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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. 27, 7:19 AM
Tue, Jan. 26, 5:30 PM
Fri, Jan. 22, 8:23 AM
- Credit Suisse analysts have been very busy lately with a long list of initiations: Acceleron Pharma (NASDAQ:XLRN) Outperform with $50 (47% upside) price target; BioMarin Pharmaceutical (NASDAQ:BMRN) Outperform with $110 (36% upside) price target; Amgen (NASDAQ:AMGN) Outperform with $205 (34% upside) price target.
- Celgene (NASDAQ:CELG) Outperform with $149 (41% upside) price target; Coherus Biosciences (NASDAQ:CHRS) Outperform with $25 (79% upside) price target; Gilead Sciences (NASDAQ:GILD) Outperform with $125 (40% upside) price target.
- Regeneron Pharmaceuticals (NASDAQ:REGN) Neutral with $552 (19% upside) price target; Vertex Pharmaceuticals (NASDAQ:VRTX) Outperform with $151 (59% upside) price target; Alnylam Pharmaceuticals (NASDAQ:ALNY) Outperform with $154 (117% upside) price target.
- Alexion Pharmaceuticals (NASDAQ:ALXN) Neutral rating with $201 (29% upside) price target; Biogen (NASDAQ:BIIB) Neutral with $322 (23% upside) price target; XenoPort (NASDAQ:XNPT) Underperform with $4 (16% downside risk) price target.
- PTC Therapeutics (NASDAQ:PTCT) Outperform with $36 (33% upside) price target; Mesoblast Limited (NASDAQ:MESO) Outperform with $10 (92% upside) price target and Incyte (NASDAQ:INCY) Outperform with $110 (49% upside) price target.
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%)
Sun, Jan. 17, 6:02 PM
- The European Commission approves the first biosimilar referencing Amgen's (NASDAQ:AMGN) Enbrel (etanercept). The product, branded as BENEPALI, was developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB).
- Samsung Bioepis and Biogen established their partnership in 2012 with the aim of developing affordable biologics. Biogen will lead the commercialization and distribution of BENEPALI in the 28 EU member states in addition to Norway, Iceland and Liechtenstein. The product launch will commence in the next few weeks.
- Samsung Bioepis is also partnering with Merck (NYSE:MRK) on developing biosimilars in certain territories under a February 2013 agreement. Their Enbrel biosimilar, branded as BRENZYS (formerly SB4), was cleared in South Korea in September. Merck has global rights to SB4 except in the U.S., EU and Japan.
- Enbrel is Amgen's top seller, generating $5.3B in sales over the most recent four quarters.
- Previously: Merck's Enbrel biosimilar cleared in Korea (Sept. 8, 2015)
Tue, Jan. 12, 7:23 AM
- Ionis Pharmaceuticals (NASDAQ:IONS) earns a $2.15M milestone payment from Biogen (NASDAQ:BIIB) for completing enrollment in its Phase 3 clinical trial, CHERISH, assessing nusinersen in children with spinal muscular atrophy (SMA).
- CHERISH is a randomized, double-blind, sham-procedure-controlled 15-month study in ~117 children between the ages of 2 and 12 who are non-ambulatory with SMA. According to clinicaltrials.gov, the estimated study completion date is July 2017.
- SMA is an inherited disorder affecting ~35K people in the U.S., Europe and Japan. There are no approved treatments for the condition, which is caused by a defect in a gene called survival motor neuron 1 (SMN1). The defect leads to decreased survival of the motor neuron protein which is critical to the health and survival of nerve cells in the spinal cord.
- Fast Track- and Orphan Drug-tagged nusinersen (ISIS-SMNrx) is an antisense drug designed to correct the splicing defect that causes SMA by increasing the production of fully functional SMN protein.
Fri, Jan. 8, 10:15 AM
- Novo Nordisk (NVO -0.4%) submits its Marketing Authorization Application (MAA) to the European Medicines Agency seeking clearance for the use of nonacog beta pegol, a long-acting recombinant factor IX, for the treatment of hemophilia B. Compared to standard factor IX products, nanacog beta pegol has a 5x longer half-life which enables once-weekly administration.
- The company intends to file a BLA with the FDA no later than mid-year.
- Hemophilia B-related tickers: (DMTX -0.1%)(QURE +5.8%)(SGMO +1.2%)(BIIB +0.4%)(BXLT +0.5%)(PFE)
Dec. 22, 2015, 8:39 AM
- Ionis Pharmaceuticals (NASDAQ:IONS) bags a $5M milestone payment from Biogen (NASDAQ:BIIB) related to the validation of an undisclosed target to treat patients with an undisclosed neurological disorder.
- Ionis will continue to evaluate the target with the aim of advancing it into development.
- The company has earned more than $350M from Biogen across four collaborations. The companies have a broad strategic alliance to leverage antisense technology to advance the treatment of neurological and neuromuscular disorders.
Dec. 18, 2015, 12:18 PM
- Biogen (BIIB +0.2%) initiated with Overweight rating and $344 (16% upside) price target by Atlantic Equities.
- CVS Health (CVS -0.1%) initiated with Overweight rating and $110 (16% upside) price target by Barclays.
- Clovis Oncology (CLVS +0.9%) initiated with Buy rating and $50 (48% upside) price target by Janney.
- Relypsa (RLYP +2.6%) initiated with Buy rating and $63 (123% upside) price target by H.C. Wainwright.
- HCA Holdings (HCA -0.2%) initiated with Outperform rating and $75 (16% upside) price target; LifePoint Health (LPNT +0.4%) with an Outperform rating and $79 (13% upside) price target; Tenet Healthcare (THC +1.2%) with a Neutral rating and $33 (18% upside) price target and Universal Health Services (UHS +0.4%) with a Neutral rating and $129 (11% upside) price target by Credit Suisse.
- Amgen (AMGN -0.1%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $193 (20% upside) from $160.
- Valeant Pharmaceuticals (VRX -1.8%) downgraded to Neutral from Buy by Mizuho Securities. Price target raised to $130 (19% upside) from $111.
Dec. 11, 2015, 11:08 AM
- Isis Pharmaceuticals (ISIS -3%) announces that alliance partner Biogen (BIIB -1.1%) has commenced a Phase 1/2 clinical trial evaluating ISIS-SODrx (BIIB067) in patients with amyotrophic lateral sclerosis (ALS).
- ISIS-SOD1rx is a Gen. 2.0+ antisense drug designed to reduce the production of the enzyme superoxide dismutase 1 (SOD1). A mutation in the SOD-1 gene causes an inherited form of ALS, which is the second most common familial form of ALS, accounting for up to 20% of familial cases and 10% of all ALS cases. Sufferers have virtually no effective therapeutic options.
- ISIS-SOD1rx will be administered intrathecally (directly into the cerebrospinal fluid) in the trial. Other antisense drugs administered this way have been well-tolerated in other studies.
Dec. 7, 2015, 4:36 PM
Dec. 2, 2015, 6:49 AM
- PDL BioPharma (NASDAQ:PDLI) reports that it received $133.7M in cash payments in November including:
- $14.0M royalty payment from Biogen (NASDAQ:BIIB).
- $104.9M royalty payment from Roche's (OTCQX:RHHBY) Genentech unit.
- $5.3M royalty payment from Valeant Pharmaceuticals (NYSE:VRX) related to Glumetza.
- $9.5M payment from kaleo subsidiary Accel 300, LLC, for note payments.
- For comparison purposes, PDL's total Q3 revenues were $124.6M, down 24% yoy due primarily to lower Depomed (NASDAQ:DEPO) royalty rights cash proceeds (none received) related to Valeant's commercialization of Glumetza, decreased interest revenues due to the early payoff of the AxoGen and Durata notes receivables and decreased Actemra royalties as a result of the conclusion of the license agreement.
Biogen Inc is a biopharmaceutical company. It is engaged in discovering, developing, manufacturing and delivering therapies to patients for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders.
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