Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 2020 Financial Results

Rhea-AI Summary

Senseonics Holdings reported financial results for 2020, with Q4 revenue at $3.9 million, down from $9.0 million in Q4 2019. U.S. sales were $0.4 million, while international sales were $3.5 million. The company raised $175 million in equity offerings early 2021 to bolster its balance sheet. Net loss for Q4 2020 was $101.6 million, increasing from $35.6 million in Q4 2019. For the full year, total revenue was $4.9 million, significantly down from $21.3 million in 2019. Looking ahead, 2021 guidance estimates revenue between $12 million and $15 million.

Positive

• Raised $175 million through equity offerings in Q1 2021 to strengthen balance sheet.
• Fourth quarter gross profit increased by $10.8 million year-over-year to $2.6 million.
• Reduced fourth quarter operating expenses by $13.8 million compared to the prior year.

Negative

• Q4 2020 revenue decreased to $3.9 million from $9.0 million in Q4 2019.
• Net loss in Q4 2020 was $101.6 million, up from $35.6 million in Q4 2019.
• Full year 2020 revenue dropped to $4.9 million from $21.3 million in 2019.

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 and full year ended December 31, 2020.

Recent Highlights & Accomplishments:

• Generated fourth quarter 2020 revenue of $3.9 million primarily driven by orders to support the European installed base up to the Ascensia Diabetes Care commercial transition
• Raised $175 million of proceeds from equity offerings in the first quarter of 2021 to strengthen the balance sheet
• Ascensia Diabetes Care initiated Eversense^® sales and marketing activities in Europe in select markets on February 1, 2021
• Eversense implantable CGM CPT codes were added to the 2021 Medicare Physician Fee Schedule improving national reimbursement payment availability for implantable CGM systems and physician services
• Reduced fourth quarter operating expenses by $13.8 million, compared to the prior year period, resulting from the execution of strategic cost reductions and the streamlined operational focus

“We are very pleased with our fourth quarter results, our commercial collaboration agreement with Ascensia, and the success of our recent financings. These steps conclude a strategically transformational year for Senseonics,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We believe Ascensia’s commercial experience and global footprint will help grow the market for Eversense in 2021 and beyond. We are working with Ascensia to further expand commercial activity in the coming months. These collaborative efforts include developing plans for new programs designed to raise patient and provider awareness, reduce patient cost, and continually expand global access for Eversense.”

Fourth Quarter 2020 Results:

Total revenue for the quarter was $3.9 million compared to $9.0 million for the fourth quarter of 2019. U.S. revenue was $0.4 million and revenue outside the U.S. was $3.5 million.

Fourth quarter 2020 gross profit increased by $10.8 million year-over-year, to $2.6 million. 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.

Fourth quarter 2020 sales and marketing expenses decreased by $8.0 million year-over-year, to $3.0 million. The decrease was primarily due to the recent changes in our go-to-market strategy.

Fourth quarter 2020 research and development expenses decreased by $5.1 million year-over-year, to $4.7 million. The decrease was primarily driven by lower clinical study costs and personnel related expenses.

Fourth quarter 2020 general and administrative expenses decreased by $0.7 million year-over-year, to $5.2 million. The decrease was primarily due to a decrease in miscellaneous general and administrative costs.

Net loss was $101.6 million, or $0.41 per share, in the fourth quarter of 2020, compared to $35.6 million, or $0.18 per share, in the fourth quarter of 2019. Net loss increased by $66.0 million due to a $90.6 million increase to other expenses primarily related to non-cash accounting charges resulting from the accounting for imbedded derivatives related to certain of the company financings, partially offset by a $24.6 million decrease in loss from operations.

Full Year 2020 Results:

Total revenue for 2020 was $4.9 million compared to total revenue of $21.3 million in 2019. U.S. revenue was $1.1 million. Revenue outside the U.S. was $3.8 million.

2020 gross profit increased by $2.1 million year-over-year, to ($17.4) million.

2020 sales and marketing expenses decreased by $29.0 million year-over-year, to $20.6 million. The decrease was primarily due to the recent changes in our go-to-market strategy.

2020 research and development expenses decreased by $18.0 million year-over-year, to $20.4 million. The decrease was primarily driven by lower clinical study costs and personnel related expenses.

2020 general and administrative expenses decreased by $2.4 million year-over-year, to $20.8 million. The decrease was primarily due to decrease in other general and administrative costs.

Net loss was $175.2 million, or $0.77 per share, in 2020, compared to $115.5 million, or $0.61 per share, in 2019. Net loss increased by $59.6 million due to a $111.2 million increase to other expenses primarily related to non-cash accounting entries for the company’s financings, partially offset by a $51.5 million decrease in loss from operations.

As of December 31, 2020, cash, cash equivalents and restricted cash were $18.2 million and outstanding indebtedness was $117.2 million. Cash, cash equivalents, and restricted cash rose to $187.3 million on January 31, 2021 following the equity financings completed in the first quarter of 2021.

2021 Financial Outlook

Global net revenue to Senseonics for the full year 2021 is expected to be in the range of $12.0 million to $15.0 million.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, March 4, 2021, 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: 3569931 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. 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 the revenue projections under “2021 Financial Outlook,” statements about the potential benefits of the Ascensia commercialization and collaboration agreement, including the ability of Ascensia to grow the market for Eversense, the future increase in patient and provider awareness of Eversense, reductions in patient costs and expansion of access to Eversense, 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 for the 180-day Eversense product, uncertainties inherent in the commercial launch and commercial expansion of the product, uncertainties inherent in the transition of commercialization responsibilities to Ascensia, 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, 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. Consolidated Balance Sheets (in thousands, except for share and per share data)
		December 31,
		2020				2019
Assets
Current assets:
Cash and cash equivalents		$	18,005			$	95,938
Restricted cash			200				—
Accounts receivable, net			565				3,239
Accounts receivable - related parties			2,421				7,140
Inventory, net			5,281				16,929
Prepaid expenses and other current assets			3,774				4,512
Total current assets			30,246				127,758
Option			1,886				—
Deposits and other assets			2,229				3,042
Property and equipment, net			1,557				2,001
Total assets		$	35,918			$	132,801
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable		$	1,762			$	4,285
Accrued expenses and other current liabilities			11,674				18,636
Term Loans, net			3,202				43,434
2025 Notes, net			—				60,353
Total current liabilities			16,638				126,708
Long-term debt and notes payables, net			57,216				11,800
Derivative liabilities			62,119				664
Options			39,734
Other liabilities			1,483				2,278
Total liabilities			177,190				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 December 31, 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; 265,582,688 and 203,452,812 shares issued and outstanding as of December 31, 2020 and 2019			266				203
Additional paid-in capital			504,162				464,491
Accumulated deficit			(648,511	)			(473,343	)
Total stockholders' deficit			(144,083	)			(8,649	)
Total liabilities and stockholders’ deficit		$	35,918			$	132,801

Senseonics Holdings, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except for share and per share data)
		Years Ended
		December 31,
		2020				2019				2018
Revenue, net		$	1,368			$	4,924			$	2,039
Revenue, net - related parties			3,581				16,377				16,874
Total revenue			4,949				21,301				18,913
Cost of sales			22,315				40,749				27,059
Gross profit (loss)			(17,366	)			(19,448	)			(8,146	)
Expenses:
Sales and marketing expenses			20,550				49,555				27,730
Research and development expenses			20,413				38,430				31,863
General and administrative expenses			20,801				23,229				19,839
Operating loss			(79,130	)			(130,662	)			(87,578	)
Other (expense) income, net:
Interest income			175				1,933				2,001
Loss on fair value adjustment			(30,721	)			—				—
Loss on extinguishment of debt			(21,112	)			(398	)			—
Loss on issuance of debt & other issuance costs			(12,706	)			—				—
Interest expense			(16,167	)			(11,799	)			(8,282	)
Debt issuance costs			(1,216	)			(3,344	)			—
Gain (Loss) on fair value and change in fair value of derivatives			(11,641	)			29,232				209
Impairment costs			(2,339	)
Other expense			(311	)			(511	)			(321	)
Total other (expense) income, net			(96,038	)			15,113				(6,393	)
Net loss			(175,168	)			(115,549	)			(93,971	)
Total comprehensive loss		$	(175,168	)		$	(115,549	)		$	(93,971	)
Basic and diluted net loss per common share		$	(0.77	)		$	(0.61	)		$	(0.14	)
Basic and diluted weighted-average shares outstanding			227,912,358				188,754,160				157,429,145

 

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FAQ

What were Senseonics' Q4 2020 financial results?

In Q4 2020, Senseonics reported revenue of $3.9 million, a decline from $9.0 million in Q4 2019, and a net loss of $101.6 million.

How much revenue does Senseonics expect in 2021?

Senseonics expects global net revenue for the full year 2021 to be between $12 million and $15 million.

What were the key accomplishments reported by Senseonics in 2020?

Key accomplishments include raising $175 million from equity offerings and reducing operating expenses significantly.

How did Senseonics' gross profit change in Q4 2020?

The gross profit for Q4 2020 increased by $10.8 million year-over-year to $2.6 million.

What were the full-year financial results for Senseonics in 2020?

For 2020, Senseonics reported total revenue of $4.9 million, down from $21.3 million in 2019, with a net loss of $175.2 million.