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Novartis Annual Review 2018 | 1
Contents
Chairman’s letter 2
CEO’s letter 3
Who we are 4
What we do 6
Key performance indicators consolidated highlights 8
Highlights 14
Performance
Group performance 15
Division performance 17
Our priorities
Unleash the power of our people 22
Deliver transformative innovation 26
– Key products in development 30
Embrace operational excellence 32
Go big on data and digital 38
Build trust with society 40
Chairman’s letter
Dear shareholder,
In 2018, Novartis strengthened its oper- development activities, we expect in rity and ethical behavior across our
ations, expanded its therapeutic plat- novative medical approaches in areas company, we have further strengthened
forms, and accelerated its push into the such as gene therapy and immunology our risk and compliance structure and
data and digital healthcare space. to hold the potential for the development improved our respective processes,
Together, these steps are set to increase of curative therapies. In domains such including our approach toward the man-
our ability to develop breakthrough as chimeric antigen receptor T-cell agement of cyber risk.
therapies, improve patient outcomes, (CAR-T) therapy, we have made good
and support our sales and profit growth progress over the past few years. We I thank you for the confidence you have
to create sustainable value for our also deepened our digital footprint by placed in our company and am pleased
shareholders and society as a whole. initiating a range of collaborations to to be able to propose a dividend
strengthen scientific and commercial increase of 2% to CHF 2.85 at the next
Last year, we announced the intention operations. Annual General Meeting.
to spin off our eye care division, Alcon;
divested a part of the US-based gener- In view of the rising healthcare chal-
ics business of Sandoz; and sold our lenges both in industrialized and in Sincerely,
remaining consumer healthcare stake developing and emerging countries, we
to joint venture partner GlaxoSmith- remain acutely aware of the need to
Kline. These moves were designed deliver our medicines to more patients.
to position Alcon as an independent We have a proven track record of sup-
leader in ophthalmology, strengthen the porting individual patient assistance
existing operations of Sandoz, and and global drug access programs, such
solidify the position of Novartis as a as the Novartis Malaria Initiative and our Joerg Reinhardt
focused pharmaceutical company. Novartis Access program, and we remain Chairman of the Board of Directors
dedicated to these global activities. We
We also made substantial investments believe they help stabilize healthcare
in breakthrough technologies such as systems and increase trust in Novartis
gene therapy, nuclear medicine and data as a reliable healthcare partner.
science. These include the acquisitions
of gene therapy firm AveXis and radio- As much as we are dedicated to the
pharmaceutical companies Advanced highest scientific standards when devel-
Accelerator Applications and E
ndocyte, oping new medicines, Novartis is also
which are set to strengthen our position committed to the highest ethical norms
in neuroscience and oncology. As a regarding the execution and gover-
science-based healthcare company
nance of our business. As part of our
with cutting-edge global research and continual efforts to maintain high integ-
As a science-based
healthcare company with
cutting-edge global research
and development activities,
we expect innovative medical
approaches in areas such
as gene therapy and
immunology to hold the
potential for the development
of curative therapies
Joerg Reinhardt
CEO’s letter Novartis Annual Review 2018 | 3
CEO’s letter
Dear shareholder,
We are endeavoring every day to We began a cultural transformation We want to help lead a digital revolution
reimagine medicine to truly impact the aimed at empowering our people to in our industry. We built a team of 1 500
lives of people all around the world. As apply their full creativity to tackling big experts across the enterprise and are
I wrap up my first year as CEO, I’m scientific and healthcare challenges. pursuing 12 major projects to embed
pleased to report that Novartis contin- This is the start of a multi-year journey digital technologies and advanced data
ued to deliver on its purpose while we that we believe will help us continue to analytics in our labs, factories and com-
transformed the company into a more create long-term value for shareholders mercial operations. For instance, a new
focused, agile enterprise that is well and society. To help drive change, we system called Nerve Live uses insights
placed to deliver cutting-edge innova- revitalized the top leadership of the from hundreds of past drug develop-
tion, drive sustained, profitable growth, company, appointing seven new mem- ment clinical trials to help design and
and earn the long-term trust of the bers to the Executive Committee. I also run more effective trials today.
stakeholders we serve. visited our teams in more than 25 coun-
tries to learn about the organizational We need society’s trust to continue
Over the course of 2018, we took sig- hurdles our people face and to gather doing the incredible work we do, and we
nificant steps to focus Novartis as a ideas for addressing them. I thank them strive to earn that trust through our
leading medicines company. We sold for their energy and commitment, which actions. We have made clear to every-
our stake in our global consumer health are both encouraging and infectious. one at Novartis that we must never com-
joint venture and announced plans to promise our ethical standards to meet
spin off our eye care division, Alcon. We Our research and development teams business objectives. We reinforced our
built up three new technology platforms secured 20 major approvals during compliance function and added the role
that we believe offer powerful new 2018, including a second indication for of Chief Ethics, R isk and Compliance
treatment options to doctors and our breakthrough cell therapy, Kymriah, Officer to the Executive Committee. To
patients, including cell and gene thera- to treat large B-cell lymphoma. They further expand access to our medicines,
pies and radioligand therapies. And we also made 20 major filings, including we renewed commitments to fighting
signed more than 100 collaboration and for BAF312 to treat multiple sclerosis, malaria and leprosy, and adopted princi-
licensing agreements to build greater and for AVXS-101, a potentially trans- ples aimed at embedding access into
depth in our core areas. formative treatment for spinal muscular our everyday business. Our systematic
atrophy. We believe we have more than approach helped us rise to No. 2 in the
Meanwhile, our teams delivered strong 20 potential blockbusters in develop- 2018 Access to Medicine Index.
performance. Growth accelerated, ment, and we plan to make 60 major
driven by strong sales of key products. submissions to regulators from 2019 to More work remains, but I hope you
Net sales of USD 51.9 billion grew 5%, 2021. share my enthusiasm for the strides
measured in constant currencies (cc). we’re making in all of these areas.
Our core operating income grew 8% to We are taking steps to build greater
USD 13.8 billion (cc). effectiveness and efficiency into how
we work. In manufacturing, we’re adjust- Sincerely,
We also defined five strategic priorities ing production capacity to match our
that we believe will drive the successful evolving product mix, and in business
future of Novartis – and we made services, we’re further concentrating
important progress in each of these operations in five global service cen-
areas. Here are some highlights. ters. Our commercial teams are focused
on improving how we plan and execute Vas Narasimhan
new product launches. Chief Executive Officer
4 | Novartis Annual Review 2018
Who we are
Our purpose
medicines discovered by
ss
i
ces (
neuroscience; respiratory;
and cardio-metabolic. NOVARTIS TECHNICAL
NBS)
OPERATIONS (NTO)
handles manufacturing of
y
SANDOZ
c olo g
high-quality, affordable
cation and capacity planning
generics and biosimilars.
Sa
Ma
O)
oz
n uf
ALCON a c t u ri n g ( N T NOVARTIS BUSINESS
With its Surgical and Vision Care SERVICES (NBS)
businesses, Alcon offers one of A lc o n consolidates support
the world’s widest selections of services across our organi
eye care devices – from sophisti- zation, helping drive effi-
cated equipment for delicate eye ciency, simplification, stan-
surgery, to a wide portfolio of dardization and quality.
advanced contact lenses.
CORPORATE FUNCTIONS
In 2018, Novartis announced the
intention to spin off Alcon, Corporate functions support
pending approval from share- the enterprise in specific
holders and regulators. areas of expertise, including
finance, human resources,
legal and communications.
Who we are Novartis Annual Review 2018 | 5
Our people
The greatest strength of Novartis is our people, whose diversity,
energy and creativity are crucial to our success.
HEADCOUNT NATIONALITIES
129 924 147
22.6 42 %
t
rib
ibu
Dist
Distr
6 | Novartis Annual Review 2018
in g
Com
Co
What we do
tur
mm
in g
me
ac
ia ci
uf
er
ur
ct an
rc
liz a li
ati fa za M
on M anu ti o n
R&D R&D
Talented people ion
n but R& n Improved health and
i
io
io
r
well-being for people
D
st
ut
ut
Financial capital Di
rib
rib
Access to medicine
Dist
Dist
in g
in g
Jobs
Co
Co
tur
tur
in g
me
Technology
mm
mm
ac
ac
ur
rc
uf
er
an
uf
er
ct
ia
liz
Infrastructure
a an at u fa a li
za
at & facilities
io n
M io n an ti o n M
M
155 817 m 24 m
COUNTRIES PATIENTS PATIENTS
where Novartis reached in total reached through
products are sold access programs
What we do Novartis Annual Review 2018 | 7
Our environment
We live in an era of amazing medical innovation, driven by better understanding of the genetic and biological roots of
disease, and surging use of data analytics and digital technology in science and healthcare. At the same time, the world’s
population continues to grow and people are living longer, fueling a rise in chronic diseases. Together, these factors are
increasing demand for high-quality care worldwide and pressuring healthcare systems to restrain spending growth.
Our strategy
STRATEGIC PRIORITIES
As we implement our strategy, we have five priorities to shape our future and help us continue to
create value for our company, our shareholders and society.
p. 22 p. 26 p. 32 p. 38 p. 40
8 | Novartis Annual Review 2018
Financial
Key figures1
(in USD millions, unless indicated otherwise)
% Change
Constant
2018 2017 USD currencies
Share
2018 information 2017
% Change
This Novartis Annual Review 2018 includes non-IFRS financial measures such as core
1 2
2018 weighted average number of shares outstanding: 2 319 million (2017: 2 346 million)
results, constant currencies and free cash flow. Novartis believes that investor 3
Dividend 2018: proposal to shareholders for approval at the Annual General Meeting on
understanding of the Group’s performance is enhanced by disclosing these non-IFRS February 28, 2019
measures. A definition of non-IFRS measures used by Novartis, and further details,
including reconciliation tables, can be found in “Item 5. Operating and Financial Review
and Prospects” of the Novartis Annual Report 2018.
Key performance indicators consolidated highlights Novartis Annual Review 2018 | 9
Innovation
Key figures 1
2018 2017
Social
Access
2018 2017
People
Health,
safety and environment 13
Lost-time injury and illness rate (per 200 000 hours worked) 14 0.16 0.12
Greenhouse gas emissions, total Scope 1 and Scope 2 (1 000 t) 15 1 123.24 1 250.39
1
Includes Innovative Medicines and Sandoz biosimilars only 7
The 2017 patient number was restated to account for the Ophtha OTC brands that
2
Includes programs entering confirmatory development, based on internal R&D were carved out from Novartis Pharmaceuticals.
activities. First patient, first visit (FPFV) has occurred in post-proof-of-concept stage 8
Programs run by Novartis Social Business and Novartis Foundation. Programs at scale
after NIBR or external entry report the catchment of a population in the area where a program has been
3
Includes projects with FPFV in a Phase III study but not yet filed in the US, EU or Japan implemented.
4
Number of breakthrough therapy designations granted by the US Food and Drug 9
Headcount reflects the total number of associates in our payroll systems. Full-time
Administration for therapies under development by Novartis equivalent adjusts headcount for associates working less than 100%. All data as of
5
Includes small molecules, biologics; new fixed-dose combinations of existing APIs; and December 31
new target indications, defined as new disease or new line of treatment (e.g., first line 10
Management defined by Global Job Level Architecture and Novartis Top Leaders
vs. second line) 11
Novartis Top Leaders comprise the approximately 350 most senior managers at
6
Includes NMEs such as small molecules, biologics; in the EU, new fixed-dose Novartis, including the Executive Committee of Novartis.
combinations of existing APIs 12
The number of misconduct cases reported may change, as matters may be reassessed
in the course of the case lifecycle. The number of substantiated allegations may
change due to the fact that investigation reports with assessments are received on an
ongoing basis, which potentially leads to a difference in numbers at a later stage.
13
The 2018 environmental sustainability data published in this report are actual data for
the period from January through September, and best estimates for the period from
October through December, which will be updated with actual data in the first quarter
of 2019. Significant deviations will be reported on our website and restated in next
year’s report.
14
Data include Novartis associates and third-party personnel managed by Novartis
associates.
15
Scope 1: combustion and process, and vehicles; Scope 2: purchased energy
Novartis Annual Review 2018 | 11
Mongolia
Dr. Naranjargal Dashdorj
After training
abroad, a
doctor returns
to her roots
Dr. Naranjargal Dashdorj has been
on a journey for most of her life. She
grew up as a nomad in Mongolia
with dreams of becoming a surgeon,
and studied her way to prestigious
universities and training programs in
China, the UK and the US. After
fulfilling her childhood goal, she was
inspired to return to her homeland
to make a difference in the lives of
disadvantaged Mongolians. Today
she heads the Onom Foundation,
an organization she co-founded to
address education and healthcare
challenges in Mongolia, including
liver disease. Mongolia has the
world’s highest rate of liver cancer
mortality – and both liver cancer and
cirrhosis (late-stage liver scarring)
account for 15% of all deaths in the
country each year. In September
2014, the foundation and its partners
initiated a program in Mongolia
aiming to eliminate hepatitis C by
2020. As part of the program, the
foundation established the Liver
Center, Mongolia’s first nonprofit
healthcare facility solely dedicated
to the diagnosis, treatment and
research of liver disease.
12 | Novartis Annual Review 2018
1 Patients travel great distances to see Dr. Naranjargal Dashdorj and her team. One of them is a
woman named Tuya, a nomadic camel herder from the Gobi Desert who has liver disease.
2 Dr. Dashdorj visits the temple where her great-grandfather, a lama (spiritual leader), stored his
religious textbook. The Onom Foundation was named after her grandfather, who was also a lama.
3 Dr. Dashdorj provides medical services on World Hepatitis Day, a global event to raise awareness
about viral hepatitis. Viral hepatitis causes liver damage and is responsible for two in every three
liver cancer deaths.
Novartis Annual Review 2018 | 13
1 2
3
14 | Novartis Annual Review 2018
Highlights
JANUARY FEBRUARY MARCH APRIL
Acquire Advanced Launch Glatopa 40 mg/mL Develop digital therapeutics Renew commitment to
Accelerator Applications in the US We are working with Pear malaria elimination
(AAA) It is a generic option for relapsing Therapeutics on treatments for USD 100 million to go toward
The acquisition strengthens forms of MS schizophrenia and MS; Pear R&D over the next five years
our oncology portfolio Therapeutics and Sandoz launched
a substance use disorder app in Launch app to modernize
Obtain ex-US rights to November ophthalmic clinical trials
breakthrough gene therapy With FocalView, patients can
Luxturna, from Spark Thera Expand alliance with participate in trials from home
peutics, treats rare vision loss Science 37
The agreement aims to advance Obtain FDA approval for
Announce FDA approval virtual clinical trials Tafinlar + Mekinist in new
of Lutathera indication
Developed by AAA, the drug Receive FDA approval for Approval is for the adjuvant
is approved to treat certain Tasigna in new indication treatment of BRAF V600-
neuroendocrine tumors Tasigna is approved to treat mutant melanoma
children with a rare form of
leukemia
Receive FDA approval for Complete sale of stake in Announce expanded Announce EU approval
Kymriah in second indication consumer healthcare indications for Kisqali in of Kymriah
It is approved to treat appropriate r/r business the US Approval is for two forms of
patients with large B-cell lymphoma The GSK joint venture was formed It is approved to treat pre-, blood cancer
during our portfolio transformation peri- or postmenopausal
Secure FDA approval for women with HR+/HER2- Secure third European
Gilenya in new indication Announce planned Alcon advanced or metastatic approval for Tafinlar +
It is the first disease-modifying spin-off breast cancer Mekinist
therapy for pediatric relapsing MS We will seek shareholder It is for the adjuvant treatment
approval at the 2019 AGM Receive EU approval for of advanced melanoma
Complete AveXis acquisition biosimilar Hyrimoz
The deal could help transform spinal It is the seventh Sandoz
muscular atrophy treatment biosimilar approved in Europe
Announce plans to sell Receive FDA and EMA filing Rise to second place in Complete Endocyte
portions of the Sandoz US acceptance for BAF312 the 2018 Access to acquisition
portfolio (siponimod) Medicine Index Endocyte is focused on
We will divest the US dermatology If approved, the drug would treat We remain the industry leader in developing radioligand
and generic oral solids businesses secondary progressive MS in one area: access-to-medicine and CAR-T therapies for
to Aurobindo adults management cancer treatment
Performance
Novartis delivered strong performance in 2018. Growth accelerated, driven
mainly by rising sales of key products launched in the last several years. We
also continued to make significant progress reshaping Novartis into a company
focused on developing and commercializing transformative medicines.
Accelerating growth
Strong performance by key products (cc). Jakavi, a treatment for blood disor- ers and acquisitions, asset write-
underpinned our growth in 2018. Novartis ders and cancers, grew 24% (cc) to USD downs, and increased investment in
net sales were USD 51.9 billion, rising 5% 977 million. marketing and sales, which more than
from the prior year when measured in offset the positive impact of higher
constant currencies (cc) to remove the We continued to see strong uptake of sales. Net income of USD 12.6 billion
impact of exchange rate movements. biosimilars – less expensive follow-on benefited from a net gain of USD 5.7 bil-
Four products achieved USD 1 billion in versions of complex biologic drugs that lion from the sale of our stake in the
annual sales for the first time to become are being embraced by healthcare consumer health joint venture with
blockbusters. systems, particularly in Europe. In our GlaxoSmithKline (GSK). Earnings per
generics division, Sandoz, sales of bio- share were USD 5.44.
Cosentyx, our treatment for psoriasis similars and other biopharmaceuticals
and other autoimmune d iseases, had grew 24% (cc) to USD 1.4 billion. In our To help people understand our under-
sales of USD 2.8 billion, up 36% (cc). eye care division, Alcon, sales grew for lying performance, we also present our
Entresto, a treatment for heart failure the second consecutive year with the core results, which exclude the impact
that has now been used to treat more strong performance of Dailies Total1 of acquisitions, disposals, restructur-
than 1 million people worldwide, had advanced contact lenses and intraocu- ings and other significant items. Core
sales of USD 1.0 billion, more than dou- lar lenses for cataract surgery. operating income of USD 13.8 billion
bling from the prior year. rose 8% (cc), driven by the higher sales.
In Europe, our largest market, overall Core net income of USD 11.9 billion rose
Treatments for cancer and related rare sales grew 6% (cc). In the US, where 5% (cc). Core earnings per share were
diseases also performed well. Promacta, there is increasing pressure on prices, USD 5.15, up 6% (cc). Free cash flow of
a treatment for blood disorders and sales rose 4% (cc). Emerging growth USD 11.7 billion was up 12%.
cancers that is also known as Revolade markets, including China, grew 8% (cc).
outside the US, grew 35% (cc) to USD For more detail on our financial performance,
1.2 billion. Tafinlar + Mekinist, a combi- Operating income was USD 8.2 billion, please see our Annual Report 2018 at
nation treatment for skin and lung can- down 5% (cc), mainly due to the impact www.novartis.com/annualreport2018
cers, had sales of USD 1.2 billion, up 31% of higher restructuring charges, merg-
oz
addition to selling our stake in the con-
sumer health joint venture with GSK, we
Pha
announced plans to spin off our Alcon
r m a c e u ti c al
eye care division in 2019, pending final ALCON
A lc o n
approvals, while at the same time main-
taining our strong position in ophthal- 7 149 +5%
14%
s
mic pharmaceuticals.
62% Pharmaceuticals
Our Sandoz generics division moved to 21 464 O n c olo
gy
optimize its core generics business and
increase focus on complex generics 38% Oncology
and biosimilars. As part of this effort, 13 428
Sandoz announced plans to sell a
portfolio of about 300 medicines and
dermatology products in the US to
Aurobindo.
2018 NET SALES BY GEOGRAPHICAL REGION
We continued to build new technology (% of net sales and in USD millions)
platforms that we believe will address Asia, Africa, Canada,
important unmet medical needs. To Europe United States Australasia Latin America
reinforce our leading position in cell
and gene therapies, we purchased 19 064 17 560 11 241 4 035
AveXis, a US company developing a
breakthrough therapy for spinal mus-
cular atrophy, a severe and often deadly
37% 34%
neuromuscular disease caused by a
genetic defect.
apies for cancer treatment. 2018 51 900 +5% 2018 8 169 –5%
2017 49 109 +2%
2017 8 629 +7%
2016 48 518 0%
2016 8 268 –3%
Innovative Medicines
In the Innovative Medicines Division in 2018, key Innovative Medicines 2018 net sales by business unit and franchise
products continued to see strong growth. Net (in USD millions and % growth in constant currencies)
Sandoz
Sandoz had net sales of USD 9.9 billion, down Sandoz 2018 net sales by franchise
3% (cc), due to continued intense pressure on (in USD millions and % growth in constant currencies)
prices for generic medicines industrywide in
the US. A bright spot continued to be biopharma 80% RETAIL GENERICS 7 880 | –7%
Alcon
Alcon net sales rose 5% (cc) to USD 7.1 billion, Alcon 2018 net sales by franchise
mainly driven by intraocular lenses and (in USD millions and % growth in constant currencies)
supplies for cataract surgery, and Dailies Total1
advanced contact lenses. Sales in the 56% SURGICAL 3 999 | +7%
Slovenia
Milena Remic
A cancer
survivor makes
it her mission
to help other
patients
At age 42, Milena Remic learned
she had advanced-phase chronic
myeloid leukemia, a cancer of the
white blood cells. To survive, she
needed to receive a transplant of
blood-forming stem cells from a
genetically compatible donor.
Ms. Remic, who lives in Slovenia,
matched with a donor and
underwent the complex procedure
to replace her cells with healthy
donor cells. It was a success.
Now 54, she is committed to helping
other patients with blood cancer.
Ms. Remic is vice president of the
Slovenian Lymphoma and Leukemia
Patients Association, and spends her
days working on disease awareness
and patient support initiatives. She is
also involved in a national campaign
called Enroll Yourself, which
encourages eligible candidates to
enroll as potential blood stem cell
donors. She credits her own donor
with saving her life.
20 | Novartis Annual Review 2018
1 Milena Remic visits her bone marrow donor and “blood brother,” Thomas Renkel. They wrote
anonymous letters to each other via the transplant clinic and eventually decided to meet.
2 Ms. Remic speaks with attendees at an Enroll Yourself donor event in Prevalje, Slovenia.
After signing paperwork, eligible candidates collect cell samples using cheek swabs.
Their genetic information is then stored in a searchable database.
3 Ms. Remic meets with colleagues in her office in Ljubljana, Slovenia. From her office,
she advises and encourages patients on a daily basis.
1 2
3
Novartis Annual Review 2018 | 21
22 | Novartis Annual Review 2018
STRATEGIC PRIORITIES
ities they need to transform the culture such as health and disease awareness.
and meet the new expectations. This This includes our partnership with a
intensive leadership journey involves a sig- company that helps people maximize
nificant investment of time to benefit from their personal impact. We also launched
the webinars, simulations, social learning a program to support employees who
and personalized coaching support. are affected by cancer and cardiovas-
cular and neurological diseases. It cur-
We also designed an online tool called rently operates in Brazil, India, Italy,
Team Perspectives to help managers Switzerland and the US, and we plan to
improve their leadership skills by receiv- expand its reach in 2019.
ing upward feedback from their teams.
The company’s top 350 leaders received We will measure progress in evolving
initial feedback during the Novartis our culture by repeating the Organiza-
Leadership Forum in September, and tional Culture Inventory ® on a regular
formed small networks to provide sup- basis, to track employees’ behavior and
port as they change their approach. engagement as organizational changes
Team Perspectives will be expanded to take effect. In addition, the previous
include all 12 500 leaders in 2019. biennial Global Employee Survey will be
replaced by instantly accessible tools
The third step for transforming our to detect changing sentiment in real
culture is to ensure the company’s inter- time – for instance by analyzing internal
nal environment and processes encour- communications, and conducting sim-
age people to do their best work. For ple and frequent surveys to m easure
example, the process for reviewing and address employees’ motivations
employees’ performance has been and degree of engagement.
improved with simpler, informal check-
ins, putting more emphasis on conver-
sation and reducing written documen- Talent strategy
tation. In addition, we have introduced
a companywide business performance Our success also depends on attracting,
factor, which is one element used to
determine employees’ annual bonuses.
This replaced 57 different performance
developing and retaining people who
embody our desired culture. We have
maintained our focus on promoting
No. 2
Novartis ranking in the 2018 Thomson
factors based on individual groups or diversity and inclusion (D&I), and were
Reuters D&I Index, which evaluates
divisions, in a move designed to stimu- ranked second out of more than 7 000
companies based on 24 metrics across four
late enterprise-wide thinking.1 companies in the 2018 Thomson Reuters
categories: diversity, inclusion, people
D&I Index, up from sixth in 2017. Demon-
development and news controversies
Finally, we are taking steps to help strating our focus on inclusion, in 2018
employees sustain their energy and Novartis became the first major pharma
impact, both at work and in every other ceutical company to support the United UNBOSSED
aspect of their lives. An initiative called Nations’ workplace standards protecting
Energized for Life encourages more the rights of lesbian, gay, bisexual, trans- Our approach to empowering our people is
flexible working practices and greater gender and intersex people. inspired by ideas explored in the book
well-being through a range of p rograms, “UNBOSS” by Lars Kolind and Jacob Bøtter
1
This typically excludes sales associates, who have
a different incentive system.
24 | Novartis Annual Review 2018 Florencia Segal, a physician-researcher at Novartis
in Cambridge, Massachusetts, consults with patient
James Mulcahy at Brigham and Women’s Hospital
in Boston, where she volunteers one day a week.
AN EPIC PLEDGE In September, Novartis also joined the Another major component of our talent
United Nations Equal Pay International strategy in 2018 was the development
In 2018, Novartis pledged support for Coalition (EPIC), with a pledge to continue of an Employer Value Proposition (EVP),
the Equal Pay International Coalition its global practice of conducting regular which captures our appeal as a place
(EPIC), which is committed to gender pay equity analyses and remedi- to work and provides a framework for
achieving equal pay between men and ating where appropriate. To help prevent attracting talented people. Managers
women for work of equal value pay differences, we have pledged to and recruiters can use a toolkit of EVP
avoid using historic salary data when materials to target candidates with
making job offers and to ensure trans- specific experience and career goals.
parency by telling employees how their We have also increased our social
pay compares to internal and external media presence on websites such as
benchmarks. LinkedIn and Glassdoor.
79%
Novartis remains committed to achiev- least one successor ready to take over
ing gender balance in management immediately.
within five years. Currently, four of the
Percentage of our top 350 leaders who 19 senior positions reporting to the CEO
have at least one successor prepared are held by women. Two of them are
ECN members, up from zero in 2017.
to take over right away
Women make up 42% of management2
A major focus for the company
– the same as in 2017. Of the top 350 is to build our talent pipeline
leaders, 28% are women, a slight
increase from 2017.
and capabilities in the digital
arena
Our work in developing people was
recognized by the Dow Jones Sustain-
ability Index, a key measure of compa-
nies’ performance in the environmental, A major focus for the company is to
social and governance spheres. In build our talent pipeline and capabilities
2018, Novartis maintained its strong in the digital arena. During 2018, we
position with an overall ranking of No. 4 launched interactive online education
in the world, and was recognized as that covers many aspects of digital tech-
industry leader in the field of human nology and is open to all employees, as
capital development. We are preparing well as a series of leadership simula-
plans to address areas where there is tions to help managers enhance their
further scope for improvement, such as digital skills. To learn more, see the
talent attraction and retention. chapter “Go big on data and digital.”
STRATEGIC PRIORITIES
Deliver transformative
innovation
Our research and development activities span multiple therapeutic areas and
are fueled by creativity and commitment. Novartis employs more than 23 000
scientists, physicians and business professionals focused on finding
innovative treatments and bringing them to patients.
9.1 bn
In 2018, our dedicated researchers cular glues, while collaborating to over-
made progress on a number of fronts, come obstacles and following the sci-
especially in neuroscience, oncology ence wherever it leads. Project teams
Research and development and ophthalmology. They also embraced tap experts and inventions from across
spending in 2018, amounting to new technology as we expanded data the company and beyond, forging alli-
17% of net sales (USD) science and digital initiatives while ances with external innovators at major
acquiring key assets, such as gene ther- biomedical research institutions.
apies, to bolster our pipeline of uncon-
4 ventional medicines.
every stage of research. We’re also using While Genesis Labs emphasizes proto- means. We are collaborating with Pear
these new methods to transform large typing, other initiatives aim to increase Therapeutics, a pioneer in prescription
clinical trials that are designed to deter- the use of data science and digital tech- software applications. Such “digital
mine if therapies are safe and effective. nologies in our daily work. Take Nerve therapeutics” undergo rigorous testing
Live, a platform designed to help us run in clinical trials before they’re consid-
development operations, including clin- ered for approval by health authorities.
Data science and digital ical trials, faster and more efficiently. We’re working with Pear Therapeutics
technologies Two years ago, we began to consolidate to develop mobile apps for patients with
our huge pool of past and present data schizophrenia and multiple sclerosis
Novartis expanded key data science about our clinical trial operations into and to commercialize an app for sub-
and digital programs in 2018 to accel- one centralized system, working with stance use disorder. The apps are
erate the metamorphosis of research computational experts to create custom designed to deliver cognitive behavioral
and development. One challenge that apps that can bring actionable insights therapy anywhere at any time.
we face is finding the time to dream up at key decision-making points. Nerve
applications for emerging technologies. Live is the result.
To address this hurdle, we encourage New technology
employees to pitch projects with trans- The platform employs predictive ana- platforms
formative potential through programs lytics to help us select the best trial sites,
such as Genesis Labs, an internal predict participant enrollment, optimize The rise of digital therapeutics i llustrates
incubator for multidisciplinary ideas. drug supply, anticipate delays before that medicines increasingly take differ-
Teams – which can include external they occur, and more. It includes a con- ent forms from conventional pills and
researchers – are given the time, space, trol room that opened in 2018 and injections. In 2018, we made significant
mentors and resources to develop and receives real-time updates on all ongo- investments in several new technology
rapidly test their proposals. ing trials to direct actions in support of platforms – broadly applicable tools with
our global teams. Data is one of our the potential to become therapeutic sta-
A number of Genesis Labs projects greatest assets, and tools such as Nerve ples and game changers for patients.
focus on the integration of data science Live will help us unlock its potential.
and digital technologies in research and For example, we acquired Advanced
development. One team, for example, In addition to helping us behind the Accelerator Applications (AAA) and its
is using machine learning – a method in scenes, digital technologies are increas- radioligands, targeted drugs that are
which computers teach themselves ingly visible to patients in our clinical designed to deliver radiation to tumors.
from data – to improve how we analyze trials. We’re leveraging smartphones, AAA’s treatment for gastroenteropan-
tissue samples that have been placed electronic health diaries and wearable creatic neuroendocrine tumors, a pep-
on slides, particularly for preclinical devices to improve our research as well tide receptor radionuclide therapy
safety studies. Our researchers pro- as the patient experience. In some cases, called Lutathera, was the first of its
cess hundreds of thousands of slides it’s possible to collect comprehensive type to receive approval in the US and
each year. This project could streamline data from patients without requiring Europe. Additional radioligand therapies
and enhance their work. them to visit clinical trial sites at regular targeting other tumor types are under
intervals. To this end, we are collaborat- development. We also acquired Endo-
In 2018, we expanded Genesis Labs ing with startup companies, such as cyte, a company developing similar
beyond our early research labs, inviting Science 37, that design decentralized technology to treat prostate cancer.
employees in our drug development clinical trials, which are more convenient
and manufacturing groups to partici- for patients. We have already initiated We also advanced our portfolio of cell
pate. The program organizers received decentralized clinical trials for cluster and gene therapies in 2018. These
nearly 250 initial proposals from 22 dif- headache, acne and NASH. involve genetically reprogramming cells
ferent Novartis sites and ultimately either outside or inside the body. Our
selected six projects to move forward. In some cases, digital technologies are flagship cell therapy, Kymriah, is a CAR-T
even changing what the word “medicine” therapy that is generated by removing
28 | Novartis Annual Review 2018
a patient’s own white blood cells, repro- death in infants. AveXis has valuable
gramming them to recognize cancer, AAV manufacturing capabilities to bol-
and then reinserting them into the body. ster our expertise.
AVXS-101
In August 2017, this “living drug” became
Has been granted FDA breakthrough the first CAR-T therapy approved in the Earlier in the year, we entered into a
therapy designation for the treatment of US, providing a much-needed treat- licensing agreement with Spark Thera-
spinal muscular atrophy type 1, a life- ment option for pediatric and young peutics to register and commercialize
threatening neurological genetic disorder adult patients with a particular type of its product Luxturna (voretigene nepar-
acute lymphoblastic leukemia. In 2018, vovec) – the first AAV-based therapy
we received approval in the US, EU and approved by the US Food and Drug
other markets for a second indication: Administration – in markets outside the
a particular type of relapsed or refrac- US. Luxturna is designed to restore
tory large B-cell lymphoma in adult vision in patients with mutations in both
patients. copies of the RPE65 gene, a rare
AIMOVIG genetic condition that leads to total
Our teams are designing and develop- blindness by the time patients are in
Is approved in the US and EU for the
ing next-generation CAR-T therapies their mid-30s.
prevention of migraine, which affects
with the potential to target more than
1 billion people around the world
one protein on cells. Researchers are These agreements complement our
also working to apply CAR-T technology existing programs, including an AAV
to other tumor types, streamline our collaboration with Homology Medicines.
manufacturing processes, and further We began working with the company in
increase manufacturing capacity in an 2017 to discover therapies for genetic
effort to help more patients. blood disorders and eye diseases.
In addition to growing our CAR-T pipe- Other technology platforms are just
line, we’re investing in a platform that beginning to emerge. Our scientists are
facilitates the genetic reprogramming exploring a new class of therapeutics
of cells inside the body. In 2018, we called molecular glues. The cellular
closed deals with biotech companies world is full of compounds that bind two
that have deep experience with adeno- protein molecules together. Such
associated viruses (AAVs), the tool “glues” can help cells function and
behind a new wave of gene therapies. thrive. Inspired by Mother Nature,
CAR-T cell AAVs resemble hollow balls. They can Novartis scientists are now creating
be filled with cargo, including human new, synthetic glues to short-circuit dis-
genes, and directed toward particular ease cells and treat serious medical
cell types. AAVs differ from other conditions. Some of the proteins that
viruses in one key respect: They don’t glues target have for years been known
cancer cell
cause illness. This built-in safety feature to contribute to disease, yet conven-
makes them attractive for therapeutic tional approaches to drug discovery
applications. have failed to yield medicines. Now
some proteins that cannot easily be
CAR-T CELL In May, we acquired AveXis, including its targeted by drugs may be glued to other
lead product candidate, AVXS-101, an proteins, enabling us to degrade them.
Within the patient’s body, CAR-T cells have the AAV-based gene replacement therapy
potential to recognize cancer cells and other designed to treat a neurodegenerative
cells expressing a specific antigen, and attach disease called spinal muscular atrophy
to them, which may initiate direct cell death (SMA), the leading genetic cause of
Deliver transformative innovation Novartis Annual Review 2018 | 29
Advancing transformative coating that surrounds the brain and HER2- advanced breast cancer who
spinal cord. In total, MS affects 2.5 mil- have progressed on or after an endo-
therapies lion people worldwide, with the disease crine-based regimen. This combination
We continue to use the effective, con- occurring in different forms. Gilenya nearly doubled the time to disease
ventional tools of drug hunters to find (fingolimod), our oral treatment for progression in patients with this muta-
new ways to successfully fight disease. relapsing-remitting MS, received addi- tion compared to fulvestrant alone in a
Our teams focus on advancing small tional approval in the US and EU in 2018 Phase III clinical trial. If approved,
molecules and biologics with the poten- as the first disease-modifying therapy BYL719 would be the first and only PI3K
tial to make a big difference for patients. for young patients with the disease. inhibitor for HR+ breast cancer.
In 2018, we made significant progress Young MS patients frequently suffer
in several therapeutic areas, including double or triple the relapse rates of Our combination treatment for mela-
neuroscience, oncology and ophthal- adults, and clinical studies have shown noma, Tafinlar + Mekinist, received sev-
mology. We launched new products for that Gilenya reduces these rates by eral approvals – including in the US and
diseases with limited treatment options approximately 82% compared to inter- EU – for an additional indication as an
and laid the foundation for additional feron beta-1a, a standard MS treatment. adjuvant therapy for melanoma patients
drug approvals. We’re also advancing a different com- with a BRAF V600 mutation. Of the
pound for the treatment of secondary roughly 200 000 melanoma diagnoses
progressive MS. Phase III clinical stud- made each year, nearly half of these are
ies have shown that BAF312 (siponi- driven by a specific genetic mutation
NEUROSCIENCE mod), our investigational oral treatment, called BRAF. Tafinlar + Mekinist is one
delays disability progression in this of the only combination treatments
Our neuroscience pipeline has deliv- form of MS, a first. We have filed in the available as an adjuvant treatment for
ered innovative therapies to address US and EU for this indication. these patients, and clinical trials have
unmet medical needs in migraine and shown that this option can be used to
multiple sclerosis. In partnership with reduce the risk of death or cancer reap-
Amgen, we received approval for Aimovig pearance after tumors are removed via
(erenumab) in the US, the EU and other ONCOLOGY surgery.
markets for migraine prevention. Novartis
co-commercializes Aimovig with Amgen Our oncology pipeline delivered treat-
in the US, and Novartis has the exclu- ments for advanced breast cancer and
sive rights to Aimovig outside the US, melanoma in 2018. In July, we received OPHTHALMOLOGY
except for in Japan. Migraine affects a new approval for Kisqali in the US for
one in 10 people and is the third leading women with hormone receptor-positive We have also been working toward
cause of disability in people under 50. (HR+)/human epidermal growth factor innovative therapies for eye diseases
Patients frequently suffer from recur- receptor 2-negative (HER2-) advanced such as neovascular age-related mac-
rent, debilitating attacks, and until now, or metastatic breast cancer. Kisqali is ular degeneration (nAMD). nAMD is a
there have been no treatments specif- now the only CDK4/6 inhibitor approved leading cause of severe vision loss,
ically designed to prevent migraine. for use with an aromatase inhibitor for affecting up to 25 million people world-
Aimovig blocks a protein signal that is the treatment of pre-, peri- or post- wide, and current treatments require
believed to trigger the excruciating pain menopausal women in the US. It is also injections into the eye every four or
and other symptoms of migraine. In clin- approved for use in combination with eight weeks. In October, we announced
ical trials, many patients on Aimovig fulvestrant as both first- or second-line additional positive results from Phase
reported more than a 50% decline in therapy in postmenopausal women. III studies of RTH258 (brolucizumab)
their monthly number of migraine days. in nAMD. RTH258 is a novel antibody
We initiated global submissions for fragment with the potential to signifi-
Multiple sclerosis (MS) is a debilitating approval to market BYL719 (alpelisib) in cantly reduce the burden associated
disease in which the body’s immune combination with fulvestrant for post- with the number of treatment injections
system attacks the protective myelin menopausal women and men with HR+/ needed for nAMD.
30 | Novartis Annual Review 2018
Key products in
development
Novartis is consistently rated as having one of the industry’s most
respected development pipelines, with more than 200 projects in clinical
development, as of December 31, 2018. We highlight some promising
late-stage projects, including new molecules and existing treatments
that are under investigation for new indications.
1
The brand name Mayzent has been provisionally approved by the US
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) for BAF312, but the product itself has not been approved
for sale in any country.
2
The brand name Zolgensma has been provisionally approved by the FDA
for AVXS-101, but the product itself has not received marketing
authorization or Biologics License Application approval from any
regulatory authorities.
Key products in development Novartis Annual Review 2018 | 31
200+ 20 20
PROJECTS IN MAJOR MAJOR
CLINICAL DEVELOPMENT APPROVALS SUBMISSIONS
Ongoing trials in Phase II or III for programs that Granted in 2018 by health authorities in the US, Applications in 2018 to health authorities in the
have reached confirmatory development the EU and Japan for new treatments as well US, the EU and Japan for marketing approval
as new indications for existing treatments for new treatments and new indications
STRATEGIC PRIORITIES
Embrace operational
excellence
Novartis teams continue to find new ways to improve the effectiveness and
efficiency of our operations. These efforts help underpin our significant
investment in research and development, our investments in the launches
of innovative new treatments, and our financial performance. Our efforts cut
across the company, with special emphasis on manufacturing, business
services and new product launches.
Basel
Mohanad Fors
Using digital
technology
to enhance
clinical trials
Mohanad Fors has a passion for
digital technology. He co-founded
the Novartis Biome, a digital
innovation lab and series of open
innovation initiatives. He also led the
team that developed a first-of-its-
kind app called FocalView, launched
by Novartis in the US in 2018.
FocalView is an ophthalmic digital
research platform created with
Apple’s ResearchKit. It enables
patients participating in studies of
experimental eye disease treatments
to test their vision on their iPhones®
– without having to visit a doctor.
The app collects real-time, patient-
reported data, which researchers
use to track disease progression.
By making clinical trials more
accessible and flexible, FocalView
could increase the volume and
accuracy of patient data. Ultimately,
the work of Mr. Fors and the team
that developed FocalView could
improve our understanding of eye
diseases and help lead to new and
better treatments.
36 | Novartis Annual Review 2018
3
Novartis Annual Review 2018 | 37
4
FocalView helps patients complete various assessments like visual acuity and
contrast sensitivity tests. They can do this all from the comfort of their own
home – a major convenience for patients, especially those with mobility issues.
5 By accommodating patients’ daily routines, FocalView could break down
barriers to clinical trial participation.
1 2
4 5
38 | Novartis Annual Review 2018
STRATEGIC PRIORITIES
These and other digital technologies are 20 years. In a project called Data42, we
driving a new wave of scientific and hope to mine 2 million patient years of
medical innovation. They bring powerful clinical trial data to uncover new insights
new tools to every aspect of our work, into why patients suffered from dis-
from the lab to our interactions with eases such as breast cancer, multiple
doctors and patients. They are helping sclerosis and heart failure, as well as
us automate processes and support our how their disease progressed and how
decision-making as we strive to increase they responded to treatment.
productivity and find smarter ways of
working. To underscore the importance Advances in machine learning – where
of digital technologies in executing our computers learn to identify previously
strategy, in 2018 Novartis elevated the unseen patterns in large, complex data
role of Chief Digital Officer to the Exec- sets – offer the hope of identifying sub-
utive Committee of Novartis. groups of patients most likely to respond
to a particular treatment, or of identify-
Our digital strategy has several facets. ing a previously unknown benefit from
We are pursuing 12 major lighthouse a particular drug.
projects to lead the way in embedding
digital technology across the company. One example of this approach is in the
We are collaborating with other organi- area of heart disease, where we are
zations to accelerate our digital capa- working to integrate into one data pool
bilities and employ the latest technol- the results of 13 clinical trials involving
ogy. And we are equipping employees about 50 000 patients. In addition, we
with the tools to help them apply digital plan to include data about the patients’
technologies in their work. genetic makeup and the levels of import-
ant proteins in their bodies.
We are also deploying artificial intelli- Collaborations augment make it easier for patients to participate
gence to help predict if a specific prod- in our clinical trials. Their health can be
uct will be distributed to patients before know-how at least partly monitored at home, re
reaching the end of its normal shelf life. The tremendous potential of digital tools ducing the number of times they must
This should enable us to maintain high in science and healthcare is sparking visit a trial site for tests. In small trials
levels of customer service while avoid- creative ideas in universities, small start- of new drugs to treat severe acne and
ing write-offs. ups and big companies. This is a boon to cluster headache, Science 37 was more
innovation, and we are working with more successful at recruiting and retaining
than 250 collaborators to access the lat- participants than traditional sites.
Digital assistance in sales est technology and accelerate our digi-
tal and advanced analytics capabilities. We have also taken steps to support the
In our commercial operations, we are development of digital health innovators.
transforming the way we approach In recent years, we have invested in
physicians. Our sales representatives, about a dozen young digital health com-
who visit about 100 000 doctors a day panies, most of which are our collabo-
around the world, are starting to bene-
We are working with more rators, to help accelerate their growth.
fit from the capabilities of new digital than 250 collaborators to In 2018, we launched the Novartis Biome,
tools to facilitate more effective inter- an innovation lab for entrepreneurs in
actions. Working with a company called
access the latest technology digital health that provides access to
Aktana and other collaborators, we’re and accelerate our digital Novartis resources, such as data from
using machine learning to sift through and advanced analytics our clinical trials and mentoring. And we
information from multiple databases, provided support to StartUp Health, an
such as doctors’ prescribing behavior, to capabilities organization that invests in e
ntrepreneurs
suggest the best way for salespeople to working on bold solutions to major health
approach them and address their needs. challenges.
For instance, in the US we’ve learned One novel use of technology is digital
through experience that cardiologists applications that are prescription ther- Digitally savvy employees
tend to try our heart failure medicine apies for neurological disorders and
Entresto with a few patients for about other illnesses, or that work in combi- To support our transformation, we cre-
four months before deciding whether nation with drugs to improve health out- ated learning opportunities for employ-
to prescribe it for additional patients. comes for patients. We are collaborat- ees to improve their digital and data
The new digital tool uses that insight, ing with Pear Therapeutics to develop knowledge and capabilities. Our aim is
along with others from about 40 dif digital therapeutics to treat schizophre- to demystify digital technologies, show
ferent databases, to suggest to sales nia and multiple sclerosis. In addition, how they can transform our work, and
representatives when to visit individual our generics division, Sandoz, is help- accelerate their use.
doctors and how to provide them with ing to commercialize a prescription dig-
information or support they can use. ital therapeutic called reSET that was We launched interactive online educa-
developed by Pear Therapeutics to tion covering many aspects of digital
About 500 sales representatives in six treat substance use disorder and has technology and the Novartis digital
countries piloted the new system in 2018. been cleared by the US Food and Drug strategy. So far it has been used by
Initial findings show that they doubled Administration. more than 20 000 people, with 12 000
their use of the customer relationship receiving badges for completing individ-
system, resulting in increased focus on A proliferation of digital sensors is ual modules. In addition, we launched a
physicians whose patients are most enabling remote monitoring of patients’ series of leadership simulations that use
likely to benefit from a particular drug. health. We are working with a US com- realistic scenarios to help managers
We plan to expand the new system’s pany called Science 37 that uses a perform their role in adopting digital
use to 10 000 salespeople in our top 11 combination of sensors, telemedicine technology and data analytics.
markets, with full coverage after 2020. and home nursing services that can
40 | Novartis Annual Review 2018
STRATEGIC PRIORITIES
AWARDS AND RECOGNITION Holding ourselves to the engages political consultants, we will
secure an independent due diligence
highest ethical standards
No. 2
report from an external partner.
We continue to embed a principles-
based approach to compliance through In addition, we continue to strengthen
in the 2018 Access to Medicine Index, the new Professional Practices Policy our Integrity & Compliance (I&C) func-
improving by one position versus 2016 (P3), which in 2018 replaced separate tion. In 2018, we combined our risk man-
divisional compliance policies. We believe agement and compliance functions in a
No. 4
this approach will help ensure that em- single organization to help enable more
ployees act in the best interest of patients, effective risk management and mitiga-
physicians and Novartis. tion efforts. We created the role of Chief
in the 2018 Dow Jones Sustainability
Ethics, Risk and Compliance Officer to
Index World
Since 2016, we have adjusted the ratio head the combined organization, and
of fixed to variable total compensation we elevated this role to the Executive
for our sales force to help ensure that Committee of Novartis (ECN).
the target variable component is a max-
imum of 35% of total compensation, on To help monitor and enforce our in-
a country average basis. To receive any tegrity standards, we added more than
form of variable compensation, each 100 people to the I&C function in recent
employee, including the sales force, years. The expanded team has increased
must perform to a minimum standard the number of country visits to share
with regard to our Values and Behaviors, learnings from across the organization,
which include acting with integrity. For reaching about 220 in 2018. We also
our sales force, in particular, 20% of tar- harmonized our I&C risk assessment
get variable pay is based on demonstra- and monitoring process and control
tion of our Values and Behaviors. We are activities into a single, continuous pro-
in the process of implementing these cess supported by an online tool.
standards in every country in which
Novartis operates. Ultimately, no sales
representative will receive the variable
P3 PRINCIPLES compensation unless he or she meets
expectations with respect to Values
Across divisions, there was a
Novartis has adopted a single set of ethical and Behaviors. In 2018, we assessed the 54% reduction in the number
principles that should be applied in daily rollout of the new incentive system with
decision-making by all Novartis associates positive results. Across divisions, there
of reported complaints of
was a 54% reduction in the number of fraud or professional practices
reported complaints of fraud or profes- in the sales force in 2018
sional practices in the sales force in 2018
Put patients compared to 2017. versus 2017
first
Despite this progress, we are still facing
Research questions about our business practices.
for the right Fund Following the issue with Essential Con- We continue to evolve our reporting and
reason responsibly sultants, when our political consultancy data analytics to provide centralized
practices came into question, we took and aggregated data across the risk
steps to improve oversight and help functions to identify trends and help
prevent similar matters in the future. improve risk mitigation. For instance, in
Engage We have strengthened the relevant the last two years, we’ve seen a posi-
Act with
appropriately clear intent contracting and due diligence pro- tive trend in generally effective internal
cesses to help ensure more ownership compliance audits. At the same time,
and transparency at a senior manage- our whistleblower hotline continues to
ment level. For example, before Novartis receive reports of suspected cases
Build trust with society Novartis Annual Review 2018 | 41
24 m
We launched the Novartis Access In addition, we take local affordability
Principles, embarking on a journey to into account when pricing our medi
systematically integrate access strate- cines. In LMICs, for instance, we intro-
gies into how we research, develop and duced more affordable local brands of Patients reached through our
deliver our new medicines globally. many innovative therapies, such as our access-to-medicine programs
These strategies include adopting heart failure treatment Entresto, to help
innovative pricing and access models, speed up and improve access where
refocusing research and development
based on society’s healthcare needs,
and supporting approaches to streng
there is inadequate healthcare cover-
age or reimbursement. Through our
continued efforts and an impactful
17m
then healthcare systems. We made access strategy, the number of patients People reached through training,
significant progress in setting up our reached with Entresto in LMICs grew health education and service delivery
internal systems and training our inter- two-and-a-half-fold in the last 12 months. programs
nal teams on our new business stan- Overall, we have launched more than
dards. The ECN reviewed plans for key 60 local brands across more than 30
brands in launch phase to assess access developing markets, reaching more
strategies targeting underserved popu- than 220 000 additional patients to
lations. For example, Aimovig, our date. In addition, we are now able to
innovative medicine for the treatment of reduce the time lag between availabil-
migraine, is supported by programs ity of medicines in higher- and lower-in-
designed to help accelerate access come countries. For example, the first
both before and after reimbursement, Entresto local brand was launched
as well as to speed up introduction and within 12 months of the launch in the
access in low- and m iddle-income European Union. We plan to further
countries (LMICs). We are also co-creating expand these strategies.
42 | Novartis Annual Review 2018
7.2 m
with local investigators from the We have adopted a more ambitious
Oswaldo Cruz Foundation in Brazil – to 2030 environmental sustainability
aid in the early detection of leprosy. The strategy, aiming for carbon neutrality,
launch of the first public version of the plastic neutrality and water sustain- People have received free
atlas is planned for 2019. ability. We have already taken steps to treatment for leprosy since 1999
mitigate our exposure to environmental
In April, we renewed our commitment to risk, completing a series of comprehen-
malaria elimination, pledging USD 100
million to research and develop next-
generation antimalarials over the next
sive supplier audits and taking relevant
actions. For example, in the Hyderabad
area of India, we are severing ties
100 m
five years. In addition, we will help expand with six suppliers that failed to comply To be invested over the next
access to antimalarials formulated for with our Supplier Code, and we are five years in the research and
children, and we plan to implement pro- working with nine suppliers to improve development of next-generation
grams to strengthen healthcare systems their performance in critical areas such antimalarials (USD)
in four sub-Saharan countries. as operational efficiency, waste man-
agement, and use of natural resources.
We also launched efforts in other areas These suppliers share our values for en NEW ENVIRONMENTAL
where we believe we can have s ignificant vironmental stewardship and employee TARGETS
impact. In October, in Latin America, we health and safety.
kicked off our partnership with the World
Heart Federation to develop a roadmap In October, our Third-Party Risk Man-
for addressing Chagas disease, the agement program went live in Mexico.
second most common cause of chronic The program is to be rolled out globally
heart failure in Latin America. in 2019 in a phased regional approach, Carbon neutral in own operations
beginning in the Americas (including the by 2025
In Ghana, we kicked off a collaboration US) and followed by Asia-Pacific and
with the government and local partners Europe later in the year.
to e stablish our commitment to sickle
cell disease (SCD) in Africa. This colla After completing human rights impact
boration aims to support the develop- assessments in our own operations in
ment of treatment guidelines; strengthen Egypt, Turkey, China and Malaysia, we
Water neutral in all areas by 2030
the healthcare system by establishing have established that we have strong
centers of excellence to advance new- policies and solid processes to identify
born screening and train scientists; and manage potential human rights
accelerate registration and launch of risks. We have also identified common
hydroxyurea for the treatment of SCD; risk areas that require additional fol-
and integrate the needs of patients into low-up action in 2019. For example, we
our drug development strategy. We plan need more regular and broader engage- Plastic neutral by 2030
to launch our commitment in 2019 and ment and consultation with external
to also expand our efforts to other stakeholders at a local level – including
countries in sub-Saharan Africa. representatives from patient groups,
local communities, health authorities
and third-party partners – to gain a bet- For more information
Being a responsible ter understanding of issues; to help Novartis in Society 2018 report
citizen ensure that formal grievance mecha-
Corporate responsibility
nisms and processes are in place for section of our website
Building trust with society requires doing communities living close to our manu-
Transparency and disclosure
business responsibly wherever we facturing operations; and, in some mar- section of our website
operate. This includes minimizing our kets, to address risks associated with
environmental impact, managing risk in our outsourced workforce.
our supply chain, respecting human
rights and being transparent.
Novartis Annual Review 2018 | 45
Ethiopia
Dr. Helen Yifter
Addressing
the rising tide
of diabetes
in Ethiopia
In her native Ethiopia, Dr. Helen
Yifter (right) is one of only seven
endocrinologists, specialized in
treating diabetes and other hormonal
disorders. Dr. Yifter, a graduate of the
Novartis Next Generation Scientist
program, treats patients at Black Lion
Hospital in the capital of Addis
Ababa. She also helped establish
the first diabetic foot clinic in sub-
Saharan Africa. Diabetes is on the
rise in Ethiopia as more people move
from rural to urban areas and adjust
their diets and lifestyles. While nearly
3 million Ethiopians have diabetes,
the overwhelming majority are
undiagnosed – and without treat
ment, they risk developing other
serious health complications, such
as heart disease, kidney damage,
and foot and vision problems. Dr.
Yifter regularly trains other healthcare
professionals to diagnose and treat
diabetes as a way to boost patients’
access to quality care.
46 | Novartis Annual Review 2018
1 Dr. Helen Yifter checks the blood pressure of Amina Shafi, 62, who has type 2 diabetes.
Every three months, Ms. Shafi travels by bus to visit Dr. Yifter at Black Lion Hospital.
2 Dr. Yifter leads a weekly training session for medical students. As one of the few endo-
crinologists in Ethiopia, she knows it is imperative to train the next generation of doctors.
3 Ms. Shafi has developed eye and kidney complications as a result of her diabetes.
During a recent checkup, she received the upsetting news that she must switch from
oral medication to insulin injections.
Novartis Annual Review 2018 | 47
1 2
3
48 | Novartis Annual Review 2018
Our corporate
governance approach
Our corporate governance approach supports our objective of creating
long-term value for our company, our shareholders and society. We
carefully monitor developments in corporate governance and regularly
meet with shareholders to understand their expectations.
Board of Directors
Joerg Reinhardt, Ph.D. Enrico Vanni, Ph.D. Nancy C. Andrews, M.D., Dimitri Azar, M.D.
Chairman Vice Chairman Ph.D. American
German Swiss American/Swiss
Ton Buechner Srikant Datar, Ph.D. Elizabeth (Liz) Doherty Ann Fudge
Dutch/Swiss American British American
Frans van Houten Andreas von Planta, Ph.D. Charles L. Sawyers, M.D. William T. Winters
Dutch Swiss American British/American
Governance, Nomination
Audit and and Corporate Responsi Research & Development
Compliance Commitee Compensation Commitee bilities Committee Committee Risk Committee
E. Doherty (Chair) E. Vanni (Chair) A. von Planta (Chair) J. Reinhardt (Chair) S. Datar (Chair)
T. Buechner S. Datar D. Azar N. Andrews N. Andrews
S. Datar A. Fudge A. Fudge D. Azar E. Doherty
A. von Planta W. Winters C. Sawyers F. van Houten A. Fudge
E. Vanni E. Vanni C. Sawyers A. von Planta
Vasant (Vas) Narasimhan, Steven Baert Bertrand Bodson James (Jay) Bradner, M.D.
M.D. Chief People & Organization Officer Chief Digital Officer President of the Novartis Institutes
Chief Executive Officer Belgian Belgian for BioMedical Research (NIBR)
American American
Steffen Lang, Ph.D. Klaus Moosmayer, Ph.D. Susanne Schaffert,1 Ph.D. John Tsai, M.D.
Global Head of Novartis Technical Chief Ethics, Risk and CEO, Novartis Oncology Head of Global Drug Development
Operations Compliance Officer German and Chief Medical Officer
German/Swiss German American
Robert Weltevreden
Head of Novartis Business
Services (NBS)
Dutch For full CVs of our ECN members and other members of senior management
www.novartis.com/ECN
Elizabeth (Liz) Barrett stepped down as CEO of Novartis Oncology and as a
1
Board oversight and risk risks are properly assessed and profes
sionally managed by overseeing the risk Comprehensive risk
management management system and processes, as
The Board is committed to creating sus well as by reviewing the risk portfolio management is an integral
tainable shareholder value. We achieve and related actions implemented by part of the responsibility
this by setting a clear strategy and exe management. To further strengthen our
cuting effective governance. risk management efforts, we made the of the Board.
position of Chief Ethics, Risk and Com
The Board ensures that it has all infor pliance Officer part of our Executive
mation required to oversee the Execu Committee in 2018. Additionally, as of
tive Committee and senior manage January 1, 2019, we brought together
ment. The CEO regularly informs the the Internal Audit function, the SpeakUp Our capital structure and
Board of current developments, and Office and Global Security into one shareholder rights
Executive Committee members regu function called Novartis Business
larly attend Board meetings to discuss Assurance & Advisory. This new func As of December 31, 2018, the share cap
specific topics. Board members are tion is intended to drive fair and faster ital of Novartis AG is CHF 1 275 312 410
also entitled to request information investigations, deliver value-adding fully paid-in and divided into 2 550 624 820
from Executive Committee members or audits and advisory engagements, and registered shares(Novartis share). Each
any other Novartis associate, and they ensure that there is a safe place for our Novartis share has a nominal value of
may visit any Novartis site. employees to speak up. Our approach CHF 0.50. No authorized and c onditional
to risk management includes streamlin capital exists as of December 31, 2018.
Comprehensive risk management is an ing the risk assessment and monitoring
integral part of the responsibility of the process to ensure we have a single risk Novartis shares are listed on the SIX
Board. The Board regularly assesses approach through our company, fully Swiss Exchange (ISIN CH0012005267,
risks and fosters a culture of risk aware supported by online tools and data symbol: NOVN) and on the New York
ness throughout the organization, in line analytics. In 2018, we launched our Stock Exchange (NYSE) in the form of
with our Values and Behaviors. We newly harmonized Integrity & Compli American depositary receipts (ADRs)
apply principles-based decision-mak ance Risk Assessment and Monitoring representing Novartis American depos
ing and require our employees to act in (RAM) process. The RAM process in itary shares (ADSs) (ISIN US66987V1098,
every situation with strong ethics and tegrates current risk assessments, self- symbol: NVS).
integrity. The Risk Committee assists assessments, control activities and mo
the Board of Directors in ensuring that nitoring into a single, continuous, cyclical
process.
Our corporate governance approach Novartis Annual Review 2018 | 53
Shareholders have the right to receive The General Meeting must be held responsible for ensuring effective com
dividends, to vote and to execute all within six months after the close of the munication with shareholders about
other rights as granted under Swiss law financial year (December 31), and nor the company’s strategy, prospects,
and the Articles of Incorporation. Each mally takes place at the end of Febru business operations and governance.
Novartis share registered with the right ary or the beginning of March. Through communication with share
to vote entitles the holder to one vote holders, the Board also learns about
at General Meetings. To be registered and can address their expectations and
with voting rights, a shareholder must Our information policy concerns.
declare that he or she acquired the
shares in his or her own name and for Novartis is committed to open and trans
his or her own account. Shareholders parent communication with sharehold
can vote their Novartis shares by them ers, financial analysts, customers, sup
selves or appoint another shareholder pliers and other stakeholders. The CEO,
or the Independent Proxy to vote on with the CFO and Investor Relations
their behalf. team, supported by the Chairman, are
Website information
Topic Information
Compensation Report
summary
Novartis delivered strong performance in 2018 as it continues its transformation into
a leading, focused innovative medicines company. We continued to engage with
shareholders and proxy advisors to gather feedback on the proposed evolution of
the compensation system. It has helped shape the changes, enhancements and
simplifications we are making, effective January 1, 2019, to further align our
compensation systems and disclosures with our strategy and best practice.
CurrentExecutive
Current ExecutiveCommittee
Committee compensation
compensation system
system
Fixed pay and benefits performance related variable pay
annual base salary pension and other annual incentive Long-term share awards
benefits
Ltpp1 LtRpp2
purpose Reflects responsibil- Provides retirement Rewards for perfor- Rewards long-term shareholder
ities, experience and and risk insurances mance against short- value creation and innovation in line
skill sets (tailored to local market term financial and stra- with our strategy
practices/regulations) tegic objectives, and
Values and Behaviors
Form of payment Cash Country/ 50% cash Equity, vesting following a three-
individual-specific 50% equity 3 deferred year performance period
for three years
1
LTPP = Long-Term Performance Plan
2
LTRPP = Long-Term Relative Performance Plan
3
Executive Committee members may elect to receive more of their Annual Incentive in equity instead of cash.
4
Strategic objectives are aligned with the five strategic pillars: innovation, operational excellence, data and digital, people and culture, and building trust with society.
5
For the 2018-2020 performance cycle, the peer group of 15 global healthcare companies applies, as listed in the Compensation Report within the 2018 Annual Report.
Alignment
Alignmentwith
withcompany
companystrategy
strategy
The Novartis strategy is to reimagine medicine to improve system with this strategy and to ensure that Novartis is a
Theextend
and Novartis strategy
people’s is to
lives. Wereimagine medicine
use innovative to and
science system withorganization,
improve high-performing this strategytheand to ensure
company that Novartis
operates both is a
and extend people’s lives. We use innovative
technology to address some of society’s most challenging science and a short-term Annual Incentive and two Long-Term Incentive both
high-performing organization, the company operates
technologyissues.
healthcare to address some of
We discover andsociety’s
develop most challenging plansawith
breakthrough short-term
a balancedAnnual Incentive
set of measures and
andtwo Long-Term
targets. This Incentive
healthcareand
treatments issues.
find We
newdiscover and develop
ways to deliver them tobreakthrough
as many plans
includes with a balanced
strategic objectivesset of measures
within the Annualand targets. This
Incentive
treatments
people and find
as possible. We newalsoways
aim toto reward
deliverthose
them who
to asinvest
many balanced includes strategic
scorecard, objectives
which within
align with thestrategic
the five Annual Incentive
people as possible. We also aim to reward
their money, time and ideas in our company. The Novartis those who invest balanced scorecard, which align with
pillars of Novartis. The Board of Directors determinesthe five strategic
their money,
strategy time and ideas
is underpinned by fiveinstrategic
our company.
pillars: The Novartis specific,
innovation, pillars of Novartis.
measurable andThe Board ofperformance
time-bound Directors determines
mea-
operational excellence, data
strategy is underpinned by and
fivedigital, people
strategic andinnovation,
pillars: culture, suresspecific,
for the Annual Incentive
measurable andand the two Long-Term
time-bound performance mea-
and building trust
operational with society.
excellence, data Toandalign people and culture,Incentive
the compensation
digital, suresplans.
for the Annual Incentive and the two Long-Term
and building trust with society. To align the compensation Incentive plans.
Decision on
Compensation of other Executive Committee members Decision-making
Compensation Committee authority
Compensation of CEO Board of Directors
Executive Committee compensation risk management principles
Compensation of other Executive Committee members Compensation Committee
• Rigorous performance management process • Post-contractual non-compete limited to a maximum of 12 months from the
• Balanced mix of short-term and long-term variable compensation elements end of employment (annual base salary and Annual Incentive of the prior year
• Executive Committee
Performance evaluation under thecompensation
Annual Incentive includes risk management
an individual principles
only) as per contract, if applicable
balanced scorecard • Good and bad leaver provisions apply to the variable compensation of
• • Performance-based
Rigorous performance management
Long-Term process
Incentives only, with a three-year perfor- • Post-contractual non-compete limited to a maximum of 12 months from the
leavers
• mance
Balanced mix
period of short-term and long-term variable compensation elements end of employment
• No severance payments or (annual base salary
change-of-control and Annual Incentive of the prior year
clauses
• • All
Performance evaluation isunder
variable compensation theatAnnual
capped 200% Incentive
of target includes an individual • Clawback only)and
as malus
per contract,
principlesif applicable
apply to all elements of variable compensation
balanced scorecard
• Contractual notice period of 12 months • Good
• Share and requirements;
ownership bad leaver provisions
no hedging apply to the variable
or pledging compensation
of Novartis share of
• Performance-based Long-Term Incentives only, with a three-year perfor- leavers
ownership position
mance period • No severance payments or change-of-control clauses
• All variable compensation is capped at 200% of target • Clawback and malus principles apply to all elements of variable compensation
• Contractual notice period of 12 months • Share ownership requirements; no hedging or pledging of Novartis share
56 | Novartis Annual Review 2018
Group free cash flow as a % of sales (cc) (20%) 20% Significantly above
Building trust with society (including access to healthcare and reputation) (20%) Met
* The Board concluded that the achievement for Group operating income versus target was ‘met’ following adjustments mainly for M&A transactions made to transform Novartis into a leading,
focused medicines company, and for higher restructuring to drive major productivity programs, which were not known at the time of target setting.
Fixed pay and benefits Variable pay − performance-related
Annual base Pension and 2018 Annual LTPP LTRPP Total realized
CHF 000s salary1 other benefits Incentive1 2016-20182 2016-20182 compensation
Vasant Narasimhan (CEO from February 1, 2018) 1 492 203 3 190 1 796 0 6 680
Base salary and Annual Incentive reflect the compensation relating to Vasant Narasimhan’s roles in 2018 as Head of Global Drug Development (January 1, 2018 – January 31, 2018) and
1
2016-2018, which were granted before Dr. Narasimhan was appointed CEO.
Compensation Report summary Novartis Annual Review 2018 | 57
Vice Chairman 50
Total actual compensation earned by Board members in the 2018 financial year was CHF 3 804 336 for the Chairman of
the Board and CHF 4 430 625 for the other 12 members of the Board (one of whom stepped down at the 2018 AGM).
www.novartis.com/ar18english
www.novartis.com/ar18german www.novartis.com/nisreport2018
Disclaimer
These materials contain forward-looking statements that can generally be the proposed transactions may not be realized or may take longer to realize than
identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” expected; the inherent uncertainties involved in predicting shareholder returns;
“outlook,” or similar expressions, or by express or implied discussions regarding the uncertainties inherent in the research and development of new healthcare
potential new products, potential new indications for existing products, or regarding products, including clinical trial results and additional analysis of existing clinical
potential future revenues from any such products; or regarding the potential data; our ability to obtain or maintain proprietary intellectual property protection,
outcome, or financial or other impact on Novartis, of the proposed spinoff of our including the ultimate extent of the impact on Novartis of the loss of patent
Alcon Division, or of the proposed divestiture of certain portions of our Sandoz protection and exclusivity on key products that commenced in prior years and will
Division business in the US; or regarding the potential impact of the share buyback continue this year; safety, quality or manufacturing issues; uncertainties regarding
plan; or regarding potential future sales or earnings of the Group or any of its actual or potential legal proceedings, including, among others, actual or potential
divisions or potential shareholder returns; or regarding potential future credit litigation with respect to the proposed transactions, product liability litigation,
ratings of the Group; or by discussions of strategy, plans, expectations or litigation and investigations regarding sales and marketing practices, intellectual
intentions. Such forward-looking statements are based on the current beliefs and property disputes and government investigations generally; uncertainties involved
expectations of management regarding future events, and are subject to significant in the development or adoption of potentially transformational technologies and
known and unknown risks and uncertainties. Should one or more of these risks or business models; our performance on environmental, social and governance
uncertainties materialize, or should underlying assumptions prove incorrect, actual measures; general political, economic and trade conditions, including uncertainties
results may vary materially from those set forth in the forward-looking statements. regarding the effects of ongoing instability in various parts of the world; uncertain-
You should not place undue reliance on these statements. In particular, our ties regarding future global exchange rates; uncertainties regarding future demand
expectations could be affected by, among other things: global trends toward for our products; uncertainties regarding potential significant breaches of data
healthcare cost containment, including ongoing government, payer and general security or data privacy, or disruptions of our information technology systems; and
public pricing and reimbursement pressures and requirements for increased pricing other risks and factors referred to in Novartis AG’s current Form 20-F on file with
transparency; regulatory actions or delays or government regulation generally, the US Securities and Exchange Commission. Novartis is providing the information
including potential regulatory actions or delays with respect to the proposed in these materials as of this date and does not undertake any obligation to update
transactions or the development of the products described in this Annual Report; any forward-looking statements as a result of new information, future events or
the potential that the strategic benefits, synergies or opportunities expected from otherwise.
The business policy of Novartis takes into account the OECD’s Guidelines
for Multinational Enterprises, with their recommendations on the disclosure
of information.
Marie Gratia Musanabera (left), a nurse entrepreneur who owns and
Our Annual Review is published in English; a German translation is also available. runs a health clinic in rural Rwanda, speaks with one of her patients.
Publisher: Novartis International AG, Basel, Switzerland Ms. Musanabera’s clinic is part of an innovative network of more than
Design: phorbis communications, Basel, Switzerland 90 healthcare outposts in Rwanda affiliated with One Family Health, a
Production: Management Digital Data AG, Lenzburg, Switzerland
Management photography: Joey Lawrence, New York, US
nongovernmental organization.
Printer: Birkhäuser+GBC AG, Reinach, Switzerland
© Novartis AG, 2019 Back cover photo Ms. Musanabera weighs a baby.