6-K
NOVARTIS AG (NVS)
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
Report on Form 6-K dated October 26, 2021
(Commission File No. 1-15024)
Novartis AG
(Name of Registrant)
Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
| Form 20-F: x | Form 40-F: o |
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
| Yes: o | No: x |
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
| Yes: o | No: x |
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Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
| Yes: o | No: x |
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Exhibits:
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Novartis AG | |||
|---|---|---|---|
| Date:<br>October 26, 2021 | By: | /s/ PAUL PENEPENT | |
| Name: | Paul Penepent | ||
| Title: | Head Group Financial Reporting and Accounting |
99.1 Financial Report Q3 2021
Ad hoc announcement pursuant to Art. 53 LR
<br><br><br><br><br><br><br><br>FINANCIAL RESULTS |
RÉSULTATS FINANCIERS | FINANZERGEBNISSE | Novartis International AG<br><br>Novartis Global Communications<br><br>CH-4002 Basel<br><br>Switzerland<br><br><br><br>https://www.novartis.com |
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Novartis delivers solid Q3 results, with strong growth in Innovative Medicines. Announces strategic review of Sandoz
• Q3 net sales grew +5% (cc^1^, +6% USD)
o Innovative Medicines grew +7% (cc, +8% USD)
o Strong performance of key growth drivers: Entresto (+44% cc), Cosentyx (+22% cc), Kesimpta (USD 109 million), Jakavi (+26% cc), Zolgensma (+28% cc), Promacta/Revolade (+18% cc) and Kisqali (+27% cc)
o Sandoz declined -2% (cc, -1% USD), affected by continued pricing pressures. Ex-US sales grew +3% (cc)
• Q3 core^1^ operating income grew +9% (cc, +10% USD)
o Innovative Medicines grew +13% (cc, +14% USD), due to higher sales and productivity programs
o Sandoz declined -15% (cc, -13% USD), impacted by gross margin
• Q3 operating income grew +32% (cc, +34% USD)
• Q3 net income increased +41% (cc, +43% USD)
• Q3 free cash flow^1^ of USD 4.4 billion (+64% USD), with higher operating income, lower payments out of provisions and favorable changes in working capital
• Nine months sales grew +4% (cc, +7% USD) and core operating income grew +4% (cc, +7% USD)
o Innovative Medicines sales grew +6% (cc, +9% USD) and core operating income +8% (cc, +11% USD)
o Sandoz sales declined -4% (cc, 0% USD) and core operating income declined -18% (cc, -15% USD)
• Increasing peak sales guidance for Cosentyx (at least USD 7.0 billion) and Entresto (at least USD 5.0 billion)
• Key innovation milestones
o Zolgensma partial clinical trial hold lifted by FDA; Ph3 IT clinical trial for SMA to proceed Q4 2021
o Kisqali demonstrated statistically significant OS benefit for 1L HR+/HER2- advanced breast cancer
o Cosentyx met primary endpoint in Ph2 Giant Cell Arteritis study; Ph3 started
o Remibrutinib met primary endpoint in Ph2b CSU study; Ph3 in CSU and MS planned
o ^177^Lu-PSMA-617 and Asciminib granted priority review by FDA
• Commencing a strategic review of Sandoz to maximize shareholder value, options range from retaining the business to separation
• 2021 Group guidance^2^ unchanged
Basel, October 26, 2021 - commenting on the quarter, Vas Narasimhan, CEO of Novartis, said:
“Novartis delivered strong Innovative Medicines performance, driven by the continued momentum of Cosentyx and Entresto, allowing us to raise peak sales guidance for these products. Rejuvenation of our portfolio continues, from our key brands which include Kesimpta, Leqvio, Zolgensma and the oncology portfolio. We are also commencing a strategic review of Sandoz to maximize shareholder value. We remain confident in the strength of our pipeline and launch brands to fuel the growth of our company in the mid to longer term.”
| Key figures¹ | ||||||||
|---|---|---|---|---|---|---|---|---|
| Q3 2021 | Q3 2020 | % change | 9M 2021 | 9M 2020 | % change | |||
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Net sales | 13 030 | 12 259 | 6 | 5 | 38 397 | 35 889 | 7 | 4 |
| Operating income | 3 233 | 2 412 | 34 | 32 | 9 127 | 7 508 | 22 | 18 |
| Net income | 2 758 | 1 932 | 43 | 41 | 7 712 | 5 972 | 29 | 26 |
| EPS (USD) | 1.23 | 0.85 | 45 | 44 | 3.44 | 2.62 | 31 | 28 |
| Free cash flow | 4 423 | 2 697 | 64 | 10 255 | 8 349 | 23 | ||
| Core operating income | 4 467 | 4 069 | 10 | 9 | 12 769 | 11 915 | 7 | 4 |
| Core net income | 3 830 | 3 467 | 10 | 9 | 10 959 | 10 124 | 8 | 5 |
| Core EPS (USD) | 1.71 | 1.52 | 13 | 11 | 4.88 | 4.44 | 10 | 7 |
^1^ Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 47 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. ^2^ Please see detailed guidance assumptions on page 7 including the forecast assumption that we see a continuation of the return to normal global healthcare systems including prescription dynamics, particularly oncology, in the remainder of the year. In addition, we assume that no Gilenya and no Sandostatin LAR generics enter in 2021 in the US
1
Strategic review of the Sandoz Division
Novartis has commenced a strategic review of the Sandoz Division. The review will explore all options, ranging from retaining the business to separation, in order to determine how to best maximize value for our shareholders.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines.
Financials
Third quarter
Net sales were USD 13.0 billion (+6%, +5% cc) in the third quarter. Volume contributed 9 percentage points to sales growth, driven by Entresto, Cosentyx, Kesimpta and Jakavi. Volume growth was partly offset by price erosion of 2 percentage points and generic competition of 2 percentage points.
Operating income was USD 3.2 billion (+34%, +32% cc) predominately from higher sales and lower impairment charges, partly offset by higher investments in M&S and R&D.
Net income was USD 2.8 billion (+43%, +41% cc). EPS was USD 1.23 (+45%, +44% cc), growing faster than net income benefiting from lower weighted average number of shares outstanding.
Core operating income was USD 4.5 billion (+10%, +9% cc) benefiting from higher sales and productivity programs, partly offset by higher investments in M&S and R&D. Core operating income margin was 34.3% of net sales, increasing by 1.1 percentage points (+1.0 percentage point cc).
Core net income was USD 3.8 billion (+10%, +9% cc). Core EPS was USD 1.71 (+13%, +11% cc), growing faster than core net income benefiting from lower weighted average number of shares outstanding.
Net cash flows from operating activities amounted to USD 4.9 billion.
Free cash flow amounted to USD 4.4 billion (+64%). This increase was driven by higher operating income adjusted for non-cash items, favorable changes in working capital and lower payments out of provisions, mainly due to legal matters in the prior year quarter.
Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). Volume contributed 10 percentage points to sales growth. Pharmaceuticals BU sales grew +8% (cc), with continued strong growth from Entresto, Cosentyx, Kesimpta and Zolgensma. Oncology BU grew +5% (cc) driven by strong performance from Jakavi, Promacta/Revolade and Kisqali. Generic competition had a negative impact of 3 percentage points, mainly due to Diovan, Ciprodex and Exjade. Net pricing had a negligible impact on sales growth. Operating income was USD 2.8 billion (+40%, +38% cc). Core operating income was USD 4.0 billion (+14%, +13% cc). Core operating income margin was 37.8% of net sales, increasing 2.0 percentage points (+1.9 percentage points cc).
Sandoz net sales were USD 2.4 billion (-1%, -2% cc). Volume increased by 7 percentage points more than offset by a negative price effect of 9 percentage points. Sales in Europe grew +2% (cc), while sales in the US declined -20%. Global sales of Biopharmaceuticals grew +5% (cc). Operating income was USD 440 million (+11%, +9% cc). Core operating income was USD 571 million (-13%, -15% cc). Core Operating income margin was 23.8%, decreasing 3.4 percentage points (-3.6 percentage points cc).
Nine months
Net sales were USD 38.4 billion (+7%, +4% cc) in the first nine months. Volume contributed 8 percentage points to sales growth, driven by Entresto, Cosentyx and Zolgensma. Price erosion was 2 percentage points and there was an impact from generic competition of 2 percentage points.
Operating income was USD 9.1 billion (+22%, +18% cc) predominately from higher sales, lower legal expenses and lower impairment charges, partly offset by higher amortization and higher M&S and R&D investments.
2
Net income was USD 7.7 billion (+29%, +26% cc). EPS was USD 3.44 (+31%, +28% cc), growing faster than net income benefiting from lower weighted average number of shares outstanding.
Core operating income was USD 12.8 billion (+7%, +4% cc) benefiting from higher sales, partly offset by higher investments in M&S and R&D. Core operating income margin was 33.3% of net sales, increasing by 0.1 percentage point (+0.1 percentage point cc).
Core net income was USD 11.0 billion (+8%, +5% cc). Core EPS was USD 4.88 (+10%, +7% cc), growing faster than core net income benefiting from lower weighted average number of shares outstanding.
Net cash flows from operating activities amounted to USD 11.2 billion.
Free cash flow amounted to USD 10.3 billion (+23%). This increase was mainly driven by higher operating income adjusted for non-cash items, higher divestment proceeds and lower payments out of provisions, mainly due to legal matters in the prior year period, partly offset by the USD 650 million upfront payment to in-license tislelizumab from BeiGene.
Innovative Medicines net sales were USD 31.3 billion (+9%, +6% cc). Pharmaceuticals BU sales grew +7% (cc), driven by Entresto, Cosentyx, Zolgensma and Kesimpta. Oncology BU grew +4% (cc) driven by Promacta/Revolade, Jakavi and Kisqali. Volume contributed 9 percentage points to sales growth. Generic competition had a negative impact of 3 percentage points. Net pricing had a negligible impact on sales growth. Operating income was USD 8.2 billion (+21%, +18% cc). Core operating income was USD 11.6 billion (+11%, +8% cc). Core operating income margin was 37.1% of net sales, increasing 0.8 percentage point (+0.9 percentage point cc).
Sandoz net sales were USD 7.1 billion (0%, -4% cc). Volume increased by 5 percentage points from growth in Biopharmaceuticals, partly offset by softer Retail Generics demand, including a weak cough and cold season. Pricing had a negative effect of 9 percentage points. Sales in Europe declined -4% (cc), while sales in the US declined -17%. Global sales of Biopharmaceuticals grew +5% (cc). Operating income was USD 1.2 billion (+81%, +75% cc). Core operating income was USD 1.5 billion (-15%, -18% cc). Core operating income margin was 21.6%, decreasing 3.8 percentage points (-3.7 percentage points cc).
Q3 key growth drivers
Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including:
| Entresto | (USD 924 million, +44% cc) continued strong growth with increased patient share across markets, driven by demand as essential first choice therapy for HF patients |
|---|---|
| Cosentyx | (USD 1.2 billion, +22% cc) strong growth driven by sustained underlying demand across indications in the US and Europe and strong volume growth in China |
| Kesimpta | (USD 109 million) sales driven by launch uptake, strong access and increased demand based on a superior benefit-risk profile; now approved in 54 countries |
| Jakavi | (USD 426 million, +26% cc) showed double-digit growth across all regions, driven by strong demand in the myelofibrosis and polycythemia vera indications |
| Zolgensma | (USD 375 million, 28% cc) strong growth driven by expanding access in Europe and Emerging Growth Markets |
| Promacta/Revolade | (USD 522 million, +18% cc) showed double-digit growth across all regions, driven by increased use in chronic ITP and as first-line treatment for severe aplastic anemia |
| Ilaris | (USD 272 million, +24% cc) strong sales were driven by continued double-digit growth across all regions |
| Kisqali | (USD 232 million, +27% cc) continued to see growth across all regions, benefiting from the ongoing impact of positive overall survival data in three Ph3 studies |
| Xolair | (USD 365 million, +13% cc) continued to see growth, mainly driven by the chronic spontaneous urticaria and severe allergic asthma indications |
| Tasigna | (USD 514 million, +7% cc) growth was mainly driven by Emerging Growth Markets |
| Lucentis | (USD 556 million, +6% cc) sales grew in Emerging Growth Markets and Europe |
3
| Mayzent | (USD 76 million, +55% cc) continued to grow, driven by fulfilling an important unmet need in MS patients showing signs of progression despite being on other treatments |
|---|---|
| Kymriah | (USD 146 million, +20% cc) continued to see growth across all markets as coverage continued to expand, with more than 340 qualified treatment centers in 30 countries |
| Biopharmaceuticals | (USD 526 million, +5% cc) sales were driven by continued growth ex-US |
| Emerging Growth Markets* | Overall, sales grew +15% (cc). China grew strongly with sales reaching USD 839 million (+18% cc) |
* All markets except US, Canada, Western Europe, Japan, Australia and New Zealand
Net sales of the top 20 Innovative Medicines products in 2021
| Q3 2021 | % change | 9M 2021 | % change | |||
|---|---|---|---|---|---|---|
| USD m | USD | cc | USD m | USD | cc | |
| Cosentyx | 1 247 | 23 | 22 | 3 475 | 20 | 18 |
| Entresto | 924 | 46 | 44 | 2 599 | 46 | 41 |
| Gilenya | 703 | -4 | -5 | 2 131 | -5 | -7 |
| Lucentis | 556 | 8 | 6 | 1 652 | 18 | 12 |
| Tasigna | 514 | 8 | 7 | 1 552 | 7 | 5 |
| Promacta/Revolade | 522 | 18 | 18 | 1 498 | 18 | 16 |
| Tafinlar + Mekinist | 417 | 5 | 4 | 1 235 | 9 | 6 |
| Jakavi | 426 | 27 | 26 | 1 187 | 23 | 18 |
| Sandostatin | 351 | -3 | -4 | 1 068 | -1 | -2 |
| Xolair | 365 | 14 | 13 | 1 055 | 15 | 10 |
| Zolgensma | 375 | 29 | 28 | 1 009 | 52 | 49 |
| Galvus Group | 272 | -6 | -5 | 814 | -10 | -11 |
| Gleevec/Glivec | 256 | -9 | -9 | 791 | -12 | -15 |
| Ilaris | 272 | 24 | 24 | 775 | 22 | 22 |
| Afinitor/Votubia | 246 | -6 | -6 | 764 | -7 | -8 |
| Exforge Group | 203 | -14 | -16 | 704 | -4 | -8 |
| Kisqali | 232 | 27 | 27 | 652 | 30 | 27 |
| Diovan Group | 180 | -24 | -26 | 584 | -25 | -28 |
| Kymriah | 146 | 20 | 20 | 444 | 33 | 30 |
| Votrient | 142 | -11 | -12 | 438 | -10 | -12 |
| Top 20 products total | 8 349 | 11 | 10 | 24 427 | 12 | 9 |
4
R&D Update - key developments from the third quarter
New approvals
| Cosentyx | Approved in China and Japan for treatment of moderate-to-severe plaque psoriasis in pediatric patients (≥ 6 years) who are candidates for systemic therapy or phototherapy |
|---|---|
| Entresto | Approved in Japan for patients with essential hypertension |
Regulatory updates
| Inclisiran | Resubmission to the FDA for the inclisiran NDA was filed with an action date of January 1, 2022 |
|---|---|
| ^177^Lu-PSMA-617 | Granted FDA priority review for metastatic castration-resistant prostate cancer. PDUFA date anticipated in H1 2022 |
| Zolgensma | Partial clinical trial hold lifted by the FDA. OAV-101 intrathecal Ph3 STEER study (global registration-enabling study) initiating |
| Asciminib<br><br><br><br>(ABL001) | NDA accepted and priority review granted by the FDA for the treatment of chronic myeloid leukemia |
| Tislelizumab | BLA submission accepted by the FDA for the treatment of unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma in patients who had received prior systemic therapy |
| Sabatolimab<br><br><br><br>(MBG453) | Granted EC orphan drug designation for myelodysplastic syndromes |
| LNA043 | Granted FDA fast track designation for osteoarthritis of the knee |
| NIS793 | Granted FDA orphan drug designation in combination with standard of care chemotherapy for pancreatic cancer |
Results from ongoing trials and other highlights
| Kisqali | MONALEESA-2 final analysis showed statistically significant overall survival benefit for postmenopausal women in 1L HR+/HER2- advanced breast cancer. Kisqali plus letrozole achieved median OS of over five years (63.9 months) and a survival benefit of over 12 months vs. placebo plus letrozole in postmenopausal women (HR=0.76; p=0.004) |
|---|---|
| Canakinumab | Ph3 CANOPY-1 study did not meet its primary endpoints in non-small cell lung cancer (NSCLC). However, potentially clinically meaningful improvements in both progression free survival and overall survival were observed among pre-specified subgroups of patients with inflammatory biomarkers, additional analyses are ongoing. Canakinumab showed no unexpected safety signals. Results support further evaluation in lung cancer |
| Remibrutinib <br><br>(LOU064) | Ph2b study in CSU showed significant improvements in UAS7 change from baseline at week 4 and 12 with all doses compared to placebo (p<0.0001) and demonstrated a rapid improvement as of week 1. Remibrutinib showed a favorable benefit/risk profile and good tolerability across the entire dose range tested. Ph3 studies in CSU are expected to begin enrolling patients by the end of 2021<br><br><br><br><br><br><br><br>Novartis is also initiating Ph3 pivotal trials in relapsing multiple sclerosis |
5
| Leqvio<br><br><br><br>(Inclisiran) | Ph3 ORION-9, -10 and -11 pooled post hoc analyses data showed that Leqvio consistently reduced LDL cholesterol in ASCVD patients with established cerebrovascular disease (55.2% reduction vs. placebo) and polyvascular disease (48.9% reduction vs. placebo) |
|---|---|
| Iscalimab<br><br><br><br>(CFZ533) | CIRRUS-1 study in kidney transplant discontinued following an interim analysis. CFZ533 in liver transplant continues, as do studies exploring CFZ533 as a potential treatment in other autoimmune conditions, such as hidradenitis suppurativa and Sjögren’s syndrome |
| Iptacopan<br><br><br><br>(LNP023) | Final analysis of the Ph2b study in C3G showed that iptacopan met co-primary endpoints with statistically significant and clinically meaningful reduction in proteinuria in patients with C3G (native kidney) and delivered first data in patients with recurrent disease post-transplantation<br><br><br><br><br><br><br><br>Additional exploratory efficacy analyses of Ph2b study in IgAN indicate iptacopan further reduces UPCR at day 180 when compared to day 90 (primary study endpoint) |
| Cosentyx | Ph2 TitAIN study met primary endpoint in Giant Cell Arteritis (GCA) demonstrating sustained efficacy and no new safety signals were observed. Data supports further development<br><br><br><br><br><br><br><br>Ph3b MATURE study showed treatment with Cosentyx 300mg in a 2mL autoinjector resulted in high efficacy and convenient administration in adults with moderate to severe plaque psoriasis |
| Alpelisib<br><br><br><br>(BYL719) | Real-world study demonstrated clinical benefit in patients with PIK3CA-Related Overgrowth Spectrum (PROS). At 24 weeks, 38% of patients achieved ≥20% reduction in the volume of the PROS lesions assessed in the primary endpoint analysis; no patients experienced disease progression or death |
| Beovu | Ph3 KITE study year 2 (100 weeks) data for DME showed that the majority of patients were maintained on a 12- or 16-week dosing interval. Intraocular inflammation (IOI) rates were 2.2% for Beovu and 1.7% for aflibercept. Retinal vascular occlusion (RO) rates were 0.6% for Beovu vs. 0.6% for aflibercept<br><br><br><br><br><br><br><br>Ph3 KINGFISHER study in DME met its primary endpoint and key fluid-related secondary endpoints vs. aflibercept. IOI rates were 4.0% for Beovu and 2.9% for aflibercept. RO rates were 0.3% for Beovu vs. 0.6% for aflibercept |
| Kymriah | Ph3 BELINDA study did not meet primary endpoint of event-free survival for patients with aggressive B-cell NHL who had primary refractory disease or who relapsed within 12 months of 1L treatment |
| ^177^Lu-PSMA-617 | Ph3 VISION study new quality of life data showed that ^177^Lu-PSMA-617 plus standard of care (SOC) delayed worsening of health-related quality of life (54% risk reduction; HR 0.46) and pain (55% risk reduction; HR 0.45) in heavily pre-treated patients with PSMA-positive mCRPC compared to SOC alone |
| Ligelizumab | Ph2b data analysis demonstrated ligelizumab was more likely to provide complete control of CSU symptoms than omalizumab |
| Ganaplacide/ Lumefantrine | Ph2b study of novel ganaplacide/lumefantrine combination in children (<12 years old) with acute uncomplicated malaria showed positive results (adequate clinical and parasitological response at day 29 with polymerase chain reaction correction) |
| Enerzair | Ph3 IRIDIUM study post hoc analysis showed how each of the three components in Enerzair Breezhaler contribute to the substantial reduction in asthma exacerbations (36-42%) vs. twice daily high-dose salmeterol/fluticasone. Another post-hoc analysis further suggests that using Enerzair Breezhaler as a step-up therapy from medium-dose LABA/ICS provides benefit beyond increasing ICS dose alone |
6
Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.
During the first nine months of 2021, Novartis repurchased a total of 28.2 million shares for USD 2.6 billion on the SIX Swiss Exchange second trading line, including 19.6 million shares (USD 1.8 billion) under the up-to USD 2.5 billion share buyback announced in November 2020 and 8.6 million shares (USD 0.8 billion) to mitigate dilution related to participation plans of associates. In addition, 1.4 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 9.9 million shares (for an equity value of USD 0.6 billion) were delivered as a result of options exercised and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 19.7 million versus December 31, 2020. These treasury share transactions resulted in an equity decrease of USD 2.1 billion and a net cash outflow of USD 2.9 billion.
As of September 30, 2021, the net debt was USD 24.3 billion broadly in line with the USD 24.5 billion at December 31, 2020, as the USD 10.3 billion free cash flow during the first nine months of 2021 was offset by the USD 7.4 billion annual dividend payment and net cash outflow for treasury share transactions of USD 2.9 billion.
The Group has not experienced liquidity or cash flow disruptions during the first nine months of 2021 due to the COVID-19 pandemic. We are confident that Novartis is well positioned to meet its ongoing financial obligations and has sufficient liquidity to support its normal business activities.
As of Q3 2021, the long-term credit rating for the company is A1 with Moody’s Investors Service and AA- with S&P Global Ratings.
2021 outlook
Barring unforeseen events; growth vs. PY in cc
| Group | Sales expected to grow low to mid single digit<br><br><br><br>Core operating income expected to grow mid single digit, ahead of sales |
|---|---|
| Innovative <br><br> Medicines | Sales expected to grow mid single digit<br><br><br><br>Core operating income revised upwards from expected to “grow mid to high single digit” to “grow high single digit” |
| Sandoz | Sales expected to decline low to mid single digit<br><br><br><br>Core operating income revised downwards from expected to “decline low to mid-teens” to “decline mid to high teens” |
Our guidance assumes that we see a continuation of the return to normal global healthcare systems including prescription dynamics, particularly oncology, in the remainder of the year. In addition, we assume that no Gilenya and no Sandostatin LAR generics enter in 2021 in the US.
We are increasing our peak sales guidance for Cosentyx and Entresto, to at least USD 7.0 billion and at least USD 5.0 billion respectively.
Foreign exchange impact
If late-October exchange rates prevail for the remainder of 2021, the foreign exchange impact for the year would be positive 2 percentage points on net sales and positive 2 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.
7
Board of Directors Announcements
The Novartis Board of Directors announced today that it is nominating Ana de Pro Gonzalo for election to the Board at the Annual General Meeting on March 4 2022. Ms Ana de Pro Gonzalo has held executive positions in finance and general management in IT and other industries. From 2010-2020, she was Chief Financial Officer of Amadeus IT Group SA, a leading technology provider and transaction processor for global businesses. Ms Ana de Pro Gonzalo serves as an independent non-executive director on several listed company boards as well as not-for-profit organizations. Her strong record of leadership in global corporations and experience in finance, capital markets and technology will add greatly to the expertise of the Novartis Board of Directors.
The Board also noted the decision by Andreas von Planta that he will not stand for re-election at the AGM 2023.
Key Figures¹
| Group | Q3 2021 | Q3 2020 | % change | 9M 2021 | 9M 2020 | % change | ||
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Net sales | 13 030 | 12 259 | 6 | 5 | 38 397 | 35 889 | 7 | 4 |
| Operating income | 3 233 | 2 412 | 34 | 32 | 9 127 | 7 508 | 22 | 18 |
| As a % of sales | 24.8 | 19.7 | 23.8 | 20.9 | ||||
| Core operating income | 4 467 | 4 069 | 10 | 9 | 12 769 | 11 915 | 7 | 4 |
| As a % of sales | 34.3 | 33.2 | 33.3 | 33.2 | ||||
| Net income | 2 758 | 1 932 | 43 | 41 | 7 712 | 5 972 | 29 | 26 |
| EPS (USD) | 1.23 | 0.85 | 45 | 44 | 3.44 | 2.62 | 31 | 28 |
| Core net income | 3 830 | 3 467 | 10 | 9 | 10 959 | 10 124 | 8 | 5 |
| Core EPS (USD) | 1.71 | 1.52 | 13 | 11 | 4.88 | 4.44 | 10 | 7 |
| Net cash flows from<br><br> operating activities | 4 925 | 3 156 | 56 | 11 187 | 9 645 | 16 | ||
| Free cash flow | 4 423 | 2 697 | 64 | 10 255 | 8 349 | 23 | ||
| Innovative Medicines | Q3 2021 | Q3 2020 | % change | 9M 2021 | 9M 2020 | % change | ||
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Net sales | 10 628 | 9 837 | 8 | 7 | 31 291 | 28 780 | 9 | 6 |
| Operating income | 2 801 | 1 998 | 40 | 38 | 8 220 | 6 786 | 21 | 18 |
| As a % of sales | 26.4 | 20.3 | 26.3 | 23.6 | ||||
| Core operating income | 4 017 | 3 525 | 14 | 13 | 11 619 | 10 433 | 11 | 8 |
| As a % of sales | 37.8 | 35.8 | 37.1 | 36.3 | ||||
| Sandoz | Q3 2021 | Q3 2020 | % change | 9M 2021 | 9M 2020 | % change | ||
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Net sales | 2 402 | 2 422 | -1 | -2 | 7 106 | 7 109 | 0 | -4 |
| Operating income | 440 | 395 | 11 | 9 | 1 214 | 671 | 81 | 75 |
| As a % of sales | 18.3 | 16.3 | 17.1 | 9.4 | ||||
| Core operating income | 571 | 658 | -13 | -15 | 1 536 | 1 806 | -15 | -18 |
| As a % of sales | 23.8 | 27.2 | 21.6 | 25.4 | ||||
| Corporate | Q3 2021 | Q3 2020 | % change | 9M 2021 | 9M 2020 | % change | ||
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Operating (loss)/income | -8 | 19 | nm | nm | -307 | 51 | nm | nm |
| Core operating loss | -121 | -114 | -6 | -7 | -386 | -324 | -19 | -17 |
| nm = not meaningful |
^1^ Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 47 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this release refer to same period in prior year.
Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below:
https://ml-eu.globenewswire.com/resource/download/02dda0a9-9347-4427-9a5e-6a1f527e8334/
8
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “momentum,” “growth,” “continued,” “increasing,” “guidance,” “rejuvenation,” “continues,” “confident,” “will,” “driven,” “launch,” “expand,” “anticipated,” “action,” “initiating,” “continues,” “development,” “remains,” “outlook,” “expected,” “to grow,” “estimated,” “to meet,” “ongoing,” “to support,” “to gain,” “innovation,” “pipeline,” “retaining,” “can,” “resubmission,” “focus,” “priority,” “unforeseen,” “forecast,” “prevail,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on parts of our business including oncology and generics; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions or products; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our in-licensing of tislelizumab from Beigene. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of the COVID-19 pandemic on enrollment in, initiation and completion of our clinical trials in the future, and research and development timelines; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics, particularly in oncology and generics, in the fourth quarter of 2021; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this press release; the potential that the strategic benefits, synergies or opportunities expected from the transactions described, may not be realized or may be more difficult or take longer to realize than expected; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis Group companies.
9
About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting. https://www.novartis.com/investors/event-calendar
Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on Novartis divisions and pipeline of selected compounds in late stage development and a copy of today's earnings call presentation can be found at. https://www.novartis.com/investors/event-calendar
Important dates
December 2, 2021 Capital Markets Day (with a focus on R&D)
February 2, 2022 Fourth Quarter & Full Year 2021 results
March 4, 2022 Annual General Meeting
10
99.2 Interim Financial Report

Novartis Third Quarter and Nine Months 2021 Condensed Interim Financial Report – Supplementary Data
INDEX
Page
GROUP AND DIVISIONAL OPERATING PERFORMANCE
Group
3
Innovative Medicines
7
Sandoz
14
CASH FLOW AND GROUP BALANCE SHEET
16
INNOVATION REVIEW
19
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Consolidated income statements
22
Consolidated statements of comprehensive income
24
Consolidated balance sheets
25
Consolidated statements of changes in equity
26
Consolidated statements of cash flows
28
Notes to condensed interim consolidated financial statements, including update on legal proceedings
30
SUPPLEMENTARY INFORMATION
47
CORE RESULTS
Reconciliation from IFRS results to core results
49
Group
51
Innovative Medicines
53
Sandoz
54
Corporate
55
ADDITIONAL INFORMATION
Income from associated companies
55
Condensed consolidated changes in net debt / Share information
56
Free cash flow
57
Effects of currency fluctuations
59
DISCLAIMER
61
2
Group
Key Figures
| Q3 2021<br> USD m | Q3 2020<br> USD m | % change<br> USD | % change<br> cc | 9M 2021<br> USD m | 9M 2020<br> USD m | % change<br> USD | % change<br> cc^1^ | |
|---|---|---|---|---|---|---|---|---|
| Net sales to third parties | 13 030 | 12 259 | 6 | 5 | 38 397 | 35 889 | 7 | 4 |
| Divisional operating income | 3 241 | 2 393 | 35 | 33 | 9 434 | 7 457 | 27 | 23 |
| Corporate income and expense, net | -8 | 19 | nm | nm | -307 | 51 | nm | nm |
| Operating income | 3 233 | 2 412 | 34 | 32 | 9 127 | 7 508 | 22 | 18 |
| As % of net sales | 24.8 | 19.7 | 23.8 | 20.9 | ||||
| Income from associated companies | 223 | 226 | -1 | -1 | 718 | 532 | 35 | 35 |
| Interest expense | -202 | -209 | 3 | 3 | -605 | -668 | 9 | 9 |
| Other financial income and expense | -24 | -19 | -26 | 7 | -54 | -53 | -2 | 52 |
| Income taxes | -472 | -478 | 1 | 2 | -1 474 | -1 347 | -9 | -7 |
| Net income | 2 758 | 1 932 | 43 | 41 | 7 712 | 5 972 | 29 | 26 |
| Basic earnings per share (USD) | 1.23 | 0.85 | 45 | 44 | 3.44 | 2.62 | 31 | 28 |
| Net cash flows from operating<br>activities | 4 925 | 3 156 | 56 | 11 187 | 9 645 | 16 | ||
| Free cash flow^1^ | 4 423 | 2 697 | 64 | 10 255 | 8 349 | 23 | ||
| Core^1^ | ||||||||
| Core operating income | 4 467 | 4 069 | 10 | 9 | 12 769 | 11 915 | 7 | 4 |
| As % of net sales | 34.3 | 33.2 | 33.3 | 33.2 | ||||
| Core net income | 3 830 | 3 467 | 10 | 9 | 10 959 | 10 124 | 8 | 5 |
| Core basic earnings per share (USD) | 1.71 | 1.52 | 13 | 11 | 4.88 | 4.44 | 10 | 7 |
| ^1^ Constant currencies (cc), core results and free cash flow are non-IFRS measures. An<br> explanation of non-IFRS measures can be found on page 47. Unless otherwise noted,<br> all growth rates in this Release refer to same period in prior year. | ||||||||
| nm = not meaningful |
3
COVID-19 Update
While the COVID-19 situation is now normalizing in most geographies and therapeutic areas, we still see a slight impact on parts of our business, mainly in oncology and generics.
The Group has not experienced liquidity or cash flow disruptions during Q3 2021 due to the COVID-19 pandemic. We are confident that Novartis is well positioned to meet its ongoing financial obligations and has sufficient liquidity to support its normal business activities.
Financials
Third quarter
Net sales
Net sales were USD 13.0 billion (+6%, +5% cc) in the third quarter. Volume contributed 9 percentage points to sales growth, driven by Entresto, Cosentyx, Kesimpta and Jakavi. Volume growth was partly offset by price erosion of 2 percentage points and negative impact from generic competition of 2 percentage points.
Corporate income and expense, net
Corporate income and expense, which includes the cost of Group headquarter and coordination functions, amounted to an expense of USD 8 million, compared to an income of USD 19 million in the third quarter of 2020, mainly driven by lower contributions from the Novartis Venture Fund, partially offset by income from a fair value adjustment on contingent receivables related to intellectual property rights.
Operating income
Operating income was USD 3.2 billion (+34%, +32% cc) mainly driven by higher sales and lower impairment charges, partly offset by higher investments in M&S and R&D.
Core operating income was USD 4.5 billion (+10%, +9% cc) mainly driven by higher sales and productivity programs, partly offset by higher investments in M&S and R&D. Core operating income margin was 34.3% of net sales, increasing by 1.1 percentage points (+1.0 percentage point cc).
Income from associated companies
Income from associated companies of USD 223 million in the third quarter was broadly in line with prior year quarter of USD 226 million.
Core income from associated companies increased to USD 309 million from USD 288 million in the prior year mainly due to a higher estimated core income contribution from Roche Holding AG for the current period.
Interest expense and other financial income/expense
Interest expense amounted to USD 202 million compared to the prior year interest expense of USD 209 million mainly due to lower interest expense on financial debts.
Other financial income and expense amounted to a net expense of USD 24 million compared to a net expense of USD 19 million in the prior year mainly due to higher financial expense.
Income taxes
The tax rate in the third quarter was 14.6% compared to 19.8% in the prior year. The current year third quarter tax rate was impacted by the effect of adjusting to the estimated full year tax rate, which was lower than previously estimated. The prior year quarter’s tax rate was negatively impacted by the effect of legal charges.
Excluding these impacts the current year third quarter tax rate would have been 16.0% compared to 16.7% in the prior year quarter. The decrease from prior year quarter was mainly the result of a change in profit mix.
The core tax rate was 16.0% in the current year third quarter, the same as in the prior year.
4
Net income, EPS and free cash flow
Net income was USD 2.8 billion (+43%, +41% cc) mainly driven by higher operating income. EPS was USD 1.23 (+45%, +44% cc), growing faster than net income benefiting from lower weighted average number of shares outstanding.
Core net income was USD 3.8 billion (+10%, +9% cc) mainly driven by growth in core operating income. Core EPS was USD 1.71 (+13%, +11% cc), growing faster than core net income benefiting from lower weighted average number of shares outstanding.
Net cash flows from operating activities amounted to USD 4.9 billion.
Free cash flow amounted to USD 4.4 billion (+64%), compared to USD 2.7 billion in the prior year quarter. This increase was driven by higher operating income adjusted for non-cash items and other adjustments, favorable changes in working capital and lower payments out of provisions, mainly due to legal matters in the prior year quarter.
Nine months
Net sales
Net sales were USD 38.4 billion (+7%, +4% cc) in the first nine months. Volume contributed 8 percentage points to sales growth, driven by Entresto, Cosentyx and Zolgensma. Price erosion was 2 percentage points and there was a negative impact from generic competition of 2 percentage points.
Corporate income and expense, net
Corporate income and expense, which includes the cost of Group headquarter and coordination functions, amounted to an expense of USD 307 million, compared to an income of USD 51 million in the nine months of 2020, mainly driven by royalty settlement gains related to intellectual property rights last year, lower contributions from the Novartis Venture Fund, partially offset by income from a fair value adjustment on contingent receivables related to intellectual property rights.
Operating income
Operating income was USD 9.1 billion (+22%, +18% cc) mainly driven by higher sales, lower legal expenses and lower impairment charges, partly offset by higher amortization and higher M&S and R&D investments.
Core operating income was USD 12.8 billion (+7%, +4% cc) mainly driven by higher sales, partly offset by higher investments in M&S and R&D. Core operating income margin was 33.3% of net sales, increasing by 0.1 percentage point (+0.1 percentage point cc).
Income from associated companies
Income from associated companies increased to USD 718 million in the nine months of 2021, from USD 532 million in the prior year, mainly due to the increase in the share of income from Roche Holding AG. The estimated nine months income for Roche Holding AG, net of amortization, was USD 682 million compared to USD 599 million in prior year. A positive prior year true up of USD 40 million has been recognized in the first quarter of 2021, compared to a negative true up of USD 64 million in the first quarter of 2020.
Core income from associated companies increased to USD 900 million from USD 868 million in prior year due to a higher estimated core income contribution from Roche Holding AG for the current period. The favorable prior year core income true up from Roche of USD 40 million was broadly in line with the true up recognized in the first quarter of 2020 of USD 38 million.
Interest expense and other financial income/expense
Interest expense decreased to USD 605 million from USD 668 million in prior year, mainly due to lower interest expense on financial debts.
Other financial income and expense amounted to a net expense of USD 54 million in line with a net expense of USD 53 million in the prior year.
5
Income taxes
The tax rate in the first nine months was 16.0% compared to 18.4% in the prior year period. The prior year first nine month tax rate was negatively impacted by the effect of non-deductible legal settlement expenses and legal charges.
Excluding these impacts, the first nine months prior year rate would have been 16.8% compared to 16.0% in the current year period. The decrease from prior year nine month rate was mainly the result of a change in profit mix.
The core tax rate was 16.0% in the first nine months and 16.0% in the prior year period.
Net income, EPS and free cash flow
Net income was USD 7.7 billion (+29%, +26% cc) mainly driven by higher operating income and income from associated companies. EPS was USD 3.44 (+31%, +28% cc), growing faster than net income benefiting from lower weighted average number of shares outstanding.
Core net income was USD 11.0 billion (+8%, +5% cc) mainly driven by growth in core operating income. Core EPS was USD 4.88 (+10%, +7% cc), growing faster than core net income benefiting from lower weighted average number of shares outstanding.
Net cash flows from operating activities amounted to USD 11.2 billion.
Free cash flow amounted to USD 10.3 billion (+23%), compared to USD 8.3 billion in the prior year period. This increase was mainly driven by higher operating income adjusted for non-cash items and other adjustments, higher divestment proceeds and lower payments out of provisions, mainly due to legal matters in the prior year period, partly offset by the USD 650 million upfront payment to in-license tislelizumab from BeiGene.
6
Innovative Medicines
| Q3 2021<br> USD m | Q3 2020<br> USD m | % change<br> USD | % change<br> cc | 9M 2021<br> USD m | 9M 2020<br> USD m | % change<br> USD | % change<br> cc | |
|---|---|---|---|---|---|---|---|---|
| Net sales | 10 628 | 9 837 | 8 | 7 | 31 291 | 28 780 | 9 | 6 |
| Operating income | 2 801 | 1 998 | 40 | 38 | 8 220 | 6 786 | 21 | 18 |
| As % of net sales | 26.4 | 20.3 | 26.3 | 23.6 | ||||
| Core operating income | 4 017 | 3 525 | 14 | 13 | 11 619 | 10 433 | 11 | 8 |
| As % of net sales | 37.8 | 35.8 | 37.1 | 36.3 |
COVID-19 impacts
While the COVID-19 situation is normalizing in most geographies and therapeutic areas, we still see a slight impact on parts of our business, mainly in oncology.
Third quarter
Net sales
Net sales were USD 10.6 billion (+8%, +7% cc) with volume contributing 10 percentage points to growth. Generic competition had a negative impact of 3 percentage points, mainly due to Diovan, Ciprodex and Exjade. Net pricing had negligible impact on sales growth.
In the US (USD 3.8 billion) sales grew +5% driven by Cosentyx, Kesimpta and Entresto. In Europe (USD 3.7 billion, +8%, +7% cc) sales growth was driven by Entresto, Jakavi, Cosentyx, Kisqali and Zolgensma. China sales grew to USD 0.8 billion (+27%, +19% cc) with the launches of Entresto and Cosentyx. Japan sales were USD 0.5 billion (-9%, -6% cc). Emerging Growth Markets grew +19% (+17% cc).
Pharmaceuticals BU sales were USD 6.7 billion (+10%, +8% cc) with continued strong growth from Entresto (USD 924 million, +46%, +44% cc), Cosentyx (USD 1.2 billion, +23%, +22% cc), Kesimpta (USD 109 million), Zolgensma (USD 375 million, +29%, +28% cc) and Ilaris (USD 272 million, +24%, +24% cc).
Oncology BU sales were USD 3.9 billion (+6%, +5% cc), driven by strong performance from Jakavi (USD 426 million, +27%, +26% cc), Promacta/Revolade (USD 522 million, +18%, +18% cc), Kisqali (USD 232 million, +27%, +27% cc) and Kymriah (USD 146 million, +20%, +20% cc), partly offset by generic competition mainly for Exjade and Afinitor.
Operating income
Operating income was USD 2.8 billion (+40%, +38% cc), mainly driven by strong sales growth and lower impairments partly offset by higher spend. Operating income margin was 26.4% of net sales, increasing 6.1 percentage points (+5.9 percentage points in cc).
Core adjustments were USD 1.2 billion, mainly due to amortization, compared to USD 1.5 billion in prior year. Core adjustments decreased compared to prior year mainly due to lower impairments.
Core operating income was USD 4.0 billion (+14%, +13% cc) mainly driven by higher sales and productivity, partly offset by higher spend. Core operating income margin was 37.8% of net sales, increasing 2.0 percentage points (+1.9 percentage points cc). Core gross margin as a percentage of sales increased by 0.5 percentage point (cc) mainly driven by productivity. Core R&D expenses as a percentage of net sales decreased by 0.4 percentage point (cc). Core SG&A expenses as a percentage of net sales decreased by 0.7 percentage point (cc). Core Other Income and Expense increased the margin by 0.3 percentage point (cc) mainly due to prior year pre-launch inventory provision expense.
7
Nine months
Net sales
Net sales were USD 31.3 billion (+9%, +6% cc). Volume contributed 9 percentage points to growth. Generic competition had a negative impact of 3 percentage points. Pricing had a negligible impact on sales growth.
In the US (USD 11.1 billion) sales grew +3% driven by Cosentyx, Entresto and Kesimpta. In Europe (USD 11.1 billion, +13%, +8% cc) sales growth was driven by Zolgensma, Entresto, Jakavi, Lucentis and Cosentyx. China sales were USD 2.2 billion (+24%, +15% cc) with the launches of Entresto and Cosentyx. Japan sales were USD 1.7 billion (-6%, -5% cc) including the negative impact from the Galvus co-promotion agreement. Emerging Growth Markets grew +14% (+11% cc).
Pharmaceuticals BU grew +10% (+7% cc) driven by Entresto (USD 2.6 billion, +46%, +41% cc), Cosentyx (USD 3.5 billion, +20%, +18% cc), Zolgensma (USD 1.0 billion, +52%, +49% cc), Kesimpta (0.2 billion) and Lucentis (USD 1.7 billion, +18%, +12% cc).
Oncology BU grew +7% (+4% cc) driven by Promacta/Revolade (USD 1.5 billion, +18%, +16% cc), Jakavi (USD 1.2 billion, +23%, +18% cc), Kisqali (USD 0.7 billion, +30%, +27% cc), Kymriah (USD 0.4 billion, +33%, +30% cc) and Tasigna (USD 1.6 billion, +7%, +5% cc), partly offset by generic competition mainly for Exjade, Afinitor and Glivec.
Operating income
Operating income was USD 8.2 billion (+21%, +18% cc), mainly driven by sales growth, higher divestment income and lower impairments, partly offset by higher spend and higher amortization. Operating income margin was 26.3% of net sales, increasing 2.7 percentage points (+2.7 percentage points in cc).
Core adjustments were USD 3.4 billion, mainly due to amortization. Core adjustments decreased compared to prior year (USD 3.6 billion) mainly driven by higher divestment income and lower impairments partly offset by higher amortization.
Core operating income was USD 11.6 billion (+11%, +8% cc) mainly driven by sales growth and productivity, partly offset by higher spend. Core operating income margin was 37.1% of net sales, increasing 0.8 percentage point (+0.9 percentage point cc). Core gross margin increased by 0.3 percentage point (cc). Core R&D expenses as a percentage of net sales decreased by 0.1 percentage point (cc). Core SG&A expenses as a percentage of net sales decreased by 0.4 percentage point (cc). Core Other Income and Expense increased the margin by 0.1 percentage point (cc).
8
ONCOLOGY BUSINESS UNIT
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Hematology | ||||||||
| Tasigna | 514 | 478 | 8 | 7 | 1 552 | 1 445 | 7 | 5 |
| Promacta/Revolade | 522 | 442 | 18 | 18 | 1 498 | 1 267 | 18 | 16 |
| Jakavi | 426 | 335 | 27 | 26 | 1 187 | 963 | 23 | 18 |
| Gleevec/Glivec | 256 | 280 | -9 | -9 | 791 | 897 | -12 | -15 |
| Kymriah | 146 | 122 | 20 | 20 | 444 | 333 | 33 | 30 |
| Exjade/Jadenu | 134 | 162 | -17 | -18 | 434 | 497 | -13 | -16 |
| Adakveo | 42 | 35 | 20 | 20 | 121 | 71 | 70 | 70 |
| Other | 85 | 85 | 0 | -2 | 264 | 234 | 13 | 9 |
| Total Hematology | 2 125 | 1 939 | 10 | 9 | 6 291 | 5 707 | 10 | 7 |
| Solid Tumor | ||||||||
| Tafinlar + Mekinist^1^ | 417 | 397 | 5 | 4 | 1 235 | 1 134 | 9 | 6 |
| Sandostatin | 351 | 361 | -3 | -4 | 1 068 | 1 076 | -1 | -2 |
| Afinitor/Votubia | 246 | 262 | -6 | -6 | 764 | 824 | -7 | -8 |
| Kisqali | 232 | 183 | 27 | 27 | 652 | 503 | 30 | 27 |
| Votrient | 142 | 160 | -11 | -12 | 438 | 488 | -10 | -12 |
| Lutathera | 120 | 119 | 1 | 1 | 360 | 336 | 7 | 5 |
| Piqray | 82 | 83 | -1 | -1 | 242 | 236 | 3 | 2 |
| Tabrecta | 24 | 12 | 100 | 96 | 63 | 18 | nm | nm |
| Other | 165 | 182 | -9 | -11 | 502 | 572 | -12 | -15 |
| Total Solid Tumor | 1 779 | 1 759 | 1 | 1 | 5 324 | 5 187 | 3 | 1 |
| Total Novartis Oncology business unit | 3 904 | 3 698 | 6 | 5 | 11 615 | 10 894 | 7 | 4 |
| ^1^ Majority of sales for Mekinist and Tafinlar are combination, but both<br> can be used as monotherapy | ||||||||
| nm = not meaningful |
HEMATOLOGY
Tasigna (USD 514 million, +8%, +7% cc) sales growth was mainly driven by Emerging Growth Markets.
Promacta/Revolade (USD 522 million, +18%, +18% cc) showed double-digit growth across all regions, driven by increased use in chronic immune thrombocytopenia (ITP) and as first-line treatment for severe aplastic anemia (SAA).
Jakavi (USD 426 million, +27%, +26% cc) showed double-digit growth across all regions, which was driven by strong demand in the myelofibrosis and polycythemia vera indications. Regulatory filings based on the REACH2 and REACH3 trials in steroid-resistant/dependent graft-versus-host disease (GvHD) are under review and approvals are expected in 2022.
Gleevec/Glivec (USD 256 million, -9%, -9% cc) declined due to increased generic competition.
Kymriah (USD 146 million, +20%, +20% cc) continued to see growth across all markets. Coverage continued to expand, with more than 340 qualified treatment centers in 30 countries having coverage for at least one indication. In its approved indications, Kymriah is an efficacious treatment offering potential for durable responses and a favorable safety profile based on current clinical and real-world experience in more than 5,300 patients.
Exjade/Jadenu (USD 134 million, -17%, -18% cc) declined across all regions due to pressure from generic competition.
Adakveo (USD 42 million, +20%, +20% cc) launch continued to progress in the US, with nearly all high-volume accounts purchasing Adakveo. The product is now approved in 46 countries, and reimbursement discussions are underway.
9
SOLID TUMORS
Tafinlar + Mekinist (USD 417 million, +5%, +4% cc) saw continued demand increases in BRAF+ adjuvant melanoma and NSCLC, while maintaining demand in the highly competitive metastatic melanoma market. Tafinlar + Mekinist remains the metastatic melanoma targeted therapy market leader, with currently more than 200,000 patients treated worldwide.
Sandostatin (USD 351 million, -3%, -4% cc) declined mainly in Europe due to ongoing competitive pressure, including generics impact.
Afinitor/Votubia (USD 246 million, -6%, -6% cc) declined due to generic competition in most regions. In the US, generic competition for the 10mg and disperse formulation is expected to enter in Q4 2021.
Kisqali (USD 232 million, +27%, +27% cc) continued to see growth across all regions. With new MONALEESA-2 data released at ESMO, Kisqali has demonstrated the longest median overall survival (OS) ever reported in advanced breast cancer (aBC). Kisqali is the only CDK4/6 inhibitor with statistically significant OS proven across three Ph3 trials, including in the largest patient population, first-line postmenopausal HR+/HER2- aBC. Novartis is in US ANDA litigation with generic manufacturers.
Votrient (USD 142 million, -11%, -12% cc) declined due to increased competition in Europe, US and Japan.
Lutathera (USD 120 million, +1%, +1% cc) was broadly in line with prior year, with approximately 450 centers now actively treating patients globally. Sales from all AAA brands (including Lutathera and radiopharmaceutical diagnostic products) were USD 179 million.
Piqray (USD 82 million, -1%, -1% cc) was broadly in line with prior year, as launches in Europe and Emerging Growth Markets were offset by declining sales in the US. Piqray is the first and only therapy specifically developed for the approximately 40% of HR+/HER2- advanced breast cancer patients who have a PIK3CA mutation, which is associated with poor prognosis. Piqray is approved in more than 60 countries, including the US and EU member states.
Tabrecta (USD 24 million) continued to gain traction in the US with prescribing across all major lung cancer centers and remains the leading treatment for metastatic NSCLC patients tested for MET exon 14 (METex14), based on its robust first-line efficacy data. In July, the US FDA approved a liquid biopsy companion diagnostic, making Tabrecta the first and only treatment for METex14 with approved tests using tissue and blood. Tabrecta is now approved in seven countries.
PHARMACEUTICAL BUSINESS UNIT
Immunology, Hepatology and Dermatology
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Immunology, Hepatology and Dermatology | ||||||||
| Cosentyx | 1 247 | 1 012 | 23 | 22 | 3 475 | 2 886 | 20 | 18 |
| Ilaris | 272 | 220 | 24 | 24 | 775 | 633 | 22 | 22 |
| Total Immunology, Hepatology and Dermatology | 1 519 | 1 232 | 23 | 22 | 4 250 | 3 519 | 21 | 19 |
| Xolair sales for all indications are reported in the Respiratory and Allergy<br> franchise |
Cosentyx (USD 1.2 billion, +23%, +22% cc) saw strong growth driven by sustained underlying demand across indications in the US and Europe and strong volume growth in China following National Reimbursement Drug List (NRDL) listing in Q1 2021. During the quarter, Cosentyx received approval from the China NMPA for moderate to severe plaque psoriasis in pediatric patients, and the FDA granted two Priority Reviews for the treatment of enthesitis-related arthritis and the treatment of juvenile psoriatic arthritis (JPsA). Read-outs from INVIGORATE 2 study in PsA demonstrated the short term efficacy and safety of Cosentyx using an IV dosing regimen. A proof-of-concept phase 2 study (TitAIN) data supports the further development of Cosentyx as a potential treatment in Giant Cell Arteritis.
Ilaris (USD 272 million, +24%, +24% cc) strong sales were driven by continued double-digit growth across all regions. Contributors to continuing growth include launch of adult-onset Still’s disease, the other adult rheumatology indications in the US and Periodic Fever Syndromes (PFS) indications in Europe.
10
Neuroscience
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Neuroscience | ||||||||
| Gilenya | 703 | 733 | -4 | -5 | 2 131 | 2 243 | -5 | -7 |
| Zolgensma | 375 | 291 | 29 | 28 | 1 009 | 666 | 52 | 49 |
| Kesimpta | 109 | 1 | nm | nm | 225 | 1 | nm | nm |
| Mayzent | 76 | 49 | 55 | 55 | 200 | 113 | 77 | 74 |
| Aimovig | 56 | 39 | 44 | 45 | 156 | 108 | 44 | 37 |
| Other | 11 | 12 | -8 | -15 | 34 | 39 | -13 | -13 |
| Total Neuroscience | 1 330 | 1 125 | 18 | 18 | 3 755 | 3 170 | 18 | 16 |
| nm = not meaningful |
Gilenya (USD 703 million, -4%, -5% cc) sales declined due to increased competition. Novartis is in US patent litigation with manufacturers of generic and other tablet forms of Gilenya. In August 2020, the US District Court in Delaware issued a favorable decision finding the dosage regimen patent valid and infringed; this decision has been appealed.
Zolgensma (USD 375 million, +29%, +28% cc) had a strong third quarter with growth driven by expanding access in Europe and emerging markets, combined with steady US sales. Zolgensma is approved in 41 countries.
Kesimpta (USD 109 million) sales were driven by launch uptake, strong access and increased demand. To initiate access, Kesimpta is being provided free of charge for US patients who are eligible for reimbursement until they are covered by their insurance. The share of Novartis free goods is decreasing as reimbursement progresses. Kesimpta is now approved in 54 countries.
Mayzent (USD 76 million, +55%, +55% cc) continued to grow, driven by fulfilling an important unmet need in MS patients showing signs of progression despite being on other treatments. Mayzent is the first and only oral disease modifying therapy (DMT) studied and proven to delay disease progression in a broad SPMS patient population. Mayzent is now approved in 62 countries.
Aimovig (USD 56 million, ex-US, ex-Japan +44%, +45% cc). Novartis and Amgen agreed in June to transfer US business operations for Aimovig to Amgen. Novartis retains the exclusive rights to commercialize Aimovig in the rest of the world with the exception of Japan. During the ongoing litigation between the companies the collaboration continues and will remain in force until a final court decision. Aimovig has been prescribed to over 600,000 patients worldwide in the post-trial setting.
Ophthalmology
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Ophthalmology | ||||||||
| Lucentis | 556 | 515 | 8 | 6 | 1 652 | 1 403 | 18 | 12 |
| Xiidra | 108 | 99 | 9 | 10 | 334 | 268 | 25 | 25 |
| Beovu | 49 | 51 | -4 | -3 | 135 | 153 | -12 | -13 |
| Other | 358 | 487 | -26 | -28 | 1 155 | 1 461 | -21 | -24 |
| Total Ophthalmology | 1 071 | 1 152 | -7 | -8 | 3 276 | 3 285 | 0 | -4 |
Lucentis (USD 556 million, +8%, +6% cc) sales grew versus prior year in Emerging Growth Markets and Europe, driven by solid commercial execution and strong growth in China following NRDL listing in Q4 2019.
Xiidra (USD 108 million, +9%, +10% cc) showed double-digit growth, benefiting from increased brand awareness among diagnosed patients suffering from signs and symptoms of dry eye disease and a lower prior year base. Novartis is in US ANDA litigation with generic manufacturers.
Beovu (USD 49 million, -4%, -3% cc) sales declined in the US partly offset by growth in other markets versus prior year following continued geographic expansion. Launch roll-out continues, with approval now in 72 countries.
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Other ophthalmology products declined mainly due to generic impacts in the US, primarily for Ciprodex and Travatan.
Cardiovascular, Renal and Metabolism
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Cardiovascular, Renal and Metabolism | ||||||||
| Entresto | 924 | 632 | 46 | 44 | 2 599 | 1 781 | 46 | 41 |
| Leqvio | 5 | nm | nm | 8 | nm | nm | ||
| Other | 1 | nm | nm | |||||
| Total Cardiovascular, Renal and Metabolism | 929 | 632 | 47 | 45 | 2 607 | 1 782 | 46 | 42 |
| nm = not meaningful |
Entresto (USD 924 million, +46%, +44% cc) sustained strong growth with increased patient share across markets, driven by demand as the essential first choice therapy for HF patients (with reduced ejection fraction). Sales in the US continue to benefit from the FDA approval in February of an expanded indication in patients with left ventricular ejection fraction (LVEF) below normal, making Entresto the first therapy indicated for HFrEF and the majority of HFpEF patients. The European Society of Cardiology HF guidelines and the American College of Cardiology Expert Consensus Decision Pathway recommend Entresto as first line HF therapy. During the quarter, Entresto was also approved for the treatment of hypertension in Japan.
Leqvio (USD 5 million) is now approved in more than 45 countries, with most awaiting reimbursement. Leqvio is approved for the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet and statin therapy. In the UK, Novartis has launched in September a world-first collaboration with NHS England to address elevated LDL-C in eligible patients with ASCVD. Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals. After US resubmission in early July, Leqvio has a PDUFA date of January 1, 2022.
Respiratory AND ALLERGY
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Respiratory and Allergy | ||||||||
| Xolair | 365 | 320 | 14 | 13 | 1 055 | 916 | 15 | 10 |
| Ultibro Group | 137 | 154 | -11 | -12 | 436 | 463 | -6 | -11 |
| Other | 15 | 6 | 150 | 100 | 36 | 16 | 125 | 100 |
| Total Respiratory and Allergy | 517 | 480 | 8 | 6 | 1 527 | 1 395 | 9 | 4 |
| Xolair sales for all indications are reported in the Respiratory and Allergy<br> franchise |
Xolair (USD 365 million, +14%, +13% cc) continued growth, mainly driven by the chronic spontaneous urticaria (CSU) and severe allergic asthma (SAA) indications. The indication of nasal polyps has been approved and currently launched in the US, Germany, Canada and several other countries. In April 2021 the FDA approved Xolair for self-injection, which was also launched in the US in Q2 2021. Novartis co-promotes Xolair with Genentech in the US and shares a portion of operating income, but we do not record any US sales.
Ultibro Group (USD 137 million, -11%, -12% cc) sales declined in Europe due to competition. Ultibro Group consists of Ultibro Breezhaler, Seebri Breezhaler and Onbrez Breezhaler.
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Established Medicines
| Q3 2021 | Q3 2020 | % change | % change | 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|---|---|---|---|
| USD m | USD m | USD | cc | USD m | USD m | USD | cc | |
| Established Medicines | ||||||||
| Galvus Group | 272 | 289 | -6 | -5 | 814 | 906 | -10 | -11 |
| Exforge Group | 203 | 237 | -14 | -16 | 704 | 733 | -4 | -8 |
| Diovan Group | 180 | 237 | -24 | -26 | 584 | 779 | -25 | -28 |
| Zortress/Certican | 105 | 107 | -2 | -2 | 321 | 340 | -6 | -8 |
| Neoral/Sandimmun(e) | 92 | 93 | -1 | -2 | 279 | 290 | -4 | -8 |
| Voltaren/Cataflam | 94 | 91 | 3 | 1 | 276 | 265 | 4 | 2 |
| Other | 412 | 464 | -11 | -12 | 1 283 | 1 422 | -10 | -13 |
| Total Established Medicines | 1 358 | 1 518 | -11 | -11 | 4 261 | 4 735 | -10 | -13 |
Galvus Group (USD 272 million, -6%, -5% cc) declined mainly in Europe and in Japan due to the co-promotion agreement.
Exforge Group (USD 203 million, -14%, -16% cc) declined mainly due to generic competition and the impact of Volume-Based Procurement in China.
Diovan Group (USD 180 million, -24%, -26% cc) declined mainly due to generic competition and the impact of Volume-Based Procurement in China.
Zortress/Certican (USD 105 million, -2%, -2% cc) declined mainly due to generic competition in the US.
Neoral/Sandimmun(e) (USD 92 million, -1%, -2% cc) declined in US, Europe and Japan mainly due to generic competition.
Voltaren/Cataflam (USD 94 million, +3%, +1% cc) grew mainly driven by APMA and LaCan.
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Sandoz
| Q3 2021<br> USD m | Q3 2020<br> USD m | % change<br> USD | % change<br> cc | 9M 2021<br> USD m | 9M 2020<br> USD m | % change<br> USD | % change<br> cc | |
|---|---|---|---|---|---|---|---|---|
| Net sales | 2 402 | 2 422 | -1 | -2 | 7 106 | 7 109 | 0 | -4 |
| Operating income | 440 | 395 | 11 | 9 | 1 214 | 671 | 81 | 75 |
| As % of net sales | 18.3 | 16.3 | 17.1 | 9.4 | ||||
| Core operating income | 571 | 658 | -13 | -15 | 1 536 | 1 806 | -15 | -18 |
| As % of net sales | 23.8 | 27.2 | 21.6 | 25.4 |
COVID-19 impacts
The Sandoz business is beginning to normalize from the impact of COVID-19. However, we continue to see an impact on parts of our business, particularly for the Retail Generics and third-party Anti-Infectives businesses.
Third quarter
Net sales
Sandoz net sales were USD 2.4 billion (-1%, -2% cc). Volume increased by 7 percentage points more than offset by a negative price effect of 9 percentage points. The sales decline was mainly due to the US (-20%). Ex-US sales grew (+5%, +3% cc).
Sales in Europe were USD 1.3 billion (+3%, +2% cc), in the US USD 440 million (-20%), in Asia / Africa / Australasia USD 400 million (+4%, +2% cc) and in Canada and Latin America USD 223 million (+16%, +12% cc). Ex-US sales growth was driven by Biopharmaceuticals and Retail Generics growing across most regions. Sales decline in the US was due to the Retail Generics business especially oral solids including partnership terminations, as well as Biopharmaceuticals impacted by higher off-contract sales in prior year.
Global sales of Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa) grew to USD 526 million (+6%, +5% cc), driven by continued growth ex-US.
Retail Generics sales were USD 1.8 billion (-2%, -3% cc). Total Anti-Infectives sales were USD 273 million (+3%, +2% cc).
Operating income
Operating income was USD 440 million (+11%, +9% cc), mainly driven by lower impairments partly offset by unfavorable gross margin. Operating income margin increased by 1.8 percentage points in constant currencies. Currency had a positive impact of 0.2 percentage point, resulting in a net increase of 2.0 percentage points to 18.3% of net sales.
Core adjustments were USD 131 million, including USD 55 million of amortization. Prior year core adjustments were USD 263 million. The change in core adjustments compared to prior year was driven mainly by lower impairments.
Core operating income was USD 571 million (-13%, -15% cc). The decrease was mainly due to unfavorable gross margin. Core operating income margin was 23.8% of net sales, decreasing 3.4 percentage points (-3.6 percentage points cc) compared to prior year. Core gross margin as a percentage of sales decreased by 2.7 percentage points (cc), due to unfavorable price effects, product and geographic mix, partly offset by ongoing productivity improvements. Gross margin was also impacted by the recall of Losartan due to quality issues at a third-party API supplier. Core R&D expenses as a percentage of net sales increased by 0.7 percentage point (cc). Core SG&A expenses did not impact the margin. Core Other Income and Expenses decreased the margin by 0.2 percentage point (cc).
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Nine months
Net sales
Sandoz net sales were USD 7.1 billion (0%, -4% cc). Volume increased by 5 percentage points from growth in Biopharmaceuticals partly offset by the impact of softer Retail Generics demand, with a weak cough and cold season. Volume growth was more than offset by a negative price effect of 9 percentage points mainly due to increasing competition and the impact of prior year off-contract sales in the US.
Sales in Europe were USD 3.9 billion (+1%, -4% cc), in the US USD 1.3 billion (-17%), in Asia / Africa / Australasia USD 1.2 billion (+14%, +10% cc) and in Canada and Latin America USD 656 million (+15%, +12% cc). Sales in Europe declined due to the impact of COVID-19 on the Retail Generics business. Sales decline in the US was due to the Retail Generics business, especially oral solids including partnership terminations, as well as Biopharmaceuticals impacted by higher off-contract sales in prior year.
Global sales of Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa) grew to USD 1.6 billion (+10%, +5% cc), driven by continued growth ex-US.
Retail Generics sales were USD 5.2 billion (-2%, -6% cc), declining due to the above-mentioned factors. Total Anti-Infectives sales were USD 793 million (-6%, -9% cc), impacted by softer retail demand and a weak cough and cold season.
Operating income
Operating income was USD 1.2 billion (+81%, +75% cc), mainly driven by lower legal settlements, lower impairments and lower amortization partly offset by unfavorable gross margin and lower sales. Operating income margin increased by 7.8 percentage points in constant currencies. Currency had a negative impact of 0.1 percentage point, resulting in a net increase of 7.7 percentage points to 17.1% of net sales.
Core adjustments were USD 322 million, including USD 175 million of amortization. Prior year core adjustments were USD 1.1 billion. The change in core adjustments compared to prior year was driven by lower legal settlements, lower impairments and lower amortization.
Core operating income was USD 1.5 billion (-15%, -18% cc), declining due to unfavorable gross margin and lower sales. Core operating income margin was 21.6% of net sales, decreasing 3.8 percentage points (-3.7 percentage points cc) versus prior year. Core gross margin as a percentage of sales decreased by 3.1 percentage points (cc), due to unfavorable price effects, product and geographic mix, partly offset by ongoing productivity improvements. Core R&D expenses as a percentage of net sales increased by 0.7 percentage point (cc) driven by biopharmaceutical pipeline investments. Core SG&A expenses increased by 0.2 percentage point (cc) mainly due to lower sales. Core Other Income and Expenses increased the margin by 0.3 percentage point (cc) driven by higher divestment income.
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Group Cash Flow and Balance Sheet
Cash Flow
Third quarter
Net cash flows from operating activities amounted to USD 4.9 billion, compared to USD 3.2 billion in the prior year quarter. This increase was driven by higher net income adjusted for non-cash items and other adjustments, including divestment gains, favorable changes in working capital and lower payments out of provisions, mainly due to legal matters in the prior year quarter.
Net cash flows used in investing activities from continuing operations amounted to USD 1.2 billion, compared to USD 2.0 billion in the prior year quarter.
The current year quarter cash outflows were driven by USD 0.7 billion net purchases of marketable securities, commodities and time deposits; USD 0.4 billion for purchases of property, plant and equipment; and USD 0.2 billion for purchases of intangible assets. These cash outflows were partly offset by cash inflows of USD 0.1 billion proceeds from the sale of property, plant and equipment and intangible assets.
In the prior year quarter, net cash flows used in investing activities from continuing operations of USD 2.0 billion were driven by USD 1.5 billion net purchases of marketable securities, commodities and time deposits. Cash outflows for acquisitions and divestments of businesses, net amounted to USD 0.1 billion. Net other cash outflows of USD 0.4 billion were driven by purchases of property, plant and equipment, intangible assets, financial assets and other non-current assets of USD 0.6 billion, partly offset by cash inflows of USD 0.2 billion proceeds mainly from the sale of financial assets and intangible assets.
Net cash outflows used in financing activities from continuing operations amounted to USD 1.5 billion, compared to net cash inflows of USD 1.9 billion in the prior year quarter.
The current year quarter cash outflows were driven by USD 1.2 billion net decrease in current financial debts and USD 0.3 billion for net treasury share transactions.
In the prior year quarter, net cash inflows from financing activities from continuing operations of USD 1.9 billion included cash inflows of USD 2.2 billion from the increase in non-current financial debts, mainly consisting of USD 2.1 billion from the issuance of a sustainability-linked bond denominated in euro (notional amount of EUR 1.85 billion); and cash inflows of USD 0.7 billion from the net increase in current financial debts. These cash inflows were partly offset by cash outflows of USD 0.9 billion for net treasury share transactions; and USD 0.1 billion net payments for lease liabilities.
Free cash flow amounted to USD 4.4 billion (+64%), compared to USD 2.7 billion in the prior year quarter. This increase was driven by higher operating income adjusted for non-cash items and other adjustments, favorable changes in working capital and lower payments out of provisions, mainly due to legal matters in the prior year quarter.
Nine months
Net cash flows from operating activities amounted to USD 11.2 billion, compared to USD 9.6 billion in the prior year period. This increase was mainly driven by higher net income adjusted for non-cash items and other adjustments, including divestment gains, favorable changes in working capital and lower payments out of provisions, mainly due to legal matters in the prior year period. This was partly offset by unfavorable hedging results.
Net cash flows used in investing activities from continuing operations amounted to USD 0.4 billion, compared to USD 12.5 billion in the prior year period.
The current year period cash outflows were driven by USD 1.1 billion for purchases of intangible assets (including USD 650 million upfront payment to in-license tislelizumab from BeiGene); USD 0.9 billion for purchases of property, plant and equipment; USD 0.2 billion for purchases of financial and other non-current assets; and USD 0.2 billion for acquisitions and divestments of businesses, net. These cash outflows were partly offset by USD 1.2 billion proceeds from the sale of intangible assets, financial assets and property, plant and equipment; and USD 0.8 billion net proceeds from the sale of marketable securities, commodities and time deposits.
In the prior year period, net cash outflows used in investing activities from continuing operations of USD 12.5 billion were driven by the USD 10.0 billion for the acquisitions and divestments of businesses, net (including the
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acquisition of The Medicines Company for USD 9.5 billion, net of cash acquired USD 0.1 billion, and the acquisition of Japanese business of Aspen Global Incorporated for USD 0.3 billion). Net purchases of marketable securities, commodities and time deposits amounted to USD 1.4 billion. Net other cash outflows of USD 1.1 billion were driven by purchases of property, plant and equipment, intangible assets, financial assets and other non-current assets of USD 1.8 billion, partly offset by cash inflows of USD 0.7 billion proceeds from the sale of financial assets (including the USD 0.2 billion proceeds from the sale of Alcon Inc. shares) and intangible assets.
Net cash outflows used in financing activities from continuing operations amounted to USD 13.0 billion, compared to net cash inflows of USD 0.8 billion in the prior year period.
The current year period cash outflows were driven by USD 7.4 billion for the dividend payment; USD 2.9 billion for net treasury share transactions; USD 1.2 billion net decrease in current financial debts; and USD 1.5 billion for the repayment of a bond denominated in euro (notional amount of EUR 1.25 billion) at maturity.
In the prior year period, net cash inflows from financing activities from continuing operations of USD 0.8 billion were driven by USD 7.1 billion from the increase in non-current financial debts, mainly consisting of USD 4.9 billion from issuance of bonds denominated in US dollars (notional amount of USD 5.0 billion) and USD 2.1 billion from the issuance of a sustainability-linked bond denominated in euro (notional amount of EUR 1.85 billion); and cash inflows of USD 3.2 billion from the net increase in current financial debts. These cash inflows were partly offset by cash outflows of USD 7.0 billion for the dividend payment; USD 2.0 billion for the repayment of two US dollar bonds at maturity; USD 0.2 billion net payments for lease liabilities; USD 0.2 billion for net treasury share transactions; and USD 0.1 billion for other financing cash outflows, net.
Free cash flow amounted to USD 10.3 billion (+23%), compared to USD 8.3 billion in the prior year period. This increase was mainly driven by higher operating income adjusted for non-cash items and other adjustments, higher divestment proceeds and lower payments out of provisions, mainly due to legal matters in the prior year period, partly offset by the USD 650 million upfront payment to in-license tislelizumab from BeiGene.
Balance sheet
Assets
Total non-current assets of USD 95.0 billion at September 30, 2021, decreased by USD 3.1 billion compared to December 31, 2020.
Intangible assets other than goodwill decreased by USD 2.9 billion as net additions (including the in-licensing of tislelizumab from BeiGene) were more than offset by amortization, unfavorable currency translation adjustments and impairments.
Property, plant and equipment decreased by USD 0.7 billion, as net additions were more than offset by depreciation, unfavorable currency translation adjustments and impairments.
Goodwill and investments in associated companies decreased by USD 0.4 billion and USD 0.3 billion, respectively, mainly due to unfavorable currency translation adjustments.
These decreases were partly offset by an increase in other non-current assets of USD 1.2 billion, driven by an increase in the prepaid benefit costs of USD 1.1 billion, resulting from actuarial gains primarily from the changes in discount rates used to calculate the defined benefit obligations and valuation impact on plan assets.
Right of use assets, deferred tax assets and financial assets were broadly in line with December 31, 2020.
Total current assets of USD 26.3 billion at September 30, 2021 decreased by USD 3.4 billion compared to December 31, 2020.
Cash and cash equivalents decreased by USD 2.4 billion and marketable securities, commodities, time deposits and derivative financial instruments decreased by USD 1.0 billion, mainly due to the dividend payment, the purchase of treasury shares, the repayment of the current portion of a non-current financial debt partly offset by the cash generated through operating activities.
Inventories decreased by USD 0.2 billion, offset by an increase in trade receivables of USD 0.2 billion, whereas income tax receivables and other current assets were broadly in line with December 31, 2020.
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Liabilities
Total non-current liabilities of USD 34.4 billion decreased by USD 3.7 billion compared to December 31, 2020.
Non-current financial debts decreased by USD 3.2 billion mainly due to the reclassification of USD 2.5 billion from non-current to current financial debts of two USD denominated bonds with notional amounts of USD 1.0 billion and USD 1.5 billion maturing in 2022, and favorable currency translation adjustments of USD 0.6 billion.
Provisions and other non-current liabilities decreased by USD 0.6 billion, mainly due to a USD 1.0 billion decrease in defined benefit plans resulting primarily from actuarial gains from the changes in discount rates used to calculate the defined benefit obligations and valuation impact on plan assets. This decrease was partly offset by an increase in deferred revenue and provisions for legal liabilities, amounting USD 0.2 billion each.
Non-current lease liabilities and deferred tax liabilities were broadly in line with December 31, 2020.
Total current liabilities of USD 29.9 billion decreased by USD 3.2 billion compared to December 31, 2020.
Provisions and other current liabilities decreased by USD 2.0 billion mainly due to the decrease of the treasury share repurchase obligation amounting to USD 1.8 billion.
Current financial debts and derivative financial instruments decreased by USD 0.4 billion mainly due to the repayment of a USD 1.5 billion bond denominated in euro (notional amount of EUR 1.25 billion) at maturity, repayments of current financial debts of USD 1.1 billion and favorable currency translation adjustments of USD 0.3 billion, partly offset by the reclassification of USD 2.6 billion from non-current to current financial debts.
Trade payables decreased by USD 0.7 billion, whereas current lease liabilities and current income tax liabilities were broadly in line with December 31, 2020.
Equity
The Group`s equity increased by USD 0.3 billion to USD 56.9 billion at September 30, 2021 compared to December 31, 2020.
This increase was mainly due to the net income of USD 7.7 billion, net actuarial gains of USD 1.8 billion, the decrease of the treasury share repurchase obligation of USD 1.8 billion, equity-based compensation of USD 0.5 billion and the net favorable fair value adjustments on financial instruments of USD 0.2 billion.
This was partially offset by the cash-dividend payment of USD 7.4 billion, purchase of treasury shares of USD 2.7 billion and unfavorable currency translation differences of USD 2.1 billion.
Net debt and debt/equity ratio
The Group’s liquidity amounted to USD 8.2 billion at September 30, 2021, compared to USD 11.6 billion at December 31, 2020. Total non-current and current financial debts, including derivatives, amounted to USD 32.4 billion at September 30, 2021, compared to USD 36.0 billion at December 31, 2020.
The debt/equity ratio decreased to 0.57:1 at September 30, 2021, compared to 0.64:1 at December 31, 2020. As of September 30, 2021 the net debt was USD 24.3 billion broadly in line with the USD 24.5 billion at December 31, 2020.
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Innovation Review
Benefiting from our continued focus on innovation, Novartis has one of the industry’s most innovative and inventive pipelines with more than 160 projects in clinical development.
Selected Innovative Medicines projects awaiting regulatory decisions
| Completed submissions | |||||
|---|---|---|---|---|---|
| Product | Indication | US | EU | Japan | News update |
| Cosentyx | Cosentyx 300mg auto-injector <br> and pre-filled syringe | Q4 2020 | Approved | Q3 2021 | |
| Cosentyx | Juvenile idiopathic arthritis | Q2 2021 | Q2 2021 | ||
| Leqvio | Hyperlipidemia | Q2 2021 | Approved | – FDA action date of January 1, 2022 | |
| Jakavi | Acute graft-versus-host <br> disease (GvHD) | Q1 2021 | Q1 2021 | – US filing by Incyte | |
| Chronic GvHD | Q1 2021 | Q1 2021 | – US filing by Incyte | ||
| ABL001 (asciminib) | 3L Chronic myeloid leukemia | Q2 2021 | Q2 2021 | Q3 2021 | – FDA priority review granted |
| Beovu | Diabetic macular edema | Q3 2021 | Q3 2021 | Q3 2021 | |
| ^177^Lu-PSMA-617 | Metastatic castration-resistant<br> prostate cancer, post-taxane | Q3 2021 | – FDA priority review granted | ||
| VDT482 <br>(tislelizumab) | 2L Esophageal cancer (ESCC) | Q3 2021 | – BLA submitted by BeiGene to FDA | ||
| Kymriah | Relapsed/refractory follicular <br> lymphoma | Q3 2021 | Q3 2021 |
Selected Innovative Medicines pipeline projects
| Compound/<br>product | Potential indication/<br> Disease area | First planned<br> submissions | Current <br> Phase | News update |
|---|---|---|---|---|
| ABL001 <br>(asciminib) | 1L Chronic myeloid leukemia | ≥2025 | 3 | – Ph3 initiated |
| ACZ885 <br> (canakinumab) | Adjuvant NSCLC | 2023 | 3 | – Enrollment ongoing |
| 1L NSCLC | 3 | – Ph3 study did not meet primary endpoints | ||
| Aimovig | Migraine, pediatrics | ≥2025 | 3 | |
| AVXS-101 (OAV101) | Spinal muscular atrophy <br> (IT formulation) | ≥2025 | 3 | – Clinical hold lifted, pivotal confirmatory study<br> initiating |
| AVXS‑201 (OAV201) | Rett syndrome | 1 | – The totality of the pre-clinical data does not <br> support a path forward to human clinical trials. <br> Exploring other options for this indication | |
| Beovu | Retinal vein occlusion | 3 | – Indication removed following RAPTOR <br> and RAVEN study termination | |
| Diabetic retinopathy | ≥2025 | 3 | ||
| BYL719 (alpelisib) | PIK3CA-related overgrowth spectrum | H2 2021 | 2 | – Planned US filing based on RWE data <br> – EU Orphan Drug designation |
| Triple negative breast cancer | 2023 | 3 | ||
| Human epidermal growth factor <br> receptor 2-positive (HER2+) <br> advanced breast cancer | ≥2025 | 3 | ||
| Ovarian cancer | 2023 | 3 | ||
| CEE321 | Atopic dermatitis | ≥2025 | 1 | |
| CFZ533 (iscalimab) | Renal transplantation | 2 | – Lack of superiority vs standard of care,<br> project will be discontinued | |
| Liver transplantation | ≥2025 | 2 | ||
| Sjögren's syndrome | ≥2025 | 2 | ||
| Coartem | Malaria, uncomplicated (<5 kg patients) | 2024 | 3 | – Submission planned in Switzerland |
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| Compound/<br>product | Potential indication/<br> Disease area | First planned<br> submissions | Current <br> Phase | News update |
|---|---|---|---|---|
| Cosentyx | Ankylosing spondylitis head‑to‑head study <br> versus Sandoz biosimilar Hyrimoz <br> (adalimumab) | 2022 | 3 | |
| Hidradenitis suppurativa | 2022 | 3 | ||
| Giant cell arteritis | 2024 | 3 | – First interpretable results from the TiTAIN Ph2<br> study demonstrate sustained efficacy, sound <br> tolerability and favorable safety profile in adult<br> GCA subjects | |
| Lichen planus | ≥2025 | 2 | ||
| Lupus nephritis | ≥2025 | 3 | ||
| Psoriatic arthritis (IV formulation) | 2022 | 3 | ||
| Ankylosing spondylitis (IV formulation) | 2023 | 3 | ||
| CPK850 | Retinitis pigmentosa | ≥2025 | 2 | |
| CSJ117 | Asthma | ≥2025 | 2 | |
| JDQ443 | Non-small cell lung cancer, 2/3L | 2024 | 3 | – Ph3 to be initiated in H1 2022 |
| KAE609 <br> (cipargamin) | Malaria, uncomplicated | ≥2025 | 2 | |
| Malaria, severe | ≥2025 | 2 | ||
| KAF156 <br>(ganaplacide) | Malaria, uncomplicated | ≥2025 | 2 | – Ph2b study showed positive results<br> in children (<12 years old) with acute <br> uncomplicated malaria |
| Kisqali + <br>endocrine therapy | Hormone receptor-positive <br> (HR+)/human epidermal growth <br> factor receptor 2-negative (HER2-)<br> early breast cancer (adjuvant) | 2023 | 3 | |
| Kymriah | Relapsed/refractory aggressive <br> non-Hodgkin's lymphoma | 3 | – BELINDA study did not meet primary endpoint | |
| Leqvio | Secondary prevention of cardiovascular <br> events in patients with elevated levels of LDL-C | ≥2025 | 3 | |
| LJN452 <br>(tropifexor + <br>licogliflozin) | Nonalcoholic steatohepatitis | ≥2025 | 2 | |
| LMI070 (branaplam) | Huntington’s disease | ≥2025 | 1 | – FDA Orphan Drug designation |
| LNA043 | Osteoarthritis | ≥2025 | 2 | – FDA Fast Track designation granted |
| LNP023 (iptacopan) | Paroxysmal nocturnal hemoglobinuria | 2023 | 3 | – FDA, EU Orphan Drug designation<br> – FDA Breakthrough Therapy designation |
| IgA nephropathy | 2023 | 3 | – EU Orphan Drug designation | |
| C3 glomerulopathy | 2023 | 3 | – FDA, EU Orphan Drug designation <br> – EU PRIME designation <br> – FDA Rare Pediatric designation <br> – Positive final Ph2 results to be presented <br> at upcoming congress | |
| Membranous nephropathy | ≥2025 | 2 | ||
| Atypical haemolytic uraemic syndrome | ≥2025 | 3 | – Ph3 initiated | |
| LOU064 <br> (remibrutinib) | Chronic spontaneous urticaria | 2024 | 3 | – Ph2b data presented at EADV showed<br> rapid and effective disease control<br> in CSU patients |
| Multiple sclerosis | ≥2025 | 3 | – Ph3 to be initiated in H2 2021 | |
| Sjögren's syndrome | ≥2025 | 2 | ||
| Lutathera | Gastroenteropancreatic <br> neuroendocrine tumors, <br> 1st line in G2/3 tumors | 2023 | 3 | |
| ^177^Lu-PSMA-617 | Metastatic castration-resistant <br> prostate cancer pre-taxane | 2023 | 3 | |
| Metastatic hormone sensitive prostate cancer | 2024 | 3 | ||
| ^177^Lu-PSMA-R2 | Prostate cancer | 1 | – Project will be discontinued to prioritize <br> other key programs in portfolio | |
| ^177^Lu-NeoB | Multiple solid tumors | ≥2025 | 1 | |
| LXE408 | Visceral leishmaniasis | ≥2025 | 2 | |
| MBG453 <br> (sabatolimab) | Myelodysplastic syndrome | 2022/2023 | 3 | – FDA Fast Track designation <br> – EU Orphan Drug designation granted |
| Unfit acute myeloid leukemia | 2024 | 2 | ||
| MIJ821 | Depression | ≥2025 | 2 |
20
| Compound/<br>product | Potential indication/<br> Disease area | First planned<br> submissions | Current <br> Phase | News update |
|---|---|---|---|---|
| NIS793 | 1L Pancreatic cancer | ≥2025 | 3 | – FDA Orphan Drug designation granted |
| PDR001 <br>(spartalizumab) | Malignant melanoma (combo) | 2 | – Project will be discontinued to prioritize <br> other key programs in portfolio | |
| QBW251 <br>(icenticaftor) | Chronic obstructive pulmonary disease | ≥2025 | 2 | |
| QGE031 <br> (ligelizumab) | Chronic spontaneous urticaria | 2022 | 3 | – FDA Breakthrough Therapy designation |
| Chronic inducible urticaria | ≥2025 | 3 | – Ph3 to be initiated in H2 2021 | |
| Food allergy | ≥2025 | 3 | – Ph3 to be initiated in H2 2021 | |
| SAF312<br>(libvatrep) | Chronic ocular surface pain | ≥2025 | 2 | – Submission delay due to study recruitment <br> challenges |
| TQJ230 <br>(pelacarsen) | Secondary prevention of cardiovascular <br> events in patients with elevated levels <br> of lipoprotein(a) | ≥2025 | 3 | – Enrollment ongoing <br> – FDA Fast Track designation <br> – China Breakthrough Therapy designation |
| UNR844 | Presbyopia | 2024 | 2 | |
| VAY736 <br> (ianalumab) | Auto-immune hepatitis | ≥2025 | 2 | |
| Sjögren’s syndrome | ≥2025 | 2 | – FDA Fast Track designation | |
| VDT482 <br> (tislelizumab) | NSCLC | H1 2022 | 3 | – Evaluation of US BLA submission <br> options on-going |
| 1L Nasopharyngeal carcinoma | 2022 | 3 | ||
| 1L Gastric cancer | 2023 | 3 | ||
| 1L ESCC | 2023 | 3 | ||
| Localized ESCC | 2023 | 3 | ||
| 1L Hepatocellular carcinoma | 2023 | 3 | ||
| 1L Small cell lung cancer | 2024 | 3 | ||
| 1L Bladder urothelial cell carcinoma | 2024 | 3 | ||
| VPM087 <br>(gevokizumab) | Colorectal cancer, 1st line | ≥2025 | 1 | |
| Xolair | Food allergy | 2023 | 3 | |
| YTB323 | 2L r/r Diffuse large B-cell lymphoma | 2024 | 3 | – Ph3 to be initiated in H1 2022 |
Selected Sandoz approvals and pipeline projects
| Project/<br>Compound | Potential indication/ <br> Disease area | News update |
|---|---|---|
| GP2411 <br>(denosumab) | Osteoporosis (same as originator) | – In Ph3 |
| SOK583<br>(aflibercept) | Ophthalmology (same as originator) | – In Ph3 |
| Insulin glargine, <br>lispro, aspart | Diabetes | – Collaboration with Gan & Lee |
| Natalizumab | Multiple sclerosis and Crohn’s disease | – Collaboration Polpharma Biologics |
| Trastuzumab | HER2-positive cancer tumors | – Collaboration EirGenix |
| Bevacizumab | Solid tumors | – Bio-Thera Solutions |
21
Condensed Interim Consolidated Financial Statements
Consolidated income statements
Third quarter (unaudited)
| ( millions unless indicated otherwise) | Q3 2021 | Q3 2020 |
|---|---|---|
| Net sales to third parties | 13 030 | 12 259 |
| Other revenues | 337 | 279 |
| Cost of goods sold | -3 938 | -3 753 |
| Gross profit | 9 429 | 8 785 |
| Selling, general and administration | -3 618 | -3 419 |
| Research and development | -2 380 | -2 146 |
| Other income | 373 | 406 |
| Other expense | -571 | -1 214 |
| Operating income | 3 233 | 2 412 |
| Income from associated companies | 223 | 226 |
| Interest expense | -202 | -209 |
| Other financial income and expense | -24 | -19 |
| Income before taxes | 3 230 | 2 410 |
| Income taxes | -472 | -478 |
| Net income | 2 758 | 1 932 |
| Attributable to: | ||
| Shareholders of Novartis AG | 2 758 | 1 935 |
| Non-controlling interests | 0 | -3 |
| Weighted average number of shares outstanding – Basic (million) | 2 237 | 2 285 |
| Basic earnings per share () 1 | 1.23 | 0.85 |
| Weighted average number of shares outstanding – Diluted (million) | 2 254 | 2 302 |
| Diluted earnings per share () 1 | 1.22 | 0.84 |
| 1 Earnings per share (EPS) is calculated on the amount of net income attributable to<br> shareholders of Novartis AG. |
All values are in US Dollars.
22
Consolidated income statements
Nine months to September 30 (unaudited)
| ( millions unless indicated otherwise) | 9M 2021 | 9M 2020 |
|---|---|---|
| Net sales to third parties | 38 397 | 35 889 |
| Other revenues | 958 | 979 |
| Cost of goods sold | -11 891 | -10 904 |
| Gross profit | 27 464 | 25 964 |
| Selling, general and administration | -10 901 | -10 273 |
| Research and development | -7 131 | -6 647 |
| Other income | 1 481 | 1 099 |
| Other expense | -1 786 | -2 635 |
| Operating income | 9 127 | 7 508 |
| Income from associated companies | 718 | 532 |
| Interest expense | -605 | -668 |
| Other financial income and expense | -54 | -53 |
| Income before taxes | 9 186 | 7 319 |
| Income taxes | -1 474 | -1 347 |
| Net income | 7 712 | 5 972 |
| Attributable to: | ||
| Shareholders of Novartis AG | 7 713 | 5 978 |
| Non-controlling interests | -1 | -6 |
| Weighted average number of shares outstanding – Basic (million) | 2 244 | 2 282 |
| Basic earnings per share () 1 | 3.44 | 2.62 |
| Weighted average number of shares outstanding – Diluted (million) | 2 261 | 2 300 |
| Diluted earnings per share () 1 | 3.41 | 2.60 |
| 1 Earnings per share (EPS) is calculated on the amount of net income attributable to<br> shareholders of Novartis AG. |
All values are in US Dollars.
23
Consolidated statements of comprehensive income
Third quarter (unaudited)
| (USD millions) | Q3 2021 | Q3 2020 |
|---|---|---|
| Net income | 2 758 | 1 932 |
| Other comprehensive income to be eventually recycled into the consolidated income<br> statement: | ||
| Novartis share of other comprehensive income recognized by associated companies,<br> net of taxes | 114 | -44 |
| Net investment hedge | 55 | -97 |
| Currency translation effects | -513 | 1 111 |
| Total of items to eventually recycle | -344 | 970 |
| Other comprehensive income never to be recycled into the consolidated income statement: | ||
| Actuarial gains/(losses) from defined benefit plans, net of taxes | 129 | -189 |
| Fair value adjustments on equity securities, net of taxes | 16 | -53 |
| Total of items never to be recycled | 145 | -242 |
| Total comprehensive income | 2 559 | 2 660 |
| Attributable to: | ||
| Shareholders of Novartis AG | 2 559 | 2 663 |
| Non-controlling interests | 0 | -3 |
Nine months to September 30 (unaudited)
| (USD millions) | 9M 2021 | 9M 2020 |
|---|---|---|
| Net income | 7 712 | 5 972 |
| Other comprehensive income to be eventually recycled into the consolidated income<br> statement: | ||
| Novartis share of other comprehensive income recognized by associated companies,<br> net of taxes | 43 | -56 |
| Net investment hedge | 127 | -98 |
| Currency translation effects | -2 063 | 1 493 |
| Total of items to eventually recycle | -1 893 | 1 339 |
| Other comprehensive income never to be recycled into the consolidated income statement: | ||
| Actuarial gains/(losses) from defined benefit plans, net of taxes | 1 803 | -482 |
| Fair value adjustments on equity securities, net of taxes | 242 | 46 |
| Total of items never to be recycled | 2 045 | -436 |
| Total comprehensive income | 7 864 | 6 875 |
| Attributable to: | ||
| Shareholders of Novartis AG | 7 868 | 6 882 |
| Non-controlling interests | -4 | -7 |
24
Consolidated balance sheets
| (USD millions) | Note | Sep 30, <br> 2021<br> (unaudited) | Dec 31, <br> 2020<br> (audited)^1^ |
|---|---|---|---|
| Assets | |||
| Non-current assets | |||
| Property, plant and equipment | 10 | 11 602 | 12 263 |
| Right-of-use assets | 1 555 | 1 676 | |
| Goodwill | 10 | 29 572 | 29 999 |
| Intangible assets other than goodwill | 10 | 33 951 | 36 809 |
| Investments in associated companies | 9 337 | 9 632 | |
| Deferred tax assets | 3 802 | 3 933 | |
| Financial assets | 3 010 | 2 901 | |
| Other non-current assets | 2 127 | 892 | |
| Total non-current assets | 94 956 | 98 105 | |
| Current assets | |||
| Inventories | 6 885 | 7 131 | |
| Trade receivables | 8 377 | 8 217 | |
| Income tax receivables | 255 | 239 | |
| Marketable securities, commodities, time deposits and derivative financial instruments | 951 | 1 905 | |
| Cash and cash equivalents | 7 211 | 9 658 | |
| Other current assets | 2 574 | 2 523 | |
| Total current assets | 26 253 | 29 673 | |
| Total assets | 121 209 | 127 778 | |
| Equity and liabilities | |||
| Equity | |||
| Share capital | 901 | 913 | |
| Treasury shares | -47 | -53 | |
| Reserves | 55 917 | 55 738 | |
| Equity attributable to Novartis AG shareholders | 56 771 | 56 598 | |
| Non-controlling interests | 166 | 68 | |
| Total equity | 56 937 | 56 666 | |
| Liabilities | |||
| Non-current liabilities | |||
| Financial debts | 23 101 | 26 259 | |
| Lease liabilities | 1 614 | 1 719 | |
| Deferred tax liabilities | 3 349 | 3 141 | |
| Provisions and other non-current liabilities | 6 328 | 6 934 | |
| Total non-current liabilities | 34 392 | 38 053 | |
| Current liabilities | |||
| Trade payables | 4 665 | 5 403 | |
| Financial debts and derivative financial instruments | 9 337 | 9 785 | |
| Lease liabilities | 277 | 286 | |
| Current income tax liabilities | 2 463 | 2 458 | |
| Provisions and other current liabilities | 13 138 | 15 127 | |
| Total current liabilities | 29 880 | 33 059 | |
| Total liabilities | 64 272 | 71 112 | |
| Total equity and liabilities | 121 209 | 127 778 | |
| ^1^ The December 31, 2020 deferred tax assets and deferred tax liabilities balances have<br> been adjusted to conform with the 2021 presentation, see Note 4 for additional disclosures. |
25
Consolidated statements of changes in equity
Third quarter (unaudited)
| Reserves | ||||||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Note | Share<br> capital | Treasury<br> shares | Retained<br> earnings | Total value<br> adjustments | Issued share <br> capital and <br> reserves <br> attributable <br> to Novartis <br> shareholders | Non-<br> controlling<br> interests | Total<br> equity |
| Total equity at July 1, 2021 | 913 | -65 | 54 400 | -1 206 | 54 042 | 86 | 54 128 | |
| Net income | 2 758 | 2 758 | 2 758 | |||||
| Other comprehensive income | 114 | -313 | -199 | -199 | ||||
| Total comprehensive income | 2 872 | -313 | 2 559 | 2 559 | ||||
| Purchase of treasury shares | 0 | -9 | -9 | -9 | ||||
| Reduction of share capital | -12 | 18 | -6 | |||||
| Equity-based compensation | 0 | 161 | 161 | 161 | ||||
| Transaction costs, net of taxes | 5.2 | 10 | 10 | 10 | ||||
| Changes in non-controlling interests | -1 | -1 | ||||||
| Fair value adjustments on financial assets sold | 1 | -1 | ||||||
| Impact of change in ownership of consolidated entities | -2 | 0 | -2 | 81 | 79 | |||
| Other movements | 5.3 | 10 | 10 | 10 | ||||
| Total of other equity movements | -12 | 18 | 165 | -1 | 170 | 80 | 250 | |
| Total equity at September 30, 2021 | 901 | -47 | 57 437 | -1 520 | 56 771 | 166 | 56 937 | |
| Reserves | ||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (USD millions) | Note | Share<br> capital | Treasury<br> shares | Retained<br> earnings | Total value<br> adjustments | Issued share <br> capital and <br> reserves <br> attributable <br> to Novartis <br> shareholders | Non-<br> controlling<br> interests | Total<br> equity |
| Total equity at July 1, 2020 | 913 | -37 | 57 495 | -4 559 | 53 812 | 73 | 53 885 | |
| Net income | 1 935 | 1 935 | -3 | 1 932 | ||||
| Other comprehensive income | -44 | 772 | 728 | 0 | 728 | |||
| Total comprehensive income | 1 891 | 772 | 2 663 | -3 | 2 660 | |||
| Purchase of treasury shares | -8 | -1 302 | -1 310 | -1 310 | ||||
| Exercise of options and employee transactions | -17 | -17 | -17 | |||||
| Equity-based compensation | 1 | 187 | 188 | 188 | ||||
| Taxes on treasury share transactions | 1 | 1 | 1 | |||||
| Increase of treasury share repurchase obligation <br>under a share buyback trading plan | 5.1 | -857 | -857 | -857 | ||||
| Fair value adjustments on financial assets sold | 1 | -1 | ||||||
| Other movements | 5.3 | 4 | 4 | 4 | ||||
| Total of other equity movements | -7 | -1 983 | -1 | -1 991 | -1 991 | |||
| Total equity at September 30, 2020 | 913 | -44 | 57 403 | -3 788 | 54 484 | 70 | 54 554 |
26
Consolidated statements of changes in equity
Nine months to September 30 (unaudited)
| Reserves | ||||||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Note | Share<br> capital | Treasury<br> shares | Retained<br> earnings | Total value<br> adjustments | Issued share <br> capital and <br> reserves <br> attributable <br> to Novartis <br> shareholders | Non-<br> controlling<br> interests | Total<br> equity |
| Total equity at January 1, 2021 | 913 | -53 | 57 157 | -1 419 | 56 598 | 68 | 56 666 | |
| Net income | 7 713 | 7 713 | -1 | 7 712 | ||||
| Other comprehensive income | 43 | 112 | 155 | -3 | 152 | |||
| Total comprehensive income | 7 756 | 112 | 7 868 | -4 | 7 864 | |||
| Dividends | -7 368 | -7 368 | -7 368 | |||||
| Purchase of treasury shares | -17 | -2 678 | -2 695 | -2 695 | ||||
| Reduction of share capital | -12 | 18 | -6 | |||||
| Exercise of options and employee transactions | 0 | 39 | 39 | 39 | ||||
| Equity-based compensation | 5 | 493 | 498 | 498 | ||||
| Shares delivered to Alcon employees <br>as a result of the Alcon spin-off | 0 | 17 | 17 | 17 | ||||
| Decrease of treasury share repurchase obligation <br>under a share buyback trading plan | 5.1 | 1 769 | 1 769 | 1 769 | ||||
| Transaction costs, net of taxes | 5.2 | 10 | 10 | 10 | ||||
| Changes in non-controlling interests | -1 | -1 | ||||||
| Fair value adjustments on financial assets sold | 210 | -210 | ||||||
| Fair value adjustments related to divestments | 3 | -3 | ||||||
| Impact of change in ownership of consolidated entities | -2 | 0 | -2 | 103 | 101 | |||
| Other movements | 5.3 | 37 | 37 | 37 | ||||
| Total of other equity movements | -12 | 6 | -7 476 | -213 | -7 695 | 102 | -7 593 | |
| Total equity at September 30, 2021 | 901 | -47 | 57 437 | -1 520 | 56 771 | 166 | 56 937 | |
| Reserves | ||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (USD millions) | Note | Share<br> capital | Treasury<br> shares | Retained<br> earnings | Total value<br> adjustments | Issued share <br> capital and <br> reserves <br> attributable <br> to Novartis <br> shareholders | Non-<br> controlling<br> interests | Total<br> equity |
| Total equity at January 1, 2020 | 936 | -80 | 59 275 | -4 657 | 55 474 | 77 | 55 551 | |
| Net income | 5 978 | 5 978 | -6 | 5 972 | ||||
| Other comprehensive income | -56 | 960 | 904 | -1 | 903 | |||
| Total comprehensive income | 5 922 | 960 | 6 882 | -7 | 6 875 | |||
| Dividends | -6 987 | -6 987 | -6 987 | |||||
| Purchase of treasury shares | -9 | -1 451 | -1 460 | -1 460 | ||||
| Reduction of share capital | -23 | 31 | -8 | |||||
| Exercise of options and employee transactions | 8 | 798 | 806 | 806 | ||||
| Equity-based compensation | 6 | 547 | 553 | 553 | ||||
| Shares delivered to Alcon employees <br>as a result of the Alcon spin-off | 0 | 29 | 29 | 29 | ||||
| Taxes on treasury share transactions | 31 | 31 | 31 | |||||
| Increase of treasury share repurchase obligation <br>under a share buyback trading plan | 5.1 | -857 | -857 | -857 | ||||
| Fair value adjustments on financial assets sold | 91 | -91 | ||||||
| Other movements | 5.3 | 13 | 13 | 13 | ||||
| Total of other equity movements | -23 | 36 | -7 794 | -91 | -7 872 | -7 872 | ||
| Total equity at September 30, 2020 | 913 | -44 | 57 403 | -3 788 | 54 484 | 70 | 54 554 |
27
Consolidated statements of cash flows
Third quarter (unaudited)
| (USD millions) | Note | Q3 2021 | Q3 2020 |
|---|---|---|---|
| Net income | 2 758 | 1 932 | |
| Adjustments to reconcile net income to net cash flows from operating activities | |||
| Reversal of non-cash items and other adjustments | 7.1 | 2 376 | 2 682 |
| Interest received | 2 | 5 | |
| Interest paid | -157 | -161 | |
| Other financial receipts | 27 | ||
| Other financial payments | 6 | -9 | |
| Income taxes paid | 7.2 | -315 | -316 |
| Net cash flows from operating activities before working capital <br>and provision changes | 4 670 | 4 160 | |
| Payments out of provisions and other net cash movements in non-current liabilities | -154 | -968 | |
| Change in net current assets and other operating cash flow items | 409 | -36 | |
| Net cash flows from operating activities | 4 925 | 3 156 | |
| Purchases of property, plant and equipment | -351 | -279 | |
| Proceeds from sale of property, plant and equipment | 81 | 2 | |
| Purchases of intangible assets | -188 | -348 | |
| Proceeds from sale of intangible assets | 35 | 99 | |
| Purchases of financial assets | -46 | -35 | |
| Proceeds from sale of financial assets | -20 | 108 | |
| Purchases of other non-current assets | -14 | -6 | |
| Proceeds from sale of other non-current assets | 1 | 0 | |
| Acquisitions and divestments of interests in associated companies, net | -2 | -2 | |
| Acquisitions and divestments of businesses, net | 7.3 | -15 | -110 |
| Purchases of marketable securities, commodities and time deposits | -741 | -1 500 | |
| Proceeds from sale of marketable securities, commodities and time deposits | 22 | 46 | |
| Net cash flows used in investing activities from continuing operations | -1 238 | -2 025 | |
| Net cash flows from/used in investing activities from discontinued operations | 6 | -20 | |
| Net cash flows used in investing activities | -1 232 | -2 045 | |
| Acquisitions of treasury shares | -284 | -924 | |
| Increase in non-current financial debts | 2 181 | ||
| Change in current financial debts | -1 182 | 710 | |
| Payments of lease liabilities, net | -78 | -75 | |
| Impact of change in ownership of consolidated entities | -4 | ||
| Other financing cash flows, net | 0 | 19 | |
| Net cash flows used in/from financing activities from continuing operations | -1 548 | 1 911 | |
| Net cash flows from/used in financing activities from discontinued operations | 14 | -11 | |
| Net cash flows used in/from financing activities | -1 534 | 1 900 | |
| Net change in cash and cash equivalents before effect of exchange rate changes | 2 159 | 3 011 | |
| Effect of exchange rate changes on cash and cash equivalents | -65 | 66 | |
| Net change in cash and cash equivalents | 2 094 | 3 077 | |
| Cash and cash equivalents at July 1 | 5 117 | 5 917 | |
| Cash and cash equivalents at September 30 | 7 211 | 8 994 |
28
Consolidated statements of cash flows
Nine months to September 30 (unaudited)
| (USD millions) | Note | 9M 2021 | 9M 2020 |
|---|---|---|---|
| Net income | 7 712 | 5 972 | |
| Adjustments to reconcile net income to net cash flows from operating activities | |||
| Reversal of non-cash items and other adjustments | 7.1 | 6 642 | 7 884 |
| Dividends received from associated companies and others | 523 | 489 | |
| Interest received | 8 | 42 | |
| Interest paid | -458 | -482 | |
| Other financial receipts | 288 | ||
| Other financial payments | -316 | -28 | |
| Income taxes paid | 7.2 | -1 459 | -1 215 |
| Net cash flows from operating activities before working capital <br>and provision changes | 12 652 | 12 950 | |
| Payments out of provisions and other net cash movements in non-current liabilities | -530 | -1 792 | |
| Change in net current assets and other operating cash flow items | -935 | -1 513 | |
| Net cash flows from operating activities | 11 187 | 9 645 | |
| Purchases of property, plant and equipment | -918 | -754 | |
| Proceeds from sale of property, plant and equipment | 166 | 6 | |
| Purchases of intangible assets | -1 076 | -808 | |
| Proceeds from sale of intangible assets | 664 | 204 | |
| Purchases of financial assets | -124 | -125 | |
| Proceeds from sale of financial assets | 408 | 467 | |
| Purchases of other non-current assets | -56 | -54 | |
| Proceeds from sale of other non-current assets | 4 | 0 | |
| Acquisitions and divestments of interests in associated companies, net | -6 | -6 | |
| Acquisitions and divestments of businesses, net | 7.3 | -224 | -10 011 |
| Purchases of marketable securities, commodities and time deposits | -836 | -1 845 | |
| Proceeds from sale of marketable securities, commodities and time deposits | 1 643 | 440 | |
| Net cash flows used in investing activities from continuing operations | -355 | -12 486 | |
| Net cash flows used in investing activities from discontinued operations | -125 | ||
| Net cash flows used in investing activities | -355 | -12 611 | |
| Dividends paid to shareholders of Novartis AG | -7 368 | -6 987 | |
| Acquisitions of treasury shares | -2 909 | -1 074 | |
| Proceeds from exercised options and other treasury share transactions, net | 53 | 846 | |
| Increase in non-current financial debts | 7 126 | ||
| Repayments of non-current financial debts | -1 466 | -2 002 | |
| Change in current financial debts | -1 174 | 3 196 | |
| Payments of lease liabilities, net | -236 | -217 | |
| Impact of change in ownership of consolidated entities | -4 | ||
| Other financing cash flows, net | 91 | -123 | |
| Net cash flows used in/from financing activities from continuing operations | -13 013 | 765 | |
| Net cash flows used in financing activities from discontinued operations | -37 | ||
| Net cash flows used in/from financing activities | -13 013 | 728 | |
| Net change in cash and cash equivalents before effect of exchange rate changes | -2 181 | -2 238 | |
| Effect of exchange rate changes on cash and cash equivalents | -266 | 120 | |
| Net change in cash and cash equivalents | -2 447 | -2 118 | |
| Cash and cash equivalents at January 1 | 9 658 | 11 112 | |
| Cash and cash equivalents at September 30 | 7 211 | 8 994 |
29
Notes to the Condensed Interim Consolidated Financial Statements for the three-month and nine-month period ended September 30, 2021 (unaudited)
- Basis of preparation
These Condensed Interim Consolidated Financial Statements for the three-month and nine-month interim period ended September 30, 2021, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2020 Annual Report published on January 26, 2021.
- Selected critical accounting policies
The Group’s principal accounting policies are set out in Note 1 to the Consolidated Financial Statements in the 2020 Annual Report and conform with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board.
The preparation of financial statements requires management to make certain estimates and assumptions, either at the balance sheet date or during the year, which affect the reported amounts of revenues, expenses, assets, liabilities and contingent amounts.
Estimates are based on historical experience and other assumptions that are considered reasonable under the given circumstances and are continually monitored. Actual outcomes and results could differ from those estimates and assumptions. Revisions to estimates are recognized in the period in which the estimate is revised.
As disclosed in the 2020 Annual Report, goodwill, and acquired In-Process Research & Development projects are reviewed for impairment at least annually and these, as well as all other investments in intangible assets, are reviewed for impairment whenever an event or decision occurs that raises concern about their balance sheet carrying value. The amount of goodwill and other intangible assets on the Group’s consolidated balance sheet has risen significantly in recent years, primarily from acquisitions. Impairment testing may lead to potentially significant impairment charges in the future that could have a materially adverse impact on the Group’s results of operations and financial condition.
- Significant transactions
The Group applied the acquisition method of accounting for businesses acquired, and did not elect to apply the optional concentration test to account for acquired business as an asset separately acquired.
Significant transactions in 2021
There were no significant business acquisition transactions that closed in the nine months of 2021. For disclosure on significant research and development agreements, see Note 11.
Significant transaction entered into the first nine months of 2021 and closed in October 2021
Sandoz – acquisition of GSK’s cephalosporin antibiotics business
On February 10, 2021, Sandoz entered into an agreement with certain subsidiaries of GlaxoSmithKline plc (GSK) for the acquisition of GSK’s cephalosporin antibiotics business.
Under the agreement, Sandoz acquired the global rights to three established brands (Zinnat®, Zinacef® and Fortum®) in more than 100 markets. It excludes the rights in the US, Australia and Germany to certain of those
30
brands, which were previously divested by GSK, and the rights in India, Pakistan, Egypt, Japan (to certain of the brands) and China, which will be retained by GSK. The transaction closed on October 8, 2021.
The purchase price consists of a USD 350 million upfront payment paid at closing and potential milestone payments up to USD 150 million, which GSK will be eligible to receive upon the achievement of certain annual sales milestones for the portfolio.
The fair value of the total purchase consideration was USD 415 million. The amount consisted of a payment of USD 351 million and the fair value of contingent consideration of USD 64 million, which GSK is eligible to receive upon the achievement of specified milestones. The preliminary purchase price allocation resulted in net identifiable assets of USD 308 million, consisting of USD 292 million intangible assets and USD 16 million net deferred tax assets. Goodwill amounted to USD 107 million.
Significant transactions in 2020
Innovative Medicines – acquisition of The Medicines Company
On November 23, 2019, Novartis entered into an agreement and plan of merger (the Merger Agreement) with The Medicines Company, a US-based pharmaceutical company headquartered in Parsippany, New Jersey USA. Pursuant to the Merger Agreement, on December 5, 2019, Novartis, through a subsidiary, commenced a tender offer to acquire all outstanding shares of The Medicines Company for USD 85 per share, or a total consideration of approximately USD 9.6 billion in cash on a fully diluted basis, including the equivalent share value related to The Medicines Company’s convertible notes, in accordance with their terms. The tender offer expired on January 3, 2020, and on January 6, 2020, the acquiring subsidiary merged with and into The Medicines Company, resulting in The Medicines Company becoming an indirect wholly owned subsidiary of Novartis. Novartis financed the transaction through available cash, and short- and long-term borrowings.
The Medicines Company is focused on the development of inclisiran, a potentially first-in-class, twice yearly therapy that allows administration during patients’ routine visits to their healthcare professionals and will potentially contribute to improved patient adherence and sustained lower LDL-C levels.
The fair value of the total purchase consideration was USD 9.6 billion. The purchase price allocation resulted in net identifiable assets of approximately USD 7.1 billion, consisting of USD 8.5 billion intangible assets, USD 1.4 billion net deferred tax liabilities and goodwill of approximately USD 2.5 billion.
The 2020 results of operations since the date of acquisition were not material.
Sandoz – acquisition of the Japanese business of Aspen Global Incorporated
On November 11, 2019, Sandoz entered into an agreement for the acquisition of the Japanese business of Aspen Global Incorporated (AGI), a wholly owned subsidiary of Aspen Pharmacare Holdings Limited. Under the agreement, Sandoz acquired the shares in Aspen Japan K.K. and associated assets held by AGI. The transaction closed on January 31, 2020.
Aspen’s portfolio in Japan consists of off-patent medicines with a focus on anesthetics and specialty brands. The acquisition enabled Sandoz to expand its presence in the third-largest worldwide generics marketplace.
The purchase price consists of EUR 274 million (USD 303 million) upfront payment, less customary purchase price adjustment of EUR 27 million (USD 30 million), plus potential milestone payments of up to EUR 70 million (USD 77 million), which AGI is eligible to receive upon the achievement of specified milestones.
The fair value of the total purchase consideration was EUR 294 million (USD 324 million). The amount consisted of a cash payment of EUR 247 million (USD 273 million) and the fair value of contingent consideration of EUR 47 million (USD 51 million), which AGI is eligible to receive upon the achievement of specified milestones. The purchase price allocation resulted in net identifiable assets of USD 238 million, consisting of USD 196 million intangible assets, USD 26 million other net assets, and USD 16 million net deferred tax assets. Goodwill amounted to USD 86 million.
The 2020 results of operations since the date of acquisition were not material.
Sandoz – retention of US dermatology business and generic US oral solids portfolio, previously planned to be divested
On September 6, 2018, Novartis announced that it entered into a stock and asset purchase agreement (SAPA) with Aurobindo Pharma USA Inc. (Aurobindo) for the sale of selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, for USD 0.8 billion in cash and potential earnouts. The closing was conditional on obtaining regulatory approval.
In March 2020, Novartis took the decision to retain the Sandoz US generic oral solids and dermatology businesses and on April 2, 2020 entered into a mutual agreement with Aurobindo to terminate the transaction. The decision was taken as approval from the US Federal Trade Commission for the transaction was not obtained within the agreed timelines.
The cumulative amount of the depreciation on property, plant and equipment (USD 38 million) and amortization on intangible assets (USD 102 million), not recorded in the consolidated income statement since the date of classification as held for sale was recognized in the consolidated income statement in the first quarter of 2020. In addition, an impairment of currently marketed products of USD 42 million was recognized in the first quarter of 2020 consolidated income statement.
As at March 31, 2020, the assets and liabilities of the Sandoz US generic oral solids and dermatology businesses were reclassified out of assets and liabilities of disposal group held for sale. The prior year balance sheet is not required to be restated.
In 2020, there were no cumulative income or expenses included in other comprehensive income relating to the disposal group.
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- Deferred tax assets and liabilities
The December 31, 2020 presentation of deferred tax liabilities and deferred tax assets on the consolidated balance sheet has been adjusted. This adjustment was made to conform with the September 30, 2021 presentation to offset all deferred tax liabilities and deferred tax assets within the same tax jurisdiction and when a legally enforceable right to offset current tax assets against current tax liabilities exists.
In the December 31, 2020 consolidated balance sheet, deferred tax liabilities and deferred tax assets were presented on a gross basis and not fully netted as required for presentation in the consolidated balance sheet, because only a certain portion of deferred tax amounts were offset.
The correction resulted in a decrease in the previously reported December 31, 2020 deferred tax liabilities, total non-current liabilities, total liabilities and total equity and liabilities by USD 4.3 billion and a corresponding USD 4.3 billion decrease in deferred tax assets, total non-current assets, and total assets. The correction resulted only in the net presentation of these deferred tax amounts in the consolidated balance sheet and management concluded the item was not material to the previously issued Consolidated Financial Statements.
- Summary of equity attributable to Novartis AG shareholders
| Number of outstanding shares (in millions) | Issued share capital and reserves attributable to Novartis AG shareholders (in millions) | |||
|---|---|---|---|---|
| Note | 2021 | 2020 | 9M 2021 | |
| Balance at beginning of year | 2 256.8 | 2 265.0 | 56 598 | |
| Shares acquired to be canceled | -28.2 | -14.7 | -2 558 | |
| Other share purchases | -1.4 | -1.6 | -137 | |
| Exercise of options and employee transactions | 0.6 | 14.7 | 39 | |
| Equity-based compensation | 9.2 | 10.8 | 498 | |
| Shares delivered to Alcon employees as a result of the Alcon spin-off | 0.1 | 0.3 | 17 | |
| Taxes on treasury share transactions | ||||
| Decrease/(increase) of treasury share repurchase obligation <br>under a share buyback trading plan | 5.1 | 1 769 | ||
| Dividends | -7 368 | |||
| Net income of the period attributable to shareholders of Novartis AG | 7 713 | |||
| Other comprehensive income attributable to shareholders of Novartis AG | 155 | |||
| Transaction costs, net of taxes | 5.2 | 10 | ||
| Impact of change in ownership of consolidated entities | -2 | |||
| Other movements | 5.3 | 37 | ||
| Balance at September 30 | 2 237.1 | 2 274.5 | 56 771 |
All values are in US Dollars.
5.1. In June 2021, Novartis entered into an irrevocable, non-discretionary arrangement with a bank to repurchase Novartis shares to mitigate dilution related to participation plans of associates. Novartis was able to cancel this arrangement at any time but would have been subject to a 90-day waiting period.
This trading plan commitment was fully executed and expired in June 2021, and as a consequence, there is no contingent liability related to this plan recognized as of September 30, 2021.
In November 2020, Novartis entered into an irrevocable, non-discretionary arrangement with a bank to repurchase Novartis shares on the second trading line under its up-to USD 2.5 billion share buyback. Novartis was able to cancel this arrangement at any time but would have been subject to a 90-day waiting period. The commitment under this arrangement therefore reflected the obligated purchases by the bank under such trading plan over a rolling 90-day period, or if shorter, until the maturity date of such trading plan.
This trading plan commitment was fully executed and expired in March 2021, and as a consequence, there is no contingent liability related to this plan recognized as of September 30, 2021.
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5.2. In 2021, transaction costs, net of taxes included adjustments to provisions for transaction costs, net of taxes, directly attributable to the distribution (spin-off) of Alcon Inc. to Novartis AG shareholders. No transaction costs were recorded to equity in 2020.
5.3. Other movements included, for subsidiaries in hyperinflationary economies, the impact of the restatement of the non-monetary assets and liabilities with the general price index at the beginning of the period as well as the restatement of the equity balances of the current year.
- Financial instruments
Fair value by hierarchy
The following table illustrates the three hierarchical levels for valuing financial instruments at fair value as of September 30, 2021, and December 31, 2020. For additional information on the hierarchies and other matters, please refer to the Consolidated Financial Statements in the 2020 Annual Report, published on January 26, 2021.
| Level 1 | Level 2 | Level 3 | Total | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2021 | Dec 31, <br> 2020 |
| Marketable securities | ||||||||
| Debt securities | 24 | 26 | 24 | 26 | ||||
| Total marketable securities | 24 | 26 | 24 | 26 | ||||
| Derivative financial instruments | 52 | 159 | 52 | 159 | ||||
| Total marketable securities and derivative financial instruments | 76 | 185 | 76 | 185 | ||||
| Long-term financial investments | ||||||||
| Debt and equity securities | 1 117 | 1 153 | 498 | 460 | 1 615 | 1 613 | ||
| Fund investments | 29 | 30 | 362 | 336 | 391 | 366 | ||
| Contingent consideration receivables | 695 | 625 | 695 | 625 | ||||
| Total long-term financial investments | 1 146 | 1 183 | 1 555 | 1 421 | 2 701 | 2 604 | ||
| Associated companies at fair value through profit or loss | 221 | 211 | 221 | 211 | ||||
| Contingent consideration payables | -1 114 | -1 046 | -1 114 | -1 046 | ||||
| Other financial liabilities | -21 | -23 | -21 | -23 | ||||
| Derivative financial instruments | -86 | -194 | -86 | -194 | ||||
| Total financial liabilities at fair value | -86 | -194 | -1 135 | -1 069 | -1 221 | -1 263 |
During the nine-month period of 2021, there was a transfer of equity security from level 1 to level 3 of USD 29 million due to de-listing. During the third quarter of 2021, there were five non-significant transfers of equity securities from level 3 to level 1 totaling USD 67 million due to Initial Public Offerings.
The fair value of straight bonds amounted to USD 28.2 billion at September 30, 2021 (USD 31.4 billion at December 31, 2020) compared to the balance sheet value of USD 26.2 billion at September 30, 2021 (USD 28.3 billion at December 31, 2020). For all other financial assets and liabilities, the carrying amount is a reasonable approximation of the fair value. The carrying amount of financial assets included in the line total long-term financial investments of USD 2.7 billion at September 30, 2021 (USD 2.6 billion at December 31, 2020) is included in the line “Financial assets” of the consolidated balance sheets.
In the nine-month period of 2021, in accordance with the consolidated foundations’ Alcon Inc. share divestment plans, Alcon Inc. shares with a fair value of USD 9 million (2020: USD 331 million) were sold, or otherwise disposed of, and the USD 1 million gain on disposal (2020: USD 13 million gain on disposal) was transferred from other comprehensive income to retained earnings (Q3 2021: nil).
In the first quarter of 2021, Novartis repaid a USD 1.5 billion (nominal amount of EUR 1.25 billion) bond, at maturity in accordance with its terms.
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The Group’s exposure to financial risks has not changed significantly during the period and there have been no major changes to the risk management department or in any risk management policies.
Interest Rate Benchmark Reform - Phase 2, Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16 was effective as of January 1, 2021. These amendments address issues that might affect financial reporting when an existing interest rate benchmark (i.e. Interbank offered rate – IBOR) is replaced with an alternative benchmark interest rate. The effects of interest rate benchmark reform on the Group’s financial instruments and risk management strategies are not expected to have a material impact on the Group’s consolidated financial statements.
- Details to the consolidated statements of cash flows
7.1. Reversal of non-cash items and other adjustments
| (USD millions) | Q3 2021 | Q3 2020 |
|---|---|---|
| Depreciation, amortization and impairments on: | ||
| Property, plant and equipment | 316 | 705 |
| Right-of-use assets | 78 | 82 |
| Intangible assets | 1 059 | 947 |
| Financial assets^1^ | -8 | -139 |
| Change in provisions and other non-current liabilities | 380 | 498 |
| Gains on disposal and other adjustments on property, plant and equipment; intangible<br> assets; <br>financial assets; and other non-current assets, net | -97 | -93 |
| Equity-settled compensation expense | 173 | 202 |
| Income from associated companies | -223 | -226 |
| Income taxes | 472 | 478 |
| Net financial expense | 226 | 228 |
| Total | 2 376 | 2 682 |
| ^1^ Includes fair value adjustments | ||
| (USD millions) | 9M 2021 | 9M 2020 |
| --- | --- | --- |
| Depreciation, amortization and impairments on: | ||
| Property, plant and equipment | 1 049 | 1 405 |
| Right-of-use assets | 238 | 236 |
| Intangible assets | 3 307 | 3 206 |
| Financial assets^1^ | -50 | -266 |
| Change in provisions and other non-current liabilities | 796 | 1 336 |
| Gains on disposal and other adjustments on property, plant and equipment; intangible<br> assets; <br>financial assets; and other non-current assets, net | -654 | -148 |
| Equity-settled compensation expense | 541 | 579 |
| Income from associated companies | -718 | -532 |
| Income taxes | 1 474 | 1 347 |
| Net financial expense | 659 | 721 |
| Total | 6 642 | 7 884 |
| ^1^ Includes fair value adjustments |
7.2. Total amount of income taxes paid
During the nine-month period of 2021, the total amount of income taxes paid was USD 1 459 million (Q3 2021: USD 315 million), which was included within “Net cash flows from operating activities.”
During the nine-month period of 2020, the total amount of income taxes paid was USD 1 303 million (Q3 2020: USD 316 million), of which USD 1 215 million (Q3 2020: USD 316 million) was included within “Net cash flows from operating activities,” and USD 88 million (Q3 2020: nil) was included within “Net cash flows used in investing activities from discontinued operations.”
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7.3. Cash flows arising from acquisitions and divestments of businesses, net
The following table is a summary of the cash flow impact of acquisitions and divestments of businesses. The most significant transactions are described in Note 3.
| ( millions) | Q3 2020 | 9M 2021 | 9M 2020 |
|---|---|---|---|
| Net assets recognized as a result of acquisitions of businesses | -143 | -320 | -10 173 |
| Fair value of previously held equity interests | 6 | 42 | 6 |
| Contingent consideration payable, net | 21 | 0 | 98 |
| Payments, deferred consideration and other adjustments, net | -29 | 3 | 36 |
| Cash flows used for acquisitions of businesses | -145 | -275 | -10 033 |
| Cash flows from divestments of businesses, net 1 | 35 | 51 | 22 |
| Cash flows used for acquisitions and divestments of businesses, net | -110 | -224 | -10 011 |
| 1 In the first nine months of 2021 the 51 million (Q3 2021: 49 million) included<br> 37 million (Q3 2021: 35 million) net cash inflows from previous years divestments<br> and 14 million (Q3 2021: 14 million) net cash inflows from business divestments<br> in 2021, comprised of an intangible asset. | |||
| In the first nine months of 2020 the 22 million (Q3 2020: 35 million) included<br> 19 million (Q3 2020: 34 million) net cash inflows from previous years divestments<br> and 3 million (Q3 2020: 1 million) net cash inflows from business divestments<br> in 2020. The net identifiable assets of the 2020 divested businesses comprised property,<br> plant and equipment of 6 million. |
All values are in US Dollars.
Notes 3 and 8 provide further information regarding acquisitions and divestments of businesses. All acquisitions were for cash.
- Acquisition of businesses
Fair value of assets and liabilities arising from acquisitions of businesses:
| (USD millions) | 9M 2021 | 9M 2020 |
|---|---|---|
| Property, plant and equipment | 26 | |
| Right-of-use assets | 32 | |
| Currently marketed products | 196 | |
| Acquired research and development | 260 | 8 600 |
| Scientific infrastructure | 98 | |
| Other intangible assets | 218 | |
| Deferred tax assets | 12 | 476 |
| Non-current financial and other assets | 49 | |
| Inventories | 84 | |
| Trade receivables and financial and other current assets | 1 | 109 |
| Cash and cash equivalents | 10 | 76 |
| Deferred tax liabilities | -70 | -1 977 |
| Current and non-current financial debts | -1 | -32 |
| Current and non-current lease liabilities | -44 | |
| Trade payables and other liabilities | -3 | -144 |
| Net identifiable assets acquired | 307 | 7 669 |
| Acquired cash and cash equivalents | -10 | -76 |
| Non-controlling interests | -105 | |
| Goodwill | 128 | 2 580 |
| Net assets recognized as a result of acquisitions of businesses | 320 | 10 173 |
There were no significant acquisitions of businesses in the nine-month period of 2021.
Note 3 details the nine-month period of 2020 significant acquisitions of businesses, specifically, The Medicines Company and the Japanese business of AGI. The goodwill arising out of these acquisitions is attributable to buyer specific synergies, the assembled workforce, and the accounting for deferred tax liabilities on the acquired assets. In the nine-month period of 2021 no goodwill (2020: USD 73 million) was tax deductible.
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- Legal proceedings update
A number of Novartis companies are, and will likely continue to be, subject to various legal proceedings, including litigations, arbitrations and governmental investigations, that arise from time to time. Legal proceedings are inherently unpredictable. As a result, the Group may become subject to substantial liabilities that may not be covered by insurance and may in the future incur judgments or enter into settlements of claims that could have a material adverse effect on its results of operations or cash flow. Note 20 to the Consolidated Financial Statements in our 2020 Annual Report and 2020 Form 20-F contains a summary as of the date of these reports of significant legal proceedings to which Novartis or its subsidiaries were a party. The following is a summary as of October 25, 2021 of significant developments in those proceedings, as well as any new significant proceedings commenced since the date of the 2020 Annual Report and 2020 Form 20-F.
Investigations and related litigations
Government generic pricing antitrust investigations, antitrust class actions
Since 2016, Sandoz Inc. has received a grand jury subpoena and a civil investigative demand and interrogatories from the Antitrust and Civil Divisions of the US Department of Justice (DOJ) in connection with those agencies’ investigation into alleged price fixing and market allocation of generic drugs in the US market as well as alleged federal False Claims Act (FCA) violations. In 2020, Sandoz Inc. reached a resolution with the DOJ Antitrust Division, pursuant to which Sandoz Inc. agreed to pay USD 195 million and entered into a deferred prosecution agreement. The Sandoz resolution related to instances of misconduct at the company between 2013 and 2015 with regard to certain generic drugs sold in the United States. At the same time, Sandoz reached an agreement in principle with the DOJ Civil Division to resolve potential related damages claims arising out of the same conduct and products on behalf of US federal health programs under the FCA for USD 185 million and fully provisioned for this resolution. In 2021, Sandoz Inc. finalized the resolution with the DOJ Civil Division, which resolved those claims. In October 2021, Sandoz Inc. paid USD 185 million plus interest from the date of the agreement in principle to settle, and entered into a corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the US Department of Health and Human Services (HHS), under which Sandoz Inc. will implement additional controls. This resolution with the DOJ Civil Division resolves all federal government matters related to price fixing allegations and HHS will not seek to exclude Sandoz Inc. from specified federal healthcare programs.
Other investigations and cases relating to this matter are described in the “Investigations and related litigations - Government generic pricing antitrust investigations, antitrust class actions” entry in Note 20 to the 2020 Annual Report and 2020 Form 20-F.
340B Drug Pricing Program investigation
In February 2021, Novartis Pharmaceuticals Corporation (NPC) received a civil investigative subpoena from the Office of the Attorney General of the State of Vermont. The subpoena requests the production of documents and information concerning NPC’s participation in the 340B Drug Pricing Program in Vermont. NPC provided documents and information to the Office of the Attorney General. In May 2021, NPC received a notification from the US Health Resources and Services Administration (HRSA) which stated that HRSA believes NPC’s contract pharmacy policy violates the 340B statute and threatened potential enforcement action. NPC subsequently sued HRSA in the U.S. District Court for the District of Columbia to challenge HRSA’s determination and to enjoin HRSA from taking action with respect to NPC’s contract pharmacy policy. HRSA then referred the matter regarding NPC’s contract pharmacy policy to OIG, which could result in the imposition of civil monetary penalties on NPC. The U.S. District Court for the District of Columbia declined NPC’s request to enjoin HRSA’s referral of this matter to OIG as Novartis’ challenge should be heard before the process is completed.
Entresto matter
In September 2021, NPC received a Civil Investigative Demand (CID) from the DOJ seeking information from 2016 to the present regarding the marketing and pricing of Entresto, including remuneration provided to healthcare professionals. NPC is evaluating the CID.
Japan investigation
In 2015, a trial started against a former Novartis Pharma K.K. (NPKK) employee, and also against NPKK under the dual liability concept in Japanese law, over allegations brought by the Tokyo District Public Prosecutor Office for alleged manipulation of data in sub-analysis publications of the Kyoto Heart Study regarding valsartan. The charges against NPKK were subject to a maximum total fine of JPY 4 million. In 2018, the Tokyo High Court upheld a not-guilty ruling of the Tokyo District Court in 2017 for both the former NPKK employee and NPKK, and that ruling was appealed to the Supreme Court of Japan. In June 2021, the Supreme Court issued its decision dismissing the prosecutors’ appeal and upholding the Tokyo District Court’s not-guilty ruling. This matter is now concluded.
In addition to the matters described above, there have been other developments in the other legal matters described in Note 20 to the Consolidated Financial Statements contained in our 2020 Annual Report and 2020 Form 20-F.
Novartis believes that its total provisions for investigations, product liability, arbitration and other legal matters are adequate based upon currently available information. However, given the inherent difficulties in estimating liabilities, there can be no assurance that additional liabilities and costs will not be incurred beyond the amounts provided.
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- Segmentation of key figures
The businesses of Novartis are divided operationally on a worldwide basis into two identified reporting segments, Innovative Medicines and Sandoz. In addition, we separately report Corporate activities.
Reporting segments are presented in a manner consistent with the internal reporting to the chief operating decision maker which is the Executive Committee of Novartis. The reporting segments are managed separately because they each research, develop, manufacture, distribute and sell distinct products that require differing marketing strategies.
The Executive Committee of Novartis is responsible for allocating resources and assessing the performance of the reporting segments.
The reporting segments are as follows:
Innovative Medicines researches, develops, manufactures, distributes and sells patented prescription medicines. The Innovative Medicines Division is organized into two global business units: Novartis Oncology and Novartis Pharmaceuticals. Novartis Oncology consists of the global business franchises Hematology and Solid Tumor, and Novartis Pharmaceuticals consists of the global business franchises Immunology, Hepatology and Dermatology; Neuroscience; Ophthalmology; Cardiovascular, Renal and Metabolism; Respiratory and Allergy; and Established Medicines.
Sandoz develops, manufactures and markets finished dosage form medicines as well as intermediary products including active pharmaceutical ingredients. Sandoz is organized globally into three franchises: Retail Generics, Anti-Infectives and Biopharmaceuticals. In Retail Generics, Sandoz develops, manufactures and markets active ingredients and finished dosage forms of small molecule pharmaceuticals to third parties across a broad range of therapeutic areas, as well as finished dosage form of anti-infectives sold to third parties. In Anti-Infectives, Sandoz manufactures and supplies active pharmaceutical ingredients and intermediates, mainly antibiotics, for the Retail Generics business franchise and for sale to third-party companies. In Biopharmaceuticals, Sandoz develops, manufactures and markets protein- or other biotechnology-based products, including biosimilars, and provides biotechnology manufacturing services to other companies.
Corporate includes the costs of the Group headquarters and those of corporate coordination functions in major countries, and items that are not specific to one segment.
Our divisions are supported by Novartis Institutes for BioMedical Research, Global Drug Development, Novartis Technical Operations and Customer and Technology Solutions (formerly named Novartis Business Services).
Further details are provided in Note 3 to the Consolidated Financial Statements of the 2020 Annual Report.
Segmentation – Consolidated income statements
Third quarter
| Innovative Medicines | Sandoz | Corporate (including eliminations) | Group | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 |
| Net sales to third parties | 10 628 | 9 837 | 2 402 | 2 422 | 13 030 | 12 259 | ||
| Sales to other segments | 189 | 193 | 37 | 45 | -226 | -238 | ||
| Net sales | 10 817 | 10 030 | 2 439 | 2 467 | -226 | -238 | 13 030 | 12 259 |
| Other revenues | 307 | 265 | 26 | 10 | 4 | 4 | 337 | 279 |
| Cost of goods sold | -2 912 | -2 750 | -1 269 | -1 255 | 243 | 252 | -3 938 | -3 753 |
| Gross profit | 8 212 | 7 545 | 1 196 | 1 222 | 21 | 18 | 9 429 | 8 785 |
| Selling, general and administration | -3 006 | -2 825 | -480 | -488 | -132 | -106 | -3 618 | -3 419 |
| Research and development | -2 156 | -1 930 | -224 | -216 | -2 380 | -2 146 | ||
| Other income | 135 | 174 | 38 | 34 | 200 | 198 | 373 | 406 |
| Other expense | -384 | -966 | -90 | -157 | -97 | -91 | -571 | -1 214 |
| Operating income | 2 801 | 1 998 | 440 | 395 | -8 | 19 | 3 233 | 2 412 |
| as % of net sales | 26.4% | 20.3% | 18.3% | 16.3% | 24.8% | 19.7% | ||
| Income from associated companies | 1 | 1 | 222 | 225 | 223 | 226 | ||
| Interest expense | -202 | -209 | ||||||
| Other financial income and expense | -24 | -19 | ||||||
| Income before taxes | 3 230 | 2 410 | ||||||
| Income taxes | -472 | -478 | ||||||
| Net income | 2 758 | 1 932 |
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Nine months to September 30
| Innovative Medicines | Sandoz | Corporate (including eliminations) | Group | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 |
| Net sales to third parties | 31 291 | 28 780 | 7 106 | 7 109 | 38 397 | 35 889 | ||
| Sales to other segments | 611 | 602 | 138 | 137 | -749 | -739 | ||
| Net sales | 31 902 | 29 382 | 7 244 | 7 246 | -749 | -739 | 38 397 | 35 889 |
| Other revenues | 898 | 772 | 51 | 45 | 9 | 162 | 958 | 979 |
| Cost of goods sold | -8 878 | -7 830 | -3 806 | -3 869 | 793 | 795 | -11 891 | -10 904 |
| Gross profit | 23 922 | 22 324 | 3 489 | 3 422 | 53 | 218 | 27 464 | 25 964 |
| Selling, general and administration | -9 032 | -8 446 | -1 494 | -1 504 | -375 | -323 | -10 901 | -10 273 |
| Research and development | -6 472 | -6 036 | -659 | -611 | -7 131 | -6 647 | ||
| Other income | 963 | 500 | 183 | 83 | 335 | 516 | 1 481 | 1 099 |
| Other expense | -1 161 | -1 556 | -305 | -719 | -320 | -360 | -1 786 | -2 635 |
| Operating income | 8 220 | 6 786 | 1 214 | 671 | -307 | 51 | 9 127 | 7 508 |
| as % of net sales | 26.3% | 23.6% | 17.1% | 9.4% | 23.8% | 20.9% | ||
| Income from associated companies | 1 | 1 | 2 | 2 | 715 | 529 | 718 | 532 |
| Interest expense | -605 | -668 | ||||||
| Other financial income and expense | -54 | -53 | ||||||
| Income before taxes | 9 186 | 7 319 | ||||||
| Income taxes | -1 474 | -1 347 | ||||||
| Net income | 7 712 | 5 972 |
Segmentation – Additional consolidated balance sheets and income statements disclosure
| Innovative Medicines | Sandoz | Corporate (including eliminations) | Group | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2021 | Dec 31, <br> 2020 |
| Total assets | 79 826 | 83 112 | 16 211 | 16 825 | 25 172 | 27 841 | 121 209 | 127 778 |
| Total liabilities | -15 498 | -15 472 | -3 693 | -3 786 | -45 081 | -51 854 | -64 272 | -71 112 |
| Total equity | 56 937 | 56 666 | ||||||
| Net debt^1^ | 24 276 | 24 481 | 24 276 | 24 481 | ||||
| Net operating assets | 64 328 | 67 640 | 12 518 | 13 039 | 4 367 | 468 | 81 213 | 81 147 |
| Included in net operating assets are: | ||||||||
| Property, plant and equipment | 9 239 | 9 863 | 1 890 | 1 849 | 473 | 551 | 11 602 | 12 263 |
| Goodwill | 21 546 | 21 718 | 8 019 | 8 274 | 7 | 7 | 29 572 | 29 999 |
| Intangible assets other than goodwill | 32 443 | 35 121 | 1 322 | 1 543 | 186 | 145 | 33 951 | 36 809 |
| ^1^ See page 56 for additional disclosures related to net debt. |
The following tables show the property, plant and equipment impairment charges and reversals, and the intangible asset impairment charges:
Third quarter
| Innovative Medicines | Sandoz | Corporate | Group | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 |
| Property, plant and equipment <br>impairment charges | -6 | -283 | -24 | -105 | -30 | -388 | ||
| Property, plant and equipment <br>impairment reversal | 2 | 3 | 5 | 3 | 7 | |||
| Intangible assets <br>impairment charges | -74 | -68 | -18 | -48 | -1 | -93 | -116 |
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Nine months to September 30
| Sandoz | Corporate | Group | |||||
|---|---|---|---|---|---|---|---|
| ( millions) | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 |
| Property, plant and equipmentimpairment charges | -293 | -60 | -117 | -244 | -410 | ||
| Property, plant and equipment impairment reversal | 2 | 58 | 5 | 101 | 7 | ||
| Intangible assets impairment charges 1 | -577 | -19 | -90 | -1 | -382 | -667 | |
| 1 Nine months 2021 includes an impairment of 201 million in Innovative Medicines related to the write-down of IPR&D related to cessation<br> of clinical development program GTX312. | |||||||
| Nine months 2020 includes an impairment of 485 million in Innovative Medicines related to the write-down of IPR&D related to cessation<br> of clinical development program ZPL389 for atopic dermatitis. |
All values are in US Dollars.
In the third quarter and nine months of 2021, there were no reversals of prior-year impairment charges on intangible assets (Q3 and 9M 2020: nil).
Segmentation – Net sales by region^1^
Third quarter
| Q3 2021<br> USD m | Q3 2020<br> USD m | % change<br> USD | % change<br> cc^2^ | Q3 2021<br> % of total | Q3 2020<br> % of total | |
|---|---|---|---|---|---|---|
| Innovative Medicines | ||||||
| Europe | 3 724 | 3 455 | 8 | 7 | 35 | 35 |
| US | 3 802 | 3 632 | 5 | 5 | 36 | 37 |
| Asia/Africa/Australasia | 2 380 | 2 154 | 10 | 8 | 22 | 22 |
| Canada and Latin America | 722 | 596 | 21 | 20 | 7 | 6 |
| Total | 10 628 | 9 837 | 8 | 7 | 100 | 100 |
| Of which in Established Markets | 7 914 | 7 556 | 5 | 4 | 74 | 77 |
| Of which in Emerging Growth Markets | 2 714 | 2 281 | 19 | 17 | 26 | 23 |
| Sandoz | ||||||
| Europe | 1 339 | 1 298 | 3 | 2 | 56 | 54 |
| US | 440 | 547 | -20 | -20 | 18 | 23 |
| Asia/Africa/Australasia | 400 | 385 | 4 | 2 | 17 | 16 |
| Canada and Latin America | 223 | 192 | 16 | 12 | 9 | 7 |
| Total | 2 402 | 2 422 | -1 | -2 | 100 | 100 |
| Of which in Established Markets | 1 696 | 1 780 | -5 | -6 | 71 | 73 |
| Of which in Emerging Growth Markets | 706 | 642 | 10 | 9 | 29 | 27 |
| Group | ||||||
| Europe | 5 063 | 4 753 | 7 | 6 | 39 | 39 |
| US | 4 242 | 4 179 | 2 | 2 | 33 | 34 |
| Asia/Africa/Australasia | 2 780 | 2 539 | 9 | 7 | 21 | 21 |
| Canada and Latin America | 945 | 788 | 20 | 18 | 7 | 6 |
| Total | 13 030 | 12 259 | 6 | 5 | 100 | 100 |
| Of which in Established Markets | 9 610 | 9 336 | 3 | 2 | 74 | 76 |
| Of which in Emerging Growth Markets | 3 420 | 2 923 | 17 | 15 | 26 | 24 |
| ^1^ Net sales to third parties by location of customer. Emerging Growth Markets comprise<br> all markets other than the Established Markets of the US, Canada, Western Europe,<br> Japan, Australia and New Zealand. | ||||||
| ^2^ Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. |
39
Segmentation – Net sales by region^1^
Nine months to September 30
| 9M 2021<br> USD m | 9M 2020<br> USD m | % change<br> USD | % change<br> cc^2^ | 9M 2021<br> % of total | 9M 2020<br> % of total | |
|---|---|---|---|---|---|---|
| Innovative Medicines | ||||||
| Europe | 11 124 | 9 821 | 13 | 8 | 36 | 34 |
| US | 11 054 | 10 689 | 3 | 3 | 35 | 37 |
| Asia/Africa/Australasia | 7 058 | 6 455 | 9 | 5 | 23 | 22 |
| Canada and Latin America | 2 055 | 1 815 | 13 | 14 | 6 | 7 |
| Total | 31 291 | 28 780 | 9 | 6 | 100 | 100 |
| Of which in Established Markets | 23 377 | 21 822 | 7 | 4 | 75 | 76 |
| Of which in Emerging Growth Markets | 7 914 | 6 958 | 14 | 11 | 25 | 24 |
| Sandoz | ||||||
| Europe | 3 896 | 3 856 | 1 | -4 | 55 | 54 |
| US | 1 344 | 1 625 | -17 | -17 | 19 | 23 |
| Asia/Africa/Australasia | 1 210 | 1 060 | 14 | 10 | 17 | 15 |
| Canada and Latin America | 656 | 568 | 15 | 12 | 9 | 8 |
| Total | 7 106 | 7 109 | 0 | -4 | 100 | 100 |
| Of which in Established Markets | 5 081 | 5 246 | -3 | -8 | 72 | 74 |
| Of which in Emerging Growth Markets | 2 025 | 1 863 | 9 | 7 | 28 | 26 |
| Group | ||||||
| Europe | 15 020 | 13 677 | 10 | 4 | 39 | 38 |
| US | 12 398 | 12 314 | 1 | 1 | 32 | 34 |
| Asia/Africa/Australasia | 8 268 | 7 515 | 10 | 6 | 22 | 21 |
| Canada and Latin America | 2 711 | 2 383 | 14 | 13 | 7 | 7 |
| Total | 38 397 | 35 889 | 7 | 4 | 100 | 100 |
| Of which in Established Markets | 28 458 | 27 068 | 5 | 2 | 74 | 75 |
| Of which in Emerging Growth Markets | 9 939 | 8 821 | 13 | 11 | 26 | 25 |
| ^1^ Net sales to third parties by location of customer. Emerging Growth Markets comprise<br> all markets other than the Established Markets of the US, Canada, Western Europe,<br> Japan, Australia and New Zealand. | ||||||
| ^2^ Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. |
40
Segmentation – Net sales by business franchise
Innovative Medicines Division net sales by business franchise
Third quarter
| Q3 2021 | Q3 2020 | % change | % change | |
|---|---|---|---|---|
| USD m | USD m | USD | cc^1^ | |
| Hematology | ||||
| Tasigna | 514 | 478 | 8 | 7 |
| Promacta/Revolade | 522 | 442 | 18 | 18 |
| Jakavi | 426 | 335 | 27 | 26 |
| Gleevec/Glivec | 256 | 280 | -9 | -9 |
| Kymriah | 146 | 122 | 20 | 20 |
| Exjade/Jadenu | 134 | 162 | -17 | -18 |
| Adakveo | 42 | 35 | 20 | 20 |
| Other | 85 | 85 | 0 | -2 |
| Total Hematology | 2 125 | 1 939 | 10 | 9 |
| Solid Tumor | ||||
| Tafinlar + Mekinist | 417 | 397 | 5 | 4 |
| Sandostatin | 351 | 361 | -3 | -4 |
| Afinitor/Votubia | 246 | 262 | -6 | -6 |
| Kisqali | 232 | 183 | 27 | 27 |
| Votrient | 142 | 160 | -11 | -12 |
| Lutathera | 120 | 119 | 1 | 1 |
| Piqray | 82 | 83 | -1 | -1 |
| Tabrecta | 24 | 12 | 100 | 96 |
| Other | 165 | 182 | -9 | -11 |
| Total Solid Tumor | 1 779 | 1 759 | 1 | 1 |
| Total Novartis Oncology business unit | 3 904 | 3 698 | 6 | 5 |
| Immunology, Hepatology and Dermatology | ||||
| Cosentyx | 1 247 | 1 012 | 23 | 22 |
| Ilaris | 272 | 220 | 24 | 24 |
| Total Immunology, Hepatology and Dermatology | 1 519 | 1 232 | 23 | 22 |
| Neuroscience | ||||
| Gilenya | 703 | 733 | -4 | -5 |
| Zolgensma | 375 | 291 | 29 | 28 |
| Kesimpta | 109 | 1 | nm | nm |
| Mayzent | 76 | 49 | 55 | 55 |
| Aimovig | 56 | 39 | 44 | 45 |
| Other | 11 | 12 | -8 | -15 |
| Total Neuroscience | 1 330 | 1 125 | 18 | 18 |
| Ophthalmology | ||||
| Lucentis | 556 | 515 | 8 | 6 |
| Xiidra | 108 | 99 | 9 | 10 |
| Beovu | 49 | 51 | -4 | -3 |
| Other | 358 | 487 | -26 | -28 |
| Total Ophthalmology | 1 071 | 1 152 | -7 | -8 |
| Cardiovascular, Renal and Metabolism | ||||
| Entresto | 924 | 632 | 46 | 44 |
| Leqvio | 5 | nm | nm | |
| Total Cardiovascular, Renal and Metabolism | 929 | 632 | 47 | 45 |
| Respiratory and Allergy | ||||
| Xolair | 365 | 320 | 14 | 13 |
| Ultibro Group | 137 | 154 | -11 | -12 |
| Other | 15 | 6 | 150 | 100 |
| Total Respiratory and Allergy | 517 | 480 | 8 | 6 |
| Established Medicines | ||||
| Galvus Group | 272 | 289 | -6 | -5 |
| Exforge Group | 203 | 237 | -14 | -16 |
| Diovan Group | 180 | 237 | -24 | -26 |
| Zortress/Certican | 105 | 107 | -2 | -2 |
| Neoral/Sandimmun(e) | 92 | 93 | -1 | -2 |
| Voltaren/Cataflam | 94 | 91 | 3 | 1 |
| Other | 412 | 464 | -11 | -12 |
| Total Established Medicines | 1 358 | 1 518 | -11 | -11 |
| Total Novartis Pharmaceuticals business unit | 6 724 | 6 139 | 10 | 8 |
| Total division net sales | 10 628 | 9 837 | 8 | 7 |
| ^1^ Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. | ||||
| nm = not meaningful |
41
Innovative Medicines Division net sales by business franchise
Nine months to September 30
| 9M 2021 | 9M 2020 | % change | % change | |
|---|---|---|---|---|
| USD m | USD m | USD | cc^1^ | |
| Hematology | ||||
| Tasigna | 1 552 | 1 445 | 7 | 5 |
| Promacta/Revolade | 1 498 | 1 267 | 18 | 16 |
| Jakavi | 1 187 | 963 | 23 | 18 |
| Gleevec/Glivec | 791 | 897 | -12 | -15 |
| Kymriah | 444 | 333 | 33 | 30 |
| Exjade/Jadenu | 434 | 497 | -13 | -16 |
| Adakveo | 121 | 71 | 70 | 70 |
| Other | 264 | 234 | 13 | 9 |
| Total Hematology | 6 291 | 5 707 | 10 | 7 |
| Solid Tumor | ||||
| Tafinlar + Mekinist | 1 235 | 1 134 | 9 | 6 |
| Sandostatin | 1 068 | 1 076 | -1 | -2 |
| Afinitor/Votubia | 764 | 824 | -7 | -8 |
| Kisqali | 652 | 503 | 30 | 27 |
| Votrient | 438 | 488 | -10 | -12 |
| Lutathera | 360 | 336 | 7 | 5 |
| Piqray | 242 | 236 | 3 | 2 |
| Tabrecta | 63 | 18 | nm | nm |
| Other | 502 | 572 | -12 | -15 |
| Total Solid Tumor | 5 324 | 5 187 | 3 | 1 |
| Total Novartis Oncology business unit | 11 615 | 10 894 | 7 | 4 |
| Immunology, Hepatology and Dermatology | ||||
| Cosentyx | 3 475 | 2 886 | 20 | 18 |
| Ilaris | 775 | 633 | 22 | 22 |
| Total Immunology, Hepatology and Dermatology | 4 250 | 3 519 | 21 | 19 |
| Neuroscience | ||||
| Gilenya | 2 131 | 2 243 | -5 | -7 |
| Zolgensma | 1 009 | 666 | 52 | 49 |
| Kesimpta | 225 | 1 | nm | nm |
| Mayzent | 200 | 113 | 77 | 74 |
| Aimovig | 156 | 108 | 44 | 37 |
| Other | 34 | 39 | -13 | -13 |
| Total Neuroscience | 3 755 | 3 170 | 18 | 16 |
| Ophthalmology | ||||
| Lucentis | 1 652 | 1 403 | 18 | 12 |
| Xiidra | 334 | 268 | 25 | 25 |
| Beovu | 135 | 153 | -12 | -13 |
| Other | 1 155 | 1 461 | -21 | -24 |
| Total Ophthalmology | 3 276 | 3 285 | 0 | -4 |
| Cardiovascular, Renal and Metabolism | ||||
| Entresto | 2 599 | 1 781 | 46 | 41 |
| Leqvio | 8 | nm | nm | |
| Other | 1 | nm | nm | |
| Total Cardiovascular, Renal and Metabolism | 2 607 | 1 782 | 46 | 42 |
| Respiratory and Allergy | ||||
| Xolair | 1 055 | 916 | 15 | 10 |
| Ultibro Group | 436 | 463 | -6 | -11 |
| Other | 36 | 16 | 125 | 100 |
| Total Respiratory and Allergy | 1 527 | 1 395 | 9 | 4 |
| Established Medicines | ||||
| Galvus Group | 814 | 906 | -10 | -11 |
| Exforge Group | 704 | 733 | -4 | -8 |
| Diovan Group | 584 | 779 | -25 | -28 |
| Zortress/Certican | 321 | 340 | -6 | -8 |
| Neoral/Sandimmun(e) | 279 | 290 | -4 | -8 |
| Voltaren/Cataflam | 276 | 265 | 4 | 2 |
| Other | 1 283 | 1 422 | -10 | -13 |
| Total Established Medicines | 4 261 | 4 735 | -10 | -13 |
| Total Novartis Pharmaceuticals business unit | 19 676 | 17 886 | 10 | 7 |
| Total division net sales | 31 291 | 28 780 | 9 | 6 |
| ^1^ Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. | ||||
| nm = not meaningful |
42
Net sales of the top 20 Innovative Medicines Division products in 2021
Third quarter
| US | Rest of world | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brands | Business franchise | Key indication | USD m | % <br> change<br> USD/cc^2^ | USD m | % <br> change<br> USD | % <br> change<br> cc^2^ | USD m | % <br> change<br> USD | % <br> change<br> cc^2^ |
| Cosentyx | Immunology,<br> Hepatology and<br> Dermatology | Psoriasis, ankylosing <br> spondylitis, <br> psoriatic arthritis<br> and non-radiographic<br> axial spondyloarthritis | 753 | 18 | 494 | 33 | 30 | 1 247 | 23 | 22 |
| Entresto | Cardiovascular,<br> Renal and <br> Metabolism | Chronic heart failure | 405 | 29 | 519 | 63 | 59 | 924 | 46 | 44 |
| Gilenya | Neuroscience | Relapsing multiple sclerosis | 359 | -5 | 344 | -3 | -4 | 703 | -4 | -5 |
| Lucentis | Ophthalmology | Age-related <br> macular degeneration | 556 | 8 | 6 | 556 | 8 | 6 | ||
| Tasigna | Hematology | Chronic myeloid leukemia | 222 | 4 | 292 | 11 | 9 | 514 | 8 | 7 |
| Promacta/Revolade | Hematology | Immune <br> thrombocytopenia (ITP), <br> severe aplastic anemia (SAA) | 246 | 17 | 276 | 19 | 19 | 522 | 18 | 18 |
| Tafinlar + Mekinist | Solid Tumor | BRAF V600+ metastatic <br> and adjuvant melanoma; <br> advanced non-small cell <br> lung cancer (NSCLC) | 154 | 9 | 263 | 3 | 2 | 417 | 5 | 4 |
| Jakavi | Hematology | Myelofibrosis (MF), <br> polycythemia vera (PV) | 426 | 27 | 26 | 426 | 27 | 26 | ||
| Sandostatin | Solid Tumor | Carcinoid tumors<br> and acromegaly | 216 | 1 | 135 | -9 | -11 | 351 | -3 | -4 |
| Xolair^1^ | Respiratory and Allergy | Severe allergic asthma (SAA), <br> chronic spontaneous urticaria <br> (CSU) and nasal polyps | 365 | 14 | 13 | 365 | 14 | 13 | ||
| Zolgensma | Neuroscience | Spinal muscular atrophy<br> (SMA) | 126 | 3 | 249 | 47 | 48 | 375 | 29 | 28 |
| Galvus Group | Established Medicines | Type 2 diabetes | 272 | -6 | -5 | 272 | -6 | -5 | ||
| Gleevec/Glivec | Hematology | Chronic myeloid<br> leukemia and GIST | 63 | -11 | 193 | -8 | -9 | 256 | -9 | -9 |
| Ilaris | Immunology,<br> Hepatology and<br> Dermatology | Auto-inflammatory (CAPS,<br> TRAPS, HIDS/MKD, FMF,<br> SJIA, AOSD and gout) | 136 | 31 | 136 | 17 | 18 | 272 | 24 | 24 |
| Afinitor/Votubia | Solid Tumor | Breast cancer/TSC | 143 | -8 | 103 | -4 | -5 | 246 | -6 | -6 |
| Exforge Group | Established Medicines | Hypertension | 2 | -71 | 201 | -13 | -15 | 203 | -14 | -16 |
| Kisqali | Solid Tumor | HR+/HER2- <br> metastatic breast cancer | 87 | 5 | 145 | 45 | 45 | 232 | 27 | 27 |
| Diovan Group | Established Medicines | Hypertension | 9 | -73 | 171 | -16 | -18 | 180 | -24 | -26 |
| Kymriah | Hematology | r/r pediatric and young <br> adults ALL, DLBCL | 53 | 8 | 93 | 27 | 28 | 146 | 20 | 20 |
| Votrient | Solid Tumor | Renal cell carcinoma | 56 | -13 | 86 | -10 | -12 | 142 | -11 | -12 |
| Top 20 products total | 3 030 | 8 | 5 319 | 13 | 12 | 8 349 | 11 | 10 | ||
| Rest of portfolio | 772 | -7 | 1 507 | 1 | -1 | 2 279 | -2 | -3 | ||
| Total division sales | 3 802 | 5 | 6 826 | 10 | 9 | 10 628 | 8 | 7 | ||
| ^1^ Net sales reflect Xolair sales for all indications. | ||||||||||
| ^2^ Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. |
43
Net sales of the top 20 Innovative Medicines Division products in 2021
Nine months to September 30
| US | Rest of world | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brands | Business franchise | Key indication | USD m | % <br> change<br> USD/cc^2^ | USD m | % <br> change<br> USD | % <br> change<br> cc^2^ | USD m | % <br> change<br> USD | % <br> change<br> cc^2^ |
| Cosentyx | Immunology,<br> Hepatology and<br> Dermatology | Psoriasis, ankylosing <br> spondylitis, <br> psoriatic arthritis<br> and non-radiographic<br> axial spondyloarthritis | 2 113 | 15 | 1 362 | 29 | 22 | 3 475 | 20 | 18 |
| Entresto | Cardiovascular,<br> Renal and <br> Metabolism | Chronic heart failure | 1 192 | 30 | 1 407 | 62 | 53 | 2 599 | 46 | 41 |
| Gilenya | Neuroscience | Relapsing multiple sclerosis | 1 082 | -8 | 1 049 | -1 | -6 | 2 131 | -5 | -7 |
| Lucentis | Ophthalmology | Age-related <br> macular degeneration | 1 652 | 18 | 12 | 1 652 | 18 | 12 | ||
| Tasigna | Hematology | Chronic myeloid leukemia | 652 | 2 | 900 | 12 | 8 | 1 552 | 7 | 5 |
| Promacta/Revolade | Hematology | Immune <br> thrombocytopenia (ITP), <br> severe aplastic anemia (SAA) | 701 | 15 | 797 | 21 | 18 | 1 498 | 18 | 16 |
| Tafinlar + Mekinist | Solid Tumor | BRAF V600+ metastatic <br> and adjuvant melanoma; <br> advanced non-small cell <br> lung cancer (NSCLC) | 445 | 6 | 790 | 11 | 6 | 1 235 | 9 | 6 |
| Jakavi | Hematology | Myelofibrosis (MF), <br> polycythemia vera (PV) | 1 187 | 23 | 18 | 1 187 | 23 | 18 | ||
| Sandostatin | Solid Tumor | Carcinoid tumors<br> and acromegaly | 635 | 1 | 433 | -4 | -8 | 1 068 | -1 | -2 |
| Xolair^1^ | Respiratory and Allergy | Severe allergic asthma (SAA), <br> chronic spontaneous urticaria <br> (CSU) and nasal polyps | 1 055 | 15 | 10 | 1 055 | 15 | 10 | ||
| Zolgensma | Neuroscience | Spinal muscular atrophy<br> (SMA) | 351 | -1 | 658 | 110 | 106 | 1 009 | 52 | 49 |
| Galvus Group | Established Medicines | Type 2 diabetes | 814 | -10 | -11 | 814 | -10 | -11 | ||
| Gleevec/Glivec | Hematology | Chronic myeloid<br> leukemia and GIST | 202 | -18 | 589 | -10 | -13 | 791 | -12 | -15 |
| Ilaris | Immunology,<br> Hepatology and<br> Dermatology | Auto-inflammatory (CAPS,<br> TRAPS, HIDS/MKD, FMF,<br> SJIA, AOSD and gout) | 356 | 24 | 419 | 21 | 20 | 775 | 22 | 22 |
| Afinitor/Votubia | Solid Tumor | Breast cancer/TSC | 447 | -8 | 317 | -6 | -9 | 764 | -7 | -8 |
| Exforge Group | Established Medicines | Hypertension | 10 | -23 | 694 | -4 | -8 | 704 | -4 | -8 |
| Kisqali | Solid Tumor | HR+/HER2- <br> metastatic breast cancer | 241 | 2 | 411 | 54 | 50 | 652 | 30 | 27 |
| Diovan Group | Established Medicines | Hypertension | 40 | -57 | 544 | -21 | -24 | 584 | -25 | -28 |
| Kymriah | Hematology | r/r pediatric and young <br> adults ALL, DLBCL | 172 | 13 | 272 | 50 | 44 | 444 | 33 | 30 |
| Votrient | Solid Tumor | Renal cell carcinoma | 168 | -16 | 270 | -6 | -10 | 438 | -10 | -12 |
| Top 20 products total | 8 807 | 6 | 15 620 | 15 | 10 | 24 427 | 12 | 9 | ||
| Rest of portfolio | 2 247 | -6 | 4 617 | 3 | -2 | 6 864 | -1 | -3 | ||
| Total division sales | 11 054 | 3 | 20 237 | 12 | 7 | 31 291 | 9 | 6 | ||
| ^1^ Net sales reflect Xolair sales for all indications. | ||||||||||
| ^2^ Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. |
44
Sandoz Division net sales by business franchise
Third quarter
| Q3 2020 | % change | % change | |
|---|---|---|---|
| USD m | USD | cc^2^ | |
| Retail Generics 1 | 1 812 | -2 | -3 |
| Biopharmaceuticals | 498 | 6 | 5 |
| Anti-Infectives 1 | 112 | -17 | -17 |
| Total division net sales | 2 422 | -1 | -2 |
| 1 Sandoz total anti-infectives net sales amounted to 273 million (Q3 2020: 266 million), of which 180 million (Q3 2020: 154 million) is sold through the Retail Generics business franchise and 93 million (Q3 2020: 112 million) is sold to other third party companies through the Anti-Infectives business<br> franchise | |||
| 2 Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. |
All values are in US Dollars.
Nine months to September 30
| 9M 2020 | % change | % change | |
|---|---|---|---|
| USD m | USD | cc^2^ | |
| Retail Generics 1 | 5 357 | -2 | -6 |
| Biopharmaceuticals | 1 414 | 10 | 5 |
| Anti-Infectives 1 | 338 | -9 | -12 |
| Total division net sales | 7 109 | 0 | -4 |
| 1 Sandoz total anti-infectives net sales amounted to 793 million (9M 2020: 848 million), of which 487 million (9M 2020: 510 million) is sold through the Retail Generics business franchise and 306 million (9M 2020: 338 million) is sold to other third party companies through the Anti-Infectives business<br> franchise | |||
| 2 Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures<br> used by Novartis can be found starting on page 47. |
All values are in US Dollars.
The product portfolio of Sandoz is widely spread in 2021 and 2020.
Segmentation – Other revenue
Third quarter
| Innovative Medicines | Sandoz | Corporate | Group | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 |
| Profit sharing income | 232 | 218 | 232 | 218 | ||||
| Royalty income | 18 | 26 | 6 | 6 | 4 | 4 | 28 | 36 |
| Milestone income | 6 | 12 | 1 | 7 | 12 | |||
| Other^1^ | 51 | 9 | 19 | 4 | 70 | 13 | ||
| Total other revenues | 307 | 265 | 26 | 10 | 4 | 4 | 337 | 279 |
| ^1^ Other includes revenue from activities such as manufacturing or other services rendered,<br> to the extent such revenue is not recorded under net sales. |
Nine months to September 30
| Innovative Medicines | Sandoz | Corporate | Group | |||||
|---|---|---|---|---|---|---|---|---|
| (USD millions) | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 |
| Profit sharing income | 637 | 625 | 637 | 625 | ||||
| Royalty income | 60 | 80 | 18 | 19 | 9 | 162 | 87 | 261 |
| Milestone income | 118 | 37 | 4 | 11 | 122 | 48 | ||
| Other^1^ | 83 | 30 | 29 | 15 | 112 | 45 | ||
| Total other revenues | 898 | 772 | 51 | 45 | 9 | 162 | 958 | 979 |
| ^1^ Other includes revenue from activities such as manufacturing or other services rendered,<br> to the extent such revenue is not recorded under net sales. |
45
- Commitments and contingencies
Research and development commitments
Significant transactions in 2021
In January 2021, Novartis entered into a long-term research and development agreement, which closed in February 2021, and Innovative Medicines recognized an IPR&D intangible asset amounting to USD 426 million. This agreement provides for potential milestones payments by Novartis that may be capitalized and royalties. Based on their estimated timing, the research and development commitments for this transaction are expected to amount to USD 260 million in 2022, USD 275 million in 2023, USD 310 million in 2024, USD 455 million in 2025, USD 0 million in 2026 and USD 250 million thereafter, for a total of USD 1.6 billion.
Significant pending transactions
In November 2020, Novartis entered into a long-term research and development agreement, which did not close as of October 25, 2021. This agreement provides for potential milestones payments by Novartis that may be capitalized and royalties. Based on their estimated timing, the payments for this transaction are expected to amount to USD 117 million in 2022, USD 63 million in 2023, USD 200 million in 2025, USD 115 million in 2026 and USD 819 million thereafter, for a total of USD 1.3 billion.
- Events subsequent to the September 30, 2021, consolidated balance sheet date
Significant transactions closed in October 2021
On February 10, 2021, Sandoz entered into an agreement with certain subsidiaries of GlaxoSmithKline plc (GSK) for the acquisition of GSK’s cephalosporin antibiotics business. The transaction was completed on October 8, 2021. For details see Note 3, “Significant transaction entered into the first nine months of 2021 and closed in October 2021.”
46
Supplementary information (unaudited)
Non-IFRS disclosures
Novartis uses certain non-IFRS metrics when measuring performance, especially when measuring current-year results against prior periods, including core results, constant currencies, free cash flow and net debt.
Despite the use of these measures by management in setting goals and measuring the Group’s performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS. As a result, such measures have limits in their usefulness to investors.
Because of their non-standardized definitions, the non-IFRS measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These non-IFRS measures are presented solely to permit investors to more fully understand how the Group’s management assesses underlying performance. These non-IFRS measures are not, and should not be viewed as, a substitute for IFRS measures.
As an internal measure of Group performance, these non-IFRS measures have limitations, and the Group’s performance management process is not solely restricted to these metrics.
Core results
The Group’s core results – including core operating income, core net income and core earnings per share – exclude fully the amortization and impairment charges of intangible assets, excluding software, net gains and losses on fund investments and equity securities valued at fair value through profit and loss, and certain acquisition- and divestment-related items. The following items that exceed a threshold of USD 25 million are also excluded: integration- and divestment-related income and expenses; divestment gains and losses; restructuring charges/releases and related items; legal-related items; impairments of property, plant and equipment, and financial assets, and income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a USD 25 million threshold.
Novartis believes that investor understanding of the Group’s performance is enhanced by disclosing core measures of performance since, core measures exclude items that can vary significantly from year to year, they enable better comparison of business performance across years. For this same reason, Novartis uses these core measures in addition to IFRS and other measures as important factors in assessing the Group’s performance.
The following are examples of how these core measures are utilized:
• In addition to monthly reports containing financial information prepared under International Financial Reporting Standards (IFRS), senior management receives a monthly analysis incorporating these core measures.
• Annual budgets are prepared for both IFRS and core measures.
As an internal measure of Group performance, the core results measures have limitations, and the Group’s performance management process is not solely restricted to these metrics. A limitation of the core results measures is that they provide a view of the Group’s operations without including all events during a period, such as the effects of an acquisition, divestment, or amortization/impairments of purchased intangible assets and restructurings.
Constant currencies
Changes in the relative values of non-US currencies to the US dollar can affect the Group’s financial results and financial position. To provide additional information that may be useful to investors, including changes in sales volume, we present information about our net sales and various values relating to operating and net income that are adjusted for such foreign currency effects.
Constant currency calculations have the goal of eliminating two exchange rate effects so that an estimate can be made of underlying changes in the consolidated income statement excluding the impact of fluctuations in exchanges rates:
• The impact of translating the income statements of consolidated entities from their non-USD functional currencies to USD
• The impact of exchange rate movements on the major transactions of consolidated entities performed in currencies other than their functional currency.
We calculate constant currency measures by translating the current year’s foreign currency values for sales and other income statement items into USD, using the average exchange rates from the prior year and comparing them to the prior-year values in USD.
We use these constant currency measures in evaluating the Group’s performance, since they may assist us in evaluating our ongoing performance from year to year. However, in performing our evaluation, we also consider equivalent measures of performance that are not affected by changes in the relative value of currencies.
Growth rate calculation
For ease of understanding, Novartis uses a sign convention for its growth rates such that a reduction in operating expenses or losses compared to the prior year is shown as a positive growth.
Free cash flow
Novartis defines free cash flow as net cash flows from operating activities and cash flows from investing activities associated with purchases and sales of property, plant and equipment, of intangible assets, of financial assets and of other non-current assets. Excluded from free cash flow are cash flows from investing activities associated with acquisitions and divestments of businesses and of interests in associated companies, purchases and sales of marketable securities, commodities,
47
time deposits and net cash flows from financing activities.
Free cash flow is a non-IFRS measure and is not intended to be a substitute measure for net cash flows from operating activities as determined under IFRS. Free cash flow is presented as additional information because management believes it is a useful supplemental indicator of the Group’s ability to operate without reliance on additional borrowing or use of existing cash. Free cash flow is a measure of the net cash generated that is available for investment in strategic opportunities, returning to shareholders and for debt repayment. Free cash flow is a non-IFRS measure, which means it should not be interpreted as a measure determined under IFRS.
Net debt
Novartis calculates net debt as current financial debts and derivative financial instruments plus non-current financial debts less cash and cash equivalents and marketable securities, commodities, time deposits and derivative financial instruments.
Net debt is a non-IFRS measure, which means it should not be interpreted as a measure determined under IFRS. Net debt is presented as additional information because management believes it is a useful supplemental indicator of the Group’s ability to pay dividends, to meet financial commitments, and to invest in new strategic opportunities, including strengthening its balance sheet.
48
CORE RESULTS – Reconciliation from IFRS results to core results – Group
Third quarter
| Sandoz | Corporate | Group | |||||
|---|---|---|---|---|---|---|---|
| ( millions unless indicated otherwise) | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 | Q3 2021 | Q3 2020 |
| IFRS operating income | 1 998 | 440 | 395 | -8 | 19 | 3 233 | 2 412 |
| Amortization of intangible assets | 740 | 55 | 67 | 931 | 807 | ||
| Impairments | |||||||
| Intangible assets | 58 | 18 | 48 | 90 | 106 | ||
| Property, plant and equipment related to the Group-wide rationalization of manufacturing sites | 283 | 19 | 98 | 23 | 381 | ||
| Other property, plant and equipment | -3 | ||||||
| Total impairment charges | 341 | 37 | 146 | 110 | 487 | ||
| Acquisition or divestment of businesses and related items | |||||||
| - Income | -48 | -14 | -49 | -14 | |||
| - Expense | 16 | 5 | 18 | 5 | 34 | ||
| Total acquisition or divestment of businesses and related items, net | 16 | -43 | 4 | -44 | 20 | ||
| Other items | |||||||
| Divestment gains | -30 | -16 | -73 | -49 | -103 | ||
| Financial assets - fair value adjustments | -87 | -2 | -52 | -9 | -139 | ||
| Restructuring and related items | |||||||
| - Income | -3 | -7 | -7 | -3 | -19 | -17 | -29 |
| - Expense | 97 | 44 | 52 | -2 | 1 | 150 | 150 |
| Legal-related items | |||||||
| - Income | |||||||
| - Expense | 453 | 5 | 6 | 174 | 459 | ||
| Additional income | -44 | -3 | -4 | -54 | -2 | -59 | -50 |
| Additional expense | 44 | 3 | 7 | 8 | 47 | 55 | |
| Total other items | 430 | 39 | 50 | -70 | -137 | 237 | 343 |
| Total adjustments | 1 527 | 131 | 263 | -113 | -133 | 1 234 | 1 657 |
| Core operating income | 3 525 | 571 | 658 | -121 | -114 | 4 467 | 4 069 |
| as % of net sales | 35.8% | 23.8% | 27.2% | 34.3% | 33.2% | ||
| Income from associated companies | 1 | 1 | 222 | 225 | 223 | 226 | |
| Core adjustments to income from associated companies, net of tax | 86 | 62 | 86 | 62 | |||
| Interest expense | -202 | -209 | |||||
| Other financial income and expense | -24 | -19 | |||||
| Core adjustments to other financial income and expense | 10 | -2 | |||||
| Income taxes, adjusted for above items (core income taxes) | -730 | -660 | |||||
| Core net income | 3 830 | 3 467 | |||||
| Core net income attributable to shareholders of Novartis AG | 3 830 | 3 470 | |||||
| Core basic EPS () 1 | 1.71 | 1.52 | |||||
| 1 Earnings per share (EPS) is calculated on the amount of net income attributable to<br> shareholders of Novartis AG. |
All values are in US Dollars.
49
CORE RESULTS – Reconciliation from IFRS results to core results – Group
Nine months to September 30
| Sandoz | Corporate | Group | |||||
|---|---|---|---|---|---|---|---|
| ( millions unless indicated otherwise) | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 | 9M 2021 | 9M 2020 |
| IFRS operating income | 6 786 | 1 214 | 671 | -307 | 51 | 9 127 | 7 508 |
| Amortization of intangible assets | 2 172 | 175 | 300 | 2 826 | 2 472 | ||
| Impairments | |||||||
| Intangible assets | 567 | 19 | 90 | 379 | 657 | ||
| Property, plant and equipment related to the Group-wide rationalization of manufacturing sites | 293 | 108 | 94 | 401 | |||
| Other property, plant and equipment | 2 | 42 | 2 | ||||
| Total impairment charges | 860 | 19 | 200 | 515 | 1 060 | ||
| Acquisition or divestment of businesses and related items | |||||||
| - Income | -3 | -53 | -67 | -55 | -70 | ||
| - Expense | 90 | 22 | 17 | 79 | 18 | 191 | |
| Total acquisition or divestment of businesses and related items, net | 87 | 22 | -36 | 12 | -37 | 121 | |
| Other items | |||||||
| Divestment gains | -178 | -4 | -66 | -51 | -662 | -229 | |
| Financial assets - fair value adjustments | -62 | 32 | -204 | -50 | -266 | ||
| Restructuring and related items | |||||||
| - Income | -14 | -24 | -19 | -5 | -21 | -50 | -54 |
| - Expense | 315 | 123 | 188 | 20 | 26 | 822 | 529 |
| Legal-related items | |||||||
| - Income | -11 | -11 | |||||
| - Expense | 540 | 47 | 398 | -26 | 217 | 912 | |
| Additional income | -134 | -3 | -5 | -54 | -142 | -81 | -281 |
| Additional expense | 61 | 51 | 30 | 31 | 153 | 143 | |
| Total other items | 528 | 128 | 613 | -43 | -387 | 338 | 754 |
| Total adjustments | 3 647 | 322 | 1 135 | -79 | -375 | 3 642 | 4 407 |
| Core operating income | 10 433 | 1 536 | 1 806 | -386 | -324 | 12 769 | 11 915 |
| as % of net sales | 36.3% | 21.6% | 25.4% | 33.3% | 33.2% | ||
| Income from associated companies | 1 | 2 | 2 | 715 | 529 | 718 | 532 |
| Core adjustments to income from associated companies, net of tax | 182 | 336 | 182 | 336 | |||
| Interest expense | -605 | -668 | |||||
| Other financial income and expense | -54 | -53 | |||||
| Core adjustments to other financial income and expense | 37 | -10 | |||||
| Income taxes, adjusted for above items (core income taxes) | -2 088 | -1 928 | |||||
| Core net income | 10 959 | 10 124 | |||||
| Core net income attributable to shareholders of Novartis AG | 10 960 | 10 130 | |||||
| Core basic EPS () 1 | 4.88 | 4.44 | |||||
| 1 Earnings per share (EPS) is calculated on the amount of net income attributable to<br> shareholders of Novartis AG. |
All values are in US Dollars.
50
CORE RESULTS – Reconciliation from IFRS results to core results – Group
Third quarter
| ( millions unless indicated otherwise) | Amortization <br> of intangible<br> assets^1^ | Impairments^2^ | Acquisition or <br> divestment of <br> businesses and<br> related items^3^ | Other <br> items^4^ | Q3 2021<br> Core results | Q3 2020<br> Core results |
|---|---|---|---|---|---|---|
| Gross profit | 906 | 17 | 73 | 10 425 | 9 765 | |
| Operating income | 931 | 110 | -44 | 237 | 4 467 | 4 069 |
| Income before taxes | 1 017 | 110 | -44 | 247 | 4 560 | 4 127 |
| Income taxes 5 | -730 | -660 | ||||
| Net income | 3 830 | 3 467 | ||||
| Basic EPS () 6 | 1.71 | 1.52 | ||||
| The following are adjustments to arrive at core gross profit | ||||||
| Cost of goods sold | 906 | 17 | 73 | -2 942 | -2 773 | |
| The following are adjustments to arrive at core operating income | ||||||
| Selling, general and administration | 17 | -3 601 | -3 412 | |||
| Research and development | 25 | 73 | 21 | -2 261 | -2 143 | |
| Other income | -3 | -49 | -196 | 125 | 77 | |
| Other expense | 23 | 5 | 322 | -221 | -218 | |
| The following are adjustments to arrive at core income before taxes | ||||||
| Income from associated companies | 86 | 309 | 288 | |||
| Other financial income and expense | 10 | -14 | -21 | |||
| 1 Amortization of intangible assets: cost of goods sold includes the amortization of<br> acquired rights to currently marketed products and other production-related intangible<br> assets; research and development includes the amortization of acquired rights for<br> technologies; income from associated companies includes 86 million for the Novartis<br> share of the estimated Roche core items | ||||||
| 2 Impairments: cost of goods sold and research and development include impairment charges<br> related to intangible assets; other income and other expense include a reversal of<br> an impairment charge and impairment charges related to property, plant and equipment | ||||||
| 3 Acquisition or divestment of businesses and related items, including restructuring<br> and integration charges: other income includes adjustments to portfolio transformation<br> and Alcon spin-off provisions; other income and other expense include transitional<br> service fee income and expenses related to the Alcon distribution | ||||||
| 4 Other items: cost of goods sold, other income and other expense include net restructuring<br> and other charges related to the Group-wide rationalization of manufacturing sites;<br> cost of goods sold, selling, general and administration, other income and other expense<br> include other restructuring income and charges and related items; selling, general<br> and administration also includes adjustments to provisions; research and development<br> includes adjustments to contingent considerations and provisions; other income includes<br> net gains from the divestment of products and an adjustment to a contingent consideration<br> receivable; other income and other expense include fair value adjustments and divestment<br> gains and losses on financial assets; other expense also includes legal-related items<br> and adjustments to provisions; other financial income and expense includes a charge<br> related to the monetary loss due to hyperinflation in Argentina and a revaluation<br> impact of a financial liability incurred through the Alcon distribution | ||||||
| 5 Taxes on the adjustments between IFRS and core results take into account, for each<br> individual item included in the adjustment, the tax rate that will finally be applicable<br> to the item based on the jurisdiction where the adjustment will finally have a tax<br> impact. Generally, this results in amortization and impairment of intangible assets<br> and acquisition-related restructuring and integration items having a full tax impact.<br> There is usually a tax impact on other items, although this is not always the case<br> for items arising from legal settlements in certain jurisdictions. Adjustments related<br> to income from associated companies are recorded net of any related tax effect. Due<br> to these factors and the differing effective tax rates in the various jurisdictions,<br> the tax on the total adjustments of 1.3 billion to arrive at the core results<br> before tax amounts to 258 million. The average tax rate on the adjustments is<br> 19.4% since the estimated quarterly core tax charge of 16.0% has been applied to the<br> pre-tax income of the period. | ||||||
| 6 Earnings per share (EPS) is calculated on the amount of net income attributable to<br> shareholders of Novartis AG. |
All values are in US Dollars.
51
CORE RESULTS – Reconciliation from IFRS results to core results – Group
Nine months to September 30
| ( millions unless indicated otherwise) | Amortization <br> of intangible <br> assets^1^ | Impairments^2^ | Acquisition or <br> divestment of <br> businesses and<br> related items^3^ | Other <br> items^4^ | 9M 2021<br> Core results | 9M 2020<br> Core results |
|---|---|---|---|---|---|---|
| Gross profit | 2 747 | 17 | 439 | 30 667 | 28 707 | |
| Operating income | 2 826 | 515 | -37 | 338 | 12 769 | 11 915 |
| Income before taxes | 3 008 | 515 | -37 | 375 | 13 047 | 12 052 |
| Income taxes 5 | -2 088 | -1 928 | ||||
| Net income | 10 959 | 10 124 | ||||
| Basic EPS () 6 | 4.88 | 4.44 | ||||
| The following are adjustments to arrive at core gross profit | ||||||
| Cost of goods sold | 2 747 | 17 | 439 | -8 688 | -8 025 | |
| The following are adjustments to arrive at core operating income | ||||||
| Selling, general and administration | 70 | -10 831 | -10 185 | |||
| Research and development | 79 | 362 | 18 | -6 672 | -6 187 | |
| Other income | -101 | -55 | -1 022 | 303 | 308 | |
| Other expense | 237 | 18 | 833 | -698 | -728 | |
| The following are adjustments to arrive at core income before taxes | ||||||
| Income from associated companies | 182 | 900 | 868 | |||
| Other financial income and expense | 37 | -17 | -63 | |||
| 1 Amortization of intangible assets: cost of goods sold includes the amortization of<br> acquired rights to currently marketed products and other production-related intangible<br> assets; research and development includes the amortization of acquired rights for<br> technologies; income from associated companies includes 182 million for the Novartis<br> share of the estimated Roche core items | ||||||
| 2 Impairments: cost of goods sold and research and development include impairment charges<br> related to intangible assets; other income and other expense include reversals of<br> impairment charges and impairment charges related to property, plant and equipment | ||||||
| 3 Acquisition or divestment of businesses and related items, including restructuring<br> and integration charges: other income includes adjustments to portfolio transformation<br> and Alcon spin-off provisions; other income and other expense include transitional<br> service fee income and expenses related to the Alcon distribution | ||||||
| 4 Other items: cost of goods sold, other income and other expense include net restructuring<br> and other charges related to the Group-wide rationalization of manufacturing sites;<br> cost of goods sold, selling, general and administration, other income and other expense<br> include other restructuring income and charges and related items; selling, general<br> and administration also includes adjustments to provisions; research and development<br> includes adjustments to contingent considerations and provisions; other income includes<br> net gains from the divestment of products and an adjustment to a contingent consideration<br> receivable; other income and other expense include fair value adjustments and divestment<br> gains and losses on financial assets and legal-related items; other expense also includes<br> adjustments to an environmental provision and other provisions; other financial income<br> and expense includes a charge related to the monetary loss due to hyperinflation in<br> Argentina and a revaluation impact of a financial liability incurred through the Alcon<br> distribution | ||||||
| 5 Taxes on the adjustments between IFRS and core results take into account, for each<br> individual item included in the adjustment, the tax rate that will finally be applicable<br> to the item based on the jurisdiction where the adjustment will finally have a tax<br> impact. Generally, this results in amortization and impairment of intangible assets<br> and acquisition-related restructuring and integration items having a full tax impact.<br> There is usually a tax impact on other items, although this is not always the case<br> for items arising from legal settlements in certain jurisdictions. Adjustments related<br> to income from associated companies are recorded net of any related tax effect. Due<br> to these factors and the differing effective tax rates in the various jurisdictions,<br> the tax on the total adjustments of 3.9 billion to arrive at the core results<br> before tax amounts to 614 million. The average tax rate on the adjustments is<br> 15.9% since the estimated full year core tax charge of 16.0% has been applied to the<br> pre-tax income of the period. | ||||||
| 6 Earnings per share (EPS) is calculated on the amount of net income attributable to<br> shareholders of Novartis AG. |
All values are in US Dollars.
52
CORE RESULTS – Reconciliation from IFRS results to core results – Innovative Medicines
Third quarter
| (USD millions) | Q3 2021<br> IFRS results | Amortization<br> of intangible<br> assets^1^ | Impairments^2^ | Acquisition or <br> divestment of <br> businesses and<br> related items^3^ | Other <br> items^4^ | Q3 2021<br> Core results | Q3 2020<br> Core results |
|---|---|---|---|---|---|---|---|
| Gross profit | 8 212 | 851 | 53 | 9 116 | 8 384 | ||
| Operating income | 2 801 | 876 | 73 | -1 | 268 | 4 017 | 3 525 |
| The following are adjustments to arrive at core gross profit | |||||||
| Cost of goods sold | -2 912 | 851 | 53 | -2 008 | -1 911 | ||
| The following are adjustments to arrive at core operating income | |||||||
| Selling, general and administration | -3 006 | 19 | -2 987 | -2 820 | |||
| Research and development | -2 156 | 25 | 72 | 22 | -2 037 | -1 932 | |
| Other income | 135 | -1 | -79 | 55 | 29 | ||
| Other expense | -384 | 1 | 253 | -130 | -136 | ||
| ^1^ Amortization of intangible assets: cost of goods sold includes the amortization of<br> acquired rights to currently marketed products and other production-related intangible<br> assets; research and development includes the amortization of acquired rights for<br> technologies | |||||||
| ^2^ Impairments: research and development includes impairment charges related to intangible<br> assets; other expense includes impairment charges related to property, plant and equipment | |||||||
| ^3^ Acquisition or divestment of businesses and related items, including restructuring<br> and integration charges: other income includes transitional service fee income related<br> to the Alcon distribution | |||||||
| ^4^ Other items: cost of goods sold and other expense include net restructuring and other<br> charges related to the Group-wide rationalization of manufacturing sites; selling,<br> general and administration, other income and other expense include other restructuring<br> income and charges and related items; research and development includes adjustments<br> to contingent considerations and provisions; other income includes net gains from<br> the divestment of products; other income and other expense include fair value adjustments<br> on financial assets; other expense also includes legal-related items and adjustments<br> to provisions |
Nine months to September 30
| (USD millions) | 9M 2021<br> IFRS results | Amortization<br> of intangible<br> assets^1^ | Impairments^2^ | Acquisition or<br> divestment of<br> businesses and<br> related items^3^ | Other <br> items^4^ | 9M 2021<br> Core results | 9M 2020<br> Core results |
|---|---|---|---|---|---|---|---|
| Gross profit | 23 922 | 2 572 | 403 | 26 897 | 24 686 | ||
| Operating income | 8 220 | 2 651 | 496 | -1 | 253 | 11 619 | 10 433 |
| The following are adjustments to arrive at core gross profit | |||||||
| Cost of goods sold | -8 878 | 2 572 | 403 | -5 903 | -5 468 | ||
| The following are adjustments to arrive at core operating income | |||||||
| Selling, general and administration | -9 032 | 72 | -8 960 | -8 384 | |||
| Research and development | -6 472 | 79 | 360 | 19 | -6 014 | -5 581 | |
| Other income | 963 | -43 | -2 | -772 | 146 | 178 | |
| Other expense | -1 161 | 179 | 1 | 531 | -450 | -466 | |
| ^1^ Amortization of intangible assets: cost of goods sold includes the amortization of<br> acquired rights to currently marketed products and other production-related intangible<br> assets; research and development includes the amortization of acquired rights for<br> technologies | |||||||
| ^2^ Impairments: research and development includes impairment charges related to intangible<br> assets; other income and other expense include reversals of impairment charges and<br> impairment charges related to property, plant and equipment | |||||||
| ^3^ Acquisition or divestment of businesses and related items, including restructuring<br> and integration charges: other income and other expense include transitional service<br> fee income and expenses related to the Alcon distribution | |||||||
| ^4^ Other items: cost of goods sold, other income and other expense include net restructuring<br> and other charges related to the Group-wide rationalization of manufacturing sites;<br> cost of goods sold, selling, general and administration, other income and other expense<br> include other restructuring income and charges and related items; selling, general<br> and administration also includes adjustments to provisions; research and development<br> includes adjustments to contingent considerations and provisions; other income includes<br> net gains from the divestment of products and financial assets; other income and other<br> expense include fair value adjustments on financial assets; other expense also includes<br> legal-related items and adjustments to provisions |
53
CORE RESULTS– Reconciliation from IFRS results to core results – Sandoz
Third quarter
| (USD millions) | Q3 2021<br> IFRS results | Amortization<br> of intangible<br> assets^1^ | Impairments^2^ | Acquisition or <br> divestment of <br> businesses and<br> related items | Other <br> items^3^ | Q3 2021<br> Core results | Q3 2020<br> Core results |
|---|---|---|---|---|---|---|---|
| Gross profit | 1 196 | 55 | 17 | 20 | 1 288 | 1 363 | |
| Operating income | 440 | 55 | 37 | 39 | 571 | 658 | |
| The following are adjustments to arrive at core gross profit | |||||||
| Cost of goods sold | -1 269 | 55 | 17 | 20 | -1 177 | -1 114 | |
| The following are adjustments to arrive at core operating income | |||||||
| Selling, general and administration | -480 | -2 | -482 | -486 | |||
| Research and development | -224 | 1 | -1 | -224 | -211 | ||
| Other income | 38 | -3 | -7 | 28 | 18 | ||
| Other expense | -90 | 22 | 29 | -39 | -26 | ||
| ^1^ Amortization of intangible assets: cost of goods sold includes the amortization of<br> acquired rights to currently marketed products and other production-related intangible<br> assets | |||||||
| ^2^ Impairments: cost of goods sold and research and development include impairment charges<br> related to intangible assets; other income and other expense include a reversal of<br> an impairment charge and impairment charges related to property, plant and equipment | |||||||
| ^3^ Other items: cost of goods sold, other income and other expense include net restructuring<br> and other charges related to the Group-wide rationalization of manufacturing sites<br> and other restructuring income and charges and related items; selling, general and<br> administration and research and development include adjustments to provisions; other<br> expense includes legal-related items |
Nine months to September 30
| (USD millions) | 9M 2021<br> IFRS results | Amortization<br> of intangible<br> assets^1^ | Impairments^2^ | Acquisition or <br> divestment of <br> businesses and<br> related items | Other <br> items^3^ | 9M 2021<br> Core results | 9M 2020<br> Core results |
|---|---|---|---|---|---|---|---|
| Gross profit | 3 489 | 175 | 17 | 36 | 3 717 | 3 939 | |
| Operating income | 1 214 | 175 | 19 | 128 | 1 536 | 1 806 | |
| The following are adjustments to arrive at core gross profit | |||||||
| Cost of goods sold | -3 806 | 175 | 17 | 36 | -3 578 | -3 352 | |
| The following are adjustments to arrive at core operating income | |||||||
| Selling, general and administration | -1 494 | -2 | -1 496 | -1 478 | |||
| Research and development | -659 | 2 | -1 | -658 | -606 | ||
| Other income | 183 | -58 | -39 | 86 | 55 | ||
| Other expense | -305 | 58 | 134 | -113 | -104 | ||
| ^1^ Amortization of intangible assets: cost of goods sold includes the amortization of<br> acquired rights to currently marketed products and other production-related intangible<br> assets | |||||||
| ^2^ Impairments: cost of goods sold and research and development include impairment charges<br> related to intangible assets; other income and other expense include reversals of<br> impairment charges and impairment charges related to property, plant and equipment | |||||||
| ^3^ Other items: cost of goods sold, other income and other expense include net restructuring<br> and other charges related to the Group-wide rationalization of manufacturing sites<br> and other restructuring income and charges and related items; selling, general and<br> administration and research and development include adjustments to provisions; other<br> income includes net gains from the divestment of a product; other income and other<br> expense include legal-related items |
54
CORE RESULTS – Reconciliation from IFRS results to core results – Corporate
Third quarter
| (USD millions) | Q3 2021<br> IFRS results | Amortization<br> of intangible<br> assets | Impairments | Acquisition or <br> divestment of <br> businesses and<br> related items^1^ | Other <br> items^2^ | Q3 2021<br> Core results | Q3 2020<br> Core results |
|---|---|---|---|---|---|---|---|
| Gross profit | 21 | 21 | 18 | ||||
| Operating loss | -8 | -43 | -70 | -121 | -114 | ||
| The following are adjustments to arrive at core operating loss | |||||||
| Other income | 200 | -48 | -110 | 42 | 30 | ||
| Other expense | -97 | 5 | 40 | -52 | -56 | ||
| ^1^ Acquisition or divestment of businesses and related items, including restructuring<br> and integration charges: other income includes adjustments to portfolio transformation<br> and Alcon spin-off provisions; other expense includes transitional service fee expenses<br> related to the Alcon distribution | |||||||
| ^2^ Other items: other income includes an adjustment to a contingent consideration receivable;<br> other income and other expense include fair value adjustments and divestment gains<br> and losses on financial assets, and restructuring income and charges and related items |
Nine months to September 30
| (USD millions) | 9M 2021<br> IFRS results | Amortization<br> of intangible<br> assets | Impairments | Acquisition or <br> divestment of <br> businesses and<br> related items^1^ | Other <br> items^2^ | 9M 2021<br> Core results | 9M 2020<br> Core results |
|---|---|---|---|---|---|---|---|
| Gross profit | 53 | 53 | 82 | ||||
| Operating loss | -307 | -36 | -43 | -386 | -324 | ||
| The following are adjustments to arrive at core operating loss | |||||||
| Other income | 335 | -53 | -211 | 71 | 75 | ||
| Other expense | -320 | 17 | 168 | -135 | -158 | ||
| ^1^ Acquisition or divestment of businesses and related items, including restructuring<br> and integration charges: other income includes adjustments to portfolio transformation<br> and Alcon spin-off provisions; other income and other expense include transitional<br> service fee income and expenses related to the Alcon distribution | |||||||
| ^2^ Other items: other income includes an adjustment to a contingent consideration receivable;<br> other income and other expense include fair value adjustments and divestment gains<br> and losses on financial assets, and restructuring income and charges and related items;<br> other expense also includes an adjustment to an environmental provision |
Income from associated companies
| (USD millions) | Q3 2021 | Q3 2020 | 9M 2021 | 9M 2020 |
|---|---|---|---|---|
| Share of estimated Roche reported results | 246 | 271 | 746 | 726 |
| Prior-year adjustment | 40 | -64 | ||
| Amortization of additional intangible assets recognized by Novartis on initial accounting for the equity interest | -21 | -44 | -64 | -127 |
| Net income effect from Roche Holding AG | 225 | 227 | 722 | 535 |
| Others | -2 | -1 | -4 | -3 |
| Income from associated companies | 223 | 226 | 718 | 532 |
Core income from associated companies
| (USD millions) | Q3 2021 | Q3 2020 | 9M 2021 | 9M 2020 |
|---|---|---|---|---|
| Income from associated companies | 223 | 226 | 718 | 532 |
| Share of estimated Roche core adjustments | 86 | 62 | 182 | 234 |
| Roche prior year adjustment | 102 | |||
| Core income from associated companies | 309 | 288 | 900 | 868 |
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Net debt
Condensed consolidated changes in net debt
Third quarter
| (USD millions) | Q3 2021 | Q3 2020 |
|---|---|---|
| Change in cash and cash equivalents | 2 094 | 3 077 |
| Change in marketable securities, commodities, time deposits, financial debts and derivatives financial instruments | 2 177 | -1 894 |
| Change in net debt | 4 271 | 1 183 |
| Net debt at July 1 | -28 547 | -26 537 |
| Net debt at September 30 | -24 276 | -25 354 |
Condensed consolidated changes in net debt
Nine months to September 30
| (USD millions) | 9M 2021 | 9M 2020 |
|---|---|---|
| Change in cash and cash equivalents | -2 447 | -2 118 |
| Change in marketable securities, commodities, time deposits, financial debts and derivatives financial instruments | 2 652 | -7 298 |
| Change in net debt | 205 | -9 416 |
| Net debt at January 1 | -24 481 | -15 938 |
| Net debt at September 30 | -24 276 | -25 354 |
Components of net debt
| (USD millions) | Sep 30, <br> 2021 | Dec 31, <br> 2020 | Sep 30, <br> 2020 |
|---|---|---|---|
| Non-current financial debts | -23 101 | -26 259 | -26 497 |
| Current financial debts and derivative financial instruments | -9 337 | -9 785 | -9 727 |
| Total financial debt | -32 438 | -36 044 | -36 224 |
| Less liquidity: | |||
| Cash and cash equivalents | 7 211 | 9 658 | 8 994 |
| Marketable securities, commodities, time deposits and derivative financial instruments | 951 | 1 905 | 1 876 |
| Total liquidity | 8 162 | 11 563 | 10 870 |
| Net debt at end of period | -24 276 | -24 481 | -25 354 |
Share information
| Sep 30, <br> 2020 | |
|---|---|
| Number of shares outstanding | 2 274 506 236 |
| Registered share price (CHF) | 79.91 |
| ADR price () | 86.96 |
| Market capitalization ( billions) 1 | 197.2 |
| Market capitalization (CHF billions) 1 | 181.8 |
| 1 Market capitalization is calculated based on the number of shares outstanding (excluding<br> treasury shares). Market capitalization in is based on the market capitalization<br> in CHF converted at the quarter end CHF/ exchange rate. |
All values are in US Dollars.
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Free cash flow
The following table is a reconciliation of the three major categories of the IFRS consolidated statements of cash flows to free cash flow:
Third quarter
| Q3 2021 | Q3 2020 | |||||
|---|---|---|---|---|---|---|
| (USD millions) | IFRS <br> Cash flow | Adjustments | Free <br> cash flow | IFRS <br> Cash flow | Adjustments | Free <br> cash flow |
| Net cash flows from operating activities | 4 925 | 4 925 | 3 156 | 3 156 | ||
| Net cash flows used in investing activities from<br>continuing operations^1^ | -1 238 | 736 | -502 | -2 025 | 1 566 | -459 |
| Net cash flows from/used in investing activities from discontinued operations^2^ | 6 | -6 | -20 | 20 | ||
| Net cash flows used in investing activities | -1 232 | 730 | -502 | -2 045 | 1 586 | -459 |
| Net cash flows used in/from financing activities from<br>continuing operations | -1 548 | 1 548 | 1 911 | -1 911 | ||
| Net cash flows from/used in financing activities from discontinued operations | 14 | -14 | -11 | 11 | ||
| Net cash used in/from financing activities^3^ | -1 534 | 1 534 | 1 900 | -1 900 | ||
| Free cash flow from continuing operations | 4 423 | 2 697 | ||||
| Free cash flow | 4 423 | 2 697 | ||||
| ^1^ Excluded from the free cash flow are cash flows from investing activities associated<br> with acquisitions and divestments of businesses and of interest in associated companies,<br> purchases and sales of marketable securities, commodities and time deposits. | ||||||
| ^2^ Net cash flows from/used in investing activities from discontinued operations are<br> activities associated with acquisitions and divestments of businesses which are excluded<br> from the free cash flow. | ||||||
| ^3^ Net cash flows used in/from financing activities are excluded from the free cash flow. |
Nine months to September 30
| 9M 2020 | |||||
|---|---|---|---|---|---|
| ( millions) | Adjustments | Free <br> cash flow | IFRS <br> Cash flow | Adjustments | Free <br> cash flow |
| Net cash flows from operating activities | 11 187 | 9 645 | 9 645 | ||
| Net cash flows used in investing activities fromcontinuing operations 1,2 | -577 | -932 | -12 486 | 11 190 | -1 296 |
| Net cash flows used in investing activities from discontinued operations 3 | -125 | 125 | |||
| Net cash flows used in investing activities | -577 | -932 | -12 611 | 11 315 | -1 296 |
| Net cash flows used in/from financing activitiesfrom continuing operations | 13 013 | 765 | -765 | ||
| Net cash flows used in financing activities from discontinued operations | -37 | 37 | |||
| Net cash flows used in/from financing activities 4 | 13 013 | 728 | -728 | ||
| Free cash flow from continuing operations | 10 255 | 8 349 | |||
| Free cash flow | 10 255 | 8 349 | |||
| 1 Excluded from the free cash flow are cash flows from investing activities associated<br> with acquisitions and divestments of businesses and of interest in associated companies,<br> purchases and sales of marketable securities, commodities and time deposits. | |||||
| 2 For the free cash flow in the nine-month period of 2020, proceeds from the sale of<br> financial assets excludes the cash inflows from the sale of a portion of the Alcon<br> Inc. shares received by certain consolidated foundations through the Alcon spin-off,<br> which amounted to 232 million. | |||||
| 3 Net cash flows used in investing activities from discontinued operations are activities<br> associated with acquisitions and divestments of businesses which are excluded from<br> the free cash flow. | |||||
| 4 Net cash flows used in/from financing activities are excluded from the free cash flow. |
All values are in US Dollars.
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The following table is a summary of the free cash flow:
Third quarter
| (USD millions) | Q3 2021 | Q3 2020 |
|---|---|---|
| Operating income | 3 233 | 2 412 |
| Adjustments for non-cash items | ||
| Depreciation, amortization and impairments | 1 445 | 1 595 |
| Change in provisions and other non-current liabilities | 380 | 498 |
| Other | 76 | 109 |
| Operating income adjusted for non-cash items | 5 134 | 4 614 |
| Interest and other financial receipts | 2 | 32 |
| Interest and other financial payments | -151 | -170 |
| Income taxes paid | -315 | -316 |
| Payments out of provisions and other net cash movements in non-current liabilities | -154 | -968 |
| Change in inventory and trade receivables less trade payables | -171 | -666 |
| Change in other net current assets and other operating cash flow items | 580 | 630 |
| Net cash flows from operating activities | 4 925 | 3 156 |
| Purchases of property, plant and equipment | -351 | -279 |
| Proceeds from sale of property, plant and equipment | 81 | 2 |
| Purchases of intangible assets | -188 | -348 |
| Proceeds from sale of intangible assets | 35 | 99 |
| Purchases of financial assets | -46 | -35 |
| Proceeds from sale of financial assets | -20 | 108 |
| Purchases of other non-current assets | -14 | -6 |
| Proceeds from sale of other non-current assets | 1 | 0 |
| Free cash flow | 4 423 | 2 697 |
Nine months to September 30
| ( millions) | 9M 2020 |
|---|---|
| Operating income | 7 508 |
| Adjustments for non-cash items | |
| Depreciation, amortization and impairments | 4 581 |
| Change in provisions and other non-current liabilities | 1 336 |
| Other | 431 |
| Operating income adjusted for non-cash items | 13 856 |
| Dividends received from associated companies and others | 489 |
| Interest and other financial receipts | 330 |
| Interest and other financial payments | -510 |
| Income taxes paid | -1 215 |
| Payments out of provisions and other net cash movements in non-current liabilities | -1 792 |
| Change in inventory and trade receivables less trade payables | -1 730 |
| Change in other net current assets and other operating cash flow items | 217 |
| Net cash flows from operating activities | 9 645 |
| Purchases of property, plant and equipment | -754 |
| Proceeds from sale of property, plant and equipment | 6 |
| Purchases of intangible assets | -808 |
| Proceeds from sale of intangible assets | 204 |
| Purchases of financial assets | -125 |
| Proceeds from sale of financial assets 1 | 235 |
| Purchases of other non-current assets | -54 |
| Proceeds from sale of other non-current assets | 0 |
| Free cash flow | 8 349 |
| 1 For the free cash flow in the nine-month period of 2020, the proceeds from the sales<br> of financial assets excludes the cash inflows from the sale of a portion of the Alcon<br> Inc. shares received by certain consolidated foundations through the Alcon spin-off,<br> which amounted to 232 million. |
All values are in US Dollars.
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Effects of currency fluctuations
Principal currency translation rates
| (USD per unit) | Average <br> rates<br> Q3 2021 | Average <br> rates<br> Q3 2020 | Average <br> rates<br> 9M 2021 | Average <br> rates<br> 9M 2020 | Period-end <br> rates<br> Sep 30, <br> 2021 | Period-end <br> rates<br> Sep 30, <br> 2020 |
|---|---|---|---|---|---|---|
| 1 CHF | 1.089 | 1.087 | 1.098 | 1.052 | 1.071 | 1.085 |
| 1 CNY | 0.155 | 0.145 | 0.155 | 0.143 | 0.155 | 0.147 |
| 1 EUR | 1.179 | 1.169 | 1.197 | 1.124 | 1.161 | 1.173 |
| 1 GBP | 1.378 | 1.292 | 1.385 | 1.271 | 1.345 | 1.284 |
| 100 JPY | 0.908 | 0.942 | 0.922 | 0.930 | 0.893 | 0.947 |
| 100 RUB | 1.361 | 1.357 | 1.351 | 1.415 | 1.376 | 1.261 |
Currency impact on key figures
The following table provides a summary of the currency impact on key Group figures due to their conversion into US dollars, the Group’s reporting currency, of the financial data from entities reporting in non-US dollars. Constant currency (cc) calculations apply the exchange rates of the prior year period to the current period financial data for entities reporting in non-US dollars.
Third quarter
| Change in<br> USD %<br> Q3 2021 | Change in<br> constant<br> currencies %<br> Q3 2021 | Percentage<br> point currency<br> impact<br> Q3 2021 | Change in<br> USD %<br> Q3 2020 | Change in<br> constant<br> currencies %<br> Q3 2020 | Percentage<br> point currency<br> impact<br> Q3 2020 | |
|---|---|---|---|---|---|---|
| Total Group | ||||||
| Net sales to third parties | 6 | 5 | 1 | 1 | 0 | 1 |
| Operating income | 34 | 32 | 2 | 2 | 9 | -7 |
| Net income | 43 | 41 | 2 | -5 | 0 | -5 |
| Basic earnings per share (USD) | 45 | 44 | 1 | -6 | 0 | -6 |
| Core operating income | 10 | 9 | 1 | 9 | 11 | -2 |
| Core net income | 10 | 9 | 1 | 8 | 10 | -2 |
| Core basic earnings per share (USD) | 13 | 11 | 2 | 8 | 9 | -1 |
| Innovative Medicines | ||||||
| Net sales to third parties | 8 | 7 | 1 | 2 | 1 | 1 |
| Operating income | 40 | 38 | 2 | -17 | -11 | -6 |
| Core operating income | 14 | 13 | 1 | 7 | 9 | -2 |
| Sandoz | ||||||
| Net sales to third parties | -1 | -2 | 1 | -2 | -3 | 1 |
| Operating income | 11 | 9 | 2 | 107 | 113 | -6 |
| Core operating income | -13 | -15 | 2 | 7 | 8 | -1 |
| Corporate | ||||||
| Operating (loss)/income | nm | nm | nm | nm | nm | nm |
| Core operating loss | -6 | -7 | 1 | 32 | 36 | -4 |
| nm = not meaningful |
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Currency impact on key figures
Nine months to September 30
| Change in<br> USD %<br> 9M 2021 | Change in<br> constant<br> currencies %<br> 9M 2021 | Percentage<br> point currency<br> impact<br> 9M 2021 | Change in<br> USD %<br> 9M 2020 | Change in<br> constant<br> currencies %<br> 9M 2020 | Percentage<br> point currency<br> impact<br> 9M 2020 | |
|---|---|---|---|---|---|---|
| Total Group | ||||||
| Net sales to third parties | 7 | 4 | 3 | 2 | 4 | -2 |
| Operating income | 22 | 18 | 4 | 3 | 11 | -8 |
| Net income | 29 | 26 | 3 | -1 | 6 | -7 |
| Basic earnings per share (USD) | 31 | 28 | 3 | 0 | 7 | -7 |
| Core operating income | 7 | 4 | 3 | 12 | 16 | -4 |
| Core net income | 8 | 5 | 3 | 11 | 15 | -4 |
| Core basic earnings per share (USD) | 10 | 7 | 3 | 12 | 16 | -4 |
| Innovative Medicines | ||||||
| Net sales to third parties | 9 | 6 | 3 | 4 | 5 | -1 |
| Operating income | 21 | 18 | 3 | -4 | 2 | -6 |
| Core operating income | 11 | 8 | 3 | 9 | 13 | -4 |
| Sandoz | ||||||
| Net sales to third parties | 0 | -4 | 4 | -2 | 0 | -2 |
| Operating income | 81 | 75 | 6 | -10 | -1 | -9 |
| Core operating income | -15 | -18 | 3 | 15 | 19 | -4 |
| Corporate | ||||||
| Operating (loss)/income | nm | nm | nm | nm | nm | nm |
| Core operating loss | -19 | -17 | -2 | 29 | 31 | -2 |
| nm = not meaningful |
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Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “momentum,” “growth,” “continued,” “increasing,” “guidance,” “rejuvenation,” “continues,” “confident,” “will,” “driven,” “launch,” “expand,” “anticipated,” “action,” “initiating,” “continues,” “development,” “remains,” “outlook,” “expected,” “to grow,” “estimated,” “to meet,” “ongoing,” “to support,” “to gain,” “innovation,” “pipeline,” “retaining,” “can,” “resubmission,” “focus,” “priority,” “unforeseen,” “forecast,” “prevail,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on parts of our business including oncology and generics; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions or products; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our in-licensing of tislelizumab from Beigene. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. In particular, our expectations could be affected by, among other things: liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; the impact of the COVID-19 pandemic on enrollment in, initiation and completion of our clinical trials in the future, and research and development timelines; the impact of a partial or complete failure of the return to normal global healthcare systems including prescription dynamics, particularly in oncology and generics, in the fourth quarter of 2021; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this press release; the potential that the strategic benefits, synergies or opportunities expected from the transactions described, may not be realized or may be more difficult or take longer to realize than expected; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, investigations or disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis Group companies.
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About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar.
Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on Novartis divisions and pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can be found at https://www.novartis.com/investors/event-calendar.
Important dates
December 2, 2021
Capital Markets Day (with a focus on R&D)
February 2, 2022
Fourth quarter & Full Year 2021 results
March 4, 2022
Annual General Meeting
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<br><br><br><br><br><br><br><br>FINANCIAL RESULTS