Prospectus • Feb 12, 2018
Prospectus
Open in ViewerOpens in native device viewer
Prospective investors should be able to bear the economic risk of an investment in the Offered Shares and should be able to sustain a partial or total loss of their investment. An investment in the Offered Shares involves substantial risks and uncertainties, in particular the risk relating to the fact that the Company has a history of operating losses, a negative operating cash flow and an accumulated deficit, and may never become profitable. The Company does not have sufficient working capital to meet its financial requirements under the development plan as described in the section "Strategy" of the prospectus and cover its working capital needs related thereto for a period of at least 12 months from the date of the prospectus. To date, none of the product candidates of the Company has been approved or commercialised; the Company has one product candidate in clinical development phase and one product candidate in preclinical development phase; both product candidates are based on the same technological platform. The Company has launched a first phase III clinical study in Europe for its lead product candidate for grass pollen rhinitis, and the Company expects to start clinical studies in Europe in the third quarter of 2016 with a second product candidate for house dust mite rhinitis. The Company does not have its own production, sales or marketing capacity. Prospective investors should read the entire prospectus before investing in the offered shares, and, in particular, should review elements D.1 and D.3 of the "Summary" and "Risk factors" for a discussion of certain factors that should be considered in connection with an investment in the Offered Shares. All of these factors should be considered before investing in the Offered Shares.
Brussels, Belgium, 28 April, 2016 – ASIT biotech SA ("ASIT biotech" or the "Company"), a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies, announces today the terms of its initial public offering of new shares, with the admission to listing of all of its shares on the regulated markets of Euronext Brussels and Euronext Paris (the "Offering").
subscribe for an aggregate amount of EUR 8.26 million (the "Irrevocable Commitments") in the Offering at the Offer Price (as defined below). These investors will be allocated all of the Offered Shares (as defined below) that they have committed to subscribe for (representing a maximum of 1,180,000 Offered Shares based on the lower end of the Price Range (as defined below)).
"Listing Date"), provided that this may be accelerated in case of early closing or postponed in case of extension.
The Offer Price (as defined below) must be paid by the investors in full, in euro, together with any applicable stock exchange taxes and costs. The closing date is expected to be 12 May 2016 (the "Closing Date") unless the Offering Period is closed earlier or extended. The Offer Price must be paid by investors upon submission of the subscription orders or, alternatively, by authorising their financial institutions to debit their bank accounts with such amount for value on the Closing Date.
Pursuant to the Company's Articles of Association, and subject to and with effect as of the closing of the Offering, the Company's shares existing as at the date of the Prospectus, as well as all new Shares that will result from the exercise of existing warrants and convertible bonds are and will be subject to a lock-up of 12 months as from the closing of the Offering, subject to certain exceptions. The Company is expected to agree to a standstill, in the frame of the underwriting agreement expected to be signed at or about the 10 May 2016,
on the issuance of new shares and issuance of new warrants for a period of 365 days following the Listing Date, subject to certain exceptions.
No fees or expenses in connection with the Offering will be charged to investors by the Company. Investors should inform themselves of fees that financial intermediaries may charge them for the subscription or the holding of the shares.
General: the tax treatment depends on your personal situation and can be modified later. General provisions are laid down in the prospectus.
Tax on market transactions: on secondary markets, the tax on stock exchange transactions currently amounts to 0.27% of the purchase price, capped at EUR 800 per transaction and per party.
Fiscal treatment in Belgium: dividend distributions as well as repurchase distributions and liquidation surpluses are subject to a 27% withholding tax, subject to some exceptions. Capital gains realised by Belgian resident individual retail investors on the disposal of the Offered Shares occurring within six months from the date of their acquisition may be subject to a 33% short term capital gains tax if the Offered Shares are held other than for professional purposes.
Innovative ASIT+™ immunotherapy: the Company's ASIT+™ technology platform (Allergen Specific ImmunoTherapy) allows for the production, characterisation and quality control of innovative active ingredients consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. With this innovative technology the Company believes it can address both the risks and limitations of current allergy immunotherapy treatments ("AIT"). The ASIT+TM allergen fragments rapidly trigger a protective immune response without the need of an adjuvant.
Phase II clinical studies have already demonstrated that the Company's lead product candidate targeting grass pollen rhinitis, gp-ASIT+TM, is capable of shortening the length of treatment to just 3 weeks (4 visits to the allergist). This represents a major reduction in the length of treatment by comparison with the majority of existing therapies for grass pollen rhinitis, requiring 40 visits to the allergist over 3 years. The shorter course of treatment is expected to improve patient acceptance and compliance leading to a higher real-life effectiveness. The absence of adjuvant improves the safety profile and is expected to increase the acceptance of ASIT+TM products.
The Company believes that its innovative ASIT+™ technology platform is applicable to a range of allergies.
1 Visiongain, allergic rhinitis drugs market forecast 2015-2025.
Extracts from the Company's consolidated income statement and balance sheet
| (in EUR 000) | Year ended 31 December | ||
|---|---|---|---|
| 2015 | 2014 | 2013 | |
| Revenue | 4 | 5 | 7 |
| Research and development expenses | (6,691) | (3,541) | (1,670) |
| General and administrative expenses | (947) | (785) | (644) |
| Operating loss for the period | (7,640) | (4,318) | (2,298) |
| Loss for the period | (7,715) | (4,429) | (2,319) |
| TOTAL ASSETS | 5,474 | 8,780 | 1,369 |
| Non-current assets | |||
| Property, plant and equipment | 494 | 202 | 39 |
| Other long term receivables | 12 | 13 | 3 |
| Current assets | |||
| Inventories | 11 | 14 | 13 |
| Trade receivables | 2 | 18 | 2 |
| Other receivables | 277 | 84 | 59 |
| Other current assets | 57 | 8 | 7 |
| Cash and cash equivalents | 4,621 | 8,441 | 1,245 |
| TOTAL EQUITY AND LIABILITIES | 5,474 | 8,780 | 1,369 |
| Capital and reserves | |||
| Capital | 11,625 | 11,625 | 14,293 |
| Share premium | - | - | 5,413 |
| Share based payment reserve | 591 | 573 | 374 |
| Accumulated deficit | (13,074) | (4,766) | (20,038) |
| Total equity attributable to shareholders | (858) | 7,432 | 42 |
| Non-current liabilities | |||
| Financial debt | - | - | 885 |
| Other non-current liabilities | - | 70 | - |
| Current liabilities | |||
| Financial debt | 4,232 | - | - |
| (in EUR 000) | Year ended 31 December | ||
|---|---|---|---|
| 2015 | 2014 | 2013 | |
| Trade payables | 1,611 | 858 | 351 |
| Other payables | 489 | 421 | 92 |
| 6,332 | 1,279 | 443 | |
| Total liabilities | 6,332 | 1,349 | 1,328 |
Since 29 February 2016, the Company's net assets have dropped below half of its share capital, and as a consequence the Company had to comply with the procedure set forth in article 633 of the Belgian company code. The shareholders' meeting of the Company dated 25 March 2016 approved the continuation of the Company's activities.
A summary of some of the key risks are presented below. More information on the risk factors can be found in the Prospectus in elements D1 and D3 of the Summary and in section "Risk Factors":
Risks relating to the Company's history of operating losses, its negative operating cash flow, its accumulated deficit and its qualified statement on working capital, bearing in mind that the Company does not have working capital to cover its needs over the next 12 months and may never become profitable.
In particular, on the date of the Prospectus, the Company is of the opinion that, if the Offering would not be completed and the Company would nevertheless continue to implement its development plan as described above, taking into account its available cash and cash equivalents and the irrevocable commitments from the participating investors for the amount of EUR 8,260,000, it would run out of working capital as from 31 July 2016. In such case, the Company's 12-month working capital shortfall is anticipated to be approximately EUR 12,647,000. The Company furthermore expects that the cash burn will increase since phase III clinical studies and commercialisation efforts involve higher costs;
this would have a material adverse effect on its business;
If the Offering is fully subscribed at the midpoint of the Price Range, the Company estimates to receive net proceeds of approximately EUR 24,061,864, or approximately EUR 27,886,489 in case of exercise in full of the Increase Option, and in case of exercise in full of the Over-Allotment Option, approximately EUR 32,284,808. Of the net proceeds of the Offering that it envisages to raise, the Company currently anticipates to use, in order of importance and in %, the net proceeds of the Offering as follows:
approximately 25% to support the last preclinical development (including the GMP manufacturing of the clinical batches) and the early stage clinical development of its second product candidate for house dust mite rhinitis immunotherapy (hdm-ASIT+TM), including the completion of a Phase I/II and Phase IIb clinical study;
approximately 8% for general corporate purposes, such as working capital needs, general and administrative expenses and the additional costs associated with being a listed company; and
The Company has the right to proceed with the capital increase in a reduced amount, but a minimum amount of EUR 22 million has been set for the Offering (below which the Offering will not be completed). In case the Company would proceed with the capital increase in a reduced amount, the Company will have to reduce its level of investment or look for further external funding in order to fund the above proposed uses.
The Company believes that the net proceeds of the Offering, together with its existing cash and cash-equivalents, will not be sufficient to fund its operations as set out in the Prospectus until 2018. Even in the case of a full placement of the Offered Shares (assuming the exercise in full of the Increase Option and of the Over-allotment Option,) at the midpoint of the Price Range, the net proceeds of the Offering will not be sufficient to finance the full completion of the phase III clinical study with gp-ASIT+TM in the United States, and they will not be sufficient to finance future developments such as a likely phase IV clinical study with gp-ASIT+TM in Germany or the sales and marketing efforts associated with the commercialisation of any of its products, or the preparation and completion of phase III clinical studies for hdm-ASIT+TM.
| Summary Timetable: | |
|---|---|
| -- | -------------------- |
| Expected start of the Offering Period |
28 April 2016 |
|
|---|---|---|
| Expected end of the Offering Period |
9 May 2016 (4:00 p.m. CET) | |
| Expected allocation date, publication results of the |
10 May 2016 |
|
| Offering and Offer Price | ||
| Expected Listing Date and start of trading on an "if-and |
||
| when-issued and/or delivered" basis |
11 May 2016 |
|
| Expected Closing Date of the Offering (payment, |
||
| settlement and delivery) |
12 May 2016 |
A prospectus, dated 26 April, has been approved by the Belgian Financial Services and Markets Authority ("the Prospectus") and has been notified to the French Autorité des marchés financiers in accordance with the European passport mechanism provided for by Directive 2003/71/CE. The Prospectus is available to prospective investors in Belgium and France in English. The summary of the Prospectus is available in English, Dutch and French. The Prospectus will be made available to prospective investors free of charge, at the registered office of the Company (5, avenue Ariane, 1200 Brussels, Belgium) and on the Company's website www.asitbiotech.com.
The Prospectus can also be obtained by prospective investors in Belgium on request from the KBC Team at +32 (0)16 43 29 15 and at the head office of Société Générale in Belgium at 11, rue des Colonies, 1000 Brussels. Subject to certain selling and transfer restrictions, the Prospectus is available to prospective investors, on the following websites: www.kbc.be, www.cbc.be, www.kbcsecurities.be, www.bolero.be, and www.fsma.be.
KBC Securities and Société Générale Corporate & Investment Banking are acting as Joint Global Coordinators and Joint Bookrunners, and Gilbert Dupont is acting as Placing Agent.
Belgian retail investors are invited to file their complaints with KBC Securities, at the following contact details KBC Securities: cliëntenservice, Havenlaan/Avenue du port 12, 1080 Brussels, at +32 078 353 353 or via email at [email protected]. Belgian retail investors who are not satisfied with the answer received or who did not receive an answer within a reasonable delay (30 days) are allowed to file a complaint with the Ombudsfin on the website Ombudsfin.be, by post at Ombudsfin, North Gate II, Koning Albert II-laan/Boulevard du Roi Albert II, 8, bte. 2, 1000 Brussels, or via email at [email protected].
| Product | Shares of ASIT biotech SA |
|---|---|
| Applicable law | Belgian |
| Maturity | Indefinite |
| Investment objective | Shares carry indefinite maturity and do not guarantee any projected reimbursement of capital. The shares are intended to trade on Euronext Brussels and Euronext Paris, which could result in capital gains and capital losses. They may entitle their bearers to dividends (although no such dividends are planned in the foreseeable future). In the event of wind-up proceedings, the shareholders will rank after other creditors. Usually, shareholders do not recover anything. The rights as shareholders in the Company are subject to Belgian law. |
ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech's product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is
flexible and would be applicable across a range of allergies.
ASIT biotech has a headcount of 22 staff members, at its headquarters in Brussels and a laboratory in Liège, Belgium.
The Company's shareholding includes private and public investors such as SFPI, Mr. Rodolphe de Spoelberch, Société de Développement et de Participation du Bassin de Liège SA (Meusinvest), Synergies WALLONIE SA (previously SRIW Techno SA), Finance.brussels/SRIB Group, Start-It SA and Epimède SA.
Further information can be found at: www.asitbiotech.com.
Thierry Legon, CEO ASIT biotech Tel. +32 2 264 03 90 [email protected]
France – NewCap Belgium – Comfi Dusan Oresansky / Pierre Laurent Laure-Eve Monfort Tel.: +33 1 44 71 94 92 Tel.: +32 2 290 90 93 [email protected] [email protected]
All statements in this announcement that do not relate to historical facts and events are "forward-looking statements". In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes," "estimates," "anticipates," "expects," "intends," "may," "will," "plans," "continue," "ongoing," "potential," "predict," "project," "target," "seek" or "should" or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company's intentions, beliefs or current expectations. By their nature, forward-looking statements involve known and unknown risks and uncertainties 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. Given these risks and uncertainties, you should not rely on forward-looking statements as a prediction of actual results. Any forward-looking statements are made only as of the date of this announcement and, without prejudice to the Company's obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update the forward-looking statements set forth in this announcement.
This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of ASIT biotech SA (the "Company" and the "Shares"). Any purchase of, subscription for or application for, Shares to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus and any supplements thereto, as the case may be. This announcement does not constitute a prospectus and the information contained herein is for information purposes only and does not purport to be full or complete. Investors should not subscribe for any Shares except on the basis of the information contained in the prospectus that the Company expects to publish after its approval by the Belgian Financial Services and Markets Authority, and which can then be obtained at the Company's registered office and on www.asitbiotech.com.
This announcement is not for distribution, directly or indirectly, in or into the United States or to any U.S. person within the meaning of the U.S. Securities Act of 1933, as amended (the "Securities Act"). The Shares have not been and will not be registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. The Company has not registered, and does not intend to register, any portion of the intended offering of Shares in the United States, and does not intend to conduct a public offering of Shares in the United States.
This announcement and the information contained herein are not for publication, distribution or release in or into the United States, Australia, Canada, Japan or any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction.
This announcement is only addressed to and directed at (i) the public in Belgium and France, and (ii) persons in member states of the European Economic Area ("EEA") other than Belgium and France who are "qualified investors" within the meaning of the Prospectus Directive (Directive 2003/71/EC and amendments thereto, including Directive 2010/73/EU, to the extent implemented in the relevant EEA Member State, and together with any applicable implementing measures in such relevant Member State, the "Prospectus Directive") ("Qualified Investors"). In addition, in the United Kingdom, this announcement is only addressed to and directed at (i) persons having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, (the "Order") or ii)"qualified investors" falling within Article 49(2)(a) to (d) of the Order, and (iii) any other person to whom it may otherwise lawfully be communicated (all such persons together being referred to as "relevant persons"). The intended offering, as the case may be, will only be available to, and any invitation, offer or agreement to subscribe for, purchase, or otherwise acquire the Shares will be engaged in only with relevant persons. Persons within the United Kingdom who receive this communication (other than persons falling within (i), (ii) and (iii) above) should not act or rely on or act upon this communication or any of its content.
The date of completion of listing on Euronext Brussels and Euronext Paris may be influenced by things such as market conditions. There is no guarantee that such listing will occur and investors should not base their financial decisions on the Company's intentions in relation to such listing at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing the entire amount invested. Persons considering such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the intended offering. The value of the shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the intended offering for the person concerned.
No announcement or information regarding the intended offering, as the case may be, or the Shares referred to above may be disseminated to the public in jurisdictions outside of Belgium and France where a prior registration or approval is required for such purpose. No steps have been taken, or will be taken, for the intended offering of the Shares of the Company in any jurisdiction outside of Belgium and France where such steps would be required. The issue, the subscription for or purchase of the Shares are subject to special legal or statutory restrictions in certain jurisdictions. The Company is not liable if the aforementioned restrictions are not complied with by any person.
The Company is responsible for the information contained in this press release.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.