Press release

Senseonics Holdings, Inc. Reports First Quarter 2019 Financial Results

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Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology
company focused on the design, development and commercialization of a
long-term, implantable continuous glucose monitoring (CGM) system for
people with diabetes, today reported financial results for the quarter
ended March 31, 2019.

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

  • First quarter 2019 revenue of $3.4 million
  • Launched Eversense Bridge Patient Access Program to expand Eversense
    access for patients across the U.S.
  • Received positive coverage decision for Eversense from Techniker, the
    largest payor in Germany covering over 10 million lives
  • Initiated Eversense CGM data integration with the Glooko platform to
    provide patients and providers insights and actions for diabetes
    management based on personal glucose profiles

“We are pleased with our progress this year, which is marked by
growing interest and support of Eversense from users, prescribers and
payors,” said Tim Goodnow, President and Chief Executive Officer of
Senseonics. “We are seeing meaningful growth in both covered lives and
new users through our European partners. In the U.S., the launch of the
Eversense Bridge Patient Access Program is simplifying the reimbursement
process for new patients and supporting their ability to act on the
interest we see across patients and providers. It is also enabling
additional opportunities to get in front of the largest national payors.
Through constructive experiences with these payors, we believe that we
will obtain additional positive coverage decisions in the future. We are
looking forward to building on this momentum.”

FIRST QUARTER 2019 RESULTS:

Revenue was $3.4 million for the first quarter of 2019 including
adjustments for the bridge program, compared to $2.9 million for the
first quarter of 2018.

First quarter 2019 gross profit decreased by $2.9 million year-over
year, to ($3.3) million. The decrease in gross profit was associated
with one-time component obsolescence due to product upgrades and product
expiry due to the timing of the extension of the company’s distribution
agreement with Roche.

First quarter 2019 sales and marketing expenses increased $9.4 million
year-over year, to $12.8 million. The increase in sales and marketing
expenses was primarily driven by the build out of the U.S. salesforce.

First quarter 2019 research and development expenses decreased $1.0
million year-over-year, to $7.1 million. The decrease in research and
development expenses was primarily driven by the completion of all
activities associated with the U.S. PMA Panel meeting for Eversense.

First quarter 2019 general and administrative expenses increased $2.5
million, year-over-year, to $6.5 million. The increase in general and
administrative expenses was primarily driven by an increase in
compensation, legal and other administrative expenses associated with
supporting operational growth.

Net loss was $29.4 million, or $0.17 per share, in the first quarter of
2019, compared to $22.3 million, or $0.16 per share, in the first
quarter of 2018.

As of March 31, 2019, cash and cash equivalents were $103.7 million and
outstanding indebtedness was $65.2 million.

2019 Financial Outlook

Revenue for full year 2019 is expected to be in the range of $25 to $30
million.

CONFERENCE CALL AND WEBCAST INFORMATION

Company management will host a conference call at 4:30 pm (Eastern Time)
today, May 9, 2019, 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: 888-378-4398
Entry Number: 756769
International
dial in: 786-789-4775

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 transformative glucose
monitoring products designed to help people with diabetes confidently
live their lives with ease. From its inception, Senseonics has been
advancing the integration of novel, fluorescence sensor technology with
smart wearable devices. The Eversense® CGM System received
PMA approval from the FDA for up to 90 days of continuous use and is
available in the United States. The Eversense® XL CGM System
received CE mark for up to 180 days of continuous use and is available
in Europe. For more information on Senseonics, please visit www.senseonics.com.

FORWARD LOOKING STATEMENTS

Any statements in this press release about future expectations, plans
and prospects for Senseonics, including statements about the potential
additional positive coverage decisions, the potential commercialization
of Eversense in additional markets, Senseonics’ projected revenue for
full year 2019, the ongoing commercialization of Eversense in the U.S.
and Eversense XL in Europe, growing patient and clinician demand for
Eversense, and the potential life-enhancing benefits Eversense offers
people with diabetes, and other statements containing the words
“believe,” “expect,” “intend,” “may,” “projects,” “will,” 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, 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, 2018, Senseonics’ Quarterly Report on Form 10-Q for
the quarter ended March 31, 2019, 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,
2019 2018
 
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 103,675 $ 136,793

Accounts receivable (primarily from a related party)

2,367 7,097
Inventory, net 14,370 10,231
Prepaid expenses and other current assets   4,698     3,985  
Total current assets 125,110 158,106
 
Deposits and other assets 114 117
Property and equipment, net 2,046 1,750
Right of use asset, building   2,131      
Total assets $ 129,401   $ 159,973  
 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 3,274 $ 4,407
Accrued expenses and other current liabilities 13,754 13,851
Right of use liability, building, current portion 431
Deferred revenue 628
Term Loans, current portion   10,000     10,000  
Total current liabilities 27,459 28,886
 
Term Loans, net of discount and current portion 2,347 4,783
2023 Notes, net of discount 36,949 36,103
Derivative liability 15,019 17,091
Term Loans, accrued interest 1,892 1,764
Right of use liability, building, net of current portion 1,791
Other liabilities       85  
Total liabilities 85,457 88,712
 
Stockholders’ equity:

Common stock, $0.001 par value per share; 450,000,000 shares
authorized; 176,958,487 and 176,918,381 shares issued and
outstanding as of March 31, 2019 and December 31, 2018

177 177
Additional paid-in capital 430,926 428,878
Accumulated deficit   (387,159 )   (357,794 )
Total stockholders’ equity   43,944     71,261  
Total liabilities and stockholders’ equity $ 129,401   $ 159,973  
 
Senseonics Holdings, Inc.
 
Unaudited Condensed Consolidated Statements of Operations and
Comprehensive Loss
(in thousands, except share and per share data)
   
Three Months Ended
March 31,
2019 2018
Revenue, primarily from a related party $ 3,423 $ 2,946
Cost of sales   6,733     3,308  
Gross profit (3,310 ) (362 )
 
Expenses:
Sales and marketing expenses 12,834 3,441
Research and development expenses 7,108 8,113
General and administrative expenses   6,516     4,011  
Operating loss (29,768 ) (15,927 )
Other income (expense), net:
Interest income 627 184
Interest expense (2,034 ) (1,771 )
Change in fair value of derivative liability 2,072 (4,847 )
Other (expense) income   (262 )   88  
Total other income (expense), net   403     (6,346 )
 
Net loss (29,365 ) (22,273 )
Total comprehensive loss $ (29,365 ) $ (22,273 )
 
Basic and diluted net loss per common share $ (0.17 ) $ (0.16 )
Basic and diluted weighted-average shares outstanding   176,954,116     137,069,008