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Menlo Reports Financial Results for Subsidiary Foamix Pharmaceuticals for Year Ended

Key Takeaway: Financial Results for Subsidiary Foamix Pharmaceuticals for Year Ended December 31, 2019 Became a Wholly Owned Subsidiary of Menlo Therapeutics Upon Closing of Merger on March 9, 2020 Conference Call and Webcast Scheduled for Thursday, March 12th at 8:30am Eastern Time BRIDGEW

Full Press Release Details

Financial Results for Subsidiary Foamix Pharmaceuticals for Year Ended December 31, 2019
Became a Wholly Owned Subsidiary of Menlo Therapeutics Upon Closing of Merger on March 9, 2020
Conference Call and Webcast Scheduled for Thursday, March 12th at 8:30am Eastern Time
BRIDGEWATER, N.J., March 12, 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 its wholly-owned
subsidiary, Foamix Pharmaceuticals Ltd. ("Foamix"), for the twelve months ended December 31, 2019 and provided a corporate
update. Menlo and Foamix announced the consummation of their merger transaction on March 9, 2020.
Recent pipeline highlights:
Financial Results for Foamix Pharmaceuticals
for the Year Ended December 31, 2019
following financial results pertain only to Menlo's wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. Foamix Pharmaceuticals
is filing its last Form 10-K this week, and Menlo does not intend to provide separate financial results for Foamix Pharmaceuticals
revenues, consisting primarily of royalties, decreased by $3.2 million, or 89%, from $3.6 million in the year ended December
31, 2018 to $0.4 million in the year ended December 31, 2019, due to the ongoing suspension of the manufacturing and
sales of Finacea by LEO, following inadequate supply of quality-compliant batches of the API used in such product.
and Development Expenses
Research and development expenses
for the year ended December 31, 2019 were $51.2 million, representing a decrease of $13.3 million, or 21%, compared to $64.5 million
for the year ended December 31, 2018. The decrease in research and development expenses resulted primarily from decrease of $21.4
million in clinical trial expenses due to the completion of AMZEEQ and FMX103 clinical trials, offset by an increase of $3.2 million
in consulting expenses, an increase of $2.8 million in payroll and payroll-related expenses due to an increase in headcount and
salaries and an increase of $2.6 million in payments related to the submission of our NDA for FMX103.
General and Administrative Expenses
General and administrative
expenses for the year ended December 31, 2019 were $45.1 million, representing an increase of $31.1 million, or 221%, compared
to $14.0 million for the year ended December 31, 2018. The increase in selling, general and administrative expenses resulted primarily
from an increase of $18.0 million in connection with the pre-commercialization activities, an increase of $5.4 million in payroll
and payroll-related expenses due to an increase in headcount as we built out our sales and marketing organization in preparation
for the AMZEEQ launch, a $3.1 million increase in costs relating to the merger transaction with Menlo and a $2.0 million increase
in other advisor and consulting expenses.
Net loss for the year ended December
31, 2019 was $95.2 million, compared to $74.2 million for the year ended December 31, 2018, an increase of $21.0 million, or 28%.
Cash & Cash Equivalents
At December 31, 2019, Foamix had cash and cash equivalents of
$73.4 million, compared to cash and cash equivalents of $99.4 million at December 31, 2018.
Pro Forma Cash Position for Combined Company
At December 31, 2019, the combined pro forma cash position for
Menlo, assuming the merger transaction with Foamix Pharmaceuticals was completed on December 31, 2019, was approximately $150.5
Conference Call & Webcast
There will be a conference call at
8:30 a.m. Eastern Time on Thursday, March 12th during which management of Menlo will provide a corporate update.
Thursday, March 12th @ 8:30amET
Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13700089
Webcast: http://public.viavid.com/index.php?id=138439
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 foam, 4%. In addition, the Company is focused on the development of serlopitant, a once-daily oral NK1 receptor
antagonist, as a novel potential treatment option for pruritus associated with prurigo nodularis.
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 anticipated announcement of results of Menlo's clinical trials for pruritus associated
with prurigo nodularis, 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, Menlo's
ability to successfully integrate the two companies; the achievement of certain expected cost synergies; the outcome of any
legal proceedings related to the merger; the outcome and cost of clinical trials for current and future product candidates,
including those for serlopitant; determination by the FDA that results from Menlo's clinical trials are not sufficient
to support registration or marketing approval of product candidates; adverse events associated with the commercialization of
AMZEEQ ; 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; 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 sections
titled "Risk Factors" in (i) Menlo's most recent annual report on Form 10-K, (ii) Foamix's most
recent annual report on Form 10-K and (iii) Menlo's definitive joint proxy statement/prospectus filed with the U.S.
Securities and Exchange Commission under Rule 424(b)(3) on January 7, 2020, as well as discussions of potential risks,
uncertainties, and other important factors in Menlo's subsequent filings with the U.S. Securities and Exchange
Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this
announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent
events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon
forward-looking statements as predictions of future events.
LifeSci Advisors, LLC
FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
December 31
2019 2018
Assets
CURRENT ASSETS:
Cash and cash equivalents $ 43,759 $ 27,868
Restricted cash 825 250
Short term bank deposits 12,102 24,047
Investment in marketable securities 16,246 46,669
Restricted investment in marketable securities 434 268
Trade receivable 135 1,066
Other 1,557 999
Inventory 1,356 -
TOTAL CURRENT ASSETS 76,414 101,167
NON-CURRENT ASSETS:
Investment in marketable securities - 150
Restricted investment in marketable securities - 133
Property and equipment, net 2,885 2,235
Operating lease right of use assets 1,694 -
Other 166 46
TOTAL NON-CURRENT ASSETS 4,745 2,564
TOTAL ASSETS $ 81,159 $ 103,731
December 31
2019 2018
Liabilities and shareholders' equity
CURRENT LIABILITIES:
Trade payables $ 19,352 $ 6,327
Accrued expenses 3,381 351
Employee related obligations 5,231 3,498
Operating lease liabilities 1,092 -
Other 270 292
TOTAL CURRENT LIABILITIES 29,326 10,468
LONG-TERM LIABILITIES:
Liability for employee severance benefits 424 367
Operating lease liabilities 653 -
Long-term debt 32,725 -
Other liabilities 456 714
TOTAL LONG-TERM LIABILITIES 34,258 1,081
TOTAL LIABILITIES 63,584 11,549
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary Shares, NIS 0.16 par value - authorized: 135,000,000 and 90,000,000 Ordinary Shares as of December 31, 2019 and December 31, 2018; issued and outstanding: 61,580,544 and 54,351,140 Ordinary Shares as of December 31, 2019 and December 31, 2018, respectively 2,659 2,331
Additional paid-in capital 325,498 305,303
Accumulated deficit (310,587 ) (215,409 )
Accumulated other comprehensive income (loss) 5 (43 )
TOTAL SHAREHOLDERS' EQUITY 17,575 92,182
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 81,159 $ 103,731
Last updated: Mar 12, 2020