After reading the transcript of their earnings call, I was struck by what could be a significant strategy change regarding how they bring new drug candidates forth.
Previously, they seemed (wisely IMO) to prefer allowing more experienced, larger and better capitalized companies to partner with. This seemed wise on numerous levels.
But now they intimated (vaguely in all fairness) about more solo involvement.
Now while they have developed a nice war chest reserve, we have all seen how quickly these war chests can get depleted (EXEL as an example) when trying to go it alone.
Any thoughts on this new strategy or much to do about nothing? It seems either a strategy change or perhaps insight into the challenges of their present discussions with partners for the FoB program who may be playing hardball?
However, the nature of the kind of deals, I would say, both on the follow-on biologics side is potentially the new drug side as well, have changed now that we have cash balance. In other words, we have the ability to take programs along further if we feel that we actually are going to get a higher partnership value for those by bringing them further along in the pipeline.
We also have the ability to potentially co-invest which actually leaves us the potential to actually get a higher share of the revenues of those products and ultimate success. So, we think we need to use it judiciously but we still think we need partnerships. We think that actually really significantly increases our ability to invest and therefore capture upside profits in the future. So we’re looking at it as actually enhancing the trajectory of the company though we’re not really adjusting too much in terms of our goal for partnership. It does give us much more freedom to invest.
[Updates: court rules in Teva’s favor on Copaxone Markman hearing; Leerink Swann’s comments on Markman ruling and overall patent trial; 2011-2013 news flow; cases where a PI has blocked the launch of a generic drug; five criteria for Lovenox “sameness” are necessary but not sufficient; recent patent applications and overview of IP estate; MNTA’s likely tax rate in 2012; table of insider shareholdings and options; new version of “What’s New in the Anticoagulant Arena?”]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-65922169 Transcript of 2Q11 conference call #msg-64030605 Goldman Sachs webcast is a must-listen (6/8/11) #msg-62559655FDA official cites MNTA in discussion of FoB pathways #msg-65845452 NEJM article on FoB pathway #msg-65845219 Musings on the NEJM article (by ‘MTB’) #msg-62941793 FDA reiterates commitment to issue FoB guidance in 2011 #msg-49883723 MNTA is a beneficiary of US FoB legislation #msg-26837144Momenta’s mantra on biogenerics #msg-28748329MNTA helps FDA solve contaminated-heparin problem #msg-54327728 MNTA receives US patent on Lovenox characterization #msg-59682546 MNTA receives US patent on Copaxone characterization #msg-28865474 Characterizing a compound by “ruling out” structures #msg-66518439 Recent patent applications and overview of IP estate
News flow #msg-666349552011-2013 possible/probable events #msg-64630031 Five bullish things that could happen at any time
Valuation and finances #msg-658575642Q11 net income=$1.26/sh #msg-65857564Effective cash balance at 6/30/11 was $331M #msg-65880685 Qtrly expenses will average $19-22M (GAAP), $15-18M (cash) #msg-62215094 ‘Cheat sheet’ on MNTA’s income taxes and NOLs #msg-66016386 MNTA’s likely tax rate in 2012 #msg-65636329 Diluted share count for valuation purposes #msg-65879687Potential Copaxone/Lovenox milestones exceed $163M #msg-62296467 Valuation musings (tinkershaw) #msg-63912789 Dew’s valuation of MNTA’s non-Lovenox assets #msg-47147018 No legal impediments to a buyout #msg-62283456 Musings on possibility of NVS buyout #msg-59693296 Teva won’t acquire MNTA
Management, BoD, and major shareholders #msg-62461556Composition of Board of Directors #msg-58383722Former Biogen executive appointed VP, Business Development #msg-55907213 Musings on Steven Brugger’s departure #msg-54286035 Ram Sasisekharan resigns from BoD (Sep 2010) #msg-54532698 Musings on Ram’s decision #msg-38633640 Bruce Downey, ex-CEO of Barr, joins BoD (Jun 2009) #msg-33979910 James Sulat named Chairman of BoD (Dec 2008) #msg-27338039 James Roach, CMO, joins MNTA (Feb 2008) #msg-12824293Craig Wheeler, CEO, joins MNTA from Chiron (Aug 2006) #msg-62463569 How MNTA executed against 2010 internal goals #msg-66636158Insider shareholdings and options #msg-61651527 Officers’ restricted stock vests on Copaxone approval #msg-60142538 Chairman exercises and holds 7K options (Feb 2011) #msg-56169633 Outgoing COO exercises and holds 56K options (Nov 2010) #msg-53029172 Tax rationale for 2H10 insider selling #msg-62462429Major shareholders
LOVENOX PROGRAM
FDA approval and related litigation #msg-52582225Why FDA approved generic Lovenox (simple version) #msg-52581746Why FDA approved generic Lovenox (technical version) #msg-58201819Five criteria for “sameness” are necessary but not sufficient (1) #msg-66390512 Five criteria for “sameness” are necessary but not sufficient (2) #msg-52620730 FDA approves NVS/MNTA’s generic Lovenox (NVS PR) #msg-29282002 End of the line for Sanofi’s Lovenox patent (May 2008)
#msg-53730236Judge denies Sanofi’s request for preliminary injunction #msg-57781462 Sanofi seeks summary judgment #msg-53731775 Index to legal/regulatory documents in SNY lawsuit
Economic rationale and profit split in US market (See related section below on potential competition from other Lovenox generics.) #msg-65315981NVS reports $284M of 2Q11 Lovenox sales #msg-65334145$993M—largest 12-month sales ever by a generic drug #msg-55818120 How NVS/MNTA account for Lovenox on financial statements #msg-65881687 MNTA’s Lovenox income depends on the number of generics #msg-65879687 Milestone payments from NVS at anniversaries of US launch #msg-44644009 Lovenox is essentially the entire LMWH market
#msg-65635956Generic’s 2Q11 market share = 55% #msg-659346042Q11 US Lovenox sales by product and market segment #msg-65934586 Table of branded and generic scripts #msg-65022529 Plot of branded and generic scripts #msg-62838164 NVS/MNTA’s capacity constraint is deliberate
#msg-54355727 60-70% of US Lovenox market is hospital-based #msg-59555188 Average price in hospital setting 35-40% lower than retail #msg-60467081 Estimated profit margin of generic Lovenox in hospital setting #msg-47460573 FDA label specs for dosing by indication #msg-53625554 Proportion of Lovenox use by dose size
Potential Lovenox generics from other companies #msg-59138957FDA does not approve Teva’s ANDA (1/25/11) #msg-59688528Teva not commenting on ANDA (draw your own conclusions) #msg-59164333Wedbush notes Teva’s disingenuous Lovenox statements #msg-59151084 Example of minor-deficiency letter that led to ultimate rejection #msg-59673351 Teva’s EPS guidance includes no contribution from Lovenox #msg-59172130 Musings on why Teva got an FDA response in Jan 2011
#msg-55670004Teva admits its version of Lovenox not developed in-house… #msg-56016886 …and my sources say it comes from ItalFarmaco #msg-59485489Court document confirms Teva’s Italian connection
#msg-54327728MNTA receives US patent on Lovenox characterization #msg-57290171MNTA sues Teva for patent infringement (PR) #msg-57302580 MNTA actual complaint filed with District Court #msg-57304268 Musings on the business rationale for MNTA’s lawsuit #msg-61591240Feb 2013 trial date->Teva has no expectation of FDA approval #msg-66603178 Cases where a PI has blocked launch of a generic drug #msg-57319356 Teva’s PR response to MNTA lawsuit
#msg-54978841Teva’s credibility is suspect on multiple fronts #msg-62133298 Cowen doubts credibility of Teva’s Lovenox ANDA #msg-61589357 Enox-o-what? #msg-56487255 Why Teva is behaving like a baseball manager (1) #msg-56956538 Why Teva is behaving like a baseball manager (2) #msg-53070505 Musings on a Teva approval (ThomasS) #msg-52985447 Musings on a Teva approval (tinker)(1) #msg-53026617 Musings on a Teva approval (tinker)(2) #msg-56047605 Musings on a Teva approval (tinker)(3) #msg-56323662 Musings on a Teva approval (tinker)(4) #msg-53053911 Musings on a Teva approval (RockRat) #msg-52894756 Musings on a Teva approval (zipjet) #msg-53090148 Musings on a Teva approval (oc631) #msg-56267201 Musings on a Teva approval (Dew)(1) #msg-56195372 Musings on a Teva approval (Dew)(2)
#msg-56531176 The sorry state of Amphastar’s application (1) #msg-55920125 The sorry state of Amphastar’s application (2) #msg-60610139 Amphastar responds to FDA’s motion to dismiss lawsuit #msg-46348431 FDA dismisses Amphastar’s conflict-of-interest complaint #msg-56496573 Link to GAO report alleging FDA bias (Nov 2010) #msg-56450420 Political considerations do not favor Teva, Amphastar
#msg-64340400 HSP’s Lovenox ANDA is for vial formulation only #msg-33961609 Vial formulation is considered a distinct product #msg-64319647 Musings on HSP’s ANDA
#msg-56123199SNY rules out an ‘authorized generic’ #msg-46578876 How MNTA would have been affected by an AG #msg-33857504 Why SNY opted not to launch an AG (zipjet) #msg-62838164 NVS/MNTA’s capacity constraint is deliberate
#msg-56096637 OSCS still contaminates US heparin supply (good for MNTA) #msg-56000748 Lovenox knockoffs have varied potential for immunogenicity #msg-58119661 Lovenox knockoffs may be unsafe in ACS #msg-58254369 Antibodies to heparin-PF4 complex associated with poor survival
Lovenox competition from other anticoagulants #msg-66636733What’s new in the anticoagulant arena? #msg-64862315How will Xarelto/Eliquis/Pradaxa affect US Lovenox sales? #msg-65788631 Eliquis update from PFE’s 2Q11 CC #msg-65132332 FDA approves generic Arixtra #msg-57502712 Angiomax backgrounder #msg-55640856 Musings on Regado’s RB006/RB007 #msg-50887745 Musings on relevance of PolyMedix’s PMX-60056
Generic/biosimilar Lovenox outside the US #msg-55882487Musings on Lovenox development outside US #msg-52625998 EU requirements for Lovenox biosimilars and patent info #msg-65879687 Estimated potential milestones from NVS: $48M
COPAXONE PROGRAM
FDA review #msg-30621490FDA accepts NVS/MNTA ANDA for review #msg-59964880 FDA review is not taking unduly long #msg-60686112 MNTA may be conducting a bioequivalence study (1) #msg-60741332 MNTA may be conducting a bioequivalence study (2) #msg-60838182Copaxone activity can be measured (1) #msg-62672351Copaxone 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-58062330 Hatch-Waxman 30-month clock has expired #msg-57427318 Copaxone FUD from Sanford Bernstein #msg-54201872 Wedbush is bullish on MNTA’s Copaxone (9/7/10) #msg-60836359 Handicapping the Copaxone ANDA #msg-30649453 Notes on Copaxone ANDA from 7/11/08 conference call #msg-57629433 Teva submits a third Citizen Petition (LOL) #msg-50163309 Link to FDA rejection of Teva’s 2nd Citizen Petition #msg-50113814Leerink Swann on rejection of Teva’s 2nd CP (1) #msg-50149604Leerink 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-48166546Teva’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-52702351 FDA might grant bioequivalence waiver #msg-62613681 Weizmann paper on chemistry of Copaxone #msg-60150443 Copaxone paper in The Journal of Immunology
Economic rationale and profit split #msg-57054326Why Copaxone? #msg-65594032Copaxone has $2.7B annualized US sales #msg-12222305NVS/MNTA split profits 50/50 in all cases #msg-65879687Estimated potential milestones from NVS: $115M #msg-62969588 Copaxone has 40% US prescription share among MS drugs #msg-53081150 Ex-US market for generic Copaxone not especially attractive
Patent litigation #msg-64376023 Main portion of Copaxone patent trial begins 9/7/11 #msg-61953697 MNTA is indemnified against liabilities from patent litigation #msg-54113660 List of Copaxone patents in Teva-NVS/MNTA litigation #msg-54150823 Index to legal documents in Teva-NVS/MNTA litigation #msg-56222992 Docket for Teva-Mylan (now consolidated w Teva-NVS/MNTA) #msg-54139320 Court denies summary judgment on indefiniteness argument #msg-66626914 Court rules in Teva’s favor on Markman hearing
#msg-56147443 NVS/MNTA will pursue four tacks in litigation #msg-66633018Leerink Swann re Markman hearing and patent trial #msg-55490818 Teva thinks it could lose patent case, evidently #msg-52735648 Branded Copaxone has weak IP protection (Wall Street) #msg-59368793 Branded Copaxone has weak IP protection (tinkershaw) #msg-64430231 Handicapping the Copaxone case (various iHub posters)
#msg-33580867 Rationale for inequitable conduct argument against Teva #msg-63573604 Showing inequitable conduct just got harder #msg-65627476 Mylan CEO’s comment re inequitable conduct
#msg-59682546MNTA receives US patent on Copaxone characterization #msg-61312284Patent suit could be settled if FDA approves ANDA #msg-62133298 Cowen agrees, evidently
Potential competition from other generic and branded drugs #msg-29902618Mylan inks Copaxone deal with India’s Natco #msg-60289240 Mylan’s 30-month Hatch-Waxman stay expires Mar 2012 #msg-59685034 MNTA’s new patent reduces MYL’s prospects
#msg-62810742 Musings on MS market from 1Q11 CC #msg-62346151 Teva might continue detailing Copaxone after generic launch #msg-62355790 Musings on a Copaxone ‘authorized generic’
#msg-58083875FDA rejects Teva’s ‘low-volume’ Copaxone #msg-50939364 Clinical data for low-volume Copaxone was weak #msg-59788384 Low-volume Copaxone is presumably dead #msg-63817727 Musings on Teva’s thrice-weekly Copaxone (1) #msg-63836262 Musings on Teva’s thrice-weekly Copaxone (2)
#msg-54677007 FDA approves NVS’ Gilenya #msg-65574194How does Gilenya affect Copaxone? #msg-56524579 Copaxone will hold its own against Gilenya (Leerink Swann) #msg-59296554 Copaxone will hold its own against Gilenya (tinkershaw)
#msg-65594032 Copaxone outsells Tysabri 4:1 in US market #msg-61835910 Apr 2011 Tysabri label update (102 cases of PML, 21% fatal) #msg-60144268 Musings on Tysabri’s PML rate #msg-60984424 Biogen halts Tysabri ‘switching’ study due to slow enrollment
#msg-54826950 FDA labels of approved MS drugs #msg-61960285 Efficacy data from FDA Copaxone label #msg-54834214 Copaxone is only approved MS drug with pregnancy Category B #msg-56125835 Worldwide market share in MS (2Q10) #msg-39971611 US market share in MS (2Q09) #msg-58131215 MS drugs in late-stage development (Oct 2010) #msg-31553565 Musings on MS drugs in development (genisi) #msg-57586166 Chart of comparative efficacy of MS drugs #msg-61959592 Musings on the crop of oral MS drugs
#msg-65742416 Laquinimod fails in phase-3 BRAVO study #msg-62320268 BG-12 data from DEFINE study are impressive #msg-62375616 BG-12 data from CONFIRM study due Sep 2011 #msg-62384175 BG-12 is not the same drug as Fumaderm #msg-62332894Musings on BG-12 threat to Copaxone #msg-55641299 Phase-3 Teriflunomide data from TESMO study #msg-55927582 SNY starts phase-3 trial of Teriflunomide+IFN #msg-64489232 Merck KGaA terminates Cladribine program
#msg-61504526 FDA denies Peptimmune’s Citizen Petition (3/11) #msg-62661879 Updated link to Peptimmune’s CP #msg-55116264 Peptimmune’s PR announcing CP filing (10/10) #msg-60953425 Mylan’s response to Peptimmune’s CP #msg-61204770 Peptimmune (unsurprisingly) files for bankruptcy
FOLLOW-ON BIOLOGICS (FoB) PROGRAM
#msg-49883723MNTA is a beneficiary of US FoB legislation #msg-48581353 What the new healthcare law says about FoB’s #msg-26837144Momenta’s mantra on biogenerics #msg-62559655FDA official cites MNTA in discussion of FoB pathways #msg-62631138 Addendum to above discussion #msg-62941793FDA reiterates commitment to issue FoB guidance in 2011 #msg-63126386 BioCentury article spells out regulatory pathway for US FoB’s #msg-63127867 Crux of the issue for US FoB’s #msg-62805964 Limited clinical trials will be required, at least initially (1) #msg-62958889 Limited clinical trials will be required, at least initially (2) #msg-64153324 Musings on MNTA’s FoB technology and partnership prospects (1) #msg-64278731 Musings on MNTA’s FoB technology and partnership prospects (2)
#msg-61414941 FoB’s will sell $3.7B in 2015, says Datamonitor #msg-60342122FoB ‘cheat sheet’ #msg-59828805 Musings on terms of an FoB collaboration #msg-57601389 Presentation by James Roach at FDA hearing on FoB’s #msg-58469454 Musings on how an FoB applies to disparate indications
OTHER R&D PROGRAMS (For info on M118, see prior version of ReadMeFirst at #msg-65636771.)
M402 oncology program #msg-37030489Rationale for a heparin-derived cancer drug #msg-47769823 Description of program from 10K report #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
INTELLECTUAL PROPERTY
#msg-57290171MNTA sues Teva for patent infringement (PR) #msg-54327728US patent #7,790,466 re Lovenox characterization #msg-55899246 US patent #7,816,144 (continuation of above) #msg-59682546MNTA receives US patent on Copaxone characterization #msg-66518439 Recent patent applications and overview of IP estate #msg-55997916 Patent app re LMWH composition #msg-55510863 Patent app re purity of heparin API
PUBLICATIONS
#msg-63126386BioCentury re prospects for US FoB’s (5/11) #msg-59966324Barron’s opines re MNTA’s business plan (2/11) #msg-52862494Globes online (Israel) interview with Sandoz CEO (8/10) #msg-52632000Forbes re ‘The Golden Age of Biogenerics’ (7/10) #msg-52606143NY Times re FDA approval (7/10) #msg-28748329Nature Biotechnology re contaminated heparin (4/08) #msg-25160571WSJ re anticoagulant market (12/07) #msg-23005127Nature re FoB’s (9/07) #msg-20308884Lab Technologist re production process (6/07) #msg-25803923The Pink Sheet interview with C. Wheeler (3/07) #msg-7370282WSJ re MNTA’s raison d’etre (8/05) #msg-25779774Boston Globe re MNTA’s IPO (11/04) #msg-33867074Signals Magazine re glycobiology (9/03)
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