Delaware | 001-35565 | 32-0375147 | ||
(State or other Jurisdiction | (Commission File Number) | (IRS Employer | ||
of Incorporation) | Identification No.) |
Exhibit No. | Exhibit | |
99.1 | Press Release dated July 28, 2017 (furnished pursuant to Item 2.02). |
ABBVIE INC. | |||
Date: | July 28, 2017 | By: | /s/ William J. Chase |
William J. Chase | |||
Executive Vice President, | |||
Chief Financial Officer |
Exhibit No. | Exhibit | |
99.1 | Press Release dated July 28, 2017 (furnished pursuant to Item 2.02). |
• | Reports Second-Quarter Diluted EPS of $1.19 on a GAAP Basis; Adjusted Diluted EPS of $1.42, Reflecting Growth of 12.7 Percent |
• | Delivers Second-Quarter Net Revenues of $6.944 Billion; Adjusted Net Revenues Increased 8.9 Percent on an Operational Basis |
• | Second-Quarter Global Humira Sales of $4.716 Billion Increased 13.7 Percent on a Reported Basis, or 14.9 Percent on an Operational Basis; Second-Quarter U.S. Humira Sales of $3.201 Billion Increased 18.0 Percent |
• | Second-Quarter Global IMBRUVICA Net Revenues Were $626 Million, an Increase of 42.6 Percent |
• | Confirms 2017 GAAP Diluted EPS Guidance Range of $4.55 to $4.65; 2017 Adjusted Diluted EPS Guidance Range of $5.44 to $5.54, Representing Growth of 13.9 Percent at the Midpoint |
• | Worldwide net revenues were $6.944 billion in the second quarter, up 7.6 percent year-over-year, on a GAAP basis. On an operational basis, adjusted net revenues increased 8.9 percent, excluding a 0.9 percent unfavorable impact from foreign exchange. |
• | Global HUMIRA sales increased 13.7 percent on a reported basis, or 14.9 percent operationally, excluding a 1.2 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 18.0 percent in the quarter. Internationally, HUMIRA sales grew 9.1 percent, excluding a 3.6 percent unfavorable impact from foreign exchange. |
• | Second-quarter global IMBRUVICA net revenues were $626 million, with U.S. sales of $528 million and international profit sharing of $98 million for the quarter, reflecting growth of 42.6 percent. |
• | On a GAAP basis, the gross margin ratio in the second quarter was 78.0 percent. The adjusted gross margin ratio was 82.3 percent. |
• | On a GAAP basis, selling, general and administrative expense was 21.7 percent of net revenues. The adjusted SG&A expense was 20.2 percent of net revenues. |
• | On a GAAP basis, research and development expense was 17.6 percent of net revenues. The adjusted R&D expense was 17.5 percent, reflecting funding actions supporting all stages of our pipeline. |
• | On a GAAP basis, the operating margin in the second quarter was 38.5 percent. The adjusted operating margin was 44.6 percent. |
• | On a GAAP basis, net interest expense was $253 million. On a GAAP basis, the tax rate in the quarter was 18.6 percent. The adjusted tax rate was 19.3 percent. |
• | Diluted EPS in the second quarter was $1.19 on a GAAP basis. Adjusted diluted EPS, excluding intangible asset amortization expense and other specified items, was $1.42, up 12.7 percent. |
• | AbbVie announced positive top-line results from a Phase 3 clinical trial of upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis. Results from the SELECT-NEXT study, which evaluated upadacitinib in patients who did not adequately respond to treatment with conventional synthetic DMARDs, showed that after 12 weeks of treatment, both doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity. Key secondary endpoints were also achieved and included ACR50, ACR70 and clinical remission. The safety profile was consistent with that observed in the upadacitinib Phase 2 clinical trials, and no new safety signals were detected. Detailed study results will be presented at an upcoming medical conference. |
• | AbbVie presented data on upadacitinib and risankizumab, an investigational IL-23 inhibitor being developed in collaboration with Boehringer Ingelheim, at the annual Digestive Disease Week (DDW) conference. These data included positive results from CELEST, a Phase 2 study evaluating upadacitinib in adult patients with moderately to severely active Crohn's disease, the majority of whom had previously failed two or more biologics. The CELEST study evaluated the safety and efficacy of multiple dosing regimens after 16 weeks of treatment, and demonstrated that significantly more patients achieved clinical remission and endoscopic remission after induction therapy with upadacitinib versus placebo. Additionally, AbbVie presented data from a Phase 2, open-label maintenance therapy study that demonstrated that after 52 weeks of treatment in patients with moderately to severely active Crohn's disease, risankizumab was effective in maintaining clinical and endoscopic remission and response in patients who were in clinical remission at week 26. The positive results from both studies support advancement of the upadacitinib and risankizumab Crohn’s disease programs to Phase 3. |
• | AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET (glecaprevir/pibrentasvir, or G/P), an investigational, pan-genotypic treatment for adults with chronic HCV infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6). This group comprises the majority of people living with HCV. MAVIRET would also be an additional HCV treatment option for patients with specific treatment challenges, such as those with compensated cirrhosis, chronic kidney disease and genotype 3 chronic HCV infection. The European Commission will review the CHMP opinion and a final decision is expected in the third quarter of 2017. AbbVie's next-generation regimen is also under priority review by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour, and Welfare, and the company anticipates regulatory approvals in the third quarter of 2017. |
• | AbbVie presented data on IMBRUVICA (ibrutinib) at the Annual Meeting of the American Society of Clinical Oncology in June. These data included long-term follow-up results from the pivotal Phase 3 RESONATE trial that showed a progression free survival rate of 59 percent in up to four years in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) treated with ibrutinib, including those with high-risk disease. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc. |
• | AbbVie announced results from an analysis of data pooled from three Phase 3 studies evaluating IMBRUVICA use in patients with high-risk CLL/SLL (RESONATE, RESONATE-2 and HELIOS), which were presented at the International Workshop on Chronic Lymphocytic Leukemia meeting. The results suggest that risk factors typically associated with poor clinical outcomes may be less important with ibrutinib treatment, and ibrutinib-treated patients with deletion 11q (a difficult-to-treat genomic abnormality) showed trends of longer progression free survival at 24 months and overall survival at 30 months. |
• | The FDA granted Breakthrough Therapy Designation (BTD) for VENCLEXTA (venetoclax) in combination with low-dose cytarabine for untreated acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy. This represents the second BTD for VENCLEXTA in AML, an aggressive blood cancer that, if left untreated, can progress quickly, and the fourth BTD overall for VENCLEXTA. VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group. |
• | AbbVie, in cooperation with Neurocrine Biosciences, Inc., presented data at the World Congress on Endometriosis from two replicate Phase 3 studies, highlighting the efficacy and safety profile of elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, in premenopausal women with endometriosis. Regulatory submission for elagolix is expected in the third quarter. |
Media: | Investors: |
Adelle Infante | Liz Shea |
(847) 938-8745 | (847) 935-2211 |
Sharon Greenlees | |
(847) 935-0900 | |
Todd Bosse | |
(847) 936-1182 |
% Change vs. 2Q16 | ||||||||||||||
Net Revenues (in millions) | International | Total | ||||||||||||
U.S. | Int’l. | Total | U.S. | Operational | Reported | Operational | Reported | |||||||
ADJUSTED NET REVENUESa | $4,646 | $2,298 | $6,944 | 13.3% | 1.0% | (1.5)% | 8.9% | 8.0% | ||||||
Humira | 3,201 | 1,515 | 4,716 | 18.0 | 9.1 | 5.5 | 14.9 | 13.7 | ||||||
Imbruvicab | 528 | 98 | 626 | 37.6 | 77.0 | 77.0 | 42.6 | 42.6 | ||||||
Viekira | 26 | 199 | 225 | (70.1) | (39.5) | (40.1) | (45.9) | (46.4) | ||||||
Lupron | 172 | 38 | 210 | (3.5) | (2.9) | (4.8) | (3.5) | (3.8) | ||||||
Creon | 196 | — | 196 | 9.5 | n/a | n/a | 9.5 | 9.5 | ||||||
Synagis | — | 40 | 40 | n/a | (9.3) | (10.7) | (9.3) | (10.7) | ||||||
Synthroid | 193 | — | 193 | 2.3 | n/a | n/a | 2.3 | 2.3 | ||||||
AndroGel | 154 | — | 154 | (10.3) | n/a | n/a | (10.3) | (10.3) | ||||||
Kaletra | 19 | 91 | 110 | (38.6) | (24.5) | (21.1) | (27.4) | (24.7) | ||||||
Sevoflurane | 19 | 85 | 104 | (7.7) | (5.2) | (8.0) | (5.7) | (8.0) | ||||||
Duodopa | 14 | 67 | 81 | 76.3 | 8.2 | 4.5 | 16.0 | 12.7 |
a | Adjusted net revenues 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. |
% Change vs. 6M16 | ||||||||||||||
Net Revenues (in millions) | International | Total | ||||||||||||
U.S. | Int’l. | Total | U.S. | Operational | Reported | Operational | Reported | |||||||
ADJUSTED NET REVENUESa | $8,698 | $4,784 | $13,482 | 14.5% | 1.5% | (0.2)% | 9.5% | 8.8% | ||||||
Humira | 5,897 | 2,937 | 8,834 | 20.1 | 6.9 | 4.2 | 15.3 | 14.3 | ||||||
Imbruvicab | 985 | 192 | 1,177 | 39.0 | 72.4 | 72.4 | 43.6 | 43.6 | ||||||
Viekira | 64 | 424 | 488 | (69.8) | (30.8) | (31.6) | (40.8) | (41.4) | ||||||
Lupron | 327 | 77 | 404 | (1.0) | (1.6) | (1.9) | (1.1) | (1.2) | ||||||
Creon | 381 | — | 381 | 15.6 | n/a | n/a | 15.6 | 15.6 | ||||||
Synagis | — | 340 | 340 | n/a | (8.3) | (6.5) | (8.3) | (6.5) | ||||||
Synthroid | 385 | — | 385 | 4.0 | n/a | n/a | 4.0 | 4.0 | ||||||
AndroGel | 290 | — | 290 | (11.5) | n/a | n/a | (11.5) | (11.5) | ||||||
Kaletra | 38 | 187 | 225 | (40.2) | (16.2) | (13.4) | (21.6) | (19.4) | ||||||
Sevoflurane | 37 | 174 | 211 | (3.8) | (4.1) | (6.4) | (4.1) | (6.0) | ||||||
Duodopa | 28 | 133 | 161 | 80.2 | 10.0 | 6.6 | 17.9 | 14.8 |
a | Adjusted net revenues 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. |
Second Quarter Ended June 30 | Six Months Ended June 30 | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Net revenues | $ | 6,944 | $ | 6,452 | $ | 13,482 | $ | 12,410 | |||||||
Cost of products sold | 1,528 | 1,405 | 3,144 | 2,774 | |||||||||||
Selling, general and administrative | 1,504 | 1,466 | 2,872 | 2,821 | |||||||||||
Research and development | 1,223 | 1,124 | 2,358 | 2,070 | |||||||||||
Acquired in-process research and development | 15 | 70 | 15 | 80 | |||||||||||
Total operating cost and expenses | 4,270 | 4,065 | 8,389 | 7,745 | |||||||||||
Operating earnings | 2,674 | 2,387 | 5,093 | 4,665 | |||||||||||
Interest expense, net | 253 | 225 | 500 | 425 | |||||||||||
Net foreign exchange loss | 6 | 15 | 19 | 317 | |||||||||||
Other expense, net | 62 | 51 | 135 | 51 | |||||||||||
Earnings before income tax expense | 2,353 | 2,096 | 4,439 | 3,872 | |||||||||||
Income tax expense | 438 | 486 | 813 | 908 | |||||||||||
Net earnings | $ | 1,915 | $ | 1,610 | $ | 3,626 | $ | 2,964 | |||||||
Diluted earnings per share | $ | 1.19 | $ | 0.98 | $ | 2.25 | $ | 1.81 | |||||||
Adjusted diluted earnings per sharea | $ | 1.42 | $ | 1.26 | $ | 2.70 | $ | 2.41 | |||||||
Weighted-average diluted shares outstanding | 1,600 | 1,632 | 1,602 | 1,629 |
a | Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. |
2Q17 | |||||||||||
Earnings | Diluted | ||||||||||
Pre-tax | After-tax | EPS | |||||||||
As reported (GAAP) | $ | 2,353 | $ | 1,915 | $ | 1.19 | |||||
Adjusted for specified items: | |||||||||||
Intangible asset amortization | 269 | 202 | 0.12 | ||||||||
Milestones and other R&D expenses | 8 | 8 | 0.01 | ||||||||
Acquired IPR&D | 15 | 15 | 0.01 | ||||||||
Acquisition related costs | 35 | 24 | 0.01 | ||||||||
Change in fair value of contingent consideration | 61 | 61 | 0.04 | ||||||||
Litigation reserves | 93 | 62 | 0.04 | ||||||||
Other | 3 | 2 | — | ||||||||
As adjusted (non-GAAP) | $ | 2,837 | $ | 2,289 | $ | 1.42 |
2Q17 | |||||||||||||||||||
Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense, net | |||||||||||||||
As reported (GAAP) | $ | 1,528 | $ | 1,504 | $ | 1,223 | $ | 15 | $ | 62 | |||||||||
Adjusted for specified items: | |||||||||||||||||||
Intangible asset amortization | (269 | ) | — | — | — | — | |||||||||||||
Milestones and other R&D expenses | — | — | (8 | ) | — | — | |||||||||||||
Acquired IPR&D | — | — | — | (15 | ) | — | |||||||||||||
Acquisition related costs | (26 | ) | (5 | ) | (3 | ) | — | (1 | ) | ||||||||||
Change in fair value of contingent consideration | — | — | — | — | (61 | ) | |||||||||||||
Litigation reserves | — | (93 | ) | — | — | — | |||||||||||||
Other | (2 | ) | (1 | ) | — | — | — | ||||||||||||
As adjusted (non-GAAP) | $ | 1,231 | $ | 1,405 | $ | 1,212 | $ | — | $ | — |
2Q17 | ||||||||||
Pre-tax income | Income taxes | Tax rate | ||||||||
As reported (GAAP) | $ | 2,353 | $ | 438 | 18.6 | % | ||||
Specified items | 484 | 110 | 22.7 | % | ||||||
As adjusted (non-GAAP) | $ | 2,837 | $ | 548 | 19.3 | % |
2Q16 | |||||||||||
Earnings | Diluted | ||||||||||
Pre-tax | After-tax | EPS | |||||||||
As reported (GAAP) | $ | 2,096 | $ | 1,610 | $ | 0.98 | |||||
Adjusted for specified items: | |||||||||||
Intangible asset amortization | 181 | 144 | 0.09 | ||||||||
Milestones and other R&D expenses | 55 | 55 | 0.03 | ||||||||
Acquired IPR&D | 70 | 70 | 0.04 | ||||||||
Acquisition related costs | 145 | 122 | 0.08 | ||||||||
Change in fair value of contingent consideration | 41 | 41 | 0.02 | ||||||||
Other | 4 | 30 | 0.02 | ||||||||
As adjusted (non-GAAP) | $ | 2,592 | $ | 2,072 | $ | 1.26 |
2Q16 | |||||||||||||||||||||||
Net revenues | Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense, net | ||||||||||||||||||
As reported (GAAP) | $ | 6,452 | $ | 1,405 | $ | 1,466 | $ | 1,124 | $ | 70 | $ | 51 | |||||||||||
Adjusted for specified items: | |||||||||||||||||||||||
Intangible asset amortization | — | (181 | ) | — | — | — | — | ||||||||||||||||
Milestones and other R&D expenses | — | — | — | (55 | ) | — | — | ||||||||||||||||
Acquired IPR&D | — | — | — | — | (70 | ) | — | ||||||||||||||||
Acquisition related costs | — | (46 | ) | (15 | ) | (72 | ) | — | (12 | ) | |||||||||||||
Change in fair value of contingent consideration | — | — | — | — | — | (41 | ) | ||||||||||||||||
Other | (20 | ) | (9 | ) | (15 | ) | — | — | — | ||||||||||||||
As adjusted (non-GAAP) | $ | 6,432 | $ | 1,169 | $ | 1,436 | $ | 997 | $ | — | $ | (2 | ) |
2Q16 | ||||||||||
Pre-tax income | Income taxes | Tax rate | ||||||||
As reported (GAAP) | $ | 2,096 | $ | 486 | 23.2 | % | ||||
Specified items | 496 | 34 | 6.9 | % | ||||||
As adjusted (non-GAAP) | $ | 2,592 | $ | 520 | 20.1 | % |
6M17 | |||||||||||
Earnings | Diluted | ||||||||||
Pre-tax | After-tax | EPS | |||||||||
As reported (GAAP) | $ | 4,439 | $ | 3,626 | $ | 2.25 | |||||
Adjusted for specified items: | |||||||||||
Intangible asset amortization | 540 | 405 | 0.25 | ||||||||
Milestones and other R&D expenses | 36 | 36 | 0.02 | ||||||||
Acquired IPR&D | 15 | 15 | 0.01 | ||||||||
Acquisition related costs | 73 | 49 | 0.03 | ||||||||
Change in fair value of contingent consideration | 146 | 145 | 0.09 | ||||||||
Litigation reserves | 93 | 62 | 0.04 | ||||||||
Other | 13 | 11 | 0.01 | ||||||||
As adjusted (non-GAAP) | $ | 5,355 | $ | 4,349 | $ | 2.70 |
6M17 | |||||||||||||||||||
Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense, net | |||||||||||||||
As reported (GAAP) | $ | 3,144 | $ | 2,872 | $ | 2,358 | $ | 15 | $ | 135 | |||||||||
Adjusted for specified items: | |||||||||||||||||||
Intangible asset amortization | (540 | ) | — | — | — | — | |||||||||||||
Milestones and other R&D expenses | — | — | (36 | ) | — | — | |||||||||||||
Acquired IPR&D | — | — | — | (15 | ) | — | |||||||||||||
Acquisition related costs | (52 | ) | (14 | ) | (5 | ) | — | (2 | ) | ||||||||||
Change in fair value of contingent consideration | — | — | — | — | (146 | ) | |||||||||||||
Litigation reserves | — | (93 | ) | — | — | — | |||||||||||||
Other | (8 | ) | (5 | ) | — | — | — | ||||||||||||
As adjusted (non-GAAP) | $ | 2,544 | $ | 2,760 | $ | 2,317 | $ | — | $ | (13 | ) |
6M17 | ||||||||||
Pre-tax income | Income taxes | Tax rate | ||||||||
As reported (GAAP) | $ | 4,439 | $ | 813 | 18.3 | % | ||||
Specified items | 916 | 193 | 21.0 | % | ||||||
As adjusted (non-GAAP) | $ | 5,355 | $ | 1,006 | 18.8 | % |
6M16 | |||||||||||
Earnings | Diluted | ||||||||||
Pre-tax | After-tax | EPS | |||||||||
As reported (GAAP) | $ | 3,872 | $ | 2,964 | $ | 1.81 | |||||
Adjusted for specified items: | |||||||||||
Intangible asset amortization | 346 | 277 | 0.17 | ||||||||
Milestones and other R&D expenses | 70 | 70 | 0.04 | ||||||||
Acquired IPR&D | 80 | 80 | 0.05 | ||||||||
Acquisition related costs | 204 | 159 | 0.11 | ||||||||
Change in fair value of contingent consideration | 41 | 41 | 0.02 | ||||||||
Venezuela devaluation loss | 298 | 298 | 0.18 | ||||||||
Other | 44 | 57 | 0.03 | ||||||||
As adjusted (non-GAAP) | $ | 4,955 | $ | 3,946 | $ | 2.41 |
6M16 | |||||||||||||||||||||||||||
Net revenues | Cost of products sold | SG&A | R&D | Acquired IPR&D | Net foreign exchange loss | Other expense, net | |||||||||||||||||||||
As reported (GAAP) | $ | 12,410 | $ | 2,774 | $ | 2,821 | $ | 2,070 | $ | 80 | $ | 317 | $ | 51 | |||||||||||||
Adjusted for specified items: | |||||||||||||||||||||||||||
Intangible asset amortization | — | (346 | ) | — | — | — | — | — | |||||||||||||||||||
Milestones and other R&D expenses | — | — | — | (70 | ) | — | — | — | |||||||||||||||||||
Acquired IPR&D | — | — | — | — | (80 | ) | — | — | |||||||||||||||||||
Acquisition related costs | — | (91 | ) | (20 | ) | (81 | ) | — | — | (12 | ) | ||||||||||||||||
Change in fair value of contingent consideration | — | — | — | — | — | — | (41 | ) | |||||||||||||||||||
Venezuela devaluation loss | — | — | — | — | — | (298 | ) | — | |||||||||||||||||||
Other | (20 | ) | (53 | ) | (18 | ) | 7 | — | — | — | |||||||||||||||||
As adjusted (non-GAAP) | $ | 12,390 | $ | 2,284 | $ | 2,783 | $ | 1,926 | $ | — | $ | 19 | $ | (2 | ) |
6M16 | ||||||||||
Pre-tax income | Income taxes | Tax rate | ||||||||
As reported (GAAP) | $ | 3,872 | $ | 908 | 23.4 | % | ||||
Specified items | 1,083 | 101 | 9.4 | % | ||||||
As adjusted (non-GAAP) | $ | 4,955 | $ | 1,009 | 20.4 | % |