Senseonics Holdings, Inc. Reports First Quarter 2022 Financial Results

Rhea-AI Summary

Senseonics Holdings, Inc. (SENS) reported Q1 2022 financial results, showcasing total revenue of $2.5 million, a decrease from $2.8 million in Q1 2021. U.S. revenue rose to $0.8 million, while international revenue dropped to $1.7 million. The net income for Q1 2022 was reported at $86.7 million, significantly higher than the net loss of $249.5 million in Q1 2021, primarily due to adjustments in embedded derivatives. The gross profit remained stable at $0.5 million, though expenses increased due to R&D and operational costs. The company anticipates full-year 2022 net revenue between $14 million and $18 million.

Positive

• FDA approval for the E3 CGM System, extending sensor wear to six months.
• Successful transition to the E3 manufacturing for U.S. launch.
• Improvement in U.S. revenue from $0.3 million year-over-year.

Negative

• Total revenue declined compared to Q1 2021.
• Operating expenses increased by $1.3 million year-over-year.
• International revenue decreased from $2.5 million in Q1 2021.

GERMANTOWN, Md.--(BUSINESS WIRE)-- 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

Source: Senseonics Holdings, Inc.

FAQ

What were the financial results for Senseonics in Q1 2022?

Senseonics reported total revenue of $2.5 million in Q1 2022, a decrease from $2.8 million in Q1 2021.

What is the expected revenue range for Senseonics in 2022?

Senseonics expects full-year 2022 global net revenue to be between $14 million and $18 million.

How did Senseonics perform in terms of net income in Q1 2022?

Senseonics reported a net income of $86.7 million in Q1 2022, a significant improvement over a net loss of $249.5 million in Q1 2021.

What factors contributed to the increase in expenses for Senseonics in Q1 2022?

Expenses increased due to higher professional fees, payroll, and R&D costs to support next-generation products.

What recent approval did Senseonics receive for its products?

Senseonics received FDA approval for the Eversense E3 CGM System, which offers a six-month sensor wear duration.