On July 24, 2015 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2015 (Press release, AbbVie, JUL 24, 2015, View Source;p=RssLanding&cat=news&id=2070868 [SID:1234506616]).

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"We are pleased with the high level of performance we’ve delivered through the first-half of 2015, consistent with our commitment to shareholders for top-tier growth this year and beyond," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "With the completion of the Pharmacyclics transaction, continued momentum from our on-market products and rapid evolution of our robust development pipeline, we are well positioned to deliver strong performance in the future."

Second-Quarter Results

Worldwide sales were $5.475 billion in the second quarter, up 11.1 percent year-over-year. On an operational basis, sales increased 19.4 percent, excluding an 8.3 percent unfavorable impact from foreign exchange rate fluctuations.

Second-quarter sales growth was driven by the continued strength of HUMIRA and other promoted products. Global HUMIRA sales increased 16.4 percent on an operational basis, or 7.6 percent including the impact of foreign exchange rate fluctuations. Strong U.S. HUMIRA growth continued, driven by double-digit growth across all three major market categories, rheumatology, dermatology and gastroenterology. Reported international HUMIRA sales growth in the quarter was reduced by nearly 18 percent due to unfavorable foreign exchange. First-half 2015 international HUMIRA sales grew nearly 9 percent on an operational basis, consistent with planning expectations and the full year forecast for international HUMIRA sales growth of 9 to 10 percent on an operational basis. As noted last quarter, the first-quarter international operational growth rate of nearly 15 percent was favorably impacted by the timing of shipments in select markets. Consequently, sales growth in the second quarter was negatively impacted by shipment timing.

Total company sales growth was also driven by $385 million in global VIEKIRA sales, now approved in 47 countries with additional approvals anticipated throughout the remainder of 2015, as well as strong operational growth from other key products including Creon, Synthroid and Duodopa.

Second-quarter U.S. IMBRUVICA sales were $234 million. AbbVie recorded a partial quarter of U.S. IMBRUVICA sales of $97 million and $10 million of international profit sharing based on the May 26 close date of the Pharmacyclics acquisition.

The adjusted gross margin ratio in the second quarter was 85.3 percent, excluding intangible asset amortization and other specified items. Gross margin expansion was driven by product mix, operating efficiencies and the impact of foreign exchange rates. The gross margin ratio under U.S. generally accepted accounting principles (GAAP) was 83.3 percent.

Adjusted selling, general and administrative (SG&A) expense was 25.1 percent of sales in the second quarter. On a GAAP basis, SG&A was 31.1 percent of sales.

Adjusted research and development (R&D) was 15.9 percent of sales in the quarter, reflecting funding actions in support of our mid- and late-stage pipeline assets. On a GAAP basis, R&D was 17.9 percent of sales.

The adjusted operating margin in the second quarter was 44.2 percent, compared to 36.4 percent in second-quarter 2014. On a GAAP basis, the operating margin was 33.8 percent.

Adjusted net interest expense was $137 million, which reflects the impact of debt issued in conjunction with the Pharmacyclics acquisition. The adjusted tax rate was 21.9 percent in the quarter and 18.6 percent on a GAAP basis.

Adjusted diluted earnings per share, excluding intangible asset amortization expense and other specified items, were $1.08 in the second quarter, up 31.7 percent. Diluted earnings per share were $0.83 on a GAAP basis.

Key Events from the Second Quarter

On May 26, AbbVie successfully completed the acquisition of Pharmacyclics, accelerating AbbVie’s clinical and commercial presence in oncology. The acquisition aligns strategically to AbbVie’s business model, strengthening the company’s already robust oncology pipeline and further diversifying AbbVie’s revenue base.

AbbVie announced that the European Commission granted marketing authorization for IMBRUVICA (ibrutinib) as the first treatment option specifically approved for treatment of adult patients with Waldenstrom’s macroglobulinemia.

Results from the Phase 3 HELIOS study of IMBRUVICA were presented at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. The data demonstrated that patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) experienced an 80 percent reduction in the risk of disease progression or death when treated with ibrutinib in combination with bendamustine and rituximab, compared to patients receiving placebo in combination with bendamustine and rituximab.

AbbVie reported top-line results from the head-to-head Phase 3, RESONATE-2 study, which evaluated efficacy and safety of ibrutinib versus traditional chemotherapy, chlorambucil. Initial findings showed that treatment with ibrutinib improved progression-free survival rates, as well as met several secondary endpoints, including overall survival and overall response rates when used in treatment-naïve patients with CLL and SLL. Additional detailed data will be presented at an upcoming medical meeting. AbbVie anticipates submitting these data for regulatory review in the second-half of 2015.

AbbVie announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent. The median life expectancy for CLL patients with 17p deletion is less than 2-3 years. AbbVie expects to submit regulatory applications to U.S. and European agencies for this indication before the end of 2015.

Data from the Phase 3 ELOQUENT-2 study of elotuzumab were recently published in the New England Journal of Medicine. Elotuzumab is being developed in partnership with Bristol Myers Squibb, for front-line and relapsed/refractory multiple myeloma. Data showed that adding elotuzumab to standard of care in patients with relapsed/refractory multiple myeloma significantly reduced the risk of disease progression and demonstrated superior progression-free survival and overall response rates. The regulatory submissions are anticipated in the second-half of 2015.

The FDA granted priority review to AbbVie for its investigational, all-oral, interferon-free (IFN) therapy for the treatment of genotype 4 (GT4) chronic HCV in the United States. The New Drug Application (NDA) was accepted by the agency and is based on results from the PEARL-I study, which demonstrated 100 percent sustained virologic response rate at 12 weeks post-treatment (SVR12) when used with ribavirin (RBV), with no discontinuations due to adverse events. This investigational therapy also previously received Breakthrough Therapy Designation, and AbbVie anticipates regulatory action in the second-half of 2015.
New, pivotal data from the GIFT-I study of AbbVie’s all-oral, IFN- and RBV-free, two direct-acting antiviral (DAA) treatment with ombitasvir/paritaprevir/ritonavir in genotype 1b (GT1b) chronic HCV infected Japanese patients with and without cirrhosis were presented at the Annual Meeting of the Japan Society of Hepatology. Patients were both treatment-naïve and treatment-experienced. Primary endpoints were achieved, demonstrating 95 percent SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b chronic HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load. In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent SVR12. AbbVie’s two-DAA combination is currently under regulatory review in Japan and a decision is expected in the second-half of 2015.
AbbVie reported results from the TURQUOISE-III study in treatment-naïve and treatment-experienced patients with GT1b chronic HCV with compensated liver cirrhosis. These data demonstrated 100 percent SVR12 rates when treated with VIEKIRA without RBV. No patients discontinued treatment due to adverse events. Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.

AbbVie announced that the FDA granted VIEKIRA orphan drug designation for the investigational treatment of HCV infection in pediatric patients, 0 – 16 years of age. Orphan drug designations recognize the need for a treatment of a rare disease or condition. AbbVie will conduct an investigational clinical study to evaluate the efficacy and safety of VIEKIRA with or without RBV in pediatric patients with chronic HCV infection. VIEKIRA is currently not approved for this indication.

AbbVie announced that the FDA granted HUMIRA orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS), a painful, chronic inflammatory skin disease. AbbVie’s supplemental Biologic License Application (sBLA) is currently under review with the agency. The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently granted a positive opinion for this indication.

AbbVie recently received approval from the EMA for a new HUMIRA formulation, specifically designed to reduce injection pain and reduce injection volume.

AbbVie announced results from VISUAL‑I, a Phase 3 study investigating the efficacy and safety of HUMIRA in adult patients with uveitis. Results showed HUMIRA significantly lowered their risk of uncontrolled uveitis or vision loss. In May 2014, AbbVie received orphan drug designation from the FDA for the investigational treatment of certain forms of non‑infectious uveitis with HUMIRA. U.S. and EU regulatory submissions are expected in the second-half of 2015, following positive results from the second pivotal trial.
On June 18, the AbbVie board of directors declared a quarterly cash dividend of $0.51 per share, payable Aug. 14, 2015 to stockholders of record at the close of business on July 15, 2015. Since the company’s inception in 2013, AbbVie has increased its dividend by 28 percent.

Full-Year 2015 Outlook

AbbVie is confirming its adjusted diluted earnings-per-share guidance for the full-year 2015 of $4.10 to $4.30. The company’s 2015 adjusted diluted earnings-per-share guidance excludes $0.84 per share of intangible asset amortization expense, deal costs, integration, and other specified items, and includes $0.20 of dilution related to the Pharmacyclics acquisition. AbbVie’s diluted earnings-per-share guidance is $3.26 to $3.46 on a GAAP basis.