Bioterm Pharmaceuticals Ltd. Investor Presentation

mutebabiesBiotechnology

Dec 6, 2012 (5 years and 1 month ago)

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Executive Staff


Dr. I. Shamir Leibovitz:
President, founder,

Chief Medical Officer, inventor of
Preventerm

&
Inducterm

Ceo.

Prof. Eliezer Shalev
:
Director of Clinical Trials

Prof. Daniel Siedman:

Associate Director of Clinical Trials


Board of Advisors


Prof. Robert Goldenberg

Prof. Phillip Robert Bennet

Prof. Emile Papiernik

Dr. Joseph Blankstein

Preterm Labor



Afflicting more than one out of ten pregnancies, preterm birth is
responsible for 75% of infant deaths and up to 50% of neurological
handicaps



In spite of great advances in medical research and development of
drugs, clinical therapies and surgical procedures, thus far no
effective solution exists to prevent preterm labor


Postterm Pregnancy



Likewise, treatments currently available to induce labor have proven
to be unsafe, costly, and mostly ineffectual



Induction of labor is generally initiated when the cervix has not
sufficiently softened to facilitate birth


Treatments for
Preterm Labor:

Preventerm

Tocolytics

Tractocile

Efficiency

High

Low

Medium

Duration of
Prevention

Up to a full
week

48 hrs. max

48 hrs. max

Major Side
Effects

None

Some, but rare

None

Drug Origin

Natural/

Organic

Natural/

Synthetic

Synthetic

Possible
office use?

Yes

Impractical

No

Treatments for
Postterm Preg.:

Inducterm

Prostaglandins

Oxytocin

Success Rate

Potentially
over 80%

30
-
55%

40
-
60%

Side Effects

Potentially
insignificant

Uterine tetany,
potential fetal distress,
uterine rupture, water
intoxication; Very
rarely: fetal or maternal
death

Uterine tetany,
potential fetal
distress, uterine
rupture; Very rarely:
fetal or maternal
death

Time to
Delivery

Est. 3
-
5
hours

12
-
48 hours

6
-
24 hours

Office Use?

Yes

No

No

Preventerm

(patent pending)

blocks 3 out of the 5 factors that prepare the
cervix for labor, representing an extremely effective multi
-
step inhibition of the
enzymes that begin the labor process

Attacking metalloproteinases and cytokine precursors,
Preventerm

interrupts
several steps in the biological pathway thereby preventing labor for an
unprecedented length of time


up to a week, and with 90% efficacy


Inducterm

(patent issued)

works by the reverse process, providing
collagenase to begin the breakdown of cervix proteins and thereby inducing
labor in a matter of 3
-
5 hours

Both drugs

are based on already scientifically and clinically proven molecules
that are safe, inexpensive, and easily administered with minor to no side effects


Preventerm

is derived from a naturally occurring amino acid derivative and
thiol reducing agent

This drug is exceptionally easy to manufacture, as it draws from a widely
available molecule

Preventerm

is ready to begin Phase II testing by our research team


Inducterm

is created from ubiquitous collagenase, an enzyme that governs the
breakdown of collagen in various human and animal systems

Collagenase is already FDA approved for unrelated indications and in use by
Biospecifics Technology Corp. (US) for tissue healing therapies

Inducterm
is ready to begin pre
-
clinical trials




Preterm births occur in approximately 11% of all deliveries, affecting
1.5 million pregnancies in Europe, Japan, and the US alone

ICU costs for these cases amount to a staggering $50 billion per year
based on an average incubation of 21 days

Health complications following delivery from preterm birth increase this
amount substantially


Induction of labor must be performed in close to 17
-
24% of
pregnancies, accounting for 3.0
-
3.4 million births

Methods of inducing labor are dangerous, controversial, and largely
ineffective


raising the need for cesarean sections and creating other costly
complications



Ferring (Sweden) manufactures Tractocile
®

(Atosiban) to prolong labor
for up to 48 hours


our major competitor

Average cost: $1,500/dose; usually given several times

Tractocile
®

produces a yearly revenue of $650 million


Various drugs exist to induce labor:


Cytotec
®

(Pharmacia/Pfizer)


Prepadil
®

Gel (Pharmacia/Pfizer)


Cervadil
®

(Controlled Therapeutics)


Pitocin
®

(King Pharmaceuticals)

Cervadil
®

alone accounts for over $67.5 million in sales per year


With 1.5 million premature births in Europe, Japan, and US per
year, and a planned cost price of $2,000 for Preventerm,
each 1%
of market share or 15,000 treatments translate into $30 million in
revenues


With annualy 3.0
-
3.4 million births requiring labor induction
treatment, and a planned cost price of $1,000 per treatment with
Inducterm,
each 1% market share or 32,000 treatments means
$32 million in revenues



Various scientific case reports on the use of the Preventerm source
molecule report no adverse side effects to the mother or infant

Preventerm stands to decrease the overall expense of preterm
infant health care and will reduce infant mortality as well as post
-
natal complications considerably

Initial tests of Preventerm have shown a 90% efficacy rate in
preventing preterm labor


overwhelmingly more effective than any
of the currently available treatment modalities



Inducterm

s source molecule has also been tried and tested and
carries an FDA approval for unrelated indications

As a result, much of Phase I testing can be foregone, saving a
considerable amount of time and needed capital

Inducterm has also shown a considerably higher efficacy rate than
any drug currently available, and induces labor in over 80% of cases
in a period of 3
-
5 hours





We intend to generate revenue through joint and/or strategic
collaborations with large pharmaceutical and biotechnology companies
in order to further develop our products, jointly facilitate regulatory
approval, and subsequently to bring our products to the global markets


Our partners will be bearing the costs of pre
-
market regulatory
approvals, marketing, distribution and sales of our drug products



Our revenues will derive from an upfront lump sum for the licensing of
our Preventerm and Inducterm, and subsequent royalties on sales



In addition we will continue our own development of drug products
for other specific indications, i.e. veterinary, independently



We expect to generate cash flow within one year by means of our
licensing and/or partnering arrangements (i.e. veterinary)



Longer term, we plan to generate proprietary drug portfolios
independently and bring them to market





Preventerm


2007


2008

2009


2010


Phase IIa



















































Phase IIb


















































Phase III


















































FDA Approval



















































Inducterm


2007


2008


5

2009

2010

Pre
-
clinical

















































Phase I


















































Phase II


















































Phase III





















































2007

2008


2009


2010


2011

Revenues


0


4,750


10,250


28,800


47,140


Cost

of

Goods

Sold


0
*


95
*


205
*


576
*


942
*


Gross

Profit


0


4,655


10,045


28,224


46,198


R&D Expenses


324


3,783


5,174


6,912


8,276


Marketing & Sales Expenses


0


276


1,258


2,084


3,672


General & Admin. Expenses


96


751


1,468


2,205


2,878


Total

Expenses


420


4,811


7,901


11,200


14,826


Pre
-
tax

Income


-
420


-
156


2,144


17,024


31,372


Income

Tax


0


0


614


6,128


11,294


Net

Income


-
420


-
156


1,
530


10,896


20,078


Capital Requirements Q3 ’047


Q4 ’11($000’s)

Research

and

Development

$5,330

Marketing

and

Sales

$550


General

and

Administrative


$1,130

Fixed

Assets

$390

TOTAL

$7,400


Bioterm Pharmaceuticals Ltd.
is a unique investment opportunity due to
its:



Patented and patent
-
pending breakthrough drugs



Direct solution to a pressing market need



Vast expertise in the OB/Gyn industry



Several discrete multi
-
billion dollar markets



Strategic value to large pharmaceutical companies


By 2010 we envisage revenues to approach $43 million with net
income reaching $18 million

Our comprehensive
business plan, executive
summary, and extensive
scientific and medical data
are available upon request











Shamir Lebovitz President CEO

sibiotec@yahoo.com

972
-
54 6375565

T: + 972 (0)54 755 614


Bioterm Pharmaceuticals

http://www.bio
-
term.com



The vast growth in medical care
expenses has generated
substantial attention to finding
treatments that are not only useful
and safe, but cost effective as well.
In 1999, gross domestic
expenditure on healthcare in the
U.S. reached $1.3 trillion and is
projected to grow to $2.1 trillion by
2007

.
-

National Center for Health
Statistics, 1995.




Similar to the overall healthcare
market, the OB/Gyn market had
experienced increasing pressures
to cut down expenses while
maintaining the quality of care.
Despite this trend, expenditures in
this market are on the rise

.
-

Am.
Family Physician, 1999