Form 20-F: x
|
Form 40-F: o
|
Yes: o
|
No: x
|
Yes: o
|
No: x
|
Yes: o
|
No: x
|
Novartis AG
|
|||
Date:
April 28, 2020
|
By:
|
/s/ PAUL PENEPENT
|
|
Name:
|
Paul Penepent
|
||
Title:
|
Head Group Financial Reporting and Accounting
|
||
|
Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
|
·
|
Q1 2020 net sales from continuing operations1 grew 13% (cc2, +11% USD) with double digit growth (cc) in Innovative Medicines and Sandoz:
|
o
|
Key growth drivers include Entresto USD 569 million (+62% cc), Zolgensma USD 170 million, Cosentyx USD 930 million (+19% cc), Kisqali USD 161 million (+82% cc) and Piqray USD 74 million
|
o
|
Biopharmaceuticals grew 31% (cc) to USD 450 million, with strong growth in Europe
|
o
|
Excluding COVID-19 related forward purchases, we estimate3 sales growth to be approximately 9% (cc)
|
·
|
Core2 operating income grew 34% (cc, +28% USD) mainly driven by higher sales, benefiting from COVID-19 forward purchasing and gross margin improvement, partly offset by launch investments
|
o
|
Excluding COVID-19 related forward purchases and lower spending, we estimate3 core operating income growth to be approximately 22% (cc)
|
·
|
Impacts of COVID-19:
|
o
|
Our operations and product demand remain very stable and strong. Mitigating actions helped to ensure minimal disruption to supply chain and ability to meet forward purchasing demand
|
o
|
We estimate3 that forward purchasing had a favorable impact of approximately USD 0.4 billion on sales. Core operating income benefited by approximately3 USD 0.4 billion from forward purchasing and lower spending. These impacts3 are expected to reverse in the remainder of 2020
|
o
|
Currently manageable disruption to clinical trials and minimal disruption to ongoing regulatory submissions
|
·
|
Net income grew 24% (cc, +16% USD), including higher legal provisions and taxes
|
·
|
Free cash flow2 increased 8% to USD 2.0 billion driven by higher cash flows from operations
|
·
|
Sandoz US generic oral solids and dermatology businesses will be retained by Novartis, after mutual agreement with Aurobindo to terminate the transaction
|
·
|
2020 guidance4 for continuing operations confirmed at this time - Net sales expected to grow mid to high-single digit (cc); core operating income expected to grow high-single to low double digit (cc)
|
Key figures2
|
Continuing operations1
|
|||||||||||||||
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Net sales
|
12 283
|
11 106
|
11
|
13
|
||||||||||||
Operating income
|
2 744
|
2 242
|
22
|
30
|
||||||||||||
Net income
|
2 173
|
1 868
|
16
|
24
|
||||||||||||
EPS (USD)
|
0.96
|
0.81
|
19
|
27
|
||||||||||||
Free cash flow
|
2 021
|
1 869
|
8
|
|||||||||||||
Core operating income
|
4 177
|
3 254
|
28
|
34
|
||||||||||||
Core net income
|
3 549
|
2 811
|
26
|
31
|
||||||||||||
Core EPS (USD)
|
1.56
|
1.21
|
29
|
34
|
·
|
Entresto (USD 569 million, +62% cc) continued demand-driven growth momentum across geographies. In the US, new weekly prescriptions reached all-time-high at >4,500.
|
·
|
Zolgensma (USD 170 million) US launch continues to progress well. Policies are in place covering ~97% of commercial patients and >50% of Medicaid patients. Currently, 25 states representing 42% of newborns are screening for SMA in the US.
|
·
|
Cosentyx (USD 930 million, +19% cc) continued to grow strongly across indications and regions. In the US sales grew 22% vs. Q1 2019 with broad first line access in all three indications.
|
·
|
Promacta/Revolade (USD 403 million, +33% cc) continued double-digit growth in all regions driven by increased use in ITP and further uptake as first-line treatment for SAA in the US.
|
·
|
Xiidra (USD 90 million) is the only prescription eye drop solution marketed in the US and Canada to treat the signs and symptoms of dry eye disease. Xiidra was acquired from Takeda in 2019.
|
·
|
Tafinlar + Mekinist (USD 366 million, +26% cc) continued double-digit growth driven by demand in adjuvant melanoma as well as NSCLC.
|
·
|
Piqray (USD 74 million) continued strong launch uptake in the US, benefiting from further uptake in PIK3CA mutation testing.
|
·
|
Kisqali (USD 161 million, +82% cc) continued strong double-digit growth driven by demand in all geographies, benefiting from the impact of positive overall survival data from two pivotal Phase III trials (MONALEESA-7 and MONALEESA-3).
|
·
|
Beovu (USD 68 million) was launched in the US in October 2019. Post marketing cases reported as severe vision loss, retinal artery occlusion and/or vasculitis had an unfavorable impact on US sales.
|
·
|
Kymriah (USD 93 million, +109% cc) grew strongly in Europe and in the US. Over 230 qualified treatment centers and more than 20 countries have coverage for at least one indication.
|
·
|
Mayzent (USD 30 million) sales increased driven by enhanced education of the EXPAND trial data.
|
·
|
Adakveo (USD 15 million) US launch is progressing well, with high brand awareness among hematologists. Payer coverage and reimbursement are expanding, including Medicaid coverage policies issued in 12 states and by many national and regional private payers; C-code was issued on April 1, and a permanent J-code is on track to be issued on July 1.
|
·
|
Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa) grew to USD 450 million (+31% cc), driven by continued strong double-digit growth in Europe.
|
·
|
Emerging Growth Markets, which comprise all markets except the US, Canada, Western Europe, Japan, Australia and New Zealand, sales grew 14% (cc) including China (USD 622 million), which grew 18% (cc).
|
Q1 2020
|
% change
|
|||||||||||
USD m
|
USD
|
cc
|
||||||||||
Cosentyx
|
930
|
18
|
19
|
|||||||||
Gilenya
|
772
|
1
|
2
|
|||||||||
Entresto
|
569
|
59
|
62
|
|||||||||
Lucentis
|
487
|
-9
|
-6
|
|||||||||
Tasigna
|
487
|
12
|
15
|
|||||||||
Promacta/Revolade
|
403
|
31
|
33
|
|||||||||
Sandostatin
|
374
|
-5
|
-3
|
|||||||||
Tafinlar + Mekinist
|
366
|
23
|
26
|
|||||||||
Galvus Group
|
338
|
7
|
10
|
|||||||||
Gleevec/Glivec
|
329
|
7
|
9
|
|||||||||
Jakavi
|
318
|
23
|
27
|
|||||||||
Xolair
|
307
|
9
|
13
|
|||||||||
Afinitor/Votubia
|
296
|
-21
|
-20
|
|||||||||
Diovan Group
|
274
|
5
|
9
|
|||||||||
Exforge Group
|
258
|
-3
|
0
|
|||||||||
Ilaris
|
213
|
41
|
44
|
|||||||||
Exjade/Jadenu
|
172
|
-28
|
-26
|
|||||||||
Zolgensma
|
170
|
nm
|
nm
|
|||||||||
Votrient
|
166
|
-11
|
-9
|
|||||||||
Kisqali
|
161
|
77
|
82
|
|||||||||
Top 20 products total
|
7 390
|
12
|
14
|
·
|
Zolgensma IV formulation received a positive opinion from the CHMP for conditional approval for patients with SMA and a clinical diagnosis of Type 1 or SMA patients with up to three copies of the SMN2 gene. Zolgensma was also approved by the Japanese MHLW for SMA in patients under the age of two, including those who are presymptomatic at diagnosis; reimbursement is expected by the end of H1 2020, pending agreement Zolgensma is expected to be available at that time.
|
·
|
Beovu (brolucizumab) was approved with a prefilled syringe in the EU, Japan, Switzerland, Canada and Australia.
|
·
|
Capmatinib (INC280) was granted Priority Review designation by the FDA and the review is expected to be completed within six months. Novartis was previously granted FDA Breakthrough Therapy designation for capmatinib.
|
·
|
Kymriah received FDA Regenerative Medicine Advanced Therapy designation for treatment of patients with follicular lymphoma.
|
·
|
Cosentyx received a positive CHMP opinion for treatment of patients with non-radiographic axSpA, the fourth indication. Also the filing was accepted in the US.
|
·
|
Inclisiran (KJX839) was filed in the US for primary hyperlipidemia and in the EU for both primary hypercholesterolemia and mixed dyslipidemia, which include Familial Hypercholesterolemia, ASCVD or ASCVD risk equivalent patients.
|
·
|
Ofatumumab (OMB157) was filed in the US and EU for treatment of RMS. US filed with priority review voucher.
|
·
|
Beovu (brolucizumab) safety update. In early April, Novartis completed its review of post-marketing safety case reports. Based on internal and Safety Review Committee assessment, Novartis concluded that there is a confirmed safety signal of rare adverse events of “retinal vasculitis and/or retinal vascular occlusion that may result in severe vision loss. Typically these events occur in the presence of intraocular inflammation.” Novartis has been in dialogue with regulatory authorities and based on this review, Novartis has initiated a safety information update to Beovu prescribing information worldwide. Novartis sponsored studies will be amended so that protocols, informed consent forms, and investigator brochures contain the new safety information and patients re-consented. Novartis is committed to continuing to collaborate with the scientific and broader retina community to better understand the root causes and potential risk factors associated with these rare adverse events. Novartis continues to believe Beovu represents an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile.
|
·
|
AveXis presented compelling data at MDA in both IV and IT formulations of AVXS-101:
|
o
|
Zolgensma IV data showed rapid, significant, clinically meaningful benefit including prolonged event-free survival, motor milestone achievement and durability for up to 5 years post-dosing.
|
o
|
AVXS-101 IT STRONG data in Type 2 patients showed a mean increase of 6.0 points in Hammersmith, twice the clinically meaningful threshold.
|
·
|
Inclisiran data from three pivotal trials was published in NEJM showing durable and potent efficacy, with a safety profile similar to placebo. Inclisiran reduced LDL-C at 17 months by 52% in patients with ASCVD (ORION-10), 50% for ASCVD and ASCVD risk equivalents (ORION-11) and by 48% in patients with HeFH (ORION-9); all of whom had elevated LDL-C levels despite maximally tolerated lipid-lowering therapy. Prespecified exploratory analysis based on safety reporting from the three trials, showed fewer major adverse cardiovascular events (MACE) with inclisiran compared to placebo. Injection site reactions were more frequent with inclisiran, the majority of them mild and none of them severe.
|
·
|
Cosentyx built on its axSpA leadership with US label update for dosing flexibility in ankylosing spondylitis, allowing 300 mg up-titration option based on Phase III MEASURE 3 study results. The label update provides clinicians with greater choice for their patients.
|
·
|
Jakavi REACH2 Phase III study of acute graft-versus-host disease (GvHD) data was published in NEJM. REACH2 trial results confirm Jakavi significantly improves overall response rate at 28 days vs. best available therapy in steroid-refractory GvHD.
|
·
|
Sandoz completed the acquisition of Aspen’s Japanese operations, strengthening its position in world’s third largest market for generics and off-patent medicines.
|
·
|
Net sales: expected to grow mid to high-single digit (cc)
|
·
|
From a divisional perspective, we expect net sales performance (cc) in 2020 to be as follows:
|
o
|
Innovative Medicines: expected to grow mid to high-single digit
|
o
|
Sandoz: expected to grow low-single digit
|
·
|
Core operating income: expected to grow high-single to low double digit (cc)
|
Continuing operations 1, 2
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc 2
|
||||||||||||
Net sales
|
12 283
|
11 106
|
11
|
13
|
||||||||||||
Operating income
|
2 744
|
2 242
|
22
|
30
|
||||||||||||
As a % of sales
|
22.3
|
20.2
|
||||||||||||||
Core operating income
|
4 177
|
3 254
|
28
|
34
|
||||||||||||
As a % of sales
|
34.0
|
29.3
|
||||||||||||||
Net income
|
2 173
|
1 868
|
16
|
24
|
||||||||||||
EPS (USD)
|
0.96
|
0.81
|
19
|
27
|
||||||||||||
Core net income
|
3 549
|
2 811
|
26
|
31
|
||||||||||||
Core EPS (USD)
|
1.56
|
1.21
|
29
|
34
|
||||||||||||
Cash flows from operating activities
|
2 528
|
2 334
|
8
|
|||||||||||||
Free cash flow
|
2 021
|
1 869
|
8
|
|||||||||||||
Innovative Medicines
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Net sales
|
9 755
|
8 780
|
11
|
13
|
||||||||||||
Operating income
|
2 755
|
2 109
|
31
|
38
|
||||||||||||
As a % of sales
|
28.2
|
24.0
|
||||||||||||||
Core operating income
|
3 607
|
2 922
|
23
|
28
|
||||||||||||
As a % of sales
|
37.0
|
33.3
|
||||||||||||||
Sandoz
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Net sales
|
2 528
|
2 326
|
9
|
11
|
||||||||||||
Operating loss / income
|
- 45
|
273
|
nm
|
nm
|
||||||||||||
As a % of sales
|
-1.8
|
11.7
|
||||||||||||||
Core operating income
|
673
|
461
|
46
|
53
|
||||||||||||
As a % of sales
|
26.6
|
19.8
|
||||||||||||||
Corporate
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Operating income / loss
|
34
|
-140
|
nm
|
nm
|
||||||||||||
Core operating loss
|
-103
|
-129
|
20
|
19
|
||||||||||||
Discontinued operations
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Net sales
|
1 777
|
|||||||||||||||
Operating income
|
71
|
|||||||||||||||
As a % of sales
|
4.0
|
|||||||||||||||
Core operating income
|
350
|
|||||||||||||||
As a % of sales
|
19.7
|
|||||||||||||||
Net loss
|
- 101
|
|||||||||||||||
Total Group
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Net income
|
2 173
|
1 767
|
23
|
31
|
||||||||||||
EPS (USD)
|
0.96
|
0.77
|
25
|
34
|
||||||||||||
Core net income
|
3 549
|
3 089
|
15
|
19
|
||||||||||||
Core EPS (USD)
|
1.56
|
1.33
|
17
|
22
|
||||||||||||
Cash flows from operating activities
|
2 528
|
2 412
|
5
|
|||||||||||||
Free cash flow
|
2 021
|
1 807
|
12
|
|||||||||||||
nm = not meaningful
|
July 21, 2020
|
Second quarter results 2020
|
October 27, 2020
|
Third quarter results 2020
|
|
Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
|
INDEX
|
Page
|
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q1 2020
|
|
Group
|
2
|
Innovative Medicines
|
5
|
Sandoz
|
10
|
CASH FLOW AND GROUP BALANCE SHEET
|
11
|
INNOVATION REVIEW
|
14
|
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
|
|
Consolidated income statements
|
18
|
Consolidated statements of comprehensive income
|
19
|
Consolidated balance sheets
|
20
|
Consolidated statements of changes in equity
|
21
|
Consolidated statements of cash flows
|
22
|
Notes to condensed consolidated interim financial statements, including update on legal proceedings
|
23
|
SUPPLEMENTARY INFORMATION
|
43
|
CORE RESULTS
|
|
Reconciliation from IFRS to core results
|
45
|
Group
|
46
|
Innovative Medicines
|
47
|
Sandoz
|
48
|
Corporate
|
49
|
Discontinued operations
|
50
|
ADDITIONAL INFORMATION
|
|
Income from associated companies
|
51
|
Condensed consolidated changes in net debt / Share information
|
52
|
Free cash flow
|
53
|
Effects of currency fluctuations
|
54
|
Impact of COVID-19 on key figures
|
55
|
DISCLAIMER
|
56
|
Key figures 1
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
|
USD m
|
USD m
|
USD
|
cc 2
|
||||||||||||
Net sales to third parties from continuing operations
|
12 283
|
11 106
|
11
|
13
|
||||||||||||
Divisional operating income from continuing operations
|
2 710
|
2 382
|
14
|
21
|
||||||||||||
Corporate income and expense, from continuing operations, net
|
34
|
- 140
|
nm
|
nm
|
||||||||||||
Operating income from continuing operations
|
2 744
|
2 242
|
22
|
30
|
||||||||||||
As % of net sales
|
22.3
|
20.2
|
||||||||||||||
Income from associated companies
|
123
|
80
|
54
|
52
|
||||||||||||
Interest expense
|
- 239
|
- 226
|
- 6
|
- 7
|
||||||||||||
Other financial income and expense
|
- 7
|
44
|
nm
|
nm
|
||||||||||||
Taxes
|
- 448
|
- 272
|
- 65
|
- 76
|
||||||||||||
Net income from continuing operations
|
2 173
|
1 868
|
16
|
24
|
||||||||||||
Net loss from discontinued operations
|
- 101
|
|||||||||||||||
Net income
|
2 173
|
1 767
|
23
|
31
|
||||||||||||
Basic earnings per share from continuing operations (USD)
|
0.96
|
0.81
|
19
|
27
|
||||||||||||
Basic earnings per share from discontinued operations (USD)
|
-0.04
|
|||||||||||||||
Basic earnings per share (USD)
|
0.96
|
0.77
|
25
|
34
|
||||||||||||
Cash flows from operating activities from continuing operations
|
2 528
|
2 334
|
8
|
|||||||||||||
Free cash flow from continuing operations 2
|
2 021
|
1 869
|
8
|
|||||||||||||
Core 2
|
||||||||||||||||
Core operating income from continuing operations
|
4 177
|
3 254
|
28
|
34
|
||||||||||||
As % of net sales
|
34.0
|
29.3
|
||||||||||||||
Core net income from continuing operations
|
3 549
|
2 811
|
26
|
31
|
||||||||||||
Core net income from discontinued operations
|
278
|
|||||||||||||||
Core net income
|
3 549
|
3 089
|
15
|
19
|
||||||||||||
Core basic earnings per share from continuing operations (USD)
|
1.56
|
1.21
|
29
|
34
|
||||||||||||
Core basic earnings per share from discontinued operations (USD)
|
0.12
|
|||||||||||||||
Core basic earnings per share (USD)
|
1.56
|
1.33
|
17
|
22
|
·
|
Our operations and product demand remain very stable and strong. Mitigating actions helped to ensure minimal disruption to supply chain and ability to meet forward purchasing demand. Product flow across country borders is working smoothly and we believe that we have sufficient inventory levels in our warehouses to meet demand
|
·
|
We estimate3 that forward purchasing had a favorable impact of approximately USD 0.4 billion on sales. Core operating income benefited by approximately USD 0.4 billion from forward purchasing and lower spending. These impacts are expected to reverse in the remainder of 2020
|
·
|
Currently manageable disruption to clinical trials and minimal disruption to ongoing regulatory submissions
|
·
|
Our cash collections continue to be according to our normal trade terms, and days sales outstanding remains at normal levels
|
·
|
Novartis is well positioned to meet its ongoing financial obligations and has sufficient liquidity to support our normal business activities
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
USD m
|
USD m
|
USD
|
cc
|
|||||||||||||
Net sales
|
9 755
|
8 780
|
11
|
13
|
||||||||||||
Operating income
|
2 755
|
2 109
|
31
|
38
|
||||||||||||
As % of net sales
|
28.2
|
24.0
|
||||||||||||||
Core operating income
|
3 607
|
2 922
|
23
|
28
|
||||||||||||
As % of net sales
|
37.0
|
33.3
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Tasigna
|
487
|
434
|
12
|
15
|
||||||||||||
Promacta/Revolade
|
403
|
307
|
31
|
33
|
||||||||||||
Sandostatin
|
374
|
392
|
-5
|
-3
|
||||||||||||
Tafinlar + Mekinist1
|
366
|
297
|
23
|
26
|
||||||||||||
Gleevec/Glivec
|
329
|
307
|
7
|
9
|
||||||||||||
Jakavi
|
318
|
258
|
23
|
27
|
||||||||||||
Afinitor/Votubia
|
296
|
373
|
-21
|
-20
|
||||||||||||
Exjade/Jadenu
|
172
|
238
|
-28
|
-26
|
||||||||||||
Votrient
|
166
|
187
|
-11
|
-9
|
||||||||||||
Kisqali
|
161
|
91
|
77
|
82
|
||||||||||||
Lutathera
|
112
|
106
|
6
|
6
|
||||||||||||
Kymriah
|
93
|
45
|
107
|
109
|
||||||||||||
Piqray
|
74
|
nm
|
nm
|
|||||||||||||
Adakveo
|
15
|
nm
|
nm
|
|||||||||||||
Other
|
282
|
286
|
-1
|
1
|
||||||||||||
Total Oncology business unit
|
3 648
|
3 321
|
10
|
12
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Lucentis
|
487
|
533
|
-9
|
-6
|
||||||||||||
Xiidra
|
90
|
nm
|
nm
|
|||||||||||||
Beovu
|
68
|
nm
|
nm
|
|||||||||||||
Other
|
551
|
628
|
-12
|
-10
|
||||||||||||
Total Ophthalmology
|
1 196
|
1 161
|
3
|
5
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Cosentyx
|
930
|
791
|
18
|
19
|
||||||||||||
Ilaris
|
213
|
151
|
41
|
44
|
||||||||||||
Total Immunology, Hepatology and Dermatology
|
1 143
|
942
|
21
|
23
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Gilenya
|
772
|
766
|
1
|
2
|
||||||||||||
Zolgensma
|
170
|
nm
|
nm
|
|||||||||||||
Aimovig
|
36
|
18
|
100
|
108
|
||||||||||||
Mayzent
|
30
|
nm
|
nm
|
|||||||||||||
Other
|
12
|
13
|
-8
|
0
|
||||||||||||
Total Neuroscience
|
1 020
|
797
|
28
|
30
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Entresto
|
569
|
357
|
59
|
62
|
||||||||||||
Other
|
1
|
6
|
-83
|
-95
|
||||||||||||
Total Cardiovascular, Renal & Metabolism
|
570
|
363
|
57
|
59
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Xolair
|
307
|
281
|
9
|
13
|
||||||||||||
Ultibro Group
|
160
|
157
|
2
|
5
|
||||||||||||
Other
|
4
|
7
|
-43
|
-25
|
||||||||||||
Total Respiratory
|
471
|
445
|
6
|
9
|
Q1 2020
|
Q1 2019
|
% change
|
||||||||||||||
|
USD m
|
USD m
|
USD
|
cc
|
||||||||||||
Galvus Group
|
338
|
315
|
7
|
10
|
||||||||||||
Diovan Group
|
274
|
261
|
5
|
9
|
||||||||||||
Exforge Group
|
258
|
267
|
-3
|
0
|
||||||||||||
Zortress/Certican
|
127
|
116
|
9
|
12
|
||||||||||||
Neoral/Sandimmun(e)
|
101
|
103
|
-2
|
1
|
||||||||||||
Voltaren/Cataflam
|
92
|
113
|
-19
|
-17
|
||||||||||||
Other
|
517
|
576
|
-10
|
-8
|
||||||||||||
Total Established Medicines
|
1 707
|
1 751
|
-3
|
0
|
Sandoz
|
Q1 2020
|
Q1 2019
|
% change
|
|||||||||||||
USD m
|
USD m
|
USD
|
cc
|
|||||||||||||
Net sales
|
2 528
|
2 326
|
9
|
11
|
||||||||||||
Operating loss / income
|
-45
|
273
|
nm
|
nm
|
||||||||||||
As % of net sales
|
-1.8
|
11.7
|
||||||||||||||
Core operating income
|
673
|
461
|
46
|
53
|
||||||||||||
As % of net sales
|
26.6
|
19.8
|
Product
|
Active ingredient/
Descriptor |
Indication
|
Region
|
Beovu
|
brolucizumab
|
Neovascular (wet) AMD
|
EU & Japan
|
Mayzent
|
siponimoid
|
Secondary Progressive Multiple Sclerosis (SPMS)
|
EU
|
Zolgensma
|
onasemnogene abepar-vovec
|
Spinal Muscular Atrophy
(IV formulation)
|
Japan
|
Completed submissions
|
|||||
Product
|
Indication
|
US
|
EU
|
Japan
|
News update
|
BYL719
(Piqray in US, alpelisib)
|
PIK3CA mutant HR+, HER2 (-) postmenopausal adv BC 2nd line (+fulv)
|
Approved
|
Q4 2018
|
||
Cosentyx
|
Non-radiographic axial spondyloarthritis
|
Q4 2019
|
Q3 2019
|
Q4 2019
|
- CHMP positive opinion received in March
- US FDA file accepted
|
Entresto
|
HF with reduced ejection fraction
|
Approved
|
Approved
|
Q3 2019
|
|
Chronic heart failure with preserved ejection fraction
|
Q2 2020
|
- Submitted to FDA in April 2020
|
|||
INC280
(capmatinib)
|
NSCLC (cMET amp and mut)
|
Q4 2019
|
Q4 2019
|
- Granted FDA Priority Review
|
|
KJX839
(inclisiran)
|
Hyperlipidemia
|
Q4 2019
|
Q1 2020
|
||
Mayzent
|
SPMS
|
Approved
|
Approved
|
Q1 2019
|
|
OMB157
(ofatumumab)
|
Relapsing Multiple Sclerosis
|
Q4 2019
|
Q1 2020
|
- on track for June 2020 FDA approval
|
|
QMF149
|
Asthma
|
Q2 2019
|
Q3 2019
|
- CHMP positive opinion received – Mar-2020
- Japan decision anticipated H1 2020
|
|
QVM149
|
Asthma
|
Q2 2019
|
Q3 2019
|
- CHMP positive opinion anticipated Q2 2020
- Japan decision anticipated H1 2020
|
|
SEG101
(Adakveo in US)
|
Sickle cell disease
|
Approved
|
Q2 2019
|
||
Xiidra
|
Dry eye
|
Approved
|
Q4 2018
|
Q1 2020
|
- CHMP opinion anticipated mid 2020
|
Xolair
|
Nasal polyps
|
Q3 2019
|
Q4 2019
|
||
Zolgensma (AVXS-101)
|
Spinal Muscular Atrophy
(IV formulation)
|
Approved
|
Q4 2018
|
Approved
|
- Positive CHMP opinion received in Q1 2020 for conditional approval
|
Project/ Compound
|
Potential indication/ Disease area
|
First planned submissions
|
Current Phase
|
News update
|
ABL001
|
Chronic myeloid leukemia 3rd line
|
2021
|
III
|
|
ACZ885
(canakinumab) |
Adjuvant NSCLC
|
2023
|
III
|
- Enrollment ongoing for Phase III studies
|
1st line NSCLC
|
2021
|
III
|
- Completed enrollment in Jan-2020
|
|
2nd line NSCLC
|
2021
|
III
|
AVXS-101 IT
|
Spinal Muscular Atrophy
(IT formulation)
|
2020
|
I / II
|
- STRONG data at MDA showed remarkable increases in HFMSE scores and a consistent clinically meaningful response
- FDA requested additional pre-clinical data to release the partial clinical hold. Plan to engage with FDA during Q2 to clarify scope of data required
- BLA submission timing dependent on FDA feedback could range from H2 2020 to 2021
|
AVXS-201
|
Rett Syndrome
|
2023
|
I
|
|
BYL719
(alpelisib)
|
PROS (PIK3CA-related overgrowth spectrum)
|
2020
|
II
|
- Potential US filing in 2020 based on RWE data
|
HER2+ adv breast cancer
|
2023
|
III
|
||
Triple negative breast cancer
|
2023
|
III
|
||
Head and neck squamous cell carcinoma
|
≥2024
|
III
|
||
Ovarian Cancer
|
2023
|
III
|
||
CEE321
|
Atopic dermatitis
|
≥2024
|
I
|
|
CFZ533
(iscalimab)
|
Renal Tx
|
2023
|
II
|
|
Liver Tx
|
≥2024
|
II
|
||
Sjoegren’s syndrome
|
≥2024
|
II
|
||
Coartem
|
Malaria uncomplicated, <5kg patients
|
2023
|
III
|
|
Cosentyx
|
Ankylosing spondylitis head-to-head vs. adalimumab
|
2022
|
III
|
|
Hidradenitis suppurativa
|
2022
|
III
|
||
Axial spondyloarthritis IV regimen
|
2022
|
III
|
||
Giant cell arteritis
|
≥2024
|
II
|
||
Lichen Planus
|
≥2024
|
II
|
||
Lupus Nephritis
|
≥2024
|
II
|
||
CPK850
|
Retinitis pigmentosa
|
≥2024
|
II
|
|
CSJ117
|
Severe asthma
|
2023
|
II
|
|
ECF843
|
Dry eye
|
2022
|
II
|
|
Entresto
|
Post-acute myocardial infarction
|
2021
|
III
|
- March 2020: Enrollment completed; Interim efficacy analysis completed, trial continues as planned
|
INC280
(capmatinib)
|
Solid Tumors
|
≥2024
|
II
|
|
Jakavi
|
Acute graft-versus-host disease (GvHD)
|
2021
|
III
|
- Phase III results published in NEJM, confirming significant improvement in overall response
|
Chronic graft-versus-host disease (GvHD)
|
2021
|
III
|
||
KAE609
(cipargamin)
|
Malaria uncomplicated
|
≥2024
|
II
|
|
Malaria severe
|
≥2024
|
II
|
||
KAF156
(ganaplacide)
|
Malaria uncomplicated
|
≥2024
|
II
|
|
Kisqali
+ endocrine therapy
|
HR+/HER2- early BC (adjuvant)
|
2022
|
III
|
- Potential for registration as early as 2022 assuming positive, pre-planned interim analysis
|
KJX839
(inclisiran)
|
Secondary prevention of cardiovascular events in patients with elevated levels of LDLC
|
≥2024
|
III
|
- Acquired from The Medicines Company in Jan 2020
|
Kymriah (tisagenlecleucel)
|
r/r Follicular lymphoma
|
2021
|
II
|
|
r/r DLBCL in 1st relapse
|
2021
|
III
|
||
+ pembrolizumab
|
r/r DLBCL
|
≥2024
|
II
|
|
LAM320
|
Multi-drug resistant tuberculosis
|
2021
|
III
|
|
LJC242
(tropifexor + cenicriviroc)
|
Non-alcoholic steatohepatitis (NASH)
|
≥2024
|
II
|
|
LJN452
(tropifexor)
|
Non-alcoholic steatohepatitis (NASH)
|
≥2024
|
II
|
- FDA Fast Track designation
|
LMI070
|
Spinal Muscular Atrophy
|
≥2024
|
II
|
- FDA Orphan designation, EMA Orphan status obtained
- Dose ranging study ongoing
|
LNA043
|
Osteoarthritis
|
≥2024
|
II
|
|
LNP023
|
Paroxysmal nocturnal hemoglobinuria
|
2023
|
II
|
|
IgA nephropathy
|
2023
|
II
|
||
Membranous nephropathy
|
≥2024
|
II
|
||
C3 glomerulopathy
|
2023
|
II
|
||
Atypical haemolytic uraemic syndrome
|
2023
|
II
|
||
LOU064
|
Chronic Spontaneous Urticaria
|
2023
|
II
|
|
Sjögren’s syndrome
|
≥2024
|
II
|
||
177Lu-PSMA-617
|
Metastatic castration-resistant prostate cancer
|
2020
|
III
|
- On track for H2 2020 readout
|
177Lu-PSMA-R2
|
Prostate cancer
|
≥2024
|
I
|
|
177Lu-NeoB
|
Multiple Solid Tumor
|
≥2024
|
I
|
|
LXE408
|
Visceral leishmaniosis
|
≥2024
|
II
|
|
MBG453
|
Myelodysplastic syndrome
|
2021
|
II
|
|
Unfit AML
|
≥2024
|
II
|
||
PDR001 + Tafinlar + Mekinist
|
Metastatic BRAF V600+ melanoma
|
2020
|
III
|
- Expected submission in H2 2020
|
PDR001 Combo
|
Malignant melanoma
|
≥2024
|
II
|
- Enrollment ongoing
|
QBW251
|
COPD
|
≥2024
|
II
|
- Phase IIb recruitment ongoing
|
QGE031
(ligelizumab)
|
Chronic Spontaneous Urticaria / Chronic
Idiopathic Urticaria
|
2021
|
III
|
|
RTH258 (brolucizumab)
|
Diabetic macular edema
|
2021
|
III
|
- Expected readout in H2 2020
|
Retinal vein occlusion
|
2023
|
III
|
||
Diabetic retinopathy
|
2023
|
III
|
||
SAF312
|
Chronic ocular surface pain
|
≥2024
|
II
|
|
TQJ230
|
Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein(a)
|
≥2024
|
III
|
- Trial initiated, FPFV in Q4 2019
|
UNR844
|
Presbyopia
|
≥2024
|
II
|
|
VAY736
(ianalumab)
|
Auto-immune hepatitis
|
≥2024
|
II
|
|
Primary Sjoegren’s syndrome
|
≥2024
|
II
|
- FDA Fast Track designation
|
|
VPM087
|
1st line colorectal cancer / 1st line renal cell carcinoma
|
≥2024
|
I
|
|
Xolair
|
Food Allergy
|
2021
|
III
|
|
ZPL389
(adriforant)
|
Atopic dermatitis
|
≥2024
|
II
|
Project/ Compound
|
Potential indication/
Disease area |
News update
|
GP2411 (denosumab)
|
Osteoporosis, skeletal-related in bone met. pts (same as originator)
|
- In Phase III
- First patient enrolled July 2019
|
Insulin glargine, lispro, aspart
|
Diabetes
|
- Collaboration with Gan & Lee
|
natalizumab
|
Multiple sclerosis and Crohn’s disease
|
- Collaboration Polpharma Biologics
|
trastuzumab
|
HER2-positive cancer tumors
|
- Collaboration EirGenix
|
(USD millions) |
Note |
Mar 31,
2020 (unaudited) |
Dec 31,
2019 (audited) |
Change |
|||||
Assets
|
|
|
|
|
|||||
Non-current assets
|
|
|
|
|
|||||
Property, plant and equipment
|
9
|
11 933
|
12 069
|
-136
|
|||||
Right-of-use assets
|
|
1 627
|
1 677
|
-50
|
|||||
Goodwill
|
9
|
28 937
|
26 524
|
2 413
|
|||||
Intangible assets other than goodwill
|
9
|
37 451
|
28 787
|
8 664
|
|||||
Investments in associated companies
|
|
8 303
|
8 644
|
-341
|
|||||
Deferred tax assets
|
|
8 542
|
7 909
|
633
|
|||||
Financial assets
|
|
2 218
|
2 518
|
-300
|
|||||
Other non-current assets
|
|
988
|
738
|
250
|
|||||
Total non-current assets
|
|
99 999
|
88 866
|
11 133
|
|||||
Current assets
|
|
|
|
|
|||||
Inventories
|
|
6 398
|
5 982
|
416
|
|||||
Trade receivables
|
|
8 541
|
8 301
|
240
|
|||||
Income tax receivables
|
|
254
|
254
|
0
|
|||||
Marketable securities, commodities, time deposits and
derivative financial instruments |
|
445 |
334 |
111 |
|||||
Cash and cash equivalents
|
|
4 528
|
11 112
|
-6 584
|
|||||
Other current assets
|
|
2 932
|
2 680
|
252
|
|||||
Total current assets without disposal group
|
|
23 098
|
28 663
|
-5 565
|
|||||
Assets of disposal group held for sale
|
3
|
|
841
|
-841
|
|||||
Total current assets
|
|
23 098
|
29 504
|
-6 406
|
|||||
Total assets
|
|
123 097
|
118 370
|
4 727
|
|||||
|
|
|
|
|
|||||
Equity and liabilities
|
|
|
|
|
|||||
Equity
|
|
|
|
|
|||||
Share capital
|
|
936
|
936
|
|
|||||
Treasury shares
|
|
-68
|
-80
|
12
|
|||||
Reserves
|
|
50 035
|
54 618
|
-4 583
|
|||||
Issued share capital and reserves attributable
to Novartis AG shareholders |
|
50 903 |
55 474 |
-4 571 |
|||||
Non-controlling interests
|
|
74
|
77
|
-3
|
|||||
Total equity
|
|
50 977
|
55 551
|
-4 574
|
|||||
Liabilities
|
|
|
|
|
|||||
Non-current liabilities
|
|
|
|
|
|||||
Financial debts
|
|
23 800
|
20 353
|
3 447
|
|||||
Lease liabilities
|
|
1 690
|
1 703
|
-13
|
|||||
Deferred tax liabilities
|
|
7 524
|
5 867
|
1 657
|
|||||
Provisions and other non-current liabilities
|
|
7 812
|
6 632
|
1 180
|
|||||
Total non-current liabilities
|
|
40 826
|
34 555
|
6 271
|
|||||
Current liabilities
|
|
|
|
|
|||||
Trade payables
|
|
4 828
|
5 424
|
-596
|
|||||
Financial debts and derivative financial instruments
|
|
10 956
|
7 031
|
3 925
|
|||||
Lease liabilities
|
|
249
|
246
|
3
|
|||||
Current income tax liabilities
|
|
2 305
|
2 194
|
111
|
|||||
Provisions and other current liabilities
|
|
12 956
|
13 338
|
-382
|
|||||
Total current liabilities without disposal group
|
|
31 294
|
28 233
|
3 061
|
|||||
Liabilities of disposal group held for sale
|
3
|
|
31
|
-31
|
|||||
Total current liabilities
|
|
31 294
|
28 264
|
3 030
|
|||||
Total liabilities
|
|
72 120
|
62 819
|
9 301
|
|||||
Total equity and liabilities
|
|
123 097
|
118 370
|
4 727
|
|||||
|
|||||||||
|
(USD millions) |
Share capital |
Treasury shares |
Retained earnings |
Total value adjustments |
Issued share
capital and reserves attributable to Novartis shareholders |
Non- controlling interests |
Total equity |
||||||||
Total equity at January 1, 2020
|
936
|
-80
|
59 275
|
-4 657
|
55 474
|
77
|
55 551
|
||||||||
Net income
|
|
|
2 176
|
|
2 176
|
-3
|
2 173
|
||||||||
Other comprehensive income
|
|
|
-12
|
-648
|
-660
|
0
|
-660
|
||||||||
Total comprehensive income
|
|
|
2 164
|
-648
|
1 516
|
-3
|
1 513
|
||||||||
Dividends
|
|
|
-6 987
|
|
-6 987
|
|
-6 987
|
||||||||
Purchase of treasury shares
|
|
-1
|
-140
|
|
-141
|
|
-141
|
||||||||
Exercise of options and employee
transactions |
|
8 |
815 |
|
823 |
|
823 |
||||||||
Equity-based compensation
|
|
5
|
157
|
|
162
|
|
162
|
||||||||
Shares delivered to Alcon employees
as a result of the Alcon spin-off |
|
0 |
21 |
|
21 |
|
21 |
||||||||
Taxes on treasury share transactions
|
|
|
30
|
|
30
|
|
30
|
||||||||
Fair value adjustments on financial
assets sold |
|
|
16 |
-16 |
|
|
|
||||||||
Other movements
|
|
|
5
|
|
5
|
|
5
|
||||||||
Total of other equity movements
|
|
12
|
-6 083
|
-16
|
-6 087
|
|
-6 087
|
||||||||
Total equity at March 31, 2020
|
936
|
-68
|
55 356
|
-5 321
|
50 903
|
74
|
50 977
|
||||||||
|
|||||||||||||||
|
(USD millions)
|
Note
|
Q1 2020
|
Q1 2019
|
Change
|
|||||
Net income from continuing operations
|
|
2 173
|
1 868
|
305
|
|||||
Adjustments to reconcile net income from continuing operations to net cash flows from operating activities from continuing operations
|
|
|
|
|
|||||
Reversal of non-cash items and other adjustments
|
6.1
|
2 857
|
2 016
|
841
|
|||||
Dividends received from associated companies and others
|
|
487
|
460
|
27
|
|||||
Interest received
|
|
32
|
85
|
-53
|
|||||
Interest paid
|
|
-94
|
-167
|
73
|
|||||
Other financial receipts
|
|
209
|
|
209
|
|||||
Other financial payments
|
|
-9
|
-44
|
35
|
|||||
Taxes paid
|
6.2
|
-596
|
-400
|
-196
|
|||||
Net cash flows from operating activities from continuing operations
before working capital and provision changes |
|
5 059 |
3 818 |
1 241 |
|||||
Payments out of provisions and other net cash movements in
non-current liabilities |
|
-404 |
-193 |
-211 |
|||||
Change in net current assets and other operating cash flow items
|
|
-2 127
|
-1 291
|
-836
|
|||||
Net cash flows from operating activities from continuing operations
|
|
2 528
|
|
2 334
|
|
194
|
|
||
Net cash flows from operating activities from discontinued operations
|
|
|
78
|
-78
|
|||||
Total net cash flows from operating activities
|
|
2 528
|
2 412
|
116
|
|||||
Purchases of property, plant and equipment
|
|
-237
|
-282
|
45
|
|||||
Proceeds from sale of property, plant and equipment
|
|
3
|
164
|
-161
|
|||||
Purchases of intangible assets
|
|
-246
|
-337
|
91
|
|||||
Proceeds from sale of intangible assets
|
|
56
|
71
|
-15
|
|||||
Purchases of financial assets
|
|
-52
|
-109
|
57
|
|||||
Proceeds from sale of financial assets
|
|
242
|
35
|
207
|
|||||
Purchases of other non-current assets
|
|
-41
|
-10
|
-31
|
|||||
Proceeds from sale of other non-current assets
|
|
0
|
3
|
-3
|
|||||
Acquisitions and divestments of interests in associated
companies, net |
|
-2 |
-2 |
0 |
|||||
Acquisitions and divestments of businesses, net
|
6.3
|
-9 901
|
-96
|
-9 805
|
|||||
Purchases of marketable securities and commodities
|
|
-271
|
-45
|
-226
|
|||||
Proceeds from sale of marketable securities and commodities
|
|
322
|
2 359
|
-2 037
|
|||||
Net cash flows used in/from investing activities from continuing
operations |
|
-10 127 |
1 751 |
-11 878 |
|||||
Net cash flows used in investing activities from discontinued operations
|
10
|
-14
|
-423
|
409
|
|||||
Total net cash flows used in/from investing activities
|
|
-10 141
|
1 328
|
-11 469
|
|||||
Dividends paid to shareholders of Novartis AG
|
|
-6 987
|
-6 645
|
-342
|
|||||
Acquisitions of treasury shares
|
|
-141
|
-222
|
81
|
|||||
Proceeds from exercised options and
other treasury share transactions |
|
816 |
200 |
616 |
|||||
Increase in non-current financial debts
|
|
4 945
|
|
4 945
|
|||||
Repayments of non-current financial debts
|
|
-1 000
|
-3 001
|
2 001
|
|||||
Change in current financial debts
|
|
3 655
|
-149
|
3 804
|
|||||
Payment of lease liabilities, net
|
|
-68
|
-22
|
-46
|
|||||
Other financing cash flows, net
|
|
-194
|
-461
|
267
|
|||||
Net cash flows from/used in financing activities from continuing operations
|
|
1 026
|
-10 300
|
11 326
|
|||||
Net cash flows used in/from financing activities from discontinued operations
|
10
|
-13
|
617
|
-630
|
|||||
Total net cash flows from/used in financing activities
|
|
1 013
|
-9 683
|
10 696
|
|||||
Net change in cash and cash equivalents before
effect of exchange rate changes |
|
-6 600 |
-5 943 |
-657 |
|||||
Less cash and cash equivalents of discontinued operations
at March 31, 2019 |
|
|
-499 |
499 |
|||||
Effect of exchange rate changes on cash and cash equivalents
|
|
16
|
-22
|
38
|
|||||
Total net change in cash and cash equivalents
|
|
-6 584
|
-6 464
|
-120
|
|||||
Cash and cash equivalents at January 1
|
|
11 112
|
13 271
|
-2 159
|
|||||
Cash and cash equivalents at March 31
|
|
4 528
|
6 807
|
-2 279
|
|||||
|
(USD millions) |
|
Dec 31,
2019 |
|||
Assets of disposal group classified as held for sale
|
|
|
|||
Property, plant and equipment
|
|
169
|
|||
Intangible assets other than goodwill
|
|
475
|
|||
Deferred tax assets
|
|
11
|
|||
Other non-current assets
|
|
2
|
|||
Inventories
|
|
181
|
|||
Other current assets
|
|
3
|
|||
Total
|
|
841
|
|||
Liabilities of disposal group classified as held for sale
|
|
|
|||
Deferred tax liabilities
|
|
2
|
|||
Provisions and other non-current liabilities
|
|
4
|
|||
Provisions and other current liabilities
|
|
25
|
|||
Total
|
|
31
|
|||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
(USD millions) |
Mar 31,
2020 |
Dec 31,
2019 |
Mar 31,
2020 |
Dec 31,
2019 |
Mar 31,
2020 |
Dec 31,
2019 |
Mar 31,
2020 |
Dec 31,
2019 |
|||||||||
Marketable securities
|
|
|
|
|
|
|
|
|
|||||||||
Debt securities
|
|
|
23
|
24
|
|
|
23
|
24
|
|||||||||
Fund investments
|
35
|
37
|
|
|
|
|
35
|
37
|
|||||||||
Total marketable securities
|
35
|
37
|
23
|
24
|
|
|
58
|
61
|
|||||||||
Derivative financial instruments
|
|
|
209
|
102
|
|
|
209
|
102
|
|||||||||
Total marketable securities and derivative financial instruments
|
35
|
37
|
232
|
126
|
|
|
267
|
163
|
|||||||||
Long-term financial investments
|
|
|
|
|
|
|
|
|
|||||||||
Debt and equity securities
|
593
|
976
|
|
|
594
|
581
|
1 187
|
1 557
|
|||||||||
Fund investments
|
|
|
|
|
233
|
233
|
233
|
233
|
|||||||||
Contingent consideration receivables
|
|
|
|
|
444
|
399
|
444
|
399
|
|||||||||
Total long-term financial investments
|
593
|
976
|
|
|
1 271
|
1 213
|
1 864
|
2 189
|
|||||||||
Associated companies at fair value through profit or loss
|
|
|
|
|
173
|
186
|
173
|
186
|
|||||||||
Contingent consideration payables
|
|
|
|
|
-1 085
|
-1 036
|
-1 085
|
-1 036
|
|||||||||
Other financial liabilities
|
|
|
|
|
-26
|
-29
|
-26
|
-29
|
|||||||||
Derivative financial instruments
|
|
|
-85
|
-185
|
|
|
-85
|
-185
|
|||||||||
Total financial liabilities at fair value
|
|
|
-85
|
-185
|
-1 111
|
-1 065
|
-1 196
|
-1 250
|
|||||||||
Coupon |
Currency |
Nominal
amount (USD million) |
Maturity year |
Issuer |
Issue price |
Carrying
value Mar 31, 2020 (USD millions) |
|||||||
1.75% |
USD |
1 000 |
2025 |
Novartis Capital Corporation,
New York, United States |
99.852% |
996 |
|||||||
2.00% |
USD |
1 250 |
2027 |
Novartis Capital Corporation,
New York, United States |
99.909% |
1 245 |
|||||||
2.20% |
USD |
1 500 |
2030 |
Novartis Capital Corporation,
New York, United States |
99.869% |
1 492 |
|||||||
2.75%
|
USD
|
1 250
|
2050
|
Novartis Capital Corporation, New York, United States
|
97.712%
|
1 213
|
|||||||
(USD millions)
|
Q1 2020
|
Q1 2019
|
|||
Property, plant and equipment
|
26
|
43
|
|||
Right-of-use assets
|
32
|
|
|||
Currently marketed products
|
269
|
|
|||
Acquired research and development
|
8 575
|
|
|||
Deferred tax assets
|
464
|
2
|
|||
Financial and other assets
|
49
|
|
|||
Inventories
|
84
|
6
|
|||
Trade receivables, marketable securities and other current assets
|
109
|
|
|||
Cash and cash equivalents
|
76
|
|
|||
Deferred tax liabilities
|
-1 924
|
|
|||
Current and non-current financial debts
|
-32
|
|
|||
Current and non-current lease liabilities
|
-44
|
|
|||
Trade payables and other liabilities
|
-144
|
-6
|
|||
Net identifiable assets acquired
|
7 540
|
45
|
|||
Acquired cash and cash equivalents
|
-76
|
|
|||
Goodwill
|
2 534
|
34
|
|||
Net assets recognized as a result of business combinations
|
9 998
|
79
|
|||
|
|||||
|
Innovative Medicines | Sandoz | Corporate (including eliminations) | Group | ||||||||||||||
(USD millions)
|
Q1 2020
|
Q1 2019
|
Q1 2020
|
Q1 2019
|
Q1 2020
|
Q1 2019
|
Q1 2020
|
Q1 2019
|
|||||||||
Net sales to third parties from continuing operations
|
9 755
|
8 780
|
2 528
|
2 326
|
|
|
12 283
|
11 106
|
|||||||||
Sales to continuing and discontinued segments
|
190
|
249
|
49
|
39
|
-239
|
-235
|
|
53
|
|||||||||
Net sales from continuing operations
|
9 945
|
9 029
|
2 577
|
2 365
|
-239
|
-235
|
12 283
|
11 159
|
|||||||||
Other revenues
|
256
|
261
|
13
|
28
|
156
|
7
|
425
|
296
|
|||||||||
Cost of goods sold
|
-2 526
|
-2 224
|
-1 456
|
-1 276
|
260
|
249
|
-3 722
|
-3 251
|
|||||||||
Gross profit from continuing operations
|
7 675
|
7 066
|
1 134
|
1 117
|
177
|
21
|
8 986
|
8 204
|
|||||||||
Selling, general and administration
|
-2 857
|
-2 653
|
-520
|
-562
|
-109
|
-115
|
-3 486
|
-3 330
|
|||||||||
Research and development
|
-1 866
|
-2 105
|
-194
|
-194
|
|
|
-2 060
|
-2 299
|
|||||||||
Other income
|
172
|
75
|
32
|
37
|
57
|
91
|
261
|
203
|
|||||||||
Other expense
|
-369
|
-274
|
-497
|
-125
|
-91
|
-137
|
-957
|
-536
|
|||||||||
Operating income from continuing operations
|
2 755
|
2 109
|
-45
|
273
|
34
|
-140
|
2 744
|
2 242
|
|||||||||
as % of net sales
|
28.2%
|
24.0%
|
-1.8%
|
11.7%
|
|
|
22.3%
|
20.2%
|
|||||||||
Income from associated companies
|
|
|
|
|
123
|
80
|
123
|
80
|
|||||||||
Interest expense
|
|
|
|
|
|
|
-239
|
-226
|
|||||||||
Other financial income and expense, net
|
|
|
|
|
|
|
-7
|
44
|
|||||||||
Income before taxes from continuing operations
|
|
|
|
|
|
|
2 621
|
2 140
|
|||||||||
Taxes
|
|
|
|
|
|
|
-448
|
-272
|
|||||||||
Net income from continuing operations
|
|
|
|
|
|
|
2 173
|
1 868
|
|||||||||
Net loss from discontinued operations
|
|
|
|
|
|
|
|
-101
|
|||||||||
Net income
|
|
|
|
|
|
|
2 173
|
1 767
|
|||||||||
|
|||||||||||||||||
|
|||||||||||||||||
|
Innovative Medicines | Sandoz | Corporate (including eliminations) | Group | ||||||||||||||
(USD millions) |
Mar 31,
2020 |
Dec 31,
2019 |
Mar 31,
2020 |
Dec 31,
2019 |
Mar 31,
2020 |
Dec 31,
2019 |
Mar 31,
2020 |
Dec 31,
2019 |
|||||||||
Net operating assets
|
67 647
|
55 893
|
12 490
|
12 664
|
|
|
80 760
|
71 489
|
|||||||||
Included in net operating assets are:
|
|
|
|
|
|
|
|
|
|||||||||
Property, plant and equipment
|
9 471
|
9 632
|
1 931
|
1 888
|
531
|
549
|
11 933
|
12 069
|
|||||||||
Goodwill
|
21 190
|
18 750
|
7 740
|
7 767
|
7
|
7
|
28 937
|
26 524
|
|||||||||
Intangible assets other than goodwill
|
35 683
|
27 586
|
1 675
|
1 125
|
93
|
76
|
37 451
|
28 787
|
|||||||||
|
|||||||||||||||||
|
(USD millions)
|
Q1 2019
|
||
Net sales to third parties from discontinued operations
|
1 777
|
||
Sales to continuing segments
|
32
|
||
Net sales from discontinued operations
|
1 809
|
||
Cost of goods sold
|
-860
|
||
Gross profit from discontinued operations
|
949
|
||
Selling, general and administration
|
-638
|
||
Research and development
|
-142
|
||
Other income
|
15
|
||
Other expense
|
-113
|
||
Operating income from discontinued operations
|
71
|
||
as % of net sales
|
4.0%
|
||
Interest expense
|
-10
|
||
Other financial income and expense
|
-3
|
||
Income before taxes from discontinued operations
|
58
|
||
Taxes
|
-159
|
||
Net loss from discontinued operations1
|
-101
|
||
|
|||
1 See Note 3 for further details on the non-taxable non-cash gain on distribution of Alcon Inc. to Novartis AG shareholders recognized on April 8, 2019, date of Distribution.
|
(USD millions)
|
Q1 2020
|
Q1 2019
|
|||
Payments out of provisions attributable to the spin-off of the Alcon business
|
-14
|
|
|||
Cash flows attributable to the spin-off of the Alcon business
|
-14
|
|
|||
Other cash flows used in investing activities, net
|
|
-423
|
|||
Net cash flows used in investing activities from discontinued operations
|
-14
|
-423
|
|||
(USD millions) |
Q1 2020 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or
divestment of businesses and related items 3 |
Other items 4 |
Q1 2020 Core results |
Q1 2019 Core results |
||||||||
Gross profit
|
1 134
|
163
|
42
|
11
|
56
|
1 406
|
1 242
|
||||||||
Operating income
|
-45
|
163
|
54
|
11
|
490
|
673
|
461
|
||||||||
|
|||||||||||||||
The following are adjustments to arrive at core gross profit
|
|
|
|
|
|
|
|
||||||||
Cost of goods sold
|
-1 456
|
163
|
42
|
11
|
56
|
-1 184
|
-1 151
|
||||||||
|
|||||||||||||||
The following are adjustments to arrive at core operating income
|
|
|
|
|
|
|
|
||||||||
Selling, general and administration
|
-520
|
|
|
|
1
|
-519
|
-559
|
||||||||
Other income
|
32
|
|
|
|
-10
|
22
|
37
|
||||||||
Other expense
|
-497
|
|
12
|
|
443
|
-42
|
-65
|
||||||||
|
|||||||||||||||
1 Amortization of intangible assets: cost of goods sold includes the amortization of acquired rights to in-market products and other production-related intangible assets
|
|||||||||||||||
2 Impairments: cost of goods sold includes impairment charges related to intangible assets, other expense includes impairment charges related to property, plant and equipment
|
|||||||||||||||
3 Acquisition or divestment of businesses and related items, including restructuring and integration charges: cost of goods sold includes net charges related to an acquisition
|
|||||||||||||||
4 Other items: cost of goods sold includes the cumulative amount of the depreciation up to December 31, 2019, recognized with the reclassification of property, plant and equipment out of assets of disposal group held for sale (see Note 3); cost of goods sold, selling, general and administration, other income and other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites and other restructuring related items; other expense also includes a legal provision
|
(USD millions)
|
Q1 2019
|
||
Gross profit
|
1 123
|
||
Operating income
|
350
|
||
Income before taxes
|
337
|
||
Taxes
|
-59
|
||
Net income
|
278
|
||
Basic EPS (USD)
|
0.12
|
||
|
|||
The following are adjustments to arrive at core gross profit
|
|
||
Cost of goods sold
|
-686
|
||
|
|||
The following are adjustments to arrive at core operating income
|
|
||
Selling, general and administration
|
-624
|
||
Research and development
|
-136
|
||
Other income
|
12
|
||
Other expense
|
-25
|
||
(USD millions)
|
Q1 2020
|
Q1 2019
|
|||
Share of estimated Roche reported results
|
230
|
206
|
|||
Prior-year adjustment
|
-64
|
-129
|
|||
Amortization of additional intangible assets recognized
by Novartis on initial accounting for the equity interest |
-42 |
-40 |
|||
Partial release of deferred tax liability recognized
|
|
43
|
|||
Net income effect from Roche Holding AG
|
124
|
80
|
|||
Others
|
-1
|
|
|||
Income from associated companies
|
123
|
80
|
|||
|
(USD millions)
|
Q1 2020
|
Q1 2019
|
|||
Income from associated companies
|
123
|
80
|
|||
Share of estimated Roche core adjustments
|
83
|
37
|
|||
Roche prior year adjustment
|
102
|
161
|
|||
Core income from associated companies
|
308
|
278
|
|||
|
(USD millions)
|
Q1 2020
|
Q1 2019
|
|||
Change in cash and cash equivalents
|
-6 584
|
-6 464
|
|||
Change in marketable securities, commodities, financial debts and financial derivatives
|
-7 261
|
1 107
|
|||
Increase in net debt
|
-13 845
|
-5 357
|
|||
Net debt at January 1
|
-15 938
|
-16 184
|
|||
Net debt at March 31
|
-29 783
|
-21 541
|
|||
(USD millions) |
Mar 31,
2020 |
Mar 31,
2019 |
|||
Non-current financial debts
|
-23 800
|
-21 225
|
|||
Current financial debts and derivative financial instruments
|
-10 956
|
-7 428
|
|||
Total financial debt
|
-34 756
|
-28 653
|
|||
Less liquidity:
|
|
|
|||
Cash and cash equivalents
|
4 528
|
6 807
|
|||
Marketable securities, commodities, time deposits and derivative financial instruments
|
445
|
305
|
|||
Total liquidity
|
4 973
|
7 112
|
|||
Net debt at March 31
|
-29 783
|
-21 541
|
|||
|
Mar 31,
2020 |
Mar 31,
2019 |
|||
Number of shares outstanding
|
2 288 678 157
|
2 322 827 946
|
|||
Registered share price (CHF)
|
79.85
|
95.78
|
|||
ADR price (USD)
|
82.45
|
96.14
|
|||
Market capitalization (USD billions)1
|
189.9
|
223.4
|
|||
Market capitalization (CHF billions)1
|
182.8
|
222.5
|
|||
|
|||||
1 Market capitalization is calculated based on the number of shares outstanding (excluding treasury shares). Market capitalization in USD is based on the market capitalization in CHF converted at the quarter end CHF/USD exchange rate.
|
(USD millions)
|
Q1 2020
|
Q1 2019
|
Change
|
||||
Operating income from continuing operations
|
2 744
|
2 242
|
502
|
||||
Adjustments for non-cash items
|
|
|
|
||||
Depreciation, amortization and impairments
|
1 449
|
1 453
|
-4
|
||||
Change in provisions and other non-current liabilities
|
720
|
60
|
660
|
||||
Other
|
117
|
129
|
-12
|
||||
Operating income adjusted for non-cash items
|
5 030
|
3 884
|
1 146
|
||||
Dividends received from associated companies and others
|
487
|
460
|
27
|
||||
Interest and other financial receipts
|
241
|
85
|
156
|
||||
Interest and other financial payments
|
-103
|
-211
|
108
|
||||
Taxes paid
|
-596
|
-400
|
-196
|
||||
Payments out of provisions and other
net cash movements in non-current liabilities |
-404 |
-193 |
-211 |
||||
Change in inventory and trade
receivables less trade payables |
-1 418 |
-697 |
-721 |
||||
Change in other net current assets and other operating cash flow items
|
-709
|
-594
|
-115
|
||||
Net cash flows from operating activities from continuing operations
|
2 528
|
2 334
|
194
|
||||
Purchases of property, plant and equipment
|
-237
|
-282
|
45
|
||||
Proceeds from sale of property, plant and equipment
|
3
|
164
|
-161
|
||||
Purchases of intangible assets
|
-246
|
-337
|
91
|
||||
Proceeds from sale of intangible assets
|
56
|
71
|
-15
|
||||
Purchases of financial assets
|
-52
|
-109
|
57
|
||||
Proceeds from sale of financial assets1
|
10
|
35
|
-25
|
||||
Purchases of other non-current assets
|
-41
|
-10
|
-31
|
||||
Proceeds from sale of other non-current assets
|
0
|
3
|
-3
|
||||
Free cash flow from continuing operations
|
2 021
|
1 869
|
152
|
||||
Free cash flow from discontinued operations2
|
|
-62
|
62
|
||||
Total free cash flow
|
2 021
|
1 807
|
214
|
||||
|
|||||||
1 For the free cash flow in the first quarter 2020, proceeds from the sales of financial assets excludes the cash inflows from the sale of a portion of the Alcon Inc. shares recognized by certain consolidated foundations through the Alcon spin-off, which amounted to USD 232 million (Q1 2019: nil). See Note 3.
|
|||||||
2 In the first quarter 2019, the free cash flow from discontinued operations was a cash outflow of USD 62 million consisting of USD 78 million net cash inflows from operating activities from discontinued operations, USD 423 million net cash flows used in investing activities from discontinued operations adjusted by USD 283 million of net cash outflows for acquisition and divestments of businesses.
|
(USD per unit) |
Average rates Q1 2020 |
Average rates Q1 2019 |
Period-end
rates Mar 31, 2020 |
Period-end
rates Mar 31, 2019 |
|||||
1 CHF
|
1.033
|
1.003
|
1.039
|
1.004
|
|||||
1 CNY
|
0.143
|
0.148
|
0.141
|
0.149
|
|||||
1 EUR
|
1.102
|
1.136
|
1.100
|
1.123
|
|||||
1 GBP
|
1.280
|
1.302
|
1.232
|
1.303
|
|||||
100 JPY
|
0.918
|
0.908
|
0.923
|
0.903
|
|||||
100 RUB
|
1.506
|
1.517
|
1.260
|
1.543
|
July 21, 2020
|
Second quarter results 2020
|
October 27, 2020
|
Third quarter results 2020
|