UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT
TO SECTION 13 OR 15(D)
OF THE SECURITIES AND EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): May 7, 2015
HANSEN MEDICAL, INC.
(Exact name of registrant as specified in charter)
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Delaware |
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001-33151 |
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14-1850535 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
800 East Middlefield Road
Mountain View, California 94043
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (650) 404-5800
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. |
Results of Operations and Financial Condition. |
On May 7, 2015, Hansen Medical,
Inc. issued a press release announcing its financial results for the quarter ended March 31, 2015. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
The information in this current report and in the accompanying exhibit shall not be deemed to be filed for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and
in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Hansen Medical, Inc, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit
No. |
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Description |
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99.1 |
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Press release, dated May 7, 2015, entitled Hansen Medical Reports First Quarter 2015 Results and Business Update. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized.
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HANSEN MEDICAL, INC.
(Registrant) |
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Date: May 7, 2015 |
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/S/ CHRISTOPHER P. LOWE |
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Christopher P. Lowe |
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Interim Chief Financial Officer (Principal
Financial and Accounting Officer) |
Exhibit 99.1
Hansen Medical Reports First Quarter 2015 Results and Business Update
MOUNTAIN VIEW, CA May 7, 2015 Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today reported
recent business highlights and financial results for the first quarter ended March 31, 2015.
First Quarter 2015 Operating Results:
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The Company reported revenues of $5.8 million in the first quarter, up 57% over the same period in the prior year. |
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The Company sold five Magellan Robotic Systems in the first quarter of 2015 compared to two robotic systems in the first quarter of 2014. |
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The volume of catheters sold was up 22% in the first quarter over the same period in the prior year. |
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Physicians performed an estimated 891 procedures in the first quarter, up 8%, over the same period in 2014. |
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Gross margin was 20% for the first quarter 2015, an increase of 9% compared to 11% for the first quarter in 2014. Non-GAAP gross margin was 21% in the first quarter, an increase of 9% compared to 12% for the first
quarter in 2014. Diluted EPS was ($0.09) in the first quarter 2015, compared to ($0.14) for the first quarter of 2014. Non-GAAP diluted EPS was ($0.07) in the first quarter, compared to ($0.13) for the same period in 2014. |
Recent Business Highlights:
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Hansen and China National Medical Device Co., Ltd. announced an exclusive distribution agreement for commercial activities for the Magellan Robotic System in China. The agreement is with China National Medical
Device Co., Ltd. (CMIC), a subsidiary of China National Scientific Instruments and Material Corp., which reports into SINOPHARM, Chinas largest Pharmaceutical and Healthcare Group. CMIC is responsible for obtaining all regulatory approvals
from the Chinese regulatory agencies. CMIC reported approximately $1.3 billion in 2013 revenue and reported the largest nationwide medical device sales network, covering more than 20 provinces in China. |
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The Companys Magellan 10Fr Robotic Catheter has received European Conformity (CE) Marking for use in the peripheral vasculature. Achieving this milestone allows the company to market and sell the Magellan
10Fr Robotic Catheter in Europe and other countries that require the CE Mark. |
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The Company announced FDA approval of an expanded protocol for the ARTISAN-AF IDE study. The amended protocol now includes the use of the Thermocool® SmartTouch® Catheter (BioSense Webster, Diamond Bar, CA) and the EnSite Velocity Cardiac Mapping System (St. Jude Medical, St. Paul, MN). These technologies are used in conjunction with the Sensei® Robotic System to complete ablation procedures for the treatment of paroxysmal atrial fibrillation per the IDE study protocol. |
We are committed to further expand and grow the utility of our robotic platforms, maintain our leadership position in R&D and
continue to reduce our burn rate, said Cary Vance, Hansen Medicals Chief Executive Officer. The Companys burn rate was $8.0 million in the first quarter of 2015, compared to a $9.9 million for the fourth quarter of 2014 and
compared to $10.9 million for the same period in 2014.
On March 11, 2015, the Company completed a private placement transaction and
raised $35.0 million in gross proceeds from the sale of 53,846 shares of convertible preferred stock at a per share price of $650. Each share of preferred stock will be convertible into the number of shares of Common Stock equal to the number
obtained by dividing (i) the sum of $650 and the amount of any accrued but unpaid dividends by (ii) the lesser of $0.65 and the per share trailing weighted average share price of the Common Stock on NASDAQ for the ten trading days ending
on the day prior to conversion, subject to customary anti-dilution adjustments. Investors also received warrants to purchase 53,846,000 shares of Common Stock with an exercise period of two years from the date of issuance. The exercise price for the
warrants will be the lesser of $0.975 per share or a 50% premium on the per share trailing volume weighted average share price of the Common Stock on NASDAQ for the ten trading days ending on dates specified in the form of warrants filed with the
SEC. The conversion of the preferred stock occurs automatically upon receipt of shareholder approval to, among other things, increase the number of authorized shares of Common Stock of the Company, and other proposals being presented to the
shareholders for vote at the annual shareholder meeting on May 12, 2015.
1
In addition to the purchase price paid for the preferred stock at closing, additional proceeds from the exercise of the warrants, if and when exercised, could total up to an additional $52.5
million, which would result in total gross proceeds to the Company of up to $87.5 million, before transaction costs. The exercise of certain of the warrants is predicated on receipt of shareholder approval. The proceeds from this transaction will be
used to support Hansen Medicals commercialization efforts with respect to the Magellan Robotic System, drive further adoption of the Sensei® Robotic System, and strengthen our
operations.
First Quarter of 2015 Financial Results:
Total revenue for the first quarter of 2015 was $5.8 million, an increase of 57% compared with $3.7 million for the same period in 2014. The Company
shipped five Magellan Systems in the quarter compared to two robotic systems (1 Magellan System and 1 Sensei System) in the first quarter of 2014. The Company sold 837 catheters in the first quarter of 2015, up 22% over the same period in 2014.
Gross profit increased by $0.8 million in the first quarter of 2015 compared to same period in 2014, and gross margin improved to 20% of revenue for the first
quarter of 2015, an increase of 9%, compared to 11% for the same period in 2014. The increases in gross profit and gross margin were primarily driven by the increase in robotic systems and catheter sales, improved absorption rates due to higher
production levels and lower product testing costs.
Research and development expenses for the first quarter of 2015 were $3.4 million, compared to
$4.4 million for same period in 2014. The decrease of $1.0 million was primarily due to a decrease in consulting costs, a decrease in expenses associated with clinical trials and development of prototype materials.
Selling, general and administrative expenses for the first quarter of 2015 were $6.7 million, compared to $9.2 million for the same period in
2014. The decrease of $2.5 million was primarily due to an overall reduction in corporate cost initiatives as the Company continued to focus on improving the Companys operating expenses, a decrease in overall employee compensation and
related costs, a decrease in legal and consulting fees, and a decrease in marketing vendor costs.
Net loss for the first quarter of 2015 was $11.9
million, or $(0.09) per share, compared to a net loss of $14.4 million, or $(0.14) per share, for the same period in 2014. Weighted average shares outstanding used to compute diluted net loss per share were 133.4 million shares for the
first quarter of 2015, compared to 103.3 million shares in the same period in 2014.
The Companys total balances in cash, cash equivalents,
short-term investments and restricted cash were $58.6 million as of March 31, 2015 compared to $31.9 million as of December 31, 2014.
Non-GAAP Information
To supplement our consolidated
financial statements, which are prepared in accordance with accounting principles generally accepted in the United States (GAAP), we use certain non-GAAP financial measures: non-GAAP cost of revenues, non-GAAP gross margin, non-GAAP loss
from operations, non-GAAP net loss, and non-GAAP diluted net loss per common share (EPS). The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial
information prepared and presented in accordance with GAAP and may be different from non-GAAP measures used by other companies. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on
any single financial measure.
We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate
period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and liquidity by excluding non-cash charges, such as share-based compensation expenses and other
special items. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance. These non-GAAP financial measures also facilitate managements internal comparisons to our
historical performance and liquidity as well as comparisons to our competitors operating results.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the global leader in Intravascular Robotics, developing products and technology designed to enable
the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Companys Magellan Robotic System, Magellan Robotic Catheter, Magellan 6Fr Robotic Catheter, and related accessories are
intended to facilitate navigation to 9Fr anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Companys mission is to enable Cardiac Arrhythmia and Endovascular
Procedures and to improve patient outcomes through the use of Intravascular Robotics. Additional information can be found at www.hansenmedical.com.
2
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than
statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words plan, continue, expects, potential, believes,
goal, estimate, anticipates, and other similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks,
uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include
statements regarding user experiences, utilization and the business environment. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating
to engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and
economic conditions on capital spending by our potential customers; the rate of adoption of our systems and the rate of use of our catheters; our ability to manage expenses and cash flow, and obtain adequate financing; and other risks more fully
described in the Risk Factors in our annual report on Form 10-K for the year ended December 31, 2014, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange
Commission. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future,
even if new information becomes available.
Artisan Extend, Hansen Medical, Hansen Medical (with Heart Design),
Heart Design (Logo), Sensei, Lynx, Artisan, Instinctive Motion, Fine Force Technology, IntelliSense are registered trademarks, and Magellan and
Hansen Medical Magellan are trademarks of Hansen Medical, Inc. in the U.S. and other countries.
Investor Contacts:
Hansen Medical, Inc.
650.404.5836
investor_relations@hansenmedical.com
3
HANSEN MEDICAL, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
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Three months ended March 31, |
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2015 |
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2014 |
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Revenues: |
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Product |
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$ |
4,474 |
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$ |
2,352 |
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Service |
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1,320 |
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1,347 |
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Total revenues |
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5,794 |
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3,699 |
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Cost of revenues: |
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Product |
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3,896 |
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2,744 |
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Service |
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742 |
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557 |
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Total cost of revenues |
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4,638 |
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3,301 |
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Gross profit |
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1,156 |
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398 |
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Operating expenses: |
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Research and development |
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3,435 |
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4,415 |
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Selling, general and administrative |
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6,702 |
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9,161 |
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Total operating expenses |
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10,137 |
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13,576 |
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Loss from operations |
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(8,981 |
) |
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(13,178 |
) |
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Warrant expense |
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(1,676 |
) |
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Interest and other expense, net |
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(1,267 |
) |
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(1,249 |
) |
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Loss before income taxes |
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(11,924 |
) |
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(14,427 |
) |
Income tax expense |
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(9 |
) |
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(18 |
) |
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Net loss |
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$ |
(11,933 |
) |
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$ |
(14,445 |
) |
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Basic net loss per common share |
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$ |
(0.09 |
) |
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$ |
(0.14 |
) |
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Diluted net loss per common share |
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$ |
(0.09 |
) |
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$ |
(0.14 |
) |
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Weighted average shares used to compute basic net loss per common share |
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133,283 |
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103,334 |
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Weighted average shares used to compute diluted net loss per common share |
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133,374 |
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103,334 |
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4
HANSEN MEDICAL, INC.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
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March 31, 2015 |
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December 31, 2014 |
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ASSETS |
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Cash, cash equivalents and short-term investments |
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$ |
53,276 |
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$ |
26,501 |
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Accounts receivable, net |
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3,745 |
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5,121 |
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Inventories |
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10,192 |
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11,492 |
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Prepaids and other current assets |
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1,513 |
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1,678 |
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Property and equipment, net |
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2,823 |
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2,328 |
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Restricted cash |
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5,362 |
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5,376 |
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Other assets |
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732 |
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1,179 |
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Total assets |
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$ |
77,643 |
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$ |
53,675 |
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS EQUITY (DEFICIT) |
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Accounts payable |
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$ |
2,828 |
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$ |
2,534 |
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Deferred revenue |
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3,011 |
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3,527 |
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Warrant liability |
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16,452 |
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Debt |
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34,227 |
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34,385 |
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Other liabilities |
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5,103 |
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5,460 |
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Total liabilities |
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61,621 |
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45,906 |
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Series A convertible preferred stock |
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19,742 |
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Total stockholders equity (deficit) |
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(3,720 |
) |
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7,769 |
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Total liabilities, convertible preferred stock and stockholders equity (deficit) |
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$ |
77,643 |
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$ |
53,675 |
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5
HANSEN MEDICAL, INC.
Reconciliation of GAAP to Non-GAAP Financial Measures
(In thousands, except gross margin and per share data)
(Unaudited)
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Three months ended |
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March 31, 2015 |
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March 31, 2014 |
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Total revenues, GAAP = Non-GAAP basis: |
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$ |
5,794 |
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$ |
3,699 |
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Cost of revenues reconciliation: |
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GAAP cost of revenues |
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$ |
4,638 |
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$ |
3,301 |
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Share-based compensation expense |
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<a> |
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(47 |
) |
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(43 |
) |
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Non-GAAP cost of revenues |
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$ |
4,591 |
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$ |
3,258 |
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Gross margin reconciliation: |
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GAAP gross margin |
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20 |
% |
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11 |
% |
Share-based compensation expense |
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1 |
% |
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1 |
% |
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Non-GAAP gross margin |
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21 |
% |
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12 |
% |
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Loss from operations reconciliation: |
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GAAP loss from operations |
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$ |
(8,981 |
) |
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$ |
(13,178 |
) |
Share-based compensation expense |
|
|
<a> |
|
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|
610 |
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|
757 |
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Executive transition and employee separation |
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<b> |
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|
115 |
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|
499 |
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Non-GAAP loss from operations |
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$ |
(8,256 |
) |
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$ |
(11,922 |
) |
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Net loss reconciliation: |
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GAAP net loss |
|
|
|
|
|
$ |
(11,933 |
) |
|
$ |
(14,445 |
) |
Share-based compensation expense |
|
|
<a> |
|
|
|
610 |
|
|
|
757 |
|
Executive transition and employee separation |
|
|
<b> |
|
|
|
115 |
|
|
|
499 |
|
Warrant expense |
|
|
<c> |
|
|
|
1,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Non-GAAP net loss |
|
|
|
|
|
$ |
(9,532 |
) |
|
$ |
(13,189 |
) |
|
|
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|
|
|
|
|
|
|
|
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|
Diluted net loss per common share reconciliation: |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted net loss per common share |
|
|
|
|
|
$ |
(0.09 |
) |
|
$ |
(0.14 |
) |
Non-GAAP diluted net loss per common share |
|
|
|
|
|
$ |
(0.07 |
) |
|
$ |
(0.13 |
) |
Shares used in per common share calculation (diluted): |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Weighted average shares used to compute diluted net loss per common share |
|
|
|
|
|
|
133,374 |
|
|
|
103,334 |
|
|
|
|
Notes |
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<a> |
|
Stock-based compensation expense, a non-cash charge. |
<b> |
|
The executive transition and employee separation represented continuous effort to align with the Companys strategy to maintain a lean workforce. |
<c> |
|
Represents an increase in fair value of Series E warrants, a non-cash charge. |
6
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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