=Puma Biotech. (PBYI) reported earnings on Thur 9 May 2019 (a/h)

Puma Biotech. beats by $0.41, beats on revs

• Reports Q1 (Mar) earnings of $0.21 per share, $0.41 better than the single analyst estimate of ($0.20); revenues rose 49.0% year/year to $99.1 mln vs the $67.25 mln S&P Capital IQ Consensus.
• Commentary: "During 2019, we anticipate the following key milestones for Puma: presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019; reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019."

Puma Biotech investors dump the stock after sales breast cancer drug NERLYNX fall 25% sequentially

Shares of Puma Biotech (PBYI) -36% are getting crushed after the company reported disappointing sales of its breast cancer drug NERLYNX, its first commercial product on the market.

Net NERLYNX revenue in the first quarter of $45.6 mln grew 27% yr/yr but fell 25% qtr/qtr in the seventh quarter since the drug's launch in 3Q17. New drugs don't experience seasonality like other industries that see a sequential decline from the fourth quarter to the first quarter, so a sequential decline is worrisome for investors.

The company said that there was an increase in patients discontinuing use of the drug due to its side effects. A key concern for the drug even before approval was diarrhea.

Management said that it continues to educate physicians and patients about the importance of antidiarrheal medicine along with the NERLYNX as some physicians don't prescribe antidiarrheal medicine and some patients don't fill the prescription.

The stock got crushed on disappointing 3Q18 NETLYNX sales in November as well.

Cantor Fitzgerald and Citigroup downgraded the stock this morning.

Puma has a ~$700 mln market value with the stock testing late 2018 lows down ~36% premarket.

Earnings this week : May 6 - 10, 19 (wk 19)

 

Monday (May 6)

• Premarket: AMG, BHC, CAMT, CEVA, DK, DSKE, KOS, NSSC, PETS, SPNS, SYY, TSN    

• After-Hours: AEIS, AIG, AIZ, ANDE, APU, AVID, AWR, BE, BHF, BKD, CBT, CDEV, CENT, COHU, CPE, DCO, DCP, EGOV, ENSG, EVBG, EVER, FBM, FMC, FN, FRAC, FRGI, FRPT, FRTA, GLPI, GLUU, HBM, HHC, HIIQ, HPR, HTZ, IAG, IFF, INVH, IPAR, ITRI, IVC, KLAC, KMT, KRC, KRG, LCI, LMNX, MASI, MOS, MTSC, MWA, NCMI, NGHC, NLS, OFIX, ORA, OTTR, OXY, PAHC, PLOW, PXD, QGEN, RARE, RBC, RCII, RE, RNG, RP, RTEC, SEDG, SHO, SKT, SNHY, STRL, SYKE, TACO, TCMD, TXMD, UGI, VECO, XENT

Tuesday (May 7)

• Premarket: ADNT, AES, AGN, AKRX, AMAG, ARMK, ARRY, ATH, ATKR, AVNS, BCC, BGCP, BLD, BR, BUD, CJ, CLVS, CNHI, CNK, CRL, CROX, CTLT, CWEN, DEA, DF, DNR, DPLO, DXPE, EGRX, EMR, ENR, EXPD, FI, GSKY, GTE, GTX, HAE, HSIC, ICL, IMOS, IPI, JEC, JELD, JLL, KEYW, KL, LCII, LGIH, LITE, LPX, MDCA, MFA, MLCO, MNK, MYL, NHI, NOVT, NWN, OCN, OMI, PINC, PNM, PRIM, REGN, RHP, SEAS, SERV, SND, SRE, TA, TDG, USAC, USFD, VAC, VCEL, VGR, VPG, WBT, WOW

• After hours: ACLS, ADT, APEI, ATO, ATSG, AVD, AVLR, BECN, BOLD, CERS, CGBD, CHUY, COLD, CRAY, CRZO, CSOD, CTRE, CWK, DDD, DIOD, DVA, EA, EDIT, ENTA, ESE, EVH, EVRI, FANG, FARM, FATE, FG, FLT, FTSI, GHDX, GTES, HALO, HCKT, HCLP, HUBS, ICHR, IMMR, INGN, INSP, IOSP, IRTC, JAZZ, JCOM, KAR, KGC, LADR, LC, LOPE, LTHM, LYFT, MMI, MODN, MTCH, MTSI, MYGN, NCR, NVTA, OAS, OHI, OPK, OSPN, PAA, PAGP, PBPB, PEGA, PEN, PLT, PLYA, POWL, PRI, PRMW, PUMP, PZZA, QRVO, QTWO, QUOT, RGR, RNR, RTRX, S, SEMG, SGMS, SUPN, SWX, TRIP, TWO, TWOU, VOYA, VREX, WING, WMC, WMGI, WTTR, WU, Y, ZAGG

Wednesday (May 8)

• Premarket: ACM, ANDX, ATHM, ATRO, BCOR, BG, BV, CBB, CBRE, CEIX, CFX, CHK, CHSP, CORE, COTY, FOLD, FTDR, FUN, GCP, GOLD, GOLF, GTN, GTT, HMC, HZNP, ICPT, LXP, MCHP, MCK, MIDD, MPC, MPLX, MRNA, MSG, MYE, NCS, NXST, NYT, ODP, PFGC, PLUG, PTLA, RDUS, SBGI, SGRY, SPB, STWD, SUM, TAST, TGI, TRI, VER, VG, WAAS, WEN, YRCW
• After hours: AAOI, AGS, AIMT, AKCA, ALB, ANGI, APLE, APYX, ARNA, ASRT, AXGN, BIO, BREW, CCMP, CECO, CNDT, COLL, CPA, CTL, CVNA, CW, CWH, CXW, DAR, DIS, DRH, DVAX, ECPG, EGAN, ELF, ENV, ETSY, EVRG, EZPW, FLNT, FNV, FOSL, FOXA, FTK, GBDC, GDOT, GKOS, GPRE, HLI, IAC, IMMU, INFN, INSG, IVR, KIDS, KINS, KRO, KTOS, LASR, LHCG, MATX, MBI, MRAM, MTRX, NKTR, NNI, NUAN, NVEE, OSUR, PAAS, PETQ, PK, PRGO, PRSC, PSDO, PSEC, QDEL, RDFN, RLJ, ROKU, RUN, RWT, RXN, RYAM, SAIL, SCOR, SGMO, SIEN, SJI, SLF, SMI, SRPT, STMP, SUN, SVMK, SWAV, SWCH, TCX, TLND, TPC, TPIC, TRHC, TTGT, TVTY, TWNK, UPWK, VERI, WIFI, WPM, WTRH, XEC, ZGNX

Thursday (May 9)

• Premarket: ACIW, AEE, AMC, AMRX, ANIP, BAM, BDX, BPMC, BPMP, CAH, CHH, CNNE, CNP, CNQ, COMM, CPG, CRCM, CVIA, DESP, DSX, DUK, EBIX, ECOM, ELAN, ENDP, EPAM, EPC, EYE, FOCS, GOGO, GTS, HAIN, HIMX, HL, HMHC, HSC, INAP, INXN, IONS, KDP, LAUR, LNG, MBUU, MCFT, MGA, MMS, NCLH, NMRK, NOMD, NS, OMER, OSTK, OXFD, PBH, PQG, PRTY, RCM, RDNT, REZI, RGEN, SNH, SQNS, SUP, SYNH, TEN, TGNA, TLRA, TPR, TTD, TTI, TU, TW, UNVR, USCR, VNTR, VRTV, VSH, VSTO, WRLD, WWW

• After hours: AAXN, AGO, AIRG, AL, ALRM, ALTR, AMBC, AMBR, AQ, AQN, ASYS, BKNG, CABO, CARG, CDLX, CISN, CTRL, CUTR, DBX, DHT, EFX, ELY, EQH, FLY, FSCT, GH, GPRO, GSBD, ICUI, JAG, MAIN, MAXR, MESA, MTD, MTW, NDLS, NNBR, NTR, NTRA, NVRO, NWSA, PBYI, PRAA, QNST, QRTEA, RBA, ROAD, SCSC, SENS, SNCR, SONO, SPPI, SPWR, SSRM, SSTI, SWIR, SYMC, SYNA, TGH, TIVO, TROX, TRUE, TRXC, UEPS, UNIT, VFF, VSLR, WPRT, XLRN, XON, YELP, ZAYO, ZG, ZVO

Friday (May 10)

• Premarket: AQUA, BPL, CLNY, ENB, ERF, HPT, JD, MAR, PEGI, PTE, SSP, TRCO, VIAB
• After hours: CBPO

Notable earnings reports: Tyson Foods (NYSE:TSN), Hertz Global (NYSE:HTZ) and Bausch Health (NYSE:BHC) on May 6; Electronic Arts (NASDAQ:EA), Lyft (NASDAQ:LYFT), Anheuser-Busch InBev (NYSE:BUD) and Wynn Resorts (NASDAQ:WYNN) on May 7; Disney (DIS), Roku (NASDAQ:ROKU), Etsy (NASDAQ:ETSY), Fox (NASDAQ:FOXA) and Madison Square Garden (NYSE:MSG) on May 8; GoPro (NASDAQ:GPRO), Booking Holdings (NASDAQ:BKNG), Keurig Dr Pepper (NYSE:KDP) and Trade Desk (NASDAQ:TTD) on May 9; Viacom (NASDAQ:VIAB), JD.com (NASDAQ:JD) and Linde (NYSE:LIN) on May 10.

=Puma Biotech (PBYI) reported earnings on Thur 9 Aug 2018 (a/h)

Puma Biotech. beats by $0.23, beats on revs 

• Reports Q2 (Jun) loss of $0.59 per share, excluding non-recurring items, $0.23 better than the single analyst estimate of ($0.82); revenues rose to $50.8 mln vs the $45.67 mln Capital IQ Consensus.
• "We continued to grow NERLYNX sales in the United States, with net sales of NERLYNX rising approximately 41% from the 2018 first quarter. We were also pleased that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for NERLYNX for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU)."
• "We anticipate the following key milestones over the next 12 months: (i) in the third quarter of 2018, a decision by the European Commission (EC) regarding the Marketing Authorisation Application for neratinib; (ii) in the second half of 2018 or first half of 2019, reporting data from the Phase III NALA trial in third-line metastatic breast cancer patients; (iii) in the second half of 2018 and first half of 2019, submitting for regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries; (iv) in the fourth quarter of 2018, reporting additional data from the Phase II CONTROL trial; and (v) in the fourth quarter of 2018 and first half of 2019, reporting additional data from the Phase II SUMMIT trial."
• At June 30, 2018, Puma had cash and cash equivalents of $95.9 million and marketable securities of $38.6 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

-=Puma Biotech (PBYI) reported earnings on Wed 9 May 2018 (a/h)

Puma Biotech. beats by $0.34, misses on revs 

• Reports Q1 (Mar) earnings of $0.03 per share, $0.34 better than the single analyst estimate of ($0.31).
• For the first quarter of 2018, total revenue was $66.5 million, of which $36.0 million was net product revenue and $30.5 million was license revenue received from Puma's sub-licensees.

Earnings this week : May 7 - 11, 18 (wk 19)

81% of the S&P 500 has reported first quarter results. Q1 earnings are now expected to be up 24.3%. Earnings are expected to grow 18.8% in Q2 and 19.5% for the year. Next week is still quite busy on the earnings front as more small and mid caps report quarterly results.

Monday (May 7)

• Pre-Market: CTSH SYY SRE TSN WLTW LPX KOS VGR TSEM WBT GCI SSP GPRE PETS MYE SPNS NCMI TLRA TA
• After-Hours: NTR ANDV IAG IFF MOS ZG ANDX TRMB BKI AIV BHF OHI DCP EVHC DK APLE JCOM EQC SHO SWX OAS AMC  CBT RBC TREX ORA NVRO NGHC RARE SJI AMED AWR MYGN CENT HTZ PINC OTTR PAHC KAMN CRZO RMBS DPLO SNHY MWA LBRT BKD FN ATSG TRTX RWT SYKE EVBG GBDC RYAM PLOW LMNX ANDE MTSC CARB MTW VECO REN FRPT TCMD IVC LCI FRGI DHT EVRI NLS WMC WAAS STRL PI EGAN

Tuesday (May 8)

• Pre-Market: CRSP JD MCHP DISH DISCA MLM BR HSIC IT EXPD ATHM PRGO ARMK AES JEC JLL USFD VRX EGN ACM HAE VSM LOXO SUM JELD MFA HAIN NHI VG BLD VSH  ZBRA  AQUA TGNA NOVT ICPT GCP LXP NWN FI LGIH SGMO RGEN MNTA DNR ETM SEAS HUD STFC PRIM FSS ENDP BMCH WLH CROX MNK TGH GTN CWH DEA EPZM CORE ATKR DF ANIP DQ GTS COHU VRTV TTI SD DSKE CRCM MGI FRTA ONDK TAST VPG KEYW 

• After-Hours: DIS OXY MAR EA MNST PAA O CA FANG MTCH GDDY XEC JAZZ WR TRQ BIO KAR MIDD DEI WTR TRIP PEN TWLO NEWR WEN GWPH PAGP ETSY PLNT

Wednesday (May 9)

• Pre-Market: WB MYL AEE COTY STE SINA ADT EPAM JHG CNK HPT DLPH SYNH CNDT WIX CABO PFGC SBGI WRD GRPN HZNP MDP CARS PNK USAC
• After-Hours: FOXA DXC CTRP ETP CTL ETE FNV IAC ALB ANGI RNG ICUI CPA NUAN GDOT ROKU HLI FNGN DAR ENV PBYI SEDG BKNG   SEP FTI MELI ZTO ATUS IAC ALB OTEX BGNE ANGI RNG ICUI CPA NUAN DNB FGEN EEP SNH RLJ  PAAS HLI FNGN PTLA DAR WRD ENV  PSEC BLDR WMGI SAIL SUN TROX AYX FG INFN PRAA SYNA AG PTCT TWNK NP ZGNX BOLD EVH GKOS FSM SCOR TPC RUN PRSC ELF AMPH MBI COLL CVNA CHEF TCX UPLD NVGS NVAX TTGT NNBR MTRX SIEN MDCA BREW NVTA QHC FTK MRAM (finviz-change)

Thursday (May 10)

• Pre-Market: AZUL TU DUK BAM WP NICE ICL YY UBNT CRL SATS MIXT CHH MMS UNVR GDS DKS CLNS AMCX TRCO PQG BIG PEGI KLIC PBH HL BITA SPH AMRX UNVR  LHO  TRCO  NOMD ACIW BTG MDP BPMP PQG DDS DESP PEGI KLIC HL RDUS SPH TGI HIMX KELY.A WRLD OMI EGRX KND SNR DSX DEPO ECOM BIOS SND MGA TSG ENB   (finviz-change)
• After-Hours: NVDA SYMC NKTR WPM DOX NWSA FLS PPC PEGA AL HUBS YELP XON ANAB  HRTX TTD RDFN GLOB WTTR TIVO SSRM TLND  RBA UNIT JAG HALO XON CASA WTTR GLOB TIVO KLIC PSDO KTOS ARCB OMER FATE VRAY CSLT CIVI PFLT UEPS MCFT SENS SGYP DCO IMMR NDLS AMBR FNKO AVID ASYS

Friday (May 11)

• Pre-Market: TRI, WPRT, WOW

=Incyte (INCY) and Merck (MRK) : failed key Phase 3 melanoma study

• Biotech stocks (XBI) lower after important immune-oncology combo data (Incyte's IDO inhibitor plus Merck's Keytruda) fails in key Phase 3 melanoma study:  NLNK (IDO inhibitor peer) -37.57%,  INCY -18.23%,  NKTR -9.84%,  JNCE -10.20%,  LABU -5.14%,  FPRX -3.84%,  ONCS -3.72%,  SAGE -2.21%,  SGEN -1.81%,  BLUE -4.85%,  PBYI-1.85%,  SPPI -2.46%,  CRVS -9.17%,  TSRO +0.37%,  BMRN -2.01%, GLYC-2.03%, MRK-1.19% 
• IBB -1.99%,  XBI -1.78%

Incyte announces that the External Data Monitoring Committee determined that the Phase 3 ECHO-301/KEYNOTE-252 study did not meet the primary endpoint 

The co and Merck (MRK) announced that an external Data Monitoring Committee review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte's epacadostat in combination with Merck's KEYTRUDA in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.

• The study's second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.

Incyte and Merck will inform investigators of the results and work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

-=Puma Biotechnology (PBYI) reported earnings on Thur 1 March 2018 (a/h)

LOS ANGELES (AP) _ Puma Biotechnology Inc. (PBYI) on Thursday reported a loss of $64.1 million in its fourth quarter.

The Los Angeles-based company said it had a loss of $1.71 per share. Losses, adjusted for stock option expense, were $1.03 per share.

For the fourth quarter, sales of Puma's breast cancer drug Nerlynx were $20.1 million in the U.S., just short of the consensus for $20.8 million, Leerink's Schmidt said. But Puma pre-announced $11.6 million in January net sales, indicating the consensus view for $31.7 million in the first quarter could be too low.

"We expect this to be a clearing event similar to the recent Clovis Oncology (CLVS) fourth-quarter earnings report," he said in a note. "Fundamentally, Nerlynx U.S. launch metrics look solid."

On the call, Puma guided to 2018 sales of $175 million to $200 million in the U.S. Consensus figures are between $184 million and $204 million, RBC analyst Kennen MacKay said in a report. Leerink's Schmidt sees the outlook as conservative.

Puma could also have some good news around midyear. The firm is expected to have data from a Phase 3 study of Nerlynx in an advanced form of breast cancer. Further, European officials are reconsidering Nerlynx in another form of breast cancer.

=Puma Biotech (PBYI) reported earnings on Thu 9 Nov 2017 (a/h)

Puma Biotech. beats by $0.07, beats on revs 

• Reports Q3 (Sep) loss of $1.36 per share, excluding non-recurring items, $0.07 better than the two analyst estimate of ($1.43); revenues were $6.1 mln vs the $3.78 mln Capital IQ Consensus.
• Net cash used in operating activities for the third quarter of 2017 was $54.9 million. Net cash used in operating activities for the nine months ended September 30, 2017 was $136.9 million. At September 30, 2017, Puma had cash and cash equivalents of $79.7 million and marketable securities of $26.6 million, compared to cash and cash equivalents of $194.5 million and marketable securities of $35.0 million at December 31, 2016.
• "Looking forward, we anticipate the following milestones: (i) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2017; (ii) receiving a regulatory opinion from the Committee for Medicinal Products for Human Use (CHMP) for neratinib in extended adjuvant HER2-positive early stage breast cancer in the first quarter of 2018; and (iii) reporting Phase III trial results in third-line HER2- positive metastatic breast cancer patients in the first half of 2018." 

=Puma Biotech (PBYI) jumps after FDA approval of breast-cancer treatment

Puma Biotechnology Inc. (PBYI) jumped  after the company announced that the Food and Drug Administration had approved a breast-cancer treatment for medical use. The medicine, which will be marketed as Nerlynx and is expected to hit the market in September, is used after traditional treatment to avoid recurrence of HER2 breast cancer. Puma said up to one in four patients experience recurrence after treatment, but studies of its drug showed a 34% reduction in recurrence. "HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan," Richard Pazdur, director of the FDA Oncology Center of Excellence, said in the FDA's announcement. "Now, these patients have an option after initial treatment that may help keep the cancer from coming back." Puma shares moved as high as $96 in late trading after closing at $86.10, though prices settled at closer to $92 later in the after-hours session. The stock enjoyed a larger surge after an FDA panel recommended its approval in May, and has gained more than 117% in the past three months, as the S&P 500 index (SPX) has gained less than 5%.