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InspireMD Announces Second Quarter 2019 Financial ResultsU.S. Investigational Device Exemption (IDE) application submitted to FDA Company to host investor conference call today, August 6, at 8:00am ET TEL AVIV, Israel, Aug. 06, 2019 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced results for the second quarter ended June 30, 2019. Second Quarter 2019 and recent highlights:
“Despite the headwinds that we faced in the first quarter of the year with the company’s prior sterilization partner that limited us to selling products that were predominantly in stock in our warehouse from 2018, we were pleased to see the entire $592,000 of product backlog shipped in the second quarter, as key accounts were once again able to obtain the products, and we returned to normalizing product availability in all of our markets,” said James Barry, PhD, Chief Executive Officer of InspireMD. “Importantly, we submitted our IDE application as planned, and if approved, we would have the ability to begin U.S. clinical trials. We believe CGuard™ represents a true paradigm shift in the treatment of carotid artery disease, and we continue to execute on our multi-faceted growth plan with the goal of making this cutting-edge device technology platform available to patients worldwide.” Financial Results For the three months ended June 30, 2019, revenue was $1,354,000, representing an increase of 35.0% from the comparable period in 2018. This increase was predominantly driven by a 34.0% increase in sales of CGuard EPS from $833,000 in the three months ended June 30, 2018, to $1,116,000 in the three months ended June 30, 2019, and a 39.9% increase in sales of MGuard EPS from $170,000 in the three months ended June 30, 2018, to $238,000 in the three months ended June 30, 2019. Both increases were due to the shipments during the three months ended June 30, 2019 of approximately $592,000 of backlog that accumulated in the three months ended March 31, 2019 that we were unable to previously ship. These increases, however, were partially offset by sales decreases in certain markets during the three months ended June 30, 2019, resulting from new orders being delayed while the product backlog was being cleared. The Company's gross profit for the quarter ended June 30, 2019 was $442,000 compared to a gross profit of $277,000 for the same period in 2018. Gross margin increased to 32.6% in the three months ended June 30, 2019 from 27.6% in the same period in 2018. This increase in gross profit resulted from a $180,000 increase in revenues, less the related material and labor costs, as discussed above, and a receipt of $135,000 compensation from the company’s former third-party sterilizer for the delays related to the product sterilization interruption during the first quarter of 2019. These increases were offset by $69,000 of expenses related to upgrades made to the company’s production facilities, $40,000 of expenses pertaining to annual and new employee training of the production workers and an increase of $41,000 in miscellaneous expenses. Total operating expenses for the quarter ended June 30, 2019 were $2,625,000, an increase of 50.0% compared to $1,750,000 for the same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2019 and due to a salary related accrual reversal in the second quarter of 2018 that did not repeat itself in the same period this year. Financial expenses for the quarter ended June 30, 2019 were $23,000 compared to financial income of $846,000 for the same period in 2018. This decrease in financial income of $869,000 was predominately due to a non-cash income associated with the company’s preferred stock in the quarter ended June 30, 2018, which did not occur during this quarter. Net loss for the quarter ended June 30, 2019 totaled $2,206,000, or $1.59 per basic and diluted share, compared to a net loss of $627,000, or $7.66 per basic and diluted share, for the same period in 2018. For the six months ended June 30, 2019, revenue was $1,769,000, representing a decrease of 12.0% from the comparable period in 2018. This decrease was predominantly driven by a 10.3% decrease in sales of CGuard EPS from $1,664,000 in the six months ended June 30, 2018, to $1,492,000 in the six months ended June 30, 2019, and a 19.9% decrease in sales of MGuard EPS from $346,000 in the six months ended June 30, 2018, to $277,000 in the six months ended June 30, 2019. Both decreases were primarily due to shipment delays in the three months ended March 31, 2019 associated with us changing sterilization companies and sales decreases in certain of the company’s markets. The transition to the company’s new sterilization is now complete and we do not currently anticipate any future disruptions in fulfilling new orders. The Company's gross profit for the six months ended June 30, 2019 was $369,000 compared to a gross profit of $570,000 for the same period in 2018. Gross margin decreased to 20.9 % in the six months ended June 30, 2019 from 28.4% in the same period in 2018. This decrease in gross profit resulted from a $69,000 decrease in revenues (as mentioned above), less the related material and labor costs, $69,000 of expenses related to upgrades made to the company’s production facilities, $38,000 of expenses pertaining to annual and new employee training of the production workers, and an increase of $25,000 in miscellaneous expenses. Total operating expenses for the six months ended June 30, 2019 were $5,682,000, an increase of 42.2% compared to $3,996,000 for the same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2019 and due to a settlement payment made to a former service provider pursuant to a settlement agreement. Financial expenses for the six months ended June 30, 2019 were $100,000 compared to financial income of 410,000 for the same period in 2018. This decrease in financial income of $510,000 was predominately due to a non-cash income associated with the company’s preferred stock in the six months ended June 30, 2018, which did not occur during the six months ended June 30, 2019. Net loss for the six months ended June 30, 2019 totaled $5,413,000, or $4.86 per basic and diluted share, compared to a net loss of $3,016,000, or $38.48 per basic and diluted share, for the same period in 2018. As of June 30, 2019, cash and cash equivalents were $4,823,000, compared to $9,384,000 at December 31, 2018. Conference Call and Webcast Details The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13683949. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=135364. The webcast will be archived on the Company’s website. About InspireMD, Inc. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB. Forward-looking Statements Investor Contacts: Craig Shore Jeremy Feffer
(1) All 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2018 financial information is derived from the Company’s 2018 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. (2) All June 30, 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2018 financial information is derived from the Company’s 2018 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2018 filed with the Securities and Exchange Commission. |