Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. http://www.biocon.com

Bengaluru, India, January 24, 2017/Team Estrade//– Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia’s premier biopharmaceuticals company, announced today its consolidated financial results for the third quarter ended on December 31, 2016.

Commenting on the quarterly performance and highlights, Chairperson and Managing Director, Kiran Mazumdar-Shaw stated:

“Our strong performance in Q3FY17 was led by robust growth of our Biologics business with both insulins and biosimilar MAbs gaining traction in Japan and key emerging markets. The commercialization of our Malaysian facility was a key milestone this quarter. Other major milestones this quarter were the acceptance of our first Biologics License Application (BLA) for the proposed biosimilar Trastuzumab by US FDA, and Marketing Authorization Application (MAA) for Insulin Glargine by EMA. These developments have strengthened Biocon’s position as a front runner in the arena of biosimilars. Our Small Molecules and Research Services businesses also reported strong growth this quarter.”

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. http://www.biocon.com
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. http://www.biocon.com

 

 

Highlights: Q3FY17

  • Biologics License Application (BLA) for a proposed biosimilar Trastuzumab accepted for review by the US FDA; Marks first US regulatory submission through the Mylan/Biocon collaboration.
  • Marketing Authorization Application (MAA) for Insulin Glargine co-developed by Biocon and Mylan accepted for review by European Medicines Agency (EMA)
  • The prestigious Journal of the American Medical Association (JAMA) published the clinical study results of biosimilar Trastuzumab after a rigorous peer review process.
  • Biocon’s Insulins facility in Malaysia commenced commercial operations with ‘Made in Malaysia’ product introduced in Malaysia.
  • A three year contract for supplying rh-Insulin cartridges and re-usable insulin pens awarded to Biocon SDN. BHD. by Ministry of Health (MoH) Malaysia.
  • Biocon ranked among the world’s Top Ten Best Employers in Biotechnology by Science magazine; The only Asian company to feature in 2016 list.
  • Biocon’s novel diabetes education initiative for medical practitioners, ABIDE, conferred with the ‘Award of Recognition’ by the prestigious Research Society for the Study of Diabetes in India.
  • Biocon debuts on the prestigious Asia IP Elite 2016 list; Only pharmaceutical company from India to be recognized for IP-led value creation by IP Business Congress Asia.

Financial Highlights: Q3 FY17

As per IND-AS (In Rs crore, except growth numbers)
 Particulars Q3 FY17 Q3 FY16 Growth (%)
 INCOME
  Small Molecules 390 315 24
  Biologics 120 75 61
  Branded Formulations 123 104 18
  Licensing 79 32 148
  Syngene: Research   Services 317 270 17
 Total Sales 1029 796 29
 Other Income 63 33 88
 TOTAL REVENUE 1092 829 32
 EBITDA 324 206 57
 Net Profit 171 104 65
 R&D Expenses in
P&L
85 68 25
 Gross R&D Spends 100 91 10
 EBITDA Margin 30% 25%
 Net Profit Margin 16% 13%

 

Note:
The figures above are rounded off to the nearest Cr; % based on absolute nos.
For financials in IGAAP kindly refer to the fact sheet

EXECUTIVE COMMENTARY

PERFORMANCE OVERVIEW

Biocon reported a revenue growth of 32% at Rs 1092 Cr in Q3FY17, which was led by a robust growth of 61% in the Biologics business, 24% growth recorded by Small Molecules, 18% by Branded Formulations and 17 % growth by Research Services businesses. Licensing Income stood at Rs 79 Cr and Other Income was Rs 63 Cr.

EBITDA rose 57% to Rs 324 Cr; Net Profit stood at Rs 171 Cr a growth of 65% over last year.

Net R&D spends during the quarter stood at Rs. 85 Cr, an increase of 25% YoY. At a Gross level, R&D spends in Q3FY17 were Rs 100 Cr largely on account of the clinical advancement of several of our programs.

Q3FY17 also saw a strong contribution from our international business wherein we supply both Active Pharmaceutical Ingredients (APIs) and formulations across our Small Molecules and Biosimilars segments.

SMALL MOLECULES

The Small Molecules business reported strong revenue growth of 24% to Rs 390 Cr, led by good traction in its business in India, Europe, LatAm and NAFTA for statins, immunosuppressants and specialty products. A strong demand for Rosuvastatin API post genericization in the US market as well as the acquisition of new customers for statins and immunosuppressant APIs provided a fillip to the business.

Biocon received Final Approval from the US FDA for generic Rosuvastatin Calcium tablets, the first such approval for our Generic Formulations business in the US.

BIOLOGICS

The Biologics segment comprising Novels and Biosimilars, including rh-insulin, insulin analogs, monoclonal antibodies and recombinant proteins, reported a strong growth of 61% at Rs 120 Cr. Biocon with its global partner Mylan made good regulatory progress in its biosimilar and insulin analogs global development programs.

Biosimilars
Insulins & Analogs

Our Insulins business recorded a strong growth this quarter led by the expansion of our commercial footprint and increased traction in some of the key emerging markets.

Biocon commenced commercial operations from its Malaysian manufacturing facility with the launch of its rh-Insulin in Malaysia. The Company has been awarded a three-year contract by Ministry of Health (MoH) for supplying rh-Insulin cartridges and re-usable insulin pens for people with diabetes in Malaysia. The contract is extendable for additional two years, subject to government’s approval.

Biocon’s ready-to-use, prefilled disposable Insulin Glargine pen, launched in Japan in Q2FY17 continues to do well with increase in market share. The product has been introduced in a few more emerging markets this quarter.

During the quarter, the Marketing Authorization Application (MAA) for Insulin Glargine, co-developed by Biocon and Mylan was accepted for review by the European Medicines Agency (EMA). It is a significant development considering it is the first filing in a developed market incorporating a product validated at our state-of-the-art Malaysia facility.

Several other regulatory filings and audits are underway to enable commercial sales from the new Malaysian manufacturing facility.

Monoclonal Antibodies & Recombinant Proteins

The Biocon-Mylan collaboration to co-develop a broad portfolio of biosimilar products for the global marketplace made good progress and achieved critical milestones in US and Europe in Q3FY17.

The most significant development was the acceptance for review of our Biologics License Application (BLA) for a proposed biosimilar Trastuzumab by the US FDA. This is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway and the acceptance of the BLA positions the two companies among the first to be able to address the critical need of US patients for a high-quality biosimilar to treat certain HER2-positive breast cancers.

Earlier in the quarter, the Journal of the American Medical Association (JAMA) had published data from Biocon and Mylan’s safety and efficacy study that demonstrated equivalent overall response rate for their proposed biosimilar Trastuzumab in comparison to branded Trastuzumab. The results indicate that a biosimilar can deliver similar safety, efficacy and immunogenicity in comparison to a branded product.

Biocon also entered into a strategic agreement for Trastuzumab in one of the leading emerging markets.

Novel Biologics
Our Novel programs, Itolizumab (anti-CD6 monoclonal antibody) and QPI 1007 (SiRNA), are progressing actively in the ongoing clinical trials. The clinical study using a sub-cutaneous form of Itolizumab, currently on in Australia has completed stage-1 dose escalation and stage-2 is being initiated. No severe adverse safety events have been reported. QPI 1007, undergoing a global phase III trial in NIAON patients, a rare ophthalmic disease, is recruiting actively in several regions including India.

We have finalized the clinical plan to progress Insulin Tregopil and will file a Clinical Trial Application (CTA) with the Indian regulator to clinically validate its promise as an orally delivered, rapid acting prandial insulin.

New preclinical data on the novel immunotherapy product, Fmab2, was presented at the Society for Immunotherapy meeting in Washington DC, recently.

BRANDED FORMULATIONS

The Branded Formulations business which includes sales in India and UAE reported sales of Rs 123 Cr during Q3FY17. The business was impacted by the discontinuance of in-licensed Abraxane®.

The Branded Formulations India business focuses on critical therapies and specialty brands. 16 of our brands are category leaders and feature amongst the Top three.

CANMAb our Trastuzumab brand continues to gain traction and features in the Top 10 Oncology brands in India with a market share of 22% (MAT-IPSoS).

Our novel diabetes education initiative for medical practitioners, ABIDE, was conferred with the ‘Award of Recognition’ by the prestigious Research Society for the Study of Diabetes in India.

Our key brands in UAE continue to gain traction with overall prescription share of the Company recording a 60% growth as per IMS (Apr-Sep 2016).

RESEARCH SERVICES – SYNGENE

Our Research Services business through Syngene reported revenue growth of 17% to Rs 317 Cr, which was driven by broad-based growth across the Dedicated R&D Centers and Discovery Services verticals.

During the quarter, there was an unfortunate fire at one of the blocks of Syngene that housed some biologics and analytical laboratories. There were no injuries or loss of life due to the fire. Following the incident, Syngene implemented its business continuity plan and all ongoing projects of that block along with the scientific teams were relocated to other parts of the facility to minimize impact on the client projects. The Company’s ‘Industrial All Risk’ policy will help in minimizing financial impact of the incident.

NEW APPOINTMENT

The Board of Directors of the Company have approved the appointment of Rajiv Balakrishnan as the Company Secretary for Biocon Limited. Rajiv is a Fellow Company Secretary from Institute of Company Secretaries of India and brings with him over 15 years of diverse experience across Secretarial, Legal, Investor Relations and Finance functions. Prior to joining Biocon, he was working as Company Secretary & Additional General Manager – Investor Relations with VA Tech Wabag Limited.

Enclosed: Fact Sheet – with Financials as per IND-AS and IGAAP

BIOCON LIMITED (CONSOLIDATED)

 

BALANCE SHEET

 

(Rs Cr)

December 31, 2016

March 31, 2016

ASSETS
Non-current assets
(a) Property, plant and equipment

1,763

1,681

(b) Capital work-in-progress

2,330

2,062

(c) Investment property

1

1

(d) Goodwill

26

26

(e) Other intangible assets

46

41

(f) Intangible assets under development

296

180

(g) Investments in associates and a joint venture

43

32

(h) Financial assets
Loans and advances

30

31

Other financial assets

111

114

(i) Income tax asset, net

91

91

(j) Deferred tax asset, net

70

74

(k) Other non-current assets

240

234

5,047

4,567

Current assets
(a) Inventories

604

542

(b) Financial assets
Investments

441

432

Trade receivables

907

712

Cash and cash equivalents

551

1,123

Other bank balances

1,260

805

Other financial assets

238

233

(c) Other current assets

167

65

4,168

3,912

TOTAL

9,215

8,479

EQUITY AND LIABILITIES
Equity
(a) Share capital

100

100

(b) Other equity

4,528

3,958

Equity attributable to equity holders of the Company

4,628

4,058

Non-controlling interest

352

286

4,980

4,344

Non-current liabilities
(a) Financial liabilities
Borrowings

2,230

2,072

Other financial liabilities

8

19

(b) Provisions

35

30

(c) Other non-current liabilities

364

371

2,637

2,492

Current liabilities
(a) Financial liabilities
Borrowings

315

395

Trade payables

695

524

Other financial liabilities

327

296

(b) Short-term provision

46

37

(c) Income tax liability, net

113

75

(d) Other current liabilities

102

316

1,598

1,643

TOTAL

9,215

8,479

 

 

BIOCON LIMITED (CONSOLIDATED)
PROFIT & LOSS STATEMENT

(Rs. Cr)

9M – FY17

9M – FY16 Variance

Variance

Particulars

IGAAP

Adj IndAS IGAAP Adj IndAS IGAAP

IndAS

INCOME
Biocon

1,982

102 2,084 1,737 (89) 1,648 14%

27%

Small molecules

1,121

78 1,199 977 15 992 15%

21%

Biologics

322

16 338 237 (15) 222 36%

52%

Branded formulations

419

(1) 418 425 (89) 336 -2%

24%

Licensing#

120

9 129 98 98 24%

33%

Syngene – Research Services

866

866 744 744 16%

16%

Total Sales

2,848

102 2,950 2,481 (89) 2,392 15%

23%

Other income

158

9 167 87 8 95 80%

74%

TOTAL REVENUE

3,006

111 3,117 2,568 (81) 2,487 17%

25%

EXPENDITURE
Material & Power costs

1,183

45 1,228 1,085 (11) 1,074 9%

14%

Staff costs

504

5 509 424 (19) 405 19%

26%

Research & Development expenses*

201

201 175 (1) 174 15%

15%

Other expenses

263

10 273 217 (10) 207 21%

31%

Manufacturing, staff & other expenses

2,151

60 2,211 1,901 (41) 1,860 13%

19%

EBITDA

855

51 906 667 (40) 627 28%

45%

Interest & Finance charges

21

21 9 9 139%

139%

Depreciation & Amortisation

199

6 205 180 4 184 11%

11%

Share of profit in JV

(11)

(11) (16) (16)

-34%

PBT BEFORE EXCEPTIONAL ITEM

646

45 691 478 (28) 450 35%

54%

Exceptional item, Net

307 (415) (108)

PBT

646

45 691 785 (443) 342 -18%

102%

Taxes

135

16 151 95 (7) 88 43%

73%

Taxes on exceptional item

104 (104)

NET PROFIT BEFORE MINORITY INTEREST

511

29 540 586 (332) 254 -13%

112%

Minority interest

54

1 55 51 (14) 37 5%

48%

NET PROFIT FOR THE PERIOD

457

28 485 535 (318) 217 -15%

123%

EPS Rs.

22.9

24.3 26.8 10.9
NET PROFIT BEFORE EXCEPTIONAL ITEM

457

28 485 332 (7) 325 38%

49%

Exceptional item, net of taxes

203 (311) (108)
NET PROFIT FOR THE PERIOD

457

28 485 535 (318) 217 -15%

123%

Note: The figures are rounded off to the nearest crore, percentages are based on absolute numbers
# Including one time compensation from customer during Q1 – FY16
* Gross Research & Development expenses

304

275

 

 

BIOCON LIMITED (CONSOLIDATED)
PROFIT & LOSS STATEMENT

(Rs. Cr)

Q3 – FY17

Q3 – FY16 Variance

Variance

Particulars

IGAAP

Adj IndAS IGAAP Adj IndAS IGAAP

IndAS

INCOME
Biocon

705

7 712 558 (32) 526 26%

35%

Small molecules

383

7 390 318 (3) 315 20%

24%

Biologics

120

120 80 (5) 75 51%

61%

Branded formulations

123

123 128 (24) 104 -4%

18%

Licensing#

79

79 32 32 147%

148%

Syngene – Research Services

317

317 270 270 17%

17%

Total Sales

1,022

7 1,029 828 (32) 796 23%

29%

Other income

59

4 63 25 8 33 136%

88%

TOTAL REVENUE

1,081

11 1,092 853 (24) 829 27%

32%

EXPENDITURE
Material & Power costs

407

407 354 (10) 344 15%

18%

Staff costs

177

2 179 146 (7) 139 21%

29%

Research & Development expenses*

85

85 68 68 25%

25%

Other expenses

90

7 97 76 (4) 72 17%

34%

Manufacturing, staff & other expenses

759

9 768 644 (21) 623 18%

23%

EBITDA

322

2 324 209 (3) 206 54%

57%

Interest & Finance charges

9

9 2 2 487%

487%

Depreciation & Amortisation

69

2 71 62 2 64 10%

10%

Share of profit in JV

(1)

(1) (3) (3)

-69%

PBT BEFORE EXCEPTIONAL ITEM

245

245 145 (2) 143 69%

71%

Exceptional item, Net

PBT

245

245 145 (2) 143 69%

71%

Taxes

54

1 55 24 (2) 22 122%

150%

Taxes on exceptional item

NET PROFIT BEFORE MINORITY INTEREST

191

(1) 190 121 121 58%

57%

Minority interest

19

19 18 (1) 17 8%

10%

NET PROFIT FOR THE PERIOD

172

(1) 171 103 1 104 67%

65%

EPS Rs.

8.6

8.6 5.2 5.2
Note: The figures are rounded off to the nearest crore, percentages are based on absolute numbers
* Gross Research & Development expenses

100

91

 

 

BIOCON LIMITED (CONSOLIDATED)
PROFIT & LOSS STATEMENT

(Rs. Cr)

Q3 – FY17 Q2 – FY17 Variance

Variance

Particulars

IGAAP

Adj IndAS IGAAP Adj IndAS IGAAP

IndAS

INCOME
Biocon

705

7 712 637 17 654 11%

9%

Small molecules

383

7 390 380 9 389 1%

0%

Biologics

120

120 96 96 24%

24%

Branded formulations

123

123 137 (1) 136 -10%

-10%

Licensing

79

79 24 9 33 225%

142%

Syngene – Research Services

317

317 286 286 11%

11%

Total Sales

1,022

7 1,029 923 17 940 11%

9%

Other income

59

4 63 50 3 53 19%

20%

TOTAL REVENUE

1,081

11 1,092 973 20 993 11%

10%

EXPENDITURE
Material & Power costs

407

407 382 1 383 6%

6%

Staff costs

177

2 179 164 2 166 8%

8%

Research & Development expenses*

85

85 65 65 30%

30%

Other expenses

90

7 97 99 2 101 -9%

-4%

Manufacturing, staff & other expenses

759

9 768 710 5 715 7%

8%

EBITDA

322

2 324 263 15 278 23%

16%

Interest & Finance charges

9

9 7 7 35%

35%

Depreciation & Amortisation

69

2 71 66 2 68 3%

3%

Share of profit in JV

(1)

(1) (5) (5)

-83%

PBT BEFORE EXCEPTIONAL ITEM

245

245 195 13 208 26%

18%

Exceptional item, Net

PBT

245

245 195 13 208 26%

18%

Taxes

54

1 55 39 2 41 38%

30%

Taxes on exceptional item

NET PROFIT BEFORE MINORITY INTEREST

191

(1) 190 156 11 167 23%

15%

Minority interest

19

19 18 1 19 6%

-2%

NET PROFIT FOR THE PERIOD

172

(1) 171 138 10 148 26%

17%

EPS Rs.

8.6

8.6 6.9 7.4
Note: The figures are rounded off to the nearest crore, percentages are based on absolute numbers
* Gross Research & Development expenses 100 113

 

 

About Biocon Limited
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 100 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from ‘Lab to Market’. Some of its key brands are INSUGEN®(rh-insulin), BASALOG®(Glargine), CANMAb (Trastuzumab), BIOMAb-EGFR(Nimotuzumab) and ALZUMAb (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin analog. Visit: www.biocon.com

Earnings Call
The company will conduct a call at 9.00 AM IST on January 25, 2017 where the senior management will discuss the company’s performance and answer questions from participants. 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 +91-22-3938 1081. 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 from the conclusion of the call till January 29, 2017 on +91 22 3065 2322/6181 3322 , Playback ID: 44711. Transcript of the conference call will be uploaded on the company website in due course.

Disclaimer:
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 forward-looking statements. Important factors that could cause actual results to differ materially from our 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 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 biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither our company, our directors, nor any of our affiliates, have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition.

 

SOURCE: http://www.biocon.com/

 

Biocon Q3 FY17 Net Profit Up 65% at Rs 171 Crore