Roche is developing the company’s internal capabilities and building strategic partnerships ready for the next stage in personalized healthcare.
F. Hoffmann-La Roche ltd.
Telephone: +41-61-688 1111
Best-Selling Rx Products
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exchange in 2017: SFr 0.9842.
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All sales are in millions of dollars, except EPS,
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Board’s average rate of exchange in 2017:
With an in-house combo of Pharmaceuticals and Diagnostics, Roche is uniquely positioned to deliver personalized healthcare. Roche is combining insights from multiple data sources with sophisticated analytics to drive more effective and efficient research, and allow for better therapeutic decisions for patients. Company management says Roche will continue to focus entirely on prescription medicines and in vitro diagnostics, rather than diversify into other sectors such as generics and biosimilars, over-the-counter products, and medical devices.
As digital technology transforms healthcare, the innovation-focused Roche is at the forefront of driving key developments such as machine learning, robotics and deep data in diagnostics and pharmaceuticals. Roche leadership sees the digital revolution having a major impact in four key areas: transforming clinical studies, improving treatment outcomes, enabling patient empowerment, and efficiency.
According to company management, the combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is also the world’s leading biotechnology company with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and CNS diseases. Roche is also the global leader in in vitro diagnostics and tissue-based cancer diagnostics, as well as a front-runner in diabetes management.
“To ensure we can continue providing innovative products and services for patients, we invest about one-fifth of our sales in research and development (R&D) activities every year,” Roche executives say. “Thanks to our focus on science in areas of high unmet need, and with our expertise in pharmaceuticals and diagnostics under one roof, we have been successful in introducing six new medicines in different diseases and indications and many new diagnostic tests, instruments and services since late 2015. Additionally, we have broad and exciting pipelines in both our Pharmaceuticals and Diagnostics Divisions.”
Roche is additionally innovating in fields of unmet need by developing new medicines for diseases in which there has been no major progress for decades, including bladder cancer (Tecentriq), multiple sclerosis (Ocrevus) and giant cell arteritis (Actemra/RoActemra). Cleared for U.S. marketing by the FDA during November, Hemlibra offers immense potential for an improved quality of life for those with hemophilia A. Roche says the company’s point-of-care cobas Liat system tests provide precise test results rapidly, when time is of the essence for a patient’s survival.
“2018 will be a year of transition: as has long been foreseen, we expect more competition from biosimilars for our cancer medicines Rituxan/MabThera and Herceptin, mainly in Europe, initially,” says Roche CEO Severin Schwan. “At the same time, however, we are systematically renewing our portfolio with innovative products. Though the challenges are multiplying, we believe we are well positioned to successfully overcome them, thanks to our ongoing strength in medical innovation.”
During first-half 2018, Roche continued with the implementation of various resourcing flexibility plans initiated during 2017 in the Group’s Pharmaceuticals Division to address future challenges, including biosimilar competition. The areas of the plans consist of biologics manufacturing, commercial operations and product development/strategy. Management also continued with the implementation of several major worldwide restructuring plans initiated in prior years, notably the strategic realignment of the Pharmaceuticals Division’s manufacturing network and programs to address long-term strategy in the Diagnostics Division, including costs related to a reorganization in the Molecular Diagnostics business.
For the 10th consecutive year, Roche was recognized as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). The No. 1 ranking is based on an in-depth analysis of economic, social and environmental performance. The DJSI family of indices operates as a benchmark for investors who integrate sustainability considerations into their portfolios. Management says Roche has maintained the company’s leadership through an excellent sustainability strategy, which is fully embedded in the organization’s business and culture.
“We are proud of being recognized once again for our sustainability efforts,” Dr. Schwan states. “Our most important contribution to society is the development of medicines and diagnostics that significantly improve people’s lives. Open and constructive dialogue with other companies, universities, doctors and patients plays an essential role here in understanding the needs of our partners in the healthcare sector and enabling us to work together to develop more targeted medical solutions faster.”
2018 Performance & Outlook
Group sales for Roche increased 7 percent during the first six months of 2018 and core EPS advanced 19 percent year-over-year.
Excluding the U.S. tax reform effect, core EPS rose 8 percent, ahead of sales. Management says core EPS growth reflects the strong underlying business performance. IFRS net income in first-half 2018 rose 33 percent compared to the one-year-earlier period, due to the underlying core results and lower impairment of intangible assets compared to 2017.
Pharmaceuticals Division sales were up 7 percent over the 2017 first-half performance, coming in at CHF 21.8 billion. Key growth drivers were the recently launched products Ocrevus, used to treat two forms of multiple sclerosis, and the cancer drugs Perjeta, Alecensa and Tecentriq. According to Roche, Tamiflu contributed with high sales at the beginning of 2018 due to a severe flu season. As expected by management, the strong growth reported for the Pharmaceuticals Division was partially offset by decreased sales of Rituxan/MabThera and Tarceva.
U.S. sales during the January-June 2018 period went up 15 percent, driven by Ocrevus, Herceptin, and Perjeta. Ocrevus sales were bolstered by continued strong new patient demand. Perjeta’s 27 percent sales growth was fueled by the medicine’s use for adjuvant (after surgery) treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
Europe sales were down 8 percent, as strong launches of the new medicines Ocrevus, Tecentriq, and Alecensa (especially in Germany) partially offset decreasing sales of Rituxan/MabThera (-47 percent), which were impacted by biosimilars. Perjeta sales continued to improve during the 2018 first half, specifically in the metastatic and neoadjuvant settings. International region sales climbed up 5 percent, led by the Latin America and Asia-Pacific subregions. Japan sales were stable compared to the January-June 2017 performance, despite government price cuts.
Diagnostics Division sales in the first six months of 2018 improved 6 percent to CHF 6.3 billion. Centralized and Point of Care Solutions (+6 percent) was the leading contributor, paced by the growth of the immunodiagnostics business (+9 percent). According to Roche, sales grew in all business areas. In regional terms, growth was propelled by Asia-Pacific (+14 percent) and North America (+7 percent). Sales during first-half 2018 went up 1 percent in EMEA and 6 percent in Latin America. For Japan, sales dropped off 2 percent versus the first-half 2017 result because of lower sales in the molecular diagnostics business.
First-half 2018 core operating profit increased 11 percent in the Pharmaceuticals Division while remaining stable in the Diagnostics Division. The IFRS results include lower intangible asset impairment charges of CHF 0.3 billion versus CHF 1.5 billion between 2017’s first two quarters.
In announcing the company’s first-half 2018 results, Roche’s outlook was raised for the full year. Group leadership anticipates mid-single digit sales growth at constant exchange rates. Core EPS is projected to grow in the mid-teen digits at constant exchange rates for full-year 2018.
EvaluatePharma’s World Preview 2018 edition projects that Roche will generate $50.6 billion in prescription drug sales in 2024, which would place the company in third place among the industry titans.
“Oncology still dominates the Swiss company’s portfolio, with Tecentriq its leading single growth driver, but the company is increasingly relying on non-oncology assets to drive growth with products like Ocrevus and Hemlibra,” according to the analysis.
The EvaluatePharma (EP) report forecasts that biotechnology leader Roche will continue to significantly outpace the rest of its peers in the years to come in terms of annual biotech sales, with a compound annual growth rate (CAGR) of 3 percent from 2017 resulting in $41.1 billion in biotech sales in 2024.
“Roche will continue to be the undisputed market leader for biotechnology products in 2024, highlighting again the long-term value Roche gained through its acquisition of Genentech, a biotechnology pioneer, and continued investments in biotechnology products.”
The EP analysis also highlights that Roche’s recently launched (products introduced from 2015 onward) and pipeline portfolio is forecast to generate the second-highest value in cumulative sales during 2018 to 2024 among all pharma companies with projected sales of $94.9 billion, “surprisingly due in large part to non-oncology therapies.” Roche’s trio of Ocrevus, Tecentriq and Hemlibra are expected to lead the sales charge during that time period among the company’s recently launched and pipeline products.
Roche will continue to lead the industry in R&D spending with a projected $11.7 billion expenditure in 2024 stemming from 3 percent CAGR from 2017, EP analysts predict. That total would eclipse the predicted No. 2 R&D spender (J&J) in 2024 by a hefty $1.7 billion.
“Roche maintains its position as the top forecasted spender on R&D in 2024, with a spend of $11.7bn, with forecasts likely driven by its historically intense R&D operations and estimates of the trial programs needed by Roche within its core oncology business to ensure continued label expansions after initial approvals,” EP analysis notes.
Oncology sales will continue to be a Roche pillar, coming in at $27.82 billion during 2024 according to EP projections. “In 2024, five of the top 10 companies in oncology will hold their 2017 position, including Roche – the market leader. Nonetheless, Roche’s market share is forecast to decline by 14.5 percent from 2017 to 2024 with a CAGR of only 0.2 percent, lower than the 12 percent average for the other nine companies in the top 10. The low growth is due to expected biosimilar erosion of key products (Avastin, Rituxan, Herceptin) and the company being late to market in the PD-1/PDL-1 space with Tecentriq (third-to-market)However, Roche has made steps this year to combat stagnancy with multiple deals in oncology, including acquiring Ignyta (gaining multiple novel oncology compounds) and Flatiron (a big data analytics company focused on oncology health records),” according to EP analysts.
Billion-Dollar Deals During 2018
Roche completed the acquisition of Ignyta on February 8 after announcing a definitive merger agreement on Dec. 22, 2017. At a price of $27 per share in an all-cash transaction, the total deal value amounted to $1.7 billion on a fully diluted basis.
Ignyta has concentrated on precision medicine in oncology aiming to test, identify, and treat patients with cancers harboring specific rare mutations. Ignyta develops potentially life-saving, precisely targeted therapeutics (Rx) guided by diagnostic (Dx) tests to cancer patients. Ignyta’s integrated Rx/Dx strategy allows the company to enter uncharted territory, according to its management, illuminating the molecular and immunological drivers of cancer and quickly advancing treatments to address them. The San Diego-based company’s lead molecule entrectinib is an orally bioavailable, CNS-active tyrosine kinase inhibitor being developed in a pivotal phase 2 study for tumors that harbor ROS1 or NTRK fusions.
Roche completed the acquisition of the privately held healthcare technology and services company Flatiron Health on April 8. The New York-based company is a market leader in oncology-specific electronic health record (EHR) software as well as in the curation and development of real-world evidence for cancer research. With a large U.S. network of community oncology practices and academic medical centers, Flatiron Health leadership says the company has created a technology platform designed to learn from the experience of every patient.
The deal value for the Flatiron acquisition totaled $1.9 billion on a fully diluted basis, subject to certain adjustments. Flatiron Health continues business operations as a separate legal entity and the company’s existing business model, network of partnerships and overall objectives remain intact. As oncology leaders in their respective areas, the acquisition enables Roche and Flatiron to accelerate progress towards data-driven personalized healthcare in cancer.
“This is an important step in our personalized healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments,” comments Daniel O’Day, CEO of the Roche Pharmaceuticals business. “As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry. A key principle of this is to preserve Flatiron’s autonomy and their ability to continue providing their services to all existing and future partners.”
In another billion-dollar deal during 2018, Roche and Foundation Medicine reached a definitive merger agreement to accelerate broad availability of comprehensive genomic profiling in oncology. The total transaction value is $2.4 billion on a fully diluted basis, with a total company value of $5.3 billion on a fully diluted basis.
The two companies are leveraging expertise in genomics and molecular information to enhance the development of personalized medicines and care for cancer patients. Management says the merger focuses on driving ubiquity of Foundation Medicine’s high-quality comprehensive genomic profiling (CGP) testing and innovative data services to realize Roche’s vision of personalized healthcare. Foundation Medicine continues to operate as a separate and autonomous legal entity.
Roche announced during September the worldwide availability of FoundationOne Liquid. The biopsy test can identify circulating tumor DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumors.
Product Approvals/Launches & Pipeline Updates During 2018
Hemlibra became the first new medicine approved in more than 20 years to treat people with hemophilia A with inhibitors in Europe after winning regulatory clearance on Feb. 23. The European Commission cleared Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors and can be used in all age groups.
The bispecific factor IXa- and factor X-directed antibody is available in the United States for patients with hemophilia A with factor VIII inhibitors. FDA marketing clearance was granted during November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.
The EU marketing approval is based on two of the largest pivotal trials (HAVEN 1 and 2) in people with hemophilia A with inhibitors. In the clinical studies, Hemlibra showed superior efficacy versus prior treatment with bypassing agents as prophylaxis or on-demand. The medicine is being studied in a robust clinical development program that includes two additional phase III trials, HAVEN 3 and HAVEN 4. The clinical development program is evaluating the safety and efficacy of Hemlibra and the drug’s potential to help overcome current clinical challenges: the short-lasting effects of existing treatments, the development of factor VIII inhibitors, and the need for frequent venous access.
Hemlibra is designed to bring together factor IXa and factor X, proteins necessary to activate the natural coagulation cascade and restore the blood-clotting process for individuals with hemophilia A. The prophylactic (preventative) treatment is the first medicine that can be administered by an injection of a ready-to-use solution under the skin once per week.
Hemlibra was created by Roche Group member Chugai Pharmaceutical and is being jointly developed by Chugai, Roche, and Genentech.
Another growth driver for Roche that won initial approval from the European Commission during the 2018 first quarter was Ocrevus (ocrelizumab). Cleared for marketing by the EU health regulator on January 8, the new drug was approved for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (PPMS). Ocrevus is the first approved disease-modifying medicine for people in the European Union with early PPMS.
Ocrevus was introduced to the U.S. marketplace in April 2017. The medicine has been granted approval for use in countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia and Switzerland.
The humanized monoclonal antibody Ocrevus is designed to target CD20-positive B cells, a specific type of immune cell believed to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can result in disability in people with multiple sclerosis. Preclinical studies demonstrate that Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore significant functions of the immune system may be preserved.
In September, FDA approved a subcutaneous version of Actemra for use in active systemic juvenile idiopathic arthritis (sJIA), a rare form of juvenile arthritis. Approved for use in patients 2 years and older, Actemra can be administered alone or in combination with methotrexate (MTX) in patients with sJIA. U.S. regulators approved the intravenous form of Actemra (tocilizumab) for patients 2 years of age and older with active sJIA in 2011.
Actemra/RoActemra is the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for treating adults with moderate-to-severe active rheumatoid arthritis. The medicine can be used alone or with methotrexate in adult rheumatoid arthritis patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). RoActemra IV and SC are additionally available in Europe for use in adults with severe, active, and progressive RA who previously have not been treated with MTX. The IV and SC formulations are approved around the world for polyarticular juvenile idiopathic arthritis (pJIA) and the IV version is available for sJIA in children 2 years of age and older.
Actemra/RoActemra SC injection is the first approved therapy for treating giant cell arteritis (GCA) in more than 40 countries, including the United States and Europe. In the United States and Europe, Actemra/RoActemra IV injection is marketed for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people 2 years of age and older. Actemra represents the first approved treatment for CRS in this setting. Approved in Japan since 2005, Actemra is cleared for marketing in that country as a treatment for Castleman’s Disease and Takayasu Arteritis. Actemra/RoActemra is part of a joint-development agreement with Chugai Pharmaceutical.
Some of Roche’s top-selling medicines were granted new indications during the course of 2018, including the blockbuster anti-cancer treatment Avastin (bevacizumab). During June, Avastin received U.S. marketing clearance in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with advanced (stage III or IV) ovarian cancer following initial surgical resection.
With this approval, Avastin is available in the United States for 10 distinct uses across six different types of cancer (colorectal, non-small cell lung, kidney, cervical, ovarian, and glioblastoma). The approval also marks Avastin’s fourth gynecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.
Initially approved by the FDA for advanced colorectal cancer during 2004, Avastin was the first anti-angiogenic therapy made widely available for treating patients with an advanced cancer. As of June, more than 2.7 million patients had been treated with Avastin. A comprehensive clinical program has studied Avastin in 50-plus tumor types.
Another multi-billion brand approved for a new indication in the United States in June was Rituxan (rituximab). The drug won FDA approval for the treatment of moderate to severe pemphigus vulgaris. The rare, serious, life-threatening condition is characterized by progressive painful blistering of the skin and mucous membranes. Rituxan is the first biologic therapy to receive U.S. marketing clearance for pemphigus vulgaris and represents the first major advancement in the treatment of the disease in more than 60 years.
Initially approved by FDA during February 2004, Rituxan is marketed around the globe for forms of blood cancer, rheumatoid arthritis and certain types of vasculitis.
Additionally in June, Rituxan won U.S. regulatory approval in combination with Venclexta (venetoclax) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. The first-of-its-kind targeted therapy is jointly commercialized by AbbVie and Genentech in the United States and is commercialized by AbbVie as Venclyxto in non-U.S markets.
FDA’s marketing clearance in June converted Venclexta’s accelerated approval to a full approval. The U.S. regulatory agency additionally updated the indication for Venclexta as a single agent for treating people with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy. The medicine was previously granted accelerated approval during April 2016 as a single agent for treating CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
The supplemental new drug application based on the MURANO phase III clinical data was issued priority review by the FDA. U.S. regulators additionally previously granted breakthrough therapy designation for Venclexta in combination with Rituxan for relapsed or refractory CLL.
An application for a variation of the marketing authorization based on the MURANO clinical data has been filed to and validated by the European Medicines Agency. Other submissions of the MURANO data to health authorities around the globe are under way. MURANO (NCT02005471) is an open-label, international, multicenter, randomized trial assessing the efficacy and safety of Venclexta in combination with Rituxan versus bendamustine in combination with Rituxan (BR).
Venclexta is being assessed in phase III studies for treating CLL, along with studies in several other types of cancers. The product has received four FDA Breakthrough Therapy Designations. Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays a significant role in a process known as apoptosis (programmed cell death).
The European Commission during June granted marketing clearance to Perjeta in combination with fellow blockbuster drug Herceptin and chemotherapy for post-surgery treatment of adults with HER2-positive early breast cancer at high risk of recurrence. The combo therapy was previously approved for treating advanced HER2-positive breast cancer, having been demonstrated to significantly extend survival versus Herceptin and chemotherapy alone.
The EU regulatory body on April 30 approved the use of Perjeta with a subcutaneous formulation of Herceptin as an alternative to the previously approved co-administration of Perjeta with the Herceptin intravenous formulation. The SC formulation allows Herceptin to be delivered to patients in two to five minutes through an injection under the skin, compared to 30 to 90 minutes necessary for the original IV formulation.
Perjeta works with Herceptin to provide a more comprehensive, dual blockade of the HER2 receptor. As a result, the drug combo prevents tumor cell growth and survival. The HER2 receptor is a protein located on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process thought to play a role in tumor growth and survival. Binding of Perjeta to HER2 may additionally signal the body’s immune system to eliminate the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, with each binding to the HER2 receptor, but to different places.
Roche announced marketing authorization for Alecensa (alectinib) during August as a treatment for anaplastic lymphoma kinase-positive lung cancer in China, the world’s second-largest pharma market. The approval followed priority review of Alecensa in China, occurring eight months after EMA marketing authorization and nine months after FDA regulatory clearance were granted.
Alecensa has been approved in more than 57 countries as of August as an initial (first-line) treatment for ALK-positive advanced NSCLC. The medicine was cleared for marketing by U.S. regulators in November 2017 and by EU health authorities during December 2017. Alecensa also has been approved in major markets – including the United States (December 2015) and European Union (April 2017) – for treating people with advanced ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib.
The highly selective, CNS active, oral drug Alecensa was created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumors are identified as ALK-positive.
Tecentriq (atezolizumab) in combination with Avastin as an initial treatment for advanced or metastatic hepatocellular carcinoma (HCC) was granted breakthrough therapy designation in July by U.S. regulators. HCC represents the most common type of liver cancer. Earlier during 2018, Roche started the IMbrave150 (NCT03434379) open-label, multicenter, randomized phase III trial studying the drug combo compared to sorafenib for previously untreated locally advanced, unresectable or metastatic HCC.
The monoclonal antibody Tecentriq is designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may allow for the activation of T cells. The drug has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across an extensive range of cancers.
Tecentriq is marketed in the United States, European Union, and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
Avastin is a biologic antibody designed to specifically bind to a protein called VEGF that plays a significant role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process called angiogenesis. Avastin is developed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is believed to be critical to a tumor’s ability to grow and spread.
Priority review was granted in June by the FDA for baloxavir marboxil as a single-dose, oral treatment for acute uncomplicated influenza in patients 12 years and older. The first-in-class drug has a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Roche says unlike other currently available antiviral treatments, baloxavir is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.
Baloxavir is also being evaluated in a phase III development program including pediatric and severely ill hospitalized patients with influenza. The new drug candidate was discovered by Shionogi and is being developed worldwide by Roche, Genentech, and Shionogi. Roche maintains global rights to baloxavir excluding Japan and Taiwan, which are retained exclusively by Shionogi. Baloxavir was granted approval in Japan during February 2018 under the brand name Xofluza.