Receptos Continues To Reward
Stephen Simpson, CFA
Stephen Simpson, CFA
Multiple Observations On Celgene's Latest Licensing Deals, And Its Valuation
DoctoRx • 75 Comments
DoctoRx • 75 Comments
Celgene: A Pre-Earnings Discussion Based On Recent News
DoctoRx • 39 Comments
DoctoRx • 39 Comments
Oct. 27, 2014, 6:25 PM
- Receptos' (RCPT +35%) lead product candidate, RPC1063, achieved its primary endpoint in a 199-patient Phase 2 clinical trial evaluating its safety and efficacy for the treatment of ulcerative colitis at a dose of 1 mg. The primary endpoint was the proportion of patients in clinical remission at week 8 as defined by Mayo scoring criteria. For the 1 mg dose, 16.4% of patients achieved the endpoint compared to 6.2% for placebo (p<0.05). The low dose group, 0.5 mg, failed to demonstrate statistical significance versus placebo.
- The company intends to move forward into Phase 3 development for this indication.
- Shares are up 29% AH on robust volume.
Oct. 27, 2014, 5:40 PM
Oct. 23, 2014, 4:12 PM
- Celgene (CELG +5.9%) likes its partnership with privately-held Sutro Biopharma so much that is has inked another deal with the antibody-based therapeutics developer. Under the terms of the agreement, Sutro receives a upfront payment of $95M that includes an equity stake, $90M during the research phase and potentially more than $1B, including milestones.
- Celgene also has an option to buy Sutro under undisclosed terms.
- The partners will work on PD-1 and PD-L1 inhibitors, the most promising cancer immunotherapy area. Sutro's value proposition is a better way to build antibody-drug conjugates that are more selective in their binding targets. Its technology enables a simpler method of making biologics, more akin to small molecule drugs.
Oct. 23, 2014, 8:24 AM
- Celgene (NASDAQ:CELG) Q3 results ($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
- Celgene (NASDAQ:CELG): Q3 EPS of $0.97 beats by $0.02.
- Revenue of $1.98B (+18.6% Y/Y) beats by $20M.
- Shares -0.34% PM.
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. 22, 2014, 11:31 AM
- The European Commission approves privately-held Switzerland-based Ferring Pharmaceuticals' Cortiment (budesonide) for the induction of remission in patients with active mild-to-moderate ulcerative colitis. Budesonide is a locally acting glucocorticosteroid.
- Ferring licensed Cortiment from Cosmo Pharmaceuticals SpA for the EU, Asia (ex-Japan), Australia, Canada, Latin America and Africa. The product is sold under the brand name Uceris in the U.S. by Salix Pharmaceuticals (SLXP -0.2%).
- UC-related tickers: (NASDAQ:VBLX) (RCPT)(OTCPK:TKPHF)(OTCPK:TKPYY +0.2%)(ATHX +2.3%)(SHPG +1.3%)(PFE +0.7%)(ABT -0.4%)(ABBV +1.2%)(CNDO +1.1%)(JNJ +1%)(SGYP -3.2%)
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. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Oct. 1, 2014, 9:27 AM
- Celgene (NASDAQ:CELG) will report Q3 results on October 23 before the open. The conference call and webcast will begin at 9:00 am ET.
- Consensus view is EPS of $0.95 on revenues of $1.96B.
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 AM
- 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%).
Sep. 10, 2014, 12:47 PM
Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling... More
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