$VYNE
VYNE Therapeutics Inc.

2023 Q3 Form 10-Q Financial Statement

#000162828023029334 Filed on August 14, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2
Revenue $114.0K $135.0K
YoY Change -31.74% 7.14%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $3.030M $3.220M
YoY Change -23.37% -25.2%
% of Gross Profit
Research & Development $3.318M $7.233M
YoY Change -40.17% 76.07%
% of Gross Profit
Depreciation & Amortization $0.00 $0.00
YoY Change -100.0% -100.0%
% of Gross Profit
Operating Expenses $6.348M $10.45M
YoY Change -33.18% 24.25%
Operating Profit -$6.234M -$10.32M
YoY Change -33.2% 24.51%
Interest Expense $0.00
YoY Change
% of Operating Profit
Other Income/Expense, Net $163.0K $280.0K
YoY Change 108.97% 438.46%
Pretax Income -$6.071M -$10.04M
YoY Change -34.4% 21.89%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$6.584M -$10.06M
YoY Change -30.39% 18.66%
Net Earnings / Revenue -5775.44% -7450.37%
Basic Earnings Per Share -$2.01 -$3.09
Diluted Earnings Per Share -$2.01 -$3.09
COMMON SHARES
Basic Shares Outstanding 3.280M shares 3.271M shares
Diluted Shares Outstanding 3.282M shares 3.274M shares

Balance Sheet

Concept 2023 Q3 2023 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $15.40M $20.63M
YoY Change -56.63% -51.81%
Cash & Equivalents $15.45M $20.63M
Short-Term Investments
Other Short-Term Assets $1.900M $2.091M
YoY Change -38.01% -45.0%
Inventory
Prepaid Expenses
Receivables $250.0K $234.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $17.51M $22.96M
YoY Change -60.24% -55.78%
LONG-TERM ASSETS
Property, Plant & Equipment
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.800M $2.000M
YoY Change -34.19% -32.75%
Total Long-Term Assets $1.756M $2.000M
YoY Change -38.64% -38.88%
TOTAL ASSETS
Total Short-Term Assets $17.51M $22.96M
Total Long-Term Assets $1.756M $2.000M
Total Assets $19.27M $24.96M
YoY Change -58.93% -54.78%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $700.0K $1.159M
YoY Change -72.26% -19.01%
Accrued Expenses $4.452M $4.379M
YoY Change 105.73% 24.62%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $6.449M $6.374M
YoY Change -5.7% -6.74%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.300M $1.313M
YoY Change
Total Long-Term Liabilities $1.300M $1.313M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $6.449M $6.374M
Total Long-Term Liabilities $1.300M $1.313M
Total Liabilities $7.762M $7.687M
YoY Change 13.5% 12.47%
SHAREHOLDERS EQUITY
Retained Earnings -$685.1M -$678.6M
YoY Change 4.95% 5.49%
Common Stock $0.00 $0.00
YoY Change -100.0% -100.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $11.51M $17.27M
YoY Change
Total Liabilities & Shareholders Equity $19.27M $24.96M
YoY Change -58.93% -54.78%

Cashflow Statement

Concept 2023 Q3 2023 Q2
OPERATING ACTIVITIES
Net Income -$6.584M -$10.06M
YoY Change -30.39% 18.66%
Depreciation, Depletion And Amortization $0.00 $0.00
YoY Change -100.0% -100.0%
Cash From Operating Activities -$5.150M -$9.574M
YoY Change -27.72% 16.4%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00
YoY Change -100.0%
Cash From Investing Activities $0.00 $0.00
YoY Change -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 -50.00K -5.000K
YoY Change 92.31% -91.8%
NET CHANGE
Cash From Operating Activities -5.150M -9.574M
Cash From Investing Activities 0.000 0.000
Cash From Financing Activities -50.00K -5.000K
Net Change In Cash -5.200M -9.579M
YoY Change -28.15% 15.6%
FREE CASH FLOW
Cash From Operating Activities -$5.150M -$9.574M
Capital Expenditures
Free Cash Flow
YoY Change

Facts In Submission

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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-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. The Company believes that these data suggest potential broad utility for VYN201 across multiple routes of administration. 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. The Company expects to announce preliminary Phase 1b safety and efficacy data in the third quarter of 2023, followed by final results in October 2023. </span></div><div><span><br/></span></div><div style="text-align:justify"><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. IND-enabling studies for VYN202 are ongoing, and the Company anticipates filing an IND by year-end 2023. </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 actively evaluate and enter into strategic partnerships to advance its product candidates through the clinic toward commercialization, and may also partner with leading pharmaceutical companies to advance the Company's molecules in therapeutic areas outside of its core focus in immunology. The Company believes selectively entering into collaborations has the potential to expand and accelerate the development of its programs and 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 number of shares issuable under the Company’s 2019 Equity Incentive Plan, 2018 Omnibus Incentive Plan and 2019 Employee </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%">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 six months ended June 30, 2023, the Company incurred a net loss of $15.7 million and used $15.1 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 June 30, 2023, the Company had cash and cash equivalents, and restricted cash of $20.7 million and an accumulated deficit of $678.6 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 June 30, 2023.</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. </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 described above, the Company refocused its limited resources on its immuno-inflammatory pipeline. Continued research and development activities for these programs, including preclinical and clinical testing of the Company's product candidates, will require significant additional financing. The future viability of the Company and its ability to continue as a going concern is dependent on its ability to raise sufficient working capital through either debt or equity financings to fund its operations and successfully develop commercially viable product candidates. There is no assurance the Company will be able to achieve these objectives under acceptable terms or at all.</span></div><div style="text-align:justify"><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">In accordance with Accounting Standards Update (“ASU”) 2014-15, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:115%">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%"> (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that its unaudited interim condensed consolidated financial statements are issued. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. The Company's ability to continue as a going concern is expected to be impacted by the outcome of the plans outlined above, including the Company's ability to raise additional capital to fund its operations and the development and results from clinical trials for the BET inhibitor programs. Based on its current plans and assumptions, the Company believes that absent sufficient proceeds received from financing transactions or business development transactions, the Company will not have sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these unaudited interim condensed consolidated financial statements. This assumption does not include proceeds that can be drawn from Lincoln Park. Accordingly, the Company will, over the course of the next twelve months, require significant additional financing to continue its operations and meaningfully advance the development of its product candidates, including potentially selling a significant amount of shares pursuant to the Equity Purchase Agreement. The Company may also employ strategies to further extend its ability to fund its operations including: (1) identification of third-party partners to further develop, obtain marketing approval for and/or commercialize its product candidates, which may generate revenue and/or milestone payments and/or (2) refocusing its resources on research and development programs it chooses to prioritize and reducing spending on other programs by delaying or discontinuing development.</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:115%"> </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">In addition, the amount of proceeds the Company may be able to raise pursuant to its existing shelf registration statement on Form S-3 may be limited. As of the filing of this Quarterly Report on Form 10-Q, the Company is subject to the general instructions of Form S-3 known as the "baby shelf rules." Under these instructions, the amount of funds the Company can raise through primary public offerings of securities in any 12-month period using its registration statement on Form S-3 is limited to one-third of the aggregate market value of the shares of its common stock held by non-affiliates of the Company. Therefore, the Company will be limited in the amount of proceeds it is able to raise by selling shares of its common stock using its Form S-3 until such time as its public float exceeds $75.0 million. These factors raise substantial doubt about the Company's ability to continue as a going concern. Failure to successfully receive additional financing will require the Company to delay, </span></div>scale back or otherwise modify its business and its research and development activities and other operations. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern.
us-gaap Number Of Reportable Segments
NumberOfReportableSegments
1 segment
us-gaap Net Income Loss
NetIncomeLoss
-15700000 usd
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-15100000 usd
CY2023Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
20700000 usd
CY2023Q2 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-678600000 usd
CY2023Q2 us-gaap Long Term Debt
LongTermDebt
0 usd
CY2023Q2 vyne Sale Of Stock Public Float Threshold
SaleOfStockPublicFloatThreshold
75000000 usd
us-gaap Use Of Estimates
UseOfEstimates
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.
CY2023Q2 vyne Accrued Sales Provisions Current
AccruedSalesProvisionsCurrent
1900000 usd
CY2022Q4 vyne Accrued Sales Provisions Current
AccruedSalesProvisionsCurrent
2700000 usd
us-gaap Provision For Doubtful Accounts
ProvisionForDoubtfulAccounts
0 usd
CY2022 us-gaap Provision For Doubtful Accounts
ProvisionForDoubtfulAccounts
0 usd
us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
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
DisposalGroupIncludingDiscontinuedOperationConsiderationReceivable
5000000 usd
CY2023Q2 us-gaap Restricted Cash
RestrictedCash
100000 usd
CY2022 vyne Employee Retention Tax Credit
EmployeeRetentionTaxCredit
1300000 usd
CY2023Q1 vyne Proceeds From Employee Retention Tax Credit
ProceedsFromEmployeeRetentionTaxCredit
1300000 usd
CY2023Q2 us-gaap Other Liabilities
OtherLiabilities
1300000 usd
CY2023Q2 vyne Disposal Group Milestone Payments Receivable Upon Achievement Of Net Sales
DisposalGroupMilestonePaymentsReceivableUponAchievementOfNetSales
450000000 usd
vyne Milestone Payments Upon Achieving Certain Criteria Exceeding Annual Net Sales
MilestonePaymentsUponAchievingCertainCriteriaExceedingAnnualNetSales
100000000 usd
vyne Amount Due From Sale Of Mst Franchise1
AmountDueFromSaleOfMSTFranchise1
5000000 usd
CY2023Q2 us-gaap Temporary Equity Shares Authorized
TemporaryEquitySharesAuthorized
20000000 shares
CY2023Q2 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.0001
CY2023Q1 vyne Stock Redeemed Or Called During Period Price As Percentage Of Stated Value
StockRedeemedOrCalledDuringPeriodPriceAsPercentageOfStatedValue
1.20
CY2023Q2 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
150000000 shares
CY2023Q2 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.0001
CY2023Q2 us-gaap Class Of Warrant Or Right Number Of Securities Called By Warrants Or Rights
ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights
27509 shares
CY2023Q2 us-gaap Class Of Warrant Or Right Exercise Price Of Warrants Or Rights1
ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1
76.08
us-gaap Stock Issued During Period Shares Employee Stock Purchase Plans
StockIssuedDuringPeriodSharesEmployeeStockPurchasePlans
8339 shares
us-gaap Stock Issued During Period Shares Employee Stock Purchase Plans
StockIssuedDuringPeriodSharesEmployeeStockPurchasePlans
3704 shares
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
0 usd
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
800000 usd
CY2023Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
876000 usd
CY2022Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1163000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1732000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2056000 usd
CY2023Q2 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
300000 usd
CY2023Q2 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
0 usd
CY2023Q2 us-gaap Operating Lease Liability
OperatingLeaseLiability
0 usd
CY2022Q2 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.1310
CY2022Q2 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P0Y3M
CY2022Q2 vyne Restricted Investments To Secure Lease Agreements
RestrictedInvestmentsToSecureLeaseAgreements
600000 usd
CY2022Q2 vyne Lessee Proceeds From Lien Release
LesseeProceedsFromLienRelease
600000 usd
CY2023Q2 us-gaap Loss Contingency Pending Claims Number
LossContingencyPendingClaimsNumber
0 claim

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