SENS Senseonics Holdings Inc

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 fourth quarter and full year ended December 31, 2018.

RECENT HIGHLIGHTS & ACCOMPLISHMENTS:

• Received positive reimbursement decisions for Eversense® from several payors with coverage reaching approximately 60 million lives in the U.S.
• Obtained Regulatory approval to expand Eversense certification to Nurse Practitioners and Physician Assistants, both in the U.S. and Europe
• Commenced the PROMISE 180-day sensor clinical study in the U.S.
• Submitted a PMA supplement to the FDA seeking to secure an insulin dosing claim for Eversense
• Extended Roche distribution agreement through January 2021 while expanding to an additional 17 countries, including Brazil, Russia, India and China
• Appointed Jon D. Isaacson as Chief Financial Officer and Dr. Francine Kaufman as Chief Medical Officer

“We are pleased with 2018 which was a milestone year for Senseonics highlighted by FDA approval of the Eversense system, the build out of our commercial organization, and continued penetration in Europe” said Tim Goodnow, President and Chief Executive Officer of Senseonics. “We continue to learn and adapt from the launch of this highly innovative product and expect real-world experience to drive patient and clinician demand for Eversense. With additional coverage policy wins and raising awareness of the benefits of a long-term implantable CGM, we are confident we have the strategy and team in place to accelerate adoption and help more patients manage their diabetes.”

FOURTH QUARTER 2018 RESULTS:

Revenue was $7.2 million for the fourth quarter of 2018, compared to $2.9 million for the fourth quarter of 2017.

Fourth quarter 2018 sales and marketing expenses increased $7.9 million year-over year, to $10.3 million. The increase in sales and marketing expenses was primarily driven by an increase in compensation expenses associated with new hires supporting the commercial launch of Eversense in the U.S. and to support and expand the distribution of Eversense® XL in Europe.

Fourth quarter 2018 research and development expenses decreased $0.3 million year-over-year, to $8.1 million. The decrease in research and development expenses was primarily driven by the completion of all activities associated with the U.S. PMA approval, including preparation for the FDA panel held in the first quarter of 2018.

Fourth quarter 2018 general and administrative expenses increased $1.5 million, year-over-year, to $5.3 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 $7.3 million, or $0.04 per share, in the fourth quarter of 2018, compared to $16.3 million, or $0.12 per share, in the fourth quarter of 2017. Fourth quarter 2018 net loss per share was based on 176.9 million weighted average shares outstanding, compared to 136.8 million weighted average shares outstanding in the fourth quarter of 2017.

FULL YEAR 2018 RESULTS:

Revenue for the year ended December 31, 2018 was $18.9 million, compared to $6.4 million in 2017.

Sales and marketing expenses for the year ended December 31, 2018 increased $20.8 million year-over year, to $27.7 million, compared to $6.9 million for 2017. The increase in sales and marketing expenses was primarily related to investments in additional headcount to support the U.S. commercial launch of Eversense and support of the expanding commercial efforts for Eversense XL in Europe.

Research and development expenses for the year ended December 31, 2018 increased $1.2 million year-over-year, to $31.9 million, compared to $30.7 million for 2017. The increase in research and development expenses was primarily driven by product development expenses for future versions of Eversense and clinical trial costs related to the PMA approval of Eversense in the U.S.

General and administrative expenses for the year ended December 31, 2018 increased $4.5 million, year-over-year, to $19.8 million, compared to $15.3 million for 2017. The increase in general and administrative expenses was driven primarily by an increase in personnel-related expenses, increased facility expenses and increased legal and audit expenses.

Net loss was $94.0 million, or $0.60 per share, for the year ended December 31, 2018, compared to $59.1 million, or $0.51 per share, for 2017. Net loss per share for 2018 was based on 157.4 million weighted average shares outstanding, compared to 116.0 million weighted average shares outstanding for 2017.

As of December 31, 2018, cash and cash equivalents were $136.8 million and outstanding indebtedness was $67.7 million.

2019 Financial Outlook

Management updates its projected revenue for full year 2019 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, March 12, 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: 866-519-2796Entry Number: 117792International dial in: 786-789-4771

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 expanded relationship with Roche, the potential commercialization of Eversense in additional markets, Senseoncis’ projected revenue for full year 2019, the ongoing commercialization of Eversense in the U.S. and Eversense XL in Europe, the acceleration of the adoption of Eversense, 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, 2017, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 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.  

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)   December 31, 2018   2017 Assets Current assets: Cash and cash equivalents $ 136,793 $ 16,150 Marketable securities — 20,300 Accounts receivable, primarily from a related party 7,097 3,382 Inventory, net 10,231 2,991 Prepaid expenses and other current assets   3,985     2,092   Total current assets 158,106 44,915   Deposits and other assets 117 176 Property and equipment, net   1,750     853   Total assets $ 159,973   $ 45,944     Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 4,407 $ 7,712 Accrued expenses and other current liabilities 13,851 5,428 Deferred Revenue 628 — Notes payable, current portion   10,000     10,000   Total current liabilities 28,886 23,140   Notes payable, net of discount 4,783 14,414 Convertible senior notes, net of discount 36,103 — Derivative liability 17,091 — Notes payable, accrued interest 1,764 1,054 Other liabilities   85     69   Total liabilities 88,712 38,677   Commitments and contingencies (Note 9)   Stockholders’ equity:

Common stock, $0.001 par value per share; 450,000,000 and 250,000,000 shares authorized as of December 31, 2018 and 2017; 176,918,381 and 136,882,735 shares issued and outstanding as of December 31, 2018 and 2017

177 137 Additional paid-in capital 428,878 270,953 Accumulated deficit   (357,794 )   (263,823 ) Total stockholders' equity   71,261     7,267   Total liabilities and stockholders’ equity $ 159,973   $ 45,944     Senseonics Holdings, Inc.   Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands, except share and per share data)   Years Ended December 31, 2018   2017   2016 Revenue, primarily from a related party $ 18,913 $ 6,373 $ 332 Cost of sales   27,059     9,758     660   Gross profit (8,146 ) (3,385 ) (328 )   Expenses: Sales and marketing expenses 27,730 6,857 2,736 Research and development expenses 31,863 30,735 26,347 General and administrative expenses   19,839     15,336     13,022   Operating loss (87,578 ) (56,313 ) (42,433 ) Other income (expense), net: Interest income 2,001 135 80 Interest expense (8,282 ) (3,099 ) (1,602 ) Change in fair value of derivative liability 209 — — Other (expense) income   (321 )   176     25   Total other expense, net (6,393 ) (2,788 ) (1,497 )   Net loss (93,971 ) (59,101 ) (43,930 ) Total comprehensive loss $ (93,971 ) $ (59,101 ) $ (43,930 )   Basic and diluted net loss per common share $ (0.60 ) $ (0.51 ) $ (0.49 ) Basic and diluted weighted-average shares outstanding   157,429,145     115,975,402     89,243,853    

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INVESTOR CONTACTLynn Lewis or Philip TaylorInvestor Relations415-937-5406Investors@senseonics.com