Year Established: 1896
Total Revenue: $66,049 (-5%)
Pharma Revenues: $50,431 (-8%)
Net Income: $17,06 (+25%)
R&D: $12,934 (+25%)
TOP SELLING DRUGS
|Ocrevus||Relapsing-Remitting MS (RRMS)||$4,703||26%|
|Tecentriq||bladder, lung and breast cancer||$2,978||58%|
Despite posting negative sales growth in 2020, Roche claimed the top spot in this year’s report backed by $50.4 billion of revenue in its pharmaceuticals division. Sales dipped 8% due to biosimilar erosion—strongest in the U.S.—and the impact of COVID-19, which reduced hospitalizations and outpatient visits.
New products were a major growth driver for Roche in 2020 with Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla leading the charge. Tecentriq sales were 58% higher at $3 billion, with growth in all regions. The launch and rollout of Hemlibra continued with sales reaching $2.4 billion—a 59% growth. Sales of Ocrevus were 26% higher at $4.7 billion while Perjeta sales were $4.2 billion, an increase of 19%, mostly due to growth in China. Kadcyla sales grew by 35% to $1.9 billion mainly due to higher demand in both the U.S. and Europe.
In the U.S., the first biosimilar versions of Herceptin (-33%), Avastin (-24%) and MabThera/Rituxan (-46%) entered the market in the second half of 2019 and U.S. sales of these three products dropped significantly as a result in 2020. At the same time, in Europe, the first biosimilar versions of Avastin came to market from mid-2020 and were a significant factor in the sales decline for the breast cancer drug in the second half of 2020.
In 2020 Roche responded to the challenges of the COVID-19 pandemic with both its pharmaceuticals and diagnostics businesses. In the pharmaceuticals division, Actemra/RoActemra has been adopted by many countries in their treatment guidelines to treat patients with severe COVID-19 pneumonia.
In August, Roche and Regeneron partnered to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 provided a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus. This collaboration aims to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.
In April 2021, Roche and Regeneron announced that the Phase III clinical trial REGN-COV 2069 met both primary and secondary endpoints, reducing risk of infection by 81% for the non-infected patients, and reducing time-to-resolution of symptoms for symptomatic patients to one week vs. three weeks in the placebo group. Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S. Each company has committed to dedicate manufacturing capacity to REGN-COV2 each year.
In other COVID news, Roche formed a partnership with Atea Pharmaceuticals in October to develop, manufacture and distribute AT-527, an investigational novel oral antiviral. In April 2021, Atea dosed the first subject in the Phase III MORNINGSKY trial.
Drug development during the pandemic
Despite the massive disruption of a global pandemic, Roche’s commitment to developing new medicines resulted in seven new molecules moving to pivotal clinical studies in 2020, compared to approximately three per year over the last four years. Partnering efforts provided access to four late-stage medicines, about four times the average of recent years. In 2020, Roche was granted authorizations for four new medicines, and has a record number of 19 new medicines in registrational studies or filed for approval.
Two FDA approvals offer benefits for patients living with rare disorders of the central nervous system (CNS) which previously had limited treatment options. Enspryng is the first and only subcutaneous treatment for adults living with neuromyelitis optica spectrum disorder. This condition primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness, and paralysis. It often is misdiagnosed as multiple sclerosis.
Evrysdi was also approved for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older. Throughout their lives, many people with SMA may lose their ability to perform critical physical movements, such as sitting upright.
On the cancer drug front, Gavreto (pralsetinib) received FDA approval for the treatment of adults with metastatic RET-altered non-small cell lung cancer, as detected by an FDA-approved test. This is a once-daily, oral precision therapy. Phesgo received approvals in the U.S. and the EU for the treatment of early and metastatic HER2-positive breast cancer. This fixed-dose combination of Perjeta and Herceptin with hyaluronidase is administered by subcutaneous injection, and is used in combination with intravenous chemotherapy.
Acquisitions and alliances
In 2020 Roche made several significant asset acquisitions and alliances. In September, Roche acquired the Irish biotech firm Inflazome for $449 million. Founded in 2016, the firm is developing inflammasome inhibitors to treat clinically unmet needs across various inflammatory diseases including Parkinson’s disease, Alzheimer’s disease, asthma, inflammatory bowel disease and arthritis, among other chronic inflammatory diseases. The firm’s portfolio includes orally available small molecule NLRP3 inhibitors. Through the acquisition, Roche gained complete rights to Inflazome’s portfolio of clinical and preclinical NLRP3 inhibitors.
In October, Roche bolstered is portfolio for cystic fibrosis (CF) treatment with the acquisition of Enterprise Therapeutics’ TMEM16A potentiator portfolio, which includes ETD002, a therapeutic candidate being evaluated in Phase 1 clinical trials for the treatment of CF. The TMEM16A portfolio is focused on treatments for CF and other severe respiratory disorders characterized by excessive mucus congestion. Genentech, a member of the Roche Group, is leading the development of the TMEM16A portfolio.
During the year Roche completed a licensing agreement with Sarepta Therapeutics under which it acquired the exclusive rights to launch and commercialize SRP-9001, Sarepta’s investigational micro-dystrophin gene therapy for Duchenne muscular dystrophy (DMD) outside the U.S. Roche paid Sarepta $1.15 billion upfront.
In July, Roche paid Blueprint Medicines $775 million for the co-development and co-commercialization rights for pralsetinib (Gavreto), an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer (NSCLC), various types of thyroid cancer and other solid tumors.
Other significant transactions included an upfront payment of $190 million to Arrakis Therapeutics for a strategic collaboration and licensing agreement for the discovery of RNA-targeted small molecule (rSM) drugs against a broad set of targets across all of the Pharmaceutical Division’s research and development areas.
There was also an upfront payment of $200 million to Vaccibody AS for a worldwide collaboration and licensing agreement to develop DNA-based individualized neoantigen cancer vaccines based on VB10.NEO across multiple tumor types.
In addition, there was an upfront payment of $135 million to Vividion Therapeutics for rights to Vividion’s proteomics screening platform and proprietary small molecule library to target novel E3 ligases, as well as a range of oncology and immunology therapeutic targets.
Lastly, an upfront payment of $120 million was paid to UCB for rights to UCB’s investigational monoclonal antibody drug being developed as a potential treatment for patients with Alzheimer’s disease.