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Harrow Health Announces First Quarter 2022 Financial Results

Seventh Consecutive Quarter of Record Results

Highlights for First Quarter 2022:

  • Record revenues of $22.1 million, up 43% over $15.4 million for the prior-year quarter
  • Record gross profit of $16.2 million, up 38% over $11.7 million for the prior-year quarter
  • Record number of 689,000 product units shipped, up 72% from the prior-year quarter
  • Cash and cash equivalents of $42.0 million as of March 31, 2022

Harrow Health, Inc. (NASDAQ: HROW), an ophthalmic‑focused healthcare company, today announced results for the first quarter ended March 31, 2022. The Company also posted its first quarter Letter to Stockholders and corporate presentation to the “Investors” section of its website, harrowinc.com.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220505006029/en/

“Our first quarter financial and operational results, combined with our internal forecasts and the opportunities we are currently pursuing, have validated our belief that 2022 would be a ‘break-out’ year for Harrow,” said Mark L. Baum, CEO of Harrow Health. “We had a tremendous start to 2022, continuing the momentum from 2021 and the consistent record-breaking quarters our team delivered. Our first quarter results, reported today, represent our seventh consecutive quarter of record financial results, including a 43% increase in year-over-year revenues and a nearly 10% increase from the sequential quarter.

“We see ongoing organic growth in our core business; and in addition to the other value drivers identified in our Letter to Stockholders we published today, Harrow stockholders can count on our team being ready to launch AMP-100 as we approach a potential commercial launch during the first half of 2023, assuming we receive FDA approval on our PDUFA target action date of October 16, 2022.

“We remain confident in Harrow’s future as we implement our growth plan, build a profitable business, and serve our customers with products and services that are being chosen by an ever-expanding group of leading U.S. ophthalmologists, optometrists, hospitals, and ambulatory surgery centers, which has allowed us to continue to take an increasing share of the market for several large categories of ophthalmic pharmaceutical products in the United States.”

First quarter figures of merit:

 

For the Three Months Ended

March 31,

 

2022

2021

Total revenues

$

22,120,000

 

$

15,443,000

 

Gross margin

 

73

%

 

76

%

Core gross margin(1)

 

75

%

 

76

%

Net (loss) income

 

(2,438,000

)

 

217,000

 

Core net income(1)

 

713,000

 

 

2,444,000

 

Adjusted EBITDA(1)

 

4,940,000

 

 

4,276,000

 

Diluted net (loss) income per share

 

(0.09

)

 

0.01

 

Core diluted net income per share(1)

 

0.03

 

 

0.09

 

(1)

Core gross margin, core net income, and core diluted net income per share (“Core Results”), and Adjusted EBITDA are non GAAP measures. For additional information, including a reconciliation of such Core Results and Adjusted EBITDA to the most directly comparable measures presented in accordance with GAAP, see the explanation of non-GAAP measures and reconciliation tables in the financial tables section.

Conference Call and Webcast

The Company’s management team will host a conference call and live webcast today at 4:45 p.m. Eastern Time to discuss the results and provide a business update. To participate in the call, see details below:

Conference Call Details:

 

Date:

Thursday, May 5, 2022

Time:

4:45 p.m. Eastern time

Participant Dial-in:

1-833-953-2434 (U.S.)

1-412-317-5763 (International)

Replay Dial-in (Passcode 9985794):

(telephonic replay through May 12, 2022)

1-877-344-7529 (U.S.)

1-412-317-0088 (International)

Webcast: (online replay through August 5, 2022)

harrowinc.com

About Harrow Health

Harrow Health, Inc. (NASDAQ: HROW) is an ophthalmic-focused healthcare company. The Company owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical businesses, and Visionology, a direct-to-consumer eye care subsidiary focused on chronic vision care. Harrow Health also holds non-controlling equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries, and owns royalty rights in four clinical-stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. For more information about Harrow Health, please visit the Investors section of the corporate website, harrowinc.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the continued impact of the COVID-19 pandemic and any future health epidemics on our financial condition, liquidity and results of operations; our ability to make commercially available our FDA-approved products and compounded formulations and technologies in a timely manner or at all; market acceptance of the Company’s products and challenges related to the marketing of the Company’s products; risks related to our pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our products; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and products; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow Health’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow Health undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

HARROW HEALTH, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

March 31,

2022

March 31,

2021

(unaudited)

 

ASSETS

Cash and cash equivalents

$

41,948,000

$

42,167,000

All other current assets

 

20,367,000

 

 

18,495,000

 

Total current assets

 

62,315,000

 

 

60,662,000

 

All other assets

 

35,280,000

 

 

37,667,000

 

TOTAL ASSETS

$

97,595,000

 

$

98,329,000

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities

 

9,182,000

 

 

9,722,000

 

Senior April 2026 Notes, net of discount

 

71,847,000

 

 

71,654,000

 

All other liabilities

 

6,830,000

 

 

6,022,000

 

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

 

HARROW HEALTH, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three Months Ended

March 31,

2022

 

2021

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

 

Selling, general and administrative

 

13,398,000

 

 

8,164,000

 

Research and development

 

658,000

 

 

592,000

 

Total operating expenses

 

14,056,000

 

 

8,756,000

 

Income from operations

 

2,101,000

 

 

2,917,000

 

Total other expense, net

 

4,539,000

 

 

2,700,000

 

Income taxes

 

-

 

 

-

 

Total net (loss) income

$

(2,438,000

)

$

217,000

 

Net (loss) income per share of common stock, basic

$

(0.09

)

$

0.01

 

Net (loss) income per share of common stock, diluted

$

(0.09

)

$

0.01

 

HARROW HEALTH, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

 

For the Three Months Ended

March 31,

 

2022

 

2021

Net cash provided by (used in):

 

 

Operating activities

$

967,000

 

$

3,208,000

 

Investing activities

 

(410,000

)

 

(224,000

)

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 beginning of the period

 

42,167,000

 

 

4,301,000

 

Cash, cash equivalents and restricted cash at end of the year

$

41,948,000

 

$

6,504,000

 

Non-GAAP Figures

In addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP), which are presented and discussed above, management also utilizes Adjusted EBITDA and Core Results, unaudited financial measures that are not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA and Core Results are considered “non‑GAAP” financial measures within the meaning of Regulation G promulgated by the SEC. Management believes that these non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provides a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA and Core Results provide meaningful supplemental information regarding the Company’s performance because (i) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) they exclude the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) they are used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA, Core Results, and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

Adjusted EBITDA

The Company defines Adjusted EBITDA as net (loss) income attributable to Harrow Health, Inc., excluding the effects of stock-based compensation and expenses, interest, taxes, depreciation, amortization, investment loss, net, gain or forgiveness of debt, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net (loss) income attributable to Harrow Health, Inc. Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net (loss) income as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs.

The following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net (loss) income, for the three months ended March 31, 2022, and for the same period in 2021:

HARROW HEALTH, INC.

RECONCILIATION OF NET (LOSS) INCOME TO ADJUSTED EBITDA

 

For the Three Months Ended

March 31,

 

2022

 

2021

GAAP net (loss) income

$

(2,438,000

)

$

217,000

 

Stock-based compensation and expenses

 

2,016,000

 

 

855,000

 

Interest expense, net

 

1,792,000

 

 

513,000

 

Income taxes

 

-

 

 

-

 

Depreciation

 

419,000

 

 

464,000

 

Amortization of intangible assets

 

404,000

 

 

40,000

 

Investment loss, net

 

2,747,000

 

 

4,154,000

 

Gain on forgiveness of debt(1)

 

-

 

 

(1,967,000

)

Adjusted EBITDA

$

4,940,000

 

$

4,276,000

 

(1)

Gain on forgiveness of Paycheck Protection Program loan administered by the U.S. Small Business Administration.

Core Results

Harrow Health Core Results, including core gross margin, core net income, core operating income, core EPS (basic and diluted), and core operating margin, exclude all amortization and impairment charges of intangible assets, excluding software development costs, net gains and losses on investments and equity securities, including equity method gains and losses and equity valued at fair value through profit and loss (“FVPL”), and gains/losses on forgiveness of debt. In other periods, Core Results may also exclude fair value adjustments of financial assets in the form of options to acquire a company carried at FVPL, obligations related to product recalls, certain acquisition related items, the integration and divestment related income and expenses, divestment gains and losses, restructuring charges/releases and related items, legal related items, gains/losses on early extinguishment of debt or debt modifications, impairments of property, plant and equipment and software, as well as income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a $100,000 threshold.

The following is a reconciliation of Core Results, a non-GAAP measure, to the most comparable GAAP measure for the three months ended March 31, 2022, and for the same period in 2021:

 

For the Three Months Ended March 31, 2022

 

GAAP

Results

Amortization

of Certain

Intangible

Assets

Investment

Losses

Core Results

Gross profit

$

16,157,000

 

$

341,000

$

-

$

16,498,000

 

Core gross margin

 

73

%

 

 

 

75

%

Operating income

 

2,101,000

 

 

404,000

 

 

-

 

 

2,505,000

 

(Loss) income before taxes

 

(2,438,000

)

 

404,000

 

 

2,747,000

 

 

713,000

 

Taxes

 

-

 

 

-

 

 

-

 

 

-

 

Net (loss) income

 

(2,438,000

)

 

404,000

 

 

2,747,000

 

 

713,000

 

Basic EPS ($)(1)

 

(0.09

)

 

-

 

 

-

 

 

0.03

 

Diluted EPS ($)(1)

 

(0.09

)

 

-

 

 

-

 

 

0.03

 

Operating margin

 

9

%

 

-

 

 

-

 

 

11

%

Weighted average number of shares of common stock outstanding, basic

 

27,226,819

 

 

-

 

 

-

 

 

27,226,819

 

Weighted average number of shares of common stock outstanding, diluted

 

27,226,819

 

 

-

 

 

-

 

 

28,317,740

 

 

For the Three Months Ended March 31, 2021

 

GAAP

Results

Amortization

of Certain

Intangible

Assets

Investment

Losses

Gain on

Forgiveness

of Debt

Core Results

Gross profit

$

11,673,000

 

$

-

$

-

$

-

 

$

11,673,000

 

Gross margin

 

76

%

 

-

 

 

-

 

 

-

 

 

76

%

Operating income

 

2,917,000

 

 

40,000

 

 

-

 

 

-

 

 

2,957,000

 

(Loss) income before taxes

 

217,000

 

 

40,000

 

 

4,154,000

 

 

(1,967,000

)

 

2,444,000

 

Taxes

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Net (loss) income

 

217,000

 

 

40,000

 

 

4,154,000

 

 

(1,967,000

)

 

2,444,000

 

Basic EPS ($)(1)

 

0.01

 

 

-

 

 

-

 

 

 

0.09

 

Diluted EPS ($)(1)

 

0.01

 

 

-

 

 

-

 

 

 

0.09

 

Operating margin

 

19

%

 

-

 

 

-

 

 

 

19

%

Weighted average number of shares of common stock outstanding, basic

 

26,019,255

 

 

-

 

 

-

 

 

 

26,019,255

 

Weighted average number of shares of common stock outstanding, diluted

 

27,480,622

 

 

-

 

 

-

 

 

 

27,480,622

 

(1)

Core basic earnings per share is calculated using the weighted average number of shares of common stock outstanding during the period. Core diluted earnings per share also contemplate dilutive shares associated with equity-based awards and warrants as described in Note 2 and elsewhere in the Condensed Consolidated Interim Financial Statements filed with the Company’s Quarterly Report on Form 10-Q.

 

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