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Biotest AG — Earnings Release 2015
Aug 11, 2015
66_rns_2015-08-11_98b46a85-ade6-4024-8321-e7f0605147a2.pdf
Earnings Release
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Biotest AG
Conference call Half year 2015 11 August 2015
Disclaimer
- This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and thus are subject to risks and elements of uncertainty that could result in deviation of actual developments from expected developments.
- The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
- All comparative figures relate to the corresponding last year´s period, unless stated otherwise.
Biotest Group: H1 2015 at a glance
- Sales in H1 2015 up by 8.9% to €287.7 m vs. €264.1 m in previous year period Increase largely attributable to an increase in volume in all geographic regions
- H1 2015 EBIT decrease to €2.3 m
- Ongoing Civacir® Phase III study shows promising data in re-infection in liver transplantation patients
- IgM Study showed promising trend in reducing duration of ventilation as well as mortality
- "Biotest Next Level" project is on track
- Share split 1:3 realised on 15 July 2015
Overview on R&D projects (I)
Tregalizumab (BT-061)
- Tregalizumab Phase IIb study (TREAT 2b): to be finalised by year end
- Final study data end of the year
Indatuximab Ravtansine (BT-062)
- Multiple myeloma: all patients recruited, treatment ongoing Final study data end of the year 2015/ beginning 2016
- Solid tumours: first patients treated, recruitment ongoing
BT-063
- Monoclonal antibody for the treatment of the autoimmune disease Systemic Lupus Erythematosus
- Study sites for Phase IIa study (No. 990) approved in first countries
Overview on R&D projects (II)
Civacir®
- Interim results from the phase III study presented at 50th International Liver Congress in Vienna (April 2015)
- Final study results expected to be available end of 2015
IgM Concentrate
- Phase II trial completed in the indication sCAP*
- Study showed promising trend in reducing duration of ventilation as well as mortality
IgG Next Generation
- Development of a new generation IVIG
- First production in pilot plant established
Fibrinogen
- Fibrinogen is a plasma-derived clotting factor for the treatment of acute haemorrhages due to congenital or acquired fibrinogen deficiencies
- Phase I/II study ongoing
"Biotest Next Level": On track in terms of timeline and budget (April 2015)
"Biotest Next Level": On track in terms of timeline and budget (August 2015)
Financials H1 2015
Biotest shares – Share split 1:3 realised on 15 July
- Share split 1:3 approved by Annual General Meeting (AGM)
- Share split realised on July 15, 2015
- Depositary bank : 3 new shares for one previous share
- All historic share prices have been adapted
- Goal: increase liquidity of the shares
- No dilution of shares
Sales growth in line with expectations
- Strong market position in Germany used for further growth
- Strong revenue growth in North America
- Price pressure in rest of Europe, Middle East and Africa led to lower sales activities
Decrease in EBIT
EBIT (€ million)
- Increased costs for clinical trial material
- Unabsorbed costs due to lower production rate in the US
- Additional costs for the expansion project "Biotest Next level"
- Lower AbbVie contribution
- Pricing pressure in international markets
Decrease in EAT
Earnings after taxes (€ million)
- Financial result at € 0.2m (vs. - € 4.8 m in H1 2014)
- Tax rate of 205% vs. 36% in H1 2014 due to write-off of deferred tax assets of € 3m at Biotest Pharmaceutical Corp.
Financial position: strong equity base
Financial Position of the Biotest Group (€ million)
• Equity ratio end of H1 2015 46.0% (46.5% on 31 Dec 2014)
Cash flow from operating activities
January – June 2015 (in € m)
BT-061 – AbbVie Influence on EBIT
Tregalizumab (BT-061):
- Tregalizumab showed positive dose-dependent effect on regulatory T-cells
- Primary end point was not met in "Treat2b" clinical phase IIb study
- AbbVie took "Opt-out" decision
- Decision by Biotest to discontinue clinical study program
- Evaluation of alternative treatment options in preclinical setting ongoing
EBIT in 2015 will be lower by € 25-30 million due to
- » Write-offs
- » Unabsorbed costs in the manufacturing facility in Boca Raton
- » Earnings contribution from pre-produced clinical study material not realisable
Guidance 2015
- Sales: In the financial year 2015 sales will grow in a low single-digit percentage range
- EBIT: We expect an EBIT in the range of €20-25 million, including the one time effect due to discontinuation of clinical development of BT-061
| Contact Financial Calendar 2015 |
|---|
| Financial Calendar 2015 |
| 11 Aug 2015 6M Report 2015 |
| 10 Nov 2015 9M Report 2015 |
| Investor Relations Biotest AG: |
| Dr. Monika Buttkereit Head of Investor Relations |
| Phone: +49 (0) 6103 - 801 -4406 |
| Fax: +49 (0) 6103 - 801 -347 |
| E-Mail: [email protected] |
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