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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 10, 2023
| SENSEONICS HOLDINGS, INC. |
| (Exact Name of Registrant as Specified in its Charter) |
| Delaware | 001-37717 | 47-1210911 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
| 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
Not Applicable
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 Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock | 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 August 10, 2023, Senseonics Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023, as well as information regarding a conference call to discuss these financial results and the Company’s recent corporate highlights and outlook. This press release has been furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by this reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits.
| Exhibit | ||
| Number | Description | |
| 99.1 | Press Release of Senseonics Holdings, Inc. dated August 10, 2023. | |
| 104 | Cover Page Interactive Data (embedded within the Inline XBRL document). |
SIGNATURES
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: August 10, 2023 | SENSEONICS HOLDINGS, INC. | |
| By: | /s/ Rick Sullivan | |
| Name: | Rick Sullivan | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
SENSEONICS HOLDINGS, INC. REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS
GERMANTOWN, MD, August 10, 2023 —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 reported financial results for the quarter ended June 30, 2023.
Recent Highlights & Accomplishments:
| · | Generated revenue of $4.1 million in the second quarter of 2023 |
| · | Submitted an application to the FDA for an iCGM designation for the Eversense CGM system |
| · | Received a positive coverage decision from UnitedHealthcare, the largest healthcare insurance company in the United States, for the Eversense E3 CGM, expanding access to a total of approximately 300 million covered lives |
| · | Expanded the NPG sensor inserter network providing patients with further convenient options to start Eversense |
| · | Presented positive data at the American Diabetes Association 83rd Scientific Sessions highlighting 365 day longevity and accuracy of the Eversense System |
| · | Entered into a series of exchange agreements to exchange up to $30.8 million in principal amount of the 2025 Notes for a combination of cash and stock, further strengthening the balance sheet |
“In the second quarter, we continued to execute on our strategic priorities of advancing our product pipeline and collaborating with Ascensia Diabetes Care, our global commercial partner. The FDA submission for the iCGM designation and the expansion of both Ascensia’s dedicated U.S. CGM salesforce and the NPG partnership support our drive to increase patient and provider adoption of our Eversense System,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Additionally, we are pleased with the positive data readouts presented at ADA, demonstrating that our current sensor configuration delivered accurate results for 365 days. This data gives us confidence in the execution of our product pipeline, and we are looking forward to the next generation products which we expect to further support ADC’s efforts to build the Eversense brand and drive global adoption.”
Second Quarter 2023 Results:
Total revenue for the second quarter of 2023 was $4.1 million compared to $3.7 million for the second quarter of 2022. U.S. revenue was $1.8 million in the second quarter of 2023 compared to $1.2 million in the prior year period, and revenue outside the U.S. was $2.3 million in the second quarter of 2023 compared to $2.5 million in the prior year period.
Second quarter 2023 gross profit of $0.4 million decreased from $0.8 million in gross profit for the second quarter of 2022. The reduction in gross margin was primarily driven by an increase in the revenue share percentage due to Ascensia.
Second quarter 2023 sales and marketing and general and administrative expenses decreased by $1.1 million year-over-year, to $7.5 million. The decrease was the result of reduced personnel costs and other general and administrative costs.
Second quarter 2023 research and development expenses increased by $3.5 million year-over-year, to $12.8 million. The increase was primarily due to investments in our product pipeline for development and clinical trials of next generation technologies.
Net loss was $20.4 million, or $0.04 per share, in the second quarter of 2023 compared to a net income of $104.2 million, or $0.22 per share, in the second quarter of 2022. The change in net income was due to the accounting for embedded derivatives, fair value adjustments and the exchange of the PHC notes last quarter.
Cash, cash equivalents, short and long-term investments were $125.1 million and outstanding indebtedness was $52.4 million as of June 30, 2023.
2023 Financial Outlook
Senseonics reiterates the expectation for full year 2023 global net revenue to be in the range of $20 million to $24 million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm (Eastern Time) today, August 10, 2023, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics’ website.
|
Live Teleconference Information: Dial in number: 888-317-6003 Entry Number: 24023664 International dial in: 412-317-6061 |
Live Webcast Information: Visit http://www.senseonics.com and select the “Investor Relations” section |
A replay of the call can be accessed on Senseonics’ website http://www.senseonics.com under “Investor Relations.”
About Senseonics
Senseonics Holdings, Inc. (“Senseonics”) 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 the revenue projections under “2023 Financial Outlook,” statements about the commercial launch of Eversense® E3, statements regarding increasing patient access and patient and provider adoption, statements regarding advancing development programs and the pipeline, statements regarding strengthening the Eversense® brand, 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 of Eversense® E3 CGM system and commercial expansion of the Eversense product, uncertainties inherent in the expansion of Ascensia Diabetes Care’s U.S. salesforce and its commercial initiatives, uncertainties inherent in collaborating with a new partner in the Nurse Practitioner Group and that partner’s assumption of certain clinical and administrative activities, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology, uncertainties relating to the current economic environment, the ability to successfully complete the exchanges of 2025 Notes 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, 2022, the Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” 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.
Investor Contact
Philip Taylor
Gilmartin Group
415-937-5406
Investors@senseonics.com
Senseonics Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,551 | $ | 35,793 | ||||
| Short term investments, net | 89,067 | 108,222 | ||||||
| Accounts receivable, net | 655 | 127 | ||||||
| Accounts receivable, net - related parties | 3,020 | 2,324 | ||||||
| Inventory, net | 9,194 | 7,306 | ||||||
| Prepaid expenses and other current assets | 7,742 | 7,428 | ||||||
| Total current assets | 138,229 | 161,200 | ||||||
| Deposits and other assets | 6,755 | 3,108 | ||||||
| Long term investments, net | 7,453 | 12,253 | ||||||
| Property and equipment, net | 925 | 1,112 | ||||||
| Total assets | $ | 153,362 | $ | 177,673 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 975 | $ | 419 | ||||
| Accrued expenses and other current liabilities | 14,256 | 14,616 | ||||||
| Accrued expenses and other current liabilities, related parties | 630 | 837 | ||||||
| Note payable, current portion, net | — | 15,579 | ||||||
| Derivative liability, current portion | — | 20 | ||||||
| Total current liabilities | 15,861 | 31,471 | ||||||
| Long-term debt and notes payables, net | 39,108 | 56,383 | ||||||
| Derivative liabilities | 1,792 | 52,050 | ||||||
| Other liabilities | 6,408 | 2,689 | ||||||
| Total liabilities | 63,169 | 142,593 | ||||||
| Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares and 12,000 shares issued and outstanding as of June 30, 2023 and December 31, 2022 | 37,656 | 37,656 | ||||||
| Total temporary equity | 37,656 | 37,656 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, $0.001 par value per share; 900,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 492,826,683 shares and 479,637,138 shares issued and outstanding as of June 30, 2023 and December 31, 2022 | 493 | 480 | ||||||
| Additional paid-in capital | 880,129 | 806,488 | ||||||
| Accumulated other comprehensive loss | (120 | ) | (678 | ) | ||||
| Accumulated deficit | (827,965 | ) | (808,866 | ) | ||||
| Total stockholders’ equity (deficit) | 52,537 | (2,576 | ) | |||||
| Total liabilities and stockholders’ equity | $ | 153,362 | $ | 177,673 | ||||
Senseonics Holdings, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue, net | $ | 437 | 137 | $ | 750 | $ | 429 | |||||||||
| Revenue, net - related parties | 3,689 | 3,577 | 7,513 | 5,767 | ||||||||||||
| Total revenue | 4,126 | 3,714 | 8,263 | 6,196 | ||||||||||||
| Cost of sales | 3,709 | 2,890 | 7,433 | 4,845 | ||||||||||||
| Gross profit | 417 | 824 | 830 | 1,351 | ||||||||||||
| Expenses: | ||||||||||||||||
| Research and development expenses | 12,830 | 9,299 | 25,235 | 17,103 | ||||||||||||
| Selling, general and administrative expenses | 7,455 | 8,561 | 15,173 | 16,445 | ||||||||||||
| Operating loss | (19,868 | ) | (17,036 | ) | (39,578 | ) | (32,197 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 1,311 | 241 | 2,420 | 334 | ||||||||||||
| Gain on fair value adjustment of option | — | 28,224 | — | 49,925 | ||||||||||||
| Exchange related gain, net | — | — | 18,776 | — | ||||||||||||
| Interest expense | (2,310 | ) | (4,510 | ) | (6,962 | ) | (9,005 | ) | ||||||||
| Gain on change in fair value of derivatives | 289 | 96,548 | 6,067 | 181,117 | ||||||||||||
| Impairment cost, net | — | 816 | — | 846 | ||||||||||||
| Other income (expense) | 155 | (52 | ) | 178 | (71 | ) | ||||||||||
| Total other (expense) income, net | (555 | ) | 121,267 | 20,479 | 223,146 | |||||||||||
| Net (Loss) Income | (20,423 | ) | 104,231 | (19,099 | ) | 190,949 | ||||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized gain (loss) on marketable securities | 100 | (291 | ) | 558 | (916 | ) | ||||||||||
| Total other comprehensive gain (loss) | 100 | (291 | ) | 558 | (916 | ) | ||||||||||
| Total comprehensive (loss) income | $ | (20,323 | ) | $ | 103,940 | $ | (18,541 | ) | $ | 190,033 | ||||||
| Basic net (loss) income per common share | $ | (0.04 | ) | 0.22 | $ | (0.04 | ) | $ | 0.42 | |||||||
| Basic weighted-average shares outstanding | 567,125,022 | 464,133,903 | 532,499,776 | 460,061,022 | ||||||||||||
| Diluted net loss per common share | $ | (0.04 | ) | (0.03 | ) | $ | (0.04 | ) | $ | (0.06 | ) | |||||
| Diluted weighted-average shares outstanding | 567,125,022 | 601,330,959 | 532,499,776 | 604,342,540 | ||||||||||||