Biotech Values

[DewDiligence]

MNTA ReadMeFirst

[Corporate and miscellaneous updates:
1Q12 financial results;
3/31/12 effective cash balance was $422M;
musings on NPV of MNTA’s royalty stream for Lovenox and overall valuation;
guidance for quarterly cash operating expenses is $22-28M;
Lovenox royalty rate is 10-12% with two tiers;
Lovenox split between NVS-MNTA could be renegotiated, says SB;
MNTA’s NOL’s no longer a significant asset;
how MNTA executed against 2011 internal goals;
UBS valuation report (7/20/12);
diluted share count for valuation purposes;
transcript of 6/7/12 Goldman Sachs webcast;
transcript of 1Q12 CC
table of insider shareholdings;
recent patent applications and overview of IP estate;
2012-2014 news flow;
bullish things that could happen at almost any time;

Lovenox updates:
Appellate Court lifts preliminary injunction on Amphastar/WPI launch;
WPI is taking a go-slow approach to Lovenox;
WPI director might be worried about MNTA’s lawsuit;
Markman (claims construction) ruling in Lovenox patent case;
NVS reports $156M of 2Q12 Lovenox sales;
new version of “How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?”;
new version of “What’s New in the Anticoagulant Arena?”;

Copaxone updated:
MNTA loses Copaxone patent case in District Court…but an appeal is filed to the Federal Circuit Court;
even with a delayed launch, FDA tentative approval of MNTA’s Copaxone ANDA is consequential;
Copaxone will remain big seller despite competition (Teva’s 2012 forecast);
Copaxone has 40% prescription share in US despite new oral competition;
Teva’s PR on GALA study thrice-weekly Copaxone;
approval of Teva’s thrice-weekly Copaxone unlikely before 2015;
thrice-weekly Copaxone can’t be substituted for regular Copaxone;
estimated market share for thrice-weekly Copaxone;
US Copaxone market is “sticky”;
US sales of Gilenya have hit a plateau;
2Q12 Tysabri sales;
Tysabri label update re JCV testing;
musings on BG-12 commercial uptake;

FoB updates:
‘The Deal’ interviews Craig Wheeler on FoB’s;
redacted version of BAX-MNTA contract;
transcript of 12/23/11 CC on BAX deal;

M402 updated:
first patient dosed in M402 phase-1/2 trial;
description of M402 trial from clinicaltrials.gov;
flowchart of M402 trial design;
M402 PR and poster from 2012 ASCO;
musings on M402’s probability of regulatory success;

Enhanced-IVIG program (new section of RMF):
how MNTA intends to differentiate its version of IVIG.]



CORPORATE AND FINANCIAL

What is MNTA’s business all about?
#msg-73905464 The Deal interviews Craig Wheeler on FoB’s
#msg-76396957 Transcript of 6/7/12 Goldman Sachs webcast
#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-77982169 2012-2014 possible/probable events
#msg-78079512 Bullish things that could happen at almost any time


Valuation and finances
#msg-75150121 1Q12 financial results
#msg-75182054 Transcript of 1Q12 CC (5/3/12)
#msg-77997663 Effective cash balance at 3/31/11 was $422M
#msg-75185636 Guidance for quarterly cash operating expenses is $22-28M
#msg-76922372 Diluted share count for valuation purposes
#msg-72178468 Potential Copaxone milestones from NVS are ~$115M
#msg-77977706 MNTA’s NOL’s are no longer a significant asset
#msg-77726801 UBS has neutral rating, $15 price target, and 2012 EPS of (0.73)
#msg-71982718 Musings on NPV of MNTA’s royalty stream for Lovenox
#msg-73668882 Lovenox split between NVS-MNTA could be renegotiated, says SB
#msg-76918548 Musings on MNTA’s overall valuation
#msg-47147018 No legal impediments to a buyout


Management, BoD, and major shareholders
#msg-62461556 Composition of Board of Directors
#msg-76922328 Insider shareholdings and options
#msg-61651527 Officers’ restricted stock vests on Copaxone approval
#msg-69174646 Major shareholders
#msg-74739058 How MNTA executed against 2011 internal goals

#msg-58383722 Young Kwon named VP, Business Development (1/11)
#msg-38633640 Bruce Downey, ex-CEO of Barr, 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)



INTELLECTUAL PROPERTY

#msg-77951712 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



LOVENOX PROGRAM

FDA actions and product launches
#msg-71365074 Amphastar/WPI 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-71346891 Appellate Court lifts PI on Amphastar/WPI
#msg-68468114 District Court says NVS/MNTA likely to win patent trial
#msg-67308386 NVS/MNTA sue Amphastar/WPI for patent infringement
#msg-67310706 NVS/MNTA Complaint vs Amphastar/WPI
#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-77266994 Markman (claims construction) ruling in Lovenox patent case
#msg-68240669 Musings on the Bolar exemption safe harbor
#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-77653314 NVS reports $156M of 2Q12 Lovenox sales
#msg-71975717 MNTA’s royalty rate is 10-12% with two tiers
#msg-77884681 WPI is taking a go-slow approach to Lovenox (1)
#msg-77974723 WPI is taking a go-slow approach to Lovenox (2)
#msg-78075221 WPI director might be worried about MNTA’s lawsuit
#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-77374539 What’s new in the anticoagulant arena?
#msg-76857091 How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales?
#msg-65132332 FDA approves generic Arixtra



COPAXONE PROGRAM

FDA review
#msg-77978962 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-76420849 Teva submits fourth Citizen Petition opposing generic Copaxone
#msg-57629433 Teva submits third Citizen Petition
#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-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-75932085 Copaxone will remain big seller despite competition (2012 forecast)
#msg-76905526 Copaxone has 40% US prescription 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 especially 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-77877734 Full text of District Court Order in Copaxone patent case
#msg-54113660 List of Copaxone patents being litigated (1)
#msg-75185398 List of Copaxone patents being litigated (2)
#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-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-67094037 Teva to conduct new trial for low-volume Copaxone

#msg-76611659 Teva’s PR on thrice-weekly Copaxone
#msg-63817727 Approval of thrice-weekly Copaxone unlikely before 2015
#msg-76644423 Thrice-weekly Copaxone can’t be substituted for regular Copaxone
#msg-77016146 Estimated market share for thrice-weekly Copaxone

#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-77810032 US sales of Gilenya have hit a plateau

#msg-68381070 Musings on BG-12 threat to Copaxone
#msg-68349126 BG-12 data from CONFIRM study
#msg-68377541 Musings on the BG-12 CONFIRM data (1)
#msg-68349501 Musings on the BG-12 CONFIRM data (2)
#msg-62320268 BG-12 data from DEFINE study
#msg-62384175 BG-12 is not the same drug as Fumaderm
#msg-76925827 Musings on BG-12’s commercial uptake (Citi)

#msg-77808635 2Q12 US sales of Tysabri were $211M
#msg-71134133 Tysabri label update for JCV testing (Feb 2012)
#msg-61835910 Tysabri label update re PML incidence (Apr 2011)
#msg-60984424 Biogen halts Tysabri ‘switching’ study due to slow enrollment



FOLLOW-ON BIOLOGICS (FoB) PROGRAM

#msg-70212854 MNTA inks worldwide FoB partnership with BAX
#msg-70258421 ‘Biobucks’ scorecard for the MNTA-BAX partnership
#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 of 1st two FoB’s
#msg-70235751 Timing of MNTA’s opt-in on FoB’s #3-#6
#msg-70216712 First two FoB’s in BAX partnership could be Orencia and Humira

#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-70236725 Humira factoids
#msg-70237561 An interchangeable Humira FoB has colossal upside (1)
#msg-70238965 An interchangeable Humira FoB has colossal upside (2)

#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-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-77147254 First patient dosed in M402 phase-1/2 trial
#msg-77444006 Description of M402 trial from clinicaltrials.gov
#msg-76536593 Flowchart of M402 trial design
#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



PUBLICATIONS

#msg-73905464 The Deal interviews Craig Wheeler on FoB’s (3/12)
#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)