Sol-Gel Technologies Reports Second Quarter 2020 Financial Results and Corporate Update
- New Drug Application for Epsolay® Submitted; Twyneo® New Drug Application on track for 2H 2020
- Top-line generic product revenue of
$1.1 millionin 2Q 2020
- Launch of additional generic product expected in 2Q 2021
“The second quarter had major milestones for
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
Corporate Highlights and Recent Developments
Sol-Gelsubmitted 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-Gelexpects 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, NJand has started the hiring process for key US-based employees.
- In the second quarter of 2020,
Sol-Gelgenerated revenue of $1.1 millionfrom its collaboration agreement with Perrigo Company plc(NYSE; TASE: PRGO). Sol-Gelexpanded 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-Gelhas been informed by its collaboration partner that the launch of a second generic drug is expected in the second quarter of 2021. Sol-Gelwill 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-Gelhas commenced a preclinical animal study with an erlotinib formulation, evaluating multiple concentration strengths for the treatment of UVB-induced actinic keratosis. Sol-Gelis starting a collaboration with a leading hospital in Israelto 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-Gelbelieves this is the first time tapinarof has been evaluated in ophthalmology indications. Pending positive results from this research, Sol-Gelwill explore partnerships for further development of these exciting opportunities.
Financial Results for the Three Months ended
Revenue in the second quarter of 2020 was
Research and development expenses were
General and administrative expenses were
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.
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.
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
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
CONSOLIDATED BALANCE SHEET
|(The amounts are stated in
|A s s e t s|
|Cash and cash equivalents||$||9,412||$||5,444|
|Receivables from collaborative arrangements||4,120||1,171|
|Prepaid expenses and other current assets||1,293||1,494|
|TOTAL CURRENT ASSETS||55,791||68,687|
|Restricted long-term deposits||472||1,284|
|Property and equipment, net||2,314||2,202|
|Operating lease right-of-use assets||2,040||1,777|
|Funds in respect of employee rights upon retirement||684||682|
|TOTAL NON-CURRENT ASSETS||5,510||5,945|
|Liabilities and shareholders' equity|
|Other accounts payable||4,123||5,154|
|Current maturities of operating leases||672||525|
|TOTAL CURRENT LIABILITIES||6,505||6,911|
|LONG-TERM LIABILITIES -|
|Operating leases liabilities||1,373||1,227|
|Liability for employee rights upon retirement||958||973|
|TOTAL LONG-TERM LIABILITIES||2,331||2,200|
|Additional paid-in capital||203,977||231,139|
|TOTAL SHAREHOLDERS' EQUITY||52,465||65,521|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||61,301||$||74,632|
CONSOLIDATED FINANCIAL STATEMENTS
(The amounts are stated in
|Six months ended
||Three months ended
|RESEARCH AND DEVELOPMENT EXPENSES||22,233||14,381||11,440||6,451|
|GENERAL AND ADMINISTRATIVE EXPENSES||3,332||4,994||1,638||2,233|
|TOTAL OPERATING LOSS||11,414||14,777||5,285||7,551|
|FINANCIAL INCOME, net||(760||)||(597||)||(359||)||(481||)|
|LOSS FOR THE PERIOD||$||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:
Chief Financial Officer
Source: Sol-Gel Technologies Ltd.