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Biocon Ltd. Earnings Release 2019

Apr 25, 2019

61176_rns_2019-04-25_de74e644-3983-4fa8-bd62-7112c53b8c97.pdf

Earnings Release

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Biocon Limited

20th KM Hosur Road Electronics City Bengaluru 560 100, India T 91 80 2808 2808 F 91 80 2852 3423 CIN: l14234KA1978PLC003417

www.biocon.com

April 25, 2019

To To
The Manager The Manager
BSE Limited National Stock Exchange of India Limited
Department of Corporate Services Corporate Communication Department
Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra Kurla Complex
Dalal Street, Mumbai-400 001 Mumbai-400 050
Scrip Code - 532523 Stock Code- Biocon

Sub: Press Release on Q4 FV19 Financial Results

Dear Sir/Madam,

Pursuant to Regulation 30 of the SEBI (Listing Obligation and Disclosure Requirements) Regulations, 2015, please find enclosed the press release titled "Biocon Q4FV19 Revenue Rs. 1,557 Cr, Up 26%; EBITDA Up 43% at Rs 431 Cr; Net Profit Up 64% at Rs 214 Cr, FY19 Revenue Up 31% at Rs 5,659 Cr; Net Profit Up 143% at Rs 905 Cr, Board Recommends 1: 1 Bonus Shares" pertaining to the audited consolidated financial results of Biocon Limited for the quarter and year ended March 31, 2019.

The above information will also be available on the website of the company at www.biocon.com.

Kindly take on record the above information and acknowledge.

Thanking You,

Yours faithfully,

or BIOCON LIMITED

Chief Financial Officer & Compliance Officer

/

<$Biocon

Press Release

Biocon Q4FY19 Revenue Rs 1,557 Cr, Up 26%; EBITDA Up 43% at Rs 431 Cr; Net Profit Up 64% at Rs 214 Cr FY19 Revenue Up 31% at Rs 5,659 Cr; Net Profit Up 143% at Rs 905 Cr Board Recommends 1: 1 Bonus Shares

Bengaluru, Karnataka, India: April 25, 2019:

Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia's premier biopharmaceuticals company, today announced its consolidated financial results for the fourth quarter and fiscal year ended March 3Pt, 2019.

Commenting on the highlights, Kiron Mozumdor-Show, Chairperson & Managing Director, stated:

"Our Q4 FY19 performance was led by robust growth in our Biologics and Research Services business segments, supported by a significant growth in the Small Molecules business.

"On an annual basis, our Revenue grew 31% to Rs 5,659 Crore, and Net Profit soared 143% to Rs 905 Crore. FY19 was a landmark year for the Biologics business, which reported a growth of 97%, thus emerging as a key driver for Biocon's incremental growth. Our three strategic business segments Small Molecules, Biologics and Research Services have reported a top-tine of over Rs 1,500 Crore each this fiscal. A higher shore of Biologics revenue boosted profitability as reflected in the consolidated EBITDA margin of 27% for the full year despite a 34% increase in Net R&D expenses.

"Looking ahead in FY20, we expect to sustain the growth momentum across our business segments led by biosimilars. We expect to sustain core EBITDA margins despite higher R&D investments to fuel our future growth."

Highlights: Q4FY19

  • ~ Biologics revenue nearly doubled, led by biosimilars portfolio performance in developed and emerging markets.
  • ~ Branded Formulations India business reported a strong double digit growth which was offset by a decline in UAE.
  • ~Generic Formulations business grew multi-fold off a low base, reflecting our focus on vertical integration in the Small Molecules business
  • ~Research Services subsidiary Syngene crossed the Rs 500 Crore Revenue milestone with a Net Profit milestone of Rs 1.00 Crore in Q4 on a standalone basis.
  • ~To commemorate the 40th anniversary of Biocon Limited the Board recommended the issue of 1. bonus share for every 1. share held in Biocon.

FINANCIAL HIGHLIGHTS (CONSOLIDATED): Q4 & FULL YEAR FY19

Particulars Q4FY19 Q4FY18 Growth FY19 FY18 Growth
INCOME
Small Molecules 472 426 11% 1773 1508 18%
Biologics 451 241 87% 1517 770 97%
Branded Formulations 133 149 -11% 656 612 7%
Research Services 534 409 30% 1826 1423 28%
Inter-segment -61 -55 11% -257 -183 41%
Revenue from Operations• 1529 1170 31% 5514 4130 34%
Other Income 28 67 -58% 144 206 -30%
TOTAL REVENUE 1557 1237 26% 5659 4336 31%
EBITOA 431 300 43% 1538 1035 49%
PBT (Before exceptional items) 284 193 47% 1020 610 67%
PBT 284 193 47% 1215 610 99%
Net Profit* 214 130 64% 905 372 143%
Net Profit(excl. exceptionalincome) 214 130 64% 729 372 96%
R&D Expenses in P&L 92 51 81% 290 216 34%
Gross R&D Spends 166 98 70% 480 380 26%
EBITOA Margin 28% 24% 27% 24%
Core EBITDA Margin 34% 26% 32% 27%
Net Profit Margin(excl. exceptional income) 14% 11% 13% 9%
Net Profit Margin* 14% 11% 16% 9%
#includes Licensing Income 7 2 25 23
*·includes exceptional income,net of tax 176

Notes: Figures above are rounded off to the nearest Cr; % based on absolute numbers.

EXECUTIVE COMMENTARY:

PERFORMANCE REVIEW: Q4FY19

  • Biocon's Total Revenue for Q4FY19 at Rs 1,557 Crore grew by 26% year-on-year (YoY) with Revenue from Operations at Rs 1,529 Crore increasing by 31%.
  • EBITDA grew 43% YoY at Rs 431 Crore, with an EBITDA margin of 28% for Q4FY19. Core EBITDA margin for Q4FY19 (net of licensing, impact of forex and R&D) stood at 34%.
  • Net Profit for the quarter jumped 64% YoY to Rs 214 Crore, which represents a Net Profit margin of 14%.
  • Net R&D expenses for the quarter increased 81% to Rs 92 Crore while Gross R&D expenses stood at Rs 166 Crore, corresponding to 17% of our revenue (excluding Syngene).

Business Segment Review: Q4FV19

The Q4FY19 revenue growth was largely led by a robust performance by Biologics and Research Services, supported by a double digit growth in Small Molecules. The Biologics segment revenue grew 87% to Rs 451 Crore driven by strong sales of our biosimilars Pegfilgrastim and Trastuzumab in developed and emerging markets. Ogivri® (biosimilar Trastuzumab) was launched by our partner Mylan in Europe in Q4. We also launched our biosimilarTrastuzumab in a few more emerging markets this quarter. The product continues to gain traction in key markets of Latin America and AFMET regions.

The Small Molecules business reported a growth of 11% led by a robust performance by Generic Formulations and steady sales of APis. The strong performance of Generic Formulations was driven by increased traction in Statins sales in the U.S.

The Branded Formulations business, which includes sales in India and UAE, was adversely impacted due to headwinds in UAE. However, the business in India reported a strong performance led by double-digit growth in Metabolics, Critical Care, Immunotherapy and Market Access divisions.

Research Services reported a robust growth of 30% YoY with revenue at Rs 534 Crore on account of sustained growth in the Discovery and Development Services segments. On a standalone basis Syngene crossed the Rs 500 Crore Revenue milestone with a Net Profit milestone of Rs 100 Crore in Q4.

During the quarter, Syngene and the Government of India's Biotechnology Industry Research Assistance Council (BIRAC) collaborated to set up a Centre for Advanced Protein Studies (CAPS) .. The 2000 sq. ft. centre at Syngene's Bengaluru Campus hosts a state-of-the-art, GLP-accredited analytical laboratory which will be available to BIRAC-funded start-ups, SMEs/MMEs and academia in India at an affordable cost.

PERFORMANCE REVIEW: FULL YEAR FY19

  • Biocon's Total Revenue for FY19 rose 31% to Rs 5,659 Crore with Revenue from Operations growing 34% at Rs 5,514 Crore.
  • EBITDA expanded 49% to Rs 1,538 Crore, with an EBITDA margin of 27% for FY19.
  • Core EBITDA margin for the year (net of licensing, impact of forex and R&D) stood at 32%.
  • Net Profit (including exceptional income*) for the year climbed 143% to Rs 905 Crore.
  • Net Profit (excluding exceptional income*) stood at Rs 729 Crore reflecting a stellar growth of 96%.
  • Net Profit Margin stood at 16% in FY19 versus 9% in FY18. Net Profit Margin (excluding net exceptional income) was 13% in FY19.
  • Net R&D expenses for FY19 grew by 34% to Rs 290 Crore while Gross R&D expenses were

Rs 480 Crore, representing 13% of our revenue (excluding Syngene).

*A net exceptional income of Rs 176 Crore related to change in the fair value of our investment in U.S.-based Equillium Inc. was reported in earlier quarters during FY19.

<$siocon

Business Segment Review: FY19

SMALL MOLECULES: APis & Generic Formulations

Small Molecules revenue at Rs 1, 773 Crore in FY19 reported a growth of 18% on the back of steady API sales in global markets and robust sales in the Generic Formulations business in the U.S.

Sales of our core APis including Statins & Immunosuppressants to customers in India, Latin America and Europe contributed significantly to the overall performance. Our Generic Formulations business in the U.S. recorded a multi-fold growth off a low base, in its first full year of commercial operations, reflecting the success of our vertical integration strategy in the Small Molecules business. We successfully commercialized Atorvastatin and Simvastatin formulations in the U.S. in FY19 and recorded market share gains in the previously launched Rosuvastatin formulations.

BIOLOGICS: Biosimilars & Novels

The Biologics segment was the strongest performing segment in FY19, reporting a stellar 97% revenue growth at Rs 1,517 Crore in FY19. It has been a landmark year for the biosimilars business with revenues doubling this year led by the launch of our key biosimilars in the U.S. and Europe and ramp up of sales in the emerging markets. Inclusive of inter-segment transfers, the Biologics business crossed the US$ 200 million revenue milestone in FY19.

The launch of Fulphila® (biosimilar Pegfilgrastim) in the U.S. by our partner Mylan contributed significantly to the Biologics segment's performance in FY19. Mylan also launched Semglee® (biosimilar Insulin Glargine) and Ogivri® (biosimilar Trastuzumab) in Europe along with the in-licensed biosimilar Adalimumab, where Biocon retains its economic interest.

Significant growth in biosimilars sales was reported from emerging markets in LATAM, APAC and MENA regions. Biocon-supplied products hold dominant shares for Trastuzumab, rh-lnsulin and Insulin Glargine in many of these markets.

Strong realizations on biosimilars sales in both developed and emerging markets led to the Profit Before Interest and Tax (PBIT) margin for the Biologics segment improving from -2% in FY18 to 26% in FY19.

In keeping with our commitment to make our biosimilars affordable and hence accessible to a large global population, our Biologics business addressed the needs of nearly 2 million patients in FY19.

Till end of FY19, three of our biosimilars have been commercialized in developed markets, viz., Pegfilgrastim in U.S., Trastuzumab in Europe and Insulin Glargine in Europe and Japan. Additionally, our Trastuzumab has marketing approvals in U.S. and Australia, Pegfilgrastim has approvals in EU, Canada and Australia, and Insulin Glargine has approval in Australia. The global development programs for biosimilar Bevacizumab and Insulin Aspart are progressing well in Phase Ill clinical studies.

Novel Biologics

ltolizumab: A Phase 1b/2 trial in acute graft-versus-host disease (aGVHD) with our novel asset ltolizumab (EQOOl) was initiated by our partner Equillium, who has licensed our novel anti-COG monoclonal antibody for development in U.S. and Canada. Equillium has been awarded 'Fast

Track' and 'Orphan Drug' designations for the molecule in both prevention and treatment of aGVHD by the U.S. FDA.

We have incorporated Bicara Therapeutics based in Boston, U.S., as a wholly owned subsidiary of Biocon to focus on developing lmmuno-oncology assets.

BRANDED FORMULATIONS

In FY19, the Branded Formulations business reported growth of 7% at a revenue of Rs 656 Crore led by a strong performance by business in India which was offset by a decline in the UAE business.

The Metabolics, Nephrology, Critical Care and Market Access divisions were the key growth drivers for the Branded Formulations- India (BFI) business. The Top 10 brands in our BFI portfolio grew by 17% and accounted for 80% oftotal sales in FY19. As a specialty products company, 70% of our overall India business is now accounted for by biologics I biosimilars products. Key brands lnsugen® and Basalog® reported a combined sales of over Rs 200 Crore in FY19.

In UAE, business performance for the year was impacted by uncertainty in the local market including delays in product registrations with the local health authorities and repricing of branded generic products by the Ministry of Health.

On the positive side, we launched Canhera'M, as the first biosimilar Trastuzumab in UAE this year to enable affordable access to this therapy for breast cancer patients. Glaricon'M, our Insulin Glargine introduced earlier, is continuing to gain traction and along with some of the novel in-licensed products has improved Biocon's position in the Top 10 companies in the diabetes segment in UAE.

RESEARCH SERVICES- SVNGENE

During FY19, Research Services revenue grew 28% toRs 1,826 Crore driven by robust performances in both Discovery Services and Dedicated R&D Centre business. During the year, Syngene further expanded its customer base as well as extended its existing client relationships taking the total active client base to over 330. The expansion of ongoing strategic collaboration with Baxter Inc. led to the commissioning of additional infrastructure for Baxter.

CORPORATE SOCIAL RESPONSIBILITY

As a part of its Lake Revival Mission, Biocon Foundation has brought back to life the 35 acre dying Hebbagodi Lake in Bengaluru, using a 3- step eco-friendly bioremediation process and dedicated the lake to the community in FY19. The Project has won several awards including a place in the Limca Book of Records for introducing the largest artificial floating wetlands. Biocon Foundation has further expanded its initiative to take up the revival of Yarandahalli and Kammasandra Lakes in the same area.

RECENT KEY APPOINTMENTS

In line with our aspiration of transforming Biocon into a major global player in biologics, we appointed Dr. Christiane Hamacher as CEO of Biocon Biologics, in March 2019. Dr. Hamacher brings more than 20 years of leadership experience in both strategic and operational roles across the value chain in the global pharma sector, spanning Asia, Europe and the U.S. with leading multinational pharma companies. She holds a Ph.D. in Molecular Biology (Oncology) from the University Clinic Bergmannsheil I University of Bochum, Germany.

Dr. Gopal Krishna Dasika has also been appointed as Head of R&D at Biocon Biologics, in February 2019. Dr Dasika comes with over 20 years of experience in biologics R&D. He holds a Ph.D. from the University of Wisconsin, U.S. and a post-doctoral fellowship from the University of Texas Health Sciences Center at Saint Antonio, Texas.

DECLARATION OF BONUS SHARES & FINAL DIVIDEND

To commemorate the 401 h anniversary of Biocon the Board of Directors of the Company at the meeting held on April 25, 2019 recommended t he issue of 1 bonus share for every 1 share held in Biocon.

The Board also recommended a Final Dividend of Re 1/- per share (pre-bonus) for FY19.

Enclosed: Fact Sheet- with Financials as per IND-AS

About Biocon Ltd: Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE ld: BIOCON, ISIN ld: INE376G01013) is a fully-integrated, innovation-led global biopharmaceutical company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. The Company has developed and commercialized a range of Biosimilars (Monoclonal Antibodies, Pegfilgrastim, rhlnsulin and Insulin Glargine), Novel Biologics and differentiated Small Molecules in India and Key emerging markets. It has a large portfolio of biosimilars under global clinical development with three of these commercialized in the developed markets of EU, U.S. and Japan. It has promising novel assets in immunotherapy under development. Some of its key brands are INSUGEN® (rh-insulin), Basalog One® (prefilled Glargine pen), CANMAbrM (Trastuzumab), KRABEVA® (Bevacizumab), BIOMAb-EGFR® (Nimotuzumab) and ALZUMAbrM (ltolizumab). www.biocon.com Follow-us on Twitter: @bioconlimited

Earnings Call

The company will conduct a call at 9.00 AM /STan Apri/26, 2019 where the senior management will discuss the company's performance and answer questions from participants. This call is not open to the members of the media (print/ electronic/online/wires). To participate in this conference call, please dial the numbers provided below ten minutes ahead of the scheduled start time. The dial-in number for this call is +91 22 6280 1151. Other toll numbers are listed in the conference call invite which is posted on the company website www.biocon.com. The operator will provide instructions on asking questions before the start of the call. A replay of this call will also be available 60 minutes post the conclusion of the call till May 3, 2019 on +91 22 7194 5757 Playback Code: 91385. Transcript of the conference call will be uploaded on the company website in due course.

FOR MORE INFORMATION
MEDIA RELATIONS INVESTOR RELATIONS
SeemaAhuja Saurabh Paliwal
VP & Global Head of Communications Head, Investor Relations
'lir+9180 2808 2222; J +91 99723 17792 v +9180 6775 2040
[8] [email protected] [8] [email protected]
Alternate
Rumman Ahmed
Sr.Manager, Corporate Communications
'lir+9180 2808 2223; J +9198451 04173
[8] [email protected]

DISCLAIMER: Th1s press release may mclude statements of future expectations and ather forward-loakmg statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocan and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technaloaicol changes, changes in the value of the Rupee and other currency changes, 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 and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forwardlooking statement contained in this release.

BIOCON GROUP

FACT SHEET

March- 2019

BIOCON LIMITED (CONSOLIDATED)
BALANCE SHEET
-.;,~ J,T,F.I7iliV:~ • • r- J F.m ;w: C1.i1itT;1 (Rs Cr)
ASSETS
Non-current assets
(a) Property, plant and equipment 4,253 3,630
(b) Capital work-in-progress 1,287 779
(c) Goodwill 26 26
(d) Other intangible assets 192 43
(e) Intangible assets under development 612 524
(f) Investments in associates and a joint venture 43 64
(g) Financial assets
Investments 139 -
Derivative assets 71 111
Other financial assets 39 25
(h) Income tax asset, net 169 127
325 193
(i) Deferred tax asset, net
(j) Other non-current assets 213 319
7,370 5,841
Current assets
(a) Inventories 1,032 723
(b) Financial assets
Investments 829 611
Trade receivables 1,292 1,064
Cash and cash equivalents 730 501
Other bank balances 327 822
Derivative assets 78 99
Other financial assets 387 192
(c) Other current assets 149 137
4,823 4,149
' rnnm ~
EQUITY AND LIABILITIES
Equity
(a) Equity share capital 300 300
(b) Other equity 5,798 4,881
Equity attributable to owners of the Company 6,098 5,181
Non-controlling interests 609 468
6,707 5,649
Non-current liabilities
(a) Financial liabilities
Borrowings 1,542 1,790
Derivative liability 35 18
Other financial liabilities - -
(b) Provisions 66 49
(c) Other non-current liabilities 805 342
2,448 2,199
Current liabilities
(a) Financial liabilities
Borrowings 261 130
Trade payables 1,198 1,006
Derivative liability 14 6
Other financial liabilities 991 556
(b) Provisions 81 47
(c) Income tax liability, net 124 89
(d) Other current liabilities 369 308
3,038 2,142
llMlillr mml WID
BIOCON LIMITED (CONSOLIDATED)(Rs. Crores)PROFIT & LOSS STATEMENT
Small molecules 1,773 1,508 18%
Biologics 1,517 770 97%
Branded formulations 656 612 7%
Research services 1,826 1,423 28%
Inter-s (257) 41%
Revenue from operations # 4,130 34%
Other income
EXPENDITURE
Material & Power costs 2,136 1,825 17%
Staff costs 1,062 846 26%
Research & Development expenses* 290 216 34%
Other expenses 633 414 53%
Licensing Income 25 23
* Gross Research & 480 380
BIOCON LIMITED (CONSOLIDATED)PROFIT & LOSS STATEMENT(Rs. Crores)
Particulars Q 4FY 19 Q4FY 18 Variance
INCOME
Small molecules 472 426 11%
Biologics 451 241 87%
Branded formulations 133 149 $-11%$
Research services 534 409 30%
Inter-segment (61) (55) 11%
Revenue from operations # 1,529 1,170 31%
Other income 28 67 $-58%$
TOTAL REVENUE 1,557 1,237 26%
EXPENDITURE
Material & Power costs 549 523 5%
Staff costs$\sim$ 293 234 25%
Research & Development expenses* 92 51 81%
Other expenses 192 129 49%
Manufacturing, staff & other expenses 1,126 937 20%
EBITDA 431 300 43%
Interest & Finance charges 16 17 $-6%$
Depreciation & Amortisation 120 95 26%
Share of profit in JV / Associate, net 11 (5) $-320%$
PBT BEFORE EXCEPTIONAL ITEM 284 193 47%
Exceptional item, Net
PBT 284 193 47%
Taxes 41 41 0%
Taxes on exceptional item
NET PROFIT BEFORE MINORITY INTEREST 243 152 59%
Minority interest 29 22 33%
NET PROFIT FOR THE PERIOD 214 130 64%
EPS Rs. 3.6 2.2
Note: The figures are rounded off to the nearest crores, percentages are based on absolute numbers
# Licensing Income $\overline{7}$ 298
* Gross Research & Development expenses 166

$\tilde{\mathcal{F}}$

BIOCON LIMITED (CONSOLIDATED)PROFIT & LOSS STATEMENT (Rs. Crores)
Particulars Q 4FY 19 Q 3FY 19 Variance
INCOME
Small molecules 472 469 1%
Biologics 451 449 1%
Branded formulations 133 212 $-37%$
Research services 534 467 14%
Inter-segment (61) (56) 9%
Revenue from operations # 1,529 1,541 $-1%$
Other income 28 25 10%
TOTAL REVENUE 1,557 1,566 $-1%$
EXPENDITURE
Material & Power costs 549 590 $-7%$
Staff costs 293 269 9%
Research & Development expenses* 92 77 20%
Other expenses 192 224 $-14%$
Manufacturing, staff & other expenses 1,126 1,160 $-3%$
EBITDA 431 406 6%
Interest & Finance charges 16 19 $-15%$
Depreciation & Amortisation 120 117 3%
Share of profit in JV / Associate, net 11 (13) $-190%$
PBT BEFORE EXCEPTIONAL ITEM 284 283 0%
Exceptional item, Net 6
PBT 284 289
Taxes 41 46 $-11%$
Taxes on exceptional item $-100%$
NET PROFIT BEFORE MINORITY INTEREST 243 243 0%
Minority interest 29 26 14%
NET PROFIT FOR THE PERIOD 214 217 $-1%$
EPS Rs. 3.6 5.9
Note: The figures are rounded off to the nearest crores, percentages are based on absolute numbers
# Licensing Income $\overline{7}$ 7
* Gross Research & Development expenses 166 120