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Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update

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Sol-Gel Technologies (NASDAQ: SLGL) reported Q3 2022 financial results with revenue of $0.3 million, a significant decline from $8.8 million in Q3 2021. The decreased revenue is attributed to lower sales from EPSOLAY and TWYNEO, despite improvements in prescriber adoption. Research and development expenses dropped to $2.0 million from $6.0 million year-over-year, aiding in cash management. The company reported a loss of $3.4 million, down from a profit of $1.3 million in the previous year. However, Sol-Gel's cash runway is projected to last through Q1 2024, supported by ongoing partnerships.

Positive
  • Improved growth trends for TWYNEO and EPSOLAY.
  • Reduced research and development expenses from $6.0 million to $2.0 million year-over-year.
Negative
  • Revenue decreased from $8.8 million in Q3 2021 to $0.3 million in Q3 2022.
  • Reported a net loss of $3.4 million compared to a net income of $1.3 million in Q3 2021.
  • Growth trends for TWYNEO and EPSOLAY continue to improve, demonstrating robust uptake by prescribers
  • Sol-Gel’s cash runway expected to extend through the end of the first quarter of 2024

NESS ZIONA, Israel, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing, commercializing or partnering branded and generic topical drug products for the treatment of skin diseases, announced today financial results for the third quarter ended September 30, 2022 and provided a corporate update.

Alon Seri-Levy, PhD, Chief Executive Officer of Sol-Gel, stated, “We are very pleased with the continued growth trajectory for both TYWNEO and EPSOLAY and the effective commercial efforts of our partner, Galderma. We continue to see prescriber adoption, have received positive feedback from the dermatology community, and are pleased to report that royalty growth is now in line with volume growth.”

“We are now realizing a royalty stream from net sales of both of our partnered products and are turning our attention to building out our pipeline and to identifying new revenue-generating opportunities for our products in international markets.”

Third Quarter 2022 and Recent Corporate Developments

  • Continuous improvements in growth trends, prescriber uptake and payer coverage for newly launching brands, TWYNEO and EPSOLAY.
  • In October, Sol-Gel announced the appointment of Michael Glezin to the position of Vice President, Business Development.

Third Quarter Financial Results

Revenue was $0.3 million for the quarter ending September 30, 2022, which was received from the Sol-Gel’s commercial partner, Galderma, resulting from the sales of EPSOLAY and TWYNEO, and recorded as license revenue.This comparesto $8.8 million of revenue for the same period in 2021, which consisted of$7.5 million in Galderma licensing revenue and $1.3 million in collaboration revenue from partner Padagis.

Research and development expenses were $2.0 million for the quarter ending September 30, 2022, compared to $6.0 million for the same period in 2021. The decrease of $4.0 million was mainly attributed to a decrease of $2.3 million in expenses related to TWYNEO and EPSOLAY and a decrease of $1.8 million in research and development expenses related to the development of Sol-Gel’s proprietary assets.

General and administrative expenses were $1.8 million for the quarter ending September 30, 2022, compared to $2.1 million for the same period in 2021. The decrease of $0.3 million was mainly attributed to a decrease in professional services.

Sol-Gel reported a loss of $3.4 million for the third quarter of 2022 compared to net income of $1.3 million for the same period in 2021.

As of September 30, 2022, Sol-Gel had $25.5 million in cash, cash equivalents and deposits, and $9.8 million in marketable securities for a total balance of $35.3 million. the Company expects that its existing cash resources together with cash receipts from its previously announced agreements with Galderma regarding EPSOLAY and TWYNEO and the generics sale agreement with Padagis, will enable funding of operational and capital expenditure requirements through the first quarter of 2024.

About EPSOLAY

EPSOLAY is a topical cream containing benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY utilizes a proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile.

Visit www.epsolay.com for further information, including full Prescribing Information.

About TWYNEO

TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1% and benzoyl peroxide, 3% cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; 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. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream.

Visit www.twyneo.com for further information, including full Prescribing Information.

About Sol-Gel Technologies

Sol-Gel is a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leveraged its proprietary microencapsulation technology platform for TWYNEO, which is approved for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved for the treatment of inflammatory lesions of rosacea in adults. Both drugs are exclusively licensed to Galderma for U.S. commercialization. Founded in 1981, Galderma is the world’s largest independent dermatology company.

The Company’s pipeline also includes topical drug candidates SGT-210, SGT-310 and SGT-510 under investigation for the treatment of plaque psoriasis and other dermatologic indications.

For additional information, please visit www.sol-gel.com.

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 benefits we expect to receive under our agreement with Galderma; expected net sales and royalty income in line with volume growth of EPSOLAY and/or TWYNEO; and our expected cash runway. 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 expectations 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, the risk that we will not receive all of the anticipated benefits under our agreement with Galderma, the risk that EPSOLAY and/or TWYNEO will not provide treatment to the number of patients anticipated, risks that our cash runway will be shorter than expected, risks relating to the effects of COVID-19 (coronavirus) 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, the potential delay in receiving such regulatory approvals 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 April 4, 2022, as amended, 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. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.

For further information, please contact:

Investors:
Irina Koffler
Investor relations, LifeSci Advisors
ikoffler@lifesciadvisors.com 
+1 917 734 7387

Sol-Gel Technologies
Gilad Mamlok
Chief Financial Officer
gilad.mamlok@sol-gel.com 

 
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
         
  December 31,
  September 30,
 
  2021
  2022
 
A s s e t s        
CURRENT ASSETS:        
Cash and cash equivalents $20,085  $8,501 
Bank deposits  21,448   17,000 
Marketable securities  1,709   9,799 
Receivables from collaborative arrangements  13,065   10,783 
Prepaid expenses and other current assets  800   1,472 
TOTAL CURRENT ASSETS  57,107   47,555 
         
NON-CURRENT ASSETS:        
Long-term receivables from collaborative arrangements  7,402   - 
Restricted long-term deposits and cash  1,298   1,287 
Property and equipment, net  1,051   728 
Operating lease right-of-use assets  1,501   988 
Funds in respect of employee rights upon retirement  830   730 
TOTAL NON-CURRENT ASSETS  12,082   3,733 
         
TOTAL ASSETS $69,189  $51,288 
         
Liabilities and shareholders' equity        
         
CURRENT LIABILITIES:        
Accounts payable $766  $167 
Other accounts payable  10,145   1,741 
Current maturities of operating leases liabilities  781   689 
TOTAL CURRENT LIABILITIES  11,692   2,597 
         
LONG-TERM LIABILITIES:        
Operating leases liabilities  810   193 
Liability for employee rights upon retirement  1,093   1,024 
TOTAL LONG-TERM LIABILITIES  1,903   1,217 
COMMITMENTS        
TOTAL LIABILITIES $13,595  $3,814 
         
SHAREHOLDERS' EQUITY:        
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of
December 31, 2021 and September 30, 2022; issued and outstanding:
23,000,782 and 23,129,469 as of December 31, 2021 and September
30, 2022, respectively.
  638   638 
Additional paid-in capital  233,098   234,116 
Accumulated deficit  (178,142)  (187,280)
TOTAL SHAREHOLDERS' EQUITY  55,594   47,474 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $69,189  $51,288 


SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
 
 Nine months ended
  Three months ended
 September 30, 
  September 30,
  2021   2022   2021   2022 
COLLABORATION REVENUES$2,965   -  $1,336   - 
LICENSE REVENUES$7,500  $3,783  $7,500  $261 
TOTAL REVENUE 10,465   3,783   8,836   261 
RESEARCH AND DEVELOPMENT EXPENSES 15,388   8,465   5,989   2,042 
GENERAL AND ADMINISTRATIVE EXPENSES 6,625   5,357   2,129   1,844 
OTHER INCOME, net 554   -   554   - 
OPERATING INCOME (LOSS) (10,994)  (10,039)  1,272   (3,625)
FINANCIAL INCOME, net 184   901   14   218 
NET INCOME (LOSS) FOR THE PERIOD$(10,810) $(9,138) $1,286  $(3,407)
BASIC INCOME (LOSS) PER ORDINARY SHARE  (0.47)  (0.40)  0.06   (0.15)
DILUTED INCOME (LOSS) PER ORDINARY SHARE (0.47)  (0.40)  0.05   (0.15)
WEIGHTED AVERAGE NUMBER OF SHARES               
OUTSTANDING USED IN COMPUTATION OF
INCOME (LOSS) PER SHARE :
               
BASIC 23,043,701   23,128,469   23,097,379   23,129,469 
DILUTED 23,043,701   23,128,469   23,682,601   23,129,469 


FAQ

What are the Q3 2022 earnings results for Sol-Gel (SLGL)?

For Q3 2022, Sol-Gel reported revenue of $0.3 million and a net loss of $3.4 million.

How has Sol-Gel's revenue changed compared to Q3 2021?

Revenue decreased significantly from $8.8 million in Q3 2021 to $0.3 million in Q3 2022.

What is Sol-Gel's cash runway situation?

Sol-Gel expects its cash runway to extend through the end of Q1 2024, totaling $35.3 million in cash and securities.

What developments occurred in Q3 2022 for Sol-Gel (SLGL)?

The company witnessed improved prescriber uptake for its products and appointed a new Vice President of Business Development.

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