Full Press Release Details
Petros Pharmaceuticals Reports Third Quarter Financial Results and
Provides Corporate Update
Quarter has Record STENDRA Prescription and
New York - November 15, 2021 -
Petros Pharmaceuticals, Inc. ("Petros" or "the Company") (Nasdaq: PTPI), a leading provider of therapeutics
for men's health, today announced financial results for the third quarter ended September 30, 2021.
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.
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
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
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.
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/.
Important Risk Information
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.
can cause serious side effects.
Uncommonly reported side effects include:
you take STENDRA , tell your healthcare provider if you:
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,
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.
Please see full Prescribing Information and Patient
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.
1 See "Reconciliation of Non-GAAP Financial Measures" at the end of this press release for information regarding EBITDA.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we,"
"our," "us" or the "Company") management's assumptions, expectations, projections, intentions
and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop,"
"goal," "plan," "predict", "may," "will," "project," "estimate,"
"anticipate," "believe," "expect," "continue," "potential," "opportunity,"
"forecast," "should" and similar expressions, whether in the negative or affirmative, are intended to identify
forward-looking statements, but are not the exclusive means of identifying such statements. Actual results and the timing of certain
events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties,