===Esperion Therapeutics (ESPR) : new drug submissions in Canada for NEXLETOL treatments

Co announced that it has filed New Drug Submissions to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.

 

=Esperion Therapeutics (ESPR) reported earnings on Tue 4 May 21 (a/h)

• Reported downside Q1 EPS and revs. US product revs were $6.4 mln; growing demand was offset by lower net price. Prescriptions grew +46% sequentially. Downgraded to Hold at Stifel. At four-year lows. 

Esperion Therapeutics misses by $1.28, misses on revs 

Reports Q1 (Mar) loss of $3.50 per share, $1.28 worse than the S&P Capital IQ Consensus of ($2.22); revenues rose 344.4% year/year to $8 mln vs the $34.28 mln S&P Capital IQ Consensus.

• Research and development expenses were $28.0 million for the first quarter of 2021, compared to $34.7 million for the comparable period in 2020. The decrease in expense during the first quarter was primarily attributable to a decline in manufacturing costs which were previously classified as research and development expense prior to FDA approval of NEXLETOL and NEXLIZET in the first quarter of 2020.

Research and development expenses for the full year 2021 are expected to be $120 million to $130 million. Selling, general and administrative expenses for the full year 2021 are expected to be $200 million to $210 million.

ESPERION continues to expect full-year 2021 operating expenses to be approximately $320 million to $340 million, inclusive of $30 million of non-cash, stock-based compensation.

Earnings this week : May 3 - 7, 21 (wk 18)

Monday (May 3)

• Morning:  AMG CNA ENBL EPD EL ITRI ON PETS WEC
• Afternoon: ADUS AWR AWK AGR CAR BLDP BRX BWXT CBT CHGG CC CR FANG PLOW EVER FN FLS FRPT HLIT IAG NSP IRBT JKHY KMT KFRC LEG LGND LTHM MAXR MOS MWA MYGN NTR OHI OGS OTTR QGEN RMBS O RBC SANM SCI SEDG SU SHO RIG VRNS VNOM VNO WMB WWD XPO ZI

Tuesday (May 4)

• Morning: AME APO ARCB ARNC ATC BHC BERY BR BEP BG CWH CTLT CRL LNG CQP CVLT COP CRSR CMI CVS D DD DEA ETN ETRN EXPD FSS RACE FI BEN IT GCP GPN HSC HSIC HEP IAA IDXX INCY INGR IPGP KKR LAMR LANC LNTH LCII LDOS LGIH LPX MBUU MPC MLM MTOR MPLX NNN NXST NS PCRX PFE PINC RCM RGEN RHP SABR SAGE SPNS SEE SYY TNC TRI UAA VIRT VSH VMC WMG WLK XYL ZBRA ZBH
• Afternoon:  ATVI AKAM ALRM ALC ALGT AYX AMCR AFG ANET ARWR AMK AIZ ACLS BTG BNFT BKH EPAY CZR CDLX CMP CTVA CYRX DCPH DK DENN DVN DHT DLB DEI EQC ESE ESPR EXAS GMED GSKY PEAK HLF HI HMN HST HURN H ICFI ICHR INFN IOSP INGN INSP NVTA JAZZ JBGS KAI KAMN KAR LSCC LSI LPSN LUNG LYFT MANT DOOR MTCH MCFE MED MRCY MCY MPWR NSA NEX NMIH OSPN OUT PAYC PEN PKI PXD PAA PVG PUMP PRO PRU PTCT RDN RRR RNG SGMO SILK SITM TSLX SPT STAG SYKE SYX TMUS TTEC RARE UPWK VREX VECO VRSK VIAV SPCE WTS WU WK XLNX ZG

Wednesday (May 5)

• Morning:  AEIS ALGM ABC ASTE AAWW AVA GOLD BDC BCOR BWA BRKR CDW FUN CERN CIM CLH CNHI CRTO CYBR DIN DNB EDIT EMR AQUA EXC FLEX FTS FDP GM GEL ROCK EAF HAYW HLT HFC HZNP INMD IONS JLL LL MGPI NEO NRZ NYT NI NWN DNOW ODP OMI PSN PFGC DOC PNW PEG RDWR REYN SMG SRE SBGI SITE SPR FLOW SMP SSYS SPWR TT TUP UTHR VCEL WRK
• Afternoon:  TXG ACAD ACCD ADPT ADT ADTN ATSG ALB ALL AEL ANSS APA ARNA ARLO ATO BAND BE BKNG BFAM WHD CDNA CENX CDAY CF XEC CCMP CTSH CNDT CPA CXW CCRN CSGS CW DCP ECPG NVST EPR EQT EQH WTRG ETSY FSLY FATE FRT FICO FLT FMC FOXA FNV GIL GKOS GBT GDDY LOPE GDOT HR HUBG HUBS HPP INSG KW KTOS KRO KLIC LCI LESL LHCG LNC LUMN MTW MFC MRO VAC MDU MET MTG NBIX NVRO NUS NUVA ORA ORCC PLMR PYPL PDCE PETQ PING PLYA PRI PRIM PRA QTWO QRVO QLYS QNST RYN RDFN RGNX RCII RSG RLJ RKT ROOT RGLD RPT SRPT SIMO SJI SRC STAA RGR SLF RUN SUPN TLND TNDM SKT TTGT TRMB TWLO TWO UBER UGI UNM UPLD VAPO HCC WW ZIXI ZNGA

Thursday (May 6)

• Morning: ACIW GOLF AHCO ADNT AES ALE BUD APTV MT ARW AVYA AZUL BLL BDX TECH BKI BV BIP BLDR CAH CARS CNP ECOM CRAI CWEN COMM CORE DLX DEN XRAY DOCN UFS EPC EPAM EPZM EVRG EVOP EXPI FIS FVRR FLIR FOCS GOGO GTN HAIN HL HSKA HIMX HWM HII IIVI NSIT INSM NTLA ICPT IDCC IRM IRWD K KL KTB LAUR MGA MMS MRNA MUR MYE NTCT NLSN NJR NOMD NCLH NVMI OGE OPCH PZZA PENN PBH PWR RETA REGN SEAS FOUR STWD STOR SUN TPR TEN TMX SHYF BLD THS USCR USPH VER VIAC VSTO VG VNT WD W WBT WCC XHR ZTS
• Afternoon:  XLRN ACMR AL AQN Y LNT ALTR AMBC AMC AMH AIG COLD AMN ANGI APPN AGO AVLR AXON AXNX BECN BYND BILL BL BCC CABO CMBM CSII CARG CVNA CDK CERT CHUY CLNE NET CGNX COLL SCOR ED CSOD CVET CWK DDOG DRH DIOD DBX LOCO ENTA ENDP ET ENV EOG EXEL EXPE FNF FND FOXF FRG FTDR FLGT FNKO GPRO GRPN GH HCAT HTA ICUI PODD IAC IOVA IRTC FROG LYV CLI MAIN MTZ MCK MTD MCHP MTX MNST MSI MP NTRA NFG NTUS NKTR NWSA LASR OTEX OPRT OEC PK PCTY CNXN PTON PBA PFSI PRDO PLNT POST PRAA PGNY PBYI KWR QDEL RPD RMAX REG RGA REZI RVLV ROKU SEM SHAK SFM SPXC SQ STMP SVMK SYNA TRHC TDC TPIC TSE TRIP TRUE TWST UIS OLED WPM YELP ZIOP ZGNX

Friday (May 7)  

• Morning:  AMCX AXL AMRX ATH CCJ CVE CI CNK ROAD CRON DKNG ELAN ESNT FLR IBP TILE ITT KOP LEA LXP MMI MD MODV NFE NKLA QRTEA SSP SPB SR TRP TU VTR
• Afternoon:  ES UNVR

=Esperion Therapeutics (ESPR) : late-stage clinical trial results for cholesterol-lowering medication

• Positive top-line results from pivotal Phase 3 long-term safety study of bempedoic acid 
• Reports Q1 (Mar) loss of $1.73 per share, $0.14 worse than the Capital IQ Consensus of ($1.59). 

The phase 3 trial, which enrolled 2,230 patients, met the primary endpoint of safety and tolerability and the key efficacy endpoint, lowering LDL-C an additional 20% after 12 weeks, the company said. LDL-C was also lowered 20% at 24 weeks, and 16% at 52 weeks.

Safety issues for individuals on the therapy, bempedoic acid, happened at a rate of nearly 80%, and serious safety issues were seen at nearly 11%, with the company noting there were "no clinically relevant differences" for those measures between the therapy and the placebo groups.

Fatal adverse events that the company said were "unrelated to study treatment" happened at a nearly 1% rate for patients on bempedoic acid, or 13 patient deaths, relative to a 0.3% rate for patients on the placebo, or two patient deaths, according to an Esperion presentation. Bempedoic acid is intended for high-risk patients with atherosclerotic cardiovascular disease, or artery-clogging fat deposits, who haven't responded well enough to cholesterol-lowering drugs like statins.

Other companies that have or are developing cholesterol-lowering medications include Regeneron Pharmaceuticals (REGN), and Sanofi (SNY), Amgen Inc. (AMGN) and Medicines Company (MDCO) and Regeneron recently announced discounts for its cholesterol-lowering drug, in hopes of boosting sales.

=Esperion Therapeutics (ESPR) reported earnings on Wed 22 Feb 2017 (b/o)

Esperion Therapeutics misses by $0.05; provides update, gives cash outlook :

• Reports Q4 (Dec) loss of $1.29 per share, $0.05 worse than the Capital IQ Consensus of ($1.24).
• Upcoming Milestones
  • February 2017:
    • Initiation of the open-label extension study of the global pivotal Phase 3 long-term safety and tolerability study (Study 1) to collect additional safety data. All patients in the open-label extension study will receive bempedoic acid.
  • March 2017:
    • Initiation of the Phase 2 "triplet oral therapy" study of bempedoic acid to further explore the complementary oral LDL-C lowering of bempedoic acid, ezetimibe and atorvastatin.
    • Brian A. Ference, M.D., M.Phil, M.Sc., F.A.C.C., Associate Professor of Medicine, Wayne State University School of Medicine, will present "Genetic Target Validation for ATP Citrate Lyase Inhibition" at the upcoming American College of Cardiology 66th Annual Scientific Session.
• "Our focus in 2017 will be on the timely completion of patient enrollment of these LDL-C lowering efficacy studies to enable us to report top-line results by mid-2018. We are encouraged by the early completion of patient enrollment in our long-term safety and tolerability study in January, and remain focused on completing patient enrollment across the remaining global pivotal Phase 3 studies."
• As of December 31, 2016, cash and cash equivalents and investment securities available-for-sale totaled $242.5 million compared with $292.6 million at December 31, 2015. Esperion expects full-year 2017 net cash used in operating activities to be approximately $125 to $135 million and its cash and cash equivalents and investment securities to be approximately $105 to $115 million at December 31, 2017. The Company estimates that current cash resources are sufficient to fund operations into early 2019 and through the announcement of top-line results from all global pivotal Phase 3 safety and efficacy studies.

=Esperion Therapeutics (ESPR) reported earnings on Thur 3 Nov 2016 (a/h)

Esperion Therapeutics beats by $0.07:

• Reports Q3 (Sep) loss of $0.77 per share, $0.07 better than the Capital IQ Consensus of ($0.84).
• "While we continue to rapidly enroll patients into the global long-term safety study, we look forward to initiating the global pivotal Phase 3 LDL-C lowering efficacy studies and cardiovascular outcomes trial for bempedoic acid before year-end. With our available cash resources, we remain focused on delivering top-line results from our Phase 3 efficacy and long-term safety studies by mid-2018."
• Esperion expects full-year net cash used in operating activities in 2016 will be approximately $65 million and that its cash and cash equivalents and investment securities to be approximately $225 million at December 31, 2016. The Company expects to announce top-line results from the global pivotal Phase 3 CLEAR LDL-C lowering efficacy and safety studies in mid-2018, and that current cash resources are sufficient to fund operations into early 2019.