Johnson & Johnson delivered solid results in 2012, reflecting continued sales momentum in many parts of our business driven by our focus on delivering meaningful innovation in health care to patients and customers. Our results included strong growth of key products, successful new product launches, and the addition of Synthes to our family of companies. In addition, we continued to make important investments building strategic partnerships and in advancing our pipeline, positioning us well for delivering sustainable growth.
With $25.4 billion in worldwide sales in 2012, we are the eighth-largest pharmaceuticals business in the world and the sixth-largest biotech business. Primary contributors to strong operational growth of 6.8 percent include REMICADE® (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases; VELCADE® (bortezomib), a treatment for multiple myeloma; PREZISTA® (darunavir), a treatment for HIV; and a number of recently launched products.
We are accelerating growth while ensuring greater access and reimbursement by implementing strong launch programs for recently approved products including ZYTIGA® (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer; INVEGA® SUSTENNA®/XEPLION® (paliperidone palmitate), a once-monthly, long-acting, injectable atypical antipsychotic for treatment of schizophrenia in adults; INCIVO® (telaprevir), a direct-acting antiviral protease inhibitor for the treatment of genotype-1 chronic hepatitis C virus, in combination with peg interferon alfa and ribavirin, in adults; STELARA® (ustekinumab), a biologic approved for the treatment of adults with moderate to severe plaque psoriasis; XARELTO® (rivaroxaban), an oral anticoagulant; and SIMPONI® (golimumab), a biologic approved to treat adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis and active ankylosing spondylitis.
Sales results were negatively impacted by generic competition for LEVAQUIN® (levofloxacin), a treatment for bacterial infections, and the manufacturing suspension at a third-party supplier for DOXIL® (doxorubicin HCl liposome injection)/CAELYX® (pegylated liposomal doxorubicin hydrochloride), a medication to treat ovarian and other cancers. In December, the U.S. Food and Drug Administration (FDA) granted accelerated approval for SIRTURO™ (bedaquiline) tablets for the treatment of pulmonary multi-drug-resistant tuberculosis as part of combination therapy in adults. It is currently under review by three regulatory bodies including the European Medicines Agency (EU), State Food and Drug Administration (China) and Medicines Control Council (South Africa). The FDA and the European Commission also approved an expanded indication for ZYTIGA® (abiraterone acetate), in combination with prednisone, allowing for the use before chemotherapy in the treatment of metastatic castration-resistant disease.
In November, the FDA approved additional indications for XARELTO® (rivaroxaban) for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment. In addition, the FDA approved a new 800mg tablet of PREZISTA® (darunavir) for once-daily oral administration for the treatment of human immunodeficiency virus (HIV-1) in treatment-naïve and treatment-experienced adult patients with no darunavir resistance-associated mutations.
In August, the FDA approved the supplemental New Drug Application for NUCYNTA® ER (tapentadol) extended-release tablets for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults. In September, the European Commission approved the marketing authorization for DACOGEN® (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia, and for the subcutaneous administration of VELCADE® (bortezomib) for the treatment of multiple myeloma.
We have an exciting and late-stage pipeline of differentiated medicines. New Drug Applications are presently under review in the United States and in the European Union seeking approval for INVOKANA* (canagliflozin), our first pharmaceutical treatment for patients with type 2 diabetes. Additional submissions included a supplemental Biologics License Application to the FDA and a Type II Variation to the European Medicines Agency requesting approval of STELARA® (ustekinumab) for the treatment of adults with active psoriatic arthritis and of SIMPONI® (golimumab) for the treatment of adults with moderately to severely active ulcerative colitis. A Biologics License Application was also submitted to the FDA seeking approval of intravenous (I.V.) golimumab for the treatment of moderately to severely active RA.
* Proposed trade name.
Medical Devices and Diagnostics
With $27.4 billion in worldwide sales in 2012, our Medical Devices and Diagnostics (MD&D) business is the largest medical technology business in the world. Operational growth was 8.7 percent. Sales included the impact of the recently completed acquisition of Synthes, Inc., which contributed 7.9 percent to worldwide MD&D segment operational sales growth, net of the divestiture of the DePuy trauma business. Primary contributors to operational growth were sales from the recently completed acquisition of Synthes, Inc. in the Orthopaedics business; a number of products in the Specialty Surgery business; electrophysiology products in the Cardiovascular Care business of Biosense Webster, Inc.; disposable contact lenses from Vistakon Division of Johnson & Johnson Vision Care, Inc.
While overall market growth has slowed, we’ve been focusing on building our market leadership position and we hold No. 1 or No. 2 positions in 80 percent of our key platforms.
We continue to invest for long-term sustainable growth and completed the largest acquisition in our history with Synthes. In June, DePuy and Synthes joined to form the world’s largest, most comprehensive orthopaedics and neurologics organization. A total solutions business, DePuy Synthes offers an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials, and has the opportunity to contribute in greater ways to meet the needs of today’s dynamic health care environment.
In 2012, the FDA approved EVARREST™ Fibrin Sealant Patch, a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery. The FDA also approved the S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in the superficial femoral artery and/or the proximal popliteal artery. The HARMONIC ACE®+ Shears with Adaptive Tissue Technology, strengthening our position in the fast-growing Energy market, was also approved by the FDA in 2012.
Earlier in the year, Ethicon Endo-Surgery, Inc. received an approvable letter for the SEDASYS® System, a computer-assisted personalized sedation system, from the FDA’s Center for Devices and Radiological Health. In addition, Biosense Webster’s THERMOCOOL® SMARTTOUCH™ Contact Force Sensing Catheter received CE Mark clearance in Europe. The catheter provides real-time information about the precise amount and direction of the force being applied during cardiac ablation procedures.
We’re expanding our global presence with strong growth in emerging markets. And as we look to the future, we’re advancing innovative new products in our pipeline, continuing to take a disciplined approach to managing our portfolio and adapting our business to the changing marketplace.
With $14.4 billion in worldwide sales in 2012, our Consumer business is the sixth-largest consumer health care business in the world. Operational growth was 0.5 percent. We remain committed to strengthening the Consumer business starting by continuing to restore a reliable supply of our McNeil over-the-counter (OTC) products to the U.S. market.
Meanwhile, positive contributors to operational results were sales of upper respiratory OTC products outside the U.S.; international sales of LISTERINE® oral care products; and U.S. sales of NEUTROGENA® skin care products. Our investments for growth in Consumer will be predicated on a focused product portfolio approach to deliver science-based products with local market insights, professional endorsements and commercial excellence. We have taken steps to reshape our portfolio and have divested non-strategic products or brands. We are also investing in growth and expansion in emerging markets through the acquisition of market-specific brands like DOKTOR MOM® cough cold products in Russia and Shanghai Elsker Mother & Baby Co. Ltd. in China. We’re also continuing to leverage the strength of our iconic brands like JOHNSON’S® Baby and NEUTROGENA®.
Regarding McNeil, we’re continuing to operate in accordance with the consent decree. We’ve achieved all commitments to date under the remediation work plan, which was approved by the FDA in 2012. The work to bring our plants fully online is progressing. We expect to return to a consistent supply of key products to the market over the course of 2013. Our efforts continue to be in the interest of serving customers, consistent with the responsibilities outlined in Our Credo.
NOTE ON FORWARD-LOOKING STATEMENTS
This Annual Report contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; significant adverse litigation or government action; impact of business combinations; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available on-line at www.sec.gov, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.