- Patients & Caregivers
- Healthcare Professionals
- Society & ESG
- Over 50 million secondary prevention patients worldwide with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) on current standard of care do not achieve LDL cholesterol (LDL-C) goal and remain at increased risk of cardiovascular events1
- First-in-class siRNA biological mechanism enables unique twice-yearly, subcutaneous dosing regimen and seamless integration into routine healthcare professional visits, potentially improving adherence and patient outcomes2,3,4
- Comprehensive Phase III inclisiran program showed potent and durable reduction of >50% in LDL-C on top of standard of care, with excellent safety profile2,3,4
- Transaction expected to create significant value with soon-to-launch, potentially first-in-class product that could become one of the largest products by sales in Novartis portfolio, leveraging significant synergies with existing global cardiovascular commercial capabilities
- Highly efficacious, safe and convenient profile of inclisiran combined with flexible market access strategies and value-based pricing can enable broad access
- Offer price of USD 85.00 per share in cash represents a premium of approximately 41% over The Medicines Company’s 30-day volume weighted average price of USD 60.33; valuing the company at approximately USD 9.7 billion on a fully diluted basis
- Novartis updates Innovative Medicines (IM) Division core margin outlook; now expects to achieve mid-thirties in the near term and mid-to-high thirties in the medium term
Basel, November 24, 2019 - Novartis CEO Vas Narasimhan said:
"We are excited about entering into an agreement to acquire The Medicines Company as inclisiran is a potentially transformational medicine that reimagines the treatment of atherosclerotic heart disease and familial hypercholesterolemia. With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help healthcare systems address the leading global cause of death. The prospect of bringing inclisiran to patients also fits with our overall strategy to transform Novartis into a focused medicines company and adds an investigational therapy with the potential to be a significant driver of Novartis’ growth in the medium to long term."
Novartis announced today that it has entered into an agreement and plan of merger with The Medicines Company (NASDAQ: MDCO) to acquire the US-based biopharmaceutical company for USD 85.00 per share in cash, valuing the company at approximately USD 9.7 billion on a fully diluted equity basis. The offer price represents a premium of approximately 41% over The Medicines Company’s 30-day (to November 22, 2019) volume weighted average price of USD 60.33 and approximately 24% premium over The Medicines Company’s closing share price of USD 68.55 on November 22, 2019 which represented a fully diluted equity value of approximately USD 7.7 billion when including the impact of outstanding stock options and convertible debt. The transaction has been unanimously approved by the Boards of Directors of both companies.
The Medicines Company recently announced data from its comprehensive clinical program consisting of three Phase III trials (ORION-9, 10 and 11) for inclisiran involving over 3,600 high-risk patients with ASCVD and FH. In all trials, inclisiran demonstrated potent and durable LDL-C reduction with an excellent safety and tolerability profile2,3,4. Furthermore, inclisiran’s potentially first-in-class, twice-yearly dosing schedule allows administration during patients’ routine visits to their healthcare professionals and will likely contribute to improved patient adherence and sustained, lower LDL-C levels2,3,4. The Medicines Company expects to file regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020. An ongoing clinical trial (ORION-4) will evaluate the cardiovascular morbidity and mortality benefits of inclisiran5.
"Novartis has a longstanding history of delivering breakthrough cardiovascular treatments for patients, and I am very excited about the opportunity to add inclisiran to our cardiovascular portfolio," said Marie-France Tschudin, President, Novartis Pharmaceuticals. "This transformational, new investigational medicine has the potential to meaningfully address one of the largest areas of underserved patient need. We believe our strong capabilities and global footprint can help drive broad worldwide access to this much needed treatment."
Transaction fits long-term strategic goals
The planned acquisition of The Medicines Company would allow Novartis to continue building pipeline depth in a key therapeutic area - a central pillar of its M&A strategy - and is aligned with the Novartis strategic priority of delivering truly transformational medicines for patients. It would add a potentially first-in-class siRNA inhibitor targeting PCSK9 with the potential to fundamentally change the treatment of elevated LDL-C in high risk patients2,3,4. Additionally, with The Medicines Company expecting to file regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020, inclisiran represents a near-term product launch opportunity and is expected to contribute to Group sales from 2021. Furthermore, broadening the cardiovascular portfolio would enable Novartis to leverage its core commercial capabilities including its strong cardiovascular field force both in the US and globally. Finally, the transaction is consistent with Novartis’ capital allocation priorities to invest in transformative innovation and long term value creation for shareholders.
Financial highlights and updated IM Division margin outlook guidance
The offer price represents a premium of approximately 41% over The Medicines Company’s 30-day volume weighted average price of USD 60.33 and approximately 24% premium over The Medicines Company’s closing share price of USD 68.55 on November 22, 2019 which represented a fully diluted equity value of approximately USD 7.7 billion when including the impact of outstanding stock options and convertible debt.
The transaction is expected to create significant value for patients, payers and Novartis shareholders. Assuming completion in the first quarter of 2020, Novartis expects inclisiran to start to contribute to Group and IM Division sales from 2021. It is also expected to further drive growth of the Cardiovascular-Renal-Metabolism franchise with the potential to become one of the largest products by sales in the Novartis portfolio, leveraging Novartis’ global cardiovascular commercial capabilities.
The acquisition is expected to modestly dilute core EPS versus a no deal scenario during the next few years as the company invests for a successful launch of inclisiran. Novartis expects the transaction to be significantly accretive to Group core operating income and core EPS in the medium term, driven by sales growth and operational synergies, leveraging the worldwide footprint of the cardiovascular business.
Novartis expects to continue to expand IM Division core margins to reach mid-thirties in the near term, and mid to high-thirties in the medium term, while investing in launches, including inclisiran. This guidance assumes that no Gilenya generics will enter the US market in 2020.
The core margin expansion for IM Division is driven by the continued sales momentum of key growth drivers, expected new launches as well as previously announced productivity programs. Novartis believes these factors will offset investments in new launches including inclisiran as well as the impact of generic erosion.
The transaction is expected to close in the first quarter of 2020, subject to the satisfaction or waiver of all closing conditions. Until closing, Novartis and The Medicines Company will continue to operate as separate and independent companies.
Under the terms of the agreement and plan of merger, Novartis will, through a subsidiary, commence a tender offer to purchase all outstanding shares of The Medicines Company for USD 85.00 per share in cash. Following completion of the tender offer, Novartis expects to merge the acquiring subsidiary with The Medicines Company, resulting in The Medicines Company becoming an indirect wholly-owned subsidiary of Novartis. The transaction is subject to customary closing conditions, including antitrust clearance.
Novartis plans to finance the transaction through available cash and shortand long-term borrowings.
A conference call for investors will take place on November 25, 2019 at 7:00 CET. Details can be found at www.novartis.com/investors/event-calendar.