On April 25, 2019 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported results for the first quarter of 2019 and increased its full-year 2019 earnings outlook (Press release, Baxter, APR 25, 2019, View Source [SID1234535400]).

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"We are pleased with the solid start to 2019, establishing a foundation for accelerating performance over the course of the year," said José (Joe) E. Almeida, chairman and chief executive officer. "Our first quarter results reflect the value of our diversified portfolio, an increased emphasis on high-value innovation and an ongoing focus on operational excellence. We remain committed to executing on our strategy to deliver enhanced performance in 2019 and beyond."

First-Quarter Financial Results

Worldwide sales in the first quarter totaled approximately $2.6 billion, a decrease of 2% on a reported basis and an increase of 2% on both a constant currency and an operational basis. Operational sales in the first quarter exclude the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

Sales in the U.S. totaled $1.1 billion, decreasing 2% on both a reported and operational basis. International sales of $1.5 billion decreased 1% on a reported basis and increased 5% on a constant currency basis.

Performance in the quarter was driven by growth of Baxter’s peritoneal dialysis and continuous renal replacement therapies, certain generic injectable pharmaceuticals, and hemostats and sealants. In addition, increased demand for Baxter’s hospital pharmacy compounding and cytotoxic contract manufacturing services also contributed to growth in the quarter. Sales growth in the quarter was partially offset by expected lower sales of Medication Delivery and Nutritional therapies. Baxter’s performance in International markets reflects growth across both the Europe, Middle East and Africa (EMEA) and Asia Pacific (APAC) regions.

Please see the attached schedules accompanying this press release for additional details on sales performance in the quarter, including breakouts by Baxter’s three geographic segments and six global business units (GBUs).

Baxter reported net income of $347 million, or $0.66 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the first quarter. These results include special items totaling $52 million after-tax, which were primarily related to business optimization charges and intangible asset amortization, partially offset by an insurance recovery from a legacy product-related matter. On an adjusted basis, Baxter’s first quarter net income totaled $399 million, or $0.76 per diluted share, ahead of the company’s expectations of $0.66 to $0.68 per diluted share. Adjusted earnings per diluted share advanced 9% in the quarter, driven by solid operational performance as well as benefits from a lower tax rate and share count as compared to the prior-year period.

Business Highlights

Baxter continues to achieve notable milestones in pursuit of its Mission for patients and emphasis on accelerating profitable growth. Among recent highlights, the company:

Launched ready-to-use eptifibatide, a platelet aggregation inhibitor that prevents platelets from sticking together and clotting, using the company’s proprietary GALAXY container technology. Baxter’s premix presentation is the first of its kind available in a flexible container, offering healthcare providers preparation efficiencies and helping to avoid potential dosing errors.
Announced U.S. Food and Drug Administration (FDA) approval for faster preparation of Floseal Hemostatic Matrix. This next generation of Floseal has 20% fewer components and steps to prepare,2 making it easier and faster for operating room nurses to get Floseal into the hands of surgeons to help stop bleeding during procedures.
Initiated a collaboration with bioMérieux, a world leader in the field of in vitro diagnostics, to develop future biomarkers with the goal of rapidly identifying and informing treatment of acute kidney injury (AKI). The efforts are meant to help diagnose AKI earlier so a patient can have improved therapy options, reflecting Baxter’s growth strategy of addressing patient needs across the continuum of care.
Announced that a NantHealth digital health solution is now available to connect Baxter’s Prismaflex technology, used in the intensive care unit to treat patients with acute kidney injury, to a hospital’s electronic medical record (EMR) system. Digitally connected healthcare solutions have the potential to positively impact patient care in many ways, from reducing reliance on manual documentation to converting data into meaningful insights to improve care.
Announced the planned U.S. launch of Clinolipid (20% Lipid Injectable Emulsion), Baxter’s proprietary olive oil-based lipid emulsion, later this year. The announcement was made at the 2019 ASPEN Nutrition Science & Practice Conference, where Baxter featured its diverse portfolio of parenteral nutrition products to address and help improve care for malnourished patients.
Received recognition from multiple organizations for its commitment to workplace excellence, including:
Forbes Magazine, which included Baxter on its annual list of America’s Best Large Employers for the fifth consecutive year.
The National Association for Female Executives (NAFE), which cited Baxter among its 2019 NAFE Top Companies for Executive Women.
The Human Rights Campaign Foundation (HRC), which cited Baxter as a 2019 Best Place to Work for LGBTQ Equality based on Baxter’s perfect score on HRC’s Corporate Equality Index.
2019 Financial Outlook

For full-year 2019: Based on solid first quarter performance, Baxter is raising its earnings outlook for 2019. The company now expects adjusted earnings from continuing operations, before special items, of $3.27 to $3.35 per diluted share. The company continues to expect sales growth of 0 to 1 percent on a reported basis, 2 to 3 percent on a constant currency basis and 3 to 4 percent on an operational basis.

For second-quarter 2019: The company expects sales to decline approximately 2 percent on a reported basis, and to grow approximately 2 percent on a constant currency basis and 2 to 3 percent on an operational basis. The company expects adjusted earnings from continuing operations, before special items, of $0.80 to $0.82 per diluted share.

Full-year and quarterly operational sales estimates for 2019 have been adjusted for the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

A webcast of Baxter’s first-quarter 2019 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 25, 2019. Please see www.baxter.com for more information regarding this and future investor events and webcasts.

On April 25, 2019 Novavax, Inc. (Nasdaq: NVAX) reported it will report its first quarter 2019 financial and operating results following the close of U.S. financial markets on Thursday, May 2, 2019 (Press release, Novavax, APR 25, 2019, http://ir.novavax.com/news-releases/news-release-details/novavax-host-conference-call-discuss-first-quarter-financial-2 [SID1234535419]).

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Conference call details are as follows:

Date: May 2, 2019
Time: 4:30 p.m. U.S. Eastern Time (ET)
Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode: 5394082
Webcast: www.novavax.com, "Investors"/ "Events"

Conference call and webcast replay:

Dates: Starting at 7:30 p.m. ET, May 2, 2019 until 7:30 p.m. ET May 9, 2019
Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode: 5394082
Webcast: www.novavax.com, "Investors"/ "Events", until August 2, 2019

On April 25, 2019 Alkermes plc (Nasdaq: ALKS) reported financial results for the first quarter of 2019 (Press release, Alkermes, APR 25, 2019, View Source [SID1234535385]).

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"Our first quarter results reflect the diversity of our business, as the growth of VIVITROL net sales and royalty revenues from INVEGA SUSTENNA offset a decline in AMPYRA royalties, following generic entry in the market. As is typical, during the first quarter we saw the effect of seasonal inventory fluctuations and deductible resets for commercial payer plans impact net sales of our proprietary commercial products, which decreased sequentially. In particular, ARISTADA net sales were impacted more than anticipated by inventory fluctuations which masked underlying prescription growth of approximately 5% compared to last quarter," commented James Frates, Chief Financial Officer of Alkermes. "Today, we are reiterating our financial expectations for 2019, as we continue to position VIVITROL and ARISTADA for long-term growth, invest in our development pipeline and prepare for the potential launch of ALKS 3831."

"The first few months of 2019 were highlighted by the presentation of important new data from large clinical trials of both ALKS 3831 and ARISTADA at the 2019 Congress of the Schizophrenia International Research Society. These innovative studies demonstrated the clear antipsychotic efficacy of our medicines along with our intended patient-focused attributes relating to safety and tolerability. Our recently announced ALPINE study results also provide information useful to clinicians making treatment decisions for their patients," commented Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are focused on executing both commercially and across our development pipeline. With the planned submission of the New Drug Application for ALKS 3831 mid-year, expected regulatory action for diroximel fumarate for multiple sclerosis in the fourth quarter, and increasing momentum in the ALKS 4230 immuno-oncology program, we have a number of key milestones ahead and look forward to updating you on our progress throughout the year."

Quarter Ended Mar. 31, 2019 Financial Highlights

Total revenues for the quarter were $223.1 million, compared to $225.2 million for the same period in the prior year, reflecting the growth in our proprietary product net sales and an offsetting decrease in AMPYRAi revenues following generic entry into the market in 2018.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $96.4 million for the quarter, or a basic and diluted GAAP net loss per share of $0.62. This compared to GAAP net loss of $62.5 million, or a basic and diluted GAAP net loss per share of $0.40 for the same period in the prior year.

Non-GAAP net loss was $26.0 million for the quarter, or a non-GAAP basic and diluted net loss per share of $0.17. This compared to non-GAAP net loss of $14.2 million, or a non-GAAP basic and diluted net loss per share of $0.09 for the same period in the prior year.

Quarter Ended Mar. 31, 2019 Financial Results

Revenues

Net sales of VIVITROL were $69.2 million, compared to $62.7 million for the same period in the prior year, representing an increase of approximately 10%.

Net sales of ARISTADAii were $30.3 million, compared to $29.2 million for the same period in the prior year, representing an increase of approximately 4%.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $75.6 million, compared to $68.8 million for the same period in the prior year.

Manufacturing and royalty revenues from AMPYRA/FAMPYRA were $12.2 million, compared to $28.3 million for the same period in the prior year due to generic competition to AMPYRA entering the market in late 2018.

Research and development revenues from the collaboration with Biogen for diroximel fumarate (BIIB098) were $13.9 million, compared to $17.5 million for the same period in the prior year.

Costs and Expenses

Operating expenses were $299.1 million, compared to $287.0 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of VIVITROL and ARISTADA.

Other expense during the quarter included a $22.6 million charge due to a decrease in the fair value of contingent consideration, related to Recro Pharma, Inc.’s receipt of a second complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for IV Meloxicam.

Financial Expectations for 2019

Alkermes reiterates its financial expectations for 2019 set forth in its press release dated Feb. 14, 2019.

Recent Events:

Leadership

Appointed Todd Nichols to the role of Senior Vice President of Sales and Marketing. Mr. Nichols joins Alkermes from Celgene and his responsibilities will include leading global commercial activities, including marketing and sales of VIVITROL and ARISTADA, as well as developing and executing the commercial strategy for ALKS 3831 and other development candidates.

ARISTADA

The U.S. Department of Veterans Affairs recently added ARISTADA and ARISTADA INITIO to its National Formulary at parity with other long-acting injectable atypical antipsychotics.

Announced positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a six-month study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA, when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Results were presented at the 2019 Congress of the Schizophrenia International Research Society (SIRS).

ALKS 3831

Presented new data at SIRS from the phase 3 ALKS 3831 ENLIGHTEN-2 six-month weight study and interim results from the ENLIGHTEN-2 52-week safety extension

study.

Diroximel fumarate

Announced that the FDA accepted for review the NDA for diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY, which has been conditionally accepted by the FDA and would be confirmed upon approval.

ALKS 4230

Initiated ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with advanced solid tumors.

Announced a research collaboration with Clovis to evaluate ALKS 4230 in combination with rucaparib, Clovis’ marketed PARP inhibitor, and lucitanib, Clovis’ investigational tyrosine kinase inhibitor.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Apr. 25, 2019, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Apr. 25, 2019, through Thursday, May 2, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13690081

On April 25, 2019 Rainier Therapeutics, Inc., a privately-held clinical stage drug development company, reported that abstracts related to trials of the company’s lead therapeutic, vofatamab, have been accepted for presentation at the upcoming 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place May 31 to June 4, 2019 in Chicago, Illinois (Press release, Rainier Therapeutics, APR 25, 2019, View Source [SID1234535401]).

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"We are pleased to have abstracts related to our ongoing Phase 2 vofatamab trials accepted for a poster discussion and poster presentations at ASCO (Free ASCO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes a preliminary analysis of clinical activity in FIERCE-22 and an interim analysis in FIERCE-21."

Poster Discussion & Poster Presentation:

FIERCE-22: Clinical activity of vofatamab (V) a FGFR3 selective inhibitor in combination with pembrolizumab (P) in WT metastatic urothelial carcinoma, preliminary analysis.

Abstract: 4511

Poster Discussion Session: Genitourinary (Nonprostate) Cancer
Date/Time: Monday, June 3, 2019, 4:30 PM – 6:00 PM,
Location: Hall D2

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #337
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM,
Location: Hall A

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

Poster Presentation:

Interim analysis of the FIERCE-21 phase 2 (P2) study of vofatamab (B-701), a selective inhibitor of FGFR3, as salvage therapy in metastatic urothelial carcinoma (mUC).

Abstract: 4547

Poster Session: Genitourinary (Nonprostate) Cancer
Poster Board: #373
Date/Time: Monday, June 3, 2019, 1:15 PM – 4:15 PM
Location: Hall A

Presenter: Begona Mellado, MD, PhD, Hospital Clinic de Barcelona

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-21 and FIERCE-22.

FIERCE-21 is a Phase 2 trial evaluating vofatamab in combination with docetaxel and separately vofatamab as monotherapy in patients with locally advanced or metastatic bladder cancer with FGFR3 mutation/fusions who have relapsed after, or are refractory to, at least one prior line of chemotherapy.

FIERCE-22 is a Phase 2 trial evaluating vofatamab in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and efficacy in the treatment of patients with locally advanced or metastatic bladder cancer, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

For additional information on FIERCE-21, please visit www.clinicaltrials.gov (NCT02401542) and for more information on FIERCE-22, please visit www.clinicaltrials.gov (NCT03123055).

Rainier Therapeutics also plans to study vofatamab in non-muscle invasive bladder cancer (NMIBC) – the FIERCE-23 trial.

On April 25, 2019 AbbVie (NYSE:ABBV) reported its financial results for the first quarter ended March 31, 2019 (Press release, AbbVie, APR 25, 2019, View Source [SID1234535386]).

"We are off to another excellent start, including first quarter sales and earnings above expectations," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Additionally, we have made tremendous progress advancing our pipeline, including the recent approval of SKYRIZI, which has the potential to set a new standard of care in psoriasis and represents a significant long-term opportunity for AbbVie. We are extremely pleased with our strong performance and based on the continued business momentum, are increasing our full-year EPS guidance."

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First-Quarter Results

Worldwide net revenues of $7.828 billion decreased 1.3 percent on a reported basis and increased 0.4 percent operationally.

First-Quarter Results (continued)

Global HUMIRA net revenues of $4.446 billion decreased 5.6 percent on a reported basis, or 3.8 percent operationally. In the U.S., HUMIRA net revenues of $3.215 billion grew 7.1 percent in the quarter. Internationally, HUMIRA net revenues of $1.231 billion decreased 27.9 percent on a reported basis, or 23.0 percent operationally, due to biosimilar competition.

Global net revenues from the hematologic oncology portfolio of $1.173 billion increased 42.8 percent on a reported basis, or 43.2 percent operationally. Global IMBRUVICA net revenues were $1.022 billion, with U.S. net revenues of $829 million and international profit sharing of $193 million. Global VENCLEXTA net revenues were $151 million.

Global HCV net revenues of $815 million decreased 11.3 percent on a reported basis, or 9.1 percent operationally. In the U.S., HCV net revenues of $403 million grew 17.3 percent in the quarter.

On a GAAP basis, the gross margin ratio in the first quarter was 78.4 percent. The adjusted gross margin ratio was 83.3 percent.

On a GAAP basis, selling, general and administrative expense was 21.5 percent of net revenues. The adjusted SG&A expense was 20.0 percent of net revenues.

On a GAAP basis, research and development expense was 16.5 percent of net revenues. The adjusted R&D expense was 15.3 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

On a GAAP basis, the operating margin in the first quarter was 38.5 percent. The adjusted operating margin was 48.1 percent.

On a GAAP basis, net interest expense was $325 million. On a GAAP basis, the tax rate in the quarter was 3.5 percent. The adjusted tax rate was 7.9 percent.

Diluted EPS in the first quarter was $1.65 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.14, up 14.4 percent.

Recent Events

AbbVie announced regulatory approvals for SKYRIZI for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approvals from the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare are based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance, evaluating more than 2,000 patients with moderate to severe plaque psoriasis. Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for SKYRIZI for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Recent Events (continued)

At the American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented data from 19 abstracts, including 10 oral presentations and 9 poster presentations. Long-term data from multiple studies investigating SKYRIZI for the treatment of plaque psoriasis were presented, including the first integrated efficacy analyses highlighting response over time and across various subgroups. Additionally, AbbVie presented up to 40 months of SKYRIZI safety data indicating adverse events were low and similar to comparator groups and data showing that psoriasis patients achieved significantly higher PASI 90 response rates after switching to SKYRIZI versus those who remained on adalimumab. AbbVie also presented results from a Phase 2 upadacitinib atopic dermatitis study, as well as data from HUMIRA (adalimumab) in multiple psoriatic diseases.

AbbVie announced that the FDA accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases. The NDA is supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five of six Phase 3 studies. AbbVie anticipates a regulatory decision in the third quarter of 2019.

AbbVie announced that the FDA approved the use of IMBRUVICA (ibrutinib) in combination with obinutuzumab, for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This milestone marked the 10th FDA approval for IMBRUVICA in six different disease areas since 2013 and expands the use of IMBRUVICA, which can already be administered as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients. The FDA approval is based on results from the Phase 3 iLLUMINATE study, which showed the combination of IMBRUVICA plus obinutuzumab significantly improved progression-free survival compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. The FDA also updated the IMBRUVICA label to include additional long-term efficacy follow-up data from the Phase 3 RESONATE and RESONATE-2 studies, supporting its use as a single agent in CLL/SLL. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.

AbbVie announced that the FDA granted a fifth Breakthrough Therapy Designation to VENCLEXTA (venetoclax), for use in combination with obinutuzumab as a fixed duration investigational combination, for untreated adult patients with CLL. The designation coincides with the completion of the supplemental New Drug Application (sNDA) submission to the FDA for approval in previously-untreated CLL patients. In addition, the sNDA was granted priority review by the FDA. The sNDA for the VENCLEXTA and obinutuzumab combination is based on data from the Phase 3 CLL14 trial and is being reviewed by the FDA under its Real-Time Oncology Review pilot program. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

AbbVie provided an update on the VENCLEXTA multiple myeloma program, announcing that the FDA placed a partial clinical hold on all clinical trials evaluating VENCLEXTA for the investigational treatment of multiple myeloma. The partial clinical hold followed a review of data from the ongoing Phase 3 BELLINI trial, a study in relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the VENCLEXTA arm compared to the control arm of the trial. This action does not impact any of the approved indications for VENCLEXTA, such as CLL or acute myeloid leukemia, and is limited to investigational clinical trials in multiple myeloma. Additional analyses are ongoing and data will be published in a peer-reviewed journal and/or presented at a future medical meeting.

Recent Events (continued)

AbbVie announced a strategic partnership with Teneobio, a biotechnology company developing a new class of biologics for the treatments of cancer, autoimmunity and infectious diseases. Under the agreement, AbbVie and Teneobio will develop and commercialize TNB-383B, a B-cell maturation antigen (BCMA)-targeting immunotherapeutic for the potential treatment of multiple myeloma. TNB-383B is a bispecific antibody that simultaneously targets BCMA and CD3 and is designed to direct the body’s own immune system to target and kill BCMA expressing tumor cells. The collaboration broadens AbbVie’s oncology research platform to expand the development of potentially life-changing treatments for patients.

AbbVie announced a strategic collaboration with Voyager Therapeutics, a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. The Voyager Therapeutics transaction expands collaborative efforts on vectorized antibodies to target pathological species of alpha-synuclein for the potential treatment of Parkinson’s disease and other diseases characterized by the abnormal accumulation of misfolded alpha-synuclein protein. Voyager’s vectorized antibody platform and approach aims to improve the delivery of sufficient quantities of antibodies across the blood-brain barrier by delivering the genes that encode for the production of therapeutic antibodies. The collaboration broadens AbbVie’s neuroscience research platform to expand the development of potentially life-changing treatments for patients.

Full-Year 2019 Outlook

AbbVie is raising its GAAP diluted EPS guidance for the full-year 2019 to $7.26 to $7.36. The company’s 2019 GAAP guidance does not reflect a non-cash charge for contingent consideration related to the approval of SKYRIZI, which is planned to be communicated on the second-quarter earnings call. AbbVie is raising its previously announced adjusted EPS guidance range for the full-year 2019 from $8.65 to $8.75 to $8.73 to $8.83, representing growth of 11.0 percent at the mid-point. The company’s 2019 adjusted diluted EPS guidance excludes $1.47 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.