22
1 Investor Presentation February 2016 NASDAQ: OASM

Oasmia Nasdaq: OASM

Embed Size (px)

Citation preview

Page 1: Oasmia Nasdaq: OASM

1

Investor Presentation February 2016

NASDAQ: OASM

Page 2: Oasmia 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.

Page 3: Oasmia Nasdaq: OASM

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

Page 4: Oasmia Nasdaq: OASM

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

Page 5: Oasmia Nasdaq: OASM

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)

Page 6: Oasmia Nasdaq: OASM

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

Page 7: Oasmia Nasdaq: OASM

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

Page 8: Oasmia Nasdaq: OASM

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

Page 9: Oasmia Nasdaq: OASM

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

Page 10: Oasmia Nasdaq: OASM

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

Page 11: Oasmia Nasdaq: OASM

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

Page 12: Oasmia Nasdaq: OASM

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

Page 13: Oasmia Nasdaq: OASM

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

Page 14: Oasmia Nasdaq: OASM

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

Page 15: Oasmia Nasdaq: OASM

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

Page 16: Oasmia Nasdaq: OASM

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

Page 17: Oasmia Nasdaq: OASM

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

Page 18: Oasmia Nasdaq: OASM

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

Page 19: Oasmia Nasdaq: OASM

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

Page 20: Oasmia Nasdaq: OASM

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

Page 21: Oasmia Nasdaq: OASM

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

Page 22: Oasmia Nasdaq: OASM

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