Interim report January – September 2014

Aerocrine Achieves Record Sales for the 3rd Quarter and First Nine Months; The Board of Directors has resolved to raise further capital to support the Company’s continued growth through an upcoming financing in the amount of approximately SEK 443m of which more than 75% has been guaranteed.

January – September 2014

  • Net sales increased by 15% to SEK 116.0m (100.5)*. Adjusted for exchange rates, net sales increased by 10%.
    • Net sales for clinical use of NIOX products were SEK 92.8m, an increase of 21%.

  • Strategic sales (sales to pharmaceutical companies and CROs for clinical trials) were SEK 19.5m, an increase of 3%.
  • The Gross Margin for the period was 69% (73%). The reduction vs prior year was driven primarily by a change in channel mix.

  • Total tests sold (repeat and initial) were 1.8m (1.5) tests, an increase of 22%. Total repeat test volume increased by 26%.

  • The loss after tax was SEK 167.7m (166.5), corresponding to a loss per share before and after dilution of SEK 1.1 (1.1).
  • The operating loss improved to SEK 130.1m (154.1).
  • Cash flow from operations was negative in the amount of SEK 154.7m (-169.0).

July – September 2014

  • Net sales increased by 24% to SEK 38.5m (31.1)*. Adjusted for exchange rates, net sales increased by 16%.
    • Net sales for clinical use of NIOX products were SEK 30.4m (22.6), an increase of 34%.
    • Strategic sales were SEK 6.9m (7.1), a decrease of 2%.
  • Total tests sold (repeat and initial) were 0.6m (0.5) tests, an increase of 33%. Total repeat test volume increased by 33%.
  • Gross Margin was 68% (74%).

  • The loss after tax was SEK 60.2m (56.5), corresponding to a loss per share before and after dilution of SEK 0.4 (0.4).
  • The operating loss improved to SEK 41.8m (47.9).
  • Cash flow from operations was negative in the amount of SEK 49.5m (-50.8).

Significant Events July – September 2014

  • On September 29, 2014, the Company announced a collaboration with Microsoft.  The collaboration will utilize Microsoft’s secure cloud services to transmit device telemetry data from physician and Company sites in Sweden, UK and the US back to Aerocrine for analyses.  Aerocrine’s goal is to use this information to deploy its field resources for customer service and sales support. Microsoft chose Aerocrine due to its technology leadership, global reach and commitment to progressing human health management.

Significant Events, After the Period

  • On November 6, 2014, the United States Food and Drug Administration (FDA) granted market clearance for NIOX VERO, the Company’s next generation device for measuring Fractional exhaled Nitric Oxide (FeNO) levels in the clinical setting. NIOX VERO will add significant functionalities such as new User Interface, extended capacity and mobility (battery operated) which has been very well received in Europe during the launch 2014.
  • On November 8, 2014, A position paper from the French Speaking Respiratory Society was made available in “Revue des Maladies Respiratoires (2014)”. The French guidelines for FeNO are an important step towards submitting for reimbursement in France. The guidelines are summarized as “Measuring FeNO is the only noninvasive pulmonary function test allowing (1) detecting, (2) quantifying and (3) monitoring changes in inflammatory processes during the course of various respiratory disorders, including corticosensitive asthma”.
  • On November 26, 2014, Thomas Eklund resigned from the Board of Directors.
  • On November 26, 2014, the Board of Directors resolved to secure financing of approximately SEK 443m, before transaction costs. The financing will be structured as a rights offering, which will be subject to approval by the shareholders at an EGM to be held on January 7, 2015. Details of the rights offering will be communicated via a press release on November 28, 2014. In excess of 75% of the financing has been guaranteed by inter alia Aerocrine’s largest shareholder Novo A/S and the largest Danish public pension fund, Arbejdsmarkedets Tillægspension (ATP).                   

For further information, please contact:

Scott Myers, President and CEO: +46 768 788 379 or +1 970 368 0336,        or

Marshall Woodworth, CFO: +46 709 695 219 or + 1 919 749 8748

www.aerocrine.com or www.niox.com


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 November 27, 2014, 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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