- Outlines actions underway to accelerate launch of Entresto®, including further expansion of US primary care field force, and reinforce strong uptake of Cosentyx®
- Highlights leading pipeline of second generation immuno-oncology assets
- Confirms Sandoz on track for 10 biosimilar filings by 2017
- Shows progress on implementation of Alcon growth acceleration plan
Basel, May 25, 2016 - Today Novartis holds its third annual Meet Novartis Management event at its headquarters in Basel, Switzerland, giving investors and analysts the opportunity to meet with more than 20 top executives from Novartis Group, divisions and research. The sessions provide a deeper view into the company's strategy for long-term, sustainable value creation, as well as the key drivers for current and future performance.
"The environment in which we operate is changing, and we are positioning Novartis to thrive in this environment. Our strategy is to sharpen our focus in areas where we are strongest; ensure that we have the global scale to compete profitably across geographies; and have the innovation power to address unmet medical needs. We have a strong foundation for growth with Cosentyx® and Entresto®, as well as leading positions in oncology, eye care and biosimilars. The creation of two business units, Novartis Pharmaceuticals and Novartis Oncology, will increase management focus and speed decision-making in areas that are key to our future growth. With this move, as well as the centralization of manufacturing and integration of drug development announced in January, we are building a more focused, more profitable company that is capable of sustainable growth regardless of external changes in the environment," said Novartis CEO Joseph Jimenez.
In the Pharmaceuticals session, management highlights the strong performance of Entresto in Europe, as well as actions underway to accelerate uptake in the US. The discussion covers the strong Class I recommendation given to Entresto in both US and EU heart failure guidelines, less than a year after regulatory approvals. US guidelines now recommend Entresto as standard of care for heart failure with reduced ejection fraction as an alternative to an ACE inhibitor (ACE) or an angiotensin II receptor blocker (ARB), and call for doctors to switch patients with mild to moderate symptoms to Entresto. Following the strong guidelines, Novartis is further expanding the US primary care field force. In Europe, updated guidelines recommend Entresto instead of an ACE or ARB in patients fitting the PARADIGM-HF profile. The guidance underscores the benefits of Entresto for patients to significantly reduce risk of death due to cardiovascular causes or heart failure hospitalization.
In addition, more detail is provided on the FortiHFy clinical trial program, which encompasses over 40 active or planned clinical studies. The studies include pivotal trials with outcomes endpoints as well as a wide range of trials across the world to further characterize the clinical response, generate data regarding the impact on symptoms and quality of life, and systematically collect data in clinical practice.
Pharmaceuticals management also highlights continued strong performance of Cosentyx across its three indications, benefitting from its strong efficacy profile with data up to 3 years in psoriasis and 2 years in psoriatic arthritis (PsA) and ankylosing spondylitis (AS). An extensive clinical program, including a pivotal trial in non-radiographic axial spondyloarthritis and head-to-head superiority trials versus Humira in PsA and AS, has been initiated.
Beyond Entresto and Cosentyx, the business unit emphasizes key pipeline projects including RLX030 (serelaxin) for acute heart failure, AMG 334 for migraine, OMB157 (ofatumumab) in multiple sclerosis, RTH258 (brolucizumab) and OAP030 (Fovista®, pegpleranib) in neovascular age-related macular degeneration, and QAW039 (fevipiprant) in asthma.
In the Oncology session, management highlights its development efforts in immuno-oncology (IO), with 15 molecules planned to be in clinic by the end of 2016 (12 of which are potentially first-in-class), and its strategy to win in the second generation of IO treatments. At the same time, the business unit highlights that significant unmet need remains, and we are well positioned with its established portfolio of targeted therapies and proprietary technologies to understand and overcome the pathways in emergent resistance. LEE011, its CDK4/6 inhibitor for first line HR+/HER2- metastatic breast cancer, is another key focal point in the session, following the independent Data Monitoring Committee's decision to stop the Phase III MONALEESA-2 trial early due to positive efficacy results.
In the Sandoz session, management reiterates its commitment to growth with margin expansion, and provides an update on its biosimilars strategy and pipeline. The division has said it would announce a total of 10 new filings between 2015 and 2017. Six have been announced (including the EMA's recent acceptance of the division's biosimilar rituximab file), and Sandoz is on track for the remaining four (epoetin alfa in the US, adalimumab in the US and EU, and rituximab in the US).
In the Alcon session, investors and analysts are able to meet with Mike Ball for the first time since he joined the company, and get more insight into his perspective on the business and the growth acceleration plan. Management highlights progress in accelerating innovation, with the launch of UltraSertTM and PanOptix® across multiple regions, development of ClareonTM on track, closing of three business development deals in 60 days, and execution of promotional programs behind key contact lens brands.
Similarly, in the NIBR session, investors and analysts have the opportunity to meet with new leadership, including Jay Bradner, and understand the new focus and expertise he brings to the organization. As a well-established center of academic research and thought leadership, NIBR is a competitive advantage for Novartis, with a broad and deep pipeline of approximately 400 assets spanning therapeutic areas with significant unmet needs. Novartis led the industry with five new drugs approved in 2015, four of which originated at NIBR.
Finally, the Group session reinforces the longer term growth prospects for Novartis. We expect to establish new breakthrough medicines, leverage productivity to improve profitability, and execute strong capex discipline and free cash flow management. We expect that this will allow us to continue to increase the dividend while growing the company in a sustainable way.
For background slides and webcast (audio only) please refer to the following link: http://www.novartis.com/investors/event-calendar/index.shtml
Disclaimer
This press release contains forward-looking statements that can be identified by words such as "foundation," "long-term," "underway," "accelerate," "launch," "on track," "progress," "growth acceleration plan," "strategy," "need to," "innovation," "will," "working to," "recommendation," "recommend," "call for," "planned," "continued," "initiated," "efforts," "potentially," "well positioned," "commitment," "pipeline," "would," "focus," "expected," "trajectory," "expect," "breakthrough," 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 any potential financial or other impact on Novartis or any of our divisions as a result of the creation of the Pharmaceuticals and Oncology business units within our Innovative Medicines Division, as a result of the recently announced changes in leadership, or as a result of the strategic actions announced in January 2016 to focus our divisions, integrate certain functions and leverage our scale; or regarding any potential financial or other impact on Novartis as a result of the creation and operation of NBS; or regarding the potential financial or other impact on Novartis of the transactions with GSK, Lilly or CSL; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; 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 Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the creation of the Pharmaceuticals and Oncology business units within our Innovative Medicines Division, the recently announced changes in leadership, the strategic actions announced in January 2016, the creation and operation of NBS, or the transactions with GSK, Lilly and CSL. Neither can there be any guarantee that Novartis or any of the businesses involved in these changes or transactions will achieve any particular financial results in the future. Neither can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Nor can there be any guarantee that the 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; the potential that the strategic benefits, synergies or opportunities expected from the creation of the Pharmaceuticals and Oncology business units within our Innovative Medicines Division, the recently announced changes in leadership, the strategic actions announced in January 2016, the creation and operation of NBS, or the transactions with GSK, Lilly and 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; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and continues this year; unexpected safety, quality or manufacturing issues; global trends toward health care cost containment, including ongoing pricing pressures, in particular from increased publicity on pharmaceuticals pricing; 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, including the increases in value of the US dollar, our reporting currency, against a number of currencies; 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 our 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.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
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