BioCryst Pharmaceuticals(US:BCRX)2021-11-03 16:00Financial Performance - Total revenues for the three months ended September 30, 2021, were $40,994,000, a significant increase from $6,102,000 in the same period of 2020[25]. - Product sales reached $39,141,000 for the three months ended September 30, 2021, compared to $2,478,000 in the same period of 2020, reflecting a growth of approximately 1,479%[25]. - The net loss for the nine months ended September 30, 2021, was $166,283,000, compared to a net loss of $122,321,000 in the same period of 2020, indicating a 36% increase in losses[27]. - The company reported a comprehensive loss of $58,774,000 for the three months ended September 30, 2021, compared to a comprehensive loss of $46,109,000 in the same period of 2020, an increase of 27.5%[25]. - The total revenues for the nine months ended September 30, 2021, were $110,012, compared to $13,796 for the same period in 2020, indicating an increase of about 696%[64]. - The total operating expenses for the nine months ended September 30, 2021, were $235,555,000, compared to $136,148,000 in 2020, reflecting a 73.2% increase[25]. - The company expects its 2021 expenses to exceed its 2021 revenues, continuing to incur operating losses and negative cash flows until revenues reach a sufficient level[36]. Cash and Liabilities - Cash, cash equivalents, and restricted cash at the end of the period were $203,893,000, down from $274,348,000 at the beginning of the period, reflecting a decrease of 25.6%[27]. - Total current liabilities increased to $133,608,000 in 2021 from $105,654,000 in 2020, marking a rise of 26.4%[24]. - As of September 30, 2021, the total stockholders' equity (deficit) was $(147,044) thousand, reflecting a net loss of $(58,801) thousand for the quarter[31]. - The company may need to raise additional capital in the future to fund operations, which could impact its operational flexibility[9]. - The company has access to an additional $75 million from its existing credit facility, which it believes will fund operations into 2023[36]. Research and Development - Research and development expenses for the nine months ended September 30, 2021, were $145,279,000, up from $87,610,000 in 2020, representing a 65.7% increase[25]. - The company integrates biology, crystallography, medicinal chemistry, and computer modeling to develop small molecule pharmaceuticals[35]. - Research and development expenses include direct and indirect costs, with significant reliance on third-party contract research organizations (CROs) for clinical studies[78]. Product Development and Sales - The company is focused on advancing product candidates through clinical trials, with a particular emphasis on ORLADEYO® (berotralstat) and other candidates like BCX9930 and BCX9250[5]. - The Company’s principal sources of product sales include ORLADEYO, which began shipping in December 2020, and sales of peramivir and RAPIVAB[65]. - The company has not recorded any reserves or allowances for receivables from product sales as of September 30, 2021, indicating a positive outlook on collection[46]. - The company estimates rebates to third-party payors, which are deducted from total gross product revenues, impacting current liabilities[67]. Risks and Challenges - BioCryst incurred losses since inception and expects to continue incurring losses, indicating potential challenges in achieving profitability[9]. - The ongoing COVID-19 pandemic poses risks that could disrupt operations, including delays and increased expenses[9]. - The company relies heavily on third-party relationships for product development and commercialization, and any failure in these relationships could adversely affect business[11]. - The company faces intense competition, which could reduce demand for its products and impact future revenue generation[12]. - The company is subject to various laws and regulations, and non-compliance could result in penalties and harm its reputation[14]. Collaborations and Funding - BioCryst anticipates potential funding from contracts with BARDA/HHS and NIAID/HHS for the development of galidesivir, which could impact financial performance[5]. - The company has collaborations with partners for product commercialization, which are critical for its business model and revenue generation[5]. - The Company received an upfront payment of $22,000 from Torii Pharmaceutical Co., Ltd. for the commercialization of ORLADEYO in Japan, along with a $15,000 milestone payment triggered by regulatory approval[142]. - The Company completed a $30,000 financing transaction to monetize future royalty and milestone payments under the Shionogi Agreement, receiving net proceeds of $22,691 after transaction costs[94]. Stock and Compensation - Stock-based compensation expense for the nine months ended September 30, 2021, was $26,140,000, significantly higher than $8,907,000 in 2020, representing a 194% increase[27]. - The weighted average grant date fair value per share of stock option awards granted during the first nine months of 2021 was $8.11, compared to $3.35 for the same period in 2020[130]. - As of September 30, 2021, the Company had approximately $60,420 of total unrecognized compensation expense related to non-vested stock option awards[126].