[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase
by 2% (CER) in first quarter with both divisions growing in high
single digit ex COVID-19
- Group sales grew by
2%1 at constant exchange rates (CER) (-6% in CHF),
driven by the strong growth of newer medicines and diagnostics.
Excluding COVID-19-related products, sales increased by 7%. Going
forward, there will be no further material impact of COVID-19 sales
decline
- Due to the appratioss fn of the
Swiranc against most currencies, sales were 6%
lower when reported in CHF
- Pharmaceuticals
Division base
business2 grew by 7%, driven
by strong sales of medicines to treat severe diseases, such as
Vabysmo (eye diseases), Phesgo (breast cancer), Ocrevus (multiple
sclerosis), Polivy (blood cancer) and Hemlibra (haemophilia A).
Divisional sales growth was 2%, reflecting the
impact of the expected decline in sales of the COVID-19 medicine
Ronapreve
- Diagnostics Division base
business2 grew by 8%,
supported by growth across all regions because of demand for
immunodiagnostic products, clinical chemistry tests and advanced
staining solutions. As this growth was partially offset by the
lower demand for COVID-19 tests, divisional sales
grew by 2%
- Highlights in the
first quarter:
- US approvals of
Xolair (food allergies) and
Alecensa (early-stage lung cancer)
- Positive phase III data for
Xolair (food allergies), Columvi
(blood cancer) and Ocrevus subcutaneous injection
(multiple sclerosis); positive phase II results for
zilebesiran (hypertension in people with high
cardiovascular risk)
- New positive long-term data for
Vabysmo (retinal vein occlusion, a severe eye
disease)
- US approval for the first
molecular test to screen for malaria in blood
donors
- US Breakthrough Device Designation
for blood test to support earlier Alzheimer’s
disease diagnosis
- Outlook for 2024
confirmed
Roche CEO Thomas Schinecker: “We had a strong
start into the year, with both our divisions reporting high single
digit growth in their base business – excluding COVID-19 sales.
After this quarter, the COVID-19-related impact on sales is largely
behind us. The appreciation of the Swiss franc versus most
currencies impacted sales reported in Swiss francs compared to the
same period last year. The uptake of our eye medicine Vabysmo
continues its momentum. We are pleased about the US approval of
Xolair as the first and only medicine for multiple food allergies.
Further, we recently received the US approval for Alecensa in
early-stage lung cancer. With an unprecedented 76% reduction in the
risk of disease recurrence or death versus chemotherapy, Alecensa
significantly improves upon the standard of care for this specific
form of lung cancer.
We are confident of growing our Group sales in the mid single
digit range this year (at constant exchange rates) and therefore we
confirm our outlook for 2024.”
Sales |
CHF millions |
As % of sales |
% change |
|
January‒March |
2024 |
2023 |
2024 |
2023 |
At CER |
In CHF |
|
Group |
14,399 |
15,322 |
100.0 |
100.0 |
2 |
-6 |
|
|
|
|
|
|
|
|
|
Pharmaceuticals Division |
10,921 |
11,608 |
75.8 |
75.8 |
2 |
-6 |
|
United States |
5,692 |
5,763 |
39.5 |
37.6 |
5 |
-1 |
|
Europe |
2,200 |
2,071 |
15.3 |
13.5 |
11 |
6 |
|
Japan |
649 |
1,390 |
4.5 |
9.1 |
-45 |
-53 |
|
International* |
2,380 |
2,384 |
16.5 |
15.6 |
12 |
0 |
|
|
|
|
|
|
|
|
|
Diagnostics Division |
3,478 |
3,714 |
24.2 |
24.2 |
2 |
-6 |
|
All figures shown in the table were restated to reflect the shift
of the Foundation Medicine (FMI) business from the Pharmaceuticals
Division to the Diagnostics Division.
*Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and
Indian subcontinent), Latin America, Middle East, Africa, Canada,
others |
|
|
Outlook for 2024 confirmed
Roche expects an increase in Group sales in the mid single digit
range (CER). Core earnings per share are targeted to develop
broadly in line with sales growth (CER), excluding the impact from
the resolution of tax disputes in 2023. Roche expects to further
increase its dividend in Swiss francs.
Group sales
In the first three months of 2024, Group sales
increased by 2% CER (-6% in CHF) to
CHF 14.4 billion as strong demand for newer medicines as well
as diagnostics products including immunodiagnostics, clinical
chemistry tests and advanced staining solutions more than offset
the anticipated decline in COVID-19-related sales and the impact of
biosimilar/generic erosion.
After this quarter, the impact of the drop in COVID-19-related
sales is largely over and there will be no further material impact
on Group sales.
Excluding COVID-19-related products, sales increased by 7%.
The appreciation of the Swiss franc against most currencies had
a significant adverse impact on the sales reported in Swiss francs
compared to constant exchange rates.
Pharmaceuticals Division base business grew by
7%, while divisional sales increased by 2% to CHF
10.9 billion as the strong global demand for newer medicines to
treat severe diseases was partially offset by the expected decline
in COVID-19 Ronapreve sales.
The eye medicine Vabysmo was the biggest growth driver, with
Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood
cancer) and Hemlibra (haemophilia A) being other significant
contributors. Together, these medicines generated sales of CHF 4.2
billion, an increase of CHF 0.9 billion (at CER) from the first
quarter of 2023.
The negative impact of biosimilar/generic erosion on our
medicines Lucentis (eye diseases, US commercialisation rights
only), MabThera/Rituxan (blood cancer), Herceptin (breast and
stomach cancer), Avastin (various types of cancer), Esbriet (lung
disease) and Actemra/RoActemra (arthritis, COVID-19) totalled CHF
0.4 billion (at CER), in line with expectations.
In the United States, sales increased by 5%,
driven by strong demand for newer medicines such as Vabysmo,
Polivy, Ocrevus, Phesgo and Evrysdi (spinal muscular atrophy) as
well as for Xolair (allergies). This contrasted with lower sales of
Lucentis, MabThera/Rituxan, Tecentriq (cancer immunotherapy),
Esbriet, Avastin and Perjeta.
In Europe, sales grew by 11%, with Vabysmo,
Phesgo, Hemlibra, Evrysdi and Ocrevus being the key drivers.
Sales in Japan were down by 45%, reflecting the
base effect of the supply of Ronapreve to the government in the
first quarter of 2023.
Sales in the International region increased by
12%, driven by strong growth in Hemlibra, Perjeta, Phesgo, Ocrevus,
Tecentriq and Vabysmo. In China, sales grew by 11% due to high
demand for Xofluza (influenza), Perjeta, Avastin, Polivy and
Tecentriq.
The Diagnostics Division’s base business
continued good growth (8%), boosted by demand for immunodiagnostic
products, clinical chemistry tests and advanced staining solutions.
This was partially offset by the expected sales decline of
COVID-19-related products, leading to divisional
sales growing at 2% to CHF 3.5 billion.
Immunodiagnostic products, which include cardiac, oncology and
thyroid tests, were the main growth drivers (10%). Additional
growth impetus came from clinical chemistry (8%), advanced staining
techniques in oncology (12%) and companion diagnostics (47%).
As expected, the sales of COVID-19 tests further declined to
CHF 0.1 billion in the first quarter of 2024 from CHF 0.3
billion in the corresponding period last year.
Sales growth was reported across regions, with Europe,
Middle East and Africa (EMEA) growing by 2%,
Asia-Pacific by 1% and Latin
America by 14%. North America recorded a
decline of 1%, reflecting the drop in demand for COVID-19-related
tests.
Pharmaceuticals: key milestones in the first quarter of
2024
Compound |
Milestone |
Regulatory |
Alecensa
Lung cancer |
FDA approves Alecensa as first adjuvant treatment for
people with ALK-positive early-stage lung cancer
- Approval based on phase III ALINA study showing Alecensa
reduced the risk of disease recurrence or death by an unprecedented
76% in people with ALK-positive early-stage resected non-small cell
lung cancer (NSCLC)
- This approval helps address an urgent unmet need, with about
half of people living with early-stage NSCLC experiencing disease
recurrence following surgery, despite adjuvant chemotherapy
- The National Comprehensive Cancer Network (NCCN) Guidelines
recommend routine testing for ALK, EGFR and PD-L1 biomarkers in
people with early-stage NSCLC to inform adjuvant therapy
selection
More information: Media Release, 19 April 2024 |
Piasky
Rare blood disease |
Chugai obtains regulatory approval for Piasky 340 mg for
paroxysmal nocturnal haemoglobinuria in Japan
- Providing convenience of once every 4 week subcutaneous
administration for treatment-naive patients, or for patients
switching to this drug from other C5 inhibitors, with paroxysmal
nocturnal haemoglobinuria (PNH), a designated intractable
disease
- This approval for not only treatment-naive PNH but also
including patients switching from previously approved C5
inhibitors, is the first in the world
- Second approved drug that applies Chugai’s proprietary
recycling antibody technology and also the fifth Chugai-originated
global product
More information: Investor Relations Update, 26 March 2024 |
Xolair
Food allergy |
FDA approves Xolair as first and only medicine for children
and adults with one or more food allergies
- Approval is based on data from the NIH-sponsored phase III
OUtMATCH study, which showed a significantly higher proportion of
food allergy patients as young as one year treated with Xolair
could tolerate small amounts of peanut, milk, egg and cashew
without an allergic reaction, compared to placebo
- More than 40% of children and more than 50% of adults with food
allergies have experienced a severe reaction at least once in their
lifetime
- Detailed OUtMATCH results were featured in a late-breaking
symposium at the 2024 American Academy of Allergy, Asthma &
Immunology annual meeting
More information: Media Release, 16 February 2024 |
Phase III, pivotal and other key readouts |
Ocrevus SC
Multiple sclerosis |
Subcutaneous Ocrevus one-year data demonstrates
near-complete suppression of clinical relapses and brain lesions in
patients with progressive and relapsing forms of multiple
sclerosis
- Results from the phase III study showed that subcutaneous (SC)
injection was consistent with IV infusion and demonstrated
near-complete suppression of relapse activity (97%) and MRI lesions
(97.2%) through 48 weeks
- The twice-yearly, 10-minute SC injection has the potential to
expand the usage of Ocrevus to treatment centres without IV
infrastructure or with IV capacity limitations
- US FDA and EMA accepted filings based on the data from OCARINA
II, with EU approval anticipated mid-2024 and US approval
anticipated in September 2024
More information: Media Release, 17 April 2024 |
Columvi
Blood cancer |
Columvi meets primary endpoint of overall survival in
people with relapsed or refractory diffuse large B-cell lymphoma in
phase III STARGLO study
- Columvi, in combination with chemotherapy, demonstrated a
statistically significant improvement in overall survival for
people with relapsed or refractory diffuse large B-cell
lymphoma
- Data from the STARGLO study will be submitted to health
authorities and presented at an upcoming medical meeting
More information: Media Release, 15 April 2024 |
Zilebesiran
Cardiovascular diseases |
Roche and Alnylam present positive results from the phase
II KARDIA-2 study of zilebesiran added to standard-of-care
antihypertensives in patients with inadequately controlled
hypertension
- The KARDIA-2 study met its primary endpoint demonstrating
additive, placebo-adjusted systolic blood pressure reductions of up
to 12.1 mmHg at month three. These results were statistically
significant and clinically meaningful
- Zilebesiran demonstrated an encouraging safety and tolerability
profile when added to standard of care antihypertensives
- Roche and Alnylam have initiated the
phase II KARDIA-3 study in adults with uncontrolled hypertension at
high cardiovascular risk.
More information: Investor Relations Update, 7 March 2024 |
Xolair
Food allergies |
New England Journal of Medicine publishes phase III data
showing Xolair significantly reduced allergic reactions across
multiple foods in people with food allergies
- Detailed results from the NIH-sponsored phase III OUtMATCH
study showed treatment with Xolair increased the amount of peanuts,
tree nuts, egg, milk and wheat that people as young as one year
consumed without an allergic reaction
- The US FDA recently approved Xolair as the first and only
medicine for children and adults with one or more food
allergies
- Allergic reactions can be
life-threatening and it is estimated that food-related anaphylaxis
results in 30,000 medical events treated in emergency rooms in the
US each year
More information: Media Release, 25 February 2024 |
Vabysmo
Severe eye diseases |
New long-term data for Vabysmo show sustained retinal
drying and vision improvements in retinal vein occlusion
(RVO)
- Vabysmo sustained robust drying of retinal fluid, often
associated with distorted or blurry vision
- Up to 60% of people receiving Vabysmo were able to extend
treatment intervals to three or four months apart
- Detailed results from two global
phase III RVO studies were presented at Angiogenesis, Exudation,
and Degeneration 2024
More information: Media Release, 1 February 2024 |
Pharmaceuticals sales
Sales |
CHF millions |
As % of sales |
% change |
|
January–March |
2024 |
2023 |
2024 |
2023 |
At CER |
In CHF |
|
Pharmaceuticals Division |
10,921 |
11,608 |
100.0 |
100.0 |
2 |
-6 |
|
United States |
5,692 |
5,763 |
52.1 |
49.4 |
5 |
-1 |
|
Europe |
2,200 |
2,071 |
20.1 |
17.8 |
11 |
6 |
|
Japan |
649 |
1,390 |
5.9 |
12.0 |
-45 |
-53 |
|
International* |
2,380 |
2,384 |
21.9 |
20.8 |
12 |
0 |
|
All
figures shown in the table were restated to reflect the shift of
the Foundation Medicine (FMI) business from the Pharmaceuticals
Division to the Diagnostics Division.
*Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and
Indian subcontinent), Latin America, Middle East, Africa, Canada,
others
|
|
Top 20 best-selling pharmaceuticals
|
Total |
United States |
Europe |
Japan |
International |
CHF m |
% |
CHF m |
% |
CHF m |
% |
CHF m |
% |
CHF m |
% |
Ocrevus
Multiple sclerosis |
1,658 |
8 |
1,180 |
5 |
310 |
8 |
- |
- |
168 |
28 |
Hemlibra
Haemophilia A |
1,040 |
8 |
592 |
-1 |
231 |
17 |
79 |
2 |
138 |
51 |
Perjeta3
Breast cancer |
936 |
-3 |
343 |
-7 |
171 |
-19 |
36 |
-19 |
386 |
14 |
Tecentriq
Cancer immunotherapy |
865 |
1 |
436 |
-9 |
210 |
12 |
86 |
-4 |
133 |
34 |
Vabysmo
Eye diseases (nAMD, DME, RVO) |
847 |
108 |
650 |
91 |
138 |
224 |
23 |
33 |
36 |
397 |
Actemra/RoActemra3
RA, COVID-19 |
618 |
-2 |
278 |
-1 |
188 |
1 |
68 |
5 |
84 |
-15 |
Xolair3
Asthma, allergies |
496 |
10 |
496 |
10 |
- |
- |
- |
- |
- |
- |
Kadcyla3
Breast cancer |
483 |
3 |
186 |
-1 |
145 |
-2 |
21 |
-4 |
131 |
19 |
Phesgo
Breast cancer |
388 |
70 |
126 |
36 |
169 |
55 |
19 |
- |
74 |
165 |
Herceptin3
Breast and gastric cancer |
364 |
-17 |
67 |
-22 |
77 |
-17 |
4 |
-41 |
216 |
-14 |
Evrysdi
Spinal muscular atrophy |
356 |
7 |
135 |
16 |
137 |
27 |
20 |
13 |
64 |
-29 |
Alecensa
Lung cancer |
355 |
4 |
104 |
4 |
72 |
3 |
43 |
3 |
136 |
5 |
MabThera/Rituxan3
Blood cancer, RA |
351 |
-18 |
204 |
-21 |
39 |
-20 |
4 |
-20 |
104 |
-11 |
Avastin 3
Various cancer types |
324 |
-15 |
99 |
-22 |
21 |
-27 |
51 |
-33 |
153 |
3 |
Activase/TNKase3
Cardiac diseases |
296 |
4 |
282 |
4 |
- |
- |
- |
- |
14 |
7 |
Polivy
Blood cancer |
250 |
81 |
117 |
166 |
54 |
42 |
44 |
2 |
35 |
181 |
Gazyva/Gazyvaro3
Blood cancer |
213 |
16 |
100 |
7 |
62 |
17 |
6 |
-19 |
45 |
47 |
Pulmozyme3
Cystic fibrosis |
112 |
-6 |
66 |
-15 |
20 |
0 |
- |
27 |
26 |
22 |
Mircera3
Anaemia |
96 |
0 |
- |
- |
10 |
-8 |
9 |
-25 |
77 |
6 |
CellCept3
Immunosuppressant |
94 |
0 |
5 |
-34 |
32 |
0 |
9 |
-10 |
48 |
8 |
** Over 500%
DME: diabetic macular oedema / nAMD: neovascular or ‘wet’
age-related macular degeneration / RVO: retinal vein occlusion /
RA: rheumatoid arthritis |
Diagnostics: key milestones in the first quarter of
2024
Product |
Milestone |
Regulatory |
Elecsys pTau217 test
Alzheimer’s disease |
FDA Breakthrough Device Designation for blood test to
support earlier Alzheimer’s disease diagnosis
- The Elecsys pTau217 plasma biomarker test is being developed as
part of an ongoing partnership between Roche and Eli Lilly and
Company
- Once approved, the test will aid healthcare providers in
identifying amyloid pathology, a key feature of Alzheimer’s
disease
- Roche and Lilly believe the test
could play an important role in improving access to early and
accurate Alzheimer’s diagnosis
More information: Media Release, 11 April 2024 |
cobas Malaria test
Malaria |
FDA approval for the first molecular test to screen for
malaria in blood donors
- The cobas Malaria test is the first FDA-approved molecular test
to screen US blood donors for malaria
- Malaria is a serious and potentially fatal parasitic infection
most commonly transmitted by mosquitoes that can also be spread
through blood transfusion
- Roche is dedicated to saving
patients’ lives through diagnostic solutions that aid in the
protection of the global blood supply from infectious diseases
More information: Media Release, 26 March 2024 |
Diagnostics sales
Sales |
CHF millions |
As % of sales |
% change |
January–March |
2024 |
2023 |
2024 |
2023 |
At CER |
In CHF |
Diagnostics Division |
3,478 |
3,714 |
100.0 |
100.0 |
2 |
-6 |
Customer areas4 |
|
|
|
|
|
|
Core Lab |
1,925 |
1,928 |
55.4 |
51.9 |
9 |
0 |
Molecular Lab5 |
620 |
683 |
17.8 |
18.4 |
-3 |
-9 |
Near Patient Care6 |
570 |
774 |
16.4 |
20.8 |
-20 |
-26 |
Pathology Lab |
363 |
329 |
10.4 |
8.9 |
19 |
10 |
Regions |
|
|
|
|
|
|
Europe, Middle East, Africa |
1,188 |
1,253 |
34.2 |
33.8 |
2 |
-5 |
North America5 |
1,055 |
1,120 |
30.3 |
30.3 |
-1 |
-6 |
Asia-Pacific |
992 |
1,098 |
28.5 |
29.4 |
1 |
-10 |
Latin America |
243 |
243 |
7.0 |
6.5 |
14 |
0 |
More information on Roche sales in the first quarter of
2024:
- Q1 2024 presentation
- Appendix with tables
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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 and comparisons to
the previous year in this document are at constant exchange rates
(CER: average rates 2023) and all total figures quoted are reported
in CHF.
[2] Pharmaceuticals Division base business: excluding COVID-19
medicine Ronapreve.
Diagnostics Division base business: excluding COVID-19-related
products.
[3] Products launched before 2015.
[4] Core Lab: diagnostics solutions in the areas of immunoassays,
clinical chemistry and CustomBiotech.
Molecular Lab: diagnostics solutions for pathogen detection and
monitoring, donor screening, sexual health and genomics, genomic
tumour profiling.
Near Patient Care: diagnostics solutions in emergency rooms,
medical practices or directly with patients and integrated
personalised diabetes management.
Pathology Lab: diagnostics solutions for tissue biopsies and
companion diagnostics.
[5] Sales in the Molecular Lab customer area include sales from the
Foundation Medicine business which moved under the responsibility
of the Diagnostics Division from the Pharmaceuticals Division
effective 1 January 2024. The comparative information for 2023 has
been restated accordingly.
[6] Sales in the new Near Patient Care customer area include sales
from Diabetes Care and the Point of Care business, both previously
shown as separate customer areas. The comparative information for
2023 has been restated accordingly.
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, such as: (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 this or any subsequent period will necessarily match or exceed
the historical published earnings or earnings per share of
Roche.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
Hans Trees, PhD
Phone: +41 79 407 72 58 |
Nathalie
Altermatt
Phone: +41 79 771 05 25
|
Simon
Goldsborough
Phone: +44 797 32 72 915 |
Karsten
Kleine
Phone: +41 79 461 86 83
|
Nina
Mählitz
Phone: +41 79 327 54 74 |
Kirti
Pandey
Phone: +49 172 6367262
|
Dr.
Rebekka Schnell
Phone: +41 79 205 27 03 |
Sileia
Urech
Phone: +41 79 935 81 48 |
Roche Investor Relations
Dr. Bruno
Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com |
Dr.
Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com |
Dr.
Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com |
|
Investor Relations North America
Loren
Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com |
|
- Communications appendix tables_Q1 2024_Sales
- 24042024_MR_Roche_Q1results_EN
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