offering labs greater flexibility to ramp up their testing capacity to 
adapt to evolving testing needs. 
 
   The latest additions to Roche's comprehensive diagnostics portfolio are 
the Elecsys Epstein-Barr Virus (EBV) immunoassay panel and the Elecsys 
Anti-p53 immunoassay, both launched in countries accepting the CE Mark: 
 
 
   -- The panel consists of three specific EBV tests and accurately identifies 
      the EBV infection stage from a single blood sample, which means less 
      confirmatory testing and, potentially, faster diagnosis for patients. 
 
   -- The Anti-p53 immunoassay helps physicians to diagnose several prevalent 
      cancers in patients. 
 
 
   Furthermore, the FDA granted Breakthrough Device Designation for the 
Elecsys GDF-15 assay as a companion diagnostic in cancer treatment. It 
is intended to measure growth differentiation factor-15 (GDF-15) in 
cachectic patients who are to be treated with an investigational 
medicine from our partner Pfizer. 
 
   Pharmaceuticals sales 
 
 
 
 
   Sales                   CHF millions        As % of sales     % change 
                       --------------------  ------------------  ---------------- 
   January -- March                                                  At        In 
    2021                    2021       2020      2021      2020     CER       CHF 
---------------------  ---------  ---------  --------  --------  ------  -------- 
   Pharmaceuticals 
    Division              10,600     12,262     100.0     100.0      -9       -14 
      United States        5,292      6,616      49.9      54.0     -14       -20 
      Europe               2,175      2,264      20.4      18.4      -6        -4 
      Japan                  852        948       8.0       7.7      -7       -10 
      International*       2,281      2,434      21.7      19.9       0        -6 
---------------------  ---------  ---------  --------  --------  ------  -------- 
 
 
   *Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin 
America, Canada, others 
 
   Pharmaceuticals: Established products 
 
   Avastin (CHF 863 million, -40%). Advanced colorectal, breast, lung, 
kidney, cervical and ovarian cancer, relapsed glioblastoma (a type of 
brain tumour) and liver cancer in combination with Tecentriq. Sales were 
strongly impacted by the biosimilar competition, mainly in Europe and 
the US. 
 
   Actemra/RoActemra (CHF 779 million, +22%). Rheumatoid arthritis, forms 
of juvenile idiopathic arthritis and giant cell arteritis as well as CAR 
T cell-induced severe or life-threatening cytokine release syndrome. A 
number of countries included this medicine in their treatment guidelines 
for severe COVID-19-associated pneumonia. Actemra/RoActemra is not 
currently approved for this use; various clinical studies have been 
carried out and the results made available to healthcare authorities. 
Sales were driven by the International region, with a slight slowdown in 
other markets. 
 
   Herceptin (CHF 755 million, -35%). HER2-positive breast cancer and 
HER2-positive metastatic gastric cancer. Sales were impacted by 
biosimilars across all regions. 
 
   MabThera/Rituxan (CHF 705 million, -46%). Forms of blood cancer, 
rheumatoid arthritis and certain types of vasculitis. The sales decline 
was driven by all regions, due to the biosimilar erosion as well as 
COVID-19 pandemic restrictions. 
 
   Xolair (CHF 409 million, -6%, US only). Chronic idiopathic urticaria 
(CIU) and allergic asthma; self-injection (home use). Sales grew in the 
CIU indication. Xolair remains the market leader in the larger allergic 
asthma indication. 
 
   Lucentis (CHF 337 million, -7%, US only). Eye conditions, including 
'wet' age-related macular degeneration. 
 
   Pharmaceuticals: Medicines launched since 2012 
 
   Ocrevus (first approved in 2017; CHF 1.2 billion, +16%). Relapsing and 
primary progressive forms of multiple sclerosis; shorter 2-hour 
infusion. The demand for this treatment in both indications remained 
strong, while the COVID-19 pandemic continues to have a certain negative 
impact. In the US, growth was driven both by new and returning patients, 
with a higher proportion of sales coming from returning patients. 
 
   Perjeta (first approved in 2012; CHF 988 million, +2%). HER2-positive 
breast cancer. In the International region (+23%), patient demand for 
this cancer medicine remained strong. 
 
   Tecentriq (first approved in 2016; CHF 775 million, +26%). Cancer 
immunotherapy for various types of cancer (either alone or in 
combinations), ie, certain types of lung, bladder, breast and liver 
cancer. Continued strong sales growth reported by all regions. 
 
   Hemlibra (first approved in 2017; CHF 661 million, +33%). Haemophilia A 
with and without factor VIII inhibitors; only prophylactic treatment 
that can be administered subcutaneously once weekly, every two or every 
four weeks. Sales continued to show a strong uptake across all regions 
(especially in the US and Europe); COVID-19 restrictions still had some 
impact on potential new patients. 
 
   Kadcyla (first approved in 2013; CHF 478 million, +17%). HER2-positive 
breast cancer. The sales growth was driven by the usage of Kadcyla in 
the early breast cancer setting. Sales benefited from patients switching 
to the new standard of treatment. 
 
   Alecensa (first approved in 2015; CHF 298 million, +14%). ALK-positive 
non-small cell lung cancer. The demand for this cancer medicine was 
particularly strong in the International region (+44%). 
 
   Esbriet (first approved in 2014; CHF 256 million, -8%). Idiopathic 
pulmonary fibrosis (IPF). Sales declined or were stable across all 
regions. 
 
   Casirivimab and imdevimab antibody combination (FDA EUA in 2020, filed 
by our partner Regeneron; CHF 166 million*). For the treatment of 
recently diagnosed high-risk patients with mild to moderate COVID-19. 
Roche and Regeneron are collaborating on developing and manufacturing 
the medicine; Roche is responsible for distribution in Europe and other 
countries outside the US. There were orders from multiple countries. 
 
   Gazyva/Gazyvaro (first approved in 2013; CHF 155 million, -2%). Chronic 
lymphocytic leukaemia, rituximab-refractory follicular lymphoma and 
previously untreated advanced follicular lymphoma. 
 
   Evrysdi (first approved in 2020; CHF 80 million*). Spinal muscular 
atrophy (SMA) in adults and children two months of age and older. 
Evrysdi helps infants to survive without permanent ventilation; first 
and only medicine for SMA that can be taken at home. The new SMA 
medicine showed a very strong uptake in the US. 
 
   Erivedge (first approved in 2012; CHF 60 million, -13%). Advanced basal 
cell carcinoma. 
 
   Polivy (first approved in 2019; CHF 43 million, +18%). Relapsed or 
refractory diffuse large B-cell lymphoma; part of combination therapy; 
fixed-duration treatment option for people with this aggressive form of 
lymphoma. The strong uptake in the European market more than compensates 
for the decline in the US. 
 
   Phesgo (first approved in 2020; CHF 29 million*). Early and metastatic 
HER2-positive breast cancer (fixed-dose combination of Perjeta and 
Herceptin for subcutaneous injection). Offers faster administration in 
just minutes, compared to hours with standard intravenous 
administration. Sales showed a positive uptake in the US, and further 
strong growth is anticipated in Europe. 
 
   Enspryng (first approved in 2020; CHF 14 million*). Rare autoimmune 
disease of the central nervous system (neuromyelitis optica spectrum 
disorder; NMOSD); first subcutaneous NMOSD treatment that can be 
self-administered at home. The medicine showed a good uptake, despite 
COVID-19 restrictions having some impact on potential new patients. 
 
   Rozlytrek (first approved in 2019; CHF 9 million, +187%). Specific form 
of non-small cell lung cancer (NSCLC); solid tumours expressing a 
specific gene fusion; ROS1-positive, advanced NSCLC. Strong sales growth 
in the US. 
 
   Xofluza (first approved in 2018; CHF 0 million, -100%). Acute, 
uncomplicated influenza, for people with high risk of developing 
flu-related complications; prevention of influenza following contact 
with infected person. No sales, as no flu season occurred, probably due 
to COVID-19 restrictions. 
 
   * recently launched, no growth figures available 
 
 
 
 
Top-selling pharmaceuticals       Total       United States     Europe        Japan      International* 
----------------------------  --------------  -------------  ------------  ------------  ---------------- 
                               CHFm      %    CHFm     %     CHFm     %    CHFm     %     CHFm      % 
----------------------------  -------  -----  -----  ------  -----  -----  -----  -----  ------  -------- 
Ocrevus                         1,226     16    914       9    217     37      -      -      95        77 
Perjeta                           988      2    360      -2    301     -3     64    -11     263        23 
Avastin                           863    -40    287     -48    138    -68    161     -8     277        -4 
Actemra/RoActemra                 779     22    305      10    239     12     84     -2     151       134 
Tecentriq                         775     26    395      13    168     14    120     82      92        84 
Herceptin                         755    -35    191     -57    146    -25     22    -43     396       -16 
MabThera/Rituxan                  705    -46    426     -53     69    -45     10    -37     200       -23 
Hemlibra                          661     33    398      21    136     71     79     11      48       214 
Kadcyla                           478     17    200       5    167     24     27     54      84        28 
Xolair                            409     -6    409      -6      -      -      -      -       -         - 
----------------------------  -------  -----  -----  ------  -----  -----  -----  -----  ------  -------- 
 
 
   * Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin 
America,Canada, others 
 
   Diagnostics sales

(MORE TO FOLLOW) Dow Jones Newswires

April 21, 2021 01:00 ET (05:00 GMT)