Oct. 23, 2014, 8:24 AM
- Celgene (NASDAQ:CELG) Q3 results ($M): Total Revenues: 1,982.2 (+18.4%); Product Revenues: 1,956.8 (+19.0%); COGS: 97.7 (+13.3%); R&D Expense: 675.1 (+15.5%); SG&A Expense: 497.6 (+10.9%); Operating Income: 646.6 (+41.9%); Net Income: 508.5 (+36.5%); EPS: 0.61 (+41.9%); Quick Assets: 6,860.7 (+20.6%); CF Ops: 901.0.
- Gross Profit: 1,884.5 (+18.7%); COGS: 4.9% (-4.3%); Gross Margin: 95.1% (+0.2%); Operating Earnings Yield: 35.9% (+8.3%); Net Earnings Yield: 25.7% (+15.3%).
- Revenue By Product: Revlimid: 1,300.0 (+19.3%); Abraxane: 212.2 (+25.1%); Vidaza: 157.8 (-28.4%); Promalyst/Imnovid: 181.1 (+102.3%).
- 2014 Guidance: Total Revenue: >$7.6B; Net Product Revenue: >$7.5B; Revlimid Revenue: >$4.9B; Abraxane Revenue: ~$850M; EPS: $2.38 - 2.48 from $2.46 - 2.55; non-GAAP EPS: $3.65 - 3.70 from $3.60 - 3.65.
Oct. 23, 2014, 7:35 AM
Oct. 22, 2014, 5:30 PM
- AAL, AB, ACAT, AEP, ALK, ALV, ALXN, ARG, ASPS, AVT, BBW, BC, BCC, BHE, BKU, BMS, CAB, CAM, CAT, CCE, CELG, CFX, CHKP, CLI, CMCSA, CMS, CRI, CRS, CS, CSH, CVE, CWEI, DAN, DGX, DLX, DNKN, DO, DPS, EQM, EQT, FAF, GM, GMT, GPI, GRUB, HERO, HUB.B, IMAX, IVC, JAH, JAKK, JBLU, JNS, KKR, LAZ, LLY, LO, LSTR, LTM, LUV, MDP, MHO, MINI, MJN, MMM, MTRN, NLSN, NOK, NUE, NWE, ORI, OSIS, OSTK, OXY, PCP, PENN, PHM, PLD, POT, PRLB, PTEN, QSII, RCI, RCL, RS, RTN, RYL, SIAL, SILC, SJR, SLAB, SONS, SQNS, STC, TDY, TROW, UA, UAL, UFS, UNP, USG, UTEK, WCC, WSO, YNDX, ZMH
Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 1, 2014, 9:27 AM
Sep. 26, 2014, 1:12 PM
- Moderately-traded biotech Angios Pharmaceuticals (AGIO +19.6%) jumps on a 10x surge in volume. Shares have quadrupled since the low of $15.77 on November 18, 2013.
- In November, the company will present clinical data from a Phase 1 trial of AG-120, an orally available inhibitor of the mutated IDH1 protein, being developed to treat hematologic malignancies and solid tumors.
- Collaboration partner Celgene (CELG +0.3%) has a 15% stake in the company.
Sep. 23, 2014, 3:37 PM
- The FDA approves Celgene's (CELG +1.3%) Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. It is the only phosphodiesterase 4 (PDE4) inhibitor approved for this indication. It was cleared on March 21, 2014 for the treatment of adults with active psoriatic arthritis.
Sep. 17, 2014, 9:34 AMConcert Pharma begins clinical development of anti-inflammatory drug candidate from Celgene collaboration
- Concert Pharmaceuticals (CNCE) initiates a Phase 1 ascending dose clinical trial in 40 healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of its investigational compound CTP-730. The trial should be completed in 2015.
- CTP-730 is the initial product candidate produced from Concert's collaboration with Celgene (CELG +0.6%).
Aug. 20, 2014, 11:33 AM
- The U.K.'s National Institute for Health and Care Excellence reverses its position and now supports the use of Celgene's (CELG +1.9%) Revlimid (lenalidomide) by the National Health Service for the treatment of myelodysplastic syndromes.
- The healthcare cost and quality of care advisor changed its opinion after the company submitted revised analyses and a proposal to limit the cost of the drug, including agreeing to provide Revlimid free of charge to anyone requiring more than 26 monthly cycles of treatment.
Aug. 20, 2014, 8:29 AM
- Bristol-Myers Squibb (NYSE:BMY) and Celgene (NASDAQ:CELG) collaborate in a Phase 1 clinical trial to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers' Opdivo (nivolumab) and Celgene's Abraxane (paclitaxel) as a treatment for HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).
- Opdivo is a cancer immunotherapeutic that uses the body's own immune system to fight cancer while Abraxane works by interfering with cancer cells' ability to divide. The trial will explore if the combination of the two agents leads to an enhanced anti-tumor response.
- The clinical trial is slated to begin in Q4 and will be run by Celgene. HER-2 negative breast cancer patients will be treated with Abraxane and Opdivo, pacreatic cancer patients will be treated with the combination plus gemcitabine and NSCLC patients will be treated with the combination plus carboplatin.
Aug. 19, 2014, 8:31 AM
- The results from a Phase 2 trial evaluating the safety and efficacy of Celgene's (NASDAQ:CELG) Revlimid (lenalidomide) with R-CHOP as a treatment for treatment naive patients with diffuse large b-cell lymphoma (DLBCL) were recently published in the Journal of Clinical Oncology.
- Of the 60 patients eligible for evaluation, the overall response rate was 98% and the complete response rate was 80%. At 24 months, event-free survival (EFS) was 59% and the overall survival (OS) was 78%. EFS was identical to progression-free survival (PFS).
- The DLBCL patients were further classified as germinal B-cell (GCB) or non-GCB. The latter goup is characterized by poorer outcomes.
- The addition of Revlimid to R-CHOP resulted in similar PFS and OS rates between the subtypes which was an encouraging outcome for the non-GCB group.
- R-CHOP is rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone.
Aug. 6, 2014, 11:52 AM
- Health Canada approves Celgene's (CELG +0.6%) Abraxane (albumin-bound paclitaxel) plus gemcitabine for the treatment of patients with metastatic pancreatic cancer.
- The approval is based on the results of a Phase 3 clinical trial that compared Abraxane plus gemcitabine to gemcitabine alone in metastatic pancreatic cancer. The median overall survival (OS) of the Abraxane cohort was 8.5 months compared to 6.7 months for the gemcitabine group. The results were statistically significant.
Aug. 4, 2014, 9:45 AM
- In an interim analysis of results from Amgen's (AMGN +1.6%) Phase 3 clinical trial to expand the label of Kyprolis (carfilzomib), the study achieved its primary endpoint of progression-free survival (PFS). The trial, called ASPIRE, evaluated the safety and efficacy of Kyprolis combined with Celgene's (CELG +1.8%) Revlimid (lenalidomide) and dexamethasone compared to Revlimid and dexamethosone alone to treat patients with relapsed multiple myeloma. The median PFS of the Kyprolis cohort was 26.3 months versus the non-Kyprolis cohort's 17.6 months. The results were statistically significant.
- Possibly dampening the mood is the secondary endpoint of overall survival (OS). While the data is not yet mature, the trend favored Kyprolis, but the results did not achieve statistical significance.
- The company intends to commence its regulatory submissions throughout the world in 1H 2015.
Jul. 24, 2014, 12:30 PM
- Celgene (CELG -3.6%) Q2 results: Total Revenues: $1,872.7M (+17.1%), Net Product Sales: $1,844.6M (+17.9%); COGS: 98.9M (+22.2%); R&D Expense: $456.9M (-0.3%); SG&A Expense: $491.8M (+17.6%); Operating Income: $825.1M (+28.5%); Net Income: $597.8M (+25.0%); EPS: $0.72 (-35.1%); Gross Profit: $1,773.8M (+16.8%); COGS: 5.3% (+4.4%); Gross Margin: 94.7% (-0.2%); Operating Earnings Yield: 44.1% (+9.7%); Net Earnings Yield: 31.9% (+6.8%); Quick Assets: $6,213.0M (+52.2%).
- Sales by product: Revlimid: $1,213.7M (+15.4%); Abraxane: $215.3M (+38.9%); Vidaza: $152.0M (-28.0%); Pomalyst/Imnovid: $160.9M (+143.8%).
- 2014 Guidance: Total revenue: ~$7.6B from ~7.5B; net product sales: >$7.5B from $7.3B - 7.4B; Revlimid sales: ~$4.95B from $4.9B - 5.0B; Abraxame sales: $850M - 900M (unch); operating margin: 36.0% (unch); adjusted diluted EPS: $3.60 - 3.65 from $3.50 - 3.60; GAAP diluted EPS: $2.46 - 2.55 from $2.47 - 2.59.
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