ERIK PENSER INVESTOR EVENT
F.R. Martelet, M.D., CEO
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 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
Based in Uppsala, Sweden 26* employees
XR-17™ technology platform
Allowing micelle formulations of APIs, to be soluble in water
A growing pipeline, focused on Oncology but with potential in other therapeutic areas
NASDAQ Stockholm 2010 Market Cap approx. SEK 2,0 B
R&D-focused Production
Facility in Uppsala, Sweden
New Leadership
since March 2020
3 | *By end of Q1 2021 | ||
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
4 *Start date TBC
Meeting the challenges of poor drug solubility
POOR API1
SOLUBILITY
Major challenge in drug development
Critical to drug bioavailability
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
SPENT ON
PHARMA R&D EVERY YEAR 3
69%
OF DRUGS
FAIL DUE TO
LOW
SOLUBILITY 3
1) | API = Active Pharmaceutical Ingredient - the ingredient in a pharmaceutical drug that is biologically active | ||
5 | 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
6
XR-17™ - validated platform applicable in many therapeutic areas
Drug load capacity, enabling high drug delivery capability
Shorter infusion time1,2
Superior solubility compared with other platforms and technologies, enhances bioavailability of API
Strong, validated safety in cancer indication1
No mandatory or limited need for pre- medication1
Free from alcohol, Cremophor EL, Polysorbate-80 and Human albumin, which can cause numerous side effects
7 | 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-17™ - broad IP protection up to 2036
PROCESS
WATER-INSOLUBLE | ANTICANCER COMPOSITIONS |
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
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
(5-year the EU, pending
extension)
Protects XR-17™ in combination with chemotherapeutic agents
6 patents granted
In USA, FRA,
GBR, DEU, CHN
and HKG
1) active pharmaceutical ingredient
8PCT, Patent Cooperation Treaty
SPC, Supplementary Protection Certificates
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 / EEA | |||||||
(paclitaxel) | ||||||||
Docetaxel | Prostate cancer | Planned | Global | |||||
micellar | ||||||||
New API | Undisclosed | Global | ||||||
XR-19 | Assessments in | Global | ||||||
(combination) | various cancers | |||||||
Animal Health Portfolio | ||||||||
Paccal vet | Mammary | |||||||
Carcinoma | USA | |||||||
(paclitaxel) | ||||||||
(Canines) | ||||||||
Doxophos vet | Lymphoma | USA | ||||||
(doxorubicin) | (Canines) | |||||||
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The growing taxane market for ovarian and other cancers
Taxol® | Taxotere® | ||
• | Paclitaxel - cremophor EL | • | Docetaxel - polysorbate 80 |
• | Ovarian, breast, lung and | • | Breast, lung, prostate and |
Kaposi Sarcoma cancers | head & neck cancers |
Abraxane® | Jevtana® | ||
• | Paclitaxel - albumin bound | • | Cabazitaxel - polysorbate 80 |
• | Breast, lung and pancreatic | • | Prostate cancer |
cancers |
The 2018 global injectable taxane market was valued at $2.18B
This market is expected to grow $4.56B by the end of 2025 (CAGR 11% 2019 - 2025)
Apealea® is the only non-
cremophor drug approved for use in advanced stage ovarian cancer in the EU
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Apealea® - offering an improved treatment option
Approved in EU/EEA for treatment of first relapse ovarian cancer1 and in Russia for first line and relapsed ovarian cancer2
Current standard of care in Ovarian cancer is carboplatin + paclitaxel
A subset of patients cannot tolerate solvent-based paclitaxel
Apealea® is a solvent-free IV formulation of paclitaxel using XR-17™
- Free from polyoxyethylated castor oil and dehydrated alcohol
- No need for mandatory glucocorticosteroids pre-medication
- Shorter infusion and overall 'chair' time
1) Apealea® Summary of Product Characteristics. www.ema.europa.eu
11 2) Paclical® Instructions for medical use. https://grls.rosminzdrav.ru
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® - large market opportunity in ovarian cancer
OVARIAN CANCER INCIDENCE1
70000 | 66300 | |||
60000 | ||||
50000 | ||||
Incidence | 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 relapse three years after diagnosis2
Platinumanalogs used alone
or in combination with paclitaxel are the most used therapeutic agents3
*) China, Japan and South Korea 1) Global Cancer Observatory
13 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
$20M
%
$678M
Agreement with US-based Elevar
Therapeutics, subsidiary of South
Korea's HLB
Upfront payment
Double digit royalties on global
Apealea® sales
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 and Asian partners for commercial sales
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Docetaxel micellar poised for clinical development
1 in 7 | 1.3m | |
men will be | men were newly | |
diagnosed with | diagnosed with | |
prostate | prostate cancer | |
cancer | in 20181 | |
- Docetaxel is approved for wide range of solid malignancies and standard of care for advanced prostate cancer
- Docetaxel micellar uses XR-17™, enabling IV administration of docetaxel without traditional solubility enhancers
- Poised to start a Phase Ib clinical trial in advanced prostate cancer with the Swiss Group for Clinical Cancer Research (SAKK)
151. World Cancer Research Fund www.wcrf.org/
Q1 2020/2021 Consolidated Income Statement in brief
2020 | 2019 | 2019/20 | |
TSEK | May - Jul | May - Jul May - Apr | |
Net sales | 208 | 182 | 201,843 |
Other operating income | 421 | 70 | 427 |
Change in inventories of products in progress and finished goods | 1,886 | 2,291 | 20,904 |
Capitalized development costs | - | 1,085 | 4,356 |
Operating expenses2,3 | -51,735 | -39,392 | -257,616 |
Operating loss4 | -49,220 | -35,764 | -30,086 |
Income for the period5 | -53,105 | -39,783 | -10,533 |
Earnings per share, before and after dilution in SEK1,6 | -0.12 | -0.13 | -0.03 |
- The key figures for the comparison periods have been adjusted for the bonus issue component in the rights issue carried out in 2019/2020.
- Operating expenses excluding change in inventories and capitalized development costs.
- The figures for the first quarter of 2019 have been restated after error correction for 2019/2020 compared with the interim report on July 31, 2019, in which the amount was TSEK -39,537.
- The figures for the first quarter of 2019 have been restated after error correction for 2019/2020 compared with the interim report on July 31, 2019, in which the amount was TSEK -39,909.
- The figures for the first quarter of 2019 have been restated after error correction for 2019/2020 compared with the interim report on July 31, 2019, in which the amount was TSEK -39,928.
- The figures for the first quarter of 2019 have been restated after error correction for 2019/2020 compared with the interim report on July 31, 2019, in which the amount was SEK -0.17.
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Key metrics and other information
2020 | 2019 | 2019/20 | |
May - Jul | May - Jul | May - Apr | |
Cash and Cash equivalents, TSEK* | 354,000 | 435,000 | 201,018 |
Number of shares at the end of the period, before and after | 448,370 | 326,313 | 448,370 |
dilution, in thousands1 | |||
Weighted average number of shares, before and after dilution, in | 448,370 | 303,577 | 398,395 |
thousands1 | |||
Earnings per share, before and after dilution, SEK1,2 | -0.12 | -0.13 | -0.03 |
Equity per share, SEK1,3 | 1.71 | 1.28 | 1.83 |
Equity/assets ratio, %4 | 82 | 63 | 82 |
Net debt, TSEK | neg. | 32,001 | neg. |
Net debt/equity ratio, %5 | neg. | 8 | neg. |
Return on total assets, % | neg. | neg. | neg. |
Return on equity, % | neg. | neg. | neg. |
Number of employees at the end of the period | 59 | 55 | 63 |
* Includes short term investments
- The key figures for the comparison periods have been adjusted for the bonus issue component in the rights issue carried out in 2019/2020.
- The figures for the first quarter of 2019 have been restated after error correction for 2019/2020 compared with the interim report on July 31, 2019, in which the amount was SEK -0.17.
- The figures for the first quarter of 2019 have been restated after error correction for 2019/2020 compared with the interim report on July 31, 2019, in which the amount was SEK 1.72..
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Oasmia - a strong investment case
- Commercial stage company - proven ability to bring promising new products to market
- XR-17™- a validated technology platform, applicable across range of therapeutic areas
- Growing oncology pipeline - addressing large markets
- Transformational global partnership with Elevar Therapeutics - lucrative milestones and revenues
- Strong cash position - well placed to pursue high value M&A and 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, Asia
- Apealea® royalties
- Docetaxel micellar Phase Ib initiation / Phase II initiation
- Review of Animal Health assets
- XR-17™partnering
- M&A and in-licensing opportunities to build critical mass
- XR-19value assessment
Building a sustainable, profitable specialty pharma company
APEALEA® APPROVED | A GLOBAL | A GROWING | WELL POSITIONED FOR |
IN EUROPE | PARTNERSHIP | ONCOLOGY PIPELINE | PARTNERING / M&A |
Lead product | Elevar Apealea® deal | Underpinned by | Proven development, |
launched for | worth up to $678 | strong IP protection | regulatory and BD |
advanced ovarian | million plus royalties | skills | |
cancer | Docetaxel micellar | ||
Elevar evaluating | poised for the clinic | Solid cash position | |
Opportunity in | European and Asian | ||
develop in several | commercial partners | XR-19 and a new API | |
other cancer | |||
in preclinical | |||
indications | |||
development | |||
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Oasmia Pharmaceutical AB published this content on 24 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