Earnings release
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ASX / MEDIA ANNOUNCEMENT RESPIRI 29 April 2021 March 2021 Quarterly Cash Flow and Quarterly Activities Report Respiri Limited ( ASX : RSH ) ( " Respiri ” or the “ Company ” ) , an eHealth SaaS Company supporting respiratory health management , today announces the Appendix 4C quarterly cash flow and activities for the 3 month period ended 31 March 2021 . Operating Highlights During the quarter , Respiri secured US FDA regulatory clearance for wheezo ™ , made several important advisory appointments and shored up its global manufacturing capability , despite significant industry headwinds . In January , the Company announced the commencement of sales through the Superchem Pharmacy Network . In the quarter ending in , March 2021 , Respiri onboarded three pharmacy banner groups , with a total of 8 banner groups onboarded , covering approximately 1,000 stores . The Company continued to progress discussions with a number of other very large pharmacy banner groups representing approximately 1,000 stores across Australia , covering 22 % of the total number of pharmacies in Australia . The Company expects to finalise agreements with these banner groups in June which will see wheezo stocked by over 2,000 pharmacies across the country and in line with guidance provided . The Company continued to build out its clinical and commercial expertise , with two key advisory appointments made during the quarter . Dr Andrew Weekes was appointed a strategic advisor to the Respiri Board . Dr Weekes is currently the Country Medical Director , Australia for GlaxoSmithKline having led a number of major initiatives at GSK , including being the first pharmaceutical company in Australia to introduce a new framework for its medical education program and interactions with healthcare professionals . In addition , the Company appointed Dr Mark Levy as an advisor for the UK . Dr Levy has been a member of GINA ( Global Initiative for Asthma ) Executive Board or Directors since 2009. GINA is the preeminent body responsible for setting global treatment and management guidelines for asthma . On 23 March 2021 , the Company announced the receipt of 510 ( k ) clearance from the US Food and Drug Administration ( FDA ) for wheezo , thereby permitting Respiri to market and sell wheezo in the United States as a class II medical device , along with the wheezo App . The Company was able to secure a very broad Indication for Use ( IFU ) for wheezo , which is intended to detect and record abnormal breath sounds ( continuous adventitious breath sounds / CABS ) at the windpipe ( trachea ) , reported as Wheeze Rate in adults and children ( 2 years and older ) . This clearance by one of the most stringent health regulators globally represents a step - change in technology for patients with respiratory wheeze seeking an effective , replicable and rapid device measurement and associated App that monitors this important measurement of lung function . The Company plans to launch into the US market in Q3 2022 , with Cipla retaining a first right of refusal to distribute wheezo ™ in the US under the Sales / Marketing , Distribution & Logistics Agreement signed in July 2020 . Respiri Limited | ABN 98 009 234 173 | Level 9 , 432 St Kilda Road , Melbourne VIC 3004 | Page 1