blackcat
12 years ago
DUBLIN--(BUSINESS WIRE)--Mar. 8, 2013-- Elan Corporation, plc (NYSE:ELN) (the Company) today provides an update on the Tysabri Restructuring Transaction (“the Tysabri Transaction”) announced on February 6, 2013 and further information regarding the Company’s recently announced proposed $1billion share repurchase program.
Tysabri Transaction Update
The regulatory closing conditions in connection with the Tysabri Transaction are the review process under the Hart-Scott-Rodino Antitrust Improvements Act (“HSR”) in the United States and the review by the Spanish Competition Authority in Europe.
The waiting period for the US antitrust review under HSR expires today, Friday March 8, 2013. This follows the clearance earlier this week of the Tysabri Transaction by the Spanish Competition Authority. Consequently, in accordance with the terms of the Tysabri Transaction agreement with Biogen Idec, closing is expected to occur in the coming weeks.
$1billion Share Repurchase Program
Elan is also providing details of its proposed $1.0 billion share repurchase program (“Share Repurchase”) to be implemented following the close of the Tysabri Transaction.
The Share Repurchase is in addition to the unique Tysabri linked cash dividend announced on March 4, 2013, and will be effected through a tender offer, to be commenced on Monday next, March 11, 2013, by way of a “Dutch Auction”. The price range will be $11.25 to $13.00. In the event that the Share Repurchase is over-subscribed, the Company will purchase less than all shares tendered at or below the purchase price on a pro rata basis. Both American Depositary Shareholders and Ordinary shareholders will be able to participate in the Share Repurchase.
The Share Repurchase will be conducted in accordance with all applicable Irish and US laws and regulations. The relevant documentation, setting out full details of the Share Repurchase and convening the requisite shareholder meeting for April 12, 2013, will be circulated to shareholders shortly in accordance with applicable law.
About “Dutch Auction” Tender Offers
A “Dutch Auction” tender offer operates like an auction: a company offers to repurchase its shares within a price range up to a specified aggregate repurchase amount. Shareholders are invited to tender shares over the period during which the tender offer remains open and do so by specifying the lowest price within the range that they will accept.
A company collects investor offers, and purchases the tendered shares at the lowest price possible that will enable it to purchase up to the aggregrate repurchase amount. All shares purchased in the tender offer will be purchased at the same price, even if the shareholder tendered at a lower price. If the company receives more offers at or below the accepted price than the aggregrate repurchase amount, all shareholders who tendered at or below the accepted price will receive a pro rata allocation.
blackcat
12 years ago
DUBLIN--(BUSINESS WIRE)--Mar. 4, 2013-- The Board of Elan Corporation, plc (NYSE:ELN) (the Company) has approved the decision to initiate a unique cash dividend policy enabling its shareholders to benefit directly from the long term cash flow generated by Tysabri.
The dividend program will be directly linked to Tysabri market performance calculated as a percentage of the Tysabri royalty paid to Elan from Biogen Idec as a result of the recently announced Tysabri restructuring. The initial percentage to be paid out directly to shareholders is 20 % of those royalties.
There is no cap to the dividend cash payments that will be generated from this direct link between shareholders' equity and the long term cash flow of Tysabri. This dividend structure gives shareholders the right to enjoy unlimited participation in the upside from the Tysabri sales increase which we anticipate for the future.
The Company expects to pay these cash dividends to its shareholders in twice-yearly instalments. The first dividend is expected to be paid in the fourth quarter of 2013, subject to the closing of the recently announced Tysabri restructuring. Payment of the dividends will be made in accordance with applicable law, including, where applicable, shareholder approval.
According to the restructured Tysabri collaboration, Elan will receive 12% royalties on in-market sales of Tysabri in the first year from closing and thereafter 18% royalties on in-market sales up to $2.0 billion, and 25% royalties on sales exceeding $2.0 billion. In 2012 in-market sales of Tysabri were $1.6 billion.
Kelly Martin, the CEO of Elan, stated “As announced on February 6, the restructuring of the Tysabri collaboration with Biogen Idec enables us, upon close, to unlock value to the direct benefit of our public shareholders. These value creation initiatives consist of three related but distinctive components: a $ 1 billion dollar share repurchase program, a highly efficient cash dividend that directly links shareholders to the long term performance and cash flow generation of Tysabri and lastly, the addition of specific business assets which will allow for diversification across molecules, therapeutic areas and geographies.”
Mr Martin commented further, “This provides Elan and our shareholders significant near and longer term benefits. We continue to make tangible progress on a variety of corporate development discussions and other strategic developments and anticipate providing further clarity to the marketplace in the coming days and weeks.”
The Directors of Elan accept responsibility for the information contained in this announcement. To the best of their knowledge and belief (having taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.
Any holder of 1% or more of any class of relevant securities of Elan or of Royalty Pharma may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2007 (as amended).
blackcat
12 years ago
ELN Response
DUBLIN--(BUSINESS WIRE)--
The Board of Elan Corporation, plc (ELN/WI:...) (the Company) acknowledges this morning's announcement by Royalty Management, LLC (Royalty Pharma) regarding an indicative, conditional, proposal which may or may not lead to an offer being made for the entire issued share capital of the Company.
As previously announced, in anticipation of executing and closing the recently announced Tysabri transaction, the Company's Board of Directors, Executive Management and advisors have been working for over a year on a number of strategic transactions that, should they be consummated, would be to the benefit of our public shareholders. Returning capital through share repurchase, diversifying business and asset risk/reward through non-traditional business structures while simultaneously capturing the long term high margin royalty income from Tysabri will offer a compelling investment thesis for our current shareholders.
The Company notes the highly opportunistic timing of the announcement by Royalty Pharma - a privately held investment management company - before the Company’s shareholders have had the opportunity to assess and realize the full benefit of the Tysabri transaction and the partial unlocking of its value. We expect the Tysabri transaction to close in the near future.
The Company also notes the heavily conditional nature of this indication of interest. Any credible proposal which may be made by Royalty Pharma or any other party will of course be considered by the Company alongside the strategic transactions and unique investment thesis referred to above.
Further announcements will be made if and when appropriate.
The Directors of Elan accept responsibility for the information contained in this announcement. To the best of their knowledge and belief (having taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.
Any holder of 1% or more of any class of relevant securities of Elan or of Royalty Pharma may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2007 (as amended).
About Elan
Elan is a biotechnology company, headquartered in Ireland, committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. For additional information about Elan, please visit http://www.elan.com.
Forward Looking Statements
Source: Elan Corporation PLC (ELN/WI:...)
blackcat
12 years ago
Elan PR 8-13; Elan Announces Plan to Spin-Off Discovery Science And Neotope Biosciences to Shareholders
Creates two independent, unique companies
Transaction aligns assets, timelines, and risk/reward
Elan to become immediately profitable and a high growth company
Targeting $1.00 earnings per share by 2015 with new business construct
Commitment to science by providing initial capital to Neotope Biosciences plc
Completion of transaction expected by year end 2012
DUBLIN--(BUSINESS WIRE)--Aug. 13, 2012-- Elan Corporation, plc (NYSE:ELN) announced today that its Board of Directors has approved the spin-off of the discovery science and Neotope Biosciences from the company. Completion of this transaction will create two independent, highly focused, public companies that will enable investors to align timelines, risk and returns in order to best achieve their investment objectives. The two companies will be:
Elan Corporation plc
A focused business that will generate growth; immediate and long term profits; and expanding margins. Additionally, this profitable business will be able to utilize our advantageous tax structure and create incremental after-tax earnings to the direct benefit of shareholders.
Initially consisting of three main assets: Tysabri (marketed in collaboration with Biogen Idec) for Multiple Sclerosis (MS) and other potential indications; ELND005 a small molecule asset that is Phase 2/Phase 2b ready in a range of neuropsychiatry and symptomatic diseases that targets non-amyloid pathologies; and lastly, the continued interest in Janssen AI which with Pfizer manages the on-going AIP portfolio including Phase 2 Bapineuzumab (subQ); Phase 2 vaccine (ACC-001) and Phase 1 AAB-003 (mab).
Neotope Biosciences plc
Drug discovery business platform, originally established in 2010, focused primarily on identifying and translating targets into potential therapies for chronic degenerative and other related disease areas. This entity will continue to focus on innovation, differentiated scientific advancement, unique intellectual property creation and translational capability to transform science into clinical assets.
Transaction Conditions and Timeline
Completion of the spin-off is subject to conditions, including approval by our shareholders and by holders of our 2016 Notes, which the Company will be seeking as soon as is practical. Additional details of the proposed spin-off, including proportionate shareholding and separate financial information relating to both Elan and to Neotope Biosciences will be provided to shareholders. If the transaction is effected, we expect there to be a separate listing of Neotope Biosciences on a U.S. exchange, by the end of 2012. Elan will incur a charge upon completion of the transaction.
Leadership Comments
“This is a bold and logical strategic step as it provides shareholders with the ability to delineate risk, timelines and business characteristics to their own specific investment objectives. As we have done over the past decade and will continue to do in the future, the strengthening of the balance sheet, capital structure, income statement and progression of the science for the benefit of patients, has been a constant goal and objective of the management team and supported by the board of directors,” said Robert A. Ingram, Chairman of Elan and Kelly Martin, CEO. Messrs. Ingram and Martin added that, “All of our previous actions, including most notably the separation of the Elan Drug Technologies business and its merger with Alkermes plc as well as the establishment of Janssen AI with Johnson & Johnson in a sharing of the risk/reward around the AIP asset, have been designed to improve the risk/return profile of the company, cluster businesses and assets logically for shareholders.”
Mr. Martin commented further, “By establishing Neotope Biosciences and Elan as distinct businesses – each with its own specific business characteristics and dynamics - we provide investors with important clarity, transparency and choice as it relates to their investment decisions.”
Mr. Martin added, “For Elan Corporation, plc, the completion of this transaction is a natural progression and final step to becoming a company that generates both profits and growth to the benefit of stakeholders. The dominant focus will be broadening and deepening patient access to TYSABRI on a global basis and registering ELND005 for multiple indications in neuropsychiatry and other symptomatic indications. This move to immediate profitability will enable us to utilise the benefit of the significant accumulated losses that have been built up over the years. We intend to explore ways to share this benefit with our stakeholders through some combination of debt repurchases, share buy backs, dividends or all three. Further communication on this topic will be forthcoming in the months ahead and upon completion of the transaction.”
“With Elan’s commitment to capitalize Neotope’s Bioscience, our highly talented scientific team who have previously discovered TYSABRI and an approach to immunotherapy for Alzheimer’s, will have the resources and time to advance programs for chronic degenerative diseases, such as synuclein for Parkinson’s disease, along the drug development stages and provide opportunities for investors to participate in this journey”, said Dr. Lars Ekman, Chairman designate of Neotope Biosciences. Dr. Ekman continued, “In the longer term, the team’s heightened focus and dedication to translating unique scientific insight into clinical programs will provide benefits to the field of life sciences across a broad array of diseases for the ultimate benefit of patients. With this transaction, their successes and insights are expected to provide enormous benefit to the world.”
Messrs. Ingram and Martin concluded, “Our board and management team have spent the previous twelve months assessing the optimal alignment of assets, risk/reward and income statement dynamics to the marketplace and our shareholders. These discussions took place well in advance of the recent release of the top line outcomes of the Bapinezumab Phase 3 trials. The transparent alignment of distinctive timelines and unique business characteristics to enable shareholder investment decisions and choice was our guiding principle and remained a constant which ultimately resulted in today’s announcement.”
Highlights of Previous Decade
The previous decade for Elan has been characterized as one of consistent focus and execution on delivering improvements in all aspects of its business fundamentals. Highlights of this journey include:
Expected 2012 revenues of $1.2 – 1.25 billion; growth of 150% since 2004
Operating Expenses have decreased by more than 50% since 2002
Adjusted EBITDA of positive $147 million in 2011, versus negative $203 million in 2004
Debt and Contractual obligations reduced by 76% since 2002
Corporate tax rate of 12.5% with the benefit of accumulated losses and structures in excess of $4 billion
Launched Tysabri (twice) – for MS with potential for additional indications
Reduced AD clinical risk with J&J – maintained programs while retaining 25% of P&L
Successful divestment of EDT, generating $1 billion of non-dilutive capital for Elan plc
Advanced ELN005 through Phase 2 with potential therapeutic symptomatic applications
Advancement of pre-clinical novel targets programs: synuclein, MCAM, tau, amyloid
Strategic Rationale
Today, Elan Corporation, plc is comprised of two distinct investment propositions with differing science-business risks and timeframes:
Commercial and growth oriented profitable business capable of generating meaningful after tax earnings for the benefit of stakeholders over the long term. Time horizons immediate and on-going.
Early discovery and translation to humans focused on pathology-biology based mis-folding protein targets in chronic degenerative diseases. Science and its predictability remain the major risk factor; time horizons of 5+ years to the clinic.
The Board of Directors as well as executive management believe separating into two distinct business will enable appropriate alignment of funding/capital structures with the mission of each respective business; where the interests of the shareholders and the management team will be synchronized with the risk, return and timelines of activities.
Elan Corporation plc Profile
Immediately profitable and high growth company
Headquartered in Dublin, Ireland
2011 revenues of $1.2 billion; 2011 GAAP Operating Expenses of $403 million
Post transaction GAAP Operating Expenses of ~ $300 million
2013 post a successful spin-off transaction estimated EBITDA in excess of $400 million and estimated Net Income in excess of $250 million; and targeting $1.00 earnings per share for our shareholders by 2015, with the new business construct
Corporate tax of 12.5%; more than $4 billion in accumulated losses and other structures for after tax EPS incremental returns and stakeholder benefits
ELND005 with Phase 2/Phase 2b in several neurology and neuropsychiatry symptomatic indications
Leadership:
Chairman: Robert A. Ingram
Chief Executive Officer: Kelly Martin
Employees: approximately 90 – 110 people
Equity interests in Janssen AI - AIP Programs, Alkermes plc, Proteostasis Therapeutics, and Neotope Biosciences
Neotope Biosciences plc Profile
Drug discovery company focused on translating distinct targets into therapies for chronic degenerative and other related diseases
Incorporated in Ireland with operations in South San Francisco, California
Key targets: synuclein, tau, MCAM, amyloid for application to a wide variety of diseases
Potential for three INDs by 2015
Expected cash spend of $50 - $60 million per annum
Leadership:
Chairman: Dr. Lars Ekman
Chief Executive Officer: Dr. Dale Schenk
Employees: approximately 80 people
Elan Corporation plc to commit $120-$130 million start-up capital and to retain 14 - 18% minority equity position
Conditions
The transaction is subject to a number of conditions, including approval by shareholders and the holders of the 2016 Notes.
Advisors
Elan’s financial advisors are Citigroup and Ondra Partners.
Investor/Analyst Conference Call
Elan will host an investor/analyst conference call at 8.30am ET today. This call will be simultaneously webcast over the internet and will be available to investors, members of the news media and the general public. The event can be accessed by visiting Elan’s website at www.elan.com and clicking on the Investor Relations section, then on the event icon. Slides will be available on www.elan.com at the time of the conference call/webcast.
About Elan
Elan is a neuroscience focused biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. For additional information about Elan, please visit http://www.elan.com.
io_io
13 years ago
blackcat:
From the PFE website transcript, it looks like they will have Bapi results by mid-year, but will then keep them under lock until the annual Neuro conference?
Q+A session
Tim Anderson - Sanford C. Bernstein & Co., LLC., Research Division
....... And your product, bapineuzumab is going to have important data in the current year as well, yet you never seem to talk about it too much. I'm hoping I can kind of ask you a few questions on this. The first is what will be the timing and venue for seeing the results of the 2 U.S. trials? The second is can you confirm that you'll likely present the results of both trials at the same time like Lilly will do? And then the third point, have there been futility analyses done with the bapi Phase III trials?
Olivier Brandicourt
All right. In term of timing, it's the same timing that we talked about in the previous calls. And the studies are going to be read out by mid-year, and we will report the results as soon as possible afterwards in a scientific meeting. There was no futility analysis done on those studies. And I would like to actually mention that the 2 products or the 2 compounds are targeting a different epitope on the beta and amyloid peptides. And that may trigger 2 very different mechanism of actions. And therefore, the results of one may not be transferable to the results of the other one. However, I must say that based on what we heard this morning, we heard the alliance views the decision to continue on solanezumab with interest. And we're maintaining confidence in the amyloid pathway for our AD program.
blackcat
13 years ago
There is also this-
http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-newsArticle&ID=1640788&highlight=
Alkermes Initiates Phase 3 Clinical Study of ALKS 9070 for Treatment of Schizophrenia
-- ALKS 9070 Is Designed to Offer Best-in-Class, Extended-Release, Once-Monthly Version of Aripiprazole --
DUBLIN--(BUSINESS WIRE)--Dec. 19, 2011-- Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY® for the treatment of a number of central nervous system (CNS) disorders. The multicenter, double-blind, placebo-controlled study is designed to assess the efficacy, safety and tolerability of ALKS 9070 in approximately 690 patients experiencing acute exacerbation of schizophrenia. The clinical data from this study, expected mid-calendar 2013, will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 9070 for the treatment of schizophrenia, a chronic brain disease.
“Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs,” stated Dr. Herbert Meltzer, Professor of Psychiatry at Feinberg School of Medicine and Director of the Division of Neuropsychopharmacology at Northwestern University. “An extended-release injectable medication that incorporates the unique clinical properties and established safety and efficacy of aripiprazole would represent a significant treatment advancement for patients and physicians to manage this serious, chronic disease.”
In June 2011, Alkermes announced data from a phase 1b double-blind, randomized, placebo-controlled clinical study of ALKS 9070 in 32 patients with schizophrenia. Data from the study showed that ALKS 9070 was generally well tolerated and achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile that supports once-monthly dosing.
“Alkermes’ expertise in developing safe and effective long-acting therapeutics uniquely positions us to develop a once-monthly atypical antipsychotic medication that delivers aripiprazole, a widely prescribed oral product with an established safety and efficacy profile,” stated Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. “The advancement of ALKS 9070 into pivotal development marks an important milestone for the program, and we look forward to seeing the results in mid-2013.”
Phase 3 Study Design
The phase 3 randomized, multicenter, double-blind study is designed to assess the efficacy, safety and tolerability of ALKS 9070 compared to placebo in patients experiencing acute exacerbation of schizophrenia. Approximately 690 subjects will be randomized to receive once-monthly intramuscular injections of ALKS 9070 300 mg, ALKS 9070 600 mg or placebo for twelve weeks. In addition, subjects will receive oral study drug for the first three weeks after randomization. Subjects randomized to one of the two ALKS 9070 treatment groups will receive oral aripiprazole, while subjects randomized to the placebo group will receive matching oral placebo. The primary efficacy endpoint of the study is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline. All participants in the double-blind portion of the study will be eligible to continue in an open-label phase and receive ALKS 9070 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of once-monthly ALKS 9070.
About LinkeRx™ and ALKS 9070
LinkeRx is a novel, proprietary technology platform that enables the creation of injectable extended-release atypical antipsychotics and other CNS therapies. ALKS 9070, which leverages the LinkeRx technology, is a once-monthly, injectable atypical antipsychotic in development for the treatment of schizophrenia. Once in the body, ALKS 9070 converts to aripiprazole. Aripiprazole is commercially available under the name ABILIFY® for the treatment of a number of CNS disorders.
About Schizophrenia
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness.
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington, Ohio. For more information, please visit Alkermes’ website at http://www.alkermes.com.
ease.
blackcat
13 years ago
There was this: Although info seems much delayed
Elan Turns It Around in 2011
By Brian Orelli | More Articles
December 19, 2011 | Comments (0)
In case you didn't notice, Elan (NYSE: ELN ) is back. The biotech darling fell from investors' graces in 2008 after new cases of progressive multifocal leukoencephalopathy, a potentially deadly brain infection, cropped up in patients taking its multiple sclerosis drug Tysabri.
But shares doubled in 2011, and while they still haven't reached 2008 levels, the trajectory is impressive. The reasons for the meteoritic rise are twofold.
First, Elan has gotten its financial house in order. A couple of years ago, the company sold off half of its interest in its Alzheimer's disease drug bapineuzumab to Johnson & Johnson (NYSE: JNJ ) . The company only owned half the drug to begin with -- Pfizer (NYSE: PFE ) owns the other half --leaving just a quarter interest in the drug, minimizing the potential returns. However, it still brought in enough to pay down a substantial portion of the company's debts.
Elan was able to secure more cash through the sale of Elan Drug Technology to Alkermes (Nasdaq: ALKS ) this year. The biotech had previously tried to sell the unit that helps companies make extended-release versions of their drugs, but couldn't find a buyer. Spinning out the unit as a separate company was put on the table as an option, but a sale was really the best choice since it provided a quick infusion of cash.
As important as getting its financial situation in order, Elan and marketing partner Biogen Idec (Nasdaq: BIIB ) have demonstrated that progressive multifocal leukoencephalopathy isn't a sales-killing side effect. Sales are up 28% year over year during the first nine months of the year.
And Elan and Biogen are working on a test to detect the virus that causes PML. Patients that don’t have the virus aren't as susceptible to acquiring PML after taking Tysabri. The risk-stratification strategy could reaccelerate sales of the drug.
Increased sales and getting its financial situation in order have allowed Elan to register positive earnings last quarter. And maybe that's the ultimate reason for the stock price gain this year. Despite some biotechs' attempts, you can't keep losing money indefinitely.
If you're looking for something a little less dependent on binary events for next year, check out the Fool's new free report, where Fool analysts report their top pick for 2012. Just click here to grab your free copy.
Link: http://www.fool.com/investing/high-growth/2011/12/19/elan-turns-it-around-in-2011.aspx
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