SACHS 20TH ANNUAL BIOTECH IN EUROPE FORUM
F.R. Martelet, M.D., CEO
21 - 24th September 2020
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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 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 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.
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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 |
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The new team leading Oasmia's transformation
FRANCOIS MARTELET, M.D., Master's
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
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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
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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) | ||||||
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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
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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 |
(Excipient:API) | |||||
Infusion Time | 1h | 3h | <1h | 3h | 0.5h |
Pre-medication | Not mandatory | Yes | No | Yes | No |
Hypersensitivity | No | Yes | No | Yes | No |
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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 | |
Korea's 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
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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)
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Sustaining Oasmia's 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
-
Articulated and implemented docetaxel micellar clinical development plan incl. a collaborative agreement with
- 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
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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
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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
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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 13:29:05 UTC