Aerocrine Sales Grow to Record Levels Again for 1st Quarter, NIOX VERO Launch in the US Off to A Strong Start

January – March 2015

  • Net sales increased by 52% to SEK 53.2m (35.0)*. Adjusted for exchange rates, net sales increased by 31%.

         - Clinical sales were SEK 38.9m, an increase of 32%.

         - Global Research† sales were SEK 12.4m, an increase of 192%.

  • The launch of NIOX VERO in the US is progressing very well and the company projects to have phased out the majority of NIOX MINO devices before end of this year.  Quarter to date the US converted 310 NIOX VERO installations, but more importantly, the rate of conversions has been steadily accelerating with January at 23%, February at 83%, and March at 139% of target, as more customers become aware of the new device. 

  • Total tests sold (repeat and initial) were 732k (560)* tests, an increase of 31%. Total repeat test volume increased by 30%.
  • The Gross Margin for the period was 59% (70%)*. The reduction as compared to prior year was driven primarily by the launch of the NIOX VERO in the US, whereby existing customers are being proactively converted over to the NIOX VERO device and pricing option reductions implemented in the US market during Q3 2014. Additionally, there was a change in channel mix.
  • The operating loss increased to SEK 51.6m (44.6)*.  When adjusting for currency exchange effects of approximately SEK 10.2m, the net operating loss decreased SEK 3.2m to SEK 41.4.
  • The loss after tax was SEK 73.4m (52.9)*, corresponding to a loss per share before and after dilution of SEK 0.21 (0.16)‡.  
  • Cash flow for the period was positive in the amount of SEK 340.5m (-59.3)* due to the completion of the rights offering in February 2015 which resulted in proceeds of SEK 445m before transaction costs.

Significant Events January – March 2015

  • On January 7, 2015, the Extraordinary General Meeting resolved to approve the Board of Directors’ resolution to increase the Company’s share capital through a rights issue of shares with pre-emptive rights for the shareholders.
  • On January 29, 2015, the Company announced that Japanese health authorities have cleared the use of the Company’s FeNO-measuring device NIOX VERO® as a tool for assessing patients with allergic airway inflammation such as asthma. NIOX VERO® will be introduced on the Japanese market in the beginning of the second quarter 2015.
  • On February 6, 2015, the Company announced the completion of the rights offering, which was over-subscribed.  The Company received approximately SEK 445m, before transaction costs.
  • On March 6, 2015, the Company announced that the US FDA had granted it regulatory clearance to operate the NIOX VERO® wirelessly with BlueTooth® technology in the US.

Significant Events, After the Period

  • On April 16, 2015, the Company announced changes to the Executive Leadership Team whereby Morten Høgholm Pedersen, MD PhD will be joining the Company as VP Global R&D and Product Management and Caroline Andersson, the Company’s General Counsel was promoted to the Executive Leadership Team.  Additionally, the Company announced the departure of Ken Marshall, President of Aerocrine, Inc. and VP of Global Marketing, effective April 30th 2015.
  • On April 22, 2015, the Company announced the launch of the NIOX VERO in Japan. The Launch was marked by an event hosted with the Swedish Embassy in Tokyo Japan.  Dr. Lars Gustafsson, one of the founders of Aerocrine spoke regarding the history of FeNO.  Dr. Ichinose, Key Opinion Leader in Respiratory medicine also gave a clinical summary for the use of FeNO in clinical practice.  Several guests attended including:  Panasonic Health Care, our development partner in Japan and CHEST, MI, Aerocrine’s distributor in Japan.
  • On April 27, 2015, the Company announced that it has noted recent speculation in the markets. The Board of Aerocrine confirmed that it is in preliminary discussions with a third party concerning a public offer for Aerocrine. There can be no certainty that an offer will be made, nor as to the terms of any such offer. A further announcement will be made in due course.

For further information:

Scott Myers, Chief Executive Officer, Aerocrine AB: +1 970 368 0336 or +46 768 788 379

Marshall Woodworth, Chief Financial Officer, Aerocrine AB: +1 919 749 8748 or +46 709 695 219

Or visit www.aerocrine.com

About Aerocrine

Aerocrine AB is a medical products company focused on the improved management and care of patients with inflammatory airway diseases. As the pioneer and leader in technology to monitor and manage airway inflammation, Aerocrine markets NIOX MINO® and NIOX VERO®. Both products enable fast and reliable management of airway inflammation and may therefore play a critical role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases such as asthma. Aerocrine is based in Sweden with subsidiaries in the U.S., Germany, Switzerland and the U.K. Aerocrine shares were listed on the Nasdaq Stockholm Stock Exchange in 2007.

*Note all numbers in ( ) are the corresponding period previous year and in the same unit.

†Note Global Research sales were formally referred to as Strategic sales in prior interim and year-end financial reports issued by the Company.  The Company believes that Global Research is more descriptive of the pharmaceutical and clinical research organization sales associated with this aspect of the Company’s commercial operations and customers.  These sales are impacted by the size and timing of clinical trials and can fluctuate substantially between periods.

‡Loss per share has been calculated in accordance with IAS 33, which stipulates that if a rights issue is offered to all existing shareholders, the number of ordinary shares to be used in calculating earnings per share for all periods before the rights issues is recalculated to reflect the effect of the rights issue.

This is information that Aerocrine AB (publ) is required to publish in accordance with the Swedish Securities Markets Act and/or the Swedish Financial Trading Act. This information was submitted for publication on May 12, 2015, at 8.00 a.m.

About Us

Aerocrine AB is a medical technology company focused on the improved management and care of patients with inflammatory airway diseases. As the pioneer and leader in the technology to monitor and manage airway inflammation, Aerocrine markets NIOX® Flex and NIOX MINO®. Both products enable fast and reliable management of airway inflammation and may therefore play a critical role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases such as asthma. Aerocrine is based in Sweden with subsidiaries in the US, Germany and the UK. Aerocrine shares were listed on the Stockholm Stock Exchange on 15 June 2007.

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