07.11.16
Headquarters: New Brunswick, NJ
twitter.com/JNJComm
www.jnj.com
Headcount: 127,000
Year Established: 1887
Revenues: $70,074 (-6%)
Pharma Revenues: $31,430 (-3%)
Net Income: $16,323 (+18%)
R&D: $9,046 (+7%)
TOP SELLING DRUGS
Johnson & Johnson (J&J) has a portfolio focused on five core therapeutic areas—immunology, infectious diseases and vaccines, neuroscience, cardiovascular and metabolism, and oncology. Combined segment sales in 2015 were $31.4 billion, a decrease of 2.7% from 2014. J&J said the pharma segment was negatively impacted by the introduction of competitive products to the company’s Hepatitis C products, Olysio/Sovriad (simeprevir) and Incivo (telaprevir).
Immunology products achieved sales of $10.4 billion in 2015, representing an increase of 2.1% compared to the prior year driven by the increased sales of Sterlara (ustekinumab) and Simponi/Simponi Aria (golimumab). Growth was partially offset by lower Remicade (infliximab) sales due to the weakening of the euro and biosimilar competition in Europe.
Infectious disease products sales were $3.7 billion, a decline of 34.7% from 2014. Competitive products to the company’s Hepatitis C products, Olysio/Sovriad and Incivo had a significant negative impact on U.S. sales and will continue to have a negative impact on future sales, according to the company.
Neuroscience products sales were $6.3 billion, a decrease of 3.5% from 2014. J&J reports the U.S. sales growth of Concerta/methylphenidate was primarily due to a therapeutic equivalence reclassification of generic competitors by the FDA in November 2014. In addition, strong sales were reported upon the launch of Invega Trinza. However, neuroscience products sales were negatively impacted by the U.S. divestiture of Nucynta (tapentadol) and lower sales of Risperdal Consta (risperidone).
Oncology products achieved sales growth of $4.7 billion in 2015, representing an increase of 5.3% as compared to the prior year. Contributors to the growth were strong sales of Imbruvica (ibrutinib) due to the approval of new indications, additional country launches and strong patient uptake. Additionally, sales of Zytiga (abiraterone acetate) grew in the U.S. and in Asia and Latin America, but were lower in Europe due to competition.
Cardiovascular, metabolism and other products achieved sales of $6.4 billion in 2015, representing an increase of 15% as compared to the prior year due to strong sales of Xarelto (rivaroxaban) and Invokana/Invokamet (canagliflozin).
While overall sales were down, the innovation engine at J&J steams ahead. During the year, the pharma giant unveiled plans to file for regulatory approval of more than 10 new products between 2015 and 2019, each with the potential to exceed $1 billion in revenue, as well as more than 40 line extensions of existing and new medicines. Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has launched 14 new products since 2009, seven of which already exceed or are on track to achieve sales in excess of $1 billion.
Late-stage products expected to drive growth in the next several years, following regulatory approvals, include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 (FGFRi kinase inhibitor) for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus (RSV); fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; JNJ-922 (Orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C.
In addition, daratumumab and esketamine have both received Breakthrough Therapy Designations from the U.S. FDA. Janssen also announced plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the EMA this year for daratumumab in double refractory multiple myeloma.
Acquisitions and partnerships
In March 2015, Janssen acquired XO1 Limited, a privately held asset-centric virtual biopharmaceutical company founded to develop the anti-thrombin antibody ichorcumab. Ichorcumab is a recombinant human antibody developed to mimic the activity of a human antibody, which appears to produce an anti-coagulated state without predisposition to bleeding.
Ichorcumab complements the Janssen cardiovascular portfolio. With its strong position in the fields of anticoagulation and biologics, J&J is well positioned to explore the potential of this next generation anticoagulant. The opportunity was identified and facilitated through Johnson & Johnson Innovation, London.
Ichorcumab was initially developed by Cambridge University Hospitals and Cambridge University with support from Cambridge Enterprise, the University’s commercialization arm. The technology was licensed by Cambridge Enterprise to XO1 Limited in order to take its development towards the clinic. XO1 Limited was established by Index Ventures as an asset centric company, a model advanced by Index, via a fund launched in 2012 in which Johnson & Johnson Innovation— JJDC, Inc. is an investor.
In another acquisition deal later in the year, J&J strengthened its pipeline to combat Hepatitis B virus when it acquired Novira Therapeutics, a privately held, clinical-stage biopharmaceutical company. The acquisition included Novira’s portfolio of novel antivirals, including its lead candidate, NVR 3-778, a small molecule, direct acting antiviral, for oral administration in patients with HBV that inhibits the HBV core or capsid protein. HBV core is a novel and promising drug target since it is involved in multiple activities required for viral replication and persistence.
During the year J&J also completed the divestiture of its Cordis business to Cardinal Health for an approximate value of $2 billion. The Cordis business is a global leader in the development and manufacture of interventional vascular technology and generated net revenues of approximately $780 million in 2014. At the time of the deal J&J reinforced its commitment to cardiovascular disease, focusing on its leading cardiovascular medicine, Xarelto.
During the year Janssen entered into a collaboration and license agreement with Bavarian Nordic to leverage their MVA-BN technology, jointly with Janssen’s own AdVac technology, in the development and commercialization of a heterologous prime-boost vaccine for the treatment of Human Papillomavirus (HPV) chronic infections, which can lead to cancer. Janssen will conduct all clinical development and, subject to regulatory approval, will be responsible for registration, distribution and commercialization of the potential combination vaccine worldwide.
Janssen also obtained worldwide rights, excluding China and Korea, to develop and commercialize oxyntomodulin-based therapies including HM12525A, a biologic that is completed Phase I and entered Phase II, from Hanmi Pharmaceutical. HM12525A is an oxyntomodulin-based therapy (GLP-1/glucagon receptor dual agonist) that has shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity. J&J said this asset has the potential, as a once weekly therapy, to be a best-in-class oxyntomodulin-based therapy.
twitter.com/JNJComm
www.jnj.com
Headcount: 127,000
Year Established: 1887
Revenues: $70,074 (-6%)
Pharma Revenues: $31,430 (-3%)
Net Income: $16,323 (+18%)
R&D: $9,046 (+7%)
TOP SELLING DRUGS
Drug | Indication | 2015 Sales | (+/-%) |
Remicade | rheumatoid arthritis | $6,561 | -5% |
Stelara | psoriasis | $2,474 | 19% |
Olysio/Sovriad | hepatitis C | $2,302 | n/a |
Zytiga | prostate cancer | $2,231 | 0% |
Xarelto | deep vein thrombosis, pulmonary embolism | $1,868 | 23% |
Invega Sustenna | schizophrenia | $1,830 | 15% |
Prezista | HIV/AIDS | $1,810 | -1% |
Velcade | velcade, mantle cell lymphoma | $1,333 | -18% |
Simponi | rheumatoid arthritis | $1,328 | 12% |
Invokana | type 2 diabetes | $1,308 | n/a |
Johnson & Johnson (J&J) has a portfolio focused on five core therapeutic areas—immunology, infectious diseases and vaccines, neuroscience, cardiovascular and metabolism, and oncology. Combined segment sales in 2015 were $31.4 billion, a decrease of 2.7% from 2014. J&J said the pharma segment was negatively impacted by the introduction of competitive products to the company’s Hepatitis C products, Olysio/Sovriad (simeprevir) and Incivo (telaprevir).
Immunology products achieved sales of $10.4 billion in 2015, representing an increase of 2.1% compared to the prior year driven by the increased sales of Sterlara (ustekinumab) and Simponi/Simponi Aria (golimumab). Growth was partially offset by lower Remicade (infliximab) sales due to the weakening of the euro and biosimilar competition in Europe.
Infectious disease products sales were $3.7 billion, a decline of 34.7% from 2014. Competitive products to the company’s Hepatitis C products, Olysio/Sovriad and Incivo had a significant negative impact on U.S. sales and will continue to have a negative impact on future sales, according to the company.
Neuroscience products sales were $6.3 billion, a decrease of 3.5% from 2014. J&J reports the U.S. sales growth of Concerta/methylphenidate was primarily due to a therapeutic equivalence reclassification of generic competitors by the FDA in November 2014. In addition, strong sales were reported upon the launch of Invega Trinza. However, neuroscience products sales were negatively impacted by the U.S. divestiture of Nucynta (tapentadol) and lower sales of Risperdal Consta (risperidone).
Oncology products achieved sales growth of $4.7 billion in 2015, representing an increase of 5.3% as compared to the prior year. Contributors to the growth were strong sales of Imbruvica (ibrutinib) due to the approval of new indications, additional country launches and strong patient uptake. Additionally, sales of Zytiga (abiraterone acetate) grew in the U.S. and in Asia and Latin America, but were lower in Europe due to competition.
Cardiovascular, metabolism and other products achieved sales of $6.4 billion in 2015, representing an increase of 15% as compared to the prior year due to strong sales of Xarelto (rivaroxaban) and Invokana/Invokamet (canagliflozin).
While overall sales were down, the innovation engine at J&J steams ahead. During the year, the pharma giant unveiled plans to file for regulatory approval of more than 10 new products between 2015 and 2019, each with the potential to exceed $1 billion in revenue, as well as more than 40 line extensions of existing and new medicines. Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has launched 14 new products since 2009, seven of which already exceed or are on track to achieve sales in excess of $1 billion.
Late-stage products expected to drive growth in the next several years, following regulatory approvals, include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 (FGFRi kinase inhibitor) for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus (RSV); fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; JNJ-922 (Orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C.
In addition, daratumumab and esketamine have both received Breakthrough Therapy Designations from the U.S. FDA. Janssen also announced plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the EMA this year for daratumumab in double refractory multiple myeloma.
Acquisitions and partnerships
In March 2015, Janssen acquired XO1 Limited, a privately held asset-centric virtual biopharmaceutical company founded to develop the anti-thrombin antibody ichorcumab. Ichorcumab is a recombinant human antibody developed to mimic the activity of a human antibody, which appears to produce an anti-coagulated state without predisposition to bleeding.
Ichorcumab complements the Janssen cardiovascular portfolio. With its strong position in the fields of anticoagulation and biologics, J&J is well positioned to explore the potential of this next generation anticoagulant. The opportunity was identified and facilitated through Johnson & Johnson Innovation, London.
Ichorcumab was initially developed by Cambridge University Hospitals and Cambridge University with support from Cambridge Enterprise, the University’s commercialization arm. The technology was licensed by Cambridge Enterprise to XO1 Limited in order to take its development towards the clinic. XO1 Limited was established by Index Ventures as an asset centric company, a model advanced by Index, via a fund launched in 2012 in which Johnson & Johnson Innovation— JJDC, Inc. is an investor.
In another acquisition deal later in the year, J&J strengthened its pipeline to combat Hepatitis B virus when it acquired Novira Therapeutics, a privately held, clinical-stage biopharmaceutical company. The acquisition included Novira’s portfolio of novel antivirals, including its lead candidate, NVR 3-778, a small molecule, direct acting antiviral, for oral administration in patients with HBV that inhibits the HBV core or capsid protein. HBV core is a novel and promising drug target since it is involved in multiple activities required for viral replication and persistence.
During the year J&J also completed the divestiture of its Cordis business to Cardinal Health for an approximate value of $2 billion. The Cordis business is a global leader in the development and manufacture of interventional vascular technology and generated net revenues of approximately $780 million in 2014. At the time of the deal J&J reinforced its commitment to cardiovascular disease, focusing on its leading cardiovascular medicine, Xarelto.
During the year Janssen entered into a collaboration and license agreement with Bavarian Nordic to leverage their MVA-BN technology, jointly with Janssen’s own AdVac technology, in the development and commercialization of a heterologous prime-boost vaccine for the treatment of Human Papillomavirus (HPV) chronic infections, which can lead to cancer. Janssen will conduct all clinical development and, subject to regulatory approval, will be responsible for registration, distribution and commercialization of the potential combination vaccine worldwide.
Janssen also obtained worldwide rights, excluding China and Korea, to develop and commercialize oxyntomodulin-based therapies including HM12525A, a biologic that is completed Phase I and entered Phase II, from Hanmi Pharmaceutical. HM12525A is an oxyntomodulin-based therapy (GLP-1/glucagon receptor dual agonist) that has shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity. J&J said this asset has the potential, as a once weekly therapy, to be a best-in-class oxyntomodulin-based therapy.