Bengaluru, Karnataka, India: July 26, 2018:
Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia’s premier biopharmaceuticals company, today announced its consolidated financial results for the fiscal first quarter ended June 30, 2018.
Commenting on the highlights, Chairperson & Managing Director, Kiran Mazumdar-Shaw stated:
“We started the year with a robust Q1FY19 recording an overall revenue growth of 21% at Rs 1,193 Crore and a 47% increase in Net Profit at Rs 120 Crore, driven by a strong performance across our business segments. This performance was led by a 36% growth in our Biologics business and a 39% increase in Research Services revenues.”
“The approval and launch of our biosimilar Pegfilgrastim, Fulphila™, in the U.S. is a significant milestone for Biocon and sets the tone for the future success of our biosimilars business. The cGMP approvals for our Drug Products manufacturing facility in Bengaluru by both the U.S. FDA and EMA demonstrates our commitment to provide high quality products to address the growing needs of patients for affordable biosimilars in these markets. These developments augur well for a strong financial performance in FY19.”
- Fulphila™, co-developed by Biocon and Mylan, becomes the first biosimilar Pegfilgrastim to be approved and launched in the U.S. Biocon is the first Company from India to have two biosimilars approved by the U.S. FDA.
- Biocon’s sterile Drug Product manufacturing facility in Bengaluru receives EIR from U.S. FDA and EU GMP certification.
- Presentations made at American Society of Clinical Oncology (ASCO) annual meeting in June 2018 for novel biologic Nimotuzumab (BIOMAb EGFR®) and biosimilar Trastuzumab (Ogivri™).
- PK-PD data on novel Insulin Tregopil presented at American Diabetes Association Scientific Sessions in June 2018.
- Syngene extends its collaboration with Baxter upto 2024 and strengthens its growing client base.
FINANCIAL HIGHLIGHTS (CONSOLIDATED): Q1FY19
As per IND-AS In Rs Crore, except growth numbers
|Revenue from Operations#
|Interest & Finance charges
|Depreciation & Amortisation
|R&D Expenses in P&L
|Gross R&D Spends
|Core EBITDA Margin
|Net Profit Margin
|#includes Licensing Income
Notes: Figures above are rounded off to the nearest Cr; % based on absolute numbers.
PERFORMANCE REVIEW: Q1FY19
Biocon’s Total Revenue for Q1FY19 at Rs 1,193 Crore grew by 21%, Net Profit at Rs 120 Crore reported a growth of 47%.
EBITDA at Rs 307 Crore grew 25%, with an EBITDA margin of 26% for Q1FY19.
Core EBITDA margin for Q1FY19 (net of licensing, impact of forex and R&D) stood at 27%.
Net Profit margin stood at 10%.
Licensing Income for the quarter was Rs 5 Crore and Other Income stood at Rs 69 Crore.
Net R&D expenses for the quarter stood at Rs 44 Crore while Gross R&D expenses were Rs 88 Crore corresponding to 12% of our operating revenue (excluding Syngene).
BUSINESS SEGMENT REVIEW: Q1FY19
SMALL MOLECULES: APIs & Generic Formulations
The Small Molecules business reported a revenue growth of 10% for the quarter at Rs 400 Crore. This was largely led by the sales of key APIs including immunosuppressants and Generic Formulations.
We filed several Drug Master Files (DMFs) in developed markets and key emerging markets during the quarter, strengthening our Small Molecule APIs pipeline.
Our Generic Formulations business, which currently accounts for a small fraction of Small Molecules segment revenue, recorded strong topline growth on the back of market share gains for our Rosuvastatin Calcium formulation in the U.S. We also launched Simvastatin tablets in the U.S. this quarter.
BIOLOGICS: Biosimilars & Novels
The Biologics segment, comprising Novel Biologics and Biosimilars, recorded a strong growth of 36% at Rs 250 Crore in the quarter. This was largely driven by higher sales of biosimilar monoclonal antibodies (mAbs) in emerging markets, supported by Insulins business.
Insulins & Analogs
During the quarter, our insulins portfolio gained market share in several emerging markets such as Malaysia, Algeria and UAE. Our brand Insugen®, now holds a 75% share of the rh-insulin market in Malaysia.
During the quarter, we made several regulatory submissions for Insulin Glargine in CIS (Commonwealth of Independent States) and MENA ( Middle East & North Africa) regions.
For the US market Biocon and its partner Mylan are generating additional clinical data for Insulin Glargine, in support of the manufacturing site change from Bengaluru to Malaysia. All activities as agreed with the US FDA in this regard are progressing as planned and we will expeditiously provide the requested data to the regulator in response to the Complete Response Letter (CRL) we received for Insulin Glargine. We do not anticipate any impact on the approval and launch timing of Insulin Glargine in the U.S.
Monoclonal Antibodies & Recombinant Proteins
Biocon’s partner Mylan has launched the first U.S. FDA-approved biosimilar Pegfilgrastim, Fulphila™, as a more affordable therapy option for cancer patients undergoing chemotherapy in the U.S.
Fulphila™ is the first biosimilar Pegfilgrastim (pegfilgrastim-jmdb) to be approved by the U.S. FDA in June 2018. Biocon is the first company from India to have its biosimilar commercialized in the U.S.
The regulatory reviews of our biosimilar Pegfilgrastim dossier in EU, Australia and Canada are progressing well.
Through our biosimilar Trastuzumab, we continued to enhance access to a critical biologics therapy for cancer patients in several emerging markets. During the quarter, we witnessed strong retail market uptake of our biosimilar Trastuzumab in Brazil. Zedora®, sold through our partner Libbs Farmaceutica, is the first biosimilar Trastuzumab approved in Brazil. We also maintained a robust market share for our biosimilar Trastuzumab in Algeria, where it enjoys wide acceptance from patients and prescribers.
We made several regulatory submissions for our biosimilar Trastuzumab in the CIS, LATAM & MENA regions, during Q1.
Our biologics Drug Substances and Drug Products facilities in Bengaluru and Malaysia received approvals from regulatory agencies of several emerging and developed markets, including EU GMP certification and US FDA EIR for the Drug Products facility in Bengaluru.
During Q1, Biocon and Mylan presented 48-week additional data from the HERITAGE study at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, which further demonstrated that our biosimilar Trastuzumab, Ogivri™, does not have any clinically meaningful differences in terms of safety, purity and potency in comparison to the reference product, Herceptin®.
In order to advance our market entry in EU and certain other markets, Biocon and Mylan agreed to a commercial arrangement between Mylan and a third party for an advanced stage Etanercept asset. Biocon retains its economic interest in this arrangement vis-a-vis Mylan, in accordance with our existing Etanercept collaboration agreement.
Our basket of novel assets under development, representing an interesting combination of early and advanced stage programs, progressed in the clinics in Q1FY19.
Our oral insulin candidate, Insulin Tregopil, advanced in a pivotal Phase II/III study in Type 2 diabetes, with more patients in India being randomized during the quarter.
We presented data from the Insulin Tregopil clinical program at the American Diabetes Association’s (ADA) 78th Scientific Sessions held at Orlando, Florida. The pharmacokinetic-pharmacodyamic (PK-PD) data on Tregopil presented at ADA suggests an oral rapid acting insulin option for Type 2 diabetes patients.
The Branded Formulations business, which includes sales in India and UAE, reported a revenue of Rs 147 Crore, representing a YoY growth of 13% in Q1FY19.
The Branded Formulations – India (BFI) business performance was led by the Metabolics, Nephrology, Immunotherapy and Comprehensive Care divisions, with a strong growth reported by key brands like Insugen®, Basalog®, TACROGRAF™, Renodapt® and PSORID™.
In line with our focus on key brands, the Top 10 brands in our India portfolio, reported a strong double digit growth accounting for a significant share of BFI sales this quarter.
A large investigator-initiated study of BIOMAb EGFR® (Nimotuzumab), India’s first indigenously produced novel biologic launched by Biocon in 2006, established the ‘best-in-class’ status of the innovative therapy for head and neck cancer. The results of this large randomized, controlled clinical study at the Tata Memorial Hospital (TMH), Mumbai, were presented at the 2018 ASCO Annual Meeting. This study in head and neck cancer patients in India demonstrated that Nimotuzumab combined with chemo-radiotherapy successfully met the primary endpoint of median Progression Free Survival, which was three times than that of Standard of Care.
We also made two poster and two paper presentations on managing diabetes with insulin therapy, at the global ADA Congress in Florida, which were well received.
RESEARCH SERVICES – SYNGENE
The Research Services business through Syngene sustained its strong growth trajectory, reporting a revenue growth of 39% at Rs 406 Crore, buoyed by the performance of discovery and development services for small molecules and continued traction in the biologics business.
During the quarter, Syngene extended its collaboration with Baxter till 2024 with an increased scope of work at its dedicated R&D center in Bengaluru. It also made significant progress in making the GSK collaboration operational, where a dedicated team of Syngene scientists continue to work closely with GSK’s global R&D teams in accelerating drug discovery using Syngene’s discovery services platforms.
About Biocon Ltd:
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: 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. It has developed and taken differentiated Small Molecules, Novel Biologics and a range of Biosimilars (Monoclonal Antibodies, rh Insulin and Insulin Glargine) from ‘Lab to Market’ in India, key emerging and developed markets. It has a large portfolio of biosimilars under clinical development with three of these approved in developed markets of US, EU, Japan and Australia. Its Novel pipeline includes promising assets like Insulin Tregopil, anti-CD6 antibody and a fusion protein for immuno-oncology. Some of its key brands are INSUGEN® (rh-insulin), Basalog One® (prefilled Glargine pen), CANMAb™ (Trastuzumab), KRABEVA® (Bevacizumab), BIOMAb-EGFR® (Nimotuzumab) and ALZUMAb™ (Itolizumab). Follow-us on Twitter: @bioconlimited, archive.bioconbiologics.com
The company will conduct a call at 9.00 AM IST on July 27, 2018 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 6280 1151. Other toll numbers are listed in the conference call invite which is posted on the company website archive.bioconbiologics.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 August 3, 2018 on +91 22 7194 5757, Playback Code: 80672. Transcript of the conference call will be uploaded on the company website in due course.
This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon 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 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 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 forward-looking statement contained in this release.