NEW YORK, May 16, 2022 (GLOBE NEWSWIRE) -- Petros Pharmaceuticals, Inc. (“Petros” or “the Company”) (Nasdaq: PTPI), a leading provider of therapeutics for men’s health, today announced financial results for the first quarter ended March 31, 2022.
Recent Highlights:
- Announced the pursuit of the 505(b)(2) pathway for early stage asset, H-100 for the treatment of Peyronie’s Disease
- Initiated sponsored research agreement with Massachusetts General Hospital to evaluate incorporating the use of a tissue-specific oxygenation sensor with the goal of monitoring and understanding the success of Erectile Device Therapy.
- Reported positive results of a Phase 2 label comprehension study to initiate process for STENDRA® prescription erectile dysfunction medication to support the process for designation as over -the-counter treatment
- Engaged with celebrity physician, Dr. Drew Pinsky to provide patient education about erectile dysfunction and branded STENDRA messaging
- Announced an agreement with a leading U.S. based global contract manufacturer for STENDRA
“Petros is committed and on track to fill critical gaps in the men’s health marketplace, both, in terms of pharmaceutical and device therapeutics. In addition to our flagship, patent protected pharmaceutical grade erectile dysfunction medication, STENDRA, and our well-established industry leading device portfolio, we are also in development of multiple new products to address men’s needs in a variety of under-treated conditions. Much of our activities since the beginning of 2022 have been focused on those diverse and innovative offerings. We continue to execute on finding new ways to care for those men who experience difficulties, whether because they are suffering from underserved conditions, or by finding new, easier ways to access treatment, whether through telemedicine, online retailing, or striving to bring medications over-the-counter through the pathways laid out by the FDA,” commented Fady Boctor, Petros’s President and Chief Commercial Officer.
“During the first quarter, we experienced an impact of what has become a common supply delay provision across today’s markets, leading to disrupted availability of STENDRA to a market that continues to seek it out. However, a recent significant supply replenishment and product stability testing has strengthened our commercial availability for Q2 and beyond. In this recent supply replenishment and stability testing, STENDRA was able to extend its shelf life, which went from two years to four years, enhancing STENDRA’s market life viability. While we now have ample supply of STENDRA for the foreseeable future, we do anticipate some continued impact on revenue in Q2 based on certain temporarily and strategically placed sales allowances implemented to mitigate certain market supply and demand dynamics. Importantly, we believe that the current market conditions, increasing demand, and our strategic plans to both drive awareness and increase access will create conditions in which it may be possible to see Petros become profitable by the end of 2022. We look forward to continuing to share our progress in all of our programs for STENDRA, including expanded access, as well as those earlier-stage programs that have emerged as an integral part of our men’s health portfolio,” concluded Mr. Boctor.
Q1 2022 Financial Results
Net sales for the first quarter ended March 31, 2022 were $2.5 million, comprised of $1.5 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 March 31, 2021, which were $4.1 million, which was a record quarter. Net sales in the first quarter of 2021 was comprised of $3.2 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®, Q1 2022 net sales declined 52% year-over-year vs the first quarter of 2021, a record quarter. The decline over the year-ago period was due to a supply shortage of STENDRA® in the first quarter of 2022. The supply challenges that were experienced in the first quarter were resolved in Q2 as the channels have been replenished with new inventory.
Total gross profit for the first quarter of 2022 was $2.0 million versus $3.4 million in the year-ago quarter, which was a record gross profit quarter. Gross profit in the first quarter of 2022 was comprised of $1.4 million from Prescription Medicines and $0.6 million from Medical Devices. Gross profit for the first quarter of 2021 was of $2.8 million from Prescription Medicines and $0.6 million from Medical Devices. Overall gross margins were 81% in the first quarter of 2022 versus 84% in the year-ago period.
Selling, general and administrative expenses for the first quarter of 2022 were $3.9 million, consistent with the year-ago period.
Research and development expenses for the first quarter of 2022 were $405,000 versus approximately $19,000 in the prior-year period. The increase over the prior-year period was driven by several key portfolio development initiatives, including H100 formulation development, STENDRA OTC Draft Label development and regulatory filings and engagements with the FDA.
Net income for the first quarter of 2022 was negative $174,000 versus positive $3 million in the year-ago period. The increase in net loss in the first quarter of 2022 was primarily the result of a $5.4 million non-operating gain from change in fair value of derivative liability gain recognized in the prior-year period.
Cash totaled $17.7 million at March 31, 2022, compared to $23.9 million at December 31, 2021.
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:
- 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.
STENDRA® 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.
- Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness.
Before 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
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:
- 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®, 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.
Please see full Prescribing Information and Patient Information.
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.
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, including, without limitation, Petros’ ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros’ ability to comply with obligations as a public reporting company; the ability of Petros to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act of 2002; the risk that the financial performance of Petros may not be as anticipated by the merger transactions that resulted in the Company’s creation; risks resulting from Petros’ status as an emerging growth company, including that reduced disclosure requirements may make shares of Petros common stock less attractive to investors; risks related to Petros’ history of incurring significant losses; risks related to Petros’ dependence on the commercialization of a single product, STENDRA®, and on a single distributor thereof; risks related to the termination of Petros’ commercial supply agreement with Vivus, including the risk that Petros may not be able to obtain sufficient quantities of STENDRA® in a timely manner or on commercially viable terms; risks related to Petros’ ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates; and the expected or potential impact of the novel coronavirus (“COVID-19”) pandemic, including the emergence of new variants, such as the Delta variant, and the related responses of governments, consumers, customers, suppliers, employees and the Company, on our business, operations, employees, financial condition and results of operations. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company’s periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the “SEC”) under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.
The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.
CONTACTS:
Investors:
CORE IR
ir@petrospharma.com
Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com
PETROS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | (Audited) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 17,671,871 | $ | 23,847,572 | ||||
| Accounts receivable, net | 3,740,775 | 2,455,386 | ||||||
| Inventories | 1,942,873 | 519,649 | ||||||
| Prepaid expenses and other current assets | 3,482,586 | 3,720,088 | ||||||
| Total current assets | 26,838,105 | 30,542,695 | ||||||
| Fixed assets, net | 46,842 | 49,397 | ||||||
| Intangible assets, net | 23,734,834 | 25,293,149 | ||||||
| API purchase commitment | 4,796,771 | 11,029,260 | ||||||
| Other assets | 447,595 | 475,557 | ||||||
| Total assets | $ | 55,864,147 | $ | 67,390,058 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,700,326 | $ | 4,557,969 | ||||
| Accrued expenses | 5,512,006 | 11,957,384 | ||||||
| Accrued inventory purchases | — | 14,203,905 | ||||||
| Other current liabilities | 352,436 | 260,818 | ||||||
| Current portion of promissory note | 723,982 | — | ||||||
| Total current liabilities | 10,288,750 | 30,980,076 | ||||||
| Promissory note | 9,477,776 | — | ||||||
| Derivative liability | — | 460,000 | ||||||
| Other long-term liabilities | 371,053 | 405,018 | ||||||
| Total liabilities | 20,137,579 | 31,845,094 | ||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock (par value of $0.0001 per share, 50,000,000 shares authorized, 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively) | — | — | ||||||
| Common stock (par value of $0.0001 per share, 150,000,000 shares authorized, 20,684,723 shares issued and outstanding as of March 31, 2022, and December 31, 2021, respectively) | 2,068 | 2,068 | ||||||
| Additional paid-in capital | 106,587,544 | 106,231,716 | ||||||
| Accumulated deficit | (70,863,044 | ) | (70,688,820 | ) | ||||
| Total Stockholders’ Equity | 35,726,568 | 35,544,964 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 55,864,147 | $ | 67,390,058 | ||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
PETROS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Net sales | $ | 2,465,169 | $ | 4,075,606 | ||||
| Cost of goods sold | 472,340 | 643,386 | ||||||
| Gross profit | 1,992,829 | 3,432,220 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative | 3,897,738 | 3,881,717 | ||||||
| Gain on settlement with Vivus | (3,389,941 | ) | — | |||||
| Research and development expense | 405,360 | 19,181 | ||||||
| Depreciation and amortization expense | 1,560,870 | 1,728,829 | ||||||
| Total operating expenses | 2,474,027 | 5,629,727 | ||||||
| Loss from operations | (481,198 | ) | (2,197,507 | ) | ||||
| Change in fair value of derivative liability | 460,000 | 5,380,000 | ||||||
| Interest expense, senior debt | — | (173,412 | ) | |||||
| Interest expense, promissory note | (153,026 | ) | — | |||||
| Net income (loss) | $ | (174,224 | ) | $ | 3,009,081 | |||
| Net income (loss) per common share | ||||||||
| Basic and Diluted | $ | (0.01 | ) | $ | 0.31 | |||
| Weighted average common shares outstanding | ||||||||
| Basic | 20,684,723 | 9,753,086 | ||||||
| Effects of common share equivalents | — | 1,600 | ||||||
| Diluted | 20,684,723 | 9,754,686 | ||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
PETROS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| For the Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash flows from operating activities: | ||||||||
| Net income (loss) | $ | (174,224 | ) | $ | 3,009,081 | |||
| Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1,560,870 | 1,728,829 | ||||||
| Bad debt expense (recoveries) | (115,364 | ) | 2,984 | |||||
| Inventory and sample inventory reserve | 3,594 | 48,228 | ||||||
| Amortization of deferred financing costs and debt discount | — | 12,500 | ||||||
| Lease expense | 27,962 | 25,156 | ||||||
| Derivative liability | (460,000 | ) | (5,380,000 | ) | ||||
| Deferred revenue | (70,343 | ) | — | |||||
| Gain on settlement with Vivus | (3,389,941 | ) | — | |||||
| Employee stock-based compensation | 355,828 | 347,207 | ||||||
| Non-employee stock-based compensation | — | 97,800 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,170,025 | ) | (1,044,213 | ) | ||||
| Inventories | (1,426,818 | ) | 193,987 | |||||
| Prepaid expenses and other current assets | 237,502 | 172,051 | ||||||
| Accounts payable | (857,643 | ) | (333,273 | ) | ||||
| Accrued expenses | 74,905 | 698,498 | ||||||
| Other current liabilities | 161,961 | 74,992 | ||||||
| Other long-term liabilities | (33,965 | ) | (100,408 | ) | ||||
| Net cash used in operating activities | (5,275,701 | ) | (446,581 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Payment of promissory note | (900,000 | ) | — | |||||
| Payment of senior debt | — | (1,592,028 | ) | |||||
| Payment of portion of senior debt end of term fee | — | (534,375 | ) | |||||
| Net cash used in financing activities | (900,000 | ) | (2,126,403 | ) | ||||
| Net decrease in cash | (6,175,701 | ) | (2,572,984 | ) | ||||
| Cash, beginning of period | 23,847,572 | 17,139,694 | ||||||
| Cash, end of period | $ | 17,671,871 | $ | 14,566,710 | ||||
| Supplemental cash flow information: | ||||||||
| Cash paid for interest during the period | $ | — | $ | 176,677 | ||||
| Noncash Items: | ||||||||
| Noncash decrease in accrued expenses related to Vivus settlement | $ | (6,520,283 | ) | $ | — | |||
| Noncash decrease in accrued inventory purchases related to Vivus settlement | (14,203,905 | ) | — | |||||
| Noncash increase in promissory note related to Vivus settlement | 10,201,758 | — | ||||||
| Noncash decrease in API purchase commitment related to Vivus settlement | 6,232,489 | — | ||||||
The accompanying Notes are an integral part of the Consolidated Financial Statements.
