Senseonics Announces Organization Update

GERMANTOWN, Md.–(Business WIRE)–Dec 23, 2020–

Senseonics Holdings, Inc. (NYSE American: SENS), a health-related know-how firm focused on the improvement and commercialization of long-phrase, implantable steady glucose monitoring (CGM) techniques for men and women with diabetes, announced currently financial and operational company updates.

Modern Developments

• Fourth quarter 2020 net income is anticipated to be about $3.5 million, improved from the prior expectation of roughly $2.5 million
• Obtained communication from the Food and drug administration explaining the reallocation of agency methods to handle Crisis Use Authorization (EUA) apps for items related to the COVID-19 public health crisis is influencing advertising and marketing application opinions, which includes the Eversense 180-working day merchandise, which will be delayed by at the very least 60 days. This is constant with what Senseonics understands other healthcare know-how companies have noted.
• Inclusion of Eversense Category III CPT codes in the Centers for Medicare & Medicaid Providers (CMS) 2021 Physician Cost Agenda (PFS), establishing international payment for the machine cost and process charges for healthcare companies across the United States
• Comprehensive year 2021 web earnings is predicted to be among $12 and $15 million, based mostly on set up foundation, acceleration of Ascensia’s industrial things to do and other variables
• Achieved settlement with Roche to aid changeover of distribution to Ascensia, as Roche income conclude January 31, 2021, like final purchases, transition help routines, and resolution of other matters
• Highbridge next lien personal loan extinguished by concluded conversion of their 2nd lien credit card debt to popular inventory, simplifying capital construction

“Strong fourth quarter general performance was driven by product sales in Europe and supported by Ascensia’s original US sales. In the initial quarter of next yr our major priority is executing an orderly industrial transition in Europe from Roche to Ascensia even though sustaining uninterrupted client and supplier support. On the regulatory entrance we comprehend the FDA’s prioritization of Unexpected emergency Use Authorization apps for items to aid handle the COVID-19 pandemic. We remain assured that the Assure research demonstrates that the great overall performance of the current Eversense technique is prolonged for up to 180 days, and that there however is potential for a determination from the agency by the end of the stop of the 2nd quarter,” claimed Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “The inclusion of implantable CGM in the doctor cost schedule for 2021 will enhance entry to Eversense for Medicare clients who are uniquely suited to advantage from the functions of the method. Seeking ahead to 2021, although the US affected individual inhabitants represents a significant growth chance for Senseonics and Ascensia, we ultimately assume OUS earnings to continue to account for over 50 % of full earnings.”

“We have established a solid commercial team built-in with the Eversense operations across the US and our original initiatives have been profitable equally with reinsertions of present-day clients and the addition of new clients,” stated Robert Schumm, President of Ascensia Diabetic issues Care. “As we look to 2021, we intend to ramp up our investment decision in the starting of the new yr to boost access to the technology globally. We will be targeted on growing our throughout the world gross sales and advertising and marketing pursuits while creating out a in depth infrastructure to generate ongoing Eversense adoption. We are psyched to perform with this enthusiastic group of health care companies and sufferers who believe in the outstanding benefits of the Eversense merchandise.”

About Senseonics

Senseonics Holdings, Inc. is a healthcare technologies firm targeted on the style and design, advancement and commercialization of transformational glucose monitoring products intended to assistance folks with diabetic issues confidently reside their life with relieve. Senseonics’ CGM systems, Eversense® and Eversense® XL, consist of a tiny sensor inserted absolutely under the skin that communicates with a wise transmitter worn around the sensor. The glucose info are routinely despatched each 5 minutes to a cell application on the user’s smartphone.

Ahead Searching Statements

Any statements in this press release about future anticipations, plans and prospects for Senseonics, together with statements about Senseonics’ predicted internet earnings for the fourth quarter of 2020 and the entire yr of 2021, the timing and final result of the prospective determination on the 180-working day Eversense technique from the Fda, improved access to Eversense for Medicare patients, development chances in 2021, the proportion of OUS revenue to total profits, the likely ramp of globally profits and promoting pursuits in 2021, and other statements containing the phrases “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and very similar expressions, constitute forward-hunting statements in just the meaning of The Non-public Securities Litigation Reform Act of 1995. True final results may differ materially from those indicated by these types of forward-wanting statements as a outcome of many crucial variables, including: uncertainties in the regulatory approval system, uncertainties inherent in the commercial start and business enlargement of the products, uncertainties in insurance provider, regulatory and administrative procedures and choices, uncertainties in the period and severity of the COVID-19 pandemic, and these kinds of other components as are established forth in the threat factors comprehensive in Senseonics’ Once-a-year Report on Sort 10-K for the calendar year ended December 31, 2019, Senseonics’ Quarterly Report on Form 10-Q for the quarter finished September 30, 2020 and Senseonics’ other filings with the SEC beneath the heading “Risk Things.” In addition, the forward-on the lookout statements bundled in this push release signify Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent gatherings and developments will cause Senseonics’ views to modify. On the other hand, even though Senseonics may perhaps elect to update these ahead-seeking statements at some point in the foreseeable future, Senseonics specially disclaims any obligation to do so except as necessary by regulation. These forward-seeking statements should really not be relied upon as representing Senseonics’ sights as of any date subsequent to the date hereof.

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Call: Senseonics Investor Get in touch with

Lynn Lewis or Philip Taylor

Trader Relations

415-937-5406

[email protected] Media Get in touch with:

Mirasol Panlilio

301-556-1631

[email protected]

Search phrase: MARYLAND UNITED STATES NORTH America

Market Keyword: Diabetes Wellness Professional medical Materials Clinical Units

Source: Senseonics Holdings, Inc.

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PUB: 12/23/2020 04:49 PM/DISC: 12/23/2020 04:49 PM

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