Replies to post #160736 on Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Updates:
2013-2014 news flow;
transcript of webcast at Bank of America conference (5/16/13);
clinicaltrials.gov listing for revised M402 trial.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-87974272 Transcript of Bank of America webcast (5/16/13)
#msg-87418114 Transcript of 1Q13 conference call (4/30/13)
#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-87862037 2013-2014 possible/probable events
#msg-87414106 Bullish things that could happen at almost any time


Valuation and finances
#msg-87393720 1Q13 financial results
#msg-87393720 3/31/13 cash=$344M; projected 2013 burn=$80-90M
#msg-76922372 Diluted share count for valuation purposes
#msg-87412567 Estimated NPV of MNTA’s Lovenox royalty stream
#msg-81498217 Timing of FoB payments from BAX
#msg-72178468 Potential Copaxone milestones from NVS are ~$115M
#msg-77977706 MNTA’s NOL’s are no longer a significant asset
#msg-73668882 Lovenox split between NVS-MNTA could be renegotiated, says SB
#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-86824967 Insider shareholdings and options
#msg-61651527 Officers’ restricted stock vests on Copaxone approval
#msg-85541345 Major shareholders

#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)



LOVENOX PROGRAM

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


Patent-infringement suit
#msg-78175269 Appellate Court lifts preliminary injunction against Amphastar
#msg-85069427 MNTA seeks review by US Supreme Court
#msg-85000563 Crux of MNTA’s argument for USSC review
#msg-85001482 Musings on USSC review (FDA Law Blog)
#msg-85463936 Musings on USSC review (Hyman Phelps)
#msg-86729956 Musings on USSC review (Fenwick & West)
#msg-85329473 Musings on USSC review (mouton29)
#msg-85074161 Musings on USSC review (biomaven)
#msg-78279823 Musings on Hatch-Waxman ‘safe harbor’ (ipwatchdog.com)

#msg-67308386 NVS/MNTA sue Amphastar/ACT for patent infringement
#msg-67310706 NVS/MNTA Complaint vs Amphastar/ACT
#msg-68468114 District Court says NVS/MNTA likely to win patent trial
#msg-78395974 Parties stay proceedings in District Court pending higher review
#msg-77266994 Markman (claims construction) ruling in Lovenox patent case
#msg-67313777 Descriptions of MNTA’s ‘886 and ‘466 patents
#msg-68479105 ‘466 patent could still be in play
#msg-67941277 Patent claims where NVS/MNTA allege infringement
#msg-69012802 NVS/MNTA agree on 65/35 split of $100M Court bond
#msg-69022234 Split of Court bond suggests potential split of judgment/settlement
#msg-57290171 NVS/MNTA sue Teva for patent infringement
#msg-57302580 NVS/MNTA complaint vs Teva


Sales, market share, and pricing of generic Lovenox
#msg-87216520 NVS reports $47M of 1Q13 Lovenox sales
#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-44644009 Lovenox is essentially the entire LMWH market
#msg-55882487 Musings on Lovenox development outside US


Lovenox competition from other anticoagulants
#msg-87324014 What’s new in the anticoagulant arena?
#msg-82279707 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?



COPAXONE PROGRAM

FDA review
#msg-87862037 Even with delayed launch, FDA tentative approval is consequential
#msg-30621490 FDA accepts NVS/MNTA ANDA for review
#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-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)

#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-60686112 MNTA may be conducting a bioequivalence study (1)
#msg-60741332 MNTA may be conducting a bioequivalence study (2)
#msg-52702351 FDA might grant bioequivalence waiver


Economic rationale and profit split
#msg-57054326 Why Copaxone?
#msg-87482341 Annualized US Copaxone sales=$3.3B, despite competition
#msg-81090759 Copaxone has >40% US Rx share among MS drugs
#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-76898031 MNTA loses Copaxone patent case in District Court…
#msg-77983332 …but an appeal is filed to the Federal Circuit Court
#msg-85870008 ‘De novo’ claims construction enables possible appellate reversal
#msg-77877734 Full text of District Court Order in Copaxone patent case
#msg-54113660 List of Copaxone patents being litigated
#msg-81717993 Timing of Copaxone patent expirations
#msg-66864421 Summary of NVS/MNTA/MYL arguments in patent trial
#msg-61953697 MNTA is indemnified against liabilities from patent litigation


Potential competition from other generic and branded drugs
#msg-29902618 Mylan inks Copaxone deal with India’s Natco
#msg-59685034 MNTA’s patent could impede Mylan’s prospects
#msg-70039774 Synthon submits Copaxone ANDA
#msg-70049144 Synthon’s Copaxone trial for FoB approval in Europe
#msg-62355790 Musings on a Copaxone ‘authorized generic’

#msg-76905526 US Copaxone market is sticky (1)
#msg-62810742 US Copaxone market is sticky (2)
#msg-61960285 Efficacy data from FDA Copaxone label
#msg-54834214 Copaxone is only approved MS drug with pregnancy Category B

#msg-87520671 Teva submits sNDA for thrice-weekly Copaxone
#msg-87522151 Musings on prospects for thrice-weekly Copaxone
#msg-76611659 Teva’s phase-3 data on thrice-weekly Copaxone
#msg-76644423 Thrice-weekly Copaxone can’t be substituted for regular Copaxone
#msg-58083875 FDA rejects Teva’s “low-volume” Copaxone

#msg-86187520 FDA approves Tecfidera (BG-12)
#msg-76925827 Musings on Tecfidera’s commercial uptake (Citi)
#msg-77810032 US sales of Gilenya have hit a plateau
#msg-79503144 FDA approves SNY’s Aubagio


FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#msg-70212854 MNTA inks worldwide FoB partnership with BAX
#msg-70258421 ‘Biobucks’ scorecard for the MNTA-BAX partnership
#msg-81498217 Timing of Fob Payments from BAX
#msg-80359616 Slide on MNTA partnership from BAX Investor Day
#msg-70612914 Transcript of 12/23/11 CC to discuss BAX deal
#msg-72624576 Redacted version of BAX-MNTA contract
#msg-70261411 BAX pays for post-IND development and commercialization
#msg-78116738 BAX-MNTA begin work of a third undisclosed FoB compound
#msg-78126680 Fees earned by MNTA on third compound come when BAX licenses it
#msg-70235751 Timing of MNTA’s opt-in on FoB’s #3-#6
#msg-78125123 Musings on identities of first three FoB compounds
#msg-78163795 US patent expirations of Humira, Orencia, and Erbitux
#msg-78195937 Why Rituxan is probably not one of the BAX-MNTA FoB’s

#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-78005361 Orencia sells at annualized rate of $1.2B

#msg-70249988 Musings on the terms of the BAX deal (rkrw)
#msg-70239632 Musings on the terms of the BAX deal (Dew)
#msg-70266174 Musings on BAX as the chosen partner

#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-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-61414941 FoB’s will sell $3.7B in 2015, says Datamonitor
#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



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-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



INTELLECTUAL PROPERTY

#msg-84501925 Musings on trade secrets and FDA disclosure policy
#msg-84865864 Recent patent applications and overview of IP estate
#msg-54327728 ‘466 patent issued on Lovenox characterization
#msg-69165740 ‘235 patent is workaround to Teva’s “Gad” patents
#msg-59682546 ‘187 patent issued on Copaxone manufacturing
#msg-69595597 MNTA acquires sialic switch IP from Virdante Pharmaceuticals
#msg-69681347 Musings on the Virdante deal



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)