sandoz division (pdf 1.2 mb)
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Disclaimer
This presentation contains forward-looking statements that can be identified by words such as “momentum,” “progress,” “building,” “focused,” “pipeline,” “focusing,” “focus,” “expect,” “target,” “on track,” “strategy,” “accelerating,” “well positioned,” “ongoing,” “planned,” “aim,” “being investigated,” “continuing,” “potential,” “preparing,” “launch,” “underway,” “working,” “committed,” “potentially,” “developing,” “initiated,” “continued,” “development,” “plans,” “evolving,” “will,” “expects,” “continue,” “expected,” “progressing,” “priorities,” or similar terms, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; potential shareholder returns or credit ratings; or regarding the potential completion of the announced transaction with CSL, or regarding the potential financial or other impact on Novartis of the transactions with GSK, Lilly or CSL, or regarding any potential strategic benefits, synergies or opportunities as a result of these transactions; or regarding potential future sales or earnings of the Novartis Group or its divisions and associated companies; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. 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. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the announced transaction with CSL will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the transactions with GSK, Lilly or CSL. Neither can there be any guarantee that the Novartis Group or any of its divisions or associated companies will achieve any particular financial results in the future. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Neither can there be any guarantee that the Novartis Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the announced transaction with CSL, or unexpected delays in obtaining such approvals; the potential that the strategic benefits, synergies or opportunities expected from the transactions with GSK, Lilly or CSL may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the Company’s ability to obtain or maintain proprietary intellectual property protection; unexpected manufacturing or quality issues; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; uncertainties regarding potential significant breaches of data security or disruptions of the Company’s information technology systems; 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.
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 2
Sandoz is a full-service generics provider, well positioned within the Novartis enterprise
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 3
Our Mission: We will be the main provider of
high-quality, affordable medicines, helping
secure long-term access to healthcare for
people around the world
Pharmaceuticals
Alcon
Sandoz
NIBR1
NBS2
26,000+ 160+ >1100
Employees
worldwide
Countries in which
Sandoz products
are sold
Large portfolio
of compounds
1 Novartis Institutes for BioMedical Research 2 Novartis Business Services
Sandoz is a global leader in generics
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 4
1 Pro forma by including all acquired companies; figures reflect sales for generics and OTC only, including API and excluding originator (e.g. Copaxone®) and proprietary business (e.g. Women’s Health)
Source: Individual company annual and quarterly reports; FactSet. Note: All trademarks, logos and pictures are the property of the respective owner
Top generics companies, 2014 sales1
USD millions
1,739
2,254
2,365
2,395
2,496
6,459
6,747
9,562
10,810
Sandoz achieved solid performance in 2014 and we are off to a strong start in 2015
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 5
Q1 2015 Results
USD m
+9%
+17%
NET
SALES
CORE
OPERATING
INCOME
2,237
406
Variance (cc)1
vs. Q1
2014
FY 2014 Results
USD m
NET
SALES
CORE
OPERATING
INCOME
+7%
+7%
9,562
1,571
Variance (cc)1
vs. FY
2013
1 Constant currencies (cc) and core results are non-IFRS measures. See page 42 of the Novartis AG Q1 Condensed Financial Report
Sandoz is focused on 6 key priorities to drive performance
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 6
Geographic
Focus
Portfolio
Priorities
Biosimilars Tech Ops
& Quality
D&R1 and
BD&L Patients,
People,
Collaboration
Sandoz 6 Priorities
1 Development and Registration
Geographic focus: Targeted segmentation within expansive global footprint
Sandoz’s geographic
footprint is expansive.
Within this vast network, we
have identified geographic
segmentations to secure
short-, mid- and long-term
growth
2 critical segments:
Priority Focus markets Pillars of our business driving a significant part of our existing and future business, e.g. US, Germany
Priority Growth markets Markets where we expect to see significant absolute growth top and bottom line for the future, e.g. Brazil, China
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 7
Geographic
Focus
Distributor model
Representative office
Sandoz office
Great start to the year across all major commercial regions
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 8
Commercial regions
Q1 2015 net sales growth vs. PY (% cc)
1615
7
4
13
Latin America Asia Pacific2 Central
and
Eastern Europe
Western
Europe, Middle
East & Africa1
US
8
1 Including Germany 2 Including Japan
Geographic
Focus
Priority Focus markets: Strong US performance, with growth outpacing competition
Key Facts
#1
TRx growth vs. PY,
% MAT March 2
5.3
-6.2
16.9
-7.7
-3.4
TRx market
share, %2
First FDA approved
biosimilar under new
regulatory pathway (Zarxio™)
+13% Strong Q1 cc growth vs. PY
12.8
9.1
7.2
6.5
5.9
Innovative businesses
1 Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd 2 Source: IMS NPA TRx – MAT Mar 2015, Generics only. MAT: Moving Annual Total
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 9
Received approval for the
fully substitutable Gx of
Copaxone®1 20mg
Glatopa™
Geographic
Focus
Priority Focus markets: Germany returned to growth, while Russia continues to hold strong
Germany
Russia
#1 6 +10%
#1 (Hexal/
Sandoz)
and #2
(1A Pharma)
Local
manufacturing
sites1
#2 Neva
Plant2 +13%
#2 in Russian
Gx market
Local
manufacturing
capabilities
Return to
growth in Q1
(cc), +5% Q4
2014 growth
Strong Q1
growth (cc),
+4% Q4
2014 growth
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 10
Geographic
Focus
1 Discussions have been initiated with Works Councils at Gerlingen and Frankfurt, Germany sites about plans to close down these sites 2 Expected to become operative in 2017
Priority Growth markets: Strong growth in key emerging markets
Select Priority Growth markets
Q1 2015 net sales growth vs. PY (% cc)
14
28
42
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 11
Geographic
Focus
RESPIRATORY
BIOSIMILARS
Sandoz FY
2014 sales
$514 m 5
Molecules in
Phase III /
Registration
+19%
Q1 cc growth
vs. PY
Portfolio priorities: Continue to fuel further growth through growth drivers
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 12
ANTI INFECTIVES
Sandoz FY
2014 sales1
$1.5 bn #1
Gx market
leader by
volume
#3
Overall global
market
GLATOPA™
Region Growth
Drivers
Dermatology Ophthalmics Pain
Portfolio
Priorities
1 Including retail business
San
do
z G
row
th D
rivers
Inhalers
Patches/
transdermals/
thin films
Innovative
solid
formulations
Implants
Biosimilars
API Cytotoxics
Hormones
Lyophilization
Injectables Ophthalmics
Dermatology
Broad
portfolio
Projects in
development >1,100 >800
D&R: Strong pipeline and a broad range of differentiated development capabilities
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 13
D&R and
BD&L
Cost
Service
Geography
Technology Production
sites in network 451
2011 Warning Letter
lifted on North
American sites
WL
Lifted
Positive progress
FDA inspections
from Jan 2014 to Q1
2015
8
Tech Ops & Quality: Focusing on key sites while continuously strengthening Quality
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 14
1 Continuous streamlining of Sandoz manufacturing network with discussions initiated with Works Councils at Gerlingen and Frankfurt, Germany sites
about plans to close down these sites
Tech Ops
& Quality
Biosimilars: Global leader, achieving milestone FDA approval for Zarxio™
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 15
Leading brands2
#1
#1
#1
Strong pipeline –
anticipating 10 filings
within next 3 years
Phase III / Registration
Significant milestone achieved: Approval for the first ever biosimilar under the new
pathway in the US (Zarxio™)
#1
Leading company globally1
USD 514 m sales
generated in 2014
+19% cc growth in Q1 vs. PY
Biosimilars
1 In the combined regions of North America, Europe, Japan and Australia 2 2014 global biosimilars position in their categories. Worldwide ranking is based on volume market share
Biosimilar stakeholder environment expected to continue to evolve
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 16
Current situation Key remaining challenges
Increasing awareness
Increased understanding of
health economic value of
biosimilars
Labeling: “generic like”
Extrapolation possible
Ambiguities of new law
Requirements for interchangeability
Naming protocols
Guidelines published Q1
2015
Market policies continue to evolve
Lack of familiarity with concept of
extrapolation
Clear revised guidelines
Local Phase III required
File IND after EU/US approval
Stakeholder
Reg
ula
tors
Patients &
physicians
Governments &
payors
Biosimilars
Sandoz is well positioned to compete in different market settings
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 17
Market
model
Physician-driven retail market Contract based hospital/clinic market
Payors influence drug use
Physician decides on drug class,
brand, biosimilar use
Retail pharmacist
dispenses prescribed drug
Patient self administers drug
Buying group or regional payor
Drug board decides formulary listings
Hospital or Clinic
Physician decides within formulary
listings
Physician / nurse administers drug
Hospital pharmacist / outpatient clinic
dispenses prepared drug
Influence Decide Limited impact
Illustrative
Biosimilars
Glatopa™ approval paves the way for further growth in US and strengthens Sandoz differentiated portfolio
First FDA-approved substitutable generic Copaxone® (glatiramer acetate injection) once daily 20mg1
Sandoz committed to providing patients with comparable product offering including support services
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 18
With Glatopa your
routine stays
routine.
Coming Soon
1 Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Sandoz is a full-service generics provider with #1 positions in biosimilars1, anti-infectives, ophthalmics, transplant/immunosuppressants
We are driving the business in-line with 6 key priorities to ensure growth with margin expansion, including renewed geographic and portfolio focus areas
Sandoz has a broad range of development capabilities and is pushing forward on new differentiated generics
We are streamlining our manufacturing footprint to optimize and gain efficiencies
Sandoz has an unwavering commitment to quality and has made great progress
Sandoz is the industry leader in biosimilars, paving the way forward with the first ever biosimilar approval under the new regulatory pathway in the US
Concluding takeaways
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 19
1 In the combined regions of North America, Europe, Japan and Australia
Communications Steffen Kurzawa
Human Resources
(Vacant)
Legal
Shannon Klinger
Finance
Tobias Hestler
Sandoz is led by a highly experienced global leadership team
| Meet Novartis Management | June 17-18, 2015 | Investor Presentation 21
Global Head of Sandoz
Richard Francis
Quality Assurance
Andreas Brutsche
Strategic Planning
Sylke Hassel
Technical Operations
Jeff Rope
Biopharma &
Oncology Injectables
Carol Lynch
This chart indicates the functional reporting relationship of the respective leadership team.
The members‘ actual reporting is within the companies that employ them.
Latin America Francisco Ballester
North America Peter Goldschmidt
Western Europe, Middle East & Africa Nick Haggar
Functions Commercial Operations
Product
Development
Josef Egerbacher
Anti-Infectives
Rex Clements
Asia Pacific Paul Geymayer
Central & Eastern Europe Francesco Balestrieri
Commercial Strategy
Isabel Afonso