Ad hoc announcement pursuant to Art. 53 LR
FINANCIAL RESULTS | RÉSULTATS FINANCIERS | FINANZERGEBNISSE
|
Novartis International AG
Novartis Global Communications CH-4002 Basel Switzerland https://www.novartis.com |
•
|
Net sales grew +4% (cc1, -2% USD) with core operating income growing +8% (cc, 0% USD)
|
o
|
IM sales grew +4% (cc, -2% USD) and core operating income +8% (cc, 0% USD), with IM core margin reaching 36.9% (+130 bps cc)
|
o
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Sandoz sales grew +4% (cc, -4% USD) with core operating income decreasing -1% (cc, -8% USD)
|
•
|
Operating income declined -13% (cc, -21% USD), mainly due to higher restructuring and impairments. Net income declined -67% (cc, -71% USD), or -9% (cc)
excluding the impact of Roche income2. Free cash flow was USD 11.9 billion (-10% USD)
|
•
|
Core EPS was USD 6.12 +6% (cc, -3% USD); excluding Roche core income impact, core EPS grew +14% (cc)
|
•
|
Net sales grew +3% (cc, -4% USD) with core operating income growing +15% (cc, +6% USD), mainly driven by higher sales and productivity
|
o
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Innovative Medicines (IM) sales grew +3% (cc, -3% USD), growth drivers include: Entresto (+44% cc), Kesimpta (+157% cc), Pluvicto (reaching USD 179 million) and Kisqali (+33% cc)
|
o
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Sandoz sales were in line with the prior year (0% cc, -8% USD) with continued growth in biopharmaceuticals
|
•
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Q4 selected innovation milestones:
|
o
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Pluvicto Ph3 PSMAfore positive results in mCRPC; EC approval for progressive PSMA+ mCRPC
|
o
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Iptacopan Ph3 APPLY-PNH demonstrated iptacopan superiority vs. anti-C5 in refractory PNH
|
o
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Iptacopan Ph3 APPOINT-PNH met primary endpoint in complement inhibitor naive PNH patients
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•
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Previously announced up-to USD 15 billion share buyback ongoing; USD 4.9 billion still to be executed3
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•
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Dividend of CHF 3.20 per share, an increase of 3.2%, proposed for 2022
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•
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2023 guidance4 – Group expected to grow sales low-to-mid single digit and core operating income mid single digit. IM expected to grow sales low-to-mid single digit and core operating
income mid-to-high single digit
|
Q4 2022
|
Q4 2021
|
% change
|
FY 2022
|
FY 2021
|
% change
|
|||
|
USD m
|
USD m
|
USD
|
cc
|
USD m
|
USD m
|
USD
|
cc
|
Net sales
|
12 690
|
13 229
|
-4
|
3
|
50 545
|
51 626
|
-2
|
4
|
Operating income
|
1 949
|
2 562
|
-24
|
-14
|
9 197
|
11 689
|
-21
|
-13
|
Net income
|
1 466
|
16 306
|
-91
|
-90
|
6 955
|
24 018
|
-71
|
-67
|
EPS (USD)
|
0.69
|
7.29
|
-91
|
-89
|
3.19
|
10.71
|
-70
|
-66
|
Free cash flow
|
3 552
|
3 027
|
17
|
|
11 945
|
13 282
|
-10
|
|
Core operating income
|
4 030
|
3 819
|
6
|
15
|
16 665
|
16 588
|
0
|
8
|
Core net income
|
3 251
|
3 135
|
4
|
14
|
13 352
|
14 094
|
-5
|
3
|
Core EPS (USD)
|
1.52
|
1.40
|
9
|
19
|
6.12
|
6.29
|
-3
|
6
|
1.
|
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
|
2.
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Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with
substantial cash generation and a strong capital structure supporting continued flexibility.
|
3.
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Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.
|
Entresto
|
(USD 1,291 million, +44% cc) sustained robust demand-led growth, with increased patient share across all geographies
|
Kesimpta
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(USD 369 million, 157% cc) driven by strong launch uptake, access and increased demand; approved in 80 countries
|
Pluvicto
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(USD 179 million, nm cc) with strong US launch performance, more than 160 active centers
|
Kisqali
|
(USD 357 million, +33% cc) grew strongly across all geographies, based on increasing recognition of its overall survival and quality of life benefits in
HR+/HER2- advanced breast cancer
|
Promacta/Revolade
|
(USD 540 million, +11% cc) showed growth across most regions, driven by increased use in chronic ITP and as first-line and/or second-line treatment for severe
aplastic anemia
|
Scemblix
|
(USD 52 million, nm cc) continued its strong launch uptake demonstrating the high unmet need in CML, particularly patients previously treated with 2 or more
tyrosine kinase inhibitors, or with the T315I mutation
|
Leqvio
|
(USD 42 million, nm cc) launch is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education
|
Ilaris
|
(USD 301 million, +14% cc) showed continued growth across all geographies
|
Tafinlar + Mekinist
|
(USD 465 million, +8% cc) sales grew across all geographies, driven by demand in BRAF+ adjuvant melanoma and NSCLC indications
|
Jakavi
|
(USD 388 million, +8% cc) sales grew (cc) mainly in Europe, Emerging Growth Markets and Japan, driven by strong demand in both the myelofibrosis and polycythemia
vera indications
|
Piqray
|
(USD 112 million, +30% cc) sales grew mainly in the US, benefiting from indication expansion into PIK3CA-related overgrowth spectrum (PROS)
|
Mayzent
|
(USD 99 million, +28% cc) continued to grow in patients with multiple sclerosis showing signs of progression despite being on other treatments
|
Lutathera
|
(USD 128 million, +15% cc) sales grew across all geographies, with approximately 500 centers actively treating patients globally
|
Cosentyx
|
(USD 1,080 million, -9% cc), with ex-US growing +5% (cc). US sales growth was impacted by a revenue deduction true-up for Cosentyx
(mainly due to higher than expected Medicaid patient mix), which was related to prior quarters in 2022. For the full year, Cosentyx grew +5% (cc) worldwide
|
Sandoz Biopharmaceuticals
|
(USD 517 million, +3% cc) with growth in Europe, Canada and Latin America
|
Emerging Growth Markets*
|
Grew +5% (cc) overall. China declined (-2% cc) to USD 581 million, with sales impacted by COVID-19 related regional lockdowns. For the full year, China grew +6%
(cc)
*All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand
|
Q4 2022
|
% change
|
FY 2022
|
% change
|
|||
USD m
|
USD
|
cc
|
USD m
|
USD
|
cc
|
|
Cosentyx / excl. revenue deduction true-up*
|
1 080
|
-13 / -6*
|
-9 / -2*
|
4 788
|
1
|
5
|
Entresto
|
1 291
|
36
|
44
|
4 644
|
31
|
37
|
Promacta/Revolade
|
540
|
4
|
11
|
2 088
|
4
|
9
|
Gilenya
|
346
|
-47
|
-44
|
2 013
|
-28
|
-24
|
Tasigna
|
475
|
-6
|
0
|
1 923
|
-7
|
-1
|
Lucentis
|
398
|
-22
|
-12
|
1 874
|
-13
|
-4
|
Tafinlar + Mekinist
|
465
|
2
|
8
|
1 770
|
5
|
11
|
Jakavi
|
388
|
-5
|
8
|
1 561
|
-2
|
9
|
Zolgensma
|
309
|
-10
|
-5
|
1 370
|
1
|
5
|
Xolair
|
323
|
-13
|
-3
|
1 365
|
-4
|
6
|
Sandostatin
|
305
|
-12
|
-8
|
1 238
|
-12
|
-10
|
Kisqali
|
357
|
25
|
33
|
1 231
|
31
|
38
|
Ilaris
|
301
|
6
|
14
|
1 133
|
7
|
15
|
Kesimpta
|
369
|
151
|
157
|
1 092
|
194
|
200
|
Galvus Group
|
209
|
-25
|
-16
|
859
|
-21
|
-12
|
Gleevec/Glivec
|
175
|
-25
|
-18
|
745
|
-27
|
-22
|
Exforge Group
|
159
|
-19
|
-12
|
743
|
-18
|
-12
|
Diovan Group
|
142
|
-25
|
-16
|
652
|
-16
|
-9
|
Kymriah
|
139
|
-3
|
5
|
536
|
-9
|
-2
|
Afinitor/Votubia
|
106
|
-39
|
-32
|
512
|
-45
|
-41
|
Top 20 products total
|
7 877
|
-4
|
2
|
32 137
|
-1
|
5
|
Pluvicto
|
EC approval for treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen-receptor pathway inhibition and taxane-based chemotherapy
|
Pluvicto
|
Ph3 PSMAfore trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in radiographic PFS in patients with PSMA-positive mCRPC who have been treated with androgen-receptor pathway
inhibition. No unexpected safety findings were observed. Detailed data to be presented at an upcoming medical meeting with submission to regulatory authorities for approval planned for 2023
|
Iptacopan
|
Ph3 APPLY-PNH study met both primary and most secondary endpoints demonstrating iptacopan’s superiority over anti-C5 treatment in adult PNH patients with residual anemia despite prior anti-C5 treatment. Iptacopan demonstrated an 80%
difference to anti-C5 in the estimated proportion of patients achieving ≥2 g/dL Hb-level increases from baseline and a 67% difference to anti-C5 in the estimated proportion of patients achieving ≥12 g/dL Hb levels without the need for red
blood cell transfusions. Iptacopan also provided blood-transfusion independence for almost all patients with no serious cases of breakthrough hemolysis and clinically meaningful patient-reported fatigue improvements. Data presented at ASH
2022
Ph3 APPOINT-PNH study (evaluating iptacopan in complement-inhibitor-naïve PNH patients) met its primary endpoint. With iptacopan, a significant proportion of patients achieved clinically meaningful Hb-level increases of ≥2 g/dL from
baseline without the need for blood transfusions at 24 weeks. Detailed data to be presented at an upcoming medical meeting and included in iptacopan PNH global regulatory submissions planned in 2023
|
Kisqali
|
Ph2 RIGHT Choice trial demonstrated approximately one year PFS benefit of Kisqali plus ET over combination chemotherapy (24 months compared to 12.3 months; HR=0.54; p=.0007) in the 1L setting
for pre- and perimenopausal patients with aggressive forms of HR+/HER2− mBC, including patients with visceral crisis. RIGHT Choice is the first randomized study comparing a CDK4/6i plus ET vs. combination CT in aggressive HR+/HER2− mBC.
Data presented at SABCS 2022
|
Leqvio
|
New long-term data from the ORION-3 open-label study demonstrated effective and sustained reductions in LDL cholesterol over four years of treatment. At any
|
|
time throughout the trial, approximately 80% of patients reached an LDL-C level of <70mg/dL. Data presented at AHA 2022
|
Ganaplacide/ lumefantrine-SDF combination
|
Novartis and Medicines for Malaria Venture announced that ganaplacide/ lumefantrine would advance to a Ph3 study in patients with acute uncomplicated malaria due to Plasmodium falciparum
|
Branaplam
|
Novartis ended the development of branaplam in Huntington’s Disease based on an overall assessment of potential benefit-risk from the Ph2b VIBRANT-HD study
|
Innovative Medicines
|
Sales expected to grow low-to-mid single digit
Core OpInc expected to grow mid-to-high single digit
|
Novartis ex. Sandoz
(IM + Corporate)
|
Sales expected to grow low-to-mid single digit
Core OpInc expected to grow mid-to-high single digit
|
Novartis incl. Sandoz
(IM + Sandoz + Corporate)*
|
Sales expected to grow low-to-mid single digit
Core OpInc expected to grow mid single digit
|
Sandoz
|
Sales expected to grow low-to-mid single digit
Core OpInc expected to decline low double digit, reflecting required stand-up investments to transition Sandoz to a separate company and continued inflationary pressures
|
Excluding Roche income
|
Reported
|
|||||||
Group
|
Q4 2022
|
Q4 2021
|
% change
|
Q4 2021
|
% change
|
|||
|
USD m
|
USD m
|
USD
|
cc
|
|
USD m
|
USD
|
cc
|
Net sales
|
12 690
|
13 229
|
-4
|
3
|
|
13 229
|
-4
|
3
|
Operating income
|
1 949
|
2 562
|
-24
|
-14
|
|
2 562
|
-24
|
-14
|
As a % of sales
|
15.4
|
19.4
|
|
|
|
19.4
|
|
|
Core operating income
|
4 030
|
3 819
|
6
|
15
|
|
3 819
|
6
|
15
|
As a % of sales
|
31.8
|
28.9
|
|
|
|
28.9
|
|
|
Net income
|
1 466
|
1 671
|
-12
|
2
|
|
16 306
|
-91
|
-90
|
EPS (USD)
|
0.69
|
0.75
|
-8
|
7
|
|
7.29
|
-91
|
-89
|
Core net income
|
3 251
|
3 044
|
7
|
17
|
|
3 135
|
4
|
14
|
Core EPS (USD)
|
1.52
|
1.36
|
12
|
23
|
|
1.40
|
9
|
19
|
Cash flows from
operating activities |
4 111
|
3 884
|
6
|
|
|
3 884
|
6
|
|
Free cash flow
|
3 552
|
3 027
|
17
|
|
|
3 027
|
17
|
|
Innovative Medicines
|
Q4 2022
|
Q4 2021
|
% change
|
|||||
|
USD m
|
USD m
|
USD
|
cc
|
||||
Net sales
|
10 360
|
10 704
|
-3
|
3
|
||||
Operating income
|
1 945
|
2 468
|
-21
|
-12
|
||||
As a % of sales
|
18.8
|
23.1
|
|
|
||||
Core operating income
|
3 768
|
3 596
|
5
|
14
|
||||
As a % of sales
|
36.4
|
33.6
|
|
|
||||
Sandoz
|
Q4 2022
|
Q4 2021
|
% change
|
|||||
|
USD m
|
USD m
|
USD
|
cc
|
||||
Net sales
|
2 330
|
2 525
|
-8
|
0
|
||||
Operating income
|
273
|
386
|
-29
|
-20
|
||||
As a % of sales
|
11.7
|
15.3
|
|
|
||||
Core operating income
|
391
|
528
|
-26
|
-18
|
||||
As a % of sales
|
16.8
|
20.9
|
|
|
||||
Corporate
|
Q4 2022
|
Q4 2021
|
% change
|
|||||
|
USD m
|
USD m
|
USD
|
cc
|
||||
Operating loss
|
-269
|
-292
|
8
|
2
|
||||
Core operating loss
|
-129
|
-305
|
58
|
57
|
Excluding Roche income
|
Reported
|
|||||||
Group
|
FY 2022
|
FY 2021
|
% change
|
FY 2021
|
% change
|
|||
|
USD m
|
USD m
|
USD
|
cc
|
|
USD m
|
USD
|
cc
|
Net sales
|
50 545
|
51 626
|
-2
|
4
|
|
51 626
|
-2
|
4
|
Operating income
|
9 197
|
11 689
|
-21
|
-13
|
|
11 689
|
-21
|
-13
|
As a % of sales
|
18.2
|
22.6
|
|
|
|
22.6
|
|
|
Core operating income
|
16 665
|
16 588
|
0
|
8
|
|
16 588
|
0
|
8
|
As a % of sales
|
33.0
|
32.1
|
|
|
|
32.1
|
|
|
Net income
|
6 955
|
8 661
|
-20
|
-9
|
|
24 018
|
-71
|
-67
|
EPS (USD)
|
3.19
|
3.86
|
-17
|
-7
|
|
10.71
|
-70
|
-66
|
Core net income
|
13 352
|
13 099
|
2
|
11
|
|
14 094
|
-5
|
3
|
Core EPS (USD)
|
6.12
|
5.84
|
5
|
14
|
|
6.29
|
-3
|
6
|
Cash flows from
operating activities |
14 236
|
14 549
|
-2
|
|
|
15 071
|
-6
|
|
Free cash flow
|
11 945
|
12 760
|
-6
|
|
|
13 282
|
-10
|
|
Innovative Medicines
|
FY 2022
|
FY 2021
|
% change
|
|||||
|
USD m
|
USD m
|
USD
|
cc
|
||||
Net sales
|
41 296
|
41 995
|
-2
|
4
|
||||
Operating income
|
8 786
|
10 688
|
-18
|
-9
|
||||
As a % of sales
|
21.3
|
25.5
|
|
|
||||
Core operating income
|
15 237
|
15 215
|
0
|
8
|
||||
As a % of sales
|
36.9
|
36.2
|
|
|
||||
Sandoz
|
FY 2022
|
FY 2021
|
% change
|
|||||
|
USD m
|
USD m
|
USD
|
cc
|
||||
Net sales
|
9 249
|
9 631
|
-4
|
4
|
||||
Operating income
|
1 448
|
1 600
|
-10
|
-2
|
||||
As a % of sales
|
15.7
|
16.6
|
|
|
||||
Core operating income
|
1 903
|
2 064
|
-8
|
-1
|
||||
As a % of sales
|
20.6
|
21.4
|
|
|
||||
Corporate
|
FY 2022
|
FY 2021
|
% change
|
|||||
|
USD m
|
USD m
|
USD
|
cc
|
||||
Operating loss
|
-1 037
|
-599
|
-73
|
-84
|
||||
Core operating loss
|
-475
|
-691
|
31
|
28
|
March 7, 2023
|
Annual General Meeting
|
April 25, 2023
|
First quarter 2023 results
|
July 18, 2023
|
Second quarter & Half year 2023 results
|
October 24, 2023
|
Third quarter & Nine months 2023 results
|