Core Insights - Lyra Therapeutics announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 for chronic rhinosinusitis (CRS), achieving its primary endpoint with significant symptom improvement compared to sham control [1][4][5] Clinical Trial Results - The ENLIGHTEN 2 trial met its primary endpoint, showing a statistically significant improvement in the composite of the three cardinal symptoms (3CS) of CRS at week 24 (-1.13; p=0.0078) in patients without nasal polyps [1][5] - Key secondary endpoints were also met, including a significant improvement in 3CS at 24 weeks in the full population (-0.90; p=0.0209) and in the SNOT-22 score (-8.7; p=0.0101) [2][4] - Symptom improvement was observed as early as week 4, with sustained improvements throughout the trial [2][5] Safety and Tolerability - LYR-210 was well-tolerated, with a safety profile similar to sham control and no product-related serious adverse events reported [6] - Commonly reported adverse events included epistaxis, upper respiratory tract infection, and headache [6] Future Development Plans - The company plans to review the total dataset from the ENLIGHTEN trials to evaluate next steps for pursuing an indication in non-polyp patients and to continue development in patients with nasal polyps [4][7] - Lyra aims to align with the FDA for a New Drug Application (NDA) submission for patients without nasal polyps [7] Market Potential - LYR-210 is designed to provide six months of continuous anti-inflammatory therapy with a single administration, targeting the estimated four million CRS patients in the U.S. who fail medical management each year [12]

Core Viewpoint - Lyra Therapeutics is set to present 52-week results from the ENLIGHTEN 1 Phase 3 study for LYR-210, a treatment for chronic rhinosinusitis (CRS), at the COSM 2025 conference [1][2] Group 1: Product Overview - LYR-210 is a bioabsorbable nasal implant designed to deliver six months of continuous anti-inflammatory therapy using mometasone furoate for CRS patients who have failed current therapies [3][4] - The ENLIGHTEN program includes two pivotal Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, with approximately 180 CRS patients enrolled in each trial [2][4] Group 2: Clinical Trial Results - Results from the ENLIGHTEN 1 Phase 3 Extension Stage indicate a favorable safety profile for LYR-210, consistent with the Primary Study Phase [5][6] - In the subgroup of CRS patients with nasal polyps, improvements were observed in both symptoms and polyp size among those who crossed over from the sham group to receive LYR-210 [5][6] Group 3: Upcoming Events - The poster presentation for LYR-210 is scheduled for May 16 and 17, 2025, at the COSM 2025 conference in New Orleans [6]

Company Performance - Lyra Therapeutics reported a quarterly loss of $0.12 per share, better than the Zacks Consensus Estimate of a loss of $0.15, and an improvement from a loss of $0.35 per share a year ago, representing an earnings surprise of 20% [1] - The company posted revenues of $0.18 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 23.75%, and a decline from year-ago revenues of $0.53 million [2] - Over the last four quarters, the company has surpassed consensus EPS estimates three times, but has topped consensus revenue estimates only once [2] Stock Performance - Lyra Therapeutics shares have declined approximately 49.7% since the beginning of the year, compared to a decline of 3.9% for the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $0.24 million, and for the current fiscal year, it is -$0.61 on revenues of $0.97 million [7] Industry Outlook - The Medical - Drugs industry, to which Lyra Therapeutics belongs, is currently ranked in the top 22% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - The performance of Lyra Therapeutics may be influenced by the overall industry outlook, as empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions [5][8]

Financial Performance - As of March 31, 2025, total assets decreased to $56,316,000 from $66,346,000 as of December 31, 2024, representing a decline of approximately 15%[20] - Collaboration revenue for the three months ended March 31, 2025, was $183,000, down 65% from $532,000 in the same period of 2024[22] - Total operating expenses for Q1 2025 were $9,024,000, a decrease of 62% compared to $24,056,000 in Q1 2024[22] - The net loss for Q1 2025 was $8,547,000, compared to a net loss of $22,452,000 in Q1 2024, indicating a reduction of approximately 62%[22] - Cash and cash equivalents at the end of Q1 2025 were $31,735,000, down from $40,577,000 at the end of 2024, reflecting a decrease of about 22%[20] - The accumulated deficit increased to $413,337,000 as of March 31, 2025, from $404,790,000 at the end of 2024[20] - The Company recorded a restructuring charge of $10.9 million in 2024 and an additional $0.9 million in Q1 2025, primarily related to severance and retention costs[35] - The Company has reported basic net loss per share attributable to common stockholders, reflecting ongoing financial challenges since inception[48] - The Company may need additional financing to support future operations and growth strategies, as it has incurred recurring net operating losses[42] - The Company has incurred net losses of $413.3 million since inception, with cash and cash equivalents of approximately $31.7 million as of March 31, 2025, raising doubts about its ability to continue as a going concern[133] Workforce and Restructuring - Following the failure of the ENLIGHTEN 1 trial, the company reduced its workforce by 87 employees and halted commercialization efforts for LYR-210[33] - The Company has a restructuring liability balance of $4.039 million as of March 31, 2025, which includes severance and retention costs[55] - The Company engaged a valuation specialist to determine the fair value of right-of-use assets using a discount rate of 9.5-10.5%[61] - The company has initiated a strategic review, leading to a workforce reduction of approximately 75% in May 2024[162] - A reduction in force was approved by the Board, affecting up to 87 employees, with charges of approximately $11.8 million incurred for severance and related costs[216] Research and Development - The Company plans to report results from the ongoing Phase 3 ENLIGHTEN 2 trial for LYR-210 in the second quarter of 2025[122] - LYR-210 showed a mean improvement in the 3CS score of 3.21 points in CRS patients with nasal polyps, compared to 0.96 points in sham control, achieving statistical significance (p-value 0.0058)[129] - The Company has paused development efforts for LYR-220 as part of cost-saving measures announced in May 2024[128] - The company expects to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution if marketing approval is obtained for any product candidates[188] - The costs to advance product candidates to marketing approval are expected to be substantial, particularly for the LYR-210 product candidate[217] Financing and Capital Requirements - The Company raised an aggregate of $424.8 million since inception, primarily from equity securities[39] - The Company plans to seek stockholder approval for a reverse stock split to regain compliance with Nasdaq's minimum bid price requirement[38] - The Company has $50.2 million available for future sale under the Amended Sales Agreement as of March 31, 2025[73] - The company plans to fund operations through public or private equity or debt financings, as it does not expect to generate significant revenue from product sales in the foreseeable future[135] - Future capital requirements will depend on costs related to clinical trials, manufacturing, and commercialization activities for product candidates[191] Lease and Operating Costs - The Company executed the Waltham Lease in May 2022, comprising approximately 29,000 square feet with an initial base rent of $2.2 million per year, increasing by 3% annually until June 30, 2033[106] - The Waltham Sublease was executed in December 2023, covering approximately 24,000 square feet with a base rent of $1.8 million per year, also increasing by 3% annually until November 30, 2032[108] - Total lease costs for the three months ended March 31, 2025, were $1.895 million, down from $2.531 million for the same period in 2024, reflecting a decrease of approximately 25%[110] - The Company's operating lease liabilities as of March 31, 2025, totaled $41.355 million, with a present value of $33.356 million after accounting for imputed interest[113] - The operating lease for office and laboratory space in Watertown has a base rent of $2.0 million per year, expiring in April 2027[210] Collaboration and Revenue Generation - The company has not generated revenue from product sales and recognized $4.9 million in collaboration revenue from the LianBio License Agreement as of March 31, 2025[147] - Under the LianBio License Agreement, the company received an upfront payment of $12.0 million and is eligible for up to $135.0 million in future milestone payments[150] - Deferred revenue related to the Combined Performance Obligation was $11,748,000 as of March 31, 2025, with no revenue recognized during the three months ended March 31, 2025[99] - LianBio's collaboration revenue decreased from $532,000 in Q1 2024 to $183,000 in Q1 2025, a decline of 65.5%[173] Future Outlook and Strategic Options - The company is exploring operational and strategic options, including additional clinical trials and potential asset sales, following the failure of the ENLIGHTEN 1 trial[146] - The company anticipates that its cash, cash equivalents, and short-term investment balance will be sufficient to fund operating expenses into the first quarter of 2026[189] - The company may need to relinquish rights to technologies or future revenue streams if it raises additional funds through collaborations or licensing arrangements[140] - Future acquisitions or partnerships may dilute stockholder value and incur additional debt or liabilities[214] - The timing and size of future acquisitions or partnerships remain unpredictable and could impact operating results[214]

Financial Performance - Cash and cash equivalents as of March 31, 2025, were $31.7 million, down from $40.6 million at December 31, 2024[8] - Research and development expenses for Q1 2025 were $4.9 million, a decrease of 73% compared to $18.2 million for the same period in 2024[9] - General and administrative expenses for Q1 2025 were $3.3 million, down from $5.8 million in Q1 2024, reflecting a reduction in professional and consulting fees[10] - Net loss for Q1 2025 was $8.5 million, significantly reduced from $22.5 million in Q1 2024[11] - Total operating expenses for Q1 2025 were $9.0 million, compared to $24.1 million for the same period in 2024[12] Clinical Trials - The ENLIGHTEN 2 pivotal Phase 3 trial results for LYR-210 in CRS are expected in Q2 2025[7] - The ENLIGHTEN program includes two pivotal Phase 3 trials, with approximately 180 CRS patients enrolled in each trial[5] Strategic Plans - The company plans to implement a reverse stock split to comply with Nasdaq's minimum bid price requirement[6] - The company anticipates that its cash balance will fund operations into Q1 2026[8] Product Information - LYR-210 is designed to deliver six months of continuous anti-inflammatory therapy for CRS patients[15]

Clinical Trials and Development - The Phase 3 ENLIGHTEN 1 trial for LYR-210 did not meet its primary endpoint, showing a mean improvement in the 3CS score of 2.13 points compared to 2.06 points in sham control at 24 weeks, which was not statistically significant[21] - The ENLIGHTEN 2 trial for LYR-210 is ongoing, with topline results expected in Q2 2025, which will inform the future development path for LYR-210[22] - In the ENLIGHTEN 1 trial, LYR-210 showed a mean improvement in the SNOT-22 score of 20.2 points compared to 15.70 points in sham control[24] - The 52-week extension stage of the ENLIGHTEN 1 trial was completed in Q4 2024, showing consistent safety data with no product-related serious adverse events[26] - LYR-210 is designed to provide six months of continuous anti-inflammatory treatment with a single administration, targeting CRS patients who have failed previous medical management[34] - In the Phase 1 trial, LYR-210 achieved a significant improvement in SNOT-22 scores, with an average change from baseline of -20.5 points at week 24 (p < 0.0001)[44] - The Phase 2 trial (LANTERN) showed that at the 7,500 µg dose, LYR-210 achieved a statistically significant improvement in SNOT-22 scores, with a change from baseline of -19.0 points at week 24 (p=0.001)[44] - The Phase 3 trial (ENLIGHTEN 1) did not meet its primary endpoint, showing a mean improvement in the 3CS score of 2.13 points compared to 2.06 points in sham control[46] - The Phase 3 trial (ENLIGHTEN 2) is ongoing, with topline results expected in Q2 2025[49] - LYR-210 was generally well tolerated, with no product-related serious adverse events reported in both the treatment and extension phases[48] - The Phase 2 trial was impacted by COVID-19, leading to enrollment discontinuation at 67 patients[44] - Treatment with LYR-210 resulted in a statistically significant improvement in the 3CS score of 3.21 points compared to 0.96 points in sham control, with a difference of 2.25 points (p-value 0.0058) in CRS patients with nasal polyps[51] - In patients with a nasal congestion score of 2 or greater, LYR-210 showed an LS mean improvement of 3.69 points compared to 0.75 points in sham control, resulting in a difference of 2.94 points (p-value 0.0017)[51] - The Phase 2 LANTERN clinical trial enrolled 67 patients due to COVID-19, falling short of the planned 99 evaluable patients[52] - At the 7,500 µg dose, LYR-210 achieved significant improvements in 4CSS at weeks 16 (-1.47, p=0.021), 20 (-1.61, p=0.012), and 24 (-1.64, p=0.016), but did not meet the primary endpoint at week 4[56] - Approximately 50% of patients experienced a durable response post-removal of LYR-210, with no worsening of 4CSS from the Week 24 baseline[58] - The clinical development process is long and uncertain, with significant risks of failure at any stage, impacting the company's ability to commercialize its product candidates[186] - Delays in clinical trials may arise from various factors, including regulatory disagreements, recruitment challenges, and unforeseen safety issues, potentially increasing costs and delaying marketing approval[189] - The company has transitioned most of its clinical manufacturing to an in-house facility but is no longer engaged in manufacturing its product candidates as of May 2024[193][194] - The company has suspended its manufacturing activities, which may affect its ability to meet clinical and regulatory timelines[195] - If LYR-210 fails to demonstrate safety and efficacy, the company may face significant setbacks in its development plans and revenue generation[199] - The company has not conducted head-to-head trials comparing LYR-210 to other treatments, which could impact its market acceptance if LYR-210 is not shown to be more effective[202] - The company may incur unplanned costs and face delays in obtaining marketing approval for its product candidates due to various unforeseen events during clinical trials[188] - Regulatory authorities may impose modifications or suspensions on clinical trials, which could further delay the development of LYR-210[190] - The company has limited influence over the performance of third-party contractors involved in clinical trials, which may lead to compliance issues and delays[190] - The company is currently seeking feedback from regulatory authorities, which may not be provided in a timely manner, potentially impacting development timelines[190] - The company intends to seek FDA approval for LYR-210 through the Section 505(b)(2) regulatory pathway, which could potentially expedite the development program by relying on existing data[206] - If the FDA does not allow the use of the Section 505(b)(2) pathway, the company may face significantly longer approval times and increased costs, potentially delaying market entry[206] - The pharmaceutical industry is highly competitive, and patent litigation could delay NDA approvals for up to 30 months or longer[207] - Clinical trials for LYR-210 are being conducted outside the United States, primarily in Europe, but the FDA may not accept data from these trials, which could necessitate additional costly trials[209] - LYR-210 will be regulated as a drug-device combination product, which may complicate the approval process and increase the time and resources required for market entry[211] - The company has not obtained regulatory approval for any product candidates, and the lengthy approval process may hinder commercialization efforts[217] - Approval processes vary among countries, and failure to comply with international regulatory requirements could limit market potential[216] - The company must demonstrate substantial evidence from well-controlled clinical trials to satisfy regulatory agencies, which may require additional studies and resources[218] - Only a small percentage of products in development successfully complete the regulatory approval process, posing a significant risk to the company's business prospects[219] - Delays in obtaining regulatory approvals may diminish competitive advantages and hinder the ability to generate revenue from product candidates[214] Financial and Operational Impact - Following the trial results, the company reduced its workforce by approximately 75%, impacting 87 employees, and paused development efforts for LYR-220[21] - The company estimates that approximately 14 million people in the U.S. are affected by CRS, with about 4 million failing medical management annually[31] - LYR-210 aims to address the needs of up to 4 million CRS patients in the U.S. who fail current medical management[38] - The company is evaluating strategic options to maximize shareholder value, with no assurance that any transaction will be completed[34] - LYR-220 development has been paused as part of cost-saving measures, following positive topline results from the Phase 2 BEACON trial[27] - The company plans to build a targeted in-house sales force to engage ENT physicians, who perform 80% of CRS procedural volume, for the commercialization of LYR-210[75] - A holistic reimbursement strategy will be executed to ensure market access, focusing on educating payors about the clinical and pharmacoeconomic attributes of LYR-210[76] - The company entered into a License and Collaboration Agreement with LianBio for the development and commercialization of LYR-210, receiving an upfront payment of $12.0 million and potential future payments of up to $135.0 million based on milestone achievements[78] - The company is entitled to receive low double-digit royalties on net sales of LYR-210 in the licensed territories, while LianBio is responsible for clinical development and commercialization in those regions[79] - The company faces significant competition from larger pharmaceutical and biotechnology firms, which may have greater financial resources and established market presence[82] - The company has 27 issued U.S. patents and 41 foreign issued patents as of December 31, 2024, with additional pending applications[88] - The first lineage of patents provides protection potentially until 2030, while the fourth lineage, filed in 2021, could extend protection until 2042[89] - The company relies on single source suppliers for key components, which may impact its ability to supply products and develop candidates[85] - The company incurred operating losses of approximately $93.4 million and $62.7 million for the years ended December 31, 2024 and 2023 respectively[149] - The company has no approved products and has generated no product revenues to date[164] - The company executed a sublease agreement for approximately 24,000 square feet at a base rent of $1.8 million per year, increasing 3% annually until November 30, 2032[146] - The company expects to incur significant additional operating losses for the foreseeable future and may never achieve profitability[151] - The company has suspended further development of LYR-220 and will require substantial additional funds to develop and commercialize LYR-210[158][165] - The company incurred charges of approximately $10.9 million related to a reduction in force affecting up to 87 employees[150] - The company maintains cash and cash equivalents in accounts exceeding insured limits, which could be impacted by market conditions[160] - The company may need to raise additional capital through equity offerings or debt financings, which could dilute existing shareholders[162][163] - The company is responsible for real estate taxes, maintenance, and other operating expenses under its leases, which could impact financial condition if subleasing is unsuccessful[147] - The company is exploring strategic alternatives following the failure to meet the primary endpoint of the ENLIGHTEN 1 Phase 3 clinical trial announced in May 2024[141] - The company has three leaseholds in Massachusetts representing significant operating costs and is attempting to sublease or assign these leaseholds[143] - Third-party payors are increasingly reducing reimbursements for pharmaceutical products and services, impacting sales potential[130] - The IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare beginning in 2026[134] - The distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, which regulates drug distribution at the federal level[127] - The company may incur significant costs related to the evaluation of strategic options, including legal and advisory fees[142] - The FDA imposes strict regulations on marketing, labeling, and promotion of pharmaceutical products, with potential consequences for non-compliance[125] Regulatory Environment - The regulatory approval process for LYR-210 involves multiple stages, including preclinical studies, IND submission, and clinical trials, requiring substantial time and financial resources[92] - The company is subject to extensive FDA regulations, and failure to comply may result in sanctions that could adversely affect its operations[92] - The FDA has a goal of 10 months to review and act on a standard NDA and 6 months for a priority NDA, measured from the filing date[100] - The FDA may require submission of a risk evaluation and mitigation strategy (REMS) plan to ensure that the benefits of the drug outweigh its risks[102] - The FDA conducts a preliminary review of all NDAs within the first 60 days after submission to determine completeness for substantive review[103] - The FDA may refer an application for a novel drug to an advisory committee for independent expert evaluation and recommendations[104] - The FDA generally accepts data from foreign clinical trials in support of an NDA if conducted under an IND and in accordance with GCP requirements[106] - The Hatch-Waxman Amendments allow for a Section 505(b)(2) NDA, which can rely on existing studies not conducted by the applicant[110] - The FDA may grant Fast Track Designation for drugs intended to treat serious conditions and demonstrating potential to address unmet medical needs[115] - Priority review designation can reduce the FDA review period to 6 months for drugs offering major advances in treatment[116] - Accelerated approval may be granted based on surrogate endpoints that predict clinical benefit, with post-marketing studies required[117] - Breakthrough therapy designation expedites the development and review of drugs showing substantial improvement over existing therapies[119] - The FDA may require post-marketing testing, including Phase 4 clinical trials, to monitor product safety and effectiveness after commercialization[122]

Financial Performance - As of December 31, 2024, cash and cash equivalents were $40.6 million, down from $51.6 million at September 30, 2024, with sufficient funds projected to cover operating expenses into Q1 2026[11] - Research and development expenses for the full year 2024 were $43.8 million, a decrease of 8.5% from $48.0 million in 2023, primarily due to reduced clinical costs[12] - General and administrative expenses for the full year 2024 were $18.5 million, down from $19.1 million in 2023, reflecting a decrease in professional and consulting fees[13] - The net loss for the full year 2024 was $93.4 million, compared to a net loss of $62.7 million in 2023, indicating a significant increase in losses year-over-year[14] - The total operating expenses for the full year 2024 were $97.9 million, an increase from $68.7 million in 2023, driven by various impairment and restructuring charges[15] - The company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future[20] Clinical Trials and Product Development - The ENLIGHTEN 2 Phase 3 trial results for LYR-210 are expected in Q2 2025, which will provide critical data on its efficacy in chronic rhinosinusitis patients[4] - The ENLIGHTEN program includes two pivotal Phase 3 trials, with approximately 180 CRS patients enrolled in each trial, randomized 2:1 to receive either LYR-210 or sham control[5] - LYR-210 is designed to deliver six months of continuous anti-inflammatory therapy and is being evaluated for patients with chronic rhinosinusitis, including those with nasal polyps[18] - The company received FDA feedback in December 2024, clarifying the potential path forward for LYR-210 in treating chronic rhinosinusitis with nasal polyps[9] - The company needs to conduct at least one additional Phase 3 clinical trial[20] - Clinical trials required for the company's product candidates are expensive and time-consuming, with uncertain outcomes[20] - The company relies on third parties to conduct its preclinical studies and clinical trials[21] - There are no approved products currently available from the company[20] Corporate Actions and Management - The company plans to implement a reverse stock split to comply with Nasdaq's minimum bid price requirement of $1.00[9] - Approximately 87 employees were terminated following the failure to meet the primary endpoint in the ENLIGHTEN 1 Phase 3 clinical trial[20] - Significant costs and management time are required due to operating as a public company[21] - The price of the company's common stock may be volatile and fluctuate substantially[21] - The company disclaims any obligation to update forward-looking statements even if subsequent events cause its views to change[21]

Core Insights - Lyra Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing long-acting, anti-inflammatory sinonasal implants for chronic rhinosinusitis (CRS) treatment [19] - The company reported its financial results for Q4 and full year 2024, highlighting a net loss of $93.4 million for the year, compared to a loss of $62.7 million in 2023 [12][16] Financial Highlights - Cash and cash equivalents as of December 31, 2024, were $40.6 million, down from $51.6 million at September 30, 2024 [9] - Research and development expenses for Q4 2024 were $6.4 million, and for the full year, they totaled $43.8 million, a decrease from $48.0 million in 2023 [10] - General and administrative expenses for Q4 2024 were $3.6 million, compared to $4.4 million in Q4 2023, with full-year expenses at $18.5 million, down from $19.1 million [11] Clinical Development - The company is awaiting results from the ENLIGHTEN 2 Phase 3 study, expected in Q2 2025, which will provide insights into the efficacy of LYR-210 for CRS patients [2][14] - The ENLIGHTEN program includes two pivotal Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, with approximately 180 CRS patients enrolled in each trial [3] - Positive post-hoc data analyses from the ENLIGHTEN 1 Extension Study indicate LYR-210's potential in treating CRS patients with nasal polyps [3][4] Regulatory Engagement - Lyra has engaged with the FDA regarding the registration path for LYR-210 in CRS patients with nasal polyps, receiving clarifications that the safety dataset from ongoing studies may be sufficient for a pivotal study [7] Corporate Actions - The company plans to implement a reverse stock split to comply with Nasdaq's minimum bid price requirement, pending approval from the board and stockholders [8]

Lyra Therapeutics, Inc. (LYRA) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked ...

Lyra Therapeutics, Inc. (LYRA) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.27 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 21.74%. A quarter ago, it was expected that this company would post a loss of $0.34 per share when it actually produced a loss of $0.29, delivering a surprise of 14.71%.Over the last four quarters, the company has ...