Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
NVS/MNTA had 55% share of 2Q11 US Lovenox dollar sales;
Copaxone had record $2.7B annualized US sales in 2Q11;
MYL CEO’s comment on Copaxone litigation to date;
how Gilenya is affecting Copaxone;
2011-2013 news flow;
quarterly expenses will average $19-22M (GAAP), $15-18M (cash);
diluted share count for valuation purposes.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-64030605 Goldman Sachs webcast is a must-listen (6/8/11)
#msg-62559655 FDA official cites MNTA in discussion of FoB pathways
#msg-62941793 FDA reiterates commitment to issue FoB guidance in 2011
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-26837144 Momenta’s mantra on biogenerics
#msg-28748329 MNTA helps FDA solve contaminated-heparin problem
#msg-54327728 MNTA receives US patent on Lovenox characterization
#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-28865474 Characterizing a compound by “ruling out” structures
#msg-62805507 Transcript of 1Q11 conference call (5/5/11)
#msg-65394680 Recent patent applications and overview of IP estate


News flow
#msg-65636755 2011-2013 possible/probable events
#msg-64630031 Five bullish things that could happen at any time


Valuation and finances
#msg-62771119 1Q11 net income=$1.13/sh (2Q11 results 8/4/11)
#msg-62862460 Effective cash balance at 3/31/11 was $260M
#msg-65391960 Qtrly expenses will average $19-22M (GAAP), $15-18M (cash)
#msg-62215094 ‘Cheat sheet’ on MNTA’s income taxes
#msg-65636329 Diluted share count for valuation purposes
#msg-60906809 Potential Copaxone/Lovenox milestones exceed $163M
#msg-62296467 Valuation musings (tinkershaw)
#msg-63912789 Dew’s valuation of MNTA’s non-Lovenox assets
#msg-47147018 No legal impediments to a buyout
#msg-62283456 Musings on possibility of NVS buyout
#msg-59693296 Teva won’t acquire MNTA


Management, BoD, and major shareholders
#msg-62461556 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-62463569 How MNTA executed against 2010 internal goals
#msg-65105650 Insider shareholdings and options
#msg-61651527 Officers’ restricted stock vests on Copaxone approval
#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-62462429 Major shareholders



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-65315981 NVS reports $284M of 2Q11 Lovenox sales
#msg-65334145 $993M—largest 12-month sales ever by a generic drug
#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-60906809 Milestone payments from NVS at anniversaries of US launch
#msg-44644009 Lovenox is essentially the entire LMWH market

#msg-65000799 Generic had 86% of Lovenox outpatient scripts in Jun 2011…
#msg-65635956 …and 55% share of US dollar sales in 2Q11
#msg-65022529 Plot of branded and generic Lovenox scripts (7/10-6/11)
#msg-62838164 NVS/MNTA’s capacity constraint is deliberate

#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-59164333 Wedbush notes Teva’s disingenuous Lovenox statements
#msg-59151084 Example of minor-deficiency letter that led to ultimate rejection
#msg-59673351 Teva’s EPS guidance includes no contribution from Lovenox
#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-57304268 Musings on the business rationale for MNTA’s lawsuit
#msg-61591240 Feb 2013 trial date->Teva has no expectation of FDA approval
#msg-57319356 Teva’s PR response to MNTA lawsuit

#msg-54978841 Teva’s credibility is suspect on multiple fronts
#msg-62133298 Cowen doubts credibility of Teva’s Lovenox ANDA
#msg-61589357 Enox-o-what?
#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-64340400 HSP’s Lovenox ANDA is for vial formulation only
#msg-33961609 Vial formulation is considered a distinct product
#msg-64319647 Musings on HSP’s ANDA

#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-62838164 NVS/MNTA’s capacity constraint is deliberate

#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-64862415 What’s new in the anticoagulant arena?
#msg-64862315 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?
#msg-65132332 FDA approves generic Arixtra
#msg-57502712 Angiomax backgrounder
#msg-55640856 Musings on Regado’s RB006/RB007
#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
#msg-60906809 Estimated potential milestones from NVS: $48M



COPAXONE PROGRAM

FDA review
#msg-30621490 FDA accepts NVS/MNTA ANDA for review
#msg-59964880 FDA review is not taking unduly long
#msg-60686112 MNTA may be conducting a bioequivalence study (1)
#msg-60741332 MNTA may be conducting a bioequivalence study (2)
#msg-60838182 Copaxone activity can be measured (1)
#msg-62672351 Copaxone activity can be measured (2)
#msg-48167251 Safety and efficacy trials will not be needed
#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-60836359 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-62613681 Weizmann paper on chemistry of Copaxone
#msg-60150443 Copaxone paper in The Journal of Immunology


Economic rationale and profit split
#msg-57054326 Why Copaxone?
#msg-65594032 Copaxone has $2.7B annualized US sales
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-60906809 Estimated potential milestones from NVS: $115M
#msg-62969588 Copaxone has 40% US prescription share among MS drugs
#msg-53081150 Ex-US market for generic Copaxone not especially attractive


Patent litigation
#msg-64376023 Main portion of Copaxone patent trial begins 9/7/11
#msg-65627476 MYL CEO’s comment on the inequitable conduct mini-trial
#msg-61953697 MNTA is indemnified against liabilities from 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-60899488 Markman ruling prior to trial is not assured
#msg-54139320 Court denies summary judgment on indefiniteness argument

#msg-59682546 MNTA receives US patent on Copaxone characterization
#msg-56147443 NVS/MNTA will pursue four tacks in litigation
#msg-33580867 Rationale for inequitable conduct argument against Teva
#msg-63573604 Showing inequitable conduct just got harder
#msg-55490818 Teva thinks it could lose patent case, evidently
#msg-61312284 Patent suit could be settled if FDA approves ANDA
#msg-62133298 Cowen agrees, evidently

#msg-52735648 Branded Copaxone has weak IP protection (Wall Street)
#msg-59368793 Branded Copaxone has weak IP protection (tinkershaw)
#msg-64430231 Handicapping the Copaxone case (various iHub posters)


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-62810742 Musings on MS market from 1Q11 CC
#msg-62346151 Teva might continue detailing Copaxone after generic launch
#msg-62355790 Musings on a Copaxone ‘authorized generic’

#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-63817727 Musings on Teva’s thrice-weekly Copaxone (1)
#msg-63836262 Musings on Teva’s thrice-weekly Copaxone (2)

#msg-54677007 FDA approves NVS’ Gilenya
#msg-65574194 How does Gilenya affect Copaxone?
#msg-56524579 Copaxone will hold its own against Gilenya (Leerink Swann)
#msg-59296554 Copaxone will hold its own against Gilenya (tinkershaw)

#msg-65594032 Copaxone outsells Tysabri 4:1 in US market
#msg-61835910 Apr 2011 Tysabri label update (102 cases of PML, 21% fatal)
#msg-60144268 Musings on Tysabri’s PML rate
#msg-60984424 Biogen halts Tysabri ‘switching’ study due to slow enrollment

#msg-54826950 FDA labels of approved MS drugs
#msg-61960285 Efficacy data from FDA Copaxone label
#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-58131215 MS drugs in late-stage development (Oct 2010)
#msg-31553565 Musings on MS drugs in development (genisi)
#msg-57586166 Chart of comparative efficacy of MS drugs
#msg-61959592 Musings on the crop of oral MS drugs

#msg-61953183 Laquinimod data from ALLEGRO study
#msg-62320268 BG-12 data from DEFINE study are impressive
#msg-62375616 BG-12 data from CONFIRM study due Sep 2011
#msg-62384175 BG-12 is not the same drug as Fumaderm
#msg-62332894 Musings on BG-12 threat to Copaxone
#msg-55641299 Phase-3 Teriflunomide data from TESMO study
#msg-55927582 SNY starts phase-3 trial of Teriflunomide+IFN
#msg-64489232 Merck KGaA terminates Cladribine program

#msg-65048827 Mixed phase-3 data for Lemtrada
#msg-57981307 Lemtrada slides from 12/20/10 Genzyme webcast
#msg-62085679 Lemtrada 5-year data from phase-2

#msg-61504526 FDA denies Peptimmune’s Citizen Petition (3/11)
#msg-62661879 Updated link to Peptimmune’s CP
#msg-55116264 Peptimmune’s PR announcing CP filing (10/10)
#msg-60953425 Mylan’s response to Peptimmune’s CP
#msg-61204770 Peptimmune (unsurprisingly) files for bankruptcy



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#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-62559655 FDA official cites MNTA in discussion of FoB pathways
#msg-62631138 Addendum to above discussion
#msg-62941793 FDA reiterates commitment to issue FoB guidance in 2011
#msg-63126386 BioCentury article spells out regulatory pathway for US FoB’s
#msg-63127867 Crux of the issue for US FoB’s
#msg-62805964 Limited clinical trials will be required, at least initially (1)
#msg-62958889 Limited clinical trials will be required, at least initially (2)
#msg-64153324 Musings on MNTA’s FoB technology and partnership prospects (1)
#msg-64278731 Musings on MNTA’s FoB technology and partnership prospects (2)

#msg-61414941 FoB’s will sell $3.7B in 2015, says Datamonitor
#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-54034992 Speculation re Integrilin FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena



OTHER R&D PROGRAMS

M402 oncology program
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-47769823 Description of program from 10K report
#msg-64437243 M402 paper in PLoS ONE
#msg-60373285 Presentation at 2011 AACR
#msg-56822655 Paper from Investigational New Drugs
#msg-55872859 Paper from Journal of Hematological Oncology
#msg-55517588 Paper from Methods in Molecular Biology


M118 program for acute coronary syndromes
#msg-63912778 M118 program removed from Dew’s valuation model
#msg-39146357 M118 quick primer
#msg-56915307 M118 partnership musings
#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-26898084 Cartoon: How M118 binds to FIIa and FXa
#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 Musings on above by an interventional cardiologist



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-65394680 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-63126386 BioCentury re prospects for US FoB’s (5/11)
#msg-59966324 Barron’s opines re MNTA’s business plan (2/11)
#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)