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 March 31, 2023.

Recent Highlights & Accomplishments:

  • Generated revenue of $4.1 million in the first quarter of 2023.
  • Ascensia Diabetes Care, Senseonics’ global commercial partner, is expanding their U.S. salesforce to a planned nearly 50 professionals, compared to an average of approximately 20 during 2022.
  • Initiated the enrollment of a pediatric cohort in the ENHANCE trial evaluating the 365-day sensor configuration.
  • Strengthened the balance sheet through financings from PHC Holdings, which included PHC Holdings’ exchange of its $35 million senior secured convertible notes for equity and an additional $15 million equity investment.

“In the first quarter, we made progress in our initiatives to support global patient and provider adoption of Eversense,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We believe continuing to work to drive commercial awareness and access through the Ascensia collaboration, along with advancing our technology pipeline, will drive future growth and create durable shareholder value.”

First Quarter 2023 Results:

Total revenue for the first quarter of 2023 was $4.1 million compared to $2.5 million for the first quarter of 2022. U.S. revenue was $2.1 million in the first quarter of 2023 compared to $0.8 million in the prior year period, and revenue outside the U.S. was $2.0 million in the first quarter of 2023 compared to $1.7 million in the prior year period.

First quarter 2023 gross profit of $0.4 million decreased from $0.5 million in gross profit for the first quarter of 2022.

First quarter 2023 sales and marketing and general and administrative expenses decreased by $0.2 million year-over-year, to $7.7 million. The decrease was primarily the result of a reduction in spend related to personnel costs, general administrative costs and selling and marketing consulting services.

First quarter 2023 research and development expenses increased by $4.6 million year-over-year, to $12.4 million. The increase was due to investments for next generation technologies including clinical studies activities, personnel related costs due to the expansion of our research and development workforce, consulting, contract fabrication and other R&D support services.

Net income was $1.3 million, or $0.00 per share, in the first quarter of 2023 compared to a net income of $86.7 million, or $0.19 per share, in the first quarter of 2022. The change in net income was the result of accounting for the exchange of the PHC notes, embedded derivatives and fair value adjustments.

Cash, cash equivalents, short and long-term investments were $136.6 million and outstanding indebtedness was $51.8 million as of March 31, 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, May 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: 7018265

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 adoption, statements regarding advancing development programs, 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, 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 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)

 

 

 

 

 

 

 

 

 

 

March 31,

 

December 31,

 

 

 

2023

 

2022

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,085

 

 

$

35,793

 

 

Short term investments, net

 

 

83,359

 

 

 

108,222

 

 

Accounts receivable, net

 

 

451

 

 

 

127

 

 

Accounts receivable, net - related parties

 

 

2,953

 

 

 

2,324

 

 

Inventory, net

 

 

8,195

 

 

 

7,306

 

 

Prepaid expenses and other current assets

 

 

6,293

 

 

 

7,428

 

 

Total current assets

 

 

146,336

 

 

 

161,200

 

 

 

 

 

 

 

 

 

 

Deposits and other assets

 

 

2,998

 

 

 

3,108

 

 

Long term investments, net

 

 

8,157

 

 

 

12,253

 

 

Property and equipment, net

 

 

1,042

 

 

 

1,112

 

 

Total assets

 

$

158,533

 

 

$

177,673

 

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

646

 

 

$

419

 

 

Accrued expenses and other current liabilities

 

 

12,808

 

 

 

14,616

 

 

Accrued expenses and other current liabilities, related parties

 

 

823

 

 

 

837

 

 

Note payable, current portion, net

 

 

 

 

 

15,579

 

 

Derivative liability, current portion

 

 

 

 

 

20

 

 

Total current liabilities

 

 

14,277

 

 

 

31,471

 

 

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

37,479

 

 

 

56,383

 

 

Derivative liabilities

 

 

2,081

 

 

 

52,050

 

 

Other liabilities

 

 

2,576

 

 

 

2,689

 

 

Total liabilities

 

 

56,413

 

 

 

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 March 31, 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 March 31, 2023 and December 31, 2022; 479,780,414 shares and 479,637,138 shares issued and outstanding as of March 31, 2023 and December 31, 2022

 

 

480

 

 

 

480

 

 

Additional paid-in capital

 

 

871,746

 

 

 

806,488

 

 

Accumulated other comprehensive loss

 

 

(220

)

 

 

(678

)

 

Accumulated deficit

 

 

(807,542

)

 

 

(808,866

)

 

Total stockholders’ equity (deficit)

 

 

64,464

 

 

 

(2,576

)

 

Total liabilities and stockholders’ equity (deficit)

 

$

158,533

 

 

$

177,673

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

Senseonics Holdings, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

March 31,

 

 

2023

 

2022

Revenue, net

 

$

313

 

 

$

292

 

Revenue, net - related parties

 

 

3,824

 

 

 

2,189

 

Total revenue

 

 

4,137

 

 

 

2,481

 

Cost of sales

 

 

3,723

 

 

 

1,954

 

Gross profit

 

 

414

 

 

 

527

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

Research and development expenses

 

 

12,405

 

 

 

7,804

 

Selling, general and administrative expenses

 

 

7,718

 

 

 

7,883

 

Operating loss

 

 

(19,709

)

 

 

(15,160

)

Other income (expense), net:

 

 

 

 

 

 

Interest income

 

 

1,108

 

 

 

93

 

Gain on fair value adjustment of option

 

 

 

 

 

21,701

 

Exchange related gain, net

 

 

18,776

 

 

 

 

Interest expense

 

 

(4,652

)

 

 

(4,494

)

Gain on change in fair value of derivatives

 

 

5,778

 

 

 

84,569

 

Impairment cost, net

 

 

 

 

 

30

 

Other income (expense)

 

 

23

 

 

 

(21

)

Total other income (expense), net

 

 

21,033

 

 

 

101,878

 

 

 

 

 

 

 

 

Net Income

 

 

1,324

 

 

 

86,718

 

Other comprehensive income (loss)

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

458

 

 

 

(625

)

Total other comprehensive gain (loss)

 

 

458

 

 

 

(625

)

Total comprehensive income

 

$

1,782

 

 

$

86,093

 

 

 

 

 

 

 

 

Basic net income per common share

 

$

0.00

 

 

$

0.19

 

Basic weighted-average shares outstanding

 

 

497,473,222

 

 

 

455,942,886

 

 

 

 

 

 

 

 

Diluted net income (loss) per common share

 

$

0.00

 

 

$

(0.03

)

Diluted weighted-average shares outstanding

 

 

540,532,813

 

 

 

605,198,839

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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

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