Adding the 4.6M shares issued in the latest financing (including 0.6M shares for the underwriter’s over-allotment), MNTA now has about 49.1M diluted shares for valuation purposes.
Discussion: the 49.1M figure consists of 44.5M basic shares and 4.6M employee options. The highest exercise price for a consequential number of employee options is $23.62, which is a price I consider well within reach during the next few years; therefore, I include all 4.6M of the options in the share count for valuation purposes. However, the 49.1M figure excludes 4.2M shares reserved for granting but not yet granted under the company’s incentive plans.
[Updates: new valuation analysis for the single-generic Lovenox case (based on the updated share count); revised post on the description of MNTA’s BoD; new entries re FTY720 and Cladribine (in the “Competition: MS” section); descriptions of MNTA’s EU patent applications (thanks, floblu).]
Management and BoD #msg-37687271How MNTA executed against its 2008 internal goals #msg-38645684Bruce Downey, ex-CEO of Barr, joins BoD #msg-42166392Composition of Board of Directors #msg-33979910 James Sulat appointed Chairman of Board #msg-12824293 CEO, Craig Wheeler, hired from Chiron (Aug 2006) #msg-27338039 CMO, James Roach, hired from Sepracor (Feb 2008) #msg-37695353 Major shareholders #msg-38645904 Insider shareholdings
Generic Lovenox program (See separate section below on competition from other Lovenox generics.) #msg-41323601FDA “ready to approve,” says Craig Wheeler #msg-41414776Handicapping the Lovenox ANDA’s #msg-32449872 Sandoz submits response to FDA (9/08) #msg-37892516FDA request for new clinical trial is unlikely #msg-38682430Immunogenicity data is measure of product purity #msg-39720275FDA completes inspections of manufacturing facilities #msg-35090820 Why the Lovenox ANDA has taken so long to process #msg-38585972 Musings on Sanofi’s Citizen Petition #msg-37893451 FDA can’t keep the ANDA in limbo indefinitely #msg-40073523Lovenox sells $4B/yr, 61% in US #msg-35544866Single generic would be largest-selling of all time #msg-41482908 Lovenox is not at all like Omnitrope #msg-33862924Sandoz pays the freight #msg-33839164Profit split depends on # of generics #msg-42166244Share-price upside in the best-case scenario #msg-41326335 Approval of multiple generics is not the ticket #msg-41324486 Estimated royalty if multiple generics #msg-12685766 Royalty payable to MIT #msg-36972416Status of generic Lovenox program in the EU #msg-38113820 EMEA guidelines for biosimilar heparin-based drugs #msg-29728035 How generic Rx’s are written in EU
M118 (proprietary anticoagulant) program (See separate section below on the competitive landscape for anticoagulants.) #msg-41846746Phase-2 data from EMINENCE trial #msg-41820503Musings on the EMINENCE data #msg-39146357M118 ‘refresher course’ #msg-41897705 Musings on M118 differentiation #msg-39180621 Why M118 is not ‘Recothrom Part Deux’ #msg-39151654 Index to M118 clinical trials #msg-27272430 Meeting an unmet need #msg-31029674 Advantage vs Lovenox re drug interactions #msg-26898084 How M118 binds both FIIa and FXa (graphic)
Generic Copaxone program (See separate section below on the competitive landscape in MS.) #msg-30621490FDA accepts Copaxone ANDA for review #msg-36604466 Leerink Swann report on Teva’s Citizen Petition (3/27/09) #msg-36600603 Will Copaxone be regulated as a biologic? #msg-30938608MNTA/Sandoz have first-filer status #msg-33580867 MNTA/Sandoz allege inequitable conduct #msg-36601428 Teva counters with claim of stolen IP #msg-30960930 List of Copaxone patents being challenged #msg-12222305 Copaxone falls under 2006 collaboration #msg-30649453 Notes from 7/11/08 Copaxone conference call #msg-30647865 “Controlled chaos” and reverse engineering #msg-36015642 FDA approves Copaxone for CIS
Follow-on Biologics (FoB) programs #msg-27114485US FoB’s are a question of when not if #msg-35824847 Update on the same topic #msg-26837144Momenta’s Mantra on FoB’s #msg-40156726 MNTA only marginally affected by terms of FoB legislation #msg-35607204 Biogenerics vs biosimilars #msg-12222305 2006 PR announcing FoB deal with Sandoz #msg-34383144 $178M in remaining potential milestones #msg-37325602What is M178? (table of biologic patent expirations) #msg-20699044 Largest-selling biologics by class #msg-33866262 Reference website for FoB’s
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-37152092 Presentation at 2009 AACR
Competition from other Lovenox generics #msg-38044302What about ANDA’s from Teva and Amphastar? #msg-38906603Musings on likelihood of an ‘authorized’ generic #msg-35170055 Amphastar’s 180-day ‘exclusivity’ expired on 3/31/09 #msg-33960572 HSP filed an ANDA for vial formulation only
Competition from other anticoagulants #msg-40342721Why Arixtra is inconsequential to MNTA #msg-33630772 Lovenox more cost-effective than Arixtra, says SNY #msg-29698599Competition from new oral anticoagulants #msg-39151366Xarelto has a long way to go in ACS #msg-41177613Index to posts on anticoagulants
Competition: multiple sclerosis #msg-39971611Copaxone US sales and market share (2Q09) #msg-37325488Worldwide market share of MS drugs (2004-mid 2008) #msg-35065247 Comparative efficacy of approved MS drugs #msg-41292688 Tysabri’s 3-year PML rate #msg-37325525 MS drugs in phase-2 or phase-3 #msg-31553565 Musings on MS drugs in development (genisi) #msg-37060245 New orals to be used mostly in the second line #msg-42057827 Merck Serono submits Cladribine NDA #msg-42018880 FTY720 data from the FREEDOMS study #msg-34832939 Musings on Campath (with another table of MS drugs) #msg-39934109 Dirucotide from BioMS fails—program terminated #msg-41481687FDA to review Mylan’s Copaxone ANDA #msg-37567642 Teva begins work on “low volume” Copaxone
Competition: miscellaneous #msg-33839321 Procognia is not a serious competitor #msg-33597614 Also-ran companies in the FoB arena
Intellectual property #msg-41924957 Overview of MNTA’s patent estate #msg-42006364 MNTA’s EU patent applications
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