Oasmia Pharmaceutical : Presentation at Sachs Biotech in Europe Forum

10/01/2020 | 09:25am EDT

SACHS 20TH ANNUAL BIOTECH IN EUROPE FORUM

F.R. Martelet, M.D., CEO

21 - 24th September 2020

1

Forward-looking statement

IMPORTANT NOTICE

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.

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.

FORWARD LOOKING STATEMENTS

This presentation contains forward-looking statements that reflect managements 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 Oasmia 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.

2

Oasmia - an innovation-focused specialty pharmaceutical company

Founded in 1999 HQ Uppsala, Sweden 26* employees

XR-17™ technology platform,

allowing micelle formulations of APIs, to be

soluble in water - broad applications in oncology, human and animal health

Lead product Apealea® approved in EU/EEA for advanced ovarian cancer, partner Elevar in discussions with FDA; global commercial deal worth up to $698m + royalties

NASDAQ Stockholm 2010 Market Cap approx. SEK 2,1 B

R&D-certified Production Facility and R&D, in Uppsala,

Sweden

New CEO in place since March 2020

3

*By end of Q1 2021

Building a sustainable, profitable specialty pharma company

MEETING UNMET

APEALEA® APPROVED

A GLOBAL

MEDICAL NEED

IN EUROPE

PARTNERSHIP

IMPROVING SOLUBILITY &

LEAD PRODUCT LAUNCHED

WORTH UP TO $678

SIDE EFFECT PROFILS OF

FOR ADVANCED OVARIAN

MILLION PLUS ROYALTIES

ESTABLISHED & NOVEL

CANCER

CANCER DRUGS

INCREASING R&D

EFFICIENCY

A GROWING PIPELINE

POSITIONED FOR M&A,

NEW MANAGEMENT &

IN/OUT-LICENSING

STRATEGY

UNDERPINNED BY STRONG

PROVEN DEVELOPMENT,

FOCUSING RESOURCES

IP PROTECTION

REGULATORY AND BD SKILLS

TO ​BUILD A SUSTAINABLE,

+ SOLID CASH POSITION

PROFITABLE BUSINESS

4

The new team leading Oasmias transformation

FRANCOIS MARTELET, M.D., Masters

Degree Business

Chief Executive Officer

Previous experience:

CEO in Biotechnology/ BioPharma in UK, DNK, US and senior executive global roles at Novartis Oncology, Merck & Co., Inc with large P&L responsibility

ANDERS HÄRFSTRAND, M.D., PhD.

Non-executive Chairman

Previous experience: Experienced

Pharma BoD, M&A experience, former executive positions in Pfizer, Pharmacia.

Pharmacia & Upjohn

FREDRIK JÄRRSTEN*

Chief Finance Officer

REINHARD KOENIG, M.D.

Acting Chief Medical

Officer

HEGE HELLSTRÖM,

B.A.

Board Member

PETER ZONABEND,

LL.M, EMLE

Board Member

ELIN TRAMPE,

Chief Technical

Officer

PETER SELIN*

Chief Business

Officer

BIRGIT STATTIN

NORINDER, MSc.

Board Member

5 *Start date TBC

Meeting the challenges of poor drug solubility

POOR API1 SOLUBILITY

MAJOR CHALLENGE IN DRUG DEVELOPMENT

CRITICAL TO DRUG

BIOAVILABILITY

c.40% OF APPROVED

DRUGS AFFECTED2

70-90% OF PIPELINE DRUGS CLASSED AS POORLY SOLUBLE2

LEADING CAUSE OF PROJECT TERMINATION

A FACTOR IN SERIOUS

ADVERSE EVENTS (SAEs)

SOLUBILITY ENHANCERS CAN CAUSE SAEs AND / OR REQUIRE USE OF FURTHER DRUGS

AN ACCEPTED TRADE OFF IN CANCER THERAPY

$180 bn

69%

OF DRUGS

SPENT ON

FAIL DUE TO

PHARMA R&D

LOW

EVERY YEAR

3

SOLUBILITY 3

1)

API = Active Pharmaceutical Ingredient - the ingredient in a pharmaceutical drug that is biologically active

6

2)

Nikolakakis & Partheniadis

3)

GlobalData

XR-17™ - powerful platform that can increase solubility of insoluble compounds

Active Pharmaceutical Ingredient

(API)

XR-17™

XR-17™ + API

WATER INSOLUBLE

Hydrophilic head Hydrophobic chain

WATER SOLUBLE

XR-17™ increases small molecule solubility and potentially improves

safety and efficacy of new formulations

7

XR-17™ - a validated platform applicable in many therapeutic areas

Strong, validated safety in cancer indication1

Drug load capacity, enabling high drug delivery capability

Shorter infusion time1,2

Superior solubility compared with other platforms and technologies, enhances bioavailability of API

No mandatory or limited need for pre- medication1

Free from alcohol, Cremophor EL, Polysorbate-80 and Human albumin, which can cause numerous side effects

Enable new

Improve

2nd chance for

drugs

existing drugs

failed drugs

8

1)

Apealea Summary of Product Characteristics. www.ema.europa.eu

2)

Paclitaxel 6 mg/ml Summary of Product Characteristics. https://products.mhra.gov.uk

XR-17TM - multiple opportunities in oncology, human and animal health

XR-17™

ANIMAL

ONCOLOGY

OTHER

HEALTH

THERAPEUTIC

AREAS

Lymph-

Lung

Cervical

oma

cancer

cancer

Masto-

Prostate

Breast

Ovarian

Bladder

cytoma

cancer

cancer

cancer

cancer

Docetaxel Micellar

9

Building a diverse portfolio based on XR-17™ platform technology

Registration /

Product

Indication

Pre-clinical

Phase I

Phase II

Phase III

approval

Geography

Human Health Portfolio

Apealea® /

Ovarian cancer

Pre-NDA meeting

USA

Paclical®

Ovarian cancer

EU / EEA1

(paclitaxel)

Technology Platform Portfolio

Docetaxel

Prostate cancer

Planned

Global

micellar

New API

Undisclosed

Global

XR19

Assessments in

Global

(combination)

various cancers

Animal Health Portfolio

Paccal vet

Mammary

Carcinoma

No

US

(paclitaxel)

(Canines)

Doxophos vet

Lymphoma

No

US

(doxorubicin)

(Canines)

10

XR-17™ - broad IP protection up to 2036

PROCESS

Protects the

manufacturing process

for XR-17™

PCT applicationgranted

4

patents granted

In USA, ZAF

Application pending in Eurasia, European Patent Office, AUS, BRA, CAN, CHN, IND, IDN, JPN, MYS, MEX, NZL, KOR, SGP and

UKR

WATER-INSOLUBLE

Protects poorly water-

soluble APIs1 in combination

with XR-17™

56 patents granted

across Eurasia, European Patent Office, AUS, CAN, CHN, HKG, JPN, KOR, MEX, MYS, NZL,

UKR, USA, ZAF

SPC applied for in the EU, pending

(5-year extension)

ANTICANCER COMPOSITIONS

Protects XR-17™ in combination with chemotherapeutic agents

6 patents granted

In USA, FRA,

GBR, DEU, CHN

and HKG

1) active pharmaceutical ingredient

11 PCT, Patent Cooperation Treaty

SPC, Supplementary Protection Certificates

Apealea® - offering improved treatment options

Approved in

EU/EEA for

Current standard of care in Ovarian cancer is carboplatin + paclitaxel

treatment of first

relapse ovarian

Subset of patients cannot tolerate solvent-based paclitaxel

cancer1 and in

Russia for first line

Apealea® is an IV injectable formulation using XR-17™ which

and relapsed

facilitates solubility of paclitaxel

ovarian cancer

2

1) Apealea® Summary of Product Characteristics. www.ema.europa.eu

12

2) Paclical® Instructions for medical use. https://grls.rosminzdrav.ru

The growing taxane market for ovarian and other cancers

The 2018 global injectable taxane market was valued at $2.18B

The market is expected to grow $4.56B by the end of 2025 (CAGR 11% 2019 - 2025)

Taxol®

  • Paclitaxel - cremophor EL
  • Ovarian, breast, lung and Kaposi Sarcoma cancers
  • Best selling drug of all time with annual sales of $1.6B prior to patent expiration (2000)

Taxotere®

  • Docetaxel - polysorbate 80
  • Breast, lung, prostate and head & neck cancers
  • Peak sales $3B (2010)
  • ~$170M (2019)

Abraxane®

Jevtana®

Paclitaxel - albumin bound

Cabazitaxel - polysorbate 80

Breast, lung and pancreatic cancers

Prostate cancer

$1.35B (2019)

~$480M (2019)

Apealea® is the only non-cremophor drug approved for use in advanced stage

ovarian cancer in the EU

13

Apealea® - multiple benefits compared to the competition

Company

Ovarian Cancer

Ovarian Cancer

Ovarian Cancer

Indication

Ovarian Cancer

Breast Cancer

Breast Cancer

Breast Cancer

Breast Cancer

NSCLC

NSCLC

NSCLC

Infusion Solution

Micellar Solution

Emulsion

Colloidal Suspension

Liposome

Micellar Solution

Particle Size

25nm

10-22nm

130nm

400nm

~25nm

Excipient

XR-17™

Cremophor EL

Human Albumin

Lecithin/Cholesterol

PEG-PDLLA

Dose

250mg/m2

175mg/m2

260mg/m2

175mg/m2

260mg/m2

Ratio

1.3:1.0

88.0:1.0

9.0:1.0

-

5.0:1.0

ExcipientAPI

Infusion Time

1h

3h

<1h

3h

0.5h

Pre-medication

Not mandatory

Yes

No

Yes

No

Hypersensitivity

No

Yes

No

Yes

No

14

Apealea® - meeting unmet medical needs in selected ovarian cancer

OVARIAN CANCER INCIDENCE1

7000066300

60000

Incidence

50000

40000

30000

26600

24500

20000

10000

0

Main Asia *

EU Top 5

US

295,000 women diagnosed in 2018 - 8th most common cancer in women1

70% of women have a relapsethreeyears after diagnosis2

Platinumanalogs used

alone or in combinationwith paclitaxel are the most used therapeutic agents3

*) China, Japan and South Korea 1) Global Cancer Observatory

15 2) Springerplus. 2016; 5(1): 1197. Published online 2016 Jul 28. doi: 10.1186/s40064-016-2660-0

3) ESMO guidelines: Annals of Oncology 30: 672-705, 2019 doi:10.1093/annonc/mdz062 Published online 2 May 2019

Apealea® - global partnership worth up to $698m + royalties

Agreement with US-based Elevar

Therapeutics, subsidiary of South

Koreas HLB

$20M

Upfront payment

%

Double digit royalties on global

Apealea® sales

$678M

Milestones based on regulatory and

sales achievements

Oasmia retains sole control over development of XR-17TM in other APIs

Named patient program initiated with Tanner Pharma Group ex US

Elevar considering European partners for commercial sales

16

Docetaxel micellar in clinical development

  • Prostate cancer is a leading cause of cancer death in men worldwide
  • Widely approved for wide range of solid malignancies and standard of care for advanced prostate cancer
  • Docetaxel micellar uses XR-17™, enabling IV administration of water- insoluble compounds without traditional solubility enhancers
  • Being investigated for advanced prostate cancer in a Phase I clinical trial with the Swiss Group for Clinical Cancer Research (SAKK)

17

Sustaining Oasmias transformation since CEO appointment

  • Strategic
    • Working progress on
    • Achieving Elevar deal milestones
    • Creating revenue opportunities for the animal health business and for XR-17™
  • Human Resources
    • Reviewed and implemented right-sizing of the organization
    • Strengthened management team with C level hires
  • Operational
    • Articulated and implemented docetaxel micellar clinical development plan incl. a collaborative agreement with
      SAKK
    • Preclinical work with new API and XR-19on-going
    • Starting up a Patient Access Program in the EU through Elevar
  • Financials
    • Implemented cost savings of SEK 100m and burn rate of less than SEK 10m/month
    • Resolved large corporate liabilities
  • Investor Relations
    • Broadened research coverage

Opportunity to build long-term, profitable specialty pharma company through in-house R&D, M&A, and in-licensing of late-stage assets

18

Oasmia - An investment opportunity

  • Commercial stage company with proven ability to bring promising new products to market
  • XR-17- validated technology platform applicable across range of therapeutic areas
  • Transformational global strategic partnership with Elevar Therapeutics - lucrative milestones and revenues
  • Strong cash position - well placed to pursue high value M&A licensing opportunities
  • Strong and experienced management team focused on delivering growth

19

Multiple potential near and mid-term

catalysts & value drivers…

  • Elevar partnering for Apealea® in Europe, China
  • Apealea® royalties
  • Docetaxel micellar Phase 1 initiation / phase 2 initiation
  • Review of Animal Health assets
  • XR-17™partnering
  • M&A and in-licensing opportunities to build critical mass
  • XR-19value assessment

Solid foundations in place to build a profitable speciality pharma company

Platform to build a Sweden-

based cash-flow positive specialty pharma leader

Realising our vision

for success

Well placed for M&A and licensing

collaborations

20

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Oasmia Pharmaceutical AB published this content on 21 September 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 October 2020 13:24:04 UTC

© Publicnow 2020

All news about OASMIA PHARMACEUTICAL AB (PUBL)
08/31OASMIA PHARMACEUTICAL : to present at Aktiedagen Stockholm on September 7

AQ

08/26OASMIA PHARMACEUTICAL : strengthens internal capabilities with the appointments ..

AQ

08/26Oasmia Pharmaceutical AB Announces Executive Appointments

CI

08/19OASMIA PHARMACEUTICAL : Interim report for the period January 1, 2021 – Ju..

PU

08/19Oasmia Pharmaceutical AB Publ Reports Earnings Results for the Second Quarter..

CI

08/11OASMIA PHARMACEUTICAL : First Patient enrolled in the SAKK Investigator-Initiate..

AQ

08/10OASMIA PHARMACEUTICAL : Invitation to presentation of Oasmias Q2 report on Augu..

AQ

06/30OASMIA PHARMACEUTICAL : Cantrixil positive Phase I trial data published in the j..

AQ

06/28OASMIA PHARMACEUTICAL : transfers Nordic commercialization rights for Apealea® t..

AQ

06/11OASMIA PHARMACEUTICAL : First Patient enrolled in the SAKK Investigator-Initiate..

AQ

Financials

Sales 2021 4,90 M 0,57 M 0,57 M
Net income 2021 -179 M -20,7 M -20,7 M
Net cash 2021 135 M 15,7 M 15,7 M
P/E ratio 2021 -7,20x
Yield 2021 -
Capitalization 1 291 M 149 M 150 M
EV / Sales 2021 236x
EV / Sales 2022 31,9x
Nbr of Employees 25
Free-Float 61,3%
Chart OASMIA PHARMACEUTICAL AB (PUBL)

Duration : Period :

Oasmia

Technical analysis trends OASMIA PHARMACEUTICAL AB (PUBL)

Short TermMid-TermLong Term
TrendsBearishBearishBearish

Income Statement Evolution

Consensus

Sell

Buy

Mean consensus BUY
Number of Analysts 0
Last Close Price 2,88 SEK
Average target price 5,70 SEK
Spread / Average Target 97,9%

EPS Revisions

Managers and Directors

François R. Martelet Chief Executive Officer
Fredrik Järrsten Chief Financial Officer
Karl Anders Olof Härfstrand Chairman
Mikael Asp Chief Technology Officer
Carina Eklöw Director-Global Medical Affairs

Sector and Competitors

1st jan.Capi. (M$)
OASMIA PHARMACEUTICAL AB (PUBL)-30.10%149
JOHNSON & JOHNSON10.01%455 762
ROCHE HOLDING AG19.01%350 194
PFIZER, INC.27.03%258 300
ELI LILLY AND COMPANY52.98%234 161
NOVO NORDISK A/S47.12%228 262

Tell us about you

Find us at the office

Kajioka- Constanza street no. 39, 50889 Kuala Lumpur, Malaysia

Give us a ring

Deunte Staunton
+59 850 269 756
Mon - Fri, 10:00-14:00

Reach out