Sol-Gel Technologies Reports Full Year 2019 Financial Results and Corporate Update
- Top-line generic product revenue of
$22.8 millionin fiscal 2019
- New Drug Applications for Epsolay® and Twyneo® remain on track for the second quarter and second half 2020, respectively
“I am very proud of the major milestones that were accomplished by
“In terms of COVID-19 impact,” continued Dr. Seri-Levy, “given that
Corporate Highlights and Recent Developments
- Strengthened balance sheet with underwritten public offerings of
$23 millionof gross proceeds in February 2020and $11.5 millionof gross proceeds in August 2019; Sol-Gel’s controlling shareholder, M. Arkin Dermatology Ltd., has agreed to invest an additional $5 millionon the same terms as the February 2020public offering, subject to shareholder approval.
- In the fiscal year 2019,
Sol-Gelgenerated revenue of $22.8 millionfrom its collaboration agreement with Perrigo.
September 2019, Sol-Gelwas granted a patent from the United States Patent and Trademark Office for a patent covering Twyneo for the treatment of acne vulgaris. The newly granted patent will extend protection to July 2038, which Sol-Gelbelieves will prevent the launch of AB-rated generics of Twyneo during the life of the patent
Clinical Program Updates
December 2019, Sol-Gelannounced that Twyneo met all co-primary endpoints in the treatment of patients with acne vulgaris. Sol-Gelexpects to file a NDA in the second half of 2020. If approved, Twyneo has the potential to become a preferred treatment for acne.
July 2019, Sol-Gelannounced that Epsolay met all primary and secondary endpoints in both Phase 3 trials in papulopustular rosacea. Epsolay also demonstrated a rapid onset of action with statistically significant improvement seen as early as Week 2 compared with vehicle. Sol-Gelexpects to file a NDA in the first half of 2020. If approved, Epsolay has the potential to be the first FDA-approved single-agent BPO prescription drug product and to redefine the standard of care for the treatment of inflammatory lesions associated with subtype II rosacea.
- A proof of concept clinical study of SGT-210, erlotinib gel, a topical epidermal growth factor receptor inhibitor, for the potential treatment of punctuate palmoplantar keratoderma type 1 initiated in
January 2020. Data is expected in the first half of 2021.
- In early 2020,
Sol-Geladded to its pre-clinical pipeline tapinarof, an aryl hydrocarbon receptor agonist, and roflumilast, a PDE4 inhibitor, each to be developed for potential treatment of psoriasis, as mono or combination therapies and other dermatological indications.
Financial Results for the Twelve Months Ended
Revenue in 2019 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 Twyneo, for the treatment of acne vulgaris, and Epsolay, for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, for the treatment of punctate 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 microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product.
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
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 upcoming events and presentations, the clinical progress of our product candidates, plans and timing for the release of clinical data, our expectations surrounding the progress of our generic product pipeline, and the sufficiency of our cash resources to meet our operating 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
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||5,325||$||9,412|
|Receivables from collaborative arrangements||-||4,120|
|Prepaid expenses and other current assets||2,987||1,293|
|TOTAL CURRENT ASSETS||65,974||55,791|
|Restricted long-term deposits||462||472|
|Property and equipment, net||2,604||2,314|
|Operating lease right-of-use assets||-||2,040|
|Funds in respect of employee rights upon retirement||642||684|
|TOTAL NON-CURRENT ASSETS||3,708||5,510|
|Liabilities and shareholders' equity|
|Other accounts payable||1,971||4,123|
|Current maturities of operating leases||-||672|
|TOTAL CURRENT LIABILITIES||4,895||6,505|
|Operating leases liabilities||-||1,373|
|Liability for employee rights upon retirement||878||958|
|TOTAL LONG-TERM LIABILITIES||878||2,331|
|Additional paid-in capital||190,853||203,977|
|TOTAL SHAREHOLDERS' EQUITY||63,909||52,465|
|TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY||$||69,682||$||61,301|
CONSOLIDATED STATEMENTS OF OPERATIONS
|Research and Development||25,805||28,146||40,578|
|General and Administrative||6,002||5,504||8,276|
|TOTAL OPERATING LOSS||31,633||33,521||25,950|
|FINANCIAL INCOME, net||(65)||(1,318)||(1,374)|
|LOSS BEFORE INCOME TAXES||31,568||33,203||24,576|
|LOSS FOR THE YEAR||$||31,568||$||32,203||$||24,609|
|BASIC AND DILUTED LOSS PER ORDINARY SHARE||$||5.02||$||1.80||$||1.26|
|WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE||6,290,244||17,867,589||19,534,562|
For further information, please contact:
Chief Financial Officer
Source: Sol-Gel Technologies Ltd.