Petros Pharmaceuticals, Inc., a leading provider of therapeutics for men’s health, today announced financial results for the third quarter ended September 30, 2021.
Recent Highlights:
“Petros continued its momentum during the third quarter with the number of prescriptions and tablets hitting record levels. The demand for STENDRA® continues to be strong with total milligrams sold (total milligrams of all tablets sold, including 50mg, 100mg, and 200mg) increasing 6% over the prior quarter. Prescription Medications segment gross sales increased 46% quarter over quarter during the third quarter; however, net sales declined 17% during the same period. Net sales is adjusted for various allowances such as product returns, contract rebates, coupon redemptions and other reasons, related primarily to STENDRA®. During the third quarter, the allowances were impacted by greater coupon redemptions which increased as a result of a larger discount provided to one of our online distributors as a result of a new contract. In addition, our product returns increased during the third quarter as a result of certain STENDRA® inventory at resellers approaching expiration. The impact from these allowances is mostly complete and we expect the amount of STENDRA® returns to decline in future periods as a result of two factors. First, we have improved our wholesale inventory levels to 25 days on hand, down from an average of 40 days on hand in prior periods, decreasing the risk of obsolescence. Second, in recent formulations of STENDRA®, we have been able to extend its shelf life by over 30% to 4 years. Both of these factors should result in lower product returns in future periods,” stated Fady Boctor, Petros Pharmaceuticals’ President and Chief Commercial Officer.
“We continue to make progress with our strategies, particularly with our objective of obtaining over-the-counter status for STENDRA®, our lead product for erectile dysfunction. During July, we completed the enrollment of our pivotal-grade label comprehension study, a key milestone as we work with the U.S Food and Drug Administration (the FDA) to have STENDRA® labeled as an over-the-counter treatment. While we are still in the very early stages of this process, we believe the market opportunity is significant. Currently, there are no FDA approved erectile dysfunction medications on the market that are available without a prescription. We believe that, if successful, this labeling could drive strong STENDRA® growth for years as well as significantly expand the market,” concluded Mr. Boctor.
Q3 2021 Financial Results
Net sales for the third quarter ended September 30, 2021 were $2.2 million, comprised of $1.4 million of net sales from Prescription Medicines and net sales of $0.8 million from Medical Devices. This compares to net sales for the quarter ended September 30, 2020, which were $3.5 million comprised of $2.6 million of net sales from Prescription Medicines and net sales of $0.9 million from Medical Devices. Prescription Medicines consists primarily of STENDRA®, which is indicated for male erectile dysfunction and Medical Devices, which includes vacuum erection devices (“VEDs”) and associated accessories and products. The Prescription Medicines segment, primarily STENDRA®, net sales declined 47% year-over-year in the third quarter, driven by higher sales allowances resulting mostly from higher discounting provided to online distributors and returns from expired products.
Total gross profit for the third quarter of 2021 decreased to $1.8 million, comprised of $1.3 million from Prescription Medicines and $0.5 million from Medical Devices. Gross profit for the third quarter of 2020 was $2.5 million, comprised of $1.8 million from Prescription Medicines and $0.6 million from Medical Devices. Overall gross margins increased to 85%, up from 72% in the year-ago period, an increase of 1,300 basis points. This increase was driven by gross margins from prescription medicines increasing to 97% compared to 71% in the prior-year period. Gross margins from the medical devices segment decreased to 64% in the third quarter compared to 75% in the year-ago period.
Selling, general and administrative expenses for the third quarter of 2021 were $3.6 million, up from $3.1 million in the year-ago period. The increase in selling general and administrative expense during the third quarter was driven by higher expenses associated with the Metuchen merger that took place in December of 2020.
Research and development expenses for the third quarter of 2021 were approximately $281,000 versus approximately $37,000 in the prior-year period.
Adjusted EBITDA loss for the third quarter of 2021 was ($1.9) million versus $(0.7) million in the year-ago period. EBITDA was negatively impacted primarily due to lower net sales partially offset by a decrease in operating expenses of $0.5 million.
Net income for the third quarter of 2021 was negative $1.7 million versus negative $3.3 million in the year-ago period. The improvement in the net loss for the third quarter of 2021 was partially due to a non-operating gain from change in fair value of derivative liability related to the earnout from the Metuchen acquisition that was completed in December of 2020.
Cash totaled $8.1 million at September 30, 2021, compared to $17.1 million at December 31, 2020. This does not include cash raised in October 2021 of approximately $5.3 million net of fees and expenses.
About STENDRA® (avanafil)
STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company’s sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA® is not for use in women or children. It is not known if STENDRA® is safe and effective in women or children under 18 years of age. 100-mg and 200-mg tablets can be taken as early as ~15 minutes before sexual activity. STENDRA® works only with sexual stimulation and should not be taken more than once a day. STENDRA® can be taken with or without food; do not drink too much alcohol when taking STENDRA® (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, stopped taking STENDRA® (50 mg, 100 mg, or 200 mg, respectively) due to side effects compared to 1.7% on placebo. STENDRA® was designed and developed expressly for erectile dysfunction. Currently, STENDRA® is covered for ~75% of commercially insured lives, with a co-pay as low as $0. For more information visit: https://STENDRA.com/.
STENDRA® Important Risk Information
STENDRA® can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
Do not take STENDRA® if you:
Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex.
STENDRA® can cause serious side effects.
Uncommonly reported side effects include:
Before you take STENDRA®, tell your healthcare provider if you:
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA® may affect the way other medicines work, and other medicines may affect the way STENDRA® works, which may cause side effects. Especially tell your healthcare provider if you take any of the following:
Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA®, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure.
STENDRA® does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA® are headache, flushing, stuffy or runny nose, sore throat, and back pain.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA®. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.
About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a world-leading specialized men’s health company by identifying, developing, acquiring, and commercializing innovative therapeutics for men’s health issues, including, but not limited to, erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial ailments, Peyronie’s disease, hormone health, and substance use disorders.