AVITA Medical(US:RCEL)2023-11-08 16:00Financial Performance - Revenues for the three months ended September 30, 2023, were $13,645,000, a 50.1% increase from $9,092,000 in the same period of 2022[16] - Gross profit for the nine months ended September 30, 2023, was $29,964,000, compared to $20,272,000 for the same period in 2022, reflecting a 47.9% increase[16] - Operating loss for the three months ended September 30, 2023, was $9,306,000, compared to a loss of $5,748,000 in the same period of 2022, indicating a 62.5% increase in losses[16] - Net loss for the nine months ended September 30, 2023, was $28,316,000, compared to $21,312,000 for the same period in 2022, representing a 33% increase in net losses[16] - Net loss for the nine months ended September 30, 2023, was $28.316 million, compared to a net loss of $21.312 million for the same period in 2022, representing a 33.9% increase in losses[27] - The net loss for the three months ended September 30, 2023, was $8.712 million, compared to a net loss of $5.588 million for the same period in 2022, representing a 56.5% increase in losses[84] - The basic and diluted net loss per share for the three months ended September 30, 2023, was $0.34, up from $0.22 in the same period of 2022, indicating a 54.5% increase[84] Assets and Liabilities - Total current assets decreased to $73,927,000 as of September 30, 2023, from $87,458,000 as of December 31, 2022, a decline of 15.4%[14] - Total liabilities increased to $17,407,000 as of September 30, 2023, compared to $12,967,000 as of December 31, 2022, reflecting a 34.5% increase[14] - Stockholders' equity decreased to $62,978,000 as of September 30, 2023, from $84,740,000 as of December 31, 2022, a decline of 25.7%[14] - Cash and cash equivalents rose to $50,854,000 as of September 30, 2023, up from $18,164,000 as of December 31, 2022, a significant increase of 179.5%[14] - Cash used in operations for the nine months ended September 30, 2023, was $27.148 million, up from $15.654 million in the prior year, indicating a 73.5% increase in cash outflow[27] - As of September 30, 2023, cash and cash equivalents amounted to $4.4 million, with cash equivalents primarily in money market funds totaling $46.4 million[46] - Total current marketable securities as of September 30, 2023, were valued at $9.3 million, with U.S. Treasury securities contributing $5.4 million[51] - The Company reported a net unrealized loss of $20,000 on marketable securities as of September 30, 2023, compared to a net unrealized loss of $426,000 as of December 31, 2022[53] - The Company has accrued interest income of $228,000 as of September 30, 2023, compared to $168,000 as of December 31, 2022[53] Revenue Sources - The company reported BARDA income of $212,000 for the three months ended September 30, 2023, down from $904,000 in the same period of 2022, a decrease of 76.5%[16] - The Company recognized $90,000 and $250,000 in revenue from BARDA for the three-months and nine-months ended September 30, 2023, respectively, compared to $93,000 and $279,000 for the same periods in 2022[62] - Estimated revenue from remaining performance obligations is $469,000 as of September 30, 2023, down from $698,000 as of December 31, 2022, with a notable portion related to the BARDA contract[59] Research and Development - Research and development expenses for the nine months ended September 30, 2023, were $14,056,000, compared to $10,478,000 for the same period in 2022, an increase of 34.7%[16] Stock and Compensation - Total stock-based compensation for the nine months ended September 30, 2023, was $6.213 million, compared to $5.782 million in the prior year, marking a 7.5% increase[27] - Stock-based compensation expense for the three-months ended September 30, 2023, was $2.4 million, compared to $1.4 million in 2022, a 71.4% increase[78] - The Company’s total common stock increased to 25,550,694 shares by September 30, 2023, from 25,030,902 shares a year earlier, reflecting a growth of 2.1%[24] - The Company had a payout of approximately $753,000 in the deferred compensation liability for terminated employees during the third quarter of 2023[87] Operational Changes - The Company received FDA approval for the RECELL System for full-thickness skin defects on June 7, 2023, and commenced commercial launch on June 8, 2023[30] - The FDA approved a PMA application for the repigmentation of stable depigmented vitiligo lesions on June 16, 2023, with a post-market study expected to be completed by the end of 2024[31] - The company submitted a PMA supplement for RECELL GO™ on June 29, 2023, with a complete response to the FDA expected by February 28, 2024, potentially leading to a product launch on May 31, 2024[32] Inventory and Assets Management - Total inventory increased to $4,377,000 as of September 30, 2023, compared to $2,125,000 as of December 31, 2022, reflecting growth in raw materials, work in process, and finished goods[67] - The Company recorded charges for estimated excess and obsolescence in inventory of $81,000 for the three-months ended September 30, 2023, compared to $125,000 for the same period in 2022[67] - Total plant and equipment, net increased to $1,862,000 as of September 30, 2023, from $1,200,000 as of December 31, 2022, representing a 55.0% increase[70] - Depreciation expense for the three-months ended September 30, 2023, was $156,000, up from $130,000 for the same period in 2022, a 20.0% increase[70] Lease and Other Liabilities - Operating lease liabilities increased to $2,749,000 as of September 30, 2023, from $918,000 as of December 31, 2022, due to new lease agreements[66] - Other current liabilities increased to $1,341,000 as of September 30, 2023, from $990,000 as of December 31, 2022, a 35.4% increase[73] Future Financial Planning - The Company entered into a Credit Agreement on October 18, 2023, providing a five-year senior secured credit facility of up to $90 million, with an initial borrowing of $40 million[95] - The Company issued a warrant to purchase up to 409,661 shares of common stock at an exercise price of $10.9847 per share as part of the Credit Agreement[96] - The Company expects future amortization expenses for intangible assets to total $405,000, with $9,000 expected for the remainder of 2023[69]