Abbott to Acquire Cardiovascular Systems, Inc.

Abbott will gain an innovative, complementary solution in treating vascular disease through CSI's leading atherectomy system, which prepares vessels for angioplasty or stenting to restore blood flow
CSI's offering will support Abbott's ability to provide better care for patients with peripheral and coronary artery disease

Abbott (NYSE: ABT) and Cardiovascular Systems, Inc. (CSI), today announced a definitive agreement for Abbott to acquire CSI, a medical device company with an innovative atherectomy system used in treating peripheral and coronary artery disease. Under terms of the agreement, CSI stockholders will receive $20 per common share at a total expected equity value of approximately $890 million .

CSI is a leader in devices for atherectomy, a minimally invasive treatment for plaque build-up in arteries that can restrict blood flow. Procedural use of atherectomy can help maximize the benefits of standard balloon angioplasty or stent treatments in restoring blood flow in complex arterial disease. CSI also has an early-stage pipeline of complementary vascular intervention devices in development.

"The acquisition of CSI will add new, complementary technologies to Abbott's leading vascular device offerings," said Lisa Earnhardt , executive vice president, Medical Devices, Abbott. "CSI has a talented and experienced team and a leading atherectomy system that will allow Abbott to provide physicians more tools to help patients live fuller lives."

"We are pleased to have reached an agreement with a leading global company that shares our passion for the development and commercialization of innovative solutions for treating complex peripheral vascular disease and coronary artery disease," said Scott Ward , CSI's chairman, president and chief executive officer. "We believe combining with Abbott delivers value to our patients, physician customers, employees and stockholders while continuing our work to save limbs and save lives every day."

Financial Impact of Transaction

Upon close, the transaction is expected to be neutral to Abbott's recently issued 2023 ongoing earnings per share guidance.

The transaction, which has been approved by the boards of directors of CSI and Abbott, is subject to the approval of CSI stockholders and the satisfaction of customary closing conditions, including applicable regulatory approvals.

J.P. Morgan Securities LLC is serving as financial advisor to CSI.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn. , is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company's orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For more information, visit www.csi360.com and follow us on LinkedIn and Twitter.

Additional Information and Where to Find It

This news release may be deemed to be solicitation material in respect of the proposed acquisition of Cardiovascular Systems, Inc. (CSI), by Abbott. In connection with the proposed acquisition, CSI intends to file relevant materials with the United States Securities and Exchange Commission (the "SEC"), including CSI's preliminary and definitive proxy statements relating to the transaction. CSI stockholders are urged to read all relevant documents filed with the SEC, including CSI's preliminary and definitive proxy statements, because they will contain important information about the proposed transaction and the parties to the proposed transaction. Investors and security holders are able to obtain the documents (once available) free of charge at the SEC's website at www.sec.gov , or free of charge from CSI at www.investors.csi360.com .

Participants in the Solicitation

CSI and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be "participants" in the solicitation of proxies from CSI stockholders in favor of the proposed transaction. Information about CSI's directors and executive officers is set forth in CSI's Proxy Statement on Schedule 14A for its 2022 Annual Meeting of Stockholders, as revised, which was filed with the SEC on Oct. 26, 2022 , and its Annual Report on Form 10-K for the fiscal year ended June 30, 2022 , which was filed with the SEC on Aug. 18, 2022 . Information concerning the interests of CSI's participants in the solicitation, which may, in some cases, be different than those of CSI's stockholders generally, is set forth in the materials filed by CSI with the SEC, and will be set forth in the preliminary and definitive proxy statements relating to the proposed transaction.

— Private Securities Litigation Reform Act of 1995 —
A Caution Concerning Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott and CSI caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements, including but not limited to the ability of the parties to consummate the proposed transaction on a timely basis or at all, the ability of the parties to satisfy the conditions precedent to consummation of the proposed transaction, including the ability to secure the applicable regulatory approvals on the terms expected, at all or in a timely manner, the effect of the announcement of the proposed transaction on the ability of CSI to retain and hire key personnel and maintain relationships with its key business partners and customers, and others with whom it does business, or on its operating results and businesses generally, the response of competitors to the proposed transaction, risks associated with the disruption of CSI management ' s attention from ongoing business operations due to the proposed transaction, significant costs associated with the proposed transaction, potential litigation relating to the proposed transaction, restrictions during the pendency of the proposed transaction that may impact CSI ' s ability to conduct its business, the ability of Abbott to successfully integrate CSI ' s operations, and the ability of Abbott to implement its plans, forecasts and other expectations with respect to CSI ' s business after the completion of the transaction and realize expected synergies. Economic, competitive, governmental, technological and other factors that may affect Abbott ' s and CSI ' s operations are discussed in Item 1A, " Risk Factors, " in each of Abbott ' s Annual Report on Form 10-K for the year ended Dec. 31, 2021 , and CSI ' s Annual Report on Form 10-K for the year ended June 30, 2022 , respectively, and are incorporated herein by reference. Abbott and CSI are providing the information in this news release as of this date. Abbott and CSI undertake no obligation to release publicly any revisions to the information included in this news release or any forward-looking statements as a result of new information, subsequent events or developments, except as required by law.

View original content: https://www.prnewswire.com/news-releases/abbott-to-acquire-cardiovascular-systems-inc-301742551.html

SOURCE Abbott; Cardiovascular Systems, Inc.

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Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
The new programs build on a successful first year of the multi-million-dollar corporate initiative

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The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie. G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.¹ In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD².
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.³
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR₄
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR₁₂) are considered cured of
hepatitis C
About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR₁₂.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
¹ Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
² IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
³ American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.

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About Medtronic
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Abbott to Acquire Cardiovascular Systems, Inc.

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