Nephros Announces Results for Quarter Ended June 30, 2021

Rhea-AI Summary

Nephros reported a 44% increase in net revenue for Q2 2021, totaling $2.3 million, driven by strong performance in their water filtration segment. The company achieved a 35% reduction in net loss, improving to $1.1 million, and an adjusted EBITDA improvement of 46%. The acquisition of GenArraytion, Inc. is expected to enhance capabilities in PCR testing. Additionally, the company submitted their HDF Assist Module for FDA 510(k) clearance, with potential for limited commercial launch later this year.

Positive

• 44% increase in consolidated net revenue to $2.3 million.
• 35% reduction in net loss to $1.1 million.
• 46% improvement in adjusted EBITDA to ($0.8 million).
• Acquisition of GenArraytion, Inc. enhances PCR testing capabilities.
• FDA submission for HDF Assist Module may lead to market expansion.

Negative

• Gross margins decreased slightly to 56% from 57% in 2020.
• Cost of goods sold increased by 43% to $1.0 million.

Second Quarter Net Revenue of $2.3 Million; 44% Year-Over-Year Increase; Strategic Acquisition of GenArraytion, Inc.; HDF Product Submitted to FDA for 510(k) Clearance

SOUTH ORANGE, NJ, Aug. 05, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Nephros, Inc. (Nasdaq: NEPH), a leading biotechnology company providing innovative filtration and pathogen detection solutions to healthcare and commercial markets, today announced results for the three months ended June 30, 2021.

Financial Highlights

Water Filtration Business Segment Highlights*

• Net revenue increased 40% to $2.2 million 
• Net loss of $0.9 million, no change from 2020  
• Adjusted EBITDA improved by 23% to ($0.5 million)

Consolidated Highlights*

• Net revenue increased by 44% to $2.3 million
• Net loss improved by 35% to $1.1 million
• Adjusted EBITDA improved by 46% to ($0.8 million)

*Stated performance is relative to same period prior year (second quarter of 2020)

“We are pleased that net revenue growth in the second quarter was strong, with a 44% year-over-year increase on a consolidated basis. This growth included solid performance from our water filtration business, as well as early success within our Pathogen Detection Systems (PDS) segment,” said Andy Astor, Chief Executive Officer of Nephros. “Our acquisition of GenArraytion, Inc. last month further bolstered our position in the PCR testing marketplace, expanding our abilities to detect and mitigate the spread of infectious disease, while empowering customers to conduct on-site water testing quickly and accurately.”

Mr. Astor continued, “Our potential for long-term growth is additionally supported by the recent submission of an FDA 510(k) clearance for our second-generation HDF Assist Module. We are now in discussion with the FDA and anticipate that the product may be cleared later this year for a limited commercial launch in the dialysis clinic market.”

Consolidated Financial Performance for the Quarter Ended June 30, 2021

Net revenue for the quarter ended June 30, 2021 was $2.3 million, compared with $1.6 million in the corresponding period in 2020, an increase of 44%.

Net loss for the quarter ended June 30, 2021 was $1.1 million, compared with a net loss of $1.7 million for the quarter ended June 30, 2020, a decrease of 35%.

Adjusted EBITDA for the quarter ended June 30, 2021 was ($0.8 million), compared with ($1.4 million) during the same period in 2020.

Cost of goods sold for the quarter ended June 30, 2021 was $1.0 million, compared with $0.7 million for the quarter ended June 30, 2020, an increase of 43%. Gross margins for the quarter ended June 30, 2021 were 56%, compared with 57% in the same period in 2020. Management expects future gross margins to continue in the range of 55% to 60%.

Research and development expenses for the quarter ended June 30, 2021 were $0.5 million, compared with $0.8 million during the quarter ended June 30, 2020.

Depreciation and amortization expenses for the quarter ended June 30, 2021 were approximately $51,000, compared with approximately $47,000 for the corresponding period 2020, an increase of 9%.

Selling, general and administrative expenses for the quarter ended June 30, 2021 were $1.9 million, compared with $1.6 million during the same period in 2020, an increase of 19%.

As of June 30, 2021, Nephros had cash and cash equivalents of $8.3 million.

Adjusted EBITDA Definition and Reconciliation to GAAP Financial Measures

Adjusted EBITDA is calculated by taking net (loss) income calculated in accordance with generally accepted accounting principles (“GAAP”) and excluding all interest-related expenses and income, tax-related expenses and income, non-recurring expenses and income, and non-cash items, including depreciation and amortization and non-cash compensation. The following table presents a reconciliation of Adjusted EBITDA to net (loss) income, the most directly comparable GAAP financial measure, for the second quarter of the 2021 and 2020 fiscal years for both Nephros (on a consolidated basis) and the Water Filtration Business Segment:

	3 Months Ended Jun 30,
Water Filtration Business Segment	2021	2020
Net loss	(884)	(911)
Adjustments:
Depreciation of property and equipment	7	6
Amortization of other assets	48	45
Interest expense	11	30
Interest income	(3)	(4)
Stock based compensation	269	166
Other noncash items	24	12
Adjusted EBITDA	(528)	(656)

	3 Months Ended Jun 30,
Consolidated Results	2021	2020
Net loss	(1,126)	(1,657)
Adjustments:
Depreciation of property and equipment	8	6
Amortization of other assets	48	45
Interest expense	11	30
Interest income	(3)	(4)
Noncash compensation	281	179
Other noncash items	24	12
Adjusted EBITDA	(757)	(1,389)

Nephros believes that Adjusted EBITDA provides useful information to management and investors regarding certain financial and business trends relating to Nephros’s financial condition and results of operations. Management does not consider Adjusted EBITDA in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recognized in Nephros’s consolidated financial statements.  In addition, Adjusted EBITDA is subject to inherent limitations as it reflects the exercise of judgments by management about which expenses and income are excluded or included in determining Adjusted EBITDA. In order to compensate for these limitations, management presents Adjusted EBITDA in connection with net (loss) income, the most directly comparable GAAP financial measure. Nephros urges investors to review the reconciliation of Adjusted EBITDA to net (loss) income and not to rely on any single financial measure to evaluate the business.

Conference Call Today at 4:30 p.m. ET

Nephros will host a conference call today at 4:30 PM Eastern Time, during which management will discuss Nephros’s financial results and provide a general business overview.

Participants may dial into the call as follows:
Domestic access: 1-844-808-7106
International access: 1-412-317-5285

Upon joining, please ask to be joined into the Nephros conference call.

A replay of the call can be accessed until August 12, 2021 at 1-877-344-7529 or 1-412-317-0088 for international callers and entering replay access code: 10157406.

An audio archive of the call will be available shortly after the call on the Nephros investor relations page at https://investors.nephros.com/events/.

About Nephros

Nephros, Inc. is a leading biotechnology company focused on improving the human relationship with water. We provide innovative filtration and pathogen detection as part of an integrated approach to water safety that combines science, solutions, and support services. Nephros products serve the needs of customers within the healthcare and commercial markets, offering both proactive and emergency responses for water management.

For more information about Nephros, please visit www.nephros.com.

Forward-Looking Statements

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding Nephros’s expected benefits from its recent acquisition of GenArraytion, expected future growth in demand and the timing of such growth, expected future revenue and gross margins, the timing of receiving 510(k) clearance for Nephros’s second-generation HDF Assist Module and the expected timing of commercially launching such product, if cleared, and other statements that are not historical facts, including statements that may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including the impact of the ongoing COVID-19 pandemic, uncertainty in clinical outcomes, potential delays in the regulatory approval process, changes in business, economic and competitive conditions, the availability of capital when needed, dependence on third-party manufacturers and researchers, regulatory reforms, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Nephros’s reports filed with the U.S. Securities and Exchange Commission. Nephros does not undertake any responsibility to update the forward-looking statements in this release.

Investor Relations Contacts:

Kirin Smith, President
PCG Advisory, Inc.
(646) 823-8656
ksmith@pcgadvisory.com

Andy Astor, CEO
Nephros, Inc.
(201) 345-0824
andy@nephros.com

NEPHROS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)

ASSETS		June 30, 2021		December 31, 2020
Current assets:
Cash and cash equivalents		$                      8,278		$                     8,249
Accounts receivable, net		1,382		1,364
Inventory, net		5,087		5,304
Prepaid expenses and other current assets		93		237
Total current assets		14,840		15,154
Property and equipment, net		303		295
Operating right-use-of assets		897		1,037
Intangible assets, net		485		506
Goodwill		759		759
License and supply agreement, net		603		670
Other assets		104		89
Total assets		$                    17,991		$                   18,509
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Secured revolving credit facility		-		$                            -
Secured note, current portion		238		229
PPP loan, current portion		-		-
Accounts payable		1,100		423
Accrued expenses		476		341
Current portion of contingent consideration		-		-
Current portion lease liabilities		356		332
Total current liabilities		2,170		1,325
Secured note payable, long term portion		232		364
PPP loan, net of current portion		-		482
Financing obligation, net of current portion		5		7
Contingent consideration, net of current portion		-		-
Lease liabilities		593		759
Total liabilities		3,000		2,937
COMMITMENTS AND CONTINGENCIES
Stockholders' equity:
Preferred stock, $.001 par value; 5,000,000 shares authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding and June 30, 2021 and December 31, 2020		-		-
Common stock, $.001 par value; 40,000,000 shares authorized at June 30, 2021 and December 31, 2020; 10,087,811 and 9,873,006 shares issued and outstanding and June 30, 2021 and December 31, 2020, respectively		10		10
Additional paid-in capital		145,378		144,296
Accumulated other comprehensive income		70		74
Accumulated deficit		(133,521)		(131,858)
Subtotal		11,937		12,522
Noncontrolling interest		3,054		3,051
Total stockholders' equity		14,991		15,573
Total liabilities and equity		$                    17,991		$                   18,510

 NEPHROS, INC. AND SUBSIDIARIES 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(Unaudited)

		Three Months Ended June 30,
		2021		2020
Net revenues:
Product revenues		$                  2,196		$                  1,564
Royalty and other revenues		70		13
Total net revenues		2,266		1,577
Cost of goods sold		991		682
Gross margin		1,275		895
Gross margin %		56%		57%
Operating expenses:
Research and development		487		836
Depreciation and amortization		51		47
Selling, general and administrative		1,854		1,610
Change in fair value of contingent consideration		-		-
Total operating expenses		2,392		2,493
Loss from operations		(1,117)		(1,598)
Interest expense		(11)		(30)
Interest income		3		4
Other income (expense), net		(1)		(33)
Loss before income taxes		(1,126)		(1,657)
Income tax benefit		-		-
Net profit (loss)		(1,126)		(1,657)
Less: Deemed dividend attributable to noncontrolling interest		(60)		(60)
Net loss attributable to Nephros Inc		(1,186)		(1,717)
Net loss per common share, basic and diluted		$                   (0.12)		$                  (0.19)
Weighted average common shares outstanding, basic and diluted		9,943,026		8,986,134
Comprehensive loss:
Net Loss		(1,126)		(1,657)
Other comprehensive income(loss), foreign currency translation adjustments		2		1
Comprehensive loss		(1,124)		(1,656)
Comprehensive loss attirbutable to noncontrolling interest		(60)		(60)
Total comprehensive loss attributable to Nephros Inc shareholders		$                 (1,184)		$                (1,716)

FAQ

What were Nephros' Q2 2021 net revenue results?

Nephros reported a net revenue of $2.3 million for Q2 2021, a 44% increase year-over-year.

How did Nephros' net loss change in Q2 2021?

Net loss improved by 35% to $1.1 million in Q2 2021 compared to the same period in 2020.

What is the significance of the GenArraytion acquisition for NEPH?

The acquisition of GenArraytion enhances Nephros' capabilities in PCR testing, enabling better pathogen detection.

What FDA submission did Nephros make recently?

Nephros submitted their HDF Assist Module for FDA 510(k) clearance, with potential for a limited commercial launch.

What are the financial expectations for Nephros moving forward?

Management expects gross margins to remain in the range of 55% to 60% in the future.