U.S. and total net revenues in both years exclude specified items. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Percentage change is calculated using adjusted net revenues.

b Reflects profit sharing for Imbruvica international revenues.

 

View News Release Full Screen

AbbVie Inc.

Key Product Revenues

Twelve Months Ended Dec. 31, 2015

(Unaudited)

     

% Change vs. 12M14

 

Net Revenues (in millions)

 

International

Total

 

U.S.

Int'l.

Total

U.S.

Operational

Reported

Operational

Reported

ADJUSTED NET REVENUES a

$13,521 a

$9,298

$22,819 a

25.6% a

17.9%

2.0%

22.1% a

14.8% a

Humira

8,405

5,607

14,012

28.8

8.6

(6.9)

19.1

11.7

Imbruvica

659

95b

754c

n/m

n/m

n/m

n/m

n/m

Viekira

804

835

1,639

n/m

n/m

n/m

n/m

n/m

Creon

632

--

632

22.5

n/a

n/a

22.5

22.5

Synagis

--

740

740

n/a

0.6

(11.3)

0.6

(11.3)

Lupron

653

173

826

12.5

(0.2)

(12.9)

9.3

6.1

Synthroid

755

--

755

6.4

n/a

n/a

6.4

6.4

Kaletra

163

537

700

(23.8)

(4.9)

(18.2)

(9.6)

(19.6)

AndroGel

694

--

694

(25.7)

n/a

n/a

(25.7)

(25.7)

Sevoflurane

81

393

474

(2.5)

(4.0)

(15.9)

(3.8)

(13.9)

Duodopa

12

219

231

n/m

18.1

(0.6)

23.5

4.8

 

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 U.S. and total net revenues in both years exclude specified items. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Percentage change is calculated using adjusted net revenues.

b Reflects profit sharing for Imbruvica international revenues.

c Reflects Imbruvica revenue from the May 26 close date of the Pharmacyclics acquisition.

 

AbbVie Inc.

Consolidated Statements of Earnings

Quarter and Twelve Months Ended Dec. 31, 2015 and 2014

(Unaudited) (In millions, except per share data)

   

Fourth Quarter 
Ended Dec. 31

 

Twelve Months
Ended Dec. 31

   

2015

 

2014

 

2015

 

2014

 

Net revenues

$6,400

 

$5,452

 

$22,859

 

$19,960

                   

Cost of products sold

1,475

 

1,119

 

4,500

 

4,426

 

Selling, general and administrative

1,737

 

3,341

 

6,387

 

7,724

 

Research and development

1,075

 

879

 

4,285

 

3,297

 

Acquired in-process research and development

--

 

28

 

150

 

352

 

Other expense

--

 

500

 

--

 

750

 

Total operating costs and expenses

4,287

 

5,867

 

15,322

 

16,549

                   

Operating earnings (loss)

2,113

 

(415)

 

7,537

 

3,411

                   

Interest expense, net

199

 

129

 

686

 

391

 

Net foreign exchange loss

2

 

496

 

193

 

678

 

Other (income) expense, net

(12)

 

(3)

 

13

 

(27)

 

Earnings (loss) before income tax expense

1,924

 

(1,037)

 

6,645

 

2,369

 

Income tax expense (benefit)

407

 

(227)

 

1,501

 

595

 

Net earnings (loss)

$1,517

 

$(810)

 

$5,144

 

$1,774

                   

Diluted earnings (loss) per share

$0.92

 

$(0.51)

 

$3.13

 

$1.10

                   

Diluted earnings per share, excluding specified items

$1.13

 

$0.89

 

$4.29

 

$3.32

a)

                 

Average diluted shares outstanding     

1,640

 

1,597

 

1,637

 

1,610

   

a) Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.

 

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Quarter Ended Dec. 31, 2015

(Unaudited) (In millions, except per share data)

 

1.

Specified items impacted results as follows:

       

4Q15

     

Earnings

Diluted

     

Pre-tax

After-tax

EPS

   

As reported (GAAP)

$1,924

$1,517

$0.92

   

Adjusted for specified items:

         

Other revenue

(40)

(25)

(0.02)

   

Intangible asset amortization

140

116

0.07

   

Pharmacyclics acquisition related costs

105

68

0.04

   

Restructuring

79

58

0.04

   

Legal reserves

125

101

0.06

   

Separation costs and other      

43

26

0.02

   

As adjusted (non-GAAP)

$2,376

$1,861

$1.13

       

Other revenue is associated with milestone revenue under a previously announced collaboration. Intangible asset amortization reflects costs recognized as a result of licensing and acquisition activities. Pharmacyclics acquisition related costs reflect acquisition-related compensation expense, integration and other costs related to the acquisition of Pharmacyclics. Restructuring is primarily associated with streamlining our global operations. Separation costs and other is primarily related to the separation of AbbVie from Abbott.

   

2.

The impact of the specified items by line item was as follows:

       

 

4Q15

   

Net

Revenues

Cost of products
sold

SG&A

R&D

 

 As reported (GAAP)

$6,400

$1,475

$1,737

$1,075

 

 Adjusted for specified items:

         

Other revenue

(40)

--

--

--

 

Intangible asset amortization

--

(140)

--

--

 

Pharmacyclics acquisition related costs

--

(49)

(15)

(41)

 

Restructuring

--

(24)

(39)

(16)

 

Legal reserves

--

--

(125)

--

 

Separation costs and other

--

(16)

(27)

--

 

 As adjusted (non-GAAP)

$6,360

$1,246

$1,531

$1,018

   

3.

The adjusted tax rate for the fourth quarter of 2015 was 21.6 percent, as detailed below:

       

 

4Q15

     

Pre-tax

Income

       

income

taxes

Tax rate

   

As reported (GAAP)

$1,924

$407

21.1%

   

Specified items

452

108

23.9%

   

As adjusted (non-GAAP)

$2,376

$515

21.6%

 

 

View News Release Full Screen

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Quarter Ended Dec. 31, 2014

(Unaudited) (In millions, except per share data)

   

1.

Specified items impacted results as follows:

     

4Q14

             

Earnings

Diluted

             

Pre-tax

After-tax

EPS

           

As reported (GAAP)

($1,037)

($810)

($0.51)

           

Adjusted for specified items:

                 

Other revenue

(81)

(81)

(0.05)

           

Intangible asset amortization

96

69

0.04

           

Acquired IPR&D

28

29

0.02

           

Calico collaboration

500

500

0.31

           

Shire transaction costs      

2,227

1,623

1.00

           

Separation costs and other

134

116

0.08

           

As adjusted (non-GAAP)

$1,867

$1,446

$0.89

                 

Other revenue principally includes royalty income from prior periods recognized in the fourth quarter of 2014 as a result of the settlement of a licensing arrangement. Intangible asset amortization reflects costs recognized as a result of licensing and acquisition activities. Acquired IPR&D primarily reflects an upfront payment related to a licensing arrangement with a third party. Calico collaboration reflects a charge recorded related to the previously announced Calico collaboration. Shire transaction costs are expenses related to the terminated Shire transaction. Separation costs and other is primarily related to the separation of AbbVie from Abbott.

   

2.

The impact of the specified items by line item was as follows:

           

4Q14

   

Net

Revenues

Cost of 
products

sold

SG&A

R&D

Acquired 
IPR&D

Other 
operating 
expense

Interest 
expense

Net foreign 
exchange

loss (gain)

 

 As reported (GAAP)

$5,452

$1,119

$3,341

$879

$28

$500

$129

$496

 

 Adjusted for specified items:

                 

Other revenue

(81)

--

--

--

--

--

--

--

 

Intangible asset amortization

--

(96)

--

--

--

--

--

--

 

Acquired IPR&D

--

--

--

--

(28)

--

--

--

 

Calico collaboration

--

--

--

--

--

(500)

--

--

 

Shire transaction costs

--

--

(1,660)

--

--

--

(66)

(501)

 

Separation costs and other

--

(15)

(117)

(2)

--

--

--

--

 

 As adjusted(non-GAAP)

$5,371

$1,008

$1,564

$877

--

--

$63

($5)

   

3.

The adjusted tax rate for the fourth quarter of 2014 was 22.5 percent, as detailed below:

       

 

4Q14

             

Pre-tax

Income

               

income

taxes

Tax rate

           

As reported (GAAP)

($1,037)

($227)

21.9%

           

Specified items

2,904

648

22.3%

           

As adjusted(non-GAAP)

$1,867

$421

22.5%

         

 

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Twelve Months Ended Dec. 31, 2015

(Unaudited) (In millions, except per share data)

   

1.

Specified items impacted results as follows:

       

12M15

           

Earnings

Diluted

           

Pre-tax

After-tax

EPS

         

As reported (GAAP)

$6,645

$5,144

$3.13

         

Adjusted for specified items:

               

Other revenue

(40)

(25)

(0.02)

         

Intangible asset amortization

419

328

0.20

         

Separation costs

270

223

0.13

         

Pharmacyclics acquisition related costs

645

410

0.25

         

Milestones and other R&D expenses

480

433

0.26

         

Acquired IPR&D

150

150

0.09

         

Shire termination

170

170

0.10

         

Restructuring

113

82

0.06

         

Legal  reserves

165

129

0.08

         

Other      

23

16

0.01

         

As adjusted (non-GAAP)

$9,040

$7,060

$4.29

             

Other revenue is associated with a milestone payment received under a previously announced collaboration. 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. Pharmacyclics acquisition related costs reflect acquisition-related compensation expense, transaction, financing, integration and other costs related to the acquisition of Pharmacyclics. Milestones and other R&D expenses are associated with a milestone payment for a previously announced collaboration and the purchase of an FDA priority review voucher from a third party. Acquired IPR&D primarily reflects the C2N collaboration. Shire termination reflects the completed liquidation of remaining foreign currency positions related to the terminated Shire transaction, as communicated in the fourth quarter of 2014. Restructuring is primarily associated with streamlining our global operations.

   

2.

The impact of the specified items by line item was as follows:

       

12M15

   

Net 
Revenues

Cost of 
products 
sold

SG&A

 

R&D

Acquired 
IPR&D

Interest

expense

Net foreign 
exchange

loss

 

 As reported (GAAP)

$22,859

$4,500

$6,387

$4,285

$150

$686

$193

 

 Adjusted for specified items:

               

Other revenue

(40)

--

--

--

--

--

--

 

Intangible asset amortization

--

(419)

--

--

--

--

--

 

Separation costs

--

(5)

(265)

--

--

--

--

 

Pharmacyclics acquisition related costs

--

(113)

(294)

(152)

--

(86)

--

 

Milestones and other R&D expenses

--

--

--

(480)

--

--

--

 

Acquired IPR&D

--

--

--

--

(150)

--

--

 

Shire termination

--

--

--

--

--

--

(170)

 

Restructuring

--

(42)

(39)

(32)

--

--

--

 

Legal reserves

--

--

(165)

--

--

--

--

 

Other

--

(16)

(3)

(4)

--

--

--

 

 As adjusted (non-GAAP)

$22,819

$3,905

$5,621

$3,617

--

$600

$23

   

3.

The adjusted tax rate for the full-year 2015 was 21.9 percent, as detailed below:

       

12M15

           

Pre-tax

Income

             

income

taxes

Tax rate

         

As reported (GAAP)

$6,645

$1,501

22.6%

         

Specified items

2,395

479

20.0%

         

As adjusted (non-GAAP)

$9,040

$1,980

21.9%

       

 

View News Release Full Screen

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Twelve Months Ended Dec. 31, 2014

(Unaudited) (In millions, except per share data)

     

1.

Specified items impacted results as follows:

           

12M14

               

Earnings

Diluted

               

Pre-tax

After-tax

EPS

             

As reported (GAAP)

$2,369

$1,774

$1.10

             

Adjusted for specified items:

                   

Other revenue

(81)

(81)

(0.05)

             

Intangible asset amortization

403

287

0.18

             

Separation costs

445

385

0.24

             

Milestones and other R&D expenses

40

40

0.02

             

Acquired IPR&D

352

251

0.15

             

Calico collaboration

750

750

0.46

             

Shire transaction costs

2,510

1,802

1.12

             

Other

136

167

0.10

             

As adjusted (non-GAAP)

$6,924

$5,375

$3.32

                   

Other revenue principally includes royalty income from prior periods recognized in the fourth quarter of 2014 as a result of the settlement of a licensing arrangement. 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. Milestones and other R&D expenses are associated with payments for previously announced collaborations. Acquired IPR&D reflects upfront payments related to previously announced collaborations. Calico collaboration reflects charges related to the previously announced Calico collaboration. Shire transaction costs are expenses related to the terminated Shire transaction. Other is primarily associated with the recognition of an additional year of the Branded Prescription Drug Fee as required by new IRS regulations.

     

2.

The impact of the specified items by line item was as follows:

             

12M14

   

Net

Revenues

Cost of
products 
sold

SG&A

R&D

Acquired 
IPR&D

Other 
operating 
expense

Net foreign 
exchange 
loss

Interest 
expense

Other 
(income) 
expense

 

 As reported (GAAP)

$19,960

$4,426

$7,724

$3,297

$352

$750

$678

$391

($27)

 

 Adjusted for specified items:

                   

Other revenue

(81)

--

--

--

--

--

--

--

--

 

Intangible asset amortization

--

(403)

--

--

--

--

--

--

--

 

Separation costs

--

(18)

(422)

(5)

--

--

--

--

--

 

Milestones and other R&D expenses

--

--

--

(40)

--

--

--

--

--

 

Acquired IPR&D

--

--

--

--

(352)

--

--

--

--

 

Calico collaboration

--

--

--

--

--

(750)

--

--

--

 

Shire transaction costs

--

--

(1,703)

--

--

--

(666)

(141)

--

 

Other

--

(58)

(112)

--

--

--

--

--

34

 

 As adjusted(non-GAAP)

$19,879

$3,947

$5,487

$3,252

--

--

$12

$250

$7

   

3.

The adjusted tax rate for the full-year 2014 was 22.4 percent, as detailed below:

       

12M14

             

Pre-tax

Income

               

income

taxes

Tax rate

           

As reported (GAAP)

$2,369

$595

25.1%

           

Specified items

4,555

954

20.9%

           

As adjusted(non-GAAP)

$6,924

$1,549

22.4%

         

 

SOURCE AbbVie

For further information: Media, Adelle Infante, (847) 938-8745; Investors, Larry Peepo, (847) 935-6722; or Liz Shea, (847) 935-2211

 

 

Read more on