Biogen Idec Has BG-12, But What Excites Investors Next?
Stephen Simpson, CFA
Stephen Simpson, CFA
Thu, Jul. 21, 9:15 AM
Thu, Jul. 21, 7:44 AM
- Biogen (NASDAQ:BIIB) Q2 results ($M): Total Revenues: 2,894.2 (+11.7%); Net Product Sales: 2,466.0 (+12.2%).
- Net Income: 1,049.8 (+13.2%); Non-GAAP Net Income: 1,142.4 (+14.8%); EPS: 4.79 (+21.9%); Non-GAAP EPS: 5.21 (+23.5%).
- Key Product Sales: Tecfidera: 986.5 (+5.2%); Interferon: 728.3 (+18.4%); Tysabri: 497.4 (+7.4%); Eloctate: 124.7 (+67.8%); Alprolix: 80.3 (+47.3%).
- 2016 Guidance: Revenue: $11.2B - 11.4B; EPS: $18.10-18.40; Non-GAAP EPS: $19.70-20.00.
- Note: CEO George Scangos, Ph.D., will step down after a successor is named.
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Wed, Jun. 15, 5:32 PM
Tue, Jun. 14, 7:54 AM
- Micro cap Infinity Pharmaceuticals (NASDAQ:INFI) is down 67% premarket on increased volume in response to its announcement that will close down its discovery research organization and lay off 46 employees (21% of its workforce) prompted by less-than-expected results in a mid-stage study assessing lead product candidate duvelisib for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL), a slow-growing blood cancer. In addition, the company and development partner AbbVie (NYSE:ABBV) have agreed to pause AbbVie's Phase 1b/2 trial evaluating the combination of duvelisib and venetoclax while Infinity evaluates its options with duvelisib.
- The Phase 2 clinical trial, DYNAMO, assessed duvelisib as monotherapy in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (n=28) or marginal zone lymphoma (n=18) whose disease progressed or did not respond to treatment with Biogen's (NASDAQ:BIIB) Rituxan (rituximab) and either chemotherapy or radiotherapy. The primary endpoint was overall response rate (ORR).
- Results showed an ORR of 46%, all partial responders and below expectations. The ORR in the three lymphoma types listed above were 41%, 68% and 33%, respectively. The data will be submitted to presentation at a future medical conference.
- The most common serious adverse events (Grade 3 or higher) were neutropenia (low neutrophils) (28%), diarrhea (15%), thrombocytopenia (low blood platelets) (13%) and anemia (12%). 20% of participants experienced an infection of least Grade 3 (serious).
- CEO Adelene Perkins says, "While DYNAMO met its primary endpoint, we hoped that treatment with duvelisib as monotherapy would have provided a larger clinical benefit....We plan to seek feedback from the FDA to determine our next steps with respect to duvelisib in iNHL."
- Duvelisib is an investigational inhibitor of Class 1 phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma being jointly developed by Infinity and AbbVie. The PI3K pathway plays a key role in regulating the growth and survival of certain blood cancers. Inhibiting PI3K-delta and PI3K-gamma signaling blocks the growth and survival of tumor cells.
- Infinity will release updated guidance after all these activities have been completed. Management will host a conference call at 8:30 am to discuss the situation.
Tue, Jun. 7, 12:50 PM
Tue, Jun. 7, 11:00 AM
Tue, Jun. 7, 9:13 AM
Tue, Jun. 7, 8:45 AM
- Biogen (NASDAQ:BIIB) slumps 9% premarket on increased volume in response to its announcement that its Phase 2 clinical trial, SYNERGY, evaluating opicinumab in patients with relapsing forms of multiple sclerosis (MS) failed to achieve its primary endpoint demonstrating an improvement in physical function and its secondary endpoint of slowing disability progression.
- SYNERGY was a randomized, double-blind, placebo-controlled study that assessed opicinumab in 418 participants with relapsing forms of MS (relapsing/remitting and secondary progressive) over 72 weeks. The primary endpoint was a composite measure of patients who experienced three-month improvement in ambulation, upper extremity function, cognition and standard measures of physical disability. Opicinumab was administered intravenously every four weeks at five different doses. All participants also received 30 mcg of interferon beta-1a once a week via intramuscular injection.
- The company continues to analyze the data to inform the design of its next trial.
Mon, May 16, 10:01 AM
- Biogen (BIIB +0.5%) enters into a license agreement with REGENXBIO (RGNX +2.3%) for exclusive global rights to the latter's NAV AAV9 and AAV9 vectors for the treatment of two rare genetic vision disorders.
- Under the terms of the deal, the research license will convert to a commercial license upon the selection of a single vector for each indication. REGENXBIO will receive an undisclosed upfront payment, ongoing fees, milestones and royalties on net sales.
- REGENXBIO's NAV Technology platform is an AAV (adeno-associated vector) gene delivery platform consisting of exclusive rights to over 100 novel AAV vectors.
- The licenses are related to Biogen's funding collaboration with gene therapy researchers at the University of Pennsylvania.
- Previously: Biogen may invest up to $2B to fund gene therapy research at U Penn (May 16)
Thu, May 5, 5:35 PM
Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Wed, Jan. 27, 9:22 AM
Wed, Jan. 27, 8:05 AM
- Biogen (NASDAQ:BIIB) Q4 results ($M): Total Revenues: 2,839.3 (+7.5%); Net Product Sales: 2,425.9 (+6.1%).
- Net Income: 831.6 (-5.9%); Non-GAAP Net Income: 994.7 (+3.0%); EPS: 3.77 (+0.8%); Non-GAAP EPS: 4.50 (+10.0%).
- Net Income growth has decelerated over the past four quarters: 93.2%, 71.4%, 29.8%, 12.7%, -5.9% as has EPS growth: 94.8%, 72.8%, 30.6%, 14.6%, 0.8%.
- Key Product Sales: Tecfidera: 992.8 (+20.4%); Avonex: 637.2 (-13.4%); Tysabri: 480.7 (-0.7%); Plegridy: 102.5 (+149.4%); Eloctate: 101.2 (+175.0%); Alprolix: 71.3 (+76.9%).
- 2016 Guidance: Revenues: $11.1B - 11.3B; EPS: $16.85 - 17.15; Non-GAAP EPS: $18.30 - 18.60.
Wed, Jan. 20, 1:47 PM
Wed, Jan. 20, 11:36 AM
- To point out the obvious, the biotech sector has been unable to fight off the widespread selling. The iShares Nasdaq Biotech Index Fund (IBB -1.8%) is down again, albeit on modestly higher volume. It's down over 21% since late December.
- Representative tickers: (GILD -1.7%)(CELG +0.7%)(BIIB -2.7%)(AMGN -0.6%)(ALXN -2.8%)
Biogen, Inc. is a global biotechnology company, which develops markets and manufactures therapies for people living with neurological, autoimmune and hematologic disorders. Its products include AVONEX, PLEGRIDY, TECFIDERA, TYSABRI, and FAMPYRA for multiple sclerosis, ALPROLIX for hemophilia B... More
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