Changes for page Senseonics Holdings
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... ... @@ -4,44 +4,29 @@ 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,thecompanyenteredoamergeragreementwith Senseonics, IncorporatedandSMSI Merger Sub, Inc.,ortheMergerAgreement,to acquire Senseonics,Incorporated.Senseonics, Incorporated was originally incorporated on October30, 1996and commenced operationsonJanuary 15, 1997. Thetransactions contemplatedby theMergerAgreement wereconsummatednDecember 7, 2015, referred tohereinastheAcquisition.Pursuant to the terms of the Merger Agreement, (i) all issuedand outstanding sharesof Senseonics, Incorporated'spreferredstock were convertedintoshares of Senseonics, Incorporatedcommonstock, $0.01 parvalueper share, ortheSenseonicsShares,(ii) alloutstandingSenseonics Shareswereexchangedfor 57,739,953 shares ofitscommonstock, $0.001 par value per share,or the Company Shares, reflectinganexchangeratio of oneSenseonics Share for 2.0975 Company Shares, ortheExchangeRatio,and (iii) all outstanding options andwarrants to purchase Senseonics Shares, ortheSenseonicsOptions andSenseonics Warrants,respectively, were each exchanged or replaced withoptionsandwarrants to acquiresharesoftscommon stock, or the Company OptionsandCompany Warrants, respectively. Accordingly,Senseonics, Incorporatedbecameits wholly-owned subsidiary.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 - Followingthe closing of the Acquisition, the business ofSenseonics, Incorporated became its sole focus and all of its operations following the closing of the Acquisition consist of the historical Senseonics, Incorporatedbusiness. Unless otherwise indicated or the context otherwise requires, all references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to "the Company," "we," "our," "ours," "us" or similar terms refer to (i) Senseonics, Incorporated prior to the closingof the Acquisition, and (ii) Senseonics Holdings, Inc. and its subsidiaries subsequent to the closing of the Acquisitionand all share andper shareinformation in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section gives retroactive effect to the exchange of Senseonics Shares, Senseonics Options and Senseonics Warrants for Company Shares, Company Options and Company Warrants, respectively, in the Acquisition, as well as the corresponding exercise price adjustments for the such options and warrants.9 +== Sub-paragraph == 10 10 11 - SenseonicsHoldingsis adicaltechnologycompany focused onthe design,developmentandcommercialization of glucosemonitoring productstoimprove thelives of people with diabetesbyenhancingtheirability to managetheir diseasewithrelativeease andaccuracy. The company'scontinuousglucosemonitoring, or CGM,systems, Eversense andEversense XL, are reliable, long‑term,implantable CGM systemsthat SenseonicsHoldingshas designedto continually and accuratelymeasure glucose levelsinpeoplewith diabetesforaperiodfup to90 and 180 days, respectively,ascomparedto six to fourteendays forcurrently available CGM systems. The companybelieve EversenseandEversense XL willprovidepeople with diabeteswith a more convenientmethod to monitor their glucose levels in comparisonwith the traditionalmethodof self‑monitoringofblood glucose, or SMBG,aswell as currently availableCGM systems. The company's Eversenseand Eversense XL systems arecurrently approved for saleinEuropeand theompanysubmittedits Eversense system pre-marketapproval,or PMA, applicationothe U.S. Food and Drug Administration,or FDA,inOctober 2016. The companyintendtonitiatecommercial launch intheUnitedStates promptlyfollowingthereceiptof PMAapproval.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 -== ==Corporate History====13 +== Sub-paragraph == 14 14 15 - From itsfoundingin 1996 until2010,thecompany devoted substantiallyall ofitsresourcestoresearchingvarioussensortechnologiesandplatforms.Beginningin2010, thecompany narroweditsfocusodesigning,developingand refiningacommerciallyviable glucosemonitoringsystem.On May10,2016, the companyreceivedregulatoryapprovaltocommercializeEversense inEurope.In June2016,the companymadeitsfirst product shipment of EversensethroughitsdistributionagreementwithRubinMedical,or Rubin.Sinceitsinception, SenseonicsHoldingshas fundedits activities primarilythrough equity anddebtfinancings.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 - InMarch 2016, the company completed a public offering of itscommon stock, or the March 2016 Offering, selling 15,800,000 shares of common stock at a price to the publicof $2.85per share, foraggregate grossproceeds of $45.0 million. Net proceeds from theMarch 2016 Offering were approximately $40.9 million, after deducting underwriting discounts and commissions and estimated offering-related transaction costs payable by it. In April 2016, the underwriters for the March 2016 Offering partially exercised their option to purchase additional shares of common stock, purchasing an additional 1,439,143 shares, from which the company received additional net proceeds of approximately $3.9 million, after deducting underwriting discounts and commissions and estimated offering-related transaction costs payable by it.17 +=== Sub-sub paragraph === 18 18 19 - On June 30, 2016 the company enteredinto an AmendedandRestatedLoanand Security Agreementwith OxfordFinance LLC, or Oxford, and SiliconValley Bank,orSVB, topotentially borrowup toan aggregatepal amountof$30.0 million. Undertheterms oftheagreement, the company initially borrowedan aggregateof $15 millionfromOxfordandSVB onJune30,2016.The company used$11 millionof the $15 milliontoetire existingloanswithOxford, includingafinalaymentfeeof $1million.In eachof November 2016andMarch2017,thecompany borrowedan additional$5 millionupon achieving certainmilestones.Theagreementalso permitsit toborrowuptoan additional $5 millionupontheachievement of specifiedmilestonesthroughthe endof 2017. The agreementprovides for monthlypaymentsofinterestonly foraperiodof18 months,followedbyanamortizationperiodof30 months.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 June 2017, the company completed an underwritten offering of its common stock, or the May 2017 Offering, selling 29,078,014 shares of common stock at a price of $1.41 per share, for aggregate gross proceeds of $41.0 million. Net proceeds from the May 2017 Offering were approximately $40.4 million, after deducting underwriting discounts and commissions and estimated offering-related transaction costs payable by it. 22 22 23 - InAugust 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 grossproceeds of $28.8 million. Net proceeds from theAugust2017Offering were approximately $26.5 million after deducting underwriting discounts and commissions and estimated offering-related transaction costs payable by it.22 += Paragraph 2 = 24 24 25 - SenseonicsHoldings has neverbeen profitableand its netlosses were$17.4 millionand$10.9 millionfor three monthsendedSeptember30, 2017 and2016,respectively,and$42.8 millionand$34.0 millionfortheninemonthsended September 30,2017and2016, respectively. AsofSeptember30, 2017,itsaccumulateddeficittotaled$247.5million,primarilyas aresultofexpensesincurred inconnectionwithitsresearchanddevelopmentprogramsandfromgeneralandadministrativeexpensesassociated withits operations.The companyexpectto continuetoincursignificantexpenses and increasingoperationsandnet losses fortheforeseeable future.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 - **European Developmentand Commercializationof Eversense**26 +== Sub-paragraph == 28 28 29 - InMay2016,the company received itsCEmark forEversense,which allowsit tomarketandsell EversenseinEurope.Inconnectionwithits CE Mark,SenseonicsHoldingshasagreedtoconductpost marketsurveillanceactivities.InJune2016,thecompanycommenced commercializationof Eversensein Swedenthroughitsdistributionagreement withRubin,which alsohastherightto distributeEversense inNorwayand Denmark.Rubin marketsand sells medicalproducts for diabetes treatmentinheScandinavianregion,includingasheexclusiveScandinaviandistributorfor the insulinpump manufacturer AnimasCorporation.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 - InMay 2016, the company entered into a distribution agreement with Roche Diagnostics International AG and Roche Diabetes Care GmbH, together referred to as Roche, pursuant to which the company granted Roche the exclusive right to market, sell and distribute Eversense in Germany, Italy and the Netherlands. In November 2016, the company entered into an amendment to the distribution agreement granting Roche the exclusive right to market, sell and distribute Eversense in Europe, the Middle East and Africa, excludingSweden, Norway, Denmark, Finland and Israel. Roche is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. The company began distributing Eversense through Roche in Germany in September 2016 and in Italy and the Netherlands in the fourth quarter of 2016. To date, Senseonics Holdings has begun distributing Eversense inan aggregate of 13 European countries throughRubin and Roche.30 +== Sub-paragraph == 32 32 33 -In September 2017, the company received the CE Mark for Eversense XL, which is indicated for a sensor life to up to 180 days. The company plan to begin to commercialize Eversense XL in selected European countries by the end of 2017. Senseonics Holdings is also developing Eversense Now, an application designed to remotely monitor the Eversense users’ CGM data in real time. The company expect to receive approval to market Eversense Now in Europe by the end of 2017. 34 - 35 -**United States Development of Eversense** 36 - 37 -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. 38 - 39 -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. 40 - 41 -==== Recent development ==== 42 - 43 -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. 44 - 45 -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. 46 - 47 -“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 .” 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.