Market Newsdesk

CARLSBAD, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB) today announced the appointment of Steven Mickelsen, MD, as Chief Translational Science Officer. Dr. Mickelsen will help guide the company’s vision to deliver the most advanced electrophysiology therapeutic solutions on the market for physicians and their patients. Mickelsen’s impact will further advance the company’s commitment to innovation across its access, diagnostic and therapy product portfolio, including researching, developing and advancing gold-tip catheter technology for Pulsed Field Ablation (PFA) and Radiofrequency (RF) ablation technologies.

“Acutus is committed to creating game-changing solutions and establishing new standards of care for cardiac arrhythmia management,” said Vince Burgess, President and CEO of Acutus Medical. “Dr. Mickelsen’s clinical and technical expertise and unique history pioneering the development of breakthrough therapeutic medical devices is indispensable as we progress from research to commercialization of important technologies such as Pulsed Field Ablation.”

Dr. Mickelsen joins Acutus Medical following an esteemed career practicing as a cardiac electrophysiologist at the University of Iowa Hospitals and Clinics in Iowa City. He focuses on complex ablation procedures and serves on faculty as Assistant Professor of Cardiovascular Medicine and Internal Medicine, and will continue his tenure going forward. In 2012, Dr. Mickelsen founded Farapulse, a company devoted to the discovery of more effective treatments for atrial fibrillation through the utilization of a pulsed electric field system that he invented. He served as the company’s initial President and CEO, and later as its Chief Science Officer, before stepping down in 2016 to focus on clinical research.

“The field of arrhythmia science is evolving at a breakneck speed. Physicians want to provide the best possible care, but we’re often confined by the limitations of technology. Acutus is changing that, and this is an opportunity to play a critical role delivering advanced EP solutions to treat the entire spectrum of cardiac arrhythmias,” said Dr. Mickelsen. “Pulsed field ablation represents an exciting potential future for EP; I’m thrilled to join a team that is dedicated to creating new solutions and enhancing the possibilities for physicians and their patients.”

Dr. Mickelsen is a board-certified electrophysiologist. He received his medical degree from the University of New Mexico School of Medicine, was a Howard Hughes Research Scholar at the National Institutes of Health in Bethesda, MD, and completed his internal medicine residency and clinical research at the Mayo Clinic. He also completed fellowships in Cardiology and Cardiac Electrophysiology at the University of Iowa Hospitals and Clinics.

About Acutus Medical

Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias in each of its geographic markets. Founded in 2011, Acutus is based in Carlsbad, California.

Acutus PFA Technology is not for sale in the United States

Follow Acutus Medical on:

• Twitter: @AcutusMedical
• LinkedIn: www.linkedin.com/company/acutus-medical-inc-/
• Facebook: @AcutusMedical

US Media Contacts

Levitate
(260) 408-5383
[email protected]

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the first patient has been treated in the first-in-human Phase 1 clinical trial of NKX101 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS). The multi-center clinical trial is designed to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101.

NKX101 is the first investigational NK cell cancer immunotherapy engineered to express a chimeric activating receptor (CAR) targeting NKG2D. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely and specifically expressed on cancer cells. With NKX101, NKG2D expression is increased by 10-fold and cytotoxic activity increased by 4-fold compared to non-engineered NK cells in preclinical models. NKX101 is also designed to express membrane-bound IL-15, which in preclinical models enhances the activity and persistence of the engineered NK cells. Nkarta’s proprietary manufacturing processes enable the evaluation of cryopreserved NKX101, expanding trial access across multiple clinical centers.

“Despite recent treatment breakthroughs, AML patients who relapse after front-line therapy still have poor outcomes, underscoring the need for new treatment options for this aggressive and lethal blood cancer,” said Carlos Bachier, M.D., Director of Cellular Therapy Research, Sarah Cannon Research Institute and Program Director for Sarah Cannon Center for Blood Cancer at TriStar Centennial Medical Center in Nashville, Tennessee, where the first patient has been treated. “To date, the significant clinical benefit achieved with CAR T cell therapies in the treatment of B cell lymphomas and acute lymphocytic leukemia has not extended to AML or other myeloid malignant disorders. The investigation of NKG2D-targeting and the tumor-killing potential of an engineered innate immune cell type is a promising new approach.”

“An extensive body of academic research has already shown increased expression of NKG2D targets in AML and other cancers, and demonstrated clinical responses in relapsed/refractory AML patients who received non-engineered allogeneic NK cells in single center academic studies as treatment,” said Kanya Rajangam, M.D., Ph.D., Chief Medical Officer of Nkarta. “With its amplified NKG2D targeting and enhanced NK cell engineering, NKX101 has the potential to improve upon this earlier clinical experience with non-engineered NK cells and to activate a deep and robust immune response in AML patients.”

A poster on the design of the NKX101 clinical trial in progress has been accepted for presentation at the 2020 American Society of Hematology Annual Meeting and Exhibition, Abstract 1040, “A Phase 1 Study of NKX101, an Allogeneic CAR Natural Killer (NK) Cell Therapy, in Subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-Risk Myelodysplastic Syndrome (MDS),” Session 616, December 5, 2020. 

About the
Phase 1 Clinical Trial of NKX101 in Participants with Relapsed/Refractory Acute Myeloid Leukemia
(AML)
or Higher Risk Myelodysplastic Syndromes
(MDS)

This First-in-Human Phase 1 study evaluates the safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101, administered in a cycle of three weekly infusions following lymphodepletion, in adult patients living with relapsed/refractory AML or higher risk MDS. This single-arm, open-label, multi-center study consists of sequential dose-finding and dose-expansion. The safety of participants will be monitored by assessment of vital signs, physical examinations and laboratory tests. The clinical trial is designed to identify a recommended Phase 2 dose, and will evaluate cellular kinetics, pharmacodynamics, and preliminary anti-tumor activity using standard response criteria. Additional information is available on ClinicalTrials.gov, identifier NCT04623944.

About AML and MDS

Acute Myeloid Leukemia (AML) is a rapidly progressing blood cancer caused by abnormalities of myeloid cells, a cell type in the bone marrow that would normally develop into different types of blood cells. AML usually worsens rapidly and can lead to death if not treated. Despite recent advancements, an unmet need for novel treatment options remains high. Only approximately one in four patients with AML survive longer than five years. Patients with AML have a high rate of disease relapse after a treatment response. Due to age and comorbidities, not all patients are eligible to receive intensive chemotherapy, leaving them with limited treatment options. Once relapsed or refractory to front-line therapy, patients have limited treatment options. The worldwide incidence of AML was estimated to be more than 119,500 cases in 2017.^* In the United States, there will be an estimated 19,940 new cases of AML in 2020, with an estimated 11,180 deaths resulting from the disease.^**

Myelodysplastic Syndromes (MDS) are a group of bone marrow disorders in which the blood-forming cells in the bone marrow do not produce enough healthy blood cells. Some patients with MDS have too many young, immature blood-making cells in the bone marrow. The median overall survival rate of higher risk MDS patients is 0.8 to 3.0 years. There is currently no curative treatment for patients who relapse after front-line therapy or do not respond to front-line therapy. MDS can progress to AML in about one-third of patients.

^*Ming Yi et al, J Hematol Oncol. 2020; 13: 72; ^**National Institutes of Health, Cancer Stat Facts, accessed 11 Nov 2020.

About NKX101

NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

About
Nkarta’s
NK Cell Technologies

Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells, and builds upon the important advances in cellular immunotherapy and chimeric antigen receptor (CAR) biology. To enhance the intrinsic activity of NK cells, Nkarta genetically engineers the cells with a CAR that consists of a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta’s NK cell therapy candidates are engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.

About Nkarta

Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off the shelf natural killer (NK) cell therapies for cancer. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company’s website at www.nkartatx.com.

Cautionary Note on Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” “projects,” “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Nkarta’s expectations regarding: Nkarta’s growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101; the mechanism of action and activity of Nkarta’s product candidates, including the activity of NKX101 in AML patients; NKX101’s potential as a treatment for AML; the size of the AML market; the efficiency and cost of Nkarta’s manufacturing processes; the number of doses generated from a manufacturing run; and the proprietary nature of Nkarta’s technology. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

These and other risks are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Nkarta’s final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, and our other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Nkarta Media/Investor Contact:

Greg Mann
Nkarta, Inc.
[email protected]

 

Initiated and Advanced
C
linical Trial Evaluating Lead Product Candidate in COVID-19 Patients

Announces Next Steps in Development Program for Lead Product Candidate

Ended Quarter with $21.9 million in Cash and Cash Equivalents

CHARLOTTESVILLE, Va., Nov. 12, 2020 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) (“Diffusion” or the “Company”) today reported financial results for the three and nine months ended September 30, 2020 and provided certain updates on its development program for its lead product candidate, trans sodium crocetinate (“TSC”), which is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.

Third quarter results, recent developments, and anticipated next steps in the TSC development program include:

Third Quarter Results & Recent Developments

	•	Strengthened leadership team with additions and appointments to key management positions, including pharmaceutical industry veterans Jane Hollingsworth, as director, Robert Cobuzzi, Ph.D., as president and chief executive officer, and Chris Galloway, M.D., as chief medical officer, as well as Bill Elder, J.D., as general counsel.
	•	Ended quarter with $21.9 million in cash and cash equivalents.
	•	Announced dosing of first two patients in Phase 1b clinical trial evaluating TSC in hospitalized COVID-19 patients (the “100-303 COVID Trial”) with primary endpoint of evaluating safety and tolerability of TSC administered every six hours for up to 15 days, a more frequent dosing regimen than has been used in the Company’s previous clinical studies.
	•	As of November 11, 2020, patient enrollment continues, and no dose-limiting toxicities have been observed.

Near-Term Strategy

	•	Ongoing review of existing TSC development program with plans to modify the program and accomplish two principal strategic objectives:
			•	Optimize the clinical dose and dosing frequency for TSC.
			•	Evaluate TSC in clinical models designed to establish proof of concept for improvement in oxygenation following administration of TSC.
	•	Designing and initiating additional studies in effort to accomplish strategic objectives:
			•	Evaluating possibility of expanding 100-303 COVID Trial to include additional doses administered on the same regimen, assuming successful and timely completion of currently planned doses and final regulatory approval of pending protocol amendment to effect change.
			•	Designing additional clinical studies intended to evaluate (i) the effects of TSC using short-term experimental models of oxygenation with the expected primary objective of establishing proof of concept for improvement of tissue oxygen levels and certain other clinical parameters and (ii) depending on whether or not the Company decides to implement the expansion of the 100-303 COVID Trial, additional doses of TSC on a more frequent dosing regimen.
	•	Diffusion expects to fully fund these studies with cash-on-hand.
	•	Diffusion intends to provide certain additional details regarding the design of these new studies in January 2021 and to initiate the studies during the first quarter of 2021. The Company also now expects the 100-303 COVID Trial, whether or not the Company decides to implement the expansion described above, to be completed with topline data available by the end of first quarter of 2021.

Other Events

	•	Diffusion currently intends to participate in two virtual, biopharmaceutical and biotechnology industry conferences in mid-January 2021 – Biotech Showcase and the H.C. Wainwright 2021 Bioconnect Conference – and to provide its next update regarding its development program for TSC at that time.
	•	Launched new website design at www.diffusionpharma.com.

“Hypoxia can be a serious complication of a multitude of acute and chronic disease processes in patients of all ages and represents a continued area of unmet need that spans multiple therapeutic areas. I am excited about our development plans, which we believe will clarify TSC’s mechanism of action in controlled human studies of oxygenation. We intend to use these data to inform and evaluate our further development opportunities for TSC, as well as potential patient populations and indications,” said Chris Galloway, M.D., Chief Medical Officer of Diffusion.

“Diffusion has experienced a lot of changes over the past few months. While we continue to refine our vision for the Company, we are pleased with the progress we made during the third quarter and we are excited to begin implementing our plans during the coming months,” said Robert Cobuzzi, Ph.D., Chief Executive Officer of Diffusion. “We believe our near-term strategy will significantly improve the probability of development success for TSC by providing the opportunity to optimize dosing and obtain a clear clinical signal supporting the potential value of TSC’s mechanism of action across a broad range of conditions in which hypoxia remains a significant obstacle to effective treatment.”

Third
Quarter
Financial Results

Research and development (“R&D”) expenses were $3.1 million during the third quarter of 2020, compared with $1.7 million during the third quarter of 2019. A significant portion of the increase, $1.4 million, was attributable to expenses related to the initiation of the Company’s ongoing clinical trial evaluating TSC in COVID-19 patients. In addition, R&D expenses included $0.1 million related to winding down the Company’s Phase 2 stroke trial.

General and administrative (“G&A”) expenses were $2.1 million during the third quarter of 2020, compared with $1.3 million during the third quarter of 2019. The increase was primarily due to a $0.2 million increase in professional fees and a $0.6 million increase in salaries, wages and stock-based compensation expenses, including non-recurring expenses related to the retirement, resignation and separation of the Company’s former Chief Executive Officer in September 2020.

The Company recognized income tax benefits of $0.8 million and $0.2 million during the third quarters of 2020 and 2019, respectively. In both periods, the recognized benefit reflects the Company’s utilization of indefinite deferred tax liabilities as a source of income against indefinite lived portions of its deferred tax assets.

Diffusion had cash and cash equivalents of $21.9 million as of September 30, 2020, compared with $14.2 million as of December 31, 2019, and believes its cash and cash equivalents are sufficient to fund operating expenses and capital expenditures into the fourth quarter of 2022.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to the areas where it is needed most. The Company’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions. For more information please visit us on the web at www.diffusionpharma.com.

Forward-Looking Statements

This press release includes express and implied forward-looking statements including, without limitation, statements regarding the Company’s ongoing clinical trials and development plans for its product candidates and the Company’s financial condition, liquidity, and capital resources. By their nature, forward-looking statements involve risks and uncertainties because they relate to and depend on, among other things, events, competitive dynamics, and industry change. The Company may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, as a result of certain risks and uncertainties, known and unknown, the Company’s actual results could differ materially from any intentions, beliefs, projections, outlook, analyses, or expectations expressed herein. Particular risk and uncertainties include, among other things, those related to: the Company’s ability to design, initiate, execute, and complete its ongoing and planned studies evaluating TSC; the Company’s ability to achieve its near-term strategic objectives, in the near-term or at all; the Company’s ability to obtain additional financing; the success and timing of the Company’s clinical trials and preclinical studies, including its ability to enroll subjects in such trials and studies at anticipated rates; the Company’s ability to develop and commercialize TSC or any other product candidate; the ongoing COVID-19 pandemic; general economic, political, business, industry, and market conditions, including the recent United States (“U.S.”) presidential election; and the other factors discussed under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”). Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified) and, except as required by applicable law, rule or regulation, the Company undertakes no obligation to update any such statements after the date hereof. Comparisons of current and any prior period results are not intended to express any ongoing or future trends or indications of future performance, unless explicitly expressed as such, and should only be viewed as historical data. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contact:

LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
[email protected]

Media Contact:

Jeffrey Freedman
RooneyPartners
(646) 432-0191
[email protected]

(Tables to follow)

Diffusion Pharmaceuticals Inc.
Consolidated Balance Sheet
(unaudited)
	September 30, 2020			December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	21,910,183		$	14,177,349
Prepaid expenses, deposits and other current assets		766,932			472,464
Total current assets		22,677,115			14,649,813
Property and equipment, net		174,133			252,366
Intangible asset		8,639,000			8,639,000
Right of use asset		174,668			247,043
Other assets		252,057			322,301
Total assets	$	31,916,973		$	24,110,523
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,411,717		$	1,251,412
Accrued expenses and other current liabilities		1,162,278			358,532
Current operating lease liability		112,953			111,477
Total current liabilities		2,686,948			1,721,421
Deferred income taxes		443,893			2,119,274
Noncurrent operating lease liability		61,715			135,566
Total liabilities		3,192,556			3,976,261
Stockholders’ Equity:
Common stock, $0.001 par value:
1,000,000,000 shares authorized; 64,015,441 and 33,480,365 issued and outstanding at September 30, 2020 and December 31, 2019, respectively		64,016			33,481
Additional paid-in capital		130,507,728			111,824,859
Accumulated deficit		(101,847,327	)		(91,724,078	)
Total stockholders’ equity		28,724,417			20,134,262
Total liabilities and stockholders’ equity	$	31,916,973		$	24,110,523

Diffusion Pharmaceuticals Inc.
Consolidated Statement of Operations
(unaudited)
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Operating expenses:
Research and development	$	3,137,553			$	1,743,494			$	6,845,203			$	4,961,720
General and administrative		2,112,375				1,290,371				4,964,440				3,559,551
Depreciation		24,192				18,178				78,233				70,840
Loss from operations		(5,274,120	)			(3,052,043	)			(11,887,876	)			(8,592,111	)
Other income:
Interest income		29,233				21,991				89,246				59,596
Loss from operations before income tax benefit		(5,244,887	)			(3,030,052	)			(11,798,630	)			(8,532,515	)
Income tax benefit		805,676				225,960				1,675,381				485,216
Net loss	$	(4,439,211	)		$	(2,804,092	)		$	(10,123,249	)		$	(8,047,299	)
Deemed dividend arising from warrant exchange		—				—				(1,950,378	)			—
Net loss attributable to common stockholders	$	(4,439,211	)		$	(2,804,092	)		$	(12,073,627	)		$	(8,047,299	)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.07	)		$	(0.60	)		$	(0.24	)		$	(2.01	)
Weighted average shares outstanding, basic and diluted		64,011,342				4,693,290				50,216,239				4,005,919

 

• Record quarterly revenue of $4.69 billion, up 25 percent year over year
• Record quarterly GAAP EPS of $1.23 and non-GAAP EPS of $1.25, up 64 percent and 56 percent year over year, respectively
• Generated record annual cash from operations of $3.80 billion

SANTA CLARA, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Applied Materials, Inc. (NASDAQ: AMAT) today reported results for its fourth quarter and fiscal year ended Oct. 25, 2020.

Fourth Quarter Results

Applied generated revenue of $4.69 billion. On a GAAP basis, the company recorded gross margin of 45.4 percent, operating income of $1.28 billion or 27.4 percent of net sales, and earnings per share (EPS) of $1.23.

On a non-GAAP adjusted basis, the company reported gross margin of 45.7 percent, operating income of $1.33 billion or 28.3 percent of net sales, and EPS of $1.25.

The company generated $1.32 billion in cash from operations and returned $250 million to shareholders including $200 million in dividends and $50 million in share repurchases.

Full Year Results

In fiscal 2020, Applied generated revenue of $17.20 billion. On a GAAP basis, the company recorded gross margin of 44.7 percent, operating income of $4.37 billion or 25.4 percent of net sales, and EPS of $3.92.

On a non-GAAP adjusted basis, the company reported gross margin of 45.1 percent, operating income of $4.53 billion or 26.3 percent of net sales, and EPS of $4.17.

The company generated a record $3.80 billion in cash from operations, paid dividends of $787 million and used $649 million to repurchase 12 million shares of common stock.

“Applied Materials closed fiscal 2020 with record quarterly performance as demand for our semiconductor systems and services remains very strong,” said Gary Dickerson, president and CEO. “Our future opportunities have never looked better and, as powerful technology trends take shape, we are uniquely positioned to accelerate our customers’ roadmaps and outperform our markets.”

Results Summary

																Change
	Q4 FY2020				Q4 FY2019				FY2020				FY2019			Q4 FY2020  vs. Q4 FY2019			FY2020 vs. FY2019
	(In millions, except per share amounts and percentages)
Net sales	$	4,688			$	3,754			$	17,202			$	14,608		25	%		18	%
Gross margin	45.4		%		43.5		%		44.7		%		43.7		%	1.9 points			1.0 points
Operating margin	27.4		%		23.0		%		25.4		%		22.9		%	4.4 points			2.5 points
Net income	$	1,131			$	698			$	3,619			$	2,706		62	%		34	%
Diluted earnings per share	$	1.23			$	0.75			$	3.92			$	2.86		64	%		37	%
Non-GAAP Adjusted Results
Non-GAAP adjusted gross margin	45.7		%		43.8		%		45.1		%		44.0		%	1.9 points			1.1 points
Non-GAAP adjusted operating margin	28.3		%		23.7		%		26.3		%		23.5		%	4.6 points			2.8 points
Non-GAAP adjusted net income	$	1,148			$	744			$	3,845			$	2,875		54	%		34	%
Non-GAAP adjusted diluted EPS	$	1.25			$	0.80			$	4.17			$	3.04		56	%		37	%

A reconciliation of the GAAP and non-GAAP adjusted results is provided in the financial tables included in this release. See also “Use of Non-GAAP Adjusted Financial Measures” section.

Business Outlook

In the first quarter of fiscal 2021, Applied expects net sales to be approximately $4.95 billion, plus or minus $200 million. Non-GAAP adjusted diluted EPS is expected to be in the range of $1.20 to $1.32.

This outlook for non-GAAP adjusted diluted EPS excludes known charges related to completed acquisitions of $0.01 per share and includes a net income tax benefit related to intra-entity intangible asset transfers of $0.03 per share, but does not reflect any items that are unknown at this time, such as any additional charges related to acquisitions or other non-operational or unusual items, as well as other tax related items, which we are not able to predict without unreasonable efforts due to their inherent uncertainty.

Fourth Quarter and Fiscal Year Reportable Segment Information

Semiconductor Systems	Q4 FY2020				Q4 FY2019				FY2020				FY2019
	(In millions, except percentages)
Net sales	$	3,070			$	2,302			$	11,367			$	9,027
Foundry, logic and other	58		%		58		%		59		%		52		%
DRAM	21		%		21		%		20		%		22		%
Flash memory	21		%		21		%		21		%		26		%
Operating income	1,059				641				3,714				2,464
Operating margin	34.5		%		27.8		%		32.7		%		27.3		%
Non-GAAP Adjusted Results
Non-GAAP adjusted operating income	$	1,073			$	652			$	3,778			$	2,507
Non-GAAP adjusted operating margin	35.0		%		28.3		%		33.2		%		27.8		%

Applied Global Services	Q4 FY2020				Q4 FY2019				FY2020				FY2019
	(In millions, except percentages)
Net sales	$	1,106			$	977			$	4,155			$	3,854
Operating income	320				274				1,127				1,101
Operating margin	28.9		%		28.0		%		27.1		%		28.6		%
Non-GAAP Adjusted Results
Non-GAAP adjusted operating income	$	320			$	274			$	1,135			$	1,101
Non-GAAP adjusted operating margin	28.9		%		28.0		%		27.3		%		28.6		%

Display and Adjacent Markets	Q4 FY2020				Q4 FY2019				FY2020				FY2019
	(In millions, except percentages)
Net sales	$	485			$	457			$	1,607			$	1,651
Operating income	95				96				291				294
Operating margin	19.6		%		21.0		%		18.1		%		17.8		%
Non-GAAP Adjusted Results
Non-GAAP adjusted operating income	$	98			$	99			$	304			$	307
Non-GAAP adjusted operating margin	20.2		%		21.7		%		18.9		%		18.6		%

Use of Non-GAAP Adjusted Financial Measures

Applied provides investors with certain non-GAAP adjusted financial measures, which are adjusted for the impact of certain costs, expenses, gains and losses, including certain items related to mergers and acquisitions; restructuring charges and any associated adjustments; certain incremental expenses related to COVID-19; impairments of assets, or investments; gain or loss on sale of strategic investments; loss on early extinguishment of debt; certain income tax items and other discrete adjustments. On a non-GAAP basis, the tax effect related to share-based compensation is recognized ratably over the fiscal year. Additionally, non-GAAP results exclude estimated discrete income tax expense items associated with U.S. tax legislation. Reconciliations of these non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP are provided in the financial tables included in this release.

Management uses these non-GAAP adjusted financial measures to evaluate the company’s operating and financial performance and for planning purposes, and as performance measures in its executive compensation program. Applied believes these measures enhance an overall understanding of its performance and investors’ ability to review the company’s business from the same perspective as the company’s management, and facilitate comparisons of this period’s results with prior periods on a consistent basis by excluding items that management does not believe are indicative of Applied’s ongoing operating performance. There are limitations in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with generally accepted accounting principles, may be different from non-GAAP financial measures used by other companies, and may exclude certain items that may have a material impact upon our reported financial results. The presentation of this additional information is not meant to be considered in isolation or as a substitute for the directly comparable financial measures prepared in accordance with GAAP.

Webcast Information

Applied Materials will discuss these results during an earnings call that begins at 1:30 p.m. Pacific Time today. A live webcast and related slide presentation will be available at www.appliedmaterials.com. A replay will be available on the website beginning at 5:00 p.m. Pacific Time today.

Forward-Looking Statements

This press release contains forward-looking statements, including those regarding anticipated growth and trends in our businesses and markets, industry outlooks and demand drivers, technology transitions, our business and financial performance and market share positions, our capital allocation and cash deployment strategies, our investment and growth strategies, our development of new products and technologies, our business outlook for the first quarter of fiscal 2021 and beyond, the impact of the ongoing COVID-19 pandemic and responses thereto on our operations and financial results, strategic acquisitions and investments, including the proposed acquisition of Kokusai Electric Corporation, and other statements that are not historical facts. These statements and their underlying assumptions are subject to risks and uncertainties and are not guarantees of future performance. Factors that could cause actual results to differ materially from those expressed or implied by such statements include, without limitation: the level of demand for our products; global economic and industry conditions; the effects of regional or global health epidemics, including the severity and duration of the ongoing COVID-19 pandemic; global trade issues and changes in trade and export license policies, including the impact of the implementation and interpretation of the rules published by the U.S. Department of Commerce on April 28, 2020 and August 17, 2020 relating to certain export license requirements; consumer demand for electronic products; the demand for semiconductors; customers’ technology and capacity requirements; the introduction of new and innovative technologies, and the timing of technology transitions; our ability to develop, deliver and support new products and technologies; the concentrated nature of our customer base; acquisitions, investments and divestitures; changes in income tax laws; our ability to expand our current markets, increase market share and develop new markets; market acceptance of existing and newly developed products; our ability to obtain and protect intellectual property rights in key technologies; our ability to achieve the objectives of operational and strategic initiatives, align our resources and cost structure with business conditions, and attract, motivate and retain key employees; the variability of operating expenses and results among products and segments, and our ability to accurately forecast future results, market conditions, customer requirements and business needs;  and other risks and uncertainties described in our SEC filings, including our recent Forms 10-Q and 8-K. All forward-looking statements are based on management’s current estimates, projections and assumptions, and we assume no obligation to update them.

About Applied Materials

Applied Materials, Inc. (Nasdaq: AMAT) is the leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. Our expertise in modifying materials at atomic levels and on an industrial scale enables customers to transform possibilities into reality. At Applied Materials, our innovations make possible the technology shaping the future. Learn more at www.appliedmaterials.com.

Contact:

Ricky Gradwohl (editorial/media) 408.235.4676
Michael Sullivan (financial community) 408.986.7977

APPLIED MATERIALS, INC.
UNAUDITED CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

	Three Months Ended								Twelve Months Ended
(In millions, except per share amounts)	October 25, 2020				October 27, 2019				October 25, 2020				October 27, 2019
Net sales	$	4,688			$	3,754			$	17,202			$	14,608
Cost of products sold	2,558				2,120				9,510				8,222
Gross profit	2,130				1,634				7,692				6,386
Operating expenses:
Research, development and engineering	560				515				2,234				2,054
Marketing and selling	131				129				526				521
General and administrative	156				126				567				461
Total operating expenses	847				770				3,327				3,036
Income from operations	1,283				864				4,365				3,350
Interest expense	59				59				240				237
Interest and other income (loss), net	19				35				41				156
Income before income taxes	1,243				840				4,166				3,269
Provision for income taxes	112				142				547				563
Net income	$	1,131			$	698			$	3,619			$	2,706
Earnings per share:
Basic	$	1.24			$	0.76			$	3.95			$	2.89
Diluted	$	1.23			$	0.75			$	3.92			$	2.86
Weighted average number of shares:
Basic	914				920				916				937
Diluted	921				931				923				945

APPLIED MATERIALS, INC.
UNAUDITED CONSOLIDATED CONDENSED BALANCE SHEETS

(In millions)	October 25, 2020				October 27, 2019
ASSETS
Current assets:
Cash and cash equivalents	$	5,351			$	3,129
Short-term investments	387				489
Accounts receivable, net	2,963				2,533
Inventories	3,904				3,474
Other current assets	764				581
Total current assets	13,369				10,206
Long-term investments	1,538				1,703
Property, plant and equipment, net	1,604				1,529
Goodwill	3,466				3,399
Purchased technology and other intangible assets, net	153				156
Deferred income taxes and other assets	2,223				2,031
Total assets	$	22,353			$	19,024
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current portion of long-term debt	$	—			$	600
Accounts payable and accrued expenses	3,138				2,511
Contract liabilities	1,321				1,336
Total current liabilities	4,459				4,447
Long-term debt, net of current portion	5,448				4,713
Income taxes payable	1,206				1,275
Other liabilities	662				375
Total liabilities	11,775				10,810
Total stockholders’ equity	10,578				8,214
Total liabilities and stockholders’ equity	$	22,353			$	19,024

APPLIED MATERIALS, INC.
UNAUDITED CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(In millions)	Three Months Ended								Twelve Months Ended
	October 25, 2020				October 27, 2019				October 25, 2020				October 27, 2019
Cash flows from operating activities:
Net income	$	1,131			$	698			$	3,619			$	2,706
Adjustments required to reconcile net income to cash provided by operating activities:
Depreciation and amortization	97				92				376				363
Share-based compensation	73				66				307				263
Deferred income taxes	(18		)		(8		)		80				49
Other	5				—				60				(19		)
Net change in operating assets and liabilities	27				(22		)		(638		)		(115		)
Cash provided by operating activities	1,315				826				3,804				3,247
Cash flows from investing activities:
Capital expenditures	(162		)		(97		)		(422		)		(441		)
Cash paid for acquisitions, net of cash acquired	—				—				(107		)		(28		)
Proceeds from sales and maturities of investments	366				555				1,754				1,940
Purchases of investments	(345		)		(544		)		(1,355		)		(1,914		)
Cash used in investing activities	(141		)		(86		)		(130		)		(443		)
Cash flows from financing activities:
Debt borrowings, net of issuance costs	—				—				2,979				—
Debt repayments	—				—				(2,882		)		—
Proceeds from common stock issuances	83				72				174				145
Common stock repurchases	(50		)		(500		)		(649		)		(2,403		)
Tax withholding payments for vested equity awards	(6		)		(3		)		(172		)		(86		)
Payments of dividends to stockholders	(200		)		(194		)		(787		)		(771		)
Cash used in financing activities	(173		)		(625		)		(1,337		)		(3,115		)
Increase (decrease) in cash, cash equivalents and restricted cash equivalents	1,001				115				2,337				(311		)
Cash, cash equivalents and restricted cash equivalents—beginning of period	4,465				3,014				3,129				3,440
Cash, cash equivalents and restricted cash equivalents — end of period	$	5,466			$	3,129			$	5,466			$	3,129
Reconciliation of cash, cash equivalents, and restricted cash equivalents
Cash and cash equivalents	$	5,351			$	3,129			$	5,351			$	3,129
Restricted cash equivalents included in deferred income taxes and other assets	115				—				115				—
Total cash, cash equivalents, and restricted cash equivalents	$	5,466			$	3,129			$	5,466			$	3,129
Supplemental cash flow information:
Cash payments for income taxes	$	23			$	69			$	542			$	522
Cash refunds from income taxes	$	63			$	2			$	68			$	22
Cash payments for interest	$	68			$	76			$	219			$	219

APPLIED MATERIALS, INC.
UNAUDITED SUPPLEMENTAL INFORMATION

Corporate and Other

(In millions)	Q4 FY2020				Q4 FY2019				FY2020				FY2019
Unallocated net sales	$	27			$	18			$	73			$	76
Unallocated cost of products sold and expenses	(145		)		(99		)		(533		)		(322		)
Share-based compensation	(73		)		(66		)		(307		)		(263		)
Total	$	(191	)		$	(147	)		$	(767	)		$	(509	)

Additional Information

	Q4 FY2020			Q4 FY2019			FY2020			FY2019
Net Sales by Geography (In millions)
United States	448			412			1,619			1,871
% of Total	10	%		11	%		10	%		13	%
Europe	206			147			736			820
% of Total	4	%		4	%		4	%		6	%
Japan	706			471			1,996			2,198
% of Total	15	%		13	%		11	%		15	%
Korea	719			471			3,031			1,929
% of Total	15	%		13	%		18	%		13	%
Taiwan	872			919			3,953			2,965
% of Total	19	%		24	%		23	%		20	%
Southeast Asia	161			135			411			548
% of Total	3	%		3	%		2	%		4	%
China	1,576			1,199			5,456			4,277
% of Total	34	%		32	%		32	%		29	%
Employees (In thousands)
Regular Full Time	24.0			22.0

 APPLIED MATERIALS, INC.
UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED RESULTS

	Three Months Ended								Twelve Months Ended
(In millions, except percentages)	October 25, 2020				October 27, 2019				October 25, 2020				October 27, 2019
Non-GAAP Adjusted Gross Profit
Reported gross profit – GAAP basis	$	2,130			$	1,634			$	7,692			$	6,386
Certain items associated with acquisitions1	12				9				37				37
Certain incremental expenses related to COVID-195	—				—				23				—
Non-GAAP adjusted gross profit	$	2,142			$	1,643			$	7,752			$	6,423
Non-GAAP adjusted gross margin	45.7		%		43.8		%		45.1		%		44.0		%
Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	1,283			$	864			$	4,365			$	3,350
Certain items associated with acquisitions1	16				14				54				55
Acquisition integration and deal costs	26				10				80				22
Certain incremental expenses related to COVID-195	—				—				30				—
Non-GAAP adjusted operating income	$	1,325			$	888			$	4,529			$	3,427
Non-GAAP adjusted operating margin	28.3		%		23.7		%		26.3		%		23.5		%
Non-GAAP Adjusted Net Income
Reported net income – GAAP basis	$	1,131			$	698			$	3,619			$	2,706
Certain items associated with acquisitions1	16				14				54				55
Acquisition integration and deal costs	26				10				80				22
Certain incremental expenses related to COVID-195	—				—				30				—
Realized loss (gain) on strategic investments, net	—				—				(1		)		(6		)
Unrealized loss (gain) on strategic investments, net	(7		)		(5		)		(8		)		(30		)
Loss on early extinguishment of debt	—				—				33				—
Income tax effect of share-based compensation2	13				4				—				—
Income tax effect of changes in applicable U.S. tax laws3	—				—				—				(24		)
Income tax effects related to intra-entity intangible asset transfers	10				6				114				62
Resolution of prior years’ income tax filings and other tax items	(36		)		20				(41		)		95
Income tax effect of non-GAAP adjustments4	(5		)		(3		)		(35		)		(5		)
Non-GAAP adjusted net income	$	1,148			$	744			$	3,845			$	2,875

1	These items are incremental charges attributable to completed acquisitions, consisting of amortization of purchased intangible assets.
2	GAAP basis tax benefit related to share-based compensation is recognized ratably over the fiscal year on a non-GAAP basis.
3	Charges to income tax provision related to a one-time transition tax as a result of U.S. tax legislation.
4	Adjustment to provision for income taxes related to non-GAAP adjustments reflected in income before income taxes.
5	Temporary incremental employee compensation during the COVID-19 pandemic.

APPLIED MATERIALS, INC.
UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED RESULTS

	Three Months Ended								Twelve Months Ended
(In millions, except per share amounts)	October 25, 2020				October 27, 2019				October 25, 2020				October 27, 2019
Non-GAAP Adjusted Earnings Per Diluted Share
Reported earnings per diluted share – GAAP basis	$	1.23			$	0.75			$	3.92			$	2.86
Certain items associated with acquisitions	0.02				0.01				0.05				0.05
Acquisition integration and deal costs	0.02				0.01				0.07				0.02
Certain incremental expenses related to COVID-19	—				—				0.03				—
Loss on early extinguishment of debt	—				—				0.03				—
Unrealized loss (gain) on strategic investments, net	(0.01		)		—				(0.01		)		(0.03		)
Income tax effect of share-based compensation	0.02				—				—				—
Income tax effect of changes in applicable U.S. tax laws	—				—				—				(0.03		)
Income tax effects related to intra-entity intangible asset transfers	0.01				0.01				0.12				0.07
Resolution of prior years’ income tax filings and other tax items	(0.04		)		0.02				(0.04		)		0.10
Non-GAAP adjusted earnings per diluted share	$	1.25			$	0.80			$	4.17			$	3.04
Weighted average number of diluted shares	921				931				923				945

APPLIED MATERIALS, INC.
UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED RESULTS

	Three Months Ended								Twelve Months Ended
(In millions, except percentages)	October 25, 2020				October 27, 2019				October 25, 2020				October 27, 2019
Semiconductor Systems Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	1,059			$	641			$	3,714			$	2,464
Certain items associated with acquisitions1	12				11				41				43
Acquisition integration costs	2				—				3				—
Certain incremental expenses related to COVID-192	—				—				20				—
Non-GAAP adjusted operating income	$	1,073			$	652			$	3,778			$	2,507
Non-GAAP adjusted operating margin	35.0		%		28.3		%		33.2		%		27.8		%
AGS Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	320			$	274			$	1,127			$	1,101
Certain incremental expenses related to COVID-192	—				—				8				—
Non-GAAP adjusted operating income	$	320			$	274			$	1,135			$	1,101
Non-GAAP adjusted operating margin	28.9		%		28.0		%		27.3		%		28.6		%
Display and Adjacent Markets Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	95			$	96			$	291			$	294
Certain items associated with acquisitions1	3				3				12				12
Acquisition integration costs	—				—				—				1
Certain incremental expenses related to COVID-192	—				—				1				—
Non-GAAP adjusted operating income	$	98			$	99			$	304			$	307
Non-GAAP adjusted operating margin	20.2		%		21.7		%		18.9		%		18.6		%

1	These items are incremental charges attributable to completed acquisitions, consisting of amortization of purchased intangible assets.
2	Temporary incremental employee compensation during the COVID-19 pandemic.

Note: The reconciliation of GAAP and non-GAAP adjusted segment results above does not include certain revenues, costs of products sold and operating expenses that are reported within corporate and other and included in consolidated operating income.

UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED EFFECTIVE INCOME TAX RATE

	Three Months Ended
(In millions, except percentages)	October 25, 2020
Provision for income taxes – GAAP basis (a)	$	112
Income tax effect of share-based compensation	(13		)
Income tax effects related to intra-entity intangible asset transfers	(10		)
Resolutions of prior years’ income tax filings and other tax items	36
Income tax effect of non-GAAP adjustments	5
Non-GAAP adjusted provision for income taxes (b)	$	130
Income before income taxes – GAAP basis (c)	$	1,243
Certain items associated with acquisitions	16
Acquisition integration and deal costs	26
Unrealized loss (gain) on strategic investments, net	(7		)
Non-GAAP adjusted income before income taxes (d)	$	1,278
Effective income tax rate – GAAP basis (a/c)	9.0		%
Non-GAAP adjusted effective income tax rate (b/d)	10.2		%

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (NASDAQ: BNGO), a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business, today reported its financial results for the third quarter ended September 30, 2020 and provided a business update.

“We believe key events this quarter have set us up for continued growth and success,” said Erik Holmlin, Ph.D., CEO of Bionano. “Yesterday, in the largest Saphyr study on leukemia to date, cytogenetic thought leaders from leading U.S. institutions recommended that optical genome mapping using Saphyr be considered as a first-line diagnostic tool in leukemias. We saw continued adoption by cytogenomic labs around the world and for COVID host genome research, publication of several major studies on cancer genomics, genetic diseases and reference genome assembly, and made significant improvements to the Saphyr system. We enhanced our management team with the addition of our Chief Financial Officer and our first Chief Medical Officer. In addition, we completed the strategic acquisition of Lineagen, which adds to our revenue and outlines a potential path to reimbursement of laboratory developed tests performed on Saphyr.”

Recent Business Highlights

The Company continued building scientific momentum and driving utilization of its Saphyr System at key institutions across the globe, with the following notable announcements:

• Multi-Center Evaluation of Bionano Optical Genome Mapping by Cytogenetics Thought Leaders in the US Led to Recommendation for Bionano’s Saphyr to Replace Karyotyping as First-Line Test for Detection and Identification of Structural and Copy Number Variants in Leukemia Patients
   
• Saphyr played essential role in identifying three previously unknown genetic mutation types in cancer in study from Weill Cornell
   
• Saphyr showed to be key to understanding cancer genome structures that make tumors grow aggressively
   
• Boston Children’s Hospital used Saphyr to study children with severe COVID-19 form MIS-C, and Rockefeller University used animal species susceptible and resistant to COVID-19 in Saphyr-based comparative genomics study to identify genome variants that predispose to infection
   
• Saphyr data provided insight and understanding of repeat expansion disorders causing muscular dystrophy and ALS, and was shown to be indispensable for analysis of microdeletion syndromes
   
• Vertebrate Genome Project ruled Bionano optical genome mapping technology as essential part of assembling reference quality genomes
   
• Expanded European business with adoption of Saphyr at three of Europe’s largest pediatric hospitals in Spain, Italy and France.
   
• Expanded Global business with adoption of Saphyr for Next-Generation Cytogenomics in Eastern Europe, Australia and Canada
   
• Saphyr received German accreditation of Laboratory Developed Test for genetic disease testing

Enhanced Saphyr System

• Released fast and simple DNA isolation protocol to process solid tumor samples
   
• Released largest ever update to its suite of software tools that simplifies clinical analysis, reduces time to actionable results and makes adoption by clinical labs easier
   
• Saphyr services offered in CLIA Certified Lab Expanded Bionano Genomics’ clinical applications

Corporate

• Acquired Diagnostics Services Provider Lineagen to Accelerate Clinical Adoption of Saphyr for Digital Cytogenetics, Expanded Diagnostic Testing Menu with Launch of Lineagen’s EpiPanelDx PLUS Gene Panel Test that Identifies Genetic Conditions Related to Epilepsy
   
• Announced positive outcome from a special shareholder meeting where stockholders voted in favor of the company’s proposal to increase the number of authorized shares of common stock
   
• Enhanced senior management team with the appointments of Christopher Stewart as Chief Financial Officer and Dr. Alka Chaubey as Chief Medical Officer

Third Quarter Ended 2020 Financial Results

Total Revenue. Total revenue was $2.2 million for the three months ended September 30, 2019, up 86% sequentially from $1.2M in the prior quarter. Third quarter revenue was down 33.7% compared to $3.3 million for the same period in 2019. The decrease was driven by a change in the mix of revenue between instrument sales and our reagent rental program. Revenue for the three months ended September 30, 2020 includes service revenue of $0.4 million from our recently acquired subsidiary, Lineagen, from the date of the acquisition of August 21, 2020 to September 30, 2020.

Cost of Revenue. Total cost of revenue decreased by $0.9 million, or 38.5%, to $1.5 million for the three months ended September 30, 2020 compared to $2.4 million for the same period in 2019. The decrease was driven by a change in the mix of revenue between instrument sales and our reagent rental program. The decrease in cost was  partially offset by an increase in in cost of our consumables as the number of units sold increased 34%.  In addition, cost of service revenue increased by $0.2 million attributed to revenue generated by our recently acquired subsidiary, Lineagen, from the date of the acquisition of August 21, 2020 to September 30, 2020.

Operating Expenses. Operating expenses were $11.0 million for the three months ended September 30, 2020, compared to $6.6 million for the same period in 2019. The change is primarily due to increased legal and accounting fees to support business operations and its international presence, including approximately $1.5 million in transaction costs associated with the Lineagen acquisition, and an increase in wage expenses as a result of the addition of the 33 employees from the Lineagen acquisition and increased headcount in the Company’s global sales and marketing teams and back-office support teams to assist with the growth of its world-wide product distribution. Reduced travel and trade show expenses, in response to COVID travel protocols, have partially offset the increases in wages and professional services.

Cash and cash equivalents. At September 30, 2020, the Company had cash and cash equivalents of $18.9 million compared to cash and cash equivalents of $17.3 million at December 31, 2019.

Nine Months Ended 2020 Financial Results

Total Revenue.  Total revenue was $4.5 million for the nine months ended September 30, 2020 compared to $7.3 million for the same period in 2019. The decrease is largely driven by customers temporarily shutting down their lab operations in response to the COVID-19 pandemic. In addition, the decrease was driven by a change in the mix of revenue between instrument sales and our reagent rental program.

Cost of Revenue.  Total cost of revenue decreased by $2.2 million, or 42.5%, to $2.9 million for the nine months ended September 30, 2020 compared to $5.1 million for the same period in 2019. The decrease was driven by the reduction in revenue largely driven by customers temporarily shutting down their lab operations in response to the COVID-19 pandemic as well as a change in the mix of revenue between instrument sales and our reagent rental program. The cost reduction was  partially offset by an increase in consumable units sold of 70%.

Operating Expenses.  Operating expenses were $29.0 million for the nine months ended September 30, 2020, compared to $21.0 million for the same period in 2019. Research and development expenses increased $0.7 million, or 10.4%, to $7.4 million for the nine months ended September 30, 2020 compared to $6.7 million for the same period in 2019. This is due to headcount additions to the Company’s development teams but partially offset by the salary reductions implemented in April 2020. In addition, the Company’s materials and supply expense increased during the nine months ended September 30, 2020 due to continued efforts to innovate on Saphyr. Selling and general administrative expenses increased by $7.3 million, or 51.4%, to $21.6 million for the nine months ended September 30, 2020 compared to $14.3 million for the same period in 2019. This is primarily due to an increase in overall wage expenses due to increased headcount. In addition to the 33 employees added from the Lineagen acquisition, the Company increased headcount to its global sales and marketing teams and back-office support teams to assist with the growth of its world-wide product distribution. Also, the Company incurred increased legal and accounting fees to support business operations and its international presence, including approximately $1.5 million in transaction costs associated with the Lineagen acquisition. Lastly, the Company recognized bad debt expense of $1.3 million during the nine months ended September 30, 2020.

Conference Call & Webcast Details

Date:	Thursday November 12th
Time:	4:30 p.m. Eastern Time
Toll Free:	877-407-0784
International:	201-689-8560
Conference ID:	13712129
Webcast:	http://public.viavid.com/index.php?id=142056

To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay in the Investors section of the Bionano website.

About Bionano Genomics
Bionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business. Bionano’s Saphyr system is a platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. For more information, visit www.bionanogenomics.com or www.lineagen.com. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the contribution of our OGM technology to the improved detection of diagnostic information in the patients with leukemia and other genetic diseases, current and future utilization or adoption of Saphyr by researchers, scientists and leading medical institutions; our contributions to and the outcomes of studies discussed in this press release; our integration of Lineagen into our combined business, including any benefits or synergies from such integration; our future operating and our financial performance; potential reimbursement of laboratory developed tests performed on Saphyr; and the advancement of our strategic plans. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; the loss of key members of management and our commercial team; our inability to achieve the anticipated benefits from our acquisition of Lineagen; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS

Company Contact:

Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
[email protected]

Investor Relations Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
+1 (617) 430-7577
[email protected]

Media Contact:

Darren Opland, PhD
LifeSci Communications
+1 (617) 733-7668
[email protected]

Bionano Genomics, Inc.
Consolidated Balance Sheets
	(Unaudited)
	September 30, 2020				December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	18,867,000			$	17,311,000
Accounts receivable, net	3,860,000				6,334,000
Inventory, net	4,593,000				3,444,000
Prepaid expenses and other current assets	1,920,000				1,169,000
Total current assets	29,240,000				28,258,000
Property and equipment, net	3,635,000				1,950,000
Intangible assets, net	1,580,000				—
Goodwill	6,941,000				—
Total assets	$	41,396,000			$	30,208,000
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	5,665,000			$	2,699,000
Accrued expenses	4,466,000				3,225,000
Contract liabilities	412,000				358,000
Current portion of long-term debt	14,239,000				20,085,000
Total current liabilities	24,782,000				26,367,000
Long-term debt, net of current portion	1,775,000				—
Long-term contract liabilities	88,000				183,000
Other non-current liabilities	75,000				44,000
Total liabilities	26,720,000				26,594,000
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.0001 par value, 200,000,000 and 200,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 148,348,000 and 34,274,000 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	15,000				3,000
Additional paid-in capital	146,613,000				106,188,000
Accumulated deficit	(131,952,000		)		(102,577,000		)
Total stockholders’ equity	14,676,000				3,614,000
Total liabilities and stockholders’ equity	$	41,396,000			$	30,208,000

Bionano Genomics, Inc.
Consolidated Statements of Operations
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Revenue:
Product revenue	$	1,580,000			$	3,162,000			$	3,503,000			$	6,870,000
Service and other revenue	616,000				151,000				1,010,000				470,000
Total revenue	2,196,000				3,313,000				4,513,000				7,340,000
Cost of revenue:
Cost of product revenue	1,137,000				2,238,000				2,427,000				4,883,000
Cost of service and other revenue	324,000				137,000				493,000				194,000
Total cost of revenue	1,461,000				2,375,000				2,920,000				5,077,000
Operating expenses:
Research and development	2,304,000				2,174,000				7,379,000				6,682,000
Selling, general and administrative	8,659,000				4,449,000				21,640,000				14,295,000
Total operating expenses	10,963,000				6,623,000				29,019,000				20,977,000
Loss from operations	(10,228,000		)		(5,685,000		)		(27,426,000		)		(18,714,000		)
Other expenses:
Interest expense	(589,000		)		(578,000		)		(1,911,000		)		(1,613,000		)
Loss on debt extinguishment	—				—				—				(1,333,000		)
Other expenses	55,000				(131,000		)		—				(241,000		)
Total other expenses	(534,000		)		(709,000		)		(1,911,000		)		(3,187,000		)
Loss before income taxes	(10,762,000		)		(6,394,000		)		(29,337,000		)		(21,901,000		)
Provision for income taxes	(30,000		)		(4,000		)		(40,000		)		(13,000		)
Net loss	$	(10,792,000	)		$	(6,398,000	)		$	(29,377,000	)		$	(21,914,000	)

–  Nine Month Revenue Grew 84% to $3.8 Million During Covid-19 Economy; Exceeds Full Year 2019 Total Revenue of $2.8 Million

–  668 EV charging stations were sold, deployed, or acquired across 25 states

–  Acquired BlueLA Carsharing, Significantly Expanding Presence in California

Miami Beach, FL, Nov. 12, 2020 (GLOBE NEWSWIRE) — Blink Charging Co. (Nasdaq: BLNK, BLNKW) (“Blink” or the “Company”), a leading owner, operator, and provider of electric vehicle (EV) charging equipment and services, today announced financial results for the third quarter and nine months ended September 30, 2020. The Company reported strong quarterly earnings, notwithstanding business shutdowns during the third quarter due to the ongoing global pandemic.

Selected Highlights:

• Total revenue for the first nine months of 2020 grew 84% to $3.8 million, during Covid-19 economy; exceeds full year 2019 total revenue of $2.8 million
• Total revenue for Q3 increased by 18% to $0.9 million compared to Q3 2019 despite business interruptions due to the COVID-19 pandemic
• 668 EV charging stations were sold, deployed, or acquired across 25 states
• Product sales in Q3 2020 grew 74% to $0.6 million as compared to the prior year quarter, related primarily to increased demand for the Company’s commercial and residential products
• Company made significant progress with its owner/operator strategy; Blink owned chargers deployed during the quarter increased 87% compared to 3Q 2019
• Net loss was $3.9 million or $(0.12) per basic and diluted share in Q3 2020 compared to net loss of $2.6 million or $(0.10) in the third quarter of 2019
• During Q3 2020, the Company completed its acquisition of BlueLA Carsharing, the EV carsharing contractor for the city of Los Angeles
• From April 17, 2020 through September 30, 2020, the Company sold 3,521,971 shares of common stock for aggregate gross proceeds of $19 million
• Cash was $14.9 million on September 30, 2020

“The accelerating adoption of electric vehicles represents an enormous opportunity for EV infrastructure providers, and Blink in particular, as more and more drivers seek fast, convenient and reliable charging options. One of the key differentiators of our model is that we are the owner and operator of many of our chargers and realize an economic benefit each time a vehicle is charged at one of our owned units. We are confident that as EV adoption grows and utilization of chargers increases, we will see substantial economic returns from our owned chargers. As a leader in the EV charging space, we have been systematically expanding our footprint and growing our brand recognition by capturing premium locations and establishing strategic partnerships that promote the adoption of EV use. Importantly, these initiatives position Blink for continued growth as the EV revolution takes hold,” commented Michael D. Farkas, Founder and Chief Executive Officer of Blink.

“Our momentum continued during the third quarter of 2020 despite the ongoing pandemic, which included challenges with logistics, shipping delays, and a decrease in driving patterns impacting utilization. Our continued growth was demonstrated by increased revenue driven by significant increases in product sales. However, the quarter’s revenue was impacted by the timing of certain orders that we now expect to be completed in the fourth quarter of 2020. We sold, deployed, or acquired 668 EV charging stations across 25 states during the quarter. Eighty-nine of these deployments were upgrades as part of our aggressive initiative to replace first-generation equipment with our state-of-the-art IQ 200 chargers, 88 of which are Blink-owned. While upgrades are optional in our host-owned model, where we can control it, we want to ensure that our best equipment is made available to drivers.”

“In a key development during the quarter, we announced our acquisition of BlueLA Carsharing, the EV carsharing contractor serving the City of Los Angeles. With the acquisition, we doubled the number of Blink stations in Los Angeles, a city widely acknowledged as the epicenter for EV adoption. Not only does this acquisition position us to help drive the buildout of LA’s EV infrastructure, but the BlueLA carsharing program is also groundbreaking in its focus on making EV use attainable in low-income neighborhoods, and we look forward to advancing that mission. There is a significant market opportunity for this type of solution as urban centers throughout the U.S. transition to more sustainable transportation models. We believe LA can serve as our prototype for replicating EV carsharing and infrastructure programs in other cities.”

“We are energized by the fast-developing worldwide EV infrastructure market and by the opportunities we’re seeing for our portfolio of charging solutions. We continued to make solid progress during the third quarter, expanding and upgrading our network, developing innovative technology, and growing our customer base and partnerships. With our visibility today, we believe Blink is well positioned to grow our global position as a leading provider of charging stations as worldwide demand continues to increase for effective and convenient EV infrastructure.”

Business Updates and Highlights

During the third quarter of 2020, the Company:

• Acquired BlueLA Carsharing with 200 EV charging stations centrally located in downtown Los Angeles, CA
• Signed agreement with Cushman & Wakefield for marketing of Blink EV charging stations to that firm’s U.S. clients
• Announced interoperability agreement with SemaConnect, allowing customers of both companies to roam between charging networks without needing additional accounts or cards, establishing more accessible nationwide charging options
• Launched an upgrade program for existing host-owned Blink EV charging stations to transition from their first-generation equipment to Blink’s fast level 2 IQ 200 charging stations
• Announced a follow-on order from InterEnergy of 150 fast-charging stations, including its IQ 200 and DCFC units, for deployment in the Dominican Republic
• 668 EV charging stations were sold, deployed, or acquired across 25 states
• Joined with Sustainable Westchester in a partnership to promote EV charging infrastructure in the suburbs of New York

Subsequent to the close of the third quarter ended September 30, 2020, the Company:

• Announced the deployment of 14 IQ 200 charging stations in five locations in the city of Richmond, CA
• Announced an agreement with The Elysian residential building in downtown Los Angeles for the deployment of 44 level 2 EV charging stations in support of the building’s all-electric parking areas
• Entered into a strategic master development and production agreement with SG Blocks, a leading designer, innovator and fabricator of container-based structures, to bring solar, off-grid, modular EV charging solutions to market
• Installed six Level 2 IQ 200 EV charging stations at the Trail’s Bend and Cambium Apartments in Springfield, MO

Earnings Conference Call:

The Company will host a conference call and webcast to discuss the third quarter 2020 results today, November 12, 2020 at 4:30 P.M., Eastern Time.

To access the live webcast, log onto the Blink Charging website at www.blinkcharging.com, and click on the News/Events section of the Investor Relations page. Investors may also access the webcast via the following link: https://www.webcaster4.com/Webcast/Page/2468/38458.

To participate in the call by phone, dial (877) 876-9173 approximately five minutes prior to the scheduled start time. International callers please dial (785) 424-1667.

A replay of the teleconference will be available until December 12, 2020 and may be accessed by dialing (877) 481-4010. International callers may dial (919) 882-2331. Callers should use conference ID: 38458.

###

About Blink Charging

Blink Charging Co. (Nasdaq: BLNK, BLNKW) is a leader in electric vehicle (EV) charging equipment and has deployed over 23,000 charging stations, many of which are networked EV charging stations, enabling EV drivers to easily charge at any of the Company’s charging locations worldwide. Blink Charging’s principal line of products and services include its Blink EV charging network (“Blink Network”), EV charging equipment, and EV charging services. The Blink Network uses proprietary, cloud-based software that operates, maintains, and tracks the EV charging stations connected to the network and the associated charging data. With global EV purchases forecasted to rise to 10 million vehicles by 2025 from approximately 2 million in 2019, the Company has established key strategic partnerships for rolling out adoption across numerous location types, including parking facilities, multifamily residences and condos, workplace locations, health care/medical facilities, schools and universities, airports, auto dealers, hotels, mixed-use municipal locations, parks and recreation areas, religious institutions, restaurants, retailers, stadiums, supermarkets, and transportation hubs. For more information, please visit https://www.blinkcharging.com/.

 Forward-Looking Statements

This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, and terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” or other comparable terms, involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of Blink Charging and members of its management, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those described in Blink Charging’s periodic reports filed with the SEC, and that actual results may differ materially from those contemplated by such forward-looking statements. Except as required by federal securities law, Blink Charging undertakes no obligation to update or revise forward-looking statements to reflect changed conditions.

Blink Media Contact 


[email protected]

Blink Investor Relations Contact 


[email protected]


855-313-8187

IRVINE, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today reported financial results for its third quarter ended September 30, 2020.

Third
Quarter Highlights
:

• Record procedure volume in Q3, treated over 3,700 patients
• Reported revenue of $38.7 million in the third quarter of 2020, a 172% increase over the same quarter last year and 52% sequentially compared to Q2
• Presented the first 230 patients from our FLASH database as a late breaking clinical trial at TCT
• Ended the quarter with $168.0M in cash and equivalents

“In the third quarter we made significant progress in our mission to treat and transform the lives of patients with venous disease,” said Bill Hoffman, Chief Executive Officer of Inari Medical. “We presented ground-breaking FLASH data at TCT, expanded our Clot Warrior Academy training and education series, introduced meaningful new technology and aggressively expanded our commercial footprint. Most importantly, we treated a record number of patients. We are pleased that our team has responded so effectively to the challenges created by the pandemic, and we are grateful that our hospital customers and physicians have also adapted and established a constructive operating environment for patient treatments. In these uncertain times, we remain thankful for the opportunity and privilege to serve our patients.”

Third
Quarter 2020 Financial Results

Revenue was $38.7 million for the third quarter of 2020, compared to $25.4 million for the prior quarter and $14.2 million for the third quarter of 2019. The increase from last year was driven by continued US commercial expansion and increased product adoption.

Gross profit for the third quarter of 2020 was $35.5 million compared to $12.7 million for the third quarter of 2019. Gross margin increased slightly to 91.7% for the third quarter of 2020, compared with 89.4% in the same quarter last year.

Operating expenses were $28.3 million for the third quarter of 2020, compared with $11.8 million in the same quarter last year. The increase was driven primarily by personnel-related expenses to fund expansion of the commercial, research and development, clinical and support organizations, as well as expenses related to being a public company.

Net income was $6.5 million for the third quarter of 2020 and net income per share was $0.13 on a weighted-average basic share count of 48.3 million and $0.12 on a diluted share count of 55.4 million, compared to net income of $0.4 million and an income per share of $0.06 on a weighted-average basic share count of 6.0 million and $0.01 on a diluted share count of 43.9 million in the same period of the prior year.

Cash and cash equivalents were $168.0 million as of September 30, 2020, which reflects a $30.3 million payoff of our long-term debt during the third quarter of 2020.

Outlook and COVID-19

Due to uncertainty surrounding the COVID-19 pandemic, Inari Medical will not provide financial guidance for the remainder of 2020 at this time.  

Webcast and Conference Call Information

Inari Medical will host a conference call to discuss the third quarter financial results after market close on Thursday, November 12, 2020 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 519-1265 for U.S. callers or (914) 800-3838 for international callers, using conference ID: 6551049. The live webinar can be accessed at https://ir.inarimedical.com.

About Inari Medical, Inc.

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

Inari is focused on treating venous thromboembolism and improving the quality of life of patients suffering from this disease by safely and effectively removing blood clots. Inari has developed two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The ClotTriever system is 510(k)-cleared by the FDA for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by the FDA for the treatment of pulmonary embolism.

Forward Looking Statements

Statements in this press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements include assumptions about the impact of COVID-19, and are based on Inari’s current expectations, forecasts and assumptions, are subject to inherent uncertainties, risks and assumptions that are difficult to predict and actual outcomes and results could differ materially due to a number of factors. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Quarterly Report on Form 10-Q for the period ended September 30, 2020 and in its other reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are based on information available to Inari as of the date hereof and are made only as of the date of this release. Inari undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing Inari’s views as of any date subsequent to the date of this press release. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Inari.

Investor Contact:

Westwicke Partners
Caroline Corner
Phone +1-415-202-5678
[email protected]

INARI MEDICAL, INC.

Condensed Consolidated Statemen
ts of Operations and Comprehensive Income (Loss)

(in thousands, except share and per share data)

(unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Revenue		$	38,715			$	14,225			$	91,059			$	31,242
Cost of goods sold			3,228				1,510				9,420				3,772
Gross profit			35,487				12,715				81,639				27,470
Operating expenses
Research and development			5,217				1,722				11,863				4,511
Selling, general and administrative			23,080				10,100				58,353				23,328
Total operating expenses			28,297				11,822				70,216				27,839
Income (loss) from operations			7,190				893				11,423				(369	)
Other income (expense)
Interest income			208				19				409				66
Interest expense			(251	)			(226	)			(1,060	)			(682	)
Change in fair value of warrant liabilities			—				(320	)			(3,317	)			(562	)
Other expenses			(651	)			—				(651	)			—
Total other expenses			(694	)			(527	)			(4,619	)			(1,178	)
Net income (loss) and comprehensive income (loss)		$	6,496			$	366			$	6,804			$	(1,547	)
Net income (loss) per share
Basic		$	0.13			$	0.06			$	0.26			$	(0.27	)
Diluted		$	0.12			$	0.01			$	0.14			$	(0.27	)
Weighted average common shares used to compute net income (loss) per share,
Basic			48,335,443				5,962,665				26,423,681				5,773,263
Diluted			55,355,846				43,911,252				49,940,409				5,773,263

INARI MEDICAL, INC.

Condensed Consolidated Bal
ance Sheets

(in thousands, except share data)

(unaudited)

		September 30, 2020				December 31, 2019
Assets
Current assets
Cash and cash equivalents		$	167,988			$	23,639
Restricted cash			50				50
Accounts receivable, net			20,837				11,302
Inventories, net			7,195				3,953
Prepaid expenses and other current assets			3,391				464
Total current assets			199,461				39,408
Property and equipment, net			5,476				3,331
Restricted cash			338				338
Deposits and other assets			536				1,469
Total assets		$	205,811			$	44,546
Liabilities, Mezzanine Equity and Stockholders’ Equity (Deficit)
Current liabilities
Accounts payable		$	3,533			$	2,549
Payroll-related accruals			8,596				5,225
Accrued expenses and other current liabilities			2,198				1,096
Total current liabilities			14,327				8,870
Notes payable, net			—				19,481
Warrant liabilities			—				1,169
Total liabilities			14,327				29,520
Commitments and contingencies (Note 6)
Mezzanine equity
Redeemable convertible preferred stock, par value $0.001, no shares authorized, issued, and outstanding as of September 30, 2020; 32,225,227 shares authorized, 31,968,570 shares issued and outstanding as of December 31, 2019; aggregate liquidation preference of zero as of September 30, 2020 and $54,415 as of December 31, 2019			—				54,170
Stockholders’ equity (deficit)
Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of September 30, 2020; no shares authorized, issued, and outstanding as of December 31, 2019			—				—
Common stock, $0.001 par value, 300,000,000 and 49,019,607 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 48,658,271 and 6,720,767 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively			49				7
Additional paid in capital			225,843				2,061
Accumulated deficit			(34,408	)			(41,212	)
Total stockholders’ equity (deficit)			191,484				(39,144	)
Total liabilities, mezzanine equity and stockholders’ equity (deficit)		$	205,811			$	44,546