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 March 31, 2022.

Recent Highlights & Accomplishments:

• Received approval from the Food and Drug Administration (FDA) for the Eversense® E3 CGM System (“E3”), offering industry leading 6-month sensor wear duration, the longest lasting CGM system available
• Transitioned manufacturing to E3 to enable U.S. commercial launch through our commercial partner, Ascensia Diabetes Care, at the beginning of April and initiate retirement of the 90-day system
• Confirmed immediate coverage policy transition to E3 with select large payors

“We are excited to have received FDA approval and be underway with a comprehensive launch campaign for Eversense® E3, the world’s longest lasting CGM system,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “From awareness and access to training and operations, Senseonics and Ascensia are coordinating to engage patients and HCP’s to experience the differentiated benefits of our longer duration next generation sensor – inserting the first patient with E3 just six weeks following FDA approval. We are now focused on bringing the E3 implantable CGM with six months of wear to more people with diabetes in the U.S.”

First Quarter 2022 Results:

Total revenue for the first quarter of 2022 was $2.5 million compared to $2.8 million for the first quarter of 2021. U.S. revenue was $0.8 million in the first quarter of 2022 compared to $0.3 million in the prior year period, and revenue outside the U.S. was $1.7 million in the first quarter of 2022 compared to $2.5 million in the prior year period.

First quarter 2022 gross profit of $0.5 million was in line with gross profit for the first quarter 2021.

First quarter 2022 sales and marketing and general and administrative expenses increased by $1.3 million year-over-year, to $7.9 million. The increase was primarily the result of increased professional fees and payroll and related expenses.

First quarter 2022 research and development expenses increased by $2.5 million year-over-year, to $7.8 million. The increase was due to the expansion of the R&D workforce, and an increase in clinical studies, lab supplies and contractor expenses in order to support next generation products.

Net income was $86.7 million, or $0.19 per share, in the first quarter of 2022 compared to a net loss of $249.5 million, or ($0.68) per share, in the first quarter of 2021. Net income increased by $336.2 million due to the accounting for embedded derivatives and fair value adjustments.

Cash, cash equivalents, short and long-term investments were $166.9 million and outstanding indebtedness was $104.7 million as of March 31, 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, May 10, 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: 9027379

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 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, 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 three months ended March 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,

 

 

 

2022 unaudited

 

2021

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

39,011

 

 

$

33,461

 

 

Short term investments, net

 

 

102,755

 

 

 

96,445

 

 

Accounts receivable, net

 

 

232

 

 

 

205

 

 

Accounts receivable, net - related parties

 

 

3,797

 

 

 

1,768

 

 

Inventory, net

 

 

7,153

 

 

 

6,316

 

 

Prepaid expenses and other current assets

 

 

7,629

 

 

 

6,218

 

 

Total current assets

 

 

160,577

 

 

 

144,413

 

 

 

 

 

 

 

 

 

 

Option

 

 

269

 

 

 

239

 

 

Deposits and other assets

 

 

786

 

 

 

1,086

 

 

Long term investments, net

 

 

25,145

 

 

 

51,882

 

 

Property and equipment, net

 

 

1,320

 

 

 

1,308

 

 

Total assets

 

$

188,097

 

 

$

198,928

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Deficit

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

2,089

 

 

$

1,204

 

 

Accrued expenses and other current liabilities

 

 

8,742

 

 

 

10,667

 

 

Accrued expenses and other current liabilities - related parties

 

 

3,674

 

 

 

3,597

 

 

Note payable, current portion, net

 

 

14,534

 

 

 

—

 

 

Derivative liability, current portion

 

 

1,713

 

 

 

—

 

 

Term Loans, net

 

 

732

 

 

 

2,926

 

 

Total current liabilities

 

 

31,484

 

 

 

18,394

 

 

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

48,035

 

 

 

59,798

 

 

Derivative liabilities

 

 

150,010

 

 

 

236,291

 

 

Option

 

 

47,700

 

 

 

69,401

 

 

Other liabilities

 

 

337

 

 

 

579

 

 

Total liabilities

 

 

277,566

 

 

 

384,463

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

Common stock, $0.001 par value per share; 900,000,000 shares authorized; 463,229,779 and 447,282,263 shares issued and outstanding as of March 31, 2022 and December 31, 2021

 

 

463

 

 

 

447

 

 

Additional paid-in capital

 

 

775,172

 

 

 

765,215

 

 

Accumulated other comprehensive loss

 

 

(837

)

 

 

(212

)

 

Accumulated deficit

 

 

(864,267

)

 

 

(950,985

)

 

Total stockholders' deficit

 

 

(89,469

)

 

 

(185,535

)

 

Total liabilities and stockholders’ deficit

 

$

188,097

 

 

$

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

 

 

 

March 31,

 

 

 

2022

 

2021

 

 

 

 

 

 

 

 

 

Revenue, net

 

 

292

 

 

 

487

 

 

Revenue, net - related parties

 

 

2,189

 

 

 

2,359

 

 

Total revenue

 

 

2,481

 

 

 

2,846

 

 

Cost of sales

 

 

1,954

 

 

 

2,320

 

 

Gross profit

 

 

527

 

 

 

526

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

Sales and marketing expenses

 

 

1,509

 

 

 

1,613

 

 

Research and development expenses

 

 

7,804

 

 

 

5,255

 

 

General and administrative expenses

 

 

6,374

 

 

 

4,974

 

 

Operating loss

 

 

(15,160

)

 

 

(11,316

)

 

Other income (expense), net:

 

 

 

 

 

 

 

Interest income

 

 

93

 

 

 

9

 

 

Gain (Loss) on fair value adjustment of option

 

 

21,701

 

 

 

(52,675

)

 

Gain on extinguishment of debt and option

 

 

—

 

 

 

330

 

 

Interest expense

 

 

(4,494

)

 

 

(4,058

)

 

Gain (Loss) on change in fair value of derivatives

 

 

84,569

 

 

 

(180,899

)

 

Impairment cost

 

 

30

 

 

 

(782

)

 

Other expense

 

 

(21

)

 

 

(123

)

 

Total other income (expense), net

 

 

101,878

 

 

 

(238,198

)

 

 

 

 

 

 

 

 

 

Net Income (Loss)

 

 

86,718

 

 

 

(249,514

)

 

Other comprehensive loss

 

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

(625

)

 

 

—

 

 

Total other comprehensive loss

 

 

(625

)

 

 

—

 

 

Total comprehensive income (loss)

 

$

86,093

 

 

$

(249,514

)

 

 

 

 

 

 

 

 

 

Basic net income (loss) per common share

 

 

0.19

 

 

 

(0.68

)

 

Basic weighted-average shares outstanding

 

 

455,942,886

 

 

 

364,274,433

 

 

 

 

 

 

 

 

 

 

Diluted net loss per common share

 

 

(0.03

)

 

 

(0.68

)

 

Diluted weighted-average shares outstanding

 

 

605,198,839

 

 

 

364,274,433

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220510006342/en/

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