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Biocon Ltd. Interim / Quarterly Report 2023

Feb 15, 2023

61176_rns_2023-02-15_62356543-b064-4c3c-a87f-1b1b7d2a7f47.pdf

Interim / Quarterly Report

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Biocon Limited 20th KM, Hosur Road Electronic City Bangalore 560 100, India T 91 80 2808 2808 F 91 80 2852 3423 CIN : L24234KA1978PLC003417

www.biocon.com

February 15, 2023

February 15, 2023
To,
The Secretary
BSE Limited
Department of Corporate Services
Phiroze Jeejeebhoy Towers,
Dalal Street,Mumbai – 400 001
To,
The Secretary
National Stock Exchange of India Limited
Corporate Communication Department
Exchange Plaza, Bandra Kurla Complex
Mumbai – 400 050
Scrip Code - 532523 Scrip Symbol- BIOCON

Dear Sir/Madam,

Subject: Presentation and Video Recording of Q3 FY23 Earnings Call

Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 (“SEBI Listing Regulations”), please find enclosed the presentation on Q3 FY23 Earnings Call conducted today i.e. on February 15, 2023. The same is also available on the website of the Company at www.biocon.com.

Further, the Video Recording w.r.t. the Earnings Call is also available on the website of the Company at https://www.biocon.com/news-biocon/video-gallery-biocon/quarterlystatements-biocon/#1653297216088-5a4e9281-2d49.

Kindly take the above said information on record.

Thanking You,

Yours faithfully,

For Biocon Limited

MAYANK Digitally signed by MAYANK VERMA VERMA Date: 2023.02.15 17:52:23 +05'30'


Mayank Verma Company Secretary & Compliance Officer Membership No.: ACS 18776

Encl. as above

Q3 FY23 Earnings Call

February 15, 2023

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1

B I O C O N L I M I T E D

Safe Harbor Statement

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Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those contemplated in such statements. factors that could cause actual results to differ from our forward-looking Important materially expectations include, amongst others general economic and business conditions in India, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control in India. Neither the nor its directors and of the affiliates have to or regulations company, any any obligation update otherwise revise statements circumstances after this date or to reflect the occurrence of any reflecting arising underlying . events, even if the underlying assumptions do not come to fruition

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B I O C O N L I M I T E D

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Opening Remarks

B I O C O N L I M I T E D 3 3

Opening Remarks: Q3 FY23 Earnings Call

National budget spotlight on research and innovation

Viatris transaction completed; business integration in a phased manner

Debt reduction efforts

Recent FDA actions impacting Indian pharma industry

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B I O C O N L I M I T E D

Viatris acquisition completed

B U S I N E S S I N T E G R A T I O N

Incremental revenues & profits post deal closure reflected in earnings

Bespoke country specific strategy and business model that optimizes for revenues and profitability

Integrating country wise business operations in a phased manner in the coming quarters

‘Business continuity’ one of the key imperatives to integration

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E Q U I T Y I N F U S I O N I N B B L

SILS

$150m

Biocon Ltd

$650m

Reserves $230m

Mezzanine Financing

$420m

D E B T R E D U C T I O N E F F O R T S

Biocon Limited to reduce debt

Biocon Biologics in discussions with Private Equity investors for additional fund raise to pare down debt

Structured funding provided by Kotak Strategic Situations fund (up to ₹1,200 Cr)

Part of recent stake sale in Syngene – Biocon maintains majority control at 54.9%

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B I O C O N L I M I T E D

Opening Remarks: Q3 FY23 Earnings Call

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R E C E N T R E G U L A T O R Y I N S P E C T I O N S

National budget spotlight on research and innovation

Viatris transaction completed; business integration in a phased manner

Debt reduction efforts

Recent FDA actions impacting Indian pharma industry

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B I O C O N L I M I T E D

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Leadership Update

B I O C O N L I M I T E D 7 7

Leadership Update

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Dr. Arun Chandavarkar

Non-Executive, non-Independent Director on the Board of Biocon Biologics

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Shreehas Tambe

Appointed CEO and Managing Director of Biocon Biologics in December 2022

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B I O C O N L I M I T E D

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Q3 FY23 Financial Highlights

B I O C O N L I M I T E D 9 9

Financial Highlights: Q3 FY23

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Consolidated (in INR Cr.) Q3 FY23 Q3 FY22 YoY %
Total Revenue 3,020 2,223 36 **Biosimilars +54%
Core EBITDA1 1,069 715 49
% Margin 36% 33%
EBITDA 723 537 35 Net R&D spendat ₹337Cr, up ₹199 Cr vs Q3 FY22
Forex Lossof ₹44Cr vs gain of ₹19 Cr in Q3 FY22
% Margin 24% 24%
Profit Before Tax
(Before exceptional charge)
246 269 (9) Increase in amortisation and interest expenserelated
to the acquisition of Viatris’ biosimilar business
% Margin 8% 12%
Net Profit
(Before exceptional charge)
140 187 (25) Increase in minority interestdue to dilution of
shareholding in Biocon Biologics and Syngene
Net Profit Margin % 5% 8%

1 Core EBITDA defined as EBITDA before forex, dilution gain in Bicara, R&D, licensing income and mark to market movement investments.

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B I O C O N L I M I T E D

Exceptional Items: Q3 FY23

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Consolidated (in INR Cr.) Q3 FY23 Q3 FY22 YoY %
Net Profit
(before exceptional charge)
140 187 (25)
Exceptional Items
(net of tax and minority interest)
(182) - Exceptional items during Q3 FY23:
Primarily pertain to deal related expenses of the
Viatris transaction. .
Net Profit /(loss)
(Reported)
(42) 187

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B I O C O N L I M I T E D

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Q3 FY23 Generics

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B I O C O N L I M I T E D

Generics: Q3 FY23 Update

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K E Y H I G H L I G H T S

Revenue growth led by increased demand for Immunosuppressant APIs as well as Generic Formulations

Margins, compared to the previous year were muted due to continued pricing pressure in the US market Signed a partnership agreement with Zentiva for commercialising Liraglutide in 30 European countries

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In INR Cr Q3 FY23 Q3 FY22 YoY %
Segment Revenue 718 607 18
PBT 72 67 8
% of revenue 10% 11%
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Signed a long term strategic partnership in Brazil for the supply and techtransfer of a finished dose formulation immunosuppressant product Issued a GMP Certificate of Compliance by the European Directorate for the Quality of Medicines & HealthCare (EDQM), for our API manufacturing facility in Bengaluru, following a GMP inspection of the site conducted in September 2022.

Validation of the immunosuppressant API facility in Visakhapatnam and peptide facility in Bengaluru expected to be completed by H1 FY24

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B I O C O N L I M I T E D

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Q3 FY23 Biosimilars

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B I O C O N L I M I T E D

Biosimilars: Q3 FY23 Update

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K E Y H I G H L I G H T S Revenue growth of 54% driven by Viatris deal closure and steady growth in BBL-led business In INR Cr Q3 FY23 Q3 FY22 YoY % R&D investments increased to ₹280 Crores; completed recruitment Segment Revenue 1,507 981 54 for bDenosumab and bUstekinumab clinical trials Core EBITDA 663 363 83 bPertuzumab entered Phase 1 trials, initiated interchangeability study for bAdalimumab % of revenue 44% 38% All products surpass 10% market share in US; bAdalimumab garners PBT (before exceptions) 102 124 (17) 18% and 10% market share in Germany and France, respectively % of revenue 7% 13% Eight new launches in Emerging Markets CAPA plan submitted for bAspart and bBevacizumab; committed to closure of actions within stipulated timeline

*Core EBITDA defined as EBITDA excluding R&D, forex, licensing income and mark-to-market movement on investments

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B I O C O N L I M I T E D

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Q3 FY23 Novels

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B I O C O N L I M I T E D

Novels : Q3 FY23 Update

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K E Y H I G H L I G H T S

Enrolment continues to ramp up in the pivotal Phase III clinical study of Itolizumab in patients with aGVHD* (EQUATOR study)

Patient enrolment also continues for the pivotal Phase 1b clinical study of Itolizumab for Lupus Nephritis (equalise study)

The Phase II trial underway in India for the clinical study of Itolizumab in patients with Ulcerative Colitis, patient dosing (Randomization) began in December,2022

Equillium has recently entered into an Option and Purchase Agreement with Ono Pharmaceutical Co., Ltd, Japan, where Equillium has granted Ono the exclusive right to acquire its rights to Itolizumab

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*Acute Graft-Versus-Host Disease

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B I O C O N L I M I T E D

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Q3 FY23 Research Services

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B I O C O N L I M I T E D

Research Services: Q3 FY23 Update

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K E Y H I G H L I G H T S

Delivered positive performances in all divisions. Sustained growth in Research divisions - Discovery Services and the Dedicated Centers

Development Services growth primarily driven by repeat orders from existing clients and a growing number of collaborations with emerging biopharma companies

Syngene successfully completed the US Food and Drug Administration (US FDA), European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) regulatory audits for its biologics manufacturing facility

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In INR Cr Q3 FY23 Q3 FY22 YoY %
Segment Revenue 786 641 23%
PBT 140 128 9%
% of revenue 18% 20%
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With the cGMP certifications from the regulatory agencies in place, the Company is on track to execute manufacturing of drug substance at a commercial scale and progress its Biologics manufacturing services growth strategy

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B I O C O N L I M I T E D

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Concluding Remarks

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B I O C O N L I M I T E D

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Q&A

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