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TELA Bio(TELA) - 2024 Q3 - Quarterly Report
TELATELA Bio(TELA)2024-11-08 21:05

Revenue Growth - Revenue increased by 3.9million,or263.9 million, or 26%, from 15.1 million for Q3 2023 to 19.0millionforQ32024[85]RevenuefortheninemonthsendedSeptember30,2024,was19.0 million for Q3 2024[85] - Revenue for the nine months ended September 30, 2024, was 51.7 million, up 10.2million,or2510.2 million, or 25%, from 41.5 million for the same period in 2023[85] - Revenue increased by 3.9million,or263.9 million, or 26%, to 19.0 million for the three months ended September 30, 2024, compared to 15.1millionforthesameperiodin2023,drivenbyincreasedunitsalesandnewcustomers[108]RevenuefortheninemonthsendedSeptember30,2024,increasedby15.1 million for the same period in 2023, driven by increased unit sales and new customers[108] - Revenue for the nine months ended September 30, 2024, increased by 10.2 million, or 25%, to 51.7millionfrom51.7 million from 41.5 million for the same period in 2023, driven by increased unit sales and new customers[120] Market Opportunity - The annual U.S. total addressable market opportunity for OviTex products is estimated to be approximately 1.5billion[73]TheannualU.S.currentaddressablemarketopportunityforOviTexPRSproductsisestimatedtobeapproximately1.5 billion[73] - The annual U.S. current addressable market opportunity for OviTex PRS products is estimated to be approximately 700 million[79] Unit Sales - Unit sales of OviTex increased by 39% to 4,767 units for the three months ended September 30, 2024, compared to 3,426 units for the same period in 2023[110] - Unit sales of OviTex increased by 34% to 13,034 units for the nine months ended September 30, 2024, compared to 9,704 units for the same period in 2023[120] Financial Performance - The company has an accumulated deficit of 349.5millionasofSeptember30,2024[85]Thecompanyhasnotbeenprofitablesinceinceptionandexpectstoincurlossesfortheforeseeablefuture[85]NetlossfortheninemonthsendedSeptember30,2024,was349.5 million as of September 30, 2024[85] - The company has not been profitable since inception and expects to incur losses for the foreseeable future[85] - Net loss for the nine months ended September 30, 2024, was 28.6 million, a decrease of 5.1million,or155.1 million, or 15%, from a net loss of 33.8 million for the same period in 2023[119] Operating Expenses - Total operating expenses for the nine months ended September 30, 2024, were 68.6million,anincreaseof68.6 million, an increase of 8.3 million, or 14%, from 60.3millionforthesameperiodin2023[119]Costofrevenue(excludingamortizationofintangibleassets)increasedby60.3 million for the same period in 2023[119] - Cost of revenue (excluding amortization of intangible assets) increased by 1.4 million, or 31%, to 6.0millionforthethreemonthsendedSeptember30,2024,from6.0 million for the three months ended September 30, 2024, from 4.6 million for the same period in 2023[111] - Cost of revenue increased by 3.4million,or273.4 million, or 27%, to 16.1 million for the nine months ended September 30, 2024, compared to 12.7millionforthesameperiodin2023[121]Salesandmarketingexpensesincreasedby12.7 million for the same period in 2023[121] - Sales and marketing expenses increased by 2.0 million, or 14%, to 16.5millionforthethreemonthsendedSeptember30,2024,comparedto16.5 million for the three months ended September 30, 2024, compared to 14.5 million for the same period in 2023[114] - Sales and marketing expenses rose by 8.2million,or198.2 million, or 19%, to 50.7 million for the nine months ended September 30, 2024, from 42.5millionintheprioryear[124]Generalandadministrativeexpensesincreasedby42.5 million in the prior year[124] - General and administrative expenses increased by 0.3 million, or 3%, to 11.1millionfortheninemonthsendedSeptember30,2024,comparedto11.1 million for the nine months ended September 30, 2024, compared to 10.8 million for the same period in 2023[125] - Research and development expenses decreased by 0.2million,or20.2 million, or 2%, to 6.8 million for the nine months ended September 30, 2024, from 6.9millionintheprioryear[126]CashFlowandFinancingCashandcashequivalentsdecreasedto6.9 million in the prior year[126] Cash Flow and Financing - Cash and cash equivalents decreased to 17.3 million as of September 30, 2024, down from 46.7millionasofDecember31,2023[130]Cashusedinoperatingactivitieswas46.7 million as of December 31, 2023[130] - Cash used in operating activities was 34.1 million for the nine months ended September 30, 2024, compared to 29.8millionforthesameperiodin2023[136]Thecompanycompletedapublicofferingof14,670,000sharesatapriceof29.8 million for the same period in 2023[136] - The company completed a public offering of 14,670,000 shares at a price of 2.25 per share, resulting in gross proceeds of 46.0million[132]TheMidCapCreditAgreementhasatermloanof46.0 million[132] - The MidCap Credit Agreement has a term loan of 40.0 million, maturing in May 2027, with an interest rate of 6.25% plus the greater of one-month Term SOFR or 1.0%[145] - MidCap Credit Facility bears interest at a floating rate of 6.25% plus the greater of one-month Term SOFR or 1.0%[152] - A 1% increase in interest rates would result in a 0.3millionincreaseininterestexpensefortheninemonthsendedSeptember30,2024[152]StrategicInitiativesInSeptember2023,thecompanyenteredintoadistributionagreementwithAdvancedMedicalSolutionsLimitedforLiquiFixHerniaMeshFixationDevices[81]ThecompanylaunchedOviTexIHRReinforcedTissueMatrixinApril2024,specificallydesignedforinguinalherniaprocedures[74]ThecompanyimplementedcostcuttingmeasuresstartinginQ32024,expectedtoreduceoperatingexpensesinfutureperiods[85]InventoryandInflationGrossmargindecreasedto680.3 million increase in interest expense for the nine months ended September 30, 2024[152] Strategic Initiatives - In September 2023, the company entered into a distribution agreement with Advanced Medical Solutions Limited for LiquiFix Hernia Mesh Fixation Devices[81] - The company launched OviTex IHR Reinforced Tissue Matrix in April 2024, specifically designed for inguinal hernia procedures[74] - The company implemented cost-cutting measures starting in Q3 2024, expected to reduce operating expenses in future periods[85] Inventory and Inflation - Gross margin decreased to 68% for the three months ended September 30, 2024, down from 69% for the same period in 2023, primarily due to higher charges for excess and obsolete inventory[113] - Gross margin decreased to 68% for the nine months ended September 30, 2024, down from 69% for the same period in 2023, primarily due to higher charges for excess and obsolete inventory[123] - Inflationary factors may adversely affect operating results, particularly if selling prices do not increase in line with costs[153] Currency Exposure - Company does not currently have material exposure to foreign currency fluctuations and does not engage in hedging activities[154] Clinical Study Results - The recurrence rate at the 24-month time point in the BRAVO study was 2.6%, with surgical site occurrences observed in 38% of the study population[77] Asset Sales - The company recognized a gain of 7.6 million from the sale of certain assets related to NIVIS during the nine months ended September 30, 2024[127] - Gain on sale of product line amounted to $7.6 million during the nine months ended September 30, 2024[104]