Gross Loss
Gross loss for the three months ended September 30, 2022, was $(1,744,257), composed of $(2,176,696) of gross loss from Prescription Medicines net of $432,439, from Medical Devices. Gross profit for the three months ended September 30, 2021, was $1,826,011, or 85% of net sales, composed of $1,332,036 of gross profit from Prescription Medicines and $493,974 from Medical Devices. The decrease in gross profit was driven by the factors noted above as driving the decrease in net sales.
Operating Expenses
Selling, general and administrative
Selling, general and administrative expenses for the three months ended September 30, 2022, were $2,170,975, composed of $493,128 of selling, general and administrative expenses of our Prescription Medicines segment, $467,701 of selling, general and administrative expenses of our Medical Devices segment and $1,210,147 of general corporate expenses.
Selling, general and administrative expenses for the three months ended September 30, 2021, were $3,413,223, composed of $1,318,610 of selling, general and administrative expenses of our Prescription Medicines segment, $722,998 of selling, general and administrative expenses of our Medical Devices segment and $1,371,615 of general corporate expenses.
Selling, general and administrative expenses for both segments include selling, marketing and regulatory expenses. Unallocated general corporate expenses include costs that were not specific to a particular segment but are general to the group, including expenses incurred for administrative and accounting staff, general liability and other insurance, professional fees and other similar corporate expenses.
Selling, general and administrative expenses decreased by $1,242,249, or 36%, during the three months ended September 30, 2022, compared to the three months ended September 30, 2021. Decreased selling general and administrative expenses were primarily driven by a waiver of fees due to the FDA under PDUFA for the fiscal year 2022, resulting in a $1,083,504 decrease in fees due under PDUFA, decreased professional service fees of $295,410 as management sought to reduce expenses to improve operational efficiencies, decreased direct selling and marketing expenses of $52,328, and decreased other operating expenses of $98,326 partially offset by increased stock based compensation expense of $254,969 increased bad debt expenses of $32,350 due to reserves for uncollectible accounts.
Research and development
Research and development expenses for the three months ended September 30, 2022, were $735,916, composed of $678,552 in our Prescription Medicines segment and $57,364 for our Medical Devices segment.
Research and development expenses for the three months ended September 30, 2021, were $280,576, in our Prescription Medicines segment and $0 for our Medical Devices segment.
Research and development expenses for the Prescription Medicines segment for the three months ended September 30, 2022 are composed of $403,085 for consulting fees related to the Company’s Non-Prescription / Over-The-Counter Strategies related to Stendra®; $97,824 for clinical development expenses and $27,408 for consulting fees related to the H100 license acquired in March 2020; and $150,235 related to the Company’s tech transfer of its manufacturing process. Research and development expenses for the Prescription Medicines segment for the three months ended September 30, 2021 are composed of $232,076 for consulting fees related to the Company’s Non-Prescription / Over-The-Counter Strategies and $48,500 for legal fees related to the H100 license acquired in March 2020.
Research and development expenses for the Medical Devices segment for the three months ended September 30, 2022, are composed of $57,364 for license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies. Research and development expenses for the Medical Devices segment for the three months ended September 30, 2021 were $0.
Research and development expenses increased by $455,340, or 162%, during the three months ended September 30, 2022, compared to the three months ended September 30,2021. Increased research and development expenses were primarily driven by increased consulting fees related to the Company’s Non-Prescription / Over-The-Counter strategies related to Stendra®, increased expenses related to the Company’s tech transfer of its manufacturing process, increased clinical development expenses related to the H100 license acquired in March 2020 and license fees related to the Company’s Tissue-Specific Oxygenation Sensor Technology Strategies.