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Aerocrine Achieves Record Sales for the 4th Quarter and Full Year

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January – December 2014

  • Net sales increased by 22% to SEK 166.2m (136.2)*. Adjusted for exchange rates, net sales increased by 16%.
    • Clinical sales were SEK 129.3m, an increase of 26%.
    • Global Research† sales were SEK 32.7m, an increase of 20%.
  • The Gross Margin for the period was 67% (72%)*. The reduction as compared to prior year was driven primarily by a change in channel mix as well as the write-down in Q4 of spare part inventory for the Company’s NIOX FLEX product, which is no longer being supported and of short-dated product, also during the fourth quarter.

  • Total tests sold (repeat and initial) were 2.5m (2.0)* tests, an increase of 24%. Total repeat test volume increased by 25%.

  • The operating loss improved to SEK 168.2m (205.7)*.
  • The loss after tax was SEK 228.2m (225.6)*, corresponding to a loss per share before and after dilution of SEK 0.7 (0.7)‡. 
  • Cash flow from operations was negative in the amount of SEK 174.9m (-212.1)*.

October – December 2014

  • Net sales increased by 41% to SEK 50.2m (35.6)*. Adjusted for exchange rates, net sales increased by 31%.
    • Clinical sales were SEK 36.0m (25.9)*, an increase of 39%.
    • Global Research sales† were SEK 13.2m (8.4)*, an increase of 58%.
  • Total tests sold (repeat and initial) were 666k (508)* tests, an increase of 31%. Total repeat test volume increased by 22%.

  • Gross Margin was 63% (69%)*. The reduction as compared to prior year was driven primarily by a change in channel mix as well as the write-down in Q4 of spare part inventory for the Company’s NIOX FLEX product, which is no longer being supported and of short-dated product, also during the fourth quarter.
  • The operating loss improved to SEK 38.1m (51.6)*.
  • The loss after tax was SEK 60.5m (59.1)*, corresponding to a loss per share before and after dilution of SEK 0.2 (0.2)‡.
  • Cash flow from operations was negative in the amount of SEK 20.2m (-43.1)*.

Significant Events October – December 2014

  • 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 27, 2014, the Board of Directors resolved to secure financing of approximately SEK 445m, before transaction costs. The financing is structured as a rights offering with 67% of the financing guaranteed by inter alia Aerocrine’s largest shareholder Novo A/S and the largest Danish public pension fund, Arbejdsmarkedets Tillægspension (ATP)
  • On December 12, 2014, the Company announced the resignation of board member Staffan Lindstrand.
  • On December 12, 2014, the Company announced that a non-binding expression of strategic interest was turned down by the companys Board of Directors in order to secure full focus on the announced financing.
  • On December 15, the Company announced that its handheld airway inflammation monitoring device, NIOX MINO®, had been re-registered for marketing and sales by the China Food and Drug Administration (CFDA). The approval means that
  • Aerocrine and its partners can now resume its sales and marketing activities of NIOX MINO and grow the deployed base in the Chinese market.

Significant Events, After the Period

  • 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.      

For further information:

Scott Myers, Chief Executive Officer, Aerocrine AB, Phone: +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

*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.

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 Stockholm Stock Exchange in 2007.

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 February 20, 2015, at 8.00 a.m.

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