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Harrow Health(HROW) - 2022 Q3 - Earnings Call Transcript
2022-11-15 01:49
Harrow Health, Inc. (NASDAQ:HROW) Q3 2022 Earnings Conference Call November 14, 2022 4:45 PM ET Company Participants Jamie Webb – Director-Communications and Investor Relations Mark L. Baum – Chief Executive Officer Andrew Boll – Chief Financial Officer Conference Call Participants Jeffrey Cohen – Ladenburg Thalmann Sahil Kazmi – B. Riley Operator Good afternoon, and welcome to Harrow’s Third Quarter 2022 Earnings Conference Call. My name is Andrea, and I’ll be your operator for today’s call. At this time, ...
Harrow Health(HROW) - 2022 Q3 - Quarterly Report
2022-11-14 21:23
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: 001-35814 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 Harrow Health, Inc. (Exact name of registrant as specified in its charter) Delaware 45-0567010 (State ...
Harrow Health(HROW) - 2022 Q2 - Earnings Call Transcript
2022-08-14 02:10
Harrow Health, Inc. (NASDAQ:HROW) Q2 2022 Earnings Conference Call August 9, 2022 4:45 PM ET Company Participants Jamie Webb - Director of Communications and Investor Relations Mark Baum - Chief Executive Officer and Chairman of the Board Andrew Boll - Chief Financial Officer Conference Call Participants Destiny Buch - Ladenburg Thalmann Sahil Kazmi - B. Riley Securities Nathan Weinstein - Aegis Capital Brooks O'Neil - Lake Street Capital Markets Operator Good afternoon, and welcome to Harrow Health’s Secon ...
Harrow Health(HROW) - 2022 Q2 - Quarterly Report
2022-08-09 20:36
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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: 001-35814 Harrow Health, Inc. (Exact name of registrant as specified in its charter) Delaware 45-0567010 (State or ot ...
Harrow Health(HROW) - 2022 Q1 - Earnings Call Transcript
2022-05-09 00:32
Harrow Health’s (NASDAQ:HROW) Q1 2022 Earnings Conference Call May 5, 2022 4:45 PM ET Company Participants Jamie Webb - Director of Communications and Investor Relations Mark Baum - Chief Executive Officer and Chairman of the Board Andrew Boll - Chief Financial Officer Conference Call Participants Destiny Buch - Ladenburg Thalmann Nathan Weinstein - Aegis Capital Sahil Kazmi - B. Riley Securities Operator Good afternoon, and welcome to Harrow Health’s Q1 2022 Earnings Conference Call. My name is Allison, an ...
Harrow Health(HROW) - 2022 Q1 - Earnings Call Presentation
2022-05-06 16:35
HARROW HEALTH | INC. Corporate Presentation | May 2022 Safe Harbor 2 This presentation contains express "forward-looking statements" as defined in the U.S. Private Securities Litigation Reform Act of 1995. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projecti ...
Harrow Health(HROW) - 2022 Q1 - Quarterly Report
2022-05-05 20:31
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and accompanying notes for the period [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | March 31, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $41,948,000 | $42,167,000 | | Total current assets | $62,315,000 | $60,662,000 | | TOTAL ASSETS | $97,595,000 | $98,329,000 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $9,182,000 | $9,722,000 | | TOTAL LIABILITIES | $87,859,000 | $87,398,000 | | TOTAL STOCKHOLDERS' EQUITY | $9,736,000 | $10,931,000 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $97,595,000 | $98,329,000 | [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Product sales, net | $20,340,000 | $14,948,000 | | Other revenues | $1,780,000 | $495,000 | | Total revenues | $22,120,000 | $15,443,000 | | Cost of sales | $(5,963,000) | $(3,770,000) | | Gross profit | $16,157,000 | $11,673,000 | | Income from operations | $2,101,000 | $2,917,000 | | Net (loss) income attributable to common stockholders | $(2,438,000) | $217,000 | | Basic net (loss) income per share | $(0.09) | $0.01 | | Diluted net (loss) income per share | $(0.09) | $0.01 | [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) | Metric | Balance at Dec 31, 2021 | Net Loss (Q1 2022) | Balance at Mar 31, 2022 | | :--- | :--- | :--- | :--- | | Common Stock (Par Value) | $27,000 | - | $27,000 | | Additional Paid-in Capital | $106,666,000 | $1,243,000 | $107,909,000 | | Accumulated Deficit | $(95,407,000) | $(2,438,000) | $(97,845,000) | | Total Harrow Health, Inc. Stockholders' Equity | $11,286,000 | $(2,438,000) | $10,091,000 | | Total Stockholders' Equity | $10,931,000 | $(2,438,000) | $9,736,000 | - Total stockholders' equity decreased from **$10,931,000** at December 31, 2021, to **$9,736,000** at March 31, 2022, primarily due to a net loss of **$2,438,000**[11](index=11&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $967,000 | $3,208,000 | | Net cash used in investing activities | $(410,000) | $(224,000) | | Net cash used in financing activities | $(776,000) | $(781,000) | | Net change in cash, cash equivalents and restricted cash | $(219,000) | $2,203,000 | | Cash, cash equivalents and restricted cash, end of period | $41,948,000 | $6,504,000 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [NOTE 1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION](index=9&type=section&id=NOTE%201.%20DESCRIPTION%20OF%20BUSINESS%20AND%20BASIS%20OF%20PRESENTATION) - Harrow Health, Inc is an ophthalmic-focused healthcare company specializing in the development, production, and sale of innovative medications[14](index=14&type=chunk) - The Company wholly owns ImprimisRx and Visionology, and holds non-controlling equity positions in Surface Ophthalmics, Inc and Melt Pharmaceuticals, Inc[14](index=14&type=chunk) - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim financial information and SEC rules[15](index=15&type=chunk) [NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - Beginning January 2022, management evaluates the business as a single operating segment, focusing on ImprimisRx, due to shifts in strategic plans[20](index=20&type=chunk) Basic and Diluted Net (Loss) Income Per Share | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net (loss) income attributable to common stockholders | $(2,438,000) | $217,000 | | Weighted average shares outstanding, basic | 27,226,819 | 26,019,255 | | Net (loss) income per share, basic | $(0.09) | $0.01 | | Dilutive common equivalent shares (for diluted EPS) | - | 1,461,367 | | Number of shares used for diluted EPS computation | 27,226,819 | 27,480,622 | | Net (loss) income per share, diluted | $(0.09) | $0.01 | [NOTE 3. REVENUES](index=12&type=section&id=NOTE%203.%20REVENUES) - The Company's primary revenue streams are product sales from pharmacy services and intellectual property license/asset purchase agreements[30](index=30&type=chunk) - Deferred revenue and customer deposits increased from **$16,000** at December 31, 2021, to **$23,000** at March 31, 2022[38](index=38&type=chunk) Revenue Disaggregated by Source | Revenue Source | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Product sales, net | $20,340,000 | $14,948,000 | | Commissions | $1,320,000 | $485,000 | | Transfer of profit | $460,000 | - | | License | - | $10,000 | | Total revenues | $22,120,000 | $15,443,000 | [NOTE 4. INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS](index=14&type=section&id=NOTE%204.%20INVESTMENT%20IN%2C%20AND%20NOTE%20RECEIVABLE%20FROM%20MELT%20PHARMACEUTICALS%2C%20INC.%20-%20RELATED%20PARTY%20TRANSACTIONS) - Harrow owns approximately **46%** of Melt's equity interests and **100%** of Melt's indebtedness as of March 31, 2022, accounting for it using the equity method[24](index=24&type=chunk) - The Melt Loan Agreement, with a principal of **$13,500,000** and **12.50%** interest, was due September 1, 2022, but was subsequently extended to September 1, 2026 (see Note 17)[42](index=42&type=chunk)[44](index=44&type=chunk)[108](index=108&type=chunk) Melt Pharmaceuticals, Inc. Condensed Results of Operations | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Revenues, net | - | - | | Loss from operations | $(3,337,000) | $(1,099,000) | | Net loss | $(3,337,000) | $(1,099,000) | [NOTE 5. INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS](index=15&type=section&id=NOTE%205.%20INVESTMENT%20IN%20SURFACE%20OPHTHALMICS%2C%20INC.%20-%20RELATED%20PARTY%20TRANSACTIONS) - Harrow owns approximately **20%** of Surface's equity interests as of March 31, 2022, and uses the equity method of accounting[27](index=27&type=chunk)[48](index=48&type=chunk) - Harrow holds **mid-single digit royalty rights** on net sales of Surface's drug candidates[47](index=47&type=chunk)[125](index=125&type=chunk) Surface Ophthalmics, Inc. Condensed Results of Operations | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Revenues, net | - | - | | Loss from operations | $(1,996,000) | $(2,831,000) | | Net loss | $(1,996,000) | $(2,831,000) | [NOTE 6. INVENTORIES](index=15&type=section&id=NOTE%206.%20INVENTORIES) Inventory Composition | Category | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Raw materials | $2,441,000 | $2,441,000 | | Work in progress | $44,000 | - | | Finished goods | $1,911,000 | $1,776,000 | | Total inventories | $4,396,000 | $4,217,000 | [NOTE 7. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=17&type=section&id=NOTE%207.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) Prepaid Expenses and Other Current Assets | Category | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Prepaid insurance | $455,000 | $728,000 | | Due from Melt Pharmaceuticals | $70,000 | $48,000 | | Other prepaid expenses | $757,000 | $437,000 | | Deposits and other current assets | $52,000 | $92,000 | | Total prepaid expenses and other current assets | $1,334,000 | $1,305,000 | [NOTE 8. PROPERTY, PLANT AND EQUIPMENT](index=17&type=section&id=NOTE%208.%20PROPERTY%2C%20PLANT%20AND%20EQUIPMENT) - Depreciation related to property, plant and equipment was **$376,000** for Q1 2022, down from **$436,000** in Q1 2021[53](index=53&type=chunk) Property, Plant and Equipment, Net | Category | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Computer hardware | $786,000 | $772,000 | | Furniture and equipment | $521,000 | $443,000 | | Lab and pharmacy equipment | $4,142,000 | $4,056,000 | | Leasehold improvements | $5,728,000 | $5,703,000 | | Accumulated depreciation | $(8,209,000) | $(7,833,000) | | Total property, plant and equipment, net | $2,968,000 | $3,141,000 | [NOTE 9. CAPITALIZED SOFTWARE DEVELOPMENT COSTS](index=17&type=section&id=NOTE%209.%20CAPITALIZED%20SOFTWARE%20DEVELOPMENT%20COSTS) - Amortization expense for capitalized software development costs was **$43,000** for Q1 2022, up from **$28,000** in Q1 2021[54](index=54&type=chunk) Capitalized Software Development Costs | Category | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Capitalized internal-use software development costs | $942,000 | $942,000 | | Acquired third-party software license for internal-use | $159,000 | $159,000 | | Accumulated amortization | $(612,000) | $(569,000) | | Capitalized internal-use software in process | $982,000 | $781,000 | | Total capitalized software costs | $1,471,000 | $1,313,000 | [NOTE 10. INTANGIBLE ASSETS AND GOODWILL](index=18&type=section&id=NOTE%2010.%20INTANGIBLE%20ASSETS%20AND%20GOODWILL) - Amortization expense for intangible assets significantly increased to **$404,000** in Q1 2022 from **$40,000** in Q1 2021, primarily due to acquired NDAs[55](index=55&type=chunk) Intangible Assets at March 31, 2022 | Asset Category | Cost | Accumulated Amortization | Net Carrying Value | | :--- | :--- | :--- | :--- | | Patents | $972,000 | $(97,000) | $875,000 | | Licenses | $100,000 | $(15,000) | $85,000 | | Trademarks | $260,000 | - | $260,000 | | Acquired NDAs | $13,635,000 | $(341,000) | $13,294,000 | | Customer relationships | $1,519,000 | $(619,000) | $900,000 | | Total Intangible Assets | $16,549,000 | $(1,134,000) | $15,415,000 | Estimated Future Amortization Expense for Intangible Assets | Year | Amount | | :--- | :--- | | Remainder of 2022 | $1,194,000 | | 2023 | $1,592,000 | | 2024 | $1,592,000 | | 2025 | $1,592,000 | | 2026 | $1,595,000 | | Thereafter | $7,590,000 | | Total | $15,155,000 | [NOTE 11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES](index=18&type=section&id=NOTE%2011.%20ACCOUNTS%20PAYABLE%20AND%20ACCRUED%20EXPENSES) Accounts Payable and Accrued Expenses | Category | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Accounts payable | $5,595,000 | $5,174,000 | | Other accrued expenses | $49,000 | $49,000 | | Accrued interest | $1,114,000 | $1,114,000 | | Total accounts payable and accrued expenses | $6,758,000 | $6,337,000 | [NOTE 12. DEBT](index=19&type=section&id=NOTE%2012.%20DEBT) - The Company has **$75,000,000** aggregate principal amount of **8.625%** Senior Notes due April 2026, with interest payable quarterly[57](index=57&type=chunk) - Interest expense related to the Notes was **$1,810,000** for Q1 2022, including **$193,000** in amortization of debt issuance costs and discount[59](index=59&type=chunk) Future Minimum Debt Payments (March 31, 2022) | Year | Amount | | :--- | :--- | | Remainder of 2022 | $4,852,000 | | 2023 | $6,469,000 | | 2024 | $6,469,000 | | 2025 | $6,469,000 | | 2026 | $77,158,000 | | Total minimum payments | $101,417,000 | | Notes payable, net of unamortized discount | $71,847,000 | [NOTE 13. LEASES](index=19&type=section&id=NOTE%2013.%20LEASES) - The Company leases office and laboratory space under non-cancelable operating leases with remaining terms of one to five years[61](index=61&type=chunk) - Cash paid for operating lease liabilities was **$166,000** in Q1 2022, down from **$251,000** in Q1 2021[63](index=63&type=chunk) Operating Lease Liabilities (March 31, 2022) | Year | Operating Leases | | :--- | :--- | | Remainder of 2022 | $655,000 | | 2023 | $944,000 | | 2024 | $970,000 | | 2025 | $796,000 | | 2026 | $810,000 | | Thereafter | $6,648,000 | | Total operating lease liabilities | $7,268,000 | | Operating lease liabilities, net of current portion | $6,823,000 | [NOTE 14. STOCKHOLDERS' EQUITY AND STOCK-BASED COMPENSATION](index=21&type=section&id=NOTE%2014.%20STOCKHOLDERS'%20EQUITY%20AND%20STOCK-BASED%20COMPENSATION) - As of March 31, 2022, there were **27,031,127 shares** of common stock outstanding[4](index=4&type=chunk) - Total stock-based compensation expense was **$2,016,000** for Q1 2022, significantly up from **$855,000** in Q1 2021[83](index=83&type=chunk) - Unrecognized compensation expense related to unvested RSUs was approximately **$8,756,000** as of March 31, 2022, expected to be recognized over a weighted-average period of **1.33 years**[79](index=79&type=chunk) [NOTE 15. COMMITMENTS AND CONTINGENCIES](index=25&type=section&id=NOTE%2015.%20COMMITMENTS%20AND%20CONTINGENCIES) - The Company faces inherent risks from product and professional liability litigation in the pharmaceutical industry, covered by third-party insurance[85](index=85&type=chunk) - Royalty expenses for the Klarity License Agreement (related party) were **$71,000** in Q1 2022, up from **$35,000** in Q1 2021[88](index=88&type=chunk) - Commission revenues from the Dexycu Agreement were **$1,320,000** in Q1 2022, significantly up from **$485,000** in Q1 2021[92](index=92&type=chunk) [NOTE 16. CONCENTRATIONS](index=28&type=section&id=NOTE%2016.%20CONCENTRATIONS) - Two products collectively accounted for **32%** of total revenues in Q1 2022, down from **36%** in Q1 2021[105](index=105&type=chunk) - Three main suppliers collectively accounted for **74%** of active pharmaceutical ingredient purchases in Q1 2022, down from **82%** in Q1 2021[106](index=106&type=chunk) [NOTE 17. SUBSEQUENT EVENTS](index=28&type=section&id=NOTE%2017.%20SUBSEQUENT%20EVENTS) - In April 2022, the Melt Loan Agreement was amended to extend the maturity date to **September 1, 2026**[108](index=108&type=chunk) - The amendment requires Melt to maintain a minimum cash balance of **$7,000,000** for one year, then **$5,000,000** thereafter[108](index=108&type=chunk) - The effectiveness of the amendment is conditional on Melt consummating a qualifying financing of at least **$15,000,000** from third-party investors by August 31, 2022[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition, operational results, and key business developments [Overview](index=29&type=section&id=Overview) - Harrow Health, Inc is an ophthalmic-focused healthcare company, operating ImprimisRx and Visionology, and holding non-controlling equity in Surface and Melt[111](index=111&type=chunk) - The company specializes in developing, producing, selling, and distributing innovative prescription medications[111](index=111&type=chunk) [ImprimisRx](index=30&type=section&id=ImprimisRx) - ImprimisRx is Harrow's ophthalmology-focused prescription pharmaceutical business, offering over twenty customizable compounded formulations[113](index=113&type=chunk) - The business serves over **10,000** U.S eyecare prescribers and institutions[113](index=113&type=chunk) - ImprimisRx has expanded its product portfolio to include FDA-approved products through commercial partnerships and acquisitions[114](index=114&type=chunk) [DEXYCU®](index=30&type=section&id=DEXYCU%C2%AE) - ImprimisRx co-promotes DEXYCU® (dexamethasone intraocular suspension) 9% for post-operative ocular inflammation in the U.S under an agreement with Eyepoint Pharmaceuticals[115](index=115&type=chunk) - Eyepoint pays ImprimisRx a fee based on quarterly sales of DEXYCU[115](index=115&type=chunk) [IOPIDINE®, MAXITROL®, MOXEZA®](index=30&type=section&id=IOPIDINE%C2%AE%2C%20MAXITROL%C2%AE%2C%20MOXEZA%C2%AE) - In December 2021, Harrow acquired U.S commercial rights to four FDA-approved ophthalmic medicines: IOPIDINE 1% and 0.5%, MAXITROL, and MOXEZA[116](index=116&type=chunk) - A **six-month** transitional period is in effect where the seller continues to sell the products and transfers net profit to Harrow[117](index=117&type=chunk) [AMP-100](index=30&type=section&id=AMP-100) - Harrow acquired exclusive marketing and supply rights to AMP-100, a patented ophthalmic topical anesthetic drug candidate, in the U.S and Canada from Sintetica S.A in July 2021[118](index=118&type=chunk) - An NDA for AMP-100 was submitted in Q4 2021, with an FDA PDUFA target action date of **October 16, 2022**[118](index=118&type=chunk) [MAQ-100](index=30&type=section&id=MAQ-100) - Harrow acquired exclusive marketing rights to MAQ-100, a preservative-free triamcinolone acetonide ophthalmic injection drug candidate, in the U.S and Canada from Wakamoto Pharmaceutical Co, Ltd in August 2021[119](index=119&type=chunk) - The company plans to leverage Japanese clinical data to support a U.S market NDA submission for MAQ-100 for visualization during vitrectomy[119](index=119&type=chunk) [Visionology](index=32&type=section&id=Visionology) - Visionology is a direct-to-consumer digital eye health platform that leverages Harrow's ophthalmic experience and relationships with eyecare professionals[121](index=121&type=chunk) [Carved-Out Businesses (De-Consolidated Businesses)](index=32&type=section&id=Carved-Out%20Businesses%20(De-Consolidated%20Businesses)) - Harrow holds ownership and royalty interests in deconsolidated companies Surface, Melt, and Eton Pharmaceuticals, which are pursuing market approval for their drug candidates[122](index=122&type=chunk) [Noncontrolling Equity Interests](index=32&type=section&id=Noncontrolling%20Equity%20Interests) - Surface Ophthalmics, Inc is a clinical-stage pharmaceutical company focused on ocular surface diseases, with positive Phase 2 trial results for SURF-201 announced in January 2021[123](index=123&type=chunk)[124](index=124&type=chunk) - Melt Pharmaceuticals, Inc is a clinical-stage company developing non-intravenous sedation and anesthesia therapeutics, which began enrolling patients in its Phase 2 study for MELT-300 in Q4 2021[126](index=126&type=chunk)[127](index=127&type=chunk) - Harrow owns **1,982,000 shares** of Eton common stock, representing less than **10%** of its equity interests[129](index=129&type=chunk) [Factors Affecting Our Performance](index=33&type=section&id=Factors%20Affecting%20Our%20Performance) - Key performance factors include increasing revenues from proprietary compounded formulations and non-proprietary products, and achieving operating efficiencies in pharmacy operations[130](index=130&type=chunk) - Regulatory restrictions, pricing optimization, and obtaining reimbursement options for proprietary formulations are also critical[130](index=130&type=chunk) [Reimbursement Options](index=33&type=section&id=Reimbursement%20Options) - DEXYCU is covered under Medicare Part B, but its transitional pass-through reimbursement status is set to expire on **December 31, 2022**, which will adversely impact commission revenues[131](index=131&type=chunk)[132](index=132&type=chunk) - The company is working to extend pass-through status or secure separate payment for DEXYCU and expects newly acquired FDA-approved products (MOXEZA, MAXITROL, IOPIDINE) to be eligible for third-party reimbursement[132](index=132&type=chunk)[133](index=133&type=chunk) [COVID-19 Pandemic](index=34&type=section&id=COVID-19%20Pandemic) - The COVID-19 pandemic initially impacted the global economy and healthcare delivery, limiting elective medical procedures[134](index=134&type=chunk) - Sales have returned to near historical norms as restrictions eased, but future impacts remain uncertain if new restrictions occur[134](index=134&type=chunk)[135](index=135&type=chunk) [Recent Developments](index=34&type=section&id=Recent%20Developments) - In April 2022, the Melt Loan Agreement was amended to extend the maturity date to **September 1, 2026**, and requires Melt to maintain minimum cash balances[136](index=136&type=chunk)[139](index=139&type=chunk) - The amendment's effectiveness is contingent on Melt securing a minimum of **$15,000,000** in financing from third-party investors by August 31, 2022[139](index=139&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) [Revenues](index=34&type=section&id=Revenues) - The increase in revenues was driven by higher sales volumes of ophthalmology products, increased commissions from Dexycu®, and profit transfer from recently acquired products[138](index=138&type=chunk) Revenues (Q1 2022 vs. Q1 2021) | Revenue Type | Q1 2022 | Q1 2021 | $ Variance | | :--- | :--- | :--- | :--- | | Product sales, net | $20,340,000 | $14,948,000 | $5,392,000 | | Commission revenues | $1,320,000 | $485,000 | $835,000 | | Transfer of profit | $460,000 | - | $460,000 | | License revenues | - | $10,000 | $(10,000) | | Total revenues | $22,120,000 | $15,443,000 | $6,677,000 | [Cost of Sales](index=36&type=section&id=Cost%20of%20Sales) - The increase in cost of sales was primarily attributable to an increase in unit volumes sold[142](index=142&type=chunk) Cost of Sales (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | $ Variance | | :--- | :--- | :--- | :--- | | Cost of sales | $5,963,000 | $3,770,000 | $2,193,000 | [Gross Profit and Margin](index=36&type=section&id=Gross%20Profit%20and%20Margin) - The decrease in gross margin was primarily attributable to the amortization of certain intangible assets related to recently acquired products, which began in January 2022[143](index=143&type=chunk) Gross Profit and Margin (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | $ Variance | | :--- | :--- | :--- | :--- | | Gross profit | $16,157,000 | $11,673,000 | $4,484,000 | | Gross margin | 73.0% | 75.6% | (2.6)% | [Selling, General and Administrative Expenses](index=36&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) - The increase was primarily due to higher compensation expense, including stock-based compensation from performance stock units granted in July 2021, increased consulting expenses, and new employee costs for sales and marketing[145](index=145&type=chunk) Selling, General and Administrative Expenses (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | $ Variance | | :--- | :--- | :--- | :--- | | Selling, general and administrative | $13,398,000 | $8,164,000 | $5,234,000 | [Research and Development Expenses](index=36&type=section&id=Research%20and%20Development%20Expenses) - The increase in R&D expenses was primarily a result of increased costs associated with the clinical programs for AMP-100 and MAQ-100[149](index=149&type=chunk) Research and Development Expenses (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | $ Variance | | :--- | :--- | :--- | :--- | | Research and development | $658,000 | $592,000 | $66,000 | [Interest Expense, Net](index=38&type=section&id=Interest%20Expense%2C%20Net) - The increase in interest expense was primarily due to an increase in the outstanding principal amount of the company's debt obligations[150](index=150&type=chunk) Interest Expense, Net (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Interest expense, net | $1,792,000 | $513,000 | [Equity in Losses from Unconsolidated Entities](index=38&type=section&id=Equity%20in%20Losses%20from%20Unconsolidated%20Entities) - The loss increased to **$2,886,000** in Q1 2022 from **$1,319,000** in Q1 2021, primarily related to the company's share of losses in Melt Pharmaceuticals[151](index=151&type=chunk) Equity in Losses from Unconsolidated Entities (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Equity in losses of unconsolidated entities | $(2,886,000) | $(1,319,000) | [Investment Gain (Loss) from Eton](index=38&type=section&id=Investment%20Gain%20(Loss)%20from%20Eton) - The company recorded an unrealized investment gain of **$139,000** in Q1 2022, a significant improvement from an unrealized loss of **$2,835,000** in Q1 2021, related to the change in fair market value of Eton's common stock[152](index=152&type=chunk) Investment Gain (Loss) from Eton Pharmaceuticals (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Investment gain (loss) from Eton Pharmaceuticals | $139,000 | $(2,835,000) | [Gain on Forgiveness of PPP Loan](index=38&type=section&id=Gain%20on%20Forgiveness%20of%20PPP%20Loan) - A gain of **$1,967,000** was recorded in Q1 2021 due to the forgiveness of the Paycheck Protection Program (PPP) loan[153](index=153&type=chunk) Gain on Forgiveness of PPP Loan (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Gain on forgiveness of PPP loan | - | $1,967,000 | [Net (Loss) Income](index=38&type=section&id=Net%20(Loss)%20Income) Net (Loss) Income and Per Share (Q1 2022 vs. Q1 2021) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net (loss) income attributable to Harrow Health, Inc common stockholders | $(2,438,000) | $217,000 | | Net (loss) income per share, basic | $(0.09) | $0.01 | | Net (loss) income per share, diluted | $(0.09) | $0.01 | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) [Liquidity](index=38&type=section&id=Liquidity) - Cash on hand at March 31, 2022, was **$41,948,000**, slightly down from **$42,167,000** at December 31, 2021[155](index=155&type=chunk) - The company believes current cash and cash equivalents will be sufficient for planned operations and capital expenditures for at least the next **12 months**[156](index=156&type=chunk) - Potential acquisitions or faster-than-expected growth may require additional financing, and the company may consider selling certain assets[156](index=156&type=chunk) [Net Cash Flow](index=39&type=section&id=Net%20Cash%20Flow) Net Cash Flow Summary (Q1 2022 vs. Q1 2021) | Cash Flow Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $967,000 | $3,208,000 | | Net cash used in investing activities | $(410,000) | $(224,000) | | Net cash used in financing activities | $(776,000) | $(781,000) | | Net change in cash and cash equivalents | $(219,000) | $2,203,000 | | Cash, cash equivalents and restricted cash at end of the period | $41,948,000 | $6,504,000 | [Operating Activities](index=39&type=section&id=Operating%20Activities) - Net cash provided by operating activities decreased to **$967,000** in Q1 2022 from **$3,208,000** in Q1 2021[159](index=159&type=chunk) - The decrease was mainly attributed to an increase in accounts receivable and a decrease in accounts payable and accrued liabilities balances[159](index=159&type=chunk) [Investing Activities](index=39&type=section&id=Investing%20Activities) - Net cash used in investing activities increased to **$410,000** in Q1 2022 from **$224,000** in Q1 2021[160](index=160&type=chunk) - Cash used was primarily associated with equipment and software purchases and upgrades, along with investments in the intellectual property portfolio[160](index=160&type=chunk) [Financing Activities](index=39&type=section&id=Financing%20Activities) - Net cash used in financing activities was **$776,000** in Q1 2022, comparable to **$781,000** in Q1 2021[160](index=160&type=chunk) - Cash used was primarily related to payment of taxes upon vesting of RSUs and exercise of stock options, and principal payments on loans[160](index=160&type=chunk) [Sources of Capital](index=39&type=section&id=Sources%20of%20Capital) - Principal sources of cash include operating activities from ImprimisRx, proceeds from senior notes, and sales of Eton common stock[161](index=161&type=chunk) - The company may seek additional financing through equity or debt, corporate partnerships, licensing arrangements, or asset sales, which could lead to dilution or increased leverage[162](index=162&type=chunk) - Inability to obtain necessary financing could force the company to forego development opportunities or scale back operations[163](index=163&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=40&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) - Refer to Note 2 to the condensed consolidated financial statements for details on recently issued and adopted accounting pronouncements[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) States that there are no applicable quantitative and qualitative disclosures about market risk - This item is not applicable[165](index=165&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of disclosure controls and procedures and reports on changes in internal controls [Evaluation of Disclosure Controls and Procedures](index=40&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, including the principal executive officer and principal financial officer, concluded that the company's disclosure controls and procedures were effective as of March 31, 2022[167](index=167&type=chunk) [Changes in Internal Controls over Financial Reporting](index=40&type=section&id=Changes%20in%20Internal%20Controls%20over%20Financial%20Reporting) - There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2022[168](index=168&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) Refers to the notes to the financial statements for information regarding legal proceedings - Refer to Note 15 to the condensed consolidated financial statements for information on various legal proceedings[171](index=171&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) Directs readers to the Annual Report on Form 10-K for a comprehensive discussion of risk factors - Readers should consider the risk factors and other information in the Annual Report on Form 10-K for the year ended December 31, 2021[172](index=172&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) States that there were no unregistered sales of equity securities or use of proceeds to report - None[173](index=173&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) States that there were no defaults upon senior securities to report - Not applicable[174](index=174&type=chunk) [Item 4. Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) States that there are no mine safety disclosures applicable to the company - Not applicable[175](index=175&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) Indicates that there is no other information to report for the period - None[176](index=176&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed as part of the Quarterly Report, including certifications and XBRL documents - Exhibits include certifications (31.1, 31.2, 32.1) and Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[177](index=177&type=chunk) [Signatures](index=43&type=section&id=Signatures) Contains the required signatures certifying the accuracy of the report - The report was signed by Mark L Baum (Chief Executive Officer and Director) and Andrew R Boll (Chief Financial Officer) on May 5, 2022[183](index=183&type=chunk)
Harrow Health(HROW) - 2021 Q4 - Earnings Call Presentation
2022-03-11 14:35
HARROW HEALTH INC. Corporate Presentation | March 2022 Safe Harbor This presentation contains express "forward-looking statements" as defined in the U.S. Private Securities Litigation Reform Act of 1995. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projection ...
Harrow Health(HROW) - 2021 Q4 - Earnings Call Transcript
2022-03-11 01:02
Harrow Health, Inc. (NASDAQ:HROW) Q4 2021 Earnings Conference Call March 10, 2022 4:45 PM ET Company Participants Jamie Webb – Director-Communications and Investor Relations Mark L. Baum – Chief Executive Officer Andrew Boll – Chief Financial Officer Conference Call Participants Brooks O'Neil – Lake Street Capital Markets. Destiny Buch – Ladenburg Thalmann Justin Walsh – B. Riley Securities Nathan Weinstein – Aegis Capital Shawn Boyd – Next Mark Capital Operator Good afternoon, and welcome to Harrow Health' ...
Harrow Health(HROW) - 2021 Q4 - Annual Report
2022-03-10 21:45
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 December 31, 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: 001-35814 HARROW HEALTH, INC. (Exact name of registrant as specified in its charter) Delaware 45-0567010 (State or other jurisdiction of ...