Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
Why MNTA?
USPTO IPR re Teva’s 40mg patents on 5/2/16;
~80% of patents subject to IPR are invalidated;
possible MNTA launch of 40mg Copaxone in Jan 2017;
2015-2016 news flow;
Glatopa estimates for 3Q15;
table of insider shareholdings and options.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-116498963 Why MNTA?
#msg-115947409 Transcript of 2Q15 CC
#msg-107107809 Transcript /slide set from 10/10/14 R&D Day
#msg-49883723 MNTA is a beneficiary of US FoB legislation
#msg-26837144 Momenta’s mantra on biogenerics


News flow
#msg-116783857 2015-2016 possible/probable events


Valuation and finances
#msg-116222279 Cash (~$400M) and 2H15 expense guidance
#msg-113297958 Glatopa addressable market (items 3-5)
#msg-116782888 Glatopa estimates for 3Q15
#msg-114728853 Glatopa milestone payments from NVS
#msg-116223816 Diluted share count for valuation purposes
#msg-116498963 Why MNTA? (buyout vig)


Officers and directors
#msg-113006744 Composition of Board of Directors
#msg-116368010 Insider shareholdings and options
#msg-114980910 Heavy insider selling Apr-Jun 2015 (following Glatopa approval)

#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-113297958 MNTA’s model of Glatopa’s addressable market
#msg-113300123 MNTA guides to $35K revenue per Glatopa patient-year
#msg-12222305 NVS/MNTA split Glatopa profits 50/50
#msg-116782888 Glatopa estimates for 3Q15
#msg-114728853 Glatopa milestone payments from NVS


FDA approval of Glatopa
#msg-112799454 FDA approves Glatopa (generic 20mg Copaxone)
#msg-112799896 FDA’s rationale for approval of Glatopa


Status of MNTA’s ANDA for 40mg generic Copaxone
#msg-105740021 FDA accepts MNTA’s ANDA for 40mg Copaxone
#msg-116691993 USPTO will conduct IPR re Teva’s 40mg patents on 5/2/16
#msg-116704965 ~80% of patents subject to IPR are invalidated
#msg-116497178 MNTA might be able to launch 40mg product in Jan 2017


Potential competition from other generic Copaxone products
#msg-112812696 No FDA roadmap for competing generics
#msg-112887376 MNTA’s Copaxone IP may thwart other generics

#msg-115996641 Mylan admits it has work to do on Copaxone ANDA
#msg-90636221 Mylan and MNTA products are not identical
#msg-112817624 Musings on likelihood of competition from other generics (MTB)
#msg-112848073 Musings on likelihood of competition from other generics (indigokid)

#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-115896634 PFE licenses Synthon’s Copaxone ANDA
#msg-70039774 Synthon submits Copaxone ANDA…
#msg-99675480 …but acknowledges receiving an unresolved CRL



LOVENOX PROGRAM

Patent-infringement lawsuit against Amphastar and Teva
#msg-115466389 US Solicitor General sides with MNTA on Safe Harbor issue (chase the dropbox link)
#msg-115468100 What happens next?
#msg-115493056 Preliminary injunction unlikely


Terms of NVS/MNTA partnership
#msg-114749299 NVS/MNTA split Lovenox profits 50/50



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 FoB partnership with BXLT
#msg-72624576 Redacted version of BXLT-MNTA contract
#msg-110925786 BXLT terminates collaboration for compounds other than Humira
#msg-111045283 Rationale for BXLT decision

#msg-107076513 Lead FoB compound confirmed to be Humira
#msg-108636687 Humira FoB begins phase-1 in Europe.
#msg-97088208 Rationale for starting Humira Fob in Europe
#msg-70237561 An interchangeable Humira FoB has colossal upside
#msg-79941294 Survey of rheumatologists is (paradoxically) bullish for MNTA
#msg-107107809 MNTA’s FoB pipeline includes Orencia & several other compounds

#msg-48581353 Affordable Care Act (ObamaCare) enables US FoBs
#msg-113503321 FDA guidance documents pertaining to FoBs.
#msg-26837144 Momenta’s mantra on biogenerics
#msg-70191760 US patent-expiration dates of big-selling biologics



NECUPARANIB PROGRAM

#msg-37030489 Rationale for a heparin-derived cancer drug
#msg-108636891 Necuparanib receives FDA Fast Track designation
#msg-102765888 Necuparanib receives FDA Orphan Drug designation
#msg-113635463 Necuparanib abstract from ASCO 2015
#msg-87859870 Clinicaltrials.gov listing for Necuparanib phase-1/2 trial
#msg-107107809 Necuparanib phase-1 data (slides 31-35)
#msg-107107809 Necuparanib phase-2 design (slides 41-42)
#msg-107073252 Phase-2 powered at 80% for 50% increase in OS
#msg-107143382 Phase-2 trial has potential to be pivotal



ENHANCED-IVIG PROGRAM

#msg-111515491 What is IVIG? (short videos)
#msg-107107809 Structure & rationale for MNTA’s compound (slides 118-131)
#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
#msg-106041077 MNTA exercises Anaptys option



INTELLECTUAL PROPERTY

#msg-84501925 Musings on trade secrets and FDA disclosure policy
#msg-111389703 Recent patent applications and overview of IP estate
#msg-59682546 USPTO issues ‘187 patent re Copaxone manufacturing
#msg-112887376 MNTA’s Copaxone IP may thwart other generics
#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’ (3/12)
#msg-66837147 NEJM on FoB pathway (9/11)
#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)