Biogen reports top-line results from the Phase 2 Synergy study evaluating opicinumab missed its primary & secondary endpoints (BIIB) :
In the study, opicinumab missed the primary endpoint, a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. However, evidence of a clinical effect with a complex, unexpected dose-response was observed. Opicinumab also did not meet the secondary efficacy endpoint in Synergy, which evaluated the slowing of disability progression. Safety and pharmacokinetics were also assessed as secondary endpoints. Opicinumab was generally well-tolerated and the safety profile was consistent with what has been observed in prior studies. Opicinumab showed a linear, well-behaved PK profile over the studied dose range. Synergy results will be presented at future medical meetings
I'm bullish LT but sold the stock via a call because of the second gap. The first doens't scare me but the gap just under $300 was all driven by M&A speculation and I think it will eventually fill if no deal is announced. I'll buy once it fills it I get the opportunity
10:01 [BIIB] Early results published in the journal Nature show Aducanumab removes Amyloid Plaques in patients with Alzheimer's Disease Scientists at Neurimmune today described results from the Phase 1b PRIME clinical trial of the monoclonal antibody aducanumab. The report, published in the journal Nature, showed that aducanumab removed amyloid plaques from the brains of patients with early-stage Alzheimer's disease. Importantly, amyloid plaque reductions occurred in both a dose- and time-dependent manner.After one year, in patients receiving aducanumab, the levels of amyloid plaques, visualized using positron emission tomography (PET), were substantially reduced. There was also evidence that aducanumab slowed cognitive decline in these patients. Importantly, if confirmed by future trials, these results provide compelling support for the hypothesis that amyloid build-up is a key factor in driving cognitive decline in Alzheimer's disease. - Source TradeTheNews.com
$BIIB spun out their Hemophilia unit into Bioverativ $BIVV as of Feb 2. Market valuation is about $4b. This company is the partner of SGMO in their beta thalassemia and sickle cell ZFN research
Biogen Inc. We have a collaboration with Biogen Inc. to research, develop, and commercialize therapeutics for hemoglobinopathies, based on our ZFN-mediated genome editing cell therapy platform, specifically targeting rare blood diseases beta thalassemia and sickle cell disease.
Exclusive relationship with Biogen to supply high-quality, complex hemophilia products. Our exclusive manufacturing and supply arrangement with Biogen for hemophilia products, together with manufacturing expertise of our personnel, positions us to offer patients and providers with a consistent supply of complex products for the treatment of hemophilia that meet strict standards of quality at all stages of the manufacturing process and throughout our supply chain. See "Certain Relationships and Related Person Transactions— Agreements with Biogen—Manufacturing and Supply Agreement."
• Financial flexibility to drive future growth. Since the third quarter of 2015, Bioverativ has generated and expects to continue to generate positive cash flows from operations, which we anticipate will allow us to further invest in our marketed products and pipeline, and to pursue strategic opportunities to enhance growth. In addition, we expect to be capitalized by Biogen prior to the distribution with $[ · ] in cash and do not expect to have any indebtedness for borrowed money as of the distribution date.
• Innovative pipeline with multiple approaches to targeting hemophilia and other blood disorders. A key element of our growth strategy is advancing our current products and building and advancing our pipeline. We have multiple research initiatives and programs focused on addressing areas of unmet need in hemophilia and other blood disorders, including (i) research on the use of ELOCTATE to
induce immune tolerance induction in hemophilia A patients who develop inhibitors, (ii) BIVV 073, a next generation recombinant factor protein using XTEN technology, which has the potential to achieve once weekly or less frequent dosing in hemophilia A, (iii) a non-factor bi-specific antibody program to treat patients with hemophilia A and patients with inhibitors, (iv) two gene therapy programs for hemophilia A and B and (v) early-stage programs in sickle cell disease.
Pursue strategic opportunities to enhance our pipeline and product portfolio. We plan to expand our product portfolio through collaborations, licensing opportunities, strategic alliances and tactical acquisitions that meet our strategic business objectives. We also intend to focus on strategic opportunities that enhance our existing research and development platform, product pipeline and commercial effectiveness. One area of particular strategic interest is sickle cell disease, a genetically defined blood disorder affecting an underserved patient population that the Centers
Biogen's multiple sclerosis dominance and innovative neurology pipeline create a wide moat. Biogen’s 3Q Reflects Solid MS Sales, Pipeline Progress; Our Spinraza Peak Estimates Below Consensus by Karen Andersen, 10/24/2017
Investment Thesis 11/16/2017 We think Biogen's specialty-market-focused drug portfolio (multiple sclerosis and cancer) and novel, neurology-focused pipeline create a wide economic moat.
Biogen's strategy has its roots in the 2003 merger of Biogen (MS drug Avonex) and Idec (cancer drug Rituxan). Rituxan's market penetration is already high, and patents in the United States (where Biogen derives its profit share from Roche) expire in 2018. However, we think a subcutaneous Rituxan as well as novel antibody Gazyva will allow for extended oncology revenue. Avonex generates $3 billion in annual sales and remains the leading MS interferon therapy. Biogen acquired full rights to MS antibody Tysabri (almost $2 billion in annual sales) from partner Elan. A diagnostic test can isolate patients with the lowest progressive multifocal leukoencephalopathy risk, which allows the 50% of patients who have not been exposed to the JC virus to benefit from Tysabri's strong efficacy profile with low PML risk. That said, older products like Avonex could see pricing power and demand erode, now that a generic version of Teva's Copaxone has launched and novel high-efficacy drugs are reaching the market.
Based on a strong launch and solid safety and efficacy data, we expect oral MS drug Tecfidera to see peak sales around $4 billion. We think Tecfidera's pricing power and demand will remain relatively steady until patent expiration (a Forward Pharma settlement locks in protection until 2025, and Biogen's patents run through 2028). We also think Biogen could see significant royalties on novel high-efficacy drug Ocrevus (approved in the U.S. in 2017) and multibillion-dollar sales for its in-house remyelinating anti-LINGO drug (which missed phase 2 endpoints, but continues in a more targeted trial).
Outside of MS, Biogen has strong human genetic validation for its neurology pipeline, creating potential to offset MS pressure. Spinal muscular atrophy drug Spinraza is launching and could reach $2 billion in peak sales. Alzheimer's drug aducanumab had strong phase 1 data that could allow for multibillion-dollar potential if approved (estimated 2020).
Economic Moat 11/16/2017 Biogen has achieved strong profitability on the success of three marketed products in the fields of oncology and neuroimmunology, and the introduction of Tecfidera secures the firm's dominant share of the MS market. We think barriers to entry for potential biosimilars to Biogen's products are high, and Biogen has a strong R&D strategy for maintaining its leadership in MS, where pricing power is strong, patient need for novel therapies is high, and the pipeline has been particularly productive. These factors contribute to the firm's wide moat. Returns on invested capital, which we think will average above 20% during our 10-year explicit forecast period, easily exceed our 7.2% estimate of Biogen's cost of capital.
Rituxan remains the standard of care in several forms of hematological cancer, and Biogen's margins are boosted by collaboration revenue received from partner Roche. Biogen's Avonex is the leading interferon therapy in MS, due to its long-term safety record and relatively convenient once-weekly injections. Biogen's third drug, MS drug Tysabri, is achieving blockbuster sales based on outstanding efficacy despite rare but serious side effects, and we think efforts to target the drug to patients least likely to experience side effects will allow the firm to see continued sales despite novel products with cleaner safety profiles. We expect Tecfidera to achieve peak sales around $4 billion globally, based on its convenient oral administration and relatively strong efficacy and safety profile.
With the exception of Tecfidera, all of Biogen's current blockbusters are biologics, and while biosimilar competition is a looming threat, we think any erosion of sales of these products would be slowed by the significant manufacturing and development costs that biosimilar makers are expected to incur, limiting the number of competitors and their ability to compete on price. Data quality may also be an issue with biosimilars; the first application for an Avonex biosimilar was rejected based on insufficient efficacy, and delays and discontinuations with Rituxan biosimilars pushed European launch to 2017. Tysabri is likely to be a lower-priority target for biosimilar entrants, given the risk monitoring and potentially serious side effects in certain patients.
Valuation 11/16/2017 We're raising our Biogen fair value estimate to $349 per share from $338, after boosting our Alzheimer's-related revenue forecast. We added BIIB092 (anti-tau antibody) to our model and slightly raised our assumed probability of approval for BACE inhibitor elenbecestat (from 15% to 25%). We expect Tecfidera to peak around $4 billion, with sales declining in the low-single-digits as the MS market becomes more competitive and patients are spread across more therapies. Beyond Tecfidera, we think combined global sales of Avonex and Plegridy will continue to fall, with high-single-digit declines annually because of new competition. We expect Tysabri to decline from $2 billion in 2016 to $1 billion by the end of our 10-year forecast, as JCV-positive patients switch to other effective therapies like Ocrevus. We include Ocrevus sales hitting $5 billion by 2024 (we assume Biogen sees roughly 15-20% of global sales). We assume a 20% probability of approval for opicinumab and sales above $2 billion by year 10 of our forecast, if approved. For Spinraza (nusinersen), we think sales could peak near $2 billion, but assume sales could plateau beginning in 2021 as new patients could opt for a competing gene therapy. We include $3 billion in probability-weighted Alzheimer's sales to Biogen by 2026. We see GAAP operating margins remaining in the mid-40s, as Ocrevus royalties are countered by potential Alzheimer’s marketing costs and profit sharing with Eisai and Neurimmune, Spinraza profit sharing with partner Ionis, and potential Tecfidera royalty payments to Forward Pharma. Overall, we think Biogen's top-line growth will average 5% through 2021 (which includes an artificial headwind as hemophilia is included in the base year), and share-repurchase activity should enable the firm to achieve average earnings per share growth of 7% during this same period. We still rate the systematic risk surrounding Biogen shares as below average, and we use a 7.5% cost of equity assumption to align our capital cost assumptions with the returns equity investors are likely to demand over the long run.
Risk 11/16/2017 Biogen's profitability depends on four key blockbusters and a high-risk but potentially high-reward pipeline. If physicians and payers fail to support Gazyva use over Rituxan despite strong superiority data in leukemia and a large lymphoma setting, Biogen and Roche could be vulnerable to competition from cheaper, biosimilar Rituxan beginning as early as 2018 in the U.S., and revenue from the Roche collaboration feeds directly to the bottom line and boosts Biogen's margins. While Plegridy is likely to help Biogen maintain its lead in the interferon market, we expect generic Copaxone to weigh on sales of injectable MS therapies. Biogen's MS portfolio has enjoyed tremendous pricing power in the United States, and insurers could begin to find ways to put pressure on future price increases as more competitors reach the market (Avonex and Plegridy were excluded from the CVS national formulary in 2016-17). Tecfidera's U.S. sales are seeing slower growth, partly due to concerns about four recent cases of PML, and other oral drugs (Celgene's ozanimod) are poised to enter the market.
Management 11/16/2017 We award Biogen a Standard stewardship rating. George Scangos took over as CEO in July 2010 from longtime Biogen executive James C. Mullen, after serving as CEO of development-stage biotech Exelixis for 14 years and previously spending 10 years at Bayer. Scangos helped refocus the pipeline on neurodegenerative diseases and neurology-related indications, building a strong team in neurology drug discovery and emphasizing small, tuck-in acquisitions. Significant recent management turnover (chief commercial officer Tony Kingsley and R&D chief Doug Williams both left in 2015, and Scangos departed at the beginning of 2017) and the decision to spin off the firm's hemophilia franchise led to speculation that the firm was for sale. Despite the turnover, chief medical officer Alfred Sandrock and chief scientific officer Spyros Artavanis-Tsakonas have decades of experience to support Biogen's pipeline, and new CEO Michael Vounatsos (previously Biogen's chief commercial officer) had a 20-year career at Merck.
Longtime director William Young stepped down from his role as independent chairman and was replaced by Stelios Papadopoulos (chairman at Exelixis and Regulus) at Biogen's annual meeting in May 2014. Overall, we see the board as well qualified, diverse, and independent, despite the long tenures of several directors. We applaud Biogen's efforts to emphasize restricted stock and options in compensation packages for top executives, which we believe aligns their interests with shareholders'. However, takeover defenses, such as authorized preferred stock, may work against the interests of shareholders. Complex rights agreements between Biogen and partner Roche are also triggered if Biogen is acquired, which could damp the enthusiasm of potential acquirers.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6