HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

Transcription

1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): November 7, 2017 HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation) (Commission File Number) Sorrento Valley Road, San Diego, California (Address of principal executive offices) (IRS Employer Identification No.) (Zip Code) Registrant s telephone number, including area code: (858) Not Applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: owritten communications pursuant to Rule 425 under the Securities Act (17 CFR ) osoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR a-12) opre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR d-2(b)) opre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR e-4(c))

2 Item 2.02 Results of Operations and Financial Condition. On November 7, 2017, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the third quarter ended September 30, A copy of the press release is attached as Exhibit 99.1, which is furnished under Item 2.02 of this report and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the Exchange Act ) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. Item 9.01 Financial Statements and Exhibits. Exhibit No. Description 99.1 Press release dated November 7, 2017

3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. HALOZYME THERAPEUTICS, INC. November 7, 2017 By: /s/harryj.leonhardt,esq. Name: Harry J. Leonhardt, Esq. Title: Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary

4 Exhibit Index Exhibit No. Description 99.1 Press release dated November 7, 2017

5 Exhibit 99.1 Contacts: JimMazzola ChrisBurton HALOZYME REPORTS THIRD QUARTER 2017 RESULTS -- Strong ENHANZE Momentum Following Landmark Collaboration Agreement with Bristol-Myers Squibb Royalty Revenue Increased 31 Percent from Prior-Year Period to $17.1 million on Growing Sales of Herceptin SC, MabThera SC in Q Revenue Guidance Raised, Expense Guidance Lowered, Resulting in Higher Year-End Cash Guidance of $400 million to $415 million -- SAN DIEGO, November 7, HalozymeTherapeutics,Inc.(NASDAQ:HALO),abiotechnologycompanydevelopingnovel oncologyanddrug-deliverytherapies,todayreportedfinancialresultsandrecenthighlightsforthethirdquarterended September30. Duringthethirdquarter,werealizedclearbenefitsfromstrategieswehavebeenexecutingagainstinboththeENHANZEand PEGPH20pillarsofourbusiness, saiddr.helentorley,presidentandchiefexecutiveofficer. OnENHANZEwesignificantly increased2017revenueandthepotentialfuturevalueofthetechnologywiththesigningofthelandmarkcollaboration agreementwithbristol-myerssquibbfordevelopmentofupto11immuno-oncologytargets,andwiththeexpansionofour collaborationagreementwithroche.inaddition,ourpartnerjanssentookanimportantsteptowardsthecommercializationofa subcutaneousformulationofdarzalex withtheinitiationofaphase3study. InourPEGPH20pillar,investigatorinterestremainsstronginourHALO-301study,resultingincontinuedprogresswith enrollment.aninterimanalysiswillbeconductedforthefirstprimaryendpointofprogression-freesurvivalwhenweachievethe targetnumberofevents,whichweprojectwilloccurinlateq42018.

6 Third Quarter 2017 and Recent Highlights include: Announcing a Global Collaboration and License Agreement with Bristol-Myers Squibb todevelopsubcutaneously administeredbristol-myerssquibbimmuno-oncologymedicinesusinghalozyme senhanzedrug-deliverytechnology. Theagreementisthelargestincompanyhistoryincludinga$105millionupfrontpaymentand$160millioninpotential milestonesforeachof11immuno-oncologytargets,includingtheinitialtargetselectionofprogrammeddeath1(pd-1). Roche licensing a new ENHANZE target inexchangefora$30millionupfrontpaymentandupto$160millionin potentialdevelopment,regulatoryandsales-basedmilestones.theagreementservesasanextensiontotheoriginal collaborationbetweenthecompanies,underwhichrochehasdevelopedtwosubcutaneousformulationsofcancerdrugs formarketsworldwide. Janssen initiating the first of three planned Phase 3 studies of the subcutaneous formulation of DARZALEX (daratumumab).halozyme senhanzetechnologyhasthepotentialtoenablea15mlinjectiontobedeliveredinfive minutesorless,withnorequirementforanintravenousloadingdose.datainformingthisdecisionfromthephase1 PAVOstudyinpatientswithrelapsedorrefractorymultiplemyelomawereacceptedforpresentationatthe2017 AmericanSocietyofHematologyAnnualMeetingandExposition.Uponthedosingofthethirdpatientintherecently initiatedstudy,halozymewillearna$15millionmilestonepayment. Genentech launching RITUXAN HYCELA (rituximab/hyaluronidasehuman)forsubcutaneousinjection,a combinationofrituximabandhalozyme'shyaluronidasehumanenhanzetechnology,forpatientswithfollicular lymphoma,diffuselargeb-celllymphomaandchroniclymphocyticleukemia. Continued progress screening and enrolling patients in the HALO-301 study ofpegph20incombinationwith ABRAXANE (nab-paclitaxel)andgemcitabineinfirstlinemetastaticpancreascancerpatientswithhighlevelsoftumor hyaluronan(ha-high).aninterimanalysiswillbeconductedforthefirstprimaryendpointofprogression-freesurvival whenthetargetnumberofeventshasbeenreached,whichthecompanyprojectswillbeinlateq42018.atthattime, Halozymeprojectsapproximately500patientswillhavebeenenrolledinthestudy. Initiating multiple trials in collaboration with Genentech to evaluate PEGPH20 in combination with TECENTRIQ (atezolizumab) in four tumor types. StudiesincludeaHalozyme-sponsoredrandomizedclinicaltrialinpatientswith previouslyuntreated,unresectable,locallyadvanced,ormetastaticcholangiocarcinomaandgallbladderadenocarcinoma andtwogenentech-fundedandoperated,phase1b/2multi-armclinicalstudiesevaluatingpatientswithpreviously treatedmetastaticpancreaticductaladenocarcinomaandpreviouslytreatedlocallyadvancedunresectableormetastatic gastriccancer.thestudiesarepartofaclinicalcollaborationagreementannouncedin2016toevaluatepegph20and atezolizumabinuptoeighttumortypes.

7 Third Quarter 2017 Financial Highlights Revenueforthethirdquarterwas$63.7millioncomparedto$31.9millionforthethirdquarterof2016.Theyear-overyearincreasewasdrivenbya$30millionupfrontpaymentfromRocheandgrowthinroyaltiesfrompartnersalesof Herceptin (trastuzumab)sc,mabthera (rituximab)scandhyqvia (ImmuneGlobulinInfusion10%(Human)with RecombinantHumanHyaluronidase)offsetbyadecreaseinresearchanddevelopmentreimbursementsandlicense paymentsfromenhanzepartners.revenueforthethirdquarterincluded$17.1millioninroyalties,anincreaseof31 percentfromtheprior-yearperiod,$9.8millioninsalesofbulkrhuph20primarilyforuseinmanufacturingcollaboration productsand$3.8millioninhylenex recombinant(hyaluronidasehumaninjection)productsales. Researchanddevelopmentexpensesforthethirdquarterwere$34.0million,comparedto$33.9millionforthethird quarterof2016.theincreasewasprimarilyduetoarampinspendingassociatedwiththehalo-301study. Selling,generalandadministrativeexpensesforthethirdquarterwere$13.3million,comparedto$11.6millionforthe thirdquarterof2016.theincreasewasprimarilyduetopersonnelexpenses,includingstockcompensation,forthe period. Netincomeforthethirdquarterwas$2.7million,or$0.02pershare,comparedtonetlossinthethirdquarterof2016of $28.9million,or$0.23pershare. Cash,cashequivalentsandmarketablesecuritieswere$316.9millionatSeptember30,2017,comparedto$297.5 millionatjune30,2017. Financial Outlook for 2017 Halozymeupdatedyear-endguidance,nowexpecting: Netrevenueincreasingfromthepriorrangeof$245millionto$260millionannouncedonSept.14to$265millionto $280million,drivenbystrongerproductsales,royalties,andsponsoredresearch; Operatingexpensesdecreasingfromthepriorrangeof$240millionto$250millionto$230millionto$240million; Positiveoperatingcashflowincreasingfromthepriorrangeof$50millionto$60millionto$70millionto$85million; Year-endcashbalanceincreasingfromthepriorrangeof$380millionto$395millionto$400millionto$415million. Webcast and Conference Call HalozymewillwebcastitsQuarterlyUpdateConferenceCallforthethirdquarterof2017today,Tuesday,November7at4:30 p.m.et/1:30p.m.pt.dr.helentorley,presidentandchiefexecutiveofficer,willleadthecall.thecallwillbewebcastlive throughthe"investors"sectionofhalozyme'scorporatewebsiteandarecordingwillbemadeavailablefollowingthecloseofthe call.toaccessthewebcastandadditionaldocumentsrelatedtothecall,pleasevisithttp:// fifteenminutespriortothecalltoregister,downloadandinstallanynecessaryaudiosoftware.thecallmayalsobeaccessedat (877) (domesticcallers)(334) (internationalcallers)usingpasscode Atelephonereplaywillbe availableafterthecallbydialing(877) (domesticcallers)or(334) (internationalcallers)usingreplayid number

8 About Halozyme HalozymeTherapeuticsisabiotechnologycompanyfocusedondevelopingandcommercializingnoveloncologytherapiesthat targetthetumormicroenvironment.halozyme sleadproprietaryprogram,investigationaldrugpegph20,appliesaunique approachtotargetingsolidtumors,allowingincreasedaccessofco-administeredcancerdrugtherapiestothetumorinanimal models.pegph20iscurrentlyindevelopmentformetastaticpancreaticcancer,non-smallcelllungcancer,gastriccancer, metastaticbreastcancerandhaspotentialacrossadditionalcancersincombinationwithdifferenttypesofcancertherapies.in additiontoitsproprietaryproductportfolio,halozymehasestablishedvalue-drivingpartnershipswithleadingpharmaceutical companiesincludingroche,baxalta,pfizer,janssen,abbvie,lillyandbristol-myerssquibbforitsenhanze drugdelivery technology.halozymeisheadquarteredinsandiego.formoreinformationvisitwww.halozyme.com. Safe Harbor Statement Inadditiontohistoricalinformation,thestatementssetforthaboveincludeforward-lookingstatements(including,without limitation,statementsconcerningthecompany'sfutureexpectationsandplansforgrowthin2017,enteringintonew collaborationagreements,thedevelopmentandcommercializationofproductcandidates,includingtimingofclinicaltrialresults announcementsandfuturedevelopmentandcommercialactivitiesofourcollaborationpartners,thepotentialbenefitsand attributesofsuchproductcandidatesandexpectedfinancialoutlookfor2017)thatinvolveriskanduncertaintiesthatcould causeactualresultstodiffermateriallyfromthoseintheforward-lookingstatements.theforward-lookingstatementsare typically,butnotalways,identifiedthroughuseofthewords"believe,""enable,""may,""will,""could,""intends,""estimate," "anticipate,""plan,""predict,""probable,""potential,""possible,""should,""continue,"andotherwordsofsimilarmeaning.actual resultscoulddiffermateriallyfromtheexpectationscontainedinforward-lookingstatementsasaresultofseveralfactors, includingunexpectedexpendituresandcosts,unexpectedfluctuationsorchangesinrevenues,includingrevenuesfrom collaborators,unexpecteddelaysinenteringintonewcollaborationagreements,unexpectedresultsordelaysindevelopmentof productcandidates,includingdelaysinclinicaltrialpatientenrollmentanddevelopmentactivitiesofourcollaborationpartners, andregulatoryreview,regulatoryapprovalrequirements,unexpectedadverseeventsandcompetitiveconditions.theseand otherfactorsthatmayresultindifferencesarediscussedingreaterdetailinthecompany'squarterlyreportonform10-qfiled withthesecuritiesandexchangecommissiononnovember7,2017.

9 Revenues: Halozyme Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) Three Months Ended Nine Months Ended September 30, September 30, Product sales, net $ 13,589 $ 13,331 $ 37,803 $ 39,970 Royalties 17,119 13,036 45,839 36,695 Revenues under collaborative agreements 33,023 5,486 43,407 31,023 Total revenues 63,731 31, , ,688 Operating expenses: Cost of product sales 8,332 9,134 23,664 25,204 Research and development 33,993 33, , ,493 Selling, general and administrative 13,329 11,599 39,045 33,626 Total operating expenses 55,654 54, , ,323 Operating income (loss) 8,077 (22,743) (44,927) (60,635) Other income (expense): Investment and other income, net , Interest expense (5,538) (5,253) (16,526) (14,378) Income (loss) before income taxes 3,329 (27,662) (59,941) (74,053) Income tax expense 580 1, ,584 Net income (loss) $ 2,749 $ (28,946) $ (60,911) $ (75,637) Net income (loss) per share: Basic $ 0.02 $ (0.23) $ (0.45) $ (0.59) Diluted $ 0.02 $ (0.23) $ (0.45) $ (0.59) Shares used in computing net income (loss) per share: Basic 141, , , ,886 Diluted 143, , , ,886

10 Current assets: Halozyme Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) ASSETS September 30, 2017 December 31, 2016 Cash and cash equivalents $ 164,397 $ 66,764 Marketable securities, available-for-sale 152, ,217 Accounts receivable, net 14,695 15,680 Inventories 9,331 14,623 Prepaid expenses and other assets 12,397 21,248 Total current assets 353, ,532 Property and equipment, net 3,232 4,264 Prepaid expenses and other assets Restricted cash Total assets $ 357,149 $ 261,515 LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) Current liabilities: Accounts payable $ 4,152 $ 3,578 Accrued expenses 32,370 28,821 Deferred revenue, current portion 4,093 4,793 Current portion of long-term debt, net 61,433 17,393 Total current liabilities 102,048 54,585 Deferred revenue, net of current portion 36,755 39,825 Long-term debt, net 145, ,228 Other long-term liabilities Stockholders equity (deficit): Common stock Additional paid-in capital 718, ,737 Accumulated other comprehensive loss (53) (6) Accumulated deficit (646,253) (585,342) Total stockholders equity (deficit) 72,389 (32,481) Total liabilities and stockholders equity (deficit) $ 357,149 $ 261,515 ###