Oct. 22, 2014, 9:44 AM
- Biogen Idec (BIIB -10.6%) is under selling pressure after this morning's earnings call. Some observers perceive that Tecfidera sales came in a bit light despite its 98% yoy growth. The company also disclosed the death of one patient who had taken the drug for four years. The death was apparently due to pneumonia and not due to the drug.
Oct. 22, 2014, 9:19 AM| 1 Comment
Oct. 22, 2014, 7:55 AM
- Biogen Idec (NASDAQ:BIIB) Q3 results ($M): Total Revenues: 2,511.4 (+37.4%); Net Product Revenues: 2,117.4 (+45.7%); Joint Business: 290.7 (-4.1%); Royalty: 67.1 (+24.0%); Corporate Partner: 36.3 (+114.9%); COGS: 302.6 (+28.9%); R&D Expense: 417.2 (+1.7%); SG&A Expense: 570.4 (+40.6%); Net Income: 856.9 (+75.7%); EPS: 3.62 (+76.6%); Quick Assets: 1,861.3 (+178.4%).
- Gross Profit: 2,208.8 (+38.6%); COGS: 12.1% (-6.2%); Gross Margin: 87.9% (+0.9%); Operating Profit: 1,221.2 (+57.1%); Operating Earnings Yield: 48.6% (+14.3%); Net Earnings Yield: 34.1% (+27.9%).
- Product Sales: Tecfidera: 787.1 (+98.0%); Avonex: 741.8 (+1.1%); Tysabri: 501.2 (+25.0%); Alprolix: 25.3; Eloctate: 21.6; Fampyra: 20.4 (+22.1%).
- 2014 Guidance: Revenue growth: 38 - 41% (unch); R&D Expense: 20 - 21% of sales (unch); SG&A Expense: 22 - 23% of sales (unch); CAPEX: ~$300M (unch); GAAP EPS: $12.00 - 12.10 from $11.26 - 11.46; non-GAAP EPS: $13.45 - 13.55 from $12.90 - 13.10.
- Shares off 3% premarket on light volume.
Oct. 22, 2014, 7:06 AM
Oct. 21, 2014, 5:30 PM
Oct. 20, 2014, 10:57 AM
- Cytokinetics (CYTK +5.5%) reports that its lead drug candidate, tirasemtiv, demonstrated clinically meaningful improvements in Slow Vital Capacity (SVC) versus placebo in ALS patients in a Phase 2b study. SVC is a measure of skeletal muscle strength for breathing and is an important predictor of ALS disease progression and survival.
- The company has begun discussions with the FDA on a Phase 3 trial which would begin in 2015.
- ALS-related tickers: (CUR -6.9%)(BCLI -2.6%)(MNOV -13.7%)(BIIB +1%)
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Oct. 14, 2014, 3:31 PM
- Global growth, foreign-exchange, oil, and small caps are the subject of every client inquiry, says David Kostin. His team's recommendation: Buy "American exceptionalism."
- In Kostin's view, U.S. economy and corporate fundamentals are still strong, with economic growth expected by Goldman economists to be 3.2% next year, the fastest expansion since 2005. Europe is expected to grow just 1%.
- What his team likes are those stocks of companies which have a high proportion of domestic sales, plus sectors like Consumer Staples (XLP -0.1%) and Discretionary (XLY +0.7%) which stand to benefit from lower oil prices (plunging again today).
- As for small caps (IWM +0.9%), Kostin is wary, noting downward earnings revisions have boosted small cap P/E ratios even as prices have declined.
- The list of S&P 500 names capturing two or more of Kostin's themes: GT, GM, PCLN, AMZN, CMCSA, LOW, DG, TSN, ADM, CVS, AVP, WAG, PXD, HAL, JPM, BAC, SCHW, PNC, MS, C, GNW, LNC, MET, THC, AET, UNH, ESRX, HUM, WLP, BIIB, GILD, DAL, CMI, FLR, CRM, JBL, MA, FB, MU, FSLR, VMC, MON, T.
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)
Sep. 26, 2014, 10:06 AM
Sep. 12, 2014, 9:00 AM
- In a 1,800-patient Phase 3 clinical trial comparing Zinbryta (daclizumab) to Avonex (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (RRMS), Zinbryta demonstrated a statistically significant improvement in reducing disease activity by virtue of a 45% reduction in annualized relapse rate (p=0.0001).
- Select secondary endpoints: the Zinbryta group demonstrated superiority in reducing the number of new or newly enlarging T2-hyperintense lesions at week 96 (54% reduction compared to Avonex), 73% were relapse-free at week 96 vs. 59% for Avonex and the risk of meaningful worsening in the physical impact of MS was reduced 24% compared to the Avonex cohort.
- Development partners Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV) plan to submit regulatory applications for Zinbryta in 1H 2015.
Aug. 21, 2014, 4:31 PM
- In a regulatory filing, Isis Pharmaceuticals (ISIS -3.1%) discloses that it earned an $18M milestone payment from development partner Biogen Idec (BIIB -1.1%) by virtue of dosing the first infant in the ENDEAR Phase 3 clinical trial evaluating ISIS-SMNrx as a treatment for spinal muscular dystrophy.
Aug. 16, 2014, 9:41 PM
- The FDA approves Biogen Idec's (NASDAQ:BIIB) Plegridy (peginterferon beta-1a) for the treatment of patients with relapsing forms of multiple sclerosis (MS). It is the only pegylated beta interferon approved for this indication. The dosing regimen is once per two weeks subcutaneously.
- The European Commission approved Plegridy for relapsing-remitting MS in late July 2014.
Aug. 1, 2014, 8:32 AM
- Isis Pharmaceuticals (NASDAQ:ISIS) plans to dose the first patient in the next few weeks in a Phase 3 clinical trial evaluating the safety and efficacy of ISIS-SMNrx in infants with spinal muscular atrophy (SMA). This event will trigger an $18M milestone payment from development partner Biogen (NASDAQ:BIIB).
- The primary endpoint of the 110-infant study is survival or permanent ventilation.
Jul. 25, 2014, 10:27 AM
- The EMA's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion recommending approval for Gilead Sciences' (GILD -0.8%) Zydelig (idelalisib 150 mg film-coated tablets) as a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL).
- CHMP's opinion supports the use of Zydelig in combination with Rituxan (rituximab) (BIIB -0.2%) for the treatment of CLL patients who have received at least one prior therapy or as a first-line treatment in CLL patients with the 17p deletion or TP53 mutation who are unsuitable for chemotherapy. The Committee also supports the use of Zydelig as a monotherapy for the treatment of FL in patients refractory to two prior lines of treatment.
- A final decision from the European Commission typically takes ~3 months.
Jul. 23, 2014, 12:22 PM
- The U.S. regulator grants traditional approval for Gilead Sciences' (GILD +0.4%) Zydelig (idelalisib) as a treatment for chronic lymphocytic leukemia (CLL) that has relapsed. Zydelig is to used with Rituxan (rituximab) (OTCQX:RHHBY +0.3%) (BIIB +11.6%) in cases where Rituxan alone is appropriate therapy. In a Phase 3 clinical trial, patients treated with Zydelig + Rituxan demonstrated mean progression-free survival of 10.7 months compared to 5.5 months for the Rituxan + placebo cohort.
- The agency grants accelerated approval (BTD designation) for Zydelig as a treatment for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). It is to be used to treat patients who have received at least two prior systemic therapies.
BIIB vs. ETF Alternatives
Biogen Idec Inc, is a biotechnology company that discovers, develops, manufactures and markets therapies for the treatment of multiple sclerosis (MS) and other autoimmune disorders, neurodegenerative diseases and hemophilia.
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