Cypress Bioscience - unter Buch/Cash - Blockbuster
| eröffnet am: | 22.06.10 09:59 von: | Chalifmann3 |
| neuester Beitrag: | 15.12.10 15:02 von: | Holliday |
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Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia
NEW YORK and SAN DIEGO, Jan. 14, 2009, 2009 /PRNewswire-FirstCall via COMTEX/ -- New treatment option for the estimated 6 million Americans living with this chronic, debilitating condition
CYPB today announced that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia.
The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. The companies expect Savella to be available in pharmacies by March 2009.
"Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia,\" said Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. "The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.".
"Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint," said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience.
Howard Solomon, Chairman and Chief Executive Officer of Forest said, "We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis."
"This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States," said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA.Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.
MFG
Chali
Was soll das Managment schon machen, die haben denen ja quasi die Knarre auf die Brust gesetzt und mit rechtlichen Schritten ganz klar gedroht. Entweder die finden die Offerte akzeptabel und empfehlen die Annahme, oder die finden das Angebot zu niedrig, dann sollte der Kurs aber doch auch eher steigen (zuminmdest in die Nähe von 4,- Dollar).
Habe mir das Schreiben durchgelesen und dort wimmelt es ja nur so von Warnungen für das Management; wahrscheinlich wird das Managment in nächster Zeit sowieso den Hut nehmen müssen und da ja gestern bereits ca. 16,5 Mio Aktien gehandelt wurden, dürfte Ramius nun über eine Mehrheit > 50% der Aktien verfügen (sofern Sie gestern gekauft haben).
www.sec.gov/Archives/edgar/data/716054/...99113d06297084_07162010.htm
Das ist doch mal ein schönes Schreiben an einen Vorstand; da wird richtig schön Druck gemacht:
www.sec.gov/Archives/edgar/data/716054/...1to13da106297084_072110.htm
Ich hab weiter aufgestockt, die Übernahmeofferte liegt deutlich über dem aktuellen Kurs und irgendwann in den nächsten Tagen wird sich das Management dazu äussern müssen. In den letzten Tagen seit der Offerte sind fast 80% des Freefloat (also ohne die 9,9% von Ramius) umgesetzt worden und irgendwann in den nächsten Tagen dürfte auch eine Meldung bzgl. des Anteilsbesitzes (neue Aktionärsstruktur) kommen; dies dürfte dem Kurs den entsprechenden Schub in Richtung 4,- Dollar oder sogar deutlich darüber geben. Gehe auch davon aus, dass das Management demnächst zurücktritt.
Ich denke mal diese und nächste Woche dürfte recht interessant werden, für den 10.08. ist die Veröffentlichung des Quartalsergebnisses angesetzt. Bin ja mal gespannt, ob dieser Termin bleibt und ob der Vorstand bis dahin eine konkrete Aussage zum Übernahmeangebot macht. Der Vorstand gerät immer mehr in Bedrängnis, auch unter haftungstechnischen Gründen.
Da ist ja schon mal die erste Reaktion des Vorstandes.
www.finanznachrichten.de/nachrichten-2010-08/...arket-will-re-256.htm
Cypress Bioscience Responds to Unsolicited, Non-Binding Proposal and Recent Letter From Ramius LLC
SAN DIEGO, CA -- (Marketwire) -- 08/06/10 -- Cypress Bioscience, Inc. (NASDAQ: CYPB), a pharmaceutical company engaged in the development of innovative drugs to treat central nervous system disorders, today announced that its Board of Directors has unanimously concluded that the unsolicited, non-binding proposal by Ramius LLC to acquire all of the outstanding shares of Cypress common stock not owned by Ramius for $4.00 per share in cash grossly undervalues Cypress' current business and future prospects and consequently is not in the best interests of Cypress' other stockholders.
The Board of Directors of Cypress reached its decision after a careful and thorough review of the proposal and with the assistance of its financial and legal advisors.
Cypress is being advised by Jefferies&Company, Inc. and Perella Weinberg Partners and is receiving legal counsel from Cooley LLP.
The Board of Directors communicated its response to Ramius in a letter sent to Jeffrey Smith, Partner Managing Director of Ramius, the full text of which follows:
August 5, 2010
Mr. Jeffrey Smith
Partner Managing Director
Ramius LLC
599 Lexington Avenue
New York, NY 10022
Dear Mr. Smith:
The Board of Directors of Cypress Bioscience, Inc. has reviewed your letter, received on July 19, 2010, outlining a non-binding proposal to acquire all of the outstanding shares of Cypress not owned by Ramius LLC for $4.00 per share in cash.
After carefully and thoroughly reviewing the contents of your proposal and with the assistance of financial and legal advisors, we have unanimously concluded that your proposal is not in the best interests of the other Cypress stockholders. We concluded that your proposed price grossly undervalues our current business and future prospects. While Cypress remains confident that executing on its current business strategy would deliver superior value to its stockholders, we will continue to consider seriously any bona fide acquisition proposal or other transaction that reflects the full and fair value of Cypress' current business and future prospects.
Mr. Smith, we are keenly aware of our fiduciary duties to our stockholders and any suggestion to the contrary is completely without merit. Furthermore, suggestions of any conflict of interest or inappropriate relationship in connection with the BL-1020 transaction are equally baseless. Our Board is comprised of scientific experts and seasoned corporate executives duly elected by Cypress stockholders and assisted by independent financial and legal advisors. Our focus is on creating value for stockholders over time. During our consideration of your proposal and evaluation of our current strategy, we heard from several other Cypress stockholders. None indicated a willingness to accept $4.00 per share, and we would not recommend a sale of Cypress at this price either.
We also confirm receipt of your letter, dated August 5, 2010, in which you make several unsupported assertions regarding the decision by Cypress to discontinue the co-promotion of Savella with Forest Laboratories. Although Cypress announced that agreement yesterday, it disclosed the potential for such a strategic change several weeks ago in its Form 8-K filing. This decision, contrary to your inaccurate claims, was not rushed. In addition, this decision was fully supported by the investment community as a prudent step to conserve cash and focus on Cypress' core competencies. Importantly, the agreement Cypress reached yesterday with Forest was the result of a thorough and extended process in which several alternatives were considered and carefully reviewed and a number of which were pursued. We are highly confident that this agreement was the most attractive alternative available and is in the best interests of Cypress stockholders.
Although Ramius is among Cypress' largest stockholders, Ramius also is attempting to acquire Cypress at a price that we and other stockholders believe completely fails to reflect full and fair value. In your meetings with our investment bankers yesterday, you unambiguously confirmed that you want to buy Cypress. Moreover, an acquisition at $4.00 per share would provide substantial and differential benefits to you at the expense of the other Cypress stockholders. Consequently, we have concluded you do not have a proper purpose for the inspection of Cypress' books and records and we will take all necessary action to defend that position and protect the interests of the other Cypress stockholders.
On behalf of the Board of Directors, thank you for your continued interest in Cypress.
Sincerely,
Jay D. Kranzler, M.D., Ph.D.
Chairman and Chief Executive Officer
Jean-Pierre Millon
Lead Independent Director
Einnahmen von 17,241 Mio. $ stehen Ausgaben von 23,923 Mio $ gegenüber, das macht einen Verlust von 6,7 Mio. $, hier wird noch "interest income" i.H. von 323.000 genannt, das man abziehen muss von den Ausgaben, macht dann insgesammt 6,359 Mio. $ oder aufgeteilt auf 38.376 Mio. Aktien ergibt sich ein Nettoverlust von 0,17$ von vormals (2.Q/2009) 0,47$ per Aktie, der kommt wahrscheinlich noch durch den Erwerb der Lizenzen von BioLineRx zustande, dadurch müsste sich aber der Wert von Cypress deutlich erhöht haben. Warten wir einfach ab, ob Ramius sein Angebot erhöht.
Ich glaube nicht, dass der Kurs momentan auf oder sogar deutlich über 4,- Dollar steigt. Dies wird Ramius wahrscheinlich nicht zulassen und solange der Kurs unterhalb der Offerte liegt, haben Sie ein hervorragendes Druckmittel gegen den Vorstand.
Es ist natürlich auch schwierig für einen Vorstand, eine Übernahmeofferte "deutlich" über dem Kurs vor Angebotsveröffentlichung und auch dem aktuellen Kurs mit einer vernünftigen Begründung abzulehnen; da macht sich jeder Vorstand "indirekt" gegenüber den Aktionären haftbar und auch unglaubwürdig.
Ich persönlich denke, dass Ramius weiter massiv Druck ausüben wird und evtl. auch die ein oder andere Klage wegen Schadensersatz gegen den Vorstand einreichen wird. Der Vorstand wird sich dann zu jeder einzelnen Enscheidung rechtfertigen müssen und sobald was in die Hose geht, ist der Vorstand persönlich dran (da zahlt auch keine Managerhaftpflichtversicherung, da alles was der Vorstand derzeit unternimmt, gegen den Willen von Ramius ist und somit als leicht oder grob fahrlässig bzw. sogar vorsätzlich angesehen werden kann...dies ist eine ziemlich schwierige Situation für den Vorstand).
Der Vorstand wird massiv in die Ecke gedrängt und sobald eine Meldung über den Rücktritt kommt, schießt der Aktienkurs in die Höhe.
www.sec.gov/Archives/edgar/data/716054/...1to13da206297084_080510.htm
www.finanznachrichten.de/nachrichten-2010-08/...ss-bioscience-020.htm
http://quotes.nasdaq.com/asp/...ote.asp?symbol=CYPB&selected=CYPB
http://www.nasdaq.com/aspxcontent/...px?symbol=CYPB&selected=CYPB
Jetzt gehts aber richtig los. Da bekommt der Vorstand mal richtig Druck und ich denke, lange wird sich der Vorstand nicht mehr halten können bzw. in Verkaufsverhandlungen oder eine sog. offene Ausschreibung eintreten müssen:
www.sec.gov/Archives/edgar/data/716054/...1to13da306297084_081110.htm
Cypress Bioscience, Inc. (CYPB - Analyst Report) reported a net loss of 5 cents per share in the second quarter, six cents narrower than the Zacks Consensus Estimate and well below the year ago loss of 23 cents, mainly due to higher revenues and a significant decline in operating expenses.
Quarter in Detail
Second-quarter revenues came in at $9.1 million, in line with the Zacks Consensus Estimate and 56.9% above the year-ago revenues of $5.8 million. Second quarter revenues consisted of $8.1 million in commercial revenues, $0.8 million in revenues under collaborative agreements and $0.2 million in revenues from Cypress Bioscience’s personalized medicine service business.
Commercial revenues of $8.1 million included royalty revenue of $3.1 million and $4.6 million in co-promotion reimbursement in connection with the launch of Savella. Savella received FDA approval in January 2009 for fibromyalgia, a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms.
Fibromyalgia syndrome (FMS) is estimated to affect about 6 million people in the US. We believe Savella may have multi-hundred million dollar potential.
Total second quarter operating expenses declined 26.2% to $11 million. Research and development expenses were $1.2 million in the reported quarter, down from $2.0 million reported in the year ago quarter. Lower clinical trial costs led to the decline. However, R&D spending should increase as Cypress Bioscience focuses on the development of CYP-1020.
Selling, general and administrative expenses declined 24.4% to $9.3 million mainly due to lower costs associated with the marketing and promotion of the company’s personalized medicine services business and lower compensation costs. With Cypress Bioscience surrendering its co-promotion rights for Savella, we expect selling, general and administrative expenses to decline further.
Restructuring Initiatives Announced
Cypress Bioscience recently announced that it will be no longer be co-promoting Savella with partner Forest Laboratories (FRX - Analyst Report). However, we note that although the company will no longer be co-promoting Savella, it will continue receiving royalty on Savella sales.
In addition to returning its co-promotion rights to Forest Labs, Cypress Bioscience is also looking to discontinue or sell its personalized medicine services business by the end of the third quarter of 2010. The company plans to cut down its headcount by about 86% or 123 employees and intends to focus its resources on the development of candidates that target treatments for central nervous system (CNS) disorders. The lead candidate in this area is CYP-1020, a novel antipsychotic being developed for the treatment of schizophrenia.
These restructuring initiatives are expected to lower operating costs by about $10 million annually. The company will, however, incur restructuring-related charges of about $4.0 million to $4.5 million in 2010.
Our Take
We currently have a Neutral recommendation on Cypress Bioscience, which is supported by a Zacks #3 Rank ('Hold'). While we remain optimistic about Savella’s sales potential, we are concerned about the company’s early stage pipeline. We expect Cypress Bioscience to pursue acquisitions and in-licensing opportunities to drive growth.
Wie schon vermutet wird der Druck zu groß und gestern wurde der ertse Rücktritt verkündet. Jetzt dürften weitere folgen:
www.sec.gov/Archives/edgar/data/716054/...012310078760/a57114e8vk.htm
NEW YORK (MarketWatch) -- Cypress Bioscience rose 12.5% to $3.95 a share in pre-market trades on Wednesday. The move came after Ramius Value and Opportunity Advisors offered to buy the company for $4.25 a share in cash. Ramius raised its July 16 offer of $4 a share after Cypress rejected it.
www.finanznachrichten.de/nachrichten-2010-09/...-25-per-share-008.htm