Replies to post #115937 on Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
timetable of Lovenox patent-infringement case suggests Teva has no expectation of FDA approval;
Amphastar responds to FDA’s motion to dismiss lawsuit against FDA;
2011-2012 news flow.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-60510033 Webcast from 3/2/11 RBC conference (highly recommended)
#msg-59783582 Transcript of 4Q10 conference call (2/9/10)
#msg-28748329 MNTA helps FDA solve contaminated-heparin problem
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-52632000 ‘The Golden Age of Biogenerics’ (Forbes)
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-54327728 MNTA receives US patent on Lovenox characterization
#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-59684426 Recent patent applications and overview of IP estate


News flow
#msg-60640906 2011-2012 possible/probable events
#msg-59599399 Seven bullish things that could happen anytime


Valuation and finances
#msg-59748088 MNTA logs 4Q10 profit of $0.77/sh
#msg-59749024 Lovenox operating margin bodes well for future quarters
#msg-59789788 Operating expenses will average $15-18M/qtr (net of R&D rev)
#msg-58058451 Latest financing transaction
#msg-57575439 New money will be used for FoB program
#msg-57539980 Financing will not materially affect 4Q10 EPS
#msg-58118280 Diluted share count for valuation purposes
#msg-56176508 $92M tax credit can be applied to Lovenox profits
#msg-59164333 Wedbush notes Teva’s disingenuous PR’s re Lovenox
#msg-59201009 Canaccord reiterates $27 price target (1/26/11)
#msg-55020801 Cowen values Lovenox program alone at mid $20s/sh
#msg-54022252 Dew’s valuation of MNTA’s non-Lovenox assets
#msg-57621347 Adjustment to above for lack of progress on M118
#msg-44687884 Potential Lovenox/Copaxone milestones = $163M
#msg-56166173 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-55811231 Additional milestones at anniversaries of Lovenox launch
#msg-44367437 Shelf registration filed 12/9/09


Management, BoD, and major shareholders
#msg-54286333 Composition of Board of Directors
#msg-58383722 Former Biogen executive appointed VP, Business Development
#msg-55907213 Musings on Steven Brugger’s departure
#msg-54286035 Ram Sasisekharan resigns from BoD (Sep 2010)
#msg-54532698 Musings on Ram’s decision
#msg-38633640 Bruce Downey, ex-CEO of Barr, joins BoD (Jun 2009)
#msg-33979910 James Sulat named Chairman of BoD (Dec 2008)
#msg-27338039 James Roach, CMO, joins MNTA (Feb 2008)
#msg-12824293 Craig Wheeler, CEO, joins MNTA from Chiron (Aug 2006)
#msg-49501257 How MNTA executed against 2009 internal goals
#msg-60304685 Insider shareholdings and options
#msg-60142538 Chairman exercises and holds 7K options (Feb 2011)
#msg-56169633 Outgoing COO exercises and holds 56K options (Nov 2010)
#msg-53029172 Tax rationale for 2H10 insider selling
#msg-59949123 Major shareholders
#msg-47147018 No legal impediments to an acquisition, but…
#msg-59693296 …Teva won’t buy MNTA (I guarantee it!)



LOVENOX PROGRAM

FDA approval and related litigation
#msg-52582225 Why FDA approved generic Lovenox (simple version)
#msg-52581746 Why FDA approved generic Lovenox (technical version)
#msg-58201819 FDA’s 5 criteria for Lovenox “sameness” are merely a starting point
#msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (NVS PR)
#msg-29282002 End of the line for Sanofi’s Lovenox patent (May 2008)

#msg-53730236 Judge denies Sanofi’s request for preliminary injunction
#msg-57781462 Sanofi seeks summary judgment
#msg-53731775 Index to legal/regulatory documents in SNY lawsuit


Economic rationale and profit split in US market
(See related section below on potential competition from other Lovenox generics.)
#msg-59225528 NVS’ 4Q10 Lovenox sales=$170M ($462M all told)
#msg-59749024 Lovenox operating margin bodes well for future quarters
#msg-59286675 Estimated run rate and channel inventory
#msg-55818120 How NVS/MNTA account for Lovenox on financial statements
#msg-33839164 MNTA’s economics depends on the number of generics
#msg-43761160 Lovenox royalty if multiple generics
#msg-44687884 Potential milestone payments of $163M
#msg-56166173 $5M fm NVS for FDA Lovenox approval is separate fm above
#msg-55811231 Additional milestones at anniversaries of Lovenox launch
#msg-44644009 Lovenox is essentially the entire LMWH market

#msg-59682124 Generic Lovenox has 55% retail-script share
#msg-59695921 SNY reports €233M of US Lovenox sales in 4Q10
#msg-56123442 Beware of SNY’s claims re Lovenox “volume” share
#msg-54355727 60-70% of US Lovenox market is hospital-based
#msg-59555188 Average price in hospital setting 35-40% lower than retail
#msg-60467081 Estimated profit margin of generic Lovenox in hospital setting
#msg-47460573 FDA label specs for dosing by indication
#msg-53625554 Proportion of Lovenox use by dose size


Potential Lovenox generics from other companies
#msg-59138957 FDA does not approve Teva’s ANDA (1/25/11)
#msg-59688528 Teva not commenting on ANDA (draw your own conclusions)
#msg-59151084 Example of minor-deficiency letter that led to ultimate rejection
#msg-59673351 Teva’s EPS guidance includes no contribution from Lovenox
#msg-59669784 Enox-o-what?
#msg-59172130 Musings on why Teva got an FDA response in Jan 2011

#msg-55670004 Teva admits its version of Lovenox not developed in-house…
#msg-56016886 …and my sources say it comes from ItalFarmaco
#msg-59485489 Court document confirms Teva’s Italian connection

#msg-54327728 MNTA receives US patent on Lovenox characterization
#msg-57290171 MNTA sues Teva for patent infringement (PR)
#msg-57302580 MNTA actual complaint filed with District Court
#msg-60638698 Pretrial timetable->Teva has no expectation of FDA approval
#msg-57319356 Teva’s PR response to MNTA lawsuit
#msg-57304268 Musings on the business rationale for MNTA’s lawsuit

#msg-54978841 Teva’s credibility is suspect on multiple fronts
#msg-59164333 Wedbush notes Teva’s disingenuous Lovenox statements
#msg-56487255 Why Teva is behaving like a baseball manager (1)
#msg-56956538 Why Teva is behaving like a baseball manager (2)
#msg-53070505 Musings on a Teva approval (ThomasS)
#msg-52985447 Musings on a Teva approval (tinker)(1)
#msg-53026617 Musings on a Teva approval (tinker)(2)
#msg-56047605 Musings on a Teva approval (tinker)(3)
#msg-56323662 Musings on a Teva approval (tinker)(4)
#msg-53053911 Musings on a Teva approval (RockRat)
#msg-52894756 Musings on a Teva approval (zipjet)
#msg-53090148 Musings on a Teva approval (oc631)
#msg-56267201 Musings on a Teva approval (Dew)(1)
#msg-56195372 Musings on a Teva approval (Dew)(2)

#msg-56531176 The sorry state of Amphastar’s application (1)
#msg-55920125 The sorry state of Amphastar’s application (2)
#msg-60610139 Amphastar responds to FDA’s motion to dismiss lawsuit
#msg-46348431 FDA dismisses Amphastar’s conflict-of-interest complaint
#msg-56496573 Link to GAO report alleging FDA bias (Nov 2010)
#msg-56450420 Political considerations do not favor Teva, Amphastar

#msg-56123199 SNY rules out an ‘authorized generic’
#msg-46578876 How MNTA would have been affected by an AG
#msg-33857504 Why SNY opted not to launch an AG (zipjet)

#msg-56096637 OSCS still contaminates US heparin supply (good for MNTA)
#msg-56000748 Lovenox knockoffs have varied potential for immunogenicity
#msg-58119661 Lovenox knockoffs may be unsafe in ACS
#msg-58254369 Antibodies to heparin-PF4 complex associated with poor survival


Lovenox competition from other anticoagulants
#msg-60525389 What’s new in the anticoagulant arena?
#msg-29698599 Musings on competition from new oral anticoagulants (1)
#msg-58484489 Musings on competition from new oral anticoagulants (2)
#msg-55569376 Generic Arixtra could be approved in 2011…
#msg-40342721 …but Arixtra is all but inconsequential to MNTA
#msg-56880416 Apixaban program in ACS discontinued
#msg-39151366 Xarelto has a long way to go in ACS
#msg-57502712 What is Angiomax?
#msg-36668503 Integrilin whiffs in ‘upstream’ ACS
#msg-55348772 Phase-2a data for Regado’s RB006/RB007
#msg-55640856 Musings on Regado’s program
#msg-50887745 Musings on relevance of PolyMedix’s PMX-60056


Generic/biosimilar Lovenox outside the US
#msg-55882487 Musings on Lovenox development outside US
#msg-52625998 EU requirements for Lovenox biosimilars and patent info



COPAXONE PROGRAM

FDA application
#msg-30621490 FDA accepts NVS/MNTA ANDA for review
#msg-59964880 FDA review is not taking unduly long
#msg-60518523 MNTA has submitted workaround for ‘Gad’ patents
#msg-58062330 Hatch-Waxman 30-month clock has expired
#msg-57427318 Copaxone FUD from Sanford Bernstein
#msg-54201872 Wedbush is bullish on MNTA’s Copaxone (9/7/10)
#msg-48167251 Will Copaxone ANDA require clinical trials?
#msg-59000596 Handicapping the Copaxone ANDA
#msg-30649453 Notes on Copaxone ANDA from 7/11/08 conference call
#msg-57629433 Teva submits a third Citizen Petition (LOL)
#msg-50163309 Link to FDA rejection of Teva’s 2nd Citizen Petition
#msg-50113814 Leerink Swann on rejection of Teva’s 2nd CP (1)
#msg-50149604 Leerink Swann on rejection of Teva’s 2nd CP (2)
#msg-50185042 Musings on Teva’s CP rejection from BioWorld Today
#msg-30647865 “Controlled chaos” and reverse engineering
#msg-48166546 Teva’s disinformation campaign (10^28 permutations)
#msg-53260088 Musings on regulatory outlook (COO Steven Brugger)
#msg-48127583 Musings on regulatory outlook (dewophile)
#msg-48145473 Musings on regulatory outlook (genisi)
#msg-52577893 Musings on regulatory outlook (Dew)
#msg-57072104 Copaxone does not have any “junk” (1)
#msg-58881765 Copaxone does not have any “junk” (2)
#msg-52702351 FDA might grant bioequivalence waiver
#msg-58119344 Weizmann monograph on chemistry of Copaxone
#msg-60150443 Copaxone paper in The Journal of Immunology


Economic rationale and profit split
#msg-57054326 Why Copaxone?
#msg-59647292 US Copaxone sales are $2.6B per annum
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-44687884 Potential milestone payments are $163M
#msg-53081150 Ex-US market for generic Copaxone not especially attractive
#msg-55641123 5-year Copaxone data in CIS


Patent litigation
#msg-54113660 List of Copaxone patents in Teva-NVS/MNTA litigation
#msg-54150823 Index to legal documents in Teva-NVS/MNTA litigation
#msg-56222992 Docket for Teva-Mylan (now consolidated w Teva-NVS/MNTA)
#msg-55490818 Teva thinks it could lose patent case, evidently
#msg-56147443 NVS/MNTA will pursue four tacks in litigation
#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-59368793 Branded Copaxone has weak IP protection (tinkershaw)
#msg-52735648 Handicapping the Copaxone case (Wall Street)
#msg-59693896 Handicapping the Copaxone case (exwannabe)
#msg-59688565 Handicapping the Copaxone case (Dew)
#msg-56326587 Handicapping the Copaxone case (zipjet)
#msg-54139320 Court denies summary judgment, no trial date yet
#msg-56215358 Musings on the likelihood of “at-risk” launch


Potential competition from other generic and branded drugs
#msg-29902618 Mylan inks Copaxone deal with India’s Natco
#msg-60289240 Mylan’s 30-month Hatch-Waxman stay expires Mar 2012
#msg-59685034 MNTA’s new patent reduces MYL’s prospects
#msg-58083875 FDA rejects Teva’s ‘low-volume’ Copaxone
#msg-50939364 Clinical data for low-volume Copaxone was weak
#msg-59788384 Low-volume Copaxone is presumably dead
#msg-59919610 Musings on thrice-weekly Copaxone
#msg-51168875 FDA approves NVS’ Gilenya
#msg-59293907 How is Gilenya affecting Copaxone?
#msg-56524579 Copaxone will hold its own against Gilenya (Leerink Swann)
#msg-52553991 Copaxone will hold its own against Gilenya (haaretz.com)
#msg-54849106 Copaxone will hold its own against Gilenya (genisi)
#msg-59296554 Copaxone will hold its own against Gilenya (tinkershaw)
#msg-54826950 FDA labels of approved MS drugs
#msg-54834214 Copaxone is only approved MS drug with pregnancy Category B
#msg-56125835 Worldwide market share in MS (2Q10)
#msg-39971611 US market share in MS (2Q09)
#msg-59647292 Copaxone is cleaning Tysabri’s clock in US market
#msg-60115928 Tysabri has 95 cases of PML, 21% fatal
#msg-60144268 Musings on Tysabri’s PML rate
#msg-55805176 Black-box warning from Tysabri’s FDA label (Nov 2009)
#msg-58131215 MS drugs in late-stage development (Oct 2010)
#msg-31553565 Musings on MS drugs in development (genisi, 8/08)
#msg-57586166 Chart of comparative efficacy of MS drugs
#msg-60477805 FDA rejects Cladribine (again)
#msg-57981307 Campath slides from 12/20/10 Genzyme webcast
#msg-55545333 Campath 5-year data from phase-2
#msg-34832939 Musings on Campath
#msg-55641299 Sanofi’s Teriflunomide Cuts MS Relapse Rate by 31%
#msg-55927582 New Teriflunomide phase-3 trial with IFN
#msg-57549574 Phase-3 Laquinimod data from ALLEGRO study
#msg-55116264 Peptimmune files Citizen Petition against generic Copaxone (1)
#msg-55134848 Peptimmune files Citizen Petition against generic Copaxone (2)



OTHER R&D PROGRAMS

Follow-on Biologics (FoB) program(s)
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-48581353 What the new healthcare law says about FoB’s
#msg-26837144 Momenta’s mantra on biogenerics
#msg-60342122 FoB ‘cheat sheet’
#msg-59828805 Musings on terms of an FoB collaboration
#msg-57601389 Presentation by James Roach at FDA hearing on FoB’s
#msg-58469454 Musings on how an FoB applies to disparate indications
#msg-56429332 MNTA publishes Orencia paper in Nature Biotechnology…
#msg-56433178 …which presumably means MNTA has an Orencia FoB
#msg-59020436 Why Orencia?
#msg-56471065 Orencia factoids
#msg-59857407 Notes on possible TNF-alpha FoB’s
#msg-53728063 Prognostic value of FDA’s actions vis-à-vis Copaxone and FoB’s
#msg-54034992 Speculation re Integrilin FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena


M118 program for acute coronary syndromes
(See Lovenox section for info on potential competition from oral anticoagulants.)
#msg-39146357 M118 quick primer
#msg-51227061 How large is the anticoagulant market?
#msg-57237257 Musings on the M118 phase-2b program (1)
#msg-57258943 Musings on the M118 phase-2b program (2)
#msg-56388251 Example of how large ACS trials must be (Cangrelor)
#msg-56881418 With failure of Apixaban, BMY/PFE are potential partners
#msg-56915307 M118 partnership musings

#msg-26898084 Cartoon: How M118 binds to FIIa and FXa
#msg-31027378 M118 has no drug interaction with aspirin or Plavix…
#msg-31029674 …but Lovenox does (i.e. advantage: M118)
#msg-41846746 Data from phase-2a EMINENCE study
#msg-48837450 Non-inferiority analysis from EMINENCE study
#msg-48837695 Kaplan-Meier curves from EMINENCE study
#msg-31057367 Phase-1 results with subcutaneous formulation
#msg-48705801 Apr 2010 paper in Circulation
#msg-48815510 Review of Circulation paper by TCTMD
#msg-43301340 Nov 2009 paper in Thrombosis and Hemostasis
#msg-27272430 Feb 2008 paper in Blood


M402 oncology program
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-60373285 Upcoming presentation at 2011 AACR
#msg-56124256 Preclinical data from 2010 AACR
#msg-47769823 Description of program from 10K report
#msg-37152092 Presentation at 2009 AACR
#msg-56822655 Paper from Investigational New Drugs
#msg-55872859 Paper from Journal of Hematological Oncology
#msg-55517588 Paper from Methods in Molecular Biology



INTELLECTUAL PROPERTY

#msg-57290171 MNTA sues Teva for patent infringement (PR)
#msg-54327728 US patent #7,790,466 re Lovenox characterization
#msg-55899246 US patent #7,816,144 (continuation of above)
#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-59684426 Recent patent applications and overview of IP estate
#msg-55997916 Patent app re LMWH composition
#msg-55510863 Patent app re purity of heparin API



PUBLICATIONS

#msg-59966324 Barron’s opines re MNTA’s overall prospects (2/11)
#msg-48115945 Weizmann Institute re chemistry of Copaxone (date unknown)
#msg-52862494 Globes online (Israel) interview with Sandoz CEO (8/10)
#msg-52632000 Forbes re ‘The Golden Age of Biogenerics’ (7/10)
#msg-52606143 NY Times re FDA approval (7/10)
#msg-28748329 Nature Biotechnology re contaminated heparin (4/08)
#msg-25160571 WSJ re anticoagulant market (12/07)
#msg-23005127 Nature re FoB’s (9/07)
#msg-20308884 Lab Technologist re production process (6/07)
#msg-25803923 The Pink Sheet interview with C. Wheeler (3/07)
#msg-7370282 WSJ re MNTA’s raison d’etre (8/05)
#msg-25779774 Boston Globe re MNTA’s IPO (11/04)
#msg-33867074 Signals Magazine re glycobiology (9/03)

[HattieTheWitch]

[Updates: discovery in Lovenox patent-infringement suit runs until Nov 2012; removed entry for Copaxone ‘Gad’ lawsuit because it is now moot.]

Further to my previous question about the delayed discovery - is your opinion arrived at because of matters related to the "Gad" lawsuit (which I don't fully understand, but anyway...)?

Thank you.

[DewDiligence]

MNTA 2011-2012 News Flow

[Added qualifier re ruling on Copaxone Markman hearing.]


Lovenox

• Nov 2012: End of pretrial discovery in NVS/MNTA’s patent-infringement suit against Teva. (The earliest possible trial is in 2013.)


Copaxone

• Timing uncertain: FDA feedback on Copaxone ANDA. MNTA would presumably disclose these details only if they were deemed to have a material affect on the probability or timing of FDA approval.

• Timing uncertain: District Court ruling on Markman hearing. This may provide early feedback on the likely outcome of the Copaxone patent trial with respect to Teva’s Orange-Book and process patents; however, it is not assured that the Judge will rule on the Markman hearing prior to the trial.

• 7-Sep-2011: Start of trial on validity/enforceability of Teva’s Orange-Book and process patents.


Other programs

• Mid 2011: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.

• Timing uncertain: Announcements regarding MNTA’s FoB programs.

• Timing and occurrence uncertain: M118 partnership. (Phase-2b/3 trials in ACS are sufficiently large and expensive that MNTA will not conduct such trials without a partner.)