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Investor Presentation February 2016
NASDAQ: OASM
Forward-Looking Statement
This presentation contains forward-looking statements that reflect management’s current views with respect to certain future events and potential financial performance. Although Oasmia believes that the expectations reflected in such forward looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. Accordingly, results could differ materially from those set out in the forward-looking statements as a result of various factors. Important factors that may cause such a difference for Oasmia include, but are not limited to: (i) the macroeconomic development, (ii) change in the competitive climate and (iii) change in interest rate level. This presentation does not imply that has undertaken to revise these forward-looking statements, beyond what is required by applicable law or applicable stock exchange regulations if and when circumstances arise that will lead to changes compared to the date when these statements were provided. This document (or any part of it) is not to be reproduced, distributed, passed on, or the contents otherwise divulged, directly or indirectly, in or into the United States of America, Canada, Republic of Ireland, Switzerland, South Africa, Japan, Hong Kong, Singapore, Australia or New Zealand or in any country, territory or possession where to do so may contravene local securities laws or regulations. The information in this presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would require preparation of further prospectuses or other offer documentation, or be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction. The securities referred to herein may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the United States Securities Act of 1933 (the “Securities Act”). No representation or warranty expressed or implied is made as to, and no reliance should be placed on the fairness, accuracy, completeness or correctness of the information or opinion contained herein. The information in this presentation may not be forwarded or distributed to any other person and may not be reproduced in any manner whatsoever. Any forwarding, distribution, reproduction, or disclosure of this information in whole or in part is unauthorized. Failure to comply with this directive may result in a violation of the Securities Act or the applicable laws of other jurisdictions.
Corporate Overview Focused on innovative treatments within human and animal oncology
Product & product candidates utilize a proprietary, nanoparticle formulation
technology (XR-17) to intravenously deliver active pharmaceutical
ingredients without the addition of toxic solvents
XR-17, a novel Vitamin A-based excipient, is basis for pipeline of five
clinical-stage programs for treatment of various cancers in humans and
animals
Lead human program, Paclical®, completed Phase III study: At least equal efficacy to Taxol
Improved safety and tolerability profile to Taxol
Positive top-line results in head-to-head comparison with Abraxane
Pacilcal® approved in Russia & CIS (2015); expected approval in E.U.
(2H16) and U.S. (2017)
Paclical has received Orphan Drug Designation (ODD), providing seven
years of market exclusivity in U.S.
Doxophos, a novel formulation of XR-17 and widely-used chemotherapy
doxorubicin, filed for market approval in Russia & CIS (2015)
Patent protection until 2028 with 91 patents and 22 patents pending
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Investment Highlights
XR-17, a Novel,
Broadly Applicable
Technology
• Nanotechnology platform used to improve drug (API) solubility; patent protection filed to 2028
• Applicable across wide variety of APIs; can be combined with novel compounds and generic drugs
• Nanoparticle drug delivery within oncology has validated past (i.e. Abraxane®)
Late-stage Asset
with Near-Term Data
• Phase III trials successfully completed for Paclical® targeting ovarian cancer
– Positive risk/benefit profile compared to standard treatment
– Submission of Market Authorization Application in Europe in 2015
– Orphan designation in the U.S. and E.U. for ovarian cancer indication
• Market approval in Russia and CIS in April 2015; initial sales of $9M (end-user value)
Highly-Attractive
Oncology Market
• Oncology market is the largest market in the biopharmaceutical space, estimated at $100B+
• Oasmia’s XR-17 based product Paclical® shows at least equal efficacy with improved safety and
tolerability profiles compared to Abraxane and Taxol (ext. $1.7B combined annual sales)
• Limited commercial infrastructure needed for U.S. launch; Abraxis provides roadmap to success
Animal Health
Provides Near-Term
Revenue
• Paccal Vet-CA1 launched in July 2014 (mammary and squamous cell carcinoma)
• Approval in animals would validate CMC and toxicology work for human NDA
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Financial Snapshot1
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Stock Symbol (US)2 OASM
Price (ADR) $3.65
52-Week Range $3.24 - $4.40
Avg. Daily Volume (90-day) 9,409
ADRs Outstanding 35.0M
Float 16.6M
Market Cap $127.6M
Cash (mrq)3 $8.5M
Revenue (ttm) $2.1M
1 Trades as an American Depository Receipt (1 ADR = 3 Ordinary Shares; price & volume data from Yahoo! Finance and other reliable sources 2 Oasmia is listed on NASDAD Stockholm (OASM), Frankfurt Stock Exchange (OMAX; ISIN SE0000722365), and NASDAQ US (OASM) 3 October 31, 2015 (Fiscal Year End: April 30)
Proprietary Technology Platform Validated in Clinical and Toxicological Studies
XR-17: Novel, broadly applicable technology platform
Can encapsulate individual or multiple APIs with different
solubility profiles
Validated in three APIs across five clinical-stage programs
Improves drug solubility without adding toxic solvents
Based on a Vitamin A derivative
Clear advantages over competing drugs
Higher drug dosages
Shorter infusion times
No pre-medication
Lower costs, both in drug production and clinic costs
Patent protection until 2028
Water-Insoluble API
XR-17 Molecule
Water-Soluble Micelle
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Proprietary, Patented XR-17 Technology Applicable Across Multiple APIs
Water insoluble compounds Water soluble compounds Dual encapsulation compounds
Taxanes
• Cabazitaxel
• Docetaxel
• Ixabepilone
Etoposide
Retinoids
• Fenretinide
• Etretinate
• Tazarotene – Bexarotene /
Adapalene
Immunosuppressants
• Cyclosporine
• Sirolimus
• Tacrolimus
• Everolimus
Anthracyclines
• Doxorubicin
• Epirubicin – Idarubicin
• Daunorubicin – Mitoxantrone
Camptothecin Analogues
• Topotecan
• Irinotecan
Vinca Alkaloids
• Vinblastine
• Vincristine
• Vinorelbine
Amsacrine
Procarbazine
• Anthracyclines
• Camptothecin Analogues
• Vinca Alkaloids
• Amsacrine
• Procarbazine
• Taxanes
• Etoposide
• Retinoids
• Immunosuppressants
XR-17 technology enables proprietary development and partnering
opportunities across multiple APIs
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Initial Development Focused on $45 Billion Cytostatic Market
Source: IMS Institute for Healthcare Informatics 2013, Company estimates
$100 Billion $45 Billion
0%
25%
50%
75%
100%
Oncology Therapeutics Cytostatics
Cytostatics
45%
Other
therapies
55%
Generics
70%
Patented
drugs
30%
Total oncology therapeutics market expected
to reach $147 billion by 2018
Dominate cytostatic products:
Paclitaxel (Taxol; Abraxane)
Docetaxel (Taxotere)
Doxorubicin (Doxil; Caelyx)
Carboplatin
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
9
Robust Product Pipeline with 3 Candidates Targeting Multiple Cancer Indications
Paclical®
(paclitaxel)
Doxophos
(doxorubicin)
Docecal
(docetaxel)
Ovarian Cancer
Metastatic
Breast Cancer
Breast Cancer
Breast Cancer
Candidate Indication Pre-Clinical Phase I Phase II Phase III
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Successful Phase 3 Trial with Paclical Targeting Ovarian Cancer
XR-17: Novel, broadly applicable technology platform
Can encapsulate individual or multiple APIs with different
solubility profiles
Validated in three APIs across five clinical-stage programs
Improves drug solubility without adding toxic solvents
Based on a Vitamin A derivative
Clear advantages over competing drugs
Higher drug dosages
Shorter infusion times
No pre-medication
Lower costs, both in drug production and clinic costs
Patent protection until 2028
Met primary endpoint of progression-free survival while showing positive
risk/benefit profile compared to Taxol
Trial compared Paclical, in combination with carboplatin, to Taxol
Study showed at least equal efficacy with improved safety and tolerability profile
Taxol, approved for 12 cancer indications, peaked at $1.6 billion annual turnover before
becoming generic
No pre-medication required; higher dosage (250mg/m2 Paclical vs 175 mg/m2 Taxol)
Orphan designation granted in U.S. and E.U. (seven years market exclusivity)
185,000 women have ovarian cancer in U.S.
85%-09% of U.S. cases are most aggressive sub-type, epithelial ovarian cancer
Estimated 21,980 new ovarian cancer cases and 14,270 deaths in 2014 in U.S.
U.S. market size estimated at $366 million
SOURCE: National Cancer Institute
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Time, h
0 2 4 6 8 10 12
Mean (
±S
D)
Tota
l Pla
sma P
acl
itaxe
l C
once
ntr
atio
n, ng/m
L
0
2000
4000
6000
8000
10000
12000
14000Paclical, n= 28
Abraxane, n= 28
Positive Top-Line Results for Paclical from Head-to-Head Comparison with Abraxane
Abraxane is currently the highest grossing paclitaxel drug, with estimated
annual sales of $1.0B - $1.2B in 2015
Approved for three cancer indications; metastatic breast cancer (2005), lung cancer
(2012), and pancreatic cancer (2013)
Pharmacokinetic study (260 mg/m2) in metastatic breast cancer patients
showed nearly identical concentration curves of both total and
unbounded paclitaxel
No serious adverse effects and results implied efficacy is the same
Time, h
0 2 4 6 8 10 12
Mea
n (
±S
D)
Un
bo
und
Pla
sma
Pa
clita
xel
Co
nce
ntr
atio
n, n
g/m
L
0
200
400
600
800
Paclical, n= 28
Abraxane, n= 28
Source: Company data OAS-09APPK ”Pharmacokinetic comparison between Paclical and Abraxane”
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Approved in Russia in 2015 with Approval Expected in EU (2H16) and US (1H17)
Paclical approved in Russia and CIS in April 2015
Marketed by Pharmasyntez; orders with initial end-user sales value of $9M
Chemotherapy market in Russia estimated $2B+; growing at 36% per year
Higher cancer death rate (Russia 60%; UK 40%; U.S. 33%)
Upcoming milestones:
1H16
o European filing
o Overall survival data from Phase III study
2H16
o European approval
o U.S. NDA filing (using 505(b)(2) regulatory pathway)
2017
o U.S. approval
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Successful Direct Commercialization Strategy of Abraxane Provides Roadmap for Paclical
Launch Paclical with targeted sales force in U.S.
Focus on key specialty distributers & gaining formulary acceptance at major cancer centers
Expand label into additional indications; Phase I trial for metastatic breast cancer underway
Taxol & Abraxane currently generate in excess of $1.7B in combined annual sales
$134 $139
$288 $336 $315
$426 $473
$759
$998
$1,346
$0
$200
$400
$600
$800
$1,000
$1,200
$1,400
$1,600
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015E
Glo
bal
Ab
raxa
ne
Sal
es (
$M)
Abraxane approved & launched in 2005
Showed efficacy & safety benefits over
Taxol and Taxotere
Initial indication for metastatic breast cancer
Later expanded label to lung cancer (2012)
and pancreatic cancer (2013)
Initial sales force of approx. 80 reps
Co-promotion with AstraZeneca (April 2006
to December 2018)
189 sales reps at time of Celgene’s
acquisition Source: SEC filings for Abraxis and Celgene. Centers for Disease Control and Prevention.
Abraxane Sales Growth
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Patient Recruitment for Phase I Trial of Docecal Begins January 2016
Docecal is based on docetaxel, the most active ingredient in Sanofi-
Aventis’ chemotherapy treatment Taxotere
Taxotere (now generic) generated $2.8B in revenue for Sanofi-Aventis in 2010
2014 sales of generic Taxotere were $350M
Taxotere approved for prostate cancer, breast cancer, lung cancer, gastric cancer, and
head & neck cancer
Advantages of Docecal compared to Taxotere
Docecal is solvent free and requires no pre-medication
Significantly improved carrier to API ratio (2.25:1.00 Docecal vs. 26.00:1.00 Taxotere)
No hypersensitivity
In vitro studies across six cancer cell lines show Docecal is as effective as Taxotere in
inhibiting cell growth
Oasmia has worldwide rights for Docecal
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Market Approval for Doxophos in Russia & CIS Expected by End of 2016
Doxophos is based on doxorubicin
Same API used in Adriamycin, Caelyx, and Doxil (combined sales of $600M in 2013)
Doxorubicin used to treat leukemia, Hodgkin’s lymphoma, bladder cancer, stomach cancer,
lung cancer, ovarian cancer, and thyroid cancer
Doxorubicin named among the World Health Organization Model List of Essential
Medicines in April 2015
Market void due to permanent closing of production plant used by Johnson & Johnson’s
sole supplier of Doxil
Doxophos is a hybrid and novel nanoparticle formulation
Product is based on Oasmia’s patented XR-17 technology
Application submitted for marketing approval in Russia and the Commonwealth of
Independent States with market approval expected by end of 2016
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
16
Potential Near-Term Revenue from Paccal Vet for Mammary & Sqamous Cell Carcinoma
Paccal Vet® CA1
(paclitaxel)
Doxophos Vet
(doxorubicin)
Mammary /
Squamous Cell
Mast Cell
Lymphoma
Candidate Indication Pre-Clinical Phase I Phase II Phase III
Received conditional approval in U.S. (Feb. 2014) for mammary carcinoma
and squamous cell carcinoma in dogs
Granted Minor Use and Minor Species designation in U.S. (similar to
orphan drug designation in humans)
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
17
Growing investments from animal health industry
Increased numbers of aging animals presented to vet clinics
Veterinarians becoming gradually accustomed to treating an aging pet population
• Increasing access to specialist oncologists and willingness to refer
• Improving levels of diagnosis by first opinion vets
Diagnostic advances are likely to positively impact the oncology market
• Surgeries not expected to represent a significant market
• Long term drug therapy expected to offer the greatest opportunity
Global companion animal drug market worth ~$7 billion
Almost exclusively based on human generic products
One in four dogs will develop a tumor during its lifetime
• Significant populations of dogs in both Europe and the U.S.
• Pet population growth in line with human population
50% of dogs over 10 years old will die of cancer-related problems
• Aging pet population in both Europe and the U.S.
~80M dogs in the US and 1.1M are diagnosed with cancer each year
• 50% diagnosed with skin cancer
General Trends Owner Trends Veterinarian and Medical Trends
Owners frequently view their pets as family members
• Growing expectations for companion animal care
Owners are increasingly educated regarding cancer management
• Increased willingness to pursue cancer therapy
Owners are willing to pay out of pocket for therapy
• Estimated price per treatment of Paccal Vet-CA1 of $3,500 - $4,000 is tolerated by the broader market
Animal Health Market – Overview & Trends
Source: Oncology insight, Vetnosis, February 2008, Animal Pharm Reports “Companion Animal Health Products: 2006 Edition”
Page 24 INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Launching Animal-Focused U.S. Brand and Sales Platform
New proprietary platform and sales network to introduce veterinarians to
Oasmia’s leading companion animal therapeutic
Paccal Vet-CA1 was previously distributed by Zoetis, a veterinary drug company that was spun off from Pfizer in 2013
Oasmia owns the exclusive global rights for Paccal Vet and Doxophos Vet
Total market for Paccal Vet-CA1 in the U.S., E.U., and Japan approx.
900,000 dogs per annum
Assuming 100,000 dogs treated in year five (at a price of $3,500-$4,000), this presents an
attractive opportunity ($350M+)
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Upcoming Milestones
Q1-2016 Filing for final sales approval for Paclical® to EMA
1H-2016 Launch of Paclical® in Middle East & Africa with commercial partner
1H-2016 Sign partner relationship for sales of Paclical® in China/Europe/U.S.
1H-2016 Report overall survival data for Paclical®
2H-2016 FDA submission for market approval of Paclical® in U.S.
2H-2016 Receive market approval for Paclical® in EU
2H-2016 Receive market approval for Doxophos® in Russia and CIS
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Management
Julian Aleksov – Executive Chairman of the Board • Executive Chairman and a founder of the Company
• Extensive experience coordinating research projects and strategic development of global
intangible assets
• Economist
Mikael Asp – Chief Executive Officer • 25 years of international pharmaceutical industry experience in R&D, production, quality
assurance, and as Qualified Person (QP)
• Master of Science in Chemical Engineering
Anders Lundin – Chief Financial officer, acting Head of Information • Previously Head of Finance at Q-Med in Uppsala
• 21 years of business administration experience including Finance Manager at GE
Healthcare, Zarlink Semiconductor, Hi3g Access AB, and Elektronikgruppen AB
• Bachelor degree in Business Administration from Uppsala University
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
Extensive IP Portfolio
Patent/Application Number Title Territory Status
US 6,642,271 Potentiating Compounds
United States
Europe
Japan
Issued
(11/4/2003)
US 7,030,158 Therapeutic Compounds United States
Europe
Issued
(4/18/2006)
US 12/809,252 Drug Delivery System for Administration of Poorly
Water Soluble Pharmaceutically Active Substances
United States
Europe
Japan
Pending
(12/18/2008)
US 12/809,259
Drug Delivery System for Administration of a Water
Soluble, Cationic and Amphiphilic Pharmaceutically
Active Substance
United States Pending
(12/18/2008)
A robust intellectual property estate of issued, pending, and published patents provides extensive protection for both Paclical® as well as XR-17 across the seven major markets (US, Germany, Italy, France, Spain, UK and Japan) as well as a number of emerging markets.
Of interest, Paclical® has received Orphan Drug Designation (ODD) from the USA FDA, and as such will be privy to seven (7) years of market exclusivity.
INVESTOR PRESENTATION | 2016 OASMIA PHARMACEUTICAL AB | WWW.OASMIA.COM
22
Oasmia Pharmaceutical AB
Vallongatan 1
Uppsala 752 28
Sweden
Tel: +46 18 50 54 40
Fax: +46 18 51 08 73
IMPROVED QUALITY OF LIFE FOR HUMANS AND ANIMALS
www.oasmia.com