PLSE
$11.71
Pulse Biosciences CS
$.63
5.69%
Earnings Details
2nd Quarter June 2020
Monday, August 10, 2020 4:05:00 PM
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Summary

Pulse Biosciences CS (PLSE) Recent Earnings

Pulse Biosciences CS (PLSE) reported a 2nd Quarter June 2020 loss of $0.53 per share on revenue of $0.0 million. The consensus estimate was a loss of $0.50 per share.

Results
Reported Earnings
($0.53)
Earnings Whisper
-
Consensus Estimate
($0.50)
Reported Revenue
Revenue Estimate
Growth
Earnings Growth
Revenue Growth
Power Rating
Grade
Earnings Release

Pulse Biosciences Reports Second Quarter 2020 Financial Results

HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced financial results for the second quarter ended June 30, 2020.

Recent Highlights

  • Completed the CellFX® System GLP (good laboratory practice) preclinical study treatments to generate the data required for the planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for an initial FDA clearance with a general dermatologic indication. This puts the Company on track for a 510(k) submission in the next 60-90 days
  • Conducted a formal Pre-Submission meeting with the FDA to establish the design for the comparative study required for a subsequent 510(k) submission to expand the indication for use of the CellFX System to include a specific indication for Sebaceous Hyperplasia. The meeting resulted in a general agreement on the study design which allows the Company to move forward with an IDE submission and a potential study start in early Q4, as planned
  • Submitted the CellFX System technical file to its European notified body in pursuit of the CE mark, the regulatory approval that would authorize the Company to commercialize the CellFX System in the EU. Review is currently underway with expectations for receipt of a CE mark for the CellFX System in Q1 2021
  • Three clinical studies demonstrating favorable results from the investigational use of NPS technology in Nodular Basal Cell Carcinoma, Sebaceous Hyperplasia and Common Warts, respectively, were presented at the virtual American Society for Laser Medicine and Surgery (ASLMS) annual conference
  • Strengthened balance sheet with the successful completion of a substantially oversubscribed rights offering, incurring minimal offering costs compared to a traditional public offering, delivering greater net proceeds to the Company. The $30.0 million rights offering generated $29.5 million of net proceeds, not including additional potential gross proceeds of $4.5 million through the exercise of issued warrants
  • Expanded its Board of Directors with the appointment of Richard van den Broek, serving as a member of the audit and the compensation committees of the Board

“We had a very productive second quarter despite the challenging circumstances persisting as a result of the COVID-19 pandemic. We have remained diligent in our efforts to create the safest work environment possible for our employees and the community and I would like to thank our entire team for their continued efforts and dedication. At the same time, we are pleased that we continue to drive progress towards our top priority of achieving regulatory approvals for the CellFX System,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We believe our progress on the clinical and regulatory front combined with continued engagement from the scientific community has positioned us favorably for eventual commercialization in the US, Europe and Canada. Lastly, I would like to thank our shareholders for their participation in the rights offering. Proceeds from this offering will enable us to further progress our development, clinical and commercial objectives.”

Financial Update

Cash, cash equivalents and investments totaled $37.8 million as of June 30, 2020, compared to $15.9 million as of March 31, 2020. Excluding the net proceeds of the rights offering received in the three months ended June 30, cash used in the second quarter of 2020 totaled $7.9 million. This compares with $9.5 million used in the first quarter of 2020.

Operating expenses for the three months ended June 30, 2020 were $11.4 million, compared to $11.6 million for the prior year period. Second quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $2.7 million in the second quarter of 2019. The decrease in operating expenses was primarily driven by reduced research and development costs which were partially offset by increases in general and administrative costs in preparation for commercialization.

Operating expenses for the six months ended June 30, 2020 were $23.3 million, compared to $22.1 million for the prior year period. Stock-based compensation expense for the six months ended June 30, 2020 was $5.0 million, compared to $5.1 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure including marketing and sales functions.

Net loss for the three months ended June 30, 2020 was ($11.3) million compared to ($11.4) million for the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was ($23.2) million compared to ($21.4) million for the six months ended June 30, 2019.

Impact of COVID-19

Our operations in the second quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic. Product development and regulatory timelines have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, August 10, 2020 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-855-327-6837 for domestic callers or 1-631-891-4304 for international callers. A live and recorded webcast of the event will be available at http://investors.pulsebiosciences.com/.

About Pulse Biosciences

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX® System will be the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a broad range of dermatologic conditions that share high demand among patients and practitioners for improved and durable aesthetic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications. To learn more please visit www.pulsebiosciences.com.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance and the timing of FDA filings or approvals including meetings with FDA and the ability of the Company to successfully complete a 510(k) submission for the CellFX System, the ability of the Company to prepare and provide data to FDA and the notified body responsible for conducting CE mark review, the ability of the Company to obtain a CE mark for the CellFX System, NPS technology including the effectiveness of such technology and the effectiveness of related clinical studies in predicting outcomes resulting from the use of NPS technology, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, current and planned future clinical studies and the ability of the Company to execute such studies and results of any such studies, other matters related to its pipeline of product candidates, the Company’s market opportunity and commercialization plans, the Company’s ability to effectively use capital raised through the rights offering, future financial performance, the impact of COVID-19 and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

PULSE BIOSCIENCES, INC.

Condensed Consolidated Balance Sheets

(in thousands, except par value)

(Unaudited)

 

June 30,

December 31,

 

2020

 

 

2019

 

ASSETS

Current assets:

Cash and cash equivalents

$

37,765

 

 

$

6,899

 

Investments

 

 

 

 

18,499

 

Prepaid expenses and other current assets

 

907

 

 

 

1,005

 

Total current assets

 

38,672

 

 

 

26,403

 

 

 

 

Property and equipment, net

 

2,591

 

 

 

2,566

 

Intangible assets, net

 

4,214

 

 

 

4,547

 

Goodwill

 

2,791

 

 

 

2,791

 

Right-of-use assets

 

9,749

 

 

 

5,114

 

Other assets

 

365

 

 

 

494

 

Total assets

$

58,382

 

 

$

41,915

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

1,489

 

 

$

1,963

 

Accrued expenses

 

3,123

 

 

 

2,496

 

Lease liability, current

 

278

 

 

 

 

Total current liabilities

 

4,890

 

 

 

4,459

 

 

 

 

Lease liability, less current portion

 

11,164

 

 

 

6,719

 

Total liabilities

 

16,054

 

 

 

11,178

 

 

 

 

Stockholders’ equity:

 

 

 

Preferred stock, $0.001 par value; authorized – 50,000 shares; no shares issued and outstanding

 

 

 

 

 

Common stock, $0.001 par value: authorized – 500,000 shares; issued and outstanding – 25,149 shares and 20,825 shares at June 30, 2020 and December 31, 2019, respectively

 

25

 

 

 

21

 

Additional paid-in capital

 

188,197

 

 

 

153,401

 

Accumulated other comprehensive income

 

 

 

 

4

 

Accumulated deficit

 

(145,894

)

 

 

(122,689

)

Total stockholders’ equity

 

42,328

 

 

 

30,737

 

Total liabilities and stockholders’ equity

$

58,382

 

 

$

41,915

 

 

PULSE BIOSCIENCES, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except per share data)

(Unaudited)

 

Three-Month Periods Ended

Six-Month Periods Ended

June 30,

June 30,

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

General and administrative

 

5,317

 

 

 

5,146

 

 

 

10,920

 

 

 

9,547

 

Research and development

 

5,870

 

 

 

6,337

 

 

 

12,051

 

 

 

12,179

 

Amortization of intangible assets

 

167

 

 

 

166

 

 

 

333

 

 

 

333

 

Total operating expenses

 

11,354

 

 

 

11,649

 

 

 

23,304

 

 

 

22,059

 

Other income:

 

 

 

 

 

 

 

Interest income

 

21

 

 

 

290

 

 

 

99

 

 

 

622

 

Total other income

 

21

 

 

 

290

 

 

 

99

 

 

 

622

 

Net loss

 

(11,333

)

 

 

(11,359

)

 

 

(23,205

)

 

 

(21,437

)

Other comprehensive loss:

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

(17

)

 

 

20

 

 

 

(4

)

 

 

23

 

Comprehensive loss

$

(11,350

)

 

$

(11,339

)

 

$

(23,209

)

 

$

(21,414

)

Net loss per share:

 

 

 

 

 

 

 

Basic and diluted net loss per share

$

(0.53

)

 

$

(0.55

)

 

$

(1.10

)

 

$

(1.04

)

Weighted average shares used to compute net loss per common share — basic and diluted

 

21,528

 

 

 

20,728

 

 

 

21,183

 

 

 

20,704

 

 

 

 

 

 

 

 

 

 

 

 
 

Three-Month Periods Ended

Six-Month Periods Ended

June 30,

June 30,

Stock Based Compensation Expense:

 

2020

 

 

2019

 

 

2020

 

 

2019

 

General and administrative

$

1,515

 

 

$

1,660

 

 

$

3,264

 

 

$

3,145

 

Research and development

 

897

 

 

 

1,039

 

 

 

1,774

 

 

 

1,915

 

Total stock-based compensation expense

$

2,412

 

 

$

2,699

 

 

$

5,038

 

 

$

5,060

 

 

Investors:
Pulse Biosciences
Sandra Gardiner, EVP and CFO
510.241.1077
IR@pulsebiosciences.com
or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com

Media:
Tosk Communications
Nadine D. Tosk
504.453.8344
nadinepr@gmail.com or
press@pulsebiosciences.com

Source: Pulse Biosciences, Inc.