Erez Israeli
Analyst · Neha Manpuria from JPMorgan
Thank you, Saumen. Greetings to all. We had yet another good quarter with continued improvement witnessed across various business health and performance metrics. There has been significant growth in the free cash flow generation, and we now have much stronger balance sheet. On our quest to grow, diversify our business and become more efficient, we have seen good traction in new product launches in the U.S. and Europe markets and continued with the growth momentum in India and emerging markets. Let me take you through the key highlights across our businesses. Please note that all references to numbers in these sections are in the respective local currencies. The North America Generics revenue for the quarters are at $234 million, with a year-on-year decline of 1%. However, the business registered a growth of 10% over the sequential quarter, driven by continued ramp-up in gCopaxone sales and improved contribution from recent launches. The overall market environment has been relatively stable and with this base price erosion, consistent with past few quarters. We have been fairly busy with the uptick in the launch momentum of new products and till date have launched 10 products since the beginning of this fiscal. This includes multiple interesting products, like daptomycin, Vitamin K injection, Carboprost injection, OTC Guaifenesin, Pseudo, Ramelteon and the relaunch of Azathioprine, many of which have been either first to market or on limited competition space. We expect this launch momentum to continue in our network to bring more than 30 products to the market in FY 2020. As of now, we have around 115 commercial products in the U.S. markets. On the gNuvaring asset, we are actively awaiting the feedback from the USFDA around the approaching goal date in the coming weeks. While we have answered all the queries in our last general response, we expect to receive some additional queries. We will have better visibility on time lines once we hear back from the agency. The Europe business recorded sales of EUR 31 million with a year-on-year growth of 22% and a sequential quarter growth of 29%. The strong performance for the quarter was a result of improvement in supply situation and new product launches across markets. During the quarter, we launched 6 products in Germany, 4 in the U.K., 3 in France, 1 in Spain. We expect this business to continue to perform well during the year. The emerging markets business recorded sales of INR 730 crores with a year-on-year growth of 10% and a sequential quarterly growth of 4%. The Russia business grew by 5% year-on-year and 9% quarter-on-quarter in constant currency. The current quarter performance is in line with our expectations. As per our strategic growth plan, we are continuing to strengthen our product portfolio across the emerging markets and expect the current growth momentum to continue going forward. India business recorded sales of INR 696 crores with a year-on-year growth of 15% and a sequential quarter growth of 7% during the quarter. During the quarter, we launched 8 new brands. As per the secondary sales reported by IQVIA, we have registered strong year-to-year growth of 13%, ahead of the total market growth of 10.4% for the quarter ended June 2019. We believe that with our renewed focus on the whole market, we will continue to grow better than the overall markets. The PSAI business revenue are at $65 million, which has declined by 20% on a year-on-year basis and a sequential decline of 32%, partially impacted due to manufacturing issues, which is now being resolved. We expect that the business performance will improve from Q2 onwards. On the R&D front, we are progressing well in line with our expectations. While we have filed only 1 ANDA in this quarter, the filing run rate is expected to pick up during the balance of the year. As of the 30th of June, 2019, we had 107 cumulative filings, pending for approval with the USFDA, including 104 ANDAs and 3 NDAs. During the quarter, we filed 7 drug master files globally. On our Proprietary Products business, following the divestitures of our on-market derma brands to Encore Dermatology, we recently announced the divesture of our [ neuro bearing ] Zembrace and TOSYMRA to Upsher-Smith. The transaction value reflects the strong potential of these 2 brands, and we believe this partnership will help realize the full value for these assets. With this divestiture, we have only exited the front-end commercial business. We remain committed to developing products to address the unmet and under-met medical needs of part of our Proprietary Products business. Our focus going forward will be to leverage our core capabilities in R&D to build a self-sustained business model that consistently deliver high-value, globally relevant, differentiated products, providing meaningful health, economic outcomes to patients and payers. On the pipeline front, DFD-29, which is a low-dose minocycline, and XP23829, have both successfully completed Phase IIb studies with the data looking quite encouraging. The development on Eco-07 for CTCL indication is also on track. Consistent with these guiding principles, we will continue to further this agenda. On the quality front, I'm quite pleased with the outcome of the recent inspections, which has been the result of our focus and dedicated efforts to continuously improve our quality system. We will continue that effort of inviting highest-quality culture across the organization. As regards to CTO-VI, we had face-to-face meeting with USFDA. And based on this discussion with agency, we expect the reinspection will be conducted for the site. I'm pleased to inform that we also continue to progress well on our journey toward driving cost efficiency within CapEx investment and improvement in the business processes for a long-term sustainable growth. With this, I would like to open the floor for questions and answers.