Basel, 31 January 2019
-
Group sales increase 7% [1] at constant exchange
rates and in Swiss francs
-
Pharmaceuticals Division sales up 7%, driven
mainly by Ocrevus, Perjeta, Tecentriq, Alecensa and Hemlibra
-
Diagnostics Division sales grow 7%, primarily
due to demand for immunodiagnostic solutions
-
In the fourth quarter, the US FDA approves
Tecentriq in combination with Avastin for a specific form of lung
cancer; Venclexta for a form of leukaemia; and Xofluza for
influenza
-
Core earnings per share grow ahead of sales at
19%, or 8% excluding the effect of the US tax reform
-
On IFRS basis, net income increases 24%
-
Board proposes dividend to increase to CHF
8.70
-
Outlook for 2019: Sales are expected to grow in
the low- to 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.
Key figures |
CHF
millions |
% change |
January - December 2018 |
2018 |
2017 |
At CER1 |
In CHF |
Group
sales |
56,846 |
53,299 |
+7 |
+7 |
Pharmaceuticals Division |
43,967 |
41,220 |
+7 |
+7 |
Diagnostics Division |
12,879 |
12,079 |
+7 |
+7 |
Core
operating profit |
20,505 |
19,012 |
+9 |
+8 |
|
|
|
|
|
Core EPS -
diluted (CHF) |
18.14 |
15.34 |
+19 |
+18 |
excl. US
tax reform |
|
|
+8 |
+7 |
|
|
|
|
|
IFRS net
income |
10,865 |
8,825 |
+24 |
+23 |
Commenting on the Group's results, Roche CEO
Severin Schwan said: "In 2018, Roche achieved very good growth in
both divisions. I am particularly pleased with the very strong
demand for our new medicines, delivering significant benefit for
patients fighting serious diseases like cancer, multiple sclerosis
and haemophilia. Roche is also making major progress in driving
digitalisation, and in leveraging real-world healthcare data and
analytics to support product development and advance personalised
healthcare. Based on the successful launches and our strong product
pipeline Roche is well positioned for continued growth."
Group results
In 2018, Group
sales rose 7% to CHF 56.8 billion. Core operating profit increased
9%, reflecting the strong underlying business performance. Core EPS
grew 19% and IFRS net income increased 24%, including the benefits
from the US tax reform and higher net financial income.
Sales in the Pharmaceuticals Division increased 7% to CHF 44.0
billion. Key growth drivers were the new multiple sclerosis
medicine Ocrevus and cancer medicines Perjeta, Tecentriq, Alecensa
as well as the new haemophilia medicine Hemlibra. With sales of CHF
2.4 billion in its first full year on key markets, Ocrevus is the
most successful new product launch in the history of Roche. As
expected, the strong uptake of newly introduced medicines was
partially offset by lower sales of MabThera/Rituxan and of
Tarceva.
In the US, sales increased 14%, led by Ocrevus, Perjeta and
Lucentis. Ocrevus sales were supported by continued strong new
patient demand as well as follow-up treatments. The 32% sales
increase of Perjeta was driven by its use for adjuvant (after
surgery) treatment of patients with HER2-positive early breast
cancer at high risk of recurrence. [2]
In Europe (-7%), sales were affected by competition from
biosimilars for MabThera/Rituxan (-47%) and Herceptin (-16%),
offset by the strong launches of our new medicines Ocrevus,
Tecentriq, Alecensa, and of Perjeta in metastatic HER2-positive
breast cancer and adjuvant therapy.
In the International region, sales grew 10%, led by the
Asia-Pacific and Latin America subregions. In Japan, sales declined
1% due to government price cuts and biosimilar competition for
MabThera/Rituxan (-36%) and Herceptin (-16%).
Diagnostics Division sales increased 7% to CHF 12.9 billion.
Centralised and Point of Care Solutions (+8%) was the main
contributor, led by the growth of its immunodiagnostics business
(+11%). All business areas reported sales increases. In regional
terms, growth was driven by Asia-Pacific (+13%) and North America
(+7%). Sales increased 3% in EMEA [3], 9% in Latin America, and 6%
in Japan.
Important milestones for Roche medicines
Roche medicines passed important regulatory milestones
in recent months, including the following key achievements: In
December 2018, the US Food and Drug Administration (FDA) approved
Tecentriq in combination with Avastin, paclitaxel and carboplatin
for the initial treatment of people with metastatic non-squamous
non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic
tumour aberrations.
The FDA granted accelerated approval to Venclexta in combination
with azacitidine or decitabine, or low dose cytarabine, for the
treatment of people with newly-diagnosed acute myeloid leukaemia
(AML), aged 75 years and older, or for those ineligible for
intensive induction chemotherapy due to coexisting medical
conditions [4]. AML is the most common type of aggressive leukaemia
in adults and has the lowest survival rate of all types of
leukaemia.
In October, FDA approved Xofluza (baloxavir marboxil) for the
treatment of acute, uncomplicated influenza in people aged 12 years
and older. Xofluza is a first-in-class, single-dose oral medicine
with a novel proposed mechanism of action that inhibits polymerase
acidic endonuclease, an enzyme essential for viral
replication. [5] It has demonstrated efficacy against a wide
range of influenza viruses, including oseltamivir-resistant strains
and avian strains (H7N9, H5N1) in non-clinical studies.
[6]
Based on the IMpower133 study, the FDA granted priority review for
Tecentriq, in combination with carboplatin and etoposide
(chemotherapy), for the initial treatment of people with
extensive-stage small cell lung cancer (ES-SCLC). The IMpower133
results represent the first clinically meaningful advance in the
disease in over 20 years. [7]
Priority review was granted for Tecentriq plus Abraxane
(albumin-bound paclitaxel; nab-paclitaxel) for
the initial treatment of unresectable locally advanced or
metastatic triple-negative breast cancer (TNBC) in people whose
disease expresses the PD-L1 protein, as determined by PD-L1
biomarker testing. The priority review was based on the IMpassion
130 study, the first positive phase III immunotherapy study in
TNBC, an aggressive disease with limited treatment
options.
Polatuzumab vedotin in combination with MabThera/Rituxan plus
bendamustine has been granted breakthrough therapy designation and
orphan drug designation by the FDA, as well as PRIME designation
and orphan drug designation by the European Medical Agency (EMA),
for the treatment of adult patients with relapsed or refractory
(R/R) diffuse large B-cell lymphoma who are not candidates for
haematopoietic stem cell transplantation. Files for regulatory
review and approval of polatuzumab have been submitted to
FDA.
Entrectinib, in development for the treatment of neurotrophic
tropomyosin receptor kinase (NTRK) fusion-positive solid tumours,
was granted breakthrough therapy designation by the FDA, PRIME
designation by the EMA, and Sakigake and orphan drug designations
by the health authorities in Japan. Files for regulatory review and
approval of entrectinib have been submitted to FDA.
Advancing personalised
healthcare
In 2018, Roche
concluded several transactions to further advance its personalised
healthcare strategy. This includes three US-based companies:
Foundation Medicine, with its comprehensive genomic profiling
assays to identify the molecular alterations in a patient's cancer
and match them with relevant targeted therapies, immunotherapies
and clinical trials; Flatiron Health, a market leader in the
curation and development of real-world evidence for cancer
research; Ignyta, with entrectinib as its lead drug candidate.
Entrectinib is an example of highly targeted novel treatment
approaches based on genetic profiling.
In early 2018, Roche Diagnostics and GE
Healthcare announced their agreement to enter into a strategic
partnership, combining Roche's in vitro
diagnostics Know-how with GE Healthcare's in
vivo expertise. The aim is to co-develop and co-market decision
support software solutions, anchored by a shared digital platform
designed to also allow third parties to potentially place their
product and company-agnostic applications. The initial focus is on
oncology and acute care.
Outlook for 2019
Sales are
expected to grow in the low- to 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.
Dividend proposal
The Board of Directors proposes a dividend increase to CHF 8.70 per
share and non-voting equity security. Subject to approval by the
Annual General Meeting of Shareholders on 5 March 2019, this will
be Roche's 32nd consecutive annual dividend increase.
Pharmaceuticals Division
Sales |
CHF
millions |
As % of sales |
% change |
January - December 2018 |
2018 |
2017 |
2018 |
2017 |
At CER |
In CHF |
Pharmaceuticals Division |
43,967 |
41,220 |
100.0 |
100.0 |
+7 |
+7 |
United
States |
23,233 |
20,496 |
52.8 |
49.7 |
+14 |
+13 |
Europe |
8,693 |
9,051 |
19.8 |
22.0 |
-7 |
-4 |
Japan |
3,701 |
3,713 |
8.4 |
9.0 |
-1 |
0 |
International* |
8,340 |
7,960 |
19.0 |
19.3 |
+10 |
+5 |
*Asia-Pacific, EEMEA (Eastern Europe, Middle East
and Africa), Latin America, Canada, others
Clinical trial results on Roche
medicines
Roche announced results from a
number of late-stage studies during the fourth quarter, including
the following studies: The phase III Katherine study met its
primary endpoint, showing that Kadcyla as a single agent reduced
the risk of disease recurrence or death (invasive disease-free
survival; iDFS) by half compared to Herceptin as an adjuvant (after
surgery) treatment in people with HER2-positive early breast cancer
(eBC) who have residual disease present following neoadjuvant
(before surgery) treatment.
Data from the primary analysis of the phase III Haven 2 study
evaluating Hemlibra prophylaxis in children younger than 12 years
of age with haemophilia A with factor VIII inhibitors showed that
nearly 77% of children receiving Hemlibra once weekly experienced
zero treated bleeds. Hemlibra once weekly reduced treated bleeds by
99% compared to prior bypassing agents in a prospective
intra-patient comparison. Hemlibra every two weeks and every four
weeks also showed clinically meaningful control of
bleeding.
Results of the head-to-head phase III study of Alecensa versus
crizotinib in an Asian patient population with ALK-positive
advanced or metastatic NSCLC showed a reduction in the risk of
disease worsening or death by 78%. Alecensa lowered the risk of
tumour spread or growth in the brain or central nervous system by
86%.
An integrated analysis of the pivotal entrectinib phase II
Startrk-2, phase I Startrk -1 and phase I Alka-372-001 trials
showed that entrectinib shrank tumours (objective response rate;
ORR) in more than half (57.4%) of people with neurotrophic
tropomyosin receptor kinase (NTRK) fusion-positive solid tumours.
The study data also demonstrate the potential of entrectinib to
treat a range of difficult-to-treat and rare cancers regardless of
their site of origin.
Based on the positive phase III results, Roche will be moving
forward with satralizumab for neuromyelitis optica spectrum
disorder (NMOSD). Roche will be solely responsible for the
global regulatory filings and commercialisation except in Japan,
Taiwan and Korea. The programme transition from Chugai to
Roche was initiated in January 2019.
Key pharmaceutical products
HER2-franchise
(Herceptin, Perjeta and Kadcyla, +7%). For
HER2-positive breast cancer and HER2-positive metastatic gastric
cancer (Herceptin only).
Herceptin (+1%). For HER2-positive breast
cancer and HER2-positive metastatic gastric cancer. Sales increases
were mainly driven by growth in the US and in China. This growth
was partially offset by the sales decline in Europe (-16%) due to
the first biosimilar launches from mid-2018.
Avastin (+3%). For advanced colorectal,
breast, lung, kidney, cervical and ovarian cancer, and relapsed
glioblastoma (a type of brain tumour). Sales increased in the
International region (+12%), in particular in China due to broader
market penetration, in the US (+1%) and in Japan (+3%), but
declined in Europe (- 1%).
MabThera/Rituxan (-8%). For forms of blood
cancer, rheumatoid arthritis and certain types of vasculitis. Sales
development was impacted by Europe (-47%) as a result of the market
entry of biosimilars. In the US, sales increased 4%, with growth in
both the immunology and oncology segments, also driven by the
subcutaneous formulation. Sales were also higher in the
International region (+11%), particularly in China due to broader
market penetration.
Actemra/RoActemra (+12%). 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 continued uptake of the subcutaneous
formulation.
Xolair (+11%, US only). For chronic idiopathic
urticaria and allergic asthma. Growth was driven by demand in both
indications.
Lucentis (+18%, 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 the ongoing
rollout of prefilled syringes and sales increases in all approved
indications.
Highlights on medicines launched since 2012
Perjeta. For
HER2-positive breast cancer. Sales (CHF 2.8 billion, +27%) grew in
all regions. As of December 2018, Perjeta was registered in 73
countries including the US, the EU and recent approvals in Japan
and China for adjuvant treatment. This indication strongly supports
its continued growth, which is also driven by increased demand in
adjuvant early breast cancer therapy in the US and in neoadjuvant
metastatic usage in Europe.
Ocrevus (CHF 2.4 billion, +172%). For both the
relapsing and primary progressive forms of multiple sclerosis (MS).
Ocrevus has now been approved in 74 countries, with more than
80,000 people treated globally as of December 2018. Strong demand
in both indications has continued.
Esbriet (CHF 1.0 billion, +19%). For
idiopathic pulmonary fibrosis (IPF). Sales continued to expand,
driven by growth in the US (+19%) and Europe (+17%).
Tecentriq (CHF 772 million, +59%). For
advanced bladder cancer, advanced lung cancer and initial therapy
of non-squamous NSCLC. Sales growth was reported by all regions,
mainly driven by Europe, notably in Germany, and by the launch in
Japan in 2018.
Alecensa (CHF 637 million, +76%). For
ALK-positve lung cancer. Alecensa showed continued strong sales
growth across all regions, with the US and Europe as the main
drivers.
Gazyva/Gazyvaro (CHF 390 million, +40%). For
chronic lymphocytic leukaemia (CLL), rituximab-refractory
follicular lymphoma and previously untreated advanced follicular
lymphoma. Sales expanded, especially in Europe and in the
US.
Hemlibra (CHF 224 million). For people with
haemophilia A with inhibitors to factor VIII. Hemlibra is approved
in more than 50 countries, including the US, the EU and Japan. In
several countries, including the US, Hemlibra is also approved for
people with haemophilia A without factor VIII 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).
Top-selling pharmaceuticals |
Total |
United States |
Europe |
Japan |
International* |
CHFm |
% |
CHFm |
% |
CHFm |
% |
CHFm |
% |
CHFm |
% |
Herceptin |
6,982 |
1 |
2,908 |
9 |
1,849 |
-16 |
249 |
-16 |
1,976 |
10 |
Avastin |
6,849 |
3 |
2,904 |
1 |
1,820 |
-1 |
847 |
3 |
1,278 |
12 |
MabThera/Rituxan |
6,752 |
-8 |
4,290 |
4 |
916 |
-47 |
188 |
-36 |
1,358 |
11 |
Perjeta |
2,773 |
27 |
1,325 |
32 |
915 |
15 |
143 |
18 |
390 |
45 |
Ocrevus |
2,353 |
172 |
2,080 |
144 |
206 |
** |
- |
- |
67 |
** |
Actemra/RoActemra |
2,160 |
12 |
857 |
14 |
701 |
7 |
354 |
15 |
248 |
15 |
Xolair |
1,912 |
11 |
1,912 |
11 |
- |
- |
- |
- |
- |
- |
Lucentis |
1,659 |
18 |
1,659 |
18 |
- |
- |
- |
- |
- |
- |
Activase/TNKase |
1,284 |
6 |
1,231 |
6 |
- |
- |
- |
- |
53 |
5 |
Esbriet |
1,031 |
19 |
754 |
19 |
230 |
17 |
- |
- |
47 |
29 |
* Asia-Pacific, EEMEA (Eastern Europe, Middle
East and Africa), Latin America, Canada, others |
|
|
|
**
over 500% |
|
|
|
|
|
|
|
|
|
|
Diagnostics Division
Sales |
CHF
millions |
As % of sales |
% change |
January - December 2018 |
2018 |
2017 |
2018 |
2017 |
At CER |
In CHF |
Diagnostics
Division |
12,879 |
12,079 |
100.0 |
100.0 |
+7 |
+7 |
Business
Areas |
|
|
|
|
|
|
Centralised
and Point of Care Solutions |
7,768 |
7,179 |
60.3 |
59.4 |
+8 |
+8 |
Molecular
Diagnostics |
2,019 |
1,920 |
15.7 |
15.9 |
+5 |
+5 |
Diabetes
Care |
1,980 |
1,965 |
15.4 |
16.3 |
+2 |
+1 |
Tissue
Diagnostics |
1,112 |
1,015 |
8.6 |
8.4 |
+10 |
+10 |
Regions |
|
|
|
|
|
|
Europe,
Middle East, Africa |
4,986 |
4,773 |
38.7 |
39.5 |
+3 |
+4 |
Asia-Pacific |
3,334 |
2,939 |
25.9 |
24.4 |
+13 |
+13 |
North
America |
3,213 |
3,011 |
24.9 |
24.9 |
+7 |
+7 |
Latin
America |
844 |
884 |
6.6 |
7.3 |
+9 |
-5 |
Japan |
502 |
472 |
3.9 |
3.9 |
+6 |
+6 |
In October, Roche officially opened a new
manufacturing site and R&D centre in Suzhou, China, to support
the future diagnostic needs within China and the region. With its
regional headquarters in Singapore and eight existing branches
across China, Roche is already a major healthcare provider in
Asia-Pacific.
Centralised and Point of Care Solutions (+8%) was the largest
contributor to the division's sales growth. Serum Work Area
solutions, comprising the immunodiagnostics (+11%) and clinical
chemistry (+7%) businesses, were the main growth drivers.
cobas pro integrated solution, a Serum Work Area solution for
medium throughput to lower high throughput laboratories was
launched in countries accepting the CE mark. This new generation of
SWA solutions provides a high level of efficiency and continuous
loading of supplies. Furthermore, it offers simplicity through
automated maintenance and calibration. It also features the
broadest SWA assay menu consolidated on a single platform, short
assay incubation times and low sample volume
requirements.
Sales in Molecular Diagnostics increased 5%.
In virology, sales were up 4%, with strong growth in HIV
monitoring. Sales in the blood screening and human papillomavirus
(HPV) screening businesses grew 9% and 8% respectively. Continued
high demand was reported for cobas Liat tests, the new system for
molecular point of care testing.
The Navify Tumor Board, a cloud-based software solution that
fundamentally changes the way oncology care teams prepare for,
conduct and document clinical treatment decisions, was further
extended by the launch of the Navify Clinical Trial Match and
Navify Publication Search apps in 2018. These apps scan globally
renowned resources and are fully integrated with the Navify Tumor
Board and represent the start of the Navify apps ecosystem, with
more apps from Roche, partners and third parties to
follow.
Tissue Diagnostics sales increased 10%. The
advanced staining business continued its strong growth (+10%);
demand for the primary staining portfolio was high
(+13%).
The Ventana DP 200 slide scanner was launched in March 2018,
creating high-quality tissue slide images that offer pathologists a
digital image that accurately reproduces what would be seen under
the microscope. These images serve as the basis for a full menu of
image analysis algorithms currently under development. Roche also
launched uPath enterprise software, a universal digital pathology
software for lab administrators, histotechnicians and pathologists.
This software allows for improved case management, including case
sharing among colleagues to seek second opinions. More importantly,
uPath software enables pathologists with patient-centric case
viewing for quick diagnosis, and will provide a platform for a full
menu of image analysis algorithms currently under
development.
Diabetes Care sales increased 2%, mainly
driven by the new Accu-Chek Guide and Accu-Chek Instant blood
glucose monitoring systems. Launched in pilot markets, the new
Accu-Chek Solo micropump received encouraging customer feedback. An
enhanced positive acceptance is visible for the integrated diabetes
management solutions including mySugr.
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 2017).
[2] US Food and Drug Administration prescribing information for
Perjeta
[3] EMEA = Europe, Middle East and Africa
[4] Venclexta/Venclyxto sales are booked by partner
AbbVie.
[5] Shi F, et al. Viral RNA polymerase: a promising antiviral
target for influenza A virus. Curr Med Chem.
2013;20(31):3923-34
[6] Taniguchi K, et al. Inhibitory Effect of S-033188, a novel
inhibitor of influenza virus cap-dependent endonuclease, against
avian influenza A/H7N9 virus in vitro and in vivo. Poster
presentation at ESWI, September 2017.
[7] Evans WK, et al. J Clin Oncol, 1985
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 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
Roche-appendix-tables-FY2018
Roche-Media-Release-Full-Year-Results-2018_en