$VYNE
VYNE Therapeutics Inc.

2023 Q4 Form 10-Q Financial Statement

#000162828023038414 Filed on November 13, 2023

View on sec.gov

Income Statement

Concept 2023 Q4 2023 Q3
Revenue $76.00K $114.0K
YoY Change 1166.67% -31.74%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $3.885M $3.030M
YoY Change 4.69% -23.37%
% of Gross Profit
Research & Development $3.023M $3.318M
YoY Change -29.35% -40.17%
% of Gross Profit
Depreciation & Amortization $0.00 $0.00
YoY Change -100.0% -100.0%
% of Gross Profit
Operating Expenses $6.908M $6.348M
YoY Change -13.54% -33.18%
Operating Profit -$6.234M
YoY Change -33.2%
Interest Expense $0.00
YoY Change
% of Operating Profit
Other Income/Expense, Net $680.0K $163.0K
YoY Change 188.14% 108.97%
Pretax Income -$6.152M -$6.071M
YoY Change -20.6% -34.4%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$6.188M -$6.584M
YoY Change -37.78% -30.39%
Net Earnings / Revenue -8142.11% -5775.44%
Basic Earnings Per Share -$2.01
Diluted Earnings Per Share -$0.20 -$2.01
COMMON SHARES
Basic Shares Outstanding 13.96M shares 3.280M shares
Diluted Shares Outstanding 3.282M shares

Balance Sheet

Concept 2023 Q4 2023 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $93.25M $15.40M
YoY Change 201.71% -56.63%
Cash & Equivalents $30.62M $15.45M
Short-Term Investments $62.63M
Other Short-Term Assets $65.34M $1.900M
YoY Change 2878.26% -38.01%
Inventory
Prepaid Expenses
Receivables $250.0K
Other Receivables $0.00
Total Short-Term Assets $95.96M $17.51M
YoY Change 150.72% -60.24%
LONG-TERM ASSETS
Property, Plant & Equipment $207.0K
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.515M $1.800M
YoY Change -38.99% -34.19%
Total Long-Term Assets $1.722M $1.756M
YoY Change -30.65% -38.64%
TOTAL ASSETS
Total Short-Term Assets $95.96M $17.51M
Total Long-Term Assets $1.722M $1.756M
Total Assets $97.69M $19.27M
YoY Change 139.67% -58.93%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.659M $700.0K
YoY Change -30.47% -72.26%
Accrued Expenses $4.119M $4.452M
YoY Change -5.98% 105.73%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $7.538M $6.449M
YoY Change -19.34% -5.7%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.412M $1.300M
YoY Change
Total Long-Term Liabilities $1.412M $1.300M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $7.538M $6.449M
Total Long-Term Liabilities $1.412M $1.300M
Total Liabilities $8.950M $7.762M
YoY Change -4.23% 13.5%
SHAREHOLDERS EQUITY
Retained Earnings -$691.3M -$685.1M
YoY Change 4.32% 4.95%
Common Stock $1.000K $0.00
YoY Change -100.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $88.74M $11.51M
YoY Change
Total Liabilities & Shareholders Equity $97.69M $19.27M
YoY Change 139.67% -58.93%

Cashflow Statement

Concept 2023 Q4 2023 Q3
OPERATING ACTIVITIES
Net Income -$6.188M -$6.584M
YoY Change -37.78% -30.39%
Depreciation, Depletion And Amortization $0.00 $0.00
YoY Change -100.0% -100.0%
Cash From Operating Activities -$5.137M -$5.150M
YoY Change 32.57% -27.72%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities -$62.35M $0.00
YoY Change 6568.88% -100.0%
Cash From Investing Activities -$62.35M $0.00
YoY Change 6568.88% -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 82.66M -50.00K
YoY Change 39641.83% 92.31%
NET CHANGE
Cash From Operating Activities -5.137M -5.150M
Cash From Investing Activities -62.35M 0.000
Cash From Financing Activities 82.66M -50.00K
Net Change In Cash 15.17M -5.200M
YoY Change -429.68% -28.15%
FREE CASH FLOW
Cash From Operating Activities -$5.137M -$5.150M
Capital Expenditures
Free Cash Flow
YoY Change

Facts In Submission

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us-gaap Nature Of Operations
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NATURE OF OPERATIONS<div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">VYNE Therapeutics Inc. (the "Company") is a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">In August 2021, the Company entered into a transaction with Tay Therapeutics Limited (formerly known as In4Derm Limited, "Tay") providing the Company with exclusive worldwide rights to research, develop and commercialize products containing bromodomain and extra-terminal (“BET”) inhibitors for the treatment of any disease, disorder or condition in humans. Through the Company's access to this library of new chemical BET inhibitor compounds, the Company plans to develop product candidates for a diverse set of indications. Based on preclinical data generated to date, the Company has chosen to focus its initial efforts for this platform on select therapeutic areas in immuno-inflammatory disease.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company's lead program is VYN201, a locally administered pan-BD BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. To date, VYN201 has produced consistent reductions in pro-inflammatory and disease-related biomarkers, improvements in disease severity and a demonstrated local activity through several preclinical models. In November 2022, the Company initiated a Phase 1a/b clinical trial evaluating a topical formulation of VYN201 for the treatment of nonsegmental vitiligo. In February 2023, the Company announced positive preliminary safety and tolerability data from the Phase 1a portion of the trial. In addition, in March 2023, the Company announced positive pharmacokinetic and hematology data from the Phase 1a trial. The first nonsegmental vitiligo patient was dosed in the Phase 1b portion of the trial in January 2023, and on October 30, 2023, the Company announced positive data from the Phase 1b trial noting that significant clinical improvement in facial vitiligo area scoring index ("F-VASI") was observed in the 1% and 2% cohorts of participating subjects after 16 weeks of treatment. The Company has initiated Phase 2b preparatory activities and expects to advance VYN201 into a longer duration Phase 2b trial to evaluate optimal dosing and peak efficacy in patients with active and stable nonsegmental vitiligo in the first half of 2024. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company's second program is VYN202, an oral small molecule BD2-selective BET inhibitor. VYN202 is in preclinical development for the treatment of immuno-inflammatory indications, and has been designed to achieve class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2 and optimal oral bioavailability. By maximizing BD2 selectivity, the Company believes VYN202 has the potential to be a more conveniently-administered non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, where the damaging effects of unrestricted inflammatory signaling activity are common. The Company expects to submit its IND for VYN202 by year-end 2023 and commence a first-in-human Phase 1a single ascending dose/multiple ascending dose trial in the first quarter of 2024. Upon successful completion of the Phase 1a study, the Company expects to initiate Phase 1b trials in moderate-to-severe plaque psoriasis and in moderate-to-severe adult-onset rheumatoid arthritis in the second half of 2024. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company intends to advance its product candidates through the clinic toward regulatory approval, and may also partner with leading pharmaceutical companies to expand and accelerate the development of its programs and explore therapeutic areas outside of its core focus in immunology to maximize the value of its pipeline.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">In August 2021, the Company determined to dispose of its legacy commercial business and focus its strategy on the development of BET inhibitor product candidates through its licensing arrangements with Tay. For additional information regarding the sale of the Molecule Stabilizing Technology franchise, including AMZEEQ, ZILXI, and FCD105 (the “MST Franchise”) to Journey Medical Corporation ("Journey") in January 2022 and the Company's licensing arrangements with Tay, see "—Note 3 - Strategic Agreements." </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company is a Delaware corporation, has its principal executive offices in Bridgewater, New Jersey and operates as one business segment.</span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:100%">Reverse stock split and recasting of per-share amounts</span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On February 8, 2023, the Company's board of directors approved a 1-for-18 reverse stock split of its outstanding shares of common stock. The reverse stock split was effected on February 10, 2023 at 5:01 p.m. Eastern time. At the effective time, every 18 issued and outstanding shares of the Company's common stock were converted into one share of common stock. No fractional shares were issued in connection with the reverse stock split, and in lieu thereof, each stockholder holding fractional shares was entitled to receive a cash payment (without interest or deduction) from the Company’s transfer agent in an amount equal to such stockholder’s respective pro rata shares of the total net proceeds from the Company’s transfer agent sale of all fractional shares at the then-prevailing prices on the open market. A proportionate adjustment was also made to the maximum </span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">number of shares issuable under the Company’s 2019 Equity Incentive Plan, 2018 Omnibus Incentive Plan and 2019 Employee Share Purchase Plan. The number of authorized shares of the Company's common stock and the par value of each share of common stock remained unchanged. </span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Unless noted, all common stock and per share amounts contained in the unaudited condensed consolidated financial statements have been retroactively adjusted to reflect a 1-for-18 reverse stock split.</span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Liquidity and Capital Resources </span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Since inception, the Company has funded operations primarily through private and public placements of its equity, debt and warrants and through fees, cost reimbursements and payments received from its licensees. The Company commenced generating product revenues related to sales of AMZEEQ and ZILXI in January 2020 and October 2020, respectively. AMZEEQ and ZILXI were sold as part of the sale of the MST Franchise on January 12, 2022 and, as such, the Company no longer generates revenue from the sale of these products. The Company has incurred losses and experienced negative operating cash flows since its inception and anticipates that it will continue to incur losses until such a time when its product candidates, if approved, are commercially successful, if at all. The Company will not generate any revenue from any current or future product candidates unless and until it obtains regulatory approval and commercializes such products. For the nine months ended September 30, 2023, the Company incurred a net loss of $22.3 million and used $20.2 million of cash in operations. </span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">As of September 30, 2023, the Company had cash and cash equivalents, and restricted cash of $15.5 million and an accumulated deficit of $685.1 million. The Company received a $5.0 million deferred payment from Journey on January 12, 2023, the one-year anniversary of the sale of the MST Franchise. The Company had no outstanding debt as of September 30, 2023. In addition, on November 1, 2023, the Company completed a private placement of common stock and pre-funded warrants (the "Private Placement") resulting in aggregate gross proceeds to the Company of $88.2 million.</span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In March 2022, the Company entered into an equity purchase agreement (the “Equity Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $30.0 million of shares of its common stock over the 36-month term of the Equity Purchase Agreement. The Company has not made any sales pursuant to the Equity Purchase Agreement to date. On October 30, 2023, the Company delivered a notice of termination to Lincoln Park to terminate the Equity Purchase Agreement.</span></div><div style="margin-top:10pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In accordance with Accounting Standards Codification (“ASC”) Subtopic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that its unaudited interim condensed consolidated financial statements are issued. As of the report date, the Company believes its existing cash and cash equivalents and restricted cash, including the proceeds received from the Private Placement, are sufficient to fund its operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of these unaudited interim condensed consolidated financial statements. If the Company's available cash and cash equivalents and restricted cash are insufficient to satisfy its liquidity requirements, the Company may need to raise additional capital to fund its operations. No assurance can be given as to whether additional needed financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, the Company may be required to suspend or forego certain planned activities. Failure to manage discretionary spending or raise additional financing, as needed, would adversely impact the Company’s ability to achieve its intended business objectives and have an adverse effect on its results of operations and future prospects.</span></div>
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Use of EstimatesThe preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of income and expenses during the reporting period. Significant items subject to such estimates and assumptions include revenue recognition, product return and research and development accruals. Actual results could differ from the Company’s estimates.
CY2023Q3 vyne Accrued Sales Provisions Current
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us-gaap Concentration Risk Credit Risk
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Concentration of credit risksFinancial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, restricted cash and accounts receivables. The Company deposits cash and cash equivalents with highly rated financial institutions and, as a matter of policy, limits the amounts of credit exposure to any single financial institution. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments.
CY2023Q1 vyne Disposal Group Including Discontinued Operation Consideration Receivable
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CY2023Q1 vyne Stock Redeemed Or Called During Period Price As Percentage Of Stated Value
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27509 shares
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76.08
us-gaap Stock Issued During Period Shares Employee Stock Purchase Plans
StockIssuedDuringPeriodSharesEmployeeStockPurchasePlans
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us-gaap Stock Issued During Period Shares Employee Stock Purchase Plans
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vyne Share Based Compensation Arrangement By Share Based Payment Award Options And Equity Instruments Other Than Options Grants In Period Total Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsAndEquityInstrumentsOtherThanOptionsGrantsInPeriodTotalGrantDateFairValue
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vyne Share Based Compensation Arrangement By Share Based Payment Award Options And Equity Instruments Other Than Options Grants In Period Total Grant Date Fair Value
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CY2023Q3 us-gaap Operating Lease Liability
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CY2023Q3 us-gaap Operating Lease Right Of Use Asset
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CY2022Q2 vyne Lessee Proceeds From Lien Release
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CY2023Q3 us-gaap Loss Contingency Pending Claims Number
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