Q3 INTERRIM REPORT JANUARY – SEPTEMBER 2016 NICOCCINO HOLDING AB (publ)

Nicoccino Holding Development

THIRD QUARTER SUMMARY
JULY– SEPTEMBER 2016

  •        Net sales for the third quarter amounted to 0.1 MSEK (0.1 MSEK).
  •        Net income amounted to -3.8 MSEK (-7.3 MSEK) or -0.27 SEK per share (-0.53 SEK).
  •        Cash flow from operating activities amounted to -1.4 MSEK (-7.0 MSEK) or -0.10 SEK per share (-0.38 SEK).
  •        Liquid assets amounted to 25.9 MSEK (44.6 MSEK) by the end of the period.
  •        In September Anders Ulfhielm was appointed as new CEO. Anders has extended experience from the pharmaceutical industry, most recently from a position as partner at Avanticon networks.
  •        New Zealand has as the second country approved the Company’s nicotine patent.

PERIOD SUMMARY
JANUARY – SEPTEMBER 2016

  • Net sales amounted to 0.4 MSEK (0.6 MSEK).
  • Net income amounted to -17.7 MSEK (-23.5 MSEK) or -1.28 SEK per share (-1.85 SEK).
  • Cash flow from operating activities amounted to -9.5 MSEK (-20.5 MSEK) or -0.69 SEK per share (-1.61 SEK).

EVENTS AFTER THE END OF THE REPORTING PERIOD

  •        In October, Nicoccino signed an agreement with an American manufacturer who will produce the Company’s nicotine strip according to the regulatory requirements needed for a licensed product.

Comments from CEO

Today everyone knows that smoking is dangerous, but despite this, smoking cause 5 million deaths per year and by 2030, this figure will increase to 8 million. And for every person who dies, 20 people suffer from at least one serious illness.

Most people believe that smoking rates goes down, which it does in the West, but globally the figure is slowly increasing with 3 % a year, foremost in the Middle East, India and China. It is with legislations, restrictions and tax pressures the number of smokers can be pushed down, in combination with aids.

The market for smoking cessation products is enormous, and that Nicoccino with its unique product can provide an effective aid is fantastic. The company has during the past years gone through some different phases, however with one clear goal - that in 2016 begin the journey in getting the nicotine strip registered and approved as a smoking cessation drug.

The results of the recent period are that we have a strong patent protection; this year we received approval for our own nicotine patent in two markets, Singapore and New Zealand, which extends the platform protection to 2033. The product works from a user perspective, as it is being sold online in the UK where we have a loyal customer group. Finally, we have reports showing a 24-month shelf life and that the nicotine in a quick and efficient manner is released in the bloodstream. This we will now build on!

I have 30 years of experience within the pharmaceutical industry. During my years I have worked in various senior positions which given me in-depth knowledge of details such as active substances, of process- and documentation requirements and how to register and launch medicines.

The last few years I have supported pharmaceutical companies similar to Nicoccino to develop products and conduct clinical trials. It is with this background I am very motivated to take over and lead the Company to a registered and approved smoking cessation drug.

We now have three important phases in front of us which needs to be closely monitored and controlled. First, we need to develop a GMP approved product for clinical trials. Then conduct a clinical study to demonstrate the effect. Finally, prepare and submit a registration application to the MPA [Medical Products Agency].

Currently we are in the first phase and are excited about just having signed a contract with an American producer who will manufacture the nicotine strip. After the initial technical transfer and relevant tests, a batch will be manufactured for clinical trials.

My main objective is clear, to get the nicotine strip approved as a smoking cessation drug. This accomplishment adds value to the company as a drug approval is attractive to global players active in the smoking cessation industry.


About Nicoccino and our product

ABOUT THE COMPANY

Nicoccino has developed an innovative and patented nicotine product that after completion of a clinical study will be classified as a medicine for smoking cessation (Nicotine Replacement Therapy – NRT). With a clear classification, regulatory uncertainty will be reduced and new markets will open up that would otherwise not be accessible. Sales to consumers will be managed indirectly through a license model with international partners who are more financially equipped to reach out globally.

In 2014/2015 a commercial test launch was conducted in the UK where Nicoccino™ was sold as a consumer product online, and in retail. This introduction confirmed that the concept works and that there is a great potential for this new type of nicotine product.

In early 2016 a new strategy was formed with an increased focus on creating a product platform that can be used by partners who wish to establish themselves in the market of Nicotine Replacement Therapy (NRT) or want to expand their existing product portfolio. This new strategy has resulted in the prioritization of achieving a drugs classification for when entering partnerships.

Nicoccino has its office located in Täby, outside of Stockholm. The company's shares are listed on Nasdaq Stockholm First North since June 2014 and can be found under the abbreviation NICO.

Remium Nordic AB is the Nicoccino’s certified adviser.

For further information, please visit: www.nicoccino.se/en

ABOUT THE PRODUCT

Nicoccino has developed a patented, innovative and discrete strip that through its unique delivery method instantly provides the user with nicotine without the detrimental side effects of smoking.

The product is designed to offer smokers an attractive alternative when they want to quit smoking. After a pharmaceutical approval, the product will be sold as a smoking cessation drug (Nicotine Replacement Therapy – NRT). 

Once the strip is placed under the lip and onto the gum, it delivers a quick and potent nicotine effect. Within a couple of minutes the nicotine has been expended and the film dissolves without leaving any residue in your mouth.

The platform is formulated in Sweden and is the result of over ten years of research and development.

The strip itself is leaf thin and alginate based, about half the size of a stamp. Each dose contains 1 mg of medically classified nicotine, an alginate base (extracted from brown seaweed), as well as natural flavorings and aromas. All additional substances are medically approved.

For more information, visit Nicoccino’s website www.nicoccino.se/en, or contact:

Anders Ulfhielm, CEO Nicoccino Holding AB
+46 70 594 7618
anders.ulfhielm@nicoccino.se


This information is information that Nicoccino Holding AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 08:00 CET on 28th Oct. 2016. The report has to be communicated in Swedish and English. If differences between the versions exist, the Swedish version is pertained.

Anders Ulfhielm, CEO, Nicoccino Holding AB

+4670-594 7618
anders.ulfhielm@nicoccino.se

Nicoccino has developed a patented, innovative and discrete strip that through its unique delivery method instantly provides the user with nicotine without the detrimental side effects of smoking.
The product is designed to offer smokers an attractive alternative when they want to quit smoking.
After a pharmaceutical approval, the product will be sold as a smoking cessation drug (Nicotine Replacement Therapy – NRT).