Company presentation - Mondobiotech
Company presentation - Mondobiotech
Company presentation - Mondobiotech
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Introduction to our<br />
business, August 2010<br />
SIX Swiss<br />
Exchange<br />
Symbol R<br />
ARE
Disclaimer<br />
The shares of <strong>Mondobiotech</strong> Holding AG have been traded since August 26th,<br />
2009 on the SIX Swiss Exchange with the symbol RARE.<br />
This document does not constitute or form<br />
part, or all, of any offer or invitation to sell or<br />
issue, neither in the United States of America<br />
nor elsewhere, or any solicitation of any offer to<br />
purchase or subscribe for, any securities, nor shall<br />
part, or all, of this document or its distribution<br />
form the basis of, or be relied on in connection<br />
with, any contract or investment decision in<br />
relation to any securities.<br />
This document includes forward-looking<br />
statements that involve substantial risks and<br />
uncertainties. These forward-looking statements<br />
are based on the <strong>Company</strong>’s current expectations<br />
and projections about future events.<br />
All statements, other than statements of historical<br />
facts, included in this document regarding the<br />
<strong>Company</strong>’s future operations, future financial<br />
position, future revenues, projected costs,<br />
plans and objectives of management<br />
are forward-looking statements.<br />
The words “anticipates”, “believes”, “estimates”,<br />
“expects”, “intends”, “may”, “plans”, “projects”,<br />
“will”, “would” and similar expressions are<br />
intended to identify forward-looking statements,<br />
although not all forward-looking statements<br />
contain these identifying words. The <strong>Company</strong><br />
may not achieve the plans, intentions or<br />
expectations disclosed in its forward-looking<br />
statements and there can be no assurance that<br />
results of the <strong>Company</strong>’s activities and its results<br />
of operations will not differ materially from its<br />
expectations.<br />
This document is from <strong>Mondobiotech</strong><br />
Holding AG. The information contained<br />
in it is intended solely for the use of the<br />
individual or entity to which they are addressed.<br />
Any unauthorized dissemination or copying<br />
of this document, is strictly prohibited<br />
and may be illegal.<br />
2/33
The context<br />
30’000 is the total number of known diseases at present.<br />
7’000 diseases are neglected or rare<br />
A Rare Disease is:<br />
In USA a disease affecting less than 200’000 people.<br />
In Europe disease affecting less than 5 in 10’000 people<br />
6% to 8% of the world population<br />
is affected by a rare disease<br />
In USA 30 million affected.<br />
In Europe 35 million affected.<br />
In the World 622 million affected.<br />
Generally there is no therapy for these patients<br />
3/33
Founders’ vision<br />
“for us, <strong>Mondobiotech</strong> is a long term<br />
project for changing the world of medicine<br />
in rare and neglected diseases.”<br />
(Fabio, Dorian, Patrick, Vera)<br />
4/33
Value drivers of our business<br />
• In the classical pharmaceutical and biotech<br />
field there is no correlation between<br />
resources invested in R&D and the resulting<br />
output obtained, at least not measurable<br />
in the numbers of new medicaments.<br />
Therefore, the development process is<br />
probably characterised by other value drivers.<br />
• We believe that in-depth information<br />
exchange, interaction, versatility and flexibility<br />
are such value drivers. Therefore, we<br />
operate with a continuously expanding<br />
community (scientists, physicians, patients,<br />
patient advocacy organisations etc.)<br />
who share their experience, know-how,<br />
expertise and skills with us and who, like us,<br />
are dedicated to the search of treatments<br />
for rare and neglected diseases<br />
(the “<strong>Mondobiotech</strong> community”).<br />
+ + +<br />
connect partecipate collaborate discuss<br />
5/33
Mission & business model<br />
Finding Therapies for Rare Diseasesof known dis<br />
• <strong>Mondobiotech</strong> is a Swiss search biotech<br />
company focused on finding treatments for<br />
rare and neglected diseases through<br />
our unique “Search & Match” engine.<br />
• The company partners with relevant<br />
communities or parties who are interested in<br />
reaching solutions for specific rare diseases.<br />
• We obtain effective and safe Medicinal<br />
Product Candidates (MPC’s) through redirecting<br />
existing and known substances into new<br />
therapeutic indications.<br />
• We analyze peptides and other biological<br />
immunomodulating substances that are<br />
naturally occurring in the human body<br />
in order to identify promising candidates<br />
for the development of medicinal<br />
products for use in the treatment of rare<br />
and neglected diseases.<br />
• The Search & Match engine combined<br />
with the know-how of our worldwide orphan<br />
scientific community has so far discovered<br />
more then 300 MPC’s for further exploration<br />
in as many as possible of the 7’000 rare<br />
and neglected diseases.<br />
• We license or sell our MPC’s to third parties<br />
(such as pharmaceutical or biotechnology<br />
companies) and/or to collaborate with<br />
third parties to obtain market authorizations<br />
and to commercialize such candidates.<br />
6/33
Key competitive strength<br />
Dry search rather than classical<br />
laboratory research (Search & Match):<br />
• By using IT tools and a proven methodology<br />
we search the vast amount of globally available<br />
data on biological and medical activities<br />
on known peptides and other biological<br />
immunomodulating substances as opposed to<br />
engaging in the traditional approach of drug<br />
discovery.<br />
Focus on bioactive substances<br />
of human origin (peptides):<br />
• We believe that peptides of human origin<br />
offer better efficacy and safety profiles<br />
compared to other classes of molecular<br />
entities.<br />
Focus on rare and neglected diseases:<br />
• We believe that rare and neglected diseases<br />
offer strong competitive advantage.<br />
Working and networking in a global<br />
community:<br />
• We believe that the mondoBIOTECH<br />
community is the only way to generate and<br />
conceive hundreds of MPC’s.<br />
Dual protection of the business:<br />
• Innovative intellectual property concepts<br />
and market protection through Orphan<br />
Medicinal Product Designations (OMPD) giving<br />
regulatory exclusivity for as much as seven<br />
years in the US, and 10 years in Europe and<br />
some other parts of the world.<br />
Outsourcing supervised by management:<br />
• The outsourcing of all non-core activities<br />
enables us to focus on our business model.<br />
7/33
<strong>Mondobiotech</strong> Community<br />
<strong>Mondobiotech</strong> collaborates with two types of communities:<br />
Scientists:<br />
• From the beginning, <strong>Mondobiotech</strong> chose and<br />
developed an open and collaborative scientific model<br />
that allows the exchange of knowledge and data.<br />
• Our frequent workshops and online collaborations<br />
enable a high level of participation allowing a natural<br />
and structural growth of the scientific community.<br />
Patients Associations:<br />
• To support the communities of patients associations<br />
<strong>Mondobiotech</strong> has developed an innovative collaborative project:<br />
the Stop Rare Foundation, www.stoprare.org.<br />
• Stoprare.org is the online place for patients associations<br />
to find, bring, support and exchange information<br />
on rare and neglected diseases, projects, research, etc.<br />
• Stop Rare Foundation’s goal is to improve the lives<br />
of patients with rare diseases and their families.<br />
8/33
Model validation<br />
For our vision, business model and potential impact on world health,<br />
the World Economic Forum selected us as Technology Pioneer 2008.<br />
“Why the company is a pioneer:<br />
Developments in technology have brought<br />
better medicines within the grasp of many<br />
patients. However, drug development remains<br />
expensive, so most large drug companies play<br />
it safe and concentrate on widespread diseases.<br />
Companies such as mondobiotech play an<br />
increasingly important role in making sure that<br />
sufferers of lesser-known diseases eventually<br />
find relief from their conditions”.<br />
(Technology Pioneer Report 2008, p.14)<br />
“To be selected as a Technology Pioneer,<br />
a company must be involved in the<br />
development of life-changing technology<br />
innovation and have potential for long–term<br />
impact on business and society. In addition,<br />
it must demonstrate visionary leadership,<br />
show the signs of being a long-standing<br />
market leader - and its technology must<br />
be proven”. (Rodolfo Lara,<br />
WEF’s Technology Pioneer program)<br />
Technology Pioneers were Google, Mozilla, the Wikimedia Foundation and Twitter.<br />
9/33
The orphan market<br />
• Worldwide, the orphan drug market reached<br />
$84.9 billion in 2009. The market is expected<br />
to grow at a compound annual growth<br />
rate (CAGR) of nearly 6% to reach $112.1 billion<br />
by 2014. The US accounted for 51% of the<br />
market in 2009 and is expected to grow at<br />
a CAGR of 8.9% to reach $65.9 billion by 2014.<br />
• The total worldwide market for orphan<br />
drugs, including sales for non-orphan<br />
applications, exceeded $28 billion in 2003. The<br />
market reached $58.7 billion in 2006, growing<br />
by 8% from $54.5 billion in 2005<br />
in orphan applications only.<br />
• Biological drugs accounted for a major share<br />
(64.3%) of the orphan drug market with sales<br />
of $54.6 billion in 2009, up from $51.4 billion<br />
(Source: www.bccresearch.com/report/PHM038C.html, published:<br />
May 2010, analyst: Syamala Ariyanchira, and reports of 2004 and 2007)<br />
in 2008. The size of the biological orphan drug<br />
market is projected to grow<br />
at a 6.9% CAGR to reach $76.2 billion by 2014.<br />
• In 2009 there were a total of more then<br />
350 orphan drugs approved in USA<br />
and 62 in Europe.<br />
• 57 drugs exceeded yearly sales of $200<br />
million and 27 of those exceeded sales<br />
of $1 billion.<br />
10/33
Search & Match<br />
312 medicaments<br />
for Rare and Neglected diseases<br />
Product candidates basic characteristics:<br />
• Peptides of human origin with known<br />
biological activity.<br />
• Synthetically manufactured.<br />
• Well researched by the global scientific<br />
community.<br />
• Proven safety profile.<br />
• Mode of action through ligation to specific<br />
receptors.<br />
• Same peptide or with minor modification<br />
present in many other species, which indicates<br />
that is an ancient molecule important for the<br />
basic metabolism of life.<br />
• Therapeutic platform potential.<br />
11/33
Examples of platforms’ rationales<br />
Interferon - γ (DK 1001)<br />
Known biological activity:<br />
• Antifibrotic<br />
• Antiproliferative<br />
• Antibiotic<br />
Safety:<br />
• Approved for pediatric<br />
and adult use via subcutaneous<br />
injection in Chronic<br />
Granulomatous disease<br />
(CGD) and severe malignant<br />
osteopetrosis.<br />
Rare indications and route<br />
of administration:<br />
• IPF via inhalation.<br />
• Two other indications<br />
via injection and inhalation<br />
to be disclosed after<br />
IP protection.<br />
Aviptadil (DK 1000)<br />
Known biological activity:<br />
• Antinflammatory<br />
• Immunoregulatory<br />
• Antiproliferative<br />
• Antibiotic<br />
• Antiapoptotic<br />
Safety:<br />
• Approved in combination<br />
with phentolamine<br />
in erectile dysfunction.<br />
• Used in various clinical<br />
trials in lung diseases over<br />
more than 2 decades<br />
and hundreds of patients.<br />
Homology with other species:<br />
• Identical in the following species:<br />
human, cow, rat, pig, dog, goat,<br />
sheep, mouse, monkey.<br />
Rare indications and route<br />
of administration:<br />
• PAH via inhalation.<br />
• Sarcoidosis via inhalation.<br />
• ARDS via injection.<br />
• IPF via inhalation.<br />
DasKloster 0210 (DK 0210)<br />
Known biological activity:<br />
• Immunoregulatory<br />
• Anti-pyretic<br />
• Antiproliferative<br />
• Antiallergic<br />
• Antifibrotic<br />
• Antinflammatory<br />
Safety:<br />
• Approved in combination<br />
with met-enkephaline<br />
for multiple sclerosis.<br />
Homology with other species:<br />
• Identical in Human, mice, rat, pig.<br />
Rare indications and route<br />
of administration:<br />
• Chronic Beryllium Disease<br />
via injection.<br />
• Glomerulonephrytis<br />
via injection.<br />
• Chronic Fatigue Syndrome<br />
via injection.<br />
12/33
IP protection & orphan market exclusivity<br />
Intellectual Property protection and market exclusivity are essential for succeeding in developing new therapeutic<br />
options in rare diseases. Our products platforms are protected in a dual way, through Orphan Drug Status<br />
Designations and a novel patent concept on products and/or indications.<br />
Orphan Drug Regulations<br />
in Europe and USA<br />
• In USA rare diseases are regulated by the Jan. 4th,<br />
1983 Orphan Drug Act (ODA).<br />
• In Europe rare diseases are regulated by the year<br />
2000 EU Regulation 141/2000.<br />
• Major advantages of the Orphan Drug Regulations are:<br />
• Grants for research.<br />
• Free protocol advice assistance.<br />
• Free or consistent costs reductions<br />
for new applications, marketing<br />
authorizations and post-authorization<br />
activities.<br />
• Fast-track procedures and approvals.<br />
• Seven years (USA) and ten years<br />
(EU) market exclusivity after market authorization.<br />
<strong>Mondobiotech</strong><br />
Orphan Drug Status Designations (ODS)<br />
2003 EMEA:<br />
ODS for Aviptadil in PAH and CTEPH received 23/12/2003<br />
(EU/3/03/173).<br />
2005 FDA:<br />
ODS for Aviptadil in PAH received 22/02/2005.<br />
2005 EMEA:<br />
ODS for Interferon gamma in IPF received 30/05/2005<br />
(EU/3/05/281).<br />
2005 FDA:<br />
ODS for Aviptadil in ARDS received 01/06/2005.<br />
2006 EMEA:<br />
ODS for Aviptadil in Acute Lung Injury (ALI)<br />
received 28/08/2006 (EU/3/06/395).<br />
<strong>Mondobiotech</strong> Patents<br />
2005: Interferon gamma patent (EP 0 795 332 B1) for: “Medical use of Gamma Interferon in Interstitial Lung Diseases” received 01/06/2005.<br />
2007: Started the patent application program to cover more than 300 product platforms for rare diseases.<br />
13/33
Licensing package<br />
Products ready to enter negotiation for licensing<br />
are accompanied by full product documentation<br />
that interested parties can request.<br />
Documentation includes:<br />
Medicinal Product Candidate<br />
Development Activities<br />
Diseases<br />
Financial Information<br />
IP & Legal<br />
Offered Services<br />
Dossier, API information, Published information.<br />
In vitro activities, Pre-clinical activities, Clinical activities.<br />
Disease dossier, Centers of excellence, Patients associations & other key entities,<br />
Published data, Development plan.<br />
Key competitor, Other market information, Projected sales.<br />
Protection documentation, PCT application, ISR (if available), National applications<br />
(if available): USA, Europe, Australia, Canada, Japan, Singapore, United Arab Emirates,<br />
Korea, Russia. Orphan drug designations/Orphan drug application and granting<br />
(EU/US), EU Regulations, US Regulations, Standard licensing contract and conditions,<br />
Standard service contract.<br />
API, Protocol assistance, Orphan drug & Regulatory assistance, Networking with<br />
<strong>Mondobiotech</strong> Community (Scientific, Medical, Centers of excellence, Laboratory,<br />
Research organizations and other experts), Scientific & Medical Workshops for developing<br />
and prompting the project, Co-marketing, other development services upon request.<br />
14/33
Licensed pipeline<br />
Search & Match<br />
Patent Applied<br />
Pre-clinical<br />
Development<br />
with the Community<br />
ready for licensing in negotiation licensed<br />
Phase I<br />
Phase II<br />
Phase III<br />
Marketing<br />
Autorization Applied<br />
Marketing Approved<br />
DasKloster 1001-01<br />
Idiopathic Pulmonary Fibrosis (IPF) InterMune Inc.<br />
DasKloster 1000-01<br />
Pulmonary Arterial Hypertension (PAH)<br />
DasKloster 1000–02<br />
Sarcoidosis<br />
DasKloster 1000–03<br />
Idiopathic Pulmonary Fibrosis (IPF)<br />
DasKloster 1000–04<br />
Acute Respiratory Distress Syndrome (ARDS/ALI)<br />
DasKloster 0138–01<br />
Methicillin-Resistant Staphylococcus Aureus in Cystic Fibrosis<br />
Phase IV<br />
Biogen Idec Inc. & Lung Rx, LLC<br />
Lung Rx, LLC<br />
Lung Rx, LLC<br />
Lung Rx, LLC<br />
Lung Rx, LLC<br />
15/33
Licensed products<br />
Aviptadil platform to Lung Rx (Nasdaq: UTHR), incl. Biogen Idec (Nasdaq: BIIB)<br />
DasKloster 1000-01<br />
Indication:<br />
Milestones:<br />
Royalties:<br />
Peak sales:<br />
Status:<br />
Next milestone*:<br />
DasKloster 1000-03<br />
Indication:<br />
Milestones:<br />
Royalties:<br />
Peak sales:<br />
Status:<br />
Next milestone*:<br />
DasKloster 1000-02<br />
Indication:<br />
Milestones:<br />
Royalties:<br />
Peak sales:<br />
Status:<br />
Next milestone*:<br />
DasKloster 1000-04<br />
Indication:<br />
Milestones:<br />
Royalties:<br />
Peak sales:<br />
Status:<br />
Next milestone*:<br />
Pulmonary Arterial Hypertension (PAH)<br />
US$ 10m end of phase III; US$ 20m marketing authorization<br />
approx. 10% on net sales on the whole platform<br />
estimated US$ 1.5 billion (comparables: Actelion (ATLN))<br />
preparation of phase III<br />
end of phase III expected in 2013<br />
Idiopathic Pulmonary Fibrosis (IPF)<br />
US$ 10m end of phase III; US$ 10m marketing authorization<br />
approx. 10% on net sales on the whole platform<br />
estimated US$ 1.5 billion Status:<br />
preparation of phase IIb<br />
end of phase III expected in 2013<br />
Sarcoidosis<br />
US$ 10m end of phase III; US$ 10m marketing authorization<br />
approx. 10% on net sales on the whole platform<br />
estimated US$ 200 million<br />
preparation of phase IIb<br />
end of phase III expected in 2013<br />
Acute Respiratory Distress Syndrome/Acute Lung Injury (ARDS/ALI)<br />
US$ 10m end of phase III; US$ 10m marketing authorization<br />
approx. 10% on net sales on the whole platform<br />
estimated US$ 200m<br />
preparation of phase II<br />
end of phase III expected in 2013<br />
* based on, and subject to, licensing partners development plans. 16/33
Licensed products<br />
Secretin to Lung Rx (Nasdaq: UTHR)<br />
DasKloster 0138-01<br />
Indication:<br />
Milestones:<br />
Royalties:<br />
Peak sales:<br />
Status:<br />
Next milestone*:<br />
4 further MPC for lung diseases to be chosen by Lung Rx (Nasdaq: UTHR)<br />
Interferon-γ to Intermune (Nasdaq: ITMN)<br />
DasKloster 1001-01<br />
Indication:<br />
Peak sales:<br />
Methicillin-Resistant Staphylococcus Aureus in Cystic Fibrosis (MRSA in CF)<br />
US$ 100’000 signing-up, US$ 1m end of phase II; US$ 10m marketing authorization<br />
10% on net sales<br />
US$ 200m<br />
clinical development started<br />
end of phase II expected in 2012<br />
Lung Rx, a wholly-owned subsidiary of United Therapeutics (Nasdaq: UTHR), has the right to choose between additional 4 MPC<br />
within our pipeline at its discretion. Same conditions as above. Peak sales estimated between US$ 100 - 200 million.<br />
Idiopathic Pulmonary Fibrosis (IPF)<br />
US$ 100 - 400 million (source: Global Data - IPF market report 2010)<br />
The project is on-hold at Intermune and will not more generate revenue flows. Based on our<br />
know-how in IPF, we intend to re-define the formulation and the clinical development of INF-γ<br />
and working for having this drug approved for IPF.<br />
* based on, and subject to, licensing partners development plans. 17/33
Licensed pipeline<br />
DasKloster 0182–01<br />
Sarcoidosis<br />
DasKloster 0210–01<br />
Chronic Beryllium Disease<br />
DasKloster 0274–01<br />
Pseudomonas Aeruginosa in Cystic Fibrosis<br />
DasKloster 0249–01<br />
Drug-Resistant Tuberculosis<br />
DasKloster 0247–01<br />
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)<br />
DasKloster 0080-01<br />
Lymphangioleiomyomatosis (LAM)<br />
DasKloster 0039–01<br />
Asbestosis<br />
DasKloster 0112-01 + DasKloster 0228–01<br />
Scleroderma<br />
28 Medicinal Product Candidates<br />
Target not disclosed<br />
260 Medicinal Product Candidates<br />
Target not disclosed<br />
Search & Match<br />
Patent Applied<br />
Pre-clinical<br />
Development<br />
with the Community<br />
ready for licensing in negotiation licensed<br />
Phase I<br />
Phase II<br />
Phase III<br />
Marketing<br />
Autorization Applied<br />
Marketing Approved<br />
Phase IV<br />
In collaboration with Pharmarare SA<br />
18/33
Products for licensing<br />
MPC at advanced development stage<br />
We intend to enter into licensing-out agreements. We are also evaluating new approaches for financing further development, and with<br />
respect to one of such MPC, a development contribution agreement for CHF 1.5 million is in place with Pharmarare SA (privately held company).<br />
Once commercialized, we will share milestones and royalties on such MPC. We estimate a standard licensing-out agreement structure<br />
as it was the case with Lung Rx but with favorable royalty rates and peak sales for these MPC between US$ 100 - 200 million.<br />
DasKloster 0182-01<br />
DasKloster 0210-01<br />
DasKloster 0274-01<br />
DasKloster 0249-01<br />
DasKloster 0247-01<br />
DasKloster 0080-01<br />
DasKloster 0039-01<br />
DasKloster 0112-01 + DasKloster 0228-01<br />
MPC at early development stage<br />
We work with the mondobiotech community to complete the dossiers and have them ready to further development and/or out-licensed.<br />
We estimate a standard licensing-out agreement structure pursuant to the above and peak sales for these MPC between US$ 100 - 150 million.<br />
• 28 MPC’s (targets undisclosed)<br />
Patent filed pipeline<br />
IP filed for patent granting (start nationalization phases first half 2010) covering the MPC’s in different disease areas and ready for being further<br />
developed and/or licensed. We estimate a standard licensing-out agreement structure at least as it was the case with United Therapeutics and<br />
peak sales on these MPC between US$ 50 - 150 million.<br />
• 260 MPC’s (targets undisclosed)<br />
Sarcoidosis<br />
Chronic Beryllium Disease (CBD)<br />
Pseudomonas Aeruginosa in Cystic Fibrosis<br />
XDR & MDR Tuberculosis<br />
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)<br />
Lymphangioleiomyomatosis (LAM)<br />
Asbestosis<br />
Scleroderma<br />
19/33
Business validation<br />
Science<br />
IP<br />
Business<br />
Strategic Alliances<br />
Financial<br />
Founders<br />
More than 300 potentially efficacious treatments discovered.<br />
1 product in phase III and 4 products in phase II clinical trials,<br />
6 products ready to enter in clinical trials phases, 32 products to start<br />
clinical development, 260 products to start development.<br />
6 Orphan Medicinal Products Designations in USA and Europe, 1 patent<br />
granted for IFN-γ (EP 0 795 332 B1) and the products in the pipeline<br />
protected by patent applications.<br />
10 indications licensed to two partners, InterMune and Lung Rx, a United<br />
Therapeutics subsidiary (incl. Biogen Idec), and capacity to license more.<br />
23andMe for genetic research for patients in rare diseases;<br />
Bachem for peptides manufacturing; Nebu-Tec for inhalation;<br />
SRI for preclinical testing and biological screening.<br />
Traded at the SIX Swiss Exchange with symbol RARE,<br />
top investors from family firms continue their commitment<br />
to the company, BSI bank of Generali Insurance Group<br />
as house bank and WR Hambrecht bank as financial advisor.<br />
Majority shareholders still involved as from the beginning with the same<br />
long term investment vision.<br />
20/33
WR Hambrecht+Co.<br />
• Founded in 1998 by William R. Hambrecht,<br />
WR Hambrecht + Co is a financial services firm committed<br />
to using technology and auction processes to provide<br />
open and fair access to financial markets for all its clients.<br />
The firm’s impartial auctions, which allow the market to<br />
determine pricing and allocation, are dramatically changing<br />
the financial services landscape. www.wrhambrecht.com<br />
• William R. Hambrecht in 1968 co-founded Hambrecht &<br />
Quist, an investment banking firm specialized in emerging<br />
high-growth technology companies that was sold in 1999<br />
for US$ 1.35B to Chase Manhattan Bank.<br />
• WR Hambrecht + Co. and <strong>Mondobiotech</strong> signed<br />
a collaboration agreement in April 2010 for the exclusive<br />
placement of <strong>Mondobiotech</strong> securities and other financial<br />
and strategic services.<br />
• WR Hambrecht + Co. has auctioned in the last decade<br />
some of the most important IPOs including Google, NetSuite<br />
and Morningstar plus other important placements.<br />
21/33
Stock snapshot<br />
Reported capital Commercial register<br />
Listed share capital (in units) 1'327'805 Share capital (in units) 54'229'365<br />
Listed share capital CHF 132'781 Share capital CHF 661'797<br />
Conditional capital (in units) 3'269'413<br />
Conditional capital CHF 326'941<br />
Authorised capital (in units) 3'190'279<br />
Authorised capital CHF 319'028<br />
Shares detail<br />
Valor symbol RARE Trading 26.08.2009 -<br />
Valor number 10'191'073 Security type Registered share<br />
ISIN CH0101910732<br />
Trading currency CHF Security segment Swiss Shares<br />
Exchange SIX Swiss Exchange Primary listed yes<br />
Product line Mid & Small Caps Swiss Shares<br />
Issued by mondoBIOTECH holding AG Regulatory standard Main Standard<br />
Number in issue 1'327'805 Clearing via SegaInterSettle AG<br />
Nominal value 0.10 Settlement currency CHF<br />
Dividend entitlement 1x per year<br />
R ARE<br />
SIX Swiss<br />
Exchange<br />
Symbol<br />
Index member SPI SXI Bio+Medtech<br />
SPI Extra SXI Life Sciences<br />
SPI ex SLI Swiss All Share Index<br />
Sarasin Swiss IPO Index<br />
Stock value on July 27th, 2010 at 5pm: CHF 73.00<br />
Market Cap on July 27th, 2010 at 5pm: CHF 483.11 million<br />
Stock quote online www.six-swiss-exchange.com/shares/security_info_en.html?id=CH0101910732CHF4<br />
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Share capital structure<br />
A corporate structure to ensure stability and a long time horizon:<br />
• The original investors and co-founders<br />
own the unlisted share majority with privileged<br />
voting rights in order to underscore their<br />
commitment.<br />
• The community can also hold a financial<br />
stake in the company by purchasing SIX<br />
Swiss Exchange listed shares.<br />
• This dual share structure generates stability<br />
in the long term and ensures the company’s<br />
leadership team maintains the ability to<br />
continue the innovative approach that has<br />
characterized the company from the outset<br />
without it suffering from an unfriendly<br />
take-over or any other form of control oriented<br />
speculation.<br />
• Google, The New York Times,<br />
The Washington Post, The Wall Street Journal,<br />
Roche and Berkshire Hathaway (a Warren<br />
Buffett’s subsidiary) are all examples of<br />
companies having a similar capital structure.<br />
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Financial strategy<br />
Small, flexible and specialized<br />
organization with high value added<br />
profile and clear cost structure for:<br />
• discovering and conceiving MPC’s<br />
• interacting and networking with<br />
the <strong>Mondobiotech</strong> community<br />
• outsourcing all non-core activities<br />
Aggressive licensing strategy<br />
breaking the tradition:<br />
• moderate signing-up and milestones<br />
at early development stages<br />
• significant milestones and royalties at,<br />
and after, marketing authorization<br />
Goals:<br />
• demonstrate effectiveness and efficacy<br />
of the business model<br />
• finance organic growth of the structure<br />
through multiple fund raisings<br />
• enlarge shareholders’ basis through<br />
the public listing of the company<br />
Financials:<br />
• Cash and Cash equivalents on Dec. 31st 2009:<br />
4,6mio.<br />
• Raised on Jan. 25th 2010:<br />
net CHF 8,5mio.<br />
• Expenses estimation for 2010:<br />
CHF 12,6mio.<br />
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Financial data - segment reporting<br />
(in 1’000 CHF)<br />
‘Project’ segment (core):<br />
• moderate cost effect of our discovering and conceiving approach and the community networking clearly stated.<br />
• we are able to generate revenues.<br />
‘Services’ segment (not core - deriving from collaborations with licensing-out partners):<br />
• our partners are ready to pay for high value added services.<br />
* Financial data are in thousand CHF. Adjustments may not exactly correspond to audited financial data.<br />
Projects Services Corporate Total<br />
31.12.2009:<br />
Revenues from external customers 610 13.130 - 13.740<br />
Inter-segment revenues 95 - 685 780<br />
Segmental costs (13.398) (11.496) (1.735) (26.628)<br />
Segmental operating results (12.693) 1.635 (1.050) (12.108)<br />
Included in segmental operating resut are><br />
- depreciacion, amortization and other write-offs (5.336) (108) - (5.444)<br />
31.12.2008:<br />
Revenues from external customers 316 14.229 - 14.545<br />
Inter-segment revenues 262 - 632 894<br />
Segmental costs (11.622) (12.349) (637) (24.608)<br />
Segmental operating results (11.044) 1.880 (5) (9.169)<br />
Included in segmental operating resut are><br />
- depreciacion, amortization and other write-offs (3.402) (206) (36) (3.644)<br />
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Financial data - global view<br />
(in 1’000 CHF)<br />
We generated operating revenues of CHF 45.5 million in the last years (2006 - 2009)<br />
from licensing out (11.5m) and development services (34m), against operating expenses of CHF 74.7 million.<br />
We raised net proceeds of CHF 28 million in the same period. On February we closed a further reserved<br />
fund raising for net CHF 8.5 million. To fund the further development of our pipeline, we plan additional share<br />
capital increases. We intend to issue new shares to investors and to the <strong>Mondobiotech</strong> community.<br />
* Financial data are in thousand CHF. Adjustments may not exactly correspond to audited financial data.<br />
2009 2008 2007 2006<br />
Revenues 13.740 14.545 14.827 2.480<br />
Research & development (20.146) (20.173) (11.291) (4.824)<br />
Sales & marketing (3.632) (2.351) (3.762) (2.047)<br />
Management & administration (2.071) (1.192) (1.510) (1.754)<br />
Operating result (12.108) (9.170) (1.735) (6.145)<br />
Total non-current and other current assets 60.586 62.576 68.121 61.458<br />
Cash and cash equivalents 4.632 14.085 11.009 15.306<br />
Total assets 65.218 76.662 79.130 76.764<br />
Total shareholder's equity 56.733 68.937 64.496 66.134<br />
Liabilities 8.486 7.725 14.634 10.630<br />
Total equities and liabilities 65.218 76.662 79.130 76.764<br />
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Financial Calendar<br />
Next Corporate Appointments:<br />
• August 31st 2010<br />
• March 31st 2011<br />
• April/May 2011<br />
Half Year Financial Results 2010<br />
Annual Report 2010<br />
Ordinary General Assembly, DasKlosterStans<br />
For additional information on please contact <strong>Mondobiotech</strong> Investor & External Relations:<br />
investor@mondobiotech.com - T. +41 840 200 010.<br />
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Management<br />
Patrick<br />
Pozzorini<br />
Chief Financial<br />
Officer, founder.<br />
Patrick holds a degree<br />
in business economics<br />
from the University<br />
of Zurich. From 1995<br />
to 2000, he worked<br />
for Pricewaterhouse<br />
Coopers AG and<br />
from 1992 to 1995<br />
for Fidinam Group.<br />
He was born in 1967.<br />
Vera<br />
Cavalli<br />
Chief Pharmaceutical<br />
Officer, founder.<br />
Vera graduated<br />
in pharmacy at the<br />
University of Basel.<br />
She gained five years<br />
of pharmacy business<br />
experience working<br />
in various pharmacies.<br />
From 1999 to 2000<br />
she worked in the sales<br />
department for the<br />
Swiss market of Searle<br />
SA (Monsanto group).<br />
She was born in 1968.<br />
Fabio<br />
Cavalli<br />
Executive Chairman<br />
& Chief Business Architect,<br />
founder.<br />
Fabio has founded<br />
several successful<br />
start-ups in IT,<br />
consumer services<br />
and sports goods<br />
fields, gaining<br />
thereby considerable<br />
marketing and<br />
sales experience.<br />
Fabio is Swiss<br />
Entrepreneur of<br />
the year 2006.<br />
He was born in 1955.<br />
Ruggero<br />
Gramatica<br />
Chief Executive Officer.<br />
Ruggero has an extensive<br />
experience in startups<br />
and companies’<br />
turnaround particularly<br />
in the services industry<br />
having successfully<br />
contributed to the<br />
growth of Fastweb,<br />
Covad Communications,<br />
PacificBell, Omnitel-<br />
Vodafone, Bulldog<br />
and OnTelecoms .<br />
He brings strategic<br />
leadership as<br />
well as technological<br />
and operational<br />
expertise to bear.<br />
He was born in 1965.<br />
Maria Teresa<br />
D’Antonangelo<br />
Chief Operating Officer.<br />
Maria Teresa graduated<br />
in Law at the University<br />
of Parma. She specialized<br />
in the field of Intellectual<br />
and Industrial Property<br />
Litigations with Prof.<br />
Mario Franzosi in Milan.<br />
She has been admitted<br />
to the Doctorate in<br />
Intellectual Property Law<br />
at the University of Parma.<br />
She was born in 1973.<br />
Dorian<br />
Bevec<br />
Chief Scientific<br />
Officer, founder.<br />
Dorian holds a Ph.D.<br />
from the Ludwig-<br />
Maximilians-University<br />
of Munich and a habilitation<br />
(Venia Docendi) from<br />
the University of Vienna.<br />
He worked as Head<br />
of Molecular Biology<br />
and project team leader<br />
at the Sandoz Research<br />
Institute in Vienna for ten<br />
years and at Axxima AG<br />
in Martinsried for two years.<br />
He was born in 1957.<br />
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Board<br />
Robert Edward<br />
Patterson<br />
Managing Director<br />
Peninsula Venture<br />
Fabio Cavalli<br />
Executive Chairman,<br />
Chief Business<br />
Architect, founder<br />
Prof.<br />
Michael Alan Keller<br />
Stanford University Librarian<br />
Graf Francis<br />
von Seilern-Aspang<br />
CEO Industrie u. Finanzkontor<br />
Prof. Dr. Med.<br />
Thomas Cerny<br />
Head of Oncology,<br />
University of St. Gallen<br />
Prinz Michael von<br />
und zu Liechtenstein<br />
Vice – Chairman<br />
Ruggero<br />
Gramatica<br />
CEO <strong>Mondobiotech</strong><br />
Prof.<br />
Geoffrey West<br />
Distinguished Professor and former<br />
President of the Santa Fe Institute<br />
Vera Cavalli<br />
Chief Pharmaceutical<br />
Officer, founder<br />
Prof. Dr.<br />
Robert Huber<br />
Nobel Prize Laureate<br />
Prof.<br />
Roland M. du Bois<br />
Professor of Respiratory Medicine,<br />
Imperial College, London<br />
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Awards<br />
2008<br />
<strong>Mondobiotech</strong><br />
recepient<br />
of The Swiss<br />
Innovation<br />
Award by<br />
the Central<br />
Swiss Chamber<br />
of Commerce.<br />
2007<br />
<strong>Mondobiotech</strong><br />
selected as<br />
Technology<br />
Pioneer<br />
by the World<br />
Economic<br />
Forum.<br />
2007<br />
<strong>Mondobiotech</strong><br />
selected by<br />
an independent<br />
jury as the<br />
Best Innovator.<br />
2006<br />
Chief Business<br />
Architect<br />
Fabio Cavalli<br />
receives<br />
Start-up Swiss<br />
Entrepreneur<br />
of the Year.<br />
2005<br />
Winner<br />
of the Swiss Life<br />
Sciences Prize.<br />
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About us<br />
• We started the <strong>Company</strong> in 2001 on two<br />
fundamental ideas: use known, existing substances<br />
with safe profiles; interact and network with the<br />
communities.<br />
• The first licensing-out agreement was signed<br />
at the end 2001/beginning 2002 with NASDAQ-listed<br />
Intermune, Inc.<br />
• From 2001 to 2006 we developed the methodology<br />
to continuously generate a large number of MPC’s,<br />
the Search & Match Engine.<br />
• In 2006 we closed our second licensing-out<br />
agreement with NASDAQ-listed Biogen Idec, Inc.<br />
• In 2007, we entered into a third licensing-out<br />
agreement with NASDAQ-listed United Therapeutics,<br />
Inc. for five MPC projects at ‘dry search’ stage only.<br />
This agreement was important for us insofar as<br />
it demonstrated the scientific foundation of our<br />
business model.<br />
• In 2009 we began a partnership with 23andMe, Inc.<br />
to advance research in collecting data by genotyping<br />
patients affected by rare diseases.<br />
• As of August 2009 the shares of the <strong>Company</strong> are<br />
listed on the SIX Swiss Exchange with the symbol<br />
RARE.<br />
• In September 2009 we enforced our agreement<br />
with SIX-listed Bachem Holding AG with respect to<br />
peptides in the development of MPC’s.<br />
• Beginning 2010 we expanded our agreement<br />
with Biogen Idec Inc. to United Therapeutics, Inc.,<br />
therefore ensuring the development of Aviptadil to a<br />
whole platform.<br />
• In April 2010 we signed a collaboration agreement<br />
with WR Hambrecht + Co. for the exclusive<br />
placement of <strong>Mondobiotech</strong> securities and other<br />
financial and strategic services.<br />
• To date, we have more then 300 MPCs covered by<br />
intellectual property for further development and/or<br />
licensing.<br />
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Meet us<br />
Selected management will present the company at the following conferences:<br />
• Sept. 13-15, 2010<br />
• Sept. 15-17, 2010<br />
• Sept. 29-30, 2010<br />
• Oct. 10-12, 2010<br />
Rodman & Renshaw 12th Annual Healthcare Conference New York Palace Hotel,<br />
New York USA<br />
www.rodm.com/conferences<br />
BioPharm America 2010 Marriot Boston Copley Place, Boston USA<br />
www.ebdgroup.com/bpa/index.php<br />
10th Annual Biotech in Europe Investor Forum<br />
Radisson Blu Hotel, Zurich Airport Switzerland<br />
www.sachsforum.com/zurich10/index.html<br />
<strong>Mondobiotech</strong> will present on Sept. 29th in the afternoon session<br />
18th Annual BioPartnering Europe QEII Conference Center, London<br />
UK www.techvision.com/bpe<br />
<strong>Mondobiotech</strong> will present on Oct. 12th at 9.30am in the Abbey Room West<br />
To organize 1-to-1 meetings with the management at these events or in other venues please contact<br />
<strong>Mondobiotech</strong> Investor & External Relations: investor@mondobiotech.com - T. +41 840 200 010.<br />
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<strong>Mondobiotech</strong> Holding AG<br />
DasKloster<br />
Mürgstrasse 18<br />
CH – 6370 Stans<br />
Switzerland<br />
www.mondobiotech.com<br />
IR Contact<br />
Paolo Bassanini<br />
T +41 840 200 010<br />
F +41 840 200 011<br />
investor@mondobiotech.com