Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
table of insider shareholdings and options;
table of major shareholders.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-97088200 Transcript of 4Q13 conference call (2/10/14)
#msg-73905464 The Deal interviews Craig Wheeler on FoB’s
#msg-62559655 FDA official cites MNTA in discussion of FoB pathways
#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


News flow
#msg-97142022 2014-2015 possible/probable events


Valuation and finances
#msg-97046132 4Q13 financial results
#msg-97086827 12/31/13 cash=$266M; 2014 burn guidance=$120M
#msg-95157732 $19M milestone payments expected from BAX in 2014
#msg-76922372 Diluted share count for valuation purposes
#msg-88706198 Summary of UBS report on MNTA valuation (6/6/13)
#msg-72178468 Potential Copaxone milestones from NVS are ~$115M
#msg-87412567 Estimated NPV of MNTA’s Lovenox royalty stream
#msg-77977706 MNTA’s NOL’s are no longer a significant asset
#msg-47147018 No legal impediments to a buyout
#msg-83696645 Biotech partnerships often lead to buyout bids


Management, BoD, and major shareholders
#msg-87125406 Composition of Board of Directors
#msg-97214726 Insider shareholdings and options
#msg-61651527 Officers’ restricted stock vests on Copaxone approval
#msg-97329736 Major shareholders

#msg-94898356 Michael Franken named head of FoB program (12/13)
#msg-58383722 Young Kwon named VP, Business Development (1/11)
#msg-38633640 Bruce Downey, ex-CEO of Barr Labs, joins BoD (6/09)
#msg-33979910 James Sulat named Chairman of BoD (12/08)
#msg-27338039 James Roach, CMO, joins MNTA (2/08)
#msg-12824293 Craig Wheeler, CEO, joins MNTA from Chiron (8/06)



COPAXONE PROGRAM

Economic rationale and profit split
#msg-96918472 Annualized US Copaxone sales=$3.2B, despite competition
#msg-90394447 Musings on Copaxone’s US market share
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-72178468 Estimated potential milestones from NVS: $115M
#msg-90676220 Variables affecting NPV of NVS/MNTA Copaxone franchise
#msg-53081150 Ex-US market for generic Copaxone not attractive


Patent litigation
#msg-90362167 CAFC invalidates Teva’s 2015 patent, allowing MNTA to launch generic Copaxone in May 2014 (pending FDA approval)
#msg-90368371 MNTA’s PR on the Appellate Court ruling


FDA review
#msg-95181762 GDUFA regs suggest FDA response to Copaxone ANDA before 5/24/14
#msg-48167251 Safety and efficacy trials will not be needed…
#msg-60686112 …but MNTA may have conducted a bioequivalence study
#msg-30621490 FDA accepts MNTA’s Copaxone ANDA for review (Jul 2008)

#msg-60838182 Copaxone activity can be measured
#msg-30647865 ‘Controlled chaos’ and reverse engineering
#msg-48166546 Teva’s disinformation campaign (10^28 permutations)
#msg-82159882 FDA rejects Teva’s fourth Citizen Petition opposing generic Copaxone
#msg-76420849 Background info on Teva’s prior Copaxone CPs (1)
#msg-57629433 Background info on Teva’s prior Copaxone CPs (2)


Potential competition from other generic and branded drugs
#msg-29902618 Mylan inks Copaxone deal with India’s Natco (Jun 2008)
#msg-41441618 FDA accepts Mylan’s Copaxone ANDA for review (Sep 2009)
#msg-90636221 Mylan and MNTA products are not identical
#msg-95940872 Musings on Mylan’s Copaxone ANDA from JPM 2014
#msg-90376874 Musings on Mylan’s Copaxone ANDA (RockRat)
#msg-70039774 Synthon submits Copaxone ANDA (Dec 2011)
#msg-62355790 Musings on a Copaxone ‘authorized generic’

#msg-96486492 FDA approves Teva’s thrice-weekly Copaxone
#msg-76644423 Thrice-weekly Copaxone can’t be substituted for regular Copaxone
#msg-87522151 Musings on commercial prospects for thrice-weekly Copaxone
#msg-97213814 Pricing of thrice-weekly Copaxone (1)
#msg-97030461 Pricing of thrice-weekly Copaxone (2)
#msg-90582382 Teva will continue to detail regular Copaxone

#msg-86187520 FDA approves BIIB’s Tecfidera (BG-12)
#msg-79503144 FDA approves SNY’s Aubagio



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#msg-70212854 MNTA inks worldwide FoB partnership with BAX
#msg-72624576 Redacted version of BAX-MNTA contract
#msg-70261411 BAX pays for post-IND development and commercialization
#msg-96382526 MNTA’s opt-in right for profit/expense sharing on compounds #3–#6
#msg-97137725 M923 is very likely Humira
#msg-97088208 Musings on the clinical-trial pathway for M923
#msg-96382369 M834 could be Orencia
#msg-95157732 BAX passes on third FoB compound—MNTA to develop on own
#msg-96383250 Biobucks ‘cheat sheet’ for BAX collaboration

#msg-70236725 Humira factoids
#msg-70237561 An interchangeable Humira FoB has colossal upside (1)
#msg-70238965 An interchangeable Humira FoB has colossal upside (2)
#msg-79941294 Survey of rheumatologists is (paradoxically) bullish for MNTA

#msg-56429332 MNTA publishes Orencia paper in Nature Biotechnology (PR)
#msg-56456168 MNTA publishes Orencia paper in Nature Biotechnology (full text)
#msg-52853238 MNTA files patent application re Orencia

#msg-70249988 Musings on the terms of the BAX deal (rkrw)
#msg-70239632 Musings on the terms of the BAX deal (Dew)

#msg-73905464 The Deal interviews Craig Wheeler on FoB’s (3/30/12)
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-48581353 What the new healthcare law says about FoB’s
#msg-96733462 FDA guidelines on interchangeable FoB’s to be published in 2014
#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-66837147 NEJM article on FoB pathway
#msg-65845219 Musings on the NEJM article (by ‘MTB’)
#msg-63126386 BioCentury article spells out regulatory pathway for US FoB’s
#msg-63127867 Crux of the issue for US FoB’s
#msg-71919555 Limited clinical trials will be required, at least initially (1)
#msg-62805964 Limited clinical trials will be required, at least initially (2)

#msg-70191760 US patent-expiration dates of big-selling biologics
#msg-69265200 New AMGN patent takes Enbrel off list of MNTA’s likely candidates
#msg-57601389 Presentation by James Roach at FDA hearing on FoB’s
#msg-58469454 Musings on how an FoB applies to disparate indications
#msg-78694285 Musings on NVS’ standing in FoB market
#msg-54034992 Speculation re Integrilin FoB
#msg-33839321 Procognia is not a serious competitor
#msg-33597614 Also-ran companies in the FoB arena



LOVENOX PROGRAM

Patent-infringement lawsuit against generic competitors
#msg-95885236 Latest legal machinations
#msg-90167695 US District Court dismisses Lovenox patent case due to H-W ‘safe harbor’
#msg-89307368 US Supreme Court denies certiorari in Lovenox-patent case
#msg-89309317 Supreme Court denial presumably ends the Lovenox patent case
#msg-78175269 Appellate Court lifts preliminary injunction against Amphastar
#msg-89414428 Succinct analysis of the judicial machinations (Patent Docs blog)


Sales, market share, and pricing of generic Lovenox
#msg-96511934 NVS reports $51M of 4Q13 Lovenox sales
#msg-96531675 NVS’ Lovenox sales appear to have stabilized
#msg-71975717 MNTA’s royalty rate is 10-12% with two tiers
#msg-87412567 Estimated NPV of MNTA’s royalty stream
#msg-54355727 60-70% of US Lovenox market is hospital-based
#msg-59555188 Average price in hospital setting 35-40% lower than retail
#msg-55882487 Musings on Lovenox development outside US


FDA actions and product launches
#msg-71365074 Amphastar/ACT launch generic Lovenox
#msg-67230597 FDA approves generic Lovenox from Amphastar
#msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (syringe formulation)
#msg-69495753 FDA approves NVS/MNTA’s generic Lovenox (vial formulation)
#msg-59138957 FDA does not approve Teva’s Lovenox ANDA
#msg-66767716 Teva’s ANDA might not ever be approvable
#msg-52582225 FDA’s criteria for approval of generic Lovenox



OTHER R&D PROGRAMS

M402 oncology program
#msg-87393720 Phase-1/2 trial revised to include Abraxane
#msg-87859870 Clinicaltrials.gov listing for revised M402 trial
#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-76229566 PR re ASCO 2012 data
#msg-77188957 M402 poster from 2012 ASCO
#msg-77165730 Musings on M402’s probability of regulatory success
#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


Enhanced-IVIG program
#msg-97088208 IVIG program will seek recombinant product using Fc portion of mAbs
#msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals
#msg-69681347 Musings on the Virdante deal
#msg-77593979 How MNTA intends to differentiate its version of IVIG
#msg-89344512 USPTO issues sialylation patent licensed to MNTA


AnaptysBio collaboration
#msg-95041926 Press release from 12/17/13



INTELLECTUAL PROPERTY

#msg-84501925 Musings on trade secrets and FDA disclosure policy
#msg-96329109 Recent patent applications and overview of IP estate
#msg-69165740 ‘235 patent is workaround to Teva’s “Gad” patents
#msg-59682546 ‘187 patent re Copaxone manufacturing
#msg-89344512 USPTO issues sialylation patent licensed to MNTA



PUBLICATIONS

#msg-86139857 FiercePharma re FoB manufacturing (3/13)
#msg-85017663 Boston Business Journal re FoB’s (2/13)
#msg-73905464 The Deal interviews Craig Wheeler re FoB’s (3/12)
#msg-63126386 BioCentury re prospects for US FoB’s (5/11)
#msg-28748329 Nature Biotechnology re contaminated heparin (4/08)
#msg-23005127 Nature re FoB’s (9/07)
#msg-25803923 The Pink Sheet interviews Wheeler re MNTA’s technology (3/07)
#msg-25779774 Boston Globe re MNTA’s IPO (11/04)