|Bid||0.00 x 900|
|Ask||0.00 x 1300|
|Day's Range||13.74 - 15.15|
|52 Week Range||6.61 - 16.69|
|Beta (5Y Monthly)||1.44|
|PE Ratio (TTM)||N/A|
|Earnings Date||Mar 04, 2021|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||20.00|
There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...
In a recent note on the state of the stock markets, Raymond James equity strategist Tavis McCourt points out a series of policy factors that are playing a role in the current market volatility; the situation is more complex, perhaps, than most of us have been willing to admit. McCourt notes permutations of the SLR rule, political dynamics on the Senate Banking Committee, and the regulatory atmosphere towards potential capital return are all influencing the Fed’s moves and the market reactions. “We believe the Fed will do everything they can to ensure orderly trading in US Treasuries and does not want to see the volatility and liquidity concerns that have occurred in the last week/over the course of the pandemic. We also believe that the Fed is not interested in having a spike in yields as Treasury seeks to finance the next round of stimulus," McCourt opined. The strategist added, "While the SLR conversation is a political and market issue for the Fed, we believe that any Treasury and/or equity market sell-off tied to the debate is transitory and overblown. We are more focused on the improving economic environment, vaccine distribution, and reflation." Bearing this in mind, our focus turned to three stocks backed by Raymond James, with the firm’s analysts noting that each could soar over 50% from current levels. Running the tickers through TipRanks’ database, we found out that the rest of the Street is also on board, as each boasts a Moderate or Strong Buy consensus rating. Orasure Technologies (OSUR) We’ll start in the medical industry, a field that has seen gains through the pandemic year. Orasure, through its subsidiaries, is a producer of medical diagnostic tests, and is known for developing rapid test kits for HIV, HEP-C, and Ebola. In the past year, the company created over 150 jobs at its Bethlehem, Pennsylvania facilities as part of an effort to develop fast, at-home, COVID test kits. The company’s product line has a wide range of uses, and is marketed to clinical labs, hospitals, physician practices, and public health agencies world-wide. As can be imagined, Orasure has seen a quick recovery from a 1H20 revenue dip followed by strong gains. Q4 top-line revenues hit $62.9 million, for a 27% year-over-year gain. This was driven by product and services revenues, which grew 28% to reach $60.4 million. EPS was positive, at 3 cents per share, which was a good turnaround from negative results in the first half of the year – but was down 25% from 4Q19. For the full year, Orasure reported $172 million in net revenues, an 11% yoy gain. Of this total, $50 million came from sales of oral fluid collection devices (mouth swabs) for COVID-19 test kits. In addition, the company reported continued progress on its COVID-19 rapid antigen test, and plans to submit prescription self-tests and professional-grade tests for EUA (Emergency Use Authorization) by the FDA by the end of the first quarter. Analyst Andrew Cooper, in his coverage on the stock for Raymond James, saw plenty to like, ticking off the factors by the numbers: “What we liked: 1) Almost every revenue result. Orasure topped consensus sales estimates by 10%... 2) Concrete antigen EUA submission timeline. There is no misunderstanding an expected submission this month, with studies completed and only more administrative type work remaining... 3) More capacity expansion. Existing capacity timelines are on track, but management now intends to add another 50M of annual antigen capacity...” To this end, Cooper puts a $16 price target on the stock, implying a 52% one-year upside, and rates OSUR an Outperform (i.e. Buy). (To watch Cooper’s track record, click here) A solid reputation in the field, and clear path forward are sure to attract positive sentiment – and three Wall Street analysts have put Buy ratings on Orasure, making the analyst consensus a Strong Buy. Shares are priced at $10.49, and the $18.67 average price target is even more bullish than Coopers, suggesting a 78% upside for the next 12 months. (See OSUR stock analysis on TipRanks) Sol-Gel Technologies (SLGL) Sticking to the medical field, we’ll switch focus to a clinical stage pharmaceutical company. Sol-Gel is a biopharma with an interesting niche, developing topical medications for the treatment of skin diseases. The company’s pipeline includes two proprietary formulations based on benzoyl peroxide, both creams: Epsolay, which is a treatment for papulopustular rosacea, and Twyneo, a treatment for acne. Both medications had their NDAs (New Drug Applications) filed with the FDA, and final approval decision is expected in April and August of this year, respectively. Sol-Gel has, in addition, three other drug candidates in early stages of the pipeline process. Two are still in the research phase, while SGT-210 is in Phase I trial, with results due in 1H21. SGT-210 is a potential treatment for palmoplantar keratoderma, a thickening of the skin on the palms of the hands and feet which is sometimes seen as a symptom of several rare conditions. Furthermore, Sol-Gel is working in collaboration with Perrigo as the US manufacturer of generic labels of that company’s brand-name products. In 2020, the two companies signed four agreements, and now have 12 total collaboration projects. Among the fans is Raymond James analyst Elliot Wilbur who writes, "Given the large market opportunity in key pipeline products, coupled with recent acceptance of NDA submissions, we maintain our Strong Buy rating on SLGL shares, as we remain optimistic surrounding near-term growth prospects and financial positioning." The Strong Buy rating comes with a $23 price target, suggesting SLGL has room to grow an impressive 156% in the year ahead. (To watch Wilbur’s track record, click here) Small-cap biopharmas don’t always get a lot of analyst attention – they tend to fly under the radar. However, there are two reviews on file here and both are to Buy, making the consensus rating a Moderate Buy. SLGL shares are priced at $9, with an average price target of $22 indicating a runway toward ~145% upside for 2021. (See SLGL stock analysis on TipRanks) PAE (PAE) Let’s switch gears, and look at government support services. It’s no secret that governments are huge users of contract service companies, and PAE is a major provider of contract services for US government and defense agencies. PAE has operations on every continent and in 60 countries, providing a range of services, including analysis and training, intelligence, infrastructure operations, management and maintenance, logistic and material support, and information optimization. Until recently, PAE was a privately held company, but in February last year it was merged with Gores Holdings III in a SPAC transaction. The transaction brought PAE shares onto the NASDAQ exchange on February 10, 2020. 2021 has started with some changes in PAE’s contracts with the US government. At the end of January, the company lost a bid to renew a $125 million contract it had held with Customs and Border Patrol since 2009 – but earlier that same month, PAE was awarded a $3.3. billion contract with the US State Department. The contract with State involve consular operations at diplomatic facilities in 120 countries. 5-star analyst Brian Gesuale, in his coverage of PAE for Raymond James, notes the change in contracts, and does not believe it should trouble PAE. “PAE’s qualified pipeline still sits around $40B and pending awards north of $6B, which when combined with the company’s 2020 recompete win rate of 93% provides us confidence that CBP contract can be adequately replaced,” Gesuale commented. Turning to specifics on the State contract, Gesuale adds, “…this contract win could add upwards to $110 to $125 million of high-margin annual revenue to the 2022 model. Overall our estimates are going higher, and we continue to view PAE as one of the more compelling opportunities in the Government IT Services space. While we expect the group will face decelerating fundamentals and a potentially meaningful re-rating lower from near historically high valuations PAE should fare differently as it accelerates organic growth…” In line with these comments, the analyst puts an Outperform (i.e. Buy) rating on the stock, and his $15 price target implies a 77% one-year upside. (To watch Gesuale’s track record, click here) PAE stock has a resounding “yes” on Wall Street. TipRanks analytics show that out of 3 analysts, all 3 are bullish. The average price target of $12.67 shows a potential upside of about 50%. (See PAE stock analysis on TipRanks) To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
• Epsolay® and Twyneo® PDUFA goal dates set for April 26, 2021 and August 1, 2021 respectively • Top-line generic product revenue of $8.7 million in fiscal 2020 • Signed additional generic product collaboration agreements with Perrigo, bringing the number of collaborations between the companies to 12 NESS ZIONA, Israel, March 04, 2021 (GLOBE NEWSWIRE) -- 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 full year ended December 31, 2020 and provided corporate updates. “I am very pleased with the major milestones that were achieved by Sol-Gel last year. After announcing positive data from Phase 3 trials of Epsolay and Twyneo and submitting NDAs to the FDA within guided timelines, 2020 was highlighted by positive acceptances of both NDAs and allocated PDUFA dates,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Given the competitive landscape of the dermatology market and the significant capital that would be needed to directly commercialize our products, our current operational model assumes we will partner with a dermatology company that has a strong market presence. This would enable us to capture market share more quickly without the need to invest in building our own marketing and sales force and would allow us to further invest in the development of our pipeline of products with larger potential markets,” continued Dr. Seri-Levy. Corporate Highlights and Recent Developments Sol-Gel announced the U.S. Food and Drug Administration’s (FDA) acceptance of New Drug Application (NDA) for Epsolay (benzoyl peroxide, 5%, cream) with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first FDA-approved, single-agent benzoyl peroxide prescription drug product for the treatment of inflammatory lesions of rosacea.Sol-Gel announced FDA acceptance of NDA for Twyneo (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) with a PDUFA goal date set for August 1, 2021. If approved, Twyneo has the potential to be the first FDA-approved acne treatment that contains fixed-dose combination of benzoyl peroxide and tretinoin.Sol-Gel is in discussions with potential partners regarding the commercialization of Epsolay and Twyneo in the United States to occur if the product candidates receive regulatory approval from the FDA.In preparation for commercial launch of proprietary products the Company has opened a US headquarters in Whippany, NJ.Sol-Gel was informed by its collaboration partner that the launch of an FDA-approved generic drug is expected in the second quarter of 2021. Annual sales of the brand name product exceeded $180 million in the United States in 2019.In 2020, Sol-Gel signed four additional collaboration agreements with Perrigo for the development, manufacture, and commercialization of new generic product candidates, bringing the total number of collaborations between the companies to 12.Pre-clinical testing of erlotinib (an epidermal growth factor receptor inhibitor), tapinarof (an investigational aryl hydrocarbon receptor modulator), and roflumilast (an investigational phosphodiesterase 4 inhibitor) is progressing for various new pharmaceutical indications. A total of 25 provisional patent applications for these project candidates have been submitted to date.The enrollment of patients in the Phase 1 proof-of-concept study with SGT-210 (erlotinib gel) in patients with palmoplantar keratoderma has been slowed by the COVID-19 pandemic. The Company expects to report top-line data in the third quarter of 2021.In 2020, the Company completed financings totaling $28.0 million in gross proceeds, including the proceeds of the February underwritten public offering of $23.0 million and from the $5.0 million invested in April by Sol-Gel’s controlling shareholder, M. Arkin Dermatology Ltd. Financial Results for the Year Ended December 31, 2020 Revenue in 2020 was $8.8 million. The revenue was mainly due to sales of a generic product from a collaboration arrangement with Perrigo. Research and development expenses were $27.9 million in 2020 compared to $40.6 million during the same period in 2019. The decrease of $12.7 million was mainly attributed to a decrease of $17.9 million in clinical trial expenses, mainly due to the completion of the clinical trials of Epsolay and Twyneo towards the end of 2019, a decrease of $0.4 million in other expenses, mainly due to the purchase of raw material for manufacturing, partially offset by an increase of $5.4 million in manufacturing expenses. General and administrative expenses were $11.1 million in 2020 compared to $8.3 million in 2019. The increase of $2.8 million was mainly attributed to an increase of $3.0 million in commercialization expenses and an increase of $0.4 million in patent related expenses, partially offset by a decrease of $0.7 million in stock based compensation expenses. Sol-Gel reported a loss of $29.3 million for the full year of 2020 compared to loss of $24.6 million for the same period in 2019. As of December 31, 2020, Sol-Gel had $28.5 million in cash, cash equivalents and deposits, and $21.7 million in marketable securities for a total balance of $50.2 million. Sol-Gel expects its existing cash resources will enable funding of operational and capital expenditure requirements into the third quarter of 2022. 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 inflammatory lesions of rosacea. The Company’s pipeline also includes SGT-210 (erlotinib gel), under investigation for the treatment of palmoplantar keratoderma, and three pre-clinical assets – erlotinib, tapinarof and roflumilast – currently being tested for various pharmaceutical indications. 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, 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 PDUFA goal dates for Epsolay (benzoyl peroxide, 5%, cream) and Twyneo, the timing of commercialization of Epsolay and Twyneo, the timing and expected launch of an FDA-approved generic drug in the second quarter of 2021, and the timing of the Phase 1 data readout of SGT-210. 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) 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 to be filed with the Securities and Exchange Commission (“SEC”) on March 4, 2021 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. CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share and per share data) December 31 Assets 2019 2020 CURRENT ASSETS: Cash and cash equivalents $ 9,412 $ 7,122 Bank deposits - 21,400 Marketable securities 40,966 21,652 Receivables from collaborative arrangements 4,120 2,153 Prepaid expenses and other current assets 1,293 1,074 TOTAL CURRENT ASSETS 55,791 53,401 NON-CURRENT ASSETS: Restricted long-term deposits and cash 472 1,293 Property and equipment, net 2,314 1,817 Operating lease right-of-use assets 2,040 1,896 Funds in respect of employee rights upon retirement 684 754 TOTAL NON-CURRENT ASSETS 5,510 5,760 TOTAL ASSETS $ 61,301 $ 59,161 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable $ 1,710 $ 1,203 Other accounts payable 4,123 4,088 Current maturities of operating leases 672 673 TOTAL CURRENT LIABILITIES 6,505 5,964 LONG-TERM LIABILITIES: Operating leases liabilities 1,373 1,299 Liability for employee rights upon retirement 958 1,049 TOTAL LONG-TERM LIABILITIES 2,331 2,348 COMMITMENTS TOTAL LIABILITIES 8,836 8,312 SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2019 and 2020, respectively; issued and outstanding: 20,402,800 and 23,000,782 as of December 31, 2019 and December 31, 2020, respectively 561 635 Additional paid-in capital 203,977 231,577 Accumulated deficit (152,073 ) (181,363 ) TOTAL SHAREHOLDERS' EQUITY 52,465 50,849 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 61,301 $ 59,161 SOL-GEL TECHNOLOGIES LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) Year ended December 31, 2018 2019 2020 COLLABORATION REVENUES $ 129 $ 22,904 $ 8,771 OPERATING EXPENSES Research and Development 28,146 40,578 27,913 General and Administrative 5,504 8,276 11,091 TOTAL OPERATING LOSS 33,521 25,950 30,233 FINANCIAL INCOME, net (1,318 ) (1,374 ) (943 ) LOSS BEFORE INCOME TAXES 32,203 24,576 29,290 INCOME TAXES - 33 - LOSS FOR THE YEAR $ 32,203 $ 24,609 $ 29,290 BASIC AND DILUTED LOSS PER ORDINARY SHARE $ 1.80 $ 1.26 $ 1.30 WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 17,867,589 19,534,562 22,574,688 For further information, please contact: Sol-Gel Contact:Gilad MamlokChief Financial Officer+972-8-9313433 Investor Contact:Michael LevitanSolebury Troutemail@example.com Source: Sol-Gel Technologies Ltd.