PATIENTS DESERVE A BETTER - IMPLANT SOLUTION - Invitation to subscribe for shares in OssDsign AB (publ) prior to listing on Nasdaq First North
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PATIENTS DESERVE A BETTER IMPLANT SOLUTION Invitation to subscribe for shares in OssDsign AB (publ) prior to listing on Nasdaq First North SUBSCRIPTION PERIOD: MAY 3 – 17, 2019
OSSDSIGN
OssDsign was founded eight years ago with the
ambition to improve the quality of life for patients with
complicated bone defects. Our initial focus was on
patient specific implants for improved healing of cranial
and facial defects. At that time, the complication rate
for these patients was high and there were few or no
treatment options in the most difficult cases. Today,
Anders Lundqvist,
CEO of OssDsign thanks to our technology, these patients have a much
more promising future.
OssDsign is in an exciting growth phase. In recent years, we have focused on establishing the
company commercially in key markets in Europe and the US. We now have regulatory approvals
and certifications in place and have established sales organizations directly or through distributors
in a number of markets. Sales have experienced significant growth, driven by a unique product
with outstanding clinical data, access to payment systems (reimbursement) and a talented
”To our knowledge, no organization. Our customers in hospitals around the world understand that our technology and
our expertise in implant design directly benefit patients by decreased serious complication, and
other company has
that hospitals benefit from fewer difficult, costly operations and patient visits.
succeeded in
producing implants Our products are currently sold in approximately fifteen markets. In the past year, main focus
for these indications has been on the US market, where we use an approach consisting of our own sales staff
in a material that is combined with local distributors. This has resulted in increasing interest and accelerating growth
over the past six months. At the beginning of the first quarter last year, 4 clinics in the US carried
replaced by natural out operations with our implants. One year later, 24 clinics have performed operations. Meanwhile,
bone, and we are we have also established partnerships with opinion leaders focused on our implants’ benefits,
alone in having FDA and with surgeries performed by institutions such as Harvard, UCLA and Johns Hopkins.
clearance to claim
Another important growth market is Japan, which is the second largest market for products of
this in our marketing.”
our kind within the OECD. In parallel with an ongoing approval process, we have established
relationships with important Japanese opinion leaders, who are already carrying out operations
with our products under ethical approval. We believe that a launch supported by their positive
experiences will facilitate rapid market acceptance.
Today, OssDsign’s focus is on facial and cranial implants. However, we see exciting opportunities
to broaden the use of our technology and reach more patient groups in need of better implants.
We are currently conducting studies that explore the possibilities of using our bioceramic
material for applications in the oral cavity and in the spine, areas that both have a significant
market potential in the long term.
The opportunities we see in the US and in other markets, together with our technology platform,
mean that we are well positioned for continued strong growth, which will result in sustainable
Clinical results show a and increasing profitability. The forthcoming issue and subsequent listing on Nasdaq First North
2%
will give us the resources we need to establish OssDsign as a fast-growing and profitable
medtech company that creates value for customers and continues to fulfill our original ambition
to benefit patients.
rate of re-operation due to
infection with OSSDSIGN
Cranial¹ (compared to 7-12% Uppsala, May 2nd 2019
with traditional implants)2
Anders Lundqvist,
CEO of OssDsign
OSSDSIGN
OssDsign products
with bone-regenerating properties
OSSDSIGN Cranial
for reconstruction of cranial defects
• The company’s main product, with
positive and published clinical results¹
• Well-established with more than 500
cranial reconstructions performed in
the EU and US
• Regulatory approval in the EU and US
OSSDSIGN Facial
for reconstruction of facial defects
• Nearly 50 implants performed during
clinical evaluation
• A solution for patients with no other
current treatment options
• Regulatory approval in the EU, where
broader launch will be initiated during
2019 in parallel with regulatory
submission in the US
OSSDSIGN Cranioplug
for repair of cranial burr holes and bone
flap fixation
• Standard, high-volume product in
four formats
• Regulatory approval in the EU and US
• Planned launch: Q2 2019
OssDsign’s bioceramic – a unique material
that gradually transforms into bone tissue1
• The material is hydrophilic and stimulates growth of vascularized
bone – reduced risk for post-operative infections, complications and
reoperations
• Regenerative effect on soft tissue – improved healing of tissue
surrounding the implant
• Bone regeneration – the bioceramic material resorbs and is replaced
by bone during the healing process
BACKGROUND AND REASONS FOR THE INITIAL ISSUE
OssDsign has developed a bioceramic material that, when OBJECTIVES AND MARKET POTENTIAL
implanted into a patient’s body, is replaced by the patient’s Successful market initiatives have generated significant
own bone during the healing process. Based on this bioceramic interest in the company’s products, resulting in rapid sales
material, the company has developed patient-specific cranial growth in recent years. OssDsign has determined that there is
and facial implants that enable an improved healing process good potential to establish the company’s patient-specific
with a low risk of complications, compared with competing implants as the standard treatment for cranial and facial
products. ¹,² defects resulting from trauma, radiation therapy, tumor,
stroke or congenital defects. The company’s ambition is to
SUCCESSFULLY ESTABLISHED COMPANY achieve a world-leading position within patient-specific facial
WITH STRONG GROWTH POTENTIAL and cranial implants. OssDsign’s objective is furthermore to
The company currently has regulatory approval in the EU and achieve a rolling annual turnover that exceeds SEK 200
US and is successfully established in Europe. In the autumn million at the beginning of 2023.
of 2017, OssDsign initiated commercialisation in the US, which
is the world’s largest medtech market. The company sees THE INVITATION
strong growth potential in the US and intends to carry out Considerable market investments will be required in the
significant market initiatives there in the coming years. In coming years for the company to achieve its goals. In order
addition, OssDsign will invest in continued growth in Europe to secure financing for growth initiatives and cashflow
and establishing a position in the Japanese market. requirements during the coming twelve months, the company
has decided to issue this Invitation which, at full subscription,
will contribute an additional 139 MSEK in funding after
transaction costs.
Results of Clinical Study at Karolinska University Hospital
Published in World Neurosurgery 1
53 OSSDSIGN Cranial implants (50 patients)
• In 64% of patients OSSDSIGN Cranial was used to
replace a competing implant that had failed due to
complications
• Only one case of infection with OSSDSIGN Cranial
required re-operation
• The patient’s implant was replaced with a new
OSSDSIGN Cranial implant, with no complications
in the following 12 months
The low complication rate is supported by OssDsign’s own follow-up assessment of circa 400 implants, which shows that
2% of these patients experienced infections that required re-operation.3
OssDsign’s addressable market
OssDsign Product Segment Estimated market value
(MUSD, OECD)
OSSDSIGN Cranial PSI Patient-specific cranial implant 200
OSSDSIGN Facial Patient-specific facial implant 200
OSSDSIGN Cranioplug Burr hole covers & fixation 165
Total market value 565
Sources: Available data used as basis for estimates has been obtained from the Market&Markets report “Patient Specific Cranial/Neuro Implants Markets (2016)”, the government healthcare
organization in the United Kingdom, National Health Service (NHS) database “Hospital Episode Statistics”, and from the German database ”Information System for Federal Health Monitoring”.
References & Publications Important information
1. Kihlström et al (2018), Patient-Specific Titanium Reinforced / Reference to prospectus
Calcium Phosphate Implant for the Repair and Healing of
This information brochure is not and shall not be considered a
Complex Cranial Defects.
prospectus in accordance with applicable laws and regulations.
2. Kwarcinski J, et al. Cranioplasty and Craniofacial Re-
This document constitutes only a brief excerpt from the
construction: A Review of Implant Material, Manufacturing
prospectus and any decision to invest in OssDsign AB (publ)
Method and Infection Risk, Appl. Sci., vol. 7, no. 3, p. 276,
(“OssDsign” or the “Company”) shall be based on the prospec-
2017.
tus in its entirety.
3. Improving Outcomes In Cranioplasty - Clinical Results From
394 Patients Treated With OSSDSIGN® Cranial PSI. The prospectus, which has been approved and registered by
OssDsign 2018-2130 Rev01. the Financial Supervisory Authority (Sw. Finansinspektionen) in
4. Sundblom et al (2018): Removal of giant intraosseous accordance with Chapter 2, Sections 25 and 26 of the
meningioma followed by cranioplasty using a custom-made Swedish Financial Instruments Trading Act (1991:1980) (Sw.
bioceramic implant: case report. Lagen (1991:1980) om handel med finansiella instrument), has
5. Engstrand T, et al. Development of a bioactive implant for been published and is available on OssDsign’s website,
repair and potential healing of cranial defects. J Neurosurg ossdsign.com, and on Erik Penser Bank’s website, penser.se.
120:273–277, 2014. The prospectus can also be ordered free of charge from Erik
Penser Bank, Box 7405, 103 91 Stockholm, via telephone to
Use of Proceeds +46 (0)8-463 80 00 or by e-mail to emission@penser.se.
The prospectus includes a presentation of OssDsign, the share
The net proceeds of SEK 139 million are intended to be used
issue and the risks associated with investing in OssDsign and
according to the following order of priority and estimated extent:
participating in the new issue. The information brochure is not
• Sales and marketing activities in the US, 45 percent
intended to replace the prospectus as a basis for a decision to
• Sales and marketing activities in other markets, 20 percent
subscribe for shares in OssDsign and does not constitute a
• Investments for increased production capacity, 15 percent
recommendation to subscribe for shares in OssDsign. Investors
• Regulatory processes in Japan, 3 percent
who intend or are considering investing in OssDsign are
• Feasibility studies and product development in new areas,
therefore invited to read the prospectus. Please also note that
5 percent
this document is only a translated summary of the Swedish
• Further strengthening of working capital, 12 percent
prospectus. In case of translational discrepancies to the
Swedish version, the latter shall apply.
Subscription Commitments
Name Subscription commitment (SEK) Share of the Share issue (%)
Lancelot Asset Management 15,125,000 10.0
Consensus Asset Management 15,125,000 10.0
Handelsbanken Fonder 15,125,000 10.0
Alto Invest 10,312,500 6.8
Karolinska Development 5,500,000 3.6
LMK Forward 4,950,000 3.3
T-bolaget 4,950,000 3.3
SEB Venture Capital/SEB 4,675,000 3.1
Nordic Cross 3,987,500 2.6
Simon Cartmell, Chairman of the board 756,250 0.5
Anders Qvarnström, Board member 302,500 0.2
Erik Penser Bank on behalf of customers 30,827,500 20.4
Totalt 111,636,250 73.8
Terms for the offer in summary
Number of issued shares 5,500,000 shares OTHER INFORMATION
Issue price SEK 27.50 per share ISIN-code SE0012570448
Issue amount MSEK 151.3 Ticker OSSD
Market capitalization MSEK 336 pre-money Market place OssDsign has applied for admission to trading
Subscription commitments Subscription commitments in of the Company’s shares on Nasdaq First
the offer amount to MSEK 111.6 North. Preliminary first day of trading is May
Subscription period 3 – 17 May, 2019 24, 2019, conditional upon that the Company
Minimum subscription 200 shares (SEK 5,500) fulfills the distribution requirements and
Over-allotment option An additional maximum of 825,000 receives approval from Nasdaq Stockholm.
newly issued shares, corresponding to an additional MSEK 22.7.
May be exercised in case of oversubscription in the issue.Application form for subscription of shares in OssDsign AB
The application form shall be sent to: Subscription period May 3 - 17, 2019
Erik Penser Bank Price per share SEK 27.50 per share
Emissionsavdelningen/OssDsign Minimum subscription 200 shares (SEK 5,500)
Box 7405, 103 91 STOCKHOLM Payment According to instructions on the contract note,
distributed on May 21, 2019
Phone 08-463 80 00
Estimated first day 24 May, 2019 on Nasdaq First North
Fax 08-400 52 894
of trading
E-mail emission@penser.se
This application form shall be used for subscription of shares in OssDsign AB in accordance The undersigned hereby applies for subscription of shares in OssDsign AB in accordance
with the terms and conditions set out in the Swedish prospectus published on May 2, with the terms and conditions of the offer and hereby authorises Erik Penser Bank to
2019. Please note that the application is binding. Only one application form per person or execute the application for subscription of shares as below. Notice of any allotment
company name will be considered. If more than one application form is submitted, only of shares will be provided through distribution of a contract note which must be paid
the first to be received will be considered. Incomplete or incorrectly completed application using the instructions in the note. Notice will only be provided to those that have
forms may be disregarded. The application form shall be Erik Penser Bank at hand no received allotment of shares. The number of allotted shares may be smaller than the
later than 17:00 on May 17, 2019. number applied for, or there may be no allotment. Erik Penser Bank has not provided any
investment advice or other advice preceding this application.
A. SUBSCRIPTION AND DELIVERY INSTRUCTIONS
I/We apply for subscription of 200 shares, corresponding to SEK 5,500.
Or
I/We apply for subscription of shares corresponding to SEK
Note that the application must comprise a minimum of 200 shares, corresponding to SEK 5,500. No brokerage fee is charged.
Allotted shares should be delivered to the following VPC-account OR custody account:
VPC-account number NOTE! If you have a custody account with specific rules for securities
transactions, such as such as a Personal Retirement Savings Account
0 0 0 (Sw. IPS), Investment Savings Account (Sw. ISK) or an Endowment
insurance, you should check with your bank/securities institution
Custody account number Bank/Securities institution whether you are permitted subscription of shares in the offer. If you have
any of the above mentioned accounts, your application for subscription
of shares should be made through your bank/securities institution.
B. QUESTIONS RELATED TO MONEY LAUNDERING REGULATIONS
For subscription exceeding EUR 15,000 (corresponding to approximately 5 700 shares), the following information must be provided:
1. Enclose a certified copy of a valid ID document. Legal persons must 4. Is the purpose of the subscription for shares to increase the return
also enclose a certificate of incorporation or equivalent, not older on your capital?
than three months, evidencing authorisation of the signatory. Yes
Certified copy of ID and/or registration certificate enclosed. No. Please specify the purpose
2. Do you hold, or have you held, a prominent political or governmental 5. For legal entities, please provide the information below for natural
position, or are you a close family member or colleage to a person persons owning 25% or more, directly or indirectly, of the legal entity.
with such a position? No single owner owns more than 25%, directly or indirectly.
Yes No
6. On behalf of whom are you investing?
3. What is the source of the money you intend to invest? On my own behalf
Heritage/gift Salary or other income Pension Sale of property On someone else’s behalf, please specify name and personal identity number below
Return on investment Other
Last name First name Personal identity number Ownership % Voting rights, %
Last name First name Personal identity number Ownership % Voting rights, %
Last name First name Personal identity number Ownership % Voting rights, %
Erik Penser Bank may ask additional questions, depending on your responses in section B.) above.
C. INFORMATION ABOUT THE SUBSCRIBER – PLEASE USE BLOCK CAPITALS
Last name/Company name First name Personal/corporate identity number
LEI-code (for legal entities) NID-number (for natural persons without a Swedish identity number)
Address Telephone number (daytime)
Postal code Town/City Country E-mail
D. I HEREBY VERIFY THAT THE INFORMATION ABOVE IS ACCURATE AND TRUTHFUL
Town/City and date Signature Clarification of signature
Important information
The offer is not directed to persons whose participation requires additional prospectuses, registration measures or other measures than those required by Swedish law. By signing the application form the subscriber confirms
that he/she has understood the risks associated with an investment in the financial instruments. Further, notice is hereby provided that Erik Penser Bank is the issuing agent and that this in itself does not imply that the
Bank regards the applicant to the offer as a client of the bank. Erik Penser Bank (the ”Bank”) processes the personal data in the application in order to administer and execute its obligation as the issuing agent. The processing
of personal data also takes place in order for the Bank to fulfill its statutory obligations. Personal data may also be used for internal marketing and client analysis, business and methodology development as well as risk
management or statistics. The Bank may also, if direct mail barring has not been requested, use the data for marketing purposes. In order to maintain a good customer and registry care, the Bank may supplement personal
data through retrieval from private and public records, eg. updating address details using personal and address information provided by the government, (Sw. SPAR). Erik Penser Bank may be obliged by law, regulation, decision
of governmental authority, trading rules or similar to disclose personal data to a third party, such as the Swedish Tax Agency, the Swedish Financial Supervisory Authority or the Swedish business and credit reference agency
(Sw. UC). For more information on the Bank’s processing of personal data, see the Bank’s website: www.penser.se under About us/Customer information/Processing of personal data. Information about the processing of
personal data can also be requested in writing or via e-mail from Erik Penser Bank AB (publ), company identity number 556031-2570, Box 7405, 103 91 Stockholm, Sweden. Similarly, you can report that you do not want direct
mail from the Bank or request correction of incorrect personal data. Please note that this is a translated version of the Swedish application form. In case of discrepancies to the Swedish application form, the latter shall apply.You can also read
