Revenue Performance - For the three months ended October 31, 2022, revenues decreased to $18.276 million, down 31% from $26.519 million in the same period of 2021[140] - Clinical services revenues decreased to $11.2 million in 2023 from $19.7 million in 2022, a decline of 43%[147] - Revenues from COVID-19 testing represented 7% of clinical revenues in 2023, down from 47% in 2022, with a 92% decline in COVID-19 accessions[147] - Product revenues increased to $7.1 million in 2023, up 5% from $6.8 million in 2022, with growth in the U.S. and Asia Pacific regions[150] Operating Loss and Costs - Operating loss for the three months ended October 31, 2022, was $9.913 million, compared to an operating loss of $1.832 million in the same period of 2021, reflecting an unfavorable change of $8.081 million[140] - Total operating costs and expenses for the three months ended October 31, 2022, were $28.189 million, a slight decrease of 1% from $28.351 million in the same period of 2021[140] - The cost of clinical services decreased to $10.1 million in 2023, down 10% from $11.2 million in 2022, resulting in a gross profit margin of approximately 10%[151] Cash Flow and Liquidity - Net cash used in operating activities was $8.7 million in 2023, compared to $6.0 million in 2022, reflecting a net loss of $10.6 million[163] - The company had cash and cash equivalents of $12.1 million as of October 31, 2022, down from $21.6 million at July 31, 2022[160] - The company believes its current cash and cash equivalents are sufficient for its liquidity needs over the next twelve months, but may need to raise additional capital if losses continue[168] Accounts Receivable - As of October 31, 2022, approximately 62% of the Company's net accounts receivable relates to its Clinical Laboratory Services business, up from 59% as of July 31, 2022[180] - The Clinical Labs segment's total net accounts receivable increased to $7.096 million as of October 31, 2022, from $6.754 million as of July 31, 2022[181] - Accounts receivable from third-party payers in the Clinical Labs segment rose to $3.054 million (43%) as of October 31, 2022, compared to $2.647 million (40%) as of July 31, 2022[181] - The Company reported total net accounts receivable of $11.515 million as of October 31, 2022, nearly unchanged from $11.516 million as of July 31, 2022[181] Research and Development - The company has a substantial portfolio of approximately 472 issued patents worldwide and over 64 pending patent applications, supporting its R&D efforts[134] - Research and development expenses rose to $1.0 million in 2023, an increase of 34% from $0.7 million in 2022, focusing on lab-developed tests and COVID-19 detection[154] Market and Economic Conditions - The company continues to assess the potential adverse impacts of the recessionary economic environment on its financial position and cash flows[129] - The company expects that volume and revenues from COVID-19 testing will remain less significant as vaccination rates increase and the severity of variants declines[128] Currency Risk - The Company is exposed to a potential $2.0 million unfavorable impact on pre-tax earnings annually if the U.S. dollar appreciates by 10% against foreign currencies[192] - A hypothetical 10% increase in the U.S. dollar value would decrease the Company's net revenues and net income by $0.8 million and $0.5 million, respectively, on an annual basis[191] - The Company does not currently engage in any hedging or market risk management tools to mitigate foreign currency exchange rate risks[190] Operational Challenges - Enzo's Clinical Services segment is impacted by reduced reimbursements from third-party payers and recent healthcare legislation[136] - Selling, general and administrative expenses increased to $11.5 million in 2023, a rise of 4% from $11.1 million in 2022, primarily due to higher facility costs[155] - Enzo's proprietary technology platforms aim to reduce overall healthcare costs and improve accuracy and reproducibility in diagnostic testing[133] - The Company assesses the collectability of receivables based on the quality of its billing processes, which are critical for operating performance and cash flows[181]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended July 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-09974 ENZO BIOCHEM, INC. (Exact name of registrant as specified in its charter) | --- | --- | --- | |-------- ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $26.2 million, a decrease of 20% from $32.8 million in Q3 2021, attributed to declining COVID-19 testing volumes and economic shutdowns in Asia [29][30] - Enzo Clinical Lab Service revenue was $18.6 million, down 26% from $25 million in the same quarter last year, although routine testing revenue increased by 10% [30] - Enzo Life Sciences revenue was $7.6 million, slightly down year-over-year but up 9% year-to-date, indicating stability in the customer base [32] Business Line Data and Key Metrics Changes - Enzo Clinical Lab's non-COVID revenue increased by 3% year-over-year, demonstrating recovery in core testing [30] - The company added 43 new tests in Q3, totaling 126 new tests year-to-date, focusing on specialty testing [31] - Enzo Life Sciences faced challenges due to economic shutdowns in Asia and supply chain issues in Europe, but anticipates overall annual growth of 10% for fiscal year 2022 [32] Market Data and Key Metrics Changes - The blended gross margin for the quarter declined to 39% from 49% year-over-year, impacted by both Enzo Clinical Lab and Enzo Life Sciences [33] - Enzo Clinical Lab's margin decreased from 49% to 40% due to reduced higher-margin COVID tests, while Life Sciences gross margin fell to 36% due to increased manufacturing costs [33][34] Company Strategy and Development Direction - The company is focused on a corporate structure that supports three separate businesses: Enzo Life Sciences, Enzo Clinical Labs, and Enzo Diagnostics, which allows for synergies and tailored solutions [12][11] - Enzo is committed to investing in technology and strategic partnerships to accelerate growth in core life sciences and clinical lab businesses [19] - The company is preparing to launch new diagnostic platforms and has received approvals for several molecular tests, indicating a strong focus on expanding its diagnostic capabilities [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic vision and ability to execute on growth initiatives, particularly in Life Sciences and Diagnostic platforms [40][28] - The company is exploring strategic alternatives with the help of Jefferies LLC, indicating a proactive approach to enhancing shareholder value [39][28] Other Important Information - Cash and cash equivalents totaled $32.1 million as of April 30, 2022, down from $44.3 million at the end of fiscal year 2021, due to various strategic initiatives [37] - The company maintains a goal of achieving an additional $10 million in cost savings, with $5 million targeted for calendar year 2022 [38] Q&A Session Summary Question: Clarification on the Jefferies process and its differences from the prior process - Management indicated that they are not making public comments on the specifics but are picking up where they left off in the previous process [42]

Financial Performance - Revenues for the three months ended April 30, 2022, were $26.2 million, a decrease of $6.6 million or 20% compared to $32.8 million in the same period of 2021[140]. - The company reported a net loss of $4.9 million for the three months ended April 30, 2022, compared to a net income of $2.0 million in the same period of 2021, representing a decrease of $6.9 million[140]. - Product revenues decreased to $7.6 million in 2022 from $7.8 million in 2021, a decline of 2%[149]. - Clinical services revenues fell to $62.0 million in 2022, down 12% from $70.2 million in 2021, with COVID-19 testing representing 49% of clinical revenues in 2022[161]. Operating Costs and Expenses - The total operating costs and expenses for the three months ended April 30, 2022, were $29.4 million, a decrease of $1.4 million or 4% from $30.7 million in the same period of 2021[140]. - The cost of clinical services decreased by 7% to $35.0 million in 2022, while the gross profit margin was approximately 44% compared to 47% in 2021[165]. - Selling, general and administrative expenses rose to $37.0 million in 2022, an increase of 12% from $33.1 million in 2021[168]. - Legal and related expenses increased by 22% to $4.9 million in 2022, driven by higher legal costs associated with strategic initiatives[169]. Revenue Drivers - Clinical services revenues for the 2022 period were $18.6 million, down $6.4 million or 26% from $25.0 million in the 2021 period, with COVID-19 testing representing 43% of clinical revenues in 2022 compared to 59% in 2021[146]. - Diagnostic testing volume decreased approximately 23% period over period, contributing to the revenue decline in the 2022 period[146]. - The company anticipates that demand for COVID-19 testing will not match 2021 levels due to increased vaccination rates and the development of new therapeutics[129]. Cash Flow and Working Capital - As of April 30, 2022, the company had cash and cash equivalents of $31.1 million, down from $43.5 million at July 31, 2021, indicating a decrease of $12.4 million[174]. - Working capital decreased to $37.6 million as of April 30, 2022, from $44.5 million at July 31, 2021, a decline of $6.9 million attributed to cash usage for operations and capital expenditures[175]. - Net cash used in operating activities was approximately $7.5 million in 2022, compared to a net cash provided of $0.3 million in 2021, marking an unfavorable variance of $7.8 million due to a net loss of $9.8 million and increases in operating assets[176]. - Net cash provided by investing activities was approximately $25.6 million in 2022, contrasting with cash used of $32.9 million in 2021, as the company sold all marketable securities purchased in 2021[177]. Assets and Liabilities - The accounts receivable balance for Clinical Services was $7.775 million as of April 30, 2022, representing 66% of total net accounts receivable, an increase from $6.016 million in 2021[196]. - The contractual adjustment percentage for the three months ended April 30, 2022, was 83.3%, up from 81.2% in 2021, indicating a trend in reimbursement adjustments[189]. - A 1% change in the contractual adjustment percentage could result in a revenue change of approximately $3.5 million for the nine months ended April 30, 2022[190]. - The company had a mortgage principal balance of $4.0 million with a fixed interest rate of 5.09% per annum, requiring monthly payments of $30[179]. Research and Development - The company has a substantial portfolio of approximately 472 issued patents worldwide and over 64 pending patent applications, supporting its research and development efforts[132]. - Research and development expenses increased by 13% to $2.7 million in 2022, focusing on lab developed tests for STIs and COVID-19 detection[167]. Foreign Exchange and Impairment - The company experienced a foreign currency revaluation loss of $1.1 million in 2022, attributed to the depreciation of the Euro, British pound, and Swiss franc against the U.S. dollar[156]. - A hypothetical 10% increase in the U.S. dollar value would decrease the Company's assets by $0.3 million and net revenues by $0.9 million annually[210]. - Foreign exchange losses on intercompany balances could impact pre-tax earnings by approximately $1.9 million annually with a 10% increase in the U.S. dollar[211]. - The Company tests goodwill for impairment annually, with the option for a qualitative assessment to determine if further testing is necessary[205].

Enzo Biochem, Inc. (NYSE:ENZ) Q2 2022 Earnings Conference Call March 14, 2022 4:30 PM ET Company Participants David Holmes - Investor Relations Hamid Erfanian - Chief Executive Officer David Bench - Chief Financial Officer Conference Call Participants Paul Nouri - Noble Equity Fund Christian Schwab - Craig Hallum Kenan Lucas - Harbert Management Corporation Dan Weston - WestCap Management Operator Greetings. And welcome to the Enzo Biochem Second Quarter 2022 Financial Results and Business Update Conferenc ...

Revenue Performance - Revenues for the three months ended January 31, 2022, were $34.0 million, an increase of 8% compared to $31.5 million for the same period in 2021[138]. - Clinical services revenues decreased by $0.3 million or 1%, totaling $23.7 million in the 2022 period, with COVID-19 testing representing 56% of clinical revenues[144]. - Product revenues increased by $2.9 million or 39%, reaching $10.4 million in the 2022 period, driven by a bulk sale of a GMP reagent worth $2.8 million[146]. - Revenues for Clinical Services decreased by 4% to $43.4 million in the 2022 period from $45.2 million in 2021, with COVID-19 testing representing 52% of Clinical revenues[159]. Operating Costs and Profitability - Total operating costs and expenses for the three months ended January 31, 2022, were $36.0 million, an increase of 21% from $29.8 million in the prior year[138]. - Operating loss for the three months ended January 31, 2022, was $1.9 million, compared to an operating income of $1.7 million in the same period of 2021, reflecting a decline of $3.6 million[138]. - The company expects improved profitability with increased service volume from the introduction of new molecular and esoteric tests[133]. - Clinical Services costs increased to $12.6 million in the 2022 period, up 7% from $11.7 million in 2021, with a gross profit margin of approximately 47% compared to 51% in 2021 due to higher reagent and personnel costs[147]. - Product revenues rose to $17.2 million in the 2022 period, a 15% increase from $14.9 million in 2021, with a gross profit margin of 49% in 2022 compared to 47% in 2021[148]. - Selling, general and administrative expenses increased by 32% to $14.5 million in the 2022 period from $11.0 million in 2021, driven by higher compensation and facility costs[150]. - Legal and related expenses rose to $2.8 million in the 2022 period, a 24% increase from $2.3 million in 2021, due to higher legal activities associated with strategic initiatives[151]. Financial Position and Cash Flow - The company reported a net loss of $4.97 million in the 2022 period compared to a net income of $2.6 million in 2021, reflecting a significant unfavorable variance[157]. - Cash and cash equivalents and marketable securities totaled $33.6 million as of January 31, 2022, down from $43.5 million at July 31, 2021[172]. - Net cash used in operating activities was approximately $6.7 million in the 2022 period, an unfavorable variance of $4.6 million compared to $2.1 million in 2021[174]. - The foreign currency revaluation loss was $0.5 million in the 2022 period, compared to a gain of $0.6 million in 2021, resulting in an unfavorable variance of $1.1 million[154]. Intellectual Property and Technology - The company holds approximately 472 issued patents worldwide and over 64 pending patent applications, indicating a strong intellectual property portfolio[131]. - Enzo's proprietary technology platforms aim to reduce overall healthcare costs and improve diagnostic testing efficiency[129]. Market and Demand Outlook - The company anticipates a significant decline in demand for COVID-19 testing in fiscal year 2022 compared to 2021 levels due to increased vaccination rates and new therapeutics[128]. - Diagnostic testing volume decreased approximately 8% period over period, contributing to the revenue decline in the clinical services segment[144]. Accounts Receivable and Risk Management - As of January 31, 2022, approximately 60% of the Company's net accounts receivable related to Clinical Laboratory Services[190]. - The accounts receivable balance for Life Science products included foreign receivables of $1.2 million, representing 19% of total receivables as of January 31, 2022[191]. - Total net accounts receivable was $15.316 million as of January 31, 2022, compared to $10.198 million as of July 31, 2021[193]. - Approximately 27% of Clinical Labs receivables are from one provider, indicating a concentration risk[194]. - The Company does not engage in any hedging or market risk management tools, exposing it to market risk from foreign currency exchange rates[205]. Financial Covenants and Interest Rates - The liquidity covenant was reduced to approximately $6 million from $25 million as of January 31, 2022, and the collateral requirement increased to $1.0 million[178]. - As of January 31, 2022, the mortgage principal balance was $4.1 million with a fixed interest rate of 5.09% per annum, requiring monthly payments of $30[176]. - The Company is in compliance with financial and liquidity covenants related to its mortgage as of January 31, 2022[178]. Foreign Exchange Impact - A hypothetical 10% increase in the value of the U.S. dollar would decrease assets by $0.4 million and net revenues by $0.9 million annually[207]. - A hypothetical 10% increase in the value of the U.S. dollar would decrease liabilities by $0.1 million and net income by $0.3 million annually[207]. - Pre-tax earnings would be unfavorably impacted by approximately $1.9 million annually due to foreign exchange losses from intercompany balances and loans[208]. - As of January 31, 2022, the company has fixed interest rate financing on a building mortgage and equipment finance leases[209].

Enzo Biochem, Inc. (NYSE:ENZ) Q1 2022 Results Conference Call December 15, 2021 4:30 PM ET Company Participants David Holmes - LifeSci Advisors IR Hamid Erfanian - CEO David Bench - CFO Conference Call Participants Paul Nouri - Noble Equity Fund Operator Greetings. Welcome to the Enzo Biochem First Quarter 2022 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructi ...

Financial Performance - Revenues for the three months ended October 31, 2021, were $26,519 thousand, a decrease of 7.5% compared to $28,655 thousand for the same period in 2020[16] - Total operating costs and expenses for the same period were $28,351 thousand, slightly up from $28,158 thousand in 2020, resulting in an operating loss of $1,832 thousand[16] - The net loss for the three months ended October 31, 2021, was $2,319 thousand, compared to a net income of $299 thousand in the same period of 2020, reflecting a significant decline[16] - The company reported a basic net loss per common share of $0.05 for the three months ended October 31, 2021, compared to a basic net income per share of $0.01 in 2020[16] - For the three months ended October 31, 2021, the company reported a net loss of $2,319,000 compared to a net income of $299,000 for the same period in 2020[25] - The company reported a decrease in accounts receivable of $1,120,000 for the three months ended October 31, 2021, compared to a decrease of $2,865,000 in the same period of 2020[25] - The company reported capital expenditures of $1.033 million for the three months ended October 31, 2021[100] - Total operating costs and expenses increased to $28,351 thousand, up from $28,158 thousand in the prior year, resulting in an operating loss of $1,832 thousand compared to an operating income of $497 thousand in 2020[17] - Net loss for the period was $2,319 thousand, compared to a net income of $299 thousand in the same period last year, reflecting a significant decline in profitability[19] Cash and Liquidity - Cash and cash equivalents decreased to $6,356 thousand as of October 31, 2021, down from $13,524 thousand at July 31, 2021[13] - Total assets decreased to $108,139 thousand as of October 31, 2021, compared to $113,691 thousand at July 31, 2021[13] - The company reported inventories of $13,957 million as of October 31, 2021, an increase from $12,652 million as of July 31, 2021[61] - Total cash and cash equivalents and restricted cash at the end of the period was $7,106,000, down from $46,664,000 at the end of the same period last year[25] - Cash and cash equivalents at the end of the period were $6,356 thousand, down from $45,914 thousand at the end of October 31, 2020, indicating a decrease in liquidity[25] - Net cash used in operating activities was $6,043 thousand for the three months ended October 31, 2021, significantly higher than $1,208 thousand for the same period in 2020[25] Assets and Liabilities - Total liabilities decreased to $41,379 thousand as of October 31, 2021, from $45,105 thousand at July 31, 2021[13] - Stockholders' equity as of October 31, 2021, was $66,760 thousand, down from $68,586 thousand at July 31, 2021[13] - Current liabilities decreased to $23.106 million from $26.076 million, a reduction of about 11.3%[13] - The company reported an accumulated deficit of $272.696 million as of October 31, 2021, compared to $270.377 million at the end of July 2021, indicating an increase in the deficit[13] Revenue Breakdown - Clinical services revenue accounted for 74% of total revenues for both the three months ended October 31, 2021, and 2020[46] - Total clinical services net revenues for the three months ended October 31, 2021, were $19,741 million, a decrease from $21,223 million in the same period of 2020[55] - Revenue from third-party payers was $11,397 million, representing 58% of clinical services revenue, down from 64% in the prior year[55] - Products revenue for the three months ended October 31, 2021, was $6,778 million, compared to $7,432 million in the same period of 2020[57] - Medicare revenue was $2,880 million (14% of clinical services revenue) for the three months ended October 31, 2021, down from $3,257 million (15%) in 2020[55] - Patient self-pay revenue decreased to $1,945 million (10% of clinical services revenue) in the three months ended October 31, 2021, from $2,559 million (12%) in 2020[55] Expenses and Costs - Research and development expenses remained relatively stable at $744 thousand for the three months ended October 31, 2021, compared to $746 thousand in 2020[16] - Share-based compensation expense for the three months ended October 31, 2021, totaled $216 million, an increase from $167 million in the same period of 2020, reflecting a rise of about 29.3%[87] - The operating lease cost for the three months ended October 31, 2021, was $1,158 million, compared to $1,479 million for the same period in 2020, representing a decline of approximately 21.7%[74] - The company accrued PSU compensation expense of $66,000 for the three months ended October 31, 2021, while no expense was accrued in the same period of 2020[95] Legal and Regulatory Matters - The company is involved in ongoing litigation with Harbert Discovery Fund, alleging false and misleading representations in proxy materials[108] - The court denied Harbert's motion to dismiss the company's misrepresentation claims on September 28, 2021, allowing the company to pursue these claims[108] - Management believes that any potential liabilities from ongoing litigations will not have a material adverse effect on the company's financial position[109] Management and Governance - The company appointed Hamid Erfanian as CEO on November 8, 2021, who has over 28 years of experience in the healthcare sector[111] - The company granted equity awards to the new CEO, including 260,000 restricted stock units and options to purchase 700,000 shares, with an exercise price of $3.39[111] Market and Economic Conditions - The impact of the COVID-19 pandemic continues to affect the company's operations, with significant reductions in physician office visits and elective medical procedures[27] - Management emphasizes that the results for the three months ended October 31, 2021, are not necessarily indicative of future performance for the fiscal year ending July 31, 2022[26]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Mark one ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended April 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number 001-09974 ENZO BIOCHEM, INC. (Exact name of registrant as specified in its charter) | --- | --- | --- | |- ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2021 was $32.8 million, an increase of 94% year-over-year from $16.9 million [17][20] - Gross margins improved to 49%, up from 26% in the year-ago period, representing an increase of 2,300 basis points [20][21] - GAAP net income was $2.0 million or $0.04 per share, compared to a loss of $9.9 million or negative $0.21 per share in Q3 2020 [23] - Adjusted EBITDA was $2.7 million, a significant improvement from an adjusted loss of $7 million in the same quarter last year [23] Business Line Data and Key Metrics Changes - Clinical services revenue increased nearly 140% to $25 million from $10.5 million in Q3 2020, driven by volume growth in total accessions [21] - Clinical services gross margin increased to 49.1% from 12.9% in Q3 2020, an improvement of over 3,600 basis points [21] - Enzo Life Sciences product gross margin was 48.4%, up from 47.9% year-over-year [22] Market Data and Key Metrics Changes - Total accessions reached over 340,000 in the most recent quarter, an annualized rate of 1.36 million, compared to pre-COVID levels of approximately 800,000 [21] - The company anticipates a gradual return to regular doctor visits and expects academic institutions to reopen fully by the end of the year [14] Company Strategy and Development Direction - The company is transforming into an integrated end-to-end diagnostic products and solutions company, focusing on high-value opportunities and enhancing operational efficiencies [18][27] - Enzo is leveraging its higher-margin testing model demonstrated during COVID-19 to other markets, including women's health and sexually transmitted diseases [15] - The company is actively engaged in discussions for partnerships and potential acquisitions to complement existing activities [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the post-COVID environment, having successfully adapted during the pandemic [13] - The company is implementing operational protocols and a modified sales strategy to address the realities of a post-COVID-19 environment [14] - Management remains optimistic about achieving full-year profitability for the fiscal year ending in July [19] Other Important Information - The company received FDA EUA clearance for its AMPICOLLECT Sample Collection kit for COVID-19 testing [10] - Enzo's GoTestMeNow online platform is expanding testing access directly to consumers [19] - The company has a strong balance sheet with cash and equivalents of $45.8 million as of April 30, 2021 [24] Q&A Session Summary Question: Evolution of academic institution channels post-pandemic - Management confirmed a focus on long-term relationships with academic institutions for testing beyond COVID, including STDs and women's health [30][31] Question: Pathway for diagnostics approval - The company plans to proceed through the FDA pathway for key platform technologies, with LDT approval on many tests [32] Question: Improvement in staffing market - Management noted that the staffing market is improving, with ongoing efforts to fill openings [33][34] Question: Update on new CEO search - Management is exploring opportunities for succession planning and will report when there is news [36][38] Question: Comparison with Cepheid's testing platforms - Management acknowledged similarities but emphasized their focus on cost-efficient technologies that improve margins for clinical labs [37] Question: Involvement of external consultants in strategic review - Management confirmed that Cain Brothers was retained to assist in the strategic review process [39]