Sedana Medical’s offering was heavily oversubscribed – trading in the share on Nasdaq First North commences tomorrow

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE.

Sedana Medical AB (publ) (”Sedana Medical” or the ”Company”), a medical technology company on its way to also become a pharmaceutical company, hereby announces its outcome of the initial public offering and listing of its shares on Nasdaq First North (the "Offering").

The Offering was heavily oversubscribed and the interest in subscribing for Sedana Medical’s shares has been very strong from both Swedish and international institutions as well as the general public in Sweden. Sedana Medical has received approval for admission to trading of the Company’s shares on Nasdaq First North and trading commences tomorrow, June 21, 2017.

• As previously communicated, the price in the Offering is SEK 19.50 per share, corresponding to a total value of the Company’s outstanding shares of approximately SEK 206 million, before the Offering.[1] 
• In the Offering 5,128,205 new shares are issued and allotted, corresponding to a dilution of 31.5 percent.[2]
• In order to cover any overallotment, the Company has committed to, upon Pareto Securities’ request, issue a maximum of an additional 769,230 new shares in the Company, corresponding to up to 15 percent of the total shares offered in the Offering.
• If the overallotment option is fully utilized, the Offering will comprise a maximum of 5,897,435 new shares, corresponding to a dilution of 34.5 percent.2 
• The new share issue will render gross proceeds of SEK 100–115 million to the Company before transaction costs, depending on the extent of the exercise of the overallotment option.
• Among the new shareholders in Sedana Medical are the cornerstone investors HealthInvest Partners AB, Alto Invest SA, Brohuvudet AB, Nyenburgh Holding B.V., Alfred Berg Kapitalförvaltning and several other well-renowned institutions such as Swedbank Robur, Öhman Hjärt-Lungfond and Lancelot Asset Management. 
• Trading in Sedana Medical's shares on Nasdaq First North commences tomorrow June 21, 2017, under the ticker “SEDANA” (ISIN code: SE0009947534).
• Trading is conditional until the settlement day in the Offering, which is expected to be June 22, 2017.

Christer Ahlberg, CEO, comments:

”We are very proud and pleased with the great interest shown to participate in Sedana Medical’s offering. The listing and new share issue gives us good prospects for implementing our vision to make inhalation sedation with our AnaConDa and IsoConDa products to a global standard for sedation of mechanically ventilated patients in the intensive care unit. It is with great pleasure that we welcome all new shareholders to participate in our journey to develop Sedana Medical into a leading player in the field of inhalation sedation.”

Thomas Eklund, Chairman, comments:

”Many thanks to our new shareholders and the great trust you have shown by participating in this offer. With the proceeds from the offer, Sedana Medical is now funded to pursue the clinical registration study for the drug candidate IsoConDa and establish inhalation sedation in the intensive care setting.”

Background to the Offering

Sedana Medical is a medical technology company active within the field of sedation (treatment with sedative drugs). The Company has for a long time sold the medical device AnaConDa, which for the first time enables inhalation sedation in the intensive care setting. The therapy is widely supported by medical literature showing its many advantages over the current standard of intravenous sedation. No pharmaceutical company has up until now applied for registration of the indication of inhalation sedation in the intensive care setting and use for this indication is thus considered off label and may currently not be marketed.

The main rationale for pursuing the Offering is to fund the ongoing clinical registration study for Sedana Medical’s drug candidate IsoConDa in Europe. The study is a non-inferiority study, in which the study has to demonstrate that IsoConDa (isoflurane) is not inferior to propofol, which is currently the standard of care. The study, which will include up to 550 patients, was initiated in the fourth quarter of 2016 and is scheduled to end in the fourth quarter of 2018. The aim of the study is initially to obtain marketing approval for IsoConDa in Europe, which is expected to occur in the fourth quarter of 2019. Subject to obtaining marketing approval, Sedana Medical is expected to be the first company in the world to offer an approved solution for inhalation sedation in the intensive care setting. In addition, the Company is planning to use part of the proceeds from the Offering to fund clinical trials and registration processes for IsoConDa and AnaConDa in the United States, a process scheduled to start in 2017.

Sedana Medical's board of directors and management believe that the Offering and listing constitute an important step in the Company's development and is expected to increase awareness among current and potential partners, customers, personnel and opinion leaders in the medical technology and pharmaceutical industry. The Offering and listing are also expected to benefit Sedana Medical's future growth by improving the Company's access to Swedish and international capital markets, which in turn is expected to support the Company's continued development plan and studies. For these reasons, Sedana Medical's board of directors has applied to list the Company's shares on Nasdaq First North.

The market in brief 

Sedana Medical's market consists primarily of mechanically ventilated intensive care patients. The market for sedation of mechanically ventilated intensive care patients today consists of established drugs that are administered intravenously. The target group that the Company focuses on are those patients who are ventilated for more than 24 hours, a target group that globally amounts to between two and four million patients per year. In total, the Company consider this to be an addressable market of SEK 10-20 billion per year, of which Europe accounts for about SEK 6 billion.

Advisers 

Pareto Securities AB is acting sole manager and bookrunner in connection with the Offering. Setterwalls Advokatbyrå AB is legal adviser for the Company and Roschier Advokatbyrå AB is legal adviser for Pareto Securities AB. Pareto Securities is certified advisor for Sedana Medical.

For additional information, please contact:

Christer Ahlberg, CEO, Sedana Medical AB

Mob: +46 70 675 33 30

E-mail: Christer.ahlberg@sedanamedical.com  

Thomas Eklund, Chairman of the Board, Sedana Medical AB

Mob: +46 70 824 20 25

E-mail: Thomas.eklund@investorab.com 

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on 20 June 2017 at 11.15 a.m. (CET).

Important information

This announcement is not and does not form a part of any offer for sale of securities. Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Singapore, South Africa, South Korea or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

Any offering of securities referred to in this announcement will only be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus. In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.

This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). This communication must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this communication relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe,” “expect,” “anticipate,” “intends,” “estimate,” “will,” “may,” "continue," “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

[1] The valuation is based on the number of outstanding shares before the Offering, adjusted for the convertibles converted into 1,881,509 new shares in conjunction with the Offering (strike price of SEK 2.50), which gives a total of 10,561,509 outstanding shares before the new share issue. The value of the Company’s outstanding shares, before the Offering but including 1,040,000 outstanding warrants series 2014/2019 (strike price of SEK 2.50) amounts to SEK 226 million. In addition, the Company has an outstanding shareholder loan, which is converted into 613 594 new shares in conjunction with the Offering (at a price equivalent to the offering price), as well as a new warrant program series 2017/2021, which entitles the holders to subscribe for 310 149 new shares at 130 percent of the offering price.

[2] The dilution is based on the total number of outstanding shares after the Offering adjusted for the convertibles and shareholder loan converted into shares in conjunction with the Offering. In total, the conversions result in 2,495,103 new shares (convertibles 1,881,509 and conversion of shareholder loan 613,594), which are issued in addition to the new share issue exercised in conjunction with the Offering. This gives a total number of outstanding shares after the completion of the Offering of 16,303,308 or 17,072,538 at unutilized or fully utilized overallotment option respectively. 

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Sedana Medical AB (publ) is a Swedish company that develops, manufactures and sells the medical device AnaConDa. AnaConDa is a medical device for inhalation sedation of mechanically ventilated patients in intensive care units. At the end of 2016, the company initiated a major clinical study to receive market approval in Europe for IsoConDa (isoflurane) for inhalation sedation in intensive care units. The study is expected to end in late 2018. Registration is expected at the end of 2019. Sedana Medical has sales offices in Germany, Spain and France, as well as external distributors in Europe, the Middle East, Canada, Australia and South Korea. The headquarters is based in Danderyd, Sweden and the company has R&D operations in Ireland. 

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