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OVERVIEW

Lupin is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA NPA, March 2019). Headquartered in Baltimore, Maryland, the Company’s US marketing arm, Lupin Pharmaceuticals Inc. (LPI), is dedicated to delivering superior quality branded and generic medicines trusted by healthcare professionals and patients across the region.

Over the last five years, the Company has made strategic investments in the US-based Research & Development infrastructure and manufacturing facilities. The Research & Development centre for Inhalation, located in Coral Springs, Florida, was established in 2013 and commenced full operations in early 2014. The Somerset, New Jersey-based manufacturing and research operations were acquired in 2016 as part of the GAVIS transaction. This enabled the Company to broaden its pipeline in Controlled Substances, Dermatology, Women’s Health and other niche therapeutic areas.

In October 2017, Lupin acquired Symbiomix Therapeutics, LLC and its FDA approved brand, Solosec™. Solosec™ is the first and only approved single-dose oral treatment for Bacterial Vaginosis (BV) – the most prevalent gynaecologic infection in the US, affecting 21 million women between the ages of 21 to 49 annually. The acquisition of the Solosec™ franchise significantly expands Lupin’s Women’s Health specialty business.

The Company’s Net Sales for the US in FY2019 experienced a 12% decline from the prior year to close the year at USD 777 million. The Generics business contributed USD 748 million i.e. 96% of the total US revenues which was a decline of 5% from the previous year. The overall decline in US revenues was primarily due to the generics competition on Methergine coupled with new competition on two of our key generics products.

USA

US BRANDED

US BRANDED

One of Lupin’s differentiators traditionally has been its US branded business and the Company is committed to re-establishing the Branded business as a growth driver for the coming years. Early in FY2017, the LPI brand team repositioned and began promotion of two new products from the GAVIS portfolio, Methergine® and Methylphenidate. In FY2018, these brands contributed significantly driving the total Branded revenues to USD 90 million.

During the past year, the Branded business in the US was restructured into Pharma and Specialty salesforces to target high value Health Care Practioner groups and push for productivity. Alternative channels were also leveraged to ensure market access, coverage and trade availability. The Specialty salesforce primarily promoted Methergine® and the Pharma salesforce primarily promoted legacy brands Suprax and Antara, along with Methylphenidate.

As mentioned earlier, FY2018 also marked the successful acquisition of Symbiomix Therapeutics, LLC and its FDA approved brand SolosecTM. The current standard therapy for BV has shown 50% of women treated have a recurrence within 12 months. The Company is confident of connecting with targeted Obstetrics and Gynaecology and Primary Care Physicians and committed to helping prevent and manage women’s health conditions with serious consequences.

US GENERICS

US GENERICS

LPI is currently the 3rd largest Generics Company in the US with a 5.2% market share by prescriptions (IQVIA NPA Audit). LPI’s strength in the Generics market is best characterized by its ability to achieve leading market shares. As of March 2019, 65 of the 175 Generic products marketed by LPI in the US were Ranked No. 1 by market share and 129 of the 175 were in the Top 3 by market share (IQVIA Generics Module, March 2019). The Company has leveraged its strengths to focus on increasing its market shares not only via new launches but also through consolidating its position in existing products. Importantly, constantly engaging with trade partners, customers and world-class execution has fortified the Company’s supply chain to ensure industry leading service levels.

The Company filed 27 ANDAs in the US market during FY2019 and currently has 157 ANDAs pending approval, addressing a total market size of over USD 52 billion. Lupin’s first-to-file ANDAs pending launch stand at 40, including 15 exclusive first-to-file ANDAs targeting a market size of USD 3.4 billion.

Despite the market challenges, in-line units grew nearly 6% in the year. The Company launched 22 products in FY2019, including Ranolazine, Levothroxine Tabs, Methylergonovine, Atovaquone, and EQ Beyaz

API

API

Lupin is recognized as a leading manufacturer of cephalosporin API's, with FDA approval to manufacture complex oral and injectable cephalosporins.

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