Changes for page Senseonics Holdings
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... ... @@ -2,48 +2,31 @@ 2 2 {{toc/}} 3 3 {{/box}} 4 4 5 -= = 5 += Paragraph 1 = 6 6 7 - SenseonicsHoldingswasoriginally incorporatedasASN Technologies,Inc. in Nevada on June 26, 2014. On December 4,2015, thecompany were reincorporated in DelawareandhangeditsnametoSenseonicsHoldings,Inc. Also, on December 4, 2015,thecompany entered intoa mergeragreement with Senseonics, IncorporatedandSMSI Merger Sub, Inc., ortheMerger Agreement,toacquireSenseonics, Incorporated.Senseonics, Incorporatedwas originallyincorporatedonOctober 30, 1996andcommencedoperations on January 15,1997. The transactionscontemplatedby theMerger Agreement wereconsummatedonDecember 7, 2015, referred toherein asthe Acquisition.Pursuantto the terms of the Merger Agreement, (i)allissued and outstandingsharesof Senseonics,Incorporated's preferred stockwereconvertedintosharesof Senseonics, Incorporatedcommon stock, $0.01 parvalue pershare,or the Senseonics Shares,(ii) all outstandingSenseonics Shares wereexchangedfor 57,739,953 shares ofitscommonstock, $0.001 parvalueper share, ortheCompany Shares, reflecting an exchange ratioof oneSenseonicsSharefor 2.0975 CompanyShares,ortheExchangeRatio,and (iii) alloutstandingoptionsand warrants to purchaseSenseonics Shares, ortheSenseonics Optionsand Senseonics Warrants, respectively, were eachexchanged or replaced withoptions andwarrants toacquire shares of itscommonstock, or the CompanyOptions andCompany Warrants,respectively.Accordingly,Senseonics, Incorporatedbecameitswholly-owned subsidiary.{{footnote}}https://fintel.io/doc/sec-sens-senseonics-holdings-10k-2018-march-13-17953{{/footnote}}Following theclosing of theAcquisition,thebusiness of Senseonics, Incorporated became its sole focus and all ofitsoperations followingthe closingof theAcquisitionconsist of the historicalSenseonics, Incorporatedbusiness.7 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 8 8 9 - SenseonicsHoldings is a medical technology company focused on the design, development and commercialization of glucose monitoring products to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy. The company's continuous glucose monitoring, or CGM, systems, Eversense and Eversense XL, are reliable, long‑term, implantable CGM systems thatSenseonics Holdings has designed to continually and accurately measure glucose levels in people with diabetes for a period of up to 90 and 180 days, respectively, as compared to six to fourteen days for currently available CGM systems. The company believe Eversense and Eversense XL will provide people with diabetes with a more convenient method to monitor their glucose levels in comparison with the traditional method of self‑monitoring of blood glucose, or SMBG, as well as currently available CGM systems. The company's Eversense and Eversense XL systems are currently approved for sale in Europe and the company submitted its Eversense system pre-market approval, orPMA,application to the U.S. Food and DrugAdministration, or FDA, in October 2016. The company intend to initiate commercial launchin the United States promptly following the receipt of PMA approval.9 +== Sub-paragraph == 10 10 11 - =CorporateHistory=11 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 12 12 13 - Fromits founding in 1996 until 2010, the company devoted substantially all of its resources to researching various sensor technologies andplatforms. Beginning in 2010, the company narrowed its focus to designing, developing andrefiningacommercially viable glucose monitoring system. On May 10, 2016, the company received regulatory approval to commercialize Eversense in Europe. In June 2016, thecompany made its first product shipment of Eversense through its distribution agreement with Rubin Medical, or Rubin. Since its inception, Senseonics Holdings has funded its activities primarily through equity and debt financings.13 +== Sub-paragraph == 14 14 15 - In March 2016, thecompanycompleted a publicofferingofitscommon stock, ortheMarch 2016 Offering,selling 15,800,000sharesofcommonstock at apricetothepublicof $2.85 pershare,for aggregategross proceedsof $45.0million.Netproceeds fromthe March2016 Offeringwere approximately $40.9million,after deductingunderwritingdiscountsand commissionsand estimatedoffering-relatedtransactioncosts payableby it.In April2016,the underwritersforthe March 2016 Offeringpartiallyexercised theiroptiontopurchaseadditionalsharesofcommonstock,purchasingan additional1,439,143 shares, from whichthecompany receivedadditional netproceeds ofapproximately$3.9 million,afterductingunderwritingdiscountsandcommissionsandestimated offering-relatedtransactioncostspayable by it.15 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 16 16 17 - OnJune 30, 2016 the company entered into an Amended and Restated Loan andSecurity Agreement with Oxford Finance LLC, or Oxford, and Silicon Valley Bank, or SVB, to potentiallyborrow up to an aggregate principal amount of $30.0 million. Under the termsof the agreement, the company initially borrowed an aggregate of $15 million from Oxford and SVB on June 30, 2016. The company used $11 million of the $15 million to retire existing loans with Oxford, including a final payment fee of $1 million. In each of November2016 and March 2017, the company borrowedan additional $5 million upon achievingcertain milestones. The agreement alsopermits it to borrow up to an additional $5 million upon theachievement of specified milestones through the end of 2017. The agreement provides for monthly payments of interest only for a period of 18 months, followed by an amortization period of 30 months.17 +=== Sub-sub paragraph === 18 18 19 - InJune2017,thecompanycompletedanunderwrittenofferingofitscommonstock,or theMay 2017 Offering,selling29,078,014sharesofcommon stockat apriceof$1.41pershare,foraggregategrossproceedsof $41.0 million.Netproceeds fromtheMay 2017 Offeringwereapproximately$40.4million,afterdeductingunderwritingdiscountsandcommissionsandestimatedoffering-relatedtransactioncostspayable by it.19 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 20 20 21 -In August 2017, the company completed an underwritten offering of its common stock, or the August 2017 Offering, selling 13,383,125 shares of common stock at a price of $2.15 per share, for aggregate gross proceeds of $28.8 million. Net proceeds from the August 2017 Offering were approximately $26.5 million after deducting underwriting discounts and commissions and estimated offering-related transaction costs payable by it. 22 22 23 - SenseonicsHoldings has neverbeen profitable and its net losses were $17.4 millionand $10.9 million for three months ended September 30, 2017 and 2016, respectively, and $42.8 million and $34.0 million for thenine months ended September 30,2017and 2016, respectively. As of September 30, 2017, its accumulated deficit totaled $247.5 million, primarily as a result of expenses incurred in connection with its research and development programs and from general and administrative expenses associated with its operations. The company expect to continue to incur significant expenses and increasing operations and net losses for the foreseeable future.22 += Paragraph 2 = 24 24 25 - **EuropeanDevelopment andCommercialization of Eversense**24 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 26 26 27 - InMay 2016, the company received its CE mark for Eversense, which allows it to market and sell Eversense in Europe. In connection with its CE Mark,Senseonics Holdings has agreed to conductpost market surveillance activities. In June 2016, the company commenced commercialization of Eversense in Sweden through its distributionagreement with Rubin, which also has the right to distribute Eversense in Norway and Denmark. Rubin markets and sells medicalproducts for diabetes treatment in theScandinavian region, including as the exclusive Scandinavian distributor for the insulin pump manufacturer Animas Corporation.26 +== Sub-paragraph == 28 28 29 - In May 2016, the company enteredintoadistributionagreementwith Roche Diagnostics InternationalAGandRoche DiabetesCareGmbH,together referredtoas Roche, pursuant towhichthecompany grantedRoche the exclusive right tomarket,sellanddistributeEversense in Germany, Italyand the Netherlands.In November 2016,thecompanyenteredintoanamendmentto thedistributiongreementgrantingRochetheexclusiveghtmarket, sellnddistribute EversenseinEurope,theMiddle East and Africa, excludingSweden,Norway, Denmark,Finlandand Israel.Rocheis apioneer inthedevelopment of bloodglucosemonitoring systemsanda globalleader for diabetesmanagementsystemsandservices.ThecompanybegandistributingEversensethrough Rochein GermanyinSeptember 2016andin Italy andtheNetherlandsinhefourthquarterof2016. Toate,SenseonicsHoldingshasbegundistributingEversensein an aggregateof 13 EuropeancountrieshroughRubinand Roche.28 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. 30 30 31 - InSeptember 2017, the company received the CE Mark for Eversense XL, which is indicated for a sensor life toup to 180 days. The company plan tobegin to commercialize Eversense XL in selected European countries by the end of 2017. Senseonics Holdings isalso developingEversense Now,an application designed to remotely monitor theEversense users’ CGM data in real time. The company expect to receive approval to market Eversense Now in Europe by the end of 2017.30 +== Sub-paragraph == 32 32 33 -**United States Development of Eversense** 34 - 35 -In 2016, the company completed its Precise II pivotal clinical trial in the United States. This trial, which was fully enrolled with 90 subjects, was conducted at eight sites in the United States. In the trial, the company measured the accuracy of Eversense measurements through 90 days after insertion. The company also assessed safety through 90 days after insertion or through sensor removal. In the trial, the company observed a mean absolute relative difference, or MARD, of 8.8% utilizing two calibration points for Eversense across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period. The company also observed a MARD of 9.5% utilizing one calibration point for Eversense across the 40-400 mg/dL range when compared to YSI blood reference values during the 90-day continuous wear period. Based on the data from this trial, in October 2016 the company submitted a pre-market approval, or PMA, application to the FDA to market Eversense in the United States. Senseonics Holdings is currently anticipating approval in the first half of 2018. However, the ultimate timing of PMA approval is uncertain and will depend on many factors, including whether the FDA would require the review of Eversense by an advisory panel and the related logistics of convening a panel, the degree and nature of questions raised by the FDA in its review process, and its ability to submit additional data or other information that adequately addresses questions raised by the FDA. Accordingly, the company cannot guarantee the timing of receipt of PMA approval, if at all. For commercialization in the United States, the company intend to distribute its product through its own direct sales and marketing organization. Senseonics Holdings has received Category III CPT codes for the insertion and removal of the Eversense sensor. Following PMA approval, the company intend to pursue a Category I CPT code. 36 - 37 -The company expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. In addition, the company expect that its expenses will increase substantially as the company continue the research and development of its other products and maintain, expand and protect its intellectual property portfolio and seek regulatory approvals in other jurisdictions. Furthermore, the company expect to continue to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that the company did not incur as a private company. The company will need to obtain substantial additional funding in connection with its continuing operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. However, the company may be unable to raise additional funds when needed on favorable terms or at all. The company's failure to raise such capital as and when needed would have a material and adverse impact on its financial condition and its ability to develop and commercialize Eversense and future products and its ability to pursue its business strategy. The company will need to generate significant revenues to achieve profitability, and the company may never do so. 38 - 39 -= Recent development = 40 - 41 -March 01, 2018 Senseonics Holdings, Inc. a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the U.S. Food and Drug Administration (FDA) Clinical Chemistry and Clinical Toxicology Devices Panel is scheduled to review the premarket approval application (PMA) for Eversense on Thursday, March 29, 2018. 42 - 43 -The Eversense PMA application contains data from Senseonics’ U.S. PRECISE II study. The study, considered one of the largest studies of a CGM system in the world, includes over 2 million sensor glucose readings, from 90 patients at eight clinical centers during the full 90-day study duration. 44 - 45 -“The scheduling of the advisory panel represents a meaningful milestone toward offering patients in the U.S. a long term, implantable CGM system,” stated Tim Goodnow, President and Chief Executive Officer of Senseonics. “We are excited for the opportunity to discuss the data in support of the Eversense PMA with the panel. We believe the Eversense system’s value to people with diabetes will resonate with the panel as it has with users in Europe .” 46 - 47 -= References = 48 - 49 -{{putFootnotes/}} 32 +Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.