Erez Israeli
Analyst · JP Morgan. Please go ahead
Thank you, Saumen. Greetings to all. Thank you for joining us today for this earning conference call. Let me begin with the current quarter performance highlights. I am glad to inform you that we continued with our gross momentum in this quarter, and have performed well across our businesses. Please note that all references to numbers in this section are in the respective local currencies. The North America generics revenues both stabilized and for the quarter are at 209 million with a sequential growth of 1% during the quarter. We witnessed decent improvement in the volume uptake that help us offset the product specific price decline impacting some of our key products due to new competition. Overall, we see stabilization in the trend at a broader portfolio level. This quarter was very busy in terms of new launch activities with record number of new launches in quarter over the last five years. In all, we launched 10 new products, including some very exciting limited competition products like Colesevalam, Dipyridamole, Aspirin XR, Sevelamer sachet, Sevelamer unit dose and Omeprazole OTC tabs. We are excited about the opportunity potential and contribution from these launches and gearing towards the gradual ramp up over the next few months. We will continue in this journey in the next few quarters and we’ll be fairly busy with multiple and new product launches lined up, including some exciting limited competition opportunities. As communicated earlier, we continue to work toward potential approval launch of gNuvaring in the first half of calendar 2019 and that of gCopaxone in the second half of calendar 2019. On the gSuboxone, as you are all aware that during the quarter, the Court of Appeals of the Federal Circuit issued a decision in company's favor to vacate the preliminary injunction. On December 20, 2018, as part of a standard procedure, Indivior filed a petition seeking pre-hearing of the appeal. On this, the court sought our comments to which we immediately responded. We are awaiting for the court decisions on this matter. Let me also update you on the status of two warning letters impacted sites. In October 2018, the re-inspection for the sterile, injectable plant in Duvvada was completed and the US FDA issued formed committees with eight observations. We have comprehensively responded to this observation and we just now have received certain specific questions from the agency seeking further clarification on some of our responses. With respect to the API manufacturing facility in Srikakulam, we have submitted the results of the investigation and responded to all the queries asked by the US FDA and await for re-inspection of the facility. The Europe business recorded sales of €25 million with a sequential growth of 5% on the back of improvement in supplies and new launches. During the quarter, we launched two products in Germany and four products in the UK, including fondaparinux. We will continue to launch new products in the future in this market. The emerging market business recorded sales of INR774 crores, continuing its strong performance with growth across all key markets. The overall business grew 31% year-over-year and 3% on a sequential basis. This is all round performance was outcome of; one, healthy growth in the base business; two, new product launches in existing markets; and three, contribution of the newer markets. These geographies are expected remain a major gross driver for the company over the next few years. The India business added INR674 crores with a year-on-year growth of 10% and a sequential seasonal decline of 2%. As per the IMS, we performed better than the market for the three months ending November 2018. As a result of this sustained performance, our ranking improved by one place. India is a priority market for us and we remain committed to consistently improve our performance and grow better than the overall market. The TCI business revenue are at $83 million, a year-on-year decline of 1% and a sequential decline of 5%. We believe that the changes in the API landscape has created opportunity for us and we are preparing ourselves to serve that market. On our Proprietary Products business, we recently received US FDA approval for our intranasal sumatriptan DFN-02 under the brand name TOSYMRA. We believe TOSYMRA has a favorable profile to benefit large segments of migraine patients whose episodes are not optimally controlled with the current treatment, particularly orals. Prelaunch activities are under way and we are preparing for the launch in the next few months. On the R&D front, progress on our key pattern program is on track. During this quarter, we filed three ANDAs in the U.S market and as of 31st of December 2018, we have 103 cumulative filings spending for approval within the US FDA, which include 100 ANDAs and three NDAs. The ANDA filling rate will improve further in the next quarter. For our bio similar business, we have started the Phase III trial rituximab for developed market. Our Proprietary Products business, we expect to file the NDA for DFN-15 by Q1 FY20. Development on E7777 for CTCL indication in the U.S. is on track and we expect to file the BLA by Q1 FY21. On the business development in line with the recently stated growth strategy, we have started to divest non-core assets and we will further continue to do more of this, which will help us to focus and channel our sources to our growth basis. We also look forward to inorganic growth opportunity with right return on investments. Overall, we feel quite optimistic about our six chosen spaces; U.S. Generic, India, Russia, China, API and global hospital business. We have started to make the right moves, which focus on profitable growth, shareholders returns, cost efficiency and quality. Let me share with you some quick updates on the additions to our senior leadership team. I’m pleased to announce that Marc Kikuchi has joined us as the Head of North America Generics business. Marc brings with him extensive knowledge and vast experience in the generic space. During the quarter, we also on-boarded Sandeep Khandelwal as India business head and Dmitry Sovetkin as Russia business head. These new leaders, along with our existing strong leadership team, will help people our key business processes and drive growth for the company in chosen strategic spaces, and will enable the company to explore its potential. And with that, I now open the floor for questions and answers.