Adding Muscle - United States

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Adding Muscle


United States

Lupin by numbers in united States

THE US IS LUPIN’S LARGEST AND MOST IMPORTANT MARKET AND INTEGRAL TO THE COMPANY’S PERFORMANCE. HEADQUARTERED IN BALTIMORE, MARYLAND, THE COMPANY’S US SUBSIDIARY, LUPIN PHARMACEUTICALS, INC. (LPI), IS DEDICATED TO DELIVERING HIGH-QUALITY, BRANDED AND GENERIC MEDICINES TRUSTED BY HEALTHCARE PROFESSIONALS AND PATIENTS ACROSS THE US.

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US Formulation Revenues (USD million)

LPI enjoys strong brand equity in the US wholesale and retail channels as a preferred supplier of quality generics and is an emerging specialty major focusing on Paediatric specialists and Primary Care physicians. Strong commercial capabilities in the US market for both generic and branded products have made LPI a key contributor to the Company’s growth.

FY 2016 was a year of heightened activity and consolidation in the US as we navigated our way through a fast changing and volatile pharmaceutical marketplace while maintaining growth momentum and performance. Lupin clocked in US revenues of USD 887 million during FY 2016, contributing 43% of the Company’s global revenues. This business performance has made Lupin the 5th largest pharmaceutical player in the US (4.68% market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016).

US Generics

FY 2016 saw the US Generics business record revenues of USD 841 million, contributing 95% of the Company’s US sales. FY 2016 saw Lupin climb up one place in the leadership rankings to emerge as the 5th largest generic player in the US (5.51% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016).

We continued to build for the future. In March, 2016 the Company completed its acquisition of privately held US based Gavis Pharmaceuticals LLC and Novel Laboratories Inc. which has since been renamed Lupin Somerset. The Company specializes in formulation development, manufacturing, packaging, sales, marketing and distribution of pharmaceutical products. The acquisition enhances Lupin’s scale in the US generics marketplace and also broadens the Company’s pipeline in dermatology, controlled substance products and other niche, high-value complex generics and specialty segments. Gavis brings to Lupin a highly skilled US based manufacturing and research organization which would complement Lupin’s brand new R&D center for Inhalation in Coral Springs in Florida. The acquired company’s New Jersey facility also becomes Lupin’s first manufacturing site in the US.

The Company today has a portfolio of 124 in-market products and 163 filings pending approval, not to mention a deep pipeline of products under development for the US. The Gavis acquisition creates the 5th largest pipeline of ANDA filings with the US FDA, addressing a USD 63.8 billion market. Lupin today has 45 First-to-File (FTF) products which include 25 exclusive FTF opportunities.

The Company also had to deal with acute pricing pressure as an outcome of the ongoing consolidation and expansion of alliances amongst key customers, as well as competition on previously exclusive and semi-exclusive products. FY 2016 saw Lupin launch 21 new products, including the successful commercialization of an exclusive generic version of Glumetza®. Lupin now has 124 products in the market and the Company is the market leader in 44 generic products marketed in the US and amongst the Top 3 in 79 products (IMS Health).

US Brands

One of Lupin’s key differentiators has been our US branded business and the Company has been working hard to beef up and build on the same. The success of Lupin’s US Branded franchise is critical for our aspirations to build a sizable Specialty Pharmaceutical play in the US.

The Branded business contributed 5% of Lupin’s US revenues recording revenues of USD 46 million. The Company was able to garner 3.7% market share for its newly launched InspiraChamber® Anti-Static Valved Holding Chamber (VHC) in the US market. Lupin has exclusive rights to promote, distribute and market InspiraChamber® VHC in the US. The chewable tablet formulations for Suprax® grew 66% in prescription terms during FY 2016 as compared to FY 2015. Prescriptions for Antara® grew 16% over the previous year and branded Antara® revenues increased by 14% during FY 2016.

Secondary packaging at our Goa manufacturing facility, India US Generic Revenue Cumulative ANDA Pipeline

Lupin further strengthened its branded play in the US with the launch of two new products, Methergine® and Methylphenidate. The Company has re-introduced Methergine® (methylergonovine maleate) Oral Tablets 0.2mg for the prevention and management of postpartum hemorrhage (PPH). Methergine® is the only FDA-approved oral uterotonic and is a preferred oral agent in the management of PPH, according to guidelines issued by the American Congress of Obstetricians and Gynecologists (ACOG). More than half of all maternal deaths occur within 24 hours of birth, most commonly from excessive bleeding. Rates of maternal mortality continue to rise in the US where PPH is a leading cause of pregnancy complications. With Methergine®, Lupin is making a significant investment to help improve the management of PPH, providing professional medical education, leveraging a new specialized sales force to drive better awareness and access to care, and ensuring a more stable supply of this essential medicine.

As we move into FY 2017 and beyond, Lupin aims to continue to strengthen its market presence by launching new products; expanding its pipeline as well as targeting opportunities in therapeutic areas such as Inhalation, Paediatrics, Women’s Health, Complex Injectables and Dermatology.

We are building for the future, adding muscle to ensure that Lupin stands recognized as amongst the most successful generic and specialty pharmaceutical companies in the United States.

Dispensed TRx US Pharmaceutical Industry

Dispensed TRx Total US Industry, MAT, March 2016

Lupin is ranked 5th in the US industry standings of all pharmaceuticals

Source: IMS Health, National Prescription Audit, March 2016

Dispensed TRx US Unbranded Generics, MAT, March 2016

Lupin is ranked 5th in the US industry standings of unbranded generics

Source: IMS Health, National Prescription Audit, March 2016

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