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 IRir@petrospharma.com
Media:Jules AbrahamCORE IR917-885-7378pr@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.
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