Recent Updates
Recently added Catalysts
VYNE

Menlo Reports First Quarter 2020 Financial Results and Provides Business Update Conference Call Today at 8:30am Eastern Time BRIDGEWATER, N.J.

Key Takeaway: Reports First Quarter 2020 Financial Results and Provides Business Update Call Today at 8:30am Eastern Time BRIDGEWATER, N.J., May 11, 2020 -- Menlo Therapeutics Inc. (Nasdaq: MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and comme

Full Press Release Details

Reports First Quarter 2020 Financial Results and Provides Business Update
Call Today at 8:30am Eastern Time
BRIDGEWATER, N.J., May 11, 2020 -- Menlo Therapeutics
Inc. (Nasdaq: MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing
and commercializing proprietary therapies to address unmet needs in dermatology, today announced financial results for the first
quarter ended March 31, 2020 and provided a corporate update.
launch of AMZEEQ at the beginning of 2020 marked
the transition of Menlo to a commercial company," said Dave Domzalski, Chief Executive Officer of Menlo. "We have been
encouraged by the positive reception to AMZEEQ from both physicians and patients, and noted strong increases in weekly prescriptions
from launch through early March. During the current economic slowdown, our sales representatives are engaging with healthcare providers
virtually and we continue to see positive momentum in our discussions with payors. The recent license agreement we signed with
Cutia Therapeutics for the Chinese market underscores the demand that exists for innovative dermatology products in markets outside
the U.S. and also provides the company with non-dilutive capital."
"Our NDA for FMX103 for the potential treatment of papulopustular
rosacea is currently being reviewed by the FDA, with a PDUFA action date of June 2nd," continued Mr. Domzalski. "If
approved, we expect to have two products on the market by the end of this year, providing us with the opportunity to expand our
franchise in dermatology and create increased operational leverage for the company."
First Quarter and Recent highlights:
In January 2020, we commercially launched AMZEEQ (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. AMZEEQ is the first topical formulation of minocycline to be approved by the FDA for any condition.
In April 2020, Menlo's wholly owned subsidiary, Foamix Pharmaceuticals Ltd. ("Foamix"), entered into an exclusive licensing agreement with an affiliate of Cutia Therapeutics ("Cutia"), a specialty pharmaceutical company based in mainland China, for the sale of AMZEEQ and its other topical minocycline product candidates, once approved, in Greater China.
o Foamix will receive an upfront cash payment of $10 million and will be eligible for an additional $1 million payment upon the receipt of marketing approval in China of the first licensed product.
o Foamix is also entitled to receive mid-single digit royalties on net sales of any licensed products.
Announced top line results from two Phase 3 clinical trials evaluating the safety and efficacy of oral serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN). The studies did not meet their respective primary endpoints of demonstrating statistically significant reduction in pruritus compared with placebo. Menlo does not intend to pursue further development of serlopitant.
Entered into a settlement and license agreement to resolve the remaining pending patent litigation involving Finacea foam.
Appointed Andrew Saik as Chief Financial Officer and Treasurer.
Financial Results for the First Quarter Ended March 31, 2020
Revenues totaled $1.8 million and $0.3 million for the three
months ended March 31, 2020 and 2019, respectively. For the three months ended March 31, 2020, revenues were generated from product
sales of AMZEEQ, which was launched in January 2020. For the three months ended March 31, 2019, revenues consisted solely of royalty
Cost of goods sold was $0.3 million for the three months ended
March 31, 2020. There was no cost of goods sold in the three months ended March 31, 2019 because the revenues in that period consisted
solely of royalties, which do not bear related cost of goods sold.
Our gross margin percentage of 85% was favorably
impacted during the three months ended March 31, 2020 due to the fact that some inventory was produced prior to FDA
approval and therefore expensed in prior periods. If inventory sold during the three months ended March 31, 2020 was
valued at cost, our gross margin for the period then ended would have been 79%.
Research and Development Expenses
Our research and development expenses for the three months
ended March 31, 2020 were $16.0 million, representing an increase of $5.2 million, or 48%, compared to $10.8 million for the three
months ended March 31, 2019. Employee-related expenses increased by $4.7 million, including $3.8 million related to severance
expenses associated with legacy Menlo employees, and $0.9 million in increased payroll and related expenses. In addition, clinical
and manufacturing costs related to serlopitant, which was acquired in the transaction combining Menlo with Foamix (the "Merger"),
increased by $2.2 million, offset by a decrease of $2.2 million related to clinical and manufacturing expenses for AMZEEQ and
Selling, General and Administrative Expenses
Our selling, general and administrative expenses for the three
months ended March 31, 2020 were $25.4 million, representing an increase of $20.1 million, or 379%, compared to $5.3 million for
the three months ended March 31, 2019. Employee-related expenses increased by $10.5 million, consisting of $6.0 million primarily
due to the expansion of our employee base, including sales force, to support the growth of our operations and $4.3 million related
to severance expenses paid to legacy Menlo employees. We incurred $3.6 million expenses relating to the Merger included in selling,
general and administrative expenses. Sales and marketing expenses increased by $1.8 million related to the commercialization of
Our operating loss for the three months ended March 31, 2020
was $39.9 million, compared to an operating loss of $15.9 million for the three months ended March 31, 2019, representing an increase
of $24.0 million, or 151%.
During the three months ended March 31, 2020 we had no tax
expenses, as compared to tax benefits of $0.2 million during the three months ended March 31, 2019.
Our net loss for the three months ended March 31, 2020 was
$40.2 million or ($0.95) per share, as compared to $15.2 million or ($0.47) per share for the three months ended March 31, 2019,
representing an increase of $25.0 million, or 164%. The increase was primarily due to an increase in expenses incurred in connection
with our commercial launch of AMZEEQ, Merger expenses and severance expenses for legacy Menlo employees.
Cash & Cash Equivalents
As of March 31, 2020, the combined Company had cash, cash equivalents
and investments of $82.7 million. This amount does not include the $10 million upfront payment expected pursuant to the license
agreement entered into with Cutia in April 2020.
There will be a conference call at 8:30 a.m. Eastern Time today,
Monday, May 11, during which management of Menlo will provide a corporate update.
Monday May 11th @ 8:30amET
Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13702832
Webcast: http://public.viavid.com/index.php?id=139512
A replay of the call will be archived on the Company's
website at www.menlotherapeutics.com promptly after the conference call.
Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals
Ltd. to form a different type of biopharmaceutical company working to solve some of today's most difficult therapeutic challenges
in dermatology and beyond.
With expertise in topical medicine innovation as a springboard,
the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology
(MST ), and has received FDA approval for the world's first topical minocycline, AMZEEQ (minocycline) topical
For more information about Menlo or its investigational products,
visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Menlo's website in addition to following its press releases, filings with the U.S. Securities
and Exchange Commission, public conference calls, and webcasts.
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding expectations
with respect to the financial results of Menlo and statements regarding the development and commercialization of Menlo's
products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements
in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on
Menlo's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks,
uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied
by such forward-looking statements. These risks and uncertainties include, but are not limited to the COVID-19 pandemic and its
impact on our business operations; adverse events associated with the commercialization of AMZEEQ; the achievement of certain expected
cost synergies related to the Merger; the outcome and cost of clinical trials for current and future product candidates; determination
by the FDA that results from Menlo's clinical trials are not sufficient to support registration or marketing approval of
product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ or any other
products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose
additional requirements before approving AMZEEQ prescription reimbursement; the eligible patient base and commercial potential
of AMZEEQ or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights, such
as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly
or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable or one or
more of Menlo's patent applications may not be granted and potential competitors may also seek to design around Menlo's
granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness;
inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and retain key employees;
and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and
uncertainties, and other important factors, any of which could cause Menlo's actual results to differ from those contained
in the forward-looking statements, see the section titled "Risk Factors" in Menlo's Quarterly Report on Form
10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors
Last updated: May 11, 2020