Worth noting that BIIB has almost an identical 1 year chart to the IBB index. BIIB currently has a 20 pe (c15) which in my view means it is relatively inexpensive given their pipeline and growth. 2 other companies that have similar charts are GILD and CELG. If someone is interested in broad bio coverage, the IBB is a nice index to own. However, if you are looking for a little less volatility and more upside, I'd argue any of these and particularly GILD are the better plays. I'm long BIIB though sold CELG and GILD when I was interested in reducing my risk profile a few weeks back. Will look to start a new position in both at some point.
BIOGEN IDEC’S PLEGRIDY™(PEGINTERFERON BETA-1A) APPROVED IN THE US FOR THE TREATMENT OF MULTIPLE SCLEROSIS Friday, August 15, 2014 Released after hours − Reduces Relapses, Disability Progression and Brain Lesions with a Favorable Safety Profile − − Only Pegylated Interferon in MS, Dosed Once Every Two Weeks – − Complements Biogen Idec’s Industry-Leading Portfolio of MS Products – CAMBRIDGE, Mass.Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved PLEGRIDYTM (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). PLEGRIDY, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe. “PLEGRIDY offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “PLEGRIDY represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.” The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients. ADVANCE was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety of PLEGRIDY administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received PLEGRIDY for the duration of the study. In the first year of the ADVANCE clinical trial, PLEGRIDY dosed once every two weeks significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007). PLEGRIDY reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38 percent (p=0.0383) compared to placebo. PLEGRIDY also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001) and reduced new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001) compared to placebo. The most common adverse reactions were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain. The ADVANCE two-year safety data were consistent with safety results observed in year one. “PLEGRIDY is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two week dosing schedule administered by an innovative delivery system,” said Peter Wade, M.D., medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, CT. “As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.” PLEGRIDY has been recently approved by the European Commission. “It is always encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever,” said Dr. Timothy Coetzee, chief advocacy, services and research officer at the National MS Society. For more information on PLEGRIDY, prescribing information and financial assistance programs visit PLEGRIDY.com or biogenidec.com. About PLEGRIDY™ PLEGRIDY is a new subcutaneous injectable therapy indicated for relapsing forms of MS, in which interferon beta-1a is pegylated to extend its half-life to permit a less frequent dosing schedule. PLEGRIDY is a member of the interferon class of treatments for MS. Clinical and MRI data from the ADVANCE study of PLEGRIDY demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support its clinical efficacy profile. The safety and tolerability profile of PLEGRIDY observed in ADVANCE was consistent with that of established MS interferon therapies. The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 14 days. Patients should start treatment with 63 micrograms on day one. On day 15, the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29. Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure have been reported with interferon beta. Elevations in hepatic enzymes and hepatic injury have been observed with the use of PLEGRIDY in clinical studies. Depression, suicidal ideation and suicide have been reported in patients receiving interferon beta. Seizures are also associated with the use of interferon beta. Anaphylaxis and other serious allergic reactions are rare complications of treatment with interferon beta. Injection site reactions, including injection site necrosis, can occur with the use of subcutaneous interferon beta. Congestive heart failure, cardiomyopathy and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta. Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta. For complete PLEGRIDY prescribing information, please visit PLEGRIDY.com. About Pegylation Pegylation prolongs the circulation time of the molecule in the body by increasing its size, thus enabling a longer half-life, stabilizing the molecule by improving its solubility and shielding the molecule from enzymes in the body that try to break it down into smaller particles.1 Pegylation is a well-established scientific process that has been used in other therapeutic categories. Biogen Idec Patient Support As part of its ongoing commitment to the MS community, Biogen Idec provides a variety of support services for patients and caregivers through MS ActiveSource®. These world-class services are thoughtfully crafted around the informational, emotional, financial and logistical needs that come with living with MS. MS ActiveSource is available via phone (Monday-Friday 8:30 a.m. – 8:00 p.m. ET) at 1-800-456-2255 or via web at MSActiveSource.com. What is Multiple Sclerosis Multiple sclerosis (MS) is a chronic, often disabling disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves. Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity and specific symptoms of MS are unpredictable and vary from one person to another. 2 MS affects more than 2.3 million people worldwide.3 Best current estimates indicate that there are at least 400,000 people with MS in the United States.4 Relapsing forms of MS include: relapsing-remitting MS (RRMS), the most common form of the disease, which is characterized by clearly defined acute attacks with full recovery or with residual deficit upon recovery and progressive-relapsing MS which is characterized by steadily worsening disease from the beginning with occasional acute attacks like those experienced by people with RRMS.5 About Biogen Idec Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.
Biogen scores fresh MS advance with blockbuster Plegridy OK August 18, 2014 | By John Carroll Fierce Biotech
Biogen Idec CEO Goerge Scangos Billing it as the most important new innovation in the interferon drug class in a decade, Biogen Idec nailed down the FDA's approval of Plegridy, a new multiple sclerosis drug that patients can easily inject themselves with once every two weeks.
Essentially, Plegridy (peginterferon beta-1a) is a new-and-improved version of Avonex, Biogen's once weekly interferon beta therapy for relapsing forms of MS. Researchers added a polymer to the mix that allowed for the easier dosing schedule and Biogen gained a new therapy for its impressive portfolio of MS therapies. A little more than a year ago, Biogen gained an approval for Tecfidera, which is helping establish a new standard of care for many patients with relapsing MS. It also sells Tysabri.
The drug OK marks another improvement in Biogen's competitive position with two other key players on the market. Plegridy--also approved in Europe--should eat into Avonex's market share while also elbowing into the markets for Copaxone from Teva ($TEVA) and Merck KGaA's Rebif. EvaluatePharma pegged 2020 sales at a bit more than $1 billion, marking this as one of the top blockbusters in the industry's late-stage pipeline.
"We forecast Plegridy revenue of $1bn by 2027," Bernstein's Geoffrey Porges forecast in a note today, "but flat sales for the combined Avonex/Plegridy franchise."
Biogen's fresh advance on the MS front came as no great surprise to investors. The company's shares ($BIIB) surged a bit under 1% in after-market trading Friday as news of the approval spread.
The company devised an autoinjector device called the Plegridy Pen to inject the treatment, using a prefilled syringe.
In the 1,500-patient "Advance" study, Biogen showed that peginterferon beta-1a reduced annualized relapse rates at one year by 35.6% in patients getting injections every two weeks and by 27.5% in those on four-week dosing compared with placebo. And coming up behind this drug is a key catalyst for another MS drug that may help spur remyelination, actually repairing some of the damage done by the disease.
"Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments," said Biogen CEO George Scangos in a statement. "Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them."
Morningstar Analyst Update Fair Value Estimate $426 Biogen's MS market dominance and rich pipeline support its wide moat. by Karen Andersen Strategist
Analyst Note 04/24/2015 We're maintaining our Biogen fair value estimate of $426 per share despite weak Tecfidera sales in the first quarter. While we may reduce our $4.2 billion estimate for full-year Tecfidera sales, we don't expect this to have a significant impact on our valuation, and we already assume Tecfidera begins to see slight declines in 2019 in our base-case scenario as a result of novel competition and Tecfidera's relatively weak dosing and formulation patents in the United States. Biogen's total revenue grew 20% year over year to $2.6 billion, but this was a 3% decline from the fourth quarter, as Tecfidera sales fell from $916 million in the fourth quarter to $825 million in the first quarter. Several factors appear to be pressuring Tecfidera sales, including slower multiple sclerosis market growth, Biogen's launch of Plegridy, the PML case reported last October, and a steeper discount in Germany.
Biogen remains the dominant player in the MS market with multiple marketed products, and its pipeline is evolving rapidly, lending support to its wide moat regardless of Tecfidera's moderating growth. Alzheimer's therapy aducanumab (BIIB037) is poised to enter two Phase III trials this year, after showing statistically significant cognition benefits to patients at certain doses in Phase I. While brain swelling side effects at higher doses are concerning, we're encouraged by efficacy signals at lower doses, and we continue to assign a 50% probability of approval and see potential for $5 billion in sales by 2024. Data for the potentially key 6 mg/kg dose will be presented at the AAIC meeting in July. Data for the anti-LINGO program in MS (which we still assign a 30% probability of approval and potential sales of $10 billion by 2024, the highest in the pipeline) is still due in 2016, but there are clear value drivers (including Tysabri data in progressive MS and stroke and Neublastin data in neuropathic pain) that could drive our fair value estimate up later this year.
$BIIB followed $GILD lead with new bond issue. Both are under valued bio's that are now setting up to be more aggressively buying back stock
Biogen Prices $6.0 Billion of Senior Unsecured Notes Business Wire Biogen
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Biogen (BIIB) announced today the pricing of four series of senior unsecured notes for an aggregate principal amount of $6.0 billion. The notes will mature as follows:
$1.50 billion will mature on September 15, 2020 and will bear interest at an annual rate of 2.900% $1.00 billion will mature on September 15, 2022 and will bear interest at an annual rate of 3.625% $1.75 billion will mature on September 15, 2025 and will bear interest at an annual rate of 4.050% $1.75 billion will mature on September 15, 2045 and will bear interest at an annual rate of 5.200% The offering is expected to close on September 15, 2015, subject to customary closing conditions.
Biogen intends to use the net proceeds from this offering, together with cash on hand, to fund share repurchases of its common stock under the company’s previously authorized $5.0 billion share repurchase program, for working capital and other general corporate purposes.
Goldman, Sachs & Co. and Merrill Lynch, Pierce, Fenner & Smith Incorporated are acting as joint book-running managers and representatives of the several underwriters. A copy of the preliminary prospectus supplement and the accompanying base prospectus, which is filed as part of Biogen’s effective shelf registration statement on Form S-3 filed on September 8, 2015 (File No. 333-206799), may be obtained from either of the representatives by calling Goldman, Sachs & Co. toll-free at 1 (866) 471-2526 or Merrill Lynch, Pierce, Fenner & Smith Incorporated toll-free at 1 (800) 294-1322.
An electronic copy of the prospectus supplement and the accompanying base prospectus may also be obtained at no charge at the Securities and Exchange
Biogen Inc. (BIIB) (NASDAQ (NBI): BIIB) today reported full year and fourth quarter 2015 results, including full year revenues of $10.8 billion, an 11% increase versus 2014. Full year 2015 Non-GAAP diluted earnings per share (EPS) were $17.01, an increase of 23% versus 2014. Non-GAAP net income attributable to Biogen Inc. for the year was $3.9 billion, an increase of 20% versus the prior year.
On a reported basis, GAAP diluted EPS for 2015 were $15.34, an increase of 24% versus 2014. GAAP net income attributable to Biogen Inc. for 2015 was $3.5 billion, an increase of 21% versus 2014. (A reconciliation of GAAP to Non-GAAP full year and quarterly financial results can be found in Table 3 at the end of this release).
Biogen also announced its full year 2016 financial guidance. This guidance consists of the following components:
Revenue is expected to be approximately $11.1 to $11.3 billion.
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