Bioretec LtdĀ Inside informationĀ 27 April 2023 at 6:31 p.m. EEST
THE INFORMATION CONTAINED IN THIS RELEASE IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES OR IN ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.
TAMPERE, Finland, April 27, 2023 /PRNewswire/ —Ā Bioretec Ltd (“Bioretec” or the “Company“), a pioneer in bioabsorbable orthopedic implants, hereby announces its intention to issue new shares (the “Placing Shares“) in a private placement to institutional and other qualified investors (the “Placing“) to raise approximately EUR 10 million in gross proceeds.
The number of Placing Shares and their subscription price will be decided based on offers received in an accelerated book building. Danske Bank A/S, Finland Branch (“Danske Bank“) and Swedbank AB (publ) (“Swedbank“), in cooperation with Kepler Cheuvreux SA are acting as the Joint Bookrunners of the Placing. The result of the Placing will be published by way of a company announcement after the completion of the book building. The book building will be launched immediately following the publication of this company announcement. The book building can be discontinued or extended at any time during the book building process.
The purpose of the contemplated Placing is to raise funds to accelerate the U.S. commercialization and distribution of Bioretec’s RemeOsā¢ products, facilitate the expansion of manufacturing capacity for RemeOsā¢ products, and enhance the product development of other RemeOsā¢ products, following the U.S. market authorization received by the Company for its RemeOsā¢ trauma screw from the U.S. Food and Drug Administration (FDA), as announced on 30 March 2023.
The Placing will be carried out based on the authorization granted to the board of directors by the Company’s annual general meeting of 13 April 2022.
Subject to the completion of the Placing, the Placing Shares (ISIN code FI4000480454) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 28 April 2023. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy on or about 3 May 2023. Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland on or about 3 May 2023.
The Company as well as four of the five largest shareholders in the Company, whose shares represent approximately 20.6 per cent of the outstanding shares in the Company, intend to enter into customary lock-up undertakings for a period of 180 days in connection with and subject to completion of the Placing.
The Company estimates that considering its current business plan and the targeted size of the Placing, the gross proceeds raised in the Placing will be sufficient until the end of 2026.
The Placing is expected to allow the Company to obtain financing on terms and timetable that, in the assessment of the Company, will be more beneficial than terms that would otherwise be available, and therefore weighty financial reasons exist for deviating from the pre-emptive rights of the shareholders.
Danske Bank and Swedbank, in cooperation with Kepler Cheuvreux SA are acting as the Joint Bookrunners of the Placing. Krogerus Attorneys Ltd is acting as the legal counsel to the Company and Borenius Attorneys Ltd is acting as the legal counsel to the Joint Bookrunners.
Bioretec Ltd
Board of directors
Further enquiries
Timo Lehtonen, CEO, +358 50āÆ433 8493
Tomi Numminen, Chairman of the Board, +358 40Ā 581 2132
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioabsorbable orthopedic implants. The company has built unique competencies in theāÆbiological interfaceāÆof active implantsāÆto enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.āÆ
Bioretec isāÆdevelopingāÆthe new RemeOsā¢āÆproduct lineāÆbased on a magnesium alloy and hybrid composite, introducing a new generation of strong bioabsorbable materials for enhanced surgical outcomes. The RemeOsā¢ implants are resorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing onāÆvalue for patients through efficient healthcare. The first RemeOsā¢ product market authorization has been received in the U.S. during March 2023 and CE-mark is expected to receive in Europe during 2023. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical possibilities.
Better healing ā Better life. www.bioretec.comĀ
Forward-looking statements
This company release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Bioretec’s future financial position and results of operations, the company’s strategy, objectives, future developments in the markets in which the company participates or is seeking to participate or anticipated regulatory changes in the markets in which the company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “potential,” “predict,” “projected,” “should” or “will” or the negative of such terms or other comparable terminology.
By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The company’s actual results of operations, including the company’s financial condition and liquidity and the development of the industry in which the company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release.
Important notice
The distribution of this release may be restricted by law and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such restrictions. The information contained herein is not for publication or distribution, directly or indirectly, in or into Australia, Canada, Hong Kong, Japan, Singapore, South Africa or the United States or in any other jurisdiction in which publishing or distributing would be prohibited by applicable law. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. This release is not directed to, and is not intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.
This release does not constitute a prospectus as defined in the Prospectus Regulation ((EU) 2017/1129) and as such, does not constitute or form part of and should not be construed as, an offer to sell, or the solicitation or invitation of any offer to buy, acquire or subscribe for, any securities or an inducement to enter into investment activity.
This release is directed only to (A) persons who are outside the United States of America; (B) persons who are resident in a Member State of the European Economic Area and are a qualified investor (within the meaning of Article 2(1)(e) of Regulation (EU) 2017/1129 (the “Prospectus Regulation“)); and (C) as regards the United Kingdom, persons who are “Qualified Investors” within the meaning of Article 2(1)(e) of the Prospectus Regulation as it forms part of English law by virtue of the European Union (Withdrawal) Act 2018, who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order“); (ii) high net worth entities; and (iii) and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as “Relevant Persons“). Any securities mentioned herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, Relevant Persons. No one who is not a Relevant Person shall act on the basis of this release.
This release does not constitute an offer for sale of securities in the United States. The shares may not be offered or sold within the United States absent of registration or an exemption under the U.S. Securities Act 1933 (as amended). The Company has not registered and it does not intend to register, any portion of the offering in the United States, and it does not intend to conduct a public offering in the United States.
The Joint Bookrunners act only for and on behalf of the Company in connection with the Placing. The Joint Bookrunners do not hold any other party as their client or cannot be held accountable to advise other parties than the Company with regards to the Placing or other matters referred hereto.
Information to Distributors
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that such Placing Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Ā Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to any offering of the Placing Shares. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Danske Bank and Swedbank as Joint Bookrunners, will only procure investors who meet the criteria of professional clients and eligible counterparties.
For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Placing Shares.
Each distributor is responsible for undertaking its own target market assessment in respect of the Placing Shares and determining appropriate distribution channels.
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