Aurobindo Pharma Limited

Satakarni Makkapati

CEO of Aurobindo Biosimilars, Vaccines and

Yugandhar Puvvala

CEO of Eugia Pharma Specialties Limited

Sanjeev Dani

COO & Head Formulations, Aurobindo Pharma Limited

S. Subramanian

Chief Financial Officer, Aurobindo Pharma Limited

Swami Iyer

CEO, Aurobindo Pharma USA

rs,

team today on the call with us, represented by Dr. Satakarni Makkapati – CEO of Aurobindo Biosimilars, Vaccines and Peptide Businesses, Mr. Yugandhar Puvvala - CEO of Eugia Pharma Specialties Limited, M

Rs. 5,739 crore

of the Fiscal Year FY23 declared by the company. For Q2 FY23, the company registered a revenue of Rs. 5,739 crores; a decrease of 3.4% over last year. The EBITDA before Forex and other income was Rs. 836.9 crores

3.4%

d by the company. For Q2 FY23, the company registered a revenue of Rs. 5,739 crores; a decrease of 3.4% over last year. The EBITDA before Forex and other income was Rs. 836.9 crores. EBITDA margin for t

Rs. 836.9 crore

Rs. 5,739 crores; a decrease of 3.4% over last year. The EBITDA before Forex and other income was Rs. 836.9 crores. EBITDA margin for the quarter was 14.6%. The Net Profit decreased and for the quarter stood at R

14.6%

. The EBITDA before Forex and other income was Rs. 836.9 crores. EBITDA margin for the quarter was 14.6%. The Net Profit decreased and for the quarter stood at Rs. 409.4 crores. In terms of the busines

Rs. 409.4 crore

es. EBITDA margin for the quarter was 14.6%. The Net Profit decreased and for the quarter stood at Rs. 409.4 crores. In terms of the business breakdown, formulation business in Q2 FY23 witnessed sales of Rs. 4,7

Rs. 4,770 crore

.4 crores. In terms of the business breakdown, formulation business in Q2 FY23 witnessed sales of Rs. 4,770 crores and contributed around 83.1% of the total revenue. API business contributed around 16.9% and cloc

83.1%

akdown, formulation business in Q2 FY23 witnessed sales of Rs. 4,770 crores and contributed around 83.1% of the total revenue. API business contributed around 16.9% and clocked a revenue of Rs. 969.4 cro

16.9%

. 4,770 crores and contributed around 83.1% of the total revenue. API business contributed around 16.9% and clocked a revenue of Rs. 969.4 crores for the year. For the quarter, revenue from US Market d

Rs. 969.4 crore

around 83.1% of the total revenue. API business contributed around 16.9% and clocked a revenue of Rs. 969.4 crores for the year. For the quarter, revenue from US Market declined by 11% year-on-year to Rs. 2,637.

11%

d a revenue of Rs. 969.4 crores for the year. For the quarter, revenue from US Market declined by 11% year-on-year to Rs. 2,637.6 crores. We have received final approval for nine ANDAs and launched si

Rs. 2,637.6 crore

69.4 crores for the year. For the quarter, revenue from US Market declined by 11% year-on-year to Rs. 2,637.6 crores. We have received final approval for nine ANDAs and launched six products in the quarter under r

“We plan to unblind the clinical trial data starting end Q3 this financial year, with a series of filings to begin from Q1/Q2 in the next fiscal year, starting with India and Emerging Markets before June 2023 and the big filings of EMA, which we expect to close by August or September 2023, and FDA filing by October or November 2023.”

“So, that’s a big filing that we are looking at in the next year.”

“One of our immunology products which we think, we are one of the first 3 or 4 to be filing in FY24 or FY25 is now closing on its phase 1 trial in Australia and New Zealand.”

“We will be entering into phase 3 first patient injection milestone by Q4 of this fiscal year for this immunology program.”

“This is a large trial which will be carried out in around 13 countries and in 85 sites.”

“We are excited about the prospects that we will be able to close this trial somewhere by Q1 of FY24 and initiate the filing process in Europe and US.”

“I expect the regulatory process for approval to unfold in the next 2-4 months’ time.”

“At this time, I think we are well on track to get this product approved in India followed by our continued impetus to make this product better and increase the safety database by conducting an additional 2+1 trial and building on another trial for the WHO marketsand we believe that we will have a WHO filing in 2024.”

“We will provide a guidance on this product as the regulatory queuing procedure (unfolds) in accordance with the Indian regulator.”

“Aurobindo Pharma Limited 14 November, 2022 Surya Patra: So, sir, is it fair to believe that the contribution of this speciality project from the advanced market is likely in let’s say FY26 or so?”

Satakarni Makkapati

2

Satakarni Makkapati

Yes, thanks Yugandhar. Thanks for the question on biosimilars. I would answer your question in 2 parts. One for the biosimilars and one for the vaccine. The 3 biosimilars in phase 3 efficacy trials are progressing as desired. If you remember my last update, I had talked about the oncology biosimilar and the large trial that we have been doing in metastatic breast cancer patients even during the covid headwinds period. Now, I am pleased to inform that we have completed randomization of all 690 metastatic breast cancer subjects in our phase 3 efficacy trial comparing CuraTeQ’s version of biosimilar to the innovator’s product. We plan to unblind the clinical trial data starting end Q3 this financial year, with a series of filings to begin from Q1/Q2 in the next fiscal year, starting with India and Emerging Markets before June 2023 and the big filings of EMA, which we expect to close by August or September 2023, and FDA filing by October or November 2023. So, that’s a big filing that we ar

Satakarni Makkapati

So, in the area of biosimilars, we are expecting a product approval next year with the filings that we have in Europe. So, we expect the revenues to kick in sometime in Q3 or Q4 of the next year. So That’s when we will see the commercialization to begin for biosimilars in certain regulated markets. With the ongoing clinical trials, the three large antibody clinical trials that we are doing globally, (FY24 end or) FY25 is a fair assessment for the revenues to kick in because the regulatory process takes anywhere between 9-15 months in Europe and US (after filing). Surya Patra: Ok. Just one last question from my side. So here, about the European market and in general about the margin profile of the consolidated operations, so obviously generally the cost pressure what we are witnessing, it is common for all the markets and our key market which is a key earning contributor that US is facing is obviously the pricing pressure as well as the cost pressure. So same should be there even in the