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GTC Biotherapeutics - Deel 13

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  2. [verwijderd] 8 januari 2010 19:23

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    quote:

    ludwig mack schreef:

    nou, weer ietsje lager; we zullen zien ;-)
    Hoe bedoellu? 95ct! + 14,5%

    Maar goed,het is nog geen sluitingstijd. Zal wel eindigen rond de 90,denk ik
  4. ludwig mack 8 januari 2010 20:58

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    bijzonder stijging, maar loopt weer iets terug ........

    GTC Biotherapeutics Inc
    (NasdaqCM: GTCB)

    Real-Time: 0.86 Up 0.03 (3.61%) 10:46am ET
    Last Trade: 1.05
    Trade Time: 2:41pm ET
    Change: Up 0.22 (26.51%)
    Prev Close: 0.83
    Open: 0.85
    Bid: 1.00 x 600
    Ask: 1.05 x 4900
    1y Target Est: 0.75
    Day's Range: 0.77 - 1.05
    52wk Range: 0.33 - 9.50
    Volume: 66,743
    Avg Vol (3m): 36,209.4
    Market Cap: 25.98M
    P/E (ttm): N/A
    EPS (ttm): -3.11
    Div & Yield: N/A (N/A)
  5. [verwijderd] 8 januari 2010 21:23

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    Ludwig, je bent wel een beetje erg terughoudend vandaag hoor :) Ik weet het heus wel hoor,van die ene zwaluw.... Maar zou toch heel mooi zijn als we nu boven de 1 eindigen?! Ruim 50% stijging in de eerste week van het nieuwe jaar.

    Volgens een op de achterkant van een sigarendoosje berekening heeft LFB trouwens nu ca 21 miljoen van de ca 30 miljoen uitstaande aandelen. Correct me if i'm wrong.
  6. ludwig mack 8 januari 2010 21:59

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    bijna 25% vandaag is mooi ja!

    ik wil arbitrageuitslag, en dat die positief is ........., dan komt die stijging vanzelf en wordt die structureel .......

    positief zijn, en daarom ga ik nu niet rekenen .......;-(

    gr
  7. ludwig mack 8 januari 2010 22:08

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    p.s.

    overigens: een bewijs dat aandeelhouders, of in ieder geval de kopers van vandaag, de fransen zien zitten; wat kun je anders concluderen na het p.b. van vandaag?
  8. ludwig mack 8 januari 2010 22:10

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    Laatste 1,0400 21:59 400
    +/- 0,2100 25,30%
    Slot 0,8300 07-01-10
    Open 0,7700 15:30
    Hoog 1,0800 21:38
    Laag 0,7700 15:30
    Bied
    Laat
    Volume 97.600
  10. [verwijderd] 8 januari 2010 22:25

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    quote:

    ludwig mack schreef:

    p.s.

    overigens: een bewijs dat aandeelhouders, of in ieder geval de kopers van vandaag, de fransen zien zitten; wat kun je anders concluderen na het p.b. van vandaag?
    Jawel, maar het is natuurlijk ook wel plezierig dat GTC aankondigt binnenkort aan de Fase I en II onderzoeken te beginnen, terwijl er geen cent op de plank is.
    Tenzij je een wel hele ordinaire bluf in huis hebt, zeg je dit wanneer je weet dat je dit jaar geld zult krijgen.
    Prettig weekend!
  12. [verwijderd] 8 januari 2010 22:28

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    Ha Sky! Leuk dat je het nog volgt. Je bent achteraf bezien toch niet te vroeg uitgestapt.
    Benieuwd of je nog instapneigingen krijgt, denk het eigenlijk niet.
    Prettig weekend ook jij!
  13. [verwijderd] 8 januari 2010 23:37

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    25 procent omhoog

    De aandelen van lbf worden comon stock ?
    Dat betekent dus verhandelbaar

    OK

    We zitten weer op de rails

    boven de dollar in ieder geval

    Groet,
  15. [verwijderd] 9 januari 2010 08:45

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    quote:

    beur schreef:

    Ludwig, je bent wel een beetje erg terughoudend vandaag hoor :) Ik weet het heus wel hoor,van die ene zwaluw.... Maar zou toch heel mooi zijn als we nu boven de 1 eindigen?! Ruim 50% stijging in de eerste week van het nieuwe jaar.

    Volgens een op de achterkant van een sigarendoosje berekening heeft LFB trouwens nu ca 21 miljoen van de ca 30 miljoen uitstaande aandelen. Correct me if i'm wrong.
    Ontving zojuist van Tom N. een mailtje met o.a.:

    Dear Jan,

    LFB now holds 71% of the outstanding shares.

    (Ik had op de lagere school al een 10 voor rekenen ;))
  16. [verwijderd] 9 januari 2010 12:42

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    Governor Patrick, Massachusetts Life Sciences Center Announce Tax Incentives
    Targeted At Twenty-Eight Companies
    Center Awards $25 million to foster job growth in the Massachusetts Life Sciences Supercluster
    For Immediate Release: Date: December 23, 2009

    Waltham, MA – Governor Deval Patrick and the Massachusetts Life Sciences Center
    announced today that the Center’s Board of Directors has awarded $25 million in Tax Incentives
    to twenty-eight life sciences companies. The companies receiving tax incentive awards have
    committed to creating a combined 918 new jobs in the Commonwealth over the coming year.
    The Life Sciences Tax Incentive Program, established in 2008 as part of the state’s ten-year, $1
    billion Life Sciences Initiative, authorizes up to $25 million in tax incentives each year for
    companies engaged in life sciences research and development, commercialization, and
    manufacturing. The primary goal of the program is to incentivize life sciences companies to
    create new long-term jobs in Massachusetts.
    The Life Sciences Act provides for nine different incentives, which address the significant
    capital expenditures associated with the life sciences R&D cycle and the high costs of translating
    research into commercially viable products. Eighty-five companies applied for tax incentives in
    this first year of the program.
    “The Life Sciences Initiative was designed to bring jobs to the Commonwealth and support vital
    research, and these incentives help us do exactly that,” said Governor Patrick. “By supporting
    this growth in the life sciences, we are building upon a foundation that will benefit our economy
    for years to come.”
    (more)
    “These tax incentives will provide a solid return on our state’s investment in both the short and
    long term, including the creation of more than 900 jobs during the coming year,” said Dr. Susan
    Windham-Bannister, President & CEO of the Massachusetts Life Sciences Center. “In keeping
    with the Initiative’s mandate, we are utilizing these incentives to encourage the creation of jobs
    in an industry where Massachusetts is a global leader, and where jobs pay more than the average
    salary in Massachusetts. This tax incentive program will stimulate our economy, while holding
    the companies involved accountable for their job creation commitments.”
    “The companies that will receive these incentives are adding jobs in a cutting-edge industry that
    is a strength for Massachusetts,” said Massachusetts Administration and Finance Secretary Jay
    Gonzalez. “The Governor’s Life Sciences initiative not only offers hope to those waiting for
    cures for diseases, but to the Commonwealth as a whole as we look to grow our economy and lay
    the foundation for long-term economic competitiveness and success.”
    The Tax Incentive Program is jointly administered by the Center and the Massachusetts
    Department of Revenue (DOR), which will oversee the technical administration of the
    incentives. Jobs that are created must be maintained for at least five years. The Tax Incentive
    Program mandates that awarded companies submit reports and respond to inquiries by the Center
    and DOR regarding employment figures, revenue generation, amount of private capital
    leveraged, and information as to the recipient’s operations and business affairs. If a company
    receiving a tax incentive under the program does not meet and maintain their job creation
    commitment, the credit can be “clawed back” by DOR, requiring that the company pay back all
    or a portion of the tax incentives they’ve received.
    “Recent reforms to the state’s existing Economic Development Incentive Program, including
    clawback provisions to ensure accountability and greater protection of taxpayer dollars, have
    been modeled after the Life Sciences Center’s tax incentive program,” said Gregory Bielecki,
    Massachusetts Secretary of Housing & Economic Development. “This program is becoming the
    gold standard for tax incentive programs in the Commonwealth due to its balance between
    incentives for job creation and corporate accountability.”
    "The Center was diligent about getting experts in economic development to advise on their
    approach for reviewing the tax incentive applications," said leading economist Karl Seidman,
    President of Seidman Consulting Services and Senior Lecturer in Urban Studies and Planning at
    the Massachusetts Institute of Technology. "The approach that they are using is transparent,
    replicable and based on sound principles. I believe that the importance of job creation to their
    decision making process is a model for other tax incentives programs to follow."
    The twenty-eight life sciences companies that will receive tax incentives, the city or town in
    which they are located, and the amount awarded are as follows:
    Alnylam Pharmaceuticals, Inc. (Cambridge) — $300,000
    Biogen Idec MA, Inc. (Cambridge) — $1,500,000
    (more)
    Constellation Pharmaceuticals, Inc. (Cambridge) — $513,252
    Cubist Pharmaceuticals, Inc. (Lexington) — $1,740,000
    Dyax Corporation (Cambridge) — $100,000
    Facet Solutions (Hopkinton) — $300,000
    FoldRx Pharmaceuticals, Inc. (Cambridge) — $510,000
    Genzyme Corporation (Cambridge/Framingham) — $6,000,000
    GTC BIOTHERAPEUTICS, Inc. (Framingham) — $300,000,<<<<<<<<<<<<<<<<<<<<<
    Hologic, Inc. (Bedford) — $220,000
    Infinity Pharmaceuticals, Inc. (Cambridge) — $540,000
    InfraReDx, Inc. (Burlington) — $630,000
    Interlace Medical, Inc. (Framingham) — $300,000
    Lightlab Imaging, Inc. (Westford) — $188,951
    MERRIMACK PHARMACEUTICALS, Inc. (Cambridge) — $1,500,000<<<<<<<<<<<<<<<
    Morgan Advanced Ceramics, Inc. (New Bedford) — $570,000
    NeuroMetrix, Inc. (Waltham) — $300,000
    Nova Biomedical Corporation (Waltham) — $300,000
    OmniGuide, Inc. (Cambridge) — $540,000
    Organogenesis (Canton) — $245,240
    Pharmasphere, LLC (Worcester) — $360,000
    Sepracor, Inc. (Marlboro) — $750,000
    Shire Human Genetic Therapies, Inc. (Lexington) — $6,277,057
    STD Med, Inc. (Stoughton) — $121,000
    (more)
    Still River Systems, Inc. (Littleton) — $300,000
    TEI Biosciences, Inc. (South Boston) — $27,000
    Tolerx, Inc. (Cambridge) — $300,000
    Zoll Medical Corporation (Chelmsford) — $267,500
    -end
  17. [verwijderd] 9 januari 2010 12:55

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    Hierboven dus het subsidieverhaal van de staat Massachusetts dat nu geeffectueerd gaat worden.

    URL voor het bovenstaande is:
    www.masslifesciences.com/clips/pr1223...

    Excuus voor het matige knip- en plakwerk!

    Please note dat naast GTC ook de vrienden van Merrimack centjes toegewezen hebben gekregen.

    I.v.m. de recente besnoeiing op personeel is het volgende ook van belang:
    "If a company receiving a tax incentive under the program does not meet and maintain their job creation commitment, the credit can be “clawed back” by DOR, requiring that the company pay back all or a portion of the tax incentives they’ve received."
  18. [verwijderd] 9 januari 2010 13:07

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    quote:

    jurpsy schreef:

    [quote=SkySpam1]

    Gefeliciteerd heren Beur en Ludwig,
    met deze mooie koersstijging!!

    [/quote]

    Hoho, wij zijn der ook nog -))

    yahoo.brand.edgar-online.com/displayf...
    JP, krijg jij misschien (mogelijk als abonnee van Edgar Online?)de slide show die als annex Exhibit 99.2 aan de SEC filing van gisteren hangt hier op het forum?
  19. [verwijderd] 11 januari 2010 13:06

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    Oke,dan maar even geleend van Erik ;) :

    Corporate Presentation January 2010 NASDAQ: GTCB www.gtc-bio.com Exhibit 99.2 --------------------------------------------------------------------

    2 Safe Harbor Statement This presentation contains forward-looking statements that reflect GTC Biotherapeutics management’s current view of future events and operations. These forward- looking statements are based on assumptions, external factors, uncertainties and other risks that are detailed in the Company’s SEC reports, including its Form 10-K for the year ending December 28, 2008. Actual results may differ materially from these statements.
    -------------------------------------------------------------------------------

    3 GTC Biotherapeutics Validated “Game-Changing” Production Technology – Recombinant plasma proteins – Biosimilar/biobetter antibodies – Enabling, scalable, cost-effective – Validated regulatory path and infrastructure ATryn ® Recombinant Human Antithrombin – Approved in US & EU – Secured US commercialization partner – Expanding indications to maximize commercial opportunity Broad Pipeline Focused on High-Value Products – Low development risk – Large, established markets Corporate – Developed key strategic partnerships – Active partnering strategy
    --------------------------------------------------------------------------------

    4 Strategic Goals for Value Creation Develop Biosimilar and Biobetter Antibodies – Focus on oncology & autoimmune indications – CD20, HER2, EGFR and TNF MAbs – Enhanced ADCC biobetters – Outside key cell culture MAb IP Pipeline – Advance 2 products into the clinic in 2010 • Factor VIIa (hemophilia) into Phase I • AFP (MG and MS) into Phase II Maximize commercial opportunity of ATryn ® – Label expansion – Geographical distribution Build on Existing Strategic Relationships – Pursue additional corporate partners – Share risk and rewards – Build value but maintain financial discipline Products Transgenic Technology Business
    --------------------------------------------------------------------------------

    5 Technology to Products Production Platform Products Lower Production Costs Enabling difficult to express proteins enhanced ADCC/glycosylation High Volume Production unconstrained supply scaleable/flexible established infrastructure Validated Regulatory Path (US/EU) Protected by Intellectual Property proprietary IP (2021) and FTO Recombinant Plasma Proteins Biosimilar & Biobetter MAbs Product Portfolio known clinical profile low development risk produced cost-effectively expedited approval process large, established markets
    --------------------------------------------------------------------------------

    6 Recombinant Plasma Proteins ATryn ® (US/EU) hereditary deficiency acquired deficiencies Factor VIIa (LFB) hemophilia Factor IX (LFB) hemophilia AFP MS and MG Biosimilar/Biobetter Monoclonal Antibodies TG20 (LFB) oncology & autoimmune HER2, TNF, EGFR oncology & autoimmune Products Indications R&D PC PI PII PIII Approved GTC Product Pipeline
    --------------------------------------------------------------------------------

    7 Partnerships Key Component of GTC’s strategy – Share product rewards and risks with partners – Financial support for clinical development and commercialization Established Partners – Commercialization partnership • ATryn ® US partnership with Lundbeck • $257M development and commercialization deal – Development collaboration • JV with LFB • Multiple products FVIIa, FIX, AAT, TG20 MAb Partnering Opportunities – ATryn – Ex-US – Factor VIIa and Factor IX – AFP – Biosimilar/Biobetter MAbs
    --------------------------------------------------------------------------------

    8 Recombinant Plasma Protein Products Focused portfolio – FVIIa, FIX – AFP – antithrombin (ATryn ® ) Addressing large, established markets Deliver: unconstrained supply Ensure: safe products Provide: lower COGS
    --------------------------------------------------------------------------------

    9 ATryn ® : Marketed in US and EU ATryn ® Recombinant Human Antithrombin Anticoagulant and Anti-Inflammatory – Broad range of therapeutic indications FDA & EMEA Approved – Hereditary Deficiency Product Unique Selling Points – Safe – Consistent, reliable supply – Robust clinical data package – Only recombinant product Commercial sales in US and EU – US: Lundbeck Partnership – Ex-US: Partnership opportunities
    --------------------------------------------------------------------------------

    10 Antithrombin Deficiencies Hereditary Deficiency Genetic disease/orphan indication US Incidence 1:3000 High risk of venous thrombosis and pulmonary embolism during trauma, surgery and childbirth Acquired Deficiencies Disease-associated antithrombin deficiency – Heparin resistance/CABG – DIC – Preeclampsia – Burns/Trauma TIME >$2.5B DIC/Sepsis ~$50M Hereditary Deficiency ~$200M Heparin Resistance
    --------------------------------------------------------------------------------

    11 ATryn ® Commercial Strategy EU EMEA Approved in 2006 – HD surgical cases – Label expansion - childbirth Secure EU Commercial Partner – Expand EU commercial availability – Maximize EU sales in HD Geographical Expansion – Secure commercial partners • Canada • Japan • Middle East – Maximize sales US Commercial Partner: Lundbeck – FDA approved HD surgery & childbirth – Launched May 2009 – Initial goal to maximize US sales – Established hospital-based sales force Label Expansion – Heparin resistance in CABG • partner funded – Develop further AD indications – DIC associated with sepsis • 250,000 patients/year in US • high mortality (40-50%) • published data supports potential efficacy ROW
    --------------------------------------------------------------------------------

    12 Hemophilia Genetic Diseases Orphan Diseases (US >20,000 patients) – Hemophilia A: FVIII deficient – Hemophilia B: FIX deficient Hemophiliacs with inhibitors to FVIII or FIX – FVIIa treats both conditions VIIa IX Large, Growing Markets Overall Markets >$6B FVIIa: NovoSeven ® >$1.2B (2008) FIX: BeneFIX ® >$600M (2008) VIII
    --------------------------------------------------------------------------------

    13 Factors VIIa and IX Expand markets with strong commercial partners – Acute and prophylactic treatments – Additional geographies – Expand Labeling e.g. trauma, surgery Factor VIIa Factor IX Strategy – Difficult to produce in cell culture – Comparable to NovoSeven ® – Discounted pricing Status: – Established production line – Data shows comparability – IND 1H 2010 – Conduct Phase I in 2010 Strategy – Difficult to produce in cell culture – Extended half-life product Status: – Established production line – Preclinical studies ongoing – IND 2011 Growth Opportunities
    --------------------------------------------------------------------------------

    Alpha Fetoprotein (rhAFP) Alpha Fetoprotein Status: – Immune modulator – Disease remission during pregnancy – Compelling results in MS & MG Models Enabled by Transgenic Platform: – Difficult to express in cell culture – High expression during pregnancy Partnering Opportunity: – Strong KOL support – Strong safety database (>200 patients) – Phase II ready – Develop with partner Decreases TNF and IFN production by macrophages 14 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 Pre-pregnancy Pregnancy Post-partum Source: Confavreux et al. (1998) NEJM 339 285-291 NORMAL [AFP] 1 2 3 4 N = 227 1 2 3 4 1 2 3 1,000 100 10 1 Downregulates expressi
  20. [verwijderd] 11 januari 2010 13:08

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    Downregulates expression of MHC class II molecules Upregulates apoptosis of Inflammatory Cells 1 2 3 4 Inhibits antibody production
    -------------------------------------------------------------------------------

    15 Based on: – Pre-clinical evidence shows efficacy in robust MS animal models – Human safety data with favorable side-effect profile (>200 patients) – Competitive COGS – Convenient administration by subcutaneous injection Potential: – 1st line therapy for MS – 2nd line therapy for MG – Other autoimmune CNS diseases Significant Market Opportunity for AFP Myasthenia Gravis Multiple Sclerosis US Prevalence (per 100,000) 15 – 20 125 – 150 US Patients (‘000s) 45 – 60 >300 Potential Market $150 – 250M >$8B
    --------------------------------------------------------------------------------

    MAbs - A Manufacturing Challenge ~24 kg ~15 kg IFN- IFN- hGH G-CSF EPO ERT >2500 kg 16
    -------------------------------------------------------------------------------

    Monoclonal Antibodies Technology Proven, competitive for MAb production >20 MAbs produced Easy scalability (10 – 1000+ kg) COGS, CapEx Avoids key cell culture MAb patents Biosimilar/Biobetter MAbs TG20 (CD20 MAb) (LFB JV) – Oncology/autoimmune disease – Target specificity similar to Rituxan – Enhanced ADCC + similar CDC HER-2, TNF and EGFR initiated Targeting >$15B sales (2008) Regulatory path evolving (EU/US) Develop with partners 15 10 5 0 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ‘08 MAb Sales 2001 – 2008 (Rituxan, Humira, Erbitux & Herceptin) 17
    --------------------------------------------------------------------------------

    18 Goal: Cash Flow Positive by 2012 2010 2011 Development • ATryn ® initiate PIII HR • FVIIa conduct Phase I • AFP initiate Phase II • Biosimilar characterization Partnering • ATryn ® EU • AFP • Biosimilar(s ) Development • FVIIa initiate Phase II/III • AFP conclude Phase II • FIX file IND • TG20 Phase I (partner) Partnering • ATryn ROW • FVIIa • Biosimilar(s ) 2012 Development • ATryn HR filing • AFP initiate Phase III • FIX initiate Phase II/III • Herceptin file IND Partnering • FIX Financial • Cash - Flow Positive
    --------------------------------------------------------------------------------

    19 GTC Fundamentals Validated “game-changing” production platform – enables production of difficult to express proteins – easily scalable for high volume products – cost competitive (COGS and CapEx) Demonstrated naturally enhanced ADCC MAbs – generate high value 2nd generation oncology MAbs Recombinant versions of plasma proteins – ATryn (launched US & EU) – FVII (Phase I 2010) – AFP (Phase II 2010) Biosimilar/Biobetter MAbs – HER2, TNF and EGFR in development – TG20 (Phase I 2011) Sharing risk/rewards through partnering – LFB, Lundbeck Significant events through 2012 – Products progressing in clinical development – Partnering deals Goal to be cash-flow positive by 2012 Products Technology Value Creation
    --------------------------------------------------------------------------------

    20
    -------------------------------------------------------------------------------

    Forward-Looking Statements This slide presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements related to GTC’s plans to enter into partnerships, build upon existing strategic relationships, maximize commercial opportunities, advance its programs relating to recombinant factor VIIa, alpha-fetoprotein, ATryn and monoclonal antibodies for use as follow-on biologics, market opportunities and our plan to be cash flow positive by 2012. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in our most recent Annual Report on Form 10-K and our other periodic reports filed with the Securities and Exchange Commission, including the risks and uncertainties associated with our ability to enter into collaborations in the future, the terms of such collaborations, the performance of our partners, regulatory approval of our transgenically produced products, designing and conducting clinical trials and pre- clinical studies, developing new biological products, continuing operating losses and our ability to raise additional capital. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this presentation These statements speak only as of the date of this filing on Form 8-K, and GTC undertakes no obligation to update or revise the statements, except as may be required by law

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ASMI 4.108 39.681
ASML 1.767 111.611
ASR Nederland 21 4.521
ATAI Life Sciences 1 7
Atenor Group 1 522
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 14.262
Axsome Therapeutics 1 177
Azelis Group 1 67
Azerion 7 3.456