Basel, 17 April 2019
-
Group sales increase 8%1 at constant
exchange rates and 9% in Swiss francs
-
Pharmaceuticals Division sales up 10%, driven
mainly by Ocrevus, Perjeta, Hemlibra and Tecentriq
-
Diagnostics Division sales grow 1%, with Molecular
Diagnostics as main contributor
-
Important approvals in the first quarter. In the
US: Tecentriq combination therapy for extensive-stage small cell
lung cancer; Tecentriq combination therapy for
triple-negative breast cancer and companion diagnostic test;
Herceptin Hylecta for subcutaneous injection for breast cancer; in
the EU: Hemlibra for people with severe haemophilia A without
factor VIII inhibitors; Tecentriq plus Avastin combination therapy
for initial treatment of a form of lung cancer
-
Outlook raised for 2019 to mid-single digit sales
growth
Sales |
CHF
millions |
As % of sales |
% change |
January - March 2019 |
2019 |
2018 |
2019 |
2018 |
At CER |
In CHF |
Group
sales |
14,826 |
13,583 |
100.0 |
100.0 |
+8 |
+9 |
|
|
|
|
|
|
|
Pharmaceuticals Division |
11,927 |
10,672 |
80.4 |
78.6 |
+10 |
+12 |
United
States |
6,623 |
5,516 |
44.7 |
40.6 |
+14 |
+20 |
Europe |
2,101 |
2,287 |
14.2 |
16.8 |
-6 |
-8 |
Japan |
941 |
851 |
6.3 |
6.3 |
+7 |
+11 |
International* |
2,262 |
2,018 |
15.2 |
14.9 |
+17 |
+12 |
|
|
|
|
|
|
|
Diagnostics Division |
2,899 |
2,911 |
19.6 |
21.4 |
+1 |
0 |
*Asia-Pacific, EEMEA (Eastern Europe, Middle
East and Africa), Latin America, Canada, Others |
|
|
Commenting on the Group's sales, Roche CEO Severin
Schwan said: "We have started the year with strong sales growth,
driven by the newly launched products in our Pharmaceuticals
Division. Demand for our new medicines remains high. Health
authorities granted a number of important approvals for our
medicines in the first quarter. These include the first cancer
immunotherapies for triple-negative breast cancer and small cell
lung cancer, two diseases with high unmet patient need. Based on
our performance in the first quarter, we raise the outlook for the
full-year."
Outlook raised for 2019
Sales are now expected to grow in the mid-single digit range, at
constant exchange rates. Core earnings per share are targeted to
grow broadly in line with sales, at constant exchange rates. Roche
expects to further increase its dividend in Swiss francs.
Group sales
In the first
three months of 2019, Group sales rose 8% to CHF 14.8 billion.
Sales in the Pharmaceuticals Division increased 10% to CHF 11.9
billion. Key growth drivers were the multiple sclerosis medicine
Ocrevus and cancer medicines Perjeta and Tecentriq as well as the
new haemophilia medicine Hemlibra. As expected, the strong uptake
of newly introduced medicines was partially offset by lower sales
of Herceptin and of MabThera/Rituxan.
In the US, sales increased 14%, led by Ocrevus, Hemlibra, Perjeta
and Tecentriq. Ocrevus sales were driven by both new and continuing
patient demand.
In Europe (-6%), sales were affected by competition from
biosimilars for Herceptin (-44%) and MabThera/Rituxan (-38%). This
decline was partially offset by the strong growth of Ocrevus,
Perjeta, Tecentriq, Alecensa and Hemlibra.
In the International region sales grew 17%, mainly driven by China.
In Japan, sales increased 7%, driven by recently launched products,
including Tecentriq, Hemlibra and Perjeta. This growth was
partially offset by biosimilar competition for MabThera/Rituxan
(-50%) and Herceptin (-9%).
Diagnostics Division sales increased 1% to CHF 2.9 billion.
Molecular Diagnostics (+7%) was the main contributor, led by the
growth of its cervical cancer business. In regional terms, growth
was reported in EMEA2 (+3%) and
Latin America (+8%). Sales were impacted by one-time supply chain
effects in Centralised and Point of Care Solutions in Asia-Pacific
and in coagulation monitoring systems in North America.
Important milestones for Roche medicines
In the first quarter, regulatory authorities approved
new indications for a number of Roche medicines, granted priority
review procedures for and recommended approvals of several Roche
drug candidates.
The US Food and Drug Administration (FDA) approved Tecentriq in
combination with carboplatin and etoposide (chemotherapy) for the
initial (first-line) treatment of adults with extensive-stage small
cell lung cancer. This approval is based on results from the phase
III IMpower133 study.
The FDA granted accelerated approval to Tecentriq plus chemotherapy
(paclitaxel protein-bound particles for injectable suspension) for
the treatment of adults with unresectable locally advanced or
metastatic triple-negative breast cancer in people whose tumours
express PD-L1, as determined by an FDA-approved test. This decision
is based on progression-free survival (PFS) data from the phase III
IMpassion130 study.
The European Commission approved Tecentriq in combination with
Avastin, paclitaxel and carboplatin for the first-line treatment of
adults with metastatic non-squamous non-small cell lung cancer
(NSCLC), including EGFR mutant or ALK-positive NSCLC after failure
of appropriate targeted therapies.
Furthermore, the European Commission approved Hemlibra for routine
prophylaxis of bleeding episodes in people with severe haemophilia
A without factor VIII inhibitors. Hemlibra can be used in all age
groups, and now also at multiple dosing options (once weekly, every
two weeks, or every four weeks) for all indicated people with
haemophilia A, including those with factor VIII
inhibitors.
The FDA approved Herceptin Hylecta (trastuzumab and
hyaluronidase-oysk) for subcutaneous (under the skin) injection for
the treatment of certain people with HER2-positive early breast
cancer in combination with chemotherapy and HER2-positive
metastatic breast cancer in combination with paclitaxel or alone in
people who have received one or more chemotherapy regimens for
metastatic disease. This new treatment includes the same monoclonal
antibody as intravenous Herceptin in combination with recombinant
human hyaluronidase PH20, an enzyme that helps to deliver
trastuzumab under the skin.
The European Commission approved MabThera for the treatment of
adults with moderate to severe pemphigus vulgaris, a rare condition
characterised by progressive painful blistering of the skin and/or
mucous membranes. Extensive blistering can lead to serious,
life-threatening fluid loss, infection and/or death.
Progress in the product pipeline
The FDA granted priority review for entrectinib for
the treatment of adult and paediatric patients with neurotrophic
tropomyosin receptor kinase (NTRK) fusion-positive, locally
advanced or metastatic solid tumours who have either progressed
following prior therapies or as an initial therapy when there are
no acceptable standard therapies, and for the treatment of people
with metastatic, ROS1-positive NSCLC.
The FDA also granted priority review for polatuzumab vedotin in
combination with bendamustine plus MabThera/Rituxan (BR) for the
treatment of people with relapsed or refractory (R/R) diffuse large
B-cell lymphoma (DLBCL).
Roche completed the submission of a supplemental Biologics License
Application to the FDA for Kadcyla for adjuvant treatment of people
with HER2-positive early breast cancer (eBC) with residual disease
after neoadjuvant treatment. The FDA is reviewing the application
under the Real-Time Oncology Review and Assessment Aid pilot
programmes, which aim to explore a more efficient review process to
ensure safe and effective treatments are available to patients as
early as possible.3
Roche and Spark Therapeutics, Inc. announced that they have entered
into a definitive merger agreement for Roche to acquire Spark
Therapeutics in full. Spark Therapeutics, based in Philadelphia,
Pennsylvania, USA, is a fully integrated company committed to
discovering, developing and delivering gene therapies for genetic
diseases, including blindness, haemophilia, lysosomal storage
disorders and neurodegenerative diseases.
Roche Diagnostics: companion test for
triple-negative breast cancer
The FDA
approved the Ventana PD-L1 (SP142) Assay4 as the first
companion diagnostic to help identify triple-negative breast cancer
(TNBC) patients eligible for treatment with Tecentriq plus
chemotherapy (paclitaxel protein-bound particles for injectable
suspension). The assessment of PD-L1 biomarker status on
tumour-infiltrating immune cells with the assay is essential for
identifying the patients most likely to benefit from the
treatment.
A diagnosis of triple-negative breast cancer means that the three
most common proteins associated with breast cancer growth -
oestrogen receptor, progesterone receptor and HER2/neu - are not
expressed on the tumour.
Pharmaceuticals Division
|
Top-selling pharmaceuticals |
Total |
United States |
Europe |
Japan |
International* |
|
CHFm |
% |
CHFm |
% |
CHFm |
% |
CHFm |
% |
CHFm |
% |
|
Avastin |
1,798 |
9 |
824 |
12 |
461 |
1 |
194 |
2 |
319 |
16 |
|
MabThera/Rituxan |
1,694 |
-3 |
1,168 |
9 |
171 |
-38 |
28 |
-50 |
327 |
-4 |
|
Herceptin |
1,666 |
-6 |
791 |
3 |
300 |
-44 |
56 |
-9 |
519 |
26 |
|
Perjeta |
868 |
41 |
412 |
36 |
267 |
27 |
51 |
74 |
138 |
83 |
|
Ocrevus |
836 |
67 |
715 |
54 |
92 |
232 |
- |
- |
29 |
261 |
|
Actemra/RoActemra |
534 |
6 |
212 |
5 |
174 |
4 |
86 |
13 |
62 |
10 |
|
Xolair |
469 |
1 |
469 |
1 |
- |
- |
- |
- |
- |
- |
|
Lucentis |
457 |
11 |
457 |
11 |
- |
- |
- |
- |
- |
- |
|
Activase/TNKase |
362 |
7 |
351 |
7 |
- |
- |
- |
- |
11 |
-10 |
|
Tecentriq |
336 |
135 |
216 |
91 |
57 |
158 |
33 |
- |
30 |
262 |
|
* Asia-Pacific, EEMEA (Eastern Europe, Middle
East and Africa), Latin America, Canada, others |
|
Key pharmaceutical
products
Avastin (+9%).
For advanced colorectal, breast, lung, kidney, cervical and ovarian
cancer, and relapsed glioblastoma (a type of brain tumour). Sales
growth was driven by the US (+12%) and the International region
(+16%), in particular in China due to broader market
penetration.
MabThera/Rituxan (-3%).
For forms of blood cancer, rheumatoid arthritis and certain types
of vasculitis. In Europe (-38%) and in Japan (-50%) sales were
affected by biosimilars. In the US, sales increased 9%, with growth
in both the immunology and oncology segments, also driven by the
subcutaneous formulation.
HER2-franchise (Herceptin, Perjeta and
Kadcyla, +7%). For HER2-positive breast cancer
and HER2-positive metastatic gastric cancer (Herceptin
only).
Herceptin (-6%). For HER2-positive breast
cancer and HER2-positive metastatic gastric cancer. Sales were
impacted by biosimilar launches from mid-2018, partially offset by
increased sales in China and the US.
Actemra/RoActemra
(+6%). For 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. Sales growth
was reported in all regions, driven by the constant uptake of the
subcutaneous formulation.
Xolair (+1%, US only). For chronic idiopathic
urticaria and allergic asthma. Growth was reported in both
indications.
Lucentis (+11%, US only). For eye conditions
including neovascular ('wet') age-related macular degeneration,
macular oedema following retinal vein occlusion, diabetic macular
oedema, and diabetic retinopathy. Growth was driven by sales
increases in all approved indications.
Highlights on medicines launched since
2012
Perjeta (CHF 868
million, +41%). For HER2-positive breast cancer. Sales grew in all
regions. The increased demand for Perjeta for adjuvant early
breast cancer therapy supports its
continued strong growth. The regimen has been approved in
81 countries including the US, EU, Japan and China.
Ocrevus (CHF 836 million, +67%). For both the relapsing and
primary progressive forms of multiple sclerosis (MS). Ocrevus has
now been approved in 85 countries. The strong demand in both
indications has continued, in addition to strong sales increases in
the US growth was supported by launches in Europe and the
International region.
Tecentriq (CHF 336 million, +135%). For
advanced bladder cancer, advanced lung cancer, initial therapy of
non-squamous NSCLC, extensive-stage small cell lung cancer and
PD-L1-positive triple-negative breast cancer. Sales growth was
reported by all regions, mainly driven by the US, Europe and Japan.
In the US growth was driven by the new indications extensive-stage
small cell lung cancer and triple-negative breast cancer.
Esbriet (CHF 250 million, +10%). For
idiopathic pulmonary fibrosis (IPF). Sales continued to expand,
driven by growth in the US (+7%) and Europe (+14%).
Hemlibra (CHF 219 million). For people with
haemophilia A with inhibitors to factor VIII. Hemlibra is approved
in this indication in more than 60 countries. It is the only
approved medicine for all people with haemophilia A, with or
without factor VIII inhibitors, in the US, Australia, Singapore,
the UAE, Chile, Brazil and Japan. In Europe, Hemlibra is approved
for inhibitor patients and those with severe haemophilia A without
inhibitors. Hemlibra is the only prophylactic treatment that can be
administered subcutaneously and at multiple dosing options (once
weekly, every two weeks or every four weeks). The uptake is very
strong in the US, Japan and Europe.
Alecensa (CHF 196 million, +61%). For
ALK-positive lung cancer. Alecensa showed continued strong sales
growth across all regions, with the Europe and the International
region as the main drivers.
Gazyva/Gazyvaro (CHF 115 million, +35%). For
chronic lymphocytic leukaemia (CLL), rituximab-refractory
follicular lymphoma and previously untreated advanced follicular
lymphoma. Sales expanded, especially in the US and in Europe.
Diagnostics Division
|
Sales |
CHF
millions |
As % of sales |
% change |
|
January - March 2019 |
2019 |
2018 |
2019 |
2018 |
At CER |
In CHF |
|
Diagnostics
Division |
2,899 |
2,911 |
100.0 |
100.0 |
+1 |
0 |
|
Business
Areas |
|
|
|
|
|
|
|
Centralised
and Point of Care
Solutions |
1,681 |
1,716 |
58.0 |
58.9 |
-1 |
-2 |
|
Molecular
Diagnostics |
502 |
468 |
17.3 |
16.1 |
+7 |
+7 |
|
Diabetes
Care |
465 |
478 |
16.0 |
16.4 |
+1 |
-3 |
|
Tissue
Diagnostics |
251 |
249 |
8.7 |
8.6 |
-1 |
+1 |
|
Regions |
|
|
|
|
|
|
|
Europe,
Middle East, Africa |
1,210 |
1,221 |
41.7 |
41.9 |
+3 |
-1 |
|
North
America |
764 |
753 |
26.4 |
25.9 |
-3 |
+1 |
|
Asia-Pacific |
652 |
656 |
22.5 |
22.5 |
0 |
-1 |
|
Latin
America |
179 |
188 |
6.2 |
6.5 |
+8 |
-5 |
|
Japan |
94 |
93 |
3.2 |
3.2 |
-3 |
+1 |
|
|
|
|
|
|
|
|
Centralised and Point of Care
Solutions sales declined 1%. While the immunodiagnostics
business grew 3%, clinical chemistry was down 2%. In China, sales
were affected by reduced distributor inventory levels. Sales in the
US were impacted by free-of-charge deliveries following the recall
of CoaguChek test strips in the fourth quarter 2018.
Sales in Molecular Diagnostics increased 7%,
making this unit the largest contributor to the division's sales
growth. Sales in cervical cancer diagnosis and blood screening grew
strongly.
Tissue Diagnostics sales were down 1%. Sales
were impacted by BenchMark and Discovery Ultra instrument shipment
delays during the first quarter resulting in lower instrument
placements in the North America and the Asia-Pacific
regions.
Diabetes Care sales increased 1%, mainly
driven by the new Accu-Chek Guide and Accu-Chek Instant blood
glucose monitoring systems. Roche expanded the collaboration
agreement with Senseonics for the distribution of the Eversense XL
insertable continuous glucose monitoring sensor in 17 additional
markets in Europe, Latin America and the Asia Pacific
region.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 billion. Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche is the
majority shareholder in Chugai Pharmaceutical, Japan. For more
information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References
[1] Unless
otherwise stated, all growth rates in this document are at constant
exchange rates (CER: average 2018).
[2] EMEA = Europe, Middle East and Africa
[3]
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm.
[4] This product is intended for in vitro diagnostic (IVD)
use.
Disclaimer: Cautionary statement regarding forward-looking
statements
This document contains certain forward-looking statements. These
forward-looking statements may be identified by words such as
'believes', 'expects', 'anticipates', 'projects', 'intends',
'should', 'seeks', 'estimates', 'future' or similar expressions or
by discussion of, among other things, strategy, goals, plans or
intentions. Various factors may cause actual results to differ
materially in the future from those reflected in forward-looking
statements contained in this document, among others: (1) pricing
and product initiatives of competitors; (2) legislative and
regulatory developments and economic conditions; (3) delay or
inability in obtaining regulatory approvals or bringing products to
market; (4) fluctuations in currency exchange rates and general
financial market conditions; (5) uncertainties in the discovery,
development or marketing of new products or new uses of existing
products, including without limitation negative results of clinical
trials or research projects, unexpected side effects of pipeline or
marketed products; (6) increased government pricing pressures; (7)
interruptions in production; (8) loss of or inability to obtain
adequate protection for 12/12 intellectual property rights; (9)
litigation; (10) loss of key executives or other employees; and
(11) adverse publicity and news coverage. The statement regarding
earnings per share growth is not a profit forecast and should not
be interpreted to mean that Roche's earnings or earnings per share
for any current or future period will necessarily match or exceed
the historical published earnings or earnings per share of
Roche.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
Communication appendix tables Q1
2019
2019-04-17_Q1_2019_ Release_English