$SPRY
ARS Pharmaceuticals, Inc.

2024 Q4 Form 10-Q Financial Statement

#000095017024125924 Filed on November 13, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3 2023 Q4
Revenue $2.068M $0.00
YoY Change -100.0%
Cost Of Revenue $112.0K
YoY Change
Gross Profit $1.956M
YoY Change
Gross Profit Margin 94.58%
Selling, General & Admin $19.28M $6.822M
YoY Change 28.71% -319.36%
% of Gross Profit 985.74%
Research & Development $4.423M $3.404M
YoY Change 47.34% -155.17%
% of Gross Profit 226.12%
Depreciation & Amortization $21.00K $13.00K
YoY Change 5.0% -106.19%
% of Gross Profit 1.07%
Operating Expenses $23.82M $10.23M
YoY Change 32.47% -141.6%
Operating Profit -$21.75M
YoY Change 20.97%
Interest Expense
YoY Change
% of Operating Profit
Other Income/Expense, Net $2.620M $3.058M
YoY Change -15.81% 268.43%
Pretax Income -$19.13M -$7.168M
YoY Change 28.63% -126.31%
Income Tax
% Of Pretax Income
Net Earnings -$19.13M -$7.168M
YoY Change 28.67% -126.31%
Net Earnings / Revenue -924.95%
Basic Earnings Per Share -$0.20
Diluted Earnings Per Share -$0.20 -$0.07
COMMON SHARES
Basic Shares Outstanding 97.19M 96.94M 96.00M
Diluted Shares Outstanding 97.03M

Balance Sheet

Concept 2024 Q4 2024 Q3 2023 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $204.6M $228.4M
YoY Change -15.41% -16.78%
Cash & Equivalents $39.66M $70.97M
Short-Term Investments $165.0M $157.4M
Other Short-Term Assets $2.211M $3.366M
YoY Change -14.96% 2.0%
Inventory $715.0K $0.00
Prepaid Expenses
Receivables $773.0K $0.00
Other Receivables $133.0K $178.0K
Total Short-Term Assets $208.8M $231.7M
YoY Change -14.59% -16.56%
LONG-TERM ASSETS
Property, Plant & Equipment $843.0K $574.0K
YoY Change 36.63% 74.47%
Goodwill
YoY Change
Intangibles $7.500M $0.00
YoY Change
Long-Term Investments
YoY Change
Other Assets $377.0K $638.0K
YoY Change -45.36%
Total Long-Term Assets $8.812M $1.462M
YoY Change 115.45% -60.86%
TOTAL ASSETS
Total Short-Term Assets $208.8M $231.7M
Total Long-Term Assets $8.812M $1.462M
Total Assets $217.6M $233.2M
YoY Change -12.45% -17.14%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $8.276M $759.0K
YoY Change 179.03% -54.25%
Accrued Expenses $4.959M $916.0K
YoY Change 41.69% -46.12%
Deferred Revenue $0.00
YoY Change -100.0%
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $16.62M $2.391M
YoY Change 48.69% -56.08%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $37.00K
YoY Change -100.0% -98.81%
Total Long-Term Liabilities $0.00 $37.00K
YoY Change -100.0% -98.81%
TOTAL LIABILITIES
Total Short-Term Liabilities $16.62M $2.391M
Total Long-Term Liabilities $0.00 $37.00K
Total Liabilities $16.62M $2.428M
YoY Change 47.47% -71.6%
SHAREHOLDERS EQUITY
Retained Earnings -$173.2M -$131.3M
YoY Change 39.56% 70.66%
Common Stock $10.00K $10.00K
YoY Change 11.11% 11.11%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $201.0M $230.8M
YoY Change
Total Liabilities & Shareholders Equity $217.6M $233.2M
YoY Change -12.45% -17.14%

Cashflow Statement

Concept 2024 Q4 2024 Q3 2023 Q4
OPERATING ACTIVITIES
Net Income -$19.13M -$7.168M
YoY Change 28.67% -126.31%
Depreciation, Depletion And Amortization $21.00K $13.00K
YoY Change 5.0% -106.19%
Cash From Operating Activities -$14.47M -$17.41M
YoY Change 13.38% -252.68%
INVESTING ACTIVITIES
Capital Expenditures $140.0K -$95.00K
YoY Change 180.0% -80.21%
Acquisitions
YoY Change
Other Investing Activities $16.96M $25.95M
YoY Change -136.39%
Cash From Investing Activities $16.82M $26.04M
YoY Change -136.06% 5325.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 680.0K 1.809M
YoY Change -26.09% -99.04%
NET CHANGE
Cash From Operating Activities -14.47M -17.41M
Cash From Investing Activities 16.82M 26.04M
Cash From Financing Activities 680.0K 1.809M
Net Change In Cash 3.031M 10.44M
YoY Change -105.18% -94.81%
FREE CASH FLOW
Cash From Operating Activities -$14.47M -$17.41M
Capital Expenditures $140.0K -$95.00K
Free Cash Flow -$14.61M -$17.31M
YoY Change 14.03% -245.72%

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us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-41861000
us-gaap Payments To Acquire Short Term Investments
PaymentsToAcquireShortTermInvestments
192580000
us-gaap Payments To Acquire Short Term Investments
PaymentsToAcquireShortTermInvestments
237953000
us-gaap Proceeds From Sale Of Short Term Investments
ProceedsFromSaleOfShortTermInvestments
191000000
us-gaap Proceeds From Sale Of Short Term Investments
ProceedsFromSaleOfShortTermInvestments
125000000
spry Payments Of Milestone Obligations Under License Agreements
PaymentsOfMilestoneObligationsUnderLicenseAgreements
2500000
spry Payments Of Milestone Obligations Under License Agreements
PaymentsOfMilestoneObligationsUnderLicenseAgreements
0
us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
261000
us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
266000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
-4341000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
-113219000
us-gaap Proceeds From Issuance Of Shares Under Incentive And Share Based Compensation Plans Including Stock Options
ProceedsFromIssuanceOfSharesUnderIncentiveAndShareBasedCompensationPlansIncludingStockOptions
1483000
us-gaap Proceeds From Issuance Of Shares Under Incentive And Share Based Compensation Plans Including Stock Options
ProceedsFromIssuanceOfSharesUnderIncentiveAndShareBasedCompensationPlansIncludingStockOptions
5094000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
1483000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
5094000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-31314000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-149986000
CY2023Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
70971000
CY2022Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
210518000
CY2024Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
39657000
CY2023Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
60532000
spry Intangible Assets Included In Accounts Payable
IntangibleAssetsIncludedInAccountsPayable
5000000
spry Intangible Assets Included In Accounts Payable
IntangibleAssetsIncludedInAccountsPayable
0
spry Stock Based Compensation Capitalized Into Inventory
StockBasedCompensationCapitalizedIntoInventory
110000
spry Stock Based Compensation Capitalized Into Inventory
StockBasedCompensationCapitalizedIntoInventory
0
spry Prepayment Included In Accrued Expenses
PrepaymentIncludedInAccruedExpenses
110000
spry Prepayment Included In Accrued Expenses
PrepaymentIncludedInAccruedExpenses
0
spry Purchases Of Inventories Included In Accounts Payable
PurchasesOfInventoriesIncludedInAccountsPayable
422000
spry Purchases Of Inventories Included In Accounts Payable
PurchasesOfInventoriesIncludedInAccountsPayable
0
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
87000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
91000
spry Capital Expenditures Reclassed From Prepaid Expenses And Other Current Assets
CapitalExpendituresReclassedFromPrepaidExpensesAndOtherCurrentAssets
0
spry Capital Expenditures Reclassed From Prepaid Expenses And Other Current Assets
CapitalExpendituresReclassedFromPrepaidExpensesAndOtherCurrentAssets
174000
us-gaap Nature Of Operations
NatureOfOperations
<p id="note1" style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1. Nature of Business</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Description of Business</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">ARS Pharmaceuticals, Inc. (“ARS”, “ARS Pharma” or the “Company”) is a biopharmaceutical company focused on the commercialization and development of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">(previously referred to as ARS-1 and currently identified in the EU by the trade name </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">EURneffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">) for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis. </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">is the first and only FDA and European Commission-approved needle-free epinephrine product, and the first new delivery method for epinephrine in more than </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">35</span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> years.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company incorporated in Delaware in January 2016 and is located in San Diego, California. The Company has a wholly owned subsidiary, ARS Pharmaceuticals Operations, Inc., incorporated in Delaware in August 2015, through which it conducts substantially all its operations. ARS Pharmaceuticals Operations, Inc. has a wholly owned subsidiary in Ireland, ARS Pharmaceuticals IRL, Limited, to facilitate the filing of regulatory approval for </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in European countries.</span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Liquidity and Capital Resources</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net operating losses since its inception and had an accumulated deficit of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">173.2</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million as of September 30, 2024. The Company had cash, cash equivalents, and short-term investments of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">204.6</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million as of September 30, 2024 and has not generated positive cash flows from operations. To date, the Company has funded its operations primarily with proceeds from the merger with Silverback in November 2022 (the “Merger”), the issuance of convertible preferred stock, payments earned under collaboration agreements, bank debt, and product sales. The Company’s currently available cash, cash equivalents, and short-term investments as of September 30, 2024 are sufficient to meet its anticipated cash requirements for at least the 12 months following the date these financial statements are issued.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">From August 5, 2015 (inception) through September 30, 2024, the Company has devoted substantially all of its efforts to developing intellectual property, conducting product development and clinical trials, organizing and staffing our company, business planning, raising capital, building infrastructure, pre-commercial and commercial activities, and providing general and administrative support for these operations. The Company has a limited operating history, and the sales and income potential of the Company’s business and market are unproven. Management expects operating expenses to increase for the foreseeable future and there can be no assurance that the Company will ever achieve profitability, or if achieved, that it will be sustained on a continuing basis.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company’s ability to raise additional capital may be adversely impacted should the global economic conditions worsen or as a result of further disruptions to, and volatility in, the credit and financial markets in the United States, including bank failures, future health epidemics or pandemics, geopolitical actions or other macroeconomic factors. If such further disruption occurs, the Company could experience an inability to access additional capital. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects.</span></p>
us-gaap Use Of Estimates
UseOfEstimates
<p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Use of Estimates</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The preparation of the Company’s condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s condensed consolidated financial statements relate to revenue recognized for its collaboration agreements, reserves for variable components of product revenue, and accruals for research and development expenses and valuation of equity awards. These estimates and assumptions are based on curr</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">ent facts, historical experience and various other factors 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 and the recording of revenue and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.</span></p>
CY2024Q3 us-gaap Allowance For Doubtful Accounts Receivable
AllowanceForDoubtfulAccountsReceivable
0
us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Concentrations of Credit Risk</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to cash risk by placing its cash with high credit quality financial institutions.</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company reviews its financial instruments portfolio on a quarterly basis to determine if any unrealized losses have resulted from a credit loss or other factors. As part of the review, management considers factors such as historical experience, market data, issuer-specific factors, and current economic conditions. This review is subjective, as it requires management to evaluate whether an event or change in circumstances has occurred in that period that may be related to credit issues.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is also subject to credit risk related to its trade accounts receivable from product sales. </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> is distributed primarily through wholesale distributors and pharma</span><span style="color:#212529;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">cies. These entities are not obligated to purchase any set number of units and they distribute </span><span style="color:#212529;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#212529;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">on demand as orders are received. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition. As stated above, t</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">he Company is currently operating under the Title Agreement with its 3PL Agent (as defined in </span><a href="#footnote3revenue"><span style="color:#0000ff;white-space:pre-wrap;text-decoration:underline;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Note 3 - Revenue</span></a><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">) and the 3PL Agent retains all credit and collection risk on sales to the Company’s wholesale distributors and pharmacy customers. </span><span style="color:#212529;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">For the three and nine months ended September 30, 2024, the Company’s three largest customers combined made up approximately </span><span style="font-size:10pt;font-family:Times New Roman;color:#212529;white-space:pre-wrap;min-width:fit-content;">81</span><span style="color:#212529;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">% of its gross product sales. As of September 30, 2024 the Company’s three largest customers combined made up </span><span style="font-size:10pt;font-family:Times New Roman;color:#212529;white-space:pre-wrap;min-width:fit-content;">83</span><span style="color:#212529;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">% of its trade accounts receivable balance. </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Historically, the Company has not experienced any credit losses from product sales.</span>
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
15235844
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
14973238
CY2024Q3 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
422000
CY2023Q3 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
0
CY2024Q3 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
293000
CY2023Q3 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
0
CY2024Q3 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
0
CY2023Q3 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
0
CY2024Q3 us-gaap Inventory Net
InventoryNet
715000
CY2023Q3 us-gaap Inventory Net
InventoryNet
0
spry Inventories Cost
InventoriesCost
13000000
CY2024Q3 us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodTax
500000
us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodTax
300000
us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodTax
-600000
CY2024Q3 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2023Q4 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2024Q3 us-gaap Debt Securities Available For Sale Accrued Interest After Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAccruedInterestAfterAllowanceForCreditLoss
500000
CY2024Q3 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2023Q4 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2024Q3 us-gaap Prepaid Expense Current And Noncurrent
PrepaidExpenseCurrentAndNoncurrent
1152000
CY2023Q4 us-gaap Prepaid Expense Current And Noncurrent
PrepaidExpenseCurrentAndNoncurrent
1124000
CY2024Q3 us-gaap Interest Receivable
InterestReceivable
466000
CY2023Q4 us-gaap Interest Receivable
InterestReceivable
686000
CY2024Q3 spry Capitalized Software Implementation Costs
CapitalizedSoftwareImplementationCosts
315000
CY2023Q4 spry Capitalized Software Implementation Costs
CapitalizedSoftwareImplementationCosts
163000
CY2024Q3 spry Deposit Assets Current
DepositAssetsCurrent
192000
CY2023Q4 spry Deposit Assets Current
DepositAssetsCurrent
0
CY2024Q3 us-gaap Escrow Deposit
EscrowDeposit
152000
CY2023Q4 us-gaap Escrow Deposit
EscrowDeposit
0
CY2024Q3 us-gaap Prepaid Insurance
PrepaidInsurance
137000
CY2023Q4 us-gaap Prepaid Insurance
PrepaidInsurance
904000
CY2024Q3 spry Prepaid Development Costs
PrepaidDevelopmentCosts
137000
CY2023Q4 spry Prepaid Development Costs
PrepaidDevelopmentCosts
380000
CY2024Q3 us-gaap Other Receivables
OtherReceivables
126000
CY2023Q4 us-gaap Other Receivables
OtherReceivables
109000
CY2024Q3 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
2677000
CY2023Q4 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
3366000
CY2024Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
171000
CY2023Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
121000
CY2024Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
843000
CY2023Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
574000
CY2023Q3 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
CY2024Q3 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
CY2024Q3 us-gaap Capitalized Computer Software Net
CapitalizedComputerSoftwareNet
377000
CY2023Q4 us-gaap Capitalized Computer Software Net
CapitalizedComputerSoftwareNet
617000
CY2024Q3 us-gaap Security Deposit
SecurityDeposit
0
CY2023Q4 us-gaap Security Deposit
SecurityDeposit
21000
CY2024Q3 us-gaap Other Assets
OtherAssets
377000
CY2023Q4 us-gaap Other Assets
OtherAssets
638000
CY2024Q3 us-gaap Accounts Payable Current
AccountsPayableCurrent
8276000
CY2023Q4 us-gaap Accounts Payable Current
AccountsPayableCurrent
759000
CY2024Q3 spry Accrued Compensation
AccruedCompensation
2584000
CY2023Q4 spry Accrued Compensation
AccruedCompensation
315000
CY2024Q3 us-gaap Accrued Marketing Costs Current
AccruedMarketingCostsCurrent
2187000
CY2023Q4 us-gaap Accrued Marketing Costs Current
AccruedMarketingCostsCurrent
42000
CY2024Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
1414000
CY2023Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
174000
CY2024Q3 spry Accrued Research And Development Expenses
AccruedResearchAndDevelopmentExpenses
859000
CY2023Q4 spry Accrued Research And Development Expenses
AccruedResearchAndDevelopmentExpenses
705000
CY2024Q3 us-gaap Other Accounts Payable And Accrued Liabilities
OtherAccountsPayableAndAccruedLiabilities
1201000
CY2023Q4 us-gaap Other Accounts Payable And Accrued Liabilities
OtherAccountsPayableAndAccruedLiabilities
159000
CY2024Q3 us-gaap Accounts Payable And Accrued Liabilities Current And Noncurrent
AccountsPayableAndAccruedLiabilitiesCurrentAndNoncurrent
16521000
CY2023Q4 us-gaap Accounts Payable And Accrued Liabilities Current And Noncurrent
AccountsPayableAndAccruedLiabilitiesCurrentAndNoncurrent
2154000
us-gaap Lessee Operating Lease Description
LesseeOperatingLeaseDescription
In October 2021, the Company entered into a 38-month noncancelable lease for its current headquarters location consisting of 4,047 rentable square feet of office space in San Diego, California. Under the terms of the agreement, there is no option to extend the lease, and the Company is subject to additional charges for common area maintenance and other costs.
us-gaap Lessee Operating Sublease Option To Extend
LesseeOperatingSubleaseOptionToExtend
there is no option to extend the lease
CY2024Q3 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P5M
CY2024Q3 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.08
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
62000
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
42000
CY2024Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
104000
CY2024Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
2000
CY2024Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
102000
CY2024Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
102000
CY2024Q3 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
0
spry In Licensingandsupply Textblock
InLicensingandsupplyTextblock
<p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">9. In-Licensing and Supply</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">License Agreement with Aegis</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In June 2018, the Company entered into a License Agreement (the “Aegis Agreement”) with Aegis Therapeutics, LLC (“Aegis”). Under the Aegis Agreement, the Company licensed the exclusive, worldwide, royalty-bearing, sublicensable, rights to certain proprietary Aegis technology, patent rights and know-how to develop and commercialize epinephrine products. The Company utilizes this technology in its sole commercial product, </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">. As consideration for the license, the Company paid an upfront license fee of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">50,000</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, which was recorded in research and development expenses in the condensed consolidated statement of operations.</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is required to make aggregate milestone payments of up to $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">20.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million upon achievement of certain regulatory and commercial milestones. Regulatory milestone payments under the Aegis Agreement are recorded upon completion of the required events, as the triggering events are not considered to be probable until they are achieved. Prior to the FDA approval of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in August 2024, regulatory milestone payments were recorded as research and development expenses in the condensed consolidated statement of operations. The Company made a $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">0.5</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone payment to Aegis upon the achievement of a regulatory milestone during 2019, and a $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">1.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone payment to Aegis upon the FDA’s acceptance of the Company’s NDA submission for </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, which occurred in the third quarter of 2022. Since the approval of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in August 2024</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">, </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">regulatory milestone payments have been capitalized as intangible assets in the accompanying condensed consolidated balance sheets. Amortization expense has been recorded to cost of goods sold, in the accompanying condensed consolidated statements of operations and comprehensive loss, on a straight-line basis over the estimated life of the intellectual property of </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">14.5</span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> years. In August 2024, a $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">2.5</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone was met for achieving FDA approval of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy. </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In September 2024, a $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone was met for the first commercial sale of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">. As a result, the Company capitalized $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">7.5</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million as intangible assets in the accompanying condensed consolidated balance sheets </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">as of September 30, 2024. The Company pa</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">id the $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">2.5</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone for achieving FDA approval of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in September 2024, and paid the $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone for the first commercial sale of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in October 2024. The next milestone payment of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">2.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million is due upon the achievement of certain annual net sales.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company also pays royalties based on net product sales in the low to mid-single digits on its or its sublicensees’ net sales of the Licensed Products (as defined in the Aegis Agreement) on a product-by-product basis. Royalties are recorded to cost of goods sold in the period the related product revenue is recognized.</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is responsible for reimbursing Aegis for patent costs incurred in connection with prosecuting and maintaining patent rights that are specific to epinephrine or epinephrine products. There were </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">no</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> expenses recognized in connection with legal patent fees for the </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">nine months ended September 30, 2024 and 2023.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company may terminate the Aegis Agreement with 30 days written notice or either party may terminate the Aegis Agreement for certain breaches of the Aegis Agreement. Unless terminated earlier by either or both parties, the term of the Aegis Agreement will continue until the final expiration of all royalty obligations under the Aegis Agreement.</span></span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In conjunction with the Aegis Agreement, the Company also entered into a Supply Agreement (the “Supply Agreement”) with Aegis that allows the Company to purchase materials for preclinical, development and commercial use at predetermined prices. The Company may elect to have Aegis supply minimum quantities but there are no minimum or maximum purchase obligations under the Supply Agreement unless this election is made. The parties may terminate the Supply Agreement at any time by mutual agreement. In addition, the parties may terminate the Supply Agreement in the event of certain breaches of the Supply Agreement or upon the earlier of the expiration or termination of the Aegis Agreement or June 2028. The Supply Agreement term may be extended by mutual written agreeme</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">nt. Under the Supply Agreement, $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">0.4</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million and $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">0.7</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million in expense was recognized in the </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">three and nine months ended September 30, 2024</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, respectively, and </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">no</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> expense and $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">0.3</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million in expense was recognized in the </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">three and nine months ended September 30, 2023, respectively, in the accompanying condensed consolidated statements of operations and comprehensive loss.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Manufacturing Agreement with Renaissance</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In September 2020, the Company entered into a manufacturing agreement with Renaissance Lakewood, LLC (“Renaissance”), which was subsequently amended in July 2023 and September 2024 (the “Renaissance Agreement”). Pursuant to the Renaissance Agreement, Renaissance agreed to manufacture for, and provide to the Company, </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">nasal unit dose sprays (“Renaissance Products”). The Company is obligated to provide Renaissance with certain supplies to manufacture the Renaissance Products and to purchase from Renaissance a mid double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the E.U., and a high double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the U.S. The Renaissance Agreement contains conventional commercial pharmaceutical manufacturing provisions including certain minimum purchase amounts to be determined in the future based on forecast needs and minimum batch size projections. The Company may also request Renaissance to perform certain services related to the Renaissance Product, for which the Company will pay reasonable compensation to Renaissance.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The initial term of the Renaissance Agreement commenced on September 17, 2024 and will terminate (a) for Renaissance Product designated for commercial sale in the U.S., on December 31 immediately following the fifth anniversary of the initial U.S. launch date (“U.S. Initial Term”), and (b) for Renaissance Product designated for commercial sale in the E.U., on December 31 immediately following the fifth anniversary of the initial E.U. launch date (“E.U. Initial Term”), in each case unless earlier terminated by one of the parties. The U.S. Initial Term and E.U. Initial Term automatically renew for successive two-year terms (“Renewal Term”). Either party may elect not to renew the U.S. Renewal Term and/or the E.U. Renewal Term by providing the requisite prior notice to the other party, with the initial terms automatically renewing for successive two-year terms, unless either party gives notice pursuant to the Renaissance Agreement. </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Either party may terminate the Renaissance Agreement (1) for uncured material breach of the other party, (2) upon notice for insolvency-related events of the other party that are not discharged within a defined time period, (3) on a product-by-product basis if the manufacture, distribution or sale would materially contravene any applicable law, (4) by providing the requisite notice if (a) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before a specified date, (b) the authorization and approval representing more than a certain number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (c) the Company decided in its sole discretion to cease commercializing the Renaissance Product in the U.S., (5) in the case of a force majeure event that continues for six months or more, or (6) a violation by the other party of trade control or anti-corruption laws.</span></span>
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CY2024Q3 ecd Rule10b51 Arr Adopted Flag
Rule10b51ArrAdoptedFlag
false
CY2024Q3 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
CY2024Q3 ecd Trd Arr Ind Name
TrdArrIndName
Brian Dorsey
CY2024Q3 ecd Trd Arr Ind Title
TrdArrIndTitle
Chief Operating Officer
CY2024Q3 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
true
CY2024Q3 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false
CY2024Q3 ecd Trd Arr Termination Date
TrdArrTerminationDate
August 28, 2024
CY2024Q3 ecd Trd Arr Securities Agg Avail Amt
TrdArrSecuritiesAggAvailAmt
340000
CY2024Q3 ecd Trd Arr Expiration Date
TrdArrExpirationDate
March 31, 2025

Files In Submission

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0000950170-24-125924-index-headers.html Edgar Link pending
0000950170-24-125924-index.html Edgar Link pending
0000950170-24-125924.txt Edgar Link pending
0000950170-24-125924-xbrl.zip Edgar Link pending
Financial_Report.xlsx Edgar Link pending
img76905839_0.jpg Edgar Link pending
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spry-20240930.htm Edgar Link pending
spry-20240930.xsd Edgar Link pending
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spry-20240930_htm.xml Edgar Link completed