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Hoffmann-La Roche (Switzerland)

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Swiss drug giant Roche has come under pressure on several sides in recent years, but generally for the right reasons. Its pharmaceutical business remains very strong, with numerous new products ready for market, comparatively few facing imminent patent expiry and underlying profits at record levels. It is arguably the industry's most consistently admired company, with ten $1bn-plus blockbusters in 2018, more than any rival company. In the past, this has occasionally led to Roche being regarded as a takeover target, not least by Swiss rival Novartis which built up a shareholding of around 33% in the 2000s, against Roche's wishes. In order to focus more directly on its core business of drugs and diagnostics, Roche cut loose its consumer healthcare portfolio to Bayer in 2004. The group is a leader in in vitro diagnostics, as well as cancer and transplantation drugs. It is also a leader in biotech development, with multiple products already on the market, and more to follow from the pipeline. In addition to the main Roche business, the group operates through two important regional subsidiaries: Genentech in the US and Chugai Pharmaceuticals of Japan.

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Brands & Activities

Hoffmann-La Roche, known as Roche, is currently the world's #2 pharmaceutical company. Rather than get involved in the rush to consolidate which characterised the pharma industry between 1995 and 2003, Roche has focused on streamlining its portfolio to concentrate on personalised diagnostic systems and a portfolio of specialised drugs for high-demand illnesses such as cancer and influenza. That decision has left the group in a strong position. Its genetic testing devices in particular, which accurately measure individuals' responses to different drugs, form the vanguard for a new form of highly personalised health treatment which is likely to become standard over the next decade. It remains the #1 company in oncology drugs, #1 in biotech and #1 for in vitro diagnostics.

Pharmaceuticals

Pharmaceutical revenues were CHF 46.5bn ($47.5bn) in 2018. Although it is active in several different medical fields, the company is a world leader in oncology drugs, and its portfolio in this area now accounts for almost 60% of pharmaceutical sales. Breast cancer is a principal focus. Roche has around 30% share of the global market for cancer treatments. It has three top selling products. MabThera/Rituxan is the leading treatment for non-Hodgkin's lymphoma, and is also widely used for immunology-realted illnesses including rheumatoid arthritis. It is partnered by two major cancer products. Avastin was originally developed for colorectal cancer, but now has indications for a wide range of other diseases including ovarian cancer. Its key benefit is its ability to prevent the growth of new blood supplies to tumours, thereby inhibiting growth. Breast cancer treatment Herceptin also has indications for use in treatment of gastric cancer. It is especially strong in Japan, where it has around 90% market share. Other breast cancer drugs include Perjeta, launched in 2012, and Kadcyla, introduced in 2013. Roche groups those three drugs under the banner of the HER2 franchise.

Other key products include Pegasys for hepatitis (though sales halved in 2016 to CHF 259m), transplantation drug CellCept (CHF 741m, $753m) and NeoRecormon/Epogin for anaemia (CHF 328m, $333m). Sales of the group's flu vaccine Tamiflu soared between 2005 and 2007 as a result of governmental and corporate stockpiling in anticipation of a pandemic of avian flu. That process was completed by early 2007, and in the absence of any outbreak, sales declined sharply in 2008. They have continued to fluctuate widely, depending on levels of perceived threats. Sales soared again after 2012, reaching blockbuster levels in 2014 before slipping back to CHF 794m ($807m) in 2016.

Other important oncology products include Xeloda for colorectal, breast and stomach cancer, though sales plunged by almost half in 2014 following patent expiry. Sales for 2016 were CHF 506m ($513m). Tarceva is an important treatment for lung and pancreas cancer. The group also owns Kytril, an important remedy for chemotherapy nausea. In 2013 the group launched Gazyva for leukemia. New cancer launches in 2016 included Alecensa and Tecentriq - both likely to top CHF 1bn in 2019 along with Kadcyla - as well as Cotellic and Venclexta (the latter in partnership withn AbbVie).

The group's most successful ever launch is the multiple sclerosis treatment Ocrevus, introduced during 2017. Sales for the first full year topped CHF 3.5bn. Roche also partners with Japanese developer Shionogi on the important new-form influenza treatment Xofluza.

Another key non-cancer product is Actemra (or RoActemra in the US), approved at the end of 2007 for rheumatoid arthritis. Two new products were launched at the end of 2007. Mircera is a treatment for renal anemia. It was successfully launched in several European markets during the year, and also approved for use in the US. However, its future was complicated by a lawsuit brought by rival Amgen for over alleged infringement of one of that company's patents. Sales in 2016 were CHF 512m ($520m).

The group has bolstered its presence in the biotechnology sector through acquisition. Chugai Pharmaceuticals is a major player in the domestic Japanese market, and the developer of Epogin and other products. Roche acquired a 60% stake in 2002. There was speculation during 2014 that the group might take full control of its Japanese subsidiary, but no such deal has materialised.

US-based Genentech is one of the world's leading biotech companies. Roche floated around 45% of the equity between 1999 and 2001, but continued to control the business. In 2008, Roche made a public offer to buy back the minority shares for around $44bn. That deal was designed to give Roche full control over Genentech's star product, Avastin. After six months of negotiation, the price was rejected by Genetentech's board, and in early 2009, Roche took the decision to go hostile, announcing plans to appeal directly to the American company's shareholders with a lower bid of $42bn. Genentech eventually capitulated in March, agreeing to recommend a bid of $46.8bn for the outstanding shares. In 2014, the group expanded its presence with the acquisaition of another US biotech, InterMune, for $9.6bn. That company is the developer of Esbriet (CHF 768m, $780m), a specialised treatment for a form of pulmonary fibrosis. In 2019, the group acquired US developer Spark Therapeutics, a specialist in gene therapy, for $4.3bn. Its lead product currently is hemophilia treatment Luxturna. Rival Novartis already controls rights to that drug outside the US.

Chugai and Genentech each market several of Roche's pharmaceutical products in some markets. In addition, asthma product Xolair is marketed primarily in the US by Genentech, as is a treatment for age-related macular degeneration, Lucentis. Rights to both products are split between Roche, which has rights in the US, and Novartis, which has other markets. In 2008, Roche agreed to pay $160m for UK-based developer Piramed which already had a wide-ranging development alliance with Genentech. Other products marketed by Genentech include Pulmozyme for cystic fibrosis (CHF 685m, $696m) and Valcyte (also known as Cymevene), a treatment for AIDS-related retinitis. The latter's patent expired at the end of 2014. Sales for 2016 were CHF 306m ($311m). Genentech's newest blockbuster is Activase/TNKase, a treatment for stroke launched in 2015.

Diagnostics

In addition to its main pharmaceuticals business, Roche Diagnostics is the global #1 in medical analysis and testing, with around 20% share of the world market. It makes a wide variety of the machines used by hospitals and medical laboratories for diagnostics, blood testing and molecular analytical testing, many of them under the Cobas brand. An important new product is the AmpliChip DNA test which allows doctors to measure the rate at which different patients absorb medications, allowing for more efficient prescription. In 2004 the group acquired smaller US diagnostics company Igen for CHF1.8bn in a bid to resolve a long-running legal battle over technology licenses. Also that year, the company launched an uncharacteristic $3bn hostile takeover bid for US company Ventana Medical Systems, which specialises in diagnostics of cancer tissue. Roche said it had chosen this route after trying unsuccessfully for six months to negotiate a friendly merger. A deal was finally agreed after Roche raised its offer to $3.4bn in early 2008. There was a similar assault in 2012 on another US company, Illumina, for which it has offered $5.7bn. The group is also the world leader in diabetes management as a result of its Accu-Chek personal monitoring devices (sales of CHF 2.0bn or $1.9bn). Roche Diagnostics reported sales of CHF 12.9bn ($12.6bn) in 2018.

Discontinued Operations

For several years the group also controlled an OTC consumer health portfolio including vitamin supplements Supradyn, Sanatogen, Redoxon and Berocca, skincare product Bepanthen, antacid Rennie, Feminax analgesic and caffeine supplement Pro-Plus. This business was sold to Bayer in 2004 for €2.4bn. The group already marketed Aleve and Midol analgesics in the US through a joint venture with Bayer. Chugai's OTC portfolio was also sold in 2004, to Lion Corporation. A separate specialist vitamins division was sold in 2002 to DSM of Holland.

After several years of steady growth during the 2000s, group revenues have been mercurial over the past few years, impacted by the rising value of the Swiss France, as well as by changing demand for key products such as Tamiflu.

Financials

After several years of steady growth during the 2000s, group revenues have been mercurial over the past few years, impacted by the rising value of the Swiss France, as well as by changing demand for key products such as Tamiflu. For 2016, group revenues edged up by 4% to a record high of CHF 50.58bn ($51.4bn), while net income was up 7% to CHF 9.73bn ($9.9bn). The US accounted for 48% of pharmaceutical revenues in 2016 and Japan for 9%.

Total revenues have continued to climb, rising to CHF 59.5bn ($60.8bn) in 2018, while net income jumped by almost a quarter to CHF 10.9bn ($11.1bn).

Management

Severin Schwan became CEO of Roche in 2008. His predecessor Franz Humer initially became group chairman, but handed over that role in 2014 to Christoph Franz. Other senior executives include Daniel O'Day (CEO, pharmaceuticals), Roland Diggelmann (CEO, diagnostics), Alan Hippe (CFO), Osamu Nagayama (chairman & CEO, Chugai), Michael Varney (head of Genentech research & early development), John Reed (head of Roche pharma research & early development), Sophie Kornowski-Bonnet (head of partnering) and Stephan Feldhaus (head of communications).

Although the company's shares are publicly traded, the Hoffmann family collectively control a stake of just over 45% of the group. Andre Hoffmann is vice chairman.

Background

Swiss chemist Fritz Hoffman married Adele La Roche in 1895, and promptly adopted the hyphenated surname Hoffmann-La Roche in keeping with local custom. A year later he founded Fritz Hoffmann-La Roche & Co as one of the first companies to engage in the large-scale industrial production of pharmaceuticals, then predominantly a business confined to the backroom of local pharmacies. Its earliest medicines were iodine preparation Aiodin, antiseptic powder Airol and non-prescription cough syrup Sirolin. The company was also one of the first to market its products internationally. By 1910, Roche had established offices in several European capitals as well as in the US, but business was badly damaged by the First World War. Hoffmann died in 1920 but the company continued to expand. In 1934 it pioneered the industrial synthesis of vitamins, creating the vitamin C preparation Redoxon.

The company's most celebrated breakthroughs came in the 1960s with the development of a string of hugely successful tranquilizers including Librium, Mogadon, and above all Valium, first introduced in 1963. Funded by the worldwide success of Valium, the world's best-selling prescription drug for almost a decade, Roche moved into a number of new areas including fragrance and flavourings production (that division was spun off in 2000 as Givaudan) and diagnostics. The group also strengthened its OTC healthcare business with the purchase of French company Nicholas, and acquired US pharma developer Syntex in 1994. The purchase of Boehringer Mannheim and DePuy in 1998 made the group the world leader in diagnostics. (The latter's orthopaedics division was sold on to Johnson & Johnson). An aggressive move into specialist vitamins and fine chemicals proved less successful. That business was sold at a large loss to DSM in 2002, and a long-running US court-case over allegations of price-fixing led to a substantial one-off charge.

Since 2000, the group has been stalked by its larger Swiss rival Novartis, in part to soldify its European distribution agreement with what was then Roche's part-owned subsidiary Genentech. Novartis acquired an initial 20% shareholding in Roche through the markets that year, and has since built this up to just over 33%. The Hoffmann family, who continue to control Roche, have firmly rejected any suggestions of a merger.

Last full revision 11th January 2018

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