- 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
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.