• In January 2012, the FDA issued a Complete Response Letter (CRL) regarding the NDA for dapagliflozin. The CRL requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. The companies will continue to work closely with the FDA to determine the appropriate next steps for the dapagliflozin application, and are in ongoing discussions with health authorities in other countries as part of the application procedures. The Company has met with the FDA and now has a path forward for potential approval for Forxiga  in the U.S. The Company will provide additional data from ongoing studies to the FDA and expects to be able to resubmit the NDA for Forxiga  in mid-2013. At this time, the Company expects that the FDA will have a six–month period in which to review the resubmission and will hold an Advisory Committee meeting. 

$^{ }$Hepatitis C Portfolio – (Peginterferon lambda –a novel and potential first-in-class type 3 interferon in development; Daclatasvir – a NS5A replication complex inhibitor in development; Asunaprevir – a NS3 protease inhibitor in development) 

$^{ }$• In November 2012, the Company announced the results of the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound peginterferon lambda-1a with the investigational direct-acting antiviral (DAA) daclatasvir and ribavirin, achieved sustained virologic response 12 weeks post-treatment of treatment-naïve, genotype 1b chronic hepatitis C virus infection patients who achieved a protocol-defined response 

• In November 2012, the Company announced Phase II data demonstrating that the 12-week Triple DAA treatment regime of daclatasvir, asunaprevir, and BMS-791325 (an NS5B non-nucleoside polymerase inhibitor) achieved sustained virologic response 12 weeks post-treatment in 94% of treatment naïve, genotype 1 chronic hepatitis C virus infection patients. 

• In November 2012, the Company announced Phase II data demonstrating that the dual regiment of daclatasvir and asunaprevir, without interferon or ribavarin, achieved high rates of sustained virologic response 12 weeks post-treatment in patients with genotype 1b hepatitis C virus infections who were prior null responders to alfa interferon and ribavarin. 

$^{ }$Elotuzumab – an anti-CS1 antibody under investigation for the treatment of multiple myeloma 

$^{ }$• In December 2012, the Company announced the results of a small, randomized Phase II study in patients with previously treated myeloma. Two doses were tested, 10mg/kg and 20 mg/kg in combination with lenalidomide and low-dose dexamethasone. In the 10 mg/kg arm, median progression-free survival (PFS), or the time without disease progression or death, was not reached after 20.8 months of follow up (N=36) and the objective response rate (ORR) was 92%. Of patients who received elotuzumab at a dose of 20 mg/kg, median PFS was 18.6 months (N=37) and ORR was 76%. 

$^{ }$Necitumumab – a novel targeted cancer therapy for non-small cell lung cancer 

In November 2012, we provided notice of the termination of our global codevelopment and cocommercialization arrangement for necitumumab (IMC-11F8), a fully human monoclonal antibody being investigated as an anticancer treatment, which was discovered by ImClone and was part of the alliance between the Company and Eli Lilly and Company (Lilly), with all rights returning to Lilly. The termination is effective May 2014, though we and Lilly may terminate earlier. 

$^{ }$Sustiva  (efavirenz) – a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. 

• In February 2013, the Company announced that the FDA has granted an additional six-month period of exclusivity to market Sustiva . Exclusivity for Sustiva  in the U.S. is now scheduled to expire in March 2015. 

$^{ }$Baraclude  (entecavir) – an oral antiviral agent for the treatment of chronic hepatitis B 

$^{ }$• In February 2013, the U.S. District Court for the District of Delaware invalidated the composition of matter patent covering Baraclude , which was scheduled to expire in 2015. 

• In October 2012, a labeling update for Baraclude  was approved by the FDA to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. 

$^{ }$Erbitux  (cetuximab) – a monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor, which is expressed on the surface of certain cancer cells in multiple tumor types as well as normal cells and is currently indicated for use against colorectal cancer and head and neck cancer. Erbitux  is part of our alliance with Lilly. 

• In July 2012, the FDA granted full approval of Erbitux  in combination with the chemotherapy regimen folfiri (irinotecan, 5- fluorouracil, leucovorin) for the first-line treatment of patients with KRAS mutation-negative epidermal growth factor receptor- expressing metastatic colorectal cancer as determined by FDA-approved tests for the use. 

• In April 2012, the FDA issued a CRL regarding the supplemental Biologics License Application (sBLA) in first-line non-small cell lung cancer which stated that, based on the current data package, the first-line indication for Erbitux  in combination with vinorelbine and cisplatin is not approvable. Lilly and the Company do not plan to resubmit the filing. 

