Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter ended September 30, 2020.

Recent Highlights & Accomplishments:

  • Reinitiated Eversense® new patient sales and marketing activities in the U.S. with Ascensia Diabetes Care on October 1, 2020
  • Submitted Premarket Approval (PMA) supplement application for the extension of the wearable life of the Eversense CGM System for up to 180 days to the United States Food and Drug Administration (FDA)
  • Announced PROMISE study accuracy results for the 180-day Eversense product, demonstrating mean absolute relative difference (MARD) matching the performance of the current 90-day Eversense system of 8.5%-9.6%
  • Continued efforts to expand patient access resulted in positive coverage decisions representing approximately 80% of covered lives in the U.S. This includes Medicare patients following the issuance of Local Coverage Determinations from all Medicare Administrative Contractors ahead of the 2021 Medicare Physician Fee Schedule Proposed Rule that will provide national coverage for implantable CGMs
  • Generated third quarter 2020 revenue of $767 thousand driven by increased sensor reinsertions and supply orders from existing patients compared to the second quarter of 2020
  • Reduced third quarter operating expenses by $18.9 million, compared to the prior year period, due to the execution of cost reduction actions and the streamlined operational focus implemented in late March 2020
  • Entered into a $12.0 million equity line of credit with Energy Capital

“In the third quarter we continued to efficiently support Eversense users who understand the heightened importance of glycemic control amid this pandemic. At the start of the fourth quarter we initiated commercial activity with Ascensia. Following a successful training program, the Ascensia sales force is now calling on Eversense prescribers in pursuit of new commercial and Medicare patients,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We believe the organizational changes for Senseonics resulting from the worldwide strategic commercial collaboration, in combination with additional cost reduction initiatives, will continue to drive expense and cash burn reductions in the future. Investment and resources are focused on the approval of the 180-day Eversense system in the U.S. and driving the development of the 365-day product where we are making great strides with configuration optimization. Following our PMA supplement submission and the early efforts with Ascensia we are excited and well positioned for a potential launch of the 180-day product in the first half of next year. We continue to drive execution across the company, including our product development and commercialization efforts with our partner Ascensia, while supporting our approximately 5,000 active patients globally. With our strategic partnership set we believe we are continuing to build a compelling value proposition for patients with diabetes.”

Anticipated Key Milestones:

Q1 2021 – Proposed Medicare National Payment Schedule Q1 2021 – Initiation of commercial activities outside of the U.S. by Ascensia H1 2021 – Expected decision on approval of 180-day Eversense product by FDA H1 2021 – Planned IDE approval of 365-day Eversense clinical trial by FDA, including pediatric population H2 2021 – Planned enrollment of 365-day Eversense clinical trial

Third Quarter 2020 Results:

In the third quarter of 2020, revenue was reduced due to the temporary suspension of commercial operations in March in the U.S. following restructuring of the organization to preserve cash, as well as the effects of temporary patient deferments resulting from the global pandemic. Total net revenue for the quarter was $767 thousand compared to total net revenue of $4.3 million for the third quarter of 2019. U.S. net revenue was $509 thousand after accounting for gross to net adjustments. Net revenue outside the U.S. was $258 thousand due to the deferral of orders by Roche.

Third quarter 2020 gross profit increased by $4.2 million year-over-year, to $835 thousand. The positive gross margin in the quarter was primarily due to the ability to fill resupply orders with existing written off inventory as existing patient reinsertion rates were above the expectations established in the first quarter of 2020 amid the onset of the COVID-19 pandemic.

Third quarter 2020 sales and marketing expenses decreased by $8.3 million year-over-year, to $3.2 million. The decrease was primarily due to the recent changes in commercial activities.

Third quarter 2020 research and development expenses decreased by $6.5 million year-over-year, to $4.6 million. The decrease was primarily driven by lower clinical study costs and personnel related expenses.

Third quarter 2020 general and administrative expenses increased by $0.1 million year-over-year, to $5.5 million. The increase was primarily due to an increase in stock-based compensation expenses.

Net loss was $23.4 million, or $0.10 per share, in the third quarter of 2020, compared to $19.5 million, or $0.10 per share, in the third quarter of 2019. Net loss increased by $3.9 million due to a $22.9 million increase to other expenses primarily related to the accounting of the company’s financings partially offset by a $18.9 million decrease in loss from operations.

As of September 30, 2020, cash, cash equivalents and restricted cash were $26.4 million and outstanding indebtedness was $123.4 million.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, November 9, 2020, 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:

Live Webcast Information:

Dial in number: 888-243-4451

Visit http://www.senseonics.com and

Entry Number: 4128608

select the “Investor Relations” section

International dial in: 412-542-4135

A replay of the call can be accessed on Senseonics’ website http://www.senseonics.com under “Investor Relations.”

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense® and Eversense® XL, 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 statements about the potential benefits of the Ascensia commercialization and collaboration agreement, including future expense and cash burn reductions, potential coverage decisions, the potential approval and commercial launch of the 180-day Eversense system in the United States, the development of the 365-day product, the timing of future key milestones, including the proposed Medicare Physician Fee Schedule Proposed Rule, the initiation of commercial activities outside of the U.S. by Ascensia, the expected decision on approval of the 180-day Eversense product by FDA, the planned IDE approval of the 365-day Eversense clinical trial by FDA and the planned enrollment of the 365-day Eversense clinical trial, 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 in the development and regulatory approval processes, uncertainties inherent in the commercial launch and commercial expansion of the product, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, the necessity of receiving stockholder approval that will be required in order to raise all of the capital pursuant to the preferred stock and certain debt transactions described in this release, 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, 2019, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 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,

 

 

2020

 

2019

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,192

 

 

$

95,938

 

Restricted cash

 

 

200

 

 

 

 

Accounts receivable, net

 

 

250

 

 

 

3,239

 

Accounts receivable - related parties

 

 

251

 

 

 

7,140

 

Inventory, net

 

 

4,284

 

 

 

16,929

 

Prepaid expenses and other current assets

 

 

4,588

 

 

 

4,512

 

Total current assets

 

 

35,765

 

 

 

127,758

 

 

 

 

 

 

 

 

Purchase put option

 

 

4,224

 

 

 

 

Deposits and other assets

 

 

2,409

 

 

 

3,042

 

Property and equipment, net

 

 

1,665

 

 

 

2,001

 

Total assets

 

$

44,063

 

 

$

132,801

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Deficit

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

949

 

 

$

4,285

 

Accrued expenses and other current liabilities

 

 

9,153

 

 

 

18,636

 

Term Loans, net

 

 

 

 

 

43,434

 

2025 Notes, net

 

 

 

 

 

60,353

 

Total current liabilities

 

 

10,102

 

 

 

126,708

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

59,649

 

 

 

11,800

 

Derivative liabilities

 

 

24,590

 

 

 

664

 

Other liabilities

 

 

1,693

 

 

 

2,278

 

Total liabilities

 

 

96,034

 

 

 

141,450

 

 

 

 

 

 

 

 

Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 3,000 shares and 0 shares issued and outstanding as of September 30, 2020 and December 31, 2019

 

 

2,811

 

 

 

 

Total temporary equity

 

 

2,811

 

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

Common stock, $0.001 par value per share; 450,000,000 shares authorized; 244,238,638 and 203,452,812 shares issued and outstanding as of September 30, 2020 and December 31, 2019

 

 

244

 

 

 

203

 

Additional paid-in capital

 

 

491,853

 

 

 

464,491

 

Accumulated deficit

 

 

(546,879

)

 

 

(473,343

)

Total stockholders' deficit

 

 

(54,782

)

 

 

(8,649

)

Total liabilities and stockholders’ deficit

 

$

44,063

 

 

$

132,801

 

Senseonics Holdings, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

 

September 30,

 

 

2020

 

2019

 

2020

 

2019

Revenue, net

 

$

514

 

 

$

959

 

 

$

761

 

 

$

3,678

 

Revenue, net - related parties

 

 

253

 

 

 

3,360

 

 

 

303

 

 

 

8,671

 

Total revenue

 

 

767

 

 

 

4,319

 

 

 

1,064

 

 

 

12,349

 

Cost of sales

 

 

(68

)

 

 

7,659

 

 

 

21,006

 

 

 

23,552

 

Gross profit (loss)

 

 

835

 

 

 

(3,340

)

 

 

(19,942

)

 

 

(11,203

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing expenses

 

 

3,234

 

 

 

11,560

 

 

 

17,521

 

 

 

38,573

 

Research and development expenses

 

 

4,568

 

 

 

11,076

 

 

 

15,726

 

 

 

28,688

 

General and administrative expenses

 

 

5,501

 

 

 

5,388

 

 

 

15,635

 

 

 

17,321

 

Operating loss

 

 

(12,468

)

 

 

(31,364

)

 

 

(68,824

)

 

 

(95,785

)

Other (expense) income, net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1

 

 

 

519

 

 

 

173

 

 

 

1,556

 

Loss on extinguishment and issuance of debt

 

 

(9,527

)

 

 

(398

)

 

 

(20,458

)

 

 

(398

)

Interest expense

 

 

(3,632

)

 

 

(3,460

)

 

 

(11,560

)

 

 

(7,459

)

Debt issuance costs

 

 

(931

)

 

 

(3,344

)

 

 

(1,216

)

 

 

(3,344

)

Gain on fair value and change in fair value of derivatives

 

 

3,520

 

 

 

19,186

 

 

 

29,069

 

 

 

26,147

 

Other expense

 

 

(391

)

 

 

(638

)

 

 

(720

)

 

 

(655

)

Total other (expense) income, net

 

 

(10,960

)

 

 

11,865

 

 

 

(4,712

)

 

 

15,847

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(23,428

)

 

 

(19,499

)

 

 

(73,536

)

 

 

(79,938

)

Total comprehensive loss

 

$

(23,428

)

 

$

(19,499

)

 

$

(73,536

)

 

$

(79,938

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.10

)

 

$

(0.10

)

 

$

(0.33

)

 

$

(0.43

)

Basic and diluted weighted-average shares outstanding

 

 

236,519,812

 

 

 

197,223,419

 

 

 

220,250,060

 

 

 

183,804,257

 

 

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

Senseonics Media Contact: Mirasol Panlilio 301-556-1631 Mirasol.panlilio@senseonics.com