Insmed(US:INSM)2020-10-29 11:29Financial Performance - Total revenues for the three months ended September 30, 2020, were $43.643 million, an increase of 12.5% compared to $38.885 million for the same period in 2019[12]. - Gross profit for the nine months ended September 30, 2020, was $93.988 million, up from $75.253 million in the same period of 2019, reflecting a year-over-year increase of 24.5%[12]. - The net loss for the three months ended September 30, 2020, was $63.659 million, compared to a net loss of $60.682 million for the same period in 2019, indicating a 4.9% increase in losses[12]. - The total comprehensive loss for the three months ended September 30, 2020, was $63.447 million, compared to $60.683 million for the same period in 2019, indicating an increase of 4.6%[12]. - The company reported a net loss of $191.9 million for the nine months ended September 30, 2020, compared to a net loss of $201.3 million for the same period in 2019, representing a 4.5% improvement[24]. Cash and Assets - Cash and cash equivalents as of September 30, 2020, were $588.753 million, an increase from $487.429 million as of December 31, 2019, reflecting a growth of 20.7%[10]. - Total assets increased to $840.715 million as of September 30, 2020, from $742.299 million as of December 31, 2019, marking an increase of 13.2%[10]. - Shareholders' equity increased to $357.061 million as of September 30, 2020, compared to $261.674 million as of December 31, 2019, representing a significant increase of 36.4%[10]. - As of September 30, 2020, the company's inventory balance was $43.5 million, an increase from $28.3 million as of December 31, 2019[58]. Research and Development - Research and development expenses for the three months ended September 30, 2020, were $41.411 million, compared to $34.340 million in the same period of 2019, representing an increase of 20.5%[12]. - The company expects R&D expenses to increase with the initiation of the Phase 3 ASPEN trial of brensocatib and a confirmatory clinical trial of ARIKAYCE[149]. - The company incurred stock-based compensation expense of $27.4 million for the nine months ended September 30, 2020, compared to $21.1 million in the same period of 2019, reflecting a 30% increase[24]. Product and Revenue Sources - The company's product revenues primarily consist of sales of ARIKAYCE in the US, with revenue recognition based on the completion of five specific steps outlined in ASC 606[39]. - Net product revenues from the US increased by $4.2 million, or 11.2%, to $42.0 million compared to $37.8 million in the same quarter of 2019[146]. - Revenues from EAP sales of ARIKAYCE increased by $0.5 million, or 48.3%, to $1.6 million compared to $1.0 million in the same quarter of 2019[146]. Liabilities and Expenses - Total liabilities as of September 30, 2020, were $483.654 million, slightly up from $480.625 million as of December 31, 2019[10]. - SG&A expenses decreased to $46.6 million during the quarter ended September 30, 2020, down $6.8 million or 12.7% from $53.3 million in the same period in 2019[152]. - Interest expense for the quarter was $7.2 million, an increase of $0.3 million from $6.8 million in the same period in 2019[154]. Future Outlook and Plans - The company expects substantial future cash requirements and may need to raise additional capital to fund operations, including commercialization of ARIKAYCE and clinical trials for brensocatib and TPIP[25]. - The company plans to support the commercialization of ARIKAYCE in the US and expand into the European Union and Japan[168]. - The company is evaluating in-licensing and acquisition opportunities for a broad range of rare diseases to complement its internal research and development efforts[105]. Impact of COVID-19 - The company is closely monitoring the impact of the COVID-19 pandemic on its business, although it did not materially affect financial results for the nine months ended September 30, 2020[26]. - The COVID-19 pandemic has negatively impacted the company's operations, including access to prescribers and the ability to conduct clinical trials[186]. - The company modified its business practices in March 2020 to allow employees to work remotely, which may continue to impact business operations[187]. Clinical Trials and Approvals - The company’s clinical-stage pipeline includes brensocatib and TPIP, targeting bronchiectasis and pulmonary arterial hypertension, respectively[20]. - The Phase 3 CONVERT study demonstrated that adding ARIKAYCE to guideline-based therapy resulted in sustained culture conversion through the end of treatment and durable culture conversion three months post-treatment compared to guideline-based therapy alone[112]. - The company plans to initiate the ENCORE trial and the ARISE trial by the end of 2020 to assess the clinical benefit of ARIKAYCE in patients with MAC lung disease[114].