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Biocon Ltd. Call Transcript 2024

May 17, 2024

61176_rns_2024-05-17_144334e8-23b1-4e53-8140-4ac343a4edcc.pdf

Call Transcript

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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

BIO/SECL/AJ/2024-25/22

May 17, 2024

BIO/SECL/AJ/2024-25/22
May 17, 2024
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 Q4 FY24 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 Q4 and full year FY24 Earnings Call conducted on May 16, 2024. 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/quarterly-statementsbiocon/#1653297216088-5a4e9281-2d49.

Kindly take the above said information on record.

Thanking You,

Yours faithfully,

For Biocon Limited

Digitally signed MAYANK by MAYANK VERMA VERMA Date: 2024.05.17 15:50:27 +05'30'


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

Encl. as above

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Q4 & Full Year FY24 Earnings Call

May 16[th] , 2024

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Safe Harbor Statement

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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Group CEO Opening Remarks

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Opening Remarks: Q4 & full year FY24

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  • FY24 has been a year of balanced progress

  • Biocon Generics, Biocon Biologics and Syngene have delivered significant operational successes, also faced and addressed a range of operational challenges

Generics:

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  • Strong growth in our formulations business driven by new product launches; strengthened U.S. business footprint; expanded geographic reach through direct to market and strategic partnership models

  • First generic company to receive approval for gLiraglutide in a major regulated market

Biosimilars:

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  • Transformational year; completed the full transition of the acquired biosimilar business; maintained strong revenue growth momentum; improved market shares of our products, especially in the United States

  • Crossed USD 1 billion revenue threshold

  • Prepaid USD 250 million acquisition related balance sheet debt

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Research Services (Syngene):

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  • Syngene’s evolving CRDMO platform provided diversification to absorb slowdown from a challenging biotech funding environment that impacted its discovery services business

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  • Development and manufacturing services business, especially biomanufacturing, delivered a strong performance

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Financial Highlights Q4 and full year FY24

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Opening Remarks: Financial Highlights – Q4 FY24

In INR Cr Q4 FY24 Q4 FY23 Q3 FY24 YoY (%) QoQ(%)
Generics 719 744 703 (3) 2
Biosimilars 2,358 2,102 2,4831 12 (5)
Novels - 19 - - -
Research Services 917 994 854 (8) 7
Revenue from Operations 3,917 3,774 3,9541 4 (1)
Total Revenue 3,966 3,929 4,5192 1 (12)
R&D 246 342 329
% of Revenue (Ex. Syngene) 8% 12% 11%
Core EBITDA3 1,176 1,260 983 (7) 20
% Margin 30% 35% 27%
EBITDA 964 1,152 1,492 (16) (35)
% Margin 24% 29% 29%
Profit Before Tax (Before exceptional items) 328 500 787 (34) (58)
% Margin 8% 13% 17%
Net Profit(Before exceptional items) 144 335 644 (57) (78)
Exceptional item, net of taxes & minority interest (8) (22) 16 (66) (147)
Net Profit(Reported) 136 313 660 (57) (79)

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1 Q3 FY24 Includes income from divesture of two non-core Branded Formulations India business units in Biocon Biologics of 350 crores; 2 includes gain from Biocon’s stake dilution/ fair valuation in Bicara Therapeutics of 456 crores 3Core EBITDA defined as EBITDA before forex, dilution/ fair valuation gain in Bicara, R&D, licensing income, sale of non-core BFI assets and mark to market movement on investments.

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Opening Remarks: Financial Highlights – FY24

In INR Cr FY24 FY23 YoY (%)
Generics 2,799 2,765 1
Biosimilars 8,8241 5,584 58
Novels - 19 -
Research Services 3,489 3,193 9
Revenue from Operations 14,7561 11,174 32
Total Revenue 15,6212 11,550 35
R&D 1,154 1,119 3
% of Revenue (Ex. Syngene) 10% 14%
Core EBITDA3 4,195 3,807 10
% Margin 29% 34%
EBITDA 4,164 2,888 44
% Margin 27% 25%
Profit Before Tax (Before exceptional items) 1,537 1,189 29
% Margin 10% 10%
Net Profit(Before exceptional items) 1,030 787 31
Exceptional item, net of taxes & minority interest (8) (324)
Net Profit(Reported) 1,022 463 121

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1 FY24 Includes income from divesture of two non-core Branded Formulations India business units in Biocon Biologics of 350 crores; 2 includes gain from Biocon’s stake dilution/ fair valuation in Bicara Therapeutics of 530 crores 3 Core EBITDA defined as EBITDA before forex, dilution/ fair valuation gain in Bicara, R&D, licensing income, sale of non-core BFI assets and mark to market movement on investments.

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Generics Q4 and full year FY24

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Biocon Generics: Q4 & full year FY24 Business Performance update

Strong traction in the formulations business (up 36% YoY), led by growth of
statins and immunosuppressants across all major geographies during FY24
Despite the challenges faced in our API business, maintained Core EBITDA
margins by cost control and saving initiatives
Multiple manufacturing facility inspections with international regulatory
agencies across various sites, all with positive outcomes in FY24
Received approval for gLiraglutide in the U.K. First company globally to
receive a generic approval in a major regulated market
Made 38 drug products and 37 APIs filings and received 24 drug products and
20 API approvals across global markets during FY24

Vishal Nayyar appointed as Head – Supply Chain Management

Amit Kaptain appointed as Head - Commercial API
Formulations expected to be the key growth driver for FY25; expect
performance to build throughout the year with a stronger H2
In ₹ Cr
Q4
FY24
Q4
FY23
Q3
FY24
YoY % QoQ %
Revenue from
Operations
719
744
703
(3)
2
Core EBITDA
155
166
155
(7)
-
% of revenue
21%
21%
21%
PBT
50
75
50
(33)
-
% of revenue
7%
10%
7%
In ₹ Cr
FY24
FY23
YoY %
Revenue from
Operations
2,799
2,765
1
Core EBITDA
627
629
(0)
% of revenue
22%
22%
PBT
230
264
(13)
% of revenue
8%
10%

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Biosimilars Q4 and full year FY24

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Biocon Biologics: Biosimilars – Q4 FY24 Business Update

1[st] quarter where Biocon Biologics directly managed the acquired business across geographies Continued increase in market share across products in the US Market shares in Europe remain stable with double-digit shares in France, Germany and Belgium for bAdalimumab 7 new launches in Emerging Markets and a robust increase in demand across regions Entered a long-term commercial collaboration with Eris Lifesciences to expand patient access to our portfolio in India

Key Products’ Market Share1 Key Products’ Market Share1 Key Products’ Market Share1
United States
Mar-24 Jan-24 Mar-23
Fulphila (bPegfilgrastim) 21% 19% 14%
Ogivri (bTrastuzumab) 18% 14% 10%
Semglee (bGlargine)2 15% 12% 12%
Europe
**Q4 CY’23 ** **Q3 CY’23 ** Q4 CY’22
Fulphila (bPegfilgrastim) 8% 8% 6%
Ogivri (bTrastuzumab) 10% 10% 12%
Abvemy (bBevacizumab) 6% 6% 1%
Semglee (bGlargine) 4% 4% 3%
Hulio (bAdalimumab) 6% 6% 6%
Nepexto (bEtanercept) 2% 2% 1%

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1. Market shares based on IQVIA volumes, Eq.SU I 2. Includes both Semglee and unbranded Glargine

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Biocon Biologics: Biosimilars – Q4 & full year FY24 Financial Update

EBITDA before forex, R&D, licensing income, sale of non-core BFI assets and mark to market movement on investments;
Q3 includes 350 Cr towards income from non-core BFI divesture;3 Excluding 350 Cr income from non-core BFI divesture
Full year FY24 EBITDA Margins remain healthy at 25%
Full year FY24 R&D Investments at 10% of revenues which will be a key
driver of growth
Q4 revenue grew 12% vs. LY and 10% on a sequential quarter basis after
adjusting for income from the non-core BFI divesture in Q3 FY24
Full year FY24 revenues crossed the USD 1 billion (8,824 Cr.)threshold
driven by the acquisition and growth in core business
In INR CR
Q4
FY24
Q4
FY23
Q3
FY24
YoY
%
QoQ
%
Revenue from
Operations
2,358
2,102
2,4832
12
103
Core EBITDA1
698
742
587
(6)
19
% of revenue
30%
39%
28%
EBITDA
564
573
7142
(2)
(21)
% of Revenue
24%
27%
29%
In INR Cr
FY24
FY23
YoY %
Revenue from
Operations
8,8242
5,584
58%
Core EBITDA
2,458
2,216
11%
% of revenue
30%
41%
EBITDA
2,190
1,338
64%
% of Revenue
25%
24%

1EBITDA before forex, R&D, licensing income, sale of non-core BFI assets and mark to market movement on investments;

2Q3 includes 350 Cr towards income from non-core BFI divesture; 3 Excluding 350 Cr income from non-core BFI divesture

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Biocon Biologics: Biosimilars – Q4 FY24 Other Business Updates

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FDA accepted bUstekinumab filing and settled with J&J for a launch in the US no later than Feb’25 – will be among the first wave of entrants

Settled with Bayer and Regeneron for a launch of bAflibercept in Canada no later than July’25

Dwight D. Hanshew Jr. appointed as Chief Quality Officer (CQO) – brings over 30 years of experience

Key Catalysts

Accelerate growth for existing products & expand geographical footprint

Focus on securing Regulatory Approvals in the near and medium term to drive sustainable growth and margins

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Novels Q4 and full year FY24

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Novel Molecules: FY24 update

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During the fiscal, Equillium presented positive data from Phase 1b EQUALISE Study of itolizumab in patients with lupus nephritis at the annual meetings of America Society of Nephrology and the American College of Rheumatology

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In April 2024, Equillium announced positive topline data from the type B portion of the Phase 1b EQUALISE Study of Itolizumab in patients with lupus nephritis. Study demonstrated clinically meaningful response in highly proteinuric subjects.

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During FY24, Bicara* presented positive interim data from its ongoing, open-label Phase 1/1b dose expansion study of BCA101, at the European Society for Medical Oncology (ESMO) Congress evoking strong investigator interest

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Bicara* closed a Series C fund raise in December’23, raising USD 165 million. Post the fund raise, Biocon shareholding diluted to 14% and Bicara is no longer considered associate company of the Biocon group

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*a US based clinical-stage biotechnology company. During Q3 FY24, pursuant to Series C financing, Bicara ceases to be 'Associate Company’ of Biocon Group.

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Research Services Q4 and full year FY24

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Syngene: Q4 and full year FY24 Update

Q4 and FY24 impacted by lower demand for research services stemming from a slowdown in US biotech funding environment Full year performance supported by strong growth in development and manufacturing services, esp. biomanufacturing Concluded the acquisition of the biologics manufacturing facility from Stelis Biopharma which trebles Syngene’s biologics manufacturing capacity. Facility modifications and qualification remain on track, expected in H2 FY25 Recent step up in new funding into US biotech expected to drive a recovery in demand for research and development services FY25 guidance: Revenue growth in high single digits to low double digits; operating EBITDA margins comparable to FY24; single digit PAT growth

In INR Cr
Q4
FY24
Q4
FY23
Q3
FY24
YoY
%
QoQ
%
Revenue from
Operations
917
994
854
(8)
7
EBITDA
333
337
261
(1)
28
% of revenue
36%
33%
30%
PBT
209
231
142
(9)
47
In INR Cr
FY24
FY23
YoY %
Revenue from
Operations
3,489
3,193
9
EBITDA
1,105
1,005
10
% of revenue
31%
31%
PBT
632
594
6

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Concluding Remarks

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Concluding Remarks: Q4 & full year FY24

  • FY24 has been a year of significant operational success and clear progress across business segments

  • FY25 to be a year of both consolidation and of transitional and accelerating growth

  • Revenue growth to pick up in H2 of the fiscal year

  • Generics

  • Growth to be driven by formulations, especially new launches in the second half of the fiscal

  • Expect continued pressure in the API business

  • Major growth to be driven by GLP opportunities, impact to be more visible in FY26

  • Biosimilars

  • Base business expected to deliver robust volume growth

  • FDA inspections at Malaysia and Bengaluru would be key events; any favorable outcome expected to have limited impact in FY25

  • Syngene

  • Long term growth drivers are positive, Syngene well positioned to capitalize

  • Tailwind in biomanufacturing

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Biocon Group companies are well positioned to take advantage of significant existing and emerging opportunities

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Q&A

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