Toward a More Secure Future?. Lantheus at a Glance Lantheus Medical Imaging Headquarters:Billerica, Massachusetts Offices:Puerto Rico, Canada, Australia.

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Presentation transcript:

Toward a More Secure Future?

Lantheus at a Glance Lantheus Medical Imaging Headquarters:Billerica, Massachusetts Offices:Puerto Rico, Canada, Australia Marketed Products:9 Products in Development:3 Global Presence:Over 600 employees R&D Clinical and Medical affairs Sales & Marketing Manufacturing Distribution Rx/unit doses (Australia, Canada, PR) 2

Current Product Portfolio 3

The Reactors NRU LVR-15 HFR Osiris Safari MariaBR2 OPAL LEU - OPAL, RA-3, SAFARI HEU – BR2, HFR, LVR-15, Maria, NRU, Osiris Mo-99 TARGETS RA-3

Processors NTP Nordion ANSTO Health IRE Covidien LEU – ANSTO, CNEA, NTP HEU – Covidien, IRE, Nordion CNEA

Current U.S. Mo-99 Supply Matrix HFR Reactor Netherlands BR2 Reactor Belgium OSIRIS Reactor France NRU Reactor Canada SAFARI Reactor S. Africa ReactorMo-99 Extraction Mo-99 PurificationTc-99m Generator Manufacturer OPAL Reactor Australia Maria Reactor Poland Covidien Netherlands IRE Belgium NTP S. Africa AECL Canada Nordion Canada ANSTO Australia Covidien Lantheus LVR-15 Reactor Czech Republic RIAR Reactors Russia Under Development

Medium and Long term Mo-99 Supply Chain S.99 American Medical Isotopes Production Act of 2011 U.S. Domestic Projects 4 DOE/NNSA cooperative grants (non-HEU projects) GE Hitachi-Clinton – power reactor, neutron activation, LSA (Northstar & NuView) Babcock & Wilcox – MIPS aqueous solution reactor Morgridge Institute for Research(SHINE) – accelerator-driven fission process Northstar –Mo-100 accelerator LSA w/Tc-99m separator

Medium and Long term Mo-99 Supply Chain North American production Other (potential) projects Northstar/MURR - Mo-98 NA LSA w/Tc-99m separator Coqui Radiopharmaceuticals – fission, 2015? MURR – fission ? Perma-Fix (with PNNL) – neutron activation? MiPod - fast fission ( 238 U(n,f) 99 Mo) Canada – NISP grant (Non-reactor-based Isotope Supply Contribution Program) Cyclotron-produced Tc-99m Photon/accelerator production

Medium and Long term Mo-99 Supply Chain Europe – New RRs: FRM II Reactor – 2015 Jules Horowitz Reactor – 2016 Pallas Reactor – 2020? MYRRHA Reactor – 2022? Processors Conversion to LEU – 2015~? Australia – Phase 2, 2015 South Africa - Safari 2 DIPR, 2020?

Medium and Long term Mo-99 Supply Chain Russia – Rosatom/Isotope, 2013? (thru Nordion) Argentina – CNEA new reactor & processing, 2018 South Korea – New RR, fission 2017 India, China – fission 2014, 2015?

Diagnostic RP Reimbursement Advocacy  Separate Medicare payment for dRPs in hospital outpatient (most important setting for using RPs) was discontinued by CMS in 2008  Separate Medicare payment for dRPs continues in physician offices  Since 2008 LMI, CORAR, and medical societies continued strong advocacy with CMS to restore separate Medicare payment for dRPs in HO setting to maintain patient access to newer and better dRPs.  Increased cost of Mo-99 and Tc-99m is another very important reason for restoring such separate payment for dRPs in HO  CMS/CORAR meeting of 7/26/2011 indicated that Congressional action may be necessary in order to restore separate Medicare payment for dRPs in hospital outpatient setting

LMI Mo-99 Leadership  Secure, reliable, globally diversified supply chain, focused on reactors and processors  NRU, SAFARI, BR2, OSIRIS, HFR, LVR-15  Nordion, NTP, IRE, ANSTO  Secured FDA approval for new reactor (LVR-10) and LEU Mo-99  1 st commercial sale of NTP LEU Mo-99 (Dec. 2010)  1 st FDA approval ANSTO LEU Mo-99 processes (June 09, Apr. 11’)  regular commercial shipments from NTP and ANSTO (May-June 2011 and ongoing)  Active engagement with Mo-99 projects  Advocacy to restore separate reimbursement for diagnostic RPs in hospital outpatient

Impact of reactor outages ( ), medical reimbursement pressures, and medical radiation concerns have decreased demand for Tc-99m How will future demand evolve? The Mo-99 production landscape is changing - many new projects, including domestic U.S., on drawing board How many will succeed? When? situation unclear (post-NRU) LEU-based production will be the future of Mo-99 supply Medicare reimbursement landscape is changing with payments decreased and/or “bundled” with procedures Need for separate Medicare payment for dRPs to compensate for Mo-99/Tc-99m cost increases Lantheus has taken a leadership role in securing future Mo-99 supply Toward a More Secure Future? Conclusions

Thank you!