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, 2022.

Recent Highlights & Accomplishments:

  • Launched collaboration with the Nurse Practitioner Group designed to expand U.S. patient access to Senseonics’ six-month Eversense E3 System by providing additional convenient in-office and at-home sensor insertion options.
  • Completed enrollment of a pivotal trial for a 365-day sensor configuration and submitted IDE for enrollment of a pediatric cohort in the ENHANCE study.
  • Concluded the full transition to Eversense E3 globally, with our commercial partner Ascensia Diabetes Care, launching E3 in all planned global markets and now only E3 systems are being shipped globally.
  • Inclusion of all three CPT© codes in CMS CY 2023 Medicare Physician Fee Schedule used for the Eversense E3 system with updated national pricing that accounts for the longer 6-month sensor.
  • Received positive coverage decisions from Blue Cross Blue Shield of Florida and others, adding 5 million covered lives for Eversense E3 CGM.
  • Generated revenue of $4.6 million in the third quarter of 2022.

“Having launched the partnership with the Nurse Practitioner Group to expand access with in-home and in-office insertion options, we continue to work with Ascensia to execute and build the foundation for increased adoption of Eversense,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Together with the recent achievement of key milestones in our clinical and R&D programs, notably enrolling a pivotal 365-day trial, we continue to advance our initiatives towards delivering the benefits of long-term implantable CGM to more patients.”

Third Quarter 2022 Results:

Total revenue for the third quarter of 2022 was $4.6 million, compared to $3.5 million for the third quarter of 2021. U.S. revenue was $1.9 million in the third quarter of 2022, compared to $0.6 million in the prior year period, and revenue outside the U.S. was $2.7 million in the third quarter of 2022, compared to $2.9 million in the prior year period.

Third quarter 2022 gross profit of $0.8 million increased from $(1.2) million in the third quarter of 2021.

Third quarter 2022 research and development expenses increased by $3.8 million year-over-year, to $11.0 million. The increase was primarily due to investments in product development and clinical trials for next generation technologies.

Third quarter 2022 selling, general and administrative expenses decreased by $0.3 million year-over-year, to $7.3 million.

Net loss was $60.4 million, or ($0.13) per share, in the third quarter of 2022 compared to net income of $42.9 million, or $0.10 per share, in the third quarter of 2021. Net income decreased by $103.3 million due to the non-cash accounting for embedded derivatives and fair value adjustments.

Cash, cash equivalents, short and long-term investments were $163.0 million and outstanding indebtedness was $103.8 million as of September 30, 2022.

Updated 2022 Financial Outlook

Senseonics’ updated expectation is for full year 2022 global net revenue to be in the range of $15.0 million to $17.0 million, compared to the prior expectation for full year 2022 global net revenue to be in the range of $14.0 to $18.0 million.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, November 8, 2022, 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: 1126379

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 “Updated 2022 Financial Outlook,” statements about the commercial launch of Eversense® E3, statements regarding increasing patient access and adoption, statement 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 transition of commercialization responsibilities to Ascensia Diabetes Care 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 in the duration and severity of the COVID-19 pandemic, 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, 2021, the Quarterly Report on Form 10-Q for the nine months ended September 30, 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)

 

 

 

 

 

 

 

 

 

September 30,

 

December 31,

 

 

2022

 

2021

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

35,484

 

 

$

33,461

 

Short term investments, net

 

 

118,715

 

 

 

96,445

 

Accounts receivable, net

 

 

103

 

 

 

205

 

Accounts receivable, net - related parties

 

 

2,021

 

 

 

1,768

 

Inventory, net

 

 

7,257

 

 

 

6,316

 

Prepaid expenses and other current assets

 

 

5,714

 

 

 

6,218

 

Total current assets

 

 

169,294

 

 

 

144,413

 

 

 

 

 

 

 

 

Option

 

 

101

 

 

 

239

 

Deposits and other assets

 

 

3,241

 

 

 

1,086

 

Long term investments, net

 

 

8,851

 

 

 

51,882

 

Property and equipment, net

 

 

1,183

 

 

 

1,308

 

Total assets

 

$

182,670

 

 

$

198,928

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

684

 

 

$

1,204

 

Accrued expenses and other current liabilities

 

 

12,674

 

 

 

10,667

 

Accrued expenses and other current liabilities, related parties

 

 

671

 

 

 

3,597

 

Note payable, current portion, net

 

 

15,223

 

 

 

 

Derivative liability, current portion

 

 

328

 

 

 

 

Option, current

 

 

28,068

 

 

 

 

Term Loans, net

 

 

 

 

 

2,926

 

Total current liabilities

 

 

57,648

 

 

 

18,394

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

53,434

 

 

 

59,798

 

Derivative liabilities

 

 

83,794

 

 

 

236,291

 

Option

 

 

 

 

 

69,401

 

Other liabilities

 

 

2,859

 

 

 

579

 

Total liabilities

 

 

197,735

 

 

 

384,463

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Common stock, $0.001 par value per share; 900,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 478,211,956 shares and 447,282,263 shares issued and outstanding as of September 30, 2022 and December 31, 2021

 

 

478

 

 

 

447

 

Additional paid-in capital

 

 

806,069

 

 

 

765,215

 

Accumulated other comprehensive loss

 

 

(1,185

)

 

 

(212

)

Accumulated deficit

 

 

(820,427

)

 

 

(950,985

)

Total stockholders' equity (deficit)

 

 

(15,065

)

 

 

(185,535

)

Total liabilities and stockholders’ equity (deficit)

 

$

182,670

 

 

$

198,928

 

 

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,

 

 

2022

 

2021

 

2022

 

2021

Revenue, net

 

$

126

 

 

 

276

 

 

$

555

 

 

$

1,196

 

Revenue, net - related parties

 

 

4,496

 

 

 

3,256

 

 

 

10,263

 

 

 

8,471

 

Total revenue

 

 

4,622

 

 

 

3,532

 

 

 

10,818

 

 

 

9,667

 

Cost of sales

 

 

3,866

 

 

 

4,778

 

 

 

8,711

 

 

 

9,995

 

Gross profit (loss)

 

 

756

 

 

 

(1,246

)

 

 

2,107

 

 

 

(328

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

10,985

 

 

 

7,200

 

 

 

28,088

 

 

 

19,562

 

Selling, general and administrative expenses

 

 

7,340

 

 

 

7,585

 

 

 

23,785

 

 

 

23,347

 

Operating loss

 

 

(17,569

)

 

 

(16,031

)

 

 

(49,766

)

 

 

(43,237

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

544

 

 

 

486

 

 

 

878

 

 

 

743

 

Gain (Loss) on fair value adjustment of option

 

 

(8,592

)

 

 

13,556

 

 

 

41,333

 

 

 

(74,848

)

Gain on extinguishment of debt and option

 

 

 

 

 

 

 

 

 

 

 

330

 

Interest expense

 

 

(4,801

)

 

 

(4,245

)

 

 

(13,806

)

 

 

(12,337

)

Gain (Loss) on change in fair value of derivatives

 

 

(28,948

)

 

 

50,075

 

 

 

152,169

 

 

 

(255,185

)

Impairment cost

 

 

(984

)

 

 

(488

)

 

 

(138

)

 

 

(1,650

)

Other expense

 

 

(41

)

 

 

(439

)

 

 

(112

)

 

 

(723

)

Total other income (expense), net

 

 

(42,822

)

 

 

58,945

 

 

 

180,324

 

 

 

(343,670

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income (Loss)

 

 

(60,391

)

 

 

42,914

 

 

 

130,558

 

 

 

(386,907

)

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

(57

)

 

 

18

 

 

 

(973

)

 

 

2

 

Total other comprehensive gain (loss)

 

 

(57

)

 

 

18

 

 

 

(973

)

 

 

2

 

Total comprehensive income (loss)

 

$

(60,448

)

 

$

42,932

 

 

$

129,585

 

 

$

(386,905

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per common share

 

$

(0.13

)

 

 

0.10

 

 

$

0.28

 

 

$

(0.93

)

Basic weighted-average shares outstanding

 

 

472,475,747

 

 

 

445,378,308

 

 

 

464,244,736

 

 

 

414,128,283

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per common share

 

$

(0.13

)

 

 

0.08

 

 

$

(0.10

)

 

$

(0.93

)

Diluted weighted-average shares outstanding

 

 

472,475,747

 

 

 

581,760,516

 

 

 

608,345,713

 

 

 

414,128,283

 

 

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

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