SENS

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, 2022.

Recent Highlights & Accomplishments:

• Achieved CE mark approval for the Eversense E3 6-month CGM System with exceptional accuracy and reduced calibration planned for European commercial launch in Q3
• Completed transition of U.S. commercial patients to the Eversense E3 System--now only E3 systems are being shipped to U.S. clinics, led by our global commercial partner, Ascensia Diabetes Care.
• CMS issued G-codes became effective July 1, 2022, providing access to E3 for all eligible Medicare beneficiaries
• Anthem (now Elevance Health) coverage decision adds 45 million covered lives for Eversense E3 CGM
• Expanded data accessibility for patients to share and combine their Eversense CGM data with other data sources and third party integrated apps by making Eversense information available through AppleHealth
• Generated revenue of $3.7 million in the second quarter of 2022

“The first half of the year was focused on building the foundation to increase global patient adoption of our next generation, longer duration E3 system, with the U.S. launch and the European CE mark,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “As we execute this plan, we realized several second quarter accomplishments– inserting the first U.S. E3 patients, building brand awareness, increasing patient access through payor coverage policy transitions, scaling up manufacturing and advancing 365-day system program feasibility studies. We are encouraged by the early progress of the E3 launch and look forward to continued collaboration with Ascensia to deliver the benefits of Eversense to more patients and providers.”

Second Quarter 2022 Results:

Total revenue for the second quarter of 2022 was $3.7 million, compared to $3.3 million for the second quarter of 2021. U.S. revenue was $1.2 million in the second quarter of 2022, compared to $1.0 million in the prior year period, and revenue outside the U.S. was $2.5 million in the second quarter of 2022, compared to $2.3 million in the prior year period.

Second quarter 2022 gross profit of $0.8 million increased from $0.4 million in the second quarter of 2021.

Second quarter 2022 research and development expenses increased by $2.2 million year-over-year, to $9.3 million. The increase was primarily due to investments in product and clinical trials for next generation technologies.

Second quarter 2022 selling, general and administrative expenses decreased by $0.6 million year-over-year, to $8.6 million. The decrease was primarily the result of reduced payroll expenses related to stock-based compensation.

Net income was $104.2 million, or $0.22 per share, in the second quarter of 2022 compared to a net loss of $180.3 million, or ($0.42) per share, in the second quarter of 2021. Net income increased by $284.5 million due to the accounting for embedded derivatives and fair value adjustments.

Cash, cash equivalents, short and long-term investments were $150.5 million and outstanding indebtedness was $103.9 million as of June 30, 2022.

2022 Financial Outlook

Senseonics reiterates the expectation for full year 2022 global net revenue to be in the range of $14.0 million to $18.0 million.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, August 9, 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: 3659816

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 “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 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 six months ended June 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)

 

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

 

 

2022

 

2021

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,425

 

 

$

33,461

 

 

Short term investments, net

 

 

93,758

 

 

 

96,445

 

 

Accounts receivable, net

 

 

220

 

 

 

205

 

 

Accounts receivable, net - related parties

 

 

3,824

 

 

 

1,768

 

 

Inventory, net

 

 

7,251

 

 

 

6,316

 

 

Prepaid expenses and other current assets

 

 

7,818

 

 

 

6,218

 

 

Total current assets

 

 

158,296

 

 

 

144,413

 

 

 

 

 

 

 

 

 

 

Option

 

 

1,085

 

 

 

239

 

 

Deposits and other assets

 

 

3,347

 

 

 

1,086

 

 

Long term investments, net

 

 

11,334

 

 

 

51,882

 

 

Property and equipment, net

 

 

1,263

 

 

 

1,308

 

 

Total assets

 

$

175,325

 

 

$

198,928

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

1,734

 

 

$

1,204

 

 

Accrued expenses and other current liabilities

 

 

10,731

 

 

 

10,667

 

 

Accrued expenses and other current liabilities- related parties

 

 

3,692

 

 

 

3,597

 

 

Note payable, current portion, net

 

 

14,874

 

 

 

—

 

 

Derivative liability, current portion

 

 

438

 

 

 

—

 

 

Term Loans, net

 

 

—

 

 

 

2,926

 

 

Total current liabilities

 

 

31,469

 

 

 

18,394

 

 

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

50,650

 

 

 

59,798

 

 

Derivative liabilities

 

 

54,737

 

 

 

236,291

 

 

Option

 

 

19,476

 

 

 

69,401

 

 

Other liabilities

 

 

3,052

 

 

 

579

 

 

Total liabilities

 

 

159,384

 

 

 

384,463

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

Common stock, $0.001 par value per share; 900,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 465,326,135 shares and 447,282,263 shares issued and outstanding as of June 30, 2022 and December 31, 2021

 

 

465

 

 

 

447

 

 

Additional paid-in capital

 

 

776,640

 

 

 

765,215

 

 

Accumulated other comprehensive loss

 

 

(1,128

)

 

 

(212

)

 

Accumulated deficit

 

 

(760,036

)

 

 

(950,985

)

 

Total stockholders' equity (deficit)

 

 

15,941

 

 

 

(185,535

)

 

Total liabilities and stockholders’ equity (deficit)

 

$

175,325

 

 

$

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

 

Six Months Ended

 

 

June 30,

 

June 30,

 

 

2022

 

2021

 

2022

 

2021

Revenue, net

 

$

137

 

 

 

433

 

 

$

429

 

 

$

920

 

Revenue, net - related parties

 

 

3,577

 

 

 

2,856

 

 

 

5,767

 

 

 

5,215

 

Total revenue

 

 

3,714

 

 

 

3,289

 

 

 

6,196

 

 

 

6,135

 

Cost of sales

 

 

2,890

 

 

 

2,897

 

 

 

4,845

 

 

 

5,217

 

Gross profit

 

 

824

 

 

 

392

 

 

 

1,351

 

 

 

918

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

9,299

 

 

 

7,107

 

 

 

17,103

 

 

 

12,362

 

Selling, general and administrative expenses

 

 

8,561

 

 

 

9,175

 

 

 

16,445

 

 

 

15,762

 

Operating loss

 

 

(17,036

)

 

 

(15,890

)

 

 

(32,197

)

 

 

(27,206

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

241

 

 

 

247

 

 

 

334

 

 

 

256

 

Gain (Loss) on fair value adjustment of option

 

 

28,224

 

 

 

(35,730

)

 

 

49,925

 

 

 

(88,405

)

Gain on extinguishment of debt and option

 

 

—

 

 

 

—

 

 

 

—

 

 

 

330

 

Interest expense

 

 

(4,510

)

 

 

(4,034

)

 

 

(9,005

)

 

 

(8,092

)

Gain (Loss) on change in fair value of derivatives

 

 

96,548

 

 

 

(124,361

)

 

 

181,117

 

 

 

(305,260

)

Net gain (impairment)

 

 

816

 

 

 

(381

)

 

 

846

 

 

 

(1,163

)

Other expense

 

 

(52

)

 

 

(157

)

 

 

(71

)

 

 

(280

)

Total other income (expense), net

 

 

121,267

 

 

 

(164,416

)

 

 

223,146

 

 

 

(402,614

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income (Loss)

 

 

104,231

 

 

 

(180,306

)

 

 

190,949

 

 

 

(429,820

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

(291

)

 

 

(16

)

 

 

(916

)

 

 

(16

)

Total other comprehensive loss

 

 

(291

)

 

 

(16

)

 

 

(916

)

 

 

(16

)

Total comprehensive income (loss)

 

$

103,940

 

 

$

(180,322

)

 

$

190,033

 

 

$

(429,836

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per common share

 

$

0.22

 

 

 

(0.42

)

 

$

0.42

 

 

$

(1.08

)

Basic weighted-average shares outstanding

 

 

464,133,903

 

 

 

431,840,854

 

 

 

460,061,022

 

 

 

398,244,296

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per common share

 

$

(0.03

)

 

 

(0.42

)

 

$

(0.06

)

 

$

(1.08

)

Diluted weighted-average shares outstanding

 

 

601,330,959

 

 

 

431,840,854

 

 

 

604,342,540

 

 

 

398,244,296

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220809005985/en/

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