Core Points - Sienna Resources Inc. has successfully closed a non-brokered private placement under the Listed Issuer Financing Exemption, raising gross proceeds of $499,957.50 by selling 4,761,500 units at a price of $0.105 per unit [1] - Each unit consists of one common share and one transferable share purchase warrant, which can be exercised at a price of $0.14 for a period of 60 months [1] - The net proceeds will be allocated for general working capital and to fund exploration and development activities on existing projects [2] Financial Details - The company paid a cash finder's fee of $10,080.53 and issued 96,005 non-transferable finder's warrants, each exercisable at $0.14 for 24 months [2] - The financing is expected to provide the company with the necessary resources to initiate fieldwork and exploration activities during the summer [4] Project Focus - Sienna's immediate priority is the Stonesthrow Gold Project in Saskatchewan, covering approximately 31,718 contiguous acres [3] - The company is also evaluating its Case Lake lithium project in Ontario and its lithium assets in Nevada [3] Management Commentary - Jason Gigliotti, President of Sienna, emphasized the potential of the Stonesthrow Gold Project due to its strategic location and scale, indicating a phase of growth focused on active exploration and value creation [4]

Core Viewpoint - Sienna Resources Inc. is conducting a non-brokered private placement to raise up to $500,000 at a price of $0.105 per unit, with each unit consisting of one common share and one transferable share purchase warrant priced at $0.14 for a period of 60 months from the closing date [1][2]. Group 1 - The offering is expected to close around June 18, 2025, and is subject to necessary approvals from the TSX Venture Exchange and other regulatory bodies [2]. - Proceeds from the placement will be allocated to general working capital and evaluation of existing projects [2]. - The company aims to commence operations on at least one project this summer, focusing on the "Stonesthrow Gold Project," which spans approximately 31,718 contiguous acres [3]. Group 2 - The company is also assessing its Case Lake Project and Nevada lithium projects, indicating a diversified approach to resource exploration [3]. - The offering will be available to Canadian residents, excluding Quebec, under the Listed Issuer Financing Exemption, allowing for immediate trading of the securities without a hold period [3]. - The securities issued in the offering have not been registered under the United States Securities Act of 1933 and cannot be sold in the U.S. without proper registration or exemption [4].

Product Developments - Sientra received FDA 510k clearance for the AlloX2 Pro Tissue Expander on June 8, 2023, which is the first tissue expander cleared for MRI exposure in the U.S.[140] - The company announced the commercial launch of the Viality Fat Transfer System on March 1, 2023, with interim clinical study results showing 80% fat retention at 3, 6, and 12 months[143] - Sientra entered into a partnership with Elutia Inc. on March 22, 2023, to expand the distribution of SimpliDerm ADM for reconstruction surgery, beginning commercial sales in Q2 2023[142] Financial Performance - Net sales decreased by approximately $3.0 million, or 13.4%, to $19.5 million for the three months ended September 30, 2023, compared to $22.6 million for the same period in 2022[166] - Gross profit for the three months ended September 30, 2023, was $10.0 million, down from $12.8 million in 2022, reflecting a gross margin decrease from 56.6% to 51.3%[168] - Total operating expenses decreased by approximately $5.9 million, or 23.3%, to $19.4 million for the three months ended September 30, 2023, compared to $25.3 million for the same period in 2022[175] - The company incurred a net loss of $14.8 million for the three months ended September 30, 2023, compared to a net loss of $14.9 million for the same period in 2022[165] - For the nine months ended September 30, 2023, net sales were $65.2 million, a slight decrease of $0.3 million, or 0.4%, from $65.5 million in 2022[176] - Cost of goods sold increased by approximately $3.3 million, or 12.3%, to $30.4 million for the nine months ended September 30, 2023, compared to $27.1 million in 2022[177] - The company reported a net loss of $37.1 million for the nine months ended September 30, 2023, down from a net loss of $51.3 million in 2022[175] Cash Flow and Liquidity - Cash and cash equivalents as of September 30, 2023, were $15.0 million, with the company using $11.0 million of cash from continuing operations during the nine months[184] - The company is evaluating various cost-saving measures to reduce operating expenses and cash outflows, while also seeking to generate significant increases in net sales[185] - As of September 30, 2023, the company did not meet the required minimum revenue financial covenant under the Restated Agreement, leading to potential acceleration of debt repayment[189] - Net cash used in investing activities decreased to $1.1 million for the nine months ended September 30, 2023, from $1.9 million in the same period of 2022[195] - Net cash provided by financing activities was $0.2 million during the nine months ended September 30, 2023, down from $2.7 million in the prior year, primarily due to the absence of borrowings under the Term Loan and Revolving Loan[196] - The company’s liquidity position and capital requirements are influenced by factors such as manufacturing capacity, sales generation, and costs associated with product development and regulatory compliance[198] - The company may need to sell additional equity or debt securities if cash generated from operations is insufficient to meet working capital and capital expenditure requirements[199] Market Conditions and Business Environment - The COVID-19 pandemic has had a lingering effect on Sientra's business, with uncertainty regarding the return of aesthetic procedures to pre-pandemic levels[144] - Sientra's net sales consist primarily of silicone gel breast implants, tissue expanders, and the Viality fat transfer system, with revenue recognition based on specific return policies[147] - The company expects fluctuations in net sales due to seasonality in breast augmentation procedures and macroeconomic conditions[148] - Sientra's overall gross margin is expected to fluctuate based on unit sales, manufacturing costs, and product mix[152] - Research and development expenses are anticipated to vary with new product development and clinical studies[154] - The company has made appropriate estimates regarding the impact of macroeconomic conditions on its financial results, which may change as new information becomes available[146] Regulatory and Compliance - There are currently no off-balance sheet arrangements as defined under SEC rules[200] - The company has not disclosed any quantitative and qualitative disclosures about market risk as it is classified as a smaller reporting company[202]

Financial Performance - Net sales increased by approximately $1.6 million, or 7.5%, to $23.1 million for the three months ended June 30, 2023, compared to $21.5 million for the same period in 2022, driven by increased domestic sales of gel implants and revenue from the new Viality product [147]. - Gross profit for the three months ended June 30, 2023, was $12.6 million, a slight decrease from $12.7 million in the same period of 2022 [146]. - Net sales increased approximately $2.8 million, or 6.5%, to $45.7 million for the six months ended June 30, 2023, compared to $42.9 million for the same period in 2022, driven by increased domestic sales of gel implants and revenue from the new product Viality [156]. - Gross margins for the six months ended June 30, 2023, were approximately 54.2%, down from 59.6% in 2022, primarily due to amortization of Viality-related manufacturing know-how intangible assets [158]. Operating Expenses - Cost of goods sold rose by approximately $1.7 million, or 19.9%, to $10.5 million for the three months ended June 30, 2023, primarily due to amortization of Viality-related manufacturing know-how and increased warranty provisions [148]. - Total operating expenses decreased to $19.7 million for the three months ended June 30, 2023, from $28.7 million in the same period of 2022, reflecting reduced sales and marketing, research and development, and general and administrative expenses [146]. - Total operating expenses decreased approximately $15.2 million, or 26.4%, to $42.4 million for the six months ended June 30, 2023, compared to $57.6 million for the same period in 2022 [155]. - Research and Development expenses decreased approximately $1.0 million, or 16.5%, to $5.1 million for the six months ended June 30, 2023, due to reduced costs related to regulatory activities and product development [160]. - General and Administrative expenses decreased approximately $5.1 million, or 22.8%, to $17.2 million for the six months ended June 30, 2023, primarily due to reductions in consulting and insurance fees [161]. Losses and Cash Flow - Loss from operations improved to $(7.1) million for the three months ended June 30, 2023, compared to $(15.9) million for the same period in 2022 [146]. - The company incurred net losses of $22.4 million and used $7.4 million of cash from continuing operations during the six months ended June 30, 2023 [165]. - Cash used in operating activities was $6.8 million for the six months ended June 30, 2023, a decrease from $30.8 million in the same period of 2022, reflecting improved working capital [170]. - As of June 30, 2023, the company had cash and cash equivalents of $18.6 million, raising substantial doubt about its ability to continue as a going concern for at least one year [165]. Strategic Developments - The company received FDA 510k clearance for the AlloX2 Pro Tissue Expander on June 8, 2023, which is now MRI-conditional, enhancing its market offering [122]. - The Portfinder technology, an electronic device for locating ports in tissue expanders, received FDA 510k clearance on May 17, 2023, improving usability for clinicians [123]. - The company entered into a partnership with Aziyo Biologics on March 22, 2023, to expand the distribution of SimpliDerm ADM products in the U.S. [124]. - Commercial shipping of the Viality fat transfer system began on March 1, 2023, following its acquisition in December 2021 [125]. - The company anticipates fluctuations in net sales due to seasonal trends in aesthetic procedures and ongoing macroeconomic conditions [131]. - The company is evaluating various cost-saving measures to reduce operating expenses and cash outflows, while also seeking to generate significant increases in net sales [166]. - The company plans to seek additional funding alternatives to improve liquidity, which may include raising equity or debt capital [166].

Financial Performance - Net sales increased by approximately $1.2 million, or 5.4%, to $22.6 million for the three months ended March 31, 2023, compared to $21.4 million for the same period in 2022[143]. - Cost of goods sold increased by approximately $1.9 million, or 21.7%, to $10.4 million for the three months ended March 31, 2023, compared to $8.6 million for the same period in 2022[144]. - Gross margins decreased to approximately 53.9% for the three months ended March 31, 2023, down from 60.0% for the same period in 2022[145]. - The company incurred net losses of $12.9 million during the three months ended March 31, 2023, and used $6.7 million of cash from continuing operations[151]. - Net cash used in operating activities was $6.3 million during the three months ended March 31, 2023, a decrease from $17.9 million during the same period in 2022[157]. - Net cash used in investing activities was $0.6 million during the three months ended March 31, 2023, compared to $0.2 million in the same period in 2022[158]. - Net cash provided by financing activities was $0.2 million during the three months ended March 31, 2023, a decrease from $5.3 million during the same period in 2022[159]. Expenses - Sales and marketing expenses decreased by approximately $5.4 million, or 34.9%, to $10.2 million for the three months ended March 31, 2023, compared to $15.6 million for the same period in 2022[146]. - Research and development expenses decreased by approximately $0.4 million, or 13.9%, to $2.7 million for the three months ended March 31, 2023, compared to $3.1 million for the same period in 2022[147]. - General and Administrative (G&A) expenses decreased by approximately $0.4 million, or 3.5%, to $9.9 million for the three months ended March 31, 2023, compared to $10.2 million for the same period in 2022[148]. Cash Position and Financing - As of March 31, 2023, the company had cash and cash equivalents of $19.4 million, raising substantial doubt about its ability to continue as a going concern for at least one year[151]. - The company is evaluating various cost-saving measures to reduce operating expenses and cash outflows, while also seeking to generate significant increases in net sales[152]. - The company anticipates that losses will continue in the near term, necessitating potential additional equity or debt financing[152]. - The company issued and sold 1,778,500 shares of common stock, raising approximately $14.0 million in net proceeds on October 25, 2022[154]. Business Developments - The Company launched the Viality fat transfer system commercially on March 1, 2023, following its acquisition in December 2021[122]. - The Company entered into a partnership with Aziyo Biologics to expand the distribution of the SimpliDerm product line for reconstruction surgery[121]. - The Company has one operating segment named Plastic Surgery, focusing on breast implants, tissue expanders, fat transfer, and scar management[120]. Market Conditions - The Company expects net sales to fluctuate quarterly due to seasonality and macroeconomic conditions[127]. - The company continues to face risks from global economic conditions, including inflation and consumer confidence[124].

Financial Performance - Net sales increased by $9.9 million, or 12.2%, to $90.6 million for the year ended December 31, 2022, compared to $80.7 million in 2021, driven by higher domestic and international sales of gel implants and expanders [409]. - The company incurred a net loss of $73.3 million for the year ended December 31, 2022, compared to a net loss of $62.5 million in 2021 [408]. - Cash used in operating activities was $34.9 million for the year ended December 31, 2022, a decrease from $44.5 million in 2021, primarily due to improved working capital [424]. - As of December 31, 2022, the company had cash and cash equivalents of $26.1 million, raising substantial doubt about its ability to continue as a going concern for at least one year [419]. Debt and Financing - The company reported a total debt reduction of approximately $10 million, bringing the total debt load to $73 million, with maturity dates extended to March 2026 and beyond [348]. - The company completed an equity financing on October 25, 2022, raising approximately $14.0 million from the sale of 1,778,500 shares of common stock at an offering price of $3.80 per share [352]. - The company issued 1,778,500 shares of common stock and raised approximately $14.0 million in net proceeds on October 25, 2022 [421]. Product Development and Market Expansion - The company received approval from the UAE Ministry of Health and Prevention to market its silicone gel breast implants on December 13, 2022, and began commercialization through its distribution partner [353]. - The company launched the Viality Fat Transfer System on March 1, 2023, following its acquisition from AuraGen Aesthetics LLC [346]. - The company has expanded its market presence internationally, with approvals in Japan, Saudi Arabia, Canada, and the UAE since 2020 [344]. - The company’s breast implants are offered in approximately 350 variations, incorporating technologies that differentiate them from competitors, including High-Strength Cohesive silicone gel [364]. - The company’s clinical trial data demonstrated comparable or better rupture rates, capsular contracture rates, and reoperation rates compared to competitors [365]. - The company’s breast implants were approved by the FDA in 2012, based on a long-term clinical trial involving 1,788 women across 36 investigational sites [365]. Revenue and Cost Management - The company’s revenue recognition for breast implants and tissue expanders is net of sales discounts and estimated returns, with a standard six-month return window for customers [370]. - The overall gross margin is anticipated to fluctuate due to factors such as unit sales quantity, manufacturing price increases, and warranty costs [374]. - Gross margin decreased to 45.9% in 2022 from 54.9% in 2021, mainly due to increased reserves for excess inventory; adjusted gross margin was 52.0% excluding inventory reserve adjustments [411]. - Cost of goods sold rose by $12.6 million, or 34.7%, to $49.0 million for the year ended December 31, 2022, primarily due to increased sales activity and higher reserves for warranty and excess inventory [410]. Expenses and Liabilities - Sales and marketing expenses increased by $6.6 million, or 13.6%, to $55.0 million for the year ended December 31, 2022, attributed to higher payroll, travel, and marketing initiatives [412]. - Research and development expenses rose by $3.6 million, or 34.5%, to $14.1 million for the year ended December 31, 2022, due to increased product development and regulatory expenses [413]. - General and administrative expenses increased by $9.8 million, or 30.7%, to $41.5 million for the year ended December 31, 2022, driven by higher legal and consulting fees [414]. - The company held total warranty liabilities of $8.8 million as of December 31, 2022, compared to $2.5 million in 2021 [393]. - As of December 31, 2022, the liability for unsatisfied performance obligations under the service warranty was $3.508 million, with a long-term portion of $2.646 million [388]. - The sales return liability increased to $15.773 million as of December 31, 2022, from $13.399 million in 2021, reflecting changes in estimated sales returns [390]. Research and Development - Research and development expenses are expected to vary based on the initiation of different development projects, including improvements to existing products and new product acquisitions [376]. Warranty and Customer Support - The company introduced the Platinum20 warranty program in May 2018, which includes financial assistance for revision surgeries and no-charge contralateral replacement implants [387]. - The company expects sales and marketing expenses to fluctuate due to headcount changes and the timing of marketing programs [375]. Acquisitions - Acquisitions are evaluated to determine if they should be accounted for as business combinations or asset acquisitions based on the concentration of fair value in identifiable assets [399].

Financial Performance - Net sales increased by approximately $3.0 million, or 15.0%, to $22.6 million for the three months ended September 30, 2022, compared to $19.6 million for the same period in 2021[148] - Net sales increased by approximately $7.4 million, or 12.8%, to $65.5 million for the nine months ended September 30, 2022, compared to $58.0 million for the same period in 2021[159] - Loss from operations was $12.6 million for the three months ended September 30, 2022, compared to a loss of $11.7 million for the same period in 2021[147] - Net loss for the three months ended September 30, 2022, was $14.98 million, compared to a net loss of $28.41 million for the same period in 2021[147] - Net loss for the nine months ended September 30, 2022, was $51.3 million, compared to a net loss of $46.4 million for the same period in 2021[158] Cost and Expenses - Cost of goods sold rose by approximately $0.8 million, or 8.5%, to $9.8 million for the three months ended September 30, 2022, compared to $9.0 million for the same period in 2021[149] - Cost of goods sold increased by approximately $1.1 million, or 4.2%, to $27.1 million for the nine months ended September 30, 2022, compared to $26.0 million for the same period in 2021[160] - Sales and marketing expenses increased by approximately $0.2 million, or 2.0%, to $12.3 million for the three months ended September 30, 2022, compared to $12.1 million for the same period in 2021[151] - Sales and marketing expenses rose by approximately $7.2 million, or 20.9%, to $41.5 million for the nine months ended September 30, 2022, compared to $34.3 million for the same period in 2021[163] - Research and development expenses surged by approximately $1.4 million, or 57.2%, to $3.7 million for the three months ended September 30, 2022, compared to $2.4 million for the same period in 2021[152] - Research and development expenses increased by approximately $2.9 million, or 41.1%, to $9.8 million for the nine months ended September 30, 2022, compared to $7.0 million for the same period in 2021[164] - General and administrative expenses rose by approximately $1.5 million, or 18.6%, to $9.3 million for the three months ended September 30, 2022, compared to $7.9 million for the same period in 2021[153] - General and administrative expenses increased by approximately $8.3 million, or 35.5%, to $31.6 million for the nine months ended September 30, 2022, compared to $23.3 million for the same period in 2021[165] Profitability Metrics - Gross margin improved to approximately 56.6% for the three months ended September 30, 2022, up from 54.0% for the same period in 2021[150] - Gross margin improved to 58.6% for the nine months ended September 30, 2022, up from 55.2% for the same period in 2021[161] Cash Flow and Financing - Cash used in operating activities was $33.5 million for the nine months ended September 30, 2022, compared to $28.6 million for the same period in 2021[175] - The company had cash and cash equivalents of $19.0 million as of September 30, 2022[169] - The company completed a public offering on October 25, 2022, raising approximately $13.7 million in net proceeds[171] Interest and Taxes - Interest income was $41, while interest expense was $2.36 million for the three months ended September 30, 2022[147] - There was no income tax expense for the three months ended September 30, 2022, and 2021[155]

Financial Performance - Net sales increased by $1.4 million, or 7.0%, to $21.5 million for the three months ended June 30, 2022, compared to $20.1 million for the same period in 2021[121] - The company reported a loss from operations of $15.9 million for the three months ended June 30, 2022, compared to a loss of $9.2 million for the same period in 2021[120] - The company experienced a net loss of $18.3 million for the three months ended June 30, 2022, compared to a net loss of $20.1 million for the same period in 2021[120] - Net sales increased by $4.5 million, or 11.7%, to $42.9 million for the six months ended June 30, 2022, compared to $38.4 million for the same period in 2021[131] - The company incurred a net loss of $36.3 million for the six months ended June 30, 2022, compared to a net loss of $74.8 million for the same period in 2021[130] Cost and Expense Management - Gross margin improved to 59.2% for the three months ended June 30, 2022, up from 56.0% in the same period of 2021, primarily due to a decrease in unit costs of gel implants[122] - Total operating expenses increased to $28.7 million for the three months ended June 30, 2022, up from $20.4 million in the same period of 2021[120] - Sales and marketing expenses rose by $3.2 million, or 30.4%, to $13.7 million for the three months ended June 30, 2022, driven by increased payroll and marketing initiatives[123] - Research and development expenses increased by $0.6 million, or 23.3%, to $3.0 million for the three months ended June 30, 2022, mainly due to higher clinical and regulatory costs[124] - General and administrative expenses surged by $4.5 million, or 59.8%, to $12.1 million for the three months ended June 30, 2022, attributed to higher payroll and legal settlement fees[125] - Gross margin improved to 59.6% for the six months ended June 30, 2022, up from 55.8% in 2021, primarily due to a decrease in unit costs of gel implants[132] - Sales and marketing expenses rose by $7.0 million, or 31.2%, to $29.3 million for the six months ended June 30, 2022, driven by increased payroll and marketing initiatives[133] - Research and development expenses increased by $1.5 million, or 32.8%, to $6.1 million for the six months ended June 30, 2022, due to higher clinical and regulatory costs[134] - General and administrative expenses grew by $6.8 million, or 44.1%, to $22.3 million for the six months ended June 30, 2022, mainly from increased payroll and legal fees[135] Cash Flow and Liquidity - Cash used in operating activities was $30.8 million for the six months ended June 30, 2022, compared to $14.8 million for the same period in 2021[144] - As of June 30, 2022, the company had cash and cash equivalents of $25.0 million, with the ability to receive an additional $14.0 million on a term loan[139] - The company is evaluating various funding alternatives to improve liquidity, including potential capital raises through equity securities and debt financing[140] Business Developments - The company received approval from Health Canada on March 23, 2022, to begin commercialization of its silicone gel breast implants in Canada[103] - The sales organization consisted of 76 employees as of June 30, 2022, unchanged from the previous year[121] - Loss from discontinued operations decreased by $1.5 million for the three months ended June 30, 2022, due to the sale of the miraDry business[128]

Financial Performance - Net sales increased by $3.1 million, or 16.9%, to $21.4 million for the three months ended March 31, 2022, compared to $18.3 million for the same period in 2021[119]. - Gross margin improved to 60.0% for the three months ended March 31, 2022, up from 55.4% in the same period of 2021, primarily due to a decrease in unit costs of gel implants[122]. - Cost of goods sold increased by $0.4 million, or 4.8%, to $8.6 million for the three months ended March 31, 2022, compared to $8.2 million for the same period in 2021[121]. Operating Expenses - Sales and marketing expenses rose by $3.8 million, or 31.9%, to $15.6 million for the three months ended March 31, 2022, compared to $11.8 million for the same period in 2021[124]. - Research and development expenses increased by $0.9 million, or 43.2%, to $3.1 million for the three months ended March 31, 2022, compared to $2.2 million for the same period in 2021[125]. - General and administrative expenses increased by $2.3 million, or 29.0%, to $10.2 million for the three months ended March 31, 2022, compared to $7.9 million for the same period in 2021[126]. Cash Flow - Net cash used in operating activities was $17.9 million for the three months ended March 31, 2022, compared to $12.8 million for the same period in 2021, primarily due to increases in accounts receivable and inventory[135]. - Net cash used in investing activities was $0.2 million for the three months ended March 31, 2022, a decrease from $1.3 million in the same period in 2021, due to reduced property and equipment purchases[136]. - Net cash provided by financing activities was $5.3 million for the three months ended March 31, 2022, down from $39.4 million in the same period in 2021, primarily due to a decrease in proceeds from the issuance of common stock[138]. - As of March 31, 2022, the company had $38.9 million in cash and cash equivalents, with historical cash outflows primarily associated with research and development activities[131]. Business Operations - The company has one operating segment in continuing operations named Plastic Surgery, focusing on breast implants, tissue expanders, and scar management products[99]. - As of March 31, 2022, the sales organization consisted of 76 employees, an increase from 66 employees in the same period of 2021[120]. - The company received approval from Health Canada on March 23, 2022, to begin commercialization of its smooth round HSC and HSC+ silicone gel breast implants in Canada[102]. Challenges and Future Outlook - The ongoing impact of the COVID-19 pandemic continues to affect the company's revenues, with restrictions on non-emergency procedures leading to significant revenue harm since the second quarter of 2020[103]. - The company anticipates that operating expenses will remain consistent and will need to generate significant net sales to achieve profitability[130]. - The company may need to raise additional debt or equity capital to fund ongoing operations, as cash generated from operations may be insufficient[141]. - The company has incurred significant net operating losses since inception and expects these losses to continue in the near term[130]. - The liquidity position and capital requirements are subject to various factors, including the ability to meet customer requirements and costs associated with regulatory compliance[140]. Other Financial Information - Other income (expense), net decreased due to a change in the fair value of the derivative liability, which did not reoccur in the current period[127]. - Loss from discontinued operations increased by $2.0 million due to the sale of the miraDry business[129].

Business Focus - The company focuses on the Plastic Surgery segment, which includes silicone gel breast implants, tissue expanders, and scar management products, with a direct sales organization of 65 employees as of December 31, 2021[317]. - The company completed the sale of the miraDry business on June 10, 2021, to concentrate investments on its core Plastic Surgery segment[319]. - The company acquired assets from AuraGen Aesthetics, LLC on December 31, 2021, related to fat grafting technology, which is expected to expand its total addressable market[318]. - The company offers approximately 350 variations of breast implants, which are primarily used in elective procedures and are sold exclusively to board-certified plastic surgeons[326]. Regulatory Approvals - The company received Health Canada approval on March 23, 2022, to commercialize its smooth round HSC and HSC+ silicone gel breast implants in Canada, planning to start sales through a distribution partner[322]. - The company’s breast implants were approved by the FDA in 2012, based on a clinical trial involving 1,788 women, demonstrating competitive safety and effectiveness[327]. Financial Performance - Net sales increased by $25.7 million, or 46.7%, to $80.7 million for the year ended December 31, 2021, compared to $55.0 million for 2020[376]. - Cost of goods sold rose by $12.7 million, or 54.0%, to $36.3 million for the year ended December 31, 2021, compared to $23.6 million for 2020[378]. - Gross margin decreased to 54.9% in 2021 from 57.1% in 2020, primarily due to increased distribution and production costs[379]. - The net loss for the year ended December 31, 2021, was $62.5 million, an improvement from a net loss of $89.9 million in 2020[375]. Expenses - Sales and marketing expenses increased by $11.1 million, or 29.5%, to $48.5 million for the year ended December 31, 2021[380]. - Research and development expenses rose by $1.8 million, or 20.1%, to $10.5 million for the year ended December 31, 2021[381]. - General and administrative expenses decreased by $0.5 million, or 1.7%, to $31.8 million for the year ended December 31, 2021[382]. - Total non-cash stock-based compensation expense recorded was $10.4 million for the year ended December 31, 2021, compared to $8.2 million in 2020[363]. Cash and Financing - Cash and cash equivalents as of December 31, 2021, totaled $51.8 million[398]. - Net cash provided by financing activities increased by $4.4 million to $35.9 million for the year ended December 31, 2021[403]. - The company completed the sale of the miraDry business for an aggregate purchase price of $10.0 million, resulting in net cash proceeds of approximately $8.1 million[389]. - The company has $51.8 million in cash and cash equivalents as of December 31, 2021[408]. Liabilities and Provisions - As of December 31, 2021, the liability for unsatisfied performance obligations under the service warranty was $3.237 million, up from $1.945 million at the end of 2020[349]. - The sales return liability increased to $13.399 million as of December 31, 2021, compared to $9.192 million at the end of 2020, with actual returns of $152.773 million in 2021[351]. - The company held total warranty liabilities of $2.5 million and $1.9 million as of December 31, 2021, and 2020, respectively[358]. - The company recognized revenue from service warranties ratably over the term of the agreements, with performance obligations expected to be satisfied over 3 to 24 months for financial assistance and 20 years for product replacement[349]. Operational Insights - The company expects net sales to fluctuate quarterly due to factors such as seasonality and the ongoing impact of the COVID-19 pandemic[333]. - The company anticipates its overall gross margin to fluctuate due to unit sales volume, manufacturing costs, and product mix[337]. - Research and development expenses are expected to vary based on new product initiatives and improvements to existing products[339]. - The company is focused on maintaining unit costs to drive gross margin through its implant manufacturing facility in Franklin, Wisconsin[406]. - The company is expanding its sales force and marketing programs, which will incur associated costs[406]. - The company is investing in inventory to meet customer demands[406]. - The company is developing and commercializing proposed products or technologies, which will involve costs[406]. - The company is focused on new product acquisition and development efforts[406]. Tax and Valuation - The company maintains a full valuation allowance on its net deferred tax assets due to cumulative net losses and uncertainty regarding realization[342]. - The company evaluates acquisitions to determine if they should be accounted for as business combinations or asset acquisitions, with significant estimates involved in the valuation process[365]. - An immediate 100 basis point change in interest rates would not materially affect the fair market value of the company's cash equivalents[408]. Goodwill and Impairment - The company performed a qualitative analysis for goodwill impairment testing on October 1, 2021, concluding that the fair value of the reporting unit was likely greater than its carrying value, resulting in no impairment charges[357]. Warranty and Compensation - Stock-based compensation costs are recognized over the requisite service period, with unrecognized compensation costs related to unvested stock options totaling $1.5 million as of December 31, 2021[363].