SACHS ASSOCIATES - 11TH ANNUAL EUROPEAN LIFE SCIENCE CEO FORUM & EXHIBITION - DR. MARIOLA SÖHNGEN CHIEF EXECUTIVE OFFICER ZURICH, 26 FEBRUARY 2018 ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
SACHS ASSOCIATES –
11TH ANNUAL
EUROPEAN LIFE
SCIENCE CEO
FORUM & EXHIBITION
DR. MARIOLA SÖHNGEN
CHIEF EXECUTIVE OFFICER
ZURICH, 26 FEBRUARY 2018
www.mologen.com
Disclaimer
This presentation does not constitute an offer to buy shares or other securities of MOLOGEN AG and
does not replace the prospectus. This announcement does not contain or constitute an offer of, or the
solicitation of an offer to buy or subscribe for, securities to any person in the United States of America
(the “United States”), Australia, Canada or Japan or in any jurisdiction. The securities referred to in this
announcement will not be and have not been registered under the U.S. Securities Act of 1933, as
amended (the “U.S. Securities Act”) and may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements under the U.S. Securities Act.
There will be no public offer of the securities in the United States. Subject to certain exceptions, the
securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan,
or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan.
The offer and sale of the securities referred to in this announcement has not been and will not be
registered under the U.S. Securities Act or under the applicable securities laws of Australia, Canada or
Japan. There will be no public offer of the securities in the United States.
Note about risk for future predictions
Certain statements in this presentation contain formulations or terms referring to the future or future
developments, as well as negations of such formulations or terms, or similar terminology. These are
described as forward-looking statements. In addition, all information in this presentation regarding
planned or future results of business segments, financial classification numbers, developments of the
financial situation, or other financial or statistical data contains such forward-looking statements. The
company cautions prospective investors not to rely on such forward-looking statements as certain
prognoses of actual future events and developments. The company is neither responsible nor liable for
these forward-looking statements. It is not responsible for updating such information, which only
represents the state of affairs on the day of publication.
2
MOLOGEN Snapshot
• Based in Berlin, Germany; founded 1998
• Frankfurt Stock Exchange Prime Standard
• Approx. 50 employees
• One of the pioneers in immunotherapies
• Focus on family of TLR9 agonists:
• Lead product: immunotherapy with lefitolimod
• Next-generation technology EnanDIM®
• Highly attractive markets: A multi-billion US$ market
• Network with scientific institutions and experts
3
MOLOGEN Summary Highlights
Advanced immunotherapy player
• Late stage phase III product in mCRC
Safe & well tolerated lead product
• Safety data from more than 450 treated study participants
Multi-billion dollar target markets
• In attractive indications like mCRC, SCLC, HIV, combination treatments
Value-generating milestones reached
• PH II SCLC; PH I/II HIV read outs published; PH III mCRC recruitment finished
License deal with ONCOLOGIE Inc., US in Feb 2018
• Collaboration regarding the development, manufacture and commercialization of
lefitolimod in specific Asian territories and a co-development
Announcement capital increase from authorized capital in Feb 2018
• Binding commitments to subscription of the capital increase
• MOLOGEN expects to receive gross proceeds of around 5 million €
US-Investor Global Corporate Finance signed Share Subscription Facility in Oct 2017
• GCF commits to purchase up to 3.4 million shares – corresponding to approx. 10% of
the share capital of MOLOGEN
4
Executive Board:
Clear Commercial Focus & Successful Track Record
Dr Mariola Soehngen, CEO Walter Miller, CFO Dr Matthias Baumann, CMO
• About 30 years biotech • More than 20 years • Almost 30 years industry
industry and corporate industry as well as expertise
leadership experience financial expertise from • R&D and corporate
as founder and former leadership positions
leadership positions in
Board Member of PAION at Nuvisan and Santhera pharma, CRO and biotech
Pharmaceuticals AG
• 15 key successful in- and • Boehringer Mannheim,
out-licensing deals at • Successful IPO of
Roche, FOCUS, NOXXON
PAION across the globe Santhera
• Highly experienced senior leadership team focused on value generation
Legend: IPO initial public offering | CRO contract research organization
5Advanced Immunotherapy Pipeline:
Late-Stage Lefitolimod & Follow-Up EnanDIM®
Indication(1) PC Ph I Ph II Ph III Timeline(2) Exclusivity(3)
LPI: 05/17 EU: 2030
Metastatic colorectal Data: ’19 US: 2028
cancer (mCRC) Filing: ’19/’20
IMPALA (MGN)
04/17: top-line EU: 2030
Small-cell lung cancer results US: 2028
Lefitolimod
(SCLC)
IMPULSE (MGN)
Advanced solid LPI: ‘18 EU: 2036
malignancies Data: ’19 US: 2036
(+ ipilimumab) MD Anderson
08/17: results of EU: 2036
Human immunodeficiency extension phase US: 2036
virus (HIV)
TEACH (Aarhus)
MGN1601 EnanDIM®
Pre-clinical EU: 2035
Cancer/ US: 2035
infect. diseases
Ph I / II data EU: 2036
Renal cell carcinoma available orphan drug status
(RCC) backup compound US: 2038
ASET (MGN)
Notes: (1) Pipeline overview excludes MIDGE platform | (2) Timeline Denotes latest estimated timeline of upcoming milestones |
6 (3) Exclusivity Denotes estimated minimum market exclusivity horizon based on patent and data protection
Legend: PC Pre-clinical |Ph Phase | LPI last patient inMulti-Billion US$ Markets in Oncology:
Strong Fundamentals and Significant Unmet Needs
WW Prescription Drugs1 WW Oncology Drugs1 Sales in US$ bn
CAGR • Oncology is expected to be
+4.8% 987 CAGR 153
+11.6%
among the largest and fastest
743 growing therapeutic areas
worldwide
79
• Cancer immunotherapies
represent a huge market
potential: ~US$ 35 bn
2014 2020 2014 2020
Colorectal Cancer2 Lung Cancer3 SCLC4
CAGR
+1.8% 13
9.4 CAGR
8.3 +12.5%
CAGR
+27.7% 2.3
4
0.2
2013 2020 2010 2020 2014 2024
Source: 1EvaluatePharma 2015 | 2ResearchandMarkets Jan 2015 (5 EU, US, Japan & Canada) | 3MarketsandMarkets Nov 2011
7 (G7 Countries) | 4GlobalData, Jan 2016 (5 EU, US, Japan) | Legend: CAGR Compound Annual Growth Rate I WW worldwideKey Financials 9M 2017
9M 9M FY
In € million ∆
2017 2016 2016
R&D expenses 10.6 10.5 1% 17.0
EBIT -14.5 -14.3 1% -21.0
Cash flows from operating activities -15.4 -13.9 11% -19.3
Cash flows from financing activities 4.7 -0.5 - 15.2
Monthly cash burn 1.8 1.6 13% 1.7
30 Sep 31 Dec
In € million ∆
2017 2016
Total assets 11.0 21.4 -49%
Cash & cash equivalents 9.8 20.5 -52%
Equity -2.2 11.8 -119%
Equity ratio -20% 55% -
• Stable R&D expenses due to phasing effects ; stable R&D expenses expected in Q4
• Financing is probably secured until mid-2018: based on former capital measures and the most
recent share subscription facility
8
8Refinancing – Capital Measures
Current Shareholder Structure
• Capital increase: Oct 2016 (~11 m new shares) €13.60 m
• Convertible bond 2016/2024 (8 years, 6% interest rate) €2.54 m
• Convertible bond 2017/2025 (8 years, 6% interest rate) €4.99 m
Total gross proceeds ~ €21.10 m
• Share Subscription Facility: up to around 3.4 million MGN shares
Cash reach until mid-2018 – subject to share price when exercising Share
Subscription Facility
Shareholder Structure as of January 2018 (estimates)
Global Derivative Trading GmbH, DEOutlook 2017: Slightly Adjusted
• Advance product development
• Focus on lead compound lefitolimod and successor molecules EnanDIM®
- IMPALA: Finalize patient recruitment short-term
- IMPULSE: Present study results in Q2
- TEACH study results extension phase by mid-year
- Ongoing recruitment for combination study with ipilimumab (Yervoy®)
- Advance pre-clinical study program for EnanDIM®
• Production: Execute tech transfer and start upscaling
• Partnering discussions / Out-licensing activities to accelerate
• Ensure financing beyond early 2018
• Old: R&D expenses will further increase due to study progress; operating results below
FY 2016 expected - dependent on financing structure
New: Operating results may be slightly above FY results of 2016 as
a result of potentially stable R&D expenses
10Financial Calendar 2018 and Contact Details
22 March 2018
Full Year Report 2017
4 May 2018
Annual General Meeting
15 May 2018
Quarterly Statement as of 31 March 2018
9 August 2018
Half-Yearly Financial Report as of 30 June 2018 Claudia Nickolaus
Head of Investor Relations &
8 November 2018
Corporate Communications
Quarterly Statement as of 30 September 2018
Phone: +49-30-841788-38
Fax: +49-30-841788-50
investor@mologen.com
www.mologen.com
MOLOGEN®, MIDGE®, dSLIM®, and EnanDIM® are registered trademarks of the MOLOGEN AG
11SACHS ASSOCIATES –
11TH ANNUAL
EUROPEAN LIFE
SCIENCE CEO
FORUM & EXHIBITION
DR. MARIOLA SÖHNGEN
CHIEF EXECUTIVE OFFICER
ZURICH, 26 FEBRUARY 2018
www.mologen.comYou can also read
