Full Press Release Details
Petros Pharmaceuticals Reports Record Revenue and Gross Profit During
Q2 Net Sales Results in First Quarter of
Positive Adjusted EBITDA in Company's History
New York - August 15, 2022 -
Petros Pharmaceuticals, Inc. ("Petros" or "the Company") (Nasdaq: PTPI), a leading provider of therapeutics
for men's health, today announced financial results for the second quarter ended June 30, 2022.
| - | Reported Net Sales for Q2 of $4.2 million | |
| - | Achieved first positive quarter of Adjusted EBITDA over $200,000 | |
| - | Announced positive results of over-the-counter (OTC) label comprehension study for erectile dysfunction drug STENDRA | |
| - | Engaged Massachusetts General Hospital (MGH) in sponsored research agreement for tissue-specific oxygenation sensor device technology | |
| - | Announced the Company is pursuing the 505(b)(2) pathway for its investigational agent H-100 for Peyronie's disease | |
| - | Launched social media campaign with celebrity Physician Dr. Drew Pinsky. |
financial results mark a critical milestone in Petros' history as it represents Q2 net sales of over $4 million, and the first quarter
achieving positive adjusted EBITDA," commented Fady Boctor, Petros' President and Chief Commercial Officer. "Our ability
to achieve positive adjusted EBITDA, during a time of investing to expand our products and market opportunity, is a testament to the organizational
improvements we have made to operate as a lean and efficient company. Net revenue during the second quarter benefited from our ability
to increase sales to wholesalers and retail pharmacies, whose inventories had been depleted, partially resulting from abnormally high
product returns in recent quarters due to product expiration. Although this infrequent and extraordinary market replenishment strengthened
Q2 revenue, we expect return rates in the future to be lower (hence improved profit) as the majority of STENDRA at wholesalers
and retail pharmacies is newer supply, coupled with expanding the shelf life of STENDRA from three years to four years.
supplement our efforts to raise awareness in men's health and STENDRA , specifically, we recently engaged Dr. Drew
Pinsky to kick off our social media campaign. Our objective with this initiative is to raise awareness, foster dialogue, educate, and
alleviate the stigma associated with erectile dysfunction as it relates to sexual dysfunction and men's health.
April 2022, we continued our focus on moving STENDRA towards OTC status as we announced positive results from our
OTC label comprehension study for STENDRA . These positive results demonstrate that the proposed OTC labeling was well
understood by consumers that participated, an essential step towards the process of achieving OTC status. As we continue to work
with the Food and Drug Administration (FDA) on subsequent studies, we believe that these results should establish a strong
foundation towards the OTC pathway.
"Also, during April 2022, we engaged
MGH in a sponsored research agreement for tissue-specific oxygenation sensor technology to monitor and understand the success of Erectile
Device Therapy as another potential solution to treating erectile dysfunction.
"During May 2022, we announced the
pursuit of the 505(b)(2) pathway for H-100, our novel topical investigational treatment for Peyronie's disease, an ailment
that impacts more than 1 in 10 men in the US. We are particularly excited about this solution as, if approved, it could be the first non-invasive
treatment for Peyronie's disease.
"We are encouraged as to our progress as
we pursue multiple avenues with the theme of addressing men's health. More significant is the ability to pursue these while achieving
positive adjusted EBITDA, which is a testament to our ability to pursue various solutions in an efficient and cost-effective manner,"
concluded Mr. Boctor.
Q2 2022 Financial Results
sales for the second quarter ended June 30, 2022, were $4.2 million, comprised of $3.3 million of net sales from Prescription Medicines
and $0.9 million of net sales from Medical Devices. This compares to net sales for the quarter ended June 30, 2021, which were $2.5
million. Net sales for the second quarter of 2021 were comprised of $1.7 million of net sales from Prescription Medicines and $0.8 million
of net sales 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.
Prescription Medicines segment sales for the second quarter were up 102% over the year-ago period. STENDRA sales for the second quarter
2022 benefited from the Company's ability to address the supply challenges faced in recent quarters due to product expiration and
subsequently provide new supply to wholesalers with new longer shelf life STENDRA . The shelf-life of the new STENDRA product
has increased to four years, up from three years in its prior batch, which is expected to reduce the Company's return rate in future
Total gross profit for the second quarter of 2022
was $3.5 million versus $2.1 million for the year-ago quarter. Gross profit for the second quarter of 2022 was comprised of $3.0 million
from Prescription Medicines and $0.5 million from Medical Devices. Gross profit for the second quarter of 2021 was $1.5 million from Prescription
Medicines and $0.6 million from Medical Devices. Overall gross margins were 84% for the first quarter of 2022 versus 84% for the year-ago
Selling, general and administrative (SG&A)
expenses for the second quarter of 2022 were $3.2 million, down from $4.1 million for the year-ago period and $3.9 million for the first
quarter of 2022. The decline in SG&A resulted from the Company's cost-cutting efforts in order to improve the efficiency of
Research and development expenses for the second
quarter of 2022 were $0.4 million versus approximately $0.5 million for the prior-year period.
Net loss for the second quarter of 2022 was $1.8
million versus a loss of $2.1 million for the year-ago period.
Net sales of $4.2 million and a positive adjusted
EBITDA for the second quarter 2022 of $0.2 million, resulting in the Company's first quarter of positive adjusted EBITDA. Adjusted
EBITDA for the year-ago quarter was negative $2.0 million.
Cash totaled $13.3 million as of June 30,
2022, compared to $17.7 million at March 31, 2022.
Use of Non-GAAP Financial Measures
Adjusted EBITDA is a non-GAAP financial measure.
Our management believes that the presentation of Adjusted EBITDA is useful to investors as a supplemental way to evaluate the ongoing
operations of our business as Adjusted EBITDA may enhance investors' ability to compare historical periods as it adjusts for the
impact of financing methods, tax law and strategy changes, and depreciation and amortization and to evaluate the Company's ability
to service debt. In addition, Adjusted EBITDA is a financial measurement that our management and Board of Directors use in their financial
and operational decision-making and in the determination of certain compensation programs. Non-GAAP financial measures are meant to supplement,
and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered
in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company's
financial statements prepared in accordance with GAAP. Reconciliations of the Company's non-GAAP measures are included below.
The following table presents a reconciliation of net income (loss)
to Adjusted EBITDA for the three and six months ended June 30, 2022, and 2021:
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Net income (loss) | $ | (1,811,792 | ) | $ | (2,112,917 | ) | $ | (1,986,016 | ) | $ | 896,164 | |||||
| Interest expense, senior debt | - | 115,525 | - | 288,937 | ||||||||||||
| Interest expense, promissory note | 150,372 | - | 303,398 | - | ||||||||||||
| Income tax expense (benefit) | - | 6,700 | - | 6,700 | ||||||||||||
| Depreciation and amortization expense | 1,560,870 | 1,728,828 | 3,121,740 | 3,457,657 | ||||||||||||
| EBITDA | (100,550 | ) | (261,864 | ) | 1,439,122 | 4,649,458 | ||||||||||
| Stock based compensation | 302,267 | 680,504 | 658,093 | 1,125,511 | ||||||||||||
| Gain on settlement with Vivus | - | - | (3,389,941 | ) | - | |||||||||||
| Change in fair value of derivative liability | - | (2,290,000 | ) | (460,000 | ) | (7,670,000 | ) | |||||||||
| Adjusted EBITDA | $ | 201,717 | $ | (1,871,360 | ) | $ | (1,752,726 | ) | $ | (1,895,031 | ) |
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:
| - | take medicines called nitrates, which are used to treat chest pain (angina) | |
| - | use street drugs called "poppers," such as amyl nitrate and butyl nitrate | |
| - | take medicines called guanylate cyclase stimulators, which include Adempas (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension | |
| - | are allergic to avanafil or any of the ingredients in STENDRA |
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:
| - | An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. | |
| - | Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes. |
you take STENDRA , tell your healthcare provider if you:
| - | have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape | |
| - | have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions |
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:
| - | medicines called nitrates | |
| - | medicines called guanylate cyclase stimulators, such as riociguat | |
| - | medicines called HIV protease inhibitors, such as ritonavir (Norvir ), indinavir (Crixivan ), saquinavir (Fortavase or Invirase ), or atazanavir (Reyataz ) | |
| - | some types of oral antifungal medicines, such as ketoconazole (Nizoral ) and itraconazole (Sporanox ) | |
| - | some types of antibiotics, such as clarithromycin (Biaxin ), telithromycin (Ketek ), or erythromycin | |
| - | medicines called alpha-blockers. These include terazosin (Hytrin ), tamsulosin HCl (Flomax ), doxazosin (Cardura ), prazosin HCl (Minipress ), alfuzosin HCl (UroXatral ), dutasteride and tamsulosin HCl (Jalyn ), or silodosin (Rapaflo ). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting | |
| - | other medicines that treat high blood pressure | |
| - | other medicines or treatments for ED |
Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA ,