Thermo Fisher Scientific Completes Acquisition of PPD, Inc.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has completed its acquisition of PPD, Inc. (Nasdaq: PPD), a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion .

"We are very excited to officially welcome our PPD colleagues to Thermo Fisher Scientific," said Marc N. Casper , chairman, president and chief executive officer of Thermo Fisher Scientific. "Expanding our value proposition for our biotech and pharmaceutical customers with the addition of PPD's leading clinical research services advances our work in bringing life-changing therapies to market, benefitting patients around the world."

As previously announced, the transaction is expected to contribute $1.50 to Thermo Fisher's adjusted earnings per share in 2022. 1 Details of the 2021 impact will be provided during Thermo Fisher's fourth quarter earnings call in early 2022.

Thermo Fisher continues to expect to realize total synergies of approximately $125 million by year three following close, consisting of approximately $75 million of cost synergies and approximately $50 million of adjusted operating income benefit from revenue-related synergies. In connection with the acquisition, Thermo Fisher will also assume approximately $3.0 billion in net debt of PPD. All assumed debt will be retired in connection with the closing of the transaction. 2

With the addition of PPD, Thermo Fisher will offer a comprehensive suite of world-class services across the clinical development spectrum − from scientific discovery, to assessing safety, efficacy, and health care outcomes, to managing clinical trial logistics, to the development and manufacturing of the drug product.

In connection with the completion of the transaction, PPD's common stock ceased trading on Nasdaq prior to the opening of trading today. PPD will become part of Thermo Fisher's Laboratory Products and Services Segment.

1 Adjusted earnings per share is a non-GAAP measure that excludes certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."
2 This includes PPD's outstanding 4.625% Senior Notes due 2025 and 5.000% Senior Notes due 2028 issued by Jaguar Holding Company II and PPD Development, L.P. and guaranteed by PPD, the holders of which have been notified that PPD will redeem all of such notes at the redemption prices specified in the governing indenture, plus interest through the redemption date December 18, 2021 .

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion . Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .

Forward-looking Statements

This communication contains forward-looking statements that involve a number of risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "seeks," "estimates," and similar expressions are intended to identify forward-looking statements, but other statements that are not historical facts may also be deemed to be forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the duration and severity of the COVID-19 pandemic; any natural disaster, public health crisis or other catastrophic event; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions, including the acquisition, may not materialize as expected; PPD's business experiencing disruptions as a result of the acquisition or due to transaction-related uncertainty or other factors making it more difficult to maintain relationships with employees, customers, other business partners or governmental entities; difficulty retaining key employees; and the parties being unable to successfully implement integration strategies or to achieve expected synergies and operating efficiencies within the expected time-frames or at all. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in Thermo Fisher's Annual Report on Form 10-K for the year ended December 31, 2020 , which is on file with the U.S. Securities and Exchange Commission ("SEC") and available in the "Investors" section of Thermo Fisher's website, ir.thermofisher.com, under the heading "SEC Filings," and in any subsequent Quarterly Reports on Form 10-Q and other documents Thermo Fisher files with the SEC, and in PPD's Annual Report on Form 10-K for the year ended December 31, 2020 , on file with the SEC, and its subsequent Quarterly Reports on Form 10-Q and in other documents PPD filed with the SEC. While the company may elect to update forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing the company's views as of any date subsequent to today.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), Thermo Fisher uses certain non-GAAP financial measures, including adjusted EPS, which excludes certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; amortization of acquisition-related intangible assets; certain other gains and losses that are either isolated or cannot be expected to occur again with any regularity or predictability, tax provisions/benefits related to the previous items, benefits from tax credit carryforwards, the impact of significant tax audits or events, equity in earnings of unconsolidated entities and the results of discontinued operations. Thermo Fisher excludes the above items because they are outside of the company's normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. Thermo Fisher believes that the use of non-GAAP measures helps investors to gain a better understanding of the company's core operating results and future prospects, consistent with how management measures and forecasts the company's performance, especially when comparing such results to previous periods or forecasts.

This press release shall not constitute a notice of redemption with respect to, or an offer to purchase or sell (or the solicitation of an offer to purchase or sell) any PPD notes.

Media Contact Information:
Ron O'Brien
Thermo Fisher Scientific
Phone: 781-622-1242
E-mail: ron.obrien@thermofisher.com

Investor Contact Information:
Rafael Tejada
Thermo Fisher Scientific
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com

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SOURCE Thermo Fisher Scientific

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(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelectâ„¢ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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