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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ra Medical Systems Inc | NYSE:RMED | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 8.82 | 0 | 01:00:00 |
Delaware
|
3841
|
38-3661826
|
||
(State or other jurisdiction of
incorporation or organization)
|
(Primary Standard Industrial
Classification Code Number)
|
(I.R.S. Employer
Identification Number)
|
Martin J. Waters
Robert L. Wernli, Jr.
Eric Y. Hsu
Wilson Sonsini Goodrich & Rosati, P.C.
12235 El Camino Real
San Diego, CA 92130
Tel: (858)
350-2300
Fax: (858)
350-2399
|
Megan N. Gates
Daniel Bagliebter
Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
One Financial Center
Boston, MA 02111
Tel: (617)
542-2241
Fax: (617)
542-2241
|
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||
Emerging growth company | ☒ |
|
||||
Title of Each Class of
Securities to be Registered
|
|
Proposed
Maximum
Aggregate
Offering Price(1)(2)
|
|
Amount of
Registration Fee
|
Units, each unit consisting of (i) one share of common stock, par value $0.0001 per share, and (ii) one warrant to purchase one share of common stock(3)
|
|
$13,800,000(4)
|
|
$1,279.26
|
Pre-funded
units, each
pre-funded
unit consisting of (i) one
pre-funded
warrant to purchase one share of common stock and (ii) one warrant to purchase one share of common stock(3)
|
|
$13,800,000(3)
|
|
$1,279.26
|
Shares of common stock included in the units
|
|
$— (5)
|
|
$—
|
Warrants included in the units and
pre-funded
units
|
|
$— (5)
|
|
$—
|
Pre-funded
warrants included in the
pre-funded
units
|
|
$— (5)
|
|
$—
|
Shares of common stock issuable upon exercise of the warrants included in the units and
pre-funded
units
|
|
$13,800,000
|
|
$1,279.26
|
Shares of common stock issuable upon exercise of the
pre-funded
warrants included in the
pre-funded
units
|
|
$—
|
|
$—
|
Total
|
|
$41,400,000
|
|
$3,837.78(6)
|
|
||||
|
(1)
|
Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended (the “Securities Act”).
|
(2)
|
Pursuant to Rule 416 under the Securities Act, the securities being registered hereunder include such indeterminate number of additional securities as may be issuable to prevent dilution resulting from stock splits, dividends or similar transactions.
|
(3)
|
The proposed maximum offering price of the units proposed to be sold in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any pre-funded units offered and sold in the offering, and as such the proposed aggregate maximum offering price of the units together with the pre-funded units (including the common stock issuable upon exercise of the pre-funded warrants), if any, is $13,800,000.
|
(4)
|
Includes additional units which may be issued upon the exercise of a
45-day
option granted to the underwriters to cover over-allotments, if any, up to 15% of the total number of units to be offered, which may be exercised for shares of common stock, warrants or both at the election of the underwriters.
|
(5)
|
No separate fee is required pursuant to Rule 457(g) under the Securities Act.
|
(6)
|
$1,390.50 of this amount was previously paid.
|
|
|
Per
Unit(1) |
|
|
Per Pre-Funded
Unit(2) |
|
|
Total
|
|
|||
Public offering price
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Underwriter discounts and commissions(3)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Proceeds, before expenses, to us
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
(1)
|
The public offering price and underwriting discount corresponds, in respect of the units, to (i) a public offering price per share of common stock of $ ($ net of the underwriting discount) and (ii) a public offering price per warrant of $ ($ net of the underwriting discount).
|
(2)
|
The public offering price and underwriting discount in respect of the
pre-funded
units corresponds to (i) a public offering price per
pre-funded
warrant to purchase one share of common stock of $ ($ net of the underwriting discount) and (ii) a public offering price per warrant of $ ($ net of the underwriting discount).
|
(3)
|
We have agreed to pay certain expenses of the underwriters in this offering. We refer you to “Underwriting” on page 135 for additional information regarding underwriting compensation.
|
|
|
Page
|
|
|
|
|
1
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11
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71
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72
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73
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74
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|
|
76
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|
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78
|
|
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|
|
90
|
|
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|
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113
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|
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127
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|
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|
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130
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|
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136
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|
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|
|
142
|
|
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|
|
146
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|
146
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|
|
146
|
|
• |
Extend our catheter’s shelf life. During 2020, we identified the factors limiting our catheter’s shelf life, including the introduction of unwanted elements in the catheter’s fluid core and the degradation of the coating on the inner diameter, and we are currently implementing multiple remediations to address these issues. Our internal real-time aging test data supports shelf life for our catheter of at least six months;
|
• |
Increase the robustness of our catheter via a braided overjacket, or a similar design, to make the catheter more kink-resistant when navigating tortuous anatomy. We expect to complete the engineering work for this catheter and subsequently submit to the FDA for clearance in the first quarter of 2022; and
|
• |
Develop a version of the DABRA catheter that is compatible with a standard guidewire. We selected a design in December 2021 based on physician evaluation in a preclinical model. We expect to finalize the design for this catheter by
mid-year
2022. Engineering validation and verification will follow design freeze and we will subsequently submit to the FDA for clearance.
|
Units offered by us
|
11,320,754 units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock, at an assumed public offering price of $1.06 per unit. |
Pre-funded
units offered by us
|
We are also offering to those purchasers, if any, whose purchase of units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock immediately following the consummation of this offering, the opportunity to purchase, if such purchasers so choose,
pre-funded
units (each
pre-funded
unit consisting of one
pre-funded
warrant to purchase one share of common stock and one warrant to purchase one share of common stock), in lieu of units that would otherwise result in any such purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock. The purchase price of each
pre-funded
unit will equal the public offering price at which units are being sold to the public in this offering, minus $0.0001. For each
pre-funded
unit we sell, the number of units we are offering will be decreased on a
one-for-one
|
Warrants offered by us
|
11,320,754 warrants to purchase an aggregate of 11,320,754 shares of common stock. Each unit and
pre-funded
unit includes one warrant to purchase one share of common stock. Each warrant will have an exercise price of $ per share, will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants.
|
Pre-funded
warrants offered by us
|
11,320,754
pre-funded
warrants to purchase an aggregate of 11,320,754 shares of common stock. Each
pre-funded
unit includes one
pre-funded
warrant to purchase one share of common stock. Each
pre-funded
warrant will have an exercise price of $0.0001 per share, will be immediately exercisable and may be exercised at any time for a period of 100 years following the date of issuance. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the
pre-funded
warrants.
|
Shares of common stock to be outstanding after this offering
|
18,326,121 shares of common stock (or 20,024,234 shares of common stock if the underwriters exercise their option in full) (assuming the sale of all units covered by this prospectus, no sale of
pre-funded
units, no exercise of any warrants or
pre-funded
warrants issued in this offering and no exercise of outstanding options issued under our equity incentive plans and based on 7,005,367 shares outstanding as of September 30, 2021).
|
Underwriters’ option to purchase additional shares and/or warrants
|
We have granted the underwriters an option, exercisable for forty-five (45) days after the date of this prospectus, to purchase up to an additional 1,698,113 shares of common stock and/or 1,698,113 warrants to purchase 1,698,113 shares of common stock at the public offering price, which may be purchased in any combination of common stock and/or warrants. |
Use of proceeds
|
We intend to use the net proceeds from this offering for general corporate purposes, including working capital, our atherectomy indication trial, and engineering efforts. We may use a portion of the net proceeds to acquire complementary products, technologies or businesses; however, we currently have no agreements or commitments to complete any such transactions and are not involved in negotiations to do so. We may also use a portion of the net proceeds to reserve against certain existing liabilities, debts, contractual liabilities as well as reserve for potential future claims. We may also be required to apply a portion of the net proceeds for litigation expenses and to settle private and government claims against us, including the payment of any government fines or penalties. For more information on these matters, see “
Risk Factors
,” “—Securities and Shareholder Litigation Update” and “—Government Investigations.”
|
Dividend policy
|
We have never declared or paid any cash dividends on our shares of common stock. We do not anticipate paying any cash dividends in the foreseeable future. |
Risk factors
|
You should carefully consider the risk factors described in the section of this prospectus titled “
Risk Factors
,” together with all of the other information included in this prospectus, before deciding to purchase our shares of common stock.
|
Market and trading symbol
|
Our shares of common stock are listed on the NYSE American under the symbol “RMED.” We do not intend to list the warrants or the
pre-funded
warrants on any securities exchange or nationally recognized trading system.
|
• |
304,631 shares of common stock reserved for issuance under our equity incentive plans, of which there were (i) outstanding options to purchase 126,998 shares of common stock at a weighted average exercise price of $348.41 per share, (ii) 45,832 shares of common stock underlying unvested restricted share units, or RSUs, and (iii) 131,801 shares of common stock available for future grant;
|
• |
2,419,280 shares of common stock reserved for issuance under outstanding warrants with a weighted average exercise price of $9.64 per share; and
|
• |
11,320,754 shares of common stock issuable upon exercise of the warrants included in this offering, at an exercise price of $ per share.
|
Year Ended
December 31,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2020
|
2019
|
2021
|
2020
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Statements of Operations Data:
|
||||||||||||||||
Net revenue
|
||||||||||||||||
Product sales
|
$ | 254 | $ | 1,255 | $ | 17 | $ | 254 | ||||||||
Service and other
|
5 | 18 | — | 5 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total net revenue
|
259 | 1,273 | 17 | 259 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cost of revenue
|
||||||||||||||||
Product sales
|
1,369 | 3,375 | 676 | 1,131 | ||||||||||||
Service and other
|
803 | 758 | 537 | 615 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cost of revenue
|
2,172 | 4,133 | 1,213 | 1,746 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross loss
|
(1,913 | ) | (2,860 | ) | (1,196 | ) | (1,487 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating expenses:
|
||||||||||||||||
Selling, general and administrative
|
24,533 | 45,302 | 11,285 | 18,154 | ||||||||||||
Research and development
|
8,955 | 4,445 | 8,521 | 5,534 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses
|
33,488 | 49,747 | 19,806 | 23,688 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating loss
|
(35,401 | ) | (52,607 | ) | (21,002 | ) | (25,175 | ) | ||||||||
Other income, net
|
88 | 967 | 2,028 | 97 | ||||||||||||
|
|
|
|
|
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|
|
|||||||||
Loss from continuing operations before income taxes
|
(35,313 | ) | (51,640 | ) | (18,974 | ) | (25,078 | ) | ||||||||
Income tax expense
|
7 | 15 | — | — | ||||||||||||
|
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|
|
|
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|
|||||||||
Loss from continuing operations
|
(35,320 | ) | (51,655 | ) | (18,974 | ) | (25,078 | ) | ||||||||
|
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|
|||||||||
(Loss) income from discontinued operations before income taxes
|
(725 | ) | (5,302 | ) | 2,191 | (523 | ) | |||||||||
Income tax expense
|
— | — | — | — | ||||||||||||
|
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|
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|
|||||||||
(Loss) income from discontinued operations
|
(725 | ) | (5,302 | ) | 2,191 | (523 | ) | |||||||||
|
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|
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|
|||||||||
Net loss
|
$ | (36,045 | ) | $ | (56,957 | ) | $ | (16,783 | ) | $ | (25,601 | ) | ||||
|
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|
|
|
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|
|
As of September 30, 2021
|
||||||||
Actual
|
As Adjusted(1)
|
|||||||
(in thousands)
|
||||||||
Balance Sheet Data:
|
||||||||
Cash and cash equivalents
|
$ | 20,616 | $ | 30,906 | ||||
Working capital(3)
|
19,323 | 29,613 | ||||||
Total assets
|
27,079 | 37,369 | ||||||
Total liabilities
|
5,530 | 5,530 | ||||||
Additional
paid-in
capital
|
191,527 | 201,816 | ||||||
Accumulated deficit
|
(169,985 | ) | (169,985 | ) | ||||
Total stockholders’ equity
|
21,549 | 31,839 |
(1) |
The as adjusted balance sheet data gives effect to the sale by us of (i) 11,320,754 units (each consisting of one share of common stock and one warrant to purchase one share of common stock) in this offering at an assumed public offering price of $1.06 per unit, which is the last reported sale price of our shares of common stock on the NYSE American on January 21, 2022, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and assuming no sale of any
pre-funded
units in this offering and no exercise of any warrants included in the units.
|
(2) |
We define working capital as current assets less current liabilities.
|
• |
We require additional capital to finance our operations, which may not be available to us on acceptable terms or at all.
|
• |
We have determined that there is substantial doubt about our ability to continue as a going concern, and we will need to undertake additional financings in order to execute our business plan and fund our operations. We may not be able to obtain such funding on a timely basis, or on commercially reasonable terms, or at all. Any capital-raising transaction we are able to complete may result in substantial dilution to our existing stockholders, require us to relinquish significant rights, or restrict our operations.
|
• |
We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
|
• |
We may be unable to successfully remedy the performance, shelf life and calibration issues associated with our DABRA catheters, achieve market acceptance of DABRA, or achieve revenue growth.
|
• |
Our success depends in large part on DABRA. If we are unable to successfully manufacture, market and sell DABRA, our business prospects will be significantly harmed.
|
• |
Our ability to successfully complete our atherectomy trial may continue to be hindered or delayed by the
COVID-19
pandemic and DABRA catheter performance limitations that are currently being addressed by various engineering efforts.
|
• |
We are required to devote significant resources to complying with the terms and conditions of our Settlement Agreement and Corporate Integrity Agreement (as described below) and, if we fail to comply, we could be subject to penalties or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.
|
• |
Physicians and staff may not commit enough time to sufficiently learn how to use our products.
|
• |
Regulatory compliance is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
|
• |
Our medical device operations are subject to pervasive and continuing FDA regulatory requirements.
|
• |
Product clearances and approvals can often be denied or significantly delayed.
|
• |
Although we have obtained regulatory clearance for our products in the U.S. and certain
non-U.S.
jurisdictions, they will remain subject to extensive regulatory scrutiny.
|
• |
If we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to
|
successfully commercialize our existing products and any products we may develop, and our technology may be adversely affected.
|
• |
If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and products would be adversely affected.
|
• |
Obtaining and maintaining our patent protection depends on compliance with various procedural measures, document submissions, fee payments and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for
non-compliance
with these requirements.
|
• |
We may not be able to protect our intellectual property and proprietary rights throughout the world.
|
• |
Changes in patent law in the U.S. could diminish the value of patents in general, thereby impairing our ability to protect our products.
|
• |
Issued patents covering our products could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.
|
• |
We depend on third-party suppliers for key components and
sub-assemblies
used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate components and
sub-assemblies
could harm our business.
|
• |
Our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms.
|
• |
We and our component suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations.
|
• |
We may form or seek strategic alliances or enter into licensing arrangements in the future, and we may not realize the benefits or costs of such alliances or licensing arrangements.
|
• |
The price of our stock may be volatile, which could result in substantial losses for investors. Further, an active, liquid and orderly trading market for our common stock may not be sustained and we do not know what the market price of our common stock will be, and as a result it may be difficult for you to sell your shares of our common stock.
|
• |
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
|
• |
If we fail to comply with the continued listing standards of the NYSE American, our common stock could be delisted. If it is delisted, the market value and the liquidity of our common stock would be impacted.
|
• |
Our management will have broad discretion as to the use of the proceeds from this offering and may not use the proceeds for all the purposes contemplated at the time of the offering.
|
• |
There is no public market for the warrants or
pre-funded
warrants being offered in this offering.
|
• |
whether we are able to successfully and timely remedy the inconsistencies in our DABRA catheter performance, including extended shelf life and reduced
non-calibrations;
|
• |
whether we are able to further enhance our DABRA catheter performance with an improved design to reduce kinking and develop a guidewire-compatible version of our DABRA catheter designed to allow physicians to navigate the vasculature more easily;
|
• |
our ability to develop a larger diameter catheter to facilitate treatment of larger vessels more commonly seen in
above-the-knee
|
• |
the timing of enrollment in our clinical trial for an atherectomy indication for use;
|
• |
our ability to achieve sufficient market acceptance, the ability for our customers to get coverage and adequate reimbursement from third-party payors and our ability to achieve acceptable market share for DABRA;
|
• |
the cost to establish, maintain, expand, and defend the scope of our intellectual property portfolio, as well as any other action required in connection with licensing, preparing, filing, prosecuting, defending, and enforcing any patents or other intellectual property rights;
|
• |
the emergence of competing technologies and other adverse market developments;
|
• |
the costs associated with manufacturing, selling, and marketing DABRA for its cleared or approved indications or any other indications for use for which we receive regulatory clearance or approval, including the cost and timing of expanding our manufacturing capabilities, as well as establishing our sales and marketing capabilities;
|
• |
our ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;
|
• |
the timing, receipt, and amount of license fees and sales of, or royalties on, our future products or future improvements on our existing products, if any; and
|
• |
the time and cost necessary to complete post-marketing studies that could be required by regulatory authorities or other studies required to obtain clearance for additional indications.
|
• |
our ability to timely remedy the current inconsistencies in our DABRA catheter performance, including extended shelf life and reduce
non-calibrations,
reduced kinking, and identify future issues;
|
• |
our ability to further enhance our DABRA catheter performance with an improved design to make the catheter more kink-resistant when navigating tortuous anatomy;
|
• |
our ability to develop a guidewire-compatible version of our DABRA catheter designed to allow physicians to navigate the vasculature more easily;
|
• |
our ability to develop a larger diameter catheter to facilitate treatment of larger vessels more commonly seen in
above-the-knee
|
• |
our ability to upgrade the DABRA laser’s functionality and user interface, and maintain necessary regulatory clearances;
|
• |
our ability to continue commercializing DABRA for its cleared indications for use with a smaller sales force;
|
• |
our ability to complete our atherectomy trial in a timely manner or at all, which may be affected by reductions in voluntary medical procedures during the ongoing
COVID-19
pandemic as well as by limitations in our DABRA catheter performance, as described above;
|
• |
our ability to receive FDA clearance for an atherectomy indication for use;
|
• |
our ability to successfully complete the voluntary recall of our DABRA catheters and subsequently achieve market acceptance following the change in our labeling from a
12-month
to
two-month
shelf life;
|
• |
our ability to improve and extend the shelf life of our DABRA catheters and obtain FDA clearance for the extended shelf life;
|
• |
any agreements or punitive actions that arise out of any adverse judgment or settlement of the active and ongoing investigation by governmental agencies;
|
• |
our ability to receive regulatory clearance or approval for, and timely introduce, enhancements to the DABRA catheter design;
|
• |
the effectiveness of our and our distributors’ marketing and sales efforts in the U.S. and abroad, including our efforts to build out and properly train our sales team;
|
• |
our ability to attract, motivate, train and retain experienced and qualified sales personnel;
|
• |
the availability, perceived advantages, relative cost, relative safety, and relative efficacy of alternative and competing treatments, including the time and expertise needed for training to effectively use the DABRA system as compared to competing treatments;
|
• |
our ability to properly support DABRA usage with our own qualified personnel or our ability to properly train and support our customers to use the DABRA system effectively on their own;
|
• |
the availability of coverage and adequate levels of reimbursement under private and governmental health insurance plans for DABRA-based procedures;
|
• |
our ability to obtain, maintain, and enforce our intellectual property rights in and to DABRA;
|
• |
our ability to achieve and maintain compliance with regulatory requirements applicable to DABRA;
|
• |
our ability to continue to develop, validate and maintain a commercially viable manufacturing process that is compliant with current Good Manufacturing Practices, or cGMP; and
|
• |
whether we are required by the FDA or comparable
non-U.S.
regulatory authorities to conduct additional clinical trials for future or current indications.
|
• |
whether we are able to successfully and timely remedy the inconsistencies in our DABRA catheter performance, including extending shelf life and reducing
non-calibrations;
|
• |
whether physicians, catheterization laboratory owners and operators, patients, and others in the medical community consider our products to be safe, effective, and cost-effective treatment methods;
|
• |
our ability to improve and extend the shelf life of our DABRA catheters and obtain FDA clearance for the extended shelf life;
|
• |
our ability to further enhance our DABRA catheter performance with an improved design to reduce kinking when navigating tortuous anatomy;
|
• |
our ability to develop a guidewire-compatible version of our DABRA catheter designed to allow physicians to navigate the vasculature more easily;
|
• |
our ability to upgrade the DABRA laser’s functionality and user interface, and maintain necessary regulatory clearances;
|
• |
whether we are able to receive FDA clearance for an atherectomy indication for use;
|
• |
the potential and perceived advantages of our products over alternative treatment methods;
|
• |
the convenience, amount of training required, and ease of use of DABRA relative to alternative treatment methods;
|
• |
matters arising out of our completed Audit Committee investigation, securities class action and derivative lawsuit, including the impact of any settlement or adverse judgment;
|
• |
the prevalence and severity of any side effects associated with using our products;
|
• |
product labeling or product insert requirements of the FDA or other regulatory authorities;
|
• |
limitations or warnings contained in the labeling cleared or approved by the FDA or other authorities;
|
• |
the cost of treatment in relation to alternative treatments methods;
|
• |
pricing pressure, including from group purchasing organizations, or GPOs, seeking to obtain discounts on DABRA based on the collective buying power of the GPO members;
|
• |
the availability of adequate coverage, reimbursement and pricing by third-party payors, including government authorities;
|
• |
the willingness of patients to pay
out-of-pocket
|
• |
our ability to provide incremental clinical and economic data that shows the safety and clinical efficacy and cost effectiveness of, and patient benefits from, our products; and
|
• |
the effectiveness of our sales and marketing efforts for DABRA.
|
• |
decreased demand for our products;
|
• |
harm to our reputation;
|
• |
initiation of investigations by regulators;
|
• |
costs to defend the related litigation;
|
• |
diversion of management’s time and our resources;
|
• |
monetary awards to trial participants or patients;
|
• |
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
• |
loss of revenue;
|
• |
exhaustion of any available insurance and our capital resources;
|
• |
inability to market and sell our products; and
|
• |
a resulting decline in the price of our common stock.
|
• |
atherectomy, using mechanical and laser ablation methods to remove vascular blockages;
|
• |
balloon angioplasty and stents;
|
• |
specialty balloon angioplasty, such as scoring balloons, pillowing balloons, cutting balloons and drug-coated balloons; and
|
• |
amputation.
|
• |
differing regulatory requirements in foreign countries;
|
• |
differing reimbursement regimes in foreign countries, including price controls and lower payment;
|
• |
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
|
• |
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
• |
foreign taxes, including withholding of payroll taxes;
|
• |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
• |
difficulties staffing and managing foreign operations;
|
• |
workforce uncertainty in countries where labor unrest is more common than in the U.S.;
|
• |
potential liability under the FCPA or comparable foreign regulations;
|
• |
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.;
|
• |
product shortages resulting from any events affecting raw material or finished good supply or distribution or manufacturing capabilities abroad;
|
• |
the impact of the current situation relating to trade with China and tariffs and other trade barriers that may be implemented by governmental authorities;
|
• |
the impact of public health epidemics on the global economy, such as the new coronavirus currently impacting the U.S., Europe, China and elsewhere; and
|
• |
business interruptions resulting from
geo-political
actions, including war and terrorism.
|
• |
identifying, recruiting, integrating, maintaining, and motivating additional employees, including additional members of our sales force;
|
• |
managing our internal development efforts effectively, while complying with our contractual obligations to contractors and other third parties; and
|
• |
improving our operational, financial and management controls, reporting systems and procedures.
|
• |
product design, development, manufacture (including suppliers) and testing;
|
• |
pre-clinical
and clinical studies;
|
• |
product safety and effectiveness;
|
• |
product labeling;
|
• |
product storage and shipping;
|
• |
record keeping;
|
• |
pre-market
clearance or approval;
|
• |
marketing, advertising and promotion;
|
• |
product sales and distribution;
|
• |
product changes;
|
• |
product recalls; and
|
• |
post-market surveillance and reporting of deaths or serious injuries and certain malfunctions.
|
• |
registration with the FDA; listing commercially distributed products with the FDA;
|
• |
complying with applicable cGMPs under the Quality System Regulations, or QSR;
|
• |
filing reports with the FDA of and keeping records relative to certain types of adverse events associated with devices under the medical device reporting regulation;
|
• |
assuring that device labeling complies with device labeling requirements;
|
• |
reporting recalls and certain device field removals and corrections to the FDA; and
|
• |
obtaining premarket notification 510(k) clearance for devices prior to marketing.
|
• |
subject our manufacturing facility to an adverse inspectional finding or Form 483, or other compliance or enforcement notice, communication, or correspondence;
|
• |
issue warning or untitled letters that would result in adverse publicity or may require corrective advertising;
|
• |
impose civil or criminal penalties;
|
• |
suspend or withdraw regulatory clearances or approvals;
|
• |
refuse to clear or approve pending applications or supplements to approved applications submitted by us;
|
• |
impose restrictions on our operations, including closing our
sub-assembly
suppliers’ facilities;
|
• |
seize or detain products; or
|
• |
require a product recall.
|
• |
the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act;
|
• |
federal false claims laws, including the federal False Claims Act, imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. Persons and entities can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product
off-label;
|
• |
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, established new statutes imposing criminal healthcare fraud liability and increased civil monetary penalties for, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. A person or entity does not need to have actual knowledge of the healthcare fraud statutes HIPAA established or specific intent to violate them in order to have a liability;
|
• |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health, or HITECH, Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities subject to the rule, such as health plans, healthcare
|
clearinghouses and certain healthcare providers, as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information with respect to safeguarding the privacy, security and transmission of individually identifiable health information. We believe we are not a covered entity for purposes of HIPAA, and we believe that we generally do not conduct our business in a manner that would cause us to be a business associate under HIPAA;
|
• |
the U.S. Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members. Effective January 2022, for data reported to CMS in 2022 and collected in 2021, the reporting obligations with respect to covered recipients have been expanded to include payments or transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives; and
|
• |
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by
non-governmental
third-party payors, including private insurers.
|
• |
cease selling or using any of our products that incorporate the asserted intellectual property, which would adversely affect our revenue;
|
• |
pay substantial damages for past use of the asserted intellectual property;
|
• |
obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all, and which could reduce profitability; and
|
• |
redesign or rename, in the case of trademark claims, our products to avoid violating or infringing the intellectual property rights of third parties, which may not be possible and could be costly and time-consuming if it is possible to do so.
|
• |
others may be able to make products that are similar to our products or utilize similar technology but that are not covered by the claims of the patents that we may own or that incorporate certain technology in our products that is in the public domain;
|
• |
we, or our future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we own now or in the future;
|
• |
we, or our future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
|
• |
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
|
• |
it is possible that our current or future pending patent applications will not lead to issued patents;
|
• |
issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties;
|
• |
our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
|
• |
we may not develop additional proprietary technologies that are patentable;
|
• |
the patents of others may harm our business; and
|
• |
we may choose not to file a patent in order to maintain certain trade secrets or
know-how,
and a third party may subsequently file a patent covering such intellectual property.
|
• |
increased expenses from remedying the performance issues of our catheters;
|
• |
our failure to increase the sales of our products and remedy the performance issues associated with our DABRA catheters;
|
• |
the failure by our customers to obtain adequate reimbursements or reimbursement levels that would be sufficient to support product sales to our customers and pricing of our products to support revenue projections;
|
• |
unanticipated serious safety concerns related to the use of our products;
|
• |
changes in our organization;
|
• |
introduction of new products or services offered by us or our competitors;
|
• |
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
• |
our ability to effectively manage our future growth;
|
• |
the size and growth of our target markets;
|
• |
actual or anticipated variations in quarterly operating results;
|
• |
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
• |
significant lawsuits, including stockholder litigation, government actions or litigation related to intellectual property;
|
• |
our cash position;
|
• |
our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;
|
• |
publication of research reports about us or our industry, or positive or negative recommendations or withdrawal of research coverage by securities analysts;
|
• |
any delay in any regulatory filings for our future products and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such products;
|
• |
adverse regulatory decisions, including failure to receive regulatory approval of our future products, failure to maintain regulatory approval for our existing products or failure to obtain regulatory approval for additional indications for our existing products;
|
• |
changes in laws or regulations applicable to our products;
|
• |
adverse developments concerning our suppliers or distributors;
|
• |
our inability to obtain adequate supplies and components for our products or inability to do so at acceptable prices;
|
• |
our inability to establish and maintain collaborations if needed;
|
• |
changes in the market valuations of similar companies;
|
• |
overall performance of the equity markets;
|
• |
sales of large blocks of our common stock including sales by our executive officers and directors;
|
• |
trading volume of our common stock;
|
• |
limited “public float” in the hands of a small number of persons whose sales or lack of sales of our common stock could result in positive or negative pricing pressure on the market price for our common stock;
|
• |
additions or departures of key scientific or management personnel;
|
• |
changes in accounting practices;
|
• |
ineffectiveness of our internal controls;
|
• |
general political and economic conditions; and
|
• |
other events or factors, many of which are beyond our control.
|
• |
increased expenses from remedying the performance of our catheters;
|
• |
the timing and cost of, and level of investment in, research and development activities relating to our current and any future products, which will change from time to time;
|
• |
the cost of manufacturing our current and any future products, which may vary depending on FDA guidelines and requirements, the quantity of production and the terms of our agreements with suppliers;
|
• |
the degree and rate of market acceptance for DABRA, including the ability of our customers to receive adequate reimbursement for procedures performed using our products;
|
• |
expenditures that we will or may incur to acquire or develop additional products and technologies;
|
• |
competition from existing and potential future products that compete with our products, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;
|
• |
the level of demand for our current and future products, if approved, which may fluctuate significantly and be difficult to predict;
|
• |
the risk/benefit profile, cost and reimbursement policies with respect to our products, and existing and potential future products that compete with our products;
|
• |
our ability to commercialize additional products, if approved, inside and outside of the U.S., either independently or working with third parties;
|
• |
our ability to establish and maintain collaborations, licensing, or other arrangements;
|
• |
our ability to adequately support future growth;
|
• |
potential unforeseen business disruptions that increase our costs or expenses;
|
• |
changes in FDA regulations and comparable foreign regulations;
|
• |
future accounting pronouncements or changes in our accounting policies; and
|
• |
the changing and volatile global economic environment.
|
• |
our board of directors is divided into three classes serving staggered three-year terms, such that not all members of the board is elected at one time, which could delay the ability of stockholders to change the membership of a majority of our board of directors;
|
• |
the ability of our board of directors to issue shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer;
|
• |
the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of our board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
|
• |
a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at an annual or special meeting of our stockholders;
|
• |
a requirement that special meetings of stockholders be called only by the chairperson of the board of directors, the chief executive officer or president (in the absence of a chief executive officer) or a majority vote of our board of directors, which could delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;
|
• |
the requirement for the affirmative vote of holders of at least 66 2/3% of the voting power of all of the then outstanding shares of the voting stock, voting together as a single class, to amend the provisions of our certificate of incorporation relating to the issuance of preferred stock and management of our business or our bylaws, which may inhibit the ability of an acquirer to affect such amendments to facilitate an unsolicited takeover attempt;
|
• |
the ability of our board of directors, by majority vote, to amend our bylaws, which may allow our board of directors to take additional actions to prevent an unsolicited takeover and inhibit the ability of an acquirer to amend our bylaws to facilitate an unsolicited takeover attempt; and
|
• |
advance notice procedures with which stockholders must comply to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
|
• |
on an actual basis; and
|
• |
on an as adjusted basis, giving effect to the sale by us of 11,320,754 units (each unit consisting of one share of common stock and one warrant to purchase one share of common stock) in this offering at an assumed public offering price of $1.06 per unit, which is the last reported sale price of our shares of common stock on the NYSE American on January 21, 2022, after deducting the estimated underwriting discounts and commissions and estimated offering expenses, and assuming no sale of any
pre-funded
units in this offering and no exercise of any warrants included in the units.
|
As of September 30, 2021
|
||||||||
Actual
|
As
Adjusted(1)
|
|||||||
(in thousands, except share data)
|
||||||||
Cash and cash equivalents
|
$ | 20,616 | $ | 30,906 | ||||
|
|
|
|
|||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; none issued
|
$ | — | $ | — | ||||
Common stock, $0.0001 par value, 300,000,000 shares authorized; 7,005,367 issued and outstanding, actual; 18,326,121 shares issued and outstanding, as adjusted
|
7 | 8 | ||||||
Additional
paid-in
capital
|
191,527 | 201,816 | ||||||
Accumulated deficit
|
(169,985 | ) | (169,985 | ) | ||||
|
|
|
|
|||||
Total stockholders’ equity
|
21,549 | 31,839 | ||||||
|
|
|
|
|||||
Total capitalization
|
$ | 21,549 | $ | 31,839 | ||||
|
|
|
|
(1) |
A $0.10 increase or decrease in the assumed public offering price of $1.06 per unit, which is the last reported sale price of our shares of common stock on the NYSE American on January 21, 2022, would increase or decrease, as appropriate, our as adjusted cash and cash equivalents, additional
paid-in
capital, total assets, total stockholders’ equity and total capitalization by approximately $1.0 million, assuming the number of units offered by us as set forth on the cover page of this prospectus remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.
|
• |
304,631 shares of common stock reserved for issuance under our equity incentive plans, of which there were (i) outstanding options to purchase 126,998 shares of common stock at a weighted average exercise price of $348.41 per share, (ii) 45,832 shares of common stock underlying unvested restricted share units, or RSUs, and (iii) 131,801 shares of common stock available for future grant;
|
• |
2,419,280 shares of common stock reserved for issuance under outstanding warrants with a weighted average exercise price of $9.64 per share; and
|
• |
11,320,754 shares of common stock issuable upon exercise of the warrants included in this offering, at an exercise price of $ per share.
|
Assumed public offering price per share
|
$ | 1.06 | ||
Net tangible book value per share at September 30, 2021
|
$ | 3.10 | ||
Decrease to net tangible book value per share attributable to investors purchasing our common stock in this offering
|
$ | (1.35 | ) | |
As Adjusted net tangible book value per share as of September 30, 2021, after giving effect to this offering
|
$ | 1.75 | ||
Accretion per share to investors purchasing our common stock in this offering
|
$ | (0.69 | ) |
• |
304,631 shares of common stock reserved for issuance under our equity incentive plans, of which there were (i) outstanding options to purchase 126,998 shares of common stock at a weighted average exercise price of $348.41 per share, (ii) 45,832 shares of common stock underlying unvested restricted share units, or RSUs, and (iii) 131,801 shares of common stock available for future grant;
|
• |
2,419,280 shares of common stock reserved for issuance under outstanding warrants with a weighted average exercise price of $9.64 per share; and
|
• |
11,320,754 shares of common stock issuable upon exercise of the warrants included in this offering, at an exercise price of $ per share.
|
• |
Extend our catheter’s shelf life. During 2020, we identified the factors limiting our shelf life, including the introduction of unwanted elements in the catheter’s fluid core and the degradation of the coating on the inner diameter, and we are currently implementing multiple remediations to address these issues. Our internal real-time aging test data supports shelf life for our catheter of at least six months;
|
• |
Increase the robustness of our catheter via a braided overjacket, or a similar design, to make the catheter more kink-resistant when navigating tortuous anatomy. We expect to complete the engineering work for this catheter and subsequently submit to the FDA for clearance in the first quarter of 2022; and
|
• |
Develop a version of the DABRA catheter that is compatible with a standard guidewire. We selected a design in December 2021 based on physician evaluation in a preclinical model. We expect to finalize the design for this catheter by
mid-year
2022. Engineering validation and verification will follow design freeze and we will subsequently submit to the FDA for clearance.
|
• |
certain employee-related expenses, including salaries, benefits, travel expense and stock-based compensation expense;
|
• |
cost of clinical studies to support new products and product enhancements, including expanded indications;
|
• |
supplies used for internal R&D and clinical activities; and
|
• |
cost of outside consultants who assist with technology development and clinical affairs.
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||||||||||
2021
|
2020
|
Change
|
2021
|
2020
|
Change
|
|||||||||||||||||||
Net revenue
|
$ | 5 | $ | 68 | $ | (63 | ) | $ | 17 | $ | 259 | $ | (242 | ) | ||||||||||
Cost of revenue
|
246 | 568 | (322 | ) | 1,213 | 1,746 | (533 | ) | ||||||||||||||||
Research and development expenses
|
2,942 | 2,312 | 630 | 8,521 | 5,534 | 2,987 | ||||||||||||||||||
Selling, general and administrative expenses
|
4,211 | 4,695 | (484 | ) | 11,285 | 18,154 | (6,869 | ) | ||||||||||||||||
Other income (expense), net
|
16 | (8 | ) | 24 | 2,028 | 97 | 1,931 |
Years Ended December 31,
|
||||||||||||
2020
|
2019
|
Change $
|
||||||||||
Statements of operations data:
|
||||||||||||
Net revenue
|
||||||||||||
Product sales
|
$ | 254 | $ | 1,255 | $ | (1,001 | ) | |||||
Service and other
|
5 | 18 | (13 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total net revenue
|
259 | 1,273 | (1,014 | ) | ||||||||
|
|
|
|
|
|
|||||||
Cost of revenue
|
||||||||||||
Product sales
|
1,369 | 3,375 | (2,006 | ) | ||||||||
Service and other
|
803 | 758 | 45 | |||||||||
|
|
|
|
|
|
|||||||
Total cost of revenue
|
2,172 | 4,133 | (1,961 | ) | ||||||||
|
|
|
|
|
|
|||||||
Gross loss
|
(1,913 | ) | (2,860 | ) | 947 | |||||||
|
|
|
|
|
|
|||||||
Operating expenses:
|
||||||||||||
Selling, general and administrative
|
24,533 | 45,302 | (20,769 | ) | ||||||||
Research and development
|
8,955 | 4,445 | 4,510 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses
|
33,488 | 49,747 | (16,259 | ) | ||||||||
|
|
|
|
|
|
|||||||
Operating loss
|
(35,401 | ) | (52,607 | ) | 17,206 | |||||||
Other income, net
|
88 | 967 | (879 | ) | ||||||||
|
|
|
|
|
|
|||||||
Loss before income taxes
|
(35,313 | ) | (51,640 | ) | 16,327 | |||||||
Income tax expense
|
7 | 15 | (8 | ) | ||||||||
|
|
|
|
|
|
|||||||
Net loss from continuing operations
|
$ | (35,320 | ) | $ | (51,655 | ) | $ | 16,335 | ||||
|
|
|
|
|
|
• |
EBITDA excludes certain recurring,
non-cash
charges, such as depreciation and amortization of long-lived assets, although these
non-cash
charges are for assets that may have to be replaced in the future; and
|
• |
Adjusted EBITDA further excludes stock-based compensation expense which has been, and will continue to be for the foreseeable future, a significant recurring expense in our business and an important part of our compensation strategy.
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Loss from continuing operations
|
$ | (7,378 | ) | $ | (7,515 | ) | $ | (18,974 | ) | $ | (25,078 | ) | ||||
Depreciation and amortization
|
319 | 528 | 974 | 1,530 | ||||||||||||
Interest income
|
— | (4 | ) | (2 | ) | (128 | ) | |||||||||
Interest expense
|
— | 12 | 12 | 31 | ||||||||||||
Income tax expense
|
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
EBITDA
|
(7,059 | ) | (6,979 | ) | (17,990 | ) | (23,645 | ) | ||||||||
Stock-based compensation
|
110 | 919 | 1,887 | 2,867 | ||||||||||||
Gain on extinguishment of PPP promissory note
|
— | — | (2,023 | ) | — | |||||||||||
Loss (gain) on sales and disposals of property and equipment
|
4 | — | (489 | ) | — | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Adjusted EBITDA
|
$ | (6,945 | ) | $ | (6,060 | ) | $ | (18,615 | ) | $ | (20,778 | ) | ||||
|
|
|
|
|
|
|
|
Year Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
(in thousands)
|
||||||||
Loss from continuing operations
|
$ | (35,320 | ) | $ | (51,655 | ) | ||
Depreciation and amortization
|
1,947 | 1,342 | ||||||
Interest income
|
(129 | ) | (1,038 | ) | ||||
Interest expense
|
41 | 72 | ||||||
Income tax expense
|
7 | 15 | ||||||
|
|
|
|
|||||
EBITDA
|
(33,454 | ) | (51,264 | ) | ||||
Stock-based compensation
|
3,856 | 18,674 | ||||||
|
|
|
|
|||||
Adjusted EBITDA
|
$ | (29,598 | ) | $ | (32,590 | ) | ||
|
|
|
|
• |
our ability to complete our atherectomy trial in a timely manner or at all, which may be affected by reductions in voluntary medical procedures during the ongoing
COVID-19
pandemic as well as by limitations in our DABRA catheter performance, as described above;
|
• |
the amount and timing of revenue generated by sales of our DABRA products and other products that get approved in the U.S. and
select non-U.S. markets,
as well as the amount of sales personnel required to generate the revenue;
|
• |
our ability to remedy the inconsistencies in our DABRA catheter performance; including extending shelf life and reducing
non-calibrations,
reducing kinking, and identifying other future issues, if any;
|
• |
our ability to develop a guidewire-compatible version of our DABRA catheter designed to allow physicians to navigate the vasculature more easily;
|
• |
our ability to develop a larger diameter catheter to facilitate treatment of larger vessels more commonly seen in
above-the-knee
|
• |
following our voluntary product recall, our ability to achieve market acceptance of DABRA;
|
• |
matters arising out of our completed Audit Committee investigation;
|
• |
the cost, timing and outcomes of any litigation involving our company, products, and business activities, including securities class actions and derivative lawsuits, and government investigation in which we are involved;
|
• |
the extent to which our products are adopted by the physician community;
|
• |
the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using DABRA;
|
• |
the degree of success we experience in commercializing DABRA;
|
• |
the costs, timing and outcomes of any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our products;
|
• |
the costs and timing of developing variations of DABRA and, if necessary, obtaining FDA clearance to market such variations;
|
• |
the emergence of competing or complementary technologies;
|
• |
the number and types of future products we develop and commercialize;
|
• |
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and
|
• |
the level of our selling, general and administrative expenses.
|
Nine Months Ended
September 30, |
||||||||
2021
|
2020
|
|||||||
Net cash used in operating activities
|
$ | (21,914 | ) | $ | (18,890 | ) | ||
Net cash provided by investing activities
|
3,803 | 15,928 | ||||||
Net cash provided by financing activities
|
14,821 | 22,024 |
Years Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Net cash used in operating activities
|
$ | (28,304 | ) | $ | (33,173 | ) | ||
Net cash provided by (used in) investing activities
|
15,933 | (16,032 | ) | |||||
Net cash provided by (used in) financing activities
|
21,693 | (526 | ) |
Payments due by period
|
||||||||||||||||||||
Total
|
Less than
1 Year |
1-3
Years |
3-5
Years |
More than
5 Years |
||||||||||||||||
Operating lease obligations(1)
|
$ | 3,323 | $ | 528 | $ | 877 | $ | 931 | $ | 987 | ||||||||||
Promissory note(2)
|
2,000 | 421 | 1,579 | — | — | |||||||||||||||
Equipment financing(3)
|
265 | 265 | — | — | — | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total
|
$ | 5,588 | $ | 1,214 | $ | 2,456 | $ | 931 | $ | 987 | ||||||||||
|
|
|
|
|
|
|
|
|
|
(1) |
Consists of obligations under multi-year,
non-cancelable
building leases for our facilities in Carlsbad, California.
|
(2) |
Consists of the Paycheck Protection Program Promissory Note, which we intend to apply for forgiveness under the provisions of the Coronavirus Aid, Relief, and Economic Security Act.
|
(3) |
Consists primarily of obligations under the equipment financing for automobiles.
|
• |
Extend our catheter’s shelf life. During 2020, we identified the factors limiting our shelf life, including the introduction of unwanted elements in the catheter’s fluid core and the degradation of the coating on the inner diameter, and we are currently implementing multiple remediations to address these issues. Our internal real time aging test data supports shelf life for our catheter of at least six months;
|
• |
Increase the robustness of our catheter via a braided overjacket, or a similar design, to make the catheter more kink-resistant when navigating tortuous anatomy. We expect to complete the engineering work for this catheter and subsequently submit to the FDA for clearance in the first quarter of 2022; and
|
• |
Develop a version of the DABRA catheter that is compatible with a standard guidewire. We selected a design in December 2021 based on physician evaluation in a preclinical model. We expect to finalize the design for this catheter by
mid-year
2022. Engineering validation and verification will follow design freeze and we will subsequently submit to the FDA for clearance.
|
• |
Increased Awareness
|
• |
Evolving Physician Practice Patterns
|
• |
Conventional Means of Treatment and Their Limitations
non-invasive
management, including exercise and prescription medication, and, if symptoms worsen, may recommend interventional or surgical procedures. Some patients who initially are diagnosed with severe PAD are treated immediately through interventional or surgical procedures.
|
• |
Non-Invasive
Management
|
prescribed. Although these measures can be effective, many people do not sustain them. In addition, these measures may reduce the symptoms, but do not treat the underlying causes of the disease. Physicians may also prescribe medications that lower cholesterol and reduce blood pressure. These drug therapies are generally prescribed for the life of the patient and do not treat the obstruction, making them an ineffective treatment for many patients. As a result, many of these patients will ultimately require more aggressive treatments.
|
• |
Interventional Procedures
|
• |
Angioplasty
|
• |
Drug Coated Balloon
|
• |
Cutting Balloon
in-stent
restenosis.
|
• |
Intravascular Lithotripsy
|
• |
Stenting
|
• |
Plaque Removal Devices
|
treatments are frequently used with a stent or balloon. Atherectomy technologies can damage the vessel walls, which may increase the risk of restenosis. For example, cutting devices, such as directional or rotational devices, introduce significant mechanical trauma.
|
• |
Bypass Surgery
multi-day
hospital stays for healing and rehabilitation. General anesthesia and the potential for surgical infections make this approach less suitable for patients with conditions such as high blood pressure, heart failure, chronic obstructive pulmonary disease or poor kidney function.
|
• |
Amputation
|
• |
Safety
|
• |
Efficacy
|
• |
Utility
|
• |
Increasing the shelf life and improving the consistency of the DABRA catheter
12-month
shelf life to replace them with catheters with a
two-month
shelf life. We have identified current limitations on shelf life relating to aspects of the fluid core and coating and are currently implementing multiple remediations to address these issues. Our internal accelerated and real time aging test data supports shelf life for our catheter of at least six months.
|
• |
Product enhancements
above-the-knee
|
• |
Atherectomy indication for use
|
the FDA to evaluate the use of DABRA in atherectomy procedures. We received an IDE approval in January 2020 and the study is approved for up to 10 clinical sites and 100 subjects. In January 2022, primarily due to subject fallout for
follow-up
visits due to
COVID-19,
we filed a protocol amendment with the FDA to add an additional 25 subjects to the study. We enrolled the first subject in February 2020. Throughout much of 2021 and 2020, the
COVID-19
pandemic substantially impacted our ability to activate new sites and enroll additional subjects. Many sites or potential sites have been or are currently operating at a reduced capacity, and some have been closed from time to time. In addition, potential study subjects may voluntarily opt to postpone their procedures due to
COVID-19
concerns. As of January 14, 2022, seven sites have been cleared to enroll subjects and 90 subjects have been enrolled in the trial. Due to the unpredictable impact the
COVID-19
pandemic has had and will continue to have on enrollment in this study, we currently cannot estimate when enrollment will be completed.
|
• |
Prove utility for lithotripsy
|
• |
cease and desist orders;
|
• |
injunctions, or consent decrees;
|
• |
civil monetary penalties;
|
• |
recall, detention or seizure of our products;
|
• |
operating restrictions, partial or total shutdown of production facilities;
|
• |
refusal of or delay in granting requests for 510(k) clearance, de novo classification, or premarket approval of new products or modified products;
|
• |
withdrawing 510(k) clearances, de novo classifications, or premarket approvals that are already granted;
|
• |
refusal to grant export approval or export certificates for devices; and
|
• |
criminal prosecution.
|
• |
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a U.S. healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the U.S. federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act;
|
• |
U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. government. Persons and entities can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a
product off-label;
|
• |
HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the health care fraud statute implemented under HIPAA or specific intent to violate it in order to have committed a violation;
|
• |
in addition, HIPAA, as amended by the HITECH Act, and its implementing regulations, imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers as well as their business associates that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information;
|
• |
the U.S. Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members. Effective January 2022, for data reported to CMS in 2022 and collected in 2021, reporting obligations with respect to covered recipients have been expanded to payments or transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives; and
|
• |
analogous state
and non-U.S. laws
and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed
|
by non-governmental third-party
payors, including private insurers, or by the patients themselves; state laws that require pharmaceutical and device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and state
and non-U.S. laws
governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
Name
|
Age
|
Position
|
||
Jonathan Will McGuire | 59 | Chief Executive Officer | ||
Andrew Jackson | 52 | Chief Financial Officer |
Name and Principal Position
|
Year
|
Salary ($)
|
Bonus ($)(1)
|
Stock
Awards($)(2)
|
Option
Awards($)(3)
|
Non-Equity
Incentive Plan Compensation |
All Other
Compensation
($)(5)
|
Total ($)
|
||||||||||||||||||||||||
Jonathan Will McGuire(6)
|
2021 | 495,192 | — | — | — | — | 40,933 | 536,125 | ||||||||||||||||||||||||
Chief Executive Officer
|
2020 | 378,846 | 50,000 | 609,153 | 248,355 | 329,063 | (4) | 41,568 | 1,656,985 | |||||||||||||||||||||||
Andrew Jackson(7)
|
2021 | 366,709 | — | — | — | — | 15,141 | 381,850 | ||||||||||||||||||||||||
Chief Financial Officer
|
2020 | 385,923 | 134,415 | 162,975 | — | 173,564 | (4) | 17,754 | 874,631 | |||||||||||||||||||||||
Daniel Horwood
|
2021 | 224,578 | — | — | — | 166,829 | (8) | 13,234 | 404,641 | |||||||||||||||||||||||
Former General Counsel and Secretary
|
2020 | 328,004 | 78,678 | 90,510 | — | 153,542 | (4) | 16,964 | 667,698 |
(1) |
Amounts in this column relate to: (i) for Mr. McGuire in 2020, a signing bonus of $50,000; (ii) for Mr. Jackson, in 2020, retention bonus payments of $134,415 and (iii) for Mr. Horwood in 2020, retention bonus payments of $78,678. Year-end bonuses for 2021 have not yet been determined by the Company’s board of directors.
|
(2) |
This column reflects the aggregate grant date fair value of restricted stock units and restricted stock awards granted to the named individuals during the corresponding year, computed in accordance with the provisions of ASC Topic 718. These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of restricted stock units. The actual value that may be realized is also subject to time-based vesting restrictions that require the named executive officer to continue to provide services to us.
|
(3) |
This column reflects the aggregate grant date fair value of stock options granted to the named individuals during the corresponding year computed in accordance with the provisions of ASC Topic 718. These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the stock options, the exercise of the stock options, or the sale of the common stock underlying such stock options. The actual value that may be realized is also subject to time-based vesting restrictions that require the named executive officer to continue to provide services to us.
|
(4) |
Amounts shown represent performance bonuses earned in 2020, which were paid in cash in March 2021.
|
(5) |
Amounts reflect Company matching contributions to the Named Executive Officers’ 401(k) plans. In addition, for Mr. McGuire, this column includes $19,848 paid for a supplemental health insurance plan.
|
(6) |
Mr. McGuire was hired as our Chief Executive Officer effective March 30, 2020.
|
(7) |
Mr. Jackson also served as our Interim Chief Executive Officer from August 11, 2019 through March 29, 2020.
|
(8) |
Amount represents severance pay that Mr. Horwood received upon his resignation on July 30, 2021.
|
(9) |
Mr. Horwood served as our General Counsel and Secretary until July 30, 2021.
|
• |
a
lump-sum
payment equal to: (1) 18 months for Mr. McGuire and (2) 12 months for Mr. Jackson of the executive officer’s annual base salary as in effect immediately prior to such termination (or if such termination is due to a resignation for good reason based on a material reduction in base salary, then as in effect immediately prior to the reduction);
|
• |
for Mr. McGuire, a lump sum payment equal to the
pro-rata
amount of the executive’s annual bonus for the fiscal year in which the executive terminates employment, based on actual achievement and
pro-rated
based on the number of days the executive was employed by the Company during such year; and
|
• |
payment of premiums for coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended, or COBRA, for the executive officer and the executive officer’s eligible dependents, if any, for up to: (1) 18 months for Mr. McGuire and (2) 12 months for Mr. Jackson, or taxable
|
monthly payments for the equivalent period in the event payment of the COBRA premiums would violate or be subject to an excise tax under applicable law.
|
• |
a
lump-sum
payment equal to: (1) 24 months for Mr. McGuire and (2) 12 months for Mr. Jackson of the executive officer’s annual base salary as in effect immediately prior to such termination (or if such termination is due to a resignation for good reason based on a material reduction in base salary, then as in effect immediately prior to the reduction) or if greater, at the level in effect immediately prior to the change in control);
|
• |
a
lump-sum
payment equal to: (1) 150% for Mr. McGuire and (2) 100% for Mr. Jackson of the executive officer’s target annual bonus as in effect for the fiscal year in which such termination occurs;
|
• |
payment of premiums for coverage under COBRA for the executive officer and the named executive officer’s eligible dependents, if any, for up to; (1) 24 months for Mr. McGuire and (2) 12 months for Mr. Jackson, or taxable monthly payments for the equivalent period in the event payment of the COBRA premiums would violate or be subject to an excise tax under applicable law; and
|
• |
100% accelerated vesting and exercisability of all outstanding equity awards and, in the case of an equity award with performance-based vesting, all performance goals and other vesting criteria generally will be deemed achieved at target.
|
Option Awards
|
Stock Awards
|
|||||||||||||||||||||||
Name and Position
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
Number
of Shares
or Units
of Stock
That Have
Not
Vested (#)
|
Market
Value of
Shares or
Units of
Stock That
Have Not
Vested($)(1)
|
||||||||||||||||||
Jonathan Will McGuire
|
7,875 | (2) | 10,125 | $ | 25.50 | 3/30/2030 | ||||||||||||||||||
Chief Executive Officer
|
3,125 | (3) | $ | 4,875 | ||||||||||||||||||||
46,568 | (4) | $ | 72,646 | |||||||||||||||||||||
Andrew Jackson
|
11,600 | (5) | — | $ | 723.50 | 6/4/2028 | ||||||||||||||||||
Chief Financial Officer
|
5,562 | — | $ | 30.50 | 12/3/2029 | |||||||||||||||||||
15,757 | (4) | $ | 24,581 |
(1) |
Market value of the unvested restricted stock units identified in this column is based on a closing price of $1.56 per share of the Company’s common stock as of December 31, 2021. These amounts do not correspond to the actual value that may be realized by the Named Executive Officers.
|
(2) |
One forty-eighth of the shares subject to the option vest monthly after March 30, 2020, subject to continued service.
|
(3) |
Restricted stock award, or RSA, vests and becomes
non-forfeitable
in equal installments every six months after November 20, 2020.
|
(4) |
RSAs vest and become
non-forfeitable
according to the following schedule: 50% of the shares underlying the RSA shall vest and become
non-forfeitable
as follows: 1/3 of the number of shares vested on November 20, 2021, and 1/6th of the number of shares will vest on each May 20 and November 20 thereafter, such that 50% of the RSA will be fully vested on November 20, 2023. The remaining 50% of the shares underlying the RSA shall vest and become
non-forfeitable
upon certain performance milestones being met by November 20, 2021. Since only one of the three performance milestones was met by November 20, 2021, only 16.67% of the remaining 50% of the shares vested and became non-forfeitable on November 20, 2021. Vesting is subject to continued service.
|
(5) |
One-third
of the shares subject to the option vested on June 4, 2018 and one thirty-sixth of the shares subject to the option vested monthly thereafter, in each case subject to continued service.
|
Name
|
Class
|
Age
|
Position
|
Director
Since
|
Current
Term
Expires
|
|||||
Richard Mejia, Jr.(1)
|
III | 73 | Director | 2018 | 2024 | |||||
Martin Colombatto(2)(3)
|
II | 63 | Chairman of the Board of Directors | 2017 | 2023 | |||||
Jonathan Will McGuire
|
I | 59 | Chief Executive Officer, Director | 2020 | 2022 | |||||
Susanne Meline(2)
|
II | 54 | Director | 2021 | 2023 | |||||
Joan Stafslien(1)(3)
|
II | 57 | Director | 2020 | 2023 |
(1) |
Member of the Audit Committee.
|
(2) |
Member of the Compensation Committee.
|
(3) |
Member of the Nominating and Corporate Governance Committee.
|
• |
selecting and hiring the independent registered public accounting firm to audit our financial statements;
|
• |
overseeing the performance of the independent registered public accounting firm and taking those actions as it deems necessary to satisfy itself that the accountants are independent of management;
|
• |
reviewing financial statements and discussing with management and the independent registered public accounting firm our annual audited and quarterly financial statements, the results of the independent audit and the quarterly reviews, and the reports and certifications regarding internal control over financial reporting and disclosure controls;
|
• |
preparing the audit committee report that the SEC requires to be included in our annual proxy statement;
|
• |
reviewing the adequacy and effectiveness of our internal controls and disclosure controls and procedures;
|
• |
overseeing our policies on risk assessment and risk management;
|
• |
reviewing related party transactions; and
|
• |
approving or, as required,
pre-approving,
all audit and all permissible
non-audit
services and fees to be performed by the independent registered public accounting firm.
|
• |
reviewing and approving or recommending to the board for approval compensation of our executive officers;
|
• |
reviewing and recommending to the board for approval compensation of directors;
|
• |
overseeing our overall compensation philosophy and compensation policies, plans and benefit programs for service providers, including our executive officers;
|
• |
reviewing, approving and making recommendations to our board of directors regarding incentive compensation and equity plans; and
|
• |
administering our equity compensation plans.
|
• |
identifying, evaluating and selecting, or making recommendations to our board of directors regarding, nominees for election to our board of directors and its committees;
|
• |
evaluating the performance of our board of directors and of individual directors;
|
• |
considering and making recommendations to our board of directors regarding the composition of our board of directors and its committees; and
|
• |
developing and making recommendations to our board of directors regarding corporate governance guidelines and matters.
|
• |
$40,000 retainer per year for each
non-employee
director;
|
• |
$40,000 retainer per year for service as
non-employee
chairman of the board of directors;
|
• |
$30,000 retainer per year for service as lead
non-employee
director;
|
• |
$20,000 retainer per year for the chairman of the audit committee or $10,000 retainer per year for each other member of the audit committee;
|
• |
$15,000 retainer per year for the chairman of the compensation committee or $7,000 retainer per year for each other member of the compensation committee; and
|
• |
$8,500 retainer per year for the chairman of the nominating and corporate governance committee or $4,500 retainer per year for each other member of the nominating and corporate governance committee.
|
Name
|
Fees Earned
or Paid in
Cash ($)
|
Stock
Awards ($)(1)
|
Total ($)
|
|||||||||
Martin Colombatto(2)
|
23,897 | 90,620 | 114,517 | |||||||||
William R. Enquist, Jr.(3)
|
— | 71,018 | 71,018 | |||||||||
Richard Mejia, Jr.(4)
|
— | 86,518 | 86,518 | |||||||||
Joan Stafslien(5)
|
58,654 | 19,520 | 78,174 | |||||||||
Susanne Meline(6)
|
42,209 | 46,160 | 88,369 | |||||||||
Mark Saad(7)
|
— | 58,494 | 58,494 |
(1) |
Amounts represent the aggregate grant date fair value of the awards calculated in accordance with Financial Accounting Standards Board ASC Topic 718, Stock Compensation, without regard to estimated forfeitures. See Note 14 to our audited financial statements included elsewhere in this prospectus for a discussion of valuation assumptions made in determining the grant date fair value and compensation expense of our awards.
|
(2) |
Mr. Colombatto had 3,680 options to purchase shares of our common stock outstanding, 2,739 restricted stock units and 18,000 restricted stock awards outstanding as of December 31, 2021.
|
(3) |
Mr. Enquist had 1,746 options to purchase shares of our common stock outstanding, 1,523 restricted stock units and 15,243 restricted stock awards outstanding as of December 31, 2021. Mr. Enquist resigned from our board of directors effective as of December 31, 2021.
|
(4) |
Mr. Mejia had 2,000 options to purchase shares of our common stock outstanding, 1,523 restricted stock units and 17,423 restricted stock awards outstanding as of December 31, 2021.
|
(5) |
Ms. Stafslien had no options to purchase shares of our common stock outstanding, 1,000 restricted stock units and 8,000 restricted stock awards outstanding as of December 31, 2021.
|
(6) |
Ms. Meline had no options to purchase shares of our common stock outstanding, 4,000 restricted stock units and 4,000 restricted stock awards outstanding as of December 31, 2021.
|
(7) |
Mr. Saad had no options to purchase shares of our common stock outstanding, 1,414 restricted stock units and 2,056 restricted stock awards outstanding as of December 31, 2021. Mr. Saad resigned from our board of directors effective as of May 10, 2021.
|
• |
each person, or group of affiliated persons, who we know to beneficially own more than 5% of our common stock;
|
• |
each of our Named Executive Officers;
|
• |
each of our directors; and
|
• |
all of our executive officers and directors as a group.
|
Number of Shares of Common
Stock Beneficially Owned
Prior to this Offering
|
Number of Shares of Common
Stock Beneficially Owned
After this Offering
|
|||||||||||||||
Shares
|
Percentage
|
Shares
|
Percentage
|
|||||||||||||
5% Stockholders:
|
— | — | — | — | ||||||||||||
Other Directors and Named Executive Officers:
|
||||||||||||||||
Jonathan Will McGuire(1)
|
75,746 | 1.1 | % | 75,746 | * | |||||||||||
Andrew Jackson(2)
|
40,603 | * | 40,603 | * | ||||||||||||
Martin Colombatto(3)
|
34,619 | * | 34,619 | * | ||||||||||||
Richard Mejia, Jr.(4)
|
23,946 | * | 23,946 | * | ||||||||||||
Susanne Meline(5)
|
123,267 | 1.7 | % | 123,267 | * | |||||||||||
Joan Stafslien(6)
|
12,744 | * | 12,744 | * | ||||||||||||
All directors and executive officers as a group (6 persons)
|
310,925 | 4.4 | % | 310,925 | 1.7 | % |
(1) |
Includes 8,625 shares of common stock subject to options exercisable within 60 days of January 12, 2022.
|
(2) |
Includes 17,162 shares of common stock subject to options exercisable within 60 days of January 12, 2022.
|
(3) |
Includes (i) 3,680 shares of common stock subject to options exercisable within 60 days of January 12, 2022; and (ii) 1,500 shares held of record by M. Colombatto Trust. Martin Colombatto, a member of our board of directors, serves as trustee of the M. Colombatto Trust.
|
(4) |
Includes 2,000 shares of common stock subject to options exercisable within 60 days of January 12, 2022.
|
(5) |
Includes (i) 77,459 shares of common stock subject to warrants exercisable within 60 days of January 12, 2022 held of record by Catalysis Partners (“CP”), and (ii) 40,000 shares owned by held of record by CP. Ms. Meline has an investment interest in CP through her IRA and, together with an immediate family member, owns a controlling interest in Francis Capital Management, LLC, which also has an investment interest in CP and serves as both its Managing Member and Investment Manager. Ms. Meline disclaims beneficial interest of these securities except to the extent of her pecuniary interest therein.
|
(6) |
Includes 5,000 shares held of record by Thomas & Joan Stafslien Family B Trust dated 6/17/1997. Joan Stafslien, a member of our board of directors, serves as trustee of the Thomas & Joan Stafslien Family B Trust.
|
• |
prior to the date of the transaction, our board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
|
• |
upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, but not the outstanding voting stock owned by the interested stockholder, (1) shares owned by persons who are directors and also officers and (2) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
|
• |
at or subsequent to the date of the transaction, the business combination is approved by our board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder.
|
• |
banks, insurance companies, regulated investment companies, real estate investment trusts or other financial institutions;
|
• |
persons subject to the alternative minimum tax or the Medicare contribution tax on net investment income;
|
• |
tax-exempt organizations
or governmental organizations;
|
• |
controlled foreign corporations, passive foreign investment companies and corporations that accumulate earnings to avoid U.S. federal income tax;
|
• |
brokers or dealers in securities or currencies;
|
• |
traders in securities that elect to use
a mark-to-market method
|
• |
persons that own, or are deemed to own, more than five percent of our capital stock (except to the extent specifically set forth below);
|
• |
certain former citizens or long-term residents of the United States;
|
• |
partnerships or other entities or arrangements classified as partnerships for U.S. federal income tax purposes or other pass-through entities (and investors therein);
|
• |
persons whose functional currency is not the U.S. dollar;
|
• |
persons who hold our common stock, warrants or
pre-funded
warrants as a position in a hedging transaction, “straddle,” “conversion transaction” or other risk reduction transaction or integrated investment;
|
• |
persons who hold or receive our common stock, warrants or
pre-funded
warrants pursuant to the exercise of any warrant or option or otherwise as compensation;
|
• |
persons who hold or receive our common stock, warrants or
pre-funded
warrants pursuant to conversion rights under convertible instruments;
|
• |
persons who do not hold our common stock, warrants or
pre-funded
warrants as a capital asset within the meaning of Section 1221 of the Code;
|
• |
persons deemed to sell our common stock, warrants or
pre-funded
warrants under the constructive sale provisions of the Code; or
|
• |
persons subject to special tax accounting rules as a result of any item of gross income with respect to our common stock being taken into account in an “applicable financial statement” as defined in Section 451(b) of the Code.
|
• |
an individual who is a citizen or resident of the United States (for U.S. federal income tax purposes);
|
• |
a corporation or other entity taxable as a corporation created or organized in or under the laws of the United States, any state thereof or the District of Columbia;
|
• |
an estate whose income is subject to U.S. federal income tax regardless of its source; or
|
• |
a trust if it (i) is subject to the primary supervision of a U.S. court and one or more U.S. persons have the authority to control all substantial decisions of the trust or (ii) has made a valid election under applicable Treasury Regulations to be treated as a U.S. person.
|
• |
the gain is effectively connected with your conduct of a U.S. trade or business (and, if required by an applicable income tax treaty, the gain is attributable to a permanent establishment maintained by you in the United States);
|
• |
you are
a non-resident alien
individual who is present in the United States for a period or periods aggregating 183 days or more during the calendar year in which the sale or disposition occurs and certain other conditions are met; or
|
• |
we are treated as a “United States real property holding corporation,” or USRPHC, for U.S. federal income tax purposes within the meaning of Section 897I(2) of the Code at any time within the shorter of the five-year period preceding your disposition of, or your holding period for, our common stock, warrants or
pre-funded
warrants.
|
Underwriters
|
Number of
Units |
Number of Pre-
Funded Units
|
||||||
Ladenburg Thalmann & Co. Inc.
|
— | |||||||
Total
|
Per
Unit(1)
|
Per
Pre-Funded
Unit(2) |
Total
Without
Over-
Allotment
|
Total
With Full
Over-
Allotment
|
|||||||||||||
Public offering price
|
$ | $ | $ | $ | ||||||||||||
Underwriting discounts and commissions to be paid to underwriters by us(3)(4)
|
$ | $ | $ | $ | ||||||||||||
Proceeds, before expenses, to us
|
$ | $ | $ | $ |
(1) |
The public offering price and underwriting discount corresponds to, in respect of the units, (i) a public offering price per share of common stock of $ ($ net of the underwriting discount) and (ii) a public offering price per warrant of $ ($ net of the underwriting discount).
|
(2) |
The public offering price and underwriting discount in respect of the
pre-funded
units corresponds to (i) a public offering price per
pre-funded
warrant to purchase one share of common stock of $ ($ net of the underwriting discount) and (ii) a public offering price per warrant of $ ($ net of the underwriting discount).
|
(3) |
We have also agreed to reimburse the accountable expenses of the representative, including a
pre-closing
expense allowance of up to a maximum of $25,000 and an additional closing expense allowance up to a maximum of $95,000.
|
(4) |
We have granted a
45-
day option to the underwriters to purchase up to additional shares of common stock and/or additional warrants exercisable for up to an additional shares of common stock at the assumed public offering price per share of common stock and the assumed public offering price per warrant set forth above less the underwriting discounts and commissions solely to cover over-allotments, if any.
|
• |
Syndicate covering transactions involve purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. Such a naked short position would be closed out by buying securities in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the securities in the open market after pricing that could adversely affect investors who purchase in the offering.
|
• |
Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum.
|
• |
Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicate member are purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.
|
Page
|
||||
Ra Medical Systems, Inc.
|
||||
Financial Statements
|
||||
Years Ended December 31, 2020 and 2019
|
||||
F-2 | ||||
F-3 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
F-7 | ||||
F-8 | ||||
Condensed Financial Statements (Unaudited)
|
||||
As of December 31, 2020 and September 30, 2021 (Unaudited) and for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)
|
||||
F-33 | ||||
F-34 | ||||
F-35 | ||||
F-36 | ||||
F-37 | ||||
F-38 |
December 31,
2020
|
December 31,
2019
|
|||||||
ASSETS
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
$ | 23,906 | $ | 14,584 | ||||
Short-term investments
|
— | 15,993 | ||||||
Accounts receivable, net
|
24 | 223 | ||||||
Inventories
|
877 | 1,292 | ||||||
Prepaid expenses and other current assets
|
1,100 | 1,628 | ||||||
Current assets of discontinued operations
|
1,713 | 2,280 | ||||||
|
|
|
|
|||||
Total current assets
|
27,620 | 36,000 | ||||||
Property and equipment, net
|
2,527 | 4,144 | ||||||
Operating lease
right-of-use-assets
|
2,484 | 2,835 | ||||||
Other
non-current
assets
|
45 | 45 | ||||||
Long-term assets of discontinued operations
|
762 | 1,057 | ||||||
|
|
|
|
|||||
TOTAL ASSETS
|
$ | 33,438 | $ | 44,081 | ||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities
|
||||||||
Accounts payable
|
$ | 471 | $ | 1,220 | ||||
Accrued expenses
|
4,147 | 2,360 | ||||||
Current portion of equipment financing
|
265 | 293 | ||||||
Current portion of promissory note
|
421 | — | ||||||
Current portion of operating lease liabilities
|
356 | 318 | ||||||
Current liabilities of discontinued operations
|
2,102 | 2,623 | ||||||
|
|
|
|
|||||
Total current liabilities
|
7,762 | 6,814 | ||||||
Deferred revenue
|
— | — | ||||||
Equipment financing
|
— | 265 | ||||||
Promissory note
|
1,579 | — | ||||||
Operating lease liabilities
|
2,264 | 2,620 | ||||||
Long-term liabilities of discontinued operations
|
686 | 1,232 | ||||||
|
|
|
|
|||||
Total liabilities
|
12,291 | 10,931 | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 16)
|
||||||||
Stockholders’ Equity
|
||||||||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized at December 31, 2020 and 2019; none issued
|
— | — | ||||||
Common stock, $0.0001 par value, 300,000,000 shares authorized at December 31, 2020 and 2019; 3,188,679 and 550,814 issued and outstanding at December 31, 2020 and 2019, respectively
|
7 | 1 | ||||||
Additional
paid-in
capital
|
174,342 | 150,280 | ||||||
Accumulated deficit
|
(153,202 | ) | (117,157 | ) | ||||
Accumulated other comprehensive income
|
— | 26 | ||||||
|
|
|
|
|||||
Total stockholders’ equity
|
21,147 | 33,150 | ||||||
|
|
|
|
|||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 33,438 | $ | 44,081 | ||||
|
|
|
|
Year Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Net revenue
|
||||||||
Product sales
|
$ | 254 | $ | 1,255 | ||||
Service and other
|
5 | 18 | ||||||
|
|
|
|
|||||
Total net revenue
|
259 | 1,273 | ||||||
Cost of revenue
|
||||||||
Product sales
|
1,369 | 3,375 | ||||||
Service and other
|
803 | 758 | ||||||
|
|
|
|
|||||
Total cost of revenue
|
2,172 | 4,133 | ||||||
Gross loss
|
(1,913 | ) | (2,860 | ) | ||||
Operating expenses
|
||||||||
Selling, general and administrative
|
24,533 | 45,302 | ||||||
Research and development
|
8,955 | 4,445 | ||||||
|
|
|
|
|||||
Total operating expenses
|
33,488 | 49,747 | ||||||
|
|
|
|
|||||
Operating loss
|
(35,401 | ) | (52,607 | ) | ||||
Other income (expense), net
|
||||||||
Interest income
|
129 | 1,038 | ||||||
Interest expense
|
(41 | ) | (71 | ) | ||||
|
|
|
|
|||||
Total other income (expense), net
|
88 | 967 | ||||||
|
|
|
|
|||||
Loss before income tax expense
|
(35,313 | ) | (51,640 | ) | ||||
Income tax expense
|
7 | 15 | ||||||
|
|
|
|
|||||
Net loss from continuing operations
|
(35,320 | ) | (51,655 | ) | ||||
|
|
|
|
|||||
Gain (loss) from discontinued operations before income tax expense
|
(725 | ) | (5,302 | ) | ||||
Income tax expense
|
— | — | ||||||
|
|
|
|
|||||
Net gain (loss) from discontinued operations
|
(725 | ) | (5,302 | ) | ||||
|
|
|
|
|||||
Net loss
|
$ | (36,045 | ) | $ | (56,957 | ) | ||
|
|
|
|
|||||
Basic and diluted net loss per share
|
||||||||
Continuing operations
|
$ | (20.79 | ) | $ | (98.20 | ) | ||
Discontinued operations
|
(0.43 | ) | (10.08 | ) | ||||
|
|
|
|
|||||
$ | (21.22 | ) | $ | (108.28 | ) | |||
|
|
|
|
|||||
Basic and diluted weighted average common shares outstanding
|
1,699 | 526 | ||||||
|
|
|
|
Year Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Net loss
|
$ | (36,045 | ) | $ | (56,957 | ) | ||
|
|
|
|
|||||
Other comprehensive income:
|
||||||||
Unrealized (loss) gain related to short-term investments
|
(26 | ) | 26 | |||||
|
|
|
|
|||||
Total other comprehensive (loss) income
|
$ | (26 | ) | $ | 26 | |||
|
|
|
|
|||||
Comprehensive loss
|
$ | (36,071 | ) | $ | (56,931 | ) | ||
|
|
|
|
Common
Stock
Shares
|
Common
Stock
Amount
|
Additional
Paid- in-
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Total
Stockholders’
Equity
|
|||||||||||||||||||
Balances at January 1, 2019
|
508 | $ | 1 | $ | 126,925 | $ | — | $ | (60,200 | ) | $ | 66,726 | ||||||||||||
Common stock issued
|
43 | — | (188 | ) | — | — | (188 | ) | ||||||||||||||||
Stock-based compensation
|
— | — | 23,543 | — | — | 23,543 | ||||||||||||||||||
Other comprehensive income
|
— | — | — | 26 | — | 26 | ||||||||||||||||||
Net loss
|
— | — | — | — | (56,957 | ) | (56,957 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at December 31, 2019
|
551 | $ | 1 | $ | 150,280 | $ | 26 | $ | (117,157 | ) | $ | 33,150 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Common stock issued
|
2,551 | 5 | 11,620 | — | — | 11,625 | ||||||||||||||||||
Warrants issued, net
|
— | — | 7,492 | — | — | 7,492 | ||||||||||||||||||
Exercise of warrants
|
74 | 1 | 826 | — | — | 827 | ||||||||||||||||||
Common stock issued pursuant to the vesting of restricted stock units and ESPP
|
13 | — | 42 | — | — | 42 | ||||||||||||||||||
Stock-based compensation
|
— | — | 4,082 | — | — | 4,082 | ||||||||||||||||||
Other comprehensive loss
|
— | — | — | (26 | ) | — | (26 | ) | ||||||||||||||||
Net loss
|
— | — | — | — | (36,045 | ) | (36,045 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at December 31, 2020
|
3,189 | $ | 7 | $ | 174,342 | $ | — | $ | (153,202 | ) | $ | 21,147 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
||||||||
2020
|
2019
|
|||||||
Balance at beginning of period
|
$ | 305 | $ | 193 | ||||
Provision for doubtful accounts
|
42 | 254 | ||||||
Deductions
|
(263 | ) | (142 | ) | ||||
|
|
|
|
|||||
Balance at end of period
|
$ | 84 | $ | 305 | ||||
|
|
|
|
Computer hardware and software
|
4
-5 years
|
|||
Furniture and fixtures
|
5 years | |||
Machinery and equipment
|
5
-10 years
|
|||
Lasers
|
3
-
5
years
|
|||
Automobiles
|
5 years |
• |
Identification of each contract with a customer;
|
• |
Identification of the performance obligations in the contract;
|
• |
Determination of the transaction price;
|
• |
Allocation of the transaction price to the performance obligations in the contract; and
|
• |
Recognition of revenue when, or as, performance obligations are satisfied.
|
• |
not to adjust the promised amount of consideration for the effects of a significant financing component when the Company expects, at contract inception, that the period between the Company’s transfer of a promised product or service to a customer and when the customer pays for that product or service will be one year or less;
|
• |
to expense costs as incurred for costs to obtain a contract when the amortization period would have been one year or less;
|
• |
to exclude government assessed taxes from the transaction price; and
|
• |
not to recast revenue for contracts that begin and end in the same fiscal year.
|
Employees
|
Nonemployees
|
|||
Service condition only
|
Straight-line | In the same period and in the same manner as if the Company paid cash for services. | ||
Performance criterion is probable of being met:
|
||||
Service criterion is complete
|
Recognize the grant date fair value of the award once the performance criterion is considered probable of occurrence | Recognize the grant date fair value of the award once the performance criterion is considered probable of occurrence | ||
Service criterion is not complete
|
Straight-line | Straight-line unless a performance condition is not probable | ||
Performance criterion is not probable of being met
|
No expense is recognized until the performance criterion is considered probable, at which point expense is recognized per above | No expense is recognized until the performance criterion is considered probable, at which point expense is recognized per above |
December 31,
|
||||||||
2020
|
2019
|
|||||||
Assets of discontinued operations
|
||||||||
Accounts receivable, net
|
$ | 214 | $ | 563 | ||||
Inventories
|
1,341 | 1,485 | ||||||
Prepaid expenses and other current assets
|
158 | 232 | ||||||
Property and equipment, net
|
684 | 906 | ||||||
Other long-term assets
|
78 | 151 | ||||||
|
|
|
|
|||||
Total assets of discontinued operations
|
$ | 2,475 | $ | 3,337 | ||||
|
|
|
|
|||||
Liabilities of discontinued operations
|
||||||||
Accounts payable
|
$ | 100 | $ | 312 | ||||
Accrued expenses
|
201 | 282 | ||||||
Deferred revenue
|
2,487 | 3,261 | ||||||
|
|
|
|
|||||
Total liabilities of discontinued operations
|
$ | 2,788 | $ | 3,855 | ||||
|
|
|
|
Years Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Net revenues
|
||||||||
Product sales
|
$ | 1,154 | $ | 2,604 | ||||
Service and other
|
2,992 | 3,320 | ||||||
|
|
|
|
|||||
Total net revenues
|
4,146 | 5,924 | ||||||
|
|
|
|
|||||
Cost of revenues
|
||||||||
Product sales
|
1,522 | 2,483 | ||||||
Service and other
|
1,789 | 2,236 | ||||||
|
|
|
|
|||||
Total cost of revenues
|
3,311 | 4,719 | ||||||
|
|
|
|
|||||
Gross income (loss)
|
835 | 1,205 | ||||||
|
|
|
|
|||||
Operating expenses
|
||||||||
Selling, general and administrative
|
1,440 | 6,242 | ||||||
Research and development
|
54 | 86 | ||||||
|
|
|
|
|||||
Total operating expenses
|
1,494 | 6,328 | ||||||
|
|
|
|
|||||
Operating loss
|
(659 | ) | (5,123 | ) | ||||
Interest expense, net
|
(66 | ) | (179 | ) | ||||
|
|
|
|
|||||
Loss from discontinued operations
|
$ | (725 | ) | $ | (5,302 | ) | ||
|
|
|
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value |
|||||||||||||
Debt
Securities-available-for-sale:
|
||||||||||||||||
U.S. agency securities
|
$ | 1,000 | $ | — | $ | — | $ | 1,000 | ||||||||
U.S. government securities
|
14,967 | 26 | — | 14,993 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total debt securities
|
$ | 15,967 | $ | 26 | $ | — | $ | 15,993 | ||||||||
|
|
|
|
|
|
|
|
Total Fair
Value
|
Quoted
Market
Prices for
Identical
Assets
(Level 1)
|
Other
Observable
Inputs
(Level 2)
|
Unobservable
Inputs
(Level 3)
|
|||||||||||||
As of December 31, 2020
|
||||||||||||||||
Money market funds
|
$ | 18,394 | $ | 18,394 | $ | — | $ | — | ||||||||
As of December 31, 2019
|
||||||||||||||||
Money market funds
|
$ | 13,219 | $ | 13,219 | $ | — | $ | — | ||||||||
U.S. government securities
|
$ | 14,993 | $ | 14,993 | $ | — | $ | — | ||||||||
U.S. agency securities
|
$ | 1,000 | $ | — | $ | 1,000 | $ | — |
December 31,
|
||||||||
2020
|
2019
|
|||||||
Raw materials
|
$ | 547 | $ | 977 | ||||
Work in process
|
270 | 215 | ||||||
Finished goods
|
60 | 100 | ||||||
|
|
|
|
|||||
Inventories
|
$ | 877 | $ | 1,292 | ||||
|
|
|
|
December 31,
|
||||||||
2020
|
2019
|
|||||||
Lasers
|
$ | 3,194 | $ | 3,307 | ||||
Machinery and equipment
|
834 | 809 | ||||||
Automobiles
|
1,054 | 1,109 | ||||||
Computer hardware and software
|
353 | 348 | ||||||
Leasehold improvements
|
119 | 119 | ||||||
Furniture and fixtures
|
48 | 48 | ||||||
Construction in progress
|
51 | 23 | ||||||
|
|
|
|
|||||
Property and equipment, gross
|
5,653 | 5,763 | ||||||
Accumulated depreciation
|
(3,126 | ) | (1,619 | ) | ||||
|
|
|
|
|||||
Property and equipment, net
|
$ | 2,527 | $ | 4,144 | ||||
|
|
|
|
December 31,
|
||||||||
2020
|
2019
|
|||||||
Compensation and related benefits
|
$ | 2,479 | $ | 985 | ||||
Accrued warranty (Note 8)
|
204 | 234 | ||||||
Accrued services
|
1,464 | 1,141 | ||||||
|
|
|
|
|||||
Accrued expenses
|
$ | 4,147 | $ | 2,360 | ||||
|
|
|
|
Year ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Balance at beginning of period
|
$ | 234 | $ | 50 | ||||
Increase in warranty accrual
|
19 | 709 | ||||||
Change in liability for
pre-existing
warranties
|
4 | (28 | ) | |||||
Claims satisfied
|
(53 | ) | (497 | ) | ||||
|
|
|
|
|||||
Accrued warranty
|
$ | 204 | $ | 234 | ||||
|
|
|
|
Years Ending December 31,
|
||||
2021
|
$ | 528 | ||
2022
|
432 | |||
2023
|
445 | |||
2024
|
459 | |||
2025
|
472 | |||
Thereafter
|
987 | |||
|
|
|||
Total operating lease payments
|
$ | 3,323 | ||
|
|
|||
Less: imputed interest
|
(703 | ) | ||
Total operating lease liabilities
|
$ | 2,620 | ||
|
|
Stock
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Life
(in years)
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||||||||
Outstanding at December 31, 2018
|
76,804 | $ | 714.75 | 9.43 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Granted
|
60,854 | 30.50 | ||||||||||||||
Forfeited
|
(12,079 | ) | 670.25 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Outstanding at December 31, 2019
|
125,579 | $ | 387.50 | 9.43 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Granted
|
11,729 | 30.69 | ||||||||||||||
Forfeited
|
(13,137 | ) | 297.57 | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Outstanding at December 31, 2020
|
124,171 | $ | 363.31 | 6.42 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Exercisable at December 31, 2020
|
84,376 | $ | 466.78 | 5.89 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Vested and expected to vest at December 31, 2020
|
124,171 | $ | 363.31 | 6.42 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
Restricted
Stock
Units |
Weighted
Average
Grant Date
Fair Value
|
|||||||
Outstanding at December 31, 2018
|
59,767 | $ | 672.75 | |||||
Granted
|
12,010 | 98.75 | ||||||
Vested and released
|
(48,269 | ) | 698.25 | |||||
Forfeited
|
(12,644 | ) | 497.75 | |||||
|
|
|
|
|||||
Outstanding at December 31, 2019
|
10,864 | $ | 128.82 | |||||
Granted
|
32,019 | 10.82 | ||||||
Vested and released
|
(7,906 | ) | 114.55 | |||||
Forfeited
|
(1,429 | ) | 101.79 | |||||
|
|
|
|
|||||
Outstanding at December 31, 2020
|
33,548 | $ | 21.93 | |||||
|
|
|
|
Restricted Stock
Awards
(in shares)
|
Weighted
Average
Grant Date
Fair Value
|
|||||||
Outstanding at December 31, 2019
|
— | $ | — | |||||
Granted
|
286,161 | 4.77 | ||||||
Forfeited
|
— | — | ||||||
Vested
|
— | — | ||||||
|
|
|
|
|||||
Outstanding at December 31, 2020
|
286,161 | $ | 4.77 | |||||
|
|
|
|
Year Ended
December 31,
|
||||||||
2020
|
2019
|
|||||||
Selling, general and administrative
|
$ | 3,235 | $ | 16,141 | ||||
Research and development
|
444 | 1,537 | ||||||
|
|
|
|
|||||
Stock-based compensation in operating expenses
|
$ | 3,679 | $ | 17,678 | ||||
|
|
|
|
Year Ended
December 31,
|
||||||||
2020
|
2019
|
|||||||
Risk-free interest rate
|
1.3 | % | 1.6 | % | ||||
Volatility
|
58.96 | % | 59.26 | % | ||||
Expected dividend yield
|
0.00 | % | 0.00 | % | ||||
Expected life (in years)
|
5.8 | 5.9 |
Year Ended
December 31,
|
||||
2020
|
||||
Risk-free interest rate
|
0.5 | % | ||
Volatility
|
58.33 | % | ||
Expected dividend yield
|
0.00 | % | ||
Expected life (in years)
|
6.3 |
Year Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Tax computed at the federal statutory rate
|
21.0 | % | 21.0 | % | ||||
State income taxes, net of federal benefits
|
5.1 | 1.9 | ||||||
Nondeductible expenses
|
(0.1 | ) | (0.4 | ) | ||||
Stock-based compensation
|
(2.2 | ) | (9.5 | ) | ||||
Deferred tax adjustments
|
(57.0 | ) | — | |||||
Change in valuation allowance
|
33.2 | (13.0 | ) | |||||
|
|
|
|
|||||
— | — | |||||||
|
|
|
|
Year Ended
December 31, |
||||||||
2020
|
2019
|
|||||||
Current
|
||||||||
Federal
|
$ | — | $ | — | ||||
State
|
7 | 15 | ||||||
|
|
|
|
|||||
7 | 15 | |||||||
Deferred
|
||||||||
Federal
|
— | — | ||||||
State
|
— | — | ||||||
|
|
|
|
|||||
— | — | |||||||
|
|
|
|
|||||
Income tax expense
|
$ | 7 | $ | 15 | ||||
|
|
|
|
December 31,
|
||||||||
2020
|
2019
|
|||||||
Deferred Tax Assets:
|
||||||||
Net operating loss carryforwards
|
$ | 3,720 | $ | 16,096 | ||||
Operating lease liabilities
|
691 | 766 | ||||||
Other accruals
|
101 | 61 | ||||||
Accrued compensation
|
448 | — | ||||||
Reserves
|
299 | 301 | ||||||
Deferred revenue
|
642 | 850 | ||||||
Intangible assets
|
32 | 253 | ||||||
Stock-based compensation
|
4,910 | 4,821 | ||||||
|
|
|
|
|||||
Total gross deferred tax assets
|
$ | 10,843 | $ | 23,148 | ||||
Deferred Tax Liabilities:
|
||||||||
Property and equipment
|
(805 | ) | (1,026 | ) | ||||
Operating lease
right-of-use
|
(655 | ) | (739 | ) | ||||
Other
|
(61 | ) | (92 | ) | ||||
|
|
|
|
|||||
Total gross deferred tax liabilities
|
$ | (1,521 | ) | $ | (1,857 | ) | ||
Valuation allowance
|
(9,322 | ) | (21,291 | ) | ||||
|
|
|
|
|||||
Total deferred taxes
|
$ | — | $ | — | ||||
|
|
|
|
September 30,
2021
|
December 31,
2020
|
|||||||
ASSETS
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
$ | 20,616 | $ | 23,906 | ||||
Accounts receivable, net
|
17 | 24 | ||||||
Inventories
|
997 | 877 | ||||||
Prepaid expenses and other current assets
|
1,169 | 1,100 | ||||||
Current assets of discontinued operations
|
— | 1,713 | ||||||
|
|
|
|
|||||
Total current assets
|
22,799 | 27,620 | ||||||
Property and equipment, net
|
2,030 | 2,527 | ||||||
Operating lease
right-of-use
|
2,205 | 2,484 | ||||||
Other long-term assets
|
45 | 45 | ||||||
Long-term assets of discontinued operations
|
— | 762 | ||||||
|
|
|
|
|||||
TOTAL ASSETS
|
$ | 27,079 | $ | 33,438 | ||||
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities
|
||||||||
Accounts payable
|
$ | 543 | $ | 471 | ||||
Accrued expenses
|
2,632 | 4,147 | ||||||
Current portion of operating lease liabilities
|
301 | 356 | ||||||
Current portion of equipment financing
|
— | 265 | ||||||
Current portion of PPP promissory note
|
— | 421 | ||||||
Current liabilities of discontinued operations
|
— | 2,102 | ||||||
|
|
|
|
|||||
Total current liabilities
|
3,476 | 7,762 | ||||||
Operating lease liabilities
|
2,054 | 2,264 | ||||||
PPP promissory note
|
— | 1,579 | ||||||
Long-term liabilities of discontinued operations
|
— | 686 | ||||||
|
|
|
|
|||||
Total liabilities
|
5,530 | 12,291 | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 14)
|
||||||||
Stockholders’ Equity
|
||||||||
Preferred stock, $0.0001 par value; 10,000 shares authorized; no shares issued
|
— | — | ||||||
Common stock, $0.0001 par value; 300,000 shares authorized; 7,042 and 3,189 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively
|
7 | 7 | ||||||
Additional
paid-in
capital
|
191,527 | 174,342 | ||||||
Accumulated deficit
|
(169,985 | ) | (153,202 | ) | ||||
|
|
|
|
|||||
Total stockholders’ equity
|
21,549 | 21,147 | ||||||
|
|
|
|
|||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 27,079 | $ | 33,438 | ||||
|
|
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Net revenues
|
||||||||||||||||
Product sales
|
$ | 5 | $ | 66 | $ | 17 | $ | 254 | ||||||||
Service and other
|
— | 2 | — | 5 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total net revenues
|
5 | 68 | 17 | 259 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cost of revenues
|
||||||||||||||||
Product sales
|
68 | 323 | 676 | 1,131 | ||||||||||||
Service and other
|
178 | 245 | 537 | 615 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cost of revenues
|
246 | 568 | 1,213 | 1,746 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross loss
|
(241 | ) | (500 | ) | (1,196 | ) | (1,487 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating expenses
|
||||||||||||||||
Selling, general and administrative
|
4,211 | 4,695 | 11,285 | 18,154 | ||||||||||||
Research and development
|
2,942 | 2,312 | 8,521 | 5,534 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses
|
7,153 | 7,007 | 19,806 | 23,688 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating loss
|
(7,394 | ) | (7,507 | ) | (21,002 | ) | (25,175 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Other income (expense), net
|
||||||||||||||||
Other income (expense), net
|
16 | (8 | ) | 5 | 97 | |||||||||||
Gain on extinguishment of PPP promissory note
|
— | — | 2,023 | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total other income (expense), net
|
16 | (8 | ) | 2,028 | 97 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from continuing operations before income taxes
|
(7,378 | ) | (7,515 | ) | (18,974 | ) | (25,078 | ) | ||||||||
Income taxes
|
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from continuing operations
|
(7,378 | ) | (7,515 | ) | (18,974 | ) | (25,078 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Discontinued operations (Note 3)
|
||||||||||||||||
Income (loss) from discontinued operations (including gain on sale of $3,500 in 2021) before income taxes
|
3,080 | (264 | ) | 2,191 | (523 | ) | ||||||||||
Income taxes
|
— | — | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income (loss) from discontinued operations
|
3,080 | (264 | ) | 2,191 | (523 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss
|
$ | (4,298 | ) | $ | (7,779 | ) | $ | (16,783 | ) | $ | (25,601 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Net (loss) income per share, basic and diluted
|
||||||||||||||||
Continuing operations
|
$ | (1.15 | ) | $ | (3.15 | ) | $ | (4.23 | ) | $ | (19.32 | ) | ||||
Discontinued operations
|
0.48 | (0.11 | ) | 0.49 | (0.40 | ) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total net loss per share, basic and diluted
|
$ | (0.67 | ) | $ | (3.26 | ) | $ | (3.74 | ) | $ | (19.72 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Weighted average number of shares used in computing net income (loss) per share, basic and diluted
|
6,415 | 2,386 | 4,487 | 1,298 | ||||||||||||
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Net loss
|
$ | (4,298 | ) | $ | (7,779 | ) | $ | (16,783 | ) | $ | (25,601 | ) | ||||
Other comprehensive loss:
|
||||||||||||||||
Unrealized losses related to short-term investments
|
— | — | — | (26 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Comprehensive loss
|
$ | (4,298 | ) | $ | (7,779 | ) | $ | (16,783 | ) | $ | (25,627 | ) | ||||
|
|
|
|
|
|
|
|
Common Stock
|
Additional
Paid-In
Capital |
Accumulated
Other Comprehensive Income (Loss) |
Accumulated
Deficit |
Total
Stockholders’ Equity |
||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||
Balances at December 31, 2020
|
3,189 | $ | 7 | $ | 174,342 | $ | — | $ | (153,202 | ) | $ | 21,147 | ||||||||||||
Common stock issued, net
|
35 | — | 65 | — | — | 65 | ||||||||||||||||||
Stock-based compensation
|
35 | — | 1,169 | — | — | 1,169 | ||||||||||||||||||
Net loss
|
— | — | — | — | (7,236 | ) | (7,236 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at March 31, 2021
|
3,259 | 7 | 175,576 | — | (160,438 | ) | 15,145 | |||||||||||||||||
Common stock issued, net
|
2,582 | — | 10,645 | — | — | 10,645 | ||||||||||||||||||
Common stock issued pursuant to the vesting of restricted stock units and employee stock purchase plan
|
6 | — | 26 | — | — | 26 | ||||||||||||||||||
Stock-based compensation
|
56 | — | 696 | — | — | 696 | ||||||||||||||||||
Net loss
|
— | — | — | — | (5,249 | ) | (5,249 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at June 30, 2021
|
5,903 | 7 | 186,943 | — | (165,687 | ) | 21,263 | |||||||||||||||||
Common stock issued, net
|
1,139 | — | 4,350 | — | — | 4,350 | ||||||||||||||||||
Warrant issued
|
— | — | 132 | — | — | 132 | ||||||||||||||||||
Stock-based compensation
|
— | — | 102 | — | — | 102 | ||||||||||||||||||
Net loss
|
— | — | — | — | (4,298 | ) | (4,298 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at September 30, 2021
|
7,042 | $ | 7 | $ | 191,527 | $ | — | $ | (169,985 | ) | $ | 21,549 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
Additional
Paid-In
Capital |
Accumulated
Other Comprehensive Income (Loss) |
Accumulated
Deficit |
Total
Stockholders’ Equity |
||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||
Balances at December 31, 2019
|
551 | $ | 1 | $ | 150,280 | $ | 26 | $ | (117,157 | ) | $ | 33,150 | ||||||||||||
Common stock issued
|
5 | — | — | — | — | — | ||||||||||||||||||
Stock-based compensation
|
— | — | 1,047 | — | — | 1,047 | ||||||||||||||||||
Other comprehensive loss
|
— | — | — | (22 | ) | — | (22 | ) | ||||||||||||||||
Net loss
|
— | — | — | — | (7,701 | ) | (7,701 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at March 31, 2020
|
556 | 1 | 151,327 | 4 | (124,858 | ) | 26,474 | |||||||||||||||||
Common stock issued, net
|
889 | 2 | 5,282 | — | — | 5,284 | ||||||||||||||||||
Warrants issued, net
|
— | — | 3,464 | — | — | 3,464 | ||||||||||||||||||
Exercise of warrants
|
73 | 1 | 826 | — | — | 827 | ||||||||||||||||||
Common stock issued pursuant to the vesting of restricted stock units and employee stock purchase plan
|
9 | — | 27 | — | — | 27 | ||||||||||||||||||
Stock-based compensation
|
— | — | 1,033 | — | — | 1,033 | ||||||||||||||||||
Other comprehensive loss
|
— | — | — | (4 | ) | — | (4 | ) | ||||||||||||||||
Net loss
|
— | — | — | — | (10,121 | ) | (10,121 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at June 30, 2020
|
1,527 | 4 | 161,959 | — | (134,979 | ) | 26,984 | |||||||||||||||||
Common stock issued, net
|
1,371 | 3 | 6,338 | — | — | 6,341 | ||||||||||||||||||
Warrants issued, net
|
— | 4,028 | — | — | 4,028 | |||||||||||||||||||
Stock-based compensation
|
— | 964 | — | — | 964 | |||||||||||||||||||
Net loss
|
— | — | — | (7,779 | ) | (7,779 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balances at September 30, 2020
|
2,898 | $ | 7 | $ | 173,289 | $ | — | $ | (142,758 | ) | $ | 30,538 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2020 |
||||
Assets of discontinued operations
|
||||
Accounts receivable, net
|
$ | 214 | ||
Inventories
|
1,341 | |||
Prepaid expenses and other current assets
|
158 | |||
Property and equipment, net
|
684 | |||
Other long-term assets
|
78 | |||
|
|
|||
Total assets of discontinued operations
|
$ | 2,475 | ||
|
|
|||
Liabilities of discontinued operations
|
||||
Accounts payable
|
$ | 100 | ||
Accrued expenses
|
201 | |||
Deferred revenue
|
2,487 | |||
|
|
|||
Total liabilities of discontinued operations
|
$ | 2,788 | ||
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Net revenues
|
||||||||||||||||
Product sales
|
$ | 140 | $ | 118 | $ | 852 | $ | 670 | ||||||||
Service and other
|
349 | 729 | 1,748 | 2,259 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total net revenues
|
489 | 847 | 2,600 | 2,929 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cost of revenues
|
||||||||||||||||
Product sales
|
158 | 347 | 1,201 | 1,127 | ||||||||||||
Service and other
|
238 | 504 | 1,089 | 1,296 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cost of revenues
|
396 | 851 | 2,290 | 2,423 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross income (loss)
|
93 | (4 | ) | 310 | 506 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating expenses
|
||||||||||||||||
Selling, general and administrative
|
330 | 236 | 1,110 | 958 | ||||||||||||
Research and development
|
134 | 21 | 388 | 47 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses
|
464 | 257 | 1,498 | 1,005 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating loss
|
(371 | ) | (261 | ) | (1,188 | ) | (499 | ) | ||||||||
Interest expense, net
|
(22 | ) | (3 | ) | (94 | ) | (24 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from discontinued operations
|
(393 | ) | (264 | ) | (1,282 | ) | (523 | ) | ||||||||
Gain on sale of the Dermatology Business
|
3,473 | — | 3,473 | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Income (loss) from discontinued operations
|
$ | 3,080 | $ | (264 | ) | $ | 2,191 | $ | (523 | ) | ||||||
|
|
|
|
|
|
|
|
September 30,
2021
|
December 31,
2020
|
|||||||
Raw materials
|
$ | 884 | $ | 547 | ||||
Work in process
|
60 | 270 | ||||||
Finished goods
|
53 | 60 | ||||||
|
|
|
|
|||||
Total inventories
|
$ | 997 | $ | 877 | ||||
|
|
|
|
September 30,
2021
|
December 31,
2020
|
|||||||
Lasers
|
$ | 3,151 | $ | 3,194 | ||||
Machinery and equipment
|
812 | 834 | ||||||
Computer hardware and software
|
353 | 353 | ||||||
Construction in progress
|
209 | 51 | ||||||
Leasehold improvements
|
119 | 119 | ||||||
Automobiles
|
62 | 1,054 | ||||||
Furniture and fixtures
|
48 | 48 | ||||||
|
|
|
|
|||||
Property and equipment, gross
|
4,754 | 5,653 | ||||||
Accumulated depreciation
|
(2,724 | ) | (3,126 | ) | ||||
|
|
|
|
|||||
Total property and equipment, net
|
$ | 2,030 | $ | 2,527 | ||||
|
|
|
|
September 30,
2021
|
December 31,
2020
|
|||||||
Accrued legal expenses
|
$ | 1,393 | $ | 957 | ||||
Compensation and related benefits
|
496 | 2,479 | ||||||
Accrued warranty (Note 8)
|
195 | 204 | ||||||
Other accrued expenses
|
548 | 507 | ||||||
|
|
|
|
|||||
Total accrued expenses
|
$ | 2,632 | $ | 4,147 | ||||
|
|
|
|
Nine Months Ended
September 30, 2021 |
Year Ended
December 31, 2020 |
|||||||
Balance at beginning of period
|
$ | 204 | $ | 234 | ||||
Increase in warranty accrual
|
— | 19 | ||||||
Change in liability for
pre-existing
warranties
|
— | 4 | ||||||
Claims satisfied
|
(9 | ) | (53 | ) | ||||
|
|
|
|
|||||
Total accrued warranty
|
$ | 195 | $ | 204 | ||||
|
|
|
|
Years Ending December 31,
|
||||
2021 (remaining three months)
|
$ | 132 | ||
2022
|
432 | |||
2023
|
445 | |||
2024
|
459 | |||
2025
|
472 | |||
2026
|
486 | |||
Thereafter
|
501 | |||
|
|
|||
Total operating lease payments
|
2,927 | |||
Less: imputed interest
|
(572 | ) | ||
|
|
|||
Total operating lease liabilities
|
$ | 2,355 | ||
|
|
Stock
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Life
(in years)
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||||||||
Outstanding at December 31, 2020
|
124,171 | $ | 363.31 | 6.42 | ||||||||||||
Forfeited
|
(15,173 | ) | $ | 87.28 | ||||||||||||
|
|
|||||||||||||||
Outstanding at September 30, 2021
|
108,998 | $ | 401.74 | 4.82 | $ | — | ||||||||||
|
|
|||||||||||||||
Exercisable at September 30, 2021
|
95,096 | $ | 455.95 | 4.32 | $ | — | ||||||||||
|
|
|||||||||||||||
Vested and expected to vest at September 30, 2021
|
108,998 | $ | 401.74 | 4.80 | $ | — | ||||||||||
|
|
Stock
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Life
(in years)
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||||||||
Outstanding at December 31, 2020
|
18,000 | $ | 25.50 | 9.24 | ||||||||||||
|
|
|||||||||||||||
Outstanding at September 30, 2021
|
18,000 | $ | 25.50 | 8.50 | $ | — | ||||||||||
|
|
|||||||||||||||
Exercisable at September 30, 2021
|
6,750 | $ | 25.50 | 8.50 | $ | — | ||||||||||
|
|
|||||||||||||||
Vested and expected to vest at September 30, 2021
|
18,000 | $ | 25.50 | 8.50 | $ | — | ||||||||||
|
|
Restricted
Stock Units
|
Weighted
Average
Grant Date
Fair Value
|
|||||||
Outstanding at December 31, 2020
|
33,548 | $ | 21.93 | |||||
Granted
|
29,614 | $ | 3.99 | |||||
Vested
|
(1,845 | ) | $ | 64.80 | ||||
Forfeited
|
(15,485 | ) | $ | 14.67 | ||||
|
|
|||||||
Outstanding at September 30, 2021
|
45,832 | $ | 11.06 | |||||
|
|
Restricted
Stock Awards |
Weighted
Average
Grant Date
Fair Value
|
|||||||
Outstanding at December 31, 2020
|
286,161 | $ | 4.77 | |||||
Granted
|
103,939 | $ | 4.82 | |||||
Vested
|
(31,388 | ) | $ | 6.96 | ||||
Forfeited
|
(50,082 | ) | $ | 5.10 | ||||
|
|
|||||||
Outstanding at September 30, 2021
|
308,630 | $ | 4.51 | |||||
|
|
Restricted Stock
Awards
|
Weighted
Average
Grant Date
Fair Value
|
|||||||
Outstanding at December 31, 2020
|
4,375 | $ | 25.50 | |||||
Vested
|
(625 | ) | $ | 25.50 | ||||
|
|
|||||||
Outstanding at September 30, 2021
|
3,750 | $ | 25.50 | |||||
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Selling, general and administrative
|
$ | 78 | $ | 757 | $ | 1,551 | $ | 2,424 | ||||||||
Research and development
|
27 | 115 | 251 | 317 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Stock-based compensation in operating expenses
|
$ | 105 | $ | 872 | $ | 1,802 | $ | 2,741 | ||||||||
|
|
|
|
|
|
|
|
Amount Paid
or to Be Paid
|
||||
SEC registration fee
|
$ | 3,838 | ||
FINRA filing fee
|
2,300 | |||
Printing expenses
|
20,000 | |||
Legal fees and expenses
|
420,000 | |||
Accounting fees and expenses
|
250,000 | |||
Other fees and expenses
|
53,862 | |||
|
|
|||
Total
|
$ | 750,000 | ||
|
|
(a) |
Reference is made to the attached Exhibit Index.
|
(b) |
No financial statement schedules are provided because the information called for is not required or is shown in the financial statements or the notes thereto.
|
(a) |
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
|
(b) |
The undersigned registrant hereby undertakes:
|
(1) |
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
(i) |
To include any prospectus required by Section 10(a)(3) of the Securities Act;
|
(ii) |
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;
|
(iii) |
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
|
(2) |
That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
(3) |
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
|
(4) |
That, for the purpose of determining liability under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
|
(i) |
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424 (§230.424 of this chapter);
|
(ii) |
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
|
(iii) |
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
|
(iv) |
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
(5) |
That, for purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
|
(6) |
That, for the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |||||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
104* | Cover Page Interactive Data File (formatted as Inline XBRL) |
* |
Filed herewith.
|
+ |
Indicates a management contract or compensatory plan.
|
^ |
Previously filed.
|
RA MEDICAL SYSTEMS, INC.
|
||
By: |
/s/ Jonathan Will McGuire
|
|
Name: | Jonathan Will McGuire | |
Title: | Chief Executive Officer |
Signature
|
Title of Capacities
|
Date
|
||
/s/ Jonathan Will McGuire
Jonathan Will McGuire
|
Director and Chief Executive Officer
(Principal Executive Officer)
|
January 25, 2022 | ||
/s/ Andrew Jackson
Andrew Jackson
|
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
|
January 25, 2022 | ||
*
Martin Colombatto
|
Chairman of the Board of Directors | January 25, 2022 | ||
*
Richard Mejia, Jr.
|
Director | January 25, 2022 | ||
*
Joan Stafslien
|
Director | January 25, 2022 | ||
*
Susanne Meline
|
Director | January 25, 2022 |
*By: |
/s/ Jonathan Will McGuire
|
|
Jonathan Will McGuire | ||
Attorney-in-fact
|
1 Year Ra Medical Systems Chart |
1 Month Ra Medical Systems Chart |
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