|
•
|
Prescription volumes to date indicate strong uptake, similar to successful dermatology launches
|
|
•
|
Sol-Gel receives $3.5 million milestone payment from commercial partner Galderma Holding SA (“Galderma”) for
FDA approval of EPSOLAY
|
|
•
|
Sol-Gel’s cash runway expected to extend through the end of 2023
|
|
•
|
SGT-510 to enter clinical trial later this year
|
|
•
|
On June 2, 2022, Galderma announced the availability in the U.S of EPSOLAY (benzoyl peroxide cream, 5%) for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is the first and only benzoyl
peroxide topical treatment proven to relieve the bumps and blemishes of rosacea and provides rapid, significant and sustained relief.
|
|
•
|
On April 25, 2022, Sol-Gel announced FDA approval of EPSOLAY. Sol-Gel has granted to Galderma the exclusive rights to commercialize EPSOLAY in the U.S. A $3.5 million milestone payment was received by
Sol-Gel from Galderma related to the approval, in accordance with the U.S. commercialization agreement between the two companies and recorded as license revenue.
|
|
•
|
Following the introduction of TWYNEO by Galderma at the Annual Meeting of the American Academy of Dermatology, March 25-29 in Boston, MA, Sol-Gel announced TYWNEO was made commercially available to the U.S.
market.
|
|
•
|
Both the launch of TWYNEO and the approval of EPSOLAY were covered by various trade media outlets in print, video and audio by major beauty, personal care and industry publications and media outlets
including Allure magazine, Practical Dermatology, The Dermatologist, Medpagetoday.com, Healio.com, Personal Care Insights, Monthly Prescribing Reference (MPR) and Drug Topics.
|
|
•
|
Sol-Gel plans to progress SGT-510 into a clinical trial later this year and to progress other proprietary assets into clinical studies in the first half of next year.
|
|
December 31,
|
June 30,
|
|||||||
|
2021
|
2022
|
|||||||
|
A s s e t s
|
||||||||
|
CURRENT ASSETS:
|
||||||||
|
Cash and cash equivalents
|
$
|
20,085
|
$
|
5,765
|
||||
|
Bank deposits
|
21,448
|
21,000
|
||||||
|
Marketable securities
|
1,709
|
9,846
|
||||||
|
Receivables from collaborative arrangements
|
13,065
|
10,176
|
||||||
|
Prepaid expenses and other current assets
|
800
|
1,691
|
||||||
|
TOTAL CURRENT ASSETS
|
57,107
|
48,478
|
||||||
|
NON-CURRENT ASSETS:
|
||||||||
|
Long-term receivables from collaborative arrangements
|
7,402
|
2,499
|
||||||
|
Restricted long-term deposits and cash
|
1,298
|
1,289
|
||||||
|
Property and equipment, net
|
1,051
|
826
|
||||||
|
Operating lease right-of-use assets
|
1,501
|
1,153
|
||||||
|
Funds in respect of employee rights upon retirement
|
830
|
738
|
||||||
|
TOTAL NON-CURRENT ASSETS
|
12,082
|
6,505
|
||||||
|
TOTAL ASSETS
|
$
|
69,189
|
$
|
54,983
|
||||
|
Liabilities and shareholders' equity
|
||||||||
|
CURRENT LIABILITIES:
|
||||||||
|
Accounts payable
|
$
|
766
|
$
|
860
|
||||
|
Other accounts payable
|
10,145
|
1,664
|
||||||
|
Current maturities of operating leases
|
781
|
701
|
||||||
|
TOTAL CURRENT LIABILITIES
|
11,692
|
3,225
|
||||||
|
LONG-TERM LIABILITIES
|
||||||||
|
Operating leases liabilities
|
810
|
369
|
||||||
|
Liability for employee rights upon retirement
|
1,093
|
1,038
|
||||||
|
TOTAL LONG-TERM LIABILITIES
|
1,903
|
1,407
|
||||||
|
TOTAL LIABILITIES
|
$
|
13,595
|
$
|
4,632
|
||||
|
SHAREHOLDERS' EQUITY:
|
||||||||
|
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2021 and June 30, 2022; issued and outstanding: 23,126,804 and 23,129,469 as of December 31, 2021 and June 30, 2022, respectively.
|
638
|
638
|
||||||
|
Additional paid-in capital
|
233,098
|
233,586
|
||||||
|
Accumulated deficit
|
(178,142
|
)
|
(183,873
|
)
|
||||
|
TOTAL SHAREHOLDERS' EQUITY
|
55,594
|
50,351
|
||||||
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
$
|
69,189
|
$
|
54,983
|
||||
|
Six months ended
June 30
|
Three months ended
June 30
|
|||||||||||||||
|
2021
|
2022
|
2021
|
2022
|
|||||||||||||
|
COLLABORATION REVENUES
|
$
|
1,629
|
-
|
$
|
928
|
-
|
||||||||||
|
LICENSE REVENUES
|
-
|
3,521
|
-
|
3,518
|
||||||||||||
|
TOTAL REVENUES
|
$
|
1,629
|
$
|
3,521
|
$
|
928
|
$
|
3,518
|
||||||||
|
RESEARCH AND DEVELOPMENT EXPENSES
|
9,399
|
6,422
|
6,933
|
2,380
|
||||||||||||
|
GENERAL AND ADMINISTRATIVE EXPENSES
|
4,496
|
3,512
|
2,037
|
1,601
|
||||||||||||
|
TOTAL OPERATING LOSS
|
12,266
|
6,413
|
8,042
|
463
|
||||||||||||
|
FINANCIAL INCOME, net
|
(170
|
)
|
(682
|
)
|
(9
|
)
|
(329
|
)
|
||||||||
|
LOSS FOR THE PERIOD
|
$
|
12,096
|
$
|
5,731
|
$
|
8,033
|
$
|
134
|
||||||||
|
BASIC AND DILUTED LOSS PER ORDINARY SHARE
|
$
|
0.53
|
$
|
0.25
|
$
|
0.35
|
$
|
0.01
|
||||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
|
23,016,104
|
23,127,958
|
23,028,508
|
23,128,429
|
||||||||||||