AbbVie Issues Inaugural Full-Year Outlook for 2013
PR Newswire/Les Echos/
AbbVie Issues Inaugural Full-Year Outlook for 2013
- HUMIRA delivers 9th year of double-digit growth in 2012; forecasting low double-digit growth in 2013
- Advances 11 Phase III programs; HCV Phase III trials underway and on track for early 2015 launch
- Pro vides full-year 2013 adjusted EPS guidance of $3.03 to $3.13 ($2.66 to $2.76 on a GAAP basis)
NORTH CHICAGO, Ill., Jan. 30, 2013 -- AbbVie (NYSE: ABBV) today confirmed it delivered strong sales growth with its marketed pharmaceutical products in 2012. The proprietary pharmaceutical segment of Abbott, representing the majority of AbbVie's revenue, grew more than 8 percent globally on an operational basis, excluding a nearly 3 percent negative impact from foreign exchange.
Performance was driven by solid double-digit growth from both HUMIRA and AndroGel and continued growth from the company's portfolio of market-leading therapies, including Creon and Synthroid.
Additionally, AbbVie is issuing adjusted earnings-per-share guidance for the full-year 2013 of $3.03 to $3.13, or $2.66 to $2.76 on a Generally Accepted Accounting Principles (GAAP) basis. The company's 2013 adjusted earnings-per-share guidance excludes $0.37 per share of non-cash intangible amortization expense and specified items, primarily associated with certain separation-related costs and previously announced ongoing restructuring activities.
"AbbVie's portfolio of marketed products delivered solid growth in 2012, positioning us well for healthy performance in our first year as an independent company," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "In 2013, we expect to deliver on AbbVie's key priorities of driving continued strong growth of HUMIRA, maximizing our specialty product portfolio, advancing our promising pipeline including our late-stage HCV program, and delivering returns to shareholders through our strong dividend."
Pipeline and Regulatory Milestones
In addition to strong sales growth, in 2012 AbbVie continued to execute on its regulatory and clinical objectives. This includes securing approvals for four new HUMIRA indications; the addition of two promising mid-stage compounds, including a next-generation JAK1 inhibitor and a novel therapy for acute kidney injury; and the advancement of key development programs, including the start of Phase III studies for our interferon-free Hepatitis C (HCV) combination and elagolix.
AbbVie expects long-term growth will be fueled by a compelling pipeline of therapies in development to address medical conditions with high unmet need. The company is focused on advancing a number of Phase III programs, including: an interferon-free oral combination for HCV; daclizumab for relapsing remitting multiple sclerosis (in partnership with Biogen); elagolix for endometriosis; elotuzumab for multiple myeloma (in partnership with Bristol Myers Squibb); and several new indications for HUMIRA.
In 2013, the company expects to initiate several Phase III programs including atrasentan for diabetic kidney disease and ABT-1 99 in chronic lymphocytic leukemia (CLL). Additionally, AbbVie is planning Phase IIB starts for: elagolix in uterine fibroids; our partnered JAK1 inhibitor (GLPG0634) for rheumatoid arthritis (RA); BT-061 for RA; and ABT-719 for acute kidney injury associated with major cardiac and other surgeries. Finally, in 2013, the company intends to present data from a number of key development programs, including our rapidly advancing HCV program, oncology, renal disease, immunology and Alzheimer's disease.
Management to Discuss Company Performance and Outlook on Investor Call Today
AbbVie will host an investor conference call today at 8 a.m. Central time to discuss our fourthquarter and full-year 2012 highlights and 2013 outlook. Participating on the call will be Rick Gonzalez, chairman and chief executive officer; Bill Chase, executive vice president and chief financial officer; Laura Schumacher, executive vice president of business development, external affairs and general counsel; John Leonard, senior vice president and chief scientific officer; and Larry Peepo, vice president of investor relations. The call will be webcast through Abb Vie's Investor Relations website at www.abbvieinvestor.com. An archived edition of the call will be available after 11 a.m. Central time.
Key Product Performance:
Sales ($ in millions) U.S. Int'l Total % Change vs. 4Q11 Int'l Total
U.S. Operational Reported Operational Reported HUMIRA 1,413 1,268 2,681 31.1 17.9 15.2 24.5 23.1 TRILIPIX/ TriCor 202 -- 202 (50.7) n/a n/a (50.7) (50.7) AndroGel 364 -- 364 40.5 n/a n/a 40.5 40.5 Kaletra 83 167 250 (17.0) (9.4) (11.4) (12.1) (13.4) Lupron 155 56 211 11.3 (17.4) (18.1) 1.8 1.6 Niaspan 277 -- 277 7.4 n/a n/a 7.4 7.4 Synthroid 168 -- 168 24.9 n/a n/a 24.9 24.9 Creon 105 -- 105 3.9 n/a n/a 3.9 3.9
The following is a summary of fourth-quarter 2012 sales for select AbbVie products.
Sales ($ in millions) U.S. Int'l Total % Change vs. 12M11 Int'l Total
U.S. Operational Reported Operational Reported HUMIRA 4,376 4,889 9,265 27.7 15.4 8.5 20.7 16.8 TRILIPIX/ TriCor 1,098 -- 1,098 (19.9) n/a n/a (19.9) (19.9) AndroGel 1,152 -- 1,152 31.7 n/a n/a 31.7 31.7 Kaletra 280 733 1,013 (14.1) (7.6) (13.2) (9.4) (13.4) Lupron 569 231 800 5.4 (10.5) (14.4) 0.1 (1.2) Niaspan 911 -- 911 (6.7) n/a n/a (6.7) (6.7) Synthroid 551 -- 551 5.7 n/a n/a 5.7 5.7 Creon 353 -- 353 6.5 n/a n/a 6.5 6.5
Note: "Operational" growth reflects percentage change over the prior year excluding the impact of exchange rates.
About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. With its 1 25-year history, 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. In 2013, AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit http://www.abbvie.com/. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
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. 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. Economic, competitive, governmental, technological and other factors that may affect AbbVie's operations are discussed in the "Risk Factors" section of the Information Statement attached to our Form 10 Registration Statement, which has been filed with the SEC, and are incorporated by reference. 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.
CONTACT: Media, Jennifer Smoter, +1-847-935-8865, or Greg Miley, +1-847-938-4898, or Adelle Infante, +1-847-938-8745, or Investors, Larry Peepo, +1-847-935-6722, or, Liz Shea, +1-847-935-2211
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