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 April 27, 2017 (furnished pursuant to Item 2.02). |
ABBVIE INC. | |||
Date: | April 27, 2017 | By: | /s/ William J. Chase |
William J. Chase | |||
Executive Vice President, | |||
Chief Financial Officer |
Exhibit No. | Exhibit | |
99.1 | Press Release dated April 27, 2017 (furnished pursuant to Item 2.02). |
• | Reports First-Quarter Diluted EPS of $1.06 on a GAAP Basis; Adjusted Diluted EPS of $1.28, Reflecting Growth of 11.3 Percent |
• | Delivers First-Quarter Net Revenues of $6.538 Billion on a GAAP Basis, Reflecting Growth of 10.1 Percent on an Operational Basis |
• | First-Quarter Global Humira Sales of $4.118 Billion Increased 15.1 Percent on a Reported Basis, or 15.8 Percent on an Operational Basis; First-Quarter U.S. Humira Sales of $2.696 Billion Increased 22.8 Percent |
• | First-Quarter Global IMBRUVICA Net Revenues Were $551 Million, an Increase of 44.7 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 GAAP net revenues were $6.538 billion in the first quarter, increasing 10.1 percent, excluding a 0.4 percent unfavorable impact from foreign exchange. |
• | Global HUMIRA sales increased 15.1 percent on a reported basis, or 15.8 percent operationally, excluding a 0.7 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 22.8 percent in the quarter. Internationally, HUMIRA sales grew 4.6 percent, excluding a 1.7 percent unfavorable impact from foreign exchange. |
• | First-quarter global IMBRUVICA net revenues were $551 million, with U.S. sales of $457 million and international profit sharing of $94 million for the quarter, reflecting growth of 44.7 percent. |
• | On a GAAP basis, the gross margin ratio in the first quarter was 75.3 percent. The adjusted gross margin ratio was 79.9 percent. |
• | On a GAAP basis, selling, general and administrative expense was 20.9 percent of net revenues. The adjusted SG&A expense was 20.7 percent of net revenues. |
• | On a GAAP basis, research and development expense was 17.4 percent of net revenues. The adjusted R&D expense was 16.9 percent, reflecting funding actions supporting all stages of our pipeline. |
• | On a GAAP basis, the operating margin in the first quarter was 37.0 percent. The adjusted operating margin was 42.3 percent. |
• | On a GAAP basis, net interest expense was $247 million. On a GAAP basis, the tax rate in the quarter was 18.0 percent. The adjusted tax rate was 18.2 percent. |
• | Diluted EPS in the first quarter was $1.06 on a GAAP basis. Adjusted diluted EPS, excluding intangible asset amortization expense and other specified items, was $1.28, up 11.3 percent. |
• | AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application for IMBRUVICA in chronic graft-versus-host-disease (cGVHD), after failure of one or more lines of systemic therapy. cGVHD is a serious and debilitating complication of stem cell or bone marrow transplant. If approved, IMBRUVICA will be the first therapy specifically approved to treat this condition. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc. |
• | AbbVie announced that the U.S. FDA approved IMBRUVICA to treat patients with marginal zone lymphoma (MZL), an indolent form of non-Hodgkin's lymphoma (NHL). There are currently no other approved treatments specifically indicated for patients with MZL. This approval marks the fifth unique type of blood cancer indication for IMBRUVICA. |
• | AbbVie announced that its Phase 3 studies of veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, in patients with squamous non-small cell lung cancer (NSCLC) and triple-negative breast cancer did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel. Based on these Phase 3 data, AbbVie will not continue development in these indications. Studies of veliparib in non-squamous NSCLC, BRCA1/2 breast cancer and ovarian cancer are ongoing. |
• | AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced detailed results from a Phase 2b clinical trial evaluating the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) compared to placebo in women with uterine fibroids. The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo. Uninterrupted treatment with elagolix was associated with decreased symptom severity and improved quality of life. Phase 3 trials evaluating elagolix as a potential treatment for uterine fibroids are ongoing. Additionally, the Phase 3 program in endometreosis is nearing completion, with regulatory submission planned for later this year. |
• | AbbVie announced that the U.S. FDA accepted its New Drug Application and granted priority review for its investigational, pan-genotypic, once-daily, ribavirin-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV). Additionally, AbbVie announced that its marketing authorization application was validated and is under accelerated assessment by the European Medicines Agency (EMA), and that priority review was granted by the Japanese Ministry of Health, Labour and Welfare. The company anticipates commercialization of the next-generation combination in 2017. |
• | AbbVie recently presented data on G/P from the Phase 3 EXPEDITION-1 study and the Phase 3 ENDURANCE-3 study at the International Liver Conference for the European Association for the Study of the Liver. The EXPEDITION-1 study results demonstrated that 99 percent of chronic HCV infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis achieved sustained virologic response at 12 weeks post-treatment (SVR12). The ENDURANCE-3 study results demonstrated that 95 percent of patients infected with genotype 3 chronic HCV, without cirrhosis and who are new to treatment, achieved SVR12 following 8 weeks of treatment. Together with previously reported data, these new study results reinforce G/P’s potential to provide a faster path to cure for the majority of patients living with HCV across all genotypes, as well as offer a potential cure to patients with specific treatment challenges. |
• | AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the EMA granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) as an option for previously untreated adult patients with genotype 1b (GT1b) chronic HCV and minimal to moderate fibrosis. VIEKIRAX + EXVIERA is currently approved in the European Union for use as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis. |
• | AbbVie announced the start of two Phase 2 clinical trial programs to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with early Alzheimer's disease and progressive supranuclear palsy (PSP). In recognition of the lack of treatment options available to patients with PSP, the U.S. FDA granted Fast Track Designation to ABBV-8E12. The FDA and EMA also granted Orphan Drug Designations to ABBV-8E12 for PSP. |
Media: | Investors: |
Adelle Infante | Liz Shea |
(847) 938-8745 | (847) 935-2211 |
Sharon Greenlees | |
(847) 935-0900 | |
Todd Bosse | |
(847) 936-1182 |
% Change vs. 1Q16 | ||||||||||||||
Net Revenues (in millions) | International | Total | ||||||||||||
U.S. | Int’l. | Total | U.S. | Operational | Reported | Operational | Reported | |||||||
NET REVENUES | $4,052 | $2,486 | $6,538 | 15.9% | 1.8% | 0.9% | 10.1% | 9.7% | ||||||
Humira | 2,696 | 1,422 | 4,118 | 22.8 | 4.6 | 2.9 | 15.8 | 15.1 | ||||||
Imbruvicaa | 457 | 94 | 551 | 40.7 | 68.0 | 68.0 | 44.7 | 44.7 | ||||||
Viekira | 38 | 225 | 263 | (69.6) | (20.8) | (21.9) | (35.5) | (36.3) | ||||||
Lupron | 155 | 39 | 194 | 1.9 | (0.2) | 1.2 | 1.4 | 1.7 | ||||||
Creon | 185 | — | 185 | 22.8 | n/a | n/a | 22.8 | 22.8 | ||||||
Synagis | — | 300 | 300 | n/a | (8.2) | (5.9) | (8.2) | (5.9) | ||||||
Synthroid | 192 | — | 192 | 5.7 | n/a | n/a | 5.7 | 5.7 | ||||||
AndroGel | 136 | — | 136 | (12.8) | n/a | n/a | (12.8) | (12.8) | ||||||
Kaletra | 19 | 96 | 115 | (41.8) | (6.4) | (4.4) | (15.1) | (13.6) | ||||||
Sevoflurane | 18 | 89 | 107 | 0.7 | (3.0) | (4.9) | (2.4) | (4.0) | ||||||
Duodopa | 14 | 66 | 80 | 84.6 | 12.0 | 8.9 | 19.8 | 17.0 |
a | Reflects profit sharing for Imbruvica international revenues. |
First Quarter Ended March 31 | |||||||
2017 | 2016 | ||||||
Net revenues | $ | 6,538 | $ | 5,958 | |||
Cost of products sold | 1,616 | 1,369 | |||||
Selling, general and administrative | 1,368 | 1,355 | |||||
Research and development | 1,135 | 946 | |||||
Acquired in-process research and development | — | 10 | |||||
Total operating cost and expenses | 4,119 | 3,680 | |||||
Operating earnings | 2,419 | 2,278 | |||||
Interest expense, net | 247 | 200 | |||||
Net foreign exchange loss | 13 | 302 | |||||
Other expense, net | 73 | — | |||||
Earnings before income tax expense | 2,086 | 1,776 | |||||
Income tax expense | 375 | 422 | |||||
Net earnings | $ | 1,711 | $ | 1,354 | |||
Diluted earnings per share | $ | 1.06 | $ | 0.83 | |||
Adjusted diluted earnings per sharea | $ | 1.28 | $ | 1.15 | |||
Weighted-average diluted shares outstanding | 1,603 | 1,625 |
a | Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. |
1Q17 | |||||||||||
Earnings | Diluted | ||||||||||
Pre-tax | After-tax | EPS | |||||||||
As reported (GAAP) | $ | 2,086 | $ | 1,711 | $ | 1.06 | |||||
Adjusted for specified items: | |||||||||||
Intangible asset amortization | 271 | 203 | 0.13 | ||||||||
Milestones and other R&D expenses | 28 | 28 | 0.02 | ||||||||
Acquisition related costs | 38 | 25 | 0.01 | ||||||||
Change in fair value of contingent consideration | 85 | 84 | 0.06 | ||||||||
Other | 10 | 9 | — | ||||||||
As adjusted (non-GAAP) | $ | 2,518 | $ | 2,060 | $ | 1.28 |
1Q17 | ||||||||||||||||
Cost of products sold | SG&A | R&D | Other expense (income), net | |||||||||||||
As reported (GAAP) | $ | 1,616 | $ | 1,368 | $ | 1,135 | $ | 73 | ||||||||
Adjusted for specified items: | ||||||||||||||||
Intangible asset amortization | (271 | ) | — | — | — | |||||||||||
Milestones and other R&D expenses | — | — | (28 | ) | — | |||||||||||
Acquisition related costs | (26 | ) | (9 | ) | (2 | ) | (1 | ) | ||||||||
Change in fair value of contingent consideration | — | — | — | (85 | ) | |||||||||||
Other | (6 | ) | (4 | ) | — | — | ||||||||||
As adjusted (non-GAAP) | $ | 1,313 | $ | 1,355 | $ | 1,105 | $ | (13 | ) |
1Q17 | ||||||||||
Pre-tax income | Income taxes | Tax rate | ||||||||
As reported (GAAP) | $ | 2,086 | $ | 375 | 18.0 | % | ||||
Specified items | 432 | 83 | 19.2 | % | ||||||
As adjusted (non-GAAP) | $ | 2,518 | $ | 458 | 18.2 | % |
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 | ||||||||
Acquisition related costs | 57 | 35 | 0.02 | ||||||||
Venezuela devaluation loss | 298 | 298 | 0.18 | ||||||||
Other | 67 | 54 | 0.04 | ||||||||
As adjusted (non-GAAP) | $ | 2,363 | $ | 1,874 | $ | 1.15 |
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 | ) | — | — | — | — | |||||||||||||
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 | % |