Sandoz Division. Richard Francis Division Head, Sandoz Meet Novartis Management June 17-18, 2015

Transcription

1 Sandoz Division Richard Francis Division Head, Sandoz Meet Novartis Management June 7-8, 205

2 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. 2

3 Sandoz is a full-service generics provider, well positioned within the Novartis enterprise Pharmaceuticals Alcon 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 Sandoz 26, >00 NIBR Employees worldwide Countries in which Sandoz products are sold Large portfolio of compounds NBS 2 Novartis Institutes for BioMedical Research 2 Novartis Business Services 3

4 Sandoz is a global leader in generics Top generics companies, 204 sales USD millions 9,562 0,80 6,747 6,459 2,496 2,395 2,365 2,254,739 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 4

5 Sandoz achieved solid performance in 204 and we are off to a strong start in 205 FY 204 Results USD m Variance (cc) Q 205 Results USD m Variance (cc) vs. FY 203 vs. Q 204 NET SALES 9,562 +7% NET SALES 2,237 +9% CORE OPERATING INCOME,57 +7% CORE OPERATING INCOME % Constant currencies (cc) and core results are non-ifrs measures. See page 42 of the Novartis AG Q Condensed Financial Report 5

6 Sandoz is focused on 6 key priorities to drive performance Sandoz 6 Priorities Geographic Focus D&R and BD&L Patients, People, Collaboration Portfolio Priorities Tech Ops & Quality Biosimilars Development and Registration 6

7 Geographic focus: Targeted segmentation within expansive global footprint Geographic Focus Sandoz office Representative office Distributor model 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 7

8 Great start to the year across all major commercial regions Geographic Focus Commercial regions Q 205 net sales growth vs. PY (% cc) US Western Europe, Middle East & Africa Central and Eastern Europe Asia Pacific 2 Latin America Including Germany 2 Including Japan 8

9 Priority Focus markets: Strong US performance, with growth outpacing competition Geographic Focus # Key Facts First FDA approved biosimilar under new regulatory pathway (Zarxio ) TRx market share, % TRx growth vs. PY, % MAT March % Strong Q cc growth vs. PY Glatopa Received approval for the fully substitutable Gx of Copaxone 20mg Innovative businesses Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd 2 Source: IMS NPA TRx MAT Mar 205, Generics only. MAT: Moving Annual Total 9

10 Priority Focus markets: Germany returned to growth, while Russia continues to hold strong Geographic Focus Germany Russia # 6 +0% #2 Neva Plant 2 +3% # (Hexal/ Sandoz) and #2 (A Pharma) Local manufacturing sites Return to growth in Q (cc), +5% Q4 204 growth #2 in Russian Gx market Local manufacturing capabilities Strong Q growth (cc), +4% Q4 204 growth 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 207 0

11 Priority Growth markets: Strong growth in key emerging markets Geographic Focus Select Priority Growth markets Q 205 net sales growth vs. PY (% cc)

12 Sandoz Growth Drivers Portfolio priorities: Continue to fuel further growth through growth drivers Portfolio Priorities BIOSIMILARS $54 m 5 +9% GLATOPA Sandoz FY 204 sales Molecules in Phase III / Registration Q cc growth vs. PY ANTI INFECTIVES $.5 bn # #3 RESPIRATORY Sandoz FY 204 sales Gx market leader by volume Overall global market Region Growth Drivers Dermatology Ophthalmics Pain Including retail business 2

13 D&R: Strong pipeline and a broad range of differentiated development capabilities D&R and BD&L Biosimilars Injectables Ophthalmics Patches/ transdermals/ thin films Dermatology Lyophilization Inhalers Cytotoxics API Innovative solid formulations Implants Hormones Broad >,00 >800 portfolio Projects in development 3

14 Tech Ops & Quality: Focusing on key sites while continuously strengthening Quality Tech Ops & Quality Technology 45 Production sites in network Cost Service WL Lifted 20 Warning Letter lifted on North American sites Geography 8 Positive progress FDA inspections from Jan 204 to Q 205 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 4

15 Biosimilars: Global leader, achieving milestone FDA approval for Zarxio Biosimilars Leading company globally # USD 54 m sales generated in % cc growth in Q vs. PY Leading brands 2 # # # Strong pipeline anticipating 0 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 ) In the combined regions of North America, Europe, Japan and Australia global biosimilars position in their categories. Worldwide ranking is based on volume market share 5

16 Regulators Biosimilar stakeholder environment expected to continue to evolve Biosimilars Stakeholder Current situation Labeling: generic like Extrapolation possible Clear revised guidelines Key remaining challenges Ambiguities of new law Requirements for interchangeability Naming protocols Patients & physicians Guidelines published Q 205 Increasing awareness Local Phase III required File IND after EU/US approval Lack of familiarity with concept of extrapolation Governments & payors Increased understanding of health economic value of biosimilars Market policies continue to evolve 6

17 Sandoz is well positioned to compete in different market settings Biosimilars Illustrative Physician-driven retail market Contract based hospital/clinic market Physician decides on drug class, brand, biosimilar use Buying group or regional payor Drug board decides formulary listings Market model Payors influence drug use Hospital or Clinic Physician decides within formulary listings Retail pharmacist dispenses prescribed drug Hospital pharmacist / outpatient clinic dispenses prepared drug Patient self administers drug Physician / nurse administers drug Influence Decide Limited impact 7

18 Glatopa approval paves the way for further growth in US and strengthens Sandoz differentiated portfolio With Glatopa your routine stays routine. Coming Soon First FDA-approved substitutable generic Copaxone (glatiramer acetate injection) once daily 20mg Sandoz committed to providing patients with comparable product offering including support services Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd. 8

19 Concluding takeaways Sandoz is a full-service generics provider with # positions in biosimilars, 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 In the combined regions of North America, Europe, Japan and Australia 9

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21 Sandoz is led by a highly experienced global leadership team Global Head of Sandoz Richard Francis Functions Commercial Operations Finance Tobias Hestler Product Development Josef Egerbacher Asia Pacific Paul Geymayer Anti-Infectives Rex Clements Communications Steffen Kurzawa Quality Assurance Andreas Brutsche Central & Eastern Europe Francesco Balestrieri Biopharma & Oncology Injectables Carol Lynch Human Resources (Vacant) Strategic Planning Sylke Hassel Latin America Francisco Ballester Commercial Strategy Isabel Afonso Legal Shannon Klinger Technical Operations Jeff Rope North America Peter Goldschmidt Western Europe, Middle East & Africa Nick Haggar This chart indicates the functional reporting relationship of the respective leadership team. The members actual reporting is within the companies that employ them. 2