BBM Ltd.
Osteoporosis&FluVaccineInvestmentOpportunity
ConfidentialCorporateBrochureFebruary2019
ExecutiveSummary
Ground-breaking Micropatch Technology
A ground-breaking device, called the Micropatch, for administering drugs in the skin, that are normally administered by injection.
This technology does away with the need to inject a large volume of liquid in the skin.
A single simple device (as seen in the photo) contains the drug in a solid format as a micro dose, which can be administered very rapidly and easily by the patient, and the device thrown away.
It is poised to significantly improve the lives of patients and caregivers.
BBM has US rights for this device to deliver the Flu Vaccine and Teriparatide (for Osteoporosis) which collectively address a market potential of more than $10Billion, with revenue potential of >$300m per year based on conservative market penetration projections.
ExecutiveSummary– KeyProductFeatures
§ The Novel Micropatch Technology will replace traditional injections§ Mircopatch technology is minimally invasive and the pain the patient feels is very
slight§ The device has a small micro dose of the drug coated around a very small needle
in a small single-use device § The drug can be applied to the arm or leg in less than 2 seconds § The Micropatch overcomes difficulties and complexities of using needles, syringes
or pre-filled pens benefitting patients and caregivers.§ The differentiation will allow BBM to capture a large portion of a market that is
worth over $10Billion combined.
MarketSize
Source: https://www.pharmaceutical-technology.com/comment/global-osteoporosis-market-reach-11-2bn-2027/https://www.prnewswire.com/in/news-releases/influenza-vaccine-market-to-reach-usd-114-billion-by-2025-690251611.html
$7.5 Billion
$11.2 Billion
0
2
4
6
8
10
12
2017 2027
Global Osteoporosis Market
USD ($ Billion)
CAGR 4.3%
$4.96 Billion
$11.4 Billion
0
2
4
6
8
10
12
2017 2025
Global Influenza Vaccine Market
USD ($ Billion)
CAGR 11.0%
ExecutiveSummaryEndorsementsandthePotential
Multiple Global Patents on the Micropatch
Seal of Excellence from EU
British Government funded early vaccine study -successfully completed
2016/2017 EIS fundraise has mitigated early stage risks
Product ready for clinical development registration
Approval for market launch anticipated within 12-18 months of submission
Potential annual sales > $300 million
Leading to a multi-billion company value after product launch
OurTeam• Dr Faz Chowdhury - Chief Executive Officer
– Dr. Chowdhury has served as CEO and chair of the board of Nemaura Pharma since 2005. He is sole inventor on more than 50 granted and pending patents across over 15 technology platforms within the medical device and pharmaceutical sectors. Dr. Chowdhury holds a Masters in Microsystems and Nanotechnology from Cranfield University, UK, and Doctorate from the University of Oxford on nano-medicine and drug delivery.
• Kathryn Farrar - Director of Finance– Ms. Farrar worked within the audit department at KPMG for 9 years, prior to joining Nemaura Pharma Limited in 2010, where she has served as the
Accounts Manager. Kathryn read Chemistry at the University of Oxford.
• Dr Werner Wessling - Director of Strategic Alliances– Dr Wessling holds a Masters in Chemistry and Pharmacy, and a PhD (Dr.rer.nat.) from the University of Bonn. Dr Wessling built a successful commercial
career with LTS, helping to grow the global pharmaceutical company to become the world’s largest Transdermal Patch Manufacturer, with 1,300 employees. Most of the innovative and profitable products in the current LTS portfolio are a result of Dr. Wessling's skilful negotiation and partnering efforts and have generated more than $10 billion in lifetime marketing partner revenues.
• Steve Metcalf - Director of Operations– Steve is a pharmaceutical scientist by training and has over 30 years’ of Pharmaceutical product development experience within large and small
organisations including over 20 years with Astra Zeneca. Steve has specialist knowledge and expertise on complex drug formulations.
• David Scott - Director of Commercial Development and Licensing– David is a trained chemist with over 35 years’ experience in the Pharmaceutical Industry spanning deal brokering, marketing, strategic planning, finance,
business development and acquisitions. He is a skilled negotiator who has closed a number of major deals for inward and outward licensing for pharmaceutical products, delivery systems and technologies.
• Dr Yu-Hui Cheng – Principle Scientist– Dr. Cheng has more than 25 years’ experience of research and development and has published over 30 scientific papers, as well as 8 patents. She has a BSc
in pharmacy, furthermore an MSc/MPhil and PhD in pharmaceutics. She worked at Danbiosyst, West Pharmaceutical Services, and Archimedes Development Ltd over a period of 22 years and made numerous contributions to the company’s intellectual property, scientific discoveries, technologies, procedures and products.
MarketOpportunity– Challenges• The drug Teriparatide for Osteoporosis and most vaccines, are
administered as a liquid dose using a needle and syringe.
• These products have to be refrigerated prior to use or become unstable.
• Self-injection of Teriparatide is a very lengthy process and many patients do not comply regularly with the required daily injections, leading to further complications.
• Self-injection of vaccines is not normal as dosing is infrequent, and patients would need training. Injections given by trained personnel costs as much as the vaccine itself.
MarketOpportunity- OSTEOPEROSIS• Osteoporosis affects about 75 m people in Europe, USA and Japan. The
International Osteoporosis Foundation stated that around 200 million people suffer from osteoporosis1.
• Osteoporosis is a disabling and painful condition where the bone strength is lost. It affects men and women over 50 and there are >3 million sufferers in the UK alone2.
• Forteo® (Teriparatide) registered sales of USD 1.75 billion in 2017, representing an annual growth of 17% from previous year sales3.
• The market is rapidly growing with an ageing population worldwide. Global osteoporosis market is expected to reach $11.2bn by 20274.
Source: 1. https://www.iofbonehealth.org/facts-statistics2. https://www.ageuk.org.uk/information-advice/health-wellbeing/conditions-illnesses/osteoporosis/3. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-strong-fourth-quarter-and-full-year-2017-revenue4. https://www.pharmaceutical-technology.com/comment/global-osteoporosis-market-reach-11-2bn-2027/
MarketOpportunity– FLUVACCINE• Influenza is a potentially serious disease that can lead to hospitalization and
sometimes even death. Millions of people get the flu every year, hundreds of thousands of people are hospitalized and thousands or tens of thousands of people die from flu-related causes every year.
• Influenza vaccine market size is estimated to grow from USD 4.9 billion in 2017, to USD 11.4 billion by 2025, at a CAGR of 11.0%1.
• Growth of flu vaccines driven by increasing awareness about pandemic influenza viruses and increasing government initiatives for vaccination against influenza.
• The cost of Flu vaccine in the USA is doubled just by adding the cost of administration by a skilled person. If this cost can be removed then it adds a compelling case for health insurers.
Source: 1. https://www.prnewswire.com/in/news-releases/influenza-vaccine-market-to-reach-usd-114-billion-by-2025-690251611.html
MarketOpportunity– Thesolution• Micropatch is a groundbreaking patented technology that is poised to replace many
injections. • It can avoid the need for storing drugs in a refrigerator.
• Self administration is very easy as it is a simple 2 step process, and in the case of vaccines it can halve the cost of the product.
• Vast resources can be saved in the healthcare system by – Ease of self-administration– Improve medication compliance– Increase medication adherence– Eliminate needle injuries– Overcome needle phobia– Eliminate needle pain
• Differentiation of the drug using this delivery device and formulation will provide significant commercial advantages over other generic drugs.
Note: The technology has been in-licensed from Nemaura Pharma Limited (see Appendix 2 for further details).
CurrentProductCharacteristics- TheOsteoporosisdrug• Strict storage requirement
• Keep the device in the refrigerator between 36°F to 46°F (2°C to 8°C). The pen is required to be refrigerated immediately after use, without the needle attached to the pen.
• During the use period, time out of the refrigerator should be minimized.
• 28 doses in one unit, need to set dose each time before use
• Dosage waste• Throw away the delivery device after 28 days, even if it is not completely empty.
• Multiple steps for use
Source: http://uspl.lilly.com/forteo/forteo.html#ug0
CurrentProductCharacteristics- TheFluVaccine• Must be refrigerated• Stored in a vial
• Dosage waste from vials• Multiple steps for use:
- Shake vial and place at room temperature - Apply needle to a syringe
- Draw out vaccine from vial using syringe [potential for needle-stick injury]- Remove excess
- Inject patient - Dispose of syringe and needle and vial in sharps container
Source: http://uspl.lilly.com/forteo/forteo.html#ug0
TheMicropatch Technology– Solution• TWO STEP PROCESS – Peel off, Press on
• No need for refrigeration at pharmacy/ clinic/ home
• Very cost-effective compared to needle and syringes
Micropatch Unique Benefits to the user
Storage at ambient
temperature
Easy to travel with the
device, no strict
requirements
Easy self-application, no special
training required
User-friendly,
simple two steps: Peel off, Press
on
100% dose deliver in 2
seconds, no dose waste
One-off applicator
device
Low cost
device
MarketStrength– SIMPLETWOSTEPPROCESSTeriparatide and Flu Vaccine Micro Patch will replace the need for a syringe and needle leading to:
• significant improvement in drug administration
• increased independence and social inclusion – a growing issue in the elderly population
• stronger patient compliance to reduce the risk of subsequent fractures
NPL Micropatch
-- Two step process
Peel cover from the sachet & take the
primary patch
Place on skin & press
-- release after 3-4 seconds & dispose
Forteo®
-- Multiple steps
1. Pull off white cap
2. Attach new needle
3. Set dose
4. Inject dose
5. Confirm dose
6. Remove needle
Primary
patch
Storage at room temperature Storage in refrigerator before and after use
TechnologyEndorsement– Whatindependentpartieshavesaid,andinterestexpressedsofar
• Seal of Excellence from EU for the micro-patch product and manufacturing process, by an independent panel.
• UK government funded pre-clinical studies successfully completed for a complex triple vaccine (Diphtheria, Tetanus and Whooping Cough vaccine) – in a highly competitive grant award (£0.25m)
• Rights being sought by Big Pharma, including in China, EU & US
• Rights being sought by other parties in Middle-East – GCC
• Collaboration with worlds largest vaccine producer for Flu Vaccine
CompetitorProductsCurrently both the Teriparatide and Flu Vaccine are adminstered using pen injectors or needle and syringes. Neither have a differentiated delivery, and require refrigeration. Competition is based entirely on generic like-for-like copies for the Flu vaccine, and teriparatide does not yet have any competition in the USA currently and all sales of the product are with the originator, Eli Lilly.
OSTEO – US sales
Forteo®(Teriparatide drug) - U.S. Forteo revenue for 2017 was $965.2 million – Eli Lilly
FLU Vaccine – US Sales
• Sanofi Pasteur - €1,128 million ($1,288.49 million) in 2017
• CSL - over 50 million doses of influenza vaccines in 2015/approx. $600m
• GlaxoSmithKline - £361 million ($472.3 million) in 2017
NOTE: For the Flu vaccine the actual cost to the health insurers in the USA is approximately double the above costs, taking in to account the cost of administering the vaccine. This cost can be reduced significantly if the flu vaccine can be self-administered, or administered much quicker with less skilled personnel, as is the case for the Micropatch, thus providing a further USP for BBM’s development.
ProposedBusinessModel
• Out-license – This would allow for early
revenues based on milestone payments and royalties on sales
• Direct Distribution – Sell direct to the US market
– Whilst early milestone payments would not be received, the value of the company in the medium term would be several fold higher, and potentially >$1Billion on product launch.
InvestmentOpportunity
MarketsizeTeriparatide
- global sales of Foteo was USD 1.75 billion in 2017, global
osteoporosis market is expected to reach $11.2bn by
2027.
Influenza Vaccine - USD 4.9 billion in 2017, to
reach USD 11.4 billion by 2025, at a CAGR of 11.0% from 2018
to 2025.
Interest
Interest shown by Big-Pharma
RevenueEarly license
- $300m for Teriparatide- $200m of Influenza Vaccine
Independently submit for registration and launch product
by BBM Ltd.,- >$250m/year for Teriparatide
- >$500m.year for Influenza Vaccine
KeyRisksEarly stage risks mitigated
• Product successfully developed and tested in the lab• Device successfully developed and optimised• Positive stability profile determined
Pilot Clinical study• First stage human studies to be completed
Pivotal Clinical study• Pivotal study may require over 100 subjects
Commercial manufacture scale• Commercial operations will require the manufacture process to be scaled up,
either in-house or with an established third party contract manufacturer.
Product submission and approval• May be delayed depending on timing for each of the above stages
IntellectualProperty- 1• Multiple Global Patents both pending and granted covering various aspects of the Technology
Title Structures for Transdermal Drug Delivery - Angular particles adhered to blunt tips
Patent No. Date filed Country filed Granted/Pending
602011008288.4 10/08/2010 Germany Granted
2603209 10/08/2010 France Granted
2482691 10/08/2010 United Kingdom Granted
5837066 10/08/2010 Japan Granted
10,076,495 10/08/2010 USA Granted
Title Devices for Transdermal Drug Delivery -Carriers applied alongside or after needles (all Figs.)
Patent No. Date filed Country filed Granted/Pending
2483505 13/09/2010 United Kingdom Granted
13/09/2010 Brazil Pending
13/09/2010 Canada Pending
13/09/2010 India Pending
Title Devices for Transdermal Drug Delivery-Carriers applied after removal of needles (Figs. 1 & 2)
Patent No. Date filed Country filed Granted/Pending
2015201453 13/09/2010 Australia Granted
ZL201180044042.X 13/09/2010 China Granted
602011037861.9 13/09/2010 Germany Granted
2616133 13/09/2010 Spain Granted
2616133 13/09/2010 France Granted
2616133 13/09/2010 United Kingdom Granted
502017000074493 13/09/2010 Italy Granted
6034290 13/09/2010 Japan Granted
2616133 13/09/2010 The Netherlands Granted
2616133 13/09/2010 Poland Granted
9,770,578 13/09/2010 USA Granted
IntellectualProperty-2Title Devices for Transdermal Drug Delivery
-Carriers applied while needles remain (Figs. 3 & 4)Patent No. Date filed Country filed Granted/Pending
2011303676 13/09/2010 Australia Granted
6182227 13/09/2010 Japan Granted
13/09/2010 USA Pending
Title Devices for Transdermal Drug Delivery-Carriers applied alongside needles (Fig. 3)
201510073906.0 13/09/2010 China Granted
602011029738.4 13/09/2010 Germany Granted
2878330 13/09/2010 Spain Granted
2878330 13/09/2010 France Granted
2878330 13/09/2010 United Kingdom Granted
2878330 13/09/2010 Italy Granted
2878330 13/09/2010 The Netherlands Granted
2878330 13/09/2010 Poland Granted
Title Devices for Transdermal Drug Delivery-Drug on tips of carriers in channels (Fig. 4)
Patent No. Date filed Country filed Granted/Pending
602011039249.2 13/09/2010 Germany Granted
3023120 13/09/2010 Spain Granted
3023120 13/09/2010 France Granted
3023120 13/09/2010 United Kingdom Granted
502017000104899 13/09/2010 Italy Granted
3023120 13/09/2010 Poland Granted
IntellectualProperty-3Title Solid dosage form
Patent No. Date filed Country filed Granted/Pending
2518944 25/07/2014 GB - United Kingdom Pending
02/10/2014 AU - Australia Pending
02/10/2014 BR - Brazil Pending
02/10/2014 CA - Canada Pending
02/10/2014 CN - China Pending
3052087 02/10/2014 EP - European Patent Office Pending
02/10/2014 HK - Hong Kong Pending
02/10/2014 IN - India Pending
02/10/2014 JP - Japan Pending
02/10/2014 SA - Saudi Arabia Pending
02/10/2014 US - United States of America Pending
WO 2015/049528 02/10/2014 PC - PCT Pending
May 2016 Dec 2016 Dec 2017 June 2018 Dec 2018 Mar 2019 June 2020
Device Prototype 1 completed
Teriparatide formulation successfully completed
Close 2nd round of EIS(Up to £9m)
Complete Pilot Human Study
EIS 1st round closed£650,000
Complete human factors & local
tolerance studies
Complete Pilot Study
manufacture optimisation
Sep 2020
Submission for approval
Device optimisation completed
ProjectDelivery
Stability of formulation successfully completed
with the device
Dec 2019
OSTEO
FLU
Dec 2019 June 2020
Formulation development &
optimisation
Pilot human study
Dec 2020
Pivotal human study
Mar 2019 June 2021
Submission for approval
Pivotal human study
FINANCIALPROJECTIONS–£22mNetincomeProjectedbeforeproductLaunch
Calendar Quarters Opening Q1+2 2019 Q3+4 2019 Q1+2 2020 Q3+4 2020 Q1+2 2021 Q3+4 2021 Q1+2 2022 Q3+4 2022
Income GBP GBP GBP GBP GBP GBP GBP GBPOSTEO License fee 7,000,000
Milestone payment 5,000,000Royalty 5,000,000
FLU License fee 5,000,000 Milestone payment 5,000,000 Royalty
Total income £0 £0 £0 £0 £0 £7,000,000 £10,000,000 £5,000,000 £5,000,000
Expenditure Overheads 120,000 120,000 120,000 120,000 120,000 120,000 120,000 120,000
General and administration 90,000 90,000 90,000 90,000 90,000 90,000 90,000 90,000 Clinical Development 240,000 500,000 1,000,000 3,000,000 3,000,000 500,000Device Production 200,000 500,000 750,000 1,000,000 1,000,000 Device Scale-up 500,000 500,000 Formulation scale up 500,000 500,000 1,000,000 1,000,000
Total expenses 530,000 1,090,000 1,840,000 5,090,000 5,590,000
Cash Flow from operations -530,000 -1,090,000 -1,840,000 -5,090,000 1,410,000 10,000,000 5,000,000 5,000,000 Fundraise Private fundraise/EIS £150,000 £9,000,000Quarterly cash flow 8,470,000 -1,090,000 -1,840,000 -5,090,000 1,410,000 10,000,000 5,000,000 5,000,000 Cumulative cash flow £150,000 £8,620,000 £7,530,000 £5,690,000 £600,000 £2,010,000 £12,010,000 £17,010,000 £22,010,000
PotentialFutureRevenue• Teriparatide
– Early license: $300m
– Independently submit for registration > $100m / year
• Influenza Vaccine
– Early license: $250m
– Independently submit for registration: > $200m / year
There are two models for return on investment:1. Take product to registration in USA and then seek to distribute the product directly in the USA,
as it is a single market economy and the highest value territory in the world. We expect this has the potential to lead to a company with a >$1Billion valuation based on anticipated revenues.
2. License to a multinational pharma for upfront and milestone and Royalties. This would lead to early income in the company as indicated by the cash flow forecast.
The route to be taken will be determined in due course, based on a pro-active approach to establish long term partnerships, and may involve a hybrid of the two options.
CompanyValuation• We anticipate revenues of up to $100m per year for teriparatide, and $200m per year for Flu vaccine,
based on a conservative sub 10% market penetration. [Actual penetration could be >25%].
• This would provide total revenues of up to $300m per annum
• If we discount this by 50% to $150m and estimate a gross margin of 60%, this will provide a a gross income of $90m.
• Based on Industry standards, the company would be valued at approximately 11 x it’s gross income, thus $990m.
• Applying a 95% discount to take into account risks, a post market valuation of $49.5m, or £38m is reached. This is further discounted by 52.6% to a post-money valuation of £20m.
• A total of £9.3m is planned to be raised through a combination of the current EIS close at 31st March 2019, and if required, through future EIS or private placement.
Note 1: Zosano (a subsidiary of Johnson and Johnson) inked a deal with Eli Lilly for a micro-system based Teriparatide product for Osteoperosis, whereby they received $15m upfront, $300m in milestones were due on product launch. The Zosano technology was highly complex, and very expensive and Eli Lilly terminated the contract. This speaks to the potential that exists with Teriparatide alone.
Appendix1EUsealofExcellence
Appendix2ProductLicense• The Micropatch has been licensed from Nemaura Pharma Limited
• The license is to exploit the patents for the US territory, for Flu Vaccine and Teriparatide for Osteperosis.
• 20% of all funds raised by BBM, plus 20% of all Milestone and upfront payments received and 49% of the Royalties received on sales, or sales income, is payable to Nemaura Pharma Limited under the terms of the agreement.
• Nemaura Pharma are solely responsible at their own cost for upkeep and registration of all patents and intellectual property pertaining to the Micropatch.
If you are interested…..• If you are interested in finding out more about this investment
opportunity, please get in touch with the Simply Capital Partners team:
• Email: [email protected]
• Phone: Call Faizal Karbani on 07837 708823
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