SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 11, 2022
|SENSEONICS HOLDINGS, INC.|
|(Exact Name of Registrant as Specified in its Charter)|
(State or Other
Jurisdiction of Incorporation)
|(Commission File Number)||
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005
|(Address of Principal Executive Office) (Zip Code)|
Registrant's telephone number, including area code: (301) 515-7260
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Exchange Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, $0.001 par value||SENS||NYSE American|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results of Operations and Financial Condition.
On February 11, 2022, Senseonics Holdings, Inc. (the "Company") issued a press release announcing, among other things, its preliminary, unaudited financial results for the quarter ended December 31, 2021 and full year ended December 31, 2021, and its unaudited, estimated cash, cash equivalents and marketable securities of approximately $182 million as of December 31, 2021. These preliminary financial results and estimates are unaudited, based on currently available information and do not present all necessary information for a complete understanding of the Company’s financial condition as of December 31, 2021 or its results of operations for the quarter or year ended December 31, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
The information set forth in this Item 2.02 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 7.01 Regulation FD Disclosure.
On February 11, 2022, the Company issued a press release announcing, among other things, the receipt of U.S. Food Drug Administration approval of the six month Eversense® E-3 continuous glucose monitoring (“CGM”) system for marketing in the United States and its 2022 business outlook, including global net revenue expectations for the full year 2022.
The Company’s 2022 business outlook is based on the Company’s expected initiation of Eversense E3 commercialization in the U.S. in the second quarter of 2022, as well as the following additional key assumptions: the anticipated launch of the Eversense E3 system in Europe (where the earlier generation Eversense XL 180-day system is currently marketed) in the third quarter of 2022, subject to the receipt of regulatory approval; the approximately 600 Eversense users in the U.S. and 2,600 users in Europe as of year end 2021 upgrading to the next generation Eversense systems as they become commercially available; and current sales channel inventory levels of the 90-day Eversense CGM system in the U.S. and Eversense XL CGM system in Europe largely satisfying first quarter demand, which is expected to result in first quarter 2022 revenue being lower than fourth quarter 2021 revenue. Additionally, full year 2022 revenue is expected to be significantly weighted towards the back half of the year and, for the full year, OUS revenue is expected to be greater than U.S. revenue.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, and is not incorporated by reference into any of the Company’s filings under the Exchange Act or the Securities Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01 Other Events.
On February 11, 2022, the Company issued a press release announcing the approval by the U.S. Food and Drug Administration (“FDA”) of the Eversense E3 CGM system for marketing and sale in the U.S. and providing its 2022 business outlook. In connection with providing this outlook, the Company is providing a business update, including information concerning the commercial strategy in contemplation of the launch of its next generation Eversense systems in the U.S. and, subject to pending regulatory approval, Europe through its commercialization partner, Ascensia Diabetes Care Holdings (AG) (“Ascensia”).
As previously described, in August 2020, the Company entered into a collaboration and commercialization agreement (the “Commercialization Agreement”) with Ascensia pursuant to which it granted Ascensia the exclusive right to distribute the 90-day Eversense continuous glucose monitoring system and the six month Eversense continuous glucose monitoring system worldwide (subject to regulatory approval in certain jurisdictions) for people with diabetes, with certain initial exceptions.
Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense product on October 1, 2020 and, during 2021, the parties transitioned full commercial responsibilities to Ascensia. In light of the previously announced delay in the FDA regulatory review of the Eversense E3 six month product in the U.S., Ascensia’s commercialization activities have, to date, focused on marketing the 90-day product in the United States, including reinitiating contact with potential prescribers. The Company believes that, following the Company’s temporary suspension of commercial sales and marketing of Eversense for new users during the COVID-19 pandemic and then initiation of commercial activities through Ascensia, a number of potential prescribers and users have been waiting for the commercial availability of the six month product.
As previously announced on January 4, 2022, the Company and Ascensia have been designing the go-to-market strategy for the U.S. six month product, subject to the receipt of regulatory approval for the Eversense E3 six month product. Now that the six month product has received regulatory approval for marketing and sale in the United States, the Company expects that Ascensia will begin commercializing Eversense E3 in the U.S. in the second quarter of 2022. As with any new product, the success of the commercial launch of the Eversense E3 product in the U.S. will be subject to significant uncertainty and risks, and will require time to ramp up. Key areas of strategic focus in the U.S. commercial launch of the six month product where performance will impact the success of the launch will be: (1) growing the installed base of users, (2) increasing patient awareness of Eversense above current levels in order to expand the population of Eversense users, through driving sales and marketing efforts on the Eversense E3 system, (3) increasing awareness and adoption of Eversense by healthcare providers, including high volume CGM prescribers, through expanded targeted marketing efforts, (4) educating patients and prescribers regarding the six month product and its benefits relative to the 90-day product, (5) continuing to grow the base of the authorized inserters through geographically targeted efforts so that potential users locating a qualified inserter of Eversense is not an impediment to adoption, (6) timely establishing and maintaining favorable payor coverage for the product, including transitioning commercial payors from 90-day coverage to six month coverage, and (7) Ascensia’s continued organizational development of its U.S. sales and marketing capabilities relative to CGM.
The Company and Ascensia are also developing plans for the roll-out of the Eversense E3 next generation six month product in Europe, which, subject to receipt of regulatory approval, is expected to offer reduced calibration requirements from the Eversense XL six month product currently marketed in Europe. The roll-out of this next generation product in Europe is similarly subject to uncertainties and potential delays, including regulatory approval and launch timing, and European revenues are dependent, among other things, on success of the following: (1) Ascensia’s continued organizational development of its European sales and marketing capabilities relative to CGM, and (2) more effective tender participation, particularly in Italian markets which favor an integrated offering. The U.S. and European commercialization plans are being designed with a goal of minimizing the impact to patients, providers, and ongoing sales of Eversense CGM systems.
The Company intends to provide more details concerning the commercialization strategy for the Eversense E3 six month product and the Company’s outlook for the year in its fourth quarter earnings release and during its related investor call on March 1, 2022.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press Release dated February 11, 2022, titled “Senseonics Holdings, Inc. Announces FDA Approval of the Eversense® E3 Continuous Glucose Monitoring System for Use for Up to 6 month; Provides 2022 Business Outlook.”|
|104||Cover Page Interactive Data (embedded within the Inline XBRL document).|
Any statements in this report about future expectations, plans and prospects for the Company, including statements concerning the plans and timing of commercial launch of the Eversense E3 six month product in the U.S. and Europe, the receipt of European regulatory approval of the Eversense E3 product and the timing thereof, the Company’s expected revenues on an absolute or relative basis, patient and prescriber demand, Ascensia’s efforts and results in connection with the product launch, including Ascensia’s ability to (i) increase patient awareness of Eversense and grow the U.S. and European installed base of Eversense systems; (ii) increase awareness and adoption of Eversense by healthcare providers, (iii) educate patients and prescribers regarding the benefits of the six month product, (iv) continue to grow the base of authorized Eversense inserters, (v) establish and maintain favorable payor coverage for the six month product, including the transition of coverage from the 90-day to six month product, and (vi) continue developing its U.S. sales and marketing capabilities for CGM commercialization, as well as other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the commercial launch and commercial expansion of the Eversense six month product, including the ability to drive consumer, prescriber and inserter awareness and demand; uncertainties in insurer, regulatory and administrative processes and decisions; uncertainties with respect to patient and prescriber perceptions of and reactions to the product; the ability of Ascensia to effectively market and sell the Eversense E3 product in the U.S. and Europe; uncertainties in the duration and severity of the COVID-19 pandemic, and such other factors as are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2021, and the Company’s other filings with the SEC, including under the heading “Risk Factors.” In addition, the forward-looking statements included in this report represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: February 11, 2022||Senseonics Holdings, Inc.|
|By:||/s/ Nick B. Tressler|
|Nick B. Tressler|
|Chief Financial Officer|
Senseonics Announces FDA Approval of the Eversense® E3 Continuous Glucose Monitoring System for Use for Up to 6 months; Provides 2022 Business Outlook
The world’s first and only long-term implantable CGM system now offers patients exceptional accuracy for 6 months
GERMANTOWN, MD, February 11, 2022 -- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the approval of the next-generation Eversense® E3 CGM System by the Food and Drug Administration (FDA). The Eversense E3, including proprietary sacrificial boronic acid (SBA) technology to extend longevity to 6 months, is planned to be available to patients in the U.S. through Ascensia Diabetes Care, Senseonics’ global commercial partner, beginning in the second quarter of 2022.
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” said Satish Garg, M.D., Professor of Medicine and Director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, and the Principal Investigator of the PROMISE Study1, which formed the basis for the FDA approval. “The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last 6 months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”
The Eversense E3 CGM System offers patients:
|·||Fully implantable third generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.|
|·||Industry leading 6 month sensor wear duration, making Eversense the longest lasting CGM system available, with essentially two sensor insertion and removal procedures per year.|
|·||Removable smart transmitter, held in place with a mild silicone-based adhesive, providing discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.|
“Further extending the duration of the longest lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “The review was delayed by one year due to COVID-19 priorities and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to U.S. patients beginning in the second quarter. We look forward to initiating Eversense E3 sales and believe that, with Ascensia’s newly dedicated CGM commercial organization, the launch of the new 6-month product will establish the foundation for growth in our installed base later in 2022 and beyond.”
After the extended review during COVID-19, and with its next generation product now having been approved in the U.S., the Company concurrently is providing its 2022 financial outlook. The Company expects full year 2022 global net revenue to be in the range of $14.0 million to $18.0 million. The Company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial, subject to IDE approval. Additionally, the Company currently expects to report unaudited revenues of approximately $4.0 million for the fourth quarter of 2021 and approximately $13.7 million for the full year ended December 31, 2021. The unaudited balance of cash, cash equivalents and marketable securities at December 31, 2021 was approximately $182 million. The Company expects to report its full fourth quarter and fiscal year 2021 financial results after the market close on Tuesday, March 1, 2022. The preliminary financial results described herein have not been audited and are subject to adjustment based on the Company’s completion of year-end financial close processes.
“The Eversense E3 CGM System is an exciting advancement in diabetes management,” said Francine Kaufman, M.D., Chief Medical Officer of Senseonics. “We believe patients and providers are waiting for this step forward. I want to take this opportunity to thank the PROMISE Study investigators, study particiants, and the Senseonics team for helping us reach this important milestone, and the diligence of the FDA reviewers in this difficult environment. We are excited to begin making this next generation product available in the U.S. to people with diabetes.”
Patients who are interested in getting started on Eversense today can sign up at www.eversensediabetes.com/get-started-today, and will be among the first to know when Eversense E3 is commercially available. Physicians, nurse practitioners and physician assistants interested in offering the Eversense CGM System for their patients can sign up at https://www.ascensiadiabetes.com/eversense/become-a-provider/register/. Or contact 844-SENSE4U (844-736-7348) to learn more about the first and only long-term implantable CGM system.
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 6 months in persons age 18 and older. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a trained and certified health care provider. The Eversense CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://www.ascensiadiabetes.com/eversense/safety-info/.
Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense®, Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including 2022 revenue projections, statements concerning the Company’s unaudited preliminary financial information for the fourth quarter of 2021 and the full year ended December 31, 2021, statements regarding the timing of the commercial launch of the Eversense E3 product, statements regarding patient and provider acceptance of the Eversense product and its attributes, statements regarding future results for patients, statements regarding growth of the installed base of Eversense users, statements regarding future research and study plans, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the commercial launch and commercial expansion of a new generation of the Eversense product, uncertainties inherent in the transition of commercialization responsibilities to Ascensia and its commercial initiatives, uncertainties in the development and regulatory approval processes and timing for the E3 product in Europe, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2020 and Senseonics’ other filings with the SEC under the heading “Risk Factors,” as well as those factors referenced in Senseonics’ Current Report on Form 8-K filed with the SEC on February 11, 2022.
The preliminary financial information set forth in this press release is subject to the completion of the Company’s audit process and is subject to change. The estimated preliminary results included in this press release should not be viewed as a substitute for the Company’s annual financial statements prepared in accordance with U.S. generally accepted accounting principles. There can be no assurance that the estimated preliminary results will be realized, and you are cautioned not to place undue reliance on the preliminary financial information, which reflects management’s current expectations and anticipated results of operations, which are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements, market trends, or industry results to differ materially from those expressed or implied by such forward-looking statements. In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
1 Garg SK, MD, Liljenquist D, Bode B, et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. DIABETES TECHNOLOGY & THERAPEUTICS 24;2: 2022 DOI: 10.1089/dia.2021.0182
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