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 September 30, 2023.

Recent Highlights & Accomplishments:

  • Generated revenue of $6.1 million in the third quarter of 2023
  • Announced the last patient completion of the 365-day ENHANCE Pivotal Clinical Study adult cohort
  • Launched with our global commercial partner Ascensia Diabetes Care, a new direct to consumer U.S. advertising campaign, ‘The CGM for Real Life’ to increase awareness of Eversense’s unique benefits
  • Entered into a $50 million non-dilutive loan facility with Hercules Capital, Inc. and drew down an initial $25 million, further strengthening the balance sheet

“The third quarter was marked by milestones across our development programs, commercial collaboration with Ascensia, and continued progress in strengthening our balance sheet,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Completing the adult cohort of the ENHANCE 365-day pivotal trial, launching a new advertising campaign and finalizing a new loan facility all help position us to advance our plans to grow adoption of Eversense, the world’s only long term CGM.”

Third Quarter 2023 Results:

Total revenue for the third quarter of 2023 was $6.1 million compared to $4.6 million for the third quarter of 2022. U.S. revenue was $3.9 million in the third quarter of 2023 compared to $1.9 million in the prior year period, and revenue outside the U.S. was $2.2 million in the third quarter of 2023 compared to $2.7 million in the prior year period.

Third quarter 2023 gross profit of $1.2 million increased from $0.8 million in gross profit for the third quarter of 2022. The increase in gross margin was primarily driven by an increase to revenue as volumes increased.

Third quarter 2023 sales and marketing and general and administrative expenses increased by $0.1 million year-over-year, to $7.4 million. The consistency was the result of efforts to manage other general and administrative costs across the organization.

Third quarter 2023 research and development expenses increased by $1.8 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 $24.1 million, or $0.04 per share, in the third quarter of 2023 compared to a net loss of $60.4 million, or $0.13 per share, in the third quarter of 2022. Net income increased by $36.3 million due to the accounting for embedded derivatives, fair value adjustments and the exchange of a portion of the 2025 notes.

Cash, cash equivalents, short and long-term investments were $125.4 million and outstanding indebtedness was $45.8 million as of September 30, 2023.

2023 Financial Outlook

Senseonics expects full year 2023 global net revenue to be at the midpoint of the $20 million to $24 million range.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, November 9, 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: 1409312

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 partnering with 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 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 September 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.

Senseonics Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

September 30,

 

December 31,

 

 

 

2023

 

2022

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

55,759

 

 

$

35,793

 

 

Short term investments, net

 

 

69,648

 

 

 

108,222

 

 

Accounts receivable, net

 

 

701

 

 

 

127

 

 

Accounts receivable, net - related parties

 

 

2,749

 

 

 

2,324

 

 

Inventory, net

 

 

9,726

 

 

 

7,306

 

 

Prepaid expenses and other current assets

 

 

7,557

 

 

 

7,428

 

 

Total current assets

 

 

146,140

 

 

 

161,200

 

 

 

 

 

 

 

 

 

 

Deposits and other assets

 

 

6,991

 

 

 

3,108

 

 

Long term investments, net

 

 

 

 

 

12,253

 

 

Property and equipment, net

 

 

934

 

 

 

1,112

 

 

Total assets

 

$

154,065

 

 

$

177,673

 

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

2,669

 

 

$

419

 

 

Accrued expenses and other current liabilities

 

 

14,356

 

 

 

14,616

 

 

Accrued expenses and other current liabilities, related parties

 

 

277

 

 

 

837

 

 

Note payable, current portion, net

 

 

 

 

 

15,579

 

 

Derivative liability, current portion

 

 

 

 

 

20

 

 

Total current liabilities

 

 

17,302

 

 

 

31,471

 

 

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

40,485

 

 

 

56,383

 

 

Derivative liabilities

 

 

245

 

 

 

52,050

 

 

Other liabilities

 

 

6,312

 

 

 

2,689

 

 

Total liabilities

 

 

64,344

 

 

 

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 September 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 September 30, 2023 and December 31, 2022; 528,176,273 shares and 479,637,138 shares issued and outstanding as of September 30, 2023 and December 31, 2022

 

 

528

 

 

 

480

 

 

Additional paid-in capital

 

 

903,665

 

 

 

806,488

 

 

Accumulated other comprehensive loss

 

 

(59

)

 

 

(678

)

 

Accumulated deficit

 

 

(852,069

)

 

 

(808,866

)

 

Total stockholders’ equity (deficit)

 

 

52,065

 

 

 

(2,576

)

 

Total liabilities and stockholders’ equity

 

$

154,065

 

 

$

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

 

Nine Months Ended

 

 

September 30,

 

September 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue, net

 

$

426

 

 

$

126

 

 

$

1,176

 

 

$

555

 

Revenue, net - related parties

 

 

5,671

 

 

 

4,496

 

 

 

13,184

 

 

 

10,263

 

Total revenue

 

 

6,097

 

 

 

4,622

 

 

 

14,360

 

 

 

10,818

 

Cost of sales

 

 

4,925

 

 

 

3,866

 

 

 

12,358

 

 

 

8,711

 

Gross profit

 

 

1,172

 

 

 

756

 

 

 

2,002

 

 

 

2,107

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

12,769

 

 

 

10,985

 

 

 

38,003

 

 

 

28,088

 

Selling, general and administrative expenses

 

 

7,425

 

 

 

7,340

 

 

 

22,598

 

 

 

23,785

 

Operating loss

 

 

(19,022

)

 

 

(17,569

)

 

 

(58,599

)

 

 

(49,766

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,460

 

 

 

544

 

 

 

3,879

 

 

 

878

 

Gain (Loss) on fair value adjustment of option

 

 

 

 

 

(8,592

)

 

 

 

 

 

41,333

 

Exchange related gain (loss), net

 

 

(4,569

)

 

 

 

 

 

14,207

 

 

 

 

Interest expense

 

 

(2,425

)

 

 

(4,801

)

 

 

(9,388

)

 

 

(13,806

)

Gain (Loss) on change in fair value of derivatives

 

 

438

 

 

 

(28,948

)

 

 

6,505

 

 

 

152,169

 

Impairment cost, net

 

 

 

 

 

(984

)

 

 

 

 

 

(138

)

Other income (expense)

 

 

15

 

 

 

(41

)

 

 

194

 

 

 

(112

)

Total other (expense) income, net

 

 

(5,081

)

 

 

(42,822

)

 

 

15,397

 

 

 

180,324

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (Loss) Income

 

 

(24,103

)

 

 

(60,391

)

 

 

(43,202

)

 

 

130,558

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

61

 

 

 

(57

)

 

 

619

 

 

 

(973

)

Total other comprehensive gain (loss)

 

 

61

 

 

 

(57

)

 

 

619

 

 

 

(973

)

Total comprehensive (loss) income

 

$

(24,042

)

 

$

(60,448

)

 

$

(42,583

)

 

$

129,585

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net (loss) income per common share

 

$

(0.04

)

 

$

(0.13

)

 

$

(0.08

)

 

$

0.28

 

Basic weighted-average shares outstanding

 

 

592,452,262

 

 

 

472,475,747

 

 

 

552,703,546

 

 

 

464,244,736

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net loss per common share

 

$

(0.04

)

 

$

(0.13

)

 

$

(0.08

)

 

$

(0.10

)

Diluted weighted-average shares outstanding

 

 

592,452,262

 

 

 

472,475,747

 

 

 

552,703,546

 

 

 

608,345,713

 

 

Investor Contact Philip Taylor Gilmartin Group 415-937-5406 Investors@senseonics.com

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