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Senseonics Holdings, Inc. Reports Second Quarter 2018 Financial Results

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Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology
company focused on the development and commercialization of a long-term,
implantable continuous glucose monitoring (CGM) system for people with
diabetes, today reported financial results for the second quarter ended
June 30, 2018.

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

  • Received FDA approval for the Eversense® CGM System, the first and
    only long-term implantable continuous glucose monitoring system
  • Completed first commercial insertion in the U.S.
  • Secured first U.S. payor coverage of Eversense from Horizon Blue Cross
    Blue Shield of New Jersey
  • Eversense Mobile Clinic traveling across the U.S. training physicians
  • Eversense® XL System introduced across the existing European markets
  • Strengthened balance sheet with additional $150 million of gross
    proceeds through completion of underwritten equity offering

"Second quarter was a very significant period for Senseonics. We
received FDA approval for the Eversense System, began our U.S.
commercial launch at ADA, and subsequently, in just six weeks, secured
reimbursement from BCBS New Jersey. Additionally, our penetration in the
EMEA market continues to grow as we have expanded availability of the
Eversense XL across Europe," said Tim Goodnow, President and Chief
Executive Officer of Senseonics. "As we go forward in the balance of
2018, we will continue to execute on our commercial strategy and
clinical development programs as we work toward label expansion and
additional regulatory approvals."

SECOND QUARTER 2018 RESULTS:

Revenue was $3.6 million for the second quarter of 2018, compared to
$0.8 million for the second quarter of 2017 and $2.9 million for the
first quarter of 2018.

Second quarter 2018 sales and marketing expenses increased $2.7 million
versus first quarter 2018, to $6.2 million. The increase in sales and
marketing expenses was primarily driven by an increase in compensation
expense associated with adding additional sales resources to prepare for
a United States launch in 2018, as well as to support and expand the
distribution of Eversense in Europe.

Second quarter 2018 research and development expense was essentially
flat compared to first quarter 2018 and $2.7 million greater than second
quarter 2017. The year-over-year increase in research and development
expenses was primarily driven by the on-going support of our pre-market
approval application including the completion of the Advisory Panel
activity.

Second quarter 2018 general and administrative expenses increased $1.4
million over first quarter 2018 and increased $1.5 million over second
quarter 2017, to $5.4 million. The year-over-year increase in general
and administration expenses was primarily driven by an increase in
compensation, legal and other administrative expense associated with
supporting operational growth.

Net loss was $32.5 million, or $0.23 per share, in the second quarter of
2018, compared to $12.4 million, or $0.12 per share, in the second
quarter of 2017. This compares to a first quarter 2018 net loss of $22.3
million or $0.16 per share. The increase in net loss in the second
quarter of 2018 compared to the first quarter of 2018 was driven
primarily by a $5.3 million increase in the loss from the change in fair
value of the derivative liability and a $4.1 million increase in
operating expense. Excluding the change in the increase of the
derivative liability during the second quarter 2018, net loss for the
three months ended June 30, 2018 would have been $22.3 million or $0.16
per share. Second quarter 2018 net loss per share for the three months
ended June 30, 2018 was based on 138.8 million weighted average shares
outstanding, compared to 103.7 million weighted average shares
outstanding in the second quarter of 2017.

As of June 30, 2018, cash, cash equivalents, and marketable securities
were $191.9 million and outstanding indebtedness was $72.7 million.

CONFERENCE CALL AND WEBCAST INFORMATION

Company management will host a conference call at 4:30 pm (Eastern Time)
today, August 8, 2018, to discuss these financial results. This
conference call can be accessed live by telephone or through Senseonics'
website.

 

         

 

Live Teleconference Information:

Live Webcast Information:

Dial in number: (877)883-0383

Visit http://www.senseonics.com
and select the "Investor
Relations
" section

 

International dial in: (412)902-6506

 

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
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 application 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 clinical
development of future generations of Eversense, the expanded
commercialization of Eversense and Eversense XL in Europe, label
expansion, additional regulatory approvals, and other statements
containing the words "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 inherent in the regulatory approval process,
uncertainties inherent in the expanded commercial launch of Eversense
and Eversense XL in Europe 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, 2017, Senseonics' Quarterly Report on Form
10-Q for the quarter ended June 30, 2018, 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.

FINANCIAL STATEMENTS TO FOLLOW:

         
Senseonics Holdings, Inc.
 
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
 
June 30, December 31,
2018 2017
 
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 183,928 $ 16,150
Marketable securities 7,954 20,300
Accounts receivable, primarily from a related party 2,988 3,382
Inventory, net 8,400 2,991
Prepaid expenses and other current assets   4,195     2,092  
Total current assets 207,465 44,915
 
Deposits and other assets 205 176
Property and equipment, net   998     853  
Total assets $ 208,668   $ 45,944  
 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 5,172 $ 7,712
Accrued expenses and other current liabilities 9,863 5,428
Notes payable, current portion   10,000     10,000  
Total current liabilities 25,035 23,140
 
Notes payable, net of discount 9,619 14,414
Convertible senior notes, net of discount 34,469
Derivative liability 32,312
Notes payable, accrued interest 1,444 1,054
Other liabilities   73     69  
Total liabilities 102,952 38,677
 
Commitments and contingencies (Note 8)
 
Stockholders' equity:
Common stock, $0.001 par value per share; 450,000,000 and
250,000,000 shares authorized, 175,897,790 and 136,882,735 shares
issued and outstanding as of June 30, 2018 and December 31, 2017
177 137
Additional paid-in capital 424,131 270,953
Accumulated deficit   (318,592 )   (263,823 )
Total stockholders' equity   105,716     7,267  
Total liabilities and stockholders' equity $ 208,668   $ 45,944  
 
                 
Senseonics Holdings, Inc.
 
Unaudited Condensed Consolidated Statement of Operations and
Comprehensive Loss
(in thousands, except share and per share data)
 
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
Revenue, primarily from a related party $ 3,623 $ 814 $ 6,569 $ 1,367
Cost of sales   3,839     1,714     7,147     2,759  
Gross profit (216 ) (900 ) (578 ) (1,392 )
 
Expenses:
Sales and marketing expenses 6,177 1,249 9,618 2,389
Research and development expenses 8,289 5,604 16,402 12,602
General and administrative expenses   5,382     3,888     9,393     7,655  
Operating loss (20,064 ) (11,641 ) (35,991 ) (24,038 )
Other income (expense), net:
Interest income 241 37 425 58
Interest expense (2,236 ) (767 ) (4,007 ) (1,451 )
Change in fair value of 2023 derivative (10,166 ) (15,013 )
Other expense   (271 )   (3 )   (183 )   (16 )
Total other expense, net   (12,432 )   (733 )   (18,778 )   (1,409 )
 
Net loss (32,496 ) (12,374 ) (54,769 ) (25,447 )
Total comprehensive loss $ (32,496 ) $ (12,374 ) $ (54,769 ) $ (25,447 )
 
Basic and diluted net loss per common share $ (0.23 ) $ (0.12 ) $ (0.40 ) $ (0.26 )
Basic and diluted weighted-average shares outstanding   138,767,873     103,689,994     137,923,135     98,825,088  

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