Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage
dermatology company focused on identifying, developing and
commercializing branded and generic topical drug products for the
treatment of skin diseases, today announced financial results for
the second quarter ended June 30, 2020 and provided clinical and
regulatory updates on its programs.
“The second quarter had major milestones for
Sol-Gel, as we submitted our first NDA for Epsolay for the
treatment of papulopustular rosacea,” commented Dr. Alon Seri-Levy,
Chief Executive Officer of Sol-Gel. “We look forward to the FDA
confirming acceptance and granting a PDUFA action date in the near
future. Also, this quarter, we expanded our collaboration with
Perrigo to include three additional generic product candidates.
While generic product revenue was lower compared to previous
periods due to reduced sales stemming from COVID-19 related
stay-at-home orders, we did see positive trends exiting the second
quarter. Our cash resources will enable funding of all planned
operational and capital expenditures into the third quarter of
2021, excluding revenue we expect to receive based on the sales of
a second generic product starting in the second quarter of
2021.”
Dr. Seri-Levy continued, “There was no impact from
COVID-19 on the NDA submission for Epsolay, and we remain on track
to submit our NDA for Twyneo in the second half of this year,
another major milestone for the company. We continue our launch
preparation for Epsolay and Twyneo, which includes the planned
opening of our US headquarters in New Jersey in the coming months
and hiring key positions.”
Corporate Highlights and Recent
Developments
- Sol-Gel submitted an NDA for Epsolay (encapsulated benzoyl
peroxide, 5%, cream) in June. If approved, Epsolay has the
potential to be the first FDA-approved, single-agent BPO
prescription drug product for the treatment of subtype II
rosacea.
- Sol-Gel expects to submit an NDA for Twyneo (encapsulated
benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream) in
the second half of this year.
- In preparation for commercial launch of Epsolay and Twyneo, and
as part of Sol-Gel’s go-to-market strategy, the Company plans to
open a US headquarters in the coming months in Whippany, NJ and has
started the hiring process for key US-based employees.
- In the second quarter of 2020, Sol-Gel generated revenue of
$1.1 million from its collaboration agreement with Perrigo Company
plc (NYSE; TASE: PRGO).
- Sol-Gel expanded its collaboration with Perrigo Company
plc in June to include the development, manufacturing and
commercialization of three new generic product candidates.
- Bausch Health Companies, Inc. (NYSE: BHC) filed a patent
infringement action regarding Perrigo’s Abbreviated New Drug
Application for a generic version of Bryhali® (halobetasol
propionate) lotion, 0.01%, for the treatment of plaque psoriasis in
adults. Halobetasol propionate lotion, 0.01%, is covered under a
collaboration between Sol-Gel and Perrigo.
- Sol-Gel has been informed by its collaboration partner that the
launch of a second generic drug is expected in the second quarter
of 2021. Sol-Gel will receive payments based on product sales
beginning at the launch date.
- Results from the ongoing Phase 1 clinical trial of SGT-210 in
punctuate palmoplantar keratoderma are expected in 2021, though
COVID-19 has caused enrollment delays.
- Sol-Gel has commenced a preclinical animal study with an
erlotinib formulation, evaluating multiple concentration strengths
for the treatment of UVB-induced actinic keratosis.
- Sol-Gel is starting a collaboration with a leading hospital in
Israel to study the potential efficacy of tapinarof in in vivo
models of eye diseases. The Company has applied for patents
covering the use of tapinarof in ophthalmic disorders including dry
eye, uveitis, and blepharitis with or without demodex involvement.
Sol-Gel believes this is the first time tapinarof has been
evaluated in ophthalmology indications. Pending positive results
from this research, Sol-Gel will explore partnerships for further
development of these exciting opportunities.
Financial Results for the Three Months
ended June 30, 2020
Revenue in the second quarter of 2020 was $1.1
million. The revenue was mainly due to sales of a generic product
from the collaboration arrangement with Perrigo. The decrease in
revenue from the previous quarter was mainly attributed to COVID-19
related stay-at-home-orders.
Research and development expenses were $6.5 million
in the second quarter of 2020 compared to $11.4 million during the
same period in 2019. The decrease of $4.9 million was mainly
attributed to a decrease of $6.4 million in clinical trial
expenses, primarily related to a decrease of clinical trial
activity of Epsolay and Twyneo, partially offset by an increase of
$1.0 million in manufacturing expenses of Epsolay and Twyneo and an
increase of $0.4 million in regulatory expenses, mostly related to
preparing for the NDA submissions for Epsolay and Twyneo.
General and administrative expenses were $2.2
million in the second quarter of 2020 compared to $1.6 million
during the same period in 2019. The increase of $0.6 million was
mainly attributed to an increase of $0.4 million in
commercialization expenses and an increase of $0.1 million in other
expenses.
Sol-Gel reported a loss of $7.1 million for the
second quarter of 2020 compared to loss of $4.9 million for the
same period in 2019.
As of June 30, 2020, Sol-Gel had $25.3 million in
cash, cash equivalents and deposits and $40.7 million in marketable
securities for a total balance of $66.0 million. Based on current
assumptions, Sol-Gel expects its existing cash resources will
enable funding of operational and capital expenditure requirements
into the third quarter of 2021.
About Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology
company focused on identifying, developing and commercializing
branded and generic topical drug products for the treatment of skin
diseases. Sol-Gel leverages its proprietary
microencapsulation technology platform for the development of
Twyneo, under investigation for the treatment of acne vulgaris, and
Epsolay, under investigation for the treatment of papulopustular
rosacea. The Company’s pipeline also includes SGT-210, an
early-stage topical epidermal growth factor receptor inhibitor,
erlotinib, under investigation for the treatment
of palmoplantar keratoderma, and preclinical assets tapinarof
and roflumilast. For additional information, please
visit www.sol-gel.com.
About Epsolay®
Epsolay is an investigational topical cream
containing encapsulated benzoyl peroxide, 5%, for the treatment of
papulopustular rosacea. Epsolay utilizes a patented technology
process to encapsulate benzoyl peroxide within silica-based
microcapsules to create a barrier between the medication and the
skin. The slow migration of medication from the microcapsules is
designed to deliver an effective dose of benzoyl peroxide onto the
skin, while reducing the ability of benzoyl peroxide to induce skin
irritation, such as erythema, burning and stinging. If approved,
Epsolay has the potential to be the first FDA-approved
single-active benzoyl peroxide prescription drug product. Epsolay
is not approved by the FDA and the safety and efficacy has not been
established.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent
inflammatory skin disorder that affects nearly 5 million Americans.
The condition is common, especially in fair-skinned people of
Celtic and northern European heritage. Onset is usually after age
30 and typically begins as flushing and subtle redness on the
cheeks, nose, chin or forehead. If left untreated, rosacea can
slowly worsen over time. As the condition progresses the redness
becomes more persistent, blood vessels become visible and pimples
often appear. Other symptoms may include burning, stinging, dry
skin, plaques and skin thickening.
About Twyneo®
Twyneo is an investigational, antibiotic-free,
fixed-dose combination of encapsulated benzoyl peroxide, 3%, and
encapsulated tretinoin, 0.1%, cream for the treatment of acne
vulgaris. If approved, it will be the first acne treatment that
contains a fixed-dose combination of benzoyl peroxide and
tretinoin, which are separately encapsulated in silica using
Sol-Gel’s proprietary microencapsulation technology. Tretinoin and
benzoyl peroxide are widely prescribed separately as a combination
treatment for acne; however, benzoyl peroxide causes degradation of
the tretinoin molecule, thereby potentially reducing its
effectiveness if used at the same time or combined in the same
formulation. The silica-based microcapsule is designed to protect
tretinoin from oxidative decomposition by benzoyl peroxide, thereby
enhancing the stability of the active drug ingredients. The
silica-based shell is also designed to release the ingredients
slowly over time to provide a favorable efficacy and safety
profile. Twyneo is not approved by the FDA and the safety and
efficacy has not been established.
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin
disease that according to the American Academy of Dermatology
affects approximately 40 to 50 million people in the United States.
The disease occurs most frequently during childhood and adolescence
(affecting 80% to 85% of all adolescents) but it may also appear in
adults. Acne patients suffer from the appearance of lesions on
areas of the body with a large concentration of oil glands, such as
the face, chest, neck and back. These lesions can be inflamed
(papules, pustules, nodules) or non-inflamed (comedones). Acne can
have a profound effect on the quality of life of those suffering
from the disease. In addition to carrying a substantial risk of
permanent facial scarring, the appearance of lesions may cause
psychological strain, social withdrawal and lowered
self-esteem.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements, including, but not limited
to, statements regarding the timing of the submission of an NDA for
Twyneo and the FDA’s granting of a PDUFA action date for Epsolay,
the expectation to receive payments from the product sales of a
generic drug starting in the second quarter of 2021, the timing of
results of the ongoing Phase 1 clinical trial of SGT-210, the
Company’s plans to open US headquarters in Whippany, NJ, the
potential development and commercialization of three new generic
product candidates, and the Company’s expectations regarding
its liquidity and ability to fund operational and capital
expenditure requirements. These forward-looking statements include
information about possible or assumed future results of our
business, financial condition, results of operations, liquidity,
plans and objectives. In some cases, you can identify
forward-looking statements by terminology such as “believe,” “may,”
“estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,”
“expect,” “predict,” “potential,” or the negative of these terms or
other similar expressions. Forward-looking statements are based on
information we have when those statements are made or our
management’s current expectation and are subject to risks and
uncertainties that could cause actual performance or results to
differ materially from those expressed in or suggested by the
forward-looking statements. Important factors that could cause such
differences include, but are not limited to, risks relating to the
effects of COVID-19 (coronavirus), the timing of a launch of a
branded tapinarof product and the launch of a branded topical
roflumilast in the U.S., risks related to the timing of the
submission of an NDA for Epsolay and an NDA for Twyneo as well as
the following factors: (i) the adequacy of our financial and other
resources, particularly in light of our history of recurring losses
and the uncertainty regarding the adequacy of our liquidity to
pursue our complete business objectives; (ii) our ability to
complete the development of our product candidates; (iii) our
ability to find suitable co-development partners; (iv) our ability
to obtain and maintain regulatory approvals for our product
candidates in our target markets and the possibility of adverse
regulatory or legal actions relating to our product candidates even
if regulatory approval is obtained; (v) our ability to
commercialize our pharmaceutical product candidates; (vi) our
ability to obtain and maintain adequate protection of our
intellectual property; (vii) our ability to manufacture our product
candidates in commercial quantities, at an adequate quality or at
an acceptable cost; (viii) our ability to establish adequate sales,
marketing and distribution channels; (ix) acceptance of our product
candidates by healthcare professionals and patients; (x) the
possibility that we may face third-party claims of intellectual
property infringement; (xi) the timing and results of clinical
trials that we may conduct or that our competitors and others may
conduct relating to our or their products; (xii) intense
competition in our industry, with competitors having substantially
greater financial, technological, research and development,
regulatory and clinical, manufacturing, marketing and sales,
distribution and personnel resources than we do; (xiii) potential
product liability claims; (xiv) potential adverse federal, state
and local government regulation in the United
States, Europe or Israel; and (xv) loss or
retirement of key executives and research scientists. These and
other important factors discussed in the Company's Annual Report on
Form 20-F filed with the Securities and Exchange
Commission (“SEC”) on March 24 , 2020 and our other
reports filed with the SEC could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. Except as required by law, we undertake no
obligation to update publicly any forward-looking statements after
the date of this press release to conform these statements.
SOL-GEL TECHNOLOGIES LTD.
UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEET
(The amounts are stated in U.S. dollars in thousands, except share
and per share data) |
|
December
31, |
June 30, |
|
2019 |
2020 |
A s s e t s |
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
Cash and cash equivalents |
$ |
9,412 |
|
|
$ |
5,444 |
|
Bank deposit |
|
- |
|
|
|
19,900 |
|
Marketable securities |
|
40,966 |
|
|
|
40,678 |
|
Receivables from collaborative arrangements |
|
4,120 |
|
|
|
1,171 |
|
Prepaid expenses and other current assets |
|
1,293 |
|
|
|
1,494 |
|
TOTAL CURRENT
ASSETS |
|
55,791 |
|
|
|
68,687 |
|
|
|
|
|
|
NON-CURRENT
ASSETS: |
|
|
|
|
Restricted long-term deposits |
|
472 |
|
|
|
1,284 |
|
Property and equipment, net |
|
2,314 |
|
|
|
2,202 |
|
Operating lease right-of-use assets |
|
2,040 |
|
|
|
1,777 |
|
Funds in respect of employee rights upon retirement |
|
684 |
|
|
|
682 |
|
TOTAL NON-CURRENT
ASSETS |
|
5,510 |
|
|
|
5,945 |
|
|
|
|
|
|
TOTAL
ASSETS |
$ |
61,301 |
|
|
$ |
74,632 |
|
Liabilities and shareholders' equity |
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,710 |
|
|
$ |
1,232 |
|
Other accounts payable |
|
4,123 |
|
|
|
5,154 |
|
Current maturities of operating leases |
|
672 |
|
|
|
525 |
|
TOTAL CURRENT
LIABILITIES |
|
6,505 |
|
|
|
6,911 |
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES - |
|
|
|
|
|
|
|
Operating leases liabilities |
|
1,373 |
|
|
|
1,227 |
|
Liability for employee rights upon retirement |
|
958 |
|
|
|
973 |
|
TOTAL LONG-TERM
LIABILITIES |
|
2,331 |
|
|
|
2,200 |
|
COMMITMENTS |
|
|
TOTAL
LIABILITIES |
|
8,836 |
|
|
|
9,111 |
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY: |
|
|
|
|
|
|
|
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of
December 31, 2019 and June 30, 2020; issued and outstanding:
20,402,800 and 22,996,948 as of December 31, 2019 and June 30,
2020, respectively. |
|
561 |
|
|
|
635 |
|
Additional paid-in capital |
|
203,977 |
|
|
|
231,139 |
|
Accumulated deficit |
|
(152,073 |
) |
|
|
(166,253 |
) |
TOTAL SHAREHOLDERS'
EQUITY |
|
52,465 |
|
|
|
65,521 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY |
$ |
61,301 |
|
|
$ |
74,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOL-GEL TECHNOLOGIES LTD.UNAUDITED
CONDENSEDCONSOLIDATED FINANCIAL STATEMENTSOF OPERATIONS |
|
(The amounts are stated in U.S. dollars in
thousands, except share and per share data)
|
|
|
|
Six months endedJune 30 |
Three months endedJune 30 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
COLLABORATION REVENUES |
$ |
14,151 |
|
$ |
4,598 |
|
$ |
7,793 |
|
$ |
1,133 |
|
RESEARCH AND DEVELOPMENT EXPENSES |
|
22,233 |
|
|
14,381 |
|
|
11,440 |
|
|
6,451 |
|
GENERAL AND ADMINISTRATIVE EXPENSES |
|
3,332 |
|
|
4,994 |
|
|
1,638 |
|
|
2,233 |
|
TOTAL OPERATING LOSS |
|
11,414 |
|
|
14,777 |
|
|
5,285 |
|
|
7,551 |
|
FINANCIAL INCOME, net |
|
(760 |
) |
|
(597 |
) |
|
(359 |
) |
|
(481 |
) |
LOSS FOR THE PERIOD |
$ |
10,654 |
|
$ |
14,180 |
|
$ |
4,926 |
|
$ |
7,070 |
|
BASIC AND DILUTED LOSS PER ORDINARY SHARE |
$ |
0.56 |
|
$ |
0.64 |
|
$ |
0.26 |
|
$ |
0.31 |
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN
COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE |
|
18,949,968 |
|
|
22,143,099 |
|
|
18,949,968 |
|
|
22,920,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For further information, please
contact:
Sol-Gel Contact:
Gilad MamlokChief Financial
Officer+972-8-9313433
Investor Contact:
Lee M. SternSolebury
Trout+1-646-378-2922lstern@soleburytrout.com
Source: Sol-Gel Technologies Ltd.
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