$VYNE
VYNE Therapeutics Inc.

2020 Q1 Form 10-K Financial Statement

#000156459020008442 Filed on March 03, 2020

View on sec.gov

Income Statement

Concept 2020 Q1 2019 Q4 2019 Q3
Revenue $1.750M $135.0K $0.00
YoY Change 468.18%
Cost Of Revenue $41.64M $0.00 $23.20M
YoY Change 157.16%
Gross Profit -$39.89M $135.0K -$23.20M
YoY Change 151.13%
Gross Profit Margin -2279.37% 100.0%
Selling, General & Admin $25.42M $10.17M $10.75M
YoY Change 375.94% 202.68% 253.52%
% of Gross Profit 7533.33%
Research & Development $15.95M $11.76M $12.45M
YoY Change 0.19% -22.02% 16.73%
% of Gross Profit 8711.11%
Depreciation & Amortization $93.00K -$200.0K $100.0K
YoY Change 16.25% -2100.0%
% of Gross Profit -148.15%
Operating Expenses $41.37M $21.93M $17.43M
YoY Change 110.32% 18.93% 27.18%
Operating Profit -$39.89M -$37.43M -$23.20M
YoY Change 151.13% 69.31%
Interest Expense $1.067M $433.0K $571.0K
YoY Change 34.05% -48.82% -33.22%
% of Operating Profit
Other Income/Expense, Net $723.0K $571.0K
YoY Change -9.17% -33.22%
Pretax Income -$40.23M -$21.50M -$23.16M
YoY Change 161.59% 22.23% 80.24%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$40.23M -$21.50M -$23.16M
YoY Change 113.18% 22.19% 80.28%
Net Earnings / Revenue -2299.03% -15924.44%
Basic Earnings Per Share
Diluted Earnings Per Share -$3.785M -$3.560M -$919.0K
COMMON SHARES
Basic Shares Outstanding 24.44M 23.98M 23.95M
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q1 2019 Q4 2019 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $57.60M $60.44M $91.40M
YoY Change -52.59% -55.66% -40.14%
Cash & Equivalents $57.60M $43.76M $40.53M
Short-Term Investments $0.00 $16.68M $57.10M
Other Short-Term Assets $29.30M $19.10M $2.100M
YoY Change 691.89% 478.79% 16.67%
Inventory $3.200M $1.356M
Prepaid Expenses
Receivables $8.300M $135.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $98.40M $76.41M $93.43M
YoY Change -21.42% -45.22% -39.52%
LONG-TERM ASSETS
Property, Plant & Equipment $4.600M $2.885M $113.0K
YoY Change 3116.78% 1876.03% -16.91%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $2.000M
YoY Change
Other Assets $53.50M $166.0K $200.0K
YoY Change 26650.0% -44.67% -43.5%
Total Long-Term Assets $62.10M $4.745M $3.147M
YoY Change 5660.67% 1008.64% 542.24%
TOTAL ASSETS
Total Short-Term Assets $98.40M $76.41M $93.43M
Total Long-Term Assets $62.10M $4.745M $3.147M
Total Assets $160.5M $81.16M $96.58M
YoY Change 27.08% -42.0% -37.68%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $14.10M $3.771M $2.992M
YoY Change 271.05% 14.62% 10.73%
Accrued Expenses $13.50M $3.381M $5.719M
YoY Change 110.94% -45.94% 6.7%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $56.60M $29.33M $9.452M
YoY Change 433.96% 207.27% 17.24%
LONG-TERM LIABILITIES
Long-Term Debt $32.80M $32.73M $0.00
YoY Change
Other Long-Term Liabilities $1.600M $1.500M $100.0K
YoY Change 21328.57% 733.33%
Total Long-Term Liabilities $34.40M $34.26M $100.0K
YoY Change 489300.0% 733.33%
TOTAL LIABILITIES
Total Short-Term Liabilities $56.60M $29.33M $9.452M
Total Long-Term Liabilities $34.40M $34.26M $100.0K
Total Liabilities $91.00M $63.58M $9.574M
YoY Change 756.31% 565.73% 18.58%
SHAREHOLDERS EQUITY
Retained Earnings -$310.6M -$162.8M
YoY Change 180.73% 75.02%
Common Stock $1.000K $249.8M
YoY Change -100.0% 4.07%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $69.54M $17.58M $53.53M
YoY Change
Total Liabilities & Shareholders Equity $160.5M $81.16M $96.58M
YoY Change 27.12% -42.0% -37.68%

Cashflow Statement

Concept 2020 Q1 2019 Q4 2019 Q3
OPERATING ACTIVITIES
Net Income -$40.23M -$21.50M -$23.16M
YoY Change 113.18% 22.19% 80.28%
Depreciation, Depletion And Amortization $93.00K -$200.0K $100.0K
YoY Change 16.25% -2100.0%
Cash From Operating Activities -$52.21M -$13.95M -$21.79M
YoY Change 213.77% -16.01% 78.9%
INVESTING ACTIVITIES
Capital Expenditures $42.00K $850.0K -$410.0K
YoY Change -130.0% -4350.0% 241.67%
Acquisitions
YoY Change
Other Investing Activities $66.02M $4.690M -$4.270M
YoY Change 737.82% -215.8% -150.77%
Cash From Investing Activities $65.98M $5.530M -$4.670M
YoY Change 752.45% -235.87% -156.33%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $0.00
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $140.0K -22.96M 27.93M
YoY Change 600.0% 5600.0%
NET CHANGE
Cash From Operating Activities -$52.21M -13.95M -21.79M
Cash From Investing Activities $65.98M 5.530M -4.670M
Cash From Financing Activities $140.0K -22.96M 27.93M
Net Change In Cash $13.91M -31.38M 1.470M
YoY Change -256.63% 51.74% -143.24%
FREE CASH FLOW
Cash From Operating Activities -$52.21M -$13.95M -$21.79M
Capital Expenditures $42.00K $850.0K -$410.0K
Free Cash Flow -$52.25M -$14.80M -$21.38M
YoY Change 216.68% -10.79% 77.28%

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<div align="left"> <table border="0" cellspacing="0" cellpadding="0" style="border-collapse:collapse; width:100%;"> <tr> <td valign="top" style="width:5.24%;white-space:nowrap"> <p style="margin-top:9pt;margin-bottom:0pt;font-size:9.5pt;font-weight:bold;">1.</p></td> <td valign="top"> <p style="margin-top:9pt;margin-bottom:0pt;font-weight:bold;font-size:9.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Formation and Business of the Company </p></td></tr></table></div> <p style="margin-bottom:0pt;margin-top:4pt;text-indent:0%;color:#000000;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Menlo Therapeutics Inc., or the Company is a late&#8209;stage biopharmaceutical company focused on the development and commercialization of serlopitant for the treatment of pruritus, or itch, associated with various conditions such as prurigo nodularis, or PN and psoriasis. The Company believes that serlopitant, a highly selective small molecule inhibitor of the neurokinin 1 receptor, or NK<font style="font-size:7pt;"> 1</font>-R, given as a once-daily, oral tablet, has the potential to significantly alleviate pruritus. </p> <p style="margin-bottom:0pt;margin-top:9pt;text-indent:0%;color:#000000;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company was incorporated in Delaware in October 2011. Since commencing operations, the Company has devoted substantially all of its resources to developing its product candidate, serlopitant, including conducting clinical trials and providing general and administrative support for these operations.</p> <p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On November 10, 2019, the Company signed a definitive Merger Agreement with Foamix Pharmaceuticals Ltd., or Foamix, to create a combined biopharmaceutical company, or the Combined Company, focused on the commercialization and development of therapeutics to serve patients in the dermatology space.&nbsp;&nbsp;The transaction contemplated by the Merger Agreement will result in a change in control of the Company as described below. On February 6, 2020, the Merger was approved by both the Company stockholders and Foamix&#8217;s shareholders. The Merger is expected to close on March 9, 2020. <font style="font-size:10pt;">&#160;</font></p> <p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Combined Company will have a diversified portfolio including an approved product and three late-stage product candidates focused on dermatologic indications:</p> <div align="left"> <table border="0" cellspacing="0" cellpadding="0" style="border-collapse:collapse; width:100%;"> <tr> <td valign="top" style="width:3.85%;white-space:nowrap"> <p style="margin-bottom:0pt;margin-top:9pt;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td> <td valign="top" style="width:3.85%;white-space:nowrap"> <p style="margin-bottom:0pt;margin-top:9pt;font-family:'Times New Roman';font-size:14.25pt;line-height:10.45pt;">&#x2022;</p></td> <td valign="top"> <p style="margin-bottom:0pt;margin-top:9pt;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Foamix recently received FDA approval for AMZEEQ<sup style="font-size:85%;line-height:120%;vertical-align:top">TM</sup> (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients 9 years of age and older. AMZEEQ<sup style="font-size:85%;line-height:120%;vertical-align:top">TM</sup> is the first topical formulation of minocycline. Foamix commercially launched AMZEEQ<sup style="font-size:85%;line-height:120%;vertical-align:top">TM</sup> in the United States in January 2020. </p></td></tr></table></div> <div align="left"> <table border="0" cellspacing="0" cellpadding="0" style="border-collapse:collapse; width:100%;"> <tr> <td valign="top" style="width:3.85%;white-space:nowrap"> <p style="margin-bottom:0pt;margin-top:0pt;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td> <td valign="top" style="width:3.85%;white-space:nowrap"> <p style="margin-bottom:0pt;margin-top:0pt;font-family:'Times New Roman';font-size:14.25pt;line-height:10.45pt;">&#x2022;</p></td> <td valign="top"> <p style="margin-bottom:0pt;margin-top:0pt;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Foamix has submitted a New Drug Application, or NDA to the U.S. Food and Drug Administration (FDA) for FMX103 (minocycline) topical foam, 1.5% for the treatment of moderate-to-severe papulopustular rosacea. The FDA set a Prescription Drug User Fee Act, or PDUFA, action date of June 2, 2020.&nbsp;&nbsp;If approved, FMX103 would be the first minocycline product available for rosacea patients. Foamix is also conducting a Phase II trial for FCD105, a topical combination foam of minocycline and adapalene, currently being evaluated in a phase 2 clinical trial for the treatment of moderate-to-severe acne vulgaris.</p></td></tr></table></div> <div align="left"> <table border="0" cellspacing="0" cellpadding="0" style="border-collapse:collapse; width:100%;"> <tr> <td valign="top" style="width:3.85%;white-space:nowrap"> <p style="margin-top:0pt;margin-bottom:0pt;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td> <td valign="top" style="width:3.85%;white-space:nowrap"> <p style="margin-top:0pt;margin-bottom:0pt;font-family:'Times New Roman';font-size:14.25pt;line-height:10.45pt;">&#x2022;</p></td> <td valign="top"> <p style="margin-top:0pt;margin-bottom:0pt;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company&#8217;s lead late stage product candidate, serlopitant, is being developed as a novel treatment for pruritus.&nbsp;&nbsp;Two Phase 3 clinical trials of serlopitant for the treatment of pruritus associated with prurigo nodularis are fully enrolled, with results expected in March or April 2020.&nbsp;&nbsp;</p></td></tr></table></div> <p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The transaction is structured as a stock-for-stock exchange, enabling the Foamix and the Company shareholders to share in the upside advantages of combining the companies. Under the terms of the Merger Agreement, at closing, each ordinary share of Foamix will be exchanged for 0.5924 of a share of the Company&#8217;s common stock and a non-transferrable contingent stock right, or CSR. The number of shares of the Company common stock to be received by Foamix shareholders will be subject to upwards adjustment via a CSR to 1.2739 or 1.8006 shares of the Company&#8217;s common stock for each ordinary share of Foamix if (a) <font style="color:#000000;">on or prior to May 31, 2020, proof of statistically significant superiority of serlopitant treatment over placebo treatment on the primary endpoint, as set out in the Merger Agreement (&#8220;Serlopitant Significance&#8221;), was achieved in one Phase III PN trial but was not achieved (or has not been determined) in the other Phase III PN trial</font> or (b) <font style="color:#000000;">on or prior to May 31, 2020, Serlopitant Significant was not achieved in either Phase III PN trial or if the Efficacy Determination has not been delivered on or before May 31, 2020, respectively.</font></p> <p style="margin-bottom:0pt;margin-top:9pt;text-indent:0%;color:#000000;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">After the completion of the Merger, the Company will continue as a public company, with its common stock continuing to be listed and traded on Nasdaq, and will serve as the parent company of Foamix. The Company&#8217;s headquarters will be moved to Bridgewater, New Jersey (the location of Foamix&#8217;s current U.S. headquarters). The Company will continue as a Delaware corporation and will continue to be governed by its existing Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws and the Delaware General Corporation Law (DGCL). The Combined Company will be led by David Domzalski, CEO of Foamix, and the other members of the Foamix management team. The board of the Combined Company will consist of five members designated by Foamix (including Mr. Domzalski) and two members designated by the Company (including Steve Basta, the Company&#8217;s current CEO).</p> <p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:9.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Initial Public Offering</p> <p style="margin-top:4pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:9.5pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In January 2018, the Company completed its initial public offering (&#8220;IPO&#8221;) of shares of its common stock, pursuant to which the Company issued 8,050,000 shares of common stock, which includes 1,050,000 shares issued pursuant to the over-allotment option granted to its underwriters and received net proceeds of approximately $125.4 million, after deducting underwriting discounts, commissions and offering expenses. In connection with the completion of the Company's IPO, all shares of convertible preferred stock converted into 9,629,405 shares of common stock.</p> <p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-size:9.5pt;font-family:Times New Roman;font-weight:bold;font-style:normal;text-transform:none;font-variant: normal;">Liquidity and Capital Resources </p> <p style="margin-bottom:0pt;margin-top:4pt;text-indent:0%;color:#000000;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred losses and negative cash flows from operations. For the year ended December 31, 2019, the Company incurred a net loss of $73.7 million and used&#160;$65.1&#160;million of cash in operations. As of December 31, 2019, the Company had cash, cash equivalents and investments of $76.9 million and an accumulated deficit of&#160;$184.3 million.</p> <p style="margin-bottom:0pt;margin-top:9pt;text-indent:0%;color:#000000;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is focused on managing its operating expenses and maintaining adequate capital to run its business through consummation of the proposed merger with Foamix. The Company believes that its existing cash, cash equivalents and investments as of December 31, 2019 will provide sufficient funds to enable it to meet its obligations for at least the next 12 months from the issuance of the Company&#8217;s financial statements as of and for the year ended December 31, 2019.</p>
CY2019 us-gaap Use Of Estimates
UseOfEstimates
<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:9.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Use of Estimates</p> <p style="margin-top:4pt;margin-bottom:0pt;text-indent:0%;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Preparation of 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 financial statements and reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, stock&#8209;based compensation expense, the resolution of uncertain tax positions and valuation allowance,&nbsp;&nbsp;and accruals for research and development costs. Management bases its estimates on historical experience on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates.</p>
CY2019 us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:9.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Concentration of Credit Risk</p> <p style="margin-top:4pt;margin-bottom:0pt;text-indent:0%;font-size:9.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and investments. As of December&#160;31, 2019 and 2018, the majority of our cash, cash equivalents and investments are held by two U.S. financial institutions in excess of federally insured limits. We invest cash in excess of our current needs in United States Treasury and government agency securities, highly&#8209;rated short or medium&#8209;term debt securities and money market funds and, by policy, diversify our investments to limit the amount of credit exposure. The Company has an investment policy which limits the Company to investing in highly rated corporate and government notes, and no individual investment may comprise more than 5% of the total portfolio except for securities issued by the U.S. Treasury, U.S. government agencies and money market funds, which are exempt from this restriction.</p>
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