Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
2Q14 financial results;
projected end-of-2014 cash balance =$169M;
generic-Copaxone sales and profit arithmetic;
MNTA discontinues M511 (the original “third” FoB in BAX collaboration);
2014-2015 news flow;
transcript of 2Q14 conference call.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-104919443 Transcript of 2Q14 conference call (7/31/14)
#msg-102377753 Transcript of presentation at BofA conference (5/13/14)
#msg-25473104 Capsule summary of proprietary technology
#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-104928571 2014-2015 possible/probable events


Valuation and finances
#msg-104919839 2Q14 financial results
#msg-104919839 Projected end-of-2014 cash balance =$169M
#msg-76922372 Diluted share count for valuation purposes
#msg-72178468 Potential Copaxone milestones from NVS are ~$115M
#msg-101616310 MNTA’s Copaxone profits will receive special accounting due to litigation

#msg-104481093 Biotech partnerships often lead to buyout bids
#msg-47147018 No legal impediments to a buyout


Management, BoD, and major shareholders
#msg-87125406 Composition of Board of Directors
#msg-104514165 Insider shareholdings and options
#msg-61651527 Officers’ restricted stock vests on Copaxone approval
#msg-104507190 Major shareholders

#msg-94898356 Michael Franken named head of FoB program (12/13)
#msg-58383722 Young Kwon named VP, Business Development (1/11)
#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-104928432 Sales and profit arithmetic for generic Copaxone
#msg-12222305 NVS/MNTA split profits 50/50 in all cases
#msg-72178468 Estimated potential milestones from NVS: $115M
#msg-53081150 Ex-US market for generic Copaxone not attractive


Patent litigation
#msg-90368371 Appellate Court invalidates Teva’s ‘808 Copaxone patent
#msg-99767989 US Supreme Court to review ‘808 patent case
#msg-103869690 US DoJ amicus brief for USSC is bullish for MNTA
#msg-99802027 NVS/MNTA will surely launch “at risk” (1)
#msg-99799387 NVS/MNTA will surely launch “at risk” (2)
#msg-100003507 USPTO rejects Teva’s attempt to re-issue ‘808 patent


FDA review
#msg-101929561 FDA is presumably evaluating MNTA’s gene-expression data (1)
#msg-103988333 FDA is presumably evaluating MNTA’s gene-expression data (2)
#msg-101928410 Safety and efficacy trials will clearly not be needed
#msg-30621490 FDA accepts MNTA’s Copaxone ANDA for review (Jul 2008)


Potential competition from other generic Copaxone 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-103988333 No indication that Mylan has submitted gene-expression data
#msg-70039774 Synthon submits Copaxone ANDA (Dec 2011)…
#msg-99675480 …but acknowledges receiving an unresolved CRL
#msg-62355790 Musings on a Copaxone ‘authorized generic’



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#msg-104501563 FoBs will be $35B market by 2020, says market consultant
#msg-104534644 More color on $35B forecast for 2020
#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-104919839 MNTA discontinues M511 (the original “third” FoB in BAX program)
#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-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-71975717 MNTA’s royalty rate is 10-12% with two tiers
#msg-104919839 2Q14 Lovenox royalties were $5.7M on $54M of sales
#msg-55882487 Musings on Lovenox development outside US


FDA actions and product launches
#msg-52620730 FDA approves NVS/MNTA’s generic Lovenox
#msg-67230597 FDA approves generic Lovenox from Amphastar
#msg-71365074 Amphastar/Actavis launch generic Lovenox
#msg-103658912 FDA approves Teva’s generic Lovenox
#msg-52582225 FDA’s criteria for approval of generic Lovenox



OTHER R&D PROGRAMS

M402 oncology program
#msg-102765888 M402 receives FDA Orphan Drug designation
#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-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-77593979 How MNTA intends to differentiate its version of IVIG
#msg-101443478 MNTA reports preclinical data on IVIG program
#msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals
#msg-69681347 Musings on the Virdante deal


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-59682546 USPTO issues ‘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)